Study supporting the impact assessment of the revision of the plant and forest reproductive material legislation : final report.
Date: 2023-02-03
Institutions: Directorate-General for Health and Food Safety
Subjects: EU Member State, forest, forest conservation, legislation, plant propagation, seed, silviculture

Study supporting the Impact 
Assessment of the revision of 
the plant and forest 
reproductive material 
legislation 

Final report

Written by ICF 
For the Directorate General For Health and Food Safety 
October 2022 

DG SANTE 

 
 
 
 
 
 
 
 
 
 
 
EUROPEAN COMMISSION 

Directorate General for Health and Food Safety 
Directorate G — Crisis preparedness in food, animals and plants 
Unit G.1 – Plant health 

E-mail: SANTE-G1-PLANT-HEALTH@ec.europa.eu 

European Commission 
B-1049 Brussel

 
 
 
 
 
 
 
PROJECT TEAM 

Rupert HAINES 
Elta SMITH 
Eszter Viktoria KANTOR 

LEGAL NOTICE 

This document has been prepared for the European Commission however it reflects the views only of the 
authors, and the European Commission is not liable for any consequence stemming from the reuse of this 
publication. More information on the European Union is available on the Internet (http://www.europa.eu). 

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ISBN: 978-92-76-99310-0 

doi: 10.2875/4381 

EW-04-23-093-EN-N 

Manuscript completed in October 2022 

Luxembourg: Publications Office of the European Union, 2023 

© European Union, 2023 

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How to cite this report: European Commission, Directorate-General for Health and Food Safety, Haines, R., 

Smith, E. and Kantor, E.V., Study supporting the Impact Assessment of the revision of the plant and forest 

reproductive material legislation : final report, Publications Office, 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

Contents 

Acronyms and abbreviations .............................................................................. 6 
Abstract .......................................................................................................... 7 
Executive summary .......................................................................................... 8 

Study methodology ........................................................................................ 8 
Policy options ................................................................................................ 8 
Conclusions ................................................................................................ 10 

1 

Introduction ............................................................................................. 11 

1.1 
Political and legal context .................................................................... 11 
1.2  Objectives of the study ....................................................................... 12 
1.3  Methodology ...................................................................................... 12 

1.3.1 
1.3.2 
1.3.3 
1.3.4 
1.3.5 

Preliminary research ..................................................................... 12 
Desk Research ............................................................................. 13 
Field Research ............................................................................. 13 
Case study and QCA ..................................................................... 14 
Assessment of costs and impacts .................................................... 14 

1.4 

Strengths and limitations of the method ................................................ 15 

2  Problem definition ..................................................................................... 15 

2.1  Divergent implementation by Member States results in different conditions for 
operators across Member States .................................................................... 15 
2.2  Disproportionate burdens for certain activities ........................................ 20 
Reduced efficiency and effectiveness of processes and procedures ............. 22 
2.3 
2.4 
PRM/FRM legislation is not aligned with European Green Deal objectives and 
related strategies ........................................................................................ 24 

3  The case for EU action ............................................................................... 29 
4  Objectives of EU policy intervention ............................................................. 30 
5  Policy options ........................................................................................... 30 

5.1 

Baseline scenario ............................................................................... 31 

5.1.1 
5.1.2 
5.1.3 
5.1.4 
security, sustainable production and biodiversity protection ............................ 39 

Differences between MS in PRM & FRM marketing ............................. 31 
Ensuring diversity of PRM & FRM choice and quality ........................... 32 
Innovation and competitiveness of the EU PRM & FRM industry ........... 37 
Contribution to EU objectives regarding climate change impacts, food 

5.2  Overview of policy options ................................................................... 43 

5.2.1 
5.2.2 
5.2.3 

Option 1: ‘Highest flexibility’ .......................................................... 43 
Option 2: Balancing flexibility and harmonisation .............................. 49 
Option 3: ‘Highest harmonisation’ ................................................... 51 

6 

Impacts of the policy options and specific measures ....................................... 52 

6.1 

Economic .......................................................................................... 53 

6.1.1 
6.1.2 
6.1.3 
6.1.4 
6.1.5 
6.1.6 

Administrative burdens on business (and other operators) ................. 53 
Sectoral competitiveness, trade and investment flows ....................... 59 
Conduct of business ...................................................................... 61 
Innovation and research ................................................................ 66 
Technological development / digital economy ................................... 67 
Intellectual property rights ............................................................ 67 

 
 
Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

Fraud ......................................................................................... 68 
6.1.7 
Position of SMEs ........................................................................... 69 
6.1.8 
6.1.9 
Functioning of the internal market .................................................. 72 
6.1.10  Public authorities (and budgets) ..................................................... 73 

6.2 
6.3 

Environmental impacts ........................................................................ 78 
Social impacts – consumers and households ........................................... 82 

7  Comparison of options ............................................................................... 82 

7.1 
7.2 
7.3 

Effectiveness ..................................................................................... 83 
Efficiency .......................................................................................... 86 
Coherence ......................................................................................... 88 

8  Conclusions .............................................................................................. 89 
9  Monitoring and evaluation framework .......................................................... 91 

9.1  Overview .......................................................................................... 91 
9.2  Monitoring at the Member State level .................................................... 92 
9.3  Monitoring at the EU level .................................................................... 93 

Annex 1  Study questions and specific measures ............................................... 95 
Intervention logic .......................................................................... 104 
Annex 2 
Annex 3 
Impact screening .......................................................................... 107 
Annex 4  Methodology ................................................................................. 114 
Annex 5  Evidence synthesis by study question ............................................... 124 
Annex 6  Consultation synopsis .................................................................... 214 
Annex 7  Open Public Consultation results ...................................................... 226 
Annex 8  Targeted survey results .................................................................. 281 
Annex 9  Focus groups ................................................................................ 376 
Annex 10 
in France.................. ................................................................................... 384 
Fruit and vine QCA ..................................................................... 390 
Annex 11 
References ................................................................................ 394 
Annex 12 
EU legislation and other EU instruments ........................................ 399 
Annex 13 

Case study: Experience with seed and plant exchanges between farmers 

5 

 
 
Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

Acronyms and abbreviations 

BMT 

CAC 

CAP 

CPVO 

CPVR 

Bio-molecular techniques 

Conformitas Agraria Communitatis 

Common Agricultural Policy 

Community Plant Variety Office 

Community Plant Variety Rights 

DG SANTE 

Directorate-General for Health and Food Safety 

DUS 

EC 

EEA 

Distinctiveness, uniformity and stability 

European Commission 

European Economic Area 

FOREMATIS 

Forest Reproductive Material Information System 

FGR 

FRM 

Forest genetic resources 

Forest reproductive material 

FRUMATIS 

Fruit Reproductive Material Information System 

FSS 

GDPR 

GMO 

GO 

IA 

Farm-saved seed 

General Data Protection Regulation  

Genetically modified organism 

General objective 

Impact assessment 

IMSOC 

Information management system for official controls 

IPCC 

ISTA 

IT 

MCA 

MS 

NCA 

NGO 

Intergovernmental Panel on Climate Change 

International Seed Testing Association 

Information technology 

Multi-criteria analysis 

Member state 

National Competent Authority 

Non-governmental organisation 

OECD 

Organization for Economic Co-operation and Development 

OC 

OCR 

PGR 

PRM 

PVR 

QCA 

RACER 

R&D 

RNQPs 

SCN 

SDGs 

SME 

SO 

TFEU 

UN 

VCU 

Official control 

Official Controls Regulation 

Plant genetic resources 

Plant reproductive material 

Plant variety rights 

Qualitative comparative analysis 

Relevant, accepted, credible, easy, robust 

Research and development 

Regulated non-quarantine pests 

Seed conservation network 

Sustainable development goals 

Small or medium sized enterprise 

Specific objective 

Treaty on the Functioning of the European Union 

United Nations 

Value for cultivation and use 

6 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

Abstract 

This impact assessment support study considers the impact of proposals for revision of 
the plant and forest reproductive material (PRM and FRM) legislation. The legislation 
applies to production for marketing purposes and the marketing of PRM and FRM 
within the Union. It consists of 12 Directives. 

The study considers the problem definition, case for EU action, objectives of policy 
intervention and baseline scenario. It assesses the potential impacts of three options, 
each including variations on up to 19 specific measures, being proposed by DG SANTE. 
The assessment was informed by desk research, an open public consultation, targeted 
surveys, interviews, case studies and focus groups. 

The assessment results are presented by impact type. A comparison of the options is 
undertaken through consideration of the effectiveness of each option in delivering the 
objectives, the efficiency of each option using multi-criteria analysis, and qualitative 
review of the coherence with other initiatives. General conclusions are provided as well 
as a proposed monitoring plan. 

7 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

Executive summary 

This is the final report of the Study supporting the Impact Assessment (IA) of the 
revision of the plant and forest reproductive material legislation. The study was 
commissioned by the Directorate-General for Health and Food Safety (DG SANTE) of 
the European Commission and delivered by ICF with support from a team of sector 
experts. 

Plant reproductive material (PRM) refers to plants and parts of plants used to produce 
entire plants, encompassing seeds, seedlings, plant cuttings and young plants. PRM is 
used in agriculture (e.g. food production), forestry (i.e. forest reproductive material, 
or FRM), and for ornamental or industrial purposes.  

Study methodology 

The study considered the underlying problems that have prompted the formation of 
three proposed options and an intervention logic was developed. Potential economic, 
environmental and social impacts for each option were identified and subsequently 
assessed.  

The study comprised a desk study and field research. It relied on various data and 
information collection approaches including literature review, a 12-week public 
consultation (2,449 responses), 43 stakeholder in-depth interviews, two focus group 
sessions, and targeted surveys (99 responses). Furthermore, a case study on in-kind 
exchange of PRM in France was undertaken. In addition, a qualitative comparative 
analysis of Member State experiences with conservation and amateur varieties of fruit 
and vine plants was carried out. Stakeholder groups consulted through these activities 
were National Competent Authorities (NCAs), breeders, PRM/FRM producers, traders, 
farmers and forest managers and their associations, NGOs and academics.  

Triangulation and evidence synthesis by study question and impact category was 
undertaken. This served as the basis for comparative analysis of the options to assess 
the effectiveness, efficiency (using multi-criteria analysis, MCA) and coherence of the 
options.  

The main limitations of the study are a lack of data on aspects of the baseline scenario 
and data to support the impact assessment. Despite considerable efforts undertaken 
in this study (and in previous studies) to collect relevant data from across the EU, 
gaps remain. There is a general lack of quantitative data on issues of market size and 
costs. Consultation questions that sought this information received very low response 
rates and stakeholder replies to the consultations were quite polarised. This affected 
the extent to which firm conclusions could be drawn on the relative impacts of 
different measures and related elements of the options.  

Policy options 

Three policy options were assessed against a do nothing ‘baseline’ option.  

The baseline option is the ‘reference scenario’ describing what is expected to happen 
in the absence of new EU intervention on the legislation. There are currently 11 
Directives that apply to PRM, and one which applies to FRM. Divergent implementation 
of the legislation by Member States results in different conditions for operators across 
Member States and for products marketed in different Member States, with the risk 
that activities are duplicated, inconsistent rules applied to the same materials and 
different rules applied to similar procedures that negatively impact the market. There 
are disproportionate burdens for registration and marketing of conservation and 
organic varieties, leading to high administrative, production and marketing costs for 

8 

 
Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

such varieties. There are also issues with the efficiency and effectiveness of processes 
and procedures resulting from the legislation. The PRM/FRM legislation is not aligned 
with the European Green Deal objectives and related strategies, resulting in 
insufficient PRM and FRM to address sustainability, biodiversity and climate change 
objectives. The legislation furthermore has not kept pace with technological and 
scientific developments. It thus creates uncertainty about the use or even prevents 
the use of bio-molecular techniques, innovative production methods and digital 
solutions.  In the absence of legislative revision, these issues are expected to persist.  

Option 1 (‘highest flexibility’) aims to maximise flexibility in the implementation of the 
PRM/FRM policy instruments. Option 1 would contribute to harmonisation in the 
internal market by introducing proportionate rules for PRM/FRM and providing 
clarifications to operators regarding legislative provisions and implementation 
mechanisms. Activities of seed conservation networks and exchange in kind of seed 
would be facilitated by being exempted from the scope of legislation but this could 
weaken the quality of products on the market. Measures under Option 1 include lighter 
registration requirements for conservation varieties, including fruit plants and vine, 
which can contribute to biodiversity targets. As regards the sustainability assessment 
of new varieties the current rules for value for cultivation and use (VCU) examination 
would only be harmonised for agricultural species. Under Option 1, registration of 
organic varieties would rely on derogations for Distinctness, Uniformity and Stability 
(DUS) and VCU testing. Rules for official controls on PRM and FRM are better defined 
in relation to the type and frequencies of controls and harmonised across policy 
instruments without links to the Official Controls Regulation (OCR). Finally, basic 
principles on digitalisation, bio-molecular techniques and innovative production 
processes would be introduced. 

Option 2 (‘balance flexibility and harmonisation’) seeks to balance the needs for 
flexibility and harmonisation in the implementation of the PRM policy instruments. 
Instead of exemptions under Option 1, it provides for lighter rules to facilitate the 
activities of seed conservation networks and exchange in kind of seed. Sustainability 
related criteria would be strengthened in the acceptance of new varieties for all crops, 
but Member State authorities would retain the flexibility to adapt these to local agro-
ecological conditions. To promote the availability of organic varieties suitable for 
organic production, Option 2 defines a clear framework for the registration of such 
varieties, with adjusted DUS and VCU requirements. Option 2 extends the scope of the 
FRM legislation to cover the production of FRM for non-forestry purposes. It also 
introduces contingency planning principles for FRM as well as sustainability criteria and 
principles with flexible implementation mechanisms ensuring that Member State 
specific geographic and climate conditions can be taken into consideration during 
implementation. Under Option 2 a tailor-made approach to official controls within the 
framework of the OCR is introduced but rules and substantial requirements on PRM 
and FRM certification would remain in the PRM and FRM legislation. As in Option 1, 
basic principles on digitalisation, bio-molecular techniques and innovative production 
processes would be introduced. 

Option 3 (‘highest harmonisation’) is the most integrated of the three policy options 
and aims for the highest level of harmonisation. Differences would be minimised in 
terms of how the rules are applied in different circumstances. Option 3 retains the 
status quo in terms of marketing requirements for all products. Sustainability 
assessment of new varieties for all crops is introduced with full harmonisation between 
Member States. Under Option 3 official controls rules for PRM and FRM would be fully 
included within the scope of the OCR. As for organic varieties, Option 3 would go a 
step further than Options 1 and 2 by defining detailed variety registration 

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Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

requirements. Option 3 also introduces detailed rules on digitalisation, bio-molecular 
techniques and innovative production processes.  

Conclusions 

Under Option 1, cost increases are expected to arise for both operators and NCAs 
primarily related to legislative compliance and testing. In terms of promoting 
sustainability criteria in examination of new varieties the option merely retains the 
status quo and does not adequately support wider European environmental and 
sustainability targets. In support of stakeholders, the option introduces principles on 
digitalisation and innovative techniques, facilitating the flexible uptake of digital 
solutions without requiring the implementation of specific solutions and allowing 
stakeholders to adopt these measures according to the availability of resources. 
Option 1 promotes coherence in comparison to the baseline, but to a lesser extent 
than the other options. 

Option 2 could promote stronger coherence in implementation between Member 
States than under Option 1, particularly given the current misalignment between the 
controls regime for plant health, organic production and genetically modified 
organisms (which are all included in the OCR) and the controls regime for PRM and 
FRM. This would increase the efficiency of operation for competent authorities. As 
under the Option 1, cost increases are expected to arise for both operators and NCAs 
primarily related to legislative compliance and testing costs. Under this option, lighter 
rules for certain activities instead of total exemption under Option 1 would result in a 
higher level of traceability. 

Option 3 by introducing more detailed rules would achieve highest harmonisation. 
However this would reduce flexibility in implementation that could be 
counterproductive for achieving the set objectives as regards sustainability, 
biodiversity and climate change. Detailed rules could also constrain the potential for 
innovation. Costs are expected to be highest under Option 3 and may 
disproportionately impact SMEs. 

The analysis has found that overall Option 2 aligns the closest with the identified 
objectives. Option 2 also performed best in the MCA. Measures under Option 2 
introduce the required legislative clarifications for certification, registration and 
production. The option also protects the quality of products and supports 
competitiveness of European businesses. Flexible measures would allow Member 
States to adopt and adjust implementation according to their environmental 
sustainability targets, local characteristics as well as available resources. All legislative 
changes are likely to increase compliance costs for stakeholders and this may 
disproportionately affect SMEs. A significant share of cost increases can be linked to 
the time it takes for stakeholders to understand the new regulatory provisions and 
adjust their procedures to remain compliant. Compliance among operators, specifically 
SMEs, could be facilitated by an appropriate transition period. 

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Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

1.  Introduction 

This is the final report of the Study supporting the Impact Assessment (IA) of the 
revision of the plant and forest reproductive material legislation. The study was 
commissioned by the Directorate-General for Health and Food Safety (DG SANTE) of 
the European Commission (EC) and is being delivered by ICF with support from a 
team of sector experts.  

The purpose of the study was to analyse the impacts that would result from EU actions 
to revise the PRM and FRM policy instruments. It involved the collection and analysis 
of quantitative and qualitative data on the expected significant economic, social and 
environmental impacts. The preparation of the report was guided by the methods and 
quality standards for impact assessment specified in the European Commission's 
Better Regulation guidelines and toolbox. 

1.1. 

Political and legal context 

Plant reproductive material (PRM) refers to plants and parts of plants used to produce 
entire plants, encompassing seeds, seedlings, plant cuttings and young plants. PRM is 
used in agriculture (e.g. food production), forestry (i.e. forest reproductive material, 
or FRM), and for ornamental or industrial purposes. EU PRM and FRM legislation 
applies to the production for marketing purposes and the marketing of PRM and FRM 
within the Union. It consists of 12 Directives.  

The stated objectives of the legislation when it was first introduced in the 1960s and 
70s was to improve agricultural productivity by supporting access to new and 
improved varieties of seeds and propagating material from high quality PRM lots. 
Harmonisation of rules across Member States was expected to support the internal 
market and sector competitiveness (EC 2008). The 12 Directives aim to guarantee the 
identity, health and quality of PRM and FRM marketed and sold within the EU. The PRM 
Directives set out requirements for registration of plant varieties in national and 
common catalogues and certification/inspection in PRM production. 

Eleven Directives apply to PRM and one applies to FRM. Of the 11 PRM Directives, 6 
cover seeds of agricultural plant species and vegetables, 4 cover plant propagating 
material (vegetables, fruit plants, vine, and ornamental plants) and 1 sets out the 
rules for acceptance of varieties of agricultural plant species in a common catalogue. 
FRM legislation has been developed as a specific part of the PRM legislation, with its 
own basic concepts and approaches that significantly differ from the other PRM 
sectors. The FRM legislation helps to identify FRM and specifies the requirements such 
as origin, health and resistance, wood quality, and outstanding characteristics to be 
met by trees that will be used for production of different types of FRM. 

The Commission submitted a proposal to replace the PRM Directives with a single 
Regulation in 2013 (EC 2013a). This responded to a need to ensure PRM legislation 
could support wider strategic EU goals in areas such as food security and safety, 
biodiversity, and climate change, among others.  

The proposal aimed to ensure consistent implementation of the legislation across 
Member States. It included enabling operators to carry out examination and inspection 
tasks under supervision by national competent authorities (NCAs) to increase flexibility 
and make niche PRM exempt from registration and certification requirements to 
support biodiversity. The role of the Community Plant Variety Office (CPVO) was to be 
expanded, for example, to maintain a centralised register of varieties. The 
Commission was to be empowered to adopt secondary acts with specific requirements 

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Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

on different PRM species and categories as part of the registration and certification 
requirements. 

This proposal was rejected by the European Parliament, due to concerns that, for 
example, a single Regulation could not properly address the requirements for different 
crop groups (types of PRM) and FRM, and regarding the quality of the corresponding 
impact assessment (European Parliament 2014). Subsequently, in 2019 the Council 
requested that the Commission deliver a study on possible options for updating the 
PRM legislation. The study was published in 2021 and identified a need for policy 
action (EC 2021a). This study was supported by a contractor’s report (EC et al. 2021). 
The present study supports an impact assessment of the potential legislative revisions. 

1.2. 

Objectives of the study 

The study addresses three main objectives: 

1.  Identify, collect and analyse data on the expected significant economic, social and 
environmental impacts in line with the quality standards and principles established 
in the EC’s Better Regulation Guidelines and Toolbox. 

2.  Collate appropriate additional quantitative and qualitative evidence that is 

pertinent to the study and the wider impact assessment. 

3.  Support the full IA of the revision of the PRM and FRM legislation by: 

  Refining the intervention logic presented in the Terms of Reference, linking 

problems, drivers, specific objectives, and policy options. 

  Assessing the impacts and trade-offs of the policy options and costs based on 

quantitative and qualitative data against a reference point (baseline) of no new 
EU action as described in the Inception Impact Assessment.  

  Assessing the impact of each policy option on overall legislative burdens by 

estimating, where appropriate, the impact of individual measures described in 
the IA questions on administrative burdens and compliance costs.  

  Comparing policy options.  

  Developing a monitoring and indicators framework. 

1.3. 

Methodology 

A summary of the study methodology is provided below and in more detail in Annex 4. 

1.3.1.  Preliminary research  

Preliminary desk and field research were undertaken by the study team to finalise the 
methodological approach during the study inception phase.  

Key documents were confirmed and reviewed to help assess the available secondary 
data and information that could be used as inputs to the impact assessment. 
Preceding studies were also reviewed to enable the study team to further refine the 
methodology. 

The study team conducted six exploratory interviews with stakeholders from 1 to 30 
November 2021 to obtain general views of the study context and approach to the 
impact assessment. Interviews were conducted with representatives from a plant 
breeding association, a forest nursery association, an organic plant breeding 
consortium, an association representing seed conservation networks (SCNs), an 
association representing the farming sector, and a National Competent Authority.  

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Study supporting the Impact Assessment of the revision of the plant and forest 
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The preliminary research, along with discussions with DG SANTE and internal analysis 
supported specification of the problem definition (section 2) and why the EU should 
act (section 3). It facilitated refinement of the study objectives (section 1.2), study 
questions and specific measures (Annex 1), policy options (section 5), intervention 
logic (Annex 2), and impact screening (Annex 3). 

1.3.2.  Desk Research 

The study draws on literature from a wide range of sources: governmental and 
intergovernmental bodies, scientists, industry bodies, NGOs, etc. The types of 
information reviewed include position papers, working documents, complaints, peer-
reviewed literature, case law and infringements, legislative texts, and a wide variety of 
studies and reports. An online database was set up to compile the information on the 
literature and data collected and was shared with DG SANTE to provide a basis for 
ongoing review and inputs. It was updated throughout the data collection phase of the 
study based on suggestions from stakeholders and through ongoing searches by the 
study team. 

1.3.3.  Field Research 

The field research complemented and supplemented the desk research. The field 
research task began with a stakeholder mapping to support the distribution of the 
surveys and identification of candidate interviewees and focus group participants. The 
field research tasks included a 12-week public consultation, targeted surveys, 43 in-
depth interviews, and 2 focus groups to gather views on certain aspects of the PRM 
and FRM legislative revision across all stakeholder groups. This was supported by a 
case study on in-kind exchange of PRM in France, and a qualitative comparative 
analysis (QCA) of Member State experiences with conservation and amateur varieties 
of fruit and vine.  

Public consultation: There were 2,449 responses to the public consultation. The 
majority of responses (78%, 1908 of 2449) were from EU citizens. Of the 541 
respondents who were not citizens, 37% (202 of 541) were from companies/business 
organisations. A majority of companies/business organisations (59%, 120 of 202) 
were micro enterprises (i.e. 1 to 9 employees). Over half of all public authority 
responses (54%, 29 of 54) were from national authorities. Amongst public authorities, 
Germany had by far the highest number of responses (18 of 54), with responses from 
national, regional and local authorities. The vast majority of respondents (99%, 2414 
of 2449) were based in the EU.  

Targeted survey: In total 99 responses were received. Business associations 
represented 26% (n=26) of those responses, individual businesses 21% (n=21), 
academic/research institutions 8% (n=8); NGOs 4% (n=4); and public authorities 
31% (n=31). Stakeholders who identified as belonging to the category of “other” (9%, 
n=9) included financial and educational institutions, intergovernmental bodies, 
foundations and other Member State government organisations (i.e., a research 
organisation and a ministry). Just under half (49%) of the 99 responses came from 
five countries: Austria (n=5), Belgium (n=8), France (n=13), Germany (n=12), and 
the Netherlands (n=11). Overall, at least one response was received from 
stakeholders in 23 EU Member States. The targeted consultation collected views from 
stakeholders engaged across the supply chain of both PRM and FRM products. Two-
thirds of respondents (n=74) answered PRM related questions, while 18% (n=18) 
responded to FRM questions; the remaining 7% responded to questions about both 
topics.  

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Study supporting the Impact Assessment of the revision of the plant and forest 
reproductive material legislation – Final report 

Interviews: In-depth interviews provided an opportunity to obtain more detailed and 
contextualised views on the issues facing stakeholders than was possible through 
surveys. A total of 43 stakeholders were interviewed: 30 interviews focused on PRM 
and 13 on FRM issues. Approximately half of those interviewed (18 of 43) were 
representatives of national competent authorities in EU Member States (12 on PRM 
and 6 on FRM issues). NCAs from 15 Member States were consulted (in 3 Member 
States 2 NCAs were interviewed – one each on PRM and FRM issues). A total of 14 
representative associations at EU or national level were interviewed (10 on PRM and 4 
on FRM). Civil society organisations (5 on PRM and 1 on FRM) and scientific networks 
(2 on plant genetic resources and 1 on forest genetic resources) participated. One 
interviewee represented an international organisation (The Organization for Economic 
Co-operation and Development (OECD)) and one represented an EU Agency (CPVO). 

Focus groups: Two focus groups were conducted. The first addressed the topic of 
marketing to amateur gardeners, in response to study question B1. Ten stakeholders 
participated in the event, representing national competent authorities (6), plant 
breeders associations (2), a seed savers association and a home gardeners 
association. The second focus group addressed FRM topics to support the answers to 
study questions F1 and F2. Seven stakeholders agreed to participate, however, on the 
day of the event only three stakeholders attended, and one stakeholder sent remarks 
via email. Participants represented NCAs (2) and an organisation working in the area 
of forest genetic resources.  

1.3.4.  Case study and QCA 

A case study was undertaken to explore the experience in France with in-kind 
exchange of PRM to support the answer to study question B2. The case study draws 
on academic literature and interviews. Eight interviews were completed with the NCA, 
a seed exchange network, seed producers (2), representatives of farmers’ unions (2), 
and researchers (2). 

A qualitative comparative analysis (QCA) on Member States’ experiences with 
conservation and amateur varieties of fruit plants and vine was also undertaken to 
support the answer to study question C.1. The QCA involved documenting the 
experience of Member States through a data collection protocol covering the reasons 
for different MS experiences (e.g. national legislation and market characteristics) and 
outcomes/effects (e.g. scale of production and marketing). Data was collected against 
these indicators in 17 Member States, whose selection was based on capturing 
geographical diversity and the main fruit and vine producers in Europe. However, not 
all Member States provided data that could be included in the analysis. The 13 
Member States for which data were analysed include Austria, Belgium, Croatia, 
Czechia, Denmark, Finland, Germany, Greece, Hungary, the Netherlands, Slovakia, 
Spain, and Sweden.   

1.3.5.  Assessment of costs and impacts 

The evidence collected through the desk and field research was drawn together to 
provide an assessment of the specific measures for each study question. The analysis 
brings the assessment for each measure together to analyse the effects of the 
measures collectively by impact category, and then for each option overall. The 
assessment involved:  

  Step 1: synthesis – within- and between-method, as well as data 

triangulation of all the primary data from the stakeholder consultation and 
secondary data from desk research addressing the corresponding research 
questions (Annex 5).  

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  Step 2: analysis of impacts, building on the triangulated evidence, to map 

the most relevant and likely impacts. These have been assessed (qualitatively, 
and quantitatively where possible) by impact category for each option (section 
6).  

  Step 3: comparative analysis:  The evidence was brought together to 

compare the policy options (section 7). 

  Step 4: monitoring framework: Development of indicators to monitor the 

preferred option (section 9). 

1.4. 

Strengths and limitations of the method 

The main limitations of this study are a lack of data on certain aspects of the baseline 
scenario (as described in section 5.1) and to support the impact assessment (as 
described in section 6). Despite considerable efforts undertaken in this study (and in 
previous studies) to collect relevant data from across the EU, gaps remain pertaining 
to market size and the costs related to the implementation of the PRM and FRM 
legislations as well as some of the operational costs of stakeholder groups including 
businesses and Member State authorities. Consultation questions that sought this 
information received very low response rates. In the analysis the study team drew on 
the data that is available to establish quantitative case examples and extrapolate to 
EU/stakeholder group level where appropriate, with assumptions and data 
transformations clearly documented. Stakeholder consultation often returned polarised 
views and/or limited specific differentiation between measures, which limits the extent 
to which firm conclusions can be drawn on the relative impacts of different measures 
and related elements of the options. 

2.  Problem definition 

An initial problem definition is provided in the Study on the Union’s options to update 
the existing legislation on the production and marketing of plant reproductive material 
(EC 2021a), the Inception Impact Assessment (EC 2021b) and the terms of reference 
of this study. The present study is tasked with verifying the problem definition. It 
draws on the evidence presented in EC et al. (2021), which updated the evidence base 
on the PRM legislation problem definition and the Inception Impact Assessment 
(2021b) that followed. Additional information was gathered through the desk research 
and consultation activities for this study. A summary problem tree is provided in 
Figure 1. It traces backwards from four problems [P] to the problem drivers [D] and 
from the problems to their consequences [C]. The following sections elaborate on 
these relationships. 

2.1. 

Divergent implementation by Member States results in 

different conditions for operators across Member States  

The first problem that the potential legislative revisions seek to address is the different 
market conditions that have developed across Member States due to divergent 
implementation of the legislation by Member States [P1]. There are three main drivers 
of this problem: outdated, incoherent and fragmented legislation [D1]; the application 
of the legislation by Member States to deviate or exempt from the rules in different 
ways [D2]; and the lack of well-defined EU rules for conducting official controls and 
enforcing the marketing legislation [D3]. Together these issues mean inconsistent 
rules applicable to the same material and different rules applicable to similar 
procedures [C1], which has negatively impacted the market by creating uneven 
conditions for operators between the different Member States [C2]. 

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Fragmentation and lack of coherence between the 12 Directives has occurred due to 
the evolution of the PRM legislation, which has been developed over several decades 
[D1]. For example, there are differences in the available instruments for the 
registration of conservation varieties of certain species (i.e. there are instruments 
available for conservation varieties of agricultural and vegetables crops, but not for 
fruit plants and vine). Definitions for ‘marketing’ and related exemptions (e.g. Dir 
66/402/EEC article 1a 2nd para) and who constitutes an ‘operator’ differ and are 
unclear or missing altogether in some Directives.  

Such differences leave margin to interpret the legislation in different ways and has led 
Member States to diverge in their implementation of the PRM legislation [D2]. Under 
Article 288 of the Treaty on the Functioning of the European Union (formerly Article 
249 TEC) Member States are free to implement the 12 Directives as they see fit to 
achieve the prescribed result. This has resulted in different requirements for operators 
and certain products. For example, some Member States allow DUS examination under 
official supervision while others do not. Some Member States use Commission 
Decision 2004/842/EC on not yet listed varieties for the multiplication of seed, while 
others use tests and trials. 

There are different rules for in-kind exchange of PRM between farmers, with a few 
Member States (Austria, France and Italy) and an EEA country (Norway) currently 
allowing in-kind exchanges whilst most prohibit them. In France, under Art.315-5 of 
the Code Rural, PRM exchange between farmers of varieties which are not protected 
by plant breeders’ rights are considered to be ‘mutual assistance’ (as opposed to a 
‘commercial activity’). PRM exchange is therefore not subject to regulations 
concerning seed marketing (The European Coordination Via Campesina 2021)

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  PRM legislative revision problem tree 

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Directives concerning agricultural conservation varieties (Directive 2008/62/EC) and 
vegetable varieties with no intrinsic value for commercial crop production but 
developed for growing under particular conditions (Directive 2009/145/EC) (hereafter 
referred to as ‘amateur varieties’) were introduced to facilitate the commercialisation 
of conservation varieties. They provide for derogations on procedures which would be 
required for conventional varieties. Lower registration fees may be applied (EC et al. 
2021). Official tests may not be required for registration of conservation and amateur 
varieties, subject to the applicant providing sufficient information about the variety 
(criteria for distinctness, uniformity and stability still apply for a description of the 
material) (Liveseed 2021a). These derogations come with marketing restrictions, such 
as quantitative limits on production (Directive 2010/60/EU, Article 14; Directive 
2009/145/EC; and Directive 2008/62/EC Article 14) and marketing restricted to the 
variety’s region of origin (Commission Directive 2009/145/EC: Article 4) which varies 
across Member States (EC et al. 2021). Some respondents to the public consultation 
(about half of responding NGOs, environmental organisations, and trade unions) 
thought that different implementation of the derogations has created unequal 
conditions across Member States (Q5b, Figure 52).  

The region of origin concept is ill-defined and interpreted differently across Member 
States, even for the same varieties (EC et al. 2021). Thirteen of 18 NCA survey 
respondents for the current study indicated that ‘local’ is defined in their country 
(Q65). Austria, France, Ireland, the Netherlands and Spain consider the whole country 
as the region of origin (Q66). In contrast, other Member States have a more restricted 
definition of local. In Italy the concept of “local” refers to a limited area, represented 
by a municipality or a limited group of neighbouring municipalities.  

In the case of conservation varieties, ‘local’ refers to the area where a variety was 
traditionally cultivated. ‘Local' can thus refer to a portion of a region or multiple 
regions. In Greece, local is defined as cultivated seed produced in the region of origin. 
Local is defined in Czechia in relation to conservation varieties only as a set of 
populations or clones of a plant species that are naturally adapted to the 
environmental conditions in their area. A slightly different approach is taken in 
Germany where specific decisions are made depending on applicants’ claims at the 
time of application. For example, wheat varieties that secure timely, productive 
harvests in the south are genetically more daylength insensitive than those in the 
north. Varieties adapted to either region perform poorly in the other. The federal 
authorities add both types to the national catalogue. This distinction can also apply for 
commercial varieties and exists in other countries such as France. 

Another area of difference is in how Member States conduct the examinations for 
value for cultivation or use (VCU), and particularly the method by which varieties are 
accepted or rejected. Some Member States use single key characteristics (particularly 
for species where the yield increase is not very high) to assess VCU results and thus 
account for regional specificities in climate (EC et al. 2021). Other Member States use 
an index weighting approach across multiple criteria. In some Member States, both 
approaches are taken (Q113).  

Similarly, there can be differences in the length of the testing process between 
Member States (EC et al. 2021). One example of this variance is the testing length for 
winter wheat which is 2 years in Estonia, France and Latvia but 3 years in Germany 
and Norway (Pedersen, 2012). This can be disadvantageous for breeders testing in 
countries with longer testing periods as there is a delay to market access.  Where 
testing is faster, there is potential for innovation to be taken advantage of and better 
varieties can be utilised for their desirable qualities more rapidly. Survey responses 
indicated that the longer duration of testing needed for a specific variety being 

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compared across Member States was a minor (13 of 27, 48%) or moderate problem 
(11 of 27, 41%) (Q89).  

It is recognised by farmers and breeders and reflected in the results of the targeted 
survey for this study, that VCU testing provides a marker of quality (Q90 and Q91) 
and impartial data which enables a level playing field as it helps to balance market 
power between large operators and SMEs (EC 2013b). MS NCA respondents of the 
targeted survey of this study stated that about 25-50% of variety applications are 
withdrawn annually due to their performance in VCU testing, which signals its 
beneficial impacts on quality protection for PRM varieties (Q91).  

At the same time, VCU testing requirements and the mandatory nature of testing for 
agricultural crop varieties results in high costs and high administrative burdens for 
both NCAs and operators (EC et al. 2021). Respondent to the targeted survey 
acknowledged these challenges, as 89% (24 out of 27 respondents) said the cost and 
duration of VCU testing is a moderate or minor problem (Q89). A previous PRM study 
(EC et al. 2021) found that 36% (25 out of 70) of survey respondents felt that these 
differences were a problem and undermined the EU level playing field. When asked 
more specifically about the issues 57% agreed or strongly agreed that the differences 
in registration/certification costs and cost recovery systems were a problem. VCU 
testing costs in each Member State depend on different factors including the 
complexity of the tests as well as the variety but can reach thousands of euros (Annex 
5, Table 31) (Pedersen 2012 and EC et al. 2021). In 2010 VCU testing for all crops 
across all Member States cost between EUR 30.25 million and EUR 33 million (EC 
2013b).  

VCU testing does not require specific sustainability criteria such as resilience to climate 
change or resource efficiency. However, some Member States have independently 
added sustainability criteria as an element of their VCU testing protocol while others 
do not include sustainability criteria at all. Where sustainability criteria are applied, 
their application varies between Member States (EC et al. 2021). This may increase 
the price of VCU tests in some Member States which is passed on to the buyers of PRM 
products but can also provide competitive advantages to breeders by providing 
assurance of greater climate resilience. A preceding study on the PRM sector (EC et al. 
2021) found that 53% (36 out of 68) of survey respondents believed that these 
differences in testing criteria were a problem.  

Results of the targeted survey showed that differences in the way Member States 
apply the testing requirements also create challenges for stakeholders (Q89). 
Differences in time taken for testing, availability of sustainability testing requirements 
and testing fees can contribute to cost variations and different stringency of variety 
testing in Member States.  These differences can create disadvantages for businesses, 
particularly for SMEs in some Member States. Larger operators are able to choose 
where they test their varieties as they often operate in multiple markets. This has 
become more exaggerated in recent years as the EU seed market has become more 
concentrated, particularly for agricultural crops. For example, five companies 
constitute 75% of the market share for maize crops and eight companies constitute 
99% of the market share for sugar beet (EC et al. 2021). Where these large 
corporations choose to run their testing could therefore have a significant impact on 
demand and finances for testing within different Member States. A lack of 
harmonisation creates a reason to choose between Member States for testing that 
goes beyond the benefits of testing under different climatic conditions. 

Finally, the PRM and FRM Directives themselves lack detailed provisions for conducting 
official controls and enforcing the marketing legislation [D3], with their focus primarily 

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on the technical criteria which are checked in the process of inspection, sampling and 
testing for operators to receive marketing certification and authorization for their 
products.  

Member States can therefore take different approaches towards the implementation of 
official controls in the context of the PRM legislation, due to differences in their 
interpretation of the rules (EC et al. 2021). The survey conducted for this study 
highlighted some of the differences in the way NCAs currently administer controls. For 
example, when asked for the percentage of imported PRM/FRM consignments on 
which they carried out official controls, around a third (8 of 25 NCAs) said 25% or less 
while a further third (9 NCAs) said over 75% (Q240). 

2.2. 

Disproportionate burdens for certain activities 

The second problem that the potential legislative revisions seek to address is the 
disproportionate burdens that the current legislation places on stakeholders to 
undertake some activities [P2]. There are three main drivers of this problem. First, the 
PRM legislation marketing rules are ‘one-size-fits-all’, applying to all operators 
regardless of their size and the extent of their activities [D4]. Furthermore, marketing 
rules and VCU testing are not adapted to the needs of organic cultivation [D5]. Finally, 
the variety registration process is time-consuming for some species [D6]. This results 
in a high administrative burden, and production and marketing costs for some 
varieties [C3]. 

Currently, the PRM legislation applies the same marketing rules to all operators [D4], 
where marketing covers any supply or transfer activity of seed aimed at commercial 
exploitation. These rules may be too stringent for some activities, including the work 
of SCNs, marketing to amateur gardeners, and in-kind exchange of PRM between 
farmers.  

Amateur gardeners and SCNs have different uses and motivations compared to 
professional users. Amateur gardeners typically engage in cultivation activities for 
their own use/consumption rather than for commercial gain. Nevertheless, they want 
assurance that the PRM they use meets minimum quality requirements regarding 
identity, germination rates and plant health. SCNs exchange and market PRM in 
limited amounts with the primary non-profit purpose of conserving plant and forest 
genetic resources (EC 2021a).  

PRM marketed to amateur gardeners and by SCNs is currently subject to the same 
“complex and rigid procedures” as PRM marketed to professional users (EC 2021a). 
The current PRM regulatory framework thus places an unnecessarily heavy cost 
burden on certain categories of operators dealing with the registration and marketing 
of varieties aimed at SCNs and amateur gardeners (especially new varieties, which are 
generally required to undergo a DUS test) (EC 2021b and survey results for this study 
Q134).  

In response to an open question (Q133), business respondents of the targeted survey 
noted that the costs associated with the registration of varieties to the national 
catalogues constitute an important inhibiting factor to greater diversity of PRM 
available to amateur gardeners. These registration costs are the result of relatively 
stringent DUS and VCU tests having to be undertaken. These costs cannot be 
recouped, especially by smaller operators, as the revenue generated from selling 
varieties to the amateur sector is generally low. One interviewee for this study argued 
that amateur gardeners should be allowed to access varieties that are not listed in the 
national/ EU catalogues as their purchasing decisions are not necessarily driven by 
varietal characteristics, such as distinctness, uniformity, and stability (DUS).   

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EU legislation also requires that in-kind exchange of PRM falls under the marketing 
definition and is treated as a commercial activity. But in-kind exchange between 
farmers may present several benefits. Bellon et al. (2011) (as cited in Coomes et al. 
2015) find that exchanges between farmers (via farmer networks) can facilitate 
farmers’ access to varieties with traits not produced by formal breeding or crops 
neglected by formal research1. As such, farmers’ ongoing selection can optimise a 
plant’s adaptation to variations in local cultivation conditions (European Coordination 
Via Campesina, 2021). Commercial breeders tend to focus on varieties that can be 
adapted to large-scale markets to obtain returns on their research investment. They 
do not therefore focus in the same way on the adaptation of varieties to local 
contexts.  

In-kind exchange can increase farmers’ access to PRM of old and non-protected 
varieties, i.e. conservation varieties, that do not feature in seed dealers’ catalogues. 
For example, evidence from the French case study conducted for this study (Annex 
10) indicates that farmers have been able to adapt to new and improved agricultural 
practices (e.g. varietal mixtures) to produce crops that are more productive and more 
tolerant to pests and diseases. Smale et al. (2008) and Jensen et al. (2013) (as cited 
in Coomes et al. 2015) found that in-kind exchanges between farmers, albeit small in 
volume are “vital for building crop and varietal diversity and for renewing planting 
stock.” 

With respect to conservation and amateur varieties, EC et al. (2021) concluded that 
key factors limiting their use were (i) low market demand, relatively high costs and 
low profitability, (ii) that producers are typically small scale, and (iii) differences in the 
supportiveness of Member State authorities. The current study’s targeted survey 
asked about the extent to which different factors were limiting the market. The 
majority of responses (52%, 37 out of 70 respondents) to these questions came from 
businesses and associations. For conservation varieties (Q51), only two factors were 
considered constraining by a majority of respondents: low market demand and low 
market willingness to pay (i.e. PRM sale price). NCAs made up 25% of respondents 
(18 out of 70) who also identified the low market demand and the administrative 
process for registering a variety as constraining factors. For amateur varieties (Q43), 
no factors were considered a constraint by most respondents. 

However, NGOs and academic institutions as sub-groups (n=10) were more likely to 
identify a range of factors as market constraints (EC et al. 2021). Across conservation 
and amateur varieties, most NGOs and academic institutions considered unsuitable 
DUS tests, reporting requirements, the administrative process for registration, and 
quantitative restrictions to be a problem. For conservation varieties specifically, these 
stakeholders also noted problems with the financial cost of PRM certification 
processes, whilst for amateur varieties, these stakeholders also noted problems with 
registration and seed verification costs. It is unclear whether this is because the rules 
are still too burdensome despite the derogations or because the Member States do not 
implement the derogations. In some Member States (e.g. Poland), all varieties 
intended to be marketed are required to pass DUS tests to be listed in the national 
catalogue. This might also imply that the information submitted by the applicants is 
not sufficient for benefitting from the derogation to an official DUS test. 

1 The authors do not indicate which species are referred to as “neglected crops.” It is therefore not possible 
to determine whether these neglected crops include species regulated by the PRM directives. 

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Quantitative restrictions to the production of seed of conservation varieties do not 
appear to be a problem. EC et al. (2021) demonstrated that in cases where data was 
available production levels are typically below the quantitative limit thresholds. 
Furthermore, most surveyed stakeholders for the current study were not aware of any 
examples where demand exceeded the quantitative thresholds, except for some cereal 
conservation varieties in Italy and a rice conservation variety in Austria (Q52). 
However, low production levels may in part be caused by the quantitative limits, as 
they may discourage investment because of the restrictions they place on scale 
efficiencies and returns (EC et al. 2021, survey results (Q51) and interviews 
conducted for this study).  

Views on the degree to which the region of origin concept is a constraint on the 
market also differed. However, the concept by design has a constraining influence on 
the geographic breadth of conservation variety use. A few of the stakeholders 
consulted for this study (including civil society organisations, NCAs and industry 
representative associations) considered that restricting marketing of conservation 
varieties to their region of origin hinders commercialisation in other regions with 
similar climatic conditions, which they felt would become more important with climate 
change. 

VCU and DUS testing for variety registration is not always suitable for and has not 
been adapted to the needs of organic agriculture, particularly in relation to uniformity 
requirements [D5] (IFOAM Organics International, 2020). DUS testing is based on the 
principles of distinctness, uniformity and stability which are relevant for conventional 
agriculture (Liveseed, 2021b). However, organic varieties are often not bred to be 
uniform enough to pass these tests. Therefore, organic varieties can be disadvantaged 
by DUS testing (Liveseed, 2021b).  

VCU testing and certification processes have been established to address the needs of 
conventional agricultural crops, where productivity, for example, is one of the main 
criteria. Organic varieties do not always perform well against these criteria as their 
yields may be different and their resistance to seed borne diseases or weed 
competition is not assessed (Liveseed 2021b). Germany is one example where VCU 
testing adapted to organic varieties is offered for rye, oats, barley, wheat and triticale 
(NCA interview). But not all Member States offer a VCU test adapted to organic 
conditions or have appropriate thresholds for characteristics of interest for organic 
production, in which the new organic varieties are compared to other organic varieties 
and not those of conventional farming (EC et al. 2021).  

Variety registration and PRM certification processes are also time-consuming [D6]. At 
present, the marketing of fruit plants and vine propagating material is regulated by 
Council Directives 2008/90/EC and 68/193/EEC, respectively. The survey responses 
for this study indicate that registration of varieties of fruit plants and vine propagating 
material takes 5-6 years while it takes 1-3 years to register varieties of agricultural 
species (Q159 and Q25). The European Commission’s 2013 Impact Assessment 
identified the long time that it takes to register fruit varieties as a challenge for 
breeders (EC 2013b).  

2.3. 

Reduced efficiency and effectiveness of processes and 

procedures 

A third problem is inefficient and ineffective processes and procedures in the PRM and 
FRM legislation [P3]. This is in part a result of the fragmentation and lack of coherence 
between the 12 Directives [D1]. Other drivers include the fact that some certification 
activities can only be carried out officially [D7], overlaps and inconsistencies between 
the PRM legislation and other EU legislation – particularly for plant health [D8], and 

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rules that insufficiently emphasise innovation, the use of new technologies and the 
need for policy adaptation over time [D8]. Together, these issues have resulted in 
difficulties for operators to use new processes for PRM/FRM production, and delayed 
access to market for new varieties [C4]. 

Fragmentation and lack of coherence between the 12 Directives [D1] has created 
inefficiencies in processes and procedures. For example, the approach to adding new 
species to the Directives requires an act adopted by the Commission in some cases, 
while the Directives on marketing seed of agricultural crops (e.g. cereal Directive) 
require an act adopted by the Parliament and Council. 

Certification of PRM under official supervision2 is currently possible only for certain 
categories of seed of agricultural species. For other categories (e.g. field inspection for 
pre-basic and basic seed of agricultural crops) and certain plant species (e.g. seed 
potatoes, fruit trees) it is not allowed [D7]. The registration process for new varieties 
is lengthy and burdensome in terms of cost for NCAs and operators and limits 
flexibility for the latter (EC 2021a). Activities related to variety registration (DUS and 
VCU examination) are currently not allowed by the legislation to be performed under 
official supervision.   

Variety registration and PRM certification procedures therefore create burdens and 
there is a lack of flexibility for some operators where these activities can only be 
carried out by the competent authorities. [C3]. The approach to certification has 
changed over time, recognising that for certain categories of agricultural species 
operators are able to carry out some of these activities under official supervision.   

There are also overlaps and inconsistencies between PRM and other EU legislation 
[D8]. Most significantly, there is overlap between PRM and Plant Health legislation on 
the issue of regulated non-quarantine pests (RNQPs), with duplication of the lists of 
these pests and related measures. There are as well as some differences between the 
two lists. NCAs face uncertainty about which list to consult. Additional effort is thus 
required to check both lists and ensure appropriate application of the two sets of 
legislation. This duplication also makes it difficult for producers to comply with the 
plant health rules (EC 2021a) Furthermore, the OCR applies to official controls to 
verify compliance with plant health rules but not to the PRM rules, which means there 
are two control regimes for plant inspection services to apply (EC 2021a).  

Greater coherence between the PRM legislation and Community Plant Variety Rights 
(CPVR) legislation is needed. The DUS requirements for variety registration under the 
PRM legislation are the same to the DUS requirements for granting CPVR. The DUS 
protocols are developed by the Community Plant Variety Office (CPVO), the EU agency 
that manages CPVR. When a DUS protocol is updated by CPVO, it takes up to a year 
before the respective PRM legal text can be updated accordingly. This creates 
inconsistencies in the procedure for listing a variety in the common catalogues under 
the PRM legislation.  

The PRM legislation specifies strict requirements and procedures for variety 
registration and certification of PRM and thus restricts the potential for innovative 
processes and use of new technologies [D9]. Its rigidity means there are challenges to 
introducing rules covering innovative production processes of PRM/FRM (e.g. true 

2 In contrast to official activities carried out by NCAs, official supervision means that operators can carry out 
certain activities of the PRM certification process if they have been formally trained by NCAs and subject to 
regular inspections of these activities by NCAs. 

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potato seeds, micro-propagation). PRM and FRM obtained through such processes can 
face barriers to market access (EC 2021a). In particular, stakeholders interviewed for 
this study identified the limited scope for policy adaptations in these situations, and a 
slow and an overly complex process for amending the rules as particular problems. 
New production techniques can be tested in temporary experiments (e.g. true potato 
seeds), however, the basic legislation does not currently allow marketing after the 
experiment is over. The current legislation hinders operators of FRM and fruit plants 
from exploiting the full potential of in vitro propagation and genetic markers. 

For variety registration and consequently market access, the rules only allow for field 
DUS and VCU trials. There is scope to allow new approaches, such as biomolecular 
techniques, and harmonise their use in the policy instruments, since internationally 
such advances are already being used to some extent. For example, UPOV (the 
International Union for the Protection of New Varieties of Plants, which forms the basis 
of the EU Community Plant Variety Rights System that is managed by the CPVO) does 
allow use of biochemical and molecular markers in DUS testing (UPOV, 2020). 
However, some literature suggests UPOV too could better support biomolecular 
technological advancements (Yu and Chung 2021). Nevertheless, EU legislation has 
rigid rules and requirements (EU 2021a) which can impede the ability of NCAs to 
utilize new technologies in processes such as DUS testing.   

Current PRM/FRM legislation can impede digitalisation due to its rigid procedures and 
requirements (EC 2021b). Around half of the stakeholders responding to the survey 
for this study felt the legislation was a barrier to increasing the use of digital 
technologies in relation to inspection/certification and labelling (Q256). One 
interviewed NCA provided the specific example of the requirement in PRM legislation 
for official certification labels to be “physical documents” despite producer demand for 
digital certification labels and plant passports. For example, Directive 98/56/EC on the 
marketing of propagating material of ornamental plants requires labels to provide 
information needed for official control, in addition to the information to the grower. 
Directive (66/401/EEC) on the marketing of fodder seed similarly requires packages of 
seed to have an official label that fulfils the information requirements set out in Annex 
IV of the Directive (e.g. variety, category, officially assigned serial number etc).  

EU PRM/FRM legislation does not effectively facilitate the use of digital technologies. 
There is untapped potential to harness new digital solutions such as e-certification 
(official certificates attesting compliance for the plant type and marketing category 
that are held digitally), label tags (e.g. QR codes) and blockchain technology to 
improve traceability, label security and offer improved assurance regarding PRM 
identity, health and quality.  

In these ways, the EU PRM/FRM legislation does not align with the objectives of the 
European Digital Strategy, which specifies a need to promote ‘the digital 
transformation of public administrations throughout Europe’ and create ‘a frictionless 
single market, where companies of all sizes and in any sector can develop, market, 
and use digital technologies, products and services at a scale that boosts their 
productivity and global competitiveness’ (EC 2020a).  

2.4. 

PRM/FRM legislation is not aligned with European Green 

Deal objectives and related strategies 

The final problem that the potential legislative revisions seek to address is the lack of 
alignment between the PRM and FRM legislation and European Green Deal objectives 
and related strategies [P4]. For PRM, this is primarily due to the need for a more 
harmonised approach towards VCU, a better exchange of good practice in VCU 
examination and a lack of opportunities to expand sustainability criteria in EU 

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legislation [D10]. It is also linked to the fact that DUS and VCU testing are not 
adapted to organic production [D5] (discussed under P2).  It is also caused by the fact 
that the current rules are too strict for certain activities (seed conservation networks, 
exchange in kind of seed) and the rigid implementation by Member States of the 
Directives on conservation and amateur varieties and quantitative restrictions thus 
limiting the diversity of PRM on the market. For FRM, drivers of the problem include 
the scope of FRM legislation, which only covers marketing for forestry purposes [D11]; 
an increasing demand for FRM over time [D12]; and a lack of provisions in the FRM 
legislation to address the conservation and sustainable use of forest genetic resources 
(FGR) [D13]. This has resulted in insufficient PRM and FRM to address EU 
sustainability and climate change objectives [C4]. In the case of FRM, there is 
insufficient information on the characteristics and suitability of this material for certain 
climatic conditions. 

The prosperity of agriculture has always been tied to climatic conditions. Now, in a 
rapidly changing climate marked by increasingly frequent and severe weather 
extremes, adaptation to these projected conditions is more important than ever for 
protection of food security and livelihoods. Climate change is impacting yields, pest 
prevalence and pest geographical distribution (EC et al. 2021). It is forecast that 
European crop production will shift northwards, potentially meaning a reduction in 
production in the Mediterranean region. The northwards shift could include major crop 
groups such as cereal, pea, canola, soybean and sunflower (Hampton et al. 2016).  

The 6th Assessment Report of the Intergovernmental Panel on Climate Change (IPCC) 
highlighted that our current 1.1°C warmer world is already affecting natural and 
human systems in Europe, and it identified heat and drought stress on crops as one of 
the four key risks for Europe. Substantive agricultural production losses are projected 
for most European areas during the 21st century, which will not be offset by gains in 
Northern Europe.  

The ability to adapt by using irrigation will also be increasingly limited due to 
increasing water scarcity (IPCC 2022). The risks of crop failures and overall yield 
reductions are particularly worrying in the context of the Russian aggression against 
Ukraine, which has highlighted the need for greater self-sufficiency in food production 
in Europe. Similarly, global warming has started to change Europe’s forests – shifting 
current vegetation zones further north and/or to higher elevations, meaning that 
species may no longer be suitable for their current planting locations (EC 2021d). 
Changes in climate impact on biodiversity have contributed to unprecedented bark 
beetle outbreaks, drought damage and new wildfire patterns. The effects of climate 
change have meant that extreme weather and disaster events (including e.g. forest 
fires, pests, windstorms) are increasing in Europe and creating challenges for the 
supply and survival of FRM (EC 2021d). Large parts of forests are vulnerable to these 
disturbances (Forzieri et al. 2020 in EC 2021d), triggering the need for urgent action 
to reduce these vulnerabilities. FRM stakeholders interviewed for this study highlighted 
this as a significant problem. Specific examples mentioned include damage caused by 
ice in Slovenia in 2014, severe storms in Sweden in 2005 and 2007, and dry and hot 
weather in Germany in 2018. These issues are likely to increase and alter the demand 
for FRM, as well as contribute to disruptions in supply.  

In conclusion, market demand for new plant varieties and FRM that are resilient to and 
suitable for the EU’s changing climatic conditions is expected to rise sharply. The EU 
PRM and FRM markets need to be prepared for and support this shift.  

The current PRM legislation, including legislation on VCU testing, is considered out-
dated in relation to new environment and climate change policies and international 

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agreements (e.g. the UN Sustainable Development Goals (SDGs)). Several NCAs 
consulted for this study stated that their Member States already considered 
sustainability through breeding and VCU testing. It is important that the PRM 
legislation reflects this to maintain a level playing field in terms of resilience across 
Europe and maximise environmental benefits.  

It was also noted during an interview with an NCA for this study that there is a need 
for clear sustainability criteria for fruit plants and vines particularly due to their long 
cultivation time (can be several decades depending on the species) and large 
geographic coverage (e.g. 700,000 hectares of vines in France).  

Article 5 of the European Climate Law requires relevant Union institutions and the 
Member States to ‘ensure continuous progress in enhancing adaptive capacity, 
strengthening resilience and reducing vulnerability to climate change’. It also requires 
the national adaptation strategies of the Member States to take into account the 
particular vulnerability of agriculture, water and food systems, and to promote 
ecosystem-based adaptation (Regulation (EU) 2021/1119). The Farm to Fork Strategy 
(EC 2020b) emphasises the need for seed security and diversity to advance the 
potential for more sustainable food systems. It specifically requests that the 
Commission facilitate registration of seed varieties, including organic varieties, that 
support this mission. 

A lack of harmonised VCU rules and lack of opportunities to strengthen sustainability 
criteria in the legislation [D10], as well as the fact that VCU and DUS testing are not 
adapted to the needs of organic production [D5], means that the PRM legislation is not 
aligned with these wider EU objectives and related legislation and strategies.  

There are also concerns related to the genetic diversity of PRM in the EU. EC et al. 
(2021) found that although many amateur gardeners surveyed agreed that genetic 
diversity amongst varieties is generally satisfactory, some improvements were 
needed, notably for greater choice/ availability of traditional, local and organic 
varieties. Some of the public authorities and NGOs consulted for the current study 
indicated that PRM rules have caused a reduction in diversity (Q132 and Q133). 
Quantitative restrictions in place for conservation varieties and amateur varieties, 
notably limits on the amounts to be produced and small packaging obligations, were 
also considered to be important inhibiting factors to achieving greater diversity in PRM 
of varieties marketed to amateur gardeners (Q133). 

There are challenges for aligning the FRM legislation with the European Green Deal 
and one of its related flagship initiatives, the EU Forest Strategy for 2030 (COM(2021) 
572). The EU Forest Strategy stresses that adapting Europe’s forests to climate 
change and restoring forests following climate damages will also require large 
quantities of appropriate forest reproductive material. Specifically, it commits the 
Commission to supplement the revision of the legislation on FRM with measures to 
promote the production of FRM suitable for future climatic conditions.  

The scope of the FRM legislation only covers production with a view to marketing and 
marketing of FRM intended for forestry purposes [D11]. The rules are unclear where 
they relate to FRM marketed for non-forestry purposes (e.g. agroforestry and eco-
schemes under the Common Agricultural Policy; carbon farming and ecosystem-based 
adaptation to climate change under EU climate policy; ecosystem restoration and the 
planting of 3 billion trees planning under the EU Biodiversity Strategy; and biomass 
production under EU renewable energy policy).  

Consequently, Member States have different interpretations and understanding of 
what is included in scope of the FRM Directive. For example, agroforestry is considered 

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within scope of the Directive in some Member States (Bulgaria, Germany, Slovenia 
and Spain) but not in others (France and Finland). As a result, FRM from regulated 
species can be sold in France and Finland for agroforestry purposes without the 
approval of basic material. If this lower quality FRM is planted in proximity to certified 
FRM it may contribute to the risk of genetic pollution of certified FRM. 

Developing a common definition for forestry and non-forestry purposes is challenging, 
in part because the responsibility for certain non-forestry purposes of FRM is under the 
remit of different public authorities in Member States and in some cases is already 
included in scope of other legislation. This was noted in the consultation for this study 
by interviewees from Finland and France. 

There is a lack of information on the scale and significance of the problem. This is 
likely due in part to the differences in significance that the FRM sector and potential 
non-forestry purposes have in Member States such as the prevalence and type of 
agroforestry practiced. Spain, Greece, France and Italy all have significant 
agroforestry cover, while Denmark, Poland, Germany and Czechia have very little. 
Agroforestry includes the use of species such as fruit trees that are not regulated 
under the FRM Directive. It is not clear the extent to which regulated species are being 
used to a significant extent for agroforestry in the EU (Den Herder et al. 2016). 

Another example is biomass plantations, which are of greater significance in Western, 
Central and Eastern Europe, and are less common in Northern and Southern Europe 
(Camia et al. 2021). However, even where non-forestry purposes are more prevalent, 
there is no data available on the extent to which there is currently a problem with 
lower quality material being used for non-forestry purposes or the extent to which this 
poses a risk for genetic pollution. 

The aforementioned activities are generating increased demand for FRM. Climate 
change induced adverse weather conditions and natural disasters are already causing 
temporary difficulties in FRM supply. But supply issues do not only occur following 
extreme weather and disasters. Stakeholders consulted for this study noted a more 
general problem with supply appropriately matching demand for FRM and provided 
examples of severe shortages including of improved Picea (spruce) seeds in Finland 
and of Pinus radiata (Monterey pine) in Spain. The impacts of this more general 
problem are exacerbated when extreme weather or disaster events lead to an increase 
in demand.  

When supply of FRM cannot appropriately match demand, afforestation or 
reforestation can be delayed or become impossible. Lower FRM categories (e.g. source 
identified instead of selected) or FRM from maladapted sources may be used. Some 
consultees for this study felt that a complete failure of production and a need to 
replant FRM was likely where lower quality FRM is used. One interviewee described 
how problems with supply in Finland led to a 10 to 25% decrease in growth, poorer 
adaptation, and a reduction in quality. 

Under certain circumstances, there may be a need to import material from third 
countries. More than half of survey respondents on this issue for this study indicated 
that insufficient supply would likely result in a need to import FRM from third countries 
(Q226). Interviewees described the current process for this as complex and difficult, 
typically taking several years. Although the FRM legislation has rules to address 
temporary difficulties in supply of FRM (Article 18 of Directive 1999/105/EC), the 
current legislation is not fit to address increasing demand [D12]. 

Supply issues can result in delayed FRM planting, which can contribute to a loss of 
forest growth. Consultees for this study noted that because of the long lifecycle of 

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trees, impacts of delayed planting are often not immediately visible. It may take 
several years or even a decade to see the losses in performance, which could result in 
economic losses for users of FRM and negative impacts on the environment. 

Member States differ significantly not only in climate and climate-associated 
challenges, but also in the types of forests they have, ownership of forests, structure 
of the forestry industry, as well as the structure of the forest nursery industry. For 
example, in Eastern European countries, there is more public ownership of forest area, 
whereas in Western European countries private ownership is more prevalent (Forest 
Europe 2020). In Member States where forests are largely state-owned there is no 
significant forest nursery industry. One interviewee for this study also described how 
in Northern Europe many forestry companies have their own seed sources and 
nurseries, while in many countries in Western Europe there is a greater dependence 
on private nurseries, and consequently also greater problems with supply. Some 
Member States are largely self-sufficient in the supply of FRM (as reported by 
interviewees from Finland, Bulgaria and Slovenia) and some have not yet experienced 
any events that have led to shortages (as reported by an interviewee from Bulgaria).  

Where Member States experience supply problems, some stakeholders, largely from 
Western/Central and Southern Europe indicated that this was due in part to a lack of 
planning and communication across the supply chain. Because timelines in forestry are 
inherently long, supply cannot immediately meet an increase in demand. Longer-term 
planning is needed to determine what FRM will be needed. One expert interviewed for 
this study explained that where FRM is supplied largely by a private forest nursery 
sector, it is not economical for nurseries to stock seeds they believe they might not be 
able to sell. As such they are not willing to stock excess FRM that might be needed to 
meet unexpected increases in demand. Another interviewee explained that private 
nurseries are often not able to respond quickly enough to changes in demand and may 
be prevented from accessing materials due to national restrictions on using FRM from 
other Member States. 

There are also challenges in harvesting tree seeds compared to the agricultural sector, 
and according to some interviewees for this study, the sector can struggle to find the 
labour and capacity required to harvest certain species and of certain provenances. 
Even where seeds are harvested and available, there is also sometimes a problem 
with communicating that availability to FRM users. Some survey respondents for this 
study indicated that information on the volume of FRM available for marketing in cases 
of difficulties in supply is not accessible (Q229). Stakeholders who experienced these 
issues characterised the problem as complex and involving actors from across the 
supply chain. 

Furthermore, the FRM legislation does not contain clear rules on the information to be 
provided to end users. As a result, FRM buyers may not have the necessary 
information on the functions and traits of the materials they purchase despite the use 
of supplier documents. Additional information that a buyer may find useful includes 
information on FRM identity, genetic diversity, availability, and deployment zones 
covering both current and future bioclimatic zones and conditions for which FRM are 
suited or expected to be suited. Without this information, buyers can encounter issues 
relating to FRM identity and characteristics. 

The provision of additional information on FRM and seed stands can take different 
forms. One approach is to provide guidance to FRM users separately from the 
registration and approval of basic material. Member States differ regarding the extent 
to which they provide this type of guidance. This reflects differences in forestry 
practices across Member States (Forest Europe 2020). For example, the consultation 

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for this study found that in Bulgaria, where most of the forests are state owned with a 
small number of private owners, information and recommendations can be provided to 
FRM buyers/users on a more informal level. 

In Member States where there are larger numbers of private owners, there is a 
greater need to develop tools and strategies to provide and disseminate information. 
Some NCAs reported developing their own tools or approaches to advise FRM buyers. 
For example, Sweden and Finland have developed a map-based tool which provides 
recommendations for certain species. In France, the NCA developed brochures with 
information on different provenances and how they can best be used (Pierangelo et al. 
2017). Some Member State NCAs interviewed for this study had not developed any 
formalised approaches or tools for providing information. However, all NCAs 
interviewed mentioned some type of ongoing research or data-collection activities 
related to FRM. 

There are also European-level projects seeking to partly fill these information gaps. 
One example, Seed4Forest3 allows users to select a location in Europe and receive 
information on tree species that could be grown there now and in the future. This has 
been developed based on climatic data and information from provenance trials in 
Europe and is linked to the Forest Reproductive Material Information System 
(FOREMATIS).4 

Another approach to providing necessary information is through the assessment of 
basic material or FRM for certain sustainability characteristics. Conducting this type of 
assessment and providing the information to FRM users can support planting decisions 
that are suitable for both current and future climatic conditions. The consultation for 
this study found that Member States differ in the extent to which they conduct this 
type of assessment. 

The FRM legislation does not contain provisions on the conservation and sustainable 
use of FGR [D13]. The current emphasis on addressing the dual crises of climate 
change and biodiversity loss has resulted in new and evolving needs for FRM. 
Knowledge of how to meet these challenges has not kept pace with changing needs, 
and particularly for characterising FGR for conservation and sustainable use. Actions to 
conserve FGR are taken at national or regional levels, with the result that conservation 
knowledge is scattered across the EU. 

3.  The case for EU action 

The PRM legislative framework is based on Article 43 of the Treaty on the Functioning 
of the European Union (TFEU) implementing the Common Agricultural Policy (CAP).  

Agriculture is identified as one of the principal areas of shared competence between 
the European Union and the Member States (Article 4 TFEU). EU action to retain and 
strengthen the PRM legislative framework is necessary to sustain and improve the 
historically positive impact that PRM legislation has had on free movement, availability 
and quality of PRM, and therefore trade (Article 114 TFEU). Without the existing 
framework, the application of unique systems in each Member State would contribute 
to barriers to the movement of PRM and to the internal market. 

EU action will also help to ensure that PRM legislation responds to the corresponding 
environmental aims of the Treaty to preserve, protect and improve the quality of the 

3 https://www.seed4forest.org/ 
4 FOREMATIS is available online at: https://ec.europa.eu/forematis/  

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environment, protect human health and support prudent and rational utilisation of 
natural resources (Article 191 TFEU). 

4.  Objectives of EU policy intervention 

Four general objectives of the revisions have been established by the Commission in 
the Inception Impact Assessment to address the identified problems (Error! 
Reference source not found.). There are distinct sets of specific objectives aligned 
with each general objective. There were 7 general objectives and 14 specific 
objectives presented in the terms of reference for this study. In line with feedback 
from DG SANTE, the following 4 general objectives and 13 specific objectives guided 
this study. 

  General objectives and corresponding specific objectives 

General objectives 

Specific objectives 

GO1: Ensure there are no 
differences between MS in PRM 
and FRM marketing (level 
playing field)   

GO2: Ensure a wide diversity of 
choice and quality of PRM/FRM 
for all types of users and 
consumers 

SO1a: Increase coherence of the policy instruments and eliminate fragmentation of 
requirements 

SO1b: Create a harmonised and risk-based official control (OC) framework 

SO2a: Create proportionate rules adapted to marketing activities and types of 
PRM/FRM  

SO2b: Ensure conservation and sustainable use of plant and forest reproductive 
materials 

SO2c: Establish appropriate conditions for testing varieties suitable for organic 
production 

GO3: Support innovation & 
competitiveness of the EU PRM 
& FRM industry 

SO3a: Improve coherence with the plant health legislation 

SO3b: Support innovation and competitiveness of the EU PRM and FRM industry 

GO4: Contribute to wider EU 
objectives regarding adaptation 
to and mitigation of climate 
change impacts, food security, 
sustainable production and 
biodiversity protection  

SO3c: Increase efficiency and efficacy of the PRM sector 

SO4a: Address difficulties in supply of FRM 

SO4b: Provide better access to information on FRM for users/buyers 

SO4c: Clarify scope of forestry and non-forestry purposes 

SO4d: Promote the availability of PRM suitable for current and future climatic 
conditions 

SO4e: Promote the availability of FRM suitable for current and future climatic 
conditions  

5.  Policy options 

Three policy options have been identified by DG SANTE to achieve the objectives of 
the legislative revision by tackling the problems associated with the existing PRM and 
FRM legislation and their underlying drivers. The policy options are detailed in 
subsequent sections. These are:  

  Option 1: ‘highest flexibility’  

  Option 2: ‘balancing flexibility and harmonisation’  

  Option 3: ‘highest harmonisation’  

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The IA requires a baseline scenario against which to compare the options. This is in 
principle a “no policy change” scenario, that is, how the situation and problems would 
evolve if there were no changes in the PRM legislation. The baseline scenario is set out 
in section 5.1, followed by the descriptions of the options and their specific measures.   

5.1. 

Baseline scenario  

Assessing the impacts of any EU policy intervention on the PRM and FRM policy 
instruments requires comparing changes under the proposed options with a reference 
scenario describing what is expected to happen in the absence of new EU intervention 
on the legislation. This reference, or baseline, scenario is dynamic, capturing the 
effects of all relevant legislative and voluntary action that can be expected to be taken 
in the absence of a new EU initiative, and the impacts of any other changes relevant 
to the PRM and FRM sectors.  

Data was collected during this study to complement information provided by the 
previous data gathering study (EC et al. 2021) to assess the expected development of 
current problems over the next 10 years. Additional information on the baseline can 
be found in Annex 5. The baseline scenario is set out with reference to the problem 
definition (section 2). 

5.1.1.  Differences between MS in PRM & FRM marketing 

Fragmentation and lack of coherence between the 12 PRM Directives has led to 
different conditions for operators across Member States and for products marketed in 
different Member States. The evolution of these problems in respect of the coherence 
of the policy instruments and for the alignment of official control rules is set out in this 
section.  

5.1.1.1.  Policy instrument coherence  

In the absence of any change to the policy instruments, the problems identified with 
the internal coherence of the policy instruments will remain. Larger businesses will 
continue to take up the opportunity to register in MS with lower costs, whilst SMEs will 
be less able to compete. The complexity of the legislation will continue to be a barrier 
to SMEs and new operators entering the market.  

5.1.1.2.  Alignment of official controls rules 

Rules on official controls in PRM and FRM legislation are quite general and differ 
between the different Directives. Furthermore, they are currently not within the scope 
of the Official Controls Regulation5. Member States therefore take diverging 
approaches towards official controls in the context of PRM and FRM. With no EU action, 
it can be expected that the differences between Member States will continue, in turn 
contributing to an unequal playing field for operators (EC 2021a).  

Inefficiencies that stem from lack of application of the OCR to PRM and FRM legislation 
will also remain without EU action. Duplicated effort in carrying out controls for the 
plant health regime and for PRM was already identified in 2013 (EC 2013b) but 
remains problematic today. A 2021 study of PRM and FRM legislation (EC et al. 2021) 
observed that plant inspection services were ‘confronted with two different control 
regimes’. It is also possible that the lack of application of the OCR IT system (IMSOC) 
to PRM contributes to inefficiencies: EC 2021a observed challenges to exchange of 

5 Regulation (EU) 2017/625 (Official Controls Regulation/OCR) entered into force in 27 April 2017 and has 
been in application since 14 December 2019. 

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information on seed fraud as no secure IT system exists for PRM and FRM. However, 
there was no evidence to suggest that this is currently a significant problem for NCAs.  

No evidence was found to suggest that the current rules on official controls limit the 
ability of NCAs to implement risk-based controls at their own discretion. Most NCAs 
responding to questions on official controls in the survey for this study (18 of 25) 
reported carrying out risk-based controls for one or more types of import, production 
and/or marketing controls (Q241, Q245 and Q249). However, it is unlikely that the 
definition of ‘risk-based’ is the same in all NCAs. The survey data illustrates that NCAs 
vary in the extent to which they implement risk-based approaches for different types 
of controls (some implementing it only for imports, others only for marketing, others 
for a combination of control types etc) (Q241, Q245 and Q249). In the OCR on the 
other hand, the requirement of risk-based controls is established together with criteria 
for carrying out such controls, thus ensuring a harmonised approach across the EU 
Member States6.  

5.1.2.  Ensuring diversity of PRM & FRM choice and quality 

There is evidence of a lack of diversity in choice and quality of PRM and FRM for some 
users and types of activity. The evolution of these problems in the absence of 
legislative revision is documented in this section. 

5.1.2.1.  Rules for marketing activities and types of PRM/FRM 

Amateur gardeners 

The consultation conducted for this study found that a market for amateur gardeners 
currently exists in most EU Member States. It is difficult to estimate the market size 
(in either value or volume terms) because it is not generally possible to clearly 
separate marketing to amateur gardeners from marketing to professional operators. 
However, in most Member States, the amateur gardener market comprises the 
following two main segments: (1) professional producers selling to amateur gardeners 
(amongst other buyers); and (2) amateur gardeners exchanging PRM between 
themselves. The latter activity is out of the scope of the PRM legislation. Stakeholders 
consulted for this study confirmed that professional breeders/ seed companies across 
the EU produce with the intent to sell to any user, professional or amateur. They do 
not tend to produce exclusively for amateur gardeners, which is unlikely to change 
going forward.  

The number of varieties bred and marketed to amateur gardeners is thought to be 
increasing. This upward trend in diversity may persist, as attested by most PRM-focus 
group participants, although this may be influenced by market and regulatory 
developments. Although an earlier study indicated a decrease in availability and 
diversity (Mammana, 2014), EC et al. (2021) and evidence from several stakeholder 
interviews and the PRM focus group undertaken as part of this study suggest that the 
number and types of varieties being offered across Member States to serve the 
amateur gardener market are increasing.  

About half of the business associations and individual businesses, and most of the 
NGOs responding to the targeted survey indicated that they (or their members) 

6 At the same time, the OCR does not affect Union agri-food chain legislation that requires that official 
controls be performed irrespective of the level of risk or the likelihood of non-compliance in view of the 
issuance of an official certificate or attestation which is a pre-requisite for the placing on the market or for 
the movements of animals or goods. In such cases, the frequency of the official controls is dictated by the 
certification or attestation needs (see recital 32 and Article 9(3) of the OCR). 

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currently breed varieties for the exclusive use of amateur gardeners (Q122). Between 
1 and 20 per cent of the total varieties that these business associations’ members and 
individual businesses breed, and between 41 and 60 per cent of the total varieties that 
the NGOs breed, are for exclusive use by amateur gardeners (Q123). One NGO 
indicated that this proportion ranges between 61 and 80 per cent of total varieties 
they breed (Q123).  

Furthermore, an association representing breeders of plant varieties, seed producers, 
and seed distributors indicated that, in Italy, varieties that are commonly sold on the 
amateur gardener market include old or traditional varieties and varieties linked to 
specific territories. In France, a civil society organisation and an association 
representing national allotment and leisure garden federations indicated that varieties 
of interest to amateur gardeners include conservation varieties and varieties that 
exhibit heirloom/ traditional characteristics. Additional evidence was gathered during 
the consultation on the most important crop varieties that are sold to amateur 
gardeners in a selection of Member States (CZ, DE, ES, FR, NL, PL). These are mainly 
vegetables, followed by fruits, ornamentals, seed potatoes, and aromatic herbs. 

Evidence gathered from several interviews and the PRM focus group indicates that any 
future increase in varieties offered to amateur gardeners may be constrained by: (1) 
attitudes towards amateur gardening (i.e., higher/ lower interest in/ take-up of 
amateur gardening); (2) ongoing/ future market developments such as a potential 
increase in the existing trend of breeding company mergers, which could reduce the 
scope/ diversity of varieties available to amateur gardeners; and (3) future regulatory 
developments. Furthermore, in the absence of change in PRM legislation, requirements 
mandating that varieties be distinct, uniform, and stable (DUS) will remain in place. 
According to several interviewees for this study, this could lead to a loss in certain 
varieties (e.g., local/ traditional varieties) that may not exhibit DUS characteristics, 
but which are popular among amateur gardeners as well as SCNs for their distinct 
flavour, heirloom/ traditional characteristics, and role in increasing genetic diversity of 
cultivated plants. As demand for these varieties tends to be low, smaller operators in 
particular selling PRM of these varieties may not be able to the recoup costs arising 
from production, testing, and registration. As a result, they may stop or reduce 
breeding of these varieties in the future. This will potentially result in the loss of 
varieties and hence loss of genetic resources, which may otherwise have been 
beneficial for future adaptation to climate change. It may also result in a general 
reduction in the diversity of varieties grown in domestic gardens.  

Seed conservation networks (SCNs) 

There is little data on the number of SCNs operating in the EU or their activities. An 
estimate of the number of Community Seed Banks (CSBs) in Europe was attempted as 
part of the European research project, Diversifood (Diversifood. (2017)). The authors 
were not able to make a reliable estimation of actual numbers but provided some 
indicative figures for Spain and France. They found 40 CSB initiatives in Spain and 50 
in France. This present study also attempted to collect information to fill existing gaps 
in relation to the number of SCNs. However, the information that was obtained 
presents a scattered picture of the sector. One seed saver organisation operating in 
Austria reportedly has 14,500 members and maintains over 5,500 accessions of 
endangered vegetable, fruit and grain varieties as well as crop wild relatives (Q140). A 
seed conservation organisation in Switzerland engages in the conservation of around 
4,700 varieties, most of which in situ / on farm (Q140). Several SCNs operating in 
Germany and across German-speaking countries reported having around 100 
members each (Q140). France has between 15 and 30 SCNs, including both public and 
private entities (Q140). A national seed platform in Spain comprises 20 local seed 

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networks (Q140). In Italy, a collaborative programme links 33 member countries 
(Q140). SCNs were also reported to be operating in Croatia, Greece, Luxembourg, the 
Netherlands, Norway, and Sweden (Q140).   

Ten respondents to the survey for this study (mostly NGOs), indicated that they are 
involved in the operation and also participate in the activities of an SCN (Q137). Most 
of these stakeholders operate on a not-for-profit basis, however, two respondents 
indicated that some of their members operate with the aim to make a profit (Q138). 

The mission of SCNs is reportedly wide-ranging, and includes long-term conservation, 
development of crop diversity, and adaptation of plant genetic resources to regional 
agro-ecological conditions. Their activities can include variety collection and 
maintenance in situ and seed storage, notably of old, traditional and/or conservation 
varieties. Typically, exchange of seeds is allowed between the members of the SCNs. 
The extent of these exchange activities (in volume or value terms) is not known. In 
the absence of legislative revision in this area, the activities of SCNs are not expected 
to change in the near future, as indicated by most survey respondents for this study.  

In-kind exchange of PRM 

The EU PRM legislation does not allow in-kind exchange of PRM/ seeds between 
farmers. This activity is therefore not legally permitted in most Member States (EC et 
al. 2021). The consultation for this study found that a few Member States and an EEA 
country have exemptions for this activity in place: Austria, France, Italy, and Norway.  

In France, under Art.315-5 of the Code Rural, PRM exchange between farmers of 
varieties which are not protected by plant breeders’ rights are considered ‘mutual 
assistance’ (rather than a commercial activity). In-kind exchange is therefore not 
subject to regulations concerning seed marketing (The European Coordination Via 
Campesina 2021). The consultation for this study found that Austria applies an 
exemption to in-kind exchange. The system in place relies on trading exact amounts, 
therefore farmers/producers tend to exchange small amounts, for example, at seed 
fairs. Large seed companies do not typically participate in such exchanges. In Italy, 
national legislation was amended in 2021 to allow for in-kind exchange between 
farmers, although this only relates to a portion of their harvest. The new legislation 
does not provide any detailed information regarding the conditions of exchange, 
including quantities or varieties that can be exchanged. 

There is very limited data on the number of farmers who participate in PRM exchanges 
in those Member States where it is allowed, or the number of varieties and volumes 
exchanged. Evidence collected from the case study in France suggests that the 
number of participants in these exchanges may be small, ranging from a few hundred 
to the low thousands, equating to less than 1 per cent of French farms.7 Participating 
farmers tend to produce on a smaller scale and with greater interest in new, 
heterogeneous and less stable material (i.e. material that is more adaptable to local 
agroecological conditions) rather than larger operators who tend to participate in the 
commercial seed market.  

At EU level, the scale of in-kind exchange activities between farmers is not known. 
There is some indication that volumes of seeds exchanged in-kind between farmers 
across France have grown over the past 20 years. This trend is expected to continue, 

7 Drawing on Eurostat data (latest data (as of 2016) on the number of farms in France = 456,520), the 
extent of participation is calculated as follows: low end: (100/456,520 * 100); high end (3,000/456,520 * 
100).  

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considering national efforts to boost local food production and agroecological and 
biodiversity-based farming.  

In the absence of regulatory intervention, in-kind exchange activities between farmers 
are likely to remain prohibited in most Member States but continue to occur across 
many Member States, albeit at a relatively small scale (in terms of numbers of 
participating farmers and volumes exchanged). Farmers across the EU will continue to 
face different rules, with farmers allowed to exchange PRM in-kind having greater 
access to more locally adapted varieties. 

Organic products 

There is some promotion of diversity in recent policy introductions for organic 
production. In 2022 Regulation (EU) 2018/848 came into force. It provides for ‘organic 
varieties suitable for organic production’, that are varieties of a high level of genetic 
and phenotypical diversity. They are however subject to the general variety 
registration rules. DUS testing in particular creates a barrier for market entry for 
organic varieties, as they cannot always meet the uniformity requirements. The same 
Regulation allows for organic heterogeneous material, that is characterised by a high 
level of genetic and phenotypic diversity, is not a variety, nor a mixture of varieties8.  
The benefits for diversity by the introduction of these provisions are limited to organic 
production, as conventional production cannot benefit from similar rules. 

5.1.2.2.  Conservation and sustainable use of PRM & FRM 

The Common Catalogue database which contains records for conservation varieties 
includes 375 conservation varieties of agricultural species, 161 conservation varieties 
of vegetable species and 613 amateur varieties of vegetables species across 30 
European countries (including Switzerland, Iceland, and Norway)9. At EU level, the 
number of such varieties in the Common Catalogue has been stable over the last five 
years, although there are some indications of increases in some Member States (EC et 
al. 2021; consultation results for this study). 

There is no data available on production levels. Consultation results indicate that a 
variety of different organisations are involved in the production and/or marketing of 
conservation and amateur varieties, including conservation networks, organic 
breeders, commercial seed companies, national research institutes and local 
authorities (Q46 and Q121). A majority of business associations and NGOs surveyed 
for this study reported that their members produce or market conservation varieties, 
representing 1-20% of annual turnover in most cases although one breeder cited 61-
80% and one local organisation 81-100% (Q48).  

Factors potentially limiting the market for conservation and amateur varieties are 
expected to persist under the baseline scenario, as outlined in the problem definition. 
As a result, the number of varieties and production levels are expected to follow 
recent trends and remain broadly unchanged. In some Member States with supportive 
measures in place, it is possible that PRM of conservation varieties might increase.  

There are no directives providing derogations for conservation varieties of fruit plants 
or vines and no comprehensive data available on the number of fruit and vine 

8 Detailed rules on organic heterogeneous material are set out by Commission Delegated Regulation (EU) 
2021/1189 
9 Based on the ‘active’ records for conservation varieties in the Common catalogue as accessed in February 
2021 (EC et al. 2021) 

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conservation and amateur varieties, nor the level of production. The extent of support 
for fruit and vine conservation varieties is uneven across Member States. For example, 
of 13 NCAs who responded to the survey for this study, seven reported that their 
national legislation includes special provisions for registration of conservation varieties 
of fruit plants, and four had such provisions for vine (Q172). It is unclear from the 
available evidence whether there is any unmet demand for such varieties. Most NGOs 
consulted for this study felt that demand for fruit and vine conservation varieties was 
satisfied through in-kind exchange or other means outside the commercial market 
(Q174). 

Under the baseline scenario, no action would be taken on PRM of conservation 
varieties. As regards conservation of forest genetic resources existing empowerments 
could be used to introduce rules specifically for FRM where they do not currently exist. 
However, even if the empowerment were used it is unlikely that this would lead to an 
increase in conserved forest genetic resources because of the requirement to keep a 
formal approval process of basic material.  

Current European environmental commitments such as the European Green Deal, the 
Farm to Fork and Biodiversity strategies as well as global climate agreements such as 
the Paris agreement and the Sustainable Development Goals provide some pressure to 
increase the resilience and sustainability of PRM. In particular, the objectives of the 
Farm to Fork strategy concerning the reduction of the use of pesticides and fertilisers 
create a need for PRM which can produce strong yields in low input systems. 
Sustainability is clearly on the wider policy agenda but without conversion of these 
targets into policy actions progress is likely to be limited. 

5.1.2.3.  Conditions for testing varieties suitable for organic 

production 

VCU testing of organic varieties is currently applied differently across Member States. 
Austria, France, Czechia, Denmark, Germany, Latvia (as well as Switzerland) already 
offer organic adapted VCU testing or supplementary organic testing within variety 
registration (Liveseed 2019; confirmed through the consultation for this study). These 
countries assess traits such as weed competition, resistance, nitrogen efficiency and 
success under low input conditions in addition to the usual VCU criteria (Annex 5, 
Table 33). Without regulatory changes these internal market differences would 
continue and possibly increase as more countries adapt organic testing with price 
impacts on operators.  

No changes in respect of organic varieties are expected in the PRM legislation under 
the baseline scenario, although reference could be made to the Organic Regulation. 
Organic VCU testing would therefore rely on principles and conditions set out in the 
Organic Regulation. The PRM legislation allows for derogations for organic varieties of 
certain species (including DUS derogations as regards uniformity and general 
principles for VCU testing)10. A general framework for such derogations is however 
lacking.  

10 Commission Implementing Directive (EU) 2022/1647 of 23 September 2022 amending Directive 
2003/90/EC as regards a derogation for organic varieties of agricultural plant species suitable for organic 
production and Commission Implementing Directive (EU) 2022/1648 of 23 September 2022 amending 
Directive 2003/91/EC as regards a derogation for organic varieties of vegetable species suitable for organic 
production 

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5.1.3.  Innovation and competitiveness of the EU PRM & FRM industry 

Efficiency and effectiveness of some processes and procedures are compromised as a 
result of certain features of the PRM and FRM legislation. The evolution of these 
problems in relation to coherence with other EU legislation, innovation and 
competitiveness related to advances in science and technology, and efficiency and 
effectiveness constraints linked to rules on official supervision and ‘not yet listed 
varieties’ of PRM are considered in this section. 

5.1.3.1.  Coherence with other EU legislation 

Problems relating to the lack of alignment with the Plant Health legislation are likely to 
persist, and particularly the administrative burden on NCAs arising from overlaps and 
inefficiencies with other policy instruments. 

5.1.3.2.  Innovation and competitiveness of the EU PRM & FRM 

industry in science and technology 

Ad-hoc amendments of the PRM and FRM legislation are likely to continue to take 
longer than necessary to adapt to changes in science and technology. This in turn 
means there is greater reliance on older technology, despite the potential for newer 
scientific and technological developments to make processes such as production, and 
registration and certification more efficient. For example, the consultation for this 
study found that proving distinctness of a variety can take 1-2 years with trials in the 
case of agricultural and vegetable species and up to 5-6 years in the case of fruit 
plants and vines, because it has to be grown and observed for the characteristics that 
make it distinct to the reference varieties (Q25 and Q156). Use of BMTs can reduce 
the number of varieties to compare against (i.e. to compare against only the closets 
ones) and therefore reduce the costs. In the case of FRM molecular markers could 
help to confirm that FRM originates from a certain seed source and could support 
provenance trials. Not being able to take advantage of these capabilities represents a 
competitive disadvantage for the EU’s PRM and FRM sectors. BMTs could also be used 
during official controls carried out during the marketing of PRM and FRM to perform 
identity checks.     

The level of adoption of scientific and technological developments currently differs 
across Member States. Without EU intervention these differences are likely to continue 
to diverge. This could potentially contribute to an unequal playing field for operators. 
For example, evidence from interviews undertaken for this study indicates that some 
Member States were beginning to take action. In France, biomolecular techniques 
were being used for variety examination to verify the presence of genes that 
correspond with particular characteristics (such as disease resistance) and in 
distinctness testing to measure the genetic differences between varieties (GEVES 
2020). Biomolecular techniques were also being used in Finland, while Spain was 
undergoing a process of integrating the latest developments into their national 
legislation. By contrast, Poland was waiting for EU direction prior to introducing 
scientific and technological developments. 

The consultation undertaken for this study indicates that some progress is being made 
towards applying digital processes to PRM/FRM activities, with the majority of 
stakeholders responding to the survey reporting that they use digital processes in at 
least one type of activity (94%, or 74 of 79) (Q259). However, there is a lot of 
variation across stakeholder groups and Member States. Around half of NCAs 
consulted (n=22) reported using digital processes for certification and/or field 
inspection and testing (Q259). For other types of activities (variety examination and 
registration, seed sampling and testing, post-controls and enforcement), the number 

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of NCAs reporting use of digital processes ranged from 7 down to just 2. Other 
stakeholders including individual businesses also varied in the activities for which they 
used and/or were developing digital processes, ranging from many of them using 
digital processes for seed testing, down to two that reported using them for 
enforcement-related activities (Q259).  

For some processes, digitalisation will continue to be hampered by requirements in 
PRM and FRM legislation. For example, the requirement in PRM and FRM legislation for 
physical official certification labels may prevent the adoption of purely digital 
certification processes. However, some issues are already being addressed at EU level 
without the need for legislative changes: two NCAs interviewed referred to the 
ongoing project to launch a single EU-wide plant varieties database that combines 
existing databases (e.g. the common catalogues, the Fruit Reproductive Material 
Information System (FRUMATIS) and the Forest Reproductive Material Information 
System (FOREMATIS)). This was expected to make it easier to search for information 
and therefore reduce the administrative burden for NCAs.  

Variation in adoption of digital technologies across public authorities also points to a 
potential lack of system interoperability between Member States. Without EU 
intervention, use and development of digital technologies for labelling and 
certification/inspection processes is likely to be slow and fragmented across the EU as 
well. Digital technologies have the potential to improve traceability, label security and 
transparency of labels (EC et al. 2021) which is less likely to be realised under the 
baseline scenario.   

5.1.3.3.  Efficiency and efficacy of the PRM sector 

Official supervision 

Certification under official supervision currently takes place in most Member States 
(EC et al. 2021 and information collected through the consultation for this study).11  
Many businesses undertake certification under official supervision, including a high 
proportion of SMEs. Survey results showed that seed sampling was the certification 
activity for agricultural species most carried out by operators (Q68). Far fewer 
certification activities for vegetables in general were undertaken by operators (95% of 
vegetable seed is marketed as standard seed, that is, with no certification) (Q69). At 
the same time, several Member States do not offer the possibility of certification under 
official supervision (Cyprus, Greece, Latvia, and Ireland) (Q70).  

A temporary experiment on field inspection under official supervision for pre-basic and 
basic seed was carried out from 2012-2019 involving 10 Member States and Norway 
(EC 2019a). The purpose of the experiment was to investigate whether the 
requirement for official field inspections could be replaced by either official field 
inspections or field inspections under official supervision for pre-basic seed and basic 
seed.  

The results of the experiment were considered positive for several reasons. There was 
a small deviation rate (< 1% deviation) in the results between official field inspections 
and field inspections under official supervision, regardless of the species, which was 
considered very low (and was stable over the duration of the experiment). Seed 
companies hired staff who were officially licensed by the competent authorities to 
carry out field inspections. The certification authorities maintained their competences 

11 Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, 
Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Slovakia and Sweden 

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while developing other competences because of time available for other tasks (EC 
2019a).    

In the absence of change to the legislation and based on current practice and existing 
evidence, there is likely to either be no change in the extent to which certification is 
conducted by operators under official supervision over the next 10 years or an 
increase in these activities (to include more operators in MS where official supervision 
is provided for, and potentially to include more MS that offer the possibility).  

Not yet listed varieties of fruit and vine propagating material 

There is very little data on the size of the market for fruit and vine propagating 
material. The most recent figures come from work carried out by the European 
Commission in 2007-08 which found that 90% of the 12,000 enterprises involved in 
the production of fruit plants in the EU were SMEs often based in rural areas with few 
other economic opportunities. The value of this business was estimated at around EUR 
2.5 billion (EC 2021a). 

In the EU, 350-400 million grafted vines are produced annually; France and Italy are 
the main producers (Vivairauscedo 2021). The market in the EU can be unstable due 
to factors that affect the price of grafted vines. During economic downturns prices 
often fall below production costs. This is one reason for a decline in the number of vine 
nurseries in France (EC 2013b).  

5.1.4.  Contribution to EU objectives regarding climate change impacts, 

food security, sustainable production and biodiversity protection 

The PRM and FRM legislation is not aligned with the European Green Deal objectives 
and other related strategies. The evolution of problems related to this lack of 
alignment for FRM and in respect of sustainability testing for PRM and FRM are 
discussed in this section. 

5.1.4.1.  Difficulties in supply of FRM 

Demand for FRM is likely to increase over the next 20 years due to climate change 
according to the consultation undertaken for this study (22 of 25 respondents across 
stakeholder groups indicated a likely increase in demand) (Q228). Demand is also 
likely to increase in part due to tree planting policies, such as the EU target to plant an 
additional 3 billion trees as part of the EU’s Biodiversity Strategy. The available supply 
of FRM is likely to either stay the same or decrease over the same time period. 
Extreme weather and disaster events are increasingly likely to occur, contributing to 
both increases in demand and difficulties in supply. This suggests that problems with 
the availability of FRM are likely to worsen.    

Efforts are being made in some Member States to improve contingency planning (e.g. 
Spain, Slovenia), but there is not enough evidence to determine how widespread this 
is. Only a minority of Member States appear to have contingency plans in place (of the 
respondents to the consultation, only those from Finland and Sweden indicated that 
Member State had a contingency plan) (Annex 5, section A5.7) (Q234). Some Member 
States may store seeds as a contingency measure (e.g. the Bulgarian NCA described 
the use of gene bank stores) but without a formal contingency plan. This situation will 
likely improve even in the absence of EU regulatory intervention, but there will remain 
significant differences between Member States. Outside of contingency planning, some 
Member States and organisations operating in the sector are developing initiatives 
that could help to address supply problems, but the extent to which these efforts will 
help to address the problem is unclear.  

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Under a scenario where there is no change in the FRM policy instrument, significant 
negative economic impacts for users of FRM are likely to result. Significant negative 
environmental impacts are also expected due to reductions in the quality of planted 
trees and less resilient forests. This means a loss of the benefits provided by resilient 
forests, including support for biodiversity and mitigating climate change (EC 2021c).   

There is scope under the current legislative framework for the Commission to make 
use of existing empowerments to authorise Member States to use FRM that does not 
fulfil all requirements, thereby mitigating some of the negative effects for Member 
States who need access to FRM when there are challenges with supply. However, it is 
likely that the factors contributing to the problem of supply will worsen over the next 
10-20 years. And country-by-country efforts at contingency planning or other 
measures to address the problem are likely to improve in some Member States but 
possibly not to the extent needed to comprehensively address the problem. 

5.1.4.2.  Access to information on FRM for users/buyers 

There are existing efforts at EU-level and in different Member States to develop new 
tools and provide information to FRM users on the suitability of different material to 
current and future climatic conditions. This includes initiatives foreseen by the New EU 
Forest Strategy for 2030, including the provision of information on good practices for 
forest-relevant interventions through the Common Agricultural Policy and the 
development of a toolkit for Member States to “establish life-long programs and advice 
to foresters and adapt education and training to the challenges and needs of today’s 
forest needs and realities, and develop employment opportunities” (EC 2021c). Some 
stakeholders consulted for this study indicated that further guidance and information 
was important but would be best provided at Member State level. In the absence of 
EU intervention it is likely that future efforts to develop more sophisticated tools and 
guidance will be limited in many Member States, and the available tools and 
information will differ significantly across the EU. The impact of any such tools will 
depend in part on the extent to which they are taken up by FRM users and lead to 
them making better planting decisions. No data was collected on the extent to which 
current tools are used or are likely to be used.  

The lack of concerted EU-level action could lead to mixed economic impacts for the 
users of FRM with benefits for users in Member States where better information is 
developed (assuming there is an uptake of that information). Better information can 
result in better planting decisions and forests that are more resilient to and adapting 
better to a changing climate. In Member States where tools and guidance are not 
developed, there will likely be economic losses where this contributes to poor planting 
decisions. There may also be mixed environmental impacts due to different Member 
State approaches regarding the development of FRM tools and guidance, with 
corresponding differences in the resilience of forests being maintained or potentially 
increased. Under the baseline scenario, existing empowerments in the FRM legislation 
could also be used to improve the information provided on FRM, although their effects 
are likely to be limited. 

5.1.4.3.  Scope of FRM policy instrument for forestry and non-

forestry purposes 

In several Member States (e.g. Bulgaria, Slovenia and Spain), some non-forestry 
purposes are already included in scope of the national implementation of the Directive. 
For these Member States, this is already helping to improve the overall quality of FRM 
and reducing the risk of genetic pollution. For Member States where the 
implementation of the FRM Directive is currently more limited in scope, there are likely 
to be different outcomes. Some of these Member States may not have enough 

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production for non-forestry purposes to impact the overall quality of FRM or the 
likelihood of genetic pollution (e.g. as is the case in Finland, as described by the NCA, 
where species planted for ornamental purposes would not be in close proximity to 
areas intended for forestry purposes). In other Member States, there may be national 
efforts to improve the regulation of FRM for non-forestry purposes.  

A majority of NCA (22 of 37) and academic/research institute (9 of 14) respondents to 
the public consultation felt that the scope of the Directive should be extended, which 
suggests that there are some Member States where this poses an issue and where no 
work is currently being done to improve the situation (Q13b, Figure 85). Therefore, it 
is likely that in the absence of legislative changes at the EU level, some Member 
States will see continued use of lower quality FRM for non-forestry purposes, as well 
as a continued or increasing problem with the genetic pollution of FRM for forestry 
purposes, leading to economic losses for the users of FRM, both for non-forestry 
purposes and forestry purposes. This would be counterproductive in terms of EU’s new 
forest strategy, which promotes larger, healthier and more diverse forests to improve 
biodiversity, forest resilience and mitigate the impacts of climate change (EC 2021c). 

5.1.4.4.  Availability of FRM suitable for current and future climatic 

conditions 

Adapting forests to climate change and restoring forests following climate damages 
will also require large quantities of appropriate forest reproductive material (EC 
2021c). Under the baseline scenario, existing empowerments in the legislation could 
be used to introduce assessment of sustainability characteristics for all FRM 
categories. However, some stakeholders consulted for this study indicated that they 
already assess FRM for sustainability characteristics and some indicated that this 
assessment is already provided for in the FRM legislation (Q201). For example, one 
interviewee stated that approval of basic material and minimum requirements under 
the Directive provide for good FRM characteristics that facilitate sustainable 
afforestation and reforestation. Respondents appeared to interpret “sustainability 
characteristics” differently, and survey responses conflicted between respondents from 
the same Member State (e.g. one indicating assessment is mandatory and another 
indicating it is voluntary), data was not sufficient to develop a comprehensive picture 
of what additional assessment is occurring (Q201). Characteristics that consultees 
noted testing for include: suitability of provenance of basic material for particular 
climatic conditions, including conditions under future climate change projections; 
adaptability, for example to water stress, drought, heat, cold, wind hoses / wind 
throws; suitability of tree species for particular climatic conditions, including under 
future climate change projections; and resistance to plant pests (Q201 and Q202).  

5.1.4.5.  Availability of PRM suitable for current and future climatic 

conditions 

Currently new varieties of all regulated agricultural plant species (except fodder plant 
seed intended for grass use) must undergo VCU testing before they can be registered. 
VCU testing is seen by stakeholders consulted for this study as an independent quality 
assurance test associated with reliable, high-quality varieties (Q90 and interview 
data). The quality assurance and unbiased information provided by these tests allows 
for a level playing field as it helps to balance the market power between large 
operators and SMEs (EC 2013b).  

VCU testing is currently applied differently across Member States. Each VCU test must 
include yield, quality, disease resistance and behaviour with respect to physical factors 
in the environment (Commission Directive 2003/90/EC Annex III). EC et al (2021), 
found that in most MS there is no formal inclusion of sustainability criteria, but that 

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sustainability is considered informally or via existing criteria12. Criteria used cover 
issues including the resistance to harmful organisms and stress resistance. According 
to stakeholder responses from the targeted survey the vast majority (88%) of 
agricultural plant species are tested for their sustainability characteristics (Q110). 
Stakeholders also confirmed that various approaches exist in relation to sustainability 
assessment under VCU testing. For example, in Slovakia species are tested for frost 
resistance and in France testing is done on cereals for tolerance to harmful organisms, 
reduction of inputs such as nitrogen and water as well as testing carbon storage 
abilities (See Table 31 in Annex 5 section A5.9.2 for more examples) (Q111). 

There is also large variation in the costs of testing and differing cost systems as some 
Members States use full cost recovery for NCAs (EC 2013b). For example, 
conventional VCU testing of winter wheat in 2020 cost EUR 4652 in Denmark, EUR 
3530 in Sweden and EUR 1424.80 in Austria (EC et al 2021)13. With no EU legislative 
changes to VCU testing this variance is likely to continue as Member States implement 
different criteria.  

Without a harmonised EU-wide policy on sustainability testing, it is likely that Member 
States where such testing is available would continue their demand driven approach. 
This could create an uneven playing field across the EU as tests for these 
characteristics are not standardised.  

Current EU legislation does not require VCU testing for fruit plants, vine, vegetables or 
ornamentals. Despite this, some Member States do carry out testing for sustainability 
characteristics for these plant groups. According to responses from the targeted 
survey (n=55, including 10 NCAs) sustainability characteristics are tested on 42% of 
new varieties of vegetables, 7% of fruits, 5% of vines and 15% of ornamentals 
(Q112).   

Some countries reported that the decision on variety acceptance is based on a 
complex evaluation of all important VCU characteristics, including sustainability 
aspects while other countries use regional trials or a combination of rejection 
thresholds, bonus/malus for eco/non-eco-friendly varieties and coefficients in multi-
criteria index methods (Q113). The precise rules that are applied often depend on the 
species and the evaluation criteria.  

However, the majority of stakeholders surveyed (59% of stakeholders - 40 out of 68 
responses) favoured the introduction of a requirement to examine new varieties for 
characteristics that contribute to sustainable agri-food production in the PRM 
legislation (Q114). In the absence of changes to the current legislative framework 
varying approaches between Member States are expected to persist and potentially 
increase in response to market demand.  

Interviewees also highlighted that testing for disease-resistance is already a key part 
of the DUS testing for some vegetable species. CPVO protocols (CPVO, 2022) state 
that disease-resistance tests are used as a means to distinguish between varieties 
when necessary. Therefore, there is already some legislation in place which promotes 
sustainable characteristics in these varieties. Traditionally close connections between 
breeders, growers and buyers in these other sectors provide the required pressure to 

12 Sustainability characteristics in VCU testing are considered in Belgium, Denmark, Estonia, France, 
Germany, Greece, Italy, the Netherlands, Poland, and Sweden. Further details can be found in Annex 5, 
Table 31 
13 Data extracted from the NCA Survey Raw Data.  

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create a quality system (EC 2013b). Market forces are seen to be effective in driving 
innovation in this area (EC 2008). 

The European Green Deal’s objective to “ensure food security in the face of climate 
change and biodiversity loss” pushes for more resilient varieties which can both 
withstand more extreme changing climates and also support local biodiversity. VCU 
testing is an excellent method for delivering this as it ensures progress against 
previous generations of varieties. However, these agreements need strong backing 
from governments, in the form of regulatory and non-regulatory action14, otherwise 
progress will not be maximised. Therefore, there is still a need to strengthen the 
sustainability aspects of VCU testing. 

Market demand for varieties with more sustainability characteristics, although present 
and in some cases strong, is not uniform across the EU. Targeted survey responses 
regarding the market demand for new varieties of species with characteristics that 
contribute to sustainable agri-food production, indicated that in some countries market 
demand is increasing, while in others it is decreasing (Q109). Therefore, reliance only 
on market demand to produce varieties with these characteristics is likely to lead to a 
scenario where the range of varieties available do not cover all resilience needs in 
terms of pests and climate change mitigation in all Member States. This could leave 
the EU open to food insecurity and declining agricultural livelihoods.  

In addition, under the baseline scenario, existing empowerments such as article 7 of 
Directive 2002/53 on the common catalogue of varieties of agricultural plant species 
can be used to further elaborate the criteria for VCU testing to better cover 
sustainability aspects, while leaving flexibility for Member States to decide whether 
and how to implement them. Crops other than agricultural plant species would 
however not be covered because currently there is not a VCU test requirement nor an 
empowerment to introduce it for these species. Information provided by breeders such 
as that published in marketing documents or national recommendation lists could be 
referred to in these cases. Furthermore, roles and responsibilities of National 
Competent Authorities (NCAs) in charge of registration, VCU and DUS testing would 
continue to evolve based on national strategies.  

5.2. 

Overview of policy options 

The structure of the proposed policy options, and the specific measures that may be 
implemented within each of the options, are described in the sections that follow. 
Error! Reference source not found. lists the proposed measures (numbered M1, 
M2, etc) that align with the objectives of the legislative revision and how they will be 
bundled to form options that aim to achieve the specific objectives of the IA study. 

5.2.1.  Option 1: ‘Highest flexibility’ 

Option 1 aims to maximise flexibility in the implementation of the PRM and FRM policy 
instruments. The 12 Directives would be retained, with specific, targeted amendments 
to simplify and align them with one another. The Commission will make better use of 
the empowerments that already exist in the legislation to address issues identified 
with the legislation and will refer to other legislation where required to ensure 
coherence with other policy areas such as plant health, organics and genetically 
modified organisms (GMOs).  

14 Such as communications, joint government and industry actions and platforms etc.  

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While the structure of the PRM legislation itself remains differentiated, with several 
policy instruments dedicated to specific issues, this option responds to the inconsistent 
interpretation and implementation of the Directives by aligning the structure, 
definitions, and decision-making procedures between the PRM policy instruments 
(M1.1). For example, alignment includes addressing the different definitions for the 
term ‘marketing’ and ‘supplier’ across the policy instruments.  

The rules for official controls on PRM and FRM will be better defined in relation to the 
type and frequencies of controls and harmonised across policy instruments (M2.1). 
The official controls rules would remain outside the scope of the Official Controls 
Regulation.  

The scope of the legislation will be adjusted for certain marketing activities by 
introducing exemptions for the non-profit activities of SCNs (M3.1), exclusive 
marketing to amateur gardeners (M4.1), and in-kind exchange of non-protected 
varieties between farmers (M5.1). This may include such changes as requiring only 
labelling of the variety denomination and fulfilling minimum requirements on plant 
health and quality of the material (e.g. germination rate, technical purity, following 
the denomination rules and providing a description similar to that required for 
conservation varieties). A specific EU framework for in-kind exchange of PRM between 
farmers may also be included. This activity would be exempted from the rules, but the 
framework would define the conditions for the exemption, potentially based on 
existing models in other countries (specifically France and Switzerland). 

Lighter registration requirements for conservation varieties will be introduced in the 
PRM legislation (M6). Lighter marketing requirements will mean there are no 
quantitative restrictions and no restrictions regarding the area where PRM can be 
marketed. Production will remain in the region of origin. These rules will be extended 
to fruit plants and vine.  For all crops the rules will be extended to include new 
varieties adapted to local agro-ecological conditions. 

The need for more organically bred seed comes from the target in the European Green 
Deal which aims for 25% of agricultural land to be under organic farming by 2030. In 
order to address the need for more organically bred seed and organic varieties 
suitable for organic production a policy environment that supports organic varieties 
must be established. This includes through introduction of derogations in testing for 
variety registration where required and requirements to carry out VCU under 
conditions adapted to the principles of organic production. Under Option 1, the PRM 
legislation will refer directly to the rules set out in the Organic Regulation, which 
provides for the exemption of organic heterogeneous material from registration and 
certification requirements and for a new definition of ‘organic variety suitable for 
organic production’. Derogations for uniformity criteria in DUS testing can be 
introduced for organic varieties suitable for organic production (already the case for 
some species). 

The PRM and FRM policy instruments will also be aligned with the plant health 
legislation (M9). Specifically, PRM certification and inspection will refer to the plant 
health rules on RNQPs instead of duplicating them. This alignment will be undertaken 
under all three options. 

Faster adaptation to developments in digitalisation, biomolecular techniques, and 
innovative production processes will be supported by defining the basic principles for 
their use in the policy instruments (M10.1). Empowerments will also be included in the 
policy instruments to establish detailed rules as necessary to accommodate new 
developments. Examples of developments that may be facilitated in this regard 
include innovative PRM and FRM production processes (e.g. production of potatoes 

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through seed instead of tubers), use of digital technologies in certification (e.g. to 
improve traceability and security of the system including label security) and placing 
greater emphasis on the use of scientific and technical developments in the rules 
(e.g. bio-molecular techniques in variety testing and certification). 

Increasing the efficiency and efficacy of the PRM sector will be achieved through a 
series of measures (M11-14). The number of tasks that operators may carry out under 
official supervision will be increased (M11), such as the examination for variety 
registration (e.g. VCU) and field inspection in the context of certification of pre-basic 
and basic seed. For FRM, this would involve enabling operators to carry out certain 
tasks of the FRM certification under official supervision. Supplier registration 
requirements will be harmonised across the policy instruments. Issuing the official 
label will remain a task that can only be undertaken by competent authorities. 

The current rules will be adapted for ‘not yet listed varieties’ to allow multiplication to 
sufficient quantities for marketing while variety registration is ongoing (M12). This 
possibility will be extended to fruit plants and vine, including ‘not yet finally certified’ 
PRM provisions.

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  Summary of the main characteristics of the options 

General 
objective 

Specific objectives 

Option 1 – Highest flexibility 

Option 2 – Balance flexibility & 
harmonisation 

Option 3 – Highest harmonisation 

GO1: Ensure 
no differences 
between MS 
in PRM & FRM 
marketing 

SO1a: Increase 
coherence of the 
policy instruments 
and eliminate 
fragmentation of 
requirements 

SO1b: Create a 
harmonised and 
risk-based OC 
framework 

SO2a: Create 
proportionate rules 
adapted to 
marketing activities 
and types of 
PRM/FRM 

GO2: Ensure 
a wide 
diversity of 
choice and 
quality for all 
types of users 
and 
consumers 

M1.1 Align structure, definitions, and decision-making 
procedures between policy instruments but keep separate 
policy instruments 

M1.2 Align and merge policy instruments 
with a focus on the two pillars of the 
legislation: registration and certification  

M1.3 Align and create a single 
instrument with chapters for crop 
groups  

Keep separate FRM policy instrument 

Keep separate FRM policy instrument 

Keep existing Directive on ornamental 
plants with minimum amendments 

Keep existing Directive on ornamental 
plants with minimum amendments 

M2.1 Harmonise official controls in PRM policy instruments 

M2.2 Tailor-made application of OCR to 
PRM and FRM 

M2.3 Full application of OCR to PRM and 
FRM 

M3.1 Exemptions for activities of SCNs of PRM and FRM for 
forestry purposes 

M3.2 Lighter rules for activities of SCNs 
for PRM and FRM for forestry purposes  

M4.1 Exclusive marketing to amateur gardeners is exempted 
from the scope of the legislation 

M4.2 Lighter rules for exclusive 
marketing to amateur gardeners 

[same as baseline] Activities of SCNs of 
PRM fall under the full scope of the 
marketing legislation 

Activities of SCNs of FRM intended for 
forestry purposes fall under the full 
scope of the marketing legislation 

[same as baseline] Marketing to 
amateur gardeners falls under the full 
scope of the marketing legislation 

M5.1 Exemption for exchange in kind of PRM of non-
protected varieties between farmers  

M5.2 Lighter rules for exchange in kind of 
PRM of non-protected varieties between 
farmers  

[same as baseline] In-kind exchange of 
non-protected varieties between 
farmers falls under the full scope of the 
marketing legislation 

SO2b: Ensure 
conservation and 
sustainable use of 

M6 Define lighter registration requirements (no DUS but 
officially recognised description) for conservation varieties 
and extend them to fruit plants and vine.  

[same as O1]  

[same as O1]  

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General 
objective 

Specific objectives 

Option 1 – Highest flexibility 

Option 2 – Balance flexibility & 
harmonisation 

Option 3 – Highest harmonisation 

plant & forest 
reproductive 
materials  

[same as baseline] No specific action for FRM. Possibility to 
use the existing empowerment. However, if rules are 
introduced by empowerment, the competent authority is 
required to approve the basic material. 

M7.1 Introduce specific rules for the 
production of FRM for the purpose of 
conserving forest genetic resources. 

[same as O2] 

SO2c: Establish 
appropriate 
conditions for testing 
varieties suitable for 
organic production 

[same as baseline] Do not take any actions on organic 
varieties in PRM legislation but refer to Organic Regulation.  

Rely on Organic Regulation and the temporary DUS 
derogations and general principles for VCU testing (if 
adopted). 

M8.1 Refer to Organic Regulation by 
defining variety registration 
requirements.  

M8.2 Refer to Organic Regulation, by 
defining harmonised variety registration 
requirements.  

Retain the flexibility for Member States to 
adapt VCU to local agro-ecological 
conditions. 

GO3: Support 
innovation 
and 
competitive-
ness of the 
EU PRM and 
FRM industry 

SO3a: Improve 
coherence with plant 
health legislation 

SO3b: Support 
innovation and 
competitiveness of 
the EU PRM & FRM 
industry 

SO3c: Increase 
efficiency and 
efficacy of the PRM 
sector 

M9 Align PRM rules with plant health legislation. 

[same as O1] 

[same as O1] 

Certification and inspection of PRM refer to plant health rules 
on RNQPs instead of duplicating them.  

M10.1 Define basic principles on digitalisation, biomolecular 
techniques and innovative production processes and create 
empowerments for detailing rules according to new 
developments 

[same as O1]  

M10.2 Establish detailed rules on 
digitalisation, biomolecular techniques 
and innovative production processes  

M11 Increase certification tasks permitted under official 
supervision except issuing the official label. Permit VCU 
examination under official supervision 

[same as O1] 

[same as O1] 

M12 Adapt the current rules for “not yet listed varieties”, to 
allow multiplication to adequate marketing quantities while 
variety registration is ongoing. Extend to fruit plants and 
vine, including the “not yet finally certified PRM” provisions. 

M13.1 Harmonise procedures for lists of regulated species to 
comitology only. No specific criteria will be introduced. 

[same as O1] 

[same as O1] 

M13.2 Lay down criteria and harmonise 
the procedures for adding/removing 
species from the list of species regulated 
at Union level for PRM and FRM 

[same as O2] 

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General 
objective 

Specific objectives 

Option 1 – Highest flexibility 

Option 2 – Balance flexibility & 
harmonisation 

Option 3 – Highest harmonisation 

M14 Simplify and speed up EU wide market access for new 
varieties of agricultural species and vegetables  

[same as O1] 

[same as O1] 

GO4: 
Contribute to 
wider EU 
objectives 
regarding 
climate 
change 
impacts, food 
security, 
sustainable 
production 
and 
biodiversity 
protection 

SO4a: Address 
difficulties in supply 
of FRM 

[same as baseline] Make use of existing empowerments to 
authorise Member States to use FRM not fulfilling all 
requirements 

M15.1 Maintain the existing derogation 
[O1] 

M15.2 Maintain the existing derogation 
[O1] 

Introduce principle of contingency 
planning 

Lay down detailed rules on contingency 
planning to ensure availability of FRM 

SO4b Provide better 
access to 
information on FRM 
for users/buyers 

SO4c: Clarify scope 
of forestry and non-
forestry purposes 

SO4d: Promote the 
availability of PRM 
suitable for current 
and future climatic 
conditions  

SO4e Promote the 
availability of FRM 
suitable for current 
and future climatic 
conditions 

[same as baseline] Make use of existing empowerments to 
improve the information provided on FRM 

M16 Expand information requirements to 
include information on suitability of FRM 
for climatic/ecological conditions 

[same as O2] 

M17.1 Define forestry and non-forestry purposes but 
maintain current scope of FRM legislation 

M17.2 Define forestry and non-forestry 
purposes and extend scope of FRM 
legislation to include the production of 
FRM for specific non-forestry purposes  

[same as O2] 

[same as baseline] Make use of existing empowerments to 
review and harmonise VCU rules for agricultural species to 
better address sustainability  

M18.1 Review and harmonise VCU rules 
for agricultural species to better address 
sustainability 

M18.2 Detailed and harmonised 
“sustainability criteria” for all crop 
groups.  

For other crop groups, rely on information provided by 
breeders (published e.g. in marketing documents or national 
recommendation lists). 

For other crop groups introduce general 
principles and rules on “sustainability 
criteria” but give MS flexibility to 
implement and adapt to local agro-
ecological conditions. 

[same as baseline] Use existing empowerments to introduce 
assessment of sustainability characteristics for all FRM 
categories 

M19.1 Introduce general principles on 
assessment of sustainability 
characteristics for all FRM categories with 
flexibility for Member States to implement 

M19.2 Detailed and harmonised rules 
on assessment of sustainability 
characteristics for all FRM categories 

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Different procedures for amending the lists of regulated species (co-decision vs. 
comitology) in the policy instruments will be harmonised so that they are all 
conducted by the Commission (M13.1). No specific criteria will be introduced, rather 
the procedure will be followed on demand based on Member State requests.  

The current procedure for enabling EU wide market access for new agricultural species 
and vegetables will be simplified (M14). Currently, the procedure requires an EU level 
decision and publication in the Official Journal. The legislative revisions will enable EU 
market access for new varieties following acceptance in a national catalogue.     

Because the PRM and FRM legislation is outdated, it is not aligned with more recent EU 
objectives, and in particular the European Green Deal. FRM is increasingly required to 
address climate change impacts and support biodiversity conservation activities. 
Option 1 would clarify the rules for FRM marketing by defining forestry and non-
forestry purposes, while maintaining the current scope of the legislation (M17.1). 

5.2.2.  Option 2: Balancing flexibility and harmonisation  

Option 2 seeks to balance the needs for flexibility and harmonisation in the 
implementation of the PRM policy instruments. This option goes a step further towards 
greater structural legislative integration by merging the policy instruments to reduce 
the total number (M1.2) and thereby simplify the rules for NCAs and operators. This 
could be done in different ways, including by focusing on the two pillars of the 
legislation (i.e. registration and certification), by crop groups for which a similar 
approach can be adopted (e.g. agricultural crops) and/or by type of material (seeds, 
PRM other than seeds and FRM). FRM would remain a separate policy instrument. The 
existing Directive on ornamental plants would also be maintained with some minimal 
amendments. 

Under Option 2, a tailor-made approach to official controls (M2.2) would be 
introduced. Indicatively, the OCR general requirements for official controls (Articles 9 
to 15 of the OCR) would apply to PRM and FRM, as well as the rules on competent 
authorities (articles 4 to 8 of the OCR) and the rules on the delegation of certain tasks 
of the competent authorities. However, it would be specified under Article 1(4) of the 
OCR that it does not apply to certain areas of sectoral PRM and FRM legislation. The 
rules and substantial requirements on PRM and FRM certification would remain in the 
PRM and FRM legislation such as the need for official checking at well-defined points in 
time during certification. The OCR principle of risk-based controls would not be 
applicable to certification rules under the PRM and FRM legislation, other than for 
official check testing of the activities carried out under official supervision.  

Under Option 2 PRM and FRM would fall into the OCR’s light system for import controls 
(i.e. low risk goods, not subject to the legal regime applicable to products subject to 
official controls at border control posts). Import controls at the place of destination 
would thus be possible. OCR rules on official laboratories and reference (Articles 37-
42) would be applicable to PRM and FRM, but there would be a derogation from the 
condition for mandatory assessment and accreditation for certain official laboratories 
to allow the continued application of the International Seed Testing Association (ISTA) 
accreditation regime for seed laboratories. OCR rules on reference laboratories and 
reference centres (Articles 92-101) would also be applicable. It would be possible for 
the Commission to designate European Union reference centres to support the 
activities of the Commission and of the MSs to prevent, detect and combat violations 
of PRM and FRM rules perpetrated through fraudulent or deceptive practices, in 
accordance with Article 97 of the OCR. General rules for the financing of official 
controls in the PRM and FRM areas could be provided for, such as the the obligation of 

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Member States to ensure that adequate financial resources are available for the 
competent authorities to perform official controls and other official activities in these 
areas.  

Similar to Option 1, Option 2 addresses different needs within the PRM sector, but 
through lighter rules for certain sectors rather than exemptions. This includes 
dedicated lighter rules for the activities of SCNs for PRM and FRM for forestry purposes 
(M3.2), exclusive marketing to amateur gardeners (M4.2), and exchange in kind of 
PRM of non-protected varieties between farmers (M5.2). 

Lighter registration requirements for conservation varieties will be introduced in the 
PRM legislation (M6) as under Option 1. Additionally, specific rules will be introduced 
for FRM produced for the purpose of conserving forest genetic resources (M7.1). This 
would entail a different approach for the selection and approval of basic material. For 
the purpose of conserving forest genetic resources, producers could retain the entire 
pool of genetically diverse trees as basic material instead of selecting only superior 
trees. For these materials, instead of going through the process of approving basic 
material, the operator wanting to conserve FGR would simply notify the competent 
authority of the stand of trees intended for the purpose of conserving genetic 
resources.  

To promote the availability of organic varieties suitable for organic production, 
legislative revisions under Option 2 will define the variety registration requirements for 
these varieties (M8.1). This would involve permanent DUS derogations and principles 
for VCU testing. Member State authorities would retain the flexibility to adapt VCU to 
local agro-ecological conditions.  

Option 2 will also introduce the possibility to add new species in the scope of the PRM 
and FRM legal framework (M13.2). This may be done by laying down criteria to decide 
on the EU-regulated species (e.g. market volume, production area, climate adaptation 
and ecosystem restoration needs) and harmonising the procedure for adding new 
species to the list across the policy instruments. 

Option 2 would address difficulties in the supply of FRM by maintaining the existing 
derogation for Member States to use FRM that does not fulfil all the requirements (as 
under Option 1), and it would go a step further by introducing the principle of 
contingency planning in the legal instruments (M15.1). Member States will be required 
to prepare a contingency plan to estimate how many seeds and FRM they will need 
from different tree species, but the details will be left for Member States to determine 
for themselves.  

Better access to information on FRM for users/buyers will be enabled by expanding the 
information requirements to include information on the suitability of FRM for climatic 
and other ecological conditions (M16). This would involve harmonising the suppliers’ 
document by developing a single template to be completed by operators. Currently, 
supplier documents differ by Member State, and when FRM is marketed between 
Member States, the receiver does not always have a consistent set of information. 

As under Option 1 forestry and non-forestry purposes will be defined, but the scope of 
the legislation would be extended under Option 2 to cover specific non-forestry 
purposes (e.g. agroforestry, biomass production, energy generation and the pledge to 
plant 3 billion trees) (M17.2).  

VCU rules for agricultural species will be reviewed and harmonised under Option 2 to 
better address sustainability objectives (M18.1) General principles and rules on 
‘sustainability criteria’ will be introduced for species other than agricultural ones to 

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support alignment with the European Green Deal and related strategies. For these 
other crop groups, Member States would be given flexibility in how they implement 
the requirements, which provides opportunity to apply the requirements so that they 
can support development of varieties suited to local agro-ecological conditions. 
General principles for assessment of sustainability characteristics will also be 
introduced for all FRM categories (M19.1), with flexibility for Member States in terms 
of their implementation.   

As under Option 1 the legislative revisions will also:  

  align its rules on RNQPs with the plant health legislation (M9);  

  define basic principles on digitalisation, biomolecular techniques and 

innovative production processes, and create empowerments for detailed 
rules (M10.1); 

 

increase the number of certification tasks permitted under official 
supervision (M11); 

  adapt the rules for ‘not yet listed varieties’ and extend these to fruit plans 

and vine (M12); and 

  simplify the procedure for enabling EU wide market access for new 

agricultural species and vegetables (M14).  

5.2.3.  Option 3: ‘Highest harmonisation’  

Option 3 is the most integrated of the three policy options and aims for the highest 
level of harmonisation between the Member States. Rules for PRM would be 
harmonised and combined within a single instrument containing chapters for individual 
crop groups (M1.3), although FRM would remain a separate legal instrument as under 
Options 1 and 2 and the Directive on ornamental plants would be retained with 
minimal amendments as under Option 2. 

This option implies that differences would be minimised in terms of how the rules are 
applied in different circumstances (i.e. maximum harmonisation).  

Under Option 3, official controls rules would be fully harmonised within the scope of 
the OCR (M2.3).  

All operators, including the activities of SCNs, those marketing to amateur gardeners, 
in-kind exchange of PRM between farmers are within the scope of the legislation as 
under the baseline scenario, without specific exemptions or lighter rules. 

Option 3 will go a step further than Options 1 and 2 by defining and harmonising 
variety registration requirements for organic varieties (M8.2). Detailed rules on 
digitalisation, biomolecular techniques and innovative production processes will also be 
established (M10.2), rather than creating empowerments for such rules to be made 
according to new developments in the future. 

The existing derogation for Member States to use FRM that does not fulfil all the 
requirements will be maintained (as under Options 1 and 2), and it would go a step 
further by laying down detailed rules on contingency planning in the legal instruments 
(M15.2) (rather than general principles).  

Detailed and harmonised ‘sustainability criteria’ (rather than general principles) will be 
introduced for all crop groups (M18.2) and FRM categories (M19.2). 

As under Options 1 and 2, the legislative revisions will also:  

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 

introduce lighter registration requirements for conservation varieties in the PRM 
legislation (M6); 

  align its rules on RNQPs with the plant health legislation (M9);  

 

increase the number of certification tasks permitted under official supervision 
(M11); 

  adapt the rules for ‘not yet listed varieties’ and extend these to fruit plans and 

vine (M12); and 

  simplify the procedure for enabling EU wide market access for new agricultural 

species and vegetables (M14). 

And as under Option 2, the legislative revisions will:  

 

 

introduce specific rules for FRM produced for the purpose of conserving 
forest genetic resources (M7.1); 

introduce the possibility to add new species in the scope of the PRM and 
FRM legal framework (M13.2); 

  expand the information requirements to include information on the 

suitability of FRM for climatic and other ecological conditions (M16); and 

  define forestry and non-forestry purposes and extend the scope of the 

legislation to cover specific non-forestry purposes (M17.2). 

6.  Impacts of the policy options and specific measures 

The impacts of potential revisions to the PRM and FRM policy instruments were initially 
identified via a screening exercise using the template provided by the Better 
Regulation Guidelines Tool #1815 to identify which types of impacts are likely to result 
from the proposed legislative revisions and therefore warrant further examination in 
this impact assessment (Annex 3). The impact screening guided the data collection 
activities for the study. A synthesis of available evidence, structured by study research 
question, is presented in Annex 5. Based on the screening assessment and data 
collected during the study, the following significant impacts were prioritised for 
detailed analysis: 

  Economic impacts: 

-  Administrative burdens on businesses and other operators 

-  Sectoral competitiveness, trade and investment flows 

-  Conduct of business 

- 

Innovation and research 

-  Technological development / digital economy 

- 

Intellectual property rights 

15 Better Regulation Guidelines, Tool #18. https://ec.europa.eu/info/sites/default/files/br_toolbox-
nov_2021_en_0.pdf  

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-  Fraud 

-  Position of SMEs 

-  Functioning of the internal market and competition 

-  Public authorities and budgets 

  Environmental impacts: climate and biodiversity 

  Social impacts: consumers and households 

Potential indirect effects are also considered in the analysis. This section provides the 
analysis by impact category of the policy options under the PRM legislative revision. 

6.1. 

Economic 

6.1.1.  Administrative burdens on business (and other operators) 

6.1.1.1.  Variety registration and PRM certification costs  

Several measures will affect the costs to operators of variety registration and PRM 
certification procedures.  

VCU examination and certification by operators under official supervision 

M11 will provide for VCU examination to be undertaken by operators under official 
supervision as well as an increase in the certification tasks permitted to be undertaken 
by operators under official supervision (except issuing the official label). The measure, 
which is the same across all three options, will potentially generate savings for 
operators in the recurrent costs of variety registration and PRM certification.  

Survey data indicates that obtaining a certification under official supervision is 
estimated to be around 12% less costly to operators than certification performed by 
Member State authorities (Q79).  An illustrative estimate, based on an arbitrary 
assumption of a 10% increase in certifications being undertaken under official 
supervision, indicates a potential cost saving to operators of around EUR 1.1 million 
per annum.16  

No quantitative data was obtained on the potential cost saving of VCU examination 
under official supervision.  An illustrative estimate, assuming a 12% cost saving17 on 
VCU testing indicates an overall saving of around 7% on the average cost of 
registering a variety18.  

In terms of the time it takes to register a new variety, 72% (n=61) of stakeholders 
responding to the targeted survey (Q100) did not foresee changes if operators were 
permitted to carry out VCU tests under official supervision.  Survey responses indicate 
that there are however also upfront (one-off) investment costs required by operators 
to establish the systems and staff to conduct VCU examination and certifications under 
official supervision. Stakeholders, however, were not able to provide data related to 
the scale of such costs.   

16 See Annex A5.3 for further details on the quantitative estimate. 
17 i.e. a similar reduction in costs as seen for certification under official supervision 
18 See Annex A5.3 for further details on the quantitative estimate. 

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Sustainability testing in variety registration processes 

M18 concerns the application of sustainability criteria through variety registration 
processes. Under the baseline, sustainability criteria are already applied by some of 
the Member States through VCU testing that is in place for the regulated agricultural 
species,19 while application varies between Member States (EC et al 2021).  

All options (M18) will harmonise sustainability criteria applied to agricultural species. 
This may result in changes to sustainability-relevant aspects of VCU tests in countries 
where these are already applied, or the addition of sustainability elements in countries 
where they are not already included. Surveyed NCAs indicated that a mandatory 
requirement to examine new varieties for characteristics contributing to sustainable 
agri-food production would have a negative impact on registration costs (Q117). 
Depending on the Member State, these increased costs may be recovered from 
operators thereby increasing administrative burdens for operators. The magnitude of 
these costs will depend on the types of tests required by the new rules/criteria, which 
are not yet defined, and how they compare to existing practices. Hence it was not 
possible to conclude on the scale of likely cost increase.  

For other crop groups20, Option 1 will rely on existing information from breeders and 
hence no significant impacts are anticipated. If operators are required to supply that 
existing information, this is likely to have a negligible or small negative impact on 
administrative burdens. Option 2 (M18.1) will introduce general principles, with 
Member State level flexibility, whilst Option 3 (M18.2) will establish detailed and 
harmonised rules. Both options 2 and 3 are expected to result in new obligations and 
hence an increase in the administrative burden of variety registration. Option 2, due to 
the Member State level flexibility that it provides, may result in variation in cost 
impacts across Member States.  

In the targeted survey, the majority of NCAs were of the opinion that the addition of 
mandatory testing for sustainability characteristics (Q117) would increase breeding 
costs (53%, 9 out of 17) and compliance costs (76%, 13 out of 17). As the changes in 
registration requirements that the options will require are not known, it is difficult for 
all stakeholders to conclude on the likely scale of impact on costs. Survey data 
indicated that, per operator, total annual breeding costs could increase by EUR 18,500 
(survey data provided by business associations) and total annual compliance costs 
could increase by EUR 29,600 (survey data provided by business associations and 
businesses) (Q119). These increased costs would be particularly evident in sectors 
where VCU testing is not currently carried out. There is no data on the anticipated fee 
that may be charged for a mandatory sustainability test for non-agricultural crops. An 
illustrative estimate is established by taking the average fee of a VCU test as a proxy 
for a sustainability test. On this basis, it can be estimated that the addition of 
mandatory sustainability testing command a fee of EUR 1,332, resulting in a total cost 
to non-agricultural crop sectors of around EUR 2.1million per year21 (based on 2019 
application data and an average cost of VCU testing). In the absence of harmonised 
pricing arrangements it is not yet possible to determine the extent to which these 

19 See Annex A5.9 
20 Fruit, vine, vegetable and ornamentals 
21 Calculation: fee of 1,332 (calculated from VCU test fee data collected by the MS survey in EC et al 2021) 
multiplied by 1,562 registrations of new varieties per annum for ‘other than agricultural plant species’ 
(calculated from survey data on number of registration applications for species other than agricultural plant 
species in 2019 collected by the MS survey in EC et al 2021). 

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price increases would be levied only on the operators applying for the tests, or 
whether costs could be split with NCAs.  

Examining organic varieties suitable for organic production 

VCU testing adapted to the characteristics of organic varieties (M8) is not available in 
all Member States (5 of 18 Member States responding to the targeted survey offer 
such VCU tests) (Q104). Some MS however explained that they do not foresee VCU 
tests for organic varieties because they have not received applications for examination 
of such varieties (Q106). The cost of organic testing is higher than conventional 
testing in some cases, as operators have to pay for conventional testing as well as the 
supplementary organic testing. For example, data from Denmark in 2012 indicate that 
supplementary organic testing added to conventional testing resulted in total fees of 
EUR 3,900 whereas conventional testing cost up to EUR 2,026 (Pedersen, 2012). 
Survey data indicates that the most common view was that VCU costs for organic 
breeders would increase (this was the case regardless of whether a Member State 
already offered adapted VCU or not) but that administrative burdens would decrease 
(Figure 154) (Q107). The new derogatory approach for some species for DUS and VCU 
testing adapted to the characteristics of organic varieties will start in 2023 and results 
are not yet available. The impacts on VCU cost increases for breeders are likely to be 
similar across all options.   

Options M8.2 and M8.3 introduce derogation to DUS testing which is expected to 
result in more organic varieties being registered but could, at the same time, increase 
testing costs (depending on the complexity of the test) negatively impacting both 
operators and NCAs (although the evidence of the impact on costs is not clear). 

Conservation varieties   

M6 will introduce lighter registration requirements (no DUS but officially recognised 
description) for conservation varieties and extend these requirements to fruit plants 
and vine (for which no existing derogations for conservation varieties are in place). 
The same measure will apply across all three options. Registration fees for 
conservation and amateur varieties are lower than for conventional varieties in many 
Member States (e.g. Estonia, Lithuania, Norway, Czechia, Ireland), or even free of 
costs (e.g. Italy, Estonia, Cyprus, Bulgaria, Hungary, Denmark, Finland). In some 
cases, technical examination requirements are also lighter. Survey data from the 2021 
study indicates that the costs for operators of the conservation variety registration 
process could already be around 20% that of conventional varieties (i.e. less than EUR 
1,000), and that lighter rules are likely to decrease such costs. The extent of this 
impact will depend on what the lighter requirements are – removal of DUS tests may 
have a significant effect in Member States where a charge is levied for conservation 
variety DUS tests (e.g. Slovenia EUR 200, Greece 45% of standard DUS charge)22. 
There is insufficient data on the annual number of conservation variety registrations – 
although indications are that they account for a very small proportion of the overall 
market – and on the cost structure of registrations to establish a meaningful estimate 
of the impact on costs. 

The potential cost savings for operators from removing DUS testing for fruit and vine 
propagating material are similarly uncertain. The European Commission’s 2013 Impact 
Assessment (EC 2013b) reported that DUS testing for fruit propagating material is 
approximately 30% more expensive than testing for agricultural varieties; however 

22 EC et al (2021). Processed data file on NCA technical fees collected from Member States 

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data collected from Member States as part of EC et al 2021 showed significant 
variation across Member States (e.g. in Germany DUS test technical fees for vine 
varieties were approximately 22% more expensive that for other variety types at EUR 
1650; whereas in Czechia DUS technical fees for fruit and vine varieties were, 
respectively, approximately 22% and 39% less expensive than the average for other 
variety types at EUR 246 and EUR 170). Removal of DUS testing can be expected to 
decrease total annual costs for operators, in those Member States where operators are 
charged DUS test fees, by between a few hundred Euros and over a thousand Euros 
(depending on the Member State). 

Application of the legislation to seed conservation networks 

M3 concerns the application of the marketing directives to the activities on SCNs, with 
variations in the measure under each option. For option 1 (M3.1), targeted survey 
data (Figure 171) indicate that stakeholders expect this would result in a reduction in 
costs for SCN operators (Q143). There is insufficient data on the scale of marketing by 
SCNs to determine any quantitative estimate of the cost savings. Under option 2, 
M3.2 will apply lighter requirements. Survey data (Figure 172) indicate that cost 
savings are still anticipated, although the extent may be less than under Option 1 and 
will depend on the specifics of the lighter requirements (Q145). Option 3 envisages 
no changes and hence no cost impacts are anticipated. 

Application of the legislation to exclusive marketing to amateur gardeners 

M4 concerns the application of the marketing directives to the exclusive marketing of 
PRM to amateur gardeners (M4), with variations in the measure under each option. 
For option 1 (M4.1), targeted survey data (Figure 166) indicates that stakeholders 
expect this would result in a reduction in costs for operators (Q134). However, the 
PRM focus group (A9.2.3.1) indicated that any such reduction would not be 
meaningful, because the relative share of total costs account for by registration costs 
and certification costs in the amateur gardener market is very small. There is 
insufficient data on the scale of marketing to amateur gardeners to determine any 
quantitative estimate of the cost savings. Under option 2, M4.2 will apply lighter 
requirements. Survey data (Figure 167) indicate that cost savings are still anticipated, 
although the extent may be less than under Option 1 and will depend on the specifics 
of the lighter requirements (Q135). Option 3 envisages no changes and hence no cost 
impacts are anticipated. 

Changes to the lists of regulated species 

M13 will potentially result in changes to the lists of species regulated at EU level for 
PRM and FRM. Where species are excluded from the scope, this will remove the 
administrative burdens of registration and certification for those species. Where 
species are added in the scope, this will increase administrative burdens. All options 
are expected to make it easier for the lists of regulated species to be updated through 
a harmonisation of procedures, which may result in more changes and hence more 
changes in associated administrative burdens. Options 2 and 3 will also introduce 
specific criteria that will enable strategic consideration to be given to which species are 
included or excluded. These criteria have not yet been established but could, for 
example, be based on the economic significance of a species with some cut-off rate in 
terms of market production or value applied. It is not possible to determine the scale 
of impact, nor whether this will overall be a net increase or decrease on administrative 
burdens, as it is not possible to prejudge the potential changes to the regulated 
species lists. 

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6.1.1.2.  FRM  

Registration of basic material 

Options 2 and 3 [M7.1] would mean that businesses wishing to register basic 
material intended for the conservation of forest genetic resources would not bear the 
costs of, or be exempt from, the certification process. Respondents to the targeted 
survey indicated that fees charged vary significantly between Member States: in some 
Member States NCAs did not provide data for the cost of certification, while in other 
Member States they reported various average costs per application (e.g. 335 EUR; 
260 EUR) (Q198). Reductions in the administrative burden for those businesses who 
would make use of the derogation are possible and as such, this has been assessed as 
a small positive impact. 

FRM certification under official supervision 

M11 applies to all options. The FRM legislation does not allow FRM certification to be 
undertaken by operators under official supervision. Interviewees indicated concerns 
about fraud and conflict of interest, meaning it is unclear the extent to which this 
approach would be taken up, should it become possible. The positive impact on costs 
is therefore assumed to be small. 

Information provided on FRM 

Under all options, expanding (Options 2 and 3) and enhancing (Option 1) information 
requirements (M16) is anticipated to increase the administrative burdens on business. 
However, anecdotal evidence from stakeholder interviews and workshop indicate that 
information would be relatively simple to provide and hence would not add 
significantly to the existing administrative burdens.  

Forestry and non-forestry purposes 

Options 2 and 3 (M17.2) will expand the scope of the PRM legislation to apply to 
non-forestry purposes. This will result in an increase in administrative burden for 
operators in those Member States where non-forestry use is not currently in scope. 
Option 1 (M17.1) will not expand the scope but will define non-forestry purposes. 
This may increase or decrease the activities in scope of the legislation, depending on 
the current situation in Member States. There was insufficient evidence to conclude on 
the net impact of Option 1.   

Assessment of sustainability characteristics 

All options (M19) will introduce measures regarding sustainability assessments for 
FRM. These may impact on costs, depending on the nature of the resulting 
assessments and how they compare to the baseline. It was not feasible to collect 
evidence on the nature of these assessments nor the potential impact on costs, hence 
no conclusion on the impacts can be made.  

6.1.1.3.  PRM and FRM  

M1 will increase alignment between the PRM policy instruments. Survey data indicates 
that improved alignment will help to minimise the administrative burdens associated 
with navigating the rules (Q3 and Q5).  

M2 formalises the principles of risk-based marketing, production and import controls 
for three options. This has the potential to shift how the burden of cooperating with 
controls is distributed across operators. It may reduce the administrative burdens on 
more compliant / less risky businesses by reducing the intensity of official controls 

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that they are subject to. The opposite may be true for less compliant or otherwise 
higher risk operators/activities23. The principles of risk-based marketing and import 
controls are common to all three options. Under all options, Member States that do 
not currently take a risk-based approach may see an improvement in the quality of 
PRM by reducing the risk of fraudulent PRM entering the market. The scale of impact 
will depend on the perceived riskiness of a business’ activities, and their historic level 
of compliance. The OCR was perceived by interviewed NCAs as inappropriate for the 
FRM sector due to its focus on the agri-food chain.   

M10 may help reduce businesses’ administrative burdens through the application of 
digital technologies to decrease the time and volume of paperwork required for 
registration and certification activities. However, there were concerns that detailed 
rules on digitalisation set out in Option 3 will present a greater administrative burden 
for businesses because they would require more resources to interpret and implement 
the rules into their existing business processes. Options 1 and 2 only require 
businesses (or Member State implementation) to follow basic principles, allowing them 
more flexibility that can be more tailed to national/business needs.  

  Summary of administrative burden impacts 

Measure 

Registration and certification costs 

M3 Scope of the PRM legislation applied to SCNs 

M4 Amateur gardeners 

M6 Registration requirements for conservation varieties 

M8 Registration of organic varieties 

M11 Certification tasks permitted under official supervision 

M13: Changes to lists of regulated species 

M18 Review and harmonise VCU rules for agricultural species and 
develop sustainability criteria for other species 

FRM 

M7 Rules for producing FRM for the purpose of conserving FGR 

M11 Certification tasks permitted under official supervision 

M16 Measures to improve access to information on FRM  

M17 Clarify scope of forestry and non-forestry purposes 

M19 Assessment of sustainability characteristics for all FRM 
categories 

PRM and FRM 

M1 Align instruments 

M2 Harmonise Official Controls 

M10 Support the use of digitalisation, biomolecular techniques and 
innovative production processes 

O1 

+ 

+ 

+ 

- 

+ 

-/+ 

- 

= 

= 

- 

-/+ 

-/+ 

+ 

= 

+ 

O2 

-/+ 

-/+ 

+ 

- 

+ 

-/+ 

-- 

+ 

= 

- 

- 

O3 

= 

= 

+ 

- 

+ 

-/+ 

-- 

+ 

= 

- 

- 

-/+ 

-/+ 

+ 

= 

+ 

+ 

= 

-/+ 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain scenario. 

23 Operators with a good record from official controls performed and with reliable own controls and good 
results of own controls 

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6.1.2.  Sectoral competitiveness, trade and investment flows 

6.1.2.1.  Investment 

Amateur gardener market 

M4 will adjust the extent to which the PRM legislation applies to PRM marketed 
exclusively for amateur gardeners. The impact on investment is not clear-cut. A 
shared view among smaller operators, civil society organisations and NGOs is that 
Option 1 (M4.1), in providing an exemption which would reduce administrative costs 
of marketing to amateur gardeners, would incentivise breeding and marketing (Q134). 
However, others – including some operators, business associations and NCAs – 
anticipate that an exemption could disincentivise investment due to concerns 
regarding variety protection, a lack of standards in the market and unfair competition 
between those producing varieties exclusively for amateur gardeners and those 
producing varieties for both amateur and professional users (Q134)24. This indicates a 
potential shift in the extent to which different types of actors invest in the amateur 
gardener market, although the net effect on the overall scale of market investment is 
not clear. The imposition of lighter/ basic requirements under Option 2 (M4.2) could 
help mitigate the identified disincentive for existing operators by offering minimum 
assurance of seed quality and health, but may not sufficiently remove regulatory 
barriers and costs to sufficiently encourage investment from small operators and 
NGOs. Option 3 does not change the status quo; hence no impact is expected. 

Investment in breeding of new varieties 

M12 and M14 both address the time it takes to bring new varieties to market, which is 
identified in EC et al (2021) as a disincentive to investment. Both measures will bring 
forward the time at which breeders and growers can achieve returns on investment. 
Survey data (Figure 184) indicate that these measures will have a positive impact on 
investment (Q179). M12 applies to all Options. It will adapt the current rules for “not 
yet listed varieties”, to allow multiplication to adequate marketing quantities while 
variety registration is ongoing. Feedback from stakeholders suggests this could 
facilitate faster and easier market access. This is particularly the case for fruit plants. 
The long time that it takes to register fruit varieties (4-7 years) is a challenge for 
operators under the current rules. M14 applies to all options. It will enable new 
varieties of agricultural species and vegetables to be marketed EU-wide following 
acceptance into a national catalogue. This removes delays, which vary considerably 
across Member States, between varieties being accepted into national catalogues and 
then in turn accepted into the EU catalogues, removing a disincentive to investment 
(EC et al, 2021). All options for M12 and M14 will both bring forward the point at 
which operators are able to generate returns on their investment.  

M13 may result in changes to the lists of regulated species. All options will make 
such changes easier, and where changes occur this may impact on investment 
incentives. The effects will vary across operators. For some (e.g. NGOs, small 
operators), the reduced administrative burdens of removing species from the list is 
expected to have a positive effect, whilst for others (e.g. larger commercial operators) 
removal of species (and associated removal of regulatory oversight) may have a 
negative effect. And vice-versa for species that are added to the lists. The number of 

24 A majority of survey respondents (33 of 45 respondents, in particular businesses, business associations, 
and NGOs) indicated that they market varieties to amateur gardeners. One third (8 of 26 respondents) 
indicated that they market varieties exclusively to amateur gardeners (see Section A8.7.1). 

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species affected is likely to be small, and driven by wider market trends e.g. the 
increasing or decreasing economic importance of the species. The factors underlying 
these market trends will be the primary drivers of investment, and the measure itself 
is not expected to have a significant impact on the overall level of market investment 
in breeding or marketing of such species.  

Conservation varieties  

M6 applies to all Options. It will define lighter registration requirements for 
conservation varieties (including fruit and vine). Production and marketing costs of 
conservation varieties are often higher than for conventional varieties, reflecting the 
labour intensity and extent of expertise required to cultivate and produce native seeds 
used in preservation mixtures (EC et al, 2021). These costs are considered to be an 
important limiting factor on the market. Lighter rules are likely to decrease the cost of 
production as a result of the reduced administrative burden of registration (see section 
6.1.1.1). However several other limiting factors will remain, including low demand 
(which may in turn be influenced by prices and region of origin rules) and quantitative 
limits on production (which will place a cap on the extent to which investment in 
conservation varieties can increase). Evidence from the PRM focus group, targeted 
survey (Q55) and public consultation (additional statements provided by respondents) 
indicate that lighter registration requirements may have a limited impact on 
investment overall, and a positive effect on investment by smaller and not-for-profit 
operators.  

6.1.2.2.  Competition  

Several measures will result in some level of deregulation or lighter application of 
regulations in different part of the PRM and FRM market. These may reduce current 
barriers to market entry, particularly for smaller operators, through their impact on 
reducing administrative burdens and increasing investment incentives. The stronger 
these impacts, the more likely new actors are to enter the market and hence enhance 
competition on the EU market. For some measures (e.g. M3, M4), Option 1 provides 
the strongest effect, followed by Option 2, then Option 3. For other measures (e.g. 
M6) there is no difference across the options. 

M5 will change the scope of PRM legislation as it applies to in-kind exchange between 
farmers. Under Option 1 (M5.1) in-kind exchange could account for up to 1.0 per cent 
of the market25. This reflects an anticipated increase compared to the baseline, 
although the scale of increase is unknown as there is no data on current in-kind 
exchange activity. Evidence from the French case study (Annex 10) indicates that 
farmers participating in in-kind exchange are typically small-scale, ranging from a few 
hundreds to the low thousands, and not the primary purchasers of commercial PRM. 
The experience from France (as discussed in Annex 10) shows that the risks to 
commercial producers of seeds are negligible to inexistant. This is in contrast with the 
production by farmers of their own seeds from registered varieties, which predates 
such derogations and is carried out by farmers not involved in exchanges of non-
registered seeds. Any effect on the competitive position of commercial seed producers, 
and the scale of the commercial seed market, is therefore expected to be small.   

25 Based on findings from the French case study (Annex 10), which indicates that the number of farmers 
currently engaging in in-kind exchanges ranges between a few hundred to the low thousands, and Eurostat 
data on the number of farms in France (which, as of 2016, was 456,520). A plausible range for the 
proportion of farmers engaged in in-kind exchange in France is therefore estimated as: lower-end 
(100/456,520*100) to higher-end: (1,000/456,520*100) 

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Options 2 (M5.2) and 3 are not expected to have any meaningful effect on in-kind 
exchange activity (see Section 6.1.3) and hence there will be no impacts on 
competition.  

6.1.2.3.  Summary of competitiveness and investment impacts 

  Summary of conduct of competitiveness, trade and investment 

impacts  

Measure 

Investment 

O1 

O2 

O3 

M4 Amateur gardeners 

-/+ 

M6 Registration requirements for conservation & amateur varieties 

-/+ 

M12 Rules for ‘not yet listed’ varieties 

M14 National catalogues 

M13 Regulated species 

Competition 

M3 Seed Conservation Networks 

M4 Amateur gardeners 

M5 In-kind exchange between farmers 

M6 Conservation varieties 

+ 

+ 

= 

+ 

+ 

= 

+ 

-/+ 

-/+ 

+ 

+ 

= 

= 

= 

= 

+ 

= 

-/+ 

+ 

+ 

= 

= 

= 

= 

+ 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.1.3.  Conduct of business 

6.1.3.1.  Specific user groups 

Activities of SCNs 

SCN activities will be positively impacted by the proposed measures under Option 1 
and Option 2 as a result of reduced administrative burdens (see Section 6.1.1). In the 
context of Option 1 (M3.1), survey data (Figure 171) indicate a likely increase in the 
number of SCNs in the EU and the number of members participating in them/ their 
activities and an increase in the number of varieties and species and volume of PRM 
exchanged (Q143). Option 2 (M3.2) will have a more muted effect (Figure 172). The 
number of SCNs and scale of membership are unlikely to be affected, but the number 
of varieties and species and volume of PRM exchanged are expected to increase, 
although to a lesser degree than under Option 1. Under Option 3, no impacts are 
expected in comparison to the baseline.  

In-kind exchange between farmers 

Option 1 (M5.1), which exempts in-kind exchanges between farmers from the PRM 
legislation may boost participation in exchanges, including volumes/ quantities of PRM 
and the number of varieties exchanged between farmers. As such, it is expected that 
more farmers will be encouraged to participate in exchange activities. Based on data 

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of participation in in-kind exchange in France, it is estimated that between 0.1 and 
1.0% of EU farmers may participate in in-kind exchange under Option 1. This is likely 
to equate to a volume of seed exchanged of significantly less than 0.1 to 1.0% of the 
total market volume, given it is typically smaller farmers who participate.  

The extent to which this increase compares to the baseline is unknown. Exchange in-
kind is not permitted in most Member States, although evidence indicates that it does 
occur in Member States where it is disallowed. No data is available on the extent of 
this activity. Increased participation, and any associated increase in the seeds 
exchanged, will offer a broader spread of farmers’ (given in-kind exchanges occurs on 
a localised basis) access to varieties which are suggested to be potentially better 
adapted to local climatic and environmental conditions. It will also bring a risk that 
participating farmers access PRM of lesser quality.   

Both Option 2 (M5.2) and Option 3 (no additional measures) are expected to have 
either no impact or a negative impact on in-kind exchange. In the few Member States 
where in-kind exchange is currently permitted, imposition of EU rules may add costs 
and administrative barriers that reduce in-kind exchange activity. 

6.1.3.2.  Quantity and quality of PRM and FRM 

Several of the proposed measures are expected to influence the quantity and quality 
of PRM and FRM available on the EU market.   

Sustainability  

M18 concerns the application of sustainability rules/criteria through variety 
registration processes. Data from the targeted survey (Q109) indicates that 
stakeholders see a stable or increasing market potential in the EU for new varieties 
with characteristics that contribute to sustainable agri-food production (for example, 
reduced reliance on plant protection products and/or fertilisers, increased tolerance to 
plant pests and/or difficult environmental conditions) (Figure 155). A revision to the 
PRM policy instruments to introduce an EU requirement to examine new varieties for 
sustainability characteristics would likely result in increased innovation in breeding 
varieties that will satisfy those characteristics (section 6.1.4). Survey data indicates 
that the impacts of applying sustainability rules/criteria could include an increase in 
the quality (9 out of 17 respondents) and sustainability (11 out of 17 respondents) of 
available varieties (Q117). But it may also result in an increase in costs of breeding (9 
of 17 respondents), compliance costs (13 of 17 respondents) and market access 
burdens for breeders (9 of 17) (Q117). 

For agricultural species, Options 1 and 2 will provide the same regulatory incentives 
for breeders to innovate towards varieties with more sustainability characteristics. The 
options will harmonise VCU rules but may offer flexibility in their implementation to 
Member States. Option 3 will provide detailed sustainability criteria, which may not 
offer the same flexibility. Hence, under Options 1 and 2 there may be opportunity to 
introduce sustainability testing that is more appropriate to local/regional sustainability 
needs than might be the case under Option 3. Options 1 and 2 may therefore better 
support development of varieties adapted to more niche environments, which may 
only be found in small regions. 

For other crop types, Option 1 provides a weak incentive and may have a negligible 
impact on the availability of more varieties with sustainability characteristics. Options 
2 and 3 provide a stronger regulatory incentive and can be expected to result in an 
increase in the quality and sustainability of varieties (although some breeders already 
consider sustainability characteristics under the baseline). However these two options 

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are also more likely to impose additional costs on breeders. There are some concerns 
that this will result in a delay and reduction in new varieties coming to market, 
reducing diversity and choice (Survey, Q118; Interviews with NCAs and industry 
bodies). The options will likely differ in the sustainability characteristics that they 
stimulate, as described for agricultural species. 

VCU and certification under official supervision 

M11 applies to all options. It is unlikely that the quality of PRM would decrease 
under this measure, although strong official supervision from NCAs would be required 
to ensure that processes are carried out correctly. A temporary experiment on field 
inspection under official supervision for pre-basic and basic seed was carried out from 
2012-2019 (EC 2019a), which showed that there was little deviation in quality 
compared to official inspections. No impact is expected on the quality and quantity of 
PRM available. 

Conservation varieties  

M6 applies to all options. Lighter registration requirements, which will likely reduce 
administrative burdens (section 6.1.1), are expected to have a positive impact on the 
available quantity of conservation varieties. Evidence (e.g. EC et al. 2021) shows that 
multiple other factors constrain supply of conservation varieties, including high 
production costs, low demand (which may in turn be influenced by prices and region of 
origin rules) and quantitative limits on production. As lighter rules are expected to 
stimulate investment from small operators (section 6.1.2), any associated increase in 
supply may be similarly small. Larger increases may not be possible given production 
limits. No changes to the region of origin concept are envisaged, which will continue to 
limit access to conservation varieties that may be appropriate for use outside their 
original geographic area. Overall, the measure is expected to have a negligible impact 
on the quantity of conservation varieties available to users. Concerns were expressed 
by some stakeholders during interview (3 NCAs and 3 sector representative 
associations) that lighter rules may have a negative impact on phytosanitary risk and 
varietal purity. Impact on quality is difficult to estimate due in part to diverging views 
between stakeholder types. Commercial operators generally consider that lighter rules 
would have a negative impact on the quality of conservation varieties, whereas NGOs 
and academic institutions generally believe that quality would remain unaffected 
(Q55). 

Not yet listed varieties 

Allowing the marketing of PRM of ‘not yet listed’ varieties (M12), which applies to all 
options, is likely to lead to an increase in the diversity and quantity of PRM. 
Stakeholder opinion was divided on whether the measure would have a negative 
impact on freedom from plant pests, with a high proportion believing there would be 
no impact, whilst the risk of material not meeting plant health regulation standards 
was raised by some stakeholders. 

Organic varieties 

M8 seeks to ensure that registration and testing that is better adapted for organic 
varieties is available in all Member States. Several stakeholder groups – including 
public authorities and NGOs – expect this to lead to more organic varieties becoming 
available on the EU market; however, most businesses and business associations 
thought that it would not (Q107). There were mixed views from stakeholders on the 
impact on quality and quantity of organic varieties. Some stakeholders were 
concerned that, because organic varieties can also be used in non-organic production, 

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adjusting testing would result in a decrease in PRM quality. The majority (51%, 36 out 
of 70) of survey respondents felt that a derogation for DUS standards for organic 
production would have no impact on quantity available of organic varieties (Figure 
118) (Q41 and Q42). The majority of respondents (25 out of 36) were businesses and 
associations and a minority were NCAs (8 out of 36) (Q41 and Q42). However, a small 
proportion of survey respondents (23%, 16 out of 70) felt that such a derogation 
would increase availability of organic varieties – including all four NGO respondents, 
five (of 18) NCA respondents, and two (of four) academic institution respondents 
(Q41). This increase may be more likely in instances where breeders are not also 
seeking plant variety rights (Q42). It is concluded that there may be a small positive 
impact on the quality of organic varieties available on the market.  

Quality of PRM and FRM imports 

PRM and FRM imports from third countries are required to meet equivalent standards 
to PRM and FRM produced within the EU. M2 addresses harmonisation of PRM and 
FRM legislation with the OCR (M2.1), and the partial (M2.2) or full (M2.3) inclusion of 
PRM and FRM in the OCR. In Options 1 (M2.1) and 2 (M2.2) PRM and FRM would be 
in the lighter regime for import controls, which is risk-based and allows checks to be 
carried out on consignments at any appropriate place within the EU. The introduction 
of a risk-based approach could support higher quality imported PRM and FRM and 
reduce the risk of fraudulent PRM and FRM imports arriving in MS that currently do not 
take risk-based approaches to these imports. Under Option 3 (M2.3) PRM and FRM 
would become part of the stricter regime for imports from third countries in the OCR, 
which means all consignments would need to be controlled at border control posts on 
first arrival into the EU. This would go a step further in preventing PRM and FRM that 
is non-compliant with EU standards from entering the Union market, and therefore 
protect the EU market and its actors from sub-standard PRM. However, there may be 
variation across Member States as regards identity and/or physical checks, in case a 
minimum frequency of such checks is established at EU level and certain MSs decide 
to establish higher frequency rates at national level. In Member States that have more 
relaxed import controls, all three options may reduce the likelihood of non-compliant 
imports. However, those MS already implementing strong import controls on PRM and 
FRM are less likely to see an effect. This explains the mixed opinions of stakeholders 
on this issue.  

FRM 

Problems in supply combined with the use of lower quality FRM and/or FRM not 
suitable for the regional environmental and climatic conditions can lead to decreases 
in activity that uses FRM, and this can lead to significant economic losses for 
businesses. NCAs recognise the need for better contingency planning (NCA 
interviews), but a majority do not think that rules on contingency planning should be 
included in the FRM legislation (Figure 88). Options 2 and 3 (M15.1 and M15.2) 
will encourage greater contingency planning across the EU. Interviewed NCAs 
generally considered that contingency planning is best conducted at national level, to 
account for the specific needs and challenges faced by each Member State, implying 
that Option 2 (which provides for general principles) could result in better outcomes 
than Option 3 (which would lay down specific EU rules). Both options should have a 
positive impact on supply and access to FRM.   

The ability to select material that has a greater chance of surviving and thriving in 
current and future climatic conditions provides an economic benefit to users of FRM. 
Options 2 and 3 (M16) are expected to improve access to information on FRM, and 
hence enhance their ability to select the most appropriate FRM. 

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Options 2 and 3 (M17.2) will expand the scope of the FRM legislation to apply to 
non-forestry purposes. Survey data (Figure 205) indicates mixed views on the impact 
of this on the sufficiency of supply of FRM for non-forestry purposes, but the most 
common view was that it would increase the quality of FRM marketed for non-forestry 
purposes (Q217). Option 1 (M17.1) will not expand the scope but will define non-
forestry purposes. This may either increase or decrease the activities in scope of the 
legislation, depending on the current situation in Member States. There was 
insufficient evidence to conclude on the net impact of Option 1, although it may be 
expected to be limited.  

6.1.3.3.  Use of technology 

M10 will better enable businesses and NCAs to enjoy the efficiency gains offered by 
scientific and technological developments. Enabling the use of biomolecular techniques 
in DUS testing would make the process more efficient by reducing the need for 
physical monitoring, because a variety’s characteristics could be established with 
molecular markers. Additionally, varieties can currently fail DUS testing despite having 
a superior VCU (Gilliland et al, 2020). Varieties that fail DUS testing cannot be 
registered or gain the Plant Variety Rights (PVR) that would protect their investment. 
Using genetic markers to support DUS testing would allow a more accurate 
assessment of such varieties’ distinctness, reducing the likelihood of it being ‘blocked’ 
from achieving PVR by another variety. However, scientific and technological 
developments are costly, and businesses will need to invest in their use, meaning that 
the opportunities may only be taken up by part of the market (at least in the short 
term). In particular for smaller actors, biomolecular techniques are often cost 
prohibitive. UPOV does allow use of molecular markers as part of DUS testing. 
However, Yu and Chung (2021) concluded UPOV did not adequately accommodate 
advances in molecular technologies. Options 1 and 2 (M10.1) offer greater flexibility 
for Member State implementation / business use of scientific/technological 
developments, which may make adoption of such developments easier than under 
Option 3 (M10.2). As shown by the following table, in terms of use of technology, 
stakeholders would benefit most under Option 2.   

  Summary of conduct of business impacts  

Measure 

O1 

O2 

O3 

Specific user groups 

M3 Seed Conservation Networks 

M5 Rules for in-kind exchange of PRM between farmers 

Quantity and quality of PRM 

+ 

+ 

+ 

= 

= 

= 

M2 Harmonise Official Controls 

+/- 

+/- 

+/- 

M6 Registration requirements for conservation & amateur varieties  = 

M8 Registration of organic varieties 

M11 Certification tasks permitted under official supervision 

M12 Rules for ‘not yet listed’ varieties 

+ 

= 

= 

= 

+ 

= 

= 

= 

+ 

= 

= 

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Measure 

M18 Review and harmonise VCU rules for agricultural species and 
develop sustainability criteria for other species 

FRM 

M15 Measures to address difficulties in supply of FRM 

M16 Measures to improve access to information on FRM  

O1 

-/+ 

= 

= 

M17 Clarify scope of forestry and non-forestry purposes 

-/+ 

Use of technology 

M10 Support the use of digitalisation, biomolecular techniques and 
innovative production processes 

+ 

O2 

-/+ 

+ 

+ 

+ 

+ 

O3 

-/+ 

+ 

+ 

+ 

+ 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.1.4.  Innovation and research  

Several proposed measures are expected to have an impact on innovation and 
research, particularly those aimed at supporting biomolecular techniques and 
innovative production processes (M10).  

Innovation in PRM and FRM breeding and production processes 

Options 1 and 2 will define basic principles on biomolecular techniques and 
innovative production processes and create empowerments for detailing rules 
according to new developments (M10.1). The confidence of both industry and NCAs to 
invest in biomolecular techniques and innovative production processes is likely to 
increase where there is legal backing for the use of technologies. Offering flexibility 
through the establishment of general principles will also facilitate adaptation to specific 
circumstances and accommodate changes over time (including changes in the uses of 
those technologies and the development of new technologies). The detailed rules that 
would be introduced under Option 3 (M10.2) could be more restrictive or even act as 
a disincentive by offering less flexibility and being more prescriptive about the use of 
these technologies.  

Innovation in varieties with more sustainability characteristics 

A revision to PRM legislation to introduce an EU requirement to examine new varieties 
for sustainability characteristics (M18) would have have a positive effect on PRM 
innovation (survey data, section A5.10.2), as would the comparable measure for FRM 
(M19) by incentivising breeders to develop varieties with new characteristics. For 
agricultural species, all of the options are expected to provide the same strength of 
incentive to innovate (although they may channel innovation towards different 
sustainability characteristics, depending on the detailed rules and criteria followed). 
For other crop groups and FRM, Option 1 provides the weakest regulatory incentive 
and is expected to have little effect on innovation incentives beyond that of existing 
market demand, whilst Options 2 and 3 provide stronger regulatory incentives and 
are expected to have  greater positive impact on innovation. 

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  Summary of innovation & research impacts  

Measure 

M10 Support the use of digitalisation, biomolecular techniques and 
innovative production processes 

O1 

++ 

M18 Introduction of sustainability requirements in variety registration + 

M19 Assessment of sustainability characteristics for all FRM 
categories 

+ 

O2 

++ 

++ 

++ 

O3 

+/- 

++ 

++ 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.1.5.  Technological development / digital economy 

M10 provides a framework for a faster digital transition for NCAs and operators. 
Options 1 and 2 (M10.1) may have a positive impact on the transition to a digital 
economy through offering the principles for digitalisation, which would likely increase 
the confidence of NCAs to invest in digital technologies (with positive knock-on effects 
for industry to also invest in digitalisation). The detailed rules of Option 3 (M10.2) 
would also support this transition but may also create new barriers due to the more 
significant time and resources needed to interpret and implement the rules.  

  Summary of technological development/digital economy impacts  

Measure 

M10 Support the use of digitalisation, biomolecular techniques and 
innovative production processes 

O1 

++ 

O2 

++ 

O3 

+/- 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.1.6.  Intellectual property rights 

By providing a framework for the use of scientific and technological developments, 
M10 will offer the opportunity to deploy technology that can support intellectual 
property rights. This would be the case for the measures under all three options. 
For example, use of biomolecular techniques can offer greater protection for breeders 
of new varieties in areas related to the PRM legislation. In the context of plant variety 
rights (PVR), some varieties can fail DUS testing despite having superior VCU 
characteristics as their distinctness cannot be established. Use of biomolecular 
techniques, such as genetic markers, would provide a more accurate assessment of 
varieties’ distinctness compared to the variety that may be ‘blocking’ its PVR 
registration (as described by Gilliland et al. 2020). In turn, this would offer more 
protection to business investments by increasing the potential for PVR to be achieved. 

  Summary of intellectual property rights impacts  

Measure 

M10 Support the use of digitalisation, biomolecular techniques and 
innovative production processes 

O1 

+ 

O2 

+ 

O3 

+ 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

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6.1.7.  Fraud 

Several proposed measures are expected to have an impact on fraudulent activities, 
particularly those related to creating a harmonised and risk-based official controls 
framework (M2). Fraud effects are also likely to be seen under measures related to in-
kind exchange of PRM (M5), rules for conservation varieties (M6) and certification 
under official supervision (M11).  

Under Option 3, official controls rules for PRM and FRM would be fully included within 
the scope of the OCR (M2.3). Current PRM/FRM legislation requires products from 
third countries to fulfil the same requirements as exist within the EU but allows 
Member States to choose their approach to import controls to implement this. Under 
Option 3, PRM and FRM would fall into the OCR’s stricter import regime, which 
requires all consignments to be checked at official border posts on first entry to the 
EU. As such, Option 3 will provide an additional deterrent to non-compliant third 
country operators that wish to export to the EU, thereby having the greatest positive 
impact on reducing fraud in imported PRM and FRM.  

Within the EU, the introduction of risk-based marketing controls under all three 
options (M2.1, M2.2 and M2.3) may also contribute to a reduction in non-compliant 
PRM and FRM coming to the market by increasing the likelihood of it being detected. 
This effect will be greatest in those Member States where there are currently no 
marketing controls, or only very light controls. Likewise, the introduction of risk-based 
import controls under all three options (M2.1, M2.2 and M2.3) will mean higher 
risk PRM and operators importing into the EU will be subject to intensified controls in 
those Member States that do not currently take a risk-based approach to PRM and 
FRM imports. This will decrease the likelihood of non-compliant PRM and FRM entering 
the EU market from third countries. 

Exempting in-kind exchanges of PRM between farmers from PRM rules could result in 
an increased risk of fraudulent behaviour (Option 1, M5.1). This was reflected in 
stakeholder opinions of the targeted survey (Q151), where 53% of respondents (33 
out of 62) said the risk of illegal activities would increase or significantly increase. The 
majority of respondents were businesses and business associations (23 out of the 33) 
while NCAs were the minority respondents (9 out of the 33). For instance, 
conventional farmers may start selling their farm-saved seed (even of protected 
varieties) illegally, thereby circumventing obligatory seed certification and further 
contributing to the growth of the so-called ‘grey seed market.’ Lighter rules under 
Option 2 (M5.2) may mitigate this effect but still result in more fraudulent activity 
than under Option 3 (the baseline scenario). However, in France, where in-kind 
exchanges of PRM currently occur, it seems that there was no significant increase of 
fraudulent activity, because in-kind exchange occurs through networks of farmers 
where personal relationships are important and help limit propensity to engage in such 
behaviour (Annex 10). 

Existing lighter requirements for registering conservation and amateur varieties may 
already result in fraudulent registration of varieties because of the reduced 
registration costs for conservation varieties. The evidence26 suggests that fraud is of 
some concern where lighter requirements (M6, all options) are enhanced or 

26See Annex A5.6. Four stakeholders interviewed (1 NCA and 3 representative associations) expressed 
concern that removing quantitative limits could lead to professional operators taking advantage of the lower 
requirements aimed at conservation varieties and distorting the market. 

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extended to other PRM categories (Q151), although the effect in relation to the 
current situation is expected to be minimal. 

The FRM legislation does not allow FRM certification to be undertaken by operators 
under official supervision. Increased fraud as a consequence of FRM operators 
undertaking certification activities under official supervision (M11) is a concern 
according to eight out of the nine FRM stakeholders interviewed. This is due in part 
because traceability is dependent largely on a paper trail (with growing but not yet 
significant use of biomarker technology) and in part because the long lifecycle of trees 
means that it can take many years for fraud to be detected. This means that the 
sector is highly dependent on the integrity of the certification system to ensure FRM 
identity. Concerns about fraud mean that operators27 may not take up this approach 
should it become possible, with a resulting negligible effect for this sector. For PRM, 
extending certification of PRM under official supervision was not considered by a 
majority of stakeholders to be an issue28. 

  Summary of fraud-related impacts  

Measure 

M2 Create a harmonised and risk-based OC framework 

M5 Rules for in-kind exchange of PRM between farmers 

M6 Registration requirements for conservation varieties 

M11 Certification tasks permitted under official supervision (FRM 
only) 

O1 

+ 

- 

= 

= 

O2 

+ 

+/- 

= 

= 

O3 

++ 

= 

= 

= 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.1.8.  Position of SMEs 

SME effects are expected as a result of changing the structure of the policy 
instruments (M1). Impacts on SMEs are also foreseen in relation to changes to the 
marketing rules for SCNs (M3) and amateur gardeners (M4); support to scientific and 
technological developments (M10); harmonisation of variety registration requirements 
for organic varieties (M8); certification tasks permitted under official supervision 
(M11); support to address issues of FRM supply (M15); and rules on sustainability 
testing (M18).  

SME effects from aligning the structure of the policy instruments  

The current policy instruments are a barrier to SMEs entering the market. Aligning the 
structure, definitions, and decision-making procedures between policy instruments 
(M1, all options) is likely to support SMEs, who have fewer resources available to 
navigate the current complexity of the legislation. Option 3 (M1.3) will go furthest in 
aligning the legislation and creating coherence with other legislation; however, there is 

27 Information on the impact of allowing FRM certification tasks to be carried out by operators under official 
supervision was obtained from the interviews. All but one of the interviewed stakeholders (6 NCAs, 2 
representative associations and 1 scientific network) were not in favour of introducing this possibility. 
28 A majority of survey respondents (Q83) agreed that if more activities could be conducted under official 
supervision there would be no impact on fraudulent PRM (41 of 72). A significant number of respondents to 
this question (21 of 72) did not know. 

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a trade-off in that detailed rules can also create barriers for SMEs in the way of 
increased costs associated with adhering to those rules. Providing some flexibility in 
the policy instruments under Option 1 (M1.1), and to lesser extent under Option 2 
(M1.2) can help to balance these effects. However, the effects depend on the specific 
measures that are included in the legislative revisions.  

SME effects from changing the scope of rules for the activities of SCNs 

There is no evidence on the number of seed conservation networks that are SMEs. 
However, the consultation for this study found that SMEs could benefit from the 
proposed measures under Option 1 (M3.1) and Option 2 (M3.2): some consultees 
(e.g. in their statements provided in response to the public consultation) noted that an 
exemption from the registration requirements for SCN activities under Option 1 could 
facilitate the activities of smaller organisations operating in this area. No change is 
expected under Option 3, which is the same as the baseline scenario.     

SME effects from changing the scope of rules for marketing to amateur 
gardeners 

Option 3 maintains the current rules for operators marketing to amateur gardeners, 
which has been found to have a disproportionately negative effect on SMEs compared 
to larger businesses. Smaller businesses find it more difficult to recoup production and 
compliance costs, such as costs associated with variety registration. Deregulation, as 
foreseen by Option 1 (M4.1), through an exemption would benefit SMEs by reducing 
costs and hence barriers to marketing to the amateur gardener market, as would 
(although to a lesser degree) Option 2 (M4.2). 

SME effects from harmonisation of variety registration requirements for 
organic varieties 

Option 1 maintains the current registration requirements and supports the temporary 
derogation for DUS testing in relation to organic varieties. The temporary derogation 
on DUS testing under Option 1 is likely to be beneficial to SMEs as it increases 
market access and allows for more unbiased quality assurance of products meaning 
that SMEs are less disadvantaged compared to larger corporations. Options 2 (M8.1) 
and 3 (M8.2) will make the DUS derogation permanent, thereby solidifying the 
benefits for SMEs.  

SME effects from support the use of scientific & technological developments 

Options 1 and 2 (M10.1) provide a framework for the use of scientific and 
technological developments in the PRM and FRM sectors. This would better enable 
businesses who wish to use biomolecular techniques or innovative production 
processes to do so with fewer legislative barriers. This should also benefit SMEs who 
will have the security of legal backing to use these technologies, as well as the 
flexibility to decide whether and to what extent to invest in their use. Option 3 
(M10.2) would set out detailed rules for the use of scientific and technological 
developments. Although this option should also benefit SMEs for the reasons cited 
under Options 1 and 2, there may be a negative effect due to additional administrative 
burden for those businesses associated with interpreting and implementing detailed 
rules.  

The costs associated with investment in, and use of scientific and technological 
developments are also likely to be more prohibitive to SMEs. Larger businesses have 
more resources and can therefore make bigger investments in new technologies. SMEs 
are unlikely to see the efficiency gains offered by new technologies as quickly as larger 

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businesses. As such, Options 1 and 2 are more likely to facilitate efficiency gains 
offered by scientific and technological developments for SMEs where they can afford to 
invest in them. The impacts under Option 3 are more uncertain. 

SME effects from expanding activities under official supervision 

Certification under official supervision currently takes place in most Member States 
and many businesses undertake certification under official supervision, including a 
high proportion of SMEs (Q236).  

All three options (M11) will increase the certification tasks permitted under official 
supervision to the same extent and permit VCU examination under official supervision.  

Evidence suggests that SMEs may be less able to make the investments necessary to 
establish the systems/to undertake activities under official supervision even though 
most surveyed business associations indicated that over 50% of their SME members 
already carry out certain tasks under official supervision (Q78). Moreover, there is 
concern that NCA resources may become stretched and/or more concentrated on 
official supervisory activities, with less resources available to support businesses who 
wish to have direct NCA support for registration and certification activities. Consultees 
for this study highlighted the need for NCAs to continue offering certification and VCU 
examination services in addition to those provided under official supervision under the 
new rules. The effects of this measure on SMEs are therefore uncertain. 

SME effects from addressing problems in supply of FRM 

SME buyers/users of FRM are more likely to be dependent on private tree nurseries 
and are therefore more likely to be impacted by the current challenges in supply 
(larger firms are likely to have their own seed sources and potentially their own 
contingency plans in place). SME nurseries are also more likely to be limited in their 
options for the supply of trees. As such, where Options 2 (M15.1) and 3 (M15.2) 
improve the state of contingency planning across the EU, this should result in a 
modest positive impact for SMEs, with SMEs more likely to benefit than large firms 
compared to the baseline.  

SME effects from sustainability testing 

All of the options will harmonise sustainability criteria under VCU rules for the 
acceptance of new varieties of agricultural crops. Option 2 (M18.1) and Option 3 
(M18.2) would also introduce sustainability criteria for other crop groups. Options 1 
and 2 offer flexibility to Member States to implement the rules and adapt to their own 
agroecological conditions, whilst Option 3 (M18.2) defines detailed sustainability 
criteria for all crop groups. The need to have varieties which can pass sustainability 
testing may disproportionately affect SMEs as they are less likely to have the research 
capacity to adapt their varieties to the sustainability tests as compared to larger 
operators. This is likely to be felt most under Option 3 where there is less flexibility. 
Under Option 2 the effects are likely to be smaller, as existing market pressures may 
have already pushed SMEs to develop  varieties with characteristics contributing to 
sustainable production. Option 1 is the same as the baseline and no changes are 
expected. The effects of Options 2 and 3 will be varied depending on the extent to 
which operators are working in Member States where sustainability criteria are already 
in place, and the EU-level criteria differ from MS level criteria. However, a moderate 
negative effect is expected for SMEs under both options. As the following table shows, 
in terms of economic impacts, Option 2 is the most favourable for SMEs.  

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 Summary of SME impacts  

Measure 

O1 

O2 

M1 Alignment of PRM legislative instruments 

M3 Scope of the PRM legislation applied to SCNs 

M4 Scope of the PRM legislation applied to marketing to amateur 
gardeners 

M8 Harmonisation of variety registration requirements for organic 
varieties 

M10 Support the use of digitalisation, biomolecular techniques and 
innovative production processes 

+ 

+ 

+ 

= 

+ 

+ 

= 

= 

+ 

+ 

O3 

+/- 

= 

= 

+ 

+/- 

M11 Registration and certification under official supervision 

+/- 

+/- 

+/- 

M15 Addressing difficulties in supply of FRM 

M18 Introduction of sustainability requirements in variety 
registrations 

= 

= 

+ 

- 

+ 

- 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.1.9.  Functioning of the internal market  

Operators face different conditions in the regulation of PRM across Member States, 
which has implications for the good functioning of the legislation against its objectives 
and for the competitive position of operators. The specific measures proposed address 
different aspects of this problem. 

Some measures (e.g. M1, M13) will harmonise and clarify differences in terms and 
processes across the marketing directives (e.g. definitions for ‘marketing’), addressing 
resultant divergences in interpretation and implementation across Member States, 
with the degree and nature of harmonisation varying across the options. Others will 
clarify terminology or impose new procedures or processes on specific issues, which 
are the same across the options. For example, under M17, all options will provide a 
definition of forestry and non-forestry purposes, which currently differs across Member 
States.  

In general, Option 1 provides for the weakest level of harmonisation and Option 3 
the strongest. In several places, Option 2 provides for a balance between the need 
for harmonisation with the need for justified variation across Member States (as in the 
example of M18). Where Option 2 offers flexibility, this is on issues where 
stakeholders are generally supportive of the need for such flexibility (e.g. M15 on 
contingency planning, where public authorities indicated agreed with the need for such 
activity but stressed the benefits of enabling Member States to take their own tailored 
approaches). As such Option 2 sets better conditions for the good functioning of the 
internal market. 

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 Summary of internal market impacts  

Measure 

All measures combined 

O1 

+ 

O2 

++ 

O3 

+ 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain  

6.1.10. 

 Public authorities (and budgets) 

The following economic impacts are expected to arise under the proposed options for 
public authorities: administrative burden; operating costs, including enforcement and 
compliance monitoring; and costs related to using new developments in science and 
technology, and digitalisation. 

6.1.10.1.  Administrative burden 

In terms of administrative burden, measures under Option 1 and Option 2 are 
expected to have a positive impact by creating efficiency savings. A closer alignment 
of the structure, definitions, and decision-making procedures between policy 
instruments but keeping separate policy instruments (M1.1) could provide clarity for 
NCAs in interpreting the relevant provisions and better adapting them to their national 
priorities. This includes the proposed alignment of PRM rules with plant health 
legislation29 (M9). Alignment between the PRM/FRM Directives and the OCR (M2) is 
expected to increase efficiency and could lower administrative burden in the medium 
to long-term for some public authorities by streamlining the relevant control 
procedures between the legislation. Increased benefits may be seen by authorities 
that currently do not apply risk-based controls, those with duplicated processes for 
plant health and PRM/FRM and those that carry out a large number of controls. 
Efficiency gains can also be achieved if PRM, FRM and OCR IT systems are more 
closely aligned as proposed under options 1 and 2 (M2.2 and M2.3). This could make 
Article 134(f)30 of the OCR applicable to PRM and FRM. As there is demand for greater 
digitalisation of PRM and FRM procedures among MS (see A5.15) these measures 
would enable the use of the OCR’s information management system for official 
controls (IMSOC) of PRM and FRM. 

Similar efficiencies would arise under more streamlined policy instruments (M1.2), 
which could reduce paperwork and other administrative costs for NCAs working across 
different Directives. Furthermore, improving clarity by referring to the Organic 
Regulation for defining variety registration requirements whilst retaining the flexibility 
for Member States to adapt VCU to local agro-ecological conditions (M8.1) can also 
support efficiency gains.  

Both strong and moderate harmonisation efforts under all three options will likely 
reduce administrative burden, particularly in terms of compliance activities such as 
time spent explaining the relevant legislative provisions to operators and staff training 
costs. Additionally, proposed adjustments of current rules under such as allowing 
multiplication of “not yet listed varieties” of fruit plants and vine while variety 

29 Encompassing the references to plant health rules on RNQPs for certification and inspection of PRM 
30 “The Commission shall adopt implementing acts for the functioning of the IMSOC which lay down the 
cases where, and the conditions under which, the data, information and documents are to be transmitted 
using the IMSOC”  

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registration is ongoing (M12) were found to have no measurable impact on the 
administration burden of public authorities (Q180).   

The efficiency savings of some of the measure under Option 1 could, however, be 
balanced out by increased costs under other measures that require investment into 
training and increased compliance monitoring such as M2.1 and M11. Additionally, 
efficiency saving measures may not translate into immediate and direct economic 
benefits, but rather allow competent authorities to restructure their operations on the 
medium to long-term in such a way as to materialize various levels of cost savings.  

Option 3 measures facilitating maximum harmonisation between national 
implementation schemes and/or EU policies could potentially increase administrative 
burden for some public authorities due to the higher number of regulatory changes 
and the time and cost needed to interpret them and align compliance monitoring 
mechanisms. This includes measures bringing clarifications via directly referencing 
relevant policies such would be the case for the Organic Regulation for defining 
harmonised variety registration requirements (M8.2) as well as the full application of 
Official Control Regulation to the PRM and FRM Directives (M2.3).  

Proposed measures for FRM under Option 1 and Option 2 include the introduction of 
new rules for the conservation of forest genetic resources (M7.1). This would require 
producers to keep a sample of genetically diverse trees instead of selecting only 
superior trees, which could potentially positively impact some public authorities. Under 
the proposal, instead of going through the process of approving basic material, the 
operator wanting to conserve FGR would simply notify the competent authority of the 
stand of trees intended for the purpose of conserving genetic resources. This new 
measure could lower administrative burden related to the approval of FRM basic 
material.  

Additional harmonisation measures for FRM, such as expanding FRM requirements to 
include information on suitability for climatic/ecological conditions (M16) as well as 
defining forestry and non-forestry purposes and extend scope of FRM legislation to 
include the production of FRM for specific non-forestry purposes (M17.1, M17.2) 
could increase administrative burden for competent authorities. In some Member 
States, responsibility for certain non-forestry purposes of FRM is under the remit of 
different public authorities and in some cases is already included in the scope of other 
legislation. This would mean that the extension of scope would require a complex and 
burdensome reorganisation of competencies. Due to a lack of data, it was not possible 
to identify the extent of the reorganization needed and the corresponding 
administrative burden.  

6.1.10.2.  Operating costs 

Efficiency improvements (Specific Objective 3) derived from various measures are also 
expected to impact operating costs for public authorities. In the baseline scenario, the 
total annual costs of variety registration and PRM certification for EU-27 NCAs 
are estimated to be around EUR 73.6 million, and EUR 97.6 million respectively 
(Annex 5). A potential increase in certification tasks under official supervision except 
issuing the official label (M11) could lead to cost savings through a reduction of the 
number of required field inspectors, which could amount to EUR 11.7 million per 
annum (Annex 5). This would be the same under all three options.  

As mentioned under Section 2.1, the timeline, extent and variation of these cost 
reductions between Member States is difficult to assess owing to the different 
financing mechanisms in place.  

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Registration and certification costs are also expected to be impacted by the 
derogations proposed under the options:  

  Exemptions from the PRM legislation for marketing to amateur gardeners 
under Option 1 (M4.1) could provide costs savings for public authorities 
(Q134). While, under Option 1, businesses would no longer be required to 
register and/or certify PRM of varieties marketed to amateur gardeners, 
under Option 2, (M4.2) the registration process would be largely 
simplified. Under both scenarios, the amount of time spent by public 
authorities overseeing and delivering activities related to variety registration 
could be reduced. However, these reductions may not materialise in 
immediate costs savings as the exemptions could require the 
implementation of separate rules which may come with additional 
enforcement and compliance monitoring tasks for public authorities. 
Increased harmonisation measures under Option 3 do not entail any 
exemption therefore is expected to have no impact on operational costs.   

  Exemptions for PRM/FRM seed conservation networks under Option 1 (M 
3.1) are unlikely to have a significant impact on public authorities simply 
due to the size of the stakeholder group. Measures under Option 1 or 
Option 2 (M3.2) are not expected to reduce operating costs. Any potential 
cost savings could be offset in the short-term by increased compliance and 
enforcement costs associated with the exemptions. Option 3 does not entail 
any exemption therefore is expected to have no impact on operational costs.    

  Another set of measures introducing derogations in the form of lighter 

registration requirements (no DUS but officially recognised description) for 
conservation varieties and fruit plants and vine (M6, all options) may also 
raise compliance and enforcement costs for Member State authorities in the 
short term as they adapt their internal procedures and study the new 
requirements. This is generally considered to be within the overall 
operational cost burden of relevant public authorities. Over the medium to 
long-term, lighter variety registration requirements for conservation 
varieties are unlikely to have a negative impact on costs for public 
authorities generally as they do not foresee substantial changes to their 
tasks.  In fact, for Member States that have previously applied a heavier 
process, lighter registration requirements could reduce some of the 
administrative burden.   

Measures that maintain the status quo (baseline) such as when existing 
empowerments are used to review and harmonise VCU rules for agricultural species to 
better address sustainability (M18.1) are not expected to result in impacts on public 
authorities.  

Similarly, little to no cost implications are expected for measures maintaining the 
status quo for FRM under Option 1 where existing empowerments would be used to:  

  Authorise Member States to use FRM not fulfilling all requirements. 

  Improve the information provided on FRM. 

  Introduce assessment of sustainability characteristics for all FRM categories. 

New measures for agricultural crops (M18), such as the introduction of general 
principles and rules on sustainability criteria that allow flexibility for Member States to 
adapt implementation to local agro-ecological conditions (M18.1) could, in the short-

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term introduce one-off costs related to revised measures on enforcement and 
compliance monitoring particularly in countries where the sustainability criteria have 
not previously been used in the context of VCU testing. In the targeted survey (Q117) 
more NCA respondents (8 out of 18) expected no impact on administrative burden 
than signalled a potential negative impact (6 out of 18). Where new sustainability 
testing is to be applied to other (non-agricultural) crop groups for which VCU testing is 
not currently required, Options 2 and 3 (M18) are likely to result in increased costs 
for NCAs. In the short-term, resource constraints may limit NCAs’ ability to implement 
the new rules, although in several cases it was indicated that the costs would be 
passed on to the sector. For agricultural crops, where VCU-testing for sustainability is 
already possible, some changes to existing VCU protocols may be required (the 
magnitude of this change would depend on the current testing practices in each 
Member State and details of the sustainability requirements of the options). However 
some NCAs still expressed concerns about the potential increase in costs of 
introducing new/additional tests. .  

Changes to the current framework of FRM legislation such as the proposed measures 
to introduce principles (M15.1, Option 2) or detailed rules (M15.2, Option 3) for 
contingency planning to ensure availability of FRM can create additional costs for 
Member State authorities, especially for those that currently have functioning 
contingency measures in place which would potentially need to be adjusted to fit 
within an EU-wide approach. It is estimated that stricter requirements on contingency 
planning could increase costs of implementation however, distinguishing between the 
costs of contingency planning based on principles or detailed rules were not possible 
at this stage.   

Similarly, proposals to increase alignment between European environmental strategies 
and PRM/FRM policy instruments could also mean new costs for public authorities. 
Under Option 2 (M18.1), the introduction of general principles and rules on 
‘sustainability criteria’ for species other than agricultural ones to support alignment 
with the European Green Deal and related strategies is a flexible approach that allows 
Member States to adapt their implementation in a way that it best supports the 
development of varieties suited to local agro-ecological conditions. General principles 
for assessment of sustainability characteristics will also be introduced for all FRM 
categories (M19.1), with flexibility for Member States in terms of their 
implementation. Despite the embedded flexibility these changes will require the review 
and adjustment of current policies which will likely translate into costs. Under Option 
3 the proposed detailed and harmonised ‘sustainability criteria’ for all PRM categories 
(M18.2) and FRM categories (M19.2) would translate into potentially greater cost 
burden as compliance could mean revisions of multiple national policies.  

6.1.10.3.  Innovation, digitalisation 

In terms of impacts on innovation and digitalisation, flexible measures, under Option 1 
and Option 2, that allow Member States to better adapt regulatory provisions to their 
national context may incentivise the use of digital tools and technologies most 
appropriate to their needs. Additionally, the proposed definition (Option 1 and 
Option 2, M10.1) and establishment (Option 3, M10.2) of basic principles on 
digitalisation, biomolecular techniques and innovative production processes and the 
creation of empowerments for detailing rules according to new developments also 
support digitalisation of PRM procedures. This links to OECD work to digitalise their 
Seed Schemes, which benefits EU MS through knowledge generation about digitalising 
seed certification (facilitating EU digitalisation), closer connection between OECD and 
EU seed certification processes, improving seed trade transparency and supporting EU 
connectivity to international seed systems. Legislative support for digitalisation is to 

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increase the efficiency of public authorities and reduce the administrative burdens in 
the medium to long-term by allowing more efficient information exchange, the 
possibility of carrying out some certification activities remotely, reducing paper waste 
and the risk of document deterioration, and improving information access and working 
practices   

Increased digitalisation, however, comes with higher upfront costs that can be 
balanced in the medium to long-term through material savings, therefore these 
measures may negatively impact the cost balance of Competent Authorities on the 
short-term. The more harmonised digital requirements are, the longer the 
implementation may take as Member State Public Authorities are likely to have 
various, often incompatible IT systems in place, including software. Previous European 
projects aiming to introduce streamlined IT infrastructure across Member States (such 
as the EU single window environment for customs) were faced with unexpected delays 
and related costs due to the vastly different national infrastructures. The value of 
digital infrastructure investments that would be required under the options was not 
possible to estimate, as that would require an assessment of the current IT 
infrastructure, which was outside the scope of this study. It is estimated, however, 
that incentives for digitalisation could be stronger under Option 1 and Option 2 
because as these would allow better integration of current infrastructures and more 
flexibility. As the following table shows, in terms of economic impacts on public 
authorities, Option 2 is the most favourable.  

 Summary of public authority impacts  

Impact category 

O1 

O2 

O3 

M1 Align instruments 

M2 Harmonise Official Controls 

M3 Seed Conservation Networks 

M4 Amateur gardeners 

M6 Registration requirements for conservation varieties 

M7 Rules for producing FRM for the purpose of conserving 
FGR 

M8 Registration of organic varieties 

M9 Plant Health legislation and RNQPs 

+ 

+ 

+ 

+ 

+ 

+ 

= 

+ 

M10 Support the use of digitalisation, biomolecular techniques 
and innovative production processes 

+ 

M11 Certification tasks permitted under official supervision 

+ 

M12 Rules for ‘not yet listed’ varieties 

M13 Regulated species 

M15 Measures to address difficulties in supply of FRM 

M16 Measures to improve access to information on FRM  

+ 

+ 

+ 

= 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

- 

+ 

- 

- 

= 

= 

+ 

+ 

- 

+ 

- 

+ 

+ 

+ 

-- 

+ 

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Impact category 

O1 

O2 

O3 

M17 Clarify scope of forestry and non-forestry purposes 

M18 Review and harmonise VCU rules for agricultural species 
and develop sustainability criteria for other species 

M19 Assessment of sustainability characteristics for all FRM 
categories 

= 

= 

= 

= 

- 

+ 

= 

-- 

-- 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.2. 

Environmental impacts 

The following environmental impact categories were found to be relevant for the 
assessment:  biodiversity, including flora, fauna, ecosystems, and landscapes; 
climate; sustainable production and consumption; and food security.  

The nature of the proposed measures means that the direction of impacts related to 
biodiversity and climate are the same, with longer-term implications for more 
sustainable production and consumption and food security. Therefore, biodiversity and 
climate change impacts are treated together in this analysis and improvements in 
sustainable production and consumption and food security are expected to flow from 
positive effects on biodiversity and climate change. The impacts observed relate to 
many of the measures being considered as part of the legislation revisions.  

Seed Conservation Networks (SCNs) 

It is likely that SCN activities will be positively impacted by the proposed measures, 
particularly under Option 1 (M3.1) and to a lesser extent under Option 2 (M3.2) 
(section 6.1.3.1). The expected increase in activity will have positive knock-on effects 
for EU biodiversity and adaptation to climate change through SCN activities, which 
include long-term conservation, development of crop diversity, and adaptation of plant 
genetic resources to regional agro-ecological conditions. In particular, SCN activities 
can include variety collection and maintenance in situ and seed storage, notably of 
old, traditional and/or conservation varieties and help arrest the erosion in EU genetic 
diversity. 

Amateur gardeners 

Option 1 (M4.1) would offer an exemption to the PRM rules for varieties developed 
for and marketed exclusively to the amateur sector. The evidence suggests that 
currently, operators do not distinguish between varieties bred for the amateur market 
as opposed to the professional sector, and that this is unlikely to change in the near 
future. However, exemptions (M4.1) or lighter rules (Option 2, M4.2) may facilitate 
market entry for new operators – in particular smaller operators, undoing recent 
trends of market consolidation which has acted as a constraint on diversity of varieties 
on offer (EC et al, 2021) – which may in turn bring about an increase in breeding 
activities (especially among varieties that amateur gardeners are increasingly 
interested in, such as conservation and amateur varieties). Generating a greater 
supply of or improved access to a wider choice of old and new varieties would 
positively contribute to enhanced genetic diversity in domestic gardens.  

Lighter rules under Option 2 (M4.2) could also help improve the genetic diversity of 
the PRM available to amateur gardeners. However, basic requirements would still be in 
place, which could dissuade smaller (and new) operators from investing in additional 

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breeding. The expected impact on diversity would therefore be more limited under 
Option 2.   

Amateur gardeners are interested in diversity among varieties such as old, traditional 
and regional or local seed varieties, which may increase where an exemption (Option 
1, M4.1) or lighter rules (Option 2, M4.2) facilitate greater interest in serving this 
sector. Under Option 3, current PRM requirements would remain in place. Low market 
demand for such varieties, relatively high production costs and low profitability, 
compared to commercial varieties, mean that the market will likely remain 
unattractive for larger seed companies under Option 3. Nonetheless, adopting a lighter 
regulatory regime for varieties aimed exclusively at amateur gardeners may increase 
risks to the assurance of PRM identity, quality, and health. A survey of home 
gardeners (EC et al. 2021) shows that, in addition to the importance attributed to the 
availability of varieties with cultural/ historical significance, amateur gardeners also 
rank the health and quality of the varieties they buy as the most important decisive 
factors in their purchase decisions.   

In-kind exchange of PRM between farmers 

Providing a derogation for in-kind exchanges between farmers (Option 1, M5.1) or 
lighter rules (Option 2, M5.2) could also have a positive impact on (agro)biodiversity 
and climate change. The increased and generalised use of commercial varieties, that 
is, distinct, uniform and stable varieties, is contributing to a gradual loss of cultivated 
biodiversity. This is because these increasingly ‘standardised’ varieties are not adapted 
to local climatic and agricultural conditions. Farmers’ ongoing selection year after year 
means that there is greater focus on adapting seeds to local conditions of cultivation 
and climate change, hence promoting and increasing genetic diversity (European 
Coordination Via Campesina (2021), Coomes et al. (2015)). Through increased 
adaptability and diversity, farmers would be able to contribute to wider environmental 
objectives, notably: agricultural development, sustainable farming, and food security 
(key objectives of the EU’s ‘Farm to Fork Strategy’). Allowing in-kind exchanges 
between farmers (through an exemption under Options 1 or lighter rules under Option 
2) would therefore help bring about greater coherence between the EU PRM legislation 
and other EU-wide initiatives as well as greater alignment with international practices.  

However, the anticipated very small scale of participation in in-kind exchange means 
that the overall impact on biodiversity and climate change would likely be limited. 
Under Option 3, in-kind exchange would continue to fall under the marketing 
legislation as a commercial activity, which would result in no change against the 
baseline scenario.  

Conservation varieties 

Biodiversity benefits will also arise from measures aimed directly at encouraging the 
development of conservation varieties. Under all three options (M6), lighter 
registration requirements will be put in place for conservation varieties of agricultural 
crops and vegetables, and these will also be extended to fruit plants and vine. This will 
involve removing the DUS testing requirement but still provide for an officially 
recognised description. Lighter rules are expected to lead to a decrease in the cost of 
production and price of PRM of conservation varieties (Q55). Lighter rules are 
therefore likely to facilitate market access and lead to an increase in the amount of 
PRM of conservation varieties produced (Q55). More varieties would be registered and 
available to growers, leading to increasing awareness of such varieties, which in turn 
would promote their conservation, with implications for improved access to varieties 
that will improve biodiversity in the future. Conservation and amateur varieties 

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provide raw material inputs needed for the preservation of the natural environment 
and activities to support habitat restoration (Abbandonato et al., 2018; Mainz and 
Wieden, 2019). Increased supply of such varieties will support the objectives of the 
EU’s proposed nature restoration law.  

Organic Varieties 

Current DUS (prior to the introduction of the derogation) and VCU testing required for 
variety registration are not aligned with the principles of organic agriculture. 
Therefore, testing has been a barrier to market entry for organic varieties. Under all 
three options (M8) there would be an improvement in market access due to adapted 
testing provisions. The most improvement would come through Options 2 (M8.1) 
and 3 (M8.2) where the DUS derogation is made permanent and VCU principles are 
the most flexible to adaptation for organic agriculture. This increased market access is 
environmentally beneficial. Organic farmland is estimated to support 30% more 
biodiversity than conventional farmland, and organic farming is known for its reduced 
use of external inputs (artificial fertilisers, herbicides and pesticides) compared with 
conventional agriculture (IFOAM Organics International, 2020; EC, 2021g). Organic 
varieties are also often more adapted to local environments than conventional PRM 
meaning that they can be more resilient to climate change and improve biodiversity. 

Sustainability testing 

PRM provisions on VCU testing are currenty not fully aligned with EU sustainability 
objectives. Reviewing and harmonising VCU rules for agricultural species to better 
address sustainability would benefit biodiversity and climate change in the long-run 
regardless of the option chosen. The benefits are likely to be experienced mostly 
strongly in Member States where sustainability criteria have not already been adopted. 
Benefits will depend on the nature of sustainability characteristics targeted – but could 
encourage innovation in breeding of varities that, for example, require less use of 
chemical pesticides thereby reudcing soil, water and air pollution, and/or varities that 
are are better adapted to the potential pressures of climate change, such as greater 
drough and/or pest tolerence.  In doing so, this will support the resilience of the 
farming system and contribute to food security ambitions. 

Option 2 (M18.1) is likely to have the most beneficial effects on biodiversity and 
climate change overall. First, because it introduces general principles and rules on 
“sustainability criteria” for other crop groups, rather than relying only on breeder 
information (under Option 1). Furthermore, Member States can adapt sustainability 
testing to local conditions enabling varieties with different characteristics to be 
produced across Member States (as compared to Option 3, M18.2), which is likely to 
give the highest level of resilience to climate change at the lowest levels of production. 

FRM 

Introducing specific rules for producing FRM for the purpose of conserving forest 
genetic resources under Option 2 and Option 3 (M7.1) is expected to have positive 
impacts on biodiversity and climate change similar to those for lighter rules for 
conservation varieties in the PRM legislation. This conclusion assumes that the rules 
are designed to facilitate market access and lead to an increase in the amount of FRM 
produced for conservation of FGR.  

A delay in afforestation or reforestation can have a negative impact on the resilience 
of forests. More resilient forests provide benefits including support for biodiversity and 
the mitigation of climate change. Options 2 (M15.1) and 3 (M15.2) should both 
encourage more Member States to develop contingency plans, which should help to 

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mitigate at least some of the problems of supply. It is therefore likely that both would 
result in a small positive impact on climate as compared to the baseline. Negative 
impacts on climate are expected from the baseline scenario; Option 1 is effectively the 
same as the baseline scenario, although existing empowerments would be used under 
Option 1 to authorise Member States to use FRM not fulfilling all requirements. This is 
likely to have a minor impact on this issue since problems with supply go well beyond 
access to FRM that does meet the basic requirements.    

In general, providing more and better information to users/buyers of FRM on the 
suitability of material for current and future climatic conditions should support the 
resilience of future forests in part through improvements in biodiversity, assuming 
that this information is used in practice by buyers of FRM. Option 2 and Option 3 
(M16) would facilitate better access to information on FRM for users/buyers by 
expanding the information requirements to include information on the suitability of 
FRM for climatic and other ecological conditions.  

Greater definitional clarity under Option 1 (M17.1) and increased scope of the 
Directives under Option 2 and Option 3 (M17.2) would likely benefit the resilience 
of future forests, providing benefits including support for biodiversity and climate 
change mitigation. 

Under Option 1, existing empowerments would be used to introduce the assessment 
of sustainability characteristics for all FRM categories. This could help to redress the 
small negative impact on climate expected from the baseline scenario, although there 
is very limited evidence to support this conclusion. Option 2 (M19.1) and Option 3 
(M19.2) are likely to reduce the scale of this impact to a small extent. However, in 
both cases, these impacts are highly uncertain due to the lack of data on the scale of 
the risk of genetic pollution.    

Positive impacts of the proposed measures on FRM supply and FGR will have an effect 
on climate adaptation, helping to reduce the risk of catastrophic forest loss valued at 
several hundred billion euros (Hanewinkel et al, 2013).   

 Summary of environmental impacts  

Measure 

M3 Rules for marketing activities of SCNs 

M4 Rules for marketing to amateur gardeners 

M5 Rules for in-kind exchange of PRM between farmers 

M6 Registration requirements for conservation varieties 

M7 Rules for producing FRM for the purpose of conserving FGR 

M8 Harmonisation of variety registration requirements for organic 
varieties 

M15 Addressing difficulties in supply of FRM 

M16 Improving access to information on FRM  

M17 Clarifying scope of forestry and non-forestry purposes 

O1 

++ 

+ 

++ 

++ 

= 

+ 

= 

= 

+ 

O2 

+ 

+/- 

+ 

++ 

++ 

++ 

+ 

+ 

O3 

= 

= 

= 

++ 

++ 

++ 

+ 

+ 

++ 

++ 

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Measure 

M18 Review and harmonise VCU rules for agricultural species and 
develop sustainability criteria for other species 

O1 

+ 

O2 

++ 

O3 

+ 

M19 Assessment of sustainability characteristics for all FRM 
categories 

+/- 

+/- 

+/- 

Note: ‘-’ moderate negative impact, ‘–’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

6.3. 

Social impacts – consumers and households 

Measures to exempt (Option 1, M4.1) or provide lighter rules (Option 2, M4.2) for 
PRM marketed exclusively to amateur (home) gardeners have the potential to impact 
on consumers. However, the evidence indicates that whilst professional breeders/ 
seed companies do serve the amateur gardener market, they do not tend to produce 
exclusively for amateur gardeners, which is unlikely to change going forward. New 
operators serving the amateur gardener segment exclusively may enter the market, 
particularly where an exemption is in place under Option 1. Lighter rules under Option 
2 are less likely to bring about this change in the structure of the market but may 
have a small positive impact.  

Where operators do enter the market to serve the amateur gardener segment, there 
are some concerns that exemptions from market controls could have a negative effect 
on quality and increase phytosanitary risks. Although it can be argued that amateur 
gardeners do not require the same quality standards (as the professional market), 
many amateur gardeners seem to still rely on home gardening to grow edible produce 
for themselves and their families and/or produce that can meet their dietary needs 
(EC et al, 2021). New varieties of greater interest to amateur gardeners may however 
become available as a result of increased participation by operators. Nonetheless, 
such operators are expected to be small-scale players. Whilst the breadth of varieties 
technically available on the market may increase it is not clear the extent to which this 
would be perceptible to amateur gardeners.  The evidence is inconclusive on these 
effects. 

 Summary of consumer and household impacts  

Measure 

M4 Rules for marketing to amateur gardeners 

O1 

+/- 

O2 

+/- 

O3 

= 

Note: ‘-’ moderate negative impact, ‘--’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate 
positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

7.  Comparison of options 

Triangulation and evidence synthesis by study question (Annex 5) and impact 
category (section 6) has been performed, bringing together all of the information 
collected from desk research and consultation activities. Together this serves as the 
basis for comparative analysis of the options overall using a multi-criteria analysis 
(MCA) to assess the effectiveness, efficiency and coherence of the options.  

  Effectiveness: assesses the extent to which the options might be effective 
in achieving or progressing towards the general and specific objectives. The 
assessment takes into consideration progress that can be achieved via the 
individual options as well as the role that EU action may play in meeting the 

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relevant objectives. General and specific objectives considered within this 
context are presented in section 4.  

  Efficiency: assesses how the options compare in their aggregate key 

economic, social and environmental impacts. A multi-criteria analysis (MCA) 
was undertaken (see Section 7.2) to compare the costs and benefits, as it 
provides a more comprehensive consideration of the objectives and impacts 
than cost-benefit analysis as well as consideration of the distribution 
consequences and trade-offs inherent in the options, and is more 
appropriate in multi-dimensional assessment (particular where monetisation 
of impacts is not feasible).31 

  Coherence: assesses how the options compare to other EU policy initiatives 
and identifies the extent to which they promote horizontal objectives and 
facilitate delivery of relevant key targets.  

7.1. 

Effectiveness 

The effectiveness assessment considered three relevant general and related specific 
objectives:   

  GO 2 aims to ensure a wide diversity of choice and quality of PRM for all 
types of users and consumers. Specific objectives that aim to create 
proportionate rules adapted to marketing activities and types of PRM/FRM 
(SO2a), ensure conservation and sustainable use of plant and forest 
reproductive materials (SO2b), and establish appropriate conditions for 
testing varieties suitable for organic production (SO2c).  

  GO 3 aims to support innovation and competitiveness of the EU PRM and 

FRM industry. Specific objectives to support innovation and competitiveness 
of the EU PRM and FRM industry support the effectiveness of this 
overarching objective. SO3a: Support innovation and competitiveness of the 
EU PRM and FRM industry 

  GO 4 aims to contribute to wider EU objectives regarding adaptation to and 
mitigation of climate change impacts, food security, sustainable production 
and biodiversity protection. Specific objectives to address difficulties in 
supply of FRM (SO4a); provide better access to information on FRM for 
users/buyers (SO4b); clarify the scope of forestry and non-forestry 
purposes (SO4c); and promote the availability of PRM (SO4d) and FRM 
(SO4e) suitable for current and future climatic conditions support the 
effectiveness of this overarching objective. 

An analysis of effectiveness is shown in the following table. Both Options 2 and 3 
perform better than the baseline and Option 1 under all objectives.  Option 2 performs 
better under General Objective 2 (Ensure a wide diversity of choice and quality of PRM 
for all types of users and consumers) as it maintains flexibility of implementation, 
whereas under General Objective 3 (Support innovation & competitiveness of EU PRM 
& FRM industry) it falls slightly behind Option 3. Under General Objective 4 
(Contribute to wider EU objectives regarding adaptation to and mitigation of climate 
change impacts, food security, sustainable production and biodiversity protection) 
both Options 2 and 3 are foreseen to have similar impacts.  

31 See Better Regulation Tool #62 

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Whilst Option 3 carries benefits under both General Objectives 3 and 4, as it 
introduces stronger measures for innovation and in support of wider EU objectives, it 
can also negatively impact some Member States by enforcing detailed rules across 
various measures and containing less flexibility (than Option 2) to adapt them to local 
conditions. Some of these measures, such as detailed rules on digitalisation, may also 
disproportionately impact SMEs, who generally have fewer resources available for 
digital investments. Overall, in terms of effectiveness Options 2 slightly outperforms 
Option 3.  

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 Analysis of options based on effectiveness 

Effective
-ness 

General Objective 2: Ensure a wide diversity of choice 
and quality of PRM for all types of users and consumers 

General Objective 3: 
Support innovation & 
competitiveness of 
EU PRM & FRM 
industry 

General Objective 4: Contribute to wider EU objectives regarding 
adaptation to and mitigation of climate change impacts, food security, 
sustainable production and biodiversity protection 

Create 
proportionate 
rules adapted 
to marketing 
activities & 
PRM/FRM 
types 

(=) absence of 
proportionate rules 
impacts some 
operators 

Baseline 

Ensure conservation 
and sustainable use 
of plant and forest 
reproductive 
materials 

Establish 
conditions for 
testing varieties 
suitable for 
organic 
production 

Support innovation 
and competitiveness 
of the EU PRM and 
FRM industry 

Address 
difficulties 
in supply 
of FRM 

(=) absence of relevant 
conservation measures 

(=) absence of 
conditions for organic 
testing 

(=) innovation and 
competitiveness is expected 
to continue according to 
current trends 

(=) refers to Organic 
Regulation and 
introduces general 
principles on testing 

(+) introduces basic 
principles on digitalisation 
and innovative techniques 

Provide 
better 
access to 
information 
on FRM for 
users/buyer
s 

Clarify scope 
of forestry & 
non-forestry 
purposes 

Promote the 
availability of 
PRM suitable 
for current & 
future 
climatic 
conditions 

Promote the 
availability of 
FRM suitable 
for current & 
future 
climatic 
conditions 

(=) info. To 
buyers remains 
unchanged 

(=) absence of 
specific 
definitions 

(=) absence of 
future climate 
considerations 

(=) absence of 
future climate 
considerations 

(=) info. To 
buyers remains 
unchanged 

(+) definitions 
added 

(=) absence of 
future climate 
considerations 

(=) absence of 
future climate 
considerations 

(=) lack of 
measures 
addressing 
supply 
difficulties  

(=) lack of 
measures 
addressing 
supply 
difficulties 

Option 1 

(+) proportionate 
rules with flexible 
implementation 
through exemptions 

Option 2 

(+) proportionate 
rules with flexible 
implementation 
through lighter 
rules 

(+/-) enhanced 
sustainability measures 
are introduced (lighter 
rules for conservation 
varieties) for PRM; no 
measures for FRM 

(+) enhanced 
sustainability measures 
introduced (lighter rules 
for conservation 
varieties) for PRM and 
FRM 

Option 3 

(-) absence of 
proportionate rules 
impacts some 
operators 

(+) enhanced 
sustainability measures 
are introduced for PRM 
and FRM 

(+) refers to Organic 
Regulation with 
flexible 
implementation for 
MS  

(+/-) refers to 
Organic Regulation 
harmonised 
implementation 
without flexibility 

(+) introduces basic 
principles on digitalisation 
and innovative techniques 

(+) 
contingency 
planning 
principle 
introduced 

(+) info. 
Requirement 
amended with 
sustainability 
aspects 

(++) definitions 
added, FRM 
scope amended 
with non-forestry 
purposes 

(+) 
harmonisation & 
sustainability 
criteria 
introduced 

(+) general 
sustainability 
principles 
introduced with 
flexible 
implementation 

(++/-) detailed rules on 
digitalisation are introduced 

(++/-) 
detailed rules 
on 
contingency 
planning 
introduced 

(+) info. 
Requirement 
amended with 
sustainability 
aspects 

(++) definitions 
added, FRM 
scope amended 
for non-forestry 
purposes 

(++/-) detailed & 
harmonised 
sustainability 
criteria 
introduced 

(++/-) detailed & 
harmonised 
sustainability 
rules for all FRM 

Note: ‘-’ moderate negative impact, ‘–’ significant negative impact, ‘=‘ no significant impact, ‘+’ moderate positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain 

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7.2. 

Efficiency 

Options were also assessed based on their efficiency through a MCA that drew on the 
impact scores for the measures set out under each of the impact categories reported 
in Section 6. Table 16 presents the average scores for each impact category. The 
average impact score for each impact category reflects the average (mean) of the 
qualitative scores for each measure assessed under each impact category.32  

Several variations and tests of efficiency were conducted to examine the robustness of 
the results. These are presented in the tables below. Under all variations and tests, 
Option 2 performs the best and the baseline performs the worst. The results are 
explained below: 

  Equal weighting analysis (Table 17) was conducted, with two analyses run: 
one applying equal weighting to each impact category, and one applying 
equal weighting to each dimension.33 Option 2 performs the best followed by 
Option 1 under both variations. 

  Local sensitivity test (Table 18) removes each impact criterion one at a time 
and re-runs the two equal weighting in each case. Removal of any individual 
impact criterion does not affect the equal impact category weighting results. 
Option 2 performs the best in 100% of cases, that is, regardless of which 
impact category is removed. Applying the same test at the dimension level 
and 0, that is, removing each dimension one at a time returns the same 
results – Option 2 performs the best in each case, followed by Option 1 
except when the economic dimension is removed resulting in Option 3 
performing better than Option 1. 

  Pairwise comparison (Table 20) tests the performance of each option against 
each other option for each impact category. The results indicate that Option 
2 performs better for more impact criteria regardless of which option it is 
compared to.  

The analysis produces stable results indicating that Option 2 performs best, followed 
by Option 1. The baseline is the worst performing option. The only exception is in the 
local sensitivity test where the economic dimension is excluded, which results in 
Option 2 performing best and Option 3 performing better than Option 1. 

 Average impact scores by impact category and policy option 

Impact category 

Administrative burdens 

Competition and investment 

Conduct of business 

B 

0.0 

0.0 

0.0 

O1 

0.2 

0.6 

0.3 

O2 

0.1 

0.3 

0.5 

O3 

-0.1 

0.3 

0.4 

32 Qualitative impact scores: ‘-’ moderate negative impact, ‘–’ significant negative impact, ‘=‘ no significant impact, ‘+’ 
moderate positive impact, ‘++’ significant positive impact, ‘+/-’ inconclusive/ uncertain. These were converted to numeric 
scores as follows: (-- : -2), (- : -1), (= or -/+ : 0), (+ : 1), (++ : 2). The score of ‘-/+’ was assigned a zero value as there was 
insufficient evidence to conclude on the impact. Option impacts were assessed relative to the baseline, hence the baseline 
is always scored as ‘=’ and hence scores zero. 
33 The Dimensions are: economic, environmental, social, where dimension level scores are the average (mean) of the 
impact category scores included in each dimension 

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Impact category 

Innovation and research 

B 

0.0 

Technological development / digital economy 

0.0 

Intellectual property rights 

Fraud 

Position of SMEs 

Functioning of the internal market 

Public authorities and budgets 

Environmental  

Social  

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

O1 

1.3 

2.0 

1.0 

0.0 

0.5 

1.0 

0.7 

0.9 

0.0 

O2 

2.0 

2.0 

1.0 

0.3 

0.4 

2.0 

0.7 

1.3 

0.0 

O3 

1.3 

0.0 

1.0 

0.5 

0.1 

1.0 

-0.2 

1.0 

0.0 

Note: scores represent the mean of the individual measure scores presented for each impact category in 
Section 6 

 Ranking of options under equal weights 

MCA analysis 

Equal impact category weights 

Equal dimension weights 

B 

4th  

4th  

O1 

2nd  

2nd  

O2 

1st  

1st  

 Local sensitivity analysis: ranking of options with each impact 
category excluded 

Excluded impact category 

Administrative burdens 

Competitiveness & investment 

Conduct of business 

Innovation & research 

Technological development / digital economy 

Intellectual property rights 

Fraud 

Position of SMEs 

Functioning of the internal market 

Environmental impacts 

B 

4th  

4th  

4th  

4th  

4th  

4th  

4th  

4th  

4th  

4th  

O1 

2nd  

2nd  

2nd  

2nd  

2nd  

2nd  

2nd  

2nd  

2nd  

2nd  

O2 

1st  

1st  

1st  

1st  

1st  

1st  

1st  

1st  

1st  

1st  

O3 

3rd  

3rd  

O3 

3rd  

3rd  

3rd  

3rd  

3rd  

3rd  

3rd  

3rd  

3rd  

3rd  

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Excluded impact category 

Social impacts 

B 

4th  

O1 

2nd  

O2 

1st  

 Local sensitivity analysis: ranking of options with each impact 
dimension excluded 

Excluded impact dimension 

Economic impacts 

Environmental impacts 

Social impacts 

B 

4th  

4th  

4th  

O1 

3rd  

2nd  

2nd  

O2 

1st  

1st  

1st  

O3 

3rd  

O3 

2nd  

3rd  

3rd  

 Pairwise comparison of options: number of criteria that each option 
performs better than another 

Performing Option 

B 

O1 

O2 

O3 

B 

- 

10 

11 

8 

O1 

O2 

O3 

0 

- 

5 

3 

0 

3 

- 

1 

1 

5 

8 

- 

7.3. 

Coherence 

The proposed measures are broadly coherent with several goals of the SDGs and EU 
strategies (Farm to Fork Strategy, EU Biodiversity Strategy 2030 and EU Forest 
Strategy 2030). Key areas of coherence are: 

  More sustainable agriculture: SDG 2, the Farm to Fork Strategy and EU 
Biodiversity Strategy all target more sustainable agricultural practices. For 
example, the Farm to Fork Strategy and EU Biodiversity Strategy include 
specific targets to enhance the sustainability of agriculture including 
reducing pesticide and fertilizer use. M18 and M19 will promote innovation 
supporting more sustainable agriculture, although M18 may also negatively 
affect the overall number of varieties available. All options are expected to 
have a positive effect, with greatest impact expected under Options 2 and 3. 

  Access to appropriate PRM: The Farm to Fork Strategy states that 

“Farmers need to have access to a range of quality seeds for plant varieties 
adapted to the pressures of climate change. 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.” Several measures directly address these requirements, 
including making changes to registration and certification processes, such as 
M3, M5, M6, M18. All options will have a positive effect. The contribution of 
M3 and M5 will be greatest under Option 1, M18 will be greatest under 
Options 2 and 3, whilst M6 is the same across the options. 

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  Organic agriculture: The Farm to Fork Strategy and EU Biodiversity 

Strategy include a target for at least 25% of the EU’s agricultural land to be 
under organic farming by 2030. All options, through M6, will have a positive 
effect by improving the registration process for organic varieties. 

  Restoring ecosystems: SDG 15, EU Biodiversity Strategy 2030 and EU 
Forest Strategy 2030 all aim for the restoration of ecosystems. The EU 
strategies include a target for planting 3 billion trees by 2030. Several 
measures will support enhanced access to a supply of FRM (M15 on 
contingency planning), ensure FRM is of sufficient quality (M17 on 
application of FRM legislation to non-forestry purposes), and provide 
information to support selection of ‘the right tree in the right place’ (M16 on 
improving access to information). Options 2 and 3 are expected to be most 
supportive of the EU tree planting target. More broadly on biodiversity 
objectives, M3 and M6 are supportive of ensuring access to more genetically 
diverse PRM, thus supporting the Farm to Fork Strategy objective for a more 
sustainable food system and Biodiversity Strategy objective to reverse the 
decline of genetic diversity of cultivated crops. Option 1 is expected to have 
a slightly stronger effect than Option 2 and 3.  

Several measures will directly improve coherence with other EU legislation including 
the Organics Regulation (M8), Official Controls Regulation (M2), and Plant Health 
Regulation (M9). Specific measures will directly target coherence or establish new 
references or others that will enhance coherence. For measures M2 and M8, the 
degree to which the PRM legislation and, respectively, the Official Controls Regulation 
and Organics Regulation, are integrated vary across the options although it is not clear 
whether this will result in any meaningful difference in coherence between the options.  

8.  Conclusions  

This impact assessment has looked at the socio-economic and environmental impacts 
of harmonising the content and implementation of EU legislation on plant and forest 
reproductive material. The aim of the impact assessment was to identify option(s) that 
contribute to a more coherent legislative framework whilst maintaining, high product 
quality and increased diversity of choice and taking into consideration the 
competitiveness of the European industry as well as wider political and strategic 
objectives. Altogether, variations of 19 measures were analysed under the following 
three proposed options:  

  Highest flexibility (Option 1); 

  Balanced flexibility and harmonisation (Option 2); and 

  Highest harmonisation (Option 3).  

Data for the analysis was collected from a combination of desk-based research, 
extensive stakeholder consultation, focus group sessions and case studies. The 
impacts of measures on the key stakeholder groups were contrasted against the 
baseline scenario, which assumes no change from the status quo. The following 
stakeholder groups were consulted: Member State Competent Authorities, breeders, 
PRM/FRM producers, traders, farmers and forest managers and their associations, as 
well as NGOs.  

In summary, Option 1 would contribute to harmonisation in the internal market by 
introducing updated proportionate rules for PRM/FRM and providing clearer rules to 

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operators regarding legislative provisions and implementation mechanisms. 
Exemptions included under Option 1 – such as M3.1 for the activities of SCNs of PRM 
and FRM for forestry purposes, M4.1 for exclusive marketing to amateur gardeners 
and M5.1 for exchange in kind of PRM of non-protected varieties between farmers - 
could, however, weaken the quality of products on the market. Measures under Option 
1 include lighter registration requirements for conservation varieties, fruit plants and 
vine which can aid biodiversity targets and deliver positive environmental impacts. 
However, in terms of promoting sustainability criteria in examination of new varieties, 
Option 1 merely retains the status quo and does not adequately support wider 
European environmental and sustainability targets. As for economic impacts, 
specifically competitiveness and trade on measures relating to seed conservation 
networks and companies marketing to amateur gardeners, Option 1 delivers more 
beneficial impacts than Options 2 and 3. Cost increases, however, are expected to 
arise under Option 1 for both operators and NCAs primarily related to legislative 
compliance and testing costs. In further support to stakeholders, the option introduces 
principles on digitalisation, biomolecular techniques and innovative production 
processes, facilitating their uptake. It thereby allows stakeholders to adopt these 
measures according to the availability of their resources. Under Option 1 rules for 
official controls on PRM and FRM are better defined in relation to the type and 
frequencies of controls and harmonised across policy instruments, which promotes 
coherence in comparison to the baseline, but less than the other options.   

Option 2 introduces updated proportionate rules for PRM/FRM products and provides 
lighter rules to facilitate market access in certain categories thereby supporting both 
the competitiveness of businesses and ensuring production quality is maintained.  
Option 2 also introduces contingency planning principles as well as sustainability 
criteria and principles for FRM. These principles do not dictate any specific 
implementation mechanisms, thereby facilitating their adoption by all Member States. 
In terms of economic impacts, as under the previous option, here as well cost 
increases are expected to arise for both operators and NCAs primarily related to 
legislative compliance and testing costs. Option 2 will introduce general principles for 
VCU testing with Member State level flexibility and sustainability principles. This may 
increase administrative burden of variety registration with variation in cost impacts 
across Member States and potential implications for the volume and diversity of 
varieties available on the market. It will however also lead to more plant varieties with 
characteristics contributing to more sustainable agriculture and thus benefits for the 
agri-food chain and environment. In terms of environmental impacts, innovation in 
varieties and FRM better adapted to climate change pressures may give broader 
benefits for food security and sustainable forestry e.g. reduced risk of crop failures 
and environmental damages of forest fires. The option retains the measure under 
Option 1 for the introduction principles on digitalisation, biomolecular techniques, and 
innovative production processes. Under Option 2 a tailor-made approach to official 
controls is introduced which means that rules and substantial requirements on PRM 
and FRM certification would remain in the PRM and FRM legislation. This could promote 
stronger coherence in implementation between Member States than under Option 1, 
particularly given the current misalignment between the controls regime for plant 
health, organic production and GMOS (which are included in the OCR) and the controls 
regime for PRM and FRM. This would increase the efficiency of operation for competent 
authorities.  

Finally, under Option 3 activities of seed conservation networks, exchange in kind and 
marketing to amateur gardeners are retained under the full scope of the legislation. 
This achieves highest harmonisation but reduces flexibility for concerned stakeholders, 
thus reducing the positive impacts of these activities for genetic diversity. Genetic 

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diversity is still supported effectively by the lighter rules for conservation varieties. 
Sustainability considerations are introduced in the acceptance of new varieties for all 
regulated species with detailed, harmonised rules between Member States delivering 
environmental benefits and innovation. However, these measures can also increase 
the administrative burden of stakeholders, which may have a negative impact on the 
diversity of varieties on the market, and may also constrain the adaptation of 
instruments and solutions that suit specific regional and local climates. Option 3 also 
introduces detailed rules on digitalisation, biomolecular techniques and innovative 
production processes, which, in terms of economic impact, can negatively affect 
stakeholders. SMEs, who generally have fewer resources available for investments 
could be more disproportionately affected, at least in the short run. In the long run 
there could be benefits from efficiency gains. Costs are expected to be higher under 
Option 3 as flexible implementation is removed and higher harmonisation is sought. 
Under Option 3 official controls rules for PRM and FRM would be fully included within 
the scope of the OCR. As part of this, PRM and FRM products would be listed for 
border checks under Article 47(1) of the OCR. This could provide benefits in terms of 
stronger quality protection of imported products however, it could also increase 
control costs and the time it takes for stakeholders to bring products to the market.  

The analysis has found that overall, Option 2 aligns the closest with the objectives 
foreseen as part of the impact assessment to inform the legislative revision of the 
PRM/FRM Directives. Measures under Option 2 introduce the required legislative 
clarifications for certification, registration and production. Option 2 performs the 
strongest in terms of environmental impacts. In terms of economic impacts, the option 
also protects the quality of products and supports competitiveness of European 
businesses. Flexible measures allow Member States to adopt and adjust 
implementation according to their environmental sustainability targets, regional and 
local characteristics as well as available resources. Proposed measures relating to the 
OCR (such as M2.2, tailor made application of OCR to PRM and FRM) may contribute 
to a reduction in non-compliant PRM and FRM in the EU market by increasing the 
likelihood of it being detected. In terms of FRM measures Option 2 introduces general 
principles for assessment of sustainability characteristics (M19.1), with flexibility for 
Member States in terms of their implementation. This measure will likely require 
adjustment of current policies which may translate into some cost increases for 
authorities, however, it will also allow NCAs to adopt flexible implementation which 
may mitigate some of the costs in comparison to the baseline and Option 1.  

All legislative changes are likely to increase compliance costs for stakeholders and this 
may disproportionately affect SMEs. A significant share of cost increases can be linked 
to the time it takes for stakeholders to understand the new regulatory provisions and 
adjust their procedures to remain compliant. Compliance among operators, specifically 
SMEs, could be facilitated by an appropriate transition period. The MCA indicates that 
Option 2 provides the best balance across impact types.  

9.  Monitoring and evaluation framework 

9.1. 

Overview 

The monitoring and evaluation framework identifies the approaches and activities that 
must be taken at the EU and Member State level to effectively monitor implementation 
and compliance of any changes to PRM and FRM policy instruments. The aim is to 
ensure that appropriate arrangements are put in place to track progress of 
implementation and evaluate stakeholders. In alignment with the Better Regulation 

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Guidelines (EC 2021e), the monitoring and evaluation framework must integrate the 
following principles:  

  Monitor only data that is relevant in order to minimise administrative 

burden, but take into consideration context and timeliness of information; 

  Automate as much as possible with the use of IT tools; 

  Develop RACER  (i.e. relevant, accepted, credible, easy to monitor and 
robust) indicators to create a baseline for the monitoring framework; 

  Use common reporting standards to increase interoperability and ease 

sharing of data in the context of the different policy areas; 

  Make maximum use of existing procedures and data to save time and 

increase coherence of results; and 

  Opt for making data publicly available to increase transparency (c.f. 

principles of the eGovernment Action Plan (EC 2019b)).  

The proposed policy changes to the PRM and FRM policy instruments will require 
compliance monitoring and periodic evaluation at the Member State and EU levels. The 
aim is to ensure that the underlying general and specific objectives of the revised 
policies are being met by all relevant stakeholders across the EU.  

9.2. 

 Monitoring at the Member State level 

Member State Competent Authorities should begin collecting data and information on 
the compliance of operators prior to the enactment of revisions on the PRM and FRM 
Directives. Data collected before regulatory changes are introduced, should serve the 
purpose of establishing a baseline against which future compliance updates can be 
measured.  

It is recommended that Member States provide annual updates to the European 
Commission on the number of compliant stakeholders as well as the type and volume 
(in monetary values where possible) of technical assistance or financial support 
requested by operators to achieve compliance. The following data should be collected 
and monitored by Member State Competent Authorities:  

  Number of breeders, multipliers, producers, traders, farmers, forest 

managers involved with PRM and FRM production and trade (subdivided per 
crop groups) 

  Number and share of breeders, multipliers, producers of PRM / FRM, traders, 

farmers, forest managers compliant with registration and certification 
requirements, marketing requirements and import requirements upon 
official controls by MS'. 

  Types of changes made by NCAs to enhance digitalisation of registration and 
certification processes (this can include communication campaigns to raise 
awareness about available digital processes as well as the introduction of 
new digital tools, approaches etc.). 

  Instances of FRM shortage of supply (FRM shortage due to high demand of 

FRM for non-forestry purposes or challenges with climate change 
adaptability) 

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  Number of applications for registration of organic varieties suitable for 

organic production / of those, number of varieties accepted. 

  Number and types of new/updated protocols for sustainability assessment 
put in place to support relevant European commitments and PRM/FRM 
legislative changes. 

9.3. 

Monitoring at the EU level 

It is recommended that the European Commission reviews, annually, the Member 
State compliance reports and adjusts information and support mechanisms in light of 
the changing compliance figures. The following indicators, which have been developed 
in line with the RACER criteria (i.e. relevant, accepted, credible, easy to monitor and 
robust), are proposed for the monitoring of compliance.  

 Monitoring indicators 

General 
Objective 

Ensure that 
there are no 
differences 
between 
Member States 
in PRM and FRM 
marketing 
(level playing 
field)   

Ensure a wide 
diversity of 
choice and 
quality of 
PRM/FRM for all 
types of users 
and consumers 

Specific Objective 

Indicator 

Source 

SO1a: Increase coherence 
of the policy instruments 
and eliminate fragmentation 
of requirements 

Number and type of joint activities 
related to sharing of good practices 
between Member States’ Competent 
Authorities 

Member State annual 
reporting 

SO1b: Create a harmonised 
and risk-based official 
control (OC) framework 

Number of Member States that have 
a multi-annual national control plan 
compliant with the EU rules on 
official controls  

Member State annual 
reporting 

Number of audits carried out, in case 
OCR provisions on audits apply as 
per Options 2 and 3.  

Number and type of European 
policies specifically targeting 
PRM/FRM marketing activities.  

Survey/activity report of networks 
active in conservation of PGR/FGR 

DG SANTE reporting 

Member State annual 
reporting/ DG SANTE 
guidelines 

Number of varieties suitable for 
organic production in common 
catalogues 

Member State 
reporting based on DG 
SANTE guidelines 

SO2a: Create proportionate 
rules adapted to marketing 
activities and types of 
PRM/FRM  

SO2b: Ensure conservation 
and sustainable use of plant 
and forest reproductive 
materials 

SO2c: Establish appropriate 
conditions for testing 
varieties suitable for organic 
production 

SO3a: Improve coherence 
with the plant health 
legislation 

Existence of a mechanism for cross-
sectoral coordination between plant 
health and PRM 

DG SANTE reporting 

Support 
innovation & 
competitiveness 
of the EU PRM & 
FRM industry 

SO3b: Support innovation 
and competitiveness of the 
EU PRM and FRM industry 

Number of EU funded mechanisms 
specifically targeting innovation and 
competitiveness of the PRM/FRM 
sector 

DG SANTE reporting/ 
Horizon Europe action 
plans/ CAP rural 
development 
programs/Relevant 
Structural and 
Cohesion fund 
mechanisms 

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SO3c: Increase efficiency 
and efficacy of the PRM 
sector 

SO4a: Address difficulties in 
supply of FRM 

Existence of European guidelines and 
baselines for the monitoring of the 
efficiency and efficacy of the PRM 
sector Number of Member State 
mechanisms in place to monitor the 
efficiency of the PRM sector.  

Existence of national contingency 
plans/mechanism ensuring EU 
coordination in case of FRM supply 
difficulties  

DG SANTE reporting/ 
Member State 
reporting 

DG SANTE reporting  

SO4b: Provide better access 
to information on FRM for 
users/buyers 

Existence of national/EU mechanisms 
to improve information on FRM for 
users and buyers  

Member State annual 
reporting/future EU 
plant variety portal 

SO4c: Clarify scope of 
forestry and non-forestry 
purposes 

Existence of formal provisions on 
updated definitions for forestry and 
non-forestry purposes 

Member State annual 
reporting based on DG 
SANTE guidelines 

SO4d: Promote the 
availability of PRM suitable 
for current and future 
climatic conditions 

SO4e: Promote the 
availability of FRM suitable 
for current and future 
climatic conditions  

Existence of indicators under EU 
Adaptation Strategy 

Existence of indicators under EU 
Adaptation Strategy 

Member State annual 
reporting based on DG 
CLIMA guidelines 

Member State annual 
reporting based on DG 
CLIMA guidelines  

Contribute to 
wider EU 
objectives 
regarding 
adaptation to 
and mitigation 
of climate 
change impacts, 
food security, 
sustainable 
production and 
biodiversity 
protection 

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Annex 1  Study questions and specific measures 

Table 22 presents the study questions and aligns them with the proposed measures 
and options as they have evolved throughout the study. 

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 Presentation of the study questions and their related options and specific measures to be assessed 

Study question 

O1   O2  O3  Measure 

A.1  What are the expected economic and environmental 

 

impacts in particular for competent authorities and 
operators in terms of administrative burdens and legal 
simplification of aligning the structure, definitions, and 
decision-making procedures between the different policy 
instruments governing PRM and of ensuring coherence 
with the plant health, GMO and organic legislation? 

M1.1 Align structure, definitions, and decision-making 
procedures between policy instruments but keep 
separate policy instruments 

   M1.2 Align and merge policy instruments with a focus 

on the two pillars of the legislation: registration and 
certification  

Keep separate FRM policy instrument 

Keep existing Directive on ornamental plants with 
minimum amendments 

   M1.3 Align and create a single instrument with chapters 

for crop groups  

Keep separate FRM policy instrument 

Keep existing Directive on ornamental plants with 
minimum amendments 

   M9 Align PRM rules with plant health legislation. 

A.2  What are the expected impacts economic and 

   

environmental impacts, in particular for competent 
authorities and operators, including impacts in terms of 
legal simplification of relying on tertiary legislation (instead 
of relying on a co-decided act) to set requirements and 

Certification and inspection of PRM refer to plant health 
rules on RNQPs instead of duplicating them. 

M10.1 Define basic principles on digitalisation, 
biomolecular techniques and innovative production 
processes and create empowerments for detailing rules 
according to new developments 

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Study question 

O1   O2  O3  Measure 

adapt these requirements to technical and scientific 
developments? 

A.3  What are the expected economic impacts, in particular on 
competent authorities and operators (with a specific focus 
on SMEs), of increasing the number of tasks that operators 
may carry out under official supervision (VCU testing and 
certification activities)? 

   M10.2 Establish detailed rules on digitalisation, 

biomolecular techniques and innovative production 
processes 

      M11 Increase certification tasks permitted under official 
supervision except issuing the official label. Permit VCU 
examination under official supervision 

B.1  What are the expected economic, including in terms of 

 

administrative burdens, impacts for competent authorities, 
operators and citizens, social impacts for citizens and 
environmental impacts of restricting the scope of 
application of the PRM other than FRM legislation to the 
professional sector (excluding marketing to amateur 
gardeners and activities of seed conservation networks) 
and/or to the economically most important species on the 
EU market?  

What is in particular the expected impact on the quality 
and choice of PRM? 

M3.1 Exemptions for activities of seed conservation 
networks of PRM and FRM for forestry purposes 

M4.1 Exclusive marketing to amateur gardeners is 
exempted from the scope of the legislation 

M13.1 Harmonise procedures for lists of regulated 
species to comitology only. No specific criteria will be 
introduced. 

  

M3.2 Lighter rules for activities of seed conservation 
networks for PRM and FRM for forestry purposes 

M4.2 Lighter rules for exclusive marketing to amateur 
gardeners 

   M13.2 Lay down criteria and harmonise the procedures 

for adding/removing species from the list of species 
regulated at Union level for PRM and FRM 

B.1.1  Can it be expected that there would be more dedicated 

 

M4.1 as under B.1 

breeding aimed at the amateur sector and thus more 
choice of PRM available on the market if the applicability of 
the legislation is limited to marketing to the professional 

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Study question 

O1   O2  O3  Measure 

sector? Can it be expected that the quality of PRM for 
amateur gardeners will decrease because there is no 
variety testing and no PRM quality standards and controls? 

B.1.2  What is the estimated number and nature of non-profit 

  

M3.1 as under B.1 

seed conservation networks? 

What is the estimated volume and value of PRM marketed 
by non-profit seed conservation networks? 

   

M3.2 as under B.1 

  

M4.2 as under B.1 

How is non-profit status defined in the Member States?  

B.1.3  What would be the substantive criteria to decide which 

 

species to regulate in the PRM legislation? 

M13.1 Harmonise procedures for lists of regulated 
species to comitology only. No specific criteria will be 
introduced. 

   M13.2 Lay down criteria and harmonise the procedures 

for adding/removing species from the list of species 
regulated at Union level for PRM and FRM 

B.1.4  Does the listing of varieties in the Common Catalogues 

     M14 EU wide market access for new varieties of 

serve as an incentive or as a disincentive for the breeding 
activities in species with only a small number of registered 
varieties? 

Could the breeding of varieties of species not regulated at 
EU level, neglected or underutilised species (such as 
lentils) be incentivised by listing the varieties in the 
Common Catalogues? 

agricultural species and vegetables becomes possible 
following acceptance in a national catalogue 

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Study question 

O1   O2  O3  Measure 

B.2  What are the expected economic and environmental 

    

impacts of allowing the exchange of PRM between farmers 
under conditions defining who may participate in the 
exchange (e.g. only among members of regional mutual 
support organisations), maximum amounts to be 
exchanged and the types of varieties (e.g. non-protected 
varieties)? 

What is in particular the expected impact on the PRM 
certification system in the EU and the resilience of the EU 
agricultural system? 

M5.1 Exemption for exchange in kind of PRM of non-
protected varieties between farmers 

B.2.1  The contractor shall collect data on the experiences with 
the system established in France (Article L 315-5 of the 
French Code Rural) for the exchange of PRM between 
farmers (number of farmers making use of the possibility, 
amounts of seed exchanged in total and per exchange, 
how many varieties and what types of varieties were 
exchanged).  

Is there a measurable impact on the obligatory seed 
certification system for agricultural crops in France (i.e. 
marketing of certified seed to farmers)?  

Have there been impacts relevant to plant health or the 
presence of noxious weeds?  

How is this derogation applied and controlled in France? 

  

M5.2 Lighter rules for exchange in kind of PRM of non-
protected varieties between farmers 

    

M5.1 as under B.2 

  

M5.2 as under B.2 

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Study question 

O1   O2  O3  Measure 

C.1  What are the expected economic impacts for competent 
authorities and operators, social impacts for citizens and 
environmental impacts of establishing a simple and 
harmonised registration system (i.e. no variety testing but 
officially recognised description) for conservation varieties 
and for amateur varieties and of facilitating the marketing 
conditions for those varieties (no quantitative restrictions 
and abolishing the region-of-origin concept)? 

     M6 Define lighter registration requirements (no DUS 
but officially recognised description) for conservation 
varieties and extend them to fruit plants and vine. 

M12 Adapt the current rules for “not yet listed 
varieties”, to allow multiplication to adequate marketing 
quantities while variety registration is ongoing. Extend 
to fruit plants and vine, including the “not yet finally 
certified PRM” provisions. 

   M7.1 Introduce specific rules for the production of FRM 
for the purpose of conserving forest genetic resources. 

C.1.1  The contractor shall collect data on the experiences of 

    

M6 and M12 as under C.1 

Member States with the conservation and amateur 
varieties of fruit plants and vines. Are there indications 
that the existing national rules support the production and 
marketing of conservation and amateur varieties of fruit 
plants and vines? 

C.1.2  Can less stringent variety registration requirements 

    

M6 and M12 as under C.1 

contribute to overcoming production and marketing costs 
of conservation varieties? 

C.2  What are the expected economic impacts, including in 

  

M15.1 Introduce principle of contingency planning 

terms of administrative burdens, for competent authorities 
and operators, social impacts for citizens and 
environmental impacts of measures to address difficulties 
in supply of FRM in case of extreme weather and 
disasters?   

   M15.2 Lay down detailed rules on contingency planning 

to ensure availability of FRM 

D.1  What are the expected economic impacts, including in 

  

terms of administrative burdens, for competent authorities 

M18.1 Review and harmonise VCU rules for agricultural 
species to better address sustainability 

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Study question 

O1   O2  O3  Measure 

and operators, social impacts and environmental impacts 
of limiting mandatory VCU to the most important 
agricultural species and/or to sustainability criteria? 

For other crop groups introduce general principles and 
rules on “sustainability criteria” but give MS flexibility to 
implement and adapt to local agro-ecological 
conditions. 

   M18.2 Detailed and harmonised “sustainability criteria” 

for all crop groups.  

D.2  What are the expected economic impacts, including in 





M18.1 as under D.1 

terms of administrative burdens, for competent authorities 
and operators, social impacts and environmental impacts 
of harmonising requirements for VCU testing, of 
introducing mandatory sustainability criteria into VCU-
testing and of obliging competent authorities to offer VCU 
adapted to the needs of organic agriculture? 

D.2.
1 

How shall such a harmonisation of VCU testing be 
implemented to ensure the availability of varieties 
supporting a more sustainable agri-food production? 

Should it address criteria, testing requirements, trial 
procedures, statistical trial designs, and standard setting 
and decision procedures for the acceptance of varieties? 



    M18.2 as under D.1 

 

 M8.1 Refer to Organic Regulation by defining variety 



registration requirements.  

Retain the flexibility for Member States to adapt VCU to 
local agro-ecological conditions. 

  



M8.2 Refer to Organic Regulation, by defining 
harmonised variety registration requirements. 

 

M18.1 as under D.1 

    M18.2 as under D.1 

   M8.1 as under D.2 

   M8.2 as under D.2 

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Study question 

O1   O2  O3  Measure 

D.3  What are the expected economic impacts, including in 

  

M18.1 as under D.1 

terms of administrative burdens, for competent authorities 
and operators, social impacts and environmental impacts 
of extending VCU requirements, or at least VCU addressing 
only sustainability requirements, to other species groups, 
such as vegetables and fruit plants to ascertain that new 
varieties will be sustainable and climate resilient? 

   M18.2 as under D.1 

E.1  What are the expected economic impacts, including in 

     M12 Adapt the current rules for “not yet listed 

terms of administrative burdens, for competent authorities 
and operators, social and environmental impacts of 
allowing the marketing of ‘not yet listed varieties’ and ‘not 
yet fully tested material’ of fruit or vine propagating 
material? 

F.1  What are the expected economic impacts, including in 

    

terms of administrative burdens, for competent authorities 
and operators, social and environmental impacts of 
extending the scope of application of the FRM legislation 
(i.e. applying the same rules applicable to FRM) to certain 
FRM used for clearly defined non-forestry purposes such as 
agroforestry, biodiversity, biomass production, tree 
planting in urban areas and energy generation? The 
contractor shall collect data on the non-forestry purposes 
of tree species regulated in Annex I to Directive 
1999/105/EC and investigate if there are any 
national/regional differences. 

varieties”, to allow multiplication to adequate marketing 
quantities while variety registration is ongoing. Extend 
to fruit plants and vine, including the “not yet finally 
certified PRM” provisions. 

M17.1 Define forestry and non-forestry purposes but 
maintain current scope of FRM legislation 

   M17.2 Define forestry and non-forestry purposes and 

extend scope of FRM legislation to include the 
production of FRM for specific non-forestry purposes 

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Study question 

O1   O2  O3  Measure 

F.2  What are the expected economic impacts, including in 

    

M15.1 Introduce principle of contingency planning 

terms of administrative burdens, for competent authorities 
and operators, social and environmental impacts, of 
measures to address difficulties in supply of FRM? Could 
the provision of additional information on FRM and seed 
stands be considered as an additional measure to help 
address difficulties in supply of FRM? Could the provision of 
additional information on FRM and seed sources assist with 
the selection of climate-adapted FRM suitable for different 
bioclimatic zones? The contractor shall collect information 
on current practices in Member States in relation to supply 
difficulties of FRM and the collection of additional 
information on FRM and seed stands. 

   M15.2 Lay down detailed rules on contingency planning 

to ensure availability of FRM 

G.1  What are the expected economic impacts, including in 

    

terms of administrative burdens, for competent authorities 
of including the PRM and FRM marketing legislation into 
the scope of the Official Controls Regulation? 

M2.1 Harmonise official controls in PRM policy 
instruments outside the scope of OCR 

  

M2.2 Tailor-made inclusion of PRM and FRM in OCR 

   M2.3 Full application of OCR to PRM and FRM 

G.2  What are the expected economic impacts, including in 

 

M2.1 as under G.1 

terms of administrative burdens, for competent authorities 
of creating a specific, harmonised control regime within the
PRM and FRM marketing legislation outside of the scope of 
the Official Controls Regulation? 

   

M2.2 as under G.1 

    M2.3 as under G.1 

H.1  What are the expected economic impacts, including in 

    

M10.1 as under A.2 

terms of administrative burdens, for competent authorities 
and operators of relying more on digital technologies for 
labelling and certification/inspection processes? 

   M10.2 as under A.2 

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Annex 2 

Intervention logic 

The study team has developed an intervention logic for each general objective of the 
proposed legislative revision, building on the draft intervention logic presented in the 
study specification supplied by the Commission and revised according to information 
obtained throughout the study.  

A simplified intervention logic for the proposed revisions to the PRM legislation is 
presented in Figure 2. It illustrates the key mechanisms and causal effects of the 
proposed revisions. 

A narrative theory of change that explains the linkages from cause to effect—from 
intervention to outcome—is presented below, which helps articulate how the change is 
expected to influence the choices and behaviour of actors in the system. It can also be 
used to identify implicit assumptions (e.g. about the factors external to the 
intervention) which are relevant to the intervention bringing the anticipated results.  

A2.1 

[GO1] Ensure there are no differences between MS in PRM 

and FRM marketing 

The PRM legislation is outdated, fragmented and incoherent. This had led to different 
approaches to address the same issues, and Member States using the possibilities 
provided by the legislation in different ways, leading to divergent implementation and 
requirements for operators, and the creation of exemptions [P1]. Official control rules 
are not well-defined at present, leading to enforcement challenges and differences 
among Member States.  

The legislative revision seeks to address these issues by reducing or eliminating 
differences between Member States in PRM and FRM marketing [GO1], and specifically 
to increase legislative coherence (i.e. internal coherence of the PRM policy 
instruments) and eliminate fragmentation of requirements [SO1a]. A second specific 
objective for legislative reform is to clearly define and harmonise the official controls 
rules while not affecting the PRM certification process as such [SO1b].  

Doing so is expected to help ensure that operators and NCAs have consistency and 
certainty about what the rules require and how to implement those requirements. 
NCAs are expected to be able to focus their official control activities on the most 
important tasks. Reliable operators who follow the rules should see efficiency benefits 
(e.g. more targeted inspections) while those operators who do not follow the rules 
should have more / more focused checks and therefore have a greater opportunity to 
improve. The administrative burdens on operators and NCAs should decrease overall. 
Together, these changes will help to ensure a level playing field, supporting the 
internal market.  

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  Overall PRM revision intervention logic 

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A2.2 

[GO2] Ensure a wide diversity of PRM and FRM choice and 

quality 

The current legislative framework applies the same rules to all operators, which means 
the rules are too stringent for some areas of activity, niche areas such as seed 
conservation networks. In other cases, the rules are unclear. Together, these issues 
result in disproportionately high administrative burdens and costs to operators for 
registration and marketing of some varieties [P2].  

Revising the legislation provides an opportunity to create proportionate rules that are 
adapted to the marketing activities and types of PRM and FRM on the market [SO2a], 
as well as adaptations to the testing and certification requirements to support the 
registration of conservation varieties [SO2b] and varieties suitable for organic 
production [SO2c]. Ultimately, doing so will help to ensure a wide diversity of choice, 
while maintaining the quality of materials on the market [GO2].  

An immediate result of these kind of changes should be that administrative burdens 
for some operators and for NCAs should decrease. The costs of developing and 
marketing PRM for some operators should be reduced.  

An intermediate consequence should be that there is greater opportunity for sufficient 
and diverse PRM to become available on the EU market thereby contributing to the 
sustainable use of genetic resources and the protection and continued viability of 
European cultural heritage through landscape, forest and agricultural diversity.  

Adjusting the scope of the legislation for some areas of activity should also contribute 
to a more level playing field for operators.  

A2.3 

[GO3] Support innovation and competitiveness of the EU 

PRM & FRM industry  

The  current  PRM  legislation  hinders  alignment  with  other  policies,  adoption  of  new 
innovations and adaptation to advancements in science and technology, while there are 
procedures and processes that result in inefficiencies in the system [P3]. These issues 
can  be  addressed  by  introducing  in  the  PRM/FRM  legislation  provisions  that  would  
support  innovation and competitiveness for EU industry  [GO3].  

This will involve increasing coherence with the plant health legislation [SO3a]. There is 
scope to  make  the  legislative  instruments themselves  more  flexible  and  adaptable  to 
support  innovation  and  competitiveness  of  the  EU  PRM  and  FRM  industry  [SO3b]. 
Efficiency and efficacy of the PRM sector can also be improved [SO3c]  

There is also a need to align with the latest developments in international standards 
(OECD Seed Schemes, ISTA). Currently the legislation does not provide for such 
possibilities (e.g., use of BMT, varietal mixtures).  

The economic position of some EU operators should also improve, leading to a more 
level playing field, and efficiency in the sector overall should increase. This should also 
contribute to creating and maintaining a skilled workforce in rural and remote areas, 
which is a wider objective of EU policy. 

A2.4 

[GO4] Contribute to wider EU sustainability and food 

security objectives  

There is growing demand in the EU for different types of PRM and FRM to address 
challenges related to the adaptation to and mitigation of climate change, food 
security, sustainable production and biodiversity protection. At the same time, the 
existing legislation has few synergies with European Green Deal objectives [P4].  

The legislative revision presents an opportunity to contribute more clearly and 
definitively to wider EU sustainability and food security objectives [GO4]. The rules 

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can better address difficulties in supply of FRM to ensure availability in case of 
extreme weather and disasters [SO4a]. Better access to information on FRM identity 
can be provided to users/buyers [SO4b]. The scope of the FRM legislation can be 
clarified so that it addresses both forestry and non-forestry purposes [SO4c]. VCU 
testing rules for variety registration can also be enhanced and harmonised to support 
more sustainable food systems, alongside introducing ‘sustainability criteria’ for PRM 
[SO4d] and FRM [SO4e].  

An intermediate outcome will be to ensure the availability of sufficient and diverse 
PRM and FRM suited to supporting wider EU sustainability and food security objectives, 
and more specifically to increase the number of and extent to which plant varieties are 
pest resistant and capable of withstanding adverse weather threats. In the longer 
term, food and nutritional security for EU citizens should improve and some of the 
negative environmental impacts of agriculture and forestry should be reduced. 

Annex 3 

Impact screening 

All potential impacts to be considered in Impact Assessments, and the anticipated 
significance of each, are identified in Table 23 Using the assessment criteria outlined 
below. Explanation (justification) for the impact significance assessment results is 
provided in Table 24. 

Significance scoring: 

  Categories for which no impact is foreseen, and which will not be taken further 

in the impact assessment (indicated by a cross: ““). 

  Categories for which some impact is at least possible, which will be examined 

further during the impact assessment (indicated by a tick: ““). 

  Categories for which a more significant impact is expected, and which will be 

the primary focus during the impact assessment (indicated by two ticks: ““). 

 Impact mapping: anticipated significance of impact types 

Impact on 

Climate 

Quality of natural resources (water, soil, air etc.) 

Biodiversity, 
landscapes 

including 

flora, 

fauna,  ecosystems  and

Domain 

n
o
c
E

c
o
S

v
n
E

Significance 
of  potential 
impact 

x   

x   

x   

Animal welfare 

x 

Working conditions, job standards and quality 

Public health & safety and health systems 

Culture 

Governance, participation and good administration 

x 

x 

x 

x 

Education and training, education and training systems 

x 

x 

x 

x 

x 

 

x 

x 

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Domain 

n
o
c
E

c
o
S

v
n
E

Significance 
of  potential 
impact 

Impact on 

Conduct of business 

Position of SMEs 

Administrative burdens on business 

Sectoral competitiveness, trade and investment flows 

Functioning of the internal market and competition 

Public authorities (and budgets) 

Sustainable consumption and production 

Efficient use of resources (renewable & non-renewable) 

Land use 

The likelihood or scale of environmental risks 

Employment 

Income distribution, social protection and social inclusion (of
particular groups) 

Technological development / Digital economy 

Consumers and households 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

Capital movements; financial markets; stability of the euro  x 

x 

Property rights; intellectual property rights 

x 

x 

 

 

 

 

 

 

x   

x 

x 

x 

x 

x 

x 

 

x 

 

 

x 

 

Territorial impacts (specific (types of) regions and sectors)  x 

x 

x 

x 

Innovation  (productivity  and  resource  efficiency);
research (academic and industrial) 

x 

x 

x   

Fraud, crime, terrorism and security, including hybrid threats x 

x 

x   

Resilience, 
autonomy, security of supply 

technological  sovereignty,  open  strategic

x 

x 

x 

x 

Transport and the use of energy 

Food safety, food security and nutrition 

x 

x 

x 

x 

x 

x 

x   

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Impact on 

Domain 

n
o
c
E

c
o
S

v
n
E

Significance 
of  potential 
impact 

Waste production, generation and recycling 

x 

x 

x 

x 

Third  countries,  developing  countries,  and  international
relations 

x 

x 

x   

Fundamental rights 

x 

x 

x 

x 

 Legend:  - expected to be significant impact;  - possible/moderate impact; time;  - no impact expected.  

 Justification for significance scores in the impact screening exercise 

Category  

Justification 

Climate  

Quality of natural 
resources (water, soil, air 
etc.) 

If measures encourage greater variety innovation (e.g. through the 
inclusion of sustainability criteria or easing access to market for 
locally-adapted varieties) on climate-relevant characteristics this may 
support the sector’s ability to adapt to climate change (and alignment 
with the European Green Deal). 

Measures (e.g. FRM coordination group) may support emergency 
responses to climate-related disasters and, together with other FRM 
measures, support tree planting climate policies.  

If measures encourage greater variety innovation (e.g. through the 
inclusion of sustainability criteria or easing access to market) on 
relevant characteristics (e.g. fertiliser and irrigation requirements) in 
combination with other measures this may contribute to a reduction 
of the environmental footprint of PRM users e.g. reduced impact on 
water resources through reduced agricultural pollution and water 
abstraction.  

Biodiversity, flora, fauna 
and landscapes 

Measures which facilitate marketing of conservation varieties, 
marketing and access to locally-adapted varieties, and support the 
conservation and sustainable use of plant and forest genetic 
resources may in general contribute to conservation of biodiversity. 

Animal welfare  

Not relevant  

Working conditions, jobs 
and standards 

Not relevant.  

Public health and safety 
and health systems  

Not relevant.  

Culture  

Measures may offer an easier route to market for traditional 
varieties, which may contribute to the preservation of cultural 
heritage. 

Governance, 
participation and good 
administration  

Not relevant.  

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Category  

Justification 

Education and 
training, education 
and training systems 

Not relevant.  

Measures may directly affect PRM/FRM operators and 
indirectly affect PRM/FRM users.  

Measures may influence market incentives (e.g. through 
measures which affect administrative burdens, or encourage 
innovation) with resulting effects on PRM/FRM operator 
business decisions (e.g. investment decisions). 

PRM/FRM users may be indirectly affected. The price of 
PRM/FRM may be affected in the short term if impacts on 
PRM/FRM operator costs are significant. Over the longer-
term, measures may influence the PRM/FRM available on the 
market (e.g. by encouraging greater variety innovation, 
changes in the scale of markets such as organic, innovative 
production processes accelerating PRM and FRM production) 
or alter buyer certainty (e.g. regarding quality due to 
exclusion or lighter registration and certification 
requirements; or through increased provision of 
information). Over the very long term there may be a 
positive impact on PRM users’ business viability if varieties 
on the market support climate adaptation in the sector. 

The measures will have a variety of both positive and 
negative effects on administrative burdens. 

Where measures for lighter regimes or exclusion from 
legislative scope are implemented, this will reduce 
administrative burdens for operators in the relevant parts of 
the market (e.g. marketing to amateur gardeners, limiting 
mandatory VCU to the most important species) as a result of 
reduced costs of registration and certification. Changes to 
registration and certification processes (e.g. under official 
supervision, inclusion of sustainability criteria) may have 
positive or negative impacts on the associated administrative 
burdens. The introduction of risk-based inspections for 
certain types of official controls through alignment with the 
OCR may help reduce administrative burdens for reliable 
operators (i.e. those with a good record from official controls 
and with reliable and good performance from own controls) 
through fewer inspections. 

New actions, obligatory or voluntary, (e.g. providing more 
information on FRM) will result in new administrative 
burdens. However, the digitalisation of processes should 
reduce administrative burdens (although there may be 
transition costs). 

Changes in administrative burdens may disproportionately 
affect SMEs, if the scale of burdens (baseline or new) 
represents a higher proportion of overall costs. SMEs may be 
positively affected where administrative burdens are reduced 
(e.g. through implementation of lighter regimes) or 

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Administrative 
burdens on business 

Position of SMEs 

 
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Category  

Justification 

negatively affected where burdens are increased (e.g. 
through inclusion of more criteria in VCU tests).  

In some cases, SMEs may be less able to benefit from 
changes that impact administrative burdens compared to 
larger companies if they do not have the necessary in-house 
resources or capabilities to capitalise on the opportunities 
(e.g. tasks undertaken under official supervision). 

Sectoral 
competitiveness, trade 
& investment flows  

Measures are expected to affect market incentives through 
changes in the scope and specific application of the 
legislative instruments to different species and marketing 
channels (which will affect the ease and cost of doing 
business). This may influence investment decisions of PRM 
and FRM breeding and production businesses. 

Functioning of the 
internal market and 
competition  

Public authorities (and 
budgets) 

Sustainable 
consumption and 
production  

Multiple measures are expected to drive an increased 
harmonisation across Member States and across species, 
supporting a more level playing field for businesses across 
the EU. 

Consumer (business and citizen) choice may be enhanced as 
a result of measures to encourage innovation in the PRM and 
FRM sector and easier / less costly market access for certain 
PRM (e.g. for new varieties, organic material) and in 
particular marketing channels.  

Measures to improve harmonisation and simplification, and 
external coherence (e.g. with the OCR and plant health 
legislation) of the legislation is expected to have a positive 
effect on public authority burdens (e.g. enforcement 
efficiency), although there may be variation across MS 
depending on baseline conditions.  

Increasing the number of tasks that can be conducted under 
official supervision should decrease the burden on public 
authorities (although transition costs are likely), as will any 
net increase in exemptions from the legislation (which may 
differ across MS due to differences in existing use of 
derogations). 

New obligations may create additional burdens for MS (e.g. 
inclusion of additional criteria on sustainability in VCU tests 
may increase the costs of such tests). 

Digital solutions should improve efficiency and so ease MS 
burdens of associated processes but will require transition 
costs. 

Measures are expected to support sustainable production 
(i.e. production by users of PRM e.g. farmers) through 
encouraging greater attention to sustainability criteria. 

Measures that facilitate organic varieties may be considered 
supportive of sustainable consumption and production. 

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Category  

Justification 

Efficient use of 
resources (renewable 
& non-renewable) 

Not relevant 

Land use 

Not relevant 

The likelihood or scale 
of environmental risks 

Not relevant 

The measures do not directly target employment. However 
indirect effects may occur.  

Changes in the ownership of tasks (e.g. tasks under official 
supervision) may result in an associated shift in employment 
for specific roles from the public to the private sector. Any 
change in administrative burdens may have a small 
associated effect on employment associated with conducting 
administrative tasks. 

Where measures encourage innovation and market growth 
this may result in an increase and/or shift in employment 
within the PRM/FRM market.  

Over the very long term, employment in PRM/FRM user 
sectors may be more resilient to climate impacts affecting 
the sector. 

Not relevant.  

Specific measures that introduce digital solutions will 
encourage digital transformation within the sector 

Consumers (citizens as amateur gardeners) will be indirectly 
affected as a result of changes to the regulation of 
marketing to amateur gardeners. Measures which ease the 
route and cost of marketing to amateur gardeners may 
increase consumer choice and reduce prices but may also 
result in reduced product quality. 

Employment  

Income distribution, 
social protection and 
social inclusion  

Technology 
development / digital 
economy  

Consumers and 
households 

Capital movements; 
financial markets; 
stability of the euro 

Not relevant 

Property rights; 
intellectual property 
rights 

Plant variety rights can be obtained for new varieties 
following DUS testing and registration. Acceptance of 
varieties based on adjusted uniformity criteria (new rules in 
the pipeline for organic varieties) may lead to acceptance of 
varieties with broad characters. In turn, such varieties when 
used in the reference collections may in the future create 
difficulties for acceptance of new varieties and/or granting of 
plant variety rights.  

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Category  

Justification 

Territorial impacts 
(specific (types of) 
regions and sectors) 

Territorial impacts are expected to the extent that much of 
the economic activity in the sector takes place in rural areas. 

There are not expected to be any disproportionate effects on 
different regions, uneven territorial development or issues 
regarding territorial cohesion.  

Innovation 
(productivity and 
resource efficiency); 
research (academic 
and industrial) 

Fraud, crime, 
terrorism and 
security, including 
hybrid threats 

Resilience, 
technological 
sovereignty, open 
strategic autonomy, 
security of supply 

Measures may encourage innovation in varieties by easing 
the route to market (e.g. reducing costs and time for 
registration and certification, more easily making 
adjustments to address evolving needs of the sector) or by 
influencing innovation targeted at specific properties of PRM 
(e.g. by inclusion of sustainability criteria in VCU testing, 
thereby encouraging breeders to create varieties that 
perform well against these criteria).  

Measures which distinguish between marketing to 
professional and amateur gardeners may present challenges 
to enforcement and may increase the chances of amateur 
varieties being marketed to professionals. Measures 
exclusive to seed conservation networks and local marketing 
may risk fraudulent activity e.g. local marketing sold over 
the internet to non-local consumers. The same logic holds if 
permitting exchange in-kind between farmers: this might 
create/support an illegal market of seed between farmers 
(there is already a ‘grey market’ problem). 

Not relevant. Aspects of resilience are covered elsewhere 
e.g. climate-related resilience is covered under ‘climate’. 

Transport and the use 
of energy 

Not relevant 

Food safety, food 
security and nutrition 

Overall, measures are expected to support increased 
diversity of PRM/FRM available on the market, including 
innovation in varieties which may support climate adaptation 
and resilience, and ensure future supply. This will contribute 
to EU food security and resilient forests. 

Waste production, 
generation and 
recycling 

Not relevant 

Third countries and 
international relations 

Seed from non-EU countries has to meet equivalence 
criteria. Where changes in the substantive requirements for 
registration and certification (e.g. inclusion of sustainability 
criteria) occur, these are expected to affect third countries 
breeders and producers in similar ways to those in the EU. 

Fundamental rights 

Not relevant 

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Annex 4  Methodology 

This annex presents the full study methodology and has been updated to reflect the 
outcomes of the desk and field research. 

A4.1 

Introduction 

The research agenda has been determined by the impact assessment questions and 
specific research requirements set out in the study specification, information provided 
during the kick-off meeting, and preliminary research conducted during the inception 
phase. This study has collected and utilised quantitative and qualitative information 
from both primary and secondary sources. The team conducted desk research and 
field work to collect data on impacts. 

A4.2 

Preliminary research  

The purpose of this task was to undertake preliminary desk and field research to 
support the study team in finalising the methodological approach during the study 
inception phase. 

This task involved the mobilisation of the team, kick-off meeting, preliminary research 
and exploratory interviews. Meetings with DG SANTE officers contributed to the 
preparation of this Inception Report. Component activities included: 

  Defining and agreeing problems, drivers and their consequences. 
  Identifying the intervention objectives. 
  Refining and specifying the policy options. 
  Screening impacts. 

A4.2.1 

Preliminary desk research 

The aim of this task was to review the key documents identified in the proposal. This 
was to help assess the available secondary data and information that could be used as 
inputs to the impact assessment to identify (a) where useful information is already 
available and (b) the main knowledge and data gaps (including those to be addressed 
as far as possible via additional primary research). The second objective of this task 
was to review the key preceding studies to enable the study team to further refine the 
methodology. 

Preliminary desk research enabled the study team to gain further insights on the 
development of the policy options and problem definition, and further refine the study 
methodology. For this, the study team created an online document review template 
within a secure Teams site which covered the following aspects: 

  The relevance of the document for the impact assessment. 
  Which impact assessment questions the document might be useful in 

answering. 

  Indicator criteria emerging from relevant data. 
  A summary of each document. 

Documents reviewed included the sources listed in the proposal, and previous 
responses to stakeholder consultations. The full list of documents identified (145 in 
total) and reviewed was shared with DG SANTE via MS TEAMS. 

Through this desk research the study team was able to build understanding of the 
likely impacts of the policy options. 

A4.2.2 

Scoping interviews 

We conducted six exploratory interviews with stakeholders to obtain general views of 
the study context and approach to the impact assessment.  

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The objectives of the scoping interviews were as follows: 

  Gather an initial overview of the range of different stakeholders’ perspectives 
concerning the existing legislation and their expectations for the study.  
  Assess where we might expect data gaps or obstacles to information access. 
  Identify sources of evidence and possible key contacts for the main consultation 

phase. 

The study team designed two topic guides for the in-depth qualitative scoping 
interviews, with review and input from DG SANTE: one for the FRM stakeholder and 
one for the stakeholders concerned with PRM. Six scoping interviews were carried out 
from 1 to 30 November 2021. Participants in the scoping interviews were as follows: 

  Euroseeds – organisation representing breeders of plant reproductive materials. 
  European Forest Nursery Association – organisation representing breeders of 

forest reproductive materials. 

  European Consortium for Organic Plant Breeding (ECO-PB) – consortium 

representing breeders focusing on organic varieties. 

  Via Campesina – organisation representing seed conservation networks. 
  Italian NCA responsible for implementing and enforcing the legislation. 
  COPA-COGECA – organisation representing the farming sector. 

The scoping interviews were recorded with participants’ consent, and participants’ 
responses to each question were written up based on notes taken during the 
interview.  

The results of the scoping interviews were used to inform the research tools for 
consultation activities and as lines of enquiry for the desk review. 

A4.2.3 

Study specification 

The preliminary desk and field research, along with in depth discussions with DG 
SANTE and internal analysis supported the specification of the following elements of 
the IA: 

  Problem definition and refinement of options. 
  Impact screening. 

A4.3 

Desk research 

The first main research task involves a review of the relevant literature.  

An online database was set up on a secure Teams site to hold the information on the literature and 
data collected throughout the research tasks. It was shared with SANTE through Teams to provide 
a basis for ongoing review and inputs to this part of the research. 

The study draws on literature from a wide range of sources: governmental and intergovernmental 
bodies, scientists, industry bodies, NGOs, etc. The types of relevant information include position 
papers, working documents, complaints, peer-reviewed literature, case law and infringements, 
legislative texts, and a wide variety of studies and reports.  

Relevant source documents and data which were suggested by the stakeholders during the 
scoping interviews were incorporated into the online database which formed the basis for the 
literature review. Further relevant data sources were added as they were identified through the 
consultations.  

The information extracted from the literature was recorded according to the following framework: 

  The use of a common data extraction template in Excel.  
  Ensuring that relevant information which may not be in English was extracted and 

incorporated into the data collection template.  

  Quality control of the data extracted was undertaken by senior study team members. 

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A4.4 

Field research 

The field research complemented and supplemented the desk research.  

The study team supported DG SANTE in undertaking a 12-week publication 
consultation, and delivered targeted stakeholder surveys, in-depth interviews, and two 
focus groups to gather the views on the potential impacts of the proposed options 
across all stakeholder groups. This was supported by an in-depth case study on in-
kind exchange of PRM in France and vignettes of Member State experience with 
conservation and amateur varieties of fruits and vines.  

The results from these different strands of consultation will be described in a synopsis 
report on the stakeholder consultation, which will be submitted with the draft final 
report. 

A4.4.1 

Stakeholder mapping 

To support the distribution of the targeted surveys and identification of candidate 
interviewees, a stakeholder mapping task was conducted. In total, nearly 350 
stakeholder organisations were identified and categorised (Table 25). 

 Stakeholder mapping summary  

Stakeholder group 

Number of 
stakeholders 
identified 

Associations agricultural, horticultural and fruit plant 
reproductive material 

Associations home gardening 

Civil Society Organisation 

Community Plant Variety Office (CVPO) 

Competent Authority 

Forestry associations 

Home gardeners 

International standard setting organisations 

Nurseries forest reproductive material 

Plant breeding company 

Professional conventional & organic farmers 

Scientific networks on plant and forest genetic resources 

Seed and plant multipliers and suppliers, seed and plant 
trading companies 

15 

11 

40 

1 

93 

3 

3 

11 

3 

39 

30 

84 

13 

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A4.4.2 

Stakeholder consultation strategy 

The stakeholder consultation collected information and insights from a wide range of 
stakeholders. However, the most appropriate method of consultation varied depending 
on the type of stakeholder and the nature of the information to be collected from them 
(e.g. qualitative versus quantitative, simple versus complex).  

Table 26 provides an overview of stakeholders engaged in the consultation activities. 

 Overview of proposed consultation activities 

OPC 

Targeted 
surveys 

Focus 
groups 

Interviews  Case study 

& MS 
vignettes 

Citizens (consumers)  

Industry associations  

Nurseries in the FRM/PRM 
sector  

Forestry associations  

Farmers and farming 
associations  

Competent authorities 
(PRM, vine reproductive 
material, FRM)  

Community seed banks 
and seed savers’ 
organisations  

EU and international 
organisations  

Home gardeners & 
associations  

Scientific networks on 
PRM and FRM  

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

Non-forestry purposes of 
FRM 

X 

A4.4.3 

Public consultation 

The Public Consultation provided an opportunity for all stakeholders, across all EU 
Member States and from further afield, to provide their feedback and views, and 
ensures transparency and accountability in the legislative process.  

Drafting of the questionnaire commenced during the study inception phase. Due to the 
ambitious timeframe of the study, DG SANTE took on the task of developing the 
questions for the Public Consultation, with review and inputs from ICF. Discussions 
between ICF and DG SANTE highlighted the importance of differentiating the questions 
in the Public Consultation and the targeted surveys so they avoid duplication. It was 
agreed that the questions and language used in the Public Consultation should be as 

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accessible as possible to all stakeholder groups, with detailed technical questions 
reserved for the targeted surveys. The Public Consultation clearly stated that 
stakeholders would receive a targeted questionnaire.  

The public consultation was launched by DG SANTE on 21 December 2021 and ran for 
12 weeks, in accordance with the Better Regulation Guidelines (EC 2021e). It closed on 
27 March 2022. There were 2,449 responses to the public consultation. The majority of 
responses  (78%, 1908  of  2449)  were  from EU  Citizens.  Of  the  541 respondents  who 
were  not  citizens,  37%  (202  of  541)  were from  companies/business  organisations.  A 
majority of companies/business organisations (59%, 120 of 202) were micro enterprises 
(i.e. 1 to 9 employees). Over half of all public authority responses (54%, 29 of 54) were 
from national authorities. Amongst public authorities, Germany had by far the highest 
number  of  responses  (18  of  54),  with  responses  from  national,  regional  and  local 
authorities The vast majority of respondents (99%, 2414 of 2449) were based in the 
EU.  

Over three quarters (79%) of citizen respondents, and half (50%) of 
companies/business organisation respondents were from Sweden. It is understood 
that national press articles concerning the PRM/FRM legislation revisions and the public 
consultation may have stimulated the higher-than-average level of response from 
Sweden. Analysis shows a high level of variation in closed and open question 
responses from these two groups. It was therefore concluded that there is no evidence 
to indicate the respondents participated in a campaign directed at achieving a 
particular outcome. As such, no adjustments were made to the EU citizen or 
companies/business organisation samples for the analysis. 

Once the public consultation closed, the study team conducted a full analysis of the 
results. This included quality control of the data received, analysis of closed questions 
using descriptive statistics and a coding system for analysing responses to open 
questions. An analytical report and a factual summary report for the public 
consultation were produced by the study team and shared with DG SANTE. 
Consultation results are provided in Annex 7. 

A4.4.4 

Targeted survey 

The purpose of the survey was to collect stakeholder views and evidence on the 
challenges, costs and benefits, potential effects, and feasibility of potential changes to 
the legislation.  

A process for pre-registration was proposed by the study team to better support 
stakeholder access to the survey. Stakeholders that registered were provided with an 
email address and consent for the study team to hold their contact data for the 
purposes of survey distribution. When the surveys went live the study team issued an 
individual, personalised link to each registered person/entity. This approach, by being 
able to offer a personalised survey link, offered benefits that helped support response 
rates compared to only having a generic survey link, especially on longer / more 
technical surveys: 

  Recipients could share their unique links with colleagues, which is helpful when 

several people need to contribute knowledge to the same response.  

  The recipients could build their responses over a number of visits to the survey 

platform, and find their previous answers saved in the system. 

  The study team could issue targeted reminders to people who had individual 

links that had not submitted a response.  

At survey launch a general link to the survey was provided as well, for distribution by 
representative groups etc. This provided immediate access to the survey for 
stakeholder who had not registered but did not offer the same benefits of pre-
registration.  

Draft questionnaires were developed to collect the information specified in the 
research plan and as required to populate the indicators for each impact assessment 

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question. The questionnaire was tested by the study team and DG SANTE before it 
was implemented to iron out issues. 

The survey contained dedicated sections on PRM and FRM and focussed on a wide 
variety of potential impacts, including but not limited to the costs and administrative 
burdens of stakeholders, impacts on trade, innovation and the environment. 

The following stakeholder groups were addressed in the survey:  

  academic/research institutions;  
  business associations (including breeders, multipliers / producers of PRM / FRM, 

traders, farmers, and forest managers);  

  companies / individual businesses (including breeders, multipliers / producers 

of PRM / FRM, traders, farmers, forest managers);  

  consumer organisations;  
  environmental organisations;  
  non-governmental organisations (NGO);  
  public authorities – national competent authorities and others.   

In total 99 responses were received, out of this business associations represented 
26% (N=26), businesses 21% (N=21), academic/research institutions 8% (N=8); 
NGOs 4% (N=4); public authorities 31% (N=31). Those stakeholders, who identified 
themselves as belonging to the category of “others” (9%, N=9) contained financial 
and education institutions, intergovernmental bodies, foundations and other Member 
State government organisations  (i.e., a research organisation and a ministry). Just 
under half (49%) of the 99 responses came from five countries, these are Austria 
(N=5), Belgium (N=8), France (N=13), Germany (N=12), the Netherlands (N=11). 
Overall, at least one response was received from stakeholders in 23 EU Member 
States. The targeted consultation collected views from stakeholders engaged across 
the supply chain of both PRM and FRM products. Two-third of respondents (N=74) 
answered PRM related questions, while 18% (N=18) responded to FRM ones, the 
remaining 7% responded to both topic areas. Once the targeted survey closed, the 
study team conducted a full analysis of the results. This included quality control of the 
data received, analysis of closed questions using descriptive statistics and a coding 
system for analysing responses to open questions. An analytical report and a factual 
summary report for the targeted survey were produced by the study team and shared 
with DG SANTE. Survey results are provided in Annex 8. 

A4.4.5 

Interviews 

In-depth interviews provided an opportunity to obtain more detailed and 
contextualised views on the issues facing stakeholders than was possible through 
surveys. Separate interview guides were developed for PRM and FRM-related issues 
and to address issues relevant to national competent authorities (NCAs) and other 
stakeholder groups. Topic guides were also tailored for interviews with OECD and 
CPVO representatives. 

The interview programme was launched on 3 March and closed on 12 April 2022. A 
total of 43 stakeholders were interviewed: 30 interviews focused on PRM and 13 on 
FRM issues. 

Approximately half of those interviewed (18 of 43) were representatives of the national 
competent authorities in EU Member States (12 on PRM and 6  on  FRM  issues).  NCAs 
from 14 Member States were consulted (separate NCAs were interviewed on PRM and 
FRM  issues  in  3  Member  States).  A  total  of  14  representative  associations  at  EU  or 
national level were interviewed (10 on PRM and 4 on FRM). Civil society organisations 
(5 on PRM and 1 on FRM) and scientific networks (2 on plant genetic resources and 1 
on forest genetic resources) participated. One interviewee represented an international 
organisation (OECD) and one represented an EU Agency (CPVO). 

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Once the interview programme was complete, the study team conducted a full 
analysis of the results. Results were extracted by study question into a standardised 
Excel template to facilitate analysis. A factual summary report for the interviews was 
produced by the study team and shared with DG SANTE. A summary of the interview 
results is provided in Annex A6.5. 

A4.4.6 

Focus groups 

Two focus groups were conducted on 5 and 6 April 2022, each lasting for two hours. 
One focus group addressed the topic of marketing to amateur gardeners, to support the 
answer to study question B1. Ten stakeholders participated in the event, representing 
national  competent  authorities  (6),  plant  breeders  associations  (2),  a  seed  savers 
association and a home gardeners association.  

The second focus group addressed FRM topics to support the answers to study questions 
F1 and F2. Seven stakeholders agreed to participate, however, on the day of the event 
only  three  stakeholders  attended,  and  one  stakeholder  sent  remarks  via  email. 
Participants  represented  NCAs  (2)  and  an  organisation  working  in  the  area  of  forest 
genetic resources.  

Focus  group  results  were  summarised  in  an  analytical  note  and  a  factual  summary 
report,  which  were  shared  with  DG  SANTE.  A  summary  of  the  focus  group  results  is 
provided in Annex 9. 

A4.5 

Case study and QCA 

The purpose of this task is to address IA questions B.2 and C.1 through additional steps 
besides those prescribed in the study ToR. These steps involve:  

  A case study of the French derogation allowing for in-kind exchange of seeds 

and plants between farmers; and  

  Qualitative Comparative Analysis (QCA) of Member States’ experiences with 

conservation and amateur varieties of fruit plants and vines. 

A4.5.1 

Case study on in-kind exchange of PRM in France 

A case study was undertaken to explore the experience in France with in-kind exchange 
of PRM to support the answer to study question B.2.  

The aims of the case study were to:  

  Characterise the system (e.g. number of farmers making use of the possibility, 
amounts of seed exchanged in total and per exchange, how many varieties and 
what types of varieties were exchanged).  

  Assess whether there is a measurable impact on the obligatory seed 

certification system for agricultural crops in France (i.e. marketing of certified 
seed to farmers)?  

  Assess whether there have been impacts relevant to plant health or the 

presence of noxious weeds.  

  Articulate how is this derogation applied and controlled in France. 

The  case  study  draws  on  academic  literature  and  interviews.  Eight  interviews  were 
completed with the NCA, a seed exchange network, seed producers (2), representatives 
of farmers’ unions (2), and researchers (2). The case study combines qualitative and 
quantitative  evidence  to  the  extent  such  evidence  was  obtained  and  is  sufficiently 
robust. 

The case study followed a process tracing approach to disentangle the effects that the 
derogation may have had from those that other initiatives in that space may also have 
caused. Process tracing is a well-recognised method for within-case analysis (in other 
words, for the investigation of cause-effect linkages when comparison between one case 
and another is not possible). The approach involved mapping the sequence of events 

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while  questioning  the  plausibility  of  cause-effect  relationships  throughout:  examining 
those relationships against evidence (including interview statements) and considering 
alternative explanations until one is reassured that the process as documented provided 
a robust explanation for the outcomes observed.  

An analytical case study report was produced by the study team and shared with DG 
SANTE. It is provided in Annex 10. 

A4.5.2 

QCA of MS experience with conservation and amateur 

varieties of fruit plans and vine 

A qualitative comparative analysis (QCA) on Member States’ experiences with 
conservation and amateur varieties of fruit plants and vine was planned for the study 
to support the answer to study question C.1.  

The methodology that was applied to explore this question involved a short survey of 
NCAs from 17 Member States that covered a limited set of questions, all related 
strictly to fruit and / or vine varieties. All questions were framed in a concise manner 
and prescribed specific answers (yes/no; figures) to obtain data specific enough to 
then run a Qualitative Comparative Analysis (QCA). The variables for which data was 
sought included first a set of indicators on the national rules for registration of 
conservation varieties and varieties with no intrinsic commercial value: 

  whether national rules provided for a separate, lighter regime for conservation 

varieties or varieties with no intrinsic commercial value 

  whether fees for registration are reduced for conservation varieties and 

varieties with no intrinsic commercial value, compared to those incurred for the 
registration of other varieties 
the number of such varieties registered in the MS 

 

The survey then sought to collect evidence on other factors that may influence 
practices of production of fruit and vine PRM: 

the capacity to produce such varieties in the MS 

 
  whether there has been unmet demand for such PRM in the MS 
  whether any informal seed exchange networks have been contributing to the 

diffusion of such varieties in the MS 

Finally, the survey sought to measure actual production levels of fruit and vine 
conservation varieties and varieties with no intrinsic commercial value in the MS. The 
latter was defined as the main outcome measure. 

17 MS NCAs were approached and asked to return a partially pre-filled form, covering 
either fruit or vine, or both; 17 forms were returned. Most of them were partially 
completed. No consistent measure of volumes produced could be achieved due to a 
lack of data: not all Member States track this information. As a result, it was not 
possible to derive a common scoring for the Member States that could then be used 
for the QCA.  

By contrast, some NCAs (but not all of them) provided indications of the number of 
such varieties registered in their MS. Some of them qualify as “commonly known 
varieties” as defined in article 7 of Directive 2008/90.  

A4.6 

Synthesis and data analysis 

The aim of this task is to analyse impacts by policy option and then conduct a 
comparative assessment of policy options. This task will rely on triangulating all the 
evidence coming from desk research and the consultation activities. This task will 
follow closely Tool #18 of the 2021 Better Regulation Guidelines (EC 2021e and 
2021f). 

This task has four sub-tasks: 

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  Synthesis: Our study team will triangulate all the primary data coming from 

the stakeholder consultation and secondary data from desk research addressing 
the corresponding research questions. 

  Analysis of impacts: Building on the triangulated evidence, our study team 

will map and shortlist the most relevant and likely impacts by option. 
Quantitative assessment will be done for all the shortlisted impacts and 
quantified to the possible extent given the availability of data. 

  Comparative analysis:  Our team will bring the evidence together to compare 

the policy options. 

  Monitoring framework: Our team will produce a list of indicators to monitor 

and evaluate the preferred option. 

A4.6.1 

Evidence synthesis 

The study team prepared responses for each of the specified components of the 
impact assessment analysis. The response to each component addresses in toto the 
questions specified in the research plan. We applied the principles of synthesis and 
triangulation to the evidence synthesis. We synthesised and triangulated the 
evidence and data we gathered during the assignment in the following ways: 

  Data triangulation – gathering data by different methods and from different 

individuals, and also from different time periods (dependent on secondary data 
availability). 

  Researcher triangulation – gathering information using different researchers 
(joined-up through regular team briefing/de-briefing sessions and standard 
research protocols); and 

  Methodological triangulation – gathering and using a combination of 

quantitative research and qualitative research evidence. 

We synthesised the quantitative and qualitative evidence gathered to facilitate the 
answering of research questions and reporting of findings along thematic lines. The 
evidence base has been clearly explained, and the conclusions qualified as/where 
appropriate, to ensure transparency and support interpretation. 

The study team compiled the evidence collected in previous tasks into a structured 
statement using an appropriate mix of qualitative and quantitative data to describe 
the current situation and its likely evolution. The synthesis of data supported the 
answers to the study research questions.  

A4.6.2 

Impacts of policy options 

Impacts of the policy options have been assessed qualitatively, and quantitatively 
where possible, based on the triangulated evidence gathered in the stakeholder 
consultation and desk research. This task followed Tool #18 of the 2021 Better 
Regulation Guidelines. 

All potential impacts have been mapped and shortlisted according to their likely 
significance, drawing on detailed consideration of each of the policy measures and 
their likely causal effects. The impacts have been described and quantified to the 
extent made possible by the evidence, comparing the application of the options with 
the situation in the baseline scenario. The analysis indicates the nature and direction 
of change expected to result from application of the options, who is impacted and 
how. In assessing impacts, we have considered: 

  Direct and indirect changes expected as a result of the policy change;  
  Potential positive and negative effects;  
  The magnitude of change;  
  The numbers and types of stakeholders affected;  

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  Potential risks and unintended consequences of the option;  
  Timescales and durations over which impacts are expected;  
  Costs for different stakeholders (manufacturers, consumers, Member State 

authorities, EU institutions, etc.), monetised where feasible; 

  Benefits for different stakeholders, quantified and monetised where feasible (we 

do not expect it to be feasible to quantify environmental impacts, or some 
economic and social impacts); and 

  The likely distribution of costs and benefits (e.g., for SMEs versus larger 

enterprises and different sub-groups of consumers based on socio-economic 
status, etc.). 

Impacts on administrative burdens are a key category of impact, which may be 
feasible to both quantify and monetise. The study team drew on the Standard Cost 
Model, as outlined in the Better Regulation Guidelines (EC 2021e), although data 
limitations mean a full and structured assessment of costs was not possible.  

All monetizable costs and benefits have been analysed where data is available, with 
clear indication of the scope of impacts that are included in the monetised estimates. 
The data, factors and assumptions used to build the estimates of benefits and costs 
have been made explicit and recorded in the main text or annexes as appropriate so 
that results are transparent and reproducible. Issues affecting the reliability of 
estimates (e.g. quality of input data) are discussed within the report where the 
estimates are provided. Several of the quantitative estimates presented are labelled as 
being ‘illustrative’, indicating the low certainty in the accuracy of the estimates.  
Annexes to the final report provide the information needed by third parties to 
understand the results. 

A4.6.3 

Comparative analysis 

The comparative analysis shows the relative merits of the options against the baseline 
scenario but also against each other. The options were assessed with reference to 
their effectiveness, efficiency and coherence as required by the Better Regulation 
Guidelines (EC 2021e). 

A4.6.4 

Monitoring and evaluation framework 

This task developed a framework, in line with the Better Regulation Toolbox (EC 
2021f). The framework was defined based on the general and specific objectives. 
Advice on the appropriate data sources is provided. 

A4.7 

Conclusions 

Key finding on each option and conclusions on the best performing option were 
developed based on the impact analysis and comparison of the options analysis.   

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Annex 5  Evidence synthesis by study question 

This section provides a summary of the findings for each study question, including an 
assessment of the problem definition and baseline scenario for each issue, and 
potential impacts of changes to the policy instruments.  

Following the data collection activities for the study, changes were made to the 
specific measures and new measures were added. In some cases, there is Iimited or 
no information available on these measures, as noted in the analysis. The original 
study questions in the terms of reference have not changed; in some cases the new or 
revised measures do not respond directly to the related study question.  

A5.1 

A1: Alignment of definitions and structure of the 

legislation 

This study question assesses the problems for stakeholders which stem from the lack 
of harmonisation within the policy framework and with other relevant legislation, and 
the impact of measures to address this.  

Ref.  Study question 

O1   O2  O3  Measure 

A.1  What are the expected 

 

economic and 
environmental impacts 
in particular for 
competent authorities 
and operators in terms 
of administrative 
burdens and legal 
simplification of 
aligning the structure, 
definitions, and 
decision-making 
procedures between 
the different policy 
instruments governing 
PRM and of ensuring 
coherence with the 
plant health, GMO and 
organic legislation? 

 

M1.1 Align structure, definitions, and decision-
making procedures between policy instruments but 
keep separate policy instruments 

M1.2 Align and merge policy instruments with a 
focus on the two pillars of the legislation: registration 
and certification 

Keep separate FRM policy instrument 

Keep existing Directive on ornamental plants with 
minimum amendments 

 

M1.3 Align and create a single instrument with 
chapters for crop groups  

Keep separate FRM policy instrument 

Keep existing Directive on ornamental plants with 
minimum amendments 

 

 

 

M9 Align PRM rules with plant health legislation.  

Certification and inspection of PRM refer to plant 
health rules on RNQPs instead of duplicating them. 

A5.1.1 

Problem statement  

The 12 EU Directives which regulate the marketing of PRM and FRM are not fully 
aligned, for example, in terms of their definitions and terminology. This causes a lack 
of coherence across the policy instruments (EC 2021a), which leads to inconsistencies 
in their interpretation for operators and competent authorities and uneven 
implementation and application by Member States. This in turn creates a non-level 
playing field and different market conditions for operators. 

Most NCAs surveyed (12 of 21) found no problem with the implementation and 
enforcement of the directives, although 9 of 21 did. The majority of NCAs interviewed 
(9 of 11) identified issues relating to inconsistent terminology and definitions, and 
differences in implementation across MS and some stated that this resulted in 
increased costs and additional workload. For example, the Commission is increasingly 
receiving questions on the application of EU legislation. However, over half of the 
NCAs (5 of 9) reporting issues stated that these did not represent a significant 

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problem for them. The survey showed that a majority of businesses (10 of 19), 
representative associations (15 of 23) and NGOs (5 of 6) encountered issues due to 
the differences in implementation between Member States. The relative importance of 
the problem differs according to the stakeholder group. Responses from the public 
consultation and survey reveal that public authority respondents and business 
associations were much more likely to disagree that the current policy instruments 
present a problem whereas the majority of NGOs cited difficulties with implementation 
of the legislation. 

SMEs can be disproportionally affected by the current policy framework. Two 
organisations representing small organic breeders, and one industry association 
interviewed commented that larger businesses working across MS benefit from the 
differences in implementation of the Directives as they are able to register in countries 
with lower implementation costs and requirements.  One NGO survey respondent and 
a seed network organisation interviewed identified that varying costs of registration 
and certification across Member States can be a disadvantage for SMEs who do not 
have the resources to seek registration in other Member States. Two civil society 
organisations interviewed commented that the current legal complexity of the rules 
can disadvantage smaller actors. 

There are also overlaps and inconsistencies between PRM and other EU legislation 
leading to reduced efficiency and effectiveness of processes and procedures. The 
duplication of plant health requirements concerning Regulated Non-Quarantine Pests 
(RNQPs) in the PRM Directives and the Plant Health Regulation makes it difficult for 
producers to comply with the plant health rules (EC 2021a). The majority of NCAs 
surveyed (12 of 21) stated they encounter problems with the implementation and 
enforcement of the legislation because currently the regulated non-quarantine pests 
are listed in both the PRM marketing Directives and the Plant Health Regulation.  
Additional effort is required to ensure appropriate application of the legislation leading 
to increases in the burden on NCAs (EC et al. 2021).  

No evidence was found of incoherence between the PRM legislation and Organic 
Regulation through the desk and field research for this study. The European 
Commission’s 2021 study (EC 2021a) indicated that there was a concern about 
overlapping rules in the organic regulation and PRM production of certain species. 
However, this seems to refer to DUS testing requirements under the PRM legislation 
and Community Plant Variety Rights (CPVR) legislation to obtain plant breeders’ rights, 
rather than a lack of coherence between the organic and PRM legislation.  

The CPVO representative was of the opinion that coherence between PRM legislation 
and CPVR legislation is needed. The DUS requirement for granting plant variety rights 
and PRM marketing authorisation is identical.  DUS protocols are developed by the 
CPVO and can be applied quickly.  However, the same protocol must be updated in the 
legal text (which can take up to a year) before it can be used to list a variety in the 
common catalogues. The stakeholder explained that it would be more efficient to refer 
to CPVO protocols in any future legal text.   

A5.1.2 

Impacts  

Baseline assessment  

Internal coherence: In the absence of any change to the policy instruments it is 
likely that the problems identified by stakeholders, in particular NGOs, operators 
and NCAs will remain. The majority of stakeholders surveyed cited unnecessary 
administrative burden (as a result of a lack of harmonised definitions and uneven 
implementation) and disadvantages to SMEs. Larger businesses will continue to take 
up the opportunity to register in MS with lower costs, whilst SMEs will be less able to 
compete. The complexity of the legislation will continue to be a barrier to new seed 
companies and SMEs entering the market. 

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External coherence:  Problems relating to the lack of alignment with the Plant Health 
Regulation and CPVR are likely to persist, the administrative burden from overlaps 
and inefficiencies continuing to affect NCAs in particular. 

Several stakeholders interviewed (4 NCAs, and a plant nursery association) identified 
unnecessary administrative burdens as an impact of the current rules. An NCA 
explained that costs may differ across Member States depending on whether certain 
controls are undertaken by the competent authority or by the operator.  A PRM 
representative association explained that registration procedures can differ across 
Member States in terms of fees, standard varieties, input levels, locations for testing, 
number of locations and thresholds. (See study question A.3 for further information on 
costs of registration and certification). 

The way costs are recovered (registration costs are publicly funded in some countries 
and covered by operators in others) can lead to differences between Member States. 
The targeted survey results reflected the different practices across Member States:  of 
18 NCAS,  2 indicated that 1-20% of variety registration costs are recovered from 
operators, 3 that 21-40% of costs were recovered, 2 that it was 41-60%, 1 that it was 
61-80%, and 3 that it was 81-100%. The remainder did not know. Different 
registration procedures across Members States can have an impact on the length of 
the registration process.  One individual business surveyed provided information 
suggesting that the variation between Member States in the frequency with which they 
update the EU Common Catalogues with new varieties listed on the national registers 
ad an effect on the time taken for registration (in some countries this happens several 
times annually, in others only once).   

Businesses surveyed noted the issues that the diverse implementation of the 12 
Directives cause to their operations and consequently identified higher costs as well as 
difficulties in marketing as the main impacts. Two organisations representing organic 
seed networks considered that the complexity of the legislation made it difficult for 
new seed companies to enter the market in terms of time and costs.  

Several stakeholders interviewed (2 representative organisations for PRM and FRM, 
and one FRM scientific network) identified fraud, impact on traceability of material and 
an inconsistent level of service and costs across Member States as the main impacts of 
a lack of level playing field. One example provided by an FRM interviewee is a 
eucalyptus species which is regulated at national level in Portugal but not in Spain. 
This presents a problem for movement of the material and issuing the master 
certificate.  

Fraud is a concern, especially in the FRM sector. An FRM representative organisation 
interviewed indicated that poor controls in certain Member States contribute to the 
problem and that fraud is a significant issue with negative economic and 
environmental impacts. 

One industry association representing ornamentals cited a specific issue with 
Directives reflecting crop types rather than end use. Some species are propagated 
before the end use is known (e.g. cherry trees which can be fruit trees, ornamentals 
or forest trees) which creates problems in understanding which Directive to follow. 

Impacts of flexibility versus complete harmonisation 

 Results from the public consultation show that in eight out of the ten stakeholder 
groups a majority believe that coherence of the legislation could be best improved by 
aligning the structure and definitions of the 12 PRM directives but retaining them as 
separate policy instruments (Measure 1.1). This option had the highest level of 
agreement, with the fewest number of stakeholders across every type who thought 
that coherence of the legislation could be best improved by creating a single policy 
instrument with different chapters per crop group. Several interview responses (5 
NCAs) reflected this view.  

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The consultation results are slightly at odds with the findings of the Commission’s 
2008 study. Although 70% of surveyed stakeholders (n=215) wanted to maintain 
directives as these were dynamic and easier to adapt, more than half (53%, n=198)) 
thought that compiling directives based on crop groups could simplify the system and 
increase consistency between species which have certain common characteristics and 
could increase clarity and reduce the amount of legislation (EC 2008). 

Administrative burdens for public authorities 

Aligning the structure, definitions, and decision-making procedures between the 
different policy instruments governing PRM and ensuring coherence with other 
relevant legislation is likely to lead to reduced administrative burdens for NCAs. Three 
NCAs interviewed were clear that harmonisation would lead to less time spent 
explaining the directives to operators, less investment in staff training and reduced 
costs. 

Some interviewees identified the need for a flexible approach to implementation by MS 
so that national differences could be accounted for. For example, in the Netherlands 
national requirements for seed potatoes are higher than the EU norm, which means 
that in practice Dutch potatoes are sought after because they have a high quality 
standard. Another NCA interviewed felt that the current rules offer a good opportunity 
for implementation at a national level with flexibility. One NCA interviewed stated that 
any obligatory legislation would be complicated and expensive to implement. This is 
echoed in findings from responses to other study questions: more detailed rules risk 
creating a more significant administrative burden for public authorities due to the 
more significant time and cost needed to interpret them. A more flexible approach 
(option 1 and option 2) may offer the best balance by, for example, incentivising the 
use of digital tools while allowing NCAs to pursue technologies most appropriate to 
their needs.  

Findings from the study question on harmonisation of PRM with the OCR suggest that 
the most flexible measure under option 1 is likely to have the least negative impact on 
all NCAs in terms of administrative burden and related costs, because changes to their 
existing PRM/FRM control regimes would be minimised. There are likely to be some 
efficiency gains from closer alignment with the plant health regime. The strictest 
measure (option 3), however, represents the greatest burden for NCAs as it would 
require more resources to implement.   

Conduct of business 

The findings across the study questions as a whole show that increased alignment 
between the PRM policy instruments and coherence with other relevant legislation are 
likely to have a positive impact overall on operators. As one industry association 
representative interviewed commented, streamlining the legislation would reduce the 
additional paperwork and administrative cost of working across different Directives. 
More flexibility (option 1 and option 2) in implementation can minimise the 
administrative burden that would be associated with navigating detailed rules.  For 
example, more detailed rules are likely to disproportionately affect small businesses 
which lack the resources to invest in new technology. Larger businesses with more 
resources are more likely to see efficiency gains resulting from use of new 
technologies. One seed company surveyed explained that despite the differences in 
costs and administrative burdens in different Member States, the freedom (and 
flexibility) to choose the country where they can apply for registrations and the 
guarantee of access to the internal market were more important. One industry 
association stressed the need to keep in mind the particularities of PRM, and that 
there should be a clear differential between fruit, ornamentals, vegetables, and other 
crop types.  

 A minority view expressed by one industry association was that a regulation (closer to 
option 3) should be considered as the new PRM policy instrument because this would 

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ensure more even implementation across Member States and reduce administrative 
costs related to working across several Directives. 

There is some evidence from the findings on study question on OCR which suggests 
that harmonising the approach to controls across Member States could support a more 
level playing field for business operators. However, opinions from 2 NGOs (the group 
which cited most difficulties with implementation the legislation in its current form) 
made clear that they were not in favour of harmonising the rules around official 
controls.  Reasons cited were that Member States should retain the ability to adapt 
their controls to their climate, their cultural habits, and agricultural practices; and the 
importance of ensuring administrative burden for seed producers was not increased. 

Biodiversity 

A flexible implementation of policy instruments (option 1 and option 2) may be more 
likely to lead to positive biodiversity outcomes. For example, the study question 
findings on introducing sustainability criteria suggest that flexibility provided to 
Member States means they can adapt their VCU testing practices to local agro-
ecological conditions. These could support climate specific approaches and reflect the 
sustainability challenges of specific regions. Completely harmonised ‘sustainable VCU’ 
criteria system would be less effective in reducing biodiversity loss due to the large 
variations in climate across the EU. Regional differences should be accounted for and 
the need for national (not just EU) lists to be established to account for varying 
national/regional contexts.  

A5.2 

A.2: Relying on tertiary legislation to set requirements and 

adapt to scientific and technological developments 

This study question assesses the problems currently experienced by stakeholders with 
utilising scientific and technological developments in the PRM and FRM sectors, and 
the potential impacts of legislative changes that could address these problems.  

Ref.  Study question 

O1   O2  O3  Measure 

 

 

M10.1 Define basic principles on digitalisation, 
biomolecular techniques and innovative production 
processes and create empowerments for detailing 
rules according to new developments 

 

M10.2 Establish detailed rules on digitalisation, 
biomolecular techniques and innovative production 
processes 

A.2  What are the expected 
impacts economic and 
environmental impacts, in 
particular for competent 
authorities and operators, 
including impacts in terms 
of legal simplification of 
relying on tertiary 
legislation (instead of 
relying on a co-decided act) 
to set requirements and 
adapt these requirements 
to technical and scientific 
developments? 

A5.2.1 

Problem statement  

Current PRM legislation can impede scientific and technological development. Its 
rigidity means there are challenges to introducing rules covering innovative production 
processes. PRM and FRM obtained through some scientific and technological 
developments can face barriers to market access (EC 2021a). This was corroborated 
by stakeholders in interviews: six (including NCAs, an industry association, an 
international organisation and a scientific network) explained that problems arose due 
to the current Directives not reflecting the latest developments, and three (two 
industry associations and an NCA) specifically noted the difficulties in amending the 
Directives, Including the need for this process to be quicker. Nevertheless, views 
expressed among stakeholders were mixed, even within stakeholder groups: a fairly 

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equal proportion found a problem compared to those that did not, both in the survey 
and the public consultation. In interviews, five interviewed stakeholders (three NCAs, 
an industry association and a civil society organisation) explicitly stated that the 
Directives themselves were not a barrier. 

The most commonly mentioned developments that stakeholders felt to be restricted 
by current PRM legislation were True Potato Seed (TPS), New Genomic Technologies, 
and biochemical and biomolecular techniques (including in-vitro propagation and 
utilising genetic markers). While some new production techniques can be tested in 
temporary experiments (e.g. true potato seeds), PRM/FRM legislation does not 
currently allow marketing after the experiment is over. Operators of FRM and fruit 
plants are unable to exploit the full potential of in vitro propagation and genetic 
markers Biomolecular techniques were of particular interest to interviewed 
stakeholders, with five suggesting a need for PRM legislation to set procedures for the 
use of molecular markers (e.g. in DUS testing). One stakeholder also felt the CPVO 
Working Group IMODDUS (integration of molecular data into DUS testing) had 
expertise in molecular techniques which was not sufficiently utilised under current PRM 
legislation.   

A5.2.2 

Impacts  

Baseline assessment 

The current challenges in amending the PRM legislation are likely to continue 
without EU intervention. While it can be done, one NCA noted that it took “too much 
time”. This in turn means there is more reliance on older technology, despite the 
potential for newer scientific and technological developments to make processes 
(such as production; registration and certification) more efficient.  Another NCA and 
the CPVO provided the example of proving distinctness of a variety. This takes a 
year with trials, because the PRM has to be grown and observed for the 
characteristics that make it distinct. It could take as little as two weeks if molecular 
techniques were used instead, because it would only be necessary to look at the 
genetic markers that dictate the PRM’s characteristics in a laboratory setting. As 
such, NCAs and industry face barriers to increasing their efficiency. This is a 
competitive disadvantage for the EU’s PRM/FRM sector.    

The level of adoption of scientific and technological developments currently differs 
across Member States. Without EU intervention these differences are likely to 
continue to diverge. This could potentially contribute to an unequal playing field. For 
example, evidence from interviews indicated that some Member States were 
beginning to take action. Already, some technologies (like biomolecular techniques) 
were being used to different extents across the EU. One stakeholder stated that 
Spain was undergoing a process of integrating the latest developments into their 
national legislation. Other stakeholders stated that, in France and Finland, NCAs 
were already utilising biomolecular techniques. In France, they were being used for 
variety examination to verify the presence of genes that correspond with particular 
characteristics (such as disease resistance) and in distinctness testing to measure 
the genetic differences between varieties (GEVES 2020). By contrast, one 
stakeholder indicated that Poland waited for EU direction prior to introducing 
scientific and technological developments.  

Public authorities  

Public authorities had mixed views on the impact of legislative support for scientific 
and technological developments in the PRM and FRM sectors. Around a third of NCAs 
surveyed thought integrating the latest scientific and technological developments into 
PRM/FRM policy instruments could decrease the time it takes to register (7 of 22) or 
certify (8 of 22) PRM/FRM. In interviews, the CPVO and one NCA explained that they 

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expected time savings if biomolecular techniques could be applied in DUS testing. 
There is also potential for application of these techniques in VCU tests. 

Biomolecular techniques can be used to identify genetic markers that indicate a plant’s 
characteristics. If these characteristics are known genetically, it would negate the 
need for NCAs to wait for a plant to grow before physically observing it. It would also 
reduce the risk of VCU and DUS tests being affected by adverse environmental or 
climatic conditions (e.g. in the event of frost or drought, the tests may have to be 
repeated). The CPVO also mentioned the additional benefit of a faster and more 
reliable comparison of candidate varieties with existing varieties in reference 
collections (which is carried out to establish distinctness). This would usually be done 
manually, using the technical description to identify the most similar varieties. 
However, there can be thousands of varieties for some species (e.g. maize), 
increasing the time it takes to compare varieties and the risk of human error. 
Molecular data would decrease the chance that a variety is missed and therefore 
reduce the costs.  

These potential benefits of biomolecular techniques are supported by studies, such as 
Patra and Chawla (2010) which found that relying on morphological features in DUS 
testing alone was insufficient for establishing distinctness of some varieties of basmati 
rice, concluding that ‘molecular profiling would present a valuable addition to DUS 
testing procedures in distinguishing closely related varieties’. UPOV34 (the 
International Union for the Protection of New Varieties of Plants, which forms the basis 
of the EU Community Plant Variety Rights System that is managed by the CPVO) do 
allow molecular markers to be used as a method of examining DUS characteristics 
following particular rules (UPOV, 2020). However, Yu and Chung (2021) argued that 
UPOV did not adequately accommodate advances in molecular technologies as part of 
DUS testing, despite the ‘increased availability and cost-efficiency’ of such 
technologies. This further suggests that NCAs could see a decrease in their costs for 
some variety registration and PRM certification processes if application of molecular 
technologies was possible. BMTs could also be used during official controls carried out 
during the marketing of PRM and FRM to perform identity checks. Specifically in the 
case of FRM, molecular markers could help to confirm that FRM originates from a 
certain seed source and could support provenance trials. 

However, some NCAs felt that integrating the latest scientific and technological 
developments into PRM/FRM policy instruments would have no impact on the time it 
takes to register (7 of 22) or certify (9 of 22) PRM/FRM. This can be explained by the 
sentiment among some NCAs that there were more significant barriers to integrating 
new developments than the legislation – in particular, high costs associated with 
scientific and technological developments. Two NCAs pointed out that not all Member 
States could afford to use technologies like biomolecular techniques, and there was a 
need for more funding in this area. This is reflected in the survey: of eight NCAs that 
specified the percentage of their organisation’s annual budget dedicated to R&D 
activities in the PRM/FRM sector, seven said it was less than 10%.  

Accordingly, only a minority of surveyed NCAs believed that more timely integration of 
the latest scientific and technological developments in the PRM/FRM policy instruments 
would lead to decreased costs for registration (5 of 22) or certification (4 of 22). In 
the example of biomolecular techniques, one NCA pointed out that “high amounts” of 
investment would be needed to support its use across the EU. If this investment came 
from the private sector, and they proceeded to patent their technology, the costs for 
its use would be prohibitive to public authorities. However, initial investment by public 
authorities could yield long term benefits by making processes, like DUS testing, more 
efficient. 

34 UPOV are the organisation that awards intellectual property rights in 75 member states, including the EU. 

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Of the two measures, M10.1 is likely to offer the best solution for NCAs by better 
incentivising them to use scientific and technological developments by ensuring basic 
principles are already provided for in legislation. The detailed rules proposed under 
M10.2 risks creating a more significant administrative burden for public authorities due 
to the necessity of interpreting these rules. 

Administrative burden on business, including SMEs 

There is potential for legislative support for scientific and technological developments 
to positively impact businesses’ administrative burdens. Over half of 41 surveyed 
business associations and individual businesses expected to see a decrease in the time 
and costs associated with registration and certification if there was more timely 
integration of the latest scientific and technological developments in the PRM/FRM 
policy instruments. In interviews, two stakeholders (an NCA and an industry 
association) indicated that a faster and more flexible procedure for integrating 
developments would facilitate the use of new techniques, which themselves can make 
business processes more efficient. An industry association elaborated that use of 
molecular markers would speed up the process of ensuring a variety’s identity and 
reduce the amount of paperwork required. Another NCA stated that DUS testing based 
on molecular tools would be “more reliable, much cheaper, [and] much quicker”, 
therefore benefitting businesses subject to these tests. 

The benefits of molecular technologies for businesses are described in Gilliland et al. 
(2020), which put forward a proposal for using molecular technology to inform VCU 
and DUS testing in the EU. The study argued that some varieties would fail DUS 
testing despite having a superior VCU, in which case a business’ commercial 
investment would be unprotected (due to the need for DUS testing to gain plant 
variety rights (PVR)). Application of molecular tests would allow a more accurate 
assessment of such varieties’ distinctness compared to the variety which is ‘blocking’ 
its PVR registration.  

However, investment in scientific and technological developments by businesses would 
have corresponding costs and these were frequently seen as more prohibitive than the 
legislation itself. One NCA and one industry representative specified that businesses 
were not presently restricted by PRM legislation from using innovative techniques. The 
industry association stated that breeders were already using genomic selection and 
molecular markers “as much as possible to speed up the breeding process” and any 
constraints in their use was because they needed to be further developed before 
integration into regulated processes. They provided the example that simple 
characteristics were reliably identified using molecular markers, but for more complex 
characteristics (like yield) they were less reliable and so less useful in testing. One civil 
society organisation similarly stated that organisations were already using 
biomolecular techniques where it was useful to do so to distinguish or clone a variety. 
They asserted that larger organisations were also using molecular markers to support 
their plant variety rights (PVR) applications. For smaller actors though, these 
techniques were an expense which could create barriers to marketing new varieties 
(e.g. if use of such techniques were required as part of registration or certification 
processes). This was substantiated by an international organisation, who agreed that 
the legislation was not itself prohibitive but simply lacked rules on innovative methods 
and their application.  

As such, cost and time savings are more likely to be seen among larger businesses 
that have the capital to invest in new technologies in the short-term and would 
perhaps have more confidence to do so if it was accounted for in PRM legislation. For 
example, the majority of surveyed stakeholders (53 of 79) expected investment in 
research and innovation to increase if there was more timely integration of the latest 
scientific and technological developments in the PRM/FRM policy instruments. 
Likewise, SMEs tended to report spending less of their revenue on R&D activities in the 
survey: 3 of 4 spent less than 10%, whereas the majority (8 of 13) of businesses that 
were not SMEs reported spending more on R&D (10-25% of their annual revenue). 

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Nevertheless, in the long-term it is possible that SMEs could benefit from any 
efficiency gains made by NCAs resulting from their use of new technologies (i.e. if this 
led to decreased costs for registration, certification or controls).  

True Potato Seed (TPS) (and the fact it cannot enter the market) was not explicitly 
highlighted by any industry stakeholders in the interviews, but four referred to it in 
their survey responses as an example of a development whose use was restricted as it 
was not provided for in the existing Directives. One NCA noted that they were carrying 
out temporary experiments, under which TPS is allowed in derogation to the existing 
legislation.  

Overall, as for NCAs, M10.1 is likely the suitable option for businesses as it supports 
use of scientific and technological developments where it is appropriate for them to do 
so, while minimising the administrative burden that would be associated with 
navigating detailed rules (such as those proposed under M10.2). Likewise, there is a 
risk that more detailed rules (M10.2) would disproportionately affect smaller 
businesses who lack the resources to invest in new technology. Larger businesses with 
more resources could react faster and are therefore more likely to see any efficiency 
gains resulting from use of new technologies more quickly than their smaller 
competitors.  

Other impacts 

Legislative support for scientific and technological developments may have a positive 
indirect impact on sectoral competitiveness, trade and investment, innovation and 
research, and technological development and the digital economy, due to the 
increased confidence of NCAs and industry to invest in new techniques and R&D. An 
easier and quicker way to introduce scientific developments could help businesses 
achieve a return on their investments faster. Likewise, an NCA suggested a clear 
procedure on molecular markers would give Member States more confidence to use 
them.  

A5.3 

A.3 Increasing the number of tasks that operators may 

carry out under official supervision 

This study question assesses the problems for NCAs and operators created by variety 
registration and certification requirements and the impacts of increasing the number 
of tasks that operators may carry out under official supervision.  

Ref.  Study question 

O1   O2  O3  Measure 

A.3  What are the expected 

 

 

 

economic impacts, in 
particular on competent 
authorities and operators 
(with a specific focus on 
SMEs), of increasing the 
number of tasks that 
operators may carry out 
under official supervision 
(VCU testing and certification 
activities)? 

M11 Increase certification tasks permitted under 
official supervision except issuing the official 
label  

Permit VCU examination under official 
supervision 

A5.3.1 

Problem statement  

PRM:  The PRM Directives require inspection and testing procedures to be carried out by official 
laboratories and Competent Authorities and do not allow for operators to issue their own certificate. 
The current provisions on variety registration only allow examinations by official authorities and do 
not allow examinations to be carried out by private operators. The registration process for new 

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varieties is lengthy and burdensome in terms of cost for NCAs and operators and limits flexibility for 
the latter (EC 2021a). Under current rules, certification under official supervision is permitted, which 
relies more on activities of operators under the supervision of the competent authorities.  For 
example, operators may carry seed testing through their own laboratory (with authorisation from 
the competent authority). In this case, laboratory’s performance is supervised by the competent 
authority, and at least 5% of seed lots are checked by official seed testing. 

Certification under official supervision is currently possible only for certain categories of seed of 
agricultural species (not for field inspection for pre-basic and basic seed of agricultural crops) and 
does not allow certain plant species (e.g. seed potatoes, fruit trees)  to fully benefit from officially 
supervised inspection, sampling and testing.  

One breeders’ association interviewed indicated that fruit and potato breeding companies would 
like to be able to carry out certification under official supervision. Two NCAs interviewed indicated 
that it would be desirable for officially supervised certification activities to be expanded to include 
field inspections of category pre-basic and basic seed. One large representative association 
explained that the ability to carry out more tasks under official supervision would add flexibility and 
help reduce costs because of improved synergies with existing processes. None of the 
stakeholders consulted expressed the view that the current rules present a problem per se.  

FRM: The FRM legislation does not currently allow FRM certification to be undertaken by operators 
under official supervision. This was not considered a problem by any of the stakeholders 
interviewed.    

A5.3.2 

Impacts  

Baseline assessment 

Responses from both the survey and interviews for the current study, and results of the NCA 
survey in EC et al. (2021) revealed that certification under official supervision currently takes 
place in several Member States, namely Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, 
Estonia, Finland, France, Germany, Hungary, Italy, Lithuania, Luxembourg, the Netherlands, 
Poland, Portugal, Slovakia and Sweden. Cyprus, Greece, Latvia, and Ireland do not offer the 
possibility of certification under official supervision. Reflecting the significant number of Member 
States who have adopted a system of certification under official supervision, 26 of 54 survey 
respondents stated that they or their members conducted PRM certification under official 
supervision, including the majority of business associations (14 of 19) and businesses (10 of 18).  
Responses from surveyed business associations suggest that a high proportion of SMEs 
conduct PRM certification under official supervision, with 11 of 19 stating that 50% or more of 
their SME members do so.  

Survey results showed that seed sampling was the certification activity for agricultural species 
most carried out by operators (9 of 18 respondents indicated that over 50% of seed sampling is 
carried out under official supervision). Whilst of less relevance for vegetable seeds, given 
‘standard’ seed does not require certification, far fewer certification activities for vegetables in 
general were undertaken by operators (3 of 18 NCAs said that over 10% of certification activities 
for vegetable are conducted under official supervision).  

A temporary experiment (EC 2019a) on field inspection under official supervision for pre-basic 
and basic seed was carried out from 2012-2019 involving 10 Member States and Norway. The 
purpose of the experiment was to investigate whether the requirement for official field 
inspections could be replaced by either official field inspections or field inspections under official 
supervision for basic seed and pre-basic seed. The results of the experiment were considered 
positive for several reasons. The deviation rate between official inspections and inspections 
under official supervision was small (< 1% deviation). Seed companies hired staff who were 
officially licensed by the competent authorities to carry out field inspections. The certification 
authorities maintained their competences while developing other competences because of time 
available for other tasks. In the absence of change to the legislation it is likely that there will 
continue to be a difference in how certification is implemented across Member States. Opinion 
was split amongst the survey respondents on how the use of certification conducted by operators 
under official supervision would develop over the next 10 years. The greatest number (28 of 72) 
thought there would be no change, while slightly fewer (25 of 72) felt there would be an increase 
in certification under official supervision. 

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Increasing the number of tasks carried out for certification under official supervision 

Half (27 of 54) of non-NCA survey respondents, which included the majority of business 
associations (14 of 19) and individual businesses (12 of 18), said they would make use of 
certification conducted by operators under official supervision for all steps of the seed certification 
process if this was made available. This is consistent with the view of some of the stakeholders 
interviewed (7 NCAs and 5 industry representative associations), who wished to see an increase in 
the number of certification tasks that could be conducted under official supervision. One industry 
association interviewed explained that breeders of crops such as fruit trees and potatoes would like 
to have the option to carry out certification under official supervision. Responses from the survey 
indicated that the seed industry is also overwhelmingly in favour of the possibility of field 
inspections for pre-basic seed (14 of 19 business associations and 13 of 18 individual businesses) 
and basic seed (15 of 19 business associations and 13 of 18 individual businesses) to be carried 
out by operators under official supervision.   

Public Authorities administrative burdens 

A 2008 evaluation study (EC 2008) identified that if the tasks carried out for certification under 
official supervision were to be increased, then costs for field testing would shift from official 
authorities to private operators leading to a significant reduction in the number of required official 
inspectors. On the other hand, the study found that there would be new costs for NCAs for the 
training of private inspectors. This was partly reflected in responses from NCAs surveyed for this 
study. Opinion was divided amongst the NCAs on their ability to implement and enforce the 
legislation should they have to provide for certification under official supervision for all steps of the 
seed certification process. Seven of 18 thought it would have no impact whereas five thought it 
would have a negative impact. Examples of negative impacts were provided by one NCA 
interviewed who explained that a lot of resources, more staff and more training would be needed. 
This was because of having to train staff to ensure inspections were reliably carried out. In-house 
expertise and competence would still be required to answer questions from operators and 
undertake official examinations for companies that do not wish to carry out their own inspections 
under official supervision. Results from the temporary experiment on field inspection under official 
supervision carried out between 2012-2019 suggest that the time saved from tasks being 
conducted by operators had allowed certification authorities to develop other competences (EC 
2019a).  

NCA opinions on the impact on the time it takes to certify/label PRM were mixed (5 of 18 thought 
there would be no impact, 4 thought it would decrease, 2 that it would increase, and the remainder 
did not know). The impact on the cost of certification was also unclear: several interviewed NCAs 
indicated that NCA costs would decrease, others that NCA costs would remain unchanged (in part 
because certification under official supervision was already offered in their country), whilst a 
minority indicated that it could increase NCA costs. 

The total annual cost of variety registration for EU-27 NCAs is estimated to be approximately EUR 
55million with an average cost per registration of approximately EUR 3,36635. This is broadly in line 
with an estimate presented in EC (2011)36 of EUR 63-68million37 per year.  

The total annual cost of PRM certification for EU-27 NCAs is estimated to be approximately EUR 
73million38. This is broadly in line with an estimate presented in EC (2011)39 of EUR 83-90million40 
per year. Certification conducted by an NCA is estimated to be approximately 12% more expensive 
than certification done by operators under official supervision41, whilst the 2008 study (EC 2008) 
found that the cost savings for NCAs of a certification scheme under official supervision (based on 

35 Estimate based on targeted survey data from up to 7 Member States, grossed up to EU-27. 
36 European Commission (2011). Options and analysis of possible scenarios for the review of the EU legislation on the 
marketing of seed and plant propagating material 
37 Adjusted to current prices from as reported figures of EUR 55-60million using EU-27 CPI inflation rate  
38 Calculated by taking the estimated NCA costs of registrations and applying a ratio of the total NCA costs or registrations : 
certifications using data in EC (2013b), which states that “the registration and certification costs respectively represent 43% 
and 57% of total annual costs incurred by the national authorities of the 8 Member States considered for the analysis”. 
39 European Commission (2011). Options and analysis of possible scenarios for the review of the EU legislation on the 
marketing of seed and plant propagating material 
40 Adjusted to current prices from as reported figures of EUR 73-79million using EU-27 CPI inflation rate  
41 Average figure based on data from 30 respondents to the Targeted Survey (Q79 and Q79a). 

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a UK example) could be around 20-25% (with large variability across crops). Table 27 indicates 
that certification under official supervision already takes place in several Member States, which will 
also influence what scope there is for savings in different MS. For illustrative purposes, if one 
arbitrarily assumes a further 10% of certifications were conducted under official supervision, and 
apply a 12%-25% saving, an estimate of the savings to NCAs can be calculated as EUR 0.9 to 1.8 
million per annum. 

Administrative burden on business 

The total annual costs to businesses across the EU27 of registering varieties is estimated to be up 
to EUR 73million with an average cost to businesses per registration of EUR 4,434 (notably higher 
than the average cost per registration for NCAs), falling to around EUR 500 for conservation 
varieties and varieties with no intrinsic value42. The survey did not elicit any data on costs of 
certification. Assuming an equivalent registration-to-certification ratio as apparent in the NCA 
analysis above, it can be estimated that total annual certification costs to businesses amount to 
approximately EUR 96 million. The extent to which this estimate accounts for certification done by 
operators under official supervision is not known.  

A majority of business associations (12 of 19) and individual businesses (11 of 18) surveyed 
believe that the time required to achieve certification would decrease under official supervision. A 
majority of business associations (12 of 19) and individual businesses (13 of 18) surveyed also 
agreed that if it became mandatory for NCAs to provide for certification conducted by 
operators under official supervision for all steps of the seed certification process, then 
costs of certification would decrease (Q83).  

A further 7 individual businesses and 3 business associations surveyed indicated that 
there would be no impact on costs, and only 2 associations and 2 businesses thought 
that costs would increase. During interviews, one industry association and an NCA 
explained that certification under official supervision created additional flexibility for 
operators allowing them to plan better and assign internal responsibilities more 
efficiently, which could lead to a reduction in costs. 

Most (21 of 26) of the organisations (which included business associations, individual 
businesses and academic institutions) surveyed for the current study who said they 
conducted PRM certification under official supervision spent 5% or less of their annual 
budget on these activities (11 of 26 spent between 1-5% of their budget and 2 of 
these were SMEs). One individual business spent more than 15% of their budget on 
costs for the certification on PRM under official supervision. Eight of these 26 
organisations said that they saved 1-5% on their annual budget because of 
certification of PRM under official supervision and 3 others had savings above 15%. 
Four of 26 saved less than 1%.  

Most stakeholders who had an opinion on the matter said that more operators would 
make use of certification under official supervision (38 of 72). During interview an NCA 
stated that despite potential higher costs for some operators (these may include 
additional staff training, accreditation costs field inspections costs and additional 
laboratory equipment), companies nevertheless often prefer to carry out certification 
tasks themselves. This is because of the flexibility to make use of existing processes 
and procedures and freedom to plan ahead and perform tasks at a time convenient to 
the operator rather than depending on the availability of NCA officials.  According to 
an industry association, for some larger companies, this can “speed things up” and 
allows them to assign responsibilities better within the company, therefore reducing 
administrative costs in the long term. The upfront investment costs can be significant, 
which may present a barrier to some operators, particularly SMEs, choosing to switch 
to conducting certification tasks themselves. The majority of survey respondents (47 
of 72) thought that an increase in in-house expertise would be required to deliver 

42 Estimate based on targeted survey responses from 8 businesses and 2 business associations to establish an average 
cost per registration and total number of registrations equivalent to the total number administered by EU-27 NCAs. Estimate 
for conservation variety registration based on targeted survey responses from 4 NGOs and 1 academic institution.  

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certification under official supervision. Most business associations and individual 
businesses (12 of 17) said that additional investment in in-house training and quality 
assurance procedures would be required if they were to conduct certification under 
official supervision for all steps of the seed certification process.  One company added 
that better equipment would also be necessary. Four business associations and an 
individual business from two countries (France and Denmark) stated that no more 
investment was required as they already carry out certification procedures. Two 
French businesses considered that they would require further investment in staff 
training despite certification under official supervision being routinely carried out in 
France. 

The prevalence of certification under official supervision already appears to be quite 
high in some Member States. In at least 5 countries 76-100% of permitted 
certification activities for agricultural varieties are conducted under official supervision. 
Table 27 shows the extent of certification activities conducted under official 
supervision for agricultural plant species and vegetables where information was 
provided by the relevant public authority.  Certification under official supervision is 
carried out in Austria and the Netherlands although figures on the extent to which this 
occurs are not available. 

An illustration of the potential scale of cost saving from increased use of official 
supervision is provided by applying assumptions. An arbitrary assumption that an 
additional 10% of certification processes shift to official supervision, and that for these 
a 12% saving (based on survey respondents experience of savings by doing 
certification under official supervision) is made to the total annual cost to businesses 
of certification processes. This provides an estimated annual saving of EUR 1.1 million. 
This does not account for any costs of investment necessary for operators to establish 
the infrastructure needed to conduct certification activities under official supervision.  

 Prevalence of certification activities conducted under official 
supervision 

Proportion of certification 
activity for agricultural plant 
species conducted by 
operators under official 
supervision 

Proportion of certification 
activity for vegetables 
conducted by operators 
under official supervision 

Member 
State 

Belgium 

26-50% 

Croatia 

76-100% 

Cyprus 

None 

Czechia 

51-75% 

Denmark 

76-100% 

None 

76-100% 

None 

N/A 

None 

France 

76-100% 

Less than 10% 

Ireland 

None 

Germany 

Less than 10% 

Greece 

None 

None 

N/A 

None 

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Hungary 

76-100% 

Less than 10% 

Latvia 

None 

None 

Luxembourg 

76-100% (seed sampling only) 

76-100% 

Poland 

51-75% 

Slovakia 

11-25% 

Sweden 

26-50% 

Source: Targeted survey and EC et al. (2021) 

N/A 

11-25% 

None 

The average time from application for registration to completion of the registration 
process varies by Member States and across crop types. Information provided by 
Czechia and the Netherlands to survey conducted in EC et al. (2021) suggests that the 
shortest time required is for vegetables (1-2 years), followed by agricultural crops (3-
4 years). Fruit and vine varieties can take between 3 and 7 years to be registered. 
One company surveyed in EC et al.2021 study explained that there can be large 
variations between Member States in the time taken to complete the registration 
process depending on whether the breeder’s data is taken into account. They cited the 
example of registration for varieties of corn in Italy and France which may take one 
year only, whereas in Germany and Czechia there is a minimum of 3 years of official 
testing.  

A majority of business associations (12 of 18) and individual businesses (13 of 16) 
surveyed considered that the permitting VCU under official supervision would decrease 
costs. Just 3 business associations and 1 business thought that costs would increase. 
There is no quantitative data available on the potential change in costs as a result of 
VCU under official supervision. An illustrative estimate, to indicate the potential order 
of magnitude of cost savings for operators is established drawing on NCA registration 
cost profile information and applying the same proportional saving as is apparent for 
operators conducting certification under official supervision. Data on NCA costs of 
registrations indicate that VCU examination accounts for 57% of total annual 
registrations costs, whilst certification under official supervision is anticipated to result 
in savings of around 12%. Applying these figures as assumptions to the average 
operator costs of a registration of EUR 4,434 (i.e. assuming that VCU examination 
accounts for 57% of operator registration costs, and that a 12% cost saving is 
possible on the cost of VCU examination) indicates a potential cost saving of EUR 297 
per registration process i.e. around 7% of the total cost of registering a variety.  

Innovation and research 

Anecdotal evidence from an industry association interviewed suggests that reduced 
administrative costs mean companies can invest more in research and development 
(typically around 15% is spent on R&D by the industry). The interviewee also 
explained that it may be possible to cut one year off the total innovation cycle of 
obtaining new varieties if breeders are able to use earlier stage data (available in the 
year prior to official application) to support tests required for variety registration. 
Survey responses indicated that business associations (10 of 19) thought that 
increasing tasks for certification under official supervision presented an opportunity to 
invest in innovation and research (although whereas 9 of 18 individual businesses 
thought there would be no impact). This could lead to more competition and serve as 
an important driver for faster innovation in the sector. 

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Position of SMEs 

Most interview respondents across all stakeholder types (businesses, industry 
associations, seed networks, NCAs) felt strongly that obligations imposed by official 
supervision would create disproportionate costs for SMEs and that the possibility for 
SMEs to rely on NCAs to carry out the examinations should remain. As explained 
above, the upfront investment costs required to enable operators to conduct 
certification tasks themselves can be significant, and may present a barrier to SMEs in 
particular .This contrasts with the survey findings (see baseline assessment) that a 
majority of business associations reported that over 50% of their SME members 
already carry out certain tasks under official supervision. Opinion on SME impacts was 
divided amongst survey respondents across all stakeholder types. Of 72 organisations 
surveyed, 26 thought there would be a disadvantage (15 of the 72 stating a major 
disadvantage) to SMEs of increasing the number of tasks under official supervision, 26 
said there would be no difference and 3 indicated there would be a minor advantage. 
A potential drawback to increasing examinations under official supervision, as 
explained by an NCA during interview, is that the corresponding reduction in the 
number of official examinations could mean an increase in costs to users of that 
service. The interviewee suggested public authorities would still be required to retain 
their competencies and the costs of doing so would be spread across fewer operators, 
increasing the costs per user. These users are likely to be SMEs wanting to continue 
using official examinations as they may lack the internal resources to carry out 
inspections themselves.   

Indirect Impacts 

A majority of survey respondents agreed that if more activities could be conducted 
under official supervision there would be no impact on the quantity of PRM on the 
market (48 of 72), diversity (47 of 72) and fraudulent PRM (41 of 72). A significant 
number of respondents to these questions (ranging from 19 to 21 of 72 on each of 
these issues) did not know.  A smaller proportion (37 of 72) thought that quality of 
PRM would not be affected by the proposed measures. Two NCAs and an industry 
association stressed during interviews the need for strong official supervision from 
NCAs to ensure PRM quality was maintained. 

FRM 

Information on the impact of allowing FRM certification tasks to be carried out by 
operators under official supervision was obtained from the interviews. All but one of 
the interviewed stakeholders (9 of 10) were not in favour of introducing this 
possibility. NCAs interviewed did not see any benefit to introducing this possibility, and 
generally reported that the current burden of certification is manageable (overall 
volumes of FRM are lower than for PRM). FRM certification costs differ according to 
Member States. The targeted survey revealed that of the NCAs who responded, 
Denmark and the Netherlands charged the highest fees (EUR 335 and EUR 261 
respectively), with Belgium, Italy and Poland stating that no fees were charged for 
certification.  Fees in Finland, Bulgaria and Germany ranged from EUR 12 to EUR 30. 

One international organisation explained that a potential benefit of allowing 
certification under official supervision was the ability to continue carrying out controls 
in crisis situations when government staff shortages can be an issue. However, this 
interviewee also explained that significant upfront investment would be needed to 
train operators and digitalise current systems so that they would be ready for this type 
of approach. NCAs cited concerns about fraud and related conflicts of interest 
stemming from operators undertaking certification activities. One NCA also explained 
that operators would not have the expertise required to undertake these activities. 
Fraud is a concern in the sector, in part because traceability is dependent largely on a 
paper trail (with growing but not yet significant use of biomarker technology) and in 
part because the long lifecycle of trees means that it can take many years for fraud to 

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be detected. This means that the sector is highly dependent on the integrity of the 
certification system to ensure the identity of FRM.   

Including VCU examination under official supervision  

Almost two thirds (41 of 63) of survey respondents, including the majority of business 
associations (13 of 18), individual businesses (14 of 16) and NCAs (11 of 18) agreed 
that it should become possible for VCU examinations to be carried out under official 
supervision. The majority of stakeholders interviewed, including NCAs and 
representative associations were also in favour. Concerns were raised by most 
interviewees about the disproportionate effects of costs imposed by VCU testing on 
SMEs compared to larger companies and felt strongly that the option for NCAs to carry 
out VCU examinations should remain. 

Public Authorities administrative burdens  

Half of the competent authorities surveyed (9 of 18) believed that such a change 
would impact on their ability to implement and enforce the legislation (3 thought there 
would be no impact). In particular, seven NCAs thought annual VCU examination costs 
and in-house expertise required would increase. This contrasts with the views of two 
NCAs interviewed who cited important benefits such as a reduction in costs and 
increased in-house expertise from new learning opportunities.  

Administrative burden on business 

The majority (44 of 63) of stakeholders surveyed were clear that there would be no 
effect on the time it takes to register a variety. In addition, over half of respondents 
(34 of 63), and the majority of business associations (12 of 18) and individual 
businesses (13 of 16) considered that costs of registering a new variety would 
decrease.  

Innovation and research 

Introducing VCU examinations under official supervision was considered by a majority 
of surveyed business associations (10 of 18) and individual businesses (10 of 16) to 
be an opportunity to invest in innovation and research.   

Indirect impacts 

The survey results showed that a majority of stakeholders agreed there would be no 
impact on quantity (45 of 63), quality (42 of 63) or fraudulent PRM on the market (45 
of 63). There was a similar response on the impact on the diversity of PRM on the 
market (38 of 63), although 13 of 63 survey respondents thought that diversity would 
increase. Two stakeholders interviewed (an NCA and a representative association) 
stated that the introduction of VCU examination under official supervision would have 
no influence on quantity, quality, diversity or fraudulent PRM as long as testing was 
carried out under the same rules.   

A5.4 

B.1 Restricting the scope of application of the PRM other 

than FRM legislation to the professional sector 

The study questions under B.1 focus on the problems for stakeholders related to the 
current scope of the PRM legislation for marketing to the professional sector and 
potential impacts of changes to the policy instruments in relation to the species and 
operators within scope of the legislation. 

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Ref.  Study question 

O1  O2  O3  Measure 

B.1 

 

 

What are the expected 
economic impacts, 
including in terms of 
administrative burdens, 
for competent 
authorities, operators 
and citizens; social 
impacts for citizens; and 
environmental impacts 
of restricting the scope 
of application of the PRM 
(other than FRM) 
legislation to: (i) the 
professional sector (i.e., 
excluding marketing to 
amateur gardeners and 
activities of seed 
conservation networks); 
and/or to (ii) the 
economically most 
important species on the 
EU market? 

What is, in particular, 
the expected impact on 
the quality and choice of 
PRM? 

M3.1 Exemptions for activities of seed 
conservation networks of PRM and FRM for forestry 
purposes  

M4.1 Exclusive marketing to amateur gardeners is 
exempted from the scope of the legislation 

M13.1 Harmonise procedures for lists of regulated 
species to comitology only. No specific criteria will 
be introduced. 

M3.2 Lighter rules for activities of seed 
conservation networks PRM and FRM for forestry 
purposes 

M4.2 Lighter rules for exclusive marketing to 
amateur gardeners 

M13.2 Lay down criteria and harmonise the 
procedures for adding/removing species from the 
list of species regulated at Union level for PRM and 
FRM  

 

M13.2 Lay down criteria and harmonise the 
procedures for adding/removing species from the 
list of species regulated at Union level for PRM and 
FRM  

[same as baseline] Activities of seed conservation 
networks fall under the full scope of the marketing 
legislation  

[same as baseline] Marketing to amateur 
gardeners falls under the full scope of the 
marketing legislation  

A5.4.1 

Problem statement  

There is currently inconsistency in the definitions used for ‘marketing’ and who 
constitutes an ‘operator,’ with these being unclear or missing altogether in some of 
the PRM Directives (EC et al.2021). This has resulted in differences in how the EU PRM 
legislation is interpreted, and how lighter regimes are implemented for non-
commercial activities across EU Member States. The lack of clear rules on when and/or 
for which operators and varieties the lighter registration regime applies creates an 
incentive for fraud. Some operators may argue for varieties at the margin to be 
registered using the lighter regime (EC et al. 2021). In turn, such fraudulent activity 
has the potential to generate food safety, economic and environmental sustainability 
issues.  

Amateur gardeners and seed conservation networks have different uses and 
motivations compared to professional users. Amateur gardeners typically engage in 
cultivation activities for their own use/ consumption rather than for commercial gain. 
Seed conservation networks, on the other hand, are operators exchanging and 
marketing PRM in limited amounts with the primary non-profit purpose of conserving 
plant and forest genetic resources (EC 2021b).  

Still, PRM which is marketed to amateur gardeners and PRM marketed by seed 
conservation networks is currently subject to the same “complex and rigid procedures” 
(EC 2021b) as PRM marketed to professional users. The current PRM regulatory 
framework thus places an unnecessarily heavy cost burden on certain categories of 
operators dealing with the registration and marketing of varieties aimed at seed 
conservation networks and amateur gardeners (EC 2021b).    

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High registration costs may also be impeding breeding activities with negative impacts 
on the diversity of varieties marketed across the EU. For example, in Member States 
where the costs of registering conservation and amateur varieties are identical to 
those of new commercial varieties,43 there is little incentive for operators active in this 
domain to register conservation and amateur varieties in the national and common 
catalogues. In turn, this could be negatively impacting the diversity of seeds and PRM 
that can contribute more widely to the EU’s biodiversity targets.  

A5.4.2 

Impacts  

Baseline assessment of the amateur gardener market, SCNs and regulated 
EU species 

Baseline: The amateur gardener market  

Market size and composition (B.1, B.1.1, B.1.2) 

Some interviewees (i.e., one national competent authority (NCA) and four national 
associations representing seed producers, seed distributors, nurserystock producers’ 
organisations and the plant reproduction material sector more widely) and most 
focus group participants have indicated that a separate market for amateur 
gardeners currently exists in most EU Member States. It is however difficult to 
estimate their size (in either value or volume terms). This is because it is not 
generally possible to segment out between the amateur gardener and professional 
markets. One important finding that stemmed from the focus group is that, in most 
Member States, the amateur gardener market comprises the following two main 
segments: (1) professional producers selling to amateur gardeners (among other 
buyers); and (2) amateur gardeners exchanging varieties between themselves. The 
Survey also gauged views about the extent of breeding/ marketing that is aimed 
exclusively at amateur gardeners. 11 out of 17 business associations (or 65 per 
cent), eight out of 15 companies/ businesses (or 53 per cent), and five out of six 
NGOs (or 83 per cent) indicated that they/ their members currently breed varieties 
for the amateur gardener market, In terms of the proportion of respondents (or 
their members) also marketing varieties to the amateur gardener market, these 
comprised 14 out of 17 business associations (or 82 per cent), 12 out of 15 
companies/ businesses (or 80 per cent), and five out of six NGOs (83 per cent).  

Current availability/ diversity of PRM of varieties marketed to amateur gardeners 
(B.1 and B.1.1) 

Six out of 11 business associations (or 55 per cent) and four out of five NGOs (or 80 
per cent) indicated that their members/they currently breed varieties for the 
exclusive use of amateur gardeners. All of these six business associations further 
indicated that between one and 20 per cent of the total varieties that their members 
breed are exclusively for use by amateur gardeners; while three out of the four 
NGOs (or 75 per cent) indicated that between 41 and 60 per cent of the total 
varieties that they breed are exclusively for use by amateur gardeners; and one 
NGO indicated that this proportion ranges between 61 and 80 per cent of total 
varieties they breed. Among companies/ businesses, five out of eight survey 
respondents indicated that between one and 20 per cent of the total number of 
varieties they breed are exclusively used by amateur gardeners. EC et al. (2021) 
found that 45% of maintainer survey respondents market at least some varieties 
exclusively to amateur gardeners. Additionally, evidence from the PRM focus group 
indicated that the number of varieties on offer to amateur gardeners varies across 
Member States, though it is generally high and increasing. Indications of the 

43 Member States can choose to apply or not lighter conditions for the registration of amateur and conservation varieties (EC 
2021b). 

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proportion of varieties that are marketed to amateur gardeners provided at the 
focus group44 ranged between 20 per cent and 70 per cent. Furthermore, one 
interviewee (one association representing breeders of plant varieties, seed 
producers, and seed distributors) indicated that, in Italy, varieties that are 
commonly sold on the amateur gardener market include old/ traditional varieties 
and varieties linked to specific territories. As regards France, two interviewees (one 
European civil society organisation and one association representing national 
allotment and leisure garden federations indicated that varieties that are of interest 
to amateur gardeners include conservation varieties and varieties that exhibit 
heirloom/ traditional characteristics. Additional evidence was gathered on the most 
important crop varieties45 that are sold to amateur gardeners in the different 
Member States. These are as follows: 

 Main crop groups targeted at the amateur gardener market across 
the EU 

Sources: Survey and Focus group 

Note: green-shaded cells indicate an important/ high use, yellow-shaded cells a less 
important/ low use, grey-shaded cells no (known) use(s) 

Most survey participants (comprising business associations, businesses, and public 
authorities mainly) indicated that current PRM rules have contributed to an increase 
in or have not had any impact on the diversity of PRM available to amateur 
gardeners (38 out of 62 respondents, of whom 11 respondents indicated a 
significant positive impact and 15 respondents no impact). Among focus group 
participants, the shared view was that the amateur gardener market is not suffering 
from a lack of diversity. A number of varieties, across different crop groups, are 
currently available to amateur gardeners in the different Member States. Similarly, 
several interviewees (four associations representing inter alia breeders of plant 
varieties, seed producers, seed distributors and home gardeners (across France, 
Italy, and Poland), two NCAs, one national civil society organisation, and one 
European association representing farmers and agri-cooperatives ) did not think that 
current PRM rules were restricting choice/ diversity among varieties sold on the 
amateur gardener market. For example, in Poland, increased diversity in ornamental 
varieties has been observed in recent years, while in France, vegetable species 
available to amateur gardeners are reported to be wide-ranging and sufficiently 
diverse. In the same vein, EC et al. (2021) reveals that a majority of respondents 
(to a survey of maintainers) (61 per cent) indicated that the number of varieties 

44 For France, Czechia, Germany. See focus group Annex 9 for further details. 
45 Focus groups participants were also asked about the extent of use of varieties of vine and turf grass by amateur 
gardeners - they reported little to no use of these varieties in the different Member States / across the EU. 

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available to amateur gardeners had somewhat or significantly increased over the 
past 10 years. Other stakeholders, including amateur gardeners, also considered 
that there is a good level of PRM genetic diversity in the EU. For example, 64 per 
cent of amateur gardeners strongly or slightly agreed that there is good availability 
and diversity of varieties for amateur gardeners. Although agreeing that genetic 
diversity among varieties aimed at amateur gardeners is generally satisfactory, 
many amateur gardeners called for improvements, notably for a greater choice/ 
availability of traditional, local and organic varieties specifically.  

Conversely, some public authorities (six out of 16) and NGOs (three out of six), who 
responded to the Survey, indicated that current PRM rules have caused a reduction 
in diversity. An important constraint cited by several survey respondents (three 
public authorities, one business association, one company and one NGO) was 
reported to be high registration costs associated with DUS and VCU testing. These 
costs cannot be recouped, especially by smaller operators, as sales revenue from 
the amateur sector is generally low. Quantitative restrictions, notably limits on the 
amounts to be produced and small packaging obligations, were also considered to 
be important inhibiting factors to achieving greater diversity in PRM of varieties 
marketed to amateur gardeners. A few issues were also raised by interviewees (one 
national civil society organisation, and one European civil society organisation) in 
relation to the current regulatory regime. One interviewee remarked that the 
current PRM legislation “has completely ignored seed conservation networks,” which 
is impeding the EU’s ability to meet crop diversity targets. Another interviewee 
explained that amateur gardeners should be allowed to access varieties that are not 
listed in the national/ EU catalogues as their purchase decisions are not necessarily 
driven by varietal characteristics, such as distinctness, uniformity, and stability 
(DUS). Still, in some Member States (e.g., Poland), all varieties intended to be 
marketed are required to pass DUS tests and to be listed in the national catalogue. 
A similar concern was raised by an Austrian civil society organisation, which 
explained that the current regime does not account for the fact that “plants evolve 
and change over time.” They may therefore not exhibit certain DUS characteristics 
but are important for building/ increasing biodiversity beyond what is available from 
commercial suppliers. 

Quality of PRM currently marketed to amateur gardeners (B.1 and B.1.1) 

Evidence pertaining to the quality of PRM marketed to amateur gardeners was 
primarily gathered from the focus group and interviews. In general, there were no 
significant concerns raised by focus group participants and interviewees as regards 
the impact of the current PRM rules on the quality of PRM sold on the amateur 
gardener market. Two interviewees (one national civil society organisation and one 
European association representing farmers and agri-cooperatives ) explained that 
most varieties produced for the professional sector are also sold on the amateur 
gardener market. These varieties are generally required to pass DUS and VCU tests, 
which provide an assurance of their quality and agronomic performance. In most 
Member States, amateur gardeners can buy tested and approved varieties, 
indicating their ability to access PRM of high-quality. One interviewee however 
remarked that, unlike professional users, amateur gardeners may be more 
interested in “visual quality” as opposed to “internal quality, such as varietal purity 
or other aspects.” Similarly, a few other interviewees (one national association 
representing national allotment and leisure garden federations, one national and one 
European civil society organisation) indicated that amateur gardeners tend to show 
a preference for older, more traditional varieties, despite the fact that such varieties 
are less likely to exhibit quality characteristics, such as homogeneity/ uniformity.  

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Baseline: Seed conservation networks (B.1.2)  

Key features  

Seed conservation networks (SCNs) relate to “operators exchanging and marketing 
PRM in limited amounts with the main non-profit purpose of conserving plant and 
forest genetic resources” (EC 2021b). 10 out of 43 respondents (comprising NGOs 
mainly) indicated that they were involved in both the operation of and participation 
in the activities of an SCN. Of these, seven indicated that the activities of the SCNs 
are currently undertaken on a not-for-profit basis. Two respondents however noted 
that, while SCNs generally operate on a not-for-profit basis, their members operate 
with the aim to make a profit. Indicative data on the number of SCNs across the 
different EU Member States and EEA countries were provided by a few survey 
respondents.  

The mission of these SCNs is reportedly wide-ranging, including: long-term 
conservation, the development of crop diversity, the adaptation of plant genetic 
resources to regional agro-ecological conditions (based on responses from 10 survey 
participants). Their activities can include the collection and maintenance in situ 
and/or the storage of seeds of varieties, notably of old/ traditional and/or 
conservation varieties. Typically, the exchange of seeds is allowed between the 
members of the SCNs. The extent of these exchange activities (in volume or value 
terms) is however not known. A summary table is provided below. 

 Overview of seed conservation networks across the EU46 

Member 
State 

Type of 
organisation 

Size/ number 

Purpose/ activities 

Austria 

Seed saver 
organisation 

14,500 members 

Maintains over 
5,500 accessions of 
endangered 
vegetable, fruit and 
grain varieties as 
well as crop wild 
relatives 

Austria 

Network organisation  Not available 

Belgium 

Not available 

Croatia 

Not available 

None (according to 
one survey 
respondent) 

Several (according 
to one survey 
respondent) 

Engages in the 
conservation, 
sustainable use, and 
development of crop 
diversity 

Connects various 
independent seed 
conservation 
networks with one 
another 

Not available 

Not available 

46 The table does not provide an indication of the volume or value of PRM exchanged between members of SCNs as this 
information is not available for most Member States 

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Denmark 

Not available 

Unknown (these 
types of networks 
are not registered 
according to one 
survey respondent) 

Possibly more than 
100 across German-
speaking countries 

Not available 

Not available 

Seed conservation 
networks  

German-
speaking 
countries 

Germany 

Seed conservation 
network 

Not available  

Collects/ stores 
varieties 

Collaborates with a 
Dutch gene bank for 
the propagation/ 
support of collection 
missions, and the 
characterisation of 
accessions, 
including: Daucus, 
Allium Porum, 
Cucumis melo, 
Cucumis sativus, 
Capscium annuum, 
Lycopersicon, 
Spinacio oleracia, 
Allium sepa, Lactuca 
sativa 

Not available  

Does not sell seeds 

Germany 

Seed conservation 
network, involving 
members that work 
both on a non-profit 
and profit basis 

Germany 

Seed conservation 
network 

100+ members 

Germany 

Germany 

Seed conservation 
network, focused on 
vegetables 

Seed conservation 
network, focused on 
cereals 

70 members 

Not available  

Greece 

Seed conservation 
networks 

There could be 3 
such organisations 
in Greece–- one 
large and two 
medium-sized 

No exchange within 
the network 

Involved in the 
maintenance of 
diversity in situ 

Involved in the 
maintenance of 
diversity in situ 

Involved in the 
maintenance of 
diversity in situ 

Not available  

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France 

Seed conservation 
networks 

(according to one 
survey respondent) 

16 -27 (according 
to two survey 
respondents), 
involving both 
public and private 
entities 

Italy  

Collaborative 
programme among 
most European 
countries 

33 member 
countries 

Luxembourg  Seed conservation 

network 

Netherlands 

Seed conservation 
networks, focused on 
agricultural varieties 

Netherlands 

Seed conservation 
networks, focused on 
potatoes 

Netherlands 

Seed conservation 
network 

One such 
organisation in 
Luxembourg 
(according to one 
survey respondent) 

Two such 
organisations 
(according to one 
survey respondent) 

One such 
organisation 
(according to one 
survey respondent) 

One such 
organisation 
(according to one 
survey respondent) 

Norway 

Seed conservation / 
seed saver 
organisation 

One such 
organisation 
(according to one 
survey respondent) 

SCNs engaged in the 
conservation of the 
following species : 
Allium; Straw 
cereals; Lactuca; 
Melon; Solanaceae; 
Maize; French bean; 
Onion; Fodder 
species; Sunflower; 
Potato; Carrot and 
other Daucus ; 
Brassica oil crucifers; 
Brassica vegetable 
and fodder crucifers; 
Vitis; Olive.  

Primary aim is to 
ensure long-term 
conservation and to 
facilitate the 
utilisation of plant 
genetic resources 
across Europe 

Not available  

Not available  

Not available  

Involved in the 
collection and 
protection of genetic 
resources, including 
the collection of a 
wide range of old 
varieties and wild 
species 

Not available  

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Spain 

Sweden 

National seed 
platform 

Comprises 20 local 
seed networks 

Not available  

Seed conservation 
networks, mainly 
online 

A few (according to 
one survey 
respondent) 

Switzerland 

Seed conservation  

Not available  

Mainly/ generally 
focused on 
conservation of 
cereals and/ or 
vegetables 

Engages in the 
conservation of 
around 4,700 plant 
varieties, the 
majority in situ/on-
farm. Of these, 
around 3,400 
varieties are 
described in their 
catalogue/ ‘variety 
finder.’ 

Of the total number 
of varieties that 
feature in their 
catalogues 
(n=3,400), around 
2,500 varieties are 
available through 
commercial offers or 
directly from the 
network 

Source: Survey 

Baseline: Current rules and EU-regulated species (B.1.3) 

Most survey respondents (43 out of 66) were satisfied with the current list of 
regulated species and did not report a need to exclude certain species from the 
current PRM regulation. However, there were divergent views among some 
stakeholders. A few NGOs, companies, and public authorities (eight out of 66 
respondents) indicated that some species should be excluded. On the other hand, a 
small proportion of survey respondents (28 out of 66), comprising business 
associations, businesses, and public authorities mainly, agreed that new species 
should be added. These survey findings were generally corroborated by the results 
of the Public Consultation. Respondents within the “public authority,” 
“academic/research institution,” “business association,” and “consumer 
organisation” categories were generally in favour of an expansion of the list of EU-
regulated species. Conversely, companies, environmental organisations, and NGOs 
were generally in favour of reducing the list of EU-regulated species. Most 
respondents in these categories did not therefore support a possible expansion of 
the list of EU-regulated species. Results from the Public Consultation also showed 
general acceptance across most respondent categories (except for “trade unions”) 
for specific EU criteria to be established for deciding which species should be 
regulated. Most respondents within the “business association”, “NGO”, “academic/ 
research institution,” and “company/ business” categories were in favour of these 
criteria being harmonised at EU level. Additional information on potential species to 

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be added to or removed from the list of EU-regulated species as well as possible 
criteria for deciding which species to regulate was also gathered from the 
Interviews.  

Possible species for inclusion or exclusion, as suggested by stakeholders 
(Interviews, Survey) is provided below. In addition to the species listed below, a few 
interviewees remarked that certain species currently have more than one use and 
that all their uses ought to be regulated, including soybean and sunflower.  

 Stakeholder suggestions of species to include or exclude from the 
list of regulated species in selected Member States 

Member 
State 

Austria 

Belgium 

Croatia 

Czechia 

Denmark 

Possible species for inclusion 

Buckwheat (Fagopyrum esculentum) ; 
Lentils (Lens culinaris) 

Possible species for 
exclusion 

Welsh onion (Allium 
fistulosum); shallots 
(Allium cepa gr. 
Aggregatum); Brassica 
oleracea group 
(Kohlrabi); Prunus 
domestica and all sub 
species  

Quinoa (Chenopodium quinoa); garden 
rocket (Eruca sativa); wild rocket 
(Diplotaxis tenuifolia); Brassica 
carinata; Humulus lupulus; Kiwi 
(Actinidia) 

Buckwheat (Fagopyrum esculentum); 
Pomegranate (Punica granatum); Aronia 
sp.; Kiwi (Actinidia sp.); Lonicera 
caerulea var. kamtschatica 

Buckwheat (Fagopyrum esculentum); 
Chickpea (Cicer arietinum); Lentils 
(Lens culinaris); Proso millet 
(Panicum miliaceum) 

Ribwort plantain (Plantago lanceolata); 
Balansa clover (Trifolium michelianum); 
Bromus inermis; Quinoa (Chenopodium 
quinoa); Triticum dicoccon (Emmer); 
Triticum monococcum (Einkorn); 
Ølandshvede (old nordic crossbreed) 

n/a 

n/a 

n/a 

n/a 

Estonia 

Buckwheat (Fagopyrum esculentum) 

n/a 

France 

n/a 

True potato seeds; brassica rapa subsp. 
Chinensisl; Chickpea (Cicer arietinum); 
Kiwi (Actinidia); Buckwheat 
(Fagopyrum esculentum); Lentils 
(Lens culinaris); garden rocket (Eruca 
sativa) or Diplotaxis tenuifolia; chia 
(Salvia hispanica); Squash (Cucurbita 
moschata); Einkorn (Triticum 

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Poland 

Slovakia 

Spain 

Sweden 

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monococcum); Camelina sativa; 
Tritordeum; / Safflower; arugula 

Germany 

Emmer (Triticum dicoccum); Camelina 
sativa; Rocket (Eruca sativa); Einkorn 
(Triticum monococcum); Diplotaxis 
tenuifolia; Tritordeum; Bermuda grass 
(Cynodont dactilon) 

n/a 

Greece 

Lentil (Lens culinaris), chickpea (Cicer 
arietinum) 

n/a 

Ireland 

Wild flower mixtures 

Italy 

Rocket salad (Eruca sativa mill); 
perennial rocket (Diplotaxis tenuifolia) 

n/a 

n/a 

n/a 

n/a 

Actinidia (kiwi fruit plants; other fruit 
species–- e.g., mango, avocado; eruca 
(rucola seeds); garden rocket (Eruca 
sativa Mill.); wild rocket (Diplotaxis 
tenuifolia) 

Garden rocket (Eruca sativa); quinoa 
(Chenopodium quinoa); brassica 
carinata, buckwheat (Fagopyrum 
esculentum); and camelina sativa 

Buckwheat (Fagopyrum esculentum) ; 
Lentil (Lens culinaris) ; proso millet 
(Panicum miliaceum) 

Galega officinalis 

Quinoa (Chenopodium quinoa); 
buckwheat (Fagopyrum esculentum), 
lentil (Lens culinaris), chickpea (Cicer 
arietinum); subtropical fruits 

n/a 

Dill (Anethum graveolens); parsnip  
pastinaca sativa); buckwheat 
(Fagopyrum esculentum); seaberry 
(Hippophae rhamnoides); Thinopyrum 
intermedium 

Annual bluegrass (Poa 
annua); ribwort 
plantain (Plantago 
lanceolata); trifolium-
species; chervil 
(Anthriscus 
cerefolium); Garden 
rhubarb (Rheum 
rhabarbarum) 

Sources: Survey and Interviews. Please note that species highlighted in bold are 
species that were cited across multiple Member States. 

Several participants to the Survey and a few interviewees, notably one national 
association representing seed producers, one national public authority, and one 
European association representing farmers and agri-cooperatives  discussed possible 
criteria for deciding which species to regulate in the PRM legislation, the most 
commonly cited ones being: (1) economic/ commercial importance/ market volume; 
(2) EU/ regional/ local relevance/ importance; (3) extent of cultivation area at 

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Member State and/ or EU level; (4) extent of breeding activities; (5) extent of 
societal interest/ use/ consumption; (6) potential environmental benefits, such as 
relevance to food security, sustainability, biodiversity objectives. A few respondents 
from the Public Consultation, notably public authorities and business associations, 
however noted that overly simplified EU-level criteria may not be appropriate. They 
highlighted that any criteria should be sector/crop group-specific, that metrics such 
as market volume or value may be too simplistic, and that regional differences 
should be accounted for (e.g., a species may be nationally or regionally significant, 
but not significant at the EU level). This last point was also picked up by a few NGO 
respondents who recognised the need for national as opposed to EU lists to be 
established in order to account for varying national/regional contexts. 

Current rules and the Common Catalogues (B.1.4) 

Currently, the economically most important species are regulated by the PRM 
legislation. Their varieties are also listed in the Common Catalogues. Evidence 
pertaining to the current role of the Common Catalogues in furthering breeding 
activities was primarily gathered from survey participants, interviewees and, to a 
limited extent, the Public Consultation (this issue was not discussed at length in 
other consultation activities). According to survey respondents, the ability to list in 
the Common Catalogues has proved beneficial, notably in the context of species 
with only a small number of registered varieties. More than half of survey 
respondents (36 of 66) indicated that listing of such varieties in the Common 
Catalogues has had an incentivising effect on breeding. Similarly, two interviewees 
(both European representative associations – one association representing seed 
producers and the other representing farmers and agri-cooperatives ) discussed 
some of the key benefits of the Common Catalogues, hence the need to maintain 
them going forward. In their opinion, the Common Catalogues are useful as they 
currently allow operators to market varieties throughout the EU. As such, once 
admitted to the Common Catalogues, there is no need for operators to conduct 
additional tests for a variety to be marketed in a Member State, other than where it 
was bred/ produced. Operators do not therefore have to bear any additional 
registration costs. A few respondents to the Public Consultation also highlighted the 
role of the Common Catalogues in providing guarantees regarding the traceability of 
varieties and the quality of PRM marketed. One interviewee however opposed the 
need to regulate and list species in the Common Catalogues. They explained that 
the inclusion of new species in the Common Catalogues is enabling the gradual “loss 
of old, non-regulated, species,” which can be more easily adapted to local 
environmental conditions as opposed to commercial varieties. 

Future evolution 

As mentioned previously, professional breeders/ seed companies across the EU 
currently produce with the intent to sell to any user, professional or amateur. They 
do not tend to produce varieties exclusively for amateur gardeners. This is unlikely 
to change going forward. This was confirmed by most PRM-focus group participants 
and interviewees. Evidence from the PRM-focus group, Interviews and primary 
research in EC et al. (2021) suggests that, with regards to the amateur gardener 
market, the number and types of varieties currently being offered across Member 
States are generally high and increasing – although this contrasts with, relatively 
old, literature which indicates a decrease in availability and diversity (Mammana, 
2014). This upward trend in diversity is expected to continue, although evidence 
gathered primarily from the PRM-focus group and Interviews indicates that this 
may, to some extent, be constrained by: (1) (future) attitudes towards amateur 
gardening (i.e., whether there will continue to be a growing interest in and take-up 
of amateur gardening); (2) ongoing/ future market developments (for instance, 
some focus group participants foresaw a possible increase in the number of breeding 
company mergers in the future which, in their view, could reduce the scope/ 
diversity of varieties available to amateur gardeners); and (3) future regulatory 

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developments. In the absence of a change in PRM legislation, requirements 
mandating that varieties be distinct, uniform, and stable (DUS) (so that they can be 
marketed) will remain in place. According to several interviewees (one association 
representing organic breeders and two civil society organisations), this could lead to 
a loss in certain varieties (e.g. local/ traditional varieties) that may not exhibit DUS 
characteristics, but which are popular among amateur gardeners as well as seed 
conservation networks for their distinct flavour, their heirloom/ traditional 
characteristics, and/ or their role in building/ increasing biodiversity. As demand/ 
revenue generated by these varieties tend to be low, operators (especially smaller 
operators) selling PRM of these varieties may not be able to recoup costs (arising 
from production, testing, and registration). As a result, they may stop or reduce 
breeding of these varieties in the future. However, the impact generated by the loss 
of certain varieties may be contained if/ where it results in the breeding of varieties 
that are better suited/ adapted to future/ new challenges (e.g., climate change). 

As regards activities relating to SCNs, they are not expected to change in the near 
future. 39 out of 60 respondents to the Survey (65 per cent) agreed that there 
would be no change to SCN’s activities if the PRM legislation were to remain 
unchanged. Only seven out of 60 respondents (12 per cent) felt that there could be 
an increase or significant increase in the activities of SCNs. 

A5.4.2.1 

Impacts of revising the scope of the EU PRM legislation 

regarding operators marketing exclusively to amateur gardeners 

Direct impacts 

Administrative burdens on businesses 

A reduction in costs was among the most cited impacts by survey respondents when 
discussing the potential impacts of either an exemption of marketing to amateur 
gardeners from the PRM legislation (M64.1) (25 out of 62 respondents) or the 
implementation of lighter rules (M64.2) (29 out of 62 respondents). A few 
interviewees shared a similar view.  One interviewee (an NCA) indicated that lighter 
rules would help ease costs for operators. Another interviewee (a representative 
association) explained that either measure - an exemption or lighter requirements - 
would help alleviate production costs specifically for the least economically important 
species (such as amateur and conservation varieties). These tend to have low market 
demand, relatively high production costs and low commercial value/ profitability 
compared to commercial varieties, thus making it difficult for operators to recoup 
production costs and sustain production. In the same vein, EC et al. (2021) and 
Council of the European Union (2014) found that measures aimed at simplifying PRM 
marketing rules could reduce costs for operators, especially for SMEs. As such, smaller 
operators may lack the necessary resources to anticipate and cover registration and/ 
or certification costs. A simplified/ lighter regulatory regime would therefore help 
reduce the disproportionate burden that variety registration and certification are 
currently reported to have on SMEs (and non-profit organisations) with commercial 
activities.  

Itis however difficult to provide an accurate picture, at EU level, of the potential extent 
of reduction in administrative burdens and/ or costs for businesses that may result 
from either an exemption or lighter rules. This is because: (1) some Member States 
may already have a simplified regulatory regime in place (e.g., no/ lower fees for PRM 
of varieties aimed exclusively at the amateur gardener market), in which case either 
measure may not have a significant impact on costs/ administrative burdens; and (2) 
the number of operators involved in the exclusive marketing of PRM to amateur 
gardeners, including the number/type of varieties and registration/certification 
processes, is not known.  

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There was also a shared, albeit less common, perception among PRM-focus group 
participants and (other) interviewees that neither measure would meaningfully impact 
costs. Several PRM-focus group participants explained that the share of total 
production costs accounted for by registration and certification costs is already small. 
Similarly, commenting more generally on the share of total production costs 
accounted for by registration costs for (new) agricultural and vegetable varieties, 19 
out of 46 survey respondents indicated a share of 2-5 per cent, while 14 out of 46 
respondents reported a share of less than 1 per cent. The share of production costs 
accounted for by certification fees were also reported to be small, at 2-5 per cent (21 
out of 37 respondents) for agricultural crops and less than 1 per cent (11 out of 20 
respondents) for vegetable species. Several focus group participants also commented 
that it was not clear in what way M4.2 would differ from the current PRM regime, 
making it difficult to ascertain the extent of reduction in costs that may arise as a 
result of this measure.  

Public authorities (and budgets) 

The nature and extent of change in implementation and enforcement costs for public 
authorities that would arise from either an exemption (M4.1) or lighter requirements 
(M4.2) are not clear. In the case of an exemption, more NCA survey respondents 
expected costs to fall (six of 16) than those who believed there would be no change or 
an increase (five and three respectively out of 16). Alternatively, if lighter 
requirements were to be implemented (M4.2), most NCA survey respondents (eight of 
16) felt that there would not be any change in costs and some an increase (four out of 
16). No NCA respondents expected costs to decrease. It can be argued that, since 
many Member States already have a simplified regulatory regime in place for PRM 
marketed to the amateur sector (see previous sub-section), a further relaxation of the 
PRM rules (M4.2) may not require substantial changes to current procedures/ 
processes/ work practices, which in turn would limit any negative impact on resources 
(staff, budget, etc.) and overall implementation and/ or enforcement costs. PRM-focus 
group participants also generally noted that there may be no real impact on public 
authority costs from either an exemption or lighter requirements. However, four out 
16 NCA survey respondents and a few PRM-focus group participants warned that there 
could be an increase in administrative burdens for public authorities, especially in the 
context of a lighter regulatory regime (M4.2). This is because lighter requirements will 
likely entail a separate set of rules that will need to be enforced. Additional resources 
may therefore have to be channelled into new/ additional enforcement activities. In 
the absence of data on the nature of these new rules and additional enforcement 
activities that may ensue, it is not possible to estimate/ quantify the extent of 
additional costs/ administrative burdens that may arise for public authorities from 
M4.2.  

Indirect impacts 

Investment flows 

Views pertaining to potential impacts of measures M4.1 and M4.2 on investment 
diverged among stakeholder groups (and were in part linked to views on whether 
there would be impacts on administrative burdens).  

Almost as many survey respondents (22 of 62) felt that lighter requirements would 
not have any impact on investment as those (20 of 62) who believed it would lead to a 
reduction in investment. Several PRM-focus group participants believed that lighter 
requirements could positively influence the extent of investment in breeding of 
varieties for the amateur sector, as the measure could reduce costs whilst maintaining 
a minimum assurance of seed quality and health (which could help maintain 
confidence in the seed sector among buyers, breeders/ producers, and investors).  

As regards the impact on investment of a possible exemption (M4.1), a third of survey 
respondents (24 of 62), mainly comprising business associations (11 out of 17/ 65 per 
cent), companies/ businesses (eight out of 15/ 53 per cent), and public authorities (six 

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out of 16/ 38 per cent), and several PRM-focus group participants and interviewees 
(two NCAs and one representative association) indicated that the proposed measure 
would negatively impact investment, suggesting that breeders would be unlikely to 
invest in a market that is not adequately regulated and in which unfair competition 
conditions would prevail. Conversely, five out of six NGOs felt that an exemption 
would positively impact investment, most likely due to the reduction in costs that can 
be expected from the removal of registration and certification requirements and more 
resources available for breeding of varieties aimed at amateur gardeners.   

Functioning of the internal market and competition 

Any relaxation of the PRM rules could have a negative effect on PRM quality. More 
than half of survey respondents (35 of 62) expected lighter requirements (M4.2) to 
bring about a reduction in PRM quality. An exemption (M4.1) was also expected to 
have a negative effect on quality (29 of 62). These findings were corroborated by 
evidence gathered from the PRM-focus group. The expected reduction in quality was 
generally attributed to the absence of regulatory controls from authorities, as well as a 
potentially larger amount of fraudulent PRM in circulation (which is further discussed in 
the next sub-section). Furthermore, several interviewees (three representative 
associations, two NCAs, and one civil society organisation) commenting on the impacts 
of a possible exemption believed that the proposed measure would pose serious 
phytosanitary risks. They expressed a preference for basic/ lighter requirements to be 
introduced so that users’/ consumers’ right to information, such as the origin of the 
seed, germination rates, selection and breeding methods, etc., could be preserved. 
Respondents to the Public Consultation, notably “business associations” and 
“company/ business organisation” respondents shared similar views, recognising that 
basic requirements would be acting as a guarantee on quality. A contrasting 
perspective, typically put forward by NGOs (e.g., in the Public Consultation) was that 
amateur gardeners did not need such robust quality guarantees. Although true to 
some extent, it is important to highlight the fact that many amateur gardeners still 
rely on home gardening to grow edible produce for themselves and their families 
and/or produce that can meet their dietary needs (EC et al, 2021). 

Impacts on price were not thoroughly discussed. Most survey respondents and PRM-
focus group participants however believed that the proposed measures would not 
bring about any significant change in price.  

Fraud 

Views on the potential impacts of an exemption (M4.1) or lighter requirements (M4.2) 
on the extent of fraudulent PRM in circulation on the amateur gardener market is 
mixed. The most common view amongst survey respondents (22 of 62 or 35 per cent) 
was that an exemption would result in a significant increase in fraudulent PRM. In 
contrast, a relatively similar proportion of survey respondents (24 of 62 or 39 per 
cent) believed that lighter rules would have no impact on the extent of fraudulent PRM 
marketing, and hence no impact on PRM quality and phytosanitary conditions. As 
explained by PRM-focus group participants, this could be due to the fact that basic/ 
lighter requirements (as opposed to an exemption) would provide a minimum 
assurance of quality and health, in turn ensuring that high-performing seeds, more 
resistant to environmental and climate stresses, are able to reach the market. 
Furthermore, evidence from the literature indicates that measures that eliminate 
obligatory certification pose a risk to the health and quality of PRM (EC 2013b). This is 
because, in the absence of variety testing and PRM quality standards and controls, 
there is a greater risk of fraudulent PRM reaching the market. This means that PRM 
that is marketed as ‘high-performance’ may have actually been replaced with inferior 
products.   

Position of SMEs 

There is some evidence that SMEs could benefit from the proposed measures (M4.1, 
M4.2). A similar number of survey respondents (14 of 62) felt that SMEs and larger 

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operators would equally benefit from the proposed derogations/ measures as 
respondents who believed that SMEs would be more likely to benefit than larger 
operators (13 of 62). Among interviewees, one civil society organisation explained 
that relaxing current PRM rules would facilitate market entry, notably for smaller 
operators – something that was called for by several NGO respondents to the public 
consultation. Other interviewees (two representative associations and one scientific 
network) remarked that maintaining strict PRM requirements would continue to have a 
disproportionate impact on SMEs as they “tend to work with such small quantities” and 
would be unable to recoup production costs. Lighter requirements would thus give 
SMEs and other small players, such as seed saver organisations, greater scope to 
develop their (breeding/ production) activities.     

Biodiversity 

The assessment of impacts on biodiversity is based on the potential impacts of the 
proposed measures on the diversity of PRM marketed to amateur gardeners (itself 
influenced by potential impacts on costs, investment and SMEs already discussed 
above).  

Amongst survey respondents, the largest share (25 of 62) believed that an exemption 
for marketing to amateur gardeners (M4.1) would lead to an increase in diversity. If 
lighter requirements (M4.2) were to be imposed, the largest share (27 of 62) thought 
there would be no effect on diversity, with 18 expecting an increase and 12 expecting 
a decrease in diversity. Among PRM-focus group participants, the shared view was 
that both measures (M4.1 and M4.2) would lead to an increase in diversity. However, 
the extent of change in diversity would likely depend on current rules in place. In 
Member States where PRM rules are already relaxed, the impact on diversity and 
choice would be more limited as opposed to Member States where strict PRM rules 
currently apply. Similarly, EC et al. (2021) and EC (2013c) indicate that a lightened 
regime for PRM marketed to amateur gardeners could lead to increased choice and 
genetic diversity, comprising new improved and tested varieties, plant material not 
fulfilling variety definition (e.g., heterogeneous plant material), traditional varieties, 
and niche market material.  

Two NCAs however warned that the impact of either measure on PRM diversity could 
be limited. They explained that the measures could lead to a reduction in breeding 
activities (especially in minor or niche crop species) owing to the lack of guarantee on 
quality and, consequently, their perceived low performance and agronomic value. This 
could therefore impede efforts to increase PRM diversity and further the biodiversity 
agenda. Similarly, EC et al. (2021) reported that diversity of products could decrease 
in the long term due to a potential deterioration in quality and identity. 

A5.4.2.2 

Impacts of revising the scope of the EU PRM legislation 

regarding the activities of seed conservation networks 

The impacts of measures aimed at seed conservation networks (i.e., M3.1, M3.2) were 
not discussed at length or sufficiently evidenced as part of the research. The 
discussion below thus focuses on a smaller number of impact indicators (compared to 
the previous discussion for the amateur gardener market).  

Conduct of business/ SCN activities 

Stakeholders were asked to comment on possible impacts of an exemption of 
exchange activities between SCN members from the scope of the EU PRM legislation 
(M3.1) and from subjecting these activities to lighter requirements (M3.2) on the 
number of varieties, number of species, and volume of PRM exchanged through SCNs. 
Most survey respondents believed that the impact of either measure on these 
indicators would be positive. As regards a possible exemption, a majority of survey 
respondents indicated an increase in the number of varieties and species respectively 
(34 of 60) and an increase in the volume of PRM exchanged (38 of 60). Regarding 

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lighter requirements, survey respondents indicated an increase in the number of 
varieties (24 of 60), number of species (26 of 60) and the volume of PRM exchanged 
(28 of 60). The number of SCNs and the number of associated members were 
expected to increase under an exemption, but not change if lighter requirements were 
implemented. 

Public authorities (including budgets) 

The impacts on public authority costs of measures aimed at simplifying the rules 
around exchange activities between members of SCNs were explored to some extent. 
Most NCA survey respondents (10 of 17) did not expect any change in implementation 
and enforcement costs if exchanges were exempted (M3.1), while two expected an 
increase and three a decrease. Conversely, if exchange activities were to be subjected 
to lighter requirements (M3.2), the most common view among NCA survey 
respondents (eight of 17) was that there would be an increase in costs for public 
authorities from increased enforcement work. None expected a decrease in costs. 

Biodiversity 

SCNs play an important role in the conservation of crop/ genetic diversity (especially 
among older, more traditional varieties) which, in the long term, can help combat the 
effects of climate change and secure sustainable and resilient food systems. As 
evidenced in previous sub-sections, the current PRM rules are too burdensome for 
some varieties, such as conservation and amateur varieties. This is due to stringent 
registration and certification procedures, which could be disincentivising SCNs and 
other operators from registering these varieties and inhibiting the marketing of such 
varieties by SCNs. Any form of deregulation, i.e., an exemption (M3.1) or lighter rules 
(M3.2) could therefore help reduce the registration burden, facilitate marketing of PRM 
by SCNs and/ or improve access to and use of a more diverse range of seeds by 
members of SCNs. Either of the proposed measures would therefore help in furthering 
the role of SCNs in the conservation/ maintenance of biodiversity. 

A5.4.2.3 

Impacts of listing in the Common Catalogues  

The impact on breeding activities of including certain types of crop species in the 
Common Catalogues, notably species not regulated at EU level, neglected or 
underutilised species (NUS) (M2.2), was considered. Amongst survey respondents, the 
largest share (31 of 66) believed that the inclusion of non-regulated species in the 
Common Catalogues (while maintaining their ‘non-regulated’ status) would not have 
any further incentivising effect on breeding.  

A similar view was held by several interviewees, including one European scientific 
network and two representative associations. These stakeholders explained that 
operators tend to consider other factors when deciding which species/ varieties to 
breed, such as their commercial importance. For certain species, such as ‘niche crops,’ 
inclusion in the Common Catalogues would be unlikely to incentivise further breeding. 
This is because varieties need to be tested in order to be listed, and the testing can be 
costly. As demand for and revenue generated by ‘niche crops’ tends to be low, the 
costs incurred by listing such species in the Common Catalogues would outweigh the 
benefits. According to one representative association, listing in the Common 
Catalogues could thus disincentivise breeding, particularly for niche crops, leading to 
loss of existing varieties.  

However, commenting more broadly on the possibility to list different species in the 
Common Catalogues (other than non-regulated or NUS species), some interviewees 
explained that there could be benefits of doing so. For instance, it offers operators the 
possibility to market varieties throughout the EU and to reach a larger client base. 
Expert opinion also suggests that the possibility of registering new varieties in the 
Common Catalogues, notably new species, can provide innovation incentives for 
breeders, and that certification provides assurance of the (good) quality of species 

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being marketed, thereby increasing users’ confidence and demand for registered 
varieties. This can in turn fuel additional investment and increase innovation in 
breeding activities by breeders/ producers. Differences and often significant delays 
between inclusion in national catalogues and the EU catalogue were however identified 
by EC et al. (2021) as an important barrier to investment and innovation. In that 
regard, respondents to the public consultation (notably respondents across the 
“business,” “business association,” “academic/research institution,” “NGO,” and 
“environmental organisation” categories) generally agreed that a measure aimed at 
allowing direct notification of registered varieties by Member States to the Common 
catalogues without a Commission decision) could speed up market access for these 
varieties throughout the EU. Responses among “trade unions” and “public authorities” 
were more evenly split, with as many respondents agreeing that direct notification 
could expedite market access as respondents disagreeing that such an impact would 
arise. 

A5.5 

B.2: Allowing the exchange of PRM between farmers  

In-kind exchange between farmers refers to the supply or transfer of seed, the 
purpose of which is not for commercial exploitation. In-kind exchange between 
farmers is typically informal in nature and occurs outside of the commercial seed 
sector.  

Study question B.2 and related sub-questions assess the economic, environmental, 
and (other) wider impacts of allowing in-kind exchanges between farmers. Two 
possible measures are considered: (1) exempting in-kind exchanges from the PRM 
legislation and creating a separate regulatory framework for such exchanges; and (2) 
including in-kind exchanges within the full scope of PRM legislation, treating them as a 
commercial activity.  

Ref.  Study question 

O1   O2  O3  Measure 

 

B.2  What are the expected economic and 
environmental impacts of allowing the 
exchange of PRM between farmers under 
conditions defining who may participate 
in the exchange (e.g., only among 
members of regional mutual support 
organisations), maximum amounts to be 
exchanged and the types of varieties 
(e.g., non-protected varieties)?  

What is, in particular, the expected 
impact on the PRM certification system in 
the EU and the resilience of the EU 
agricultural system? 

M5.1 Exemption for exchange in 
kind of PRM of non-protected 
varieties between farmers 

 

M5.2 Lighter rules for exchange in 
kind of PRM of non-protected 
varieties between farmers 

 [same as baseline] In-kind 
exchange of non-protected 
varieties between farmers falls 
under the full scope of the 
marketing legislation 

A5.5.1 

Problem statement  

There are different rules for in-kind exchange of PRM between farmers across the EU. 
A few Member States currently allow in-kind exchanges, while most prohibit them. 
This variation in rules implies that farmers in many Member States, where in-kind 
exchange is not allowed, have limited access to a wider variety of seeds which may 
also be more affordable compared to commercial seeds and may be necessary for the 
sustainability and renewal of seed stocks (European Coordination Via Campesina 
2021). Varying rules may have also created an uneven playing field between seed 
companies active in the supply of seed as in-kind exchanges may have reduced the 
market size for certified seed in some Member States and not others (expert opinion).  

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According to EU legislation, exchange in-kind between farmers falls under the 
marketing definition. It is therefore regarded as a commercial activity. Internationally, 
in-kind exchange between farmers is recognised by the International Treaty on Plant 
Genetic Resources for Food and Agriculture (ITPGRFA), although it acknowledges that 
such activity should be subject to national laws. The United Nations Declaration on the 
Rights of Peasants and Other People Working in Rural Areas (UNDROP) also recognises 
farmers rights in the context of in-kind exchange activities. It is however a non-
binding instrument. Despite the restrictions on in-kind exchange activities between 
farmers, these activities are thought to take place across the EU (more broadly than 
only those Member States where the activity is currently permitted). This observation 
was made by four interviewees (comprising one national competent authority (NCA), 
one European civil society organisation, and two national representative associations). 
It is difficult to assess the extent of such activities.    

In-kind exchange between farmers may present several benefits. Farmers’ ongoing 
selection, that takes place year on year, allows for the optimisation of plants’ 
adaptation to all variations in local cultivation conditions (European Coordination Via 
Campesna 2021). In contrast, commercial breeders tend to focus on varieties that can 
be adapted to large-scale markets to ensure returns on their research investment. 
They cannot therefore consider the adaptation of varieties to local contexts (i.e. small 
markets). In-kind exchange can therefore increase farmers’ access to PRM of old and 
non-protected varieties, i.e., conservation varieties, that do not feature in seed 
dealers’ catalogues as well as crops that are more resilient to local contexts (e.g. local 
pest and climatic conditions). For example, evidence from the French case study (see 
Annex) indicates that in-kind exchange is thought to have helped farmers adapt to 
new/ and improved agricultural practices (e.g., varietal mixtures) to produce crops 
that are more productive and more tolerant to local pests and diseases. Smale et al. 
(2008) and Jensen et al. (2013) (as cited in Coomes et al. 2015) found that in-kind 
exchanges between farmers, albeit small in volume, “are vital for building crop and 
varietal diversity and for renewing planting stock […].”  

There are however concerns that in-kind exchanges between farmers could contribute 
to an increased supply of uncertified or low-quality seed on the market. This could 
explain why, in many Member States, in-kind exchange is actively discouraged by 
national agricultural policy, which in turn places a greater emphasis on the provision/ 
use of certified seed (Coomes et al., 2015). A key concern is the potential for the 
harvest generated by varieties that are not registered or certified to be mixed with the 
harvest from registered varieties (expert opinion). This could have implications for the 
quality of food or feed end-products. 

A5.5.2 

Impacts  

Baseline assessment 

The current EU PRM legislation does not allow in-kind exchange of PRM/ seeds 
between farmers. This activity is therefore not (legally) permitted in most Member 
States (EC et al. 2021). However, evidence provided by survey participants (one 
public authority), interviewees (one national and one European civil society 
organisation and two national representative associations), and case study 
participants indicates that a few Member States and another EEA country do have 
exemptions in place: Austria, France, Italy, and Norway.  

In France, under Art.315-5 of the Code Rural, PRM exchange between farmers of 
varieties which are not protected by plant breeders’ rights are considered as ‘mutual 
assistance’ (as opposed to a ‘commercial activity’). They are therefore not subject to 
regulations concerning seeds marketing (European Coordination Via Campesina 
2021). In Austria, an exemption currently applies for in-kind exchange, i.e., the 

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activity is permitted.47 The system in place relies on trading exact amounts; hence 
farmers/ producers tend to exchange small amounts (e.g., at seed fairs). Therefore, 
large seed companies do not typically participate in such exchanges. In Italy, 
national legislation was amended in 2021. It now allows for in-kind exchange 
between farmers, though this only relates to a portion of their harvest. In-kind 
exchange of PRM between farmers is still not permitted. The new legislation is 
however still quite generic, in that there is no detailed information around the 
conditions of exchange, including quantities to be exchanged, varieties that can be 
exchanged, quantitative limits, etc48. 

The case study undertaken in France indicates that data on the number of farmers 
who have made use of the allowance for in-kind exchanges, the number of varieties 
they have exchanged, or volumes exchanged are limited. There is however some 
indication that volumes of seeds exchanged in-kind between farmers across France 
have grown over the past 20 years. This trend is expected to persist, considering 
national efforts to boost local food production and agroecological and biodiversity-
based farming. Evidence from the case study indicates that the number of 
participants in these exchanges may be small, ranging from a few hundred to the 
low thousands, possibly equating to less than 1 per cent of French farms49, with 
participating farmers tending to produce on a smaller scale and with greater interest 
in new, heterogeneous and/ or less stable material (i.e., material that is more 
adaptable to local climate/ growing conditions) rather than larger farm operators 
who tend to participate in the commercial seed market. At EU level, the scale of in-
kind exchange activities between farmers is not known.  

In the absence of regulatory intervention, it can be expected that in-kind exchange 
activities between farmers will remain prohibited in most Member States but 
continue to occur across many Member States, albeit at a relatively small scale (in 
terms of numbers of participating farmers and volumes exchanged). Farmers across 
the EU will continue to face different rules, with farmers allowed to exchange PRM 
in-kind having greater access to more locally adapted varieties.  

Direct impacts 

Administrative burdens on businesses 

Exempting in-kind exchanges between farmers from PRM marketing requirements 
(M5.1) could reduce production costs and/ or administrative burdens for farmers, as 
attested by some interviewees (two NCAs). The extent of this reduction is difficult to 
estimate owing to a lack of evidence on the number of farmers who would potentially 
be affected and the likely reduction in time and effort that would result from reduced 
compliance obligations.  

In contrast, the inclusion of in-kind PRM exchange as a commercial activity in the PRM 
legislation could result in an unnecessary burden on farmers. One survey respondent 
(a public authority) and two interviewees (a civil society organisation and an NCA) 
shared this view, explaining that the imposition of registration/ certification 
requirements (M5.2), even basic, could prove costly to farmers. For instance, to 
ensure basic germination rates, farmers would require specialised equipment, which 
would likely impose additional costs or require substantial investments.  

Public authorities (and budgets) 

There is some indication that monitoring and enforcement costs could increase if in-
kind exchanges between farmers were allowed (M5.1). Several survey respondents 

47 Information gathered from an Austrian civil society organisation 
48 Information gathered from an Italian representative association 
49 Total number of farms in France = 456,520 (source: Eurostat). Calculations: low-end = (100/456,520 *100); high end = 
(3000,000/456,520 *100) 

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(seven of 17) and some interview participants (two NCAs and one representative 
association) explained that in-kind exchanges could result in higher propensities to 
engage in fraudulent behaviour, such as intellectual property rights infringements, the 
unauthorised use of plant protection products, etc. One survey respondent (an NCA) 
also evoked the possible “creation of a black market” in certain Member States, where 
lower quality/ non-certified seeds would be widely circulated, which would entail 
“knock-on effects, notably on plant, animal and human health.” Increased 
enforcement activity would be needed to deter such behaviour, which could lead to 
higher enforcement costs for NCAs. To some extent, this was also evidenced in the 
literature. Coomes et al. (2015) found that transaction costs associated with the 
regulation of small and localised farmer seed transfers were generally high, “making 
enforcement impractical and uneconomical.” 

Conduct of business 

Allowing in-kind exchanges between farmers (M5.1) could lead to an increase in the 
number of participants involved in the exchange in-kind of PRM. This was a view 
shared by one survey respondent (an EU civil society organisation) and two interview 
participants (one NCA and one European agency). Allowing in-kind exchange of PRM 
between farmers could also potentially lead to an increase in the quantities of PRM 
exchanged. 

Most survey respondents (53 of 64) expected a positive impact on quantities and/or 
volumes exchanged, a smaller proportion of whom (11) believed that this impact could 
be significant. The extent of change may however depend on market capacity and 
farmers’ preferences. For example, evidence from the case study in France and from 
consultation activities (one survey respondent (an NGO) and one interviewee (a 
European civil society organisation)) suggests that, given the low uptake of in-kind 
exchange (e.g., less than 1 per cent of farmers in France), the majority of farmers 
across the EU may still choose to buy commercial/ certified seeds. Expert opinion also 
suggests that, where in-kind exchanges are restricted to non-protected seeds, the 
impact on volumes exchanged may be small as most farmers may prefer to use their 
own farm-saved seeds, that is, the most recent (and protected) seeds.  

A separate framework for the exchange in-kind of seeds between farmers (M5.1) 
could also positively influence the number of varieties exchanged. As such, farmers 
would be able to produce seeds for their own use and then exchange part of their 
production with other farmers, which could help maintain the diversity of seed stocks 
(European Coordination via Campesina 2021). Two interviewees shared a similar view, 
indicating that allowing in-kind exchanges could generate an increased effect on the 
overall diversity of varieties used/ produced by farmers. They however stressed that 
such diversity would more likely be observed among conservation and local/ 
traditional varieties. Another interviewee (a European representative association) 
explained that allowing in-kind exchange of PRM would allow farmers to exchange 
seeds within regional communities, farmer seed networks, farmer collectives, etc., 
offering them an “additional source of seeds.” This could prove particularly useful in 
regions/ countries where farmers cannot easily access certain types of seeds, such as 
organic seeds.   

In contrast, conduct of business would be negatively impacted if in-kind exchange 
between farmers falls within the full scope of the PRM legislation (and is treated as a 
commercial activity). One survey respondent indicated that farmers would be required 
to register as ‘operators,’ while the seeds they would produce and exchange in-kind 
would be subjected to the same quality controls as for certified seeds, which could 
prove costly. Establishing lighter rules for in-kind exchanges between farmers (M5.2), 
on the other hand, could prove less burdensome, while ensuring that farmers continue 
to meet minimum quality standards and that the risk of fraudulent seeds / PRM 
reaching the market is avoided/ reduced. This was a view shared by several 
interviewees, including: four representative associations, and five NCAs.  

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Indirect impacts 

Functioning of the internal market 

Allowing in-kind exchanges between farmers (M5.1) could have unintended 
consequences on other, related market segments, notably the market for certified/ 
commercial seeds. A reduction in the use of certified seeds was foreseen by most 
survey respondents (38 of 64), comprising individual businesses, business 
associations, NGOs and public authorities. A similar proportion and profile of survey 
respondents felt that there could also be a reduction in the demand for commercial 
varieties if an exemption for in-kind exchanges between farmers was implemented. 
According to one interviewee, a reduction in the demand for or the use of certified 
seeds and commercial varieties respectively could be triggered by an exemption 
(M5.1) as “it would be difficult to draw the line between ‘exchange’ and ‘marketing.’ 
The share of uncertified seed would therefore increase, as it would be cheaper.”  

Some respondents to the public consultation, mainly business associations, also raised 
concerns regarding the potential growth of in-kind PRM exchange, following an 
exemption, and the risks posed to established systems for farm-saved seed, which 
they felt could be largely undermined. The extent of impacts on the use of certified 
seeds and/ or the demand for commercial varieties may however be limited if the level 
of in-kind exchange activity is undertaken on a small-scale (as evidenced in the 
French case study) as opposed to becoming a widespread, large-scale activity.  

Biodiversity 

Establishing a separate regulatory framework for in-kind exchanges between farmers 
(M5.1) could prove beneficial for biodiversity, agricultural systems, and other 
environmental factors. Some interviewees (two civil society organisations and two 
scientific networks) believed that an exemption could help increase and strengthen 
farmers’ role in relation to “in situ conservation of crop diversity and participatory 
plant breeding activities.” This in turn could help increase farmers’ ability to develop 
and adapt varieties to increasingly unpredictable weather patterns. This was also 
discussed by survey participants (19 of 64) who felt that an exemption (M5.1) could 
lead to an increase in farmers’ access to PRM of varieties that are more suitable or 
adaptable to local climate conditions. This expected increase in adaptability and crop 
diversity was also evidenced to a certain extent in the literature. Through increased 
adaptability and diversity, farmers would be able to contribute more significantly to 
agricultural development, sustainable farming, and food security (Coomes et al. 
(2015), (European Coordination Via Campesina (2021)), which constitute key 
objectives of the EU’s ‘Farm to Fork Strategy.’ Allowing in-kind exchanges between 
farmers would therefore bring about greater coherence between the EU PRM 
legislation and other EU-wide initiatives as well as greater alignment with international 
practices. 

There are however concerns that an exemption (M5.1) could lead to a reduction in the 
quality and health of PRM used by farmers (and/ or by users more widely). Compared 
to a system where at least basic rules on testing/ certification (M5.2) would apply to 
in-kind exchanges or a system where similar rules would apply to both commercial 
and in-kind exchanges, an exemption that removes variety testing requirements and 
quality controls for PRM exchanged in-kind could lead to seeds of lower quality in 
terms of health, germination rate, yield performance, pest resistance, etc. This was a 
shared view among most survey respondents (40 of 64) and many interviewees (five 
NCAs and four representative associations). 

A5.6 

C.1 Establishing a simple and harmonised registration 

system and facilitating the marketing conditions for 
conservation and amateur varieties 

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This study question and related sub-questions assess the problems created by current 
legislation on the availability of conservation varieties and amateur varieties, including 
conservation varieties of fruit and vine, and investigates the impacts of introducing 
derogations or lighter rules for these varieties. 

Ref.  Study question 

O1   O2  O3  Measure 

C.1 

    M6  Define lighter registration 

What are the expected economic 
impacts for competent authorities 
and operators, social impacts for 
citizens and environmental impacts 
of establishing a simple and 
harmonised registration system (i.e. 
no variety testing but officially 
recognised description) for 
conservation varieties and amateur 
varieties and of facilitating the 
marketing conditions for those 
varieties (no quantitative restrictions 
and abolishing the region-of-origin 
concept)? 

requirements (no DUS but officially 
recognised description) for 
conservation varieties and extend them 
to fruit plants and vine.  

M12 Adapt the current rules for “not 
yet listed varieties”, to allow 
multiplication to adequate marketing 
quantities while variety registration is 
ongoing. Extend to fruit plants and 
vine, including the “not yet finally 
certified PRM” provisions. 

A5.6.1 

Problem statement  

Directives concerning agricultural conservation varieties (Directive 2008/62/EC) and 
vegetable varieties with no intrinsic value for commercial crop production but 
developed for growing under particular conditions (Directive 2009/145/EC) (i.e. 
‘amateur varieties’) were introduced to facilitate the commercialisation of conservation 
varieties. They provide for derogations on procedures which would be required for 
conventional varieties. For the registration of conservation and amateur varieties 
official tests may not be required (subject to the applicant providing sufficient 
information about the variety) but criteria for distinctness, uniformity and stability still 
apply for a description of the material (Liveseed 2021a) and lower registration fees 
may apply (EC et al. 2021). These derogations come with marketing restrictions, such 
as quantitative limits50 on production and restricting marketing to the variety’s region 
of origin51 which varies across Member States (EC et al. 2021). Some respondents to 
the public consultation (22 of 39 NGOs, 5 of 7 environmental organisations, and 2 of 4 
trade unions) thought that different implementation of the derogations has created 
unequal conditions across Member States. No directives provide derogations for 
conservation varieties of fruit plants or vines. 

Responses across all consultation exercises reveal contrasting opinions between 
stakeholder types on the extent and nature of the problem. The majority of NGO 
respondents to the public consultation (21 of 39) disagreed that the current 
framework has been successful in promoting the conservation and sustainable use of 
plant genetic resources, whereas the majority of business organisations (82 of 114) 
thought derogations had been successful. Just under half of NCAs (16 of 37) agreed 
that the current rules had been successful, while a similar number (15 of 37) did not 
have an opinion. In some cases, survey respondents cited the ‘high’ number of 
conservation and amateur varieties listed in the Common Catalogues to justify their 

50 There are three such restrictions. See: Directive 2010/60/EU, Article 14; Directive 2009/145/EC; and Directive 
2008/62/EC Article 14 
51 Commission Directive 2009/145/EC: Article 4 

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view that the current framework has been successful; whereas others pointed to a 
lack of improvement in agrobiodiversity to justify their view that the framework has 
been unsuccessful. Reasons cited by one civil society organisation for the limited 
choice and diversity available is the perception that the current rules targeted at 
industrial agriculture do not allow for heterogeneity and the natural evolution of 
plants. 

EC et al. (2021) concluded that key factors limiting use of conservation and amateur 
varieties were (i) low market demand, relatively high costs and low profitability, (ii) 
that producers are typically small scale, and (iii) differences in the supportiveness of 
Member State authorities. The current study’s survey asked opinion on the extent to 
which different factors were limiting the market52. For conservation varieties, only two 
factors were considered constraining by a majority of respondents: low market 
demand and low market willingness to pay (i.e. PRM sale price) were indicated by 
most respondents as a ‘significant constraint’ or ‘constraint’ (respectively, 44 and 32 
of 72 respondents). For amateur varieties, no factors were considered a constraint by 
a majority of respondents. 

However, there were contrasting views on the influence of these factors across 
stakeholder groups. In contrast to the overall survey sample position, and that of 
other stakeholder groups, NGOs and academic institutions were more likely to identify 
factors as constraints. Concerning conservation varieties:   a majority of NGOs and 
academic institutions considered most factors (with the exception of labelling 
requirements) to be a constraint including the financial cost of PRM certification 
processes (7 of 10), reporting requirements (8 of 10), unsuitable DUS tests (10 of 
10), the administrative process for registration (8 of 10), and quantitative restrictions 
(10 of 10). Concerning amateur varieties: a majority of academic institutions and 
NGOs identified registration costs (8 of 10), the administrative process for registration 
(9 of 10), unsuitable DUS tests (9 of 10), cost of seed verification (10 of 10), 
quantitative restrictions (10 of 10) and reporting requirements (8 of 10) as 
constraints. 

Quantitative restrictions may not be considered a problem because production 
volumes are low. This view was reflected by 5 stakeholders interviewed (3 seed 
associations, an NCA and a scientific network). EC et al. (2021) demonstrated that in 
cases where data was available production levels are typically below the quantitative 
limit thresholds. Most surveyed stakeholders were not aware of any examples where 
demand exceeds the quantitative thresholds.53 However, low production levels may in 
part be caused by quantitative limits i.e. the limits discourage investment because of 
the limits they place on scale efficiencies and returns (EC et al. 2021; and interviews 
with 2 civil society organisation and one NCA). Two surveyed NGOs and a business 
association mentioned cereal and fruit tree conservation varieties in Italy and a 
conservation rice variety in Austria where the demand cannot be met because of the 
legal quantitative limits imposed.  One of these NGOs explained that the limits 
discourage many to engage in the production of conservation variety seeds. Limits 
imposed by Directive 2010/60/EU on the maximum value of native seed to 5% of the 
fodder species market is in direct contradiction with a national German requirement 
that all restoration of natural areas must use native seed (De Vitis, M. et al. 2017). 

Region of origin is ill-defined and interpreted differently across Member States, even 
for the same varieties (EC et al. 2021). Thirteen of 18 NCA survey respondents 

52 The factors were: The financial cost for registering a variety, The administrative process for registering a variety, DUS 
tests that are not suitable for these varieties, The financial cost of PRM certification processes, Quantitative restrictions on 
the PRM marketed, Labelling requirements, Rules on region of origin, Reporting requirements, Low market demand, Low 
market willingness to pay i.e. PRM sale price 
53 Conservation variety examples offered included cereal conservation varieties produced beyond their limits in Austria, and 
unmet demand for several varieties in Italy. Another example of hemp Latvia is offered in EC et al. (2021). 

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indicated that ‘local’ is defined in their country. Austria, France, Ireland, the 
Netherlands and Spain consider the whole country as the region of origin. In contrast, 
other Member States have a more restricted definition of local.  In Italy the concept of 
“local” refers to a limited area, represented by a municipality or a limited group of 
neighbouring municipalities. In the case of conservation varieties, “local” refers to the 
area where this variety was traditionally cultivated. As a consequence, it can refer to a 
portion of a region or more regions. Similarly, in Greece, local is defined as cultivated 
and seed produced in the region of origin. Local is defined in Czechia in relation to 
conservation varieties only as a set of populations or clones of a plant species that are 
naturally adapted to the environmental conditions in their area. A slightly different 
approach is taken in Germany where specific decisions are made dependent on 
applicants’ claims at the time of application.  For example, wheat varieties that secure 
timely, productive harvest in the South are genetically more daylength insensitive 
than those in the North. Varieties adapted to either region perform poorly in the other. 
The federal authorities add both types to the national catalogue. (This distinction can 
also apply for commercial varieties and exists in other countries such as France). 
Views on the degree to which the region of origin concept is a constraint on the 
market differed. However, it does – by design – have a constraining influence on the 
geographic breadth of conservation variety use. Five stakeholders interviewed (2 civil 
society organisations, 2 representative associations and 1 NCA) indicated that 
restricting marketing of conservation varieties to their region of origin hinders their 
commercialisation in other regions with similar climatic conditions – something they 
considered would become more important with climate change.  

A5.6.2 

Impacts  

Baseline assessment 

The Common Catalogue database which contains records for conservation varieties included 
375 conservation varieties of agricultural species, 161 conservation varieties of vegetable 
species and 613 vegetable amateur varieties across 30 European countries (including 
Switzerland, Iceland, and Norway)54. At EU level, the number of varieties has been stable over 
the last five years, although there are some indications of an increases in some Member States 
(EC et al. 2021; interviews with a representative association and NCA).  

There is no data available on production levels. Survey responses indicate that a variety of 
different organisation may be involved in the production and/or marketing of conservation and 
amateur varieties55, but that these are typically small/niche operators. A majority of business 
associations surveyed (11 of 19) reported that their members produced or marketed 
conservation varieties, as did 4 of the 6 NGOs surveyed. For organisations involved in marketing 
of such varieties, marketing of conservation varieties represented 1-20% of annual turnover in 
most cases (15 of 23 surveyed individual businesses, business associations and NGOs) 
although one breeder cited 61-80% and one local organisation 81-100% of turnover.  

At least half of Member States apply the derogations provided by Directives 2008/62/EC and 
2009/145/EC.56  EU legislation is in place that could potentially support conservation and 
amateur varieties.  For example, Rural Development Programmes with a specific focus on the 
EAFRD (European agricultural fund for rural development) priorities of supporting the shift 
towards a climate resilient economy in the agriculture, food and forestry sectors; and restoring, 
preserving and enhancing ecosystems related to agriculture and forestry. European Climate Law 
requires relevant Union institutions and the Member States to ‘ensure continuous progress in 
enhancing adaptive capacity, strengthening resilience and reducing vulnerability to climate 
change’. Under Article 5 of this Law, Member States are required to take into account the 

54 Based on the ‘active’ records for conservation varieties in the Commons catalogue as accessed in February 2021 (EC et 
al. 2021) 
55 e.g.  conservation networks, organic breeders, commercial seed companies, national research institutes and local 
authorities 
56 18 out of 28 MS NCAs reported in EC et al. (2021); 15 of 18 NCAs surveyed in this study 

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particular vulnerability of agriculture and food systems and promote nature-based solutions and 
ecosystem-based adaptation. This implies that under the baseline scenario MS would need to 
take action to promote the availability of PRM suitable for current and future climatic conditions. 

However, the factors potentially limiting the market for conservation and amateur varieties, 
namely quantitative limits and link to region of origin, are expected to persist under the baseline. 
As a result, the number of varieties and production levels are expected to follow recent trends 
and remain broadly unchanged. In some Member States with supportive measures in place, it is 
possible that PRM of conservation varieties might increase.    

Fruit and vine conservation varieties57 

There is no comprehensive data available on the number of fruit and vine conservation and 
amateur varieties, nor the level of production. Survey responses suggest that the extent of 
support for fruit and vine conservation varieties is uneven across Member States. Just over half 
of NCAs who responded (7 of 13) said that their national legislation included special provision for 
registration of conservation varieties of fruit plants, and only 4 of 13 NCAs had such provisions 
for vine. NCAs were more likely than all other stakeholder types to believe that national rules 
supported conservation varieties of fruit and vine (8 of 13). For example, one NCA interviewed 
reported that registration of conservation varieties of fruit plants and vines is free of charge in 
their Member State. In contrast 4 of 5 NGOs and 2 of 4 business associations thought there was 
no support. Opinion was divided on whether unmet demand exists for such varieties, with 11 of 
29 (5 of 5 NGOs and 2 of 4 business associations) stating this was the case, whereas 8 of 29 (6 
of 13 NCAs) believed it was not. Most NGOs (4 of 5) thought that this unmet demand was 
satisfied through in-kind exchange or other means outside the commercial market. 

There is general support for the principle of doing more to facilitate the availability on the EU 
market of varieties adapted to local conditions. This was demonstrated by public consultation 
respondents, a majority of whom (160 of 202 companies, 48 of 54 NGOs, and 31 of 54 public 
authorities) thought that PRM rules should facilitate their availability. Although the view was not 
universally held. A relatively high proportion of business association respondents disagreed (23 of 
57).  

A majority of respondents across a range of stakeholders surveyed (49 of 72) thought there was no 
need to provide derogations for variety registration and certification of PRM for new varieties bred 
locally, adapted to local conditions, and intended to be marketed locally. In contrast, all NGOs 
surveyed (6 of 6) thought that there was a need for this type of derogation. This is inconsistent with 
the public consultation findings, where seven out of the ten stakeholder groups thought that such 
derogations should be introduced for locally produced varieties adapted to local agro-ecological 
conditions and intended for local marketing.  The stakeholders most likely to agree were trade 
unions (4 of 4) and environmental organisations (6 of 7). Reasons offered by survey respondents 
for facilitating new locally bred and marketed varieties were high registration costs and 
inappropriate testing regimes (when required), which are a barrier to improving biodiversity, 
adaptation to climate change and enhancing rural development. Arguments against included 
concerns that the inconsistent definitions of “local” could lead to differentiated implementation 
across Member States and new rules were unnecessary because new varieties are already tested 
for local conditions.   

Impacts of removing quantitative limits   

The lighter requirements for registering conservation and amateur varieties may already result in 
incorrect or fraudulent registration of varieties (Spataro and Negri 2013; EC et al. 2021), although 
robust evidence to substantiate or refute this is not available. Four stakeholders interviewed (an 
NCA and 3 representative associations) expressed concern that removing quantitative limits could 
lead to professional operators taking advantage of the lower requirements aimed at conservation 
varieties and distorting the market. Others (5 NCAs) thought that there would be no effect as the 
limits were usually not reached (although this assumes that limits are not constraining market 
activity).   

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The majority of survey respondents said there would be no impact on the investment in production 
(42 of 72) or maintenance (41 of 72) of conservation varieties. This view was held by a majority of 
business associations, businesses and NCAs. In contrast, 9 of 10 academic institutions and NGOs 
thought investment would increase in both production and maintenance. NGOs and academic 
institutions indicated that there would be a positive effect on production costs, diversity and price, 
but no effect on demand or quality. A majority of business associations, individual businesses and 
NCAs did not think there would be any effect on these factors.   

Most NCAs surveyed (10 of 18) thought there would be no impact on overall implementation and 
enforcement costs. A minority (3 of 18) said these would increase and 5 of 18 did not know. 

Given that there may be multiple factors impacting on the scale of the market (as outlined in the 
problem analysis and EC et al. (2021), removal of production limits alone may not have a 
significant effect on the market. EC et al. (2021) provided anecdotal evidence that removal of 
production limits may put amateur and conservation varieties in direct competition with, and give 
them a competitive advantage against, commercial varieties.  

Impact of removing the requirement for linking marketing of conservation varieties to their 
region of origin from the legislation 

Removal of the link between the marketing of conservation varieties and their region of origin would 
aid EU harmonisation as the concept is currently applied differently across Member States. Opinion 
differed across stakeholder groups – business groups (26 of 37) generally considered it important 
to retain the region of origin link, NGOs (6 of 6) considered it unimportant, and academic 
institutions and NCAs held more mixed views.  

However half of those stakeholders interviewed (13 of 26) who thought the region of origin concept 
should be retained explained that this was either because it did not present a problem or because 
its application helped retain genetic distinctness of seeds, which was the original justification for its 
introduction (EC et al. 2021). Some stakeholders made the distinction between ensuring production 
is linked to a region of origin but allowing the marketing of PRM in regions with similar climatic 
conditions. Retaining the link to production within the region of origin could improve desirability of 
the product for consumers, whereas allowing marketing outside the regions of origin could broaden 
the choice of varieties suitable in other regions. Other stakeholders did not make this specific 
distinction. Other arguments in favour of retaining the link include marketing (i.e. price), 
transparency and traceability benefits (EC et al. 2021). A majority of survey respondents (44 of 72) 
believed it was important to maintain the link between conservation varieties and region of origin in 
terms of production. Opinion on the impact of removing the link to region of origin was divided. 
Business associations and businesses generally believed there would be no effect on investment, 
costs of production, price, or diversity, but there may be a negative effect on quality and demand 
(which may be related points). Academic institutions and NGOs generally considered that there 
would be a positive effect on investment, costs of production and price (i.e. they would reduce), 
and diversity and demand, with no effect on quality. 

If removing the link to region of origin facilitates more market activity, this may help to redress 
constraints in genetic variability in restored plant populations (which can in turn limit population 
resilience to climatic and other shocks) (Bocci, 2009; Winge, 2012; Bucharova et al., 2019). It may 
also support adaptation to climate change, recognising that in the face of changing climatic 
conditions many varieties may perform well outside their region of origin (EC et al. 2021).  

A majority of stakeholders (48 of 72) including NCAS, business associations and individual 
businesses said that there would be no impact on overall implementation and enforcement costs. 
No NCAs considered that it would increase costs.  

Fruit and vine conservation varieties58 

The European Commission (2021a) identified that some stakeholders wanted to extend the 
concept of conservation varieties to fruit and vine. Stakeholders surveyed for this study called for 
the possibility to list traditional varieties of fruit and vine cultivars without DUS requirements. The 
study survey asked stakeholders’ opinion on the effects of introducing derogations which would 
allow for reduced DUS requirements for the registration of conservation varieties of fruit plants and 

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vines. The greatest consensus in opinion was the positive impacts of such derogations on the 
diversity and conservation and sustainable use of plant genetic resources (15 of 29 and 13 of 29 
respectively). This is consistent with the views of 5 interviewees (3 NCAs, a scientific network and 
a civil society organisation) who indicated that derogations for fruit and vine conservation varieties 
would lead to more varieties being registered and available to growers, leading to increasing 
awareness of such varieties which would promote their conservation. 

There was a wide range of views on the effects of the derogation across all stakeholders surveyed, 
with higher proportions considering there would be no impact of proposed derogation on the 
investment, quantity, quality, freedom from plant pests of fruit and vine conservation varieties, 
although some respondents (across all stakeholder groups) stated positive and negative effects of 
these categories.  The evidence suggests that fraud is of some concern, with an almost equal 
number of respondents who thought there would be an increase in fraudulent PRM and no impact 
from Introducing derogations for fruit and vine conservation varieties.    

Impact of less stringent variety registration requirements 

There is a general view that even under lighter rules, PRM of conservation varieties should be 
subject to certain quality requirements. This is confirmed by a majority of stakeholders surveyed 
who indicated it was important that such PRM is tested to ensure basic requirements in relation to 
defects, vigour and dimensions, germination, varietal identity and purity and substantial freedom 
from plant pests. However, NGOs held the opposite view, considering basic requirement to be 
unimportant.  Some interviewees (3 NCAs and 3 representative associations) were concerned 
about the negative impact of lighter rules on phytosanitary risk and varietal purity. It is notable that 
several sources (reported in EC et al. 2021) indicate that quality is often already an issue, although 
this may be primarily due to weaknesses in control and enforcement. 

A majority of NCA survey respondents (17 of 28) in EC et al. (2021) indicated that the registration 
fees for both conservation and amateur varieties are lower than for conventional varieties (e.g. 
Estonia, Lithuania, Norway, Czechia, Ireland), or even free of costs (e.g. Italy, Estonia, Cyprus, 
Bulgaria, Hungary, Denmark, Finland). Although in some Member States the registration fees for 
conventional, conservation and amateur varieties are the same (e.g. Slovenia). Production and 
marketing costs of conservation and amateur varieties are generally higher than for conventional 
varieties highlighting the labour intensity and particularly expertise required to cultivate and 
produce native seeds used in preservation mixtures, which are considered to be a factor in limiting 
the supply of conservation varieties (EC et al. 2021).  

Opinion was divided to some extent on the effects of conservation and amateur varieties being 
subject to lighter rules. EC et al. (2021) presented mixed views on whether lighter registration 
procedures could lead to an increase in conservation varieties. Several stakeholders interviewed (2 
representative associations, 2 civil society organisations, 2 NCAs and 2 scientific networks) for the 
current study believed that lighter rules would facilitate market access and lead to an increase in 
the amount of PRM of conservation varieties produced.  A majority of stakeholders surveyed 
generally considered that there would be no impact on demand and that the price and cost of 
production of conservation varieties would decrease (for amateur varieties a majority of survey 
respondents thought there would be no impact).   Academic institutions and NGOs surveyed 
generally thought there would be an increase in investment and diversity, but that there would be 
no effect on quality. In contrast, business associations and individual businesses said that the 
quality of conservation varieties would decrease and diversity remain the same. Most NCAs (8 of 
18) thought there would be no impact on overall implementation and enforcement costs: 1 said 
costs would decrease and 3 estimated an increase in costs. 

A5.7 

C.2 Creating a voluntary coordination group for 

collaborative production, pooling and exchange of FRM  

This study question assesses the problems currently experienced by Member States to 
ensure the supply of appropriate FRM and potential impacts of legislative changes that 
could address these problems. 

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Ref.  Study question 

O1   O2  O3  Measure 

C.2  What are the expected 

 

economic impacts, including in 
terms of administrative 
burdens, for competent 
authorities and operators, 
social impacts for citizens and 
environmental impacts of 
measures to address 
difficulties in supply of FRM in 
case of extreme weather and 
disasters? The contractor shall 
collect information on current 
practices in Member States in 
relation to supply difficulties 
of FRM.  
A5.7.1 

Problem statement  

[same as baseline] Make use of existing 
empowerments to authorise Member States to 
use FRM not fulfilling all requirements 

 

M15.1  
[option 1] 

Maintain the existing derogation 

Introduce principle of contingency planning 

 

M15.2  Maintain the existing derogation [option 
1] 

Lay down detailed rules on contingency 
planning to ensure availability of FRM 

Climate change is likely to impact forests is several ways. Firstly, changes in climate 
will shift current vegetation zones further north and/or to higher elevations, meaning 
that species may no longer be suitable for their current planting locations (EC 2021d). 
Secondly, the effects of climate change have meant that extreme weather and 
disaster events (including e.g. forest fires, pests, windstorms) are increasing in Europe 
and creating challenges for the survival and supply of FRM (EC 2021d). At the same 
time, climate change has also made forests more vulnerable to these events (Forzieri 
et al. 2020 in EC 2021d). Almost all FRM stakeholders interviewed for this study 
highlighted this as a significant problem. Specific examples mentioned include damage 
caused by ice in Slovenia in 2014, severe storms in Sweden in 2005 and 2007, and 
dry and hot weather in Germany in 2018. These issues are likely to increase and alter 
the demand for FRM, as well as contribute to disruptions to supply.  

Stakeholders in interviews (5 of 13) and the FRM-focus group explained, however, 
that supply issues do not only occur following extreme weather and disasters. Rather, 
there is a more general problem with supply appropriately matching demand for FRM 
and interviewees also provided examples of severe shortages that were not related to 
extreme weather or disaster events (a shortage of improved spruce seeds in Finland, a 
shortage of Pinus Radiata in Spain). The impacts of this more general problem are 
exacerbated when extreme weather or disaster events lead to an increase in demand. 
When supply of FRM cannot appropriately match demand, this can mean that 
afforestation or reforestation is impossible or delayed or that lower FRM categories 
(e.g. source identified instead of selected) or FRM from maladapted sources is used. 
Under certain circumstances, there may be a need to import material from third 
countries. 

This situation is not the same across all Member States. Member States differ 
significantly not only in climate and climate-associated challenges, but also in the 
structure of the forestry industry, as well as the structure of the forest nursery 
industry. For example, in Eastern European countries, there is more public ownership 
of forest area, whereas in Western European countries private ownership is more 
prevalent (Forest Europe 2020). In Member States where forests are largely state-
owned, the forest nursery industry tends to be less significant. One interviewee also 
described how in Northern Europe many of the forestry companies have their own 
seed sources and nurseries, while in many countries in Western Europe there is a 
greater dependence on private nurseries, and consequently also greater problems with 
supply. This was discussed explicitly in the FRM-focus group and was also evident in 
the different ways interviewees described the problems faced. Some Member States 
are largely self-sufficient in the supply of FRM (as reported by interviewees from 

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Finland, Bulgaria and Slovenia) and some have not yet experienced any events that 
have led to shortages (as reported by an interviewee from Bulgaria).  

Where Member States are experiencing problems in supply, several interviewees (6 
out of 13 from across stakeholder groups, largely from Western/Central and Southern 
Europe) and participants in the FRM-focus group indicated that this was due in part to 
a lack of planning and communication across the supply chain. Because timelines in 
forestry are inherently long, supply cannot immediately meet an increase in demand, 
meaning that longer-term planning is needed to determine what FRM will be needed. 
One expert interviewed explained that where FRM is supplied largely by a private 
forest nursery sector, it is not economical for nurseries to stock seeds they believe 
they might not be able to sell. As such they are not willing to stock excess FRM that 
might be needed to meet unexpected increases in demand. Another interviewee 
explained that private nurseries are often not able to respond quickly enough to 
changes in demand and may also be prevented from accessing supply needed because 
of national restrictions on using FRM from other Member States.  

There are also challenges in harvesting seed compared to the agricultural sector, and 
according to some interviewees, the sector can struggle to find the labour and 
capacity required to harvest certain species and of certain provenances. Even where 
seeds are harvested and available, there is also sometimes a problem with 
communicating that availability to users of FRM. Some survey respondents (10 of 25) 
indicated that information on the volume of FRM available for marketing in cases of 
difficulties in supply is not accessible. In general, stakeholders who had experienced 
these issues characterised the problem as complex and involving actors from across 
the supply chain.  

A5.7.2 

Impacts  

Baseline assessment 

The majority of survey respondents (22 of 25) indicated that they believe demand 
for FRM is likely to increase over the next 20 years due to climate change. A 
majority (17 of 25) also indicated that the available supply of FRM is likely to either 
stay the same or decrease over the same time period. In the context of interviews 
and the FRM-focus group, a majority of stakeholders (12 of 13) also indicated that 
extreme weather and disaster events are increasingly likely to occur. This suggests 
that problems with the supply and availability of FRM are likely to get worse.   

  Problems with supply can lead to use of less appropriate FRM. The majority of 
survey respondents (17 of 25) indicated that this was a likely outcome of 
insufficient supply. Participants in the FRM-focus group felt that this outcome 
would lead to significant negative impacts such as a decrease in production 
or, in some cases, no production at all. Around half of survey respondents 
(12 of 25) felt that a complete failure of production and a need to replant 
FRM was likely where lower quality FRM is used. One interviewee described 
how problems with supply in Finland had led to a 10 to 25% decrease in 
growth, poorer adaptation and a reduction in quality.  

  Another potential impact of supply uncertainties is the increased need to 

import FRM from third countries. More than half of survey respondents (14 of 
25) indicated that insufficient supply would likely result in a need to import 
FRM from third countries. Interviewees described the current process for this 
as complex and difficult, typically taking several years. However, interviewees 
who described the current process as difficult did not make use of the OECD 
Scheme for the Certification of Forest Reproductive Material,59 which provides 

59 For further details, see: https://www.oecd.org/agriculture/forest/  

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certification similar to that provided by the Directive and facilitates trade 
between EU Member States and third countries.   

  Supply issues can result in delayed FRM planting, which can contribute to a 
loss of forest growth. According to one survey respondent, this delay does 
not have a significant negative impact in the context of the overall lifespan of 
planted trees. 

Participants in the FRM-focus group and two interviewees explained that because of 
the long life-cycle of trees, impacts of delayed planting are often not immediately 
visible. It may take several years or even a decade to see the losses in 
performance. Such losses in performance then result in economic losses for users of 
FRM (17 of 25 survey respondents indicated this was likely) and negative impacts on 
the environment.   
Interviews indicated that efforts are being made in some Member States to improve 
contingency planning (e.g. in Spain, Slovenia), but there is not enough evidence to 
determine how widespread this is. Only a minority of Member States appear to have 
contingency plans in place (of the respondents to the targeted survey and 
interviews, only those from Finland and Sweden indicated that their Member State 
had a contingency plan). Some Member States may store seeds as a contingency 
measure (e.g. the Bulgarian NCA described the use of gene bank stores) but without 
a formal contingency plan. Contingency planning in Finland was described by the 
interviewee as follows:  

There have been seed orchard programmes in Finland since 1960, they are 
currently (2022) preparing a new programme. This includes plans for how 
many seed orchards are needed for each tree species for different parts of 
Finland in 2060. This planning takes into account climate change, an increase 
in damage to trees, biodiversity and the replacement of non-renewable raw 
materials with renewables such as wood. The aim is all nursery seedlings of 
pine, spruce and birch using improved seeds produced in seed orchards. For 
Northern Finland, they use long-term seed storage for contingency planning 
as seed years are rare (with some trees only flowering once in a decade and 
conditions making collection difficult).  

This situation will likely improve even in the absence of EU regulatory intervention, 
due to efforts being made by some Member States, but there will likely remain 
significant differences between Member States. Outside of contingency planning, 
some Member States or other actors (e.g. sector organisations) are developing 
initiatives that could help to address problems of supply (this was mentioned but not 
described in interview), but it is not clear the extent to which these will help to 
address the problem.  

The baseline scenario is likely to result in significant negative economic impacts for 
users of FRM. Significant negative environmental impacts are also expected due to 
reductions in the quality of planted trees and less resilient forests. This means a loss 
of the benefits provided by resilient forests, including support for biodiversity and 
mitigating climate change (EC 2021c).   

In general, almost all stakeholders interviewed (12 of 13) recognised that there is a 
significant problem that needs to be addressed but were either sceptical or unsure of 
how EU-level action could help to address the problem.  

In response to the public consultation, support for policy instruments laying down 
rules on contingency planning (M15.2) differed between stakeholder groups, with 
academics and research institutions offering stronger support (10 of 14 agree or 
somewhat agree) than NCAs (22 of 37 disagree or somewhat disagree). 

NCAs in interview were generally sceptical about the value of principles (M15.1) or 
rules (M15.2) on contingency planning at an EU level. Most interviewees believed that 
work was needed to support better contingency planning, but that this work is best 

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undertaken at Member State level, to account for the specific needs and challenges 
faced by each Member State. For example, as described by the Spanish NCA, although 
they are working toward a contingency plan, they first need to understand how to face 
extreme weather conditions and what materials will be adaptable to those. At present, 
they do not yet have the tools to develop a plan that would make sense considering 
the specific challenges they are facing.  

M15.1 and M15.2 could address some of the current issues related to security of 
supply, particularly related to extreme weather or disaster events. However, as supply 
issues do not only occur in the face of extreme weather or disaster events, this option 
is unlikely to provide a comprehensive solution. Additionally, this measure is likely to 
add significant administrative burden to NCAs responsible for establishing these plans.  

Improving access to import from third countries 

Several stakeholders reported in interviews (5 of 13) that the process for gaining 
approval for the import of FRM from third countries (as described in Article 26.3) 
presents a barrier to importing material that could be useful to address issues with 
supply. These stakeholders requested a simpler and more understandable process for 
importing such material. To some extent, the OECD scheme should help to address 
this by providing certification similar to that provided by the Directive and facilitating 
trade between EU Member States and third countries. However, at present, not all 
countries are members of the OECD scheme.  

Supporting a wider roll-out and increased uptake of the OECD scheme could mitigate 
supply issues in Member States where there is a particular demand for imported FRM 
from third countries. It could reduce the administrative burden for NCAs and 
businesses looking to import from third countries. However two interviewees, without 
being expressly prompted, also expressed concerns regarding the risk of increasing 
the global trade in FRM, suggesting that this could ultimately have a negative impact 
on the resilience of future forests.  

Voluntary coordination group 

The possibility of a voluntary coordination group for collaborative production, pooling 
and exchange of FRM was also discussed with stakeholders. The establishment of such 
a group could occur in the baseline or under any of the options. In the public 
consultation, support for this differed between stakeholder groups. Academics and 
research institutions (10 of 14 agree or somewhat agree) and businesses and business 
associations (22 of 36 agree or somewhat agree) were more likely to indicate support 
than NCAs (16 of 37 agree or somewhat agree).  

This scepticism on the part of NCAs was reflected in discussions with interviewees. 
Three of seven NCAs interviewed felt that good communication is generally already 
established. Three stakeholders interviewed suggested that rather than a newly 
established voluntary coordination group, existing platforms or more targeted 
approaches might be used to serve the same purpose. Two stakeholders interviewed 
indicated that for such a coordination group to work, it would need to involve actors 
from across the supply chain, and that this would be difficult to achieve as a voluntary 
initiative. These stakeholders felt that such a group would be unlikely to achieve its 
goals without this cooperation.  

A minority of survey respondents felt that the establishment of a voluntary 
coordination group would have a negative impact on improving access to the supply of 
FRM (2 of 25 survey respondents), but at the same time very few indicated that it was 
likely to have a significant positive impact (3 of 25).  

The establishment of a voluntary coordination group is unlikely to comprehensively 
address current security of supply challenges in all Member States.  It is likely to 
result in similar impacts as the baseline scenario, with some benefits in certain 
Member States. In addition, the establishment of a voluntary coordination group is 
likely to increase administrative burden for those involved in its development.   

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A5.8 

D.1 Limiting mandatory VCU to the most important 

agricultural species and/or to sustainability criteria 

This study question seeks to assess the economic, social and environmental impacts of 
limiting mandatory VCU testing to only the most important agricultural species and/ or 
to sustainability criteria.  

Ref.  Research question 

O1  O2  O3  Specific measures across the 

D.1  What are the expected 

 



economic impacts, including in 
terms of administrative burdens, 
for competent authorities and 
operators, social impacts and 
environmental impacts of 
limiting mandatory VCU to the 
most important agricultural 
species and/or to sustainability 
criteria? 

options 

[Same as baseline]  Make use of existing 
empowerments to review and harmonise 
VCU rules for agricultural species to better 
address sustainability.  

For other crop groups, rely on information 
provided by breeders (published e.g. in 
marketing documents or national 
recommendation lists). 

  

M18.1 Review and harmonise VCU rules for 
agricultural species to better address 
sustainability. 

For other crop groups introduce general 
principles and rules on “sustainability 
criteria” but give MS flexibility to implement 
and adapt to local agro-ecological 
conditions.  



 

M18.2 Detailed and harmonised 
“sustainability criteria” for all crop groups. 

A5.8.1 

Problem statement  

Currently VCU (Value for Cultivation and Use) testing is required for most agricultural 
crop varieties, mandating operators to show that the varieties provide improved value 
for cultivation and use. VCU testing is one of the prerequisites for registering certain 
varieties to be accepted for certification and marketing. It is mandatory (“official 
examinations”) according to article 7 of Directives 2002/53/EC and 2002/55/EC. These 
tests are generally carried out by examination offices of national competent 
authorities.  

Current VCU testing requirements and the mandatory nature of testing for certain crop 
varieties is resulting in high costs and high administrative burdens for both NCAs and 
operators (EC et al 2021). The VCU testing costs in each Member State depend on 
different factors including the complexity of the tests as well as the variety but can 
reach several thousands of euros (Table 31) (Pedersen, 2012 and EC et al 2021). In 
2010 VCU testing for all crops across all Member States cost between EUR 30.25 
million and EUR 33 million (EC 2013b). In addition to the costs, there are also various 
criteria applied for VCU testing across the EU, to account for regional specificities in 
climate, creating fragmentation in the internal market which can place a 
disproportionate burden on operators in some Member States.  Without a change in 
the regulatory environment the number and type of species undergoing VCU testing 
are unlikely to decrease.  

The prosperity of agriculture has always been tied to the weather. Now, in a changing 
climate, adaptation to weather extremes is more important than ever for protection of 
food security and livelihoods. Climate change is impacting yields, pest prevalence and 
pest geographical distribution (EC et al 2021). It is forecast that European crop 
production will shift northwards, potentially meaning a reduction in production in the 

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Mediterranean region. The northwards shift could include major crop groups such as 
cereal, pea, canola, soybean and sunflower (Hampton et al., 2016). Therefore, it is 
likely there will be shifts in market demand for new varieties that are resilient and 
suitable for the changing conditions across the EU. The EU PRM market needs to be 
prepared for and support this shift.  

The current PRM legislation, including legislation on VCU testing, is considered out-
dated in relation to new environment and climate change policies and international 
agreements. (e.g. the UN SDGs). Results from the public consultation found that 61% 
(423 of 698) of respondents agreed or somewhat agreed that the PRM legislation 
should contain a set of general sustainability criteria which can be implemented by 
Member States. Results from interviews further display the need for further 
encouragement towards sustainable PRM as many NCAs stated that their Member 
States already considered sustainability through breeding and VCU testing. In order to 
maintain a level playing field in terms of resilience across Europe and maximise 
environmental benefits it is important that the PRM legislation reflects this. 

A5.8.2 

Impacts  

Baseline assessment  

Currently most agricultural varieties must undergo VCU testing to become a 
registered variety. VCU testing is seen by various stakeholder groups as an 
independent quality assurance test associated with reliable, high-quality varieties. 
The quality assurance and unbiased information provided by these tests allows for a 
level playing field as it helps to balance the market power between large operators 
and SMEs (EC 2013b). The costs, structure and characteristics of VCU tests differ 
between Member States. In the case where there is no EU policy change, 
interviewees indicated that it is likely that Member States will become more 
specialised in their VCU testing so availability of testing of each variety may be 
reduced across some Member States as testing can be outsourced to other Member 
States.  

The survey results suggested a range of species for which VCU testing could become 
voluntary. The most commonly suggested species was Solanum tuberosum (n=9) 
followed by Triticosecale (n=2). These were proposed by a wide range of 
stakeholders. Other suggestions (n=1 for each of the following) included Zea mays, 
Helianthus, Brassica napus, Raphanus sativus, Sinapis alba, Phacelia tanacetifolia, 
turf grasses (such as Lolium pereene), Biserrula pelecinus, Lathyrus cicerollsa, 
Medicago doliata, Plantago lanceolata and Brassica rapa var. silvestris.  

Some Member States already consider sustainable characteristics during breeding 
and VCU testing. Evidence of this comes from interview data from representative 
associations and NCAs from Belgium, France, Denmark, Germany, Poland, Sweden, 
Estonia, Poland, Netherlands, Italy and Greece. This is unlikely to be an exhaustive 
list. If there was no change in policy, it is likely that these Member States would 
continue their demand driven approach and encourage other Member States to do 
the same. This could create an uneven playing field across the EU as tests for these 
characteristics are not formalised. It was expressed by one representative 
association that standardising protocols for this type of testing would be beneficial. 

Under the baseline scenario current European environmental commitments such as 
the European Green Deal, the Farm to Fork and Biodiversity strategies as well as 
global climate agreements such as the Paris agreement and the Sustainable 
Development Goals provide some pressure to increase the resilience and 
sustainability of PRM. In particular objectives of the Farm to Fork strategy around 
reducing the use of pesticides and fertilisers creates a need for PRM which can 
produce strong yields in low input systems. The European Green Deal goal to 

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“ensure food security in the face of climate change and biodiversity loss” pushes for 
more resilient varieties which can both withstand more extreme changing climates 
and also support local biodiversity. VCU testing is an excellent method for delivering 
this as it ensures progress against previous generations of varieties. The pressure 
from these agreements means that there is less of a need to strengthen 
VCU/sustainability assessments. However, these agreements need strong backing 
from government policies otherwise progress will not be maximised. Therefore, 
there is still a need to strengthen the sustainability aspects of VCU testing. 

Pressure from the market to see more varieties with sustainability characteristics, 
although present and in some cases strong, is not uniform across the EU. Therefore, 
reliance only on this market pressure to produce sustainable resilient varieties is 
likely to lead to a scenario where the range of varieties available do not cover all 
resilience needs in terms of pests and climate in all Member States. This could leave 
the EU open to food insecurity and declining agricultural livelihoods. Therefore, 
although market pressure is positive it should not be relied upon to create resilient 
varieties across the EU.  

In addition, under the baseline scenario, existing empowerments such as article 7 of 
Directive 2002/53 on the common catalogue of varieties of agricultural plant species 
can be used to further elaborate the criteria for VCU testing to better cover 
sustainability aspects, while leaving flexibility for Member States to decide whether 
and how to implement them.  

Limiting mandatory VCU to the most important agricultural species and/or 
sustainability criteria may result in a reduction of the number of tests carried out and 
is expected to reduce associated costs according to business and NCA respondents in 
the targeted survey. Cost savings could redirect capital into breeding programmes, 
marketing or internal certification (Winge, 2012). Cost savings are likely to be more 
significant for businesses than NCAs as a number of NCAs operate a cost recovery 
system meaning that they do not take on any of the cost burden (EC et al 2021). A 
reduction in tests could result in a reduction in employment in VCU testing however 
this would depend on whether operators still chose to voluntarily VCU test their 
varieties. Using current empowerments  would ensure continuity in NCAs overseeing 
VCU testing. NGOs, consumer organisations and environmental organisations could 
benefit from an increase in diversity and increase in the number of varieties available 
with sustainability characteristics. 

In terms of social impacts, particularly employment, there are approximately 700 
employees working on VCU evaluations across the EU (EC 2013b). Some of these jobs 
may be at risk if the number of VCU tests are reduced. However, if sustainability 
criteria are added to the test this is likely to increase employment as new specialists 
would be needed to create and conduct the testing. 

In relation to reducing the list of varieties which undergo mandatory VCU testing, the 
majority (59%, 330 of 561 (excluding those who gave no opinion)) of public 
consultation respondents agreed or somewhat agreed that “there should be no 
mandatory VCU testing as the variety characteristics should be driven by market 
demand” (Q10a). The figure below shows the breakdown of responses by stakeholder 
type: 

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  Responses to Question 10a 

Figure 3 shows that across all stakeholder groups there are mixed views on whether mandatory 
VCU testing should be removed and market forces allowed to drive the market. Academics/ 
research institutions, company/business organisations and business associations are all fairly 
strong in their agreement with the statement, perhaps due to the increase in innovation and 
reduced costs that removing VCU testing could bring about. Public authorities, although split in 
their judgement, have more respondents that disagree, perhaps because this could mean less 
market control and less certainty about the quality of agricultural PRM produced.   

However, the views in the public consultation were not always supported by interviewees as 
they felt that plant variety rights for operators and the transparency that VCU testing results 
offer to consumers are significant enough that testing should not be reduced. The view from the 
public consultation was also not supported by survey respondents where 51% (32 of 63) 
indicated that there were no species for which VCU testing should be voluntary.   

Market expansion due to the increase in number of varieties available as a result of decreased 
testing for some varieties could be positive for food security as a wider range of varieties are 
available to farmers. However reduced VCU testing could be detrimental to food security as 
farmers currently rely on VCU testing as a mark of quality (EC 2013b). Reduced testing could 
therefore make it more difficult for producers to identify quality varieties and creates the risk of 
more reliance on a small number of tested species. This is also true for the addition of 
sustainability criteria as more resilient varieties that have specific characteristics for climate 
change adaptation are likely to ensure a stronger supply of food in the future. Interviewees 
highlighted the importance of VCU in terms of ensuring food security, particularly in response to 
climate change. 

Two interviewees felt that limiting VCU to the most economically important species could prove 
detrimental. The diverse EU seed sector has many farmers and plant breeders focusing on 
minor crops which are sold both domestically and globally. Eliminating VCU testing for these 
crops could compromise quality and affect the credibility of EU farmers and breeders on the 
international market.  

While VCU testing costs for businesses could increase as a result of adding sustainability 
criteria, the flexibility in implementation for NCAs (compared to having detailed rules) can 
support operators in managing their cost burdens (M18.1). At the same time, flexibility in terms 
of implementation may contribute to sustaining current internal market fragmentation in VCU 
testing practices and thereby limiting benefits for operators who trade across borders. 
Interviewees noted that the largest changes to VCU testing fees are likely to be seen where 
Member States do not already offer sustainable characteristic testing and tests need to be 
expanded. In these Member States there may also be an increase in employment for NCAs to 
ensure that there is sufficient resource to fulfil the increased requirements of the test. The 
increased cost impact would be a particular disadvantage for SMEs and therefore could reduce 
competition in the sector. The net impact on sustainability and climate targets is likely to be 
lower than in a regulation-led initiative extending VCU testing to include sustainability criteria.  

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When discussing a scenario where VCU testing requirements were reduced to only sustainability 
criteria some interviewees felt that all currently used VCU testing criteria are related to 
sustainability already. They felt that aspects such as yield contributed towards healthy and 
diverse ecosystems as well as food security and sustainable livelihoods. Many interviewees, 
particularly NCAs found that market demand for more resilient climate adapted varieties has 
been strong enough to push breeders to produce varieties with a more sustainable focus. 
Therefore, many of them feel that little more needs to be done in the legislation than perhaps 
adding more broad criteria such as testing under low input conditions to the current list of 4 
testing categories.  

Measure 18.1 is likely to give the most environmental benefits per Member State as they are 
able to focus their investment where it is needed to tackle local agro-ecological issues. This was 
supported by a number of interviewees who emphasised that sustainability criteria are already 
implemented in VCU testing in many Member States and that it is highly advantageous to allow 
flexibility in the sustainability criteria used.  

It is likely that demand may increase for research related to sustainability testing under M18.1 
and 18.2 as well as research on use of innovative technologies and plant breeding techniques 
according to two interviewees (one civil society organisation and one NCA).  

It has been suggested in a significant number of interviews that fully harmonised ‘sustainable 
VCU’ criteria (M18.2) would be an inefficient system due to the large variations in climate across 
the EU. This approach would not maximise environmental benefits or food security. Market 
forces would need to be relied upon to push for characteristics which are beneficial to specific 
Member State climates but have not been specified at the EU level.  

The impact on cost, employment and administrative burdens for businesses under M18.2 would 
be similar as for measure 18.1 but could be even higher as all Member States would have to 
change and enforce new legislation even if they were already implementing sustainability 
testing. This may negatively impact SMEs as they would have to absorb these cost increases. 
There were very split views from the public consultation about whether VCU testing should be 
extended to include sustainability characteristics of varieties: 26% agreed with this and 26% 
disagreed with this. A further 32% somewhat agreed with the suggestion highlighting that the 
sustainability of varieties is an important factor but that full harmonised extension of VCU 
testing is not required. 

The further definition of sustainability criteria within the existing policy framework is likely to 
increase research into sustainable characteristics and reliable tests for these. It is also likely to 
inspire use of more innovative technologies and plant breeding techniques. This measure is 
likely to bring about the same impacts as measure 18.1 in terms of increased demand for 
research on varieties with sustainability characteristics and corresponding tests.  

NGOs, consumer organisations and environmental organisations are unlikely to be directly 
impacted by measure 18.1 regarding the quality or variety of PRM products on the market. The 
results of the survey align with this as none of the 21 respondents indicated that there would be 
a change in quality as a result of voluntary VCU testing for some varieties. They may be 
affected by changes in price for some varieties, if some breeders pass down cost increases to 
consumers. 

A5.9 

D.2 Harmonising VCU testing requirements, introducing 

sustainability criteria into VCU-testing and obliging competent 
authorities to offer VCU adapted to the needs of organic 
agriculture 

This question seeks to assess the economic, social and environmental impacts of harmonising 
VCU testing requirements, introducing sustainability criteria into VCU testing and of obliging 
competent authorities to offer VCU adapted to the needs of organic agriculture. This section also 
examines how such harmonisation will be implemented to ensure the availability of varieties 
supporting a more sustainable agri-food production. 

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Ref.  Research question  O1  O2  O3  Specific measures across the options 

D.2  What are the 

 



expected economic 
impacts, including in 
terms of 
administrative 
burdens, for 
competent 
authorities and 
operators, social 
impacts and 
environmental 
impacts of 
harmonising 
requirements for 
VCU testing, of 
introducing 
mandatory 
sustainability criteria 
into VCU-testing and 
of obliging 
competent 
authorities to offer 
VCU adapted to the 
needs of organic 
agriculture? 

[Same as baseline] Make use of existing 
empowerments to review and harmonise VCU rules for 
agricultural species to better address sustainability.  

For other crop groups, rely on information provided by 
breeders (published e.g. in marketing documents or 
national recommendation lists). 

  

M18.1 Review and harmonise VCU rules for 
agricultural species to better address sustainability. 

For other crop groups introduce general principles and 
rules on “sustainability criteria” but give MS flexibility 
to implement and adapt to local agro-ecological 
conditions.  



 

M18.2 Detailed and harmonised “sustainability criteria” 
for all crop groups. 

 





[Same as baseline] Do not take any actions on organic 
varieties in PRM legislation, but refer to Organic 
Regulation. 

 

Rely on Organic Regulation and the temporary DUS 
derogations and general principles for VCU testing (if 
adopted). 

M8.1 Refer to Organic Regulation by defining variety 
registration requirements (permanent DUS 
derogations & principles for VCU testing) for organic 
varieties. 

Retain the flexibility for Member States to adapt VCU 
to local agro-ecological conditions.  



 M8.2 Refer to Organic Regulation by defining 
harmonised variety registration requirements 
(permanent DUS derogations and dedicated VCU 
provisions). 

A5.9.1 

Problem statement  

Currently all Member States must conduct VCU testing as part of variety registration 
for most agricultural crops. VCU testing does not require specific sustainability criteria 
such as resilience to climate change or resource efficiency. However, some Member 
States have independently added sustainability criteria as an element of their VCU 
testing protocol. This may increase the price of VCU tests in some Member States 
which is passed down to the buyers of PRM products but can also provide competitive 
advantages to breeders by providing assurance of greater climate resilience. The 
differences in VCU testing procedures, costs and corresponding impacts causes 
fragmentation of the internal market and disadvantages stakeholders in some Member 
States.  

VCU and DUS testing for variety registration is not always suitable for and has not 
been adapted to the needs of organic agriculture, particularly in relation to uniformity 
requirements [D5] (IFOAM Organics International, 2020). DUS testing is based on the 
principles of distinctness, uniformity and stability which are relevant for conventional 
agriculture (Liveseed, 2021b). However, organic varieties suitable for organic 
production are often not bred to be uniform enough to pass these tests. Therefore, 
organic seeds can be disadvantaged by DUS testing (Liveseed, 2021b). Not all 
Member States offer a VCU test which is adapted to organic conditions or have 

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appropriate thresholds for organic characteristics (in which the new seeds are 
compared to other organically farmed seeds and not those of conventional farming) 
(EC et al 2021). Organic varieties suitable for organic production have been noted to 
perform differently under conventional testing as their yields may be different while 
their resistance to seed borne diseases or weed competition is not assessed (Liveseed 
2021b). Germany is one example where an organic adapted VCU is offered for rye, 
oats, barley, wheat and triticale (NCA interview). This same NCA cautioned against 
establishing mandatory organic adapted VCU testing due to concerns about finding 
suitable trial sites for some species due to low demand. One solution to this could be 
the use of a bilateral agreement between MS which could implement centralised 
testing and reduce the burden on NCAs particularly where demand for organic 
varieties is low in their MS. 

The PRM legislation is made up of 12 Directives meaning that under Article 288 of the 
Treaty on the Functioning of the European Union (formerly Article 249 TEC) Member 
States are free to implement the legislation as they see fit in order to achieve the 
prescribed result. Subsequently there have been increasing differences in the ways in 
which the legislation is applied across the Member States. One example of 
discrepancies is the method for which varieties are accepted or rejected. A number of 
Member States use single key characteristics (particularly for species where the yield 
increase is not very high) to assess VCU results (EC et al 2021). However, other 
Member States use an index weighting approach across multiple criteria. Some 
Member States use both approaches.  

Similarly, there can be differences in the length of the testing process between 
Member States, which can take one- five years depending on the specific species and 
Member State (EC et al. 2021). One example of this is the variance in testing length 
for winter wheat which is 2 years in Estonia, France and Latvia but 3 years in Germany 
and Norway (Pedersen, 2012). This can be disadvantageous for organisation testing in 
countries with longer testing periods as there is a delay to market access. Where 
testing is faster, there is potential for innovation to be taken advantage of and better 
varieties can be utilised for their desirable qualities more rapidly. Survey responses 
indicated that the longer duration of testing needed for a specific variety being 
compared across Member States was a minor (13 out of 27, 48%) or moderate 
problem (11 out of 27, 41%). It was found in a previous PRM study that 36% of 
respondents felt that these differences were a problem and undermined the EU level 
playing field. (When asked more specifically about the issues 57% agreed or strongly 
agreed that the differences in registration/ certification costs and cost recovery 
systems were a problem (EC et al 2021). The table below illustrates some of the 
differences in cost experienced across the EU  

 The cost of VCU testing in some Member States (Pedersen, 2012). 

Member State 

Denmark 

Estonia 

France 

Germany 

Latvia 

Norway 

Cost of VCU testing (excluding 
application and maintenance fees) 
(EUR  per year of testing) 

Between 1,758 and 2,026 (all varieties) 

150 (oats), 190 (triticale), 220 (other 
varieties) 

3,500 (first year), 1,750 (second year of 
winter wheat testing) 

2,900 (winter wheat) 

Between 244 and 258 (spring barley) 

1,201 (all varieties) 

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The inclusion of sustainability criteria within testing is another example of 
discrepancies as some Member States do not include sustainability criteria at all and 
where it is applied its application varies between Member States (EC et al 2021). In 
the previous PRM study 53% of respondents indicated that these discrepancies in 
criteria tested were a problem (EC et al 2021). Results of the targeted survey showed 
that differences in the way Member States apply the testing requirements also creates 
challenges for stakeholders. Differences in time taken for testing, availability of 
sustainability testing requirements and testing fees can create disadvantages, 
particularly for SMEs, as it can vary the costs and stringency of testing between 
Member States. Larger corporations are able to choose where they test their varieties 
as they often operate in multiple markets. This has become more exaggerated in 
recent years as the EU seed market has become more concentrated. Although the EU 
seed sector is made up of a wide range of companies with the make-up of these 
varying between crop sector and Member State, for agricultural crops many of the 
markets are heavily concentrated. For EU maize crops five companies constitute ¾ of 
the market share, and for sugar beet eight companies comprise 99% of the market 
share (EC et al 2021). Where these large corporations choose to run their testing 
could therefore have a large impact on demand for and finances for testing within 
different Member States. A lack of harmonisation creates a reason to choose between 
Member States for testing, other than to test in different climatic environments.    

A5.9.2 

Impacts 

Baseline assessment 

VCU testing is currently applied differently across Member States. Each VCU test 
must include yield, quality, disease resistance and behaviour with respect to 
physical factors in the environment as stated in Commission Directive 2003/90/EC 
Annex III. However, there are national definitions for the thresholds and specific 
characteristics tested (EC 2013b). There is also large variation in the costs of testing 
and differing cost systems as some Members States use full cost recovery for NCAs 
(EC 2013b). 

Due to their different implementation and structure, the cost of VCU testing and 
recovery rates can vary considerably across Member States. For example, 
conventional VCU testing of winter wheat in 2020 cost EUR 4652 in Denmark, EUR 
3530 in Sweden and EUR 1424.80 in Austria (EC et al 2021)60. With no EU 
legislative changes to VCU testing this variance is likely to increase as different 
Member States implement different criteria, related to sustainability or organic 
varieties. This could disadvantage some operators as it would be difficult to maintain 
a level playing field across the EU. In addition, without amending the legislation, the 
possibility to move more technical requirements to the implementing measures and 
increase the flexibility of the legislation would be lost.   

The below table summarises data from the survey and interviews which indicates 
criteria used by some Member States to incorporate sustainability into their VCU 
tests. It should be noted that there are varying levels of detail as this was an open 
question response, and hence it is unlikely that the details provided are exhaustive 
list of criteria tested.  

 Criteria used in sustainability testing across some Member States 
(data from NCA survey responses) 

60 Data extracted from the NCA Survey Raw Data.  

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Member State  Species referred to 

Characteristics tested 

Austria 

Winter wheat 

Belgium 

All VCU tested species 

Czechia 

All VCU tested species 

Denmark 

All VCU tested species 

Finland 

All VCU tested species 

Standing ability, preharvest sprouting, 
9 diseases, grain yield, nitrogen 
efficiency, various grain and baking 
quality characteristics.  

Disease tolerances (bacteria, fungi and 
viruses) and response to low input 
conditions.      

Resistance to biotic and abiotic 
stresses, adaptation to different agro-
climatic conditions, response to the 
different intensity of treatment (doses 
of nitrogen, fungicide levels etc.).    

Competition towards weeds, pest 
resistance, response to low input 
conditions, yield (more for less input).   

Resistance/susceptibility to certain 
diseases, yield in different growing 
conditions, lodging, winter hardiness, 
growth time.   

France 

All VCU tested species 
and then examples for 
grain cereals, potatoes, 
oilseed rape, wheat and 
triticale. 

General criteria: tolerance or 
resistance to harmful organisms, 
reduction of inputs, carbon storage, 
reduction of fossil energy, reduction of 
water consumption.   

Grain cereals: Lodging resistance and 
fungal diseases.  

Potato: downy mildew evaluation 

Oilseed rape/ wheat/ triticale: nitrogen 
dependency. 

Germany 

All VCU tested species 
and then examples for 
beet, potato and wheat. 

Reduced fertiliser, resistance to pests 
and diseases, with and without growth 
regulators.  

Beet: nematodes, rhizoctonia 

Potato: wart disease, nematodes 

Wheat: Pseudocercosporella 
herpotrichoides, Drechslera tritici-
repens, yellow mosaic viruses BaYMV-
1, BaYMV-2, BaMMV, soil-borne 
viruses.   

High number of trial sites are used 
covering different agro-climatic 
conditions with different soil types.    

Greece 

Winter cereals  

Tolerance to low temperatures.  

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Netherlands 

All VCU tested species 
and then examples for 
potatoes, cereals. 

All outdoor crops are tested for abiotic 
stress tolerance and disease 
resistance/ tolerances.  

Norway 

Oat, barley and wheat. 

Slovakia 

All VCU tested species 

Potatoes: Disease resistance viruses, 
funges Phytopthora, yield with 
different soil types 

Cereals: Fungus Fusarium, mildew , 
yellow rust, yield with different soil 
types 

Disease resistance and susceptibility, 
winter hardiness and baking quality. 

Disease and pests resistance, winter 
hardiness, frost resistance, lodging, 
nutrition content.    

Sweden 

All VCU tested species 
and then sugar beet as 
an example 

Disease resistance and durability.  

Sugar beet: the sugar yield in relation 
to quantity harvested 

Similar fragmented approaches exist for the VCU testing of organics, as Austria, 
France, Czechia, Denmark, Germany, Latvia and Switzerland already offer organic 
adapted VCU testing or supplementary organic testing within variety registration 
(confirmed through interviews and Liveseed 2019). The targeted survey results 
correspond with this as 33% (6 of 18) Member States confirmed that they offer 
organic adjusted VCU testing. These countries assess traits such as weed 
competition, resistance, nitrogen efficiency and success under low input conditions 
in addition to the usual VCU criteria. Without regulatory changes these internal 
market differences would continue and possibly increase as more countries could 
adapt organic testing with price impacts on operators.  

Below is a summary table showing procedures for organic testing in some Member 
states (survey data). It should be noted that there are varying levels of detail as 
this was an open question response, it is unlikely that the details provided are 
exhaustive of criteria tested.  

 Details of organic testing in some Member States (data from NCA 
survey responses) 

Member State  Details of organic testing 

Austria 

Testing is carried out on organic sites (1 to 3 trials per year). 
Testing includes susceptibility to common bunt and the ability to 
out-compete weeds are tested. Varieties tested include Winter 
wheat, Winter Rye, Winter triticale, Spelt, Spring common 
wheat, Spring oats, Naked oats, Soybean and Potato. 

Czechia  

Testing is carried out on the fields under organic regime, 
modified VCU protocols used.   

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Denmark 

Germany 

Adapted VCU under organic conditions including conditions of 
reduced nitrogen and no chemical treatment. The normal VCU 
traits are tested with a supplement of organic traits e.g. 
competition against weeds.  

The VCU trials are conducted on organic trial sites of the regions 
(Länder). Guidelines concerning measurements and 
observations are the same as for conventional VCU. Where 
applicable a few characteristics/ observations are added. For the 
decision on listing of varieties, the new varieties must show an 
improvement compared to other varieties that were tested 
under organic conditions 

Greece 

Testing under very low-input conditions can be achieved easily 
upon request     

There is some promotion of diversity in recent policy introductions for organic 
varieties suitable for organic production. In 2022 Regulation (EU) 2018/848 came 
into force. It provides for ‘organic varieties suitable for organic production’, that are 
varieties of a high level of genetic and phenotypical diversity. They are however 
subject to the general variety registration rules. DUS testing in particular creates a 
barrier for market entry for organic varieties, as they cannot always meet the 
uniformity requirements. The same Regulation allows for organic heterogeneous 
material, that is characterised by a high level of genetic and phenotypic diversity, is 
not a variety, nor a mixture of varieties61.  The benefits for diversity by the 
introduction of these provisions are limited to organic production, as conventional 
production cannot benefit from similar rules 

This regulation enables the promotion of benefits from organic agriculture such as 
increased biodiversity, decreased pesticide use and decreased use of energy per unit 
of land when compared to conventional farming (Meemken and Qaim, 2018). 

In terms of sustainability, under the baseline scenario current European 
environmental commitments such as the European Green Deal, the Farm to Fork 
and Biodiversity strategies as well as global climate agreements such as the Paris 
agreement and the Sustainable Development Goals provide some pressure to 
increase the resilience and sustainability of PRM. In particular objectives of the Farm 
to Fork strategy around reducing the use of pesticides and fertilisers creates a need 
for PRM which can produce strong yields in low input systems. The European Green 
Deal goal to “ensure food security in the face of climate change and biodiversity 
loss” pushes for more resilient varieties which can both withstand more extreme 
changing climates and also support local biodiversity. VCU testing is a method for 
delivering this as it ensures progress against previous generations of varieties. 
These agreements need strong backing from government policies otherwise 
progress will not be maximised. The environmental agreements and targets 
themselves do not create progress without actions through governments. Therefore, 
there is still a need to strengthen the sustainability aspects of VCU testing. 

Pressure from the market to see more varieties with sustainability characteristics, 
although present and in some cases strong, is not uniform across the EU. Therefore, 
reliance only on this market pressure to produce sustainable resilient varieties is 
likely to lead to a scenario where the range of varieties available do not cover all 
resilience needs in terms of pests and climate in all Member States. This could leave 
the EU open to food insecurity and declining agricultural livelihoods. Therefore, 

61 Detailed rules on organic heterogeneous material are set out by Commission Delegated Regulation (EU) 2021/1189 

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although market pressure is positive cannot be relied upon to create resilient 
varieties across the EU.  

In addition, under the baseline scenario, existing empowerments such as article 7 of 
Directive 2002/53 on the common catalogue of varieties of agricultural plant species 
can be used to further elaborate the criteria for VCU testing to better cover 
sustainability aspects, while leaving flexibility for Member States to decide whether 
and how to implement them.  

Testing for sustainability  

Making use of existing empowerments and relying on NCAs to carry out VCU testing 
based on more closely defined elements of the existing VCU regime could reduce costs 
and administrative burden, particularly for operators active in multiple EU countries. 
When asked whether VCU testing was more expensive in their Member State 
compared to other Member States 16 of 27 indicated that it was a minor problem, 10 
indicated it was a moderate problem and 2 (both international businesses, one of 
which is an SME) suggested it was a major problem. This indicates that differences in 
cost can be a problem, especially when trading or operating across multiple Member 
States.  

Harmonisation could facilitate sharing of best practices and increase co-operation 
between Member State NCAs. Harmonisation of VCU testing protocols could bring 
greater transparency to protocols and the type of data used for decision making by 
Member States (NCA interview). This transparency would allow for a better 
understanding of the conditions under which varieties registered in the national and 
common catalogues are produced and selected (NCA interview). It was suggested that 
the European Commission could find ways to encourage sharing of best practices 
between Member States to improve efficiency and promote progress in the EU as a 
whole (two NCA interviews). 

In terms of the functioning of the internal market, harmonising VCU testing (M18.1 
and M18.2) is likely to support competitiveness if reduced costs and administrative 
burdens become visible in product pricing. 

Introducing general principles on sustainable VCU testing for all crop groups in the EU 
and defining harmonised marketing and VCU requirements for organic varieties 
(M18.1, M8.1) could further support harmonisation of Member State practices and 
provide clarifications for both operators and NCAs. Flexibility provided to Member 
States to be able to adapt their VCU testing practices to local agro-ecological 
conditions could support climate specific approaches and reflect the sustainability 
challenges of specific regions. At the same time maintaining different practices in 
Member State could sustain the current market fragmentation to some extent and 
contribute to cost burdens for operators in the Member States.  

Maximum harmonisation and the introduction of mandatory sustainable VCU criteria 
along with the definition of marketing requirements (M18.2) could increase 
administrative burdens for operators according to survey respondents. This view was 
supported by NCAs. 

It was emphasised by interviewees (1 NCA and 1 representative association) that 
criteria for VCU testing should not be too prescriptive as a one-size-fits all approach is 
not appropriate. One interviewee of a representative association proposed that 
statistical trial designs could be harmonised across the EU. However, they also noted 
that VCU testing cannot be fully harmonised across the EU as climates are very 
different across the Member States and this should be a key consideration in VCU 
testing. Two NCAs explained during interviews that they would like to keep all of these 
elements as Member State competences. They also expressed that they would like to 
see sustainability added as the fifth criteria alongside yield, quality, disease resistance 
and behaviour with respect to physical factors in the environment.  

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Alternatively, one representative association would like to see all of the above 
elements integrated and adapted for sustainability testing. The majority of survey 
respondents agreed with the representative association. Testing requirements 
specifically on sustainability received the most support which to some extent mirrors 
the view of NCAs that sustainability should be part of the criteria for a VCU test. 

Testing adapted for organic varieties suitable for organic production 

Demand for organic materials varies significantly across the EU. Of 14 Member State 
public authorities who responded to the survey question, nine indicated that they had 
not received any applications for organic varieties suitable for organic production in 
the last five years. Of the five that had, the number of applications in the last five 
years ranged from 2 to 30 (mean: 15 applications). In countries with a low demand, 
setting up organic adapted testing is not seen as value for money. Only one Member 
State offered testing adapted for organic varieties suitable for organic production but 
had not received any applications. Without a change in legislation, Member States are 
likely to continue taking action based on market demand. This was the preferred 
approach of some stakeholders responding to the public consultation in relation to the 
removal of testing so that market forces can drive the market, however the overall 
opinion was evenly split. References to the organic legislation in the PRM legislation, 
however, could support the work of stakeholders in countries where organic testing is 
made necessary due to demand and facilitate a more harmonised implementation.  

The cost of organic testing at present can be higher than conventional testing as in 
many places operators have to pay for conventional testing as well as the 
supplementary organic testing. In Denmark in 2012 conventional testing added to 
supplementary testing costs came to EUR 3,900 where conventional testing is up to 
EUR 2,026 (Pedersen, 2012). It was suggested by an NCA interviewee that for organic 
varieties suitable for organic production with small markets the costs and 
administrative burdens are not proportionate and can be a barrier to market entry and 
innovation. Most businesses, as well as SMEs and NCAs responding to the survey felt 
mandatory principles on reflecting the needs of the organic production would result in 
an increase or significant increase in costs of testing. Potential cost increases for both 
NCAs and operators were also identified by several interviewees (5 NCAs and 1 
representative association). This was true regardless of whether a Member State 
already offers VCU adapted for organic varieties or not. 

Current DUS (prior to the introduction of the derogation) and VCU testing required for 
variety registration are not aligned with the principles of organic agriculture. 
Therefore, testing has been a barrier to market entry for organic varieties suitable for 
organic production. Under all three options there would be an improvement in market 
access due to adapted testing provisions. The most improvement would come through 
Options 2 and 3 where the DUS derogation is made permanent and VCU principles are 
the most flexible to adaptation for organic agriculture. This increased market access is 
environmentally beneficial as organic agriculture is known for its reduced use of 
external inputs compared with conventional agriculture (IFOAM Organics International, 
2020). Organic varieties suitable for organic production are often more adapted to 
local environments than conventional PRM meaning that they can be more resilient to 
climate change and improve biodiversity. 

In terms of a change in time to market, operators considered that these measures 
would decrease or significantly decrease the time to market for organic products 
suitable for organic production, whereas NCAs and SMEs were more divided about the 
impacts. Some went as far as to say that increased costs would be disproportionate to 
the needs of the organic sector.  

In terms of competitiveness most businesses responding to the targeted survey felt 
that there would be a decrease in demand for products as a result of mandatory basic 
principles reflecting the needs of organic production. SMEs were split on how demand 
would change, if at all. In terms of innovation just under half of targeted survey 

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business and SME respondents felt that mandatory basic principles relating to organic 
production could have a negative impact.  

Several stakeholder groups – including public authorities and NGOs – expect all 
options under measure 8 to lead to more organic varieties becoming available on the 
EU market; however, most businesses and business associations thought that it would 
not (survey). There were mixed views from stakeholders on the impact on quality and 
quantity of organic varieties. Some stakeholders were concerned that, because organic 
varieties can also be used in non-organic production, adjusting testing would result in 
a decrease in PRM quality. The majority (51%, 36 out of 70) of survey respondents 
felt that a derogation for DUS standards for organic production would have no impact 
on quantity available of organic varieties. A small proportion of survey respondents 
(23%, 16 out of 70) felt that such a derogation would increase availability of organic 
varieties – notably all four NGO respondents, five (of 18) NCA respondents, and two 
(of four) academic institution respondents (Q41). Some responses (Q42) indicated 
that there may be little incentive for breeders who will also seek plant variety 
protection, but a positive inventive for those who do not want to seek plant variety 
protection.    

Option 1 maintains the current registration requirements and supports the temporary 
derogation for DUS testing in relation to organic varieties suitable for organic 
production. The temporary derogation on DUS testing under Option 1 is likely to be 
beneficial to SMEs as it increases market access and allows for more unbiased quality 
assurance of products meaning that SMEs are less disadvantaged compared to larger 
corporations. Options 2 and 3 will make the DUS derogation permanent, thereby 
solidifying the benefits for SMEs.  

NGOs responding to the survey offered more positive views, considering that demand 
would increase, that costs of VCU would decrease, time to market decrease and 
innovation increase.  

Results from the OPC indicated that a majority of NGOs and Business associations 
were in favour of establishing rules for the marketing of heterogeneous material 
intended for non-organic production, and of establishing dedicated permanent rules for 
the marketing of organic varieties suitable for organic production.  

A5.10  D.3 Extending VCU requirements to other species groups 

This question seeks to assess the economic, social and environmental impacts of extending VCU 
requirements, or at least VCU addressing only sustainability requirements, to other species groups, 
such as vegetables and fruit plants in order to ascertain that new varieties will be sustainable and 
climate resilient. 

Ref.  Research question 

O1  O2  O3  Specific measures across the options 

D.3  What are the expected economic 

 



impacts, including in terms of 
administrative burdens, for 
competent authorities and 
operators, social impacts and 
environmental impacts of 
extending VCU requirements, or 
at least VCU addressing only 
sustainability requirements, to 
other species groups, such as 
vegetables and fruit plants to 
ascertain that new varieties will 
be sustainable and climate 
resilient? 

[Same as baseline] Make use of existing 
empowerments to review and harmonise 
VCU rules for agricultural species to better 
address sustainability.  

For other crop groups, rely on information 
provided by breeders (published e.g. in 
marketing documents or national 
recommendation lists). 

  

M18.1 Review and harmonise VCU rules for 
agricultural species to better address 
sustainability. 

For other crop groups introduce general 
principles and rules on “sustainability 
criteria” but give MS flexibility to implement 

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Ref.  Research question 

O1  O2  O3  Specific measures across the options 

and adapt to local agro-ecological 
conditions.  



 

M18.2 Detailed and harmonised 
“sustainability criteria” for all crop groups. 

A5.10.1 

Problem statement  

Current PRM legislation has not been updated to reflect EU and international targets 
and strategies on sustainability, climate change and biodiversity. As a result, efforts to 
meet these environmental targets are not being maximised. As the PRM legislation is a 
key element of the production chain for plant species across Europe, it could have 
significant positive impacts on sustainability and biodiversity. This could be achieved 
through promoting a more resilient and diverse agro-ecological system which requires 
fewer inputs and can provide food security in a changing climate (EC 2021b). It was 
noted during one interview with an NCA that there is a need for clear sustainability 
criteria for fruit plants and vines particularly due to their long cultivation time (on 
average, 10-40 years for fruit plants; 50-80 years for vines) and large geographic 
coverage (e.g. 700,000 hectares  of vine plants in France). Therefore, in the face of 
climate change it is vitally important to have resilient varieties of fruit plants and vines 
which will survive their long cultivation periods. Lack of resilience would lead to large 
crop failures and significant costs, loss of income and the end of many livelihoods.  

A5.10.2 

Impacts  

Baseline assessment 

Current EU legislation requires VCU testing for most agricultural crop varieties but 
not for fruit plants, vine, vegetables or ornamentals. Despite this, some Member 
States do carry out VCU testing for sustainability characteristics of fruit, vine and 
ornamental species. Just under half (41% - 23 of 55) of survey respondents 
currently assess vegetables for sustainable characteristics on a voluntary basis. This 
includes 10 NCAs. There appears to be lower levels of testing for fruits, vine and 
ornamentals but for all of these categories there were still reports of voluntary and 
mandatory sustainability testing. In the absence of changes to the current legislative 
framework, these varying approaches between Member States are expected to 
persist and potentially increase in response to market demand.  

Interviewees also highlighted that testing for disease-resistance is already a key 
part of the DUS testing, particularly for some vegetables. Therefore, there is already 
some legislation in place which promotes sustainable characteristics in these 
varieties. Traditionally close connections between breeders, growers and buyers in 
these other sectors provides the required pressure to create a quality system (EC 
2013b). Market forces are seen to be effective in driving innovation (EC 2008).  

VCU testing is a tool currently used on agricultural crops which varies greatly between 
Member States in terms of focus on sustainability and climate related requirements. 
VCU testing could be used to add sustainability criteria to the testing regime for other 
species (vegetables, fruit, vine or ornamental varieties). Results of the survey found 
that 23 of 42 respondents would like sustainable characteristics to be tested for 
vegetable varieties. On the other hand, the majority of survey respondents were not 
in support of a sustainable VCU requirement for testing of fruit (24 of 42), vines (23 of 
42) and ornamentals (30 of 42).  

An EC study indicated that mandatory VCU testing is not demanded by consumers in 
these sectors but that they are instead satisfied with market forces driving innovation 
(EC 2008). This view was also shared by interviewees, particularly NCAs who 
expressed that this sort of testing would be impractical and disproportionate. NCAs 

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were supportive of the current system where market forces influence breeders, and 
many felt that sustainability was already a key factor considered during breeding. 
However, one NCA interviewee considered that the addition of sustainability testing 
could be beneficial particularly for maintaining or improving the quality of products 
within the vegetable, fruits, vine and ornamental sectors. There are thus mixed views 
on the best way to drive forward sustainability in the sector.  

Under option 1 NCAs and operators would have the least change as they can use 
current marketing documents to demonstrate sustainability characteristics. This option 
would most suit the current informal market structure with closer ties between 
breeders, growers and buyers (EC 2013b), allowing market forces to determine the 
direction of sustainability. The allowance of market forces to influence the direction of 
sustainability adaptation was favoured by stakeholders.  

It is likely that the introduction of a sustainable testing system for non-agricultural 
varieties will have similar impacts to the introduction of a mandatory sustainable VCU 
testing system for agricultural crops. Therefore, according to the survey responses 
there could be a negative impact on market access for breeders (9 of 17) as well as a 
negative impact on compliance costs (10 of 17). On the other hand, survey 
respondents also suggested positive impacts on innovation in plant breeding (11 of 
17) and the potential for new varieties to contribute to a more sustainable agri-food 
chain (11 of 17). However, the extent of these positive impacts may be limited by pre-
existing efforts by breeders to incorporate sustainable characteristics into new 
varieties (suggested in NCA interviews).   

In the same way to introducing a mandatory sustainable VCU for agricultural crops it 
is the opinion of NCAs (interview data) that they would prefer general principles at EU 
level which can then be applied as they wish in their Member States (M18.1). This 
measure is likely to maximise environmental and biological diversity benefits as it 
allows adaptation to local conditions down to the smallest of scales. It would also be 
flexible over time to consumer needs and the changing climate which is something 
that many VCU tests already try to accommodate (interview data with NCAs). 

Literature suggests that the fruit and vegetable sectors have the highest 
environmental impact in terms of pesticide use compared to agricultural crops (EC 
2021a) meaning that further pressure (via sustainability requirements) could 
significantly increase progress towards sustainability and climate change targets 
(M18.2). Interviewees (NCAs and representative associations) stressed the need to 
maintain diversity and for breeders to keep in mind changing conditions and not 
discard varieties which maybe have better adaptations to future climate conditions. 

One NCA highlighted in their interview that sustainability criteria set at the EU level 
would not allow for varieties specifically adapted to local conditions which may then 
leave regions vulnerable to the changing climate. Further to this the NCA indicated 
that sustainability criteria determined at the Member State level would be better 
adapted to regional climates and could be changed more easily than criteria set at EU 
level to allow response to sudden changes and extremes in climate. This level of 
criteria is likely to give the highest level of resilience to climate change at the smallest 
levels. This also is a positive impact on food security and could allow agriculture to 
prosper in areas heavily impacted by climate change for longer. Through this 
legislative mechanism environmental benefits and adaptation to climate change is not 
being maximised as the EU is a very diverse place which will experience climate 
change in very different ways which may change over time.   

A5.11 

E.1 Allowing the marketing of ‘not yet listed varieties’ and 

‘not yet fully tested material’ of fruit or vine propagating 
material 

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This study question assesses the problems for stakeholders of waiting for fruit and vine PRM to be 
fully registered and certified before it can be marketed and the impacts of introducing derogations 
which allow marketing before registration and certification has been completed.  

Ref.  Study question 

O1   O2  O3  Measure 

E.1  What are the expected economic 

 

 

 

impacts, including in terms of 
administrative burdens, for competent 
authorities and operators, social and 
environmental impacts of allowing the 
marketing of ‘not yet listed varieties’ 
and ‘not yet fully tested material’ of 
fruit or vine propagating material? 

A5.11.1 

Problem statement  

 M12 Adapt the current rules for “not 
yet listed varieties”, to allow 
multiplication to adequate marketing 
quantities while variety registration is 
ongoing. Extend to fruit plants and 
vine, including the “not yet finally 
certified PRM” provisions. 

At present, the marketing of fruit plants and vine propagating material is regulated by 
Council Directives 2008/90/EC and 68/193/EEC, respectively. Current rules for the 
marketing of propagating material of fruit plants and vine means that such can only be 
marketed if they have been certified as ‘pre-basic material’, ‘basic material’ or 
‘certified material’ and fulfil the conditions of CAC62.(for fruit plants) or standard 
material (for vines). 

The European Commission’s 2013 Impact Assessment identified the long time that it 
takes to register fruit varieties, which can be between 4 to 7 years, as a challenge for 
breeders (EC 2013b). One reason for the length of time to registration is the long 
period before characteristics of fruit and grape varieties can be observed. A range of 
stakeholders interviewed for the present study (7 of 14, including 3 plant breeding 
representative associations, 3 NCAs and a seed conservation network) who answered 
questions on this topic agreed there is a problem (of the remaining 7 interviewees, 2 
NCAs thought there was no problem, and 5 did not have an opinion). A few 
stakeholders (2 NCAs and a representative association) cited the long period required 
for testing. One representative association explained that issues arise when a breeder 
has produced plants but is unable to market them as the registration process has not 
been completed. Another representative association stated that the current rules make 
it difficult for breeders to test a variety in a cultivation area outside their country or 
region. One civil society organisation noted the high degree of uniformity across 
marketed varieties of fruit and vine and that greater emphasis should be placed on old 
and local varieties of fruit plants and vines, which could help bring about greater 
(genetic) diversity.  

A5.11.2 

Impacts  

Baseline assessment 

There is very little data on the size of the market for fruit and vine propagating 
material. The most recent figures come from work carried out by the European 
Commission in 2007-08 which found that 90% of the 12,000 enterprises involved in 
the production of fruit plants in the EU were SMEs often based in rural areas with 
few other economic opportunities. The value of this business was estimated at 
around EUR 2.5 billion (EC 2021a). 

62 CAC (Conformitas Agraria Communitatis) material means propagating material and fruit plants which have varietal identity 
and adequate varietal purity, are meant to be used for the production of propagating material, fruit plants or fruits and satisfy 
CAC quality and health requirements.  

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In the European Union 350-400 million grafted vines are produced annually, with 
France and Italy as the main producers (Vivairauscedo 2021).  There are small vine 
nurseries in Greece which almost exclusively produce standard material. Italy has 
around 500 vine nurseries, one large one and the rest medium or small-sized. 
Italian nurseries work on a pre-order basis of two years to use basic material for the 
multiplication of the mother blocks that will result in certified propagating material. 
In the case of varieties adapted to local agroecological conditions, there is no 
certification of vine propagating material that will be cultivated in very small areas 
because this is economically not viable. The market in the EU can be unstable due to 
a series of factors which affect the price of grafted vines and during economic 
downturns prices often fall below production costs. This is one reason for a decline 
in the number of vine nurseries in France (EC 2013b).  

The majority of survey respondents (16 of 29, including 5 of 5 NGOs and 8 of 13 
NCAS) indicated that there was a need for a potential derogation in EU legislation 
allowing the marketing of PRM of fruit varieties for which the registration process has 
not been completed.  The response was less clear cut for vine with 11 of 29 (including 
5 of 5 NGOs) agreeing and 11 who did not know.  A potential derogation in EU 
legislation allowing the marketing of PRM of fruit or vine varieties for which the 
certification process has not been completed was considered by a majority of survey 
respondents (13 of 29) who held a view on this to be helpful for fruit plants (11 of 29 
did not know). Opinions were split as to whether this would be beneficial in the case of 
vine (8 yes, 6 no, 15 did not know). Survey respondents’ views were also divided (7 of 
29 said yes and 7 of 29 said no, 15 did not know) on whether a derogation on 
certification should be restricted to certain PRM categories (i.e. pre-basic, basic, 
certified). Opinions were similarly divided on a derogation on registration with 10 of 29 
saying it should not be restricted and 9 of 29 who thought it should not. 

Administrative burdens on business and NCAs 

The proposed measure is unlikely to have a significant impact on the administrative 
burden linked to the registration of fruit plant and vine varieties. The majority of NCA 
survey respondents (9 of 13) thought that derogations would have no impact on the 
administration burden linked to the registration of fruit plant and vine varieties and 
one said it would increase. Six of 13 NCA survey respondents said derogations would 
have no impact on the administration burden linked to the certification of fruit plant 
and vine varieties, whilst 3 said it would increase. 

Ten NCA survey respondents provided information regarding the time it takes to 
complete registration of fruit varieties.  For most this ranged from 36 to 60 months, 
although two respondents indicated much shorter times of 0.5 and 3 months 
respectively. These estimates are broadly consistent with the findings from the 
European Commission’s 2013 Impact Assessment (EC 2013b) that DUS for fruit 
propagating material takes at least 4 years.  This study also found that DUS testing for 
fruit PRM is approximately 30% more expensive than testing for agricultural varieties. 
Information from nine NCA survey respondents on the estimated time to complete 
certification for fruit plants shows a slightly different picture.  Five respondents 
indicated this took between 36 to 60 months, whereas for 4 respondents time to 
certification ranged from 1 to 6 months. 

Information obtained from seven NCAs and an individual business surveyed indicated 
the time taken to complete registration of vine varieties from the submission of an 
application ranges from 66 to 70 months on average, although one business 
association estimated a much shorter time of 6 months. Five NCAS and 2 business 
stakeholders provided information on the time to certification of vine varieties, which 
ranges from 2-60 months. 

Expert advisors on this study indicated that the long duration in time to certification 
for both fruit plants and vine provided by some respondents was surprising and 
unlikely as certification times are usually shorter than registration.  The experts 

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suggested could be due to a misunderstanding from stakeholders about the question 
asked.  

Two NCAs and a representative association interviewed as part of the study 
commented that allowing derogations would facilitate faster and easier market access 
for fruit and vine varieties. Another NCA presented a contrasting view, suggesting that 
the derogations would not necessarily mean a quicker time to market for high volumes 
of propagating material: breeders would still only be able to offer a limited amount of 
PRM (from 10-15 mother plants) while waiting for the registration process to be 
completed. This would not be the case if multiplication to adequate marketable 
quantities were allowed. 

The interviews found that 2 NCAs and one breeders association thought it would be 
advantageous for breeders to be able to multiply stocks before registration due to the 
long period required for testing.   One of the NCAs explained that early multiplication 
of not yet listed varieties could be part of the regular certification procedure, which 
would help the certification agencies in terms of traceability. Therefore, in their view, 
early multiplication of not yet listed varieties should be provided for in the regulation. 
This was echoed by a plant breeders’ association surveyed who said members would 
prefer to test their material in various cultivation locations prior to formal marketing 
after full registration. The relative performance of the new varieties would be known to 
farmers in the area and to the plant breeder and helps align commercial benefits to 
both. 

On the other hand, as the expert advisor explained, allowing multiplication to 
adequate marketing quantities may lead to economic loss for breeders who have 
invested in multiplication of a variety which is then not approved for registration. It is 
also possible that farmers who have used the marketed (but not registered) product 
would have no recourse to the supplier for compensation should the product never be 
registered. This view was echoed by one NCA interviewed who felt that a drawback of 
such a measure could be that plants from a variety which is subsequently not listed 
might have to be destroyed by nurseries at a cost. There was also a risk that new 
varieties that had already been marketed (but fail registration) might not be 
withdrawn, which could disturb the market. There could be a perverse effect of 
allowing multiplication for marketing before registration is complete: suppliers may 
have an incentive to sell this material, and farmers to use it, to avoid the risk of being 
unable to sell it later if it is not registered. 

An individual business surveyed proposed that for seed propagated fruit crops, the 
category of standard seed should be introduced under this derogation.   

Innovation and research 

Allowing multiplication to adequate marketing quantities while variety registration is 
ongoing is likely to have a positive impact on innovation and research. A majority of 
survey respondents said that the derogation from EU legislation allowing the 
marketing of PRM of fruit or vine varieties for which the registration (16 of 29) or 
certification process (12 of 29, 11 do not know) has not been completed could have a 
positive impact on the value of investment made into relevant research by reducing 
the delay for return on such investment A majority of survey respondents stated that 
such a derogation for registration (21 of 29) or certification (18 of 29) would equally 
or more likely be beneficial for SMEs.  

Indirect Impacts 

The survey results show that 15 of 29 and 14 of 29 respondents thought the 
introduction of derogations would have no impact on the quality of PRM or substantial 
freedom of PRM from plant pests respectively. A minority (8 of 29 and 7 of 29 
respectively) said the quality of PRM or substantial freedom of PRM from plant pests 
would decrease (2 of 29 of suggested there would be an increase in both cases). One 
NCA interviewed was concerned that the derogations would lead to farmers receiving 

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material which does not meet plant health regulation standards.  Another NCA viewed 
the implementation of the derogation as a risk to plant protection rights. 

A majority of all stakeholders types surveyed agreed that the derogation from EU 
legislation allowing the marketing of PRM of fruit or vine varieties for which the 
registration process has not been completed could have a positive impact on the 
diversity (21 of 29) and quantity (17 of 29) of PRM. One representative association 
interviewed indicated that the proposed derogation would increase the number of 
varieties on the market. An NCA who was interviewed stated that a drawback to 
allowing derogations could be that plants from a variety which is subsequently not 
listed might have to be destroyed by nurseries at a cost. There was also a risk that 
new varieties that had already been marketed (but fail registration) might not be 
withdrawn, which could disturb the market. 

A5.12 

F.1 Extending the scope of application of the FRM 

legislation for non-forestry purposes 

This study question seeks to assess the impacts of extending the scope of the FRM 
Directive to include FRM used for non-forestry purposes, such as agroforestry, 
biodiversity, biomass production, tree planting in urban areas and energy generation. 

Ref.  Study question 

O1   O2  O3  Measure 

F.1  What are the expected economic impacts, 

 

including in terms of administrative burdens, for 
competent authorities and operators, social and 
environmental impacts of extending the scope of 
application of the FRM legislation (i.e. applying 
the same rules applicable to FRM) to certain FRM 
used for clearly defined non-forestry purposes 
such as agroforestry, biodiversity, biomass 
production, tree planting in urban areas and 
energy generation? The contractor shall collect 
data on the non-forestry purposes of tree 
species regulated in Annex I to Directive 
1999/105/EC and investigate if there are any 
national/regional differences. 

A5.12.1 

Problem statement  

M17.1 Define forestry and 
non-forestry purposes  but 
maintain current scope of 
FRM legislation  

 

 

M17.2 Define forestry and 
non-forestry purposes and 
extend scope of FRM 
legislation to include the 
production of FRM for 
specific non-forestry 
purposes  

There is no definition either in the Directive or more generally at EU level for what is 
meant by ‘forestry purposes’. Consequently, Member States have different 
interpretations and understanding of what is included in scope of the Directive. For 
example, agroforestry is considered within scope of the Directive in some Member 
States but not in others (e.g. within scope in Bulgaria, Germany, Slovenia and Spain; 
out of scope in France and Finland according to NCAs interviewed). This means that in 
some Member States, FRM from regulated species can be sold without the approval of 
basic material when it is being used for certain purposes. As described by several 
interviewees, this means that lower quality FRM may be used for these purposes, 
contributing to the risk of genetic pollution when these trees are planted in proximity 
to certified FRM. Developing a common definition for forestry and non-forestry 
purposes is challenging, in part because the responsibility for certain non-forestry 
purposes of FRM is under the remit of different public authorities in Member States 
and in some cases is already included in scope of other legislation. This was noted by 
interviewees from Finland and France.  

Interviewees differed in their understanding regarding the scale and significance of the 
problem. This is likely due in part to different significance that the FRM sector and the 
potential non-forestry purposes have in Member States. For example, there are 
significant differences in the prevalence and type of agroforestry practiced in Member 

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States. Spain, Greece, France and Italy all have significant agroforestry cover, while 
Denmark, Poland, Germany and Czechia have very little. Agroforestry includes the use 
of species such as fruit trees that are not regulated under the FRM Directive. It is not 
clear the extent to which regulated species are being used to a significant extent for 
agroforestry in the EU (Den Herder et al 2016). Another example is biomass 
plantations, which are of greater significance in Western, Central and Eastern Europe, 
and are less common in Northern and Southern Europe (Camia et al 2021). However, 
even where non-forestry purposes are more prevalent, there is no data available on 
the extent to which there is currently a problem with lower quality material being used 
for non-forestry purposes or the extent to which this poses a risk for genetic pollution.  

A5.12.2 

Impacts  

Baseline assessment 

In several Member States (e.g. Bulgaria, Slovenia and Spain), some non-forestry 
purposes are already included in scope of the national implementation of the 
Directive. For these Member States, the current implementation is already helping 
to improve the overall quality of FRM and reducing the risk of genetic pollution63. For 
Member States where the implementation of the FRM Directive is currently more 
limited in scope, there are likely to be different outcomes. Some of these Member 
States may not have enough production for non-forestry purposes for there to be an 
impact on the overall quality of FRM or the likelihood of genetic pollution (e.g. as is 
the case in Finland, as described by the NCA). In other Member States, there may 
be national efforts to improve the regulation of FRM for non-forestry purposes. For 
example, one interviewee who opposed the extension of the scope of the Directive 
felt that there was a problem to be addressed, but that this would be best addressed 
at Member State level.  

However, a majority of NCA (22 of 37) and academic/research institute (9 of 14) 
respondents to the public consultation felt that the scope of the Directive should be 
extended, which suggests that there are likely some Member States where this 
poses an issue and where no work is currently being done to improve the situation.  

Therefore, it is likely that in the absence of legislative changes at the EU level, some 
Member States will have  continued or increasing problems with the genetic 
pollution of FRM for forestry purposes resulting in lower quality trees, leading to 
economic losses for the users of FRM, both for non-forestry purposes and forestry 
purposes.  

The use of lower quality FRM for afforestation and reforestation may result in less 
resilient forests. As resilient forests contribute to supporting biodiversity and 
mitigating the impact of climate change (as set out in the New EU Forest Strategy 
for 2030, EC 2021c), this may also contribute to environmental losses.  

A majority of interviewees (8 of 13) expressed support for extending the scope of FRM 
legislation to include the production of FRM for specific non-forestry purposes (Option 
2- M17.2). They provided two main reasons for this: firstly, to improve the overall 
quality of FRM used for non-forestry purposes and secondly, to prevent genetic 
pollution between non-certified FRM and certified FRM when these are planted in 
proximity. In addition to these, respondents to a survey of NCAs indicated that this 
would increase clarity for operators (11 of 24) and for the users/buyers of FRM (13 of 

63 Genetic pollution occurs when plantations for non-forestry purposes using low quality FRM are adjacent to 
stands and populations of trees that are used for forestry purposes. 

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24). The need for further clarity was highlighted in a recent publication of a forestry 
association, which stated that the term “forestry purposes” should encompass 
subdivisions such as “production” or “conservation of genetic resources” alongside 
clarification of these concepts. The definition of “non forestry purposes” should also be 
clarified in order to enable harmonization at EU level (EUFORGEN 2020).  

Responses to the public consultation also indicated support for extending the scope of 
the legislation across stakeholder groups (22 of 37 NCAs, 18 of 36 individual 
companies and business associations, and 9 of 14 academic/research institutions). 
However, a separate survey of NCAs indicated greater scepticism, with 13 of 24 
indicating that overall costs would outweigh the benefits. 

For FRM for forestry purposes, a majority of targeted survey respondents felt that 
extending the scope of the Directive was unlikely to have significant negative impact 
on: 

1)  Sufficiency of supply (10 of 26 indicated no impact, 6 indicated positive impact); 

2)  Diversity of FRM (12 of 26 indicated no impact, 9 indicated positive impact); 

3)  Quality of FRM (10 of 26 indicated no impact, 7 indicated positive impact); and 

4)  Adoption of innovative FRM production processes (12 of 26 indicated no impact, 9 

of 26 indicated positive impact). 

However, for the production of FRM for non-forestry purposes, there was less 
consensus from survey respondents on likely impacts on the sufficiency and diversity 
of supply or the adoption of innovative FRM production processes. One interviewee 
highlighted the likely problem of supply, explaining that it would be a challenge for 
some nurseries to produce appropriate material. A majority of survey respondents 
indicated that an extension of scope would likely have a positive impact on the quality 
of FRM marketed for non-forestry purposes (11 of 26 as compared to 4 indicating 
negative impact and 3 indicating no impact). A majority of survey respondents also 
indicated that an extension of scope would have a positive impact on the suitability of 
FRM produced for the intended use (11 of 26 as compared to 6 indicating negative 
impact and 4 indicating no impact).  

The majority of interviewees (10 of 13) indicated that extending the scope of the 
Directive would likely add administrative burdens to NCAs and businesses, at least in 
the short term. In a separate survey of NCAs, 18 of 24 also indicated that it would 
generate burden for NCAs and 12 of 24 indicated that it would generate burden for 
businesses. In part this is because it would increase workload and therefore costs for 
these stakeholders: a majority of NCAs surveyed also indicated that this would lead to 
an increase in the administrative fee for certification (15 of 24) and the technical fee 
for inspection during certification (14 of 24). However, two interviewees, as well as 
participants in the FRM-focus group, explained that an increase in administrative 
burden is also likely to occur because many non-forestry purposes currently fall under 
the remit of other competent authorities and regulators, and that any changes would 
need to take this into account. Participants in the FRM-focus group proposed that to 
address this, any discussion about scope or definition should include these wider 
stakeholders involved in other non-forestry purposes. One stakeholder interviewed 
recommended that to address this, changes should be made to the other relevant 
legislation rather than the FRM Directive, so that these non-forestry purposes remain 
the competence of current authorities.  

Certain purposes were seen as more burdensome and less relevant for inclusion in 
scope than others. Two interviewees and participants in the FRM-focus group 
highlighted that extending the scope of the Directive to include FRM for ornamental 
purposes would be burdensome, because there are significantly more nurseries selling 
FRM for these purposes. These stakeholders also felt that including these in scope 
would bring minimal benefits, as these trees are generally used on a smaller scale and 
within cities and parks. However, two other interviewees explicitly highlighted the 

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importance of also including these types of FRM within the Directive, precisely because 
of their use in cities and parks.   

Participants in the FRM-focus group explained that trees planted for biodiversity 
purposes or as part of the EU target of planting 3 billion trees should be high quality 
material and would frequently (but not always) fall under ‘forestry purposes’. As such, 
considering these to be ‘non-forestry purposes’ is misleading: even in Member States 
where the Directive does not include non-forestry purposes, trees planted for these 
purposes are often still within scope.    

Participants in the FRM-focus group suggested that defining the scope by land use, 
rather than by purpose, may be a more appropriate approach. One participant also 
suggested that following this, creating buffer zones around forest land where only 
certified FRM could be planted might be one approach. One interviewee suggested a 
similar approach, focusing on only those non-forestry purposes where trees are being 
planted near to forest land and in significant numbers (which may be the case for 
some biomass plantations).  

When surveyed on which purposes should be included within the production of FRM, 
NCAs indicated the greatest consensus on the inclusion of reforestation, afforestation 
and the conservation and sustainable use of forest genetic resources. Other purposes 
also received strong support, including wood production, biodiversity conservation and 
agroforestry. Figure 4 provides further details.  

  Support for inclusion of different purposes within FRM legislation 

Options 2 and 3 (M17.2) would define forestry and non-forestry purposes and extend 
the scope of the current legislation to specific non-forestry purposes. The extent and 

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nature of the impacts would differ significantly depending on what purposes are 
brought within scope. In general, however, stakeholder feedback suggests that these 
changes are likely to result in:  

  A reduction in economic losses for the users of FRM, both for non-forestry 
purposes and forestry purposes in those Member States where non-forestry 
use is significant and not currently in scope;  

  A reduction in environmental losses in those Member States where non-

forestry use is significant and not currently in scope; and 

  An increase in administrative burden for NCAs and businesses in those 

Member States where non-forestry use is not currently in scope.  

This means that in Member States where non-forestry use is currently not in scope but 
is also not significant, an extension of scope may add administrative burden without 
bringing any benefit.  

Option 1 (M17.1) would establish a definition for forestry purposes, which for some 
Member States would already partially extend the scope as compared to the current 
implementation. As such, it would lead to similar impacts as M17.2, but on a smaller 
scale and in fewer Member States. It would likely also come with reduced 
administrative burden.  

A5.13 

F.2 Creating a voluntary system to provide more 

information in relation to FRM and seed stands 

This study question seeks to assess the impacts of supporting the users of FRM with 
additional information on FRM identity, either through the development of additional 
guidance or the development of a voluntary inventory on the performance of FRM.  

Ref.  Study question 

O1   O2  O3  Measure 

F.2 

Could the provision of 
additional information on FRM 
and seed stands be 
considered as an additional 
measure to help address 
difficulties in supply of FRM? 
Could the provision of 
additional information on FRM 
and seed sources assist with 
the selection of climate-
adapted FRM suitable for 
different bioclimatic zones? 
The contractor shall collect 
information on current 
practices in Member States in 
relation to the collection of 
additional information on FRM 
and seed stands. 

 

[same as baseline] Make use of existing 
empowerments to improve the information 
provided on FRM 

 

 

M16 Expand information requirements to 
include information on suitability of FRM for 
climatic/ecological conditions 

 





[same as baseline] Use existing empowerments 
to introduce assessment of sustainability 
characteristics for all FRM categories 

 

M19.1 Introduce general principles on 
assessment of sustainability characteristics for 
all FRM categories with flexibility for Member 
States to implement 



 M19.2 Detailed and harmonised rules on 

assessment of sustainability characteristics for 
all FRM categories 

A5.13.1 

Problem statement  

Survey respondents had mixed assessments on how sufficient existing efforts on 
information provision to buyers and users of FRM are: 7 of 26 felt that the current 
level of information was insufficient, 10 felt it was reasonable, and 5 felt it was 
sufficient. There was no pattern in how respondents from different Member States 
responded, suggesting that stakeholder understanding of “sufficiency of efforts” 
differs. It is also not clear to what extent any perceived problem stems from a need 
for more and better research/data collection, more and better dissemination of new 

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and existing knowledge, or a combination of the two. As explained by an expert 
consulting on this project, this is a difficult question to assess through consultation 
because stakeholders are often not  aware of their knowledge gaps. 

The provision of additional information on FRM and seed stands can take different 
forms. One approach is to provide guidance to users of FRM . Member States differ 
regarding the extent to which they provide this type of guidance. This reflects 
differences in forestry practices across Member States (Forest Europe 2020). For 
example, in Bulgaria, most of the forests are state owned with a small number of 
private owners (Hirsch et al 2017), meaning that information and recommendations 
can be provided to FRM buyers/users on a more informal level (e.g. information can 
be provided through conversations or informal exchanges, rather than a need for more 
formal dissemination tools and strategies). In Member States where there are larger 
numbers of private owners, there is a greater need to develop tools and strategies to 
provide and disseminate information.  

At a national level, some NCAs reported developing their own tools or approaches to 
advise FRM buyers. For example, Sweden and Finland have developed a map-based 
tool which provides recommendations for certain species64. In France, the NCA has 
developed brochures with information on different provenances and how they can best 
be used65. Some Member State NCAs interviewed had not developed any formalised 
approaches or tools for providing information. However, all NCAs interviewed 
mentioned some type of ongoing research or data-collection activities related to FRM.       

In interview, stakeholders also provided details on European-level projects looking to 
partly fill these information gaps. One example, Seed4Forest66 allows users to select a 
location in Europe and receive information on tree species that could be grown there 
now and in the future. This has been developed based on climatic data and on 
information from provenance trials in Europe and is linked to FOREMATIS.  

Another approach to this is through the assessment of basic material or FRM for 
certain sustainability characteristics. By conducting this type of assessment and 
providing that information to users of FRM, it can support planting decisions that are 
suitable for both current and future climatic conditions. Currently, Member States 
differ in the extent to which they conduct this type of assessment. Separate from any 
official or mandatory assessments, there is also research occurring in some Member 
States working toward an assessment of these characteristics.  

A5.13.2 

Impacts  

Baseline assessment 

Assessment of sustainability characteristics 

In interview, some stakeholders indicated that they did assess for sustainability 
characteristics but that this assessment was already provided for in the legislation 
(e.g. as described by one interviewee, the fact that basic material is approved and 
there are minimum requirements according to the Directive provides for good 
characteristics and brings us to sustainable afforestation and reforestation). 
Stakeholders were also asked in the targeted survey whether they assess basic 
material and/or FRM for characteristics that contribute to sustainable afforestation 
and reforestation. Responses to this question are difficult to interpret, as in multiple 
instances there are conflicts between responses from the same Member State.  

64 https://www.skogskunskap.se/rakna-med-verktyg/foryngring/plantval/ 
65 https://agriculture.gouv.fr/graines-et-plants-forestiers-conseils-dutilisation-des-provenances-et-varietes-forestieres 
66 https://www.seed4forest.org/ 

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In the targeted survey, similar numbers of respondents indicated that they currently 
assess basic material or FRM for the following: 

-  Suitability of tree species for particular climatic conditions (including 

conditions under future climate change projections) (9 of 14) 

-  Suitability of provenance of basic material for particular climatic conditions 
(including conditions under future climate change projections) (11 of 14) 
-  Adaptability (for example to water stress, drought, heat, cold, wind hoses 

/ wind throws) (10 of 14) 

-  Resistance to plant pests (9 of 14) 

Guidance and information tools 
As described in the problem statement, there are existing efforts in different 
Member States to develop new tools and provide information to FRM users on the 
suitability of different material to current and future climatic conditions. In the 
absence of EU-level action, it is likely that these tools will continue to be developed 
in some Member States. Current European-level tools will also likely continue to be 
developed. 

Several survey respondents (9 of 26) indicated that the provision of further 
guidance and information was important but would be best carried out at Member 
State level. However, a study on options to update existing PRM/FRM legislation 
found that one of the main contributing factors to problems in the implementation of 
the legislation is the lack of Member State resources (EC et al. 2021). It therefore 
seems likely that future efforts to develop more sophisticated tools and guidance will 
be limited in many Member States, and the available tools and information will differ 
significantly across the EU. 

The impact of any such tools will depend in part on the extent to which they are 
taken up by FRM users and lead to them making better planting decisions. No data 
was collected on the extent to which current tools are used or are likely to be used.  

It is therefore likely that in the absence of EU-level intervention, tools and guidance 
will continue to be developed and improved in some Member States and by some 
projects, while less will be done in other Member States. This could lead to mixed 
economic impacts for the users of FRM with benefits for users in Member States 
where better information is developed (assuming there is an uptake of that 
information). This can lead to better planting decisions and forests that are more 
resilient to changing climates. In Member States where further tools and guidance 
are not developed, there will likely be economic losses where this contributes to 
poor planting decisions. There may also be mixed environmental impacts due to 
different Member State approaches regarding the development of FRM tools and 
guidance, differences in the resilience of forests would be maintained or potentially 
increased.  

Within the public consultation, respondents were asked whether the FRM legislation 
should introduce rules to determine the suitability of FRM for climate change and 
extreme weather conditions. NCAs (24 of 37) and academics and research institutions 
(11 of 14) were largely in support of this, business associations and companies were 
more likely to disagree (23 of 36 disagreed or somewhat disagreed). The introduction 
of principles or detailed rules on this (M19.1 and M19.2) was not discussed in other 
consultation activities. As such, it is difficult to qualify this support or understand the 
likely impacts this measure might have.  

Although stakeholders were not consulted on M16, one interviewee from a research 
background indicated that including information on the supplier’s document on the 
climatic conditions of the FRM’s provenance could help users consider how that 
compares to their own conditions. This interviewee also indicated that this amendment 
would be relatively simple to enact and would not come with any significant 

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administrative burden. This would provide a basic level of information for users of FRM 
in the absence of the development of deployment zones or similar types of guidance at 
a Member State level. This type of information was considered likely to be the most 
useful for users of FRM according to EC et al. 2021.   

Voluntary inventory 

The majority of respondents to the public consultation were in favour of the 
development of a voluntary inventory with information on FRM characteristics and 
performance. Academics and research institutions were particularly in favour (13 of 14 
in support). NCAs were more sceptical but a majority still supported the development 
of such an inventory (21 of 37). Respondents to the targeted survey were also largely 
in favour of the development of such an inventory, but only some (8 of 26) felt that 
this should be organised at EU level.   

This scepticism was evident in stakeholder interviews. While more than half of 
interviewees (7 of 13) felt that such an inventory would have a positive impact, many 
highlighted likely challenges and downsides. Several interviewees (7 of 13) highlighted 
the likely cost of developing and maintaining an inventory and the lack of resources at 
Member State level to support this type of initiative. Others (5 of 13) emphasised the 
administrative burden, with some explaining that collecting the relevant data without 
it being compulsory and without appropriate resources would be challenging.  

All NCAs interviewed and a majority of respondents to the targeted survey (18 of 26) 
reported that there are existing data collection efforts in their Member States, but 
these generally do not relate to the use of FRM. Participants in the FRM-focus group 
also noted this as a likely challenge, explaining that the overall willingness to provide 
data would likely vary across Member States and that the resulting sparse or 
incomplete data could pose a challenge to the overall utility of the inventory. 
Responses to the targeted survey confirmed this concern: only one respondent (of 22) 
indicated that they would be ‘highly likely’ to participate and six indicated they would 
be ‘somewhat likely’ to participate. The remainder indicated that they were unlikely to 
participate (7) or did not know (8). Two interviewees (one from an international 
organisation, one from a research background) suggested that participation in such an 
inventory could be incentivised through existing subsidies (e.g. through measures 
included in the CAP). One interviewee indicated that the use of technologies such as 
remote sensing could help to facilitate data collection and might reduce some 
administrative burden.  

One participant in the FRM-focus group suggested that to avoid some of the 
challenges related to administrative burden, this could be organised as a provenance 
trials network around Europe with the results becoming available to end-users. Rather 
than a large-scale inventory, this could be something more targeted and with a 
scientific design, answering specific questions on how different origins will perform in 
certain conditions.   

Participants in the FRM-focus group also suggested that any such inventory might be 
most effective if it is first developed with a small number of parameters, so that the 
data inputted is more consistent and complete. Then at a later stage, this could be 
expanded if it works well.  

In terms of the specific parameters that would be most useful, respondents to the 
targeted survey generally found all proposed parameters67 to be useful. There were no 
significant differences in the degree of usefulness between these.  

67 Zones with similar climatic conditions, FRM characteristics, FRM performance, Ecological suitability of FRM for particular 
climatic conditions (including conditions under future climate change projections), Resistance of FRM to plant pests, 
Location of basic material, Final planting site of FRM, Traceability from the location of basic material up to the final planting 
site of FRM 

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The development of other types of guidance at EU level was not discussed in detail 
with stakeholders. One NCA interviewee explained that this type of guidance is best 
developed at national level, to take into account the specific needs and characteristics 
of FRM users in each Member State. In general, respondents to the targeted survey 
indicated a slight preference for the further development of guidance as opposed to 
the development of a voluntary inventory, but it was not specified whether this should 
be at EU or national level.  

Following this, the impacts of such an inventory are uncertain. The development of a 
voluntary inventory has the potential to provide additional information to users and 
researchers to further understanding of the most appropriate species and provenances 
for current and future climatic conditions. This would contribute positively to the 
performance of planted trees, leading to positive economic impacts for the users of 
FRM across Europe; and positive environmental impacts across Member States.  

However, these positive impacts are dependent on the success of such an inventory, 
and as described above, there would be several challenges to its implementation. 
Regardless of its success, the development of a voluntary inventory would also 
contribute to increased administrative burden for NCAs and FRM users responsible for 
collecting and reporting data. The degree of this burden would differ significantly 
depending on how the inventory was set up, the use of technology and the use of 
incentives.  

A5.14  G.1 & G.2 Including the PRM and FRM marketing 

legislation in the scope of Official Controls Regulation or 
harmonising legislation outside of OCR 

This study question seeks to assess the impacts of harmonising official controls rules 
within the PRM legislation, or the partial or full inclusion of PRM and FRM in the scope 
of the Official Controls Regulation (‘OCR’) (or a combination thereof). It looks 
specifically at impacts in areas of official controls (including import controls), 
certification and financing of official controls that are provided for in the OCR.  

Ref.  Research question 

G.1 

G.2. 

What are the expected economic impacts, 
including in terms of administrative burdens, for 
competent authorities of including the PRM and 
FRM marketing legislation into the scope of the 
Official Controls Regulation? 

What are the expected economic impacts, 
including in terms of administrative burdens, for 
competent authorities of creating a specific, 
harmonised control regime within the PRM and 
FRM marketing legislation outside of the scope of 
the Official Controls Regulation? 
A5.14.1 

Problem statement  

O1  O2  O3 

Specific measures 
across the options 

    

M2.1 Harmonise official 
controls in PRM policy 
instrument 

  

M2.2 Tailor-made application 
of OCR to PRM and FRM 

  

M2.3 Full application of OCR to 
PRM and FRM 

Currently, the Official Controls Regulation (EU) (‘OCR’) (2017/625) does not 
encompass official controls activities for PRM and FRM. The PRM and FRM Directives 
themselves lack detailed provisions on official controls and enforcement of the 
marketing legislation. For example, Directive 66/402/EEC on the marketing of cereal 
seed and Directive 66/401/EEC on the marketing of fodder plant seed require controls 
to be carried out for seed to be certified. The specific conditions to be satisfied in order 
for seed to be certified are specified within Annexes to the Directives. These conditions 
are highly technical and state specific characteristics for different species that should 
be controlled. There is some detail on carrying out these controls (primarily in respect 
of sampling and testing), but it is left to MS to implement the necessary controls to 

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ensure seed meets the conditions. By comparison, the OCR sets out detailed rules on 
the scientific validity of the methods to be used in sampling and testing. Further, the 
OCR further describes general principles for requirements for the delegation of official 
control tasks by NCAs, rules for import controls, the fees to be collected by NCAs for 
financing controls and enforcement actions. While the PRM and FRM Directives make 
some reference to these elements in certain instances, the level of detail in all of the 
Directives compared to the OCR is significantly less. This ultimately means there is 
greater room for interpretation by MS in relation to PRM and FRM controls. This is 
illustrated more extensively in the table assessing each of the PRM and FRM Directives 
with the key features of the OCR in section A5.14.3. A discussion on considerations in 
controls carried out under official supervision is also included in section A5.3.  

This can contribute to several issues. Firstly, Member States can take varying 
approaches towards the implementation of official controls in the context of the PRM 
and FRM legislation, due to differences in the interpretation of the rules across the MS 
(EC 2021a). This can be seen in the ICF stakeholder survey results, which showed 
differences in the way NCAs currently implement official controls. For example, when 
asked for the percentage of imported PRM and FRM consignments on which they 
carried out official controls, around a third (8 of 25 NCAs) said 25% or less while a 
further third (9 NCAs) said over 75%. In turn, this can contribute to an unequal 
playing field for operators as the official controls they are subject to differ across the 
Member States (EC 2021a).  

Another issue is the lack of alignment between the controls regime of PRM and FRM 
legislation, and the controls regime for plant health since its inclusion in the scope of 
the OCR. As the OCR applies official controls in the area of plant health, there are two 
control regimes for plant inspection services to manage (EC 2021a). This contributes 
to inefficiencies in the implementation of official controls by NCAs. For example, 
RNQPs are listed in the PRM Directives and the Plant Health Regulation but with some 
differences, which means MS have to consult both (EC 2021a). Lack of alignment 
between PRM and FRM legislation and the Plant Health Regulation is similarly 
discussed in section A5.1.  Accordingly, a need for more alignment between PRM and 
FRM controls with plant health controls was explicitly mentioned in interviews by three 
stakeholders (two NCAs and a business association). Nevertheless, although many 
stakeholders recognised at least some need for change in relation to official controls, 
the perceived significance of the issues varied: a majority of interviewees (13 of 18) 
did not see the exclusion of PRM and FRM from the OCR as problematic. An overview 
of interview feedback can be found in section A6.5.   

A5.14.2 

Impacts  

Baseline assessment 

The Official Controls Regulation (EU) 2017/625 (‘OCR’) entered into force in 2017 
and has been in application since 14 December 2019. It governs the official controls 
to be performed by the competent authorities in EU Member States to ensure the 
protection of the agri-food supply chain in relation to food, feed, animal health and 
welfare, plant health and plant protection products, organics, and GMOs. PRM and 
FRM are currently not within the scope of the OCR. 

Member States take diverging approaches towards official controls in the context of 
PRM and FRM. In the ICF stakeholder survey (see section A6.4), a majority (of all 
stakeholder types) agreed with the statement that there are currently differences 
between the Member States in the application of official controls and enforcement of 
the PRM/FRM legislation that create uneven conditions for operators (overall 47 
agreed, 12 disagreed, 16 neither agreed nor disagreed or did not know). Feedback 
from three interviewees indicated that some Member States were carrying out 
marketing controls whilst others were not. With no EU action, it can be expected 

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that the differences between Member States will continue, in turn contributing to an 
unequal playing field for operators (EC 2021a). However, in this scenario the 
flexibility granted to Member States means they could continue to make decisions 
on the most appropriate approach to controls for their national context (EC et al 
2021). One NCA explained that it worked well for countries to have their own 
systems, “because situations are very different in different Member States”. Some 
MS lack the financial and human resources necessary for official controls of PRM and 
FRM (EC 2021a). At the same time, the OECD Schemes for the Varietal Certification 
of Seed has harmonised procedures for the production and official control of 
agriculture seed in participating countries (OECD, n.d.). This is likely to limit the 
extent to which Member States can diverge in their approach to official control for 
this type of PRM. For FRM, there is an OECD Scheme for the Certification of Forest 
Reproductive Material, but the rules for official controls are not harmonised.  

Harmonisation or application of the OCR to PRM and FRM would still allow some 
flexibility to MS. For example, risk-based principles of the OCR could still be tailored 
to individual MS. However, this would still require some standardisation resulting 
from the parameters set out in the OCR (any such parameters are generally less 
detailed or non-existent in current PRM and FRM legislation). 

Inefficiencies that stem from lack of application of the OCR to PRM and FRM 
legislation will also remain without EU action. This is evidenced by the fact that the 
duplicated effort in carrying out controls for both the plant health regime and for 
PRM was identified in 2013 (EC 2013b) but remains problematic today. The 2021 
study (EC 2021a) observed that plant inspection services were ‘confronted with two 
different control regimes’. Three interviewed stakeholders (two NCAs and an 
industry association) expressed dissatisfaction with the lack of alignment between 
PRM and plant health in respect of official controls. It also possible that the lack of 
application of the OCR IT support systems to PRM and FRM could result in 
inefficiencies. As described in the EC 2021a study, there are challenges to exchange 
of information on seed fraud as no secure IT system exists for PRM and FRM. This in 
turn hampers the efficient functioning of the EU Seed Fraud Network (EC 2021a). 
However, NCAs themselves did not specifically mention this issue.  

No evidence was found to suggest that current arrangements limit the ability for 
NCAs to implement risk-based controls if they wish. The exception to this is for 
certification, where there is an obligation for 5% of the seed lots entered for official 
certification to be subject to official check testing during field inspection, seed 
sampling and testing. Most NCAs responding to questions about the OCR in the 
survey (18 out of 25) reported carrying out risk-based controls for one or more 
types of import, production and/or marketing controls. Five interviewed NCAs 
similarly described their current approach as being risk-based. However, it is 
unlikely the definition of ‘risk-based’ is the same in all NCAs, and the survey data 
illustrates that NCAs vary in the extent to which they implement risk-based 
approaches for different types of controls (some implementing it only for imports, 
others only for marketing etc). This creates an unequal playing field for EU business 
operators. In the OCR on the other hand, the requirement of risk-based controls is 
established together with criteria for carrying out such controls, which would support 
a more level playing field68.  

The impact of harmonising (M2.1) PRM and FRM with the OCR, or partially (M2.2) or 
fully (M2.3) including PRM and FRM legislation within the scope of the OCR, is likely to 

68 At the same time, the OCR does not affect Union agri-food chain legislation that requires that official controls be performed 
irrespective of the level of risk or the likelihood of non-compliance in view of the issuance of an official certificate or attestation 
which is a pre-requisite for the placing on the market or for the movements of animals or goods. In such cases, the frequency 
of the official controls is dictated by the certification or attestation needs (see Article 9(3) of the OCR and recital 32 of that 
Regulation).  

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vary across individual Member States due to their differing approaches to PRM and 
FRM official controls. As such, the analysis describes factors which may influence the 
impacts identified where possible. Additionally, literature on this issue is limited and 
largely originates from previous European Commission studies. This analysis therefore 
relies significantly on the results of stakeholder consultation activities carried out in 
support of this Impact Assessment study.  

Public authorities 

Under all policy options there is potential for efficiency gains by streamlining controls 
carried out for PRM with the rest of the agri-food system (EC 2021a). These benefits 
are most likely to be seen by those NCAs who do not currently carry out risk-based 
controls and those with duplicated processes for plant health controls and PRM and 
FRM controls (for example, carrying out two separate inspections of the same seed lot 
– one for PRM and FRM, and one for plant health – to account for the two separate 
control regimes). One NCA suggested that, as imports were subject to controls for 
compliance with the plant health requirements, it would be “logical” to check PRM 
identity and quality at the same time for a more integrated system.  

On the whole, NCAs did not indicate the budgets they had available for different types 
of official controls in the survey. However, those that did, show the significant level of 
variation between NCAs in the total number of controls they carry out annually and 
corresponding costs. The volume of production controls and associated budget varied 
between two NCAs from 34,000 production controls with EUR 10m (EUR 294 per 
control) and 120 production controls with EUR 17,500 (EUR 145 per control). 
Similarly, for marketing controls the variation between the two NCAs was 3,500 
marketing controls with a budget of around EUR 1m (EUR 286 per control) and 150 
marketing controls with a budget of EUR 7,500 annually (EUR 50 per control).  

A few interviewed NCAs mentioned that closer alignment between PRM legislation and 
the OCR could decrease the risk of fraud, therefore supporting higher quality PRM. 
This was primarily because the introduction of the risk-based approach, which would 
allow NCAs not currently applying this approach to focus their resources on those 
types of PRM/FRM and business operators that represented a higher risk. Further, one 
NCA expected that risk-based marketing controls would be a cost-saving because they 
currently inspected every seed lot, whereas if those controls were risk-based they 
could focus resources only on those higher risk seed lots. 

Closer alignment between PRM and FRM and OCR IT systems also have potential to 
bring efficiency gains for NCAs. This is a possibility under options 1 and 2 (M2.2 and 
M2.3) as there is potential to make Article 134(f) applicable to PRM and FRM (which 
allows for an implementing act describing the cases and conditions where information 
and documents are to be transmitted using IMSOC). There is demand for greater 
digitalisation of PRM and FRM procedures among MS (see A5.15) OCR and inclusion of 
PRM and FRM in the OCR would enable use of the OCR’s information management 
system for official controls (IMSOC) for PRM and FRM. IMSOC allows the computerised 
handling and exchange of information relating to official controls. Its objective is to 
replace paper documentation, with benefits including increasing the difficulty of 
falsifying signatures, stamps and dates, universal accessibility, unlimited storage, 
reducing paper usage and waste, and reducing the risk of documentation deterioration 
(EC 2019c). It therefore has potential to reduce costs for NCAs. However, surveyed 
NCAs had very mixed opinions: 7 said they disagreed that they wanted IMSOC to be 
used for PRM and FRM whereas 7 agreed. Two NCAs expanded on this during 
interviews, explaining that the benefits of IMSOC would only be seen if it was ensured 
that all MS used the same system as it might otherwise complicate the existing 
processes. On the other hand, one NCA stated that they expected it would improve 
the efficiency of PRM and FRM controls.  

There were concerns among NCAs about the potential additional compliance costs that 
could arise with close alignment of PRM and FRM legislation with the OCR. When asked 

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about the impacts if they were obligated to carry out risk-based controls in the survey, 
13 NCAs across 12 MS (out of a total 25 NCAs in 22 MS) said there would be an 
increase in NCA effort required to organise controls on imports, during production 
and/or on marketing of PRM and FRM. A further 11 NCAs across 10 MS said there 
would be an increased administrative burden, while only 4 NCAs (in 4 MS) said there 
would be a decrease in either their effort or administrative burden. Five interviewed 
NCAs expressed concerns about the “bureaucracy” of the OCR, stating that it would 
“overcomplicate the controls” and lead to an “additional burden”. These concerns were 
primarily tied to the expectation of existing controls being intensified and the loss of 
flexibility. However, these assessments were not substantiated with examples of 
specific costs and how they were expected to change.  Additionally, an expert on the 
OCR consulted for this study noted that inclusion of PRM and FRM in the OCR could 
also lead to NCAs employing PRM and FRM inspectors in other control activities, in 
which case the focus on PRM and FRM could in fact decrease rather than intensify. 

There are two regimes for import controls in the OCR: a stricter regime, for categories 
of animals and goods subject to official controls at border control posts (as specified in 
Article 47-64 of the OCR), and a lighter regime for categories of animals and goods 
not subject to official controls at border control posts (Articles 44-46 of the OCR). The 
stricter regime requires controls to be carried out on each consignment on first arrival 
into the EU. The lighter regime takes a risk-based approach and allows for controls to 
be carried out at any appropriate place within the EU. Under M2.3 (full application of 
OCR to PRM and FRM) PRM would fall under the stricter regime for import controls. As 
such, any increase in the compliance costs for NCAs is likely to be greatest under this 
measure. Nevertheless, just under half of surveyed NCAs (12 of 25) felt there was a 
need for stricter import controls. Despite this, stakeholders also valued the flexibility 
granted by current legislation around official controls to adapt to their national context 
(as mentioned by an NCA, an industry association and a civil society organisation). 
They feared inclusion of PRM and FRM in the OCR could reduce flexibility and changes 
to their existing processes. In this respect, M2.1 represents the least impact for NCAs 
as rules on controls would be harmonised with the OCR but remain in PRM legislation. 
M2.2 would enable greater alignment with plant health legislation as they would fall 
under the same basic controls regime, while still allowing some flexibility for PRM-
specific adaptions in the sectoral legislation. Nevertheless, even full application of OCR 
to PRM and FRM (M2.3) would not remove all flexibility afforded to MS. Rather, the 
OCR sets parameters within which MS can operate, so they could work to these 
parameters according to their national requirements.   

The OCR was perceived by interviewed NCAs as inappropriate for the FRM sector due 
to its focus on the agri-food chain. Three NCAs and one business association 
specifically stated that FRM should not be included in the OCR. One NCA explained 
that FRM objectives related to forest production and climate adaption, which did not 
align with the human health and food safety objectives of the OCR. Another NCA 
stated that FRM should be considered a low-risk material and that “risk-based controls 
are not desirable”. The business association felt that the current system for FRM 
offered “better guarantee for the final customers” and the OCR would need updating 
to accommodate FRM. Additionally, it is intended that designation of official 
laboratories and reference centres allows the ISTA (International Seed Testing 
Association) laboratory accreditation regime to be taken into account. However, two 
interviewed NCAs for FRM stated that ISTA accreditation would be too expensive in the 
context of FRM. This issue is also seen in survey responses, whereby no NCAs for FRM 
agreed that rules on designation of official laboratories and accreditation needed to 
take into account the rules on seed sampling and testing and the laboratory 
accreditation regime of ISTA (5 disagreed and 2 said they didn’t know).  

All three policy options will lead to at least some increases in compliance costs for 
NCAs. M2.1 is likely to have the more minimal impact on NCAs’ compliance costs 
initially, as NCAs would retain the greatest degree of flexibility than that offered under 
M2.2 and M2.3 and therefore changes to their existing PRM/FRM control regimes 

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would be minimised. While M2.2 and M2.3 may require more resources initially from 
NCAs to implement, it is possible that these are outweighed by the long-term 
efficiency gains from closer alignment with the plant health regime. As the stricter of 
the three measures, M2.3 likely represents the greatest impact for NCAs. By 
introducing standardisation to a risk-based approach to official controls across all MS, 
all three options are likely to support higher quality PRM and FRM, and reduce the risk 
of fraud. Nevertheless, as M2.3 applies the stricter import controls, this option is likely 
to have the greatest impact on reducing fraudulent and/or low quality PRM and FRM 
entering the EU.  

Conduct of business 

Under all measures, harmonising the approach to controls across Member States is 
likely to support a more level playing field for business operators. This is because the 
controls that operators are subject to are variable across the EU. For example, as 
described in the baseline assessment, three interviews showed that some Member 
States were carrying out marketing controls whilst others were not. One industry 
representative felt this contributed to fraudulent practices in countries without 
marketing controls, disadvantaging compliant operators. They also felt harmonisation 
would better help to prevent such fraudulent activity. Accordingly, it is possible that 
under OCR the official EU Seed Fraud Network could function more efficiently as it 
could be part of the OCR IT support systems (European Commission, 2021b).  

EC et al (2021) also observed differences in the costs of non-compliance for 
businesses, whereby an offence could result in a small fine in some MS but a prison 
sentence in others. This is because rules on penalties in current PRM and FRM 
legislation allow MS flexibility to choose how to penalise infringements, providing these 
penalties meet certain criteria (e.g. being ‘effective, proportionate and dissuasive’ – 
Directive 66/402/EEC). The OCR too offers MS some flexibility to lay down their own 
rules on penalties, but it provides more specific parameters than current PRM and FRM 
legislation – for example, financial penalties for violations of the OCR perpetrated 
through fraudulent practices must reflect ‘either the economic advantage for the 
operator’ or ‘a percentage of the operator’s turnover’ (Regulation (EU) 2017/625). 
Additionally, the OCR describes general obligations for NCAs in respect of 
enforcement, actions to be taken in the event of non-compliance and mechanisms for 
reporting infringements. These additional provisions may similarly support a more 
level playing field for business operators by increasing the consistency of the 
approaches taken to enforcement of PRM and FRM legislation across the EU.  

There may also be efficiency gains for compliant businesses operating in low-risk 
areas of PRM and FRM in MS that do not currently take a risk-based approach to 
controls, as the intensity of controls they are subject to could decrease (EC 2021a). 
This is because a risk-based approach would focus NCA resources on PRM and FRM 
and operators in the sector that represent the highest risk of non-compliance. This can 
be seen in the strong demand for risk-based controls seen among industry in the 
survey. The majority agreed that marketing controls on PRM/FRM should be risk-based 
(21 of 23 business associations and 13 of 18 individual businesses agreed) and that 
NCAs should be able to perform audits of operators that take into account operators’ 
own controls and private quality assurance schemes (21 of 23 business associations 
and 17 of 18 individual businesses agreed).  

EU businesses could see a competitive benefit of the stricter import controls proposed 
under M2.3. In the survey, the majority of businesses agreed that stricter controls 
should be carried out on PRM/FRM imported into the EU from third countries (15 of 23 
business associations and 12 of 18 businesses). One industry representative explained 
that they wanted to ensure operators exporting into the EU were subject to the same 
controls as EU operators, so operators did not face unfair competition from abroad. 
Similarly, another industry representative stated that sometimes imported PRM was of 
poorer quality and they hoped stricter controls would prevent this.  

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Sectoral competitiveness, trade and investment 

In Member States with existing strict import controls on PRM and FRM (i.e. checks on 
every or most consignments), if these controls were to become risk-based there may 
be an increase in imports from compliant operators in third countries as they do not 
need to handle the same volume of controls at EU borders. This is of note considering 
the majority of NCAs said they carried out at least one type of check (documentary, 
visual, sampling and testing and/or post control tests) on 100% of imported 
consignments (14 of 20 surveyed NCAs responding to the question).  

On the other hand, those NCAs with lighter import controls on PRM and FRM may see 
a decrease in imports under M2.3, due to these controls becoming stricter. The survey 
showed that some Member States already had a risk-based regime for PRM/FRM 
imports (e.g. 9 of 22 NCAs said their documentary checks were risk based). However, 
each consignment of goods subject to the OCR’s stricter import requirements must be 
controlled, therefore increasing the compliance costs for third country exporters. There 
could also be an indirect impact on EU businesses that rely on imports from third 
countries due to an increase in costs of these imports should they become stricter 
(M2.3), or a decrease if the import controls were risk-based (M2.1 and M2.2). 

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Study supporting the Impact Assessment of the revision of the plant and forest reproductive material legislation – Final report 

A5.14.3 

Analysis of the 11 PRM Directives and the OCR legal texts 

PRM & FRM Directives 

Directive 
66/401/EEC
 – 
marketing 
of fodder 
plant seed 

Directive 
66/402/EEC
 – 
marketing 
of cereal 
seed 

Included – 
Minimal 
detail, focus 
is on control 
procedures 
relating to 
certification 
rather than 
ongoing 
controls. 

Included- 
Minimal 
detail, focus 
is on control 
procedures 
relating to 
certification 
rather than 
ongoing 
controls. 

Included–- 
but 
requirements 
don't 
specifically 
refer to 
delegated 
bodies  
(instead sets 
out 
requirements 
for official 
supervision, 

Included–- 
but 
requirements 
don't 
specifically 
refer to 
delegated 
bodies  
(instead sets 
out 
requirements 
for official 
supervision, 

Directive 
2002/53/EC
 – common 
catalogue of 
agricultural 
plant 
species 

Directive 
2002/54/EC
 – 
marketing 
of beet seed 

Directive 
2002/55/EC
 – 
marketing 
of vegetable 
seed 

Directive 
2002/56/EC
 – 
marketing 
of seed 
potatoes 

Directive 
2002/57/EC
 – 
marketing 
of seed of 
oil and fibre 
plants 

Directive 
68/193/EEC
 – 
marketing 
of material 
for the 
propagation 
of the vine 

Directive 
1998/56/EC
 – 
marketing 
of 
propagating 
material of 
ornamental 
plants 

Directive 
2008/72/EC
 – 
marketing 
of vegetable 
material, 
other than 
seed 

Not included–
- does not 
deal with PRM 
product 
directly, as 
such, official 
controls are 
not relevant 
and are not 
referred to at 
any point in 
the 
legislation. 

N/A–- see 
above 

Included–- 
Minimal 
detail, focus 
is on control 
procedures 
relating to 
certification 
rather than 
ongoing 
controls.  

Included–- 
Minimal 
detail, focus 
is on control 
procedures 
relating to 
certification 
rather than 
ongoing 
controls.  

Included–- 
Minimal 
detail, focus 
is on control 
procedures 
relating to 
certification 
rather than 
ongoing 
controls.  

Included–- 
Minimal 
detail, focus 
is on control 
procedures 
relating to 
certification 
rather than 
ongoing 
controls.  

Included–- 
Minimal 
detail, focus 
is on control 
procedures 
relating to 
certification 
rather than 
ongoing 
controls.  

Included–- 
Contains a 
specific 
section on 
"Control 
measures and 
general 
provision" 

Included–- 
but 
requirements 
don't 
specifically 
refer to 
delegated 
bodies  
(instead sets 
out 
requirements 
for official 
supervision, 

Partly 
included–- 
states that 
"official 
measure”" 
could be 
taken by 
NCAs or 
others. Does 
refer to 
official 
supervision, 
but only in 

Partly 
included–- 
states that 
"official 
measure”" 
could be 
taken by 
NCAs or 
others. Does 
refer to 
official 
supervision, 
but only in 

Included–- 
but 
requirements 
don't 
specifically 
refer to 
delegated 
bodies  
(instead sets 
out 
requirements 
for official 
supervision, 

Partly 
included–- 
states that 
"official 
measure" 
could be 
taken by 
NCAs or 
others. Does 
refer to 
official 
supervision, 
but only in 

Included–- 
makes 
reference to 
"Responsible 
official bod”". 
They can 
"delegate the 
tasks 
provided for 
in this 
Directive to 
be 
accomplished 

Included–- 
Requires 
NCAs to 
ensure 
suppliers are 
compliant 
through 
controls. 
Allows for 
separate 
legislation on 
implementing 
procedures 
for the 
described 
controls (inc. 
official 
inspection 
and sampling 
measures).  

Included–- 
makes 
reference to 
"Responsible 
official bod”". 
They can 
"delegate the 
tasks 
provided for 
in this 
Directive to 
be 
accomplished 

Directive 
2008/90/EC
 – 
marketing 
of fruit 
propagating 
material 
and fruit 
plants for 
fruit 
production 

Included–- 
Contains a 
section on 
control 
measures 
which refers 
to official 
inspection, 
community 
monitoring, 
community 
checks in MS 
and follow-up 
actions by 
MS.  Allows 
for controls to 
be provided 
for in 
separate 
legislation. 

Included–- 
makes 
reference to 
"Responsible 
official bod”". 
They can 
"delegate the 
tasks 
provided for 
in this 
Directive to 
be 
accomplished 

Directive 
1999/105/E
C – 
marketing 
of forest 
reproductive 
material 

Included–- 
but very little 
detail, gives 
MS free reign 
"the Member 
States must 
make 
provision for 
appropriate 
control 
arrangements
”. Allows for 
controls to be 
provided for 
in separate 
legislation. 

Included–- 
makes 
reference to 
"Official 
body”.  which 
can "delegate 
the tasks 
provided for 
in this 
Directive to 
be 
accomplished 
under their 

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including 
qualifications/
skills etc of 
seed 
samplers). 
Requirements 
in OCR are 
more 
extensive.  

including 
qualifications/
skills etc of 
seed 
samplers). 
Requirements 
in OCR are 
more 
extensive.  

Included–- 
but highly 
technical and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

Included–- 
but 
technical/PRM
-specific and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

Included–- 
but reference 
to controls 
carried out on 
imports is 
very 
minimal/vagu
e (appears to 
refer only to 
information 
requirements
) 

Included–- 
but reference 
to controls 
carried out on 
imports is 
very 
minimal/vagu
e (appears to 
refer only to 
information 
requirements
) 

N/A–- see 
above 

N/A–- see 
above 

including 
qualifications/
skills etc of 
seed 
samplers). 
Requirements 
in OCR are 
more 
extensive.  

Included–- 
but 
technical/PRM
-specific and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

the context of 
labelling 
rather than 
controls. 

the context of 
labelling 
rather than 
controls. 

Included–- 
but 
technical/PRM
-specific and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

Included–- 
but 
technical/PRM
-specific and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

including 
qualifications/
skills etc of 
seed 
samplers). 
Requirements 
in OCR are 
more 
extensive.  

Included–- 
but 
technical/PRM
-specific and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

the context of 
labelling 
rather than 
controls. 

under their 
authority and 
supervision" 

under their 
authority and 
supervision” 

under their 
authority and 
supervision" 

authority and 
supervision" 

Included–- 
but 
technical/PRM
-specific and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

Not included–
- does not 
appear to be 
requirements 
for certifying 
the 
propagating 
material of 
ornamental 
plants 

Not included–
- does not 
appear to be 
requirements 
for certifying 
the vegetable 
material 
other than 
seed 

Included–- 
defines 
"certified 
material" and 
sets out some 
requirements, 
although they 
are not very 
detailed 

Included–- 
but reference 
to controls 
carried out on 
imports is 
very 
minimal/vagu
e (appears to 
refer only to 
information 
requirements
) 

Included–- 
but reference 
to controls 
carried out on 
imports is 
very 
minimal/vagu
e (appears to 
refer only to 
information 
requirements
) 

Included–- 
but reference 
to controls 
carried out on 
imports is 
very 
minimal/vagu
e (appears to 
refer only to 
information 
requirements
) 

Included–- 
but reference 
to controls 
carried out on 
imports is 
very 
minimal/vagu
e (appears to 
refer only to 
information 
requirements
) 

Included–- 
but reference 
to controls 
carried out on 
imports is 
very 
minimal/vagu
e (appears to 
refer only to 
information 
requirements
) 

Partly 
included–- 
legislation 
states that 
products from 
third 
countries 
marketed in 
the EU must 
fulfil the 
same 
requirements, 
but there are 
no specific 
control 
requirements 
set out 

Partly 
included–- 
legislation 
states that 
products from 
third 
countries 
marketed in 
the EU must 
fulfil the 
same 
requirements, 
but there are 
no specific 
control 
requirements 
set out 

Partly 
included–- 
appears to 
give MS 
option to 
"apply to the 
import of 
propagating 
material and 
fruit plants 
from third 
countries 
conditions at 
least 
equivalent to 
those 
indicate" but 
no specific 
control 
requirements 

Included–- 
technical/FRM
-specific and 
therefore 
would not be 
easily 
integrated 
with the 
existing OCR 
provisions.  

Partly 
included–- 
requires 
imports to 
offer "the 
same 
assurance" to 
FRM produced 
in the EU, but 
there are no 
specific 
control 
requirements 
set out 

ting 

N/A–- see 
above 

Included–- 
with specific 
technical 
features;  
little 
similarity to 
requirements 
described in 

Included–- 
highly 
technical, 
PRM-specific. 
Comparative 
tests appear 
to correspond 
with elements 

Included–- 
with some 
specific 
technical 
features; 
little 
similarity to 
requirements 

Included–- 
with some 
specific 
technical 
features; 
little 
similarity to 
requirements 

Included–- 
very little 
information 
on sampling.  
Only 
similarity with 
OCR is the 
comparative 

Included–- 
with lots of 
specific 
technical 
information. 
Comparative 
tests appear 
to (?) 

Included–- 
with lots of 
specific 
technical 
information. 
Comparative 
tests appear 
to correspond 

Included–- 
but 
information is 
limited. 
Requires MS 
to take 
samples to 
verify 

Included – 
but 
information is 
very limited, 
suggests 
implementing 
procedures 
for controls 

Included–- 
but 
information is 
limited and 
mostly refer 
to sampling 
by the 
Commission 

Included–- 
less detail for 
sampling, but 
testing is 
covered in 
significant 
technical 
detail.  

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Study supporting the Impact Assessment of the revision of the plant and forest reproductive material legislation – Final report 

of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS) 

the OCR. 
Comparative 
tests appear 
to correspond 
with elements 
of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS) 

described in 
the OCR 
other than 
the tests 
which appear 
to correspond 
with elements 
of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS) 

described in 
the OCR 
other than 
the tests 
which appear 
to correspond 
with elements 
of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS) 

tests which 
appear to 
correspond 
with elements 
of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS) 

correspond 
with elements 
of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS) 

with elements 
of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS). Sets out 
specific 
conditions 
relating to 
the growing 
crop. 

ies 

Included–- 
but 
requirements 
are more 
extensive in 
OCR 

Included–- 
but 
requirements 
are more 
extensive in 
OCR 

N/A–- see 
above 

Included–- 
but 
requirements 
are more 
extensive in 
OCR 

Included–- 
but 
requirements 
are more 
extensive in 
OCR 

Not included 

Included–- 
but 
requirements 
are more 
extensive in 
OCR 

Not included 

should be 
adopted in 
separate 
legislation. 
Commission 
are enabled 
To carry out 
tests, but 
there's not 
specific 
requirements 
for tests 
carried out by 
MS.  

rather than 
that required  
for MS when 
carrying out 
official 
controls. 
Suggests 
implementing 
procedures 
for controls 
should be 
adopted in 
separate 
legislation.  

Not included  Not included 

Included–- 
laboratories 
must be 
accredited, 
requirements 
for 
accreditation 
are set out 

compliance, 
and for 
suppliers to 
take samples 
for laboratory 
analysis, but 
no more 
specific 
controls 
requirements. 
Information 
on 
comparative 
tests appears 
to correspond 
with elements 
of the OCR 
(ensuring 
consistency in 
the 
methodologie
s used across 
MS) 

Partly 
included–- 
but 
information is 
minimal, only 
states that 
laboratories 
where 
samples are 
analysed 
should have 
"suitable 
facilities and 
expertise" 

Not included 

Not included  N/A–- see 

Not included  Not included  Not included  Not included  Not included  Not included 

Not included  Not included  Not included 

above 

N/A–- see 
above 

Included–- 
detail in OCR 
is more 
extensive but 
there are 
some 
parallels (e.g. 
penalties). 
Gives MS free 

Included–- 
detail in OCR 
is more 
extensive but 
there are 
some 
parallels (e.g. 
penalties). 
Gives MS free 

Included–- 
detail in OCR 
is more 
extensive but 
there are 
some 
parallels (e.g. 
penalties). 
Gives MS free 

Included–- 
detail in OCR 
is more 
extensive but 
there are 
some 
parallels (e.g. 
penalties). 
Gives MS free 

Not included–
- no 
reference to 
enforcement 
or penalties 

Not included–
- no 
reference to 
enforcement 
or penalties 

Included–- 
detail in OCR 
is more 
extensive but 
there are 
some 
parallels (e.g. 
penalties) 

Not included–
- only states 
that MS "shall 
require that 
suppliers take 
all necessary 
measures to 
guarantee 
compliance" 

Included–- in 
instances of 
non-
compliance, 
MS "shall 
take 
appropriate 
action to 
ensure that it 

Included–- 
requires MS 
to ensure 
"appropriate 
measures are 
taken against 
that supplies" 
but does not 

Not included–
- no specific 
reference 
made to 
enforcement 
or penalties 
for non-
compliance 

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reign on 
deciding rules 
for penalties. 

reign on 
deciding rules 
for penalties. 

reign on 
deciding rules 
for penalties. 

reign on 
deciding rules 
for penalties. 

ssistance and cooperation 

N/A–- see 
above 

Included – 
requires MS 
making use of
a specific 
derogation to 
"assist each 
other 
administrativ
ely as regards
inspection" 

Included–- 
requires MS 
making use 
of a specific 
derogation to 
“assist each 
other 
administrativ
ely as 
regards 
inspection" 

Included – 
requires MS 
making use 
of a specific 
derogation to 
“assist each 
other 
administrativ
ely as 
regards 
control" 

Included – 
requires MS 
making use 
of 
derogations 
to “assist 
each other 
administrativ
ely as 
regards 
inspection" 
and “as 
regards 
checks”" 

Included–-
“"Member 
States 
making use of
the 
derogations 
should assist 
each other 
administrativ
ely as regards
inspection”" 

Included–- 
requires MS 
making use 
of a specific 
derogation to 
“assist each 
other 
administrativ
ely as 
regards 
inspection”" 

Included–- 
where 
maintenance 
is carried out 
in a MS 
“other than 
that in which 
the variety 
was 
accepted” the 
MS shall 
“assist each 
other 
administrativ
ely as 
regards 
control”" 

set out 
specifics 

does comply 
with the 
provisions of 
this Directive 
or, if that is 
not possible, 
to ban the 
marketing of 
that 
vegetable 
propagating 
and planting 
material in 
the 
Community" 

Not included 

Not included  Not included 

orting 

Not included 

Not included  N/A–- see 

Not included  Not included  Not included  Not included  Not included  Not included 

Not included  Not included 

above 

Included–- 
allows for 
Commission 
to arrange for 

Included–- 
allows for 
Commission 
to carry out 

N/A–- see 
above 

Included–- 
allows for 
Commission 
to carry out 

Included–- 
allows for 
Commission 
to arrange for 

Included–- 
gives 
Commission 
powers to 

Included–- 
allows for 
Commission 
to arrange for 

Included–- 
allows for 
Commission 
to arrange for 

Included–- 
but only 
briefly states 
"The 

Included–- 
enables 
Commission 
experts to 

Included–- 
sets out 
details for 

208 

Included – MS 
must ensure 
that “the 
respective 
official bodies 
assist each 
other 
administrative
ly in order to 
obtain 
appropriate 
information 
necessary to 
ensure the 
proper 
functioning of 
this Directive" 

Partly 
included–- 
not directly 
related to 
official 
controls 
(requirements 
for planting in 
accordance 
with a plan 
approved by 
official body) 

Included–- 
enables 
Commission 
experts to 

 
Study supporting the Impact Assessment of the revision of the plant and forest reproductive material legislation – Final report 

comparative 
tests but no 
more specific 
controls 
requirements 

comparative 
tests and 
trials but no 
more specific 
controls 
requirements 

"comparative 
tests and 
trials” but 
only for the 
“post-control 
of samples of 
beet seed 
placed on the 
market". No 
more specific 
controls 
requirements 

comparative 
tests but no 
more specific 
controls 
requirements 

prohibit 
marketing of 
seed potatoes 
in a particular 
area in 
certain cases 

comparative 
tests but no 
more specific 
controls 
requirements 

comparative 
tests but no 
more specific 
controls 
requirements 

"Community 
monitoring" 

carry out "on-
the-spot 
check" 

Commission 
may organise 
inspections of 
trials by 
representativ
es of the 
Member 
States and of 
the 
Commission" 

carry out "on-
the-spot 
check " and 
trials or tests 
to check 
compliance 
with the 
Directive 

Included (for 
seed 
samplers & 
analysts only) 

N/A–- see 
above 

Included (for 
seed 
samplers & 
analysts only; 
but states 
inspection 
must have 
"necessary 
technical 
qualification") 

Included (for 
seed 
samplers & 
analysts only; 
but states 
inspectors 
must have 
"necessary 
technical 
qualification") 

Included (for 
seed 
samplers & 
analysts only; 
but states 
inspectors 
must have 
"necessary 
technical 
qualification") 

Not included 

Included (for 
seed 
samplers & 
analysts only) 

Not included  Not included 

Not included  Not included  Not included 

agement systems 

Not included 

Not included  N/A - see 

Not included  Not included  Not included  Not included  Not included  Not included 

Not included  Not included  Not included 

above 

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A5.15  H.1 Relying more on digital technologies for labelling and 

certification/inspection processes  

This study question assesses the problems currently experienced by stakeholders with 
utilising digital technologies in the PRM and FRM sectors, and the potential impacts of 
legislative changes that could address these problems.   

Ref.  Study question 

O1   O2  O3  Measure 

H.1  What are the expected 

 

 

economic impacts, 
including in terms of 
administrative burdens, 
for competent 
authorities and 
operators of relying 
more on digital 
technologies for 
labelling and 
certification/inspection 
processes? 

M10.1 Make use of existing empowerments 
(i.e. tertiary legislation) to set requirements, 
allowing faster adaptation to scientific and 
technological developments 

 

M10.2 Establish detailed rules on 
digitalisation, biomolecular techniques and 
innovative production processes 

A5.15.1 

Problem statement  

Current PRM/FRM legislation can impede digitalisation due to its rigid procedures and 
requirements (EC 2021a). It therefore does not align with the objectives of the 
European Digital Strategy, which specifies a need to promote ‘the digital 
transformation of public administrations throughout Europe’ and create ‘a frictionless 
single market, where companies of all sizes and in any sector can develop, market and 
use digital technologies, products and services at a scale that boosts their productivity 
and global competitiveness’ (EC 2020a).  

EU PRM/FRM legislation does not effectively facilitate the use of all digital 
technologies. For example, around half of the stakeholders responding to the survey 
(51%, or 40 of 79) felt the legislation was a barrier to increasing the use of digital 
technologies in relation to inspection/ certification and labelling. One interviewed NCA 
provided the specific example of the requirement in PRM legislation for certificates to 
be “physical documents” despite producer demand for digital certificates and plant 
passports.  

There are wider barriers that affect use of digital technologies, beyond the PRM/FRM 
legislation. This includes the lack of technical skills (mentioned by 65% / 51 
respondents), available finances for SMEs to digitalise their processes (57% / 47 
respondents) and connectivity among some operators (57% / 45 respondents). 
Respondents also mentioned the lack of availability of digital tools (48% / 38 
respondents) and of public finances for incentivising the use of digital technologies 
(46% / 36 respondents).  

A5.15.2 

Impacts  

Baseline assessment 

Without EU intervention, use and development of digital technologies for labelling 
and certification/inspection processes is likely to be slow and fragmented across the 
EU. Digital technologies have the potential to improve traceability and transparency 
of labels (EC et al 2021) which is therefore less likely to be realised. The stakeholder 
survey and interviews indicate that some progress is being made towards applying 

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digital processes to PRM/FRM activities, with the majority of stakeholders reporting 
that they use digital processes in at least one type of activity (94%, or 74 of 79).  

However, there is a lot of variation across stakeholder groups and Member States. 
For example, around half of NCAs reported using digital processes for certification 
(13 of 22) and/or field inspection and testing (11 of 22). For other types of activities 
(variety examination and registration, seed sampling and testing, post-controls and 
enforcement), the number of NCAs reporting use of digital processes ranged from 7 
down to just 2. Other stakeholders (including business associations and individual 
businesses) also varied in the activities for which they used digital processes, 
ranging from 18 of 52 using them for seed testing, down to 2 that reported using 
them for enforcement-related activities. A similar trend was seen when stakeholders 
were asked about the PRM/FRM activities where digital processes were being 
developed.  

For some processes, digitalisation will continue to be hampered directly by 
requirements in PRM legislation. For example, the requirement in PRM legislation for 
certificates to be physical documents, as mentioned by an NCA, may prevent the 
adoption of purely digital certification processes. However, some issues are already 
being addressed at EU level without the need for legislative changes: two NCAs 
referred to the ongoing project to launch a single EU-wide plant varieties database69 
that combines existing databases (e.g. the common catalogues, FRUMATIS). This 
was expected to make it easier to search for important information and therefore 
reduce the administrative burden for NCAs. This development linked to work by the 
OECD to digitalise their seed schemes (Schemes for the Varietal Certification of 
Seed). The OECD seed schemes promote the use of high quality PRM by 
harmonising production and official control procedures in 61 participating countries 
(to which the EU adheres).  

Four NCAs did provide examples of their own digitalised systems and their 
corresponding benefits. This suggests Member States are able to address some 
issues regardless of legislative requirements. Nevertheless, it also further indicates 
fragmented approaches towards digitalisation. This points to a lack of system 
interoperability between Member States likely to continue without an EU-wide 
intervention.   

Public authorities 

Legislative support for digitalisation is likely to increase efficiency and reduce the 
administrative burden of PRM/FRM activities carried out by public authorities. The 
Estonian NCA that already has highly digitalised processes described the benefits of 
their online portal, through which producers submit applications and receive updates. 
They have been able to exchange information with producers more efficiently and save 
time and resources as they could carry out most certification activities remotely. This 
view was supported by eight other interviewed NCAs, who listed more general benefits 
of digitalisation including faster processes, reduced likelihood of mistakes, better 
exchange of information, increased ease of accessing information and more effective 
and efficient working practices.  

The OECD published a study assessing the feasibility of digitalising their seed 
schemes. The study highlights the benefits of digitalisation for NCAs in the context of 
PRM, noting that NCAs often rely on ‘manual business processes that are 
administratively complex, resource-intensive and limit their ability to innovate’ (OECD 
2021). Additional benefits to digitalisation of the OECD schemes for EU MS include the 
generation of knowledge and tools for use in seed certification, closer links between 
OECD seed scheme and the EU certification systems, the facilitation of data collection, 

69 https://ec.europa.eu/food/plant/plant_propagation_material/plant_variety_catalogues_databases/search/public/index.cfm 

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reporting and analysis to increase transparency of the seed trade and ensuring of EU 
connectivity to seed systems internationally. Other studies indicate that digitalisation 
could help NCAs streamline their administrative procedures and improve transparency 
(e.g. Vironen and Kah 2019; Sengupta and Kim 2021). Most surveyed NCAs (18 of 22) 
said they expected a decreased administrative burden if digitalisation was increased 
for inspection and labelling.  

However, there may also be cost and resourcing challenges for NCAs associated with 
digitalisation. While the European Commission previously estimated that a ‘digital by 
default’ strategy in the public sector ‘could result in round EUR 10 billion of annual 
savings’ (European Commission, 2015), only 7 of 22 surveyed NCAs expected to see 
decreased costs if digitalisation was increased in relation to inspection/certification and 
labelling. The OECD study recognised a need for expertise and knowledge in the 
introduction of new digital technologies (e.g. like blockchain), as well as the expense 
associated with initial investment in digital technologies alongside ongoing 
maintenance costs (OECD 2021). These issues were also raised by three NCAs, with 
one also highlighting the importance of staff training and familiarisation with any new 
digital tool or process.  

Placing obligations on NCAs to digitalise their processes according to detailed rules (as 
proposed under M10.2) could therefore present a significant challenge. As such, M10.2 
may offer the best balance in terms of both incentivising use of more digital tools 
while at the same time allowing NCAs the freedom to pursue those technologies which 
are most appropriate to their needs. 

Administrative burden on business and conduct of business, including SMEs 

Digitalisation in the context of PRM/FRM can support increased business efficiency as 
well as reduced administrative burden. This is due to decreases in paperwork, 
improved transparency and traceability, and processes that enable operators to access 
the market faster (EC et al 2021). The OECD study similarly highlighted the potential 
benefits of digital technologies to offer increased traceability and transparency along 
supply chains (OECD 2021), thereby supporting label security and reducing the 
resources businesses must commit towards monitoring their supply chains. Increased 
traceability and transparency can in turn increase trust in supply chains among 
consumers (Sengupta and Kim 2021), instilling them with confidence to make 
purchases and therefore providing an economic benefit to the industry. Accordingly, 
the majority of surveyed business associations and individual businesses indicated 
that they expected a decreased administrative burden (17 of 24 business associations 
and 14 of 17 businesses) and decreased costs (15 of 24 business associations and 14 
of 17 businesses) as a result of increase digitalisation in relation to 
inspection/certification and labelling.  

However, as with public authorities, there are also cost and resourcing challenges 
associated with digitalisation that can negatively impact businesses: businesses may 
need to invest both in the technology itself, as well as new staff with expertise and/or 
staff training (OECD 2021). This can particularly disadvantage SMEs (EC et al 2021). 
For example, Bonny (2017) find that digital farming could lead to ‘dependence of 
farmers on the upstream sector’ due to reliance on larger actors for collecting big data 
on crop practices and disseminating this to smaller actors through digital tools (e.g. 
precision farming). One NCA similarly noted that costs of digital technologies can be 
“unjustifiable” for those operating in very small markets.  

Other impacts 

There may be a positive indirect impact on sectoral competitiveness, trade and 
investment, innovation and research and technological development and the digital 
economy under M10.1, due to the increased confidence of NCAs and industry to invest 
in digital technologies. By comparison, the detailed rules of M10.2 may act as a 
deterrent due to the more significant time needed to interpret them. For all measures, 
there may also be an indirect impact on consumers and households if traceability and 

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information increased as a result of the introduction of a new technology, as 
consumers (e.g. amateur gardeners) would have better information with which to 
make purchasing decisions (e.g. EC et al 2021). There is also the possibility of an 
indirect impact on the environment due to the high energy requirements of some 
digital technologies such as blockchain (e.g. Wang, Han and Beynon-Davies 2019; EC 
et al 2021). 

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Annex 6  Consultation synopsis  

A6.1 

Introduction 

This synopsis annex provides an overview of the results of the stakeholder 
consultation carried out by ICF to support proposed revision of the EU legislation on 
plant and forest reproductive material (PRM, FRM).  The stakeholder consultation 
activities began in December 2021 and concluded in April 2022. The aim of the 
stakeholder consultation was to gather opinion and evidence (qualitative and 
quantitative) from key stakeholders and experts to support the assessment of impacts 
of the policy options, and their constituent measures, under consideration.  

The following sub-sections provide an overview of the consultation activities 
undertaken and the targeted stakeholder groups. A mixed-methods approach was 
chosen for the consultation, comprising a public consultation, targeted survey, an 
interview programme and focus groups. In addition, stakeholder interviews were 
conducted as part of case study research. All relevant stakeholders were given an 
opportunity to provide their views (Table 34).    

 Summary of stakeholder consultations 

Scoping 
interviews 

OPC 

Targeted 
surveys 

Focus 
groups 

Interviews 

Specific 
issue 
interview 
& survey 

Citizens (consumers)  

Industry associations  

X 

Nurseries in the FRM/PRM 
sector  

Forestry associations  

X 

X 

X 

Farmers and farming 
associations  

Competent authorities  

Community seed banks 
and seed savers’ 
organisations  

EU and international 
organisations  

Home gardeners & 
associations  

Scientific networks on 
PRM and FRM  

Non-forestry purposes of 
FRM 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

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A6.2 

Scoping interviews 

Six exploratory interviews with stakeholders to obtain general views of the study 
context and approach to the impact assessment. Specifically, the interviews gathered 
views on the range of different stakeholders’ perspectives concerning the existing 
legislation and their expectations for the study; likely data gaps or obstacles to 
information access; and potential sources of evidence and possible contacts for the 
main consultation phase. 

A6.3 

Public Consultation 

The European Commission carried out an online public consultation on the revision of 
the  EU  legislation  on  plant  and  forest  reproductive  material  (PRM,  FRM)  from  21 
December 2021 to 27 March 2022. The questionnaire was available in 24 languages. 

The public consultation sought the views of citizens, professional and non-professional 
stakeholders about proposals for the revision across several topics: regulation of PRM 
in the EU, the scope of the marketing directives, alignment of the rules, Member State 
exemptions  and  deviations,  regulated  species,  Common  catalogues,  heterogeneous 
material  and  organic  varieties,  plant  and  forest  genetic  resources,  sustainability, 
harmonisation of official controls, innovative processes and digital transformation, FRM 
and non-forestry purposes, and FRM and the adaptation strategy. The evidence collected 
will feed into the impact assessment on the revision of the plant and forest reproductive 
material legislation. 

A6.3.1 

Overview of respondents 

There were 2,449 responses to the public consultation. The majority of responses (78%, 
1,908 of 2,449) were from EU Citizens. Of the 541 respondents who were not citizens, 
37% (202 of 541) were from Company/business organisations. By size, a majority of 
company/business  organisations  (59%,  120  of  202)  were  from  ‘Micro  (1  to  9 
employees)’  enterprises.  Over  half  of  all  public  authority  responses  (54%,  29  of  54) 
were  from  national  authorities.  Amongst  Public  authorities,  Germany  had  the  highest 
number  of  responses  (18  of  54),  with  responses  from  national,  regional  and  local 
authorities.  

The first question was targeted at the general public and was responded to by the whole 
sample. Subsequent questions were addressed to stakeholders with expert knowledge 
of  the  legislation.  90%  of  citizen  participants  did  not  respond  to  these  subsequent 
questions.  In  total,  488  responded  to  expert  questions  on  PRM  only,  61  to  expert 
questions on FRM only, and 210 to expert questions on both PRM and FRM.  

Over three quarters (79%) of citizen respondents, and half (50%) of company/business 
organisation respondents were from Sweden. National press articles concerning the PRM 
legislation  revision  and  public  consultation  may  have  stimulated  the  higher-than-
average level of response from Sweden. There was a high level of variation in Swedish 
citizen and company/business closed question responses. For Swedish citizens, only a 
small number of open question responses are identical (less than five in any one case) 
but they have a high tendency to focus on a few specific issues, in particular asking to 
facilitate the preservation of local and traditional varieties and not to impose any rules 
on  the  exchange  of  seed  between  amateur  gardeners.  In  both  categories 
“company/business  organisations”  and  “public  authorities”  there  were  cases  of 
submissions  of  identical  additional  documents,  although  less  than  10  in  each  case.  A 
campaign has been identified by which 32 respondents, mostly citizens from Germany, 
replied “disagree” to the statements “Marketing of PRM needs to be governed at EU level 
to ensure identity (e.g. 100% of seed purchased produces red tomatoes instead of green 
tomatoes), quality (e.g. germination rate) and health (absence of pests) of PRM” and 
“The current rules have enabled the free movement, availability and quality of PRM on 
the EU market”. The same respondents also submitted identical position papers. 

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  Responses disaggregated by stakeholder group 

  Responses by Country 

A6.3.2 

Topics addressed 

The  consultation  asked  respondents  to  agree  or  disagree  with  statements  regarding 
problems, objectives and options for the legislation. 

Regulation  of  PRM  in  the  EU:  Opinion  on  the  statement  “the  current  rules  are 
outdated, fragmented and incoherent” was polarised across stakeholder groups. Public 
authority  and  business  associations  were  the  only  two  stakeholder  groups  where  a 
majority of respondents ‘Disagreed’ or ‘Somewhat disagreed’ with the statement (57%, 
31 of 54, and 63%, 36 of 57, respectively). 

The scope of the marketing directives: The level of agreement/disagreement with 
the statement “the rules should apply to the marketing of PRM to all kinds of users with 
no exceptions” differed across stakeholder groups. Two thirds of Business Association 

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(69%, 31 and of 45) and Public authority (63%, 23 of 37) respondents selected ‘Agree’ 
or  ‘Somewhat  agree’;  whilst  a  majority  of  Non-Governmental  Organisation  (NGO) 
respondents (92%, 36 of 39) and EU and Non-EU citizens (79%, 303 of 383) selected 
‘Disagree’ or ‘Somewhat disagree’. Additional opinions offered articulated the potential 
impacts  of  changing  /  not  changing  the  scope  of  the  directives,  and  also  suggested 
approaches to defining the scope. 

Alignment  of  the  rules:  Respondents  were  asked  about  four  options  for  improving 
alignment of the directives. More than twice as many respondents selected ‘Agree’ or 
‘Somewhat  agree’  (60%,  218  of  363)  that  coherence  of  the  legislation  could  be  best 
improved  “by  aligning  the  structure  and  definitions  of  the  12  PRM  directives,  but 
retaining  them  as  separate  policy  instruments”,  than  agreed  with  the  other  three 
options. Additional opinions offered support for the removal of unnecessary complexity 
and  ambiguity  in  the  directives,  whilst  still  recognising  the  specifics  of  different  crop 
groups. 

Regulated  species:  Opinion  on  whether  the  list  of  EU-regulated  species  should  be 
increased  or  reduced  differed  across  stakeholder  groups.  Four  groups  had  more 
respondents agreeing that the number of species should be decreased (NGO, EU and 
Non-EU  Citizen,  Environmental  organisation,  and  Other)  and  three  had  more 
respondents  agreeing  that  the  number  may  need  to  increase  (Academic/research 
institution,  Public  Authority,  Business  Association).  Additional  opinions  offered 
articulated  views  on  why  the  list  of  regulated  species  should  increase/decrease,  and 
highlighted challenges of defining criteria to guide decisions. 

Plant genetic resources (Conservation varieties, and vegetable crop varieties with no 
intrinsic  value  for  commercial  crop  production):  Overall,  80%  (252  of  315)  of 
respondents (and a majority of respondents from each stakeholder group) ‘Agreed’ or 
‘Somewhat agreed’ that “there should be lighter rules for these varieties regarding the 
marketing  conditions  (e.g.  registration  and  certification)”.  Additional  opinions  offered 
articulated the challenges and impacts of doing so. 

Sustainability:  With  the  exception  of  Business  association  respondents,  across  the 
stakeholder  groups  a  majority  of  respondents  ‘Agreed’  or  ‘Somewhat  agreed’  –  from 
54%  (20  of  37)  for  Public  authorities  to  75%  (3  of  4)  for  Trade  unions  –  with  the 
statement “the PRM legislation should contain a set of general sustainability criteria that 
Member  States  can  apply  taking  into  account  their  agro-ecological  conditions”.  61% 
(234 of 383) of Citizen respondents ‘Agreed’ or ‘Somewhat agreed’ with the statement. 
Additional opinions offered discussed the difficulties of harmonising VCU across Member 
States, the need for and implications of new sustainability criteria as well as suggested 
approaches for sustainability criteria. 

Harmonisation  of  official  controls:  Respondents  were  asked  whether  they  agreed  or  
disagreed with six statements. Across these, the highest level of agreement was with 
the statement “Inclusion in the scope of the OCR would increase administrative burdens 
for competent authorities as regards marketing and import controls”. Additional opinions 
offered discussed the implications on costs, as well the benefits and problems of risk-
based controls. 

FRM  and  non-forestry  purposes:  Respondents  were  asked  whether  the  FRM  rules 
should  be  maintained,  covering  the  production  and  marketing  of  FRM  for  forestry 
purposes only, or extended to also cover the production and marketing of FRM for non-
forestry purposes. Five stakeholder groups had clearly more respondents in agreement 
that the rules should be maintained (Trade union, Public authorities, Company/business 
association, NGO, and EU and non-EU citizens); three had higher levels of agreement 
that  the  rules  should  be  extended  (Academic/research  organisation,  Environmental 
organisation,  and  Other).  Additional  opinions  offered  discussed  EU  involvement  in 
contingency planning, use of voluntary inventory, rules to determine the suitability of 
FRM for climate change and extreme weather conditions, and the FRM Master Certificate. 

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A6.4 

Targeted survey 

A6.4.1 

Introduction 

The purpose of the survey was to collect stakeholder views and evidence on the 
challenges, costs and benefits, potential effects, and feasibility of potential changes to 
the legislation. The following stakeholder groups were addressed in the survey: 
academic/ research institution; business association (including of breeders, multipliers 
/ producers of PRM / FRM, traders, farmers, forest managers); company / business; 
consumer organisation; environmental organisation; non-governmental organisation 
(NGO); public authority – national competent authority and others. The survey 
contained dedicated sections on PRM and FRM and focussed on a wide variety of 
potential impacts, including but not limited to the costs and administrative burdens of 
stakeholders, impacts on trade, innovation and the environment. The survey opened 
on 9 March and closed on the 1 April, 2022.  

A6.4.2 

Overview of respondents 

In total 99 responses were received, out of this business associations represented 
26% (N=26), businesses 21% (N=21), academic/research institutions 8% (N=8); 
NGOs 4% (N=4); public authorities 31% (N=31). Those stakeholders, who identified 
themselves as belonging to the category of “others” (9%, N=9) contained financial 
and education institutions, intergovernmental bodies, foundations and other Member 
State government organisations70 (i.e., a research organisation and a ministry). Just 
under half (49%) of the 99 responses came from five countries, these are Austria 
(N=5), Belgium (N=8), France (N=13), Germany (N=12), the Netherlands (N=11). 
Overall, at least one response was received from stakeholders in 23 EU Member 
States. The targeted consultation collected views from stakeholders engaged across 
the supply chain of both PRM and FRM products. Two-third of respondents (N=74) 
answered PRM related questions, while 18% (N=18) responded to FRM ones, the 
remaining 7% responded to both topic areas.  

A6.4.3 

Topics addressed 

Alignment of the rules 

One of the fundamental issues addressed in the survey was the extent to which 
stakeholders are experiencing difficulties understanding and complying with the 
current legislation, and if so, what are the primary reasons for this. In terms of 
alignment between the PRM Directives regarding their structure, the definitions, and 
decision-making procedures, 72% (39 of 54 respondents) of businesses, association, 
academics and NGOs said that they had no problems. Those who experience problems 
identified, amongst others, complexity of legislation, lack of harmonisation in the 
definitions and cost of bureaucracy as a major problem. In contrast, national 
competent authorities were more evenly split with 55% (11 out of 20 respondents) 
saying they encountered no problems in terms of monitoring and enforcement of the 
relevant Directives. Those who encountered problems identified, amongst others, the 
lack of harmonisation and lack of structural alignment of the Directives as well as 
differences in implementation between Member States as major challenges.  

Regulated Species 

Just under half, 44% (28 out of 64 respondents) of stakeholders found that the 
current regulatory scope could be extended with additional species, while 67% (43 out 
of 64 respondents) said that none of the currently regulated list of species should be 

70 Two stakeholders identified themselves as belonging to the category of “others” despite the fact that they belong to public 
organisations functioning as NCAs. 

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excluded. When prompted about the possibility of the EU’s Common Catalogue to 
include non-regulated species as a way of incentivising their use, respondents saw no 
correlation with just under half of the stakeholders saying it would have no effect.   

Registration and certification processes for agricultural crops and vegetables 

In terms of costs 73% of stakeholders (32 out of 44 respondents) said that 1-5% of 
their annual research investment for breeding is spent on registering new varieties. 
Similarly, 75% (27 out of 36 respondents) said that 1-5% of their annual production 
costs is spent on seed certification. SME responses showed the same pattern with 
80% (4 out of 5 respondents) saying they spend up to 5% of their investment budget 
on registration and 75% (3 out of 4 respondents) stating that they spend up to 5% of 
their annual production costs on certification.  

VCU examination of varieties of agricultural plant species 

Reflecting on the differences in implementation of VCU tests between Member States, 
64% (27 out of 42 respondents) said that they experienced problems. In terms of the 
specific problem 89% (24 out of 27 respondents) said the cost and duration of VCU 
testing is a moderate or minor problem. Out of the listed other potential challenges, 
stricter requirements of VCU testing were seen as a minor problem by 74% (20 out of 
27 respondents) while lower quality of VCU tests were seen as a moderate problem by 
52% (14 out of 27 respondents).  

Examination  of  varieties  for  characteristics  that  contribute  to  sustainable 
production  

In response to the question on whether producers currently assess (mandatorily or 
voluntarily) new varieties of vegetables, fruit plants, ornamentals, and vines for 
characteristics that contribute to sustainable agri-food production, vegetables were the 
only category for which over half of the stakeholders responded positively. In all other 
categories producers were either unaware or did not carry out such tests. Despite 
currently not carrying out sustainability testing 59% of stakeholders (40 out of 68 
responses) favoured the introduction of a requirement to examine new varieties for 
characteristics that contribute to sustainable agri-food production in the PRM 
legislation.  

Scope of the marketing definition     

In terms of relevance 57% (25 out of 44 respondents) said that they do breed and 
75% (33 out of 44 respondents) said that they do market their products to amateur 
gardeners. In fact, 32% (8 out of 25 respondents) said that they breed products 
exclusively for amateur gardeners. Just over one-third of stakeholders found that the 
current marketing rules of the PRM legislation negatively impact on the diversity of 
PRM available to amateur gardeners. As for the potential future work of seed 
conservation networks 64% (37 out of 58 respondents) expect no change if the 
current regulatory environment is unchanged.  However, 34% (20 out of 58 
respondents) expect the number of seed conservation networks to increase if they are 
exempted from the legislation, while 43% (25 out of 58 respondents) expects their 
number to remain unchanged. Furthermore 60% (37 out of 62 respondents) think that 
in-kind seed exchanges between farmers should not be permitted in the EU.  

Fruit and vine propagating material 

Possible regulatory changes included the introduction of certification under official 
supervision, which the 41% of stakeholders (11 out of 26 respondent) believed would 
have no impact on the time it takes to certify their products, but 23% (6 out of 26 
respondents) expected that it could lead to cost reductions for certification. Equally 
most stakeholders expect that certification under official supervision would have no 
impact on the quantity (38%, 10 out of 26), quality (50%, 13 out of 26) or diversity 
(69%, 18 out of 26 respondents) of PRM products on the market. Regarding potential 
derogations allowing the marketing of certain, not yet certified PRM categories (i.e., 

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pre-basic, basic, certified) stakeholders were evenly split with 33% (9 out of 27 
respondent) voting yes and 30% (8 out of 27 respondents) voting no while 37% of 
stakeholders (10 out of 27 respondents) not knowing the response.   

Forest reproductive material (FRM) 

Stakeholders expected that a potential extension of the FRM Directive’s scope to non-
forestry purposes could improve sufficiency of supply and diversity of FRM marketed 
for non-forestry with 24% (6 out of 25 respondents) saying it would have a significant 
positive or positive impact. The quality of FRM marketed for non-forestry purposes 
could also see a significant positive or positive improvement according to 40% (11 out 
of 25 respondents). In terms of sufficiency of information that FRM buyers/users 
receive on the suitability of FRM for specific climatic conditions, 60% (15 out of 25) 
found it to be reasonable or sufficient. According to 48% (12 out of 25 respondents) of 
stakeholders over 75% of the available FRM is suited to the current ecological 
conditions of the sites on which it is to be used. Additionally, 64% (16 out of 25) 
agreed that having some form of a voluntary inventory would be beneficial, but 
opinions were evenly split on whether this should be organised at the EU or national 
level.  

Ηarmonisation of official controls  

Most respondents, 63% (47 out of 75) agreed that the current differences between 
the Member States in the application of official controls and enforcement of the 
PRM/FRM legislation create uneven conditions for the operators. Stakeholders also 
agreed that harmonisation of the current rules would decrease the risk of fraud (65%, 
49 out of 75), improve the guaranteed quality of imports (60%, 45 out of 75) and 
establishing rules on conditions and obligations for delegating official control tasks to 
delegated bodies or natural persons would enhance the effectiveness of official 
controls (60%, 45 out of 75). Furthermore, marketing controls on PRM/FRM should be 
risk-based according to 76% (57 out of 75 respondents) and competent authorities 
responsible for the PRM/FRM legislation should be able to perform audits of operators, 
according to 70% (65 out of 75 respondents).  

Innovative processes and digital transformation 

In  terms  of  financial  resources  dedicated  to  research  and  development,  42%  of 
businesses (23 out of 55 respondents) said they dedicate 10-25% of their revenue for 
this purpose, whereas only 5% (1 out of 22 respondents) of NCAs have the same level 
of  resource  allocation.  Opinions  were  evenly  split  on  whether  the  current  PRM/FRM 
Directives  adequately  reflect  and  integrate  the  latest  scientific  and  technological 
developments, with 43% (33 out of 77 respondents) agreeing and 44% (34 out of 77 
respondents) disagreeing. Overall, 56% (43 out of 77 respondents) of stakeholders said 
that the use of some scientific and technological developments is restricted or limited 
because it is not explicitly provided for in the current PRM/FRM regulatory framework. 
Stakeholders believe that a timelier integration of the latest scientific and technological 
developments  could  increase  investment  in  research,  decrease  the  time  and  costs  of 
registration  and  certification  and  increase  product  diversity  on  the  market.  Most 
stakeholders  (71%,  55  out  of  77  respondents)  anticipate  that  improved  digitalisation 
will  decrease  administrative  burden  and the  same  ratio  of  respondents  (36  out of  55 
respondents) believe this decrease will be significant or very significant. 

A6.5 

Interviews 

A6.5.1 

Introduction 

Interviews were undertaken to collect the views of stakeholders and evidence on the 
challenges, costs and benefits, potential effects, and feasibility of potential changes to 
the PRM and FRM legislation. Interviews provided an opportunity to obtain more 
detailed and contextualised views on the issues facing stakeholders than was possible 
through surveys. 

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Separate interview guides were developed for PRM and FRM-related issues and to 
address issues relevant to national competent authorities (NCAs) and other 
stakeholder groups. Topic guides were also tailored for interviews with OECD and 
CPVO representatives. The interview programme was launched on 3 March and closed 
on 12 April 2022. A total of 43 stakeholders were interviewed. Of these, 30 interviews 
focused on PRM issues and 13 on FRM issues. Stakeholders were invited to interview 
by the study team through a direct email. Non-respondents were sent two follow-up 
messages before an alternate stakeholder was selected. Topic guides and consent 
forms were sent to consultees in advance of the interview. Interviews were recorded 
with the permission of respondents. 

A6.5.2 

Overview of respondents 

Approximately half of those interviewed (18 of 43) were representatives of the 
national competent authorities in EU Member States (12 on PRM and 6 on FRM 
issues). NCAs from 14 Member States were consulted (separate NCAs were 
interviewed on PRM and FRM issues in 3 Member States). A total of 14 representative 
associations at EU or national level were interviewed (10 on PRM and 4 on FRM). Civil 
society organisations (5 on PRM and 1 on FRM) and scientific networks (2 on plant 
genetic resources and 1 on forest genetic resources) also participated. One 
interviewee represented an international organisation (OECD) and one represented an 
EU Agency (CPVO). 

A6.5.3 

Topics addressed 

This section provides a summary of the views and concerns of the stakeholders 
interviewed across each of the main issues addressed by the study.  

Alignment between policy instruments and ensuring coherence with other 
legislation: About half of respondents who discussed this topic identified a problem 
with the alignment of definitions and structure of the legislation. NCAs were more 
likely to identify a problem than other groups, citing a lack of clarity and consistency 
across the Directives on definitions, a lack of common and clear decision-making 
procedures (e.g. to add new species) and rules on some issues (e.g. official controls), 
and lack of consistency in the transposition of the legislation from EU to Member State 
level. 

Representative associations were more likely to indicate that there are minor or no 
problems for their members on this issue. Amongst those that did cite problems, along 
with civil society organisations and scientific networks, the main problems are variance 
in implementation of the legislation across Member States and complexity of the 
legislation making it difficult to understand and follow.  

Relying on tertiary legislation to set requirements and adapt to scientific and 
technological  developments:  A  majority  of  respondents  who  discussed  this  topic 
identified  a  problem  with  the  PRM  and  FRM  legislation’s  approach  to  addressing 
developments in science and technology. About half of these were NCAs and half were 
other  stakeholders.  In  particular,  respondents  observed  that  advancements  in 
biomolecular  techniques  are  not  well  accounted  for  in  the  legislation.  Difficulties  in 
amending the legislation were discussed by several respondents as the reason for this 
problem.  

Increasing  the  number  of  tasks  that  operators  may  carry  out  under  official 
supervision:  A  majority  of  respondents  who  discussed  this  topic  did  not  identify  a 
problem with the existing legislation in respect of a need to increase the number of tasks 
that operators may carry out under official supervision. NCAs in particular believe the 
current  approach  is working well  (with  Member  States taking different  approaches  to 
tasks that may  be performed under official  supervision).  However, there was  general 
support for VCU testing under official supervision to be introduced in the legislation. 

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Restricting the scope of application of the PRM other than FRM legislation to 
the  professional  sector:  Most  respondents  who  discussed  this  topic  focused  on 
marketing to amateur gardeners and did not identify a problem with the legislation in 
respect of this market segment. Many interviewees commented that the market is very 
small and not easily distinguished between professional and amateur users.  

Allowing the exchange of PRM between farmers: Most respondents who discussed 
this topic did not identify a problem with the legislation in respect of in-kind exchange 
of  PRM  between  farmers.  In  some  Member  States,  in-kind  exchange  is  already 
undertaken.  Those  who  supported  derogations  on  in-kind  exchange  highlighted  its 
importance for increasing activity amongst seed conservation networks.  

Establishing a simple and harmonised registration system and facilitating the 
marketing conditions for conservation and amateur varieties: Most respondents 
did not view quantitative limits as a constraint on the wider use of conservation varieties 
because the production levels for most conservation varieties are so small (a few specific 
exceptions  were  noted).  Rules  of  origin  received  a  more  mixed  response.  Some 
respondents  observed  that  rules  of  origin  are  increasingly  unnecessary  or  indeed 
restrictive because changing climatic conditions mean varieties may be unsuitable for 
the area where they were originally cultivated. Others noted the importance of region 
of origin to preserve varieties for the purposes of in situ conservation.    

Creating a voluntary coordination group for collaborative production, pooling 
and exchange of FRM: Most interviewees focusing on FRM issues responded to this 
set of questions and most were aware of cases where they, themselves, or others in the 
FRM sector have faced difficulties in accessing FRM from within the EU for afforestation 
or reforestation purposes caused by extreme weather and/or disasters. However, most 
respondents  believed  that  a  voluntary  coordination  group  would  not  resolve  the 
problem.  

Variety  testing:  The  next  three  topics  (i.e.  limiting  mandatory  VCU  to  the  most 
important  agricultural  species;  harmonising  VCU  testing  requirements  for  agricultural 
species,  introducing  sustainability  criteria  into  VCU-testing  and  obliging  competent 
authorities to offer VCU adapted to the needs of organic agriculture; and extending VCU 
requirements to other species groups) focus on issues related to variety testing. About 
half of interviewees focusing on PRM issues responded to this set of questions. did not 
believe there is a problem with the current legislation in this area. 

Limiting  mandatory  VCU  to  the  most  important  agricultural  species:  Some 
interviewees noted that VCU testing is already limited to the most important agricultural 
species. Others felt that there was no justification for (further) limiting mandatory VCU 
testing to the most important agricultural species at EU level and that it could result in 
reduced  PRM  quality,  the  loss  of  traits  that  might  be  important  in  less  economically 
important species, and negatively affect competitiveness for breeders.  

Harmonising  VCU  testing  requirements  for  agricultural  species,  introducing 
sustainability  criteria  into  VCU-testing and obliging competent  authorities to 
offer  VCU  adapted  to  the  needs  of  organic  agriculture:  NCAs  observed  that 
sustainability  criteria  are  already  used  in  VCU  testing  in  their  Member  States.  Some 
NCAs noted that it is important to maintain a diversity of approaches for VCU between 
Member  States  due  to  their  different  growing  conditions  and  markets.  A  few  NCAs 
observed that the use of sustainability criteria is a demand-driven process and does not 
require regulation. VCU testing for organic varieties is already offered in some Member 
States,  but  making  it  mandatory  could  be  challenging  for  operators  due  to  the  low 
volumes involved and a lack of suitable trial sites, and also increase costs unnecessarily 
for NCAs. Other respondents noted the importance of using sustainability criteria in VCU 
testing  and  having  VCU  adapted  to  the  needs  of  organic  agriculture  but  did  not 
specifically support mandatory EU rules on this. 

Extending VCU requirements to other species groups: Most respondents indicated 
that there is no need to extend VCU requirements to other species groups. This approach 

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could result in higher costs and result in a longer registration period. Some respondents 
noted  that  there  are  existing  approaches  for  other  species  groups  in  some  Member 
States that are working well, depending on the market in those countries. Others noted 
that any VCU requirements for other species should be voluntary.   

Allowing the marketing of ‘not yet listed varieties’ and ‘not yet fully tested 
material’ of fruit or vine propagating material: About half of interviewees 
focusing on PRM issues responded to this set of questions. Most NCAs who discussed 
this issue believed the current legislation to work well and not require any changes. A 
few NCAs noted that early multiplication of stocks (prior to registration) would be 
advantageous for breeders. Some NCAs noted that the current derogation for ‘not yet 
listed’ varieties of agricultural species is used primarily or exclusively for scientific 
selection work and/or multiplication. Representative associations noted that being able 
to market these propagating materials could shorten time to market for these varieties 
and support international trade and functioning of the internal market. 

Extending  the  scope  of  application  of  the  FRM  legislation  for  non-forestry 
purposes: Most interviewees focusing on FRM issues responded to this set of questions. 
Views were mixed amongst respondents on the need to extend the scope of application 
of  the  FRM  legislation  to  non-forestry  purposes.  Some  noted  that  there  is  a  risk  of 
genetic pollution if non-forestry purposes are not regulated under the FRM legislation. 
However,  respondents  were  divided  on  the  best  approach  to  address  non-forestry 
purposes of FRM with some preferring to leave it to Member States to decide and others 
indicating that it should be harmonised at EU level.  

Creating  a  voluntary  system  to  provide  more  information  on  FRM  and  seed 
stands: Most interviewees focusing on FRM issues responded to this set of questions 
and most felt that there is currently sufficient information in relation to FRM and seeds 
stands  (although  some  noted  that  ‘more  would  be  better’).  Most  respondents  argued 
that a voluntary system to provide information on these issues is not necessary or would 
not  fulfil  its  intended  purpose,  for  example  because  it  would  not  have  sufficient 
resources and/or it would not have sufficient participation from stakeholders. 

Including the PRM and FRM marketing legislation in the scope of the Official 
Controls Regulation or harmonising legislation outside of OCR: interviewees 
had mixed views on this topic. Some agreed that official controls rules required 
changes, others felt that there were no problems with the way controls were currently 
implemented. Of those feeling that changes were necessary, some felt application of 
OCR to PRM/FRM would help while others were in favour of a hybrid approach. The 
aspects most likely in need of harmonisation were alignment of official controls carried 
out for Plant Health (which falls under the OCR) and those carried out in PRM 
legislation. Interviewees focusing on FRM issues universally agreed that the current 
approach to official controls is working well and no change is required.  

Relying more on digital technologies for labelling and certification/inspection 
processes: This set of questions was directed to NCAs only, and most NCAs 
interviewed responded to them. Most NCAs indicated that they are already developing 
or have developed digital processes for registration and certification. A wide range of 
benefits of this were cited including more efficient processes, improved 
communication, and fewer errors. No major issues with the current situation were 
identified. 

A6.6 

Focus groups 

A6.6.1 

Introduction 

Two focus groups were undertaken to explore specific issues of relevance to the study: 
(i) FRM, and (ii) marketing to amateur gardeners. Both took place in April, conducted 
as 2-hour online events.   

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The FRM focus group was divided into three main sessions: (i) Difficulties in the supply 
of FRM; (ii) The development of a voluntary inventory with information on FRM 
characteristics and performance; and (iii) FRM for non-forestry purposes. A total of 10 
participants were invited to the focus group. Seven participants were scheduled to join 
the focus group, however on the day of the focus group, four informed ICF that they 
were no longer able to join. Participants were: Finnish Food Authority,  Federal Office 
for Agriculture and Food (Germany), and the European Forest Genetic Resources 
Programme (EUFORGEN). 

The amateur gardener focus group was divided into two main sessions: (i) Current 
situation and trends in marketing to amateur gardeners, (ii) Impacts of potential 
changes to the PRM legislation for marketing to amateur gardeners. Participants 
included a mix of NCAs, representatives of seed growers from the commercial and 
amateur sector, and associations of amateur gardeners. The following organisations 
participated in the event: PVO (DE), OEVV MAPA (ES), COBORU (PL), GEVES (FR), 
Naktuinbouw (NL), Semae (FR), UKZUZ (CZ), Euroseeds, ARCHE NOAH, La Fédération 
Nationale des Jardins Familiaux et Collectifs. 

A6.6.2 

PRM Focus group 

Topic 1: Market trends 

No participants were aware of any data on the size of the amateur gardener market. 
The EU commercial seed market is worth around 15 billion euros. While the amateur 
market volumes are smaller by comparison, amateur seed is more expensive (per 
unit) due to supply chains and usage (packaging requirements). Participants discussed 
the scale and scope of varieties available in their respective Member State markets. 

Participants indicated the main crop groups relevant to amateur gardeners in their 
home markets. Vegetable and fruit plants were frequently identified by participants. 
Ornamental and aromatic herbs were also identified, but it was noted that these are 
not subject to certification. Agricultural crops were identified as of limited interest. 
Turf grass was discussed, noting that there are no known varieties aimed exclusively 
at amateur gardeners. 

Topic 2: Impacts of an exemption for marketing to amateur gardeners  

Participants discussed the potential impacts of PRM marketed exclusively to amateur 
gardeners being exempt from the variety registration and PRM certification 
requirements. In terms of the price and its impact on consumers most participants 
thought there would be no effect. The relative share of registration and certification 
costs in the production for, and marketing to, amateur gardeners is very small in 
comparison to other costs (in particular distribution costs). As regards quality, the 
majority of attendees indicated that the quality of PRM would decrease in the absence 
of regulation, but product diversity would see little impact, although the national 
context would be an important factor for these issues. However, fewer official controls 
due to the exemption from the marketing legislation rules would potentially lead to 
more fraudulent PRM on the market and concerns were raised over potential impacts 
on plant variety rights.  

Regarding the impacts on businesses and competition participants disagreed on the 
nature of any impact on investment in breeding varieties for marketing to amateur 
gardeners. One view was that operators would be less inclined to invest in a 
deregulated market. However, this was countered by pointing to other (non-specified) 
unregulated markets with high levels of investment. Most participants thought there 
would be no cost impact on public authorities, noting that all costs are typically paid 
by producers (through cost recovery system), and that the amateur gardener market 
was very small compared to the professional user market.  

As for the impact of lighter rules for marketing to amateur gardeners, participants felt 
that there was not enough information on what the basic requirements would look like 

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for a meaningful discussion.  It was noted that there are already lighter rules, and it 
was not clear if any revision would further lighten or retighten these rules. However, 
participants generally thought that any impacts of lighter rules would be less 
significant than those already discussed for a potential exemption.  

A6.6.3 

FRM Focus group 

Topic 1: Difficulties in the supply of FRM 

Participants highlighted the lack of future planning across the FRM supply chain as one 
of the main causes of difficulties in the supply of FRM. Planning is often a challenge in 
the sector due to the longer time frames inherent to the production of FRM. On 
average, it takes 2 to 3 years from harvest to seed production and stakeholders often 
find it difficult to anticipate which seeds will be needed this far in advance. These 
problems are often exacerbated or most apparent when there are extreme weather 
events or phytosanitary issues leading to poor harvests and increases in demand.  

This gap in planning means that seeds that are sold by nurseries are often those that 
are in good supply rather than those that are needed. Not all Member States face the 
same issues: in some countries (such as Sweden and Finland), there is already longer-
term planning in place. This is in part because it can take even longer to harvest seeds 
in harsher northern climates, so there is a need to think far ahead. Participants felt 
that this problem was complex and there was no easy solution.   

Participants reported that when there are difficulties in supply, lower quality FRM is 
often used as a replacement, and this can have significant impacts. In the short term, 
poor quality FRM can appear to be performing well, however problems may present in 
the longer term. In some cases, using the wrong provenance or lower quality FRM can 
lead to not just a decrease in production, but no production at all, leading to 
significant environmental, economic and social impacts.  

Topic 2: Availability of information for users 

The availability of information and the information needed to make appropriate 
planting decisions differ by Member State. Participants felt that users of FRM in the EU 
are becoming increasingly interested in more detailed information and that there is 
scope to improve the information. However, participants felt that in general this is 
best undertaken by Member States rather than at EU level. One change that could be 
made at EU level to support this (as suggested by one participant) is the inclusion of 
information on the climatic/ecological conditions at the site of origin in the supplier’s 
document.  

When discussing a potential voluntary inventory, participants felt that this would 
increase administrative burden and come with several challenges. Member States 
generally do not trace where the material is planted, meaning additional data 
collection efforts would be required. One participant highlighted that it is not possible 
for state officers to collect data from private forest owners without legislation, due to 
General Data Protection Regulation (GDPR) requirements, significantly limiting their 
ability to collect any data on the use of FRM. Participants felt that such an inventory 
would not be useful if it contained only sparse or incomplete data. Participants 
suggested that if there was a plan to develop such an inventory, it could start with a 
very small number of additional parameters, and if this works well, then it could be 
enlarged. One participant suggested that instead of a voluntary inventory, the EC 
could support the development of a provenance trials network around Europe.   

Topic  3:    The  production  of  FRM  for  non-forestry  purposes  and  potential 
impacts of extending the scope of application of the FRM legislation to certain 
clearly defined non-forestry purposes 

Participants  agreed  that  there  are  significant  differences  in  how  forestry  and  non-
forestry purposes are defined in different Member States and this can cause problems. 
However, they also highlighted that better definition might be dependent on land use 

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rather than purposes. This is because many of the purposes included under non-forestry 
are  ambiguous.  For  example,  material  planted  for  biodiversity  purposes  or  for  the 
planting of 3 billion trees should be high quality material and would frequently fall under 
the  scope  of  the  FRM  directive.  Many  ‘non-forestry’  purposes  are  currently  under  the 
competencies  of  different  administrations,  meaning  that  to  have  a  productive 
conversation on this and establish any distinctions, one would need to involve a broader 
range of stakeholders rather than just those involved in FRM. 

A6.7 

Specific issue interviews and surveys  

A6.7.1 

Case study interviews 

A case study was undertaken to explore the experience in France with in-kind exchange 
of PRM to support the answer to study question B.2. Eight interviews were completed 
with the NCA, a seed exchange network, seed producers (2), representatives of farmers’ 
unions  (2),  and  researchers  (2).  Interviewees  offered  opinions  on  the  governance, 
operation and impacts of in-kind exchange in France, as well as data and references for 
use in the analysis. 

A6.7.2 

Fruit and vine Member State survey 

A targeted survey was undertaken to support analysis of Member State experience with 
fruit  and  vine  conservation  and  amateur  varieties.  A  short  email  survey  of  National 
Competent Authorities (NCAs) from across 17 Member States (MS) was undertaken in 
April 2022. The survey sought to validate and fill gaps in the available existing evidence. 
All Member States responded to the survey. Most returns were partially completed. Key 
data received were: 

  Numbers of registered fruit conservation and amateur varieties averaged 53 

and ranged from 0 to 147 (based on 11 Member States). Numbers of registered 
vine conservation and amateur varieties averaged 63 and ranged from 0 to 223 
(based on six Member States). 

  Respondents were not able to provide consistent measures of the volumes of 

either fruit or vine produced.  

  Of 10 Member States, 10 reported reduced fees and 5 reported lighter rules for 
the registration of conservation and amateur varities of fruit plants; and of 6 
Member States, 1 rpeorted reduced fees and 4 reported lighter rules for th 
registration of conservation and amateur varities of vine plants.  

  There were mixed responses around the value of lighter rules and reduced fees. 

Some countries reported the lack of these to be a barrier to production, 
whereas others that do have such arrangements reported no registration or 
production of varieties. 

  The number of registrations does not appear to be correlated to demand for 
varieties. Both Member States with demand for conservation and amateur 
varieties and Member States without have similar levels of registrations. 

Annex 7  Open Public Consultation results 

A7.1 

Introduction 

This annex presents the analysis of the responses to the online public consultation on 
the proposed revision of the EU legislation on Plant and Forest Reproductive Materials 
(PRM, FRM). The Public Consultation is one of several consultation activities conducted 
to support the revision process.  

The consultation was launched by the European Commission’s DG SANTE on 21 
December 2021 and ran for 14 weeks, in accordance with the Better Regulation 
Guidelines (EC 2021d). It closed on 27 March 2022. The public consultation was 

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carried out using the survey tool “EU Survey”. The questionnaire was available online 
via EU Survey in 24 languages. 

The public consultation sought the views of citizens, professional and non-professional 
stakeholders about proposals for the revision across several topics: regulation of PRM 
in the EU, the scope of the marketing directives, alignment of the rules, Member State 
exemptions and deviations, Regulated species, Common catalogues, heterogeneous 
material and organic varieties, plant genetic resources, sustainability, harmonisation 
of official controls, innovative processes and digital transformation, FRM and non-
forestry purposes, and FRM and the adaptation strategy. 

Disclaimer 

This summary of the contributions received to the Public Consultation is not a representation of 
the official position of the Commission and its services, but of the stakeholders that participated 
in this public consultation. Contributions to the Public Consultation cannot be interpreted as 
representative of European or national populations or population sub-groups or stakeholder 
types, as they employ non-probability sampling.  

A7.2 

Overview of respondents 

A total of 2,449 responses were received. This section provides an overview of the 
respondents. 

A7.2.1 

Overall respondents to closed questions 

Figure 7 shows the breakdown of total responses by Stakeholder group. The majority 
of responses (78%, 1908 of 2449) were from EU Citizens. Of the 541 respondents who 
were not citizens, 37% (202 of 541) were from Company/business organisations. 
However there was a high dropout rate after Question 1, particularly amongst citizen 
respondents (only 20% answered Question 2 onwards), consumer organisation (50%, 
of 2 dropped out), environmental organisations (50% of 14 dropped out) and Other 
respondents (50% of 100 dropped out). The actual number of responses for each 
question is specified in the figure headers in this report. 

By country, the highest number of responses were from Sweden (69%, 1685 of 2449. 
The vast majority of respondents (99%, 2414 of 2449) were based in the EU.  

Figure 9 shows the breakdown of respondents by PRM/FRM activity area (it excludes 
citizen respondents. A high number of respondents undertook activities in relation to 
‘Production including growing and/or multiplication of plant and/or forest reproductive 
material’ (28%, 145 of 526). ‘Other’ (26%, 135 of 526) and ‘Breeding’ (23%, 119 of 
526). 

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  Responses disaggregated by stakeholder group 

  Responses by Country 

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  Total Activity breakdown 

A7.2.2 

Additional details for specific stakeholder groups 

A7.2.2.1  Business associations 

Business association respondents (Figure 10) were primarily engaged in activity 
related to ‘Production including growing and/or multiplication of plant and/or forest 
reproductive material’, ‘Breeding’ and ‘Forest Management or forest owners/managers 
association’. 

  Business Association Activity breakdown 

A7.2.2.2  Company/business organisation 

Company/Business Organisation respondents were primarily engaged in activities 
relating to ‘Production including growing and/or multiplication of plant and/or forest 
reproductive material’ and ‘Breeding’ (Figure 11).  By size, a majority (59%, 120 of 
202) were from ‘Micro (1 to 9 employees)’ enterprises.  

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  Company/Business Organisation Activity breakdown 

  Company/business organisation by size 

A7.2.2.3  Public authorities 

Figure 13 shows the country breakdown for the Public Authority stakeholder group. 
Germany had by far the highest number of responses (18), with responses from 
national, regional and local authorities. Figure 14 shows that over half of all public 
authority responses (54%, 29 of 54) were from national authorities.  

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  Public Authority Country breakdown 

  Public Authority Scope breakdown 

A7.2.3 

Respondents to open text and additional attachment 

questions 

There were 616 responses to the open text question asking respondents if they have any specific 
proposals for changing the PRM legislation. The majority of responses (74%) are from EU citizens 
and among these, 74% are from citizens from Sweden. The second most represented stakeholder 
group is Other (7%), followed by Company/business organisation (7%).  

There were 182 additional attachments provided by respondents, 60 (33%) of which were from EU 
and non-EU citizens. 

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  Responses to the open text question disaggregated by 
stakeholder group 

3%

3%

6%

7%

7%

EU citizen

Other

Company/business organisation

Non-governmental organisation (NGO)

Public authority

Business association

72%

Academic/research institution

Environmental organisation

Non-EU citizen

Consumer organisation

Trade union

A7.2.4 

Identification of campaign responses and treatment of the 

sample 

Over three quarters (79%) of citizen respondents, and half (50%) of 
Company/business organisation respondents were from Sweden. It is understood that 
national press articles concerning the PRM/FRM legislation revisions and Public 
Consultation may have stimulated the higher-than-average level of responses from 
Sweden. Analysis of responses from Swedish respondents indicates that there is a 
high level of variation in their closed and open question responses – there is no 
evidence to indicate that the respondents have participated in a campaign directed at 
achieving a particular outcome. As such, no adjustments have been made to the EU 
citizen or Company/business organisation samples for the analysis.  

To account for the relative weight of citizen responses in the survey sample, when 
overall analyses (i.e. for the sample as a whole) are presented, this excluded EU (and 
non-EU) citizen responses). Citizen responses are analysed alongside other 
respondents in analyses presented by Stakeholder group. 

A7.3 

Results on Q1: Regulation of PRM in the EU 

The current PRM legislation is composed of 12 directives with some dating back to the 1960s. It 
defines common rules for the marketing of PRM in the EU. Respondents were asked the extent to 
which they agree or disagree with a series of statements regarding the status and purpose of the 
regulations and rules:    

  Q1a: The current rules are outdated, fragmented and incoherent 

  Q1b: Marketing of PRM needs to be governed at EU level to ensure identity (e.g. 100% of 

seed purchased produces red tomatoes instead of green tomatoes), quality (e.g. 
germination rate) and health (absence of pests) of PRM 

  Q1c: The current rules have enabled the free movement, availability and quality of PRM on 

the EU market 

  Q1d: PRM rules should contribute to addressing biodiversity loss and climate change 

adaptation and mitigation 

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  Q1e: PRM rules should facilitate the availability on the EU market of traditional 

varieties (e.g. conservation varieties) 

  Q1f: PRM rules should facilitate the availability on the EU market of varieties 
adapted to local conditions (e.g. climatic conditions, cultural or historical 
significance) 

  Q1g: Lighter rules facilitating the availability on the EU market of varieties 

adapted to local conditions and traditional varieties should not compromise the 
quality of PRM marketed in the EU 

  Q1h: New varieties should contribute to sustainable agriculture and food 

production through, for example, efficient water and nutrient use or disease 
resistance 

  Q1i: New varieties should be climate proof (e.g. adapted to extreme weather 

conditions, drought tolerant) 

  Q1j: A wider choice of PRM intended for exclusive marketing to amateur 

gardeners should not compromise its quality  

There were 2,449 responses to this question across all respondents This figure drops 
to 532 excluding EU and non-EU citizens. 

Figure 16 shows that a large majority of stakeholders (analysis excludes citizens) 
selected ‘Agree’ or ‘Somewhat agree’ with Statements Q1d-f – that EU rules should 
“contribute to addressing biodiversity loss and climate adaptation and mitigation” and 
should facilitate the availability on the EU market of “traditional varieties” and 
“varieties adapted to local conditions”. The only statement for which levels of 
disagreement were higher than agreement was Q1c “The current rules have enabled 
the free movement, availability and quality of PRM on the EU market”. 

  Total responses (excluding EU and Non-EU citizens) 

A7.3.1 

Statement Q1a: “The current rules are outdated, 

fragmented and incoherent” 

By stakeholder group: A majority of respondents from eight out of the ten 
stakeholder groups (Figure 17) selected ‘Agree’ or ‘Somewhat agree’ with Statement 
Q1a.  Stakeholder groups with the highest level of agreement were Academic/research 
institutions (78%, 24 of 31), Environmental organisations (74%, 11 and of 15), Trade 
unions (72%, 8 of 11) and NGOs (73%, 39 of 54). For two stakeholder groups, most 
respondents disagreed (selecting ‘Disagree’ or ‘Somewhat disagree’) with the 
statement: Public authority respondents (57%, 31 of 54) and Business association 
respondents (63%, 36 of 57). There was a notable difference in the opinions of 

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Company/business organisation respondents compared to Business association 
respondents, with a majority of the former agreeing (‘Agree’ or ‘Somewhat agree’) 
with the statement and a majority of the latter disagreeing (‘Disagree’ or ‘Somewhat 
disagree’).  

By stakeholder activity: Across most activity types (seven of nine in Figure 18), a 
majority of respondents selected ‘Agree’ or ‘Somewhat agree’ with Statement Q1a 
(Figure 18). Agreement was highest amongst respondents involved in Maintaining, 
93% (14 of 15) selected ‘Agree’ or ‘Somewhat Agree’. In contrast, amongst Forest 
management or forest owners/managers’ association respondents a majority of 
respondents selected ‘Disagree’ or ‘Somewhat disagree’ (77%, 10 of 13), as was the 
case (although to a lesser extent) for respondents involved in Breeding (51%, 45 of 
89 selected ‘Disagree’ or ‘Somewhat disagree’). 

  Responses to Question 1a (Stakeholders) 

  Responses to Question 1a (Activity) 

A7.3.2 

Statement Q1b: “Marketing of PRM needs to be governed 

at EU level to ensure identity (e.g. 100% of seed purchased 

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produces red tomatoes instead of green tomatoes), quality (e.g. 
germination rate) and health (absence of pests) of PRM” 

By stakeholder group: A majority of the respondents from six out of the ten 
stakeholder groups (Figure 19) selected ‘Agree’ or ‘Somewhat agree’ with Statement 
Q1b. Stakeholder groups with the highest level of agreement were Consumer 
Organisation (100%, 3 of 3), Public Authority (87%, 47 and of 54), Business 
Association (84%, 48 of 57) and Trade Union (81%, 9 of 11). For three stakeholder 
groups, a majority of respondents disagreed (selecting ‘Disagree’ or ‘Somewhat 
disagree’) with the statement: Non-Governmental Organisation respondents (53%, 29 
of 54), EU and Non-EU Citizen respondents (67%, 1284 of 1917) and Environmental 
organisation respondents (53%, 8 of 15). Company/Business Organisations have far 
more disagreement than the Business Association counterpart with 41% compared to 
14%. 

By stakeholder activity: Across most activity types (six of nine in Figure 20), most 
respondents selected ‘Disagree’ or ‘Somewhat Disagree’ with Statement Q1b. 
Agreement was particularly high amongst Forest management or forest 
owners/managers’ association respondents, where most respondents selected ‘Agree’ 
or ‘Somewhat agree’ (93%, 12 of 13).  

  Responses to Question 1b (Stakeholders) 

  Responses to Question 1b (Activity) 

A7.3.3 

Statement Q1c: “The current rules have enabled the free 

movement, availability and quality of PRM on the EU market” 

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By stakeholder group: A majority of the respondents from two out of the ten 
stakeholder groups (Figure 21) selected ‘Agree’ or ‘Somewhat agree’ with Statement 
Q1c, whilst a majority of respondents from four out of the ten stakeholder groups 
selected ‘Disagree’ or ‘Somewhat disagree’. The stakeholder groups with the highest 
level of agreement were public authority (72%, 39 of 54) and Business association 
(72%, 47 and of 57). The three stakeholder groups with the highest level of 
disagreement (selected ‘Disagree’ or ‘Somewhat disagree’ were: Non-Governmental 
Organisation respondents (53%, 29 of 54), EU and Non-EU Citizen respondents (67%, 
1284 of 1917) and Environmental organisation respondents (53%, 8 of 15).  

By stakeholder activity: Across most activity types (four of nine in Figure 22), most 
respondents selected ‘Disagree’ or ‘Somewhat Disagree’ with Statement Q1c. The 
most disagreement came amongst respondents involved in Retail/retailers’ 
organisations (e.g. garden centres) (75%, 6 of 8) and Marketing (60%, 9 of 15). In 
contrast, amongst Breeding respondents most selected ‘Agree’ or ‘Somewhat agree’ 
(64%, 57 of 89).  

  Responses to Question 1c (Stakeholders) 

  Responses to Question 1c (Activity) 

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A7.3.4 

Statement Q1d: “PRM rules should contribute to 

addressing biodiversity loss and climate change adaptation and 
mitigation” 

By stakeholder group: A majority of respondents from all ten stakeholder groups 
(Figure 23) selected ‘Agree’ or ‘Somewhat agree’ with Statement Q1d.  

By stakeholder activity: Across most activity types (eight of nine in Figure 24), 
most respondents selected ‘Agree’ or ‘Somewhat agree’ with Statement Q1d. ‘Storage, 
collection, dispatching and/or processing of plant and/or forest reproductive material’ 
respondents presented more mixed views (44%, 4 of 9 selected ‘Agree’ or ‘Somewhat 
agree’).  

  Responses to Question 1d (Stakeholders) 

  Responses to Question 1d (Activity) 

A7.3.5 

Statement Q1e: “PRM rules should facilitate the 
availability on the EU market of traditional varieties (e.g. 
conservation varieties)” 

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By stakeholder group: A majority of the respondents from all of the ten stakeholder 
groups (Figure 25) selected ‘Agree’ or ‘Somewhat agree’ with Statement Q1e.  
Amongst the two lowest agreeing stakeholder groups, Public Authority (58%, 31 of 
54) and Consumer Organisation (66%, 2 of 3), there was a large proportion of ‘No 
opinion’ (28%, 15 of 54 and 33%, 1 of 3 respectively).  

By stakeholder activity: Across most activity types (eight of nine in Figure 26), a 
majority of respondents selected ‘Agree’ or ‘Somewhat Agree’ with Statement Q1e. 
Amongst Forest management or forest owners/managers’ association a majority of 
respondents selected ‘No Opinion’ (69%, 9 of 13) and only 30% selected ‘Agree’ or 
‘Somewhat agree’. 

  Responses to Question 1e (Stakeholders) 

  Responses to Question 1e (Activity) 

A7.3.6 

Statement Q1f: “PRM rules should facilitate the 
availability on the EU market of varieties adapted to local conditions 
(e.g. climatic conditions, cultural or historical significance)” 

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By stakeholder group: A majority of the respondents from all ten stakeholder 
groups (Figure 27) selected ‘Agree’ or ‘Somewhat agree’ with Statement Q1f.  
However relatively high proportion of Business association respondents selected 
‘Disagree’ or ‘Somewhat disagree’ (40%, 23 of 57). 

By stakeholder activity: Across most activity types (eight of nine in Figure 28), a 
majority of respondents selected ‘Agree’ or ‘Somewhat Agree’ with Statement Q1e. 
However, amongst “Forest management or forest owners/managers’ association” a 
majority of respondents selected ‘No opinion’ (54%, 7 of 13), and a minority ‘Agree’ or 
‘Somewhat Agree’ (26%, 6 of 13). 

  Responses to Question 1f (Stakeholders) 

  Responses to Question 1f (Activity) 

A7.3.7 

Statement Q1g: “Lighter rules facilitating the availability 

on the EU market of varieties adapted to local conditions and 
traditional varieties should not compromise the quality of PRM 
marketed in the EU” 

By stakeholder group: Of the respondents from seven out of the ten stakeholder 
groups (Figure 29) a majority selected ‘Agree’ or ‘Somewhat agree’ with Statement 
Q1g.  Stakeholder groups with the highest level of agreement were Public Authority 
(76%, 41 of 54), Academic/research institution (74%, 23 and of 31), Business 

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Association (72%, 41 of 57) and Consumer Organisation (67%, 2 of 3). Environmental 
Organisation and Non-Governmental organisation (NGO) had more respondents 
disagreeing than agreeing (54%, 8 of 15 and 41%, 22 of 54 respectively selected 
‘Disagree’ or ‘Somewhat Disagree’). 

By stakeholder activity: Across most activity types (seven of nine in Figure 30), a 
majority of respondents selected ‘Agree’ or ‘Somewhat Agree’ with Statement Q1g. 
Forest management or forest owners/managers’ association respondents presented 
the highest level of agreement (85%, 11 of 13 selected ‘Agree’ or ‘Somewhat agree’). 
and “Storage, collection, dispatching and/or processing of plant and/or forest 
reproductive material” (78%, 7 of 9). No activity group had more respondents 
disagreeing than agreeing with the statement however 7 out of the 9 activity groups 
have 20% or more ‘Disagree’ or ‘Somewhat disagree’ responses. 

  Responses to Question 1g (Stakeholders) 

  Responses to Question 1g (Activity) 

A7.3.8 

Statement Q1h: “New varieties should contribute to 

sustainable agriculture and food production through, for example, 
efficient water and nutrient use or disease resistance” 

By stakeholder group: Across all stakeholder groups (Figure 31) ‘Agree’ or 
‘Somewhat agree’ with Statement Q1h was the main proportion of responses. 

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Stakeholder groups with the highest level of agreement were Academic/research 
institution (78%, 24 of 31) and Business Association (74%, 42 and of 57). There are 
two stakeholder groups with the highest amount of respondents that selected 
‘Disagree’ or ‘Somewhat disagree’ were Environmental organisation respondents 
(40%, 6 of 15) and Non-Governmental Organisation respondents (37%, 20 of 54). 

By stakeholder activity: Across most activity types (eight of nine in 0), more 
respondents selected ‘Agree’ or ‘Somewhat Agree’ with Statement Q1h than ‘Disagree’ 
or ‘Strongly disagree’. Agreement was highest amongst respondents involved in 
“Breeding” (73%, 65 of 89). Agreement was lowest amongst Forest management or 
forest owners/managers’ association respondents, with ‘No Opinion’ the majority 
response (62%, 8 of 13).  

  Responses to Question 1h (Stakeholders) 

  Responses to Question 1h (Activity) 

A7.3.9 

Statement Q1i: “New varieties should be climate proof 
(e.g. adapted to extreme weather conditions, drought tolerant)” 

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By stakeholder group: Across all stakeholder groups (Figure 33) a majority of 
respondents selected ‘Agree’ or ‘Somewhat agree’ with Statement Q1i. However, all 
groups also had a meaningful level of respondents disagreeing. 

By stakeholder activity: Across most activity types (eight of nine in Figure 34), 
most respondents selected ‘Agree’ or ‘Somewhat Agree’ with Statement Q1i. 
Agreement was weakest amongst “Forest management or forest owners/managers’ 
association” respondents (38%, 5 of 13) selected ‘Agree’ or ‘Somewhat agree’. 

  Responses to Question 1i (Stakeholders) 

  Responses to Question 1i (Activity) 

A7.3.10 

Statement Q1j: “A wider choice of PRM intended for 

exclusive marketing to amateur gardeners should not compromise 
its quality” 

By stakeholder group: Opinion was very mixed across the stakeholder groups 
(Figure 35) Amongst EU and Non-EU citizen respondents, more respondents selected 

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‘Disagree’ or ‘Somewhat disagree’ (39%, 748 of 1917) than selected ‘Agree’ or 
‘Somewhat agree’.  

By stakeholder activity: Across most activity types there was a reasonably even 
balance between agreement and disagreement (Figure 36), most respondents selected 
‘Agree’ or ‘Somewhat Agree’ with Statement Q1j. Respondents involved in Forest 
management or forest owners/managers’ associations (85%, 11 of 13) and ‘Breeding 
(66%, 60 of 89) showed the highest levels of ‘Agree’ or ‘Somewhat agree’. 

  Responses to Question 1j (Stakeholders) 

  Responses to Question 1j (Activity) 

A7.4 

Results on Q3: Scope of the marketing directives 

The current rules apply to the marketing of PRM to all types of users, including 
professional users, farmers, foresters, and amateur gardeners. They also apply to 
activities such as the exchange of PRM in kind between farmers and marketing for 
non-profit purposes by seed conservation networks. Respondents were asked the 
extent to which they agree or disagree with a series of statements regarding the scope 
of the marketing directives: 

  Q3a: The rules should apply to the marketing of PRM to all kinds of users with 

no exceptions 

  Q3b: The rules should not apply to marketing to amateur gardeners 

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  Q3c: Lighter rules should apply to the marketing of PRM for non-profit purposes 

by seed conservation networks 

  Q3d: Marketing of PRM for non-profit purposes by seed conservation networks 

should be exempted from the scope of the PRM legislation 

  Q3e: Lighter rules should apply to the exchange in kind of PRM between 

farmers 

  Q3f: Exchange in kind of PRM between farmers should be exempted from the 

scope of the PRM legislation 

There were 698 responses to this question across all respondents, with 315 responses 
excluding EU and Non-EU Citizen respondents. 

Figure 37 below shows levels of agreement and disagreement were reasonably even 
across all statements. Statements Q3c and Q3d concerned marketing of PRM for non-
profit purposes by seed conservation network and Statements Q3e and Q3f concerned 
in kind exchange of PRM between farmers. In both cases, slightly more respondents 
agreed with the statements that these activities should be exempt than did with 
statements that lighter rules should be applied to these activities. Q3d 59% (186 of 
315) compared to Q3c 52% (164 of 315) selected ‘Agree’ or ‘Somewhat agree’; Q3f 
51% (161 of 315) compared to Q3e 42% (132 of 315) selected ‘Agree’ or ‘Somewhat 
agree’). 

  Total responses (excluding EU and Non-EU citizens) 

A7.4.1 

Statement Q3a: The rules should apply to the marketing of 

PRM to all kinds of users with no exceptions 

By stakeholder group: Opinion on statement 3a was highly mixed across 
stakeholder groups. Around two thirds of Business Association (69%, 31 of 45) and 
Public authority (63%, 23 of 37) selected ‘Agree’ or ‘Somewhat agree’. The 
stakeholder groups with the highest proportion of respondents that selected ‘Disagree’ 
or ‘Somewhat disagree’ were Non-Governmental Organisation respondents (92%, 36 
of 39) and EU and Non-EU citizens (79%, 303 of 383). 

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  Responses to Question 3a (Stakeholders) 

A7.4.2 

Statement Q3b: The rules should not apply to marketing 

to amateur gardeners 

By stakeholder group: For six out of ten stakeholder groups (Figure 39) a majority 
of respondents agreed with statement Q3b. Stakeholder groups with the highest level 
of agreement were Non-Governmental Organisation (NGO) (87%, 34 of 39) and EU 
and Non-EU Citizen (83%, 318 of 383). A majority of Business association (65%, 29 of 
45) and Public authority (59%, 22 of 37)) selected ‘Disagree’ or ‘Somewhat disagree’.  

  Responses to Question 3b (Stakeholders) 

A7.4.3 

Statements Q3c and Q3d on marketing of PRM for non-

profit purposes by seed conservation networks 

The statements were:  

  Q3c: Lighter rules should apply to the marketing of PRM for non-profit purposes 

by seed conservation networks 

  Q3d: Marketing of PRM for non-profit purposes by seed conservation networks 

should be exempted from the scope of the PRM legislation 

By stakeholder group: The level of agreement amongst EU and Non-EU citizens was 
almost identical across both statements (89%, 341 of 383 and 90%, 345 of 383 
respectively for Q3d and Q3c selected ‘Agree’ or ‘Somewhat agree’).  Similarly, 
Company/business organisation respondents offer similar opinions on both statements 
(54%, 62 of 114 and 58%, 66 of 114 respectively). A majority of Business association 
respondents selected ‘Disagree’ or ‘Somewhat disagree’ for both statements (58%, 26 

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of 45 and 51%, 23 of 45 respectively), although they were more positive on statement 
Q3d than Q3c. Public authority and Academic/research institution respondents were 
more likely to agree with Statement 3c than Statement 3d.  

  Responses to Question 3c (Stakeholders) 

  Responses to Question 3d (Stakeholders) 

A7.4.4 

Statements Q3e and Q3f on in kind exchange of PRM 

between farmers 

The statements were:  

  Q3e: Lighter rules should apply to the exchange in kind of PRM between 

farmers 

 

 Q3f: Exchange in kind of PRM between farmers should be exempted from the 
scope of the PRM legislation 

By stakeholder group: Opinion on Statements 3e and 3f were highly mixed across 
the stakeholder groups. Environmental group and NGO respondents were more likely 
to agree with Statement 3f – that exchange in kind between farmers should be 
exempt – than Statement 3e, although for both statements, ‘Agree’ was the most 
common response. Conversely, for “Trade union” respondents a majority selected 
‘Agree’ or ‘Somewhat agree’ with Statement 3e, and ‘Disagree’ or ‘Somewhat 

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disagree’ with Statement 3f. Amongst “Business association”, “Company/business 
organisation” and “Public authorities”, the level of agreement/disagreement was 
similar for both statements. A clear majority of both “Business association” and “Public 
authority” respondents selected ‘Disagree’ or ‘Somewhat disagree’ with both 
statements. 

  Responses to Question 3e (Stakeholder group) 

  Responses to Question 3f (Stakeholder group) 

A7.4.5 

Additional comments and suggestions regarding the scope 

of the marketing directives 

Several Public authorities and Business associations in particular expressed the opinion 
that legislation should continue to apply to all users, even if lighter rules for marketing 
to non-professional users are implemented. They cited the importance of providing 
guarantees on sanitary requirements, in particular to minimise the potential of 
spreading plant pests and diseases (with seed potato an often-highlighted example), 
and provision of basic information about the PRM. Some suggested that if exemptions 
were made, these should require regular assessments (and quantity limits) to 
demonstrate that there were no plant health risks. 

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A few respondents called for the same rules to be applied to all. They argued that 
“effective segmentation of production and distribution circuits between the ‘amateur’ 
and ‘professional’ markets” is not possible. One Public authority highlighted in 
particular “dual-use material such as grass for which there is a large professional 
market but which is also used by non-professionals”.  

Several NGO stakeholders considered the current legislation too restrictive in areas of 
amateur gardeners, seed conservation networks and seed exchange. This was 
identified as a key reason for the lack of diversity – it was considered that relaxation 
of the rules for these categories would promote PRM diversity, agrobiodiversity in food 
systems and biodiversity in general. Proposals were made for more relaxed legislation 
in these areas, or for them to be exempt from the legislation. Some considered that 
new categorisations were necessary, and that hybrids, GMOs and materials subject to 
intellectual property rights should be excluded from these more relaxed rules. 

Some NGOs went further than the differentiation between professional and non-
professional use, calling for lighter rules for small and micro enterprises compared to 
large commercial companies, often citing the highly concentrated PRM supplier market 
as a justification. 

Some NGOs promoted the idea of freedom of choice–- allowing the users (amateur 
gardeners and others) to decide whether to rely on PRM from the 
registration/certification system or to rely on seed producer labelling. In this regard, 
the importance of labelling transparency was also noted (concerning breeding 
techniques, presence of GMOs, intellectual property rights and other rights, rules or 
presence of contracts covering the use of the seeds. Pre-marketing DUS and VCU tests 
were not considered necessary to satisfy the demand of amateur gardeners – a view 
that contrasted with that held by some Business associations and Company/business 
organisation respondents who considered legal guarantees e.g. from DUS tests, 
necessary to provide amateur gardeners with sufficient assurance on plant identity 
and health, important for amateur gardeners. 

The need for a clear definition of professional and non-professional (including specific 
to seed conservation network and amateur gardener) was raised. The Federal 
Association of German Plant Breeders gave by way of example the German definition 
of "placing on the market for commercial purpose" from § 2 I No. 12 SaatG. 

Several also pointed out that non-professional production of PRM is already excluded 
from the legislation and support the continuation of this. 

Some Business associations raised concerns regarding the activities of seed 
conservation networks and in-kind exchange between farmers, stressing that it should 
not lead to commercial activity in either case. An NCA also raised concerns regarding 
the potential growth of in-kind exchange, and its potential to undermine established 
systems for farm saved seed. 

It was stated by many Business associations that exchange in kind for non-
professional purposes should be permitted whilst exchange in kind for professional use 
should not. Others offered an alternative definition that gave a more nuanced view of 
the nature of exchange i.e. that it should be ‘direct’ – for example, that in-kind 
exchange could be permitted “if its free of charge or for a fee, directly with other 
farmers, without commercial intermediaries or a public offer of marketing”. And others 
suggested that in-kind exchange for professional use may be permitted if exchanges 
are direct and local and done on a small scale. Some cited the model of in-kind 
exchange in France. 

Across all stakeholder groups there was consensus that if in-kind exchange or any 
form were permitted, it should not include varieties listed as protected in the 
CPVO/UPOV catalogue. 

EU citizens from Sweden in particular (but also other EU and non-EU citizens) discuss 
the need for legislation to differentiate by size of producer. Respondents from this 

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stakeholder group believe that legislation should be designed to work for small 
businesses and individuals and not just for large companies. Some respondents 
propose that small businesses and private individuals should be exempt from 
legislation or should be less regulated compared with large-scale producers in order 
for there to be an “extensive and varying seed bank”. Furthermore, respondents are 
against the application of patents and advocate that “it should be easy to produce, sell 
and exchange traditional or local seed varieties, and facilitate their conservation”. 

A7.5 

Results on Q4: Alignment of the rules 

Respondents were asked the extent to which they agree or disagree with a series of 
statements regarding the alignment of the rules: 

  Q4a: Lack of alignment between the existing directives (e.g. differences in 
definitions) leads to uneven implementation and application of the rules 

  Q4b: Coherence of the legislation could be best improved by aligning the 
structure and definitions of the 12 PRM directives, but retaining them as 
separate policy instruments 

  Q4c: Coherence of the legislation could be best improved by merging policy 

instruments according to crop groups (e.g. agricultural species) 

  Q4d: Coherence of the legislation could be best improved by merging policy 

instruments according to the type of material (seeds, PRM other than seeds and 
FRM) 

  Q4e: Coherence of the legislation could be best improved by creating a single 

policy instrument with different chapters per crop group 

There were 759 responses to this question across all respondents; 363 responses 
excluding EU and Non-EU citizens. 

Figure 44 shows that slightly more respondents (analysis excludes EU and non-EU 
citizens) agreed with statement Q4a “Lack of alignment between the existing 
directives (e.g. differences in definitions) leads to uneven implementation and 
application of the rules” than disagreed with it (49%, 178 or 363, compared to 34%, 
123 of 363).  

Statements Q4b to Q4e referred to options for improving coherence of the legislation. 
More than twice as many respondents selected ‘Agree’ or ‘Somewhat agree’ (60%, 
218 of 363) with Statement Q4b “Coherence of the legislation could be best improved 
by aligning the structure and definitions of the 12 PRM directives, but retaining them 
as separate policy instruments” than did for the other three statements.  

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  Total responses (excluding EU and Non-EU citizens) 

A7.5.1 

Statement 4a: Lack of alignment between the existing 

directives (e.g. differences in definitions) leads to uneven 
implementation and application of the rules 

By stakeholder group: Across all stakeholder groups (Figure 45) four out of the ten 
primarily agreed with statement 4a. Stakeholder groups with the highest level of 
agreement were Trade Union (71%, 5 of 7) and Academic/research institution (60%, 
16 of 27). Academic/research institution has 30% ‘Agree’ as a response which is the 
largest response rate of all other stakeholders. A majority of Public Authority 
respondents (54%, 28 of 52) selected ‘Disagree’ or ‘Somewhat disagree’ with the 
statement.  

  Responses to Question 4a (Stakeholder group) 

A7.5.2 

Statements 4b-e on options for improving coherence of 

the legislation 

The four statements were: 

  4b: Coherence of the legislation could be best improved by aligning the 
structure and definitions of the 12 PRM directives, but retaining them as 
separate policy instruments 

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  4c: Coherence of the legislation could be best improved by merging policy 

instruments according to crop groups (e.g. agricultural species) 

  4d: Coherence of the legislation could be best improved by merging policy 

instruments according to the type of material (seeds, PRM other than seeds and 
FRM) 

  4e: Coherence of the legislation could be best improved by creating a single 

policy instrument with different chapters per crop group 

By stakeholder group: The option which had the highest level of agreement (‘Agree’ 
or ‘Somewhat Agree’ responses) was statement Q4b, where eight out of the ten 
stakeholder groups have a majority of 50% or more in agreement. Across all 
stakeholder groups more respondents selected ‘Agree’ or ‘Somewhat agree’ for this 
statement than selected ‘Disagree’ or ‘Somewhat disagree’. 

  Responses to Question 4b (Stakeholder group) 

  Responses to Question 4c (Stakeholder group) 

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  Responses to Question 4d (Stakeholder group) 

  Responses to Question 4e (Stakeholder group) 

A7.5.3 

Additional comments and suggestions regarding 

alignment of the rules 

Additional opinions offered were consistent across stakeholder groups. There were 
calls to remove unnecessary complexity and ambiguity and to focus on ensuring clear, 
unambiguous and consistent definitions (with some suggesting alignment with 
definitions in the Plant Health Regulation). Stakeholders were clear that the legislation 
must continue to recognise the specifics of different crop groups. 

A7.6 

Results on Q5: Member State exemptions and deviations 

The current legislation allows Member States to adopt exemptions or deviate from 
certain rules. They have used these possibilities in different ways. Respondents were 
asked the extent to which they agree or disagree with a series of statements: 

  Q5a: Exemptions and deviations have caused unequal conditions for the 

marketing of PRM across Member States 

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  Q5b: Different implementation by Member States of the derogations as regards 
the registration of traditional varieties have caused unequal conditions for 
operators across Member States 

  Q5c: Derogations from the EU rules in relation to the quality of PRM (e.g. 
identity, germination rate and absence of pests) should be kept to a strict 
minimum 

  Q5d: Member States should continue to be allowed to lay down stricter rules at 

national level 

There were 759 responses to this question across all respondents; 363 excluding “EU 
and Non-EU citizens”. 

More respondents selected ‘Agree’ or ‘Somewhat agree’ with statements Q5a and b, 
(43% 156 of 363 and 42% 152 of 363 respectively) concerning issues of Member 
State exemptions and deviations, than selected ‘Disagree’ or ‘Somewhat disagree’ 
although these were still a minority of all responses. A majority of respondents (54% 
196 of 363 and 58% 211 of 363 respectively) selected ‘Agree’ or ‘Somewhat agree’ 
with Statements Q5c and d. 

  Total responses (excluding EU and Non-EU citizens) 

A7.6.1 

Statement Q5a: Exemptions and deviations have caused 

unequal conditions for the marketing of PRM across Member States  

By stakeholder group: Only two stakeholder groups (Figure 51) had a majority of 
respondents in agreement (‘Agree’ or ‘Somewhat agree’ with statement Q5a. These 
were Consumer Organisation (100%, 1 of 1) and Environmental Organisation (57%, 4 
of 7). More Public authority respondents ‘Agreed’ or ‘Somewhat agreed’ (46%, 24 of 
52) with the statement than disagreed. For other stakeholder groups (except Trade 
unions) levels of agreement and disagreement were similar. 

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  Responses to Question 5a (Stakeholders) 

A7.6.2 

Statement Q5b: Different implementation by Member 

States of the derogations as regards the registration of traditional 
varieties have caused unequal conditions for operators across 
Member States  

By stakeholder group: Across all stakeholder groups (Figure 52) two out of the ten 
primarily agreed with statement 5b. The stakeholder groups with the highest level of 
agreement were NGO (68%, 28 of 41) and Academic/research institution (52%, 14 of 
27). In seven of the nine stakeholder groups ‘No Opinion’ was the most common 
response. 

  Responses to Question 5b (Stakeholders) 

A7.6.3 

Statement Q5c: Derogations from the EU rules in relation 

to the quality of PRM (e.g. identity, germination rate and absence of 
pests) should be kept to a strict minimum  

By stakeholder group: Across stakeholder groups (Figure 53) five out of the ten 
primarily agreed with statement Q5c. Public Authorities had a high level of ‘Agree’ or 
‘Somewhat agreement’ (72%, 37 of 52). The stakeholder groups with the highest 
amount of respondents that selected ‘Disagree’ or ‘Somewhat disagree’ responses 
were Environmental organisations (85%, 6 of 7) and NGO (81%, 33 of 41).  

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  Responses to Question 5c (Stakeholders) 

A7.6.4 

Statement Q5d: Member States should continue to be 

allowed to lay down stricter rules at national level  

By stakeholder group: Across stakeholder groups (Figure 54) six out of the ten 
primarily agreed with statement Q5d. Public Authorities had high levels of ‘Agree’ or 
‘Somewhat agree’ responses (90%, 47 of 52). Only one stakeholder group, NGOs, had 
a majority select ‘Disagree’ or ‘Somewhat disagree’ (86%, 35 of 41). 

  Responses to Question 5d (Stakeholders) 

A7.6.5 

Additional comments and suggestions regarding Member 

State exemptions and deviations 

A small number of NCA and Business association respondents offered further opinion 
on Member State exemptions and deviations. The flexibility of the system was noted 
as important, with the opportunity for Member States to be able to implement stricter 
rules highlighted in particular. This was beneficial in order to project and maintain an 
image of high quality for national industries, and in cases where the specifics of 
national growing conditions and/or disease pressures require them. However, it was 
also stated that any implementation of stricter rules at the national level should not 
conflict with the principles of the internal market.  

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A7.7 

Results on Q6: Regulated species 

The current legal framework includes lists of species to which EU rules apply (EU-
regulated species) but does not specify the criteria for amending these lists. 
Respondents were asked the extent to which they agree or disagree with a series of 
statements:  

  Q6a: The number of EU-regulated species should be reduced (e.g. only cover 

economically important species) 

  Q6b: The number of EU-regulated species should be increased to cover more 

comprehensively the species marketed in the EU 

  Q6c: Criteria should be established for deciding which species should be 

regulated (e.g. market volume, production area) 

  Q6d: The procedure for adding new species to the list of EU-regulated species 

should be harmonised for all crop groups 

  Q6e: The scope of the PRM legislation should only cover plant species and not 

their intended use (e.g. regulation of soybean irrespective of its potential use as 
oil or vegetable plant 

There were 759 responses to this question; 363 responses excluding EU and Non-EU 
Citizens.  

Figure 55 below shows the total responses across all of Question 6 statements. 

Opinion was relatively evenly split as to whether the number of EU regulated species 
should be increased or decreased (Statements Q6a and b), and on Statement 6d “The 
procedure for adding new species to the list of EU-regulated species should be 
harmonised for all crop groups” and Q6e “The scope of the PRM legislation should only 
cover plant species and not their intended use (e.g. regulation of soybean irrespective 
of its potential use as oil or vegetable plant)”. 

A clear majority of respondents (65%, 236 of 363) selected ‘Agree’ or ‘Somewhat 
agree’ with Statement Q6c “EU Criteria should be established for deciding which 
species should be regulated (e.g. market volume, production area”. 

  Total responses (excluding EU and Non-EU citizens) 

A7.7.1 

Statement Q6a and Q6b on the number of EU-regulated 

species  

The two statements were: 

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  Q6a: The number of EU-regulated species should be reduced (e.g. only cover 

economically important species)  

  Q6b: The number of EU-regulated species should be increased to cover more 

comprehensively the species marketed in the EU 

By stakeholder group: By stakeholder group, four cluster of response types can be 
estimated: 

  Four stakeholder groups had clearly more respondents agreeing with Statement 
6a than 6b: Non-Governmental Organisation (NGO), EU and Non-EU Citizen, 
Environmental organisation, and Other.  

  Similar proportions of Company/Business Organisation respondents agreed with 

Statement Q6a as did Q6b.   

  Three groups had clearly more respondents selecting agreement with 
Statement Q6b than Q6a: Consumer organisation, Academic/research 
institution, Public Authority, Business Association, ((100%, 1 of 1), (79%, 41 of 
52), (67%, 18 of 27) and (56%, 28 of 50) respectively).  

  For both statements, a majority of Trade union respondents selected ‘Disagree’ 

or ‘Somewhat disagree’. 

  Responses to Question 6a (Stakeholders) 

  Responses to Question 6b (Stakeholders) 

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A7.7.2 

Statement Q6c: EU Criteria should be established for 

deciding which species should be regulated (e.g. market volume, 
production area)  

By stakeholder group: Across stakeholder groups (Figure 58) nine out of the ten 
primarily agreed with statement Q6c. A few stakeholder groups had over 70% select 
‘Agree’ or ‘Somewhat agree’. Only one Trade unions had a majority of respondents 
select ‘Disagree’ or ‘Somewhat disagree’ (72%, 5 of 7). 

  Responses to Question 6c (Stakeholders) 

A7.7.3 

Statement Q6d: The procedure for adding new species to 

the list of EU-regulated species should be harmonised for all crop 
groups  

By stakeholder group: Across stakeholder groups (Figure 60) only one out of the 
ten primarily agreed with statement Q6d. This was Business Associations (50%, 25 of 
50). There were three of the ten which had “Disagree” or “Somewhat Disagree” as the 
majority, including Trade Union (71%, 5 of 7) and Environmental Organisation (57%, 
4 of 7). The other Stakeholder groups have a fairly even spread of responses between 
agreeing and disagreeing. 

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  Responses to Question 6d (Stakeholders) 

A7.7.4 

Statement Q6e: The scope of the PRM legislation should 

only cover plant species and not their intended use (e.g. regulation 
of soybean irrespective of its potential use as oil or vegetable plant) 

By stakeholder group: Across stakeholder groups (Figure 60) three out of the ten 
primarily agreed with statement Q6e. Environmental organisation (71%, 5 of 7) and 
Public Authority (59%, 31 of 52) groups had particularly high levels of ‘Agree’ or 
‘Somewhat agree’ responses. Equally there were three stakeholders with a majority 
disagreement (‘Disagree’ or ‘Strongly disagree’). These were Trade Union (57%, 4 of 
7), Non-Governmental Organisation (NGO) (59%, 24 of 41) and Academic/research 
institution (52%, 14 of 27).  

  Responses to Question 6e (Stakeholders) 

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A7.7.5 

Additional comments and suggestions regarding 

Regulated species 

Several NGO respondents and organisations involved in organics were of the opinion 
that the number of EU-regulated species should be reduced, citing the administrative 
burden and constraints on variety development associated with such regulation. 
However some Business associations were of the opinion that the number of EU-
regulated species should be maintained or even increased as markets, uses and 
consumption preferences develop. 

Regarding criteria for deciding which species to regulate, Public authorities and 
Business associations noted that overly simplified EU level criteria may not be 
appropriate. They highlighted that any criteria should be sector/crop group-specific, 
that metrics such as market volume or value may be too simplistic, and that regional 
differences should be accounted for (e.g. a species may be nationally or regionally 
significant, but not significant at the EU level).  

This last point was also picked up by NGO respondents; some recognised that national 
lists may be necessary (with calls for these to be voluntary) to account for different 
national/regional contexts. However some respondents raised concerns regarding 
national and EU level lists claiming that they caused confusion and hindered the 
internal market. 

A7.8 

Results on Q7: Common catalogues 

Currently agricultural and vegetable crop varieties should be listed first in a national 
catalogue and then in the Common catalogues before they are allowed to be marketed 
in the EU. Respondents were asked the extent to which they agree or disagree with 
one statement. 

There were 698 responses to this question across all respondents. 

A7.8.1 

Statement Q7: Direct notification of registered varieties by 
Member States to the EU Common catalogues without a Commission 
decision would speed up market access for these varieties 
throughout the EU 

By stakeholder group: Across stakeholder groups (Figure 61) seven out of the ten 
primarily agreed with statement Q7. The stakeholder groups with the highest level of 
agreement were Business association (89%, 79 of 89) and Company/business 
organisation (87%, 101 of 114). Only one stakeholder has a high level of ‘Disagree’ or 
‘Somewhat disagree’, this is Trade Union (50%, 2 of 4). 

  Responses to Question 7 (Stakeholders) 

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A7.8.2 

Additional comments and suggestions regarding Common 

catalogues 

Very few respondents provided additional comments concerning the Common 
catalogues. A few highlighted the role of the catalogues in providing guarantees 
regarding the traceability of varieties and quality of PRM and requested that these 
principles are not undermined in any revision. 

A7.9 

Results on Q8: Heterogeneous material and organic 

varieties 

The Organic Regulation laid down rules for organic heterogeneous material intended 
for organic production. This is a new category of material that is highly diverse and it 
is not a variety nor is it a mixture of varieties. Furthermore, the Commission is 
preparing temporary derogations for the marketing of organic varieties suitable for 
organic production. Respondents were asked the extent to which they agree or 
disagree with two statements:  

  Q8a: There is a need to also establish rules for the marketing of heterogeneous 

material intended for non-organic production 

  Q8b: There should be dedicated permanent rules for the marketing of organic 

varieties suitable for organic production 

There were 1,396 responses to this question across all respondents, with 698 across 
the two statements. 

A7.9.1 

Statement Q8a: There is a need to also establish rules for 
the marketing of heterogeneous material intended for non-organic 
production 

By stakeholder group: Across stakeholder groups (Figure 62) five out of the ten 
primarily agreed with statement Q8a. The stakeholder groups with the highest level of 
agreement were Trade Union (100%, 4 of 4) and Business association (66%, 30 of 
45). Public Authorities had the highest level of ‘Disagree’ or ‘Somewhat disagree’ 
responses (41%, 15 of 37). 

  Responses to Question 8a (Stakeholders) 

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A7.9.2 

Statement Q8b: There should be dedicated permanent 
rules for the marketing of organic varieties suitable for organic 
production 

By stakeholder group: Across stakeholder groups (Figure 63) three out of the ten 
primarily agreed with statement Q8b. These stakeholder groups were Non-
Governmental organisation (NGO) (72%, 28 of 39), Business Association (65%, 29 of 
45) and Environmental Organisation (57%, 4 of 7). Only one stakeholder has a 
majority ‘Disagree’ or ‘Somewhat disagree’, this is Trade Union (75%, 3 of 4).  

  Responses to Question 8b (Stakeholders) 

A7.9.3 

Additional comments and suggestions regarding 

Heterogeneous material and organic varieties 

Some respondents recognized that heterogeneous material and organic varieties can 
be suitable for non-organic production. Some noted risks therefore with the creation of 
a specific category of ‘organic varieties’ with specific rules, including increased risk of 
seed fraud, stifling breeding and differential standards of variety and material 
guarantees.  

One respondent stated that guarantees on purity, germination and stocking are even 
more important in organic farming given that chemical inputs are not used. Some 
went further, suggesting that standard DUS and VCU tests should be applied to 
organic varieties to encourage innovation of varieties that can better satisfy these 
tests. 

Some representatives of organics industries and NGOs called for adjusted DUS and 
VCU criteria for organic varieties. The upcoming European trials to address this issue 
were noted as important but given the expected duration of the trials (seven years) a 
temporary solution was already needed. It was indicated that such adjusted DUS and 
VCU tests would support innovation. An organics organisation highlighted the 
importance of this given that “50% of the organic farmers have to rely on non-organic 
PRM (averaged across target crops and EU countries) due to the lack of adapted 
cultivars and lack of organic seed production”. It was also suggested that “since 
Organic Heterogeneous Material can be marketed after notification but without 
registration in the Organic Regulation (EC) 2018/848, the procedure of notification 
should also be implemented in the PRM rules review”.   

A7.10  Results on Q9: Plant genetic resources 

In order to ensure conservation and sustainable use of plant genetic resources, the 
current rules foresee derogations from the production and marketing requirements 
for: Conservation varieties, including landraces of agricultural and vegetable crops; 

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Vegetable crop varieties with no intrinsic value for commercial crop production but 
that have been developed for growing under particular conditions. Respondents were 
asked the extent to which they agree or disagree with a series of statements:  

  Q9a: These derogations have been successful in promoting the conservation 

and sustainable use of plant genetic resources 

  Q9b: Different implementation of these derogations by Member States has 

created unequal conditions for operators across Member States 

  Q9c: There should be lighter rules for these varieties regarding the marketing 

conditions (e.g. registration and certification) 

  Q9d: Similar derogations should be introduced for locally produced varieties 
adapted to local agro-ecological conditions and intended for local marketing 

There were 1,477 responses to this question across all respondents; with 315 
excluding EU and Non-EU citizens. 

Figure 64 shows that a majority of respondents selected ‘Agree’ or ‘Somewhat agree’ 
with Statements Q9a, Q9c and Q9d. Across all statements, more respondents agreed 
than disagreed. 

  Total responses (excluding EU and Non-EU citizens) 

A7.10.1 

Statement Q9a: These derogations have been successful 
in promoting the conservation and sustainable use of plant genetic 
resources  

By stakeholder group: Across stakeholder groups (Figure 65) five out of the ten 
primarily agreed with statement Q9a. These stakeholder groups included 
Company/Business organisation (72%, 82 of 114) and Other (72%, 33 of 46). Two of 
the ten stakeholders had a majority ‘Disagree’ or ‘Somewhat disagree’ responses, with 
Trade Union (75%, 3 of 4) and Non-Governmental organisation (NGO) (54%, 21 of 
39). 

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  Responses to Question 9a (Stakeholders) 

A7.10.2 

Statement Q9b: Different implementation of these 

derogations by Member States has created unequal conditions for 
operators across Member States  

By stakeholder group: Across all stakeholder groups (Figure 66) three out of the ten 
primarily agreed with statement Q9b. These stakeholder groups were Environmental 
Organisation (72%, 5 of 7), Non-Governmental organisation (NGO) (56%, 22 of 39) 
and Trade Union (50%, 2 of 4). No stakeholders have a majority ‘Disagree’ or 
‘Somewhat disagree’.  

  Responses to Question 9b (Stakeholders) 

A7.10.3 

Statement Q9c: There should be lighter rules for these 

varieties regarding the marketing conditions (e.g. registration and 
certification)  

By stakeholder group: Across stakeholder groups (Figure 67) nine out of the ten primarily agreed 
with statement Q9c. The stakeholders with the highest level of ‘Agree’ or ‘Somewhat agree’ 
responses were Trade Union (100%, 4 of 4) and Non-Governmental organisation (NGO) (95%, 37 
of 39).  

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  Responses to Question 9c (Stakeholders) 

A7.10.4 

Statement Q9d: Similar derogations should be introduced 

for locally produced varieties adapted to local agro-ecological 
conditions and intended for local marketing. 

By stakeholder group: Across stakeholder groups (Figure 68) seven out of the ten 
primarily agreed with statement Q9d. The stakeholders with the highest level of 
‘Agree’ or ‘Somewhat agree’ responses were Trade Union (100%, 4 of 4) and 
Environmental organisation (86%, 6 of 7).  

  Responses to Question 9d (Stakeholders) 

A7.10.5 

Additional comments and suggestions regarding Plant 

genetic resources 

Several respondents noted that ‘amateur and conservation varieties’ are used by both 
professional and non-professional users and hence need to be accessible to both.  

Some respondents, from across stakeholder groups, stated that a single approach to 
the registration/listing and marketing of conservation varieties was necessary 
(including a dedicated catalogue). However some NGO respondents considered that 
two regimes were necessary that distinguished between professional and non-
professional users.  

Across stakeholder groups some respondents argued that these varieties should still 
be subject to certain test and guarantees, however opinion on the extent of this 
varied.  

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A common position put forward was summarized by one respondent, who said that 
“we need an adaptation of the rules with simplified procedures for diverse and 
regionally adapted seeds. Quantitative and regional restrictions shall be abolished. 
Rules on identity, origin, germination rate and information on the breeding process 
shall be maintained and made available on the packaging”. 

Citizen respondents proposed that legislation should not restrict access to local and 
traditional seed varieties. As they are adapted to their specific environment, “their 
properties need to be preserved for the future.”  

A7.11  Results on Q10: Sustainability 

Agricultural crops are currently tested for their value for cultivation and use (VCU) as 
regards yield, quality and resistance to pests and adverse environmental conditions. 
The current PRM legislation does not include any further rules and Member States 
implement VCU tests in different ways. Furthermore, agricultural crops are not 
explicitly tested for their contribution to more sustainable agri-food production (i.e. 
‘sustainable VCU’). There is scope to further align the PRM legislation with the 
objectives of the European Green Deal, Farm to Fork Strategy and EU Adaptation 
Strategy in this regard. Respondents were asked the extent to which they agree or 
disagree with a series of statements:  

  Q10a: The PRM legislation should harmonise VCU testing among Member States 

  Q10b: There should be no mandatory VCU testing as the variety characteristics 

should be driven by market demand 

  Q10c: VCU testing should be extended to include testing of varieties for their 
contribution to the sustainability of the agri-food chain (sustainable VCU, e.g. 
water and nutrient use efficiency) 

  Q10d: The PRM legislation should contain a set of general sustainability criteria 

that Member States can apply taking into account their agro-ecological 
conditions 

There were 698 responses to this question across all respondents; with 315 excluding 
“EU and Non-EU Citizen”. 

Figure 69 below shows that for Statements Q10a, Q10b and Q10c opinion was 
reasonably evenly split between those agreeing and disagreeing with the statements. 
For statement Q10d a majority (70%, 221 of 315) selected ‘Agree’ or ‘Somewhat 
agree’, more than twice as many as selected ‘Disagree’ or ‘Somewhat disagree’. 

  Total responses (excluding EU and Non-EU citizens) 

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A7.11.1 

Statement Q10a: The PRM legislation should harmonise 

VCU testing among Member States  

By stakeholder group: Across stakeholder groups (Figure 70) three out of the ten 
primarily agreed with statement Q10a. The stakeholders with the highest level of 
‘Agree’ or ‘Somewhat agree’ responses were Academic/research institution (54%, 12 
of 22) and Company/business organisation (52%, 59 of 114). Five of the ten 
stakeholders had ‘No opinion’ as the most common response. 

  Responses to Question 10a (Stakeholders) 

A7.11.2 

Statement Q10b: There should be no mandatory VCU 

testing as the variety characteristics should be driven by market 
demand  

By stakeholder group: Across stakeholder groups (Figure 71) two out of the ten had 
small majorities selected ‘Agree’ or ‘Somewhat agree’ with statement Q10b: EU and 
Non-EU Citizen (55%, 211 of 383) and Non-Governmental Organisation (NGO) (51%, 
20 of 39). However three of the ten stakeholders had ‘Disagree’ or ‘Somewhat 
Disagree’ as a majority of over 50%: Business Association (60%, 27 of 45), Trade 
Union (75%, 3 of 4) and Public Authority (54%, 20 of 37).  

  Responses to Question 10b (Stakeholders) 

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A7.11.3 

Statement Q10c: VCU testing should be extended to 

include testing of varieties for their contribution to the 
sustainability of the agri-food chain (sustainable VCU, e.g. water 
and nutrient use efficiency)  

By stakeholder group: Across stakeholder groups (Figure 72) four out of the ten 
primarily agreed with statement Q10c. There is no stakeholder with a majority in 
disagreement, however Non-Governmental organisation (NGO) had more indicating 
disagreement (41%, 16 of 39 selected ‘Disagree’ or ‘Somewhat disagree’) than 
agreement. ‘No opinion’ was the most common response for three of the ten 
stakeholder groups including Public Authority and Environmental Organisations (35%, 
13 of 37, and 43%, 3 of 7, respectively). 

  Responses to Question 10c (Stakeholders) 

A7.11.4 

Statement Q10d: The PRM legislation should contain a set 

of general sustainability criteria that Member States can apply 
taking into account their agro-ecological conditions 

By stakeholder group: Across stakeholder groups (Figure 73) eight out of the ten 
primarily agreed with statement Q10d. Business associations had the highest level of 
disagreement (45%, 20 of 45 selected ‘Disagree’ or ‘Somewhat disagree’).  

  Responses to Question 10d (Stakeholders) 

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A7.11.5 

Additional comments and suggestions regarding 

Sustainability 

Harmonisation: A few Public authority and Business organization stakeholders 
commented on the potential for harmonisation of VCU amongst Member States. They 
all considered this unrealistic given the different conditions across Member States. A 
Business association suggested that “further harmonisation of VCU testing among 
Member States should not focus on uniformity of characteristics but rather on 
assurance of principles, quality standards and respective controls, i.e. on the testing 
methodology”. 

No mandatory VCU testing: few comments were received on this issue. One Public 
authority considered that most professional users are capable of choosing varieties 
based on the description from breeders. They cited experience in the vegetable seed 
market to demonstrate that VCU is of no added value to the market. One Business 
association specifically called for VCU testing of potato varieties to become voluntary. 
However most comments on this issue were to request no further extension of VCU to 
species not already covered. 

Sustainability: Some respondents questioned why sustainability tests were needed. 
Some put faith in market mechanisms, highlighting that more varieties with 
sustainability characteristics are already being developed as that is what was being 
demanded by the market, or suggesting that support to stimulate good practice 
should be provided. Others considered that existing DUS and VCU tests already 
include elements that support sustainability and that a further elaboration and/or 
differentiation of such criteria could be developed within the current VCU system. 

It was also indicated that adoption of mandatory sustainability criteria may actually 
accentuate the erosion of cultivated diversity, and potentially steer the market in too 
narrow a direction. In particular it was highlighted that if the result was an increase in 
administrative burdens, this may restrict innovation and the market – with one Public 
authority suggesting therefore that sustainability tests should be voluntary. 

Several respondents, from across the stakeholder groups, considered that any 
sustainability test should be regionally specific so as to reflect local growing 
conditions. 

Several NGOs were of the opinion that a holistic approach was necessary, rather than 
a reductionist approach focusing on just a few traits. For example examining 
performance under ‘low input’ conditions. However other respondents did suggest 
specific criteria:  

  water and nutrient use efficiency, pathogen and pest resistance, feed for 

pollinators, etc. 

  at least one of the following five elements: pest tolerance or resistance and 
levels of input use, carbon storage, (fossil fuel) energy consumption, and 
water consumption 

Some respondents, in particular from Business associations and 
Company/business organisations, anticipated potential difficulties if sustainability 
criteria were too vague, resulting in legal uncertainty and increased complexity 
and costs. They called for any tests to be measurable, reproducible and verifiable on 
the basis of scientific data.  

A7.12  Results on Q11: Harmonisation of official controls 

The current PRM legislation contains only a few general requirements for official 
controls, which results in differences of control and enforcement across Member 
States. Furthermore, it is not included in the scope of the Official Controls Regulation 
(OCR). The OCR establishes harmonised rules on official controls across the agri-food 

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chain, including for plant health, organic production and GMOs, while allowing 
adaptation to sector-specific rules (e.g. no border check system for certain sectors, 
possibility to exempt certification activities from the scope of the OCR). The OCR 
includes general principles as regards official controls (e.g. import and marketing 
controls), rules for competent authorities, IT systems and training to facilitate official 
controls. Respondents were asked the extent to which they agree or disagree with a 
series of statements:  

  Q11a: Further harmonisation of the rules on official controls for PRM would 

create a level playing field for operators across Member States  

  Q11b: Further harmonisation of the rules on official controls for PRM would 

increase the efficiency and effectiveness of these control activities  

  Q11c: Further harmonisation of import controls would improve the quality of 

PRM imported from third countries and marketed in the EU  

  Q11d: Full harmonisation of import controls of PRM through checks at border 
control posts, fees for those controls and special import documentation would 
improve the quality of PRM imported from third countries and marketed in the 
EU 

  Q11e: The use of infrastructure established under the OCR (e.g. IT systems, EU 
reference centres and training) would increase the efficiency and efficacy of 
official controls on PRM  

  Q11f: Inclusion in the scope of the OCR would increase administrative burdens 

for competent authorities as regards marketing and import controls  

There were 762 responses this question across all respondents; with 363 individual 
excluding “EU and Non-EU Citizens”. 

Figure 74 below shows the more respondents disagreed with Statements Q11a, Q11b, 
Q11d and Q11e than agreed with them. Agreement is highest for Statement Q11f, 
with a clear majority 62% (225 or 363) selecting ‘Agree’ or ‘Somewhat agree’.  

  Total responses (excluding EU and Non-EU citizens) 

A7.12.1 

Statements Q11a-f on harmonisation of official controls 

  By stakeholder group: Statement Q11f has high levels of agreement across 
all stakeholder groups. Statements Q11b and Q11e have more respondents 
disagreeing than agreeing for seven and eight of the respondents groups 
respectively.  

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  Responses to Question 11a (Stakeholders) 

  Responses to Question 11b (Stakeholders) 

  Responses to Question 11c (Stakeholders) 

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  Responses to Question 11d (Stakeholders) 

  Responses to Question 11e (Stakeholders) 

  Responses to Question 11f (Stakeholders) 

A7.12.2 

Additional comments and suggestions regarding 

Harmonisation of official controls 

Public authorities and other respondent types claimed that it would bring additional 
costs, particularly administrative burdens, and provide no added value. However 

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others considered that harmonisation would provide an opportunity for streamlined 
and cost-effective control procedures. 

The issue of risk-based controls was raised by several respondents. Two Public 
authorities were concerned about any move from their current situation of 100% pre-
marketing checks to a risk-based approach (and hence reduced level of checks) under 
the Official Controls Regulation, noting that PRM is categorised as ‘lower risk’ under 
the OCR. However respondents from across the other stakeholder groups put forward 
arguments in favour of moving to risk-based controls (for example, based on size and 
importance of seed lots), noting that this would be more efficient and help reduce 
burdens on operators without affecting quality. 

Several Business associations and Company/business organisations repeated the 
statement that “official controls should be limited to compliance with mandatory 
commercial information: name, origin, years and places of propagation, breeding 
practices and the absence of GMOs – as well as germination rate and control of 
quarantine pests”.  

A few respondents, particularly amongst Public authorities and NGOs, raised 
concerns that any shift in responsibilities from inspection bodies to operators may 
diminish the capacity of operators, although the potential reduction in costs for 
certification of doing so was also recognized. 

A7.13  Results on Q12: Innovative processes and digital 

transformation 

Respondents were asked the extent to which they agree or disagree with two 
statements: 

  Q12a: The rules should be able to adapt faster to innovations in PRM production 

processes (e.g. true potato seed) and to scientific and technological 
developments (e.g. biomolecular techniques in variety testing and certification) 

  Q12b: The rules should allow digital processes (e.g. e-certificates 

A7.13.1 

Statement 12a: The rules should be able to adapt faster to 

innovations in PRM production processes (e.g. true potato seed) 
and to scientific and technological developments (e.g. biomolecular 
techniques in variety testing and certification)  

By stakeholder group: Across stakeholder groups (Figure 81) six out of the ten have 
a majority of respondents in agreement (‘Agree’ or ‘Somewhat agree’) with statement 
Q12a. Two of the ten stakeholders had a majority disagreement (‘Disagree’ or 
‘Somewhat disagree’) which were Environmental Organisation (57%, 4 of 7) and Non-
Governmental Organisation (NGO) (66%, 27 of 41).  

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  Responses to Question 12a (Stakeholders) 

A7.13.2 

Statement 12b: The rules should allow digital processes 

(e.g. e-certificates) 

By stakeholder group: Across stakeholder groups (Figure 82) all ten agreed with 
statement Q12b. The stakeholders with the highest response rate are “Consumer 
Organisation” (100%, 1 of 1) and “Academic/research institute” (89%, 24 of 27). 
“Business Association” specifically had 72% of answers as purely ‘Agree’. Also similarly 
to Q12a, “EU and Non-EU Citizen” had a high amount of ‘No opinion’ chosen, coming 
in a close second. 

  Responses to Question 12b (Stakeholders) 

A7.13.3 

Additional comments and suggestions regarding 

Innovative processes and digital transformation 

Additional comments were broadly in support of changes to accommodate innovation 
and digital transformation. One Company/business organisation respondent outlined 
the potential benefits, stating that “digital technologies for label security and 
traceability could have a positive impact for both operators and consumers and should 
be encouraged. Their use could be beneficial for control authorities as well and help 
fighting fraud and counterfeit and intervening more rapidly when needed. That could 
result in more guarantees for farmers and consumers.” Some indicated that e-
certification is already available in their country. 

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Most comments focus on the use of bio-molecular techniques. Across stakeholder 
groups, several respondents were in favour of their use, but suggested that it should 
be optional and be used only as a complement to standard phenotypic examinations 
(and should not result in any additional burdens on operators). Some considered that 
such techniques were prohibitively expensive for SME breeders, hence needed to be 
optional only. Some NGOs raised concerns about bio-molecular techniques making 
public commercially sensitive information, such as information on breeders’ historical 
crossings of plants, as well as increasing the risk of biopiracy. It was also stated that 
intellectual property rights should not be possible to claim on gene sequences.  

A7.14  Results on Q13: FRM and non-forestry purposes 

With changing climatic conditions, the areas suitable for tree species are also 
changing. The FRM legislation helps to identify FRM and specifies the requirements, 
such as origin, health and resistance, wood quality, outstanding characters, to be met 
by trees that will be used for the production of the different types of FRM.  

Furthermore, there is increasing demand for FRM for non-forestry purposes to address 
the European Green Deal objectives and commitments under the Biodiversity 
Strategy, the EU Adaptation Strategy and the New EU Forest Strategy. Non-forestry 
purposes include agroforestry, biomass production, energy generation and the pledge 
to plant 3 billion trees, including in urban areas. 

Respondents were asked the extent to which they agree or disagree with a series of 
statements: 

  Q13a: The FRM rules should be maintained, covering the production and 

marketing of FRM for forestry purposes only  

  Q13b: The FRM rules should also cover the production and marketing of FRM for 

non-forestry purposes  

  Q13c: FRM intended for non-forestry purposes should at least fulfil the 

requirements of the lowest quality of regulated FRM  

There were 271 responses to this question across all respondents; with 123 excluding 
EU and Non-EU Citizens. 

Figure 83 shows that more respondents agreed with Statements Q13a, Q13b and 
Q13c than disagreed with them. Agreement is highest for Statement Q13c, with a 
clear majority 56% (69 or 123) selecting ‘Agree’ or ‘Somewhat agree’. 

 Total responses for Question 13 

A7.14.1 

Statements Q13a-c on FRM and non-forestry purposes 

By stakeholder group:  
Comparing responses to Statements Q13a and Q13b, three clusters can be 
approximated: 

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  Four stakeholder groups had more respondents in agreement with Q13a than 

Q13b: Trade union, Company/business organisation, NGO, and EU and non-EU 
citizens.  

  One stakeholder group had similar levels of agreement and disagreement 

amongst respondents: Business association 

  Four stakeholder groups had higher levels of agreement with Q13b than Q13a: 
Academic/research organisation, Environmental organisation, Public authority, 
and Other. 

Across seven stakeholder groups, a majority selected ‘Agree’ or ‘Somewhat agree’ 
with Statement Q13c. EU and non-EU citizens and NGOs had higher level of 
disagreement than agreement with the statement.  

  Responses to Question 13a (Stakeholders) 

  Responses to Question 13b (Stakeholders) 

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  Responses to Question 13c (Stakeholders) 

A7.14.2 

Additional comments and suggestions on FRM and non-

forestry purposes 

Several concerns were raised about the application of rules to FRM for non-forestry 
purposes, and the definition of non-forestry purposes, by Public authorities, NGOs and 
Business associations.  

Several respondents illustrated that forestry and non-forestry purposes are defined 
differently across Member States, and in some Member States the definition differed 
to that proposed in the Public Consultation questionnaire. For example, it was stated 
that in Germany biomass production and the conservation of forest genetic resources 
are regarded as forestry purposes. For Denmark, it was stated that non-forestry is 
defined as: wood production, shelterbelts, Christmas trees and ornamental greenery, 
avenue trees and recreational purposes, biomass production. 

A practical solution was called for regarding the regulation of FRM species which are 
used for both non-forestry and forestry purposes. Some respondents considered that 
production of FRM must always be subject to the requirements of the FRM directive 
and that regulation based on future use should not be considered. Amongst forest 
nursery representatives it was stated that it would not be possible “to produce 
Forestry and Non-Forestry plants in separate systems on the nursery, and it is not 
possible to have two paper / admin / traceability systems for Forestry / Non forestry 
plants in the same nursery”. 

EUFORGEN stated that the “definition of ‘forestry purposes’ should include subdivisions 
such as ‘production’, ‘conservation of genetic resources’ etc., and clarification of these 
concepts, while ‘non forestry purposes’ should be defined in order to enable 
harmonization at EU level”. 

A7.15  Results on Q14: FRM and the EU adaptation strategy 

The EU Adaptation Strategy calls for a broadening of the supply of suitable high 
quality PRM and FRM to support adaptation in agriculture, forestry, and land 
ecosystem management. It also aims to encourage more collaborative, transnational 
production and transfer of seeds and planting material. Respondents were asked the 
extent to which they agree or disagree with a series of statements: 

  Q14a: The FRM legislation should introduce rules on contingency planning to 
ensure availability of FRM in event of short supplies due to extreme weather 
conditions or disasters 

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  Q14b: A voluntary coordination group for collaborative production, pooling and 
exchange of FRM should be created to ensure availability of FRM in event of 
extreme weather and disasters 

  Q14c: A voluntary inventory should be created to enable improved access to 

information on FRM performance and contribute to traceability from the original 
location of the basic material through to the final planting site. 

  Q14d: The FRM legislation should introduce rules to determine the suitability of 

FRM for climate change and for extreme weather conditions 

There were 271 responses to in this question; with 123 responses excluding EU and 
non-EU citizens.  

Figure 87 shows that a majority of respondents were in favour of a voluntary 
coordination group and of the creation of a voluntary inventory (Statement Q11b, 
55% (68 of 123) and Statement Q11c (62% 76 of 123) respectively of respondents 
selected ‘Agree’ or ‘Somewhat agree’). Levels of agreement and disagreement were 
more evenly balanced for Statements Q11a and Q11d. 

  Total responses for Q14 (Stakeholders) 

A7.15.1 

Statement Q14a: The FRM legislation should introduce 

rules on contingency planning to ensure availability of FRM in event 
of short supplies due to extreme weather conditions or disasters  

By stakeholder group: Across stakeholder groups (Figure 1.82) for four of the ten a 
majority ‘Agreed’ or ‘Somewhat agreed’ with statement Q14a. The stakeholders with 
the highest level of agreement were Environmental Organisation (75%, 3 of 4) and 
Academic/research institute (72%, 10 of 14). Also, three of the ten stakeholder 
groups chose ‘Disagree’ or ‘Somewhat Disagree’ as an option. Some stakeholder 
groups were more likely disagree than agree, notably Public authority” (59%, 22 of 
37) and Business Association (60%, 6 of 10) respondents. 

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  Responses to Question 14a (Stakeholders) 

A7.15.2 

Statement Q14b: A voluntary coordination group for 

collaborative production, pooling and exchange of FRM should be 
created to ensure availability of FRM in event of extreme weather 
and disasters  

By stakeholder group: Across all stakeholder groups (Figure 89) six of the ten had a 
majority in agreement with statement Q14b. The stakeholders with the highest level 
of agreement were Trade Union (83%, 5 of 6) and Environmental Organisation (75%, 
3 of 4). A majority of Public Authority (52%, 22 of 37) selected ‘Disagree’ or 
‘Somewhat disagree’. 

  Responses to Question 14b (Stakeholders) 

A7.15.3 

Statement Q14c: A voluntary inventory should be created 
to enable improved access to information on FRM performance and 
contribute to traceability from the original location of the basic 
material through to the final planting site.  

By stakeholder group: Across stakeholder groups (Figure 90) seven of the ten had a 
majority selecting ‘Agree’ or ‘Somewhat agree’ with statement Q14c. The stakeholder 
group with the highest level of agreement was Academic/research institute (93%, 13 
of 14). Business Association were more likely to disagree than agree (50%, 5 of 10 
selected ‘Disagree’ or ‘Somewhat disagree’). 

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  Responses to Question 14c (Stakeholders) 

A7.15.4 

Statement Q14d: The FRM legislation should introduce 

rules to determine the suitability of FRM for climate change and for 
extreme weather conditions 

By stakeholder group: Across stakeholder groups (Figure 91) four of the ten had a 
majority select ‘Agree’ or ‘Somewhat agree’ with statement Q14d. However, five of the 
ten stakeholder groups had a majority select ‘Disagree’ or ‘Somewhat disagree’.  

  Responses to Question 14d (Stakeholders) 

A7.15.5 

Additional comments and suggestions on FRM and the EU 

adaptation strategy 

Contingency planning: Some respondents explained their lack of support for any EU 
involvement in contingency planning noting that their national approach was adequate 
and that such activities should remain the sole competence of Member States 

Voluntary inventory: One respondent stated that there is no need for voluntary 
inventories of performance of FRM, as there are already two comprehensive forest 
inventory systems in use. Two commented on FOREMATIS, making suggestions for its 

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continuous developing, content updates by Member States, an extension to include a 
common list of approved seed sources and their availability, and creation of a digital 
version.  

Rules to determine the suitability of FRM for climate change and extreme 
weather conditions: One respondent anticipated that such an approach could be 
counterproductive given the likely generalizations needed in EU rules, which would not 
be able to take sufficient account of natural differences in conditions and species 
across Member States. 

Other: some respondents called for a review of the FRM Master Certificate e.g.  a 
harmonized layout and a mandatory translation to English of the content to decrease 
the risk for errors. 

Annex 8  Targeted survey results 

The targeted survey collected information to support the assessment of options being 
considered as part of the review of the EU legislation on Plant and Forest Reproductive 
Materials (PRM, FRM). The purpose of the survey was to collect the views of 
stakeholders and evidence on the challenges, costs and benefits, potential effects, and 
feasibility of potential changes to the legislation.  

The survey contained dedicated sections on PRM and FRM and focussed on a wide 
variety of potential impacts, including but not limited to the costs and administrative 
burdens of stakeholders, impacts on trade, innovation and the environment.  

The targeted survey opened on 9 March and closed on the 1 April 2022. The total 
number of responses was 99. 

The launch of the survey was promoted via various channels including the 
Commission’s website, which provided a generic link to the survey. Stakeholders were 
also contacted by email notifying them about the survey and offering the possibility to 
request a personalised link to the survey. The personalised link allowed stakeholders 
to complete the survey in several sittings, returning to their answers each time, before 
submission, and to share the link with colleagues so that more than one person from 
their organisation could contribute to the response. 

A8.1 

Overview of respondents 

The following stakeholder groups were addressed in the survey: academic/research 
institution; business association (including of breeders, multipliers / producers of PRM 
/ FRM, traders, farmers, forest managers); company / business (including breeders, 
multipliers / producers of PRM / FRM, traders, farmers, forest managers); consumer 
organisation; environmental organisation; non-governmental organisation (NGO); 
public authority – national competent authority and others71. 

71 Two stakeholders identified themselves as belonging to the category of “others” despite the fact that they belong to public 
organisations functioning as NCAs.  

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  Distribution of Stakeholder groups (N=99) 

Just under half (49%) of the 99 responses came from five countries, these are Austria 
(N=5), Belgium (N=8), France (N=13), Germany (N=12), the Netherlands (N=11). 
Overall, at least one response was received from stakeholders in 23 EU Member 
States.  

  Member State distribution of responses (N=99) 

The targeted consultation collected views from stakeholders engaged across the 
supply chain of both PRM and FRM products. Two-third of respondents answered PRM 
related questions, while 18% responded to FRM ones, the remaining 7% respondent 
to both topic areas.  

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  Stakeholder focus (N=99) 

In terms of supply chain distribution, the majority of respondent were engaged with 
one or more of the following activities: breeding (49 respondents), maintaining (39), 
production (52), storage, collection and dispatching of products (48), as well as public 
authorities (27 were authorities for PRM/FRM certification and 23 authorities 
responsible for variety registration).  

  Supply chain distribution of responses (N=99) 

In terms of geographic scope of activities, just over half of the stakeholders are 
engaged with countries outside and inside the EU and 31% of respondents are focused 
on a single Member State.  

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  What is the geographic scope of your/your members’ activities? 
(N=70) 

Just over one third (35%, 9 out of 26 respondents) of responding associations said 
that 70-80% of their members are SMEs and another 27% (7 out of 26 respondents) 
said that their SME members make up 90-100% of all members. At the same time one 
third of businesses (7 out of 21 respondents) also identified themselves as SMEs.  

  What proportion of your members are SMEs? (N=26) 

Is your organisation an SME? (N=21) 

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A8.2 

Alignment of the rules 

A8.2.1 

Alignment of definitions and structure of legislation 

One of the fundamental issues addressed in the survey was the extent to which 
stakeholders are experiencing difficulties understanding and complying with the 
current legislation, and if so, what are the primary reasons for this. In terms of 
alignment between the 12 PRM Directives regarding their structure, the definitions, 
and decision-making procedures, 72% (39 out of 54 respondents) of businesses, 
association, academics and NGOs said that they had no problems. Those who 
experience problems identified, amongst others, complexity of legislation, lack of 
harmonisation in the definitions and cost of bureaucracy as a major problem.   

In contrast, national competent authorities were more evenly split with 55% (11 out 
of 20 respondent) saying they encountered no problems in terms of monitoring and 
enforcement of the relevant Directives. Those who encountered problems identified, 
amongst others, the lack of harmonisation and lack of structural alignment of the 
Directives as well as differences in implementation between Member States as major 
challenges.  

  Q2- 4 Responses on whether stakeholders are encountering 
problems with the current regulatory framework (N=20; N=54) 

In terms of the impacts of the problems identified the majority of stakeholders listed 
unnecessary administrative burden (as a result of a lack of harmonised definitions and 
uneven implementation) and disadvantages to SMEs. Additionally, barriers to market 
entry–- negative effect on the diversity of actors involved and a reduction in the 
availability of plant genetic sources were also mentioned. This latter element is a 
result of crop species inability to find their way into the market, which in turn 
disincentivises the work carried out by seed saver organisation and fails to provide 
farmers with suitable planting material. 

Businesses noted the difficulties that the diverse implementation of the 12 Directives 
cause to their operations and consequently identified higher costs as well as difficulties 
in marketing as the main impacts. Other issues listed by stakeholders included the 

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impacts on farmer’' seed systems at national level as well as the oversimplification of 
the legal definition of VCU in Art 5. of directive 70/457/EEC for Agricultural species 
and failure to register varieties suitable for special uses or specific regions that should 
be registered within the legal provisions of the directive when a varieties qualities are 
taken as a whole.  

It is worth noting that many stakeholders also pointed that the current differences in 
implementation do not constitute a significant barrier to their operations.  

  Q6 Do you (or your members if you reply on behalf of an 

association) encounter problems due to differences in 
implementation of the 12 Directives by the Member States? (N=54) 

  Q7 How important are the problems encountered in relation to 

the following? (N=31) 

A8.2.2 

PRM and the Plant Health Regulation 

Stakeholders signalled challenges related to the current regulation of non-quarantine 
pests, even though in most Member States inspections related to regulated non-
quarantine pests (RNQPs) is carried out by the same certification and plant health 
competent authorities. Based on the responses provided the main compliance 
challenges stem from the fact that RNQPs are regulated by both the PRM Marketing 
Directives and the Plant Health Regulation.  

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  Q8 Do you encounter problems with the implementation and 
enforcement of the legislation because currently the regulated non-
quarantine pests are listed in both the PRM marketing Directives 
and the Plant Health Regulation? (N=20) 

  Q10 In your Member State are inspections related to regulated 

non-quarantine pests currently being carried out by separate 
certification and plant health national competent authorities? 
(N=20) 

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  Q11 Do you (or your members if you reply on behalf of an 

association) encounter problems understanding and/or complying 
with the legislation because regulated non-quarantine pests are 
listed in both the PRM marketing Directives and the Plant Health 
Regulation? (N=54) 

A8.3 

Regulated Species 

Questions in this section were aimed at identifying challenges with the current scope 
of regulated and non-regulated species. Just under half, 44% (28 out of 64 
respondents) of stakeholders found that the current regulatory scope could be 
extended with additional species, while 67% (43 out of 64 respondent) said that none 
of the currently regulated list of species should be excluded 

  Q15-17 Are there any species that are currently regulated that 

you think should be excluded/included? (N=64) 

In response to the open question asking stakeholders to identify examples of “non-
regulated uses” and their importance various examples were provided, which included, 
amongst others, soybean as edamame for direct consumption, horticulture and 
ornamental use of different varieties.  

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To the follow-up open question regarding the criteria that should be used to determine 
which species are regulated within PRM legislation, stakeholders provided rather 
general responses, including environmental, economic criteria, volume of use, benefits 
for biodiversity, animal and human health. When prompted about the possibility of the 
EU’s Common Catalogue to include non-regulated species as a way of incentivising 
their use, respondents saw no correlation with just under half of the stakeholders 
saying it would have no effect.  

  Q20 Would the inclusion in the EU Common Catalogues of 

species not regulated at EU level (while maintaining their current 
status as non-regulated species) serve as an incentive or 
disincentive for breeding of such species? (N=64) 

Stakeholder opinions were more evenly spread when considering the potential inclusion 
of species that have only a small number of registered varieties. In this issue 57%  of 
respondents think that the breeding of species with a small number of varieties could 
be incentivised by the inclusion in the EU’s Common Catalogue.  

  Q21 Does the listing of varieties in the EU Common Catalogues 
serve as an incentive or disincentive for the breeding activities in 
species with only a small number of registered varieties? (N=64) 

A8.4 

Registration and certification processes for agricultural 

crops and vegetables 

This section focused on the costs of variety registration and PRM certification for 
agricultural crops and vegetables only and sought to identify the key challenges for 
stakeholders in this area. 

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A8.4.1 

Time and costs of variety registration and PRM 

certification 

In terms of relevance most stakeholders (80%) were involved in the breeding and 
registration of agricultural crop varieties while slightly less than half of them were 
working with varieties of vegetable species. 

  Q24-26 Are you (or your members if you reply on behalf of an 
association) involved in the breeding and registration of varieties of 
agricultural crops or varieties of vegetable species? (N=50) 

In terms of costs 73% of stakeholders (32 out of 44 respondents) said that 1-5% of 
their annual research investment for breeding is spent on registering new varieties. 
Similarly, 75% (27 out of 36 respondents) said that up to 5% of their annual 
production costs is spent on seed certification. SME responses showed the same 
pattern with 80% (4 out of 5 respondents) saying they spend up to 5% of their 
investment budget on registration and 75% (3 out of 4 respondents) stating that they 
spend up to 5% of their annual production costs on certification. 

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  Q30 What is your organisation’s (or your member organisations’ 

if you reply on behalf of an association) average annual cost for 
registering new varieties of agricultural crops and vegetables as a 
percentage of your annual research investment for the breeding of 
new varieties? (N=44) 

Similar figures emerged for the production of agricultural crops, with which over 70% 
of respondents (36 out of 50) were engaged and for the majority the costs of seed 
certification consisted of up to 5% of their annual production costs.  

  Q31 Are you involved in the production and certification of PRM 

of agricultural crops? (N=50) 

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  Q32 What proportion of your (or your members’ if you reply on 

behalf of an association) annual production costs of seed of 
agricultural crops are made up of the costs of certifying the seed? 
(N=36) 

Somewhat fewer respondents were active in vegetable production, however in terms 
of the costs of certification had shown a similar pattern to previous cost estimates and 
for most stakeholders it amounted to up to 5% of their annual production costs. About 
74% of respondents say that 80-100% of seeds that are marketed for vegetable 
production belong to the standard seed category.   

  Q33 Are you involved in the production and certification of PRM 

of vegetable species? (N=50) 

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  Q34 What proportion of your organisation’s (or your members’ if 

you reply on behalf of an association) annual production costs of 
seed (other than standard seed) of vegetable species are made up 
of the costs of certifying seed? (N=19) 

  Q35 What proportion of the vegetable seed marketed belongs to 

the category of “standard seed”? (N=20)  

National competent authorities were asked about the total number of registration 
processes overseen annually. Despite the fact that only about a dozen responses were 
received, these varied greatly, ranging from 25 to over 2.500 annual registrations. In 
terms of the costs of these registration processes, NCAs also provided different figures 
ranging from a thousand euros to 12.9 million euros, owing perhaps to the fact that 
some organisational budget breakdowns may not include specifically the costs of 
overseeing the registration process. Most stakeholders were not aware what 
percentage of their organizational costs are recovered from operators, but those who 
knew estimated this to be in the range of 21-40% or 81-100% depending perhaps on 
the national measures in place in the specific Member States.  

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  Q38 What proportion of the registration cost is recovered from 

operators? (N=18) 

A8.4.2 

Imports from non-EU countries 

In terms of the quality of imported seed and the guarantees provided under the 
Equivalency Regime, just over half of responding stakeholders noted no difference 
between EU and imported seed quality and only a minority believe that imported 
seeds provide worse guarantees.   

  Q39 Imports from non-EU countries: How does seed of 

agricultural crops and vegetables imported from non-EU countries 
under the equivalence regime (Council Decision 2003/17/EC) 
compared to seed produced in the EU? (N=70)   

In terms of imports of agricultural crops, stakeholders did not signal any major issues 
in fact positive impacts were identified related to availability and affordability of seeds 
as well as capacity of EU operators to multiply seeds.  

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  Q40 What impact do imports from non-EU countries of seed of 

agricultural crops and vegetables under the equivalence regime 
have on the following? (N=54) 

A8.4.3 

Derogations and exceptions from the general rules for 

variety registration 

According to stakeholders a potential derogation from DUS requirements for organic 
varieties would be unlikely to affect their availability, in fact about 23% of 
stakeholders (16 out of 70 respondents) believe it could increase the quantities of 
such varieties on the market.  

  Q41 Would derogations for DUS standards of organic varieties 

affect the availability of organic varieties suitable for organic 
production? (N=70) 

In order to ensure in situ conservation and the sustainable use of plant genetic 
resources the current EU legislation (Directives 2008/62/EU and 2009/145/EU) 
provides, in relation to conservation varieties of agricultural crops and vegetables as 
well as of vegetable varieties developed for growing under particular conditions 
(varieties informally known as “amateur varieties”), derogations to: 

 

 

the general requirements as regards the acceptance of a variety; 

the general requirements as regards the marketing of seed (certification 
requirements). 

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This framework was seen as largely useful and one that has provided positive 
contribution according to a majority of stakeholders even though one third of 
respondents noted no impact or negative contribution.  

  Q43 To what extent do you think that this framework has 

contributed to the objective of ensuring in situ conservation and the 
sustainable use of plant genetic resources? (N=70) 

The usefulness of the current EU framework for conservation varieties is also reflected 
by the fact that a majority of EU Member States have applied the derogations.  

  Q45 Does your Member State apply the derogations provided by 

Directives 2008/62/EC and 2009/145/EC? (N=18) 

However, despite the significant uptake in the derogations, there is not an 
overwhelming majority of producers engaged with PRM conservation varieties. This is 
most likely a result of the market demand rather than a reflection on the usefulness of 
the regulatory framework. The following graphs represent the market share of 
conservation varieties in terms of production and marketing.  

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  Q46 Do you (or your members if you respond on behalf of an 
association) produce PRM of conservation varieties with a view to 
marketing and/or do you market PRM of conservation varieties? 
(N=52) 

  Q47 What percentage of your members are involved in the 

marketing of PRM of conservation varieties? (N=11) 

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  Q48 What percentage of your (or your members’ if you respond 
on behalf of an association) annual turnover does the marketing of 
conservation varieties represent? (N=21) 

In terms of constraints, it was not the regulatory environment that was identified by 
the stakeholders but rather the market environment. More specifically, respondents 
viewed the low willingness of the market to pay PRM sales price for conservation 
varieties as a major constraint alongside low market demand.  

  Q51 To what extent do you think that the following factors are 

constraints on the wider use of conservation varieties? (N=70) 

In case quantitative limits were to be removed, the majority of stakeholders estimated 
no impact in the production, demand, diversity and quality of conservation varieties. 
At the same time a small minority of stakeholders expect that the removal of 
quantitative limits could bring about cost increases both for producers (costs of 
production) as well as for NCAs (costs of enforcement).    

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  Q53 If quantitative limits were removed, what impact would it 

have on the following: (N=70) 

As for maintaining the quality of conservation varieties available on the market 
stakeholders rated pest-free plants as most important alongside varietal identity, 
purity and germination.  

  Q54 How important is it that the PRM of conservation varieties is 

tested (officially or through other trusted means) to ensure basic 
requirements in relation to: (N=70) 

In fact, stakeholders expect that if the marketing of conservation varieties was subject 
only to basic requirements in relation to defects, vigour and dimensions, germination, 
varietal identity and purity, and substantial freedom from plant pests that could result 
in lower production costs and the associated costs of conservation varieties on the 
market, but it could also decrease the quality of such products.  

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  Q55 If the marketing of PRM of conservation varieties was 

subject only to basic requirements in relation to defects, vigour and 
dimensions, germination, varietal identity and purity, and 
substantial freedom from plant pests, what effect do you think this 
would have on the following: (N=70) 

In terms of the importance of maintaining the connection between conservation varieties 
and their region of origin most stakeholders found it to be very important or important 
from the perspective of production, maintenance and marketing as well. Even though 
most  stakeholders  also  found  that  the  potential  removal  of  the  link  between 
conservation varieties and their region of origin would not have far-reaching impacts on 
production, diversity and quality.  

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  Q56 In your view, how important is it to maintain the link 
between conservation varieties and region of origin, as regards: 
(N=70) 

  Q57 If the requirement for linking conservation varieties to the 

region of origin was removed from the legislation, what impact 
would it have on the following: (N=70) 

As for constraints stakeholders identified both market and regulatory factors as 
reasons for the lack of wider use of conservation varieties.  

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  Q60 To what extent do you think that the following factors are 

constraints on the wider use of conservation varieties? (N=70) 

Testing was found to be of particular importance for ensuring the quality of vegetable 
varieties developed for growing under particular conditions, specifically for maintaining 
a pest free environment of the plants.  

  Q61 How important is it that PRM of vegetable varieties 
developed for growing under particular conditions is tested 
(officially or through other trusted means) to ensure basic 
requirements in relation to the following? (N=70) 

Respondents found that if the marketing of PRM of vegetable varieties developed for 
growing under particular conditions was subject only to basic requirements in relation 

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to defects, vigour and dimensions, germination, varietal identity and purity, and 
substantial freedom from plant pests that would have no substantial impacts on 
quality, availability or costs. Again, it seems that beyond the regulatory requirements, 
the market demand is the main driving force behind production and quality of specific 
varieties.  

  Q62 If the marketing of PRM of vegetable varieties developed for 

growing under particular conditions was subject only to basic 
requirements in relation to defects, vigour and dimensions, 
germination, varietal identity and purity, and substantial freedom 
from plant pests, what effect do you think this would have on the 
following: (N=70) 

The willingness of stakeholders to rely on market dynamics was shown by the 
reluctance to introduce derogations for new varieties bred locally.   

  Q63 Do you think that there is a need to provide derogations (for 

variety registration and certification of PRM) for new varieties bred 
locally, adapted to local conditions, and intended to be marketed 
locally?: (N=70) 

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In fact, responses had shown that there is a lack of concept of what constitutes as local 
with  only  22%  of  stakeholders  saying  their  Member  State  legislation  does  provide  a 
definition on what constitutes as local PRM product. 

  Q65 Is ‘local’ defined in your Member State? (N=70) 

A8.4.4 

Certification activities carried out under official 

supervision 

The Directives on agricultural plant species and vegetables allow for several certification 
activities  to  be  undertaken  by  operators  under  official  supervision,  however,  there 
remain  some  certification  activities  that  can  only  be  carried  out  officially.  Responses 
varied between Member States on whether there is a possibility to carry out certification 
under official supervision. Seed sampling was the most frequently cited activity where 
certification under official supervision is taking place for plant species.  

Vegetables species are less likely to be undergoing certification under official supervision 
in any of the listed activities, although a large proportion of respondents were not aware 
of the relevant figures.  

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  Q68 Please state the proportion of the following types of 

certification activity for agricultural plant species that are currently 
conducted by operators under official supervision in your Member 
State? (N=18) 

  Q69 Please state the proportion of the following types of 

certification activity for vegetables that are currently conducted by 
operators under official supervision in your Member State? (N=18)  

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Overall, half of the stakeholders responding conduct certification under official 
supervision, the majority of whom spend up to 5% of their annual budgets on this 
activity. However, this is no indication that savings are made or that the certification 
costs would be lower than those carried out by competent authorities.  

  Q70 Do you (or your members if you reply on behalf of an 

association) conduct PRM certification under official supervision? 
(N=52) 

  Q73 Approximately what proportion of your (or your members’ if 

you reply on behalf of an association) annual budget is spent on 
costs for the certification of PRM under official supervision? (N=26)

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  Q75 To what extent have you had savings to your (or your 
members’ if you reply on behalf of an association) annual budget 
because of carrying out certification of PRM under official 
supervision? (N=26)   

In fact, just under one third of respondents consider that certifications carried out by 
the competent authorities has a higher cost than certification under official 
supervision, whereas about 21% of respondents see no difference in the associated 
costs.  

  Q79 How does the cost of certification conducted by operators 

under official supervision compares to the costs of certification 
conducted by a competent authority? (N=70) 

When comparing the estimated share of large businesses and SMEs carrying out 
certification under official supervision, data from associations does not show significant 

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differences. In both instances around half of the responding associations said that over 
75% of their members do carry out certification under official supervision.  

  Q79A What proportion of your members and SME members 

conduct PRM certification under official supervision? (N=19) 

NCA opinions were somewhat split on their ability to enforce the legislation if it 
became mandatory for NCAs to provide for certification conducted by operators under 
official supervision for all steps of the seed certification process. Whereas most of the 
respondents felt it would have no impact, almost one third of the respondents were 
not able to answer the question, due to perhaps insufficient information about the 
organisational capacities. 

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  Q82 If it became mandatory for NCAs to provide for certification 
conducted by operators under official supervision for all steps of the 
seed certification process, and where operators may decide 
whether or not to use this possibility, how would this impact your 
ability to implement and enforce the legislation? (N=18) 

NCAs do not anticipate any significant negative market impact if it became mandatory 
for NCAs to allow certification conducted by operators under official supervision for all 
steps of the seed certification process. In fact, they expect that cost of certification 
and time to market products could both decrease.  

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  Q83 If it became mandatory for NCAs to provide for certification 
conducted by operators under official supervision for all steps of the 
seed certification process, and where operators may decide 
whether or not to use this possibility, how would this impact the 
following? (N=72) 

A8.5 

VCU examination of varieties of agricultural plant species 

This section aimed at identifying areas of challenges and scope for improvement in 
relation to value for cultivation and use (VCU) tests. Reflecting on the differences in 
implementation of VCU tests between Member States, 64% (27 out of 42 
respondents) said that they experienced problems. 

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  Q88 Do you experience problems due to differences in the way 

different Member States apply the VCU requirements? (N=42) 

In terms of the specific problem 89% (24 out of 27 respondents) said the cost and 
duration of VCU testing is a moderate or minor problem. Out of the listed other 
potential challenges, stricter requirements of VCU testing were seen as a minor 
problem by 74% (20 out of 27 respondents) while lower quality of VCU tests were 
seen as a moderate problem by 52% (14 out of 27 respondents).  

  Q89 Please identify the problem your organisation experiences 

in your Member State compared to other Member States (N=27) 

Just about one third of the respondents said that about 25-50% of products are 
withdrawn annually due to their performance in VCU testing, which signals the quality 
protection impacts of this examination.  

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  Q90 What percentage of all varieties being VCU tested annually 

in your Member State are rejected or withdrawn because of their 
performance in this examination? (N=18) 

The importance of quality protection is confirmed by stakeholders who believe VCU 
should not be made voluntary for any species for which it is currently 
testing  
mandatory. However about one third of respondents think there are certain species 
where this would be beneficial.  

  Q91 Do you think there are species for which the current 

mandatory VCU should become voluntary? (N=61) 

In the follow-up open question requesting stakeholders to identify species for which 
the currently mandatory VCU requirements should be made voluntary, two species 
elicited more than one response, these were Solanum tuberosum (N=9) and Triticum 

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(N= 2). Other suggestion from stakeholders included Brassica napus Napobrassica 
Group, Zea mays, Helianthus, Brassica napus, Raphanus sativus, Sinapis alba, 
Phacelia tanacetifolia, turf grasses (Lolium pereene, Festuca species etc.), cover crops 
(diverse species), compaign crops (diverse species), Biserrula pelecinus, Lathyrus 
cicera, Medicago doliata, Plantago lanceolata, Brassica rapa var. silvestris,  legumes 
and Cannabis.  

Furthermore, some stakeholders noted that VCU has limited value for almost all field 
crops and pointed out that instead of VCU tests, a biodiversity test should be carried 
out to determine intravarietal diversity. Other stakeholders noted that hybrid varieties 
created by inbred lines only just pass the test, while old and new GMOs tend to fail as 
they are genetically identical clones. The cultivation is not sustainable as these are 
non-adaptable varieties and are incompatible with the Biodiversity Strategy. 

While acknowledging the importance of VCU test, a majority of stakeholders believed 
that it should be made possible to conduct these examinations under official 
supervision. At the same time NCA responses indicated that such a change could have 
a negative impact on their ability to enforce the legislation.  

  Q95 Do you think that it should become possible for VCU 

examinations to be carried out under official supervision? (N=61) 

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  Q97 If it became mandatory for NCAs to provide VCU 

examinations under official supervision, and where operators would 
decide whether or not to use this possibility, how would this impact 
your ability to implement and enforce the legislation? (N=18) 

NCAs were asked about the potential impacts of allowing operators to carry out VCU 
examinations under official supervision (chart below). Just under one third of 
respondents indicated that such a change could increase their annual VCU cost 
burden.  This contradicts the earlier statement of operators who noted no differences 
in their annual costs between VCU examinations under official supervision or 
conducted by NCAs.  

  Q99 If it became mandatory for NCAs to provide VCU 

examinations under official supervision, and where operators would 
decide whether or not to use this possibility, how would this impact 
the following? (N=18)  

At the same time respondents noted (question was open to all stakeholders) that a 
potential option for operators to carry out VCU tests under official supervision is 
unlikely to have wider impacts on the time of registration, quantity, diversity or quality 
of products on the market. However, around half of the respondents expected the 
costs of registration of a new variety to decrease and investments into research and 
innovation to increase 

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  Q100 If it became mandatory for NCAs to provide VCU 

examinations under official supervision, and where operators would 
decide whether or not to use this possibility, how would this impact 
the following?   (N=61) 

A8.5.1 

VCU adapted to the needs of organic agriculture 

Stakeholders identified a low market demand for organic varieties. To substantiate this 
data NCAs were asked about the volume of applications they have handled in the past 
5 years for new organic varieties. Responses varied greatly with the highest numbers 
being reported from Germany and France.  

France reported 12 applications in total (2 durum wheat and 10 soft wheat) whereas 
in Germany applications for organic VCU totalled 39 over the last five years and 
included winter barley (3), spring barley (3), winter rye (2), winter wheat (26), spring 
wheat (2), oat (3). As a comparison in Germany there were 500 applications per year 
for cereals, so about 2500 over five 
years.                                                                                                                                         

In Austria a total of 22 applications were submitted for organic varieties out of which 
winter wheat (18), winter spelt (3), and naked oats (1).                                                                 

In Czechia prior to the enforcement of Reg. 2018/848 there were nine applications for 
varieties suitable for organic farming, however since the enforcement no application 
were submitted.    

In Denmark there were only a couple of application for wheat and barley over the past 
years out of a total of 250 applications in the last 10 years.  

NCAs from the Netherlands reported 5 applications in total.  

Greece, Cyprus, Poland, Slovakia, Croatia, Netherlands, Hungary, Finland, Belgium, 
Norway and Sweden reported no organic applications.                                                                    

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  Q101 What is the level of demand for organic varieties (as 

defined in Regulation 2018/848/EC, Article 3(19)) in your Member 
State? (N=43) 

About one third of respondents said that their Member State offers VCU testing 
specifically adjusted to organic varieties. According to the open text responses 
Member States adopted various approaches for organic testing. Testing conditions are 
often adapted its VCU testing to fit organic conditions, and include various criteria 
reduced nitrogen and no chemical treatment meanwhile keeping the same comparison 
of varieties (a mixture of selected varieties) and same characteristics with a 
supplement of e.g., competition against weeds. In some countries for the decision on 
listing of varieties, the new varieties must show an improvement compared to other 
varieties that were tested under organic conditions. Organic testing may not be 
available for all species, however in most of the listed examples, testing is carried out 
on the fields under organic regime.         

Those Member States that do not offer organic VCU testing mentioned the lack of 
demand and the high costs of the test as reasons.                  

  Q104 Does your Member State currently offer VCU testing 

specifically adjusted for organic varieties? (N=18) 

The majority of respondents believed that a potential introduction of mandatory 
principles for organic testing could have a negative impact on the market segment 

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specifically in relation to costs and demand. Whereas it may positively affect the time 
to market.   

  Q107 What do you think the impact would be if mandatory basic 

principles reflecting the needs of organic production (for example 
testing conditions) were introduced at EU level?  (N=61) 

A8.6 

Examination of varieties for characteristics that contribute 

to sustainable production  

This section of the survey sought to identify how the current regulatory framework 
could facilitate sustainable agri-food production and what aspects should be changed 
to mitigate climate change and adapt to its impacts. Across all listed species 
(agricultural plants, vegetables, fruit, vine and ornamentals) stakeholders identified a 
stable or increasing market demand for varieties with more sustainability 
characteristics.  

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  Q109 What is the market potential in the EU for new varieties 

with characteristics that contribute to sustainable agri-food 
production (for example, reduced reliance on plant protection 
products and/or fertilisers, increased tolerance to plant pests 
and/or difficult environmental conditions)? (N=68) 

Recognising the importance of varieties with sustainability characteristics, VCU testing 
in most Member States does now include relevant criteria.  

  Q110 As regards agricultural plant species, does VCU testing in 
your Member State currently include characteristics that contribute 
to sustainable agri-food production? (N=17) 

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Stakeholders gave examples on the sustainability characteristics for which new 
varieties are tested. In Greece winter cereals are tested for tolerance to low 
temperatures, wheat is tested in the lab for characteristics for the flour industry, 
vegetables are tested for disease resistances and vines are tested for important wine 
characteristics such as sugar content and total acidity of must, etc.  

In Slovakia species are tested for disease and pest resistance, winter hardiness, frost 
resistance, lodging, nutrition content.  

In the Netherlands potatoes are tested for disease resistance viruses, fungus 
Phytopthora, yield with different soil types. Cereals tests are done for fungus 
Fusarium, mildew, yellow rust, yield with different soil types. Another respondent from 
the Netherlands also added that all outdoor crops are tested for abiotic stress 
tolerance and disease resistance/tolerances. Indoor crops are tested for disease 
resistance/tolerance as part of DUS testing.  

In Denmark agricultural species are tested for competition towards weeds, pest 
resistance, response to low input conditions, yield (more for less input).            

In Sweden agricultural species are tested for disease resistance for perennial crops the 
possibility for over wintering (durability), for beet it is sugar yield in relation to what is 
harvested from the field.                                    

In Norway species are tested for disease resistance and susceptibility, yield, fodder 
value (oat, barley and fodder plant species), straw strength and straw length 
(cereals), winter hardiness (fodder plant species and winter wheat) and baking quality 
(wheat). 

In Czechia species are tested for resistance to biotic and abiotic stresses, adaptation 
to different agro-climatic conditions, response to the different intensity of treatment 
(doses of nitrogen, fungicide levels etc.).                             

In Finland testing is done for resistance/susceptibility to certain diseases, yield in 
different growing conditions, lodging, winter hardiness, growth time (plus yield and 
quality of the yield).                                                        

In Austria winter wheat is tested for standing ability, preharvest sprouting, nine 
diseases, grain yield, nitrogen efficiency, various grain and baking quality 
characteristics.  

In Belgium testing is done for disease tolerances (bacteria, fungi and viruses). 
Varieties are tested under low input conditions.  

In Germany there are a high number of trial sites covering different agro-climatic 
conditions with different soil types. Tests are done with reduced fertiliser, resistance to 
pests and diseases, with and without growth regulators. Examples include: beet: 
nematodes, rhizoctonia potato: wart disease, nematodes wheat: Pseudocercosporella 
herpotrichoides, Drechslera tritici-repens, yellow mosaic viruses BaYMV-1, BaYMV-2, 
BaMMV, soil-borne viruses.                                                              

In France testing is done for tolerance or resistance to harmful organisms, reduction of 
inputs, carbon storage, reduction of fossil energy, reduction of water consumption, 
additional aspects for example for grain cereals: lodging resistance, etc. Another 
French NCA provided further crop examples: downy mildew evaluation for potato; 
fungal diseases in cereals, reduction of nitrogen dependency in oilseed 
rape/wheat/triticale. 

In response to the question on whether producers currently assess (mandatorily or 
voluntarily) new varieties of vegetables, fruit plants, ornamentals, and vines for 
characteristics that contribute to sustainable agri-food production, vegetables were the 
only category for which over half of the stakeholders responded positively. In all other 
categories producers were either unaware or did not carry out such tests.  

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  Q112 Do you currently assess new varieties of fruit plants, 

ornamentals, and vines for characteristics that contribute to 
sustainable agri-food production? (N=55) 

Stakeholders were asked to provide details on how the results are used for the 
decision on whether to accept new varieties. The responses showed slightly diverging 
approaches. In Czechia for vine the decision on variety acceptance is based on 
complex evaluation of all important VCU characteristics, incl. characteristics connected 
with sustainability aspects is made by expert panel meeting. In the Netherlands 
disease resistance is an important factor taken into consideration but there are no 
rejection thresholds for this. Rejection thresholds generally should be applied lightly 
and carefully in order to not reduce biodiversity in the future. In Germany regional 
trials are carried out after testing these trial results provide more details but given no 
indication of how the results are used to accept or reject a variety. In France both 
rejection thresholds, bonus/malus for eco/non-eco -friendly varieties and coefficients 
in multi-criteria index methods are used in the decision. The precise rules depend on 
the species and the evaluation criteria; for example for potato varieties, environmental 
aspects (mildew and nematode tolerance) is a bonus to promote tolerant varieties. 

Despite currently not carrying out sustainability testing 59% of stakeholders (40 out of 
68 responses) favoured the introduction of a requirement to examine new varieties for 
characteristics that contribute to sustainable agri-food production in the PRM 
legislation.  

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  Q114 Is there a need to introduce in the PRM legislation a 
requirement to examine new varieties for characteristics that 
contribute to sustainable agri-food production? (N=68) 

There was overwhelming support from respondents to extend VCU testing criteria to include 
mandatory aspects on sustainability, trial procedures and decision-making procedures for the 
acceptance of varieties. Statistical trial designs and standard setting were also favoured, albeit to a 
lesser extent.  

  Q115 In your view, which of the following elements should be 
included in variety examination to better ensure the availability of 
varieties with characteristics that contribute to sustainable agri-
food production? (N=40) 

The introduction of sustainable characteristics was seen as most important for agricultural crops 
and less relevant for ornamentals. In the case of vegetables, fruits and vines opinions were evenly 
split.  

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  Q116 For which of the below listed species group would it be 

important to introduce a requirement of examination for 
characteristics that contribute to sustainable agri-food production 
and explain which criteria should/would be important? (N=40) 

In terms of the potential impact of introducing a sustainability criterion in VCU testing, most 
stakeholders expected an increase of costs and increased time to market their products. However 
positive impacts were anticipated in relation to quality, variety of products and investment in 
innovation.  

  Q117 What could be the impacts of introducing in the PRM 

legislation a requirement to examine new varieties for 
characteristics contributing to sustainable agri-food production? 

(N=17) 

To the follow-up open question only NCAs provided responses who underlined the benefits on farm 
business resilience, quality of products and a corresponding EU competitive advantage. They also 
emphasised the cost burden that the extended criteria may have on businesses.  

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A8.7 

Scope of the marketing definition     

A8.7.1 

Marketing to amateur gardeners 

Questions in this section were seeking to identify whether the current regulatory 
context is sufficient in addressing the key issues that may emerge under marketing to 
amateur gardeners, seed conservation networks and in-kind exchanges between 
farmers. In terms of relevance 57% (25 out of 44 respondent) said that they do breed 
and 75% (33 out of 44 respondent) said that they do market their products to 
amateur gardeners.  

  Q121 Do you (or your members if you reply on behalf of an 

association) breed, sell or market varieties for the amateur 
gardener market? (N=44) 

In fact, 32% (8 out of 25 respondents) said that they breed products exclusively for amateur 
gardeners. A slight majority of stakeholders found that the current marketing rules of the PRM 
legislation negatively impact on the diversity of PRM available to amateur gardeners.  

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  Q122 Do you (or your members if you reply on behalf of an 

association) breed varieties for the exclusive use of amateur 
gardeners? (N=25) 

Just over one-third of the respondents felt that the current PRM marketing rules are 
providing a positive or significantly positive impacts in terms of diversity of products, 
and just about the same percentage had thought that it is in fact having a negative or 
significantly negative impact.  

For a majority of respondents, the costs associated with the registration of varieties to 
the national catalogues constitute an important inhibiting factor to greater diversity of 
PRM available to amateur gardeners. These registration costs are the result of 
relatively stringent DUS and VCU tests having to be undertaken. These costs cannot 
be recouped, especially by smaller operators, as the revenue generated from selling 
varieties to the amateur sector is generally low. There was a call for less stringent 
marketing rules to be allowed for varieties aimed exclusively at amateur gardeners, 
for example by simplifying/ facilitating registration procedures, removing the 
requirement for DUS/ VCU tests (or making them optional), allowing "reimbursements 
through seed sale". Other commonly cited concerns raised included specific 
quantitative restrictions, notably limits on amounts to be produced and small 
packaging obligations to be complied with. 

One respondent viewed that, currently, the agricultural sector is geared towards big, 
commercial operators. It is highly industrialised and much of the focus is on achieving 
high efficiency and yields. Agricultural safeguards, currently in place (such as DUS and 
VCU controls) are restricting the wider use of varieties that are of great interest to 
amateur gardeners, but which do not always reach the market owing to 
heterogeneous and less stable/ uniform properties. Another respondent explained 
that, at least in the context of Austria, once a variety is registered, it "loses its status 
as a genetic resource”.  For seed savers, this means a loss of power/ ownership over 
these varieties, even if they have been cultivating these varieties for years, whereas 
for agrobiodiversity, this means that "the genetically diverse lines of one and the same 
variety cultivated in different places are lost". This loss in genetic diversity may imply 
that adaptability is also lost in the long term. 

Questions aiming to identify the market size of varieties being bred for the exclusive 
use of amateur gardeners returned limited responses (N=8). Those who responded 
estimated the market size of PRM being bred exclusively to amateur gardeners to 
make up about 1-20% of all PRM seeds they produce.  

In terms of the specific varieties marketed for amateur gardeners most stakeholders 
listed vegetables as well as other non-categories varieties such as ornamentals, 
agricultural crops, e.g., Brassica napus subsp. Napobrassica, tomatoes and 
ornamentals.  

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One stakeholder also noted the need for a clear separation of the professional and 
non-professional sector in order to ensure equal treatment of all market participants. 
The stakeholder recommended that precise and unambiguous definition of the 
"professional sector" should be based on the German definition of "marketing for 
commercial purpose" in § 2 I (12) German Seed Marketing Act.  

  Q131 Please specify for which crop groups your organisation (or 

your members if you reply on behalf of an organisation) markets 
varieties for the exclusive use of amateur gardeners (N=33) 

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  Q132 Do you think that the current PRM marketing rules are 
impacting on the diversity of PRM available to amateur gardeners? 
(N=60) 

Stakeholder opinions were evenly split on the potential impacts if varieties marketed 
exclusively to amateur gardeners were exempted from the variety registration and 
PRM certification requirements or if they would be subjected to only basic 
requirements.  

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  Q134 If varieties marketed exclusively to amateur gardeners 
were exempted from the variety registration and PRM certification 
requirements, what effect do you think this would have on the 
following: (N=60) 

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  Q135 If PRM of varieties marketed exclusively to amateur 
gardeners was subject only to basic requirements in relation to 
defects, vigour and dimensions, germination, varietal identity and 
purity and substantial freedom from plant pests, what effect do you 
think this would have on the following: (N=60)   

A8.7.2 

Seed conservation networks  

Activities of seed conservation networks can include collection and maintenance in situ 
and/or storage of seed of varieties. Typically, they can include exchange of seed 
between the members of the network. Some of their activities could fall under the 
current definition of marketing in the PRM Directives.  

The limited reach and integration of these networks into national markets is indicated 
by the fact that over half of the respondents signalled that they are not taking part in 
seed conservation networks. Most of those who did take part in such networks 
indicated that they are carrying out their tasks on a not-for-profit basis.  

Most stakeholders did not provide a definition of non-profit activities however one 
stakeholder explained that gene banks within their network (and across Member 
States) operate as part of national conservation programmes. While another 
respondent explained that their organisation currently supports the conservation of 
potato varieties in Peru, they provide financing to farmers, producing on a small-scale 
basis, to help maintain those genetics. 

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  Q137 Is your organisation involved in the operation of a seed 
conservation network or participation in such a network? (N=41) 

  Q138 Are these activities undertaken on a not-for-profit basis? 

(N=8) 

As for the potential future work of seed conservation networks 64% (37 out of 58 respondents) expect no 
change in their numbers, if the current regulatory environment is unchanged.    

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  Q142 Assuming there are no changes to the PRM legislation 

regarding the definitions or activities relating to seed conservation 
networks, how do you expect the activities of seed conservation 
networks to change over the next 10 years? (N=58) 

Should not-for-profit work of seed conservation networks be exempted from the PRM 
legislation requirements, it could have a positive impact in terms of the work carried 
out by such networks, more specifically the number of species and varieties they make 
available for the market as well as the volume PRM exchanged. NCAs do not expect 
that the possible exemption would impact their activities or burdens however there is 
also no expectation that the number of such conservation networks would increase as 
a result of the exemption.  

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  Q143 If the exchange of PRM between members of seed 

conservation networks as a not-for-profit activity were exempted 
from the scope of the EU PRM legislation, what impact do you think 
this would have on the following? (N=58) 

NCA burdens however could increase if seed conservation networks as a not-for-profit 
activity were subject only to basic requirements in relation to defects, germination, 
varietal identity and purity and substantial freedom from plant pests. That is likely a 
result of them having to spend additional resources on checking the proportion of 
activity that would fall under the basic requirements. In all other aspect this proposed 
changed would carry similar, albeit weaker, benefits than a full exemption.  

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  Q145 If the exchange of PRM between members of seed 

conservation networks as a not-for-profit activity were subject only 
to basic requirements in relation to defects, germination, varietal 
identity and purity and substantial freedom from plant pests, what 
impact do you think this would have on the following? (N=58) 

A8.7.3 

In-kind exchange of seed between farmers 

Currently, the Directives do not allow exchange of material between farmers and 60% 
(37 out of 62 respondents) think that in-kind seed exchanges between farmers should 
not be permitted in the EU. There are countries, where, in specific circumstances, in-
kind exchanges can take place, for example in France, where in-kind exchange is 
permitted in the context of a "mutual aid" framework, as long as PRM/ seeds being 
exchanged do not belong to a variety protected by a Plant Variety Right, they are not 
produced within the framework of a multiplication contract, and the seeds are not 
intended for commercialisation.  

In Norway, the occasional in-kind exchange of seeds between farmers is permitted. 
In-kind exchange is not available to registered seed companies. Furthermore, PRM of 
certain varieties are excluded from in-kind exchange, notably seed potatoes and other 
vegetative plant reproductive material because of the risk posed for plant health. 

Few respondents were able to provide data on the quantity or type of products that 
are exchanged in-kind examples from France mentioned soft wheat and soy as the 
most common species in exchange transactions. 

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  Q150 In your opinion, should in-kind exchange of PRM between 

farmers (without prejudice to EU and national legislation on plant 
variety rights) be permitted by the EU PRM legislation? (N=62) 

Opinions are split in equal measures on what could be the potential impacts if in-kind 
exchanges between farmers were permitted. Most stakeholders agree that the 
quantity and variety of seeds exchanged would increase whereas the demand for 
commercial varieties may decrease.  

  Q151 What do you think the impact of such permission would be 

on the following in your country? (N=62)  

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The predominant view among respondents was that allowing in-kind exchange 
between farmers would be more detrimental than beneficial. The most commonly cited 
reasons were: 

  (1) Reduced quality of seeds/ PRM available -the reduction of quality was also 
commonly evoked in the context of staple varieties, such as seed potatoes - as 
such, there is a risk of loss of varietal purity and a significant increase in 
phytosanitary risks  

  (2) Higher propensity for fraudulent behaviour/ fraudulent practices and the 
creation of a 'black market' - an increase in the circulation of fraudulent PRM 
will have knock-on economic impacts but also a negative impact on plant, 
animal and human health more widely 

  (3) Risk of genetic erosion and reduced diversity, notably fewer varieties, with 

improved characteristics (e.g. greater tolerance/ resistance to pests and 
diseases), will likely be brought to the market; furthermore, the risk of an 
uncontrolled spread of pathogens (both Q and RNPQ) would be high and, 
consequently, demand from third countries may fall substantially for quality 
reasons and due to a lack of trust; as fewer varieties will be developed, 
innovation will likely stall and the ability to respond to future challenges, such 
as climate change, may be greatly reduced 

  (4) Failure to align with objectives pursued by other EU initiatives, such as 

Farm to Fork Strategy  

  (5) Negative spill over effects- there may be a decrease in the demand for 
certified seeds, which could lead to an overall reduction in seed quality 

  (6) Possible infringements of other regulation, i.e., there could be a greater risk 

of non-compliance with Plant Breeders Rights and/ or IP regulation. 

Some respondents recognised that in-kind exchange between farmers could prove 
beneficial, they cited the following potential benefits: 

  (1) Greater alignment with international requirements/ best practices- the right 
of farmers to save, use, exchange and sell their farm-saved seeds is set out in 
the UNDROP. The latter strongly supports Farmer Seed Systems, which are 
perceived to be crucial to enhancing agrobiodiversity 

  (2) Increased maintenance of diversity 
  (3) In-kind exchange already exists and is practised, albeit illegally. 

Recognising this activity in the legislation would be beneficial to farmers, who 
would no longer be in breach of the law 

  (4) Seed exchange between farmers can also strengthen social ties in rural 

communities and provide much needed mutual assistance and greater resilience 
to individuals generally living in precarious conditions and subject to important 
market fluctuations.  

  (5) Greater role for farmers in in-situ conservation of crop diversity and 

participatory plant breeding activities; hence increasing their ability to adapt 
and develop varieties to local growing conditions in ever-changing climatic 
conditions 

  (6) In the context of the Farm to Fork Strategy, exchanges of PRM between 

farmers could have the following benefits: (i) better renewal of intra- and extra-
varietal diversity, which cannot be brought by commercial varieties only 
(around 75% of cultivated biodiversity has been lost with the generalisation of 
the DUS commercial system); (ii) development of varieties that can be more 
easily adapted to local growing conditions and are more resilient to climatic 
stresses 

  (7) Reduced administrative costs/ burdens for farmers.     

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A8.8 

Fruit and vine propagating material 

A8.8.1 

Market access 

Questions in this section were looking to identify challenges with the current policy 
environment of fruit and vine propagating material which can only be marketed if the 
products had been certified as ‘pre-basic material’, ‘basic material’ or ‘certified 
material’ or fulfils the conditions of standard / CAC (Conformitas Agraria 
Communitatis). 

Few stakeholders were able to indicate the average time in months it takes for 
completing registration of varieties of vine from the submission of an application; 
seven responses were received providing a range of 50-70 months on average, for 
fruits 10 responses were received citing 0.5-60 months of timescale. Stakeholders 
estimated that the average time in months it takes for completing certification for PRM 
for fruit plants is between 1-60 months and for fruit plants is 12 months. As for the 
costs of registration and certification, most respondents were not able to provide an 
estimate.  

Possible regulatory changes included the introduction of certification under official 
supervision, which 41% of stakeholders (11 out of 26 respondent) believed would 
have no impact on the time it takes to certify their products, but 23% (6 out of 
26respondents) expected that it could lead to cost reductions for certification. Equally 
most stakeholders expected that certification under official supervision would have no 
impact on the quantity (38%, 10 out of 26), or diversity (69%, 18 out of 26 
respondents) of PRM products on the market, but were split on whether it could 
impact quality (50%, 13 out of 26). 

  Q168 Currently the fruit plant Directive does not allow for 

certification activities to be undertaken by operators under official 
supervision. If this possibility was introduced, what do you think 
would be the impacts compared to the current situation? (N=26) 

Similar figures were shown to apply for vine, where few stakeholders were able to estimate the 
potential impacts of allowing operators to carry out certification under official supervision. The 
majority of those who had projected impacts believed that it would not cause significant changes to 
the diversity or the time to market products.   

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  Q169 Currently the vine Directive does not allow for certification 

activities to be undertaken by operators under official supervision. 
If this possibility was introduced, what do you think would be the 
impacts compared to the current situation? (N=26) 

A8.8.2 

FRUMATIS 

Stakeholder opinions were evenly split regarding the impacts of including species with 
a small number of varieties in FRUMATIS, just over one-third of respondents were not 
able to foresee the actual impacts, those who did were split between whether this 
would be an incentive or disincentive for the production of such varieties.    

  Q170 Does the listing of fruit plant varieties in the Fruit 

Reproductive Material Information System (FRUMATIS) serve as an 
incentive or disincentive for species with only a small number of 
registered varieties? (N=27)  

At the same time respondents believed that the breeding of fruit plant species not 
regulated at EU level (while maintaining their status as non-EU regulated species) 

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would benefit from their inclusion in FRUMATIS with over one-third of stakeholders 
expecting this to be an incentive or significant incentive.  

  Q171 Would the inclusion in FRUMATIS of varieties of fruit plant 
species not regulated at EU level (while maintaining their status as 
non-EU regulated species) serve as an incentive or disincentive for 
breeding of such species? (N=27) 

A8.8.3 

Conservation varieties and varieties with no intrinsic value 

for commercial production 

As opposed to agricultural crops and vegetables, there are currently no provisions in 
the EU legislation for derogations regarding the registration of conservation varieties 
and of varieties with no intrinsic value for commercial production of fruit plants and 
vine. Information from stakeholders suggests that various national provisions do have 
a specific category for such species. However, these are not necessarily of the 
production and marketing of such varieties.  

  Q172 Does your national legislation include specific provisions 
on the registration of conservation varieties and of varieties with no 
intrinsic value for commercial production and/or the marketing of 
PRM of such varieties of fruit plants and vine? (N=13)  

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  Q173 To what extent do you think that your national rules 

support the registration of conservation varieties of fruit plants and 
vine and the production and marketing of PRM of such varieties?  
(N=27) 

Despite the perceived unhelpful national regulatory context, about one-third of 
respondents felt that there is a market need for conservation varieties and for 
varieties with no intrinsic value of fruit and vine and also believed that there is a 
demand for conservation varieties and for varieties with no intrinsic value for 
commercial production of fruit plants and/or vine that is not met by other means than 
the market (e.g. in-kind exchange).  

  Q176 Is there unmet demand for conservation varieties and for 
varieties with no intrinsic value for commercial production of fruit 
plants and vine that is not met by the market? (N=27) 

Most stakeholders did not anticipate changes in the quantity, quality or pest-free 
status of PRM on the market as a result of a derogation for DUS testing of 
conservation varieties. However, they expected positive impacts on in-situ 
conservation and the diversity or PRM on the market.   

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  Q178 If derogations regarding the DUS requirements for the 

registration of conservation varieties and of varieties with no 
intrinsic value for commercial production and/or the marketing of 
PRM of fruit plants and vine were introduced in EU legislation, what 
impact do you think it would have on the following? (N=27)   

A8.8.4 

Not yet listed varieties 

With the exception of CAC (Conformitas Agraria Communitatis) grade material of fruit 
plants, currently PRM of fruit plants and vine can only be placed on the market if it 
belongs to varieties for which the variety registration process has been completed. 

Respondents viewed that a potential derogation in EU legislation allowing the 
marketing of PRM of fruit or vine varieties for which the registration process has not 
been completed should be allowed for both fruit plants and vines. 

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  Q179 Is there a need to introduce derogations in EU legislation 
allowing the marketing of PRM of fruit plants or vine that belongs to 
varieties for which the registration process has not been 
completed? (N=27) 

In terms of market impacts, the derogation from EU legislation allowing the marketing 
of PRM of fruit or vine varieties for which the registration process has not been 
completed could have a positive impact on the diversity and quantity of PRM as well as 
the value of investment made into relevant research. Such impacts would equally or 
more likely be beneficial for SMEs according to close to over half of the respondents. 
At the same time derogations would have no impact on the administration burden 
linked to the registration of fruit plant and vine variety. 

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  Q180 If derogations were introduced in EU legislation allowing 
the marketing of fruit plant or vine PRM for which the registration 
process has not been completed, what impact do you think it would 
have on the following? (N=27) 

In terms of potential disproportionate impact on SMEs, respondents believed SMEs 
could equally or more likely benefit from the derogation than larger organisations.  

  Q181 Would SMEs be as likely as large organisations to benefit 

from such derogations? (N=27) 

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Stakeholder opinions were split on whether the derogation should be restricted to 
certain PRM categories (i.e. pre-basic, basic, certified). In the follow-up open ended 
response the majority opinion was that the derogations should not be limited to 
specific types of seed lots and establish no additional burden for operators engaged in 
these activities. The reduced limits should increase the diversity available and reduce 
barriers to market entry for SMEs. An excessively long administration process may 
delay market availability of innovative products which are suitable for the market.  

Plant breeders would prefer to test their material in various cultivation locations prior 
to full registration. This way the performance of the new varieties is known to farmers 
in the area and to the plant breeder, this helps align commercial benefits to both. For 
seed propagated fruit crops the category of standard seed should be introduced under 
this derogation. 

  Q183 Should derogations allowing the marketing of fruit and 
vine PRM of not yet listed varieties be restricted to certain PRM 
categories (i.e. pre-basic, basic, certified)? (N=27) 

A8.8.5 

Not yet certified PRM 

Respondents viewed that a potential derogation in EU legislation allowing the 
marketing of PRM of fruit or vine varieties for which the certification process has not 
been completed should be allowed for fruit plants. Opinions were split whether this 
would be beneficial in the case of vine.  

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  Q185 Is there a need to introduce derogations in EU legislation 

allowing the marketing of PRM of fruit or vine varieties for which 
the certification process has not been completed? (N=27) 

In terms of market impacts, the derogation from EU legislation allowing the marketing 
of PRM of fruit or vine varieties for which the certification process has not been 
completed could have a positive impact on the diversity and quality of PRM as well as 
the value of investment made into relevant research.  

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  Q186 If derogations were introduced in EU legislation allowing 
the marketing of fruit plant or vine PRM for which the certification 
process has not been completed, what impact do you think it would 
have on the following? (N=27) 

Again, SMEs were seen to likely benefit equally or more than larger operators from a 
potential derogation allowing the marketing of PRM of fruit or vine varieties for which 
the certification process has not been completed.   

  Q187 Would SMEs be as likely as large organisations to benefit 

from such derogations? (N=27) 

Regarding potential derogations allowing the marketing of certain, not yet certified 
PRM categories (i.e., pre-basic, basic, certified) stakeholder opinions were split with 
26% (7 out of 27 respondent) voting yes and 19% (5 out of 27 respondents) voting 
no while the majority 56% (15 out of 27 respondents) not having a position. In the 

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open text responses stakeholders were equally split with three stakeholders 
supporting derogations for pre-basic and basic only (n=3), two for pre-basic, basic 
and certified (n=2), and two for certified only (n=2).   

  Q189 Should derogations allowing the marketing of not yet 
certified PRM of fruit plants and vine be restricted to certain PRM 
categories (i.e. pre-basic, basic, certified)? (N=27) 

A8.9 

Forest reproductive material (FRM) 

A8.9.1 

Current implementation and scope of the Directive 

1999/105/EC 

Just under half of the respondents reported no problems or unnecessary 
administrative burden and costs due to differences in implementation of Directive 
1999/105/EC by the Member States.  

  Q192 Do you (or your members if you reply on behalf of an 

association) encounter problems or unnecessary 
costs/administrative burden due to differences in implementation 
of the Directive 1999/105/EC by the Member States? (N=12) 

Stakeholders, however, were evenly split on whether the current legislation should 
include additional species, but most of them agreed that none of the currently listed 
species should be excluded. 

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  Q195-196 Are there any species not currently included within 
the scope of the Directive 1999/105/EC that you think should be 
included or excluded? (N=25) 

A8.9.2 

Costs for approval of basic material 

In terms of the frequency approval requests submitted to competent authorities, most 
Member States defined a period of 1-5 years. Unfortunately, few authorities were able 
to provide any cost data relating to the approval of basic material, those who did 
(N=5) cited EUR 50-176 for administration and EUR 690-3200 for technical inspection 
fee.  

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  Q197 How often do operators usually submit requests for 

approval of basic material in your Member State?  Please define the 
average percentage of requests submitted in the given time frames 
(N=13) 

The approval of basic material is not a significant cost burden on operators as most 
report that it takes up less than 1% of their annual revenue.  

  Q200 Approximately what proportion of your (or your members’ 
if you reply on behalf of an association) annual revenue is spent on 
costs for the approval of basic material? (N=5)   

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A8.9.3 

Assessment of characteristics of basic material 

contributing to sustainable afforestation and reforestation 

Most operators do assess their FRM material for sustainability criteria, although this is 
done voluntarily in about half of the cases.  

  Q201 Do you currently assess basic material and/or FRM for 
characteristics that contribute to sustainable afforestation and 
reforestation? (N=18) 

In terms of the characteristics taken into consideration for sustainability assessment 
most reported suitability of provenance, adaptability, suitability to climatic conditions 
and pest resistance. These same characteristics were also considered to be important 
during the purchase of FRM to ensure suitability.  

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  Q202 Please define what characteristics you assess for 

sustainability (N=12) 

  Q203 How important is the assessment of the following 

characteristics in order to obtain FRM suitable for future climatic 
conditions? (N=18) 

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A8.9.4 

Costs of certification of FRM 

Few stakeholders were able to provide cost data. As for the costs of FRM certification 
eight responses were received which cited EUR 6-223 for administrative fee and EUR 
38-325 for technical inspection fee. Up to 5% of stakeholders’ annual revenues is 
spent on the costs of certification of FRM (N=5).    

A8.9.5 

The Forest reproductive material information system 

(FOREMATIS) 

Stakeholder views were divided on whether FORMATIS serves as an incentive or 
disincentive for the conservation and sustainable use of forest genetic resources of 
species that are not regulated at EU level.  

  Q206 Does the listing in FORMATIS of approved basic material of 
tree species that are not regulated at EU level serve as an incentive 
or as a disincentive for the conservation and sustainable use of 
forest genetic resources? (N=25)   

Responses were split on whether FORMATIS could have an impact on non-forestry 
purposes for species that are not regulated at EU level with 24% saying that it would 
have no effect and the same number of stakeholders anticipating it could be beneficial.   

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  Q208 Does the listing in FOREMATIS of approved basic material 

of tree species that are not regulated at EU level serve as an 
incentive or as a disincentive to produce FRM for non-forestry 
purposes of FRM such as agroforestry, EU target of planting of 3 
billion trees by 2030, plantations for biomass production and 
energy generation? (N=25)   

A8.9.6 

Production of FRM for non-forestry purposes  

Currently the production of FRM for non-forestry purposes is not within the scope of 
the FRM Directive. Non-forestry purposes of FRM comprise agroforestry, the EU target 
of planting 3 billion trees by 2030, or plantations for biomass production and energy 
generation. Responses indicate that the production of FRM for non-forestry purposes 
are wide-spread with 72% of respondents noting it takes place in their Member State. 
In most Member State production of FRM for non-forestry purposes makes up about 
10% of all FRM produced.  

  Q210 In your Member State is there production of FRM for non-

forestry purposes? (N=25) 

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  Q211 Please provide an estimate of the percentage of FRM that 

is produced annually for non-forestry purposes (N=18) 

In terms of the specific species used for non-forestry purposes respondents reported 
Abies koreana, Picea omorika, Pinus wallichiana A.B. Jacks, Pinus rigida Mill., Abies 
nordmanniana (Steven) Spach, Fagus Sylvatica, Carpinus Betulus, Quercus Robur, 
Populus, Salix, Tilia spec., Acer spec, Juglans, and Picea abies. 

  Q213 Please identify for which non-forestry purposes is there 

production in your Member State (N=9) 

The limited number of responses  (N=9) does not allow to draw conclusions for Europe 
as a whole, but biomass production seems to be the most significant non-forestry use 
both in terms of production as per the share of the total.  

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  Q213 What share of non-forestry production do these purposes 

represent? (N=4-7) 

Similar to the production figures in Q211 above, most stakeholders indicated that up 
to 10% of the total FRM marketed is sold for non-forestry purposes.  

  Q215 What percentage of the total quantity of FRM marketed by 

you (or your members if you reply on behalf of an association) is 
sold for non-forestry purposes? (N=4) 

Stakeholders expected that a potential extension of the FRM Directive’s scope to non-
forestry purposes could improve sufficiency of supply (24%, 7 out of 25 respondents) 
for forestry purposes and diversity of FRM marketed for non-forestry with and 32% (8 
out of 25 respondents) saying it would have a significant positive or positive impact. 

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The quality of FRM marketed for non-forestry purposes could also see a significant 
positive or positive improvement according to 40% (10 out of 25 respondents).  

  Q217 If the scope of the FRM legislation was extended to cover 

FRM for non-forestry purposes, what do you believe the impact 
would be on the following? (N=25) 

A8.9.7 

Access to information on FRM  

In terms of sufficiency of information that FRM buyers/users in receive on the suitability 
of FRM for specific climatic conditions, 60% (15 out of 25) found it to be reasonable or 
sufficient. According to 48% (12 out of 25 respondents) of stakeholders over 75% of 
the available FRM is suited to the current ecological conditions of the sites on which it 
is  to  be  used.  Additionally,  64%  (16  out  of  25)  agreed  that  having  some  form  of  a 
voluntary inventory would be beneficial, but opinions were evenly split on whether this 
should be organised at the EU or national level.  

  Q218 How sufficient is the information that FRM buyers/users in 

your country currently receive on the suitability of FRM for specific 
climatic conditions, in particular to respond to projected future 
climatic conditions under climate change? (N=25) 

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  Q221 Do you think that having a voluntary inventory(ies) on 
FRM characteristics and performance would be beneficial? (N=25) 

While 64% of respondents believe that voluntary inventories in FRM characteristics 
would be beneficial, there is no agreement on the level of organisation (national or 
EU) . The list of potential parameters identified by stakeholders, however, indicate 
that a supra-national organisation would most likely provide a better overview 
particularly related to climatic conditions and ecological suitability.  

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  Q222 On which parameters should a voluntary inventory(ies) be 

based? (N=16) 

Despite its perceived benefits  there is no overwhelming willingness from operators to 
participate in such a voluntary inventory. 

  Q223 What is the likelihood that you (or your members if you 

respond on behalf of an association) would participate in a 
voluntary inventory(ies) of FRM? (N=21) 

As for potential alternatives to wider EU level collaborations, stakeholders chose the 
softest option in the form of guidance notes, ahead of a voluntary inventory and 
voluntary coordination group.  

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  Q224 Which of the following options would be most beneficial 

for increasing information on FRM products? (N=21) 

A8.9.8 

Difficulties in supply of FRM 

In order to remove any temporary difficulties in the general supply of FRM to the end 
user, pursuant to Article 18 of Directive 1999/105/EC the Commission can authorise 
Member State(s) to market FRM which satisfies less stringent requirements. 

Just under half of the respondents were familiar with the challenges of insufficient 
supply and identified potential risks in the form of using lower quality FRM, economic 
losses and the increasing need of import. Other potential risk factors listed included 
increasing fraudulent FRM, forest regeneration delays and the use of tree species or 
provenances that are not the optimal first choice. 

  Q226 Are you aware of cases where you or others in the FRM 
sector have faced difficulties in accessing FRM from within the EU 
for unexpected afforestation or reforestation needs caused by 
extreme weather events and/or disasters? (N=25) 

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  Q227 What is the likelihood that insufficient quantities of FRM 

lead to the following situations? (N=25) 

With the increasing impact of climate change stakeholders expect that demand FRM 
will likely increase in the next 20 years further underlying the importance of security 
of supply and climatic suitability of FRM.  

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  Q228 How do you expect climate change to affect demand for 

FRM in the coming 20 years? (N=25) 

With the increasing need for FRM for forestry purposes, changes to the availability of 
FRM for non-forestry may be impacted. Stakeholders were split on the extent of this 
impact with about one-third of respondents believing that non-forestry FRM availability 
is likely to decrease. Based on the information provided most Member States currently 
do not have contingency plans in place for FRM security of supply emergencies.  

  Q229 Do you expect any changes in relation to the availability of 
FRM due to the use of FRM for non-forestry purposes (agroforestry, 
EU target of planting 3 billion trees by 2030, plantations for 
biomass production and energy generation)? (N=25)   

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  Q234 Does your Member State have contingency plans to ensure 

supply of FRM in case of extreme weather or other emergencies? 
(N=25) 

A8.10  Ηarmonisation of official controls  

The PRM legislation contains a few general requirements for official controls of activities 
under official supervision, and controls on operators, marketing and import of PRM. For 
example, the seed marketing directives provide that in relation to the marketing of seeds 
“Member States shall ensure that official inspections are carried out, at least by random 
checks, to verify compliance with the requirements”.  

Furthermore, PRM is not included in the scope of the Official Controls Regulation (EU) 
2017/625 (OCR). The OCR establishes harmonised rules on official controls across the 
agri-food chain, including for plant health, organic production and GMOs, while allowing 
adaptation to sector-specific rules. The OCR includes general principles for official 
controls (e.g. import and marketing controls), and rules for competent authorities, IT 
systems and training to facilitate official controls. 

Most respondent agreed that there are differences in the control and enforcement of the 
OCR at the Member State level and that increased harmonisation could reduce the risk of 
fraud and increase the quality of products on the market. Stakeholders also supported the 
idea that PRM/FRM competent authorities should be able to perform audits of operators 
and that the marketing controls of PRM/FRM operators should be risk-based.  

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  Q236 To what extent do you agree with the following 

statements? (N=75) 

A8.10.1 

Controls on certification under official supervision   

Just under half of responding NCAs reported that they carry out controls on 
certification under official supervision.  

  Q237 Do you currently carry out controls of certification 

activities under official supervision? (N=25) 

Opinions of NCAs varied on the potential impacts of introducing an obligation for 
competent authorities to perform risk-based supervision of certification conducted by 

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operators under official supervision with most respondent believing it would not have 
an impact on the quality of products on the market or the effectiveness and efficiency 
of controls.  

  Q239 If competent authorities were obligated to perform risk-

based supervision of certification conducted by operators under 
official supervision what do you think would be the impacts 
compared to implementation under current rules? (N=25) 

A8.10.2 

PRM import controls 

Over one-third of NCAs reported to carry out identity controls of 75% of the imported 
products, with one-fourth reporting to control check less than 10%. These differing 
approaches may be a result of the type of consignments that arrive to the country and 
their country of origin.  

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  Q240 On what percentage of imported PRM consignments do you 

carry out controls to check the identity and quality of PRM on an 
annual basis? (N=25) 

In terms of the type of control document checks are reported most frequently, while 
pest control tests are carried out in less than half of the reported cases. Visual 
inspections and sampling are also both frequently used methods of import control.  
Limited information was received on the annual budget of NCAs to carry out 
inspections. Altogether three datapoints were received; these were EUR 10 thousand, 
EUR 1 million and EUR 1.8 million per year.   

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  Q242 What types of import controls do you carry out? (N=25) 

  Q242A For what percentage of total imports do you carry out 

control activities in this category? (N=3-22) 

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The criteria used to select which consignment would undergo documentary checks also 
varies in Member States, with around 41% using a risk-based approach. This ratio was 
58% for visual inspections, 57% for sampling and testing and 25% in pest control 
tests.  

  Q242B What criteria are used for carrying out Documentary 

checks? (N=22) 

Would competent authorities be obligated to carry out risk-based controls over 
imported consignments of PRM/FRM, they expect this to lead to better efficiency of 
controls but also would require more effort and resources from NCAs. There is no 
overwhelming opinion that it would lead to improved quality of products.  

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  Q243 If competent authorities were obligated to carry out risk-
based controls on imported PRM/FRM, what do you think would be 
the impacts compared to implementation under current rules? 
(N=25) 

A8.10.3 

Controls on operators at production stage of PRM 

NCAs were asked to estimate the total number of controls that they carry out on 
operators at production stage on an annual basis, to which responses varied 
significantly from a few times a year to 1,000. However, the type of control varied 
which may explain the variation in responses.  

Similar to the import control checks operators at the production stage are also most 
frequently undergoing documentary checks and visual inspections while pest control 
tests are the least frequent.   

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  Q246 What types of controls do you carry out on operators at 

production stage of PRM? (N=25) 

  Q246F For what percentage of operators at production stage of 

PRM do you carry out control activities? (N=7-22) 

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In terms of the approaches, risk-based control was used in 43% of documentary 
checks, in 52% of visual inspections, in 44% of sampling and testing and in 17% of 
pest control tests.  

  Q246A What criteria are used for carrying out Documentary 

checks? (N=23) 

Should competent authorities be obligated to carry out risk-based controls on 
operators at production stage of PRM, most respondents do not expect to see an 
increase in quality or the identification of non-compliant products. In fact, in most 
criteria no significant changes are foreseen.  

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  Q247 If competent authorities were obligated to carry out risk-

based controls on operators at production stage of PRM, what do 
you think would be the impact on the following in comparison to 
implementation under current rules? (N=25) 

A8.10.4 

PRM marketing controls 

For marketing controls NCAs reported largely similar figures than for production stage 
checks consistently applying the various different controls.  

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  Q250 What types of controls do you carry out in relation to PRM 

marketing?  (N=25) 

  Q250F For what percentage of PRM marketing do you carry out 

control activities in this category? (N=4-23) 

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In terms of the criteria used, risk-based approaches were adopted in 38% of the cases 
for documentary checks, in 42% of visual inspections, in 47% of sampling and testing 
and in 28% of pest control tests.  

  Q250A What criteria are used for carrying out Documentary 

checks? (N=23) 

  Q251 If competent authorities were obligated to carry out risk-
based controls on PRM/FRM marketing, what do you think would be 
the impacts compared to implementation under current rules? 
(N=25) 

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A8.11 

Innovative processes and digital transformation 

A8.11.1 

Scientific and technological developments 

In terms of financial resources dedicated to research and development, 42% of 
businesses (23 out of 55 respondents) said they dedicate 10-25% of their revenue for 
this purpose, whereas only 5% (1 out of 22 respondents) of NCAs have the same level 
of resource allocation.   

  Q254 What percentage of your organisation’s annual revenue/ 
budget for NCAs is dedicated to research and development activities 
in the PRM/FRM sector? (N=55 businesses and N=22 Member 
States) 

Opinions were evenly split on whether the current PRM/FRM Directives adequately 
reflect and integrate the latest scientific and technological developments, with 43% 
(33 out of 77 respondents) agreeing and 44% (34 out of 77 respondents) disagreeing. 
Overall, 56% (43 out of 77 respondents) of stakeholders said that the use of some 
scientific and technological developments is restricted or limited because it is not 
explicitly provided for in the current PRM/FRM regulatory framework. These include 
True Potato Seed, DUS testing of fruit varieties, Biochemical and Biomolecular tools 
and In Vitro Propagation. 

Stakeholders believe that a timelier integration of the latest scientific and 
technological developments could increase investment in research, decrease the time 
and costs of registration and certification and increase product diversity on the 
market.  

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  Q259 What do you think would be the impacts of more timely 
integration of the latest scientific and technological developments 
in the PRM/FRM policy instruments? (N=77) 

A8.12  Digitalisation 

Digitalisation can support Member State Authorities in working more efficiently and 
effectively to implement registration and certification processes. Currently, Member 
State Authorities may have different levels of digitalisation in place. 

Testing and sampling are the activities where most stakeholders rely on digital 
technologies and even in these areas only about one-third of stakeholders were 
actively using these processes.  These numbers are showing some improvement in the 
short terms as stakeholders noted involvement in the development of e-certification 
and e-labelling technologies that would be completed in 3-5 years, however these may 
be to an extent the same stakeholders that are already using digital processes.   

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  Q260 Please identify the PRM/FRM related activities where you 
(or your members if you reply on behalf of an association) currently 
use digital processes (e.g. e-certificates, blockchain technology). 
(N=55) 

  Q261 Please identify the PRM/FRM related activities where you 

(or your members if you reply on behalf of an association) are 
developing digital processes (e.g. e-certificates, blockchain 
technology) that will be used in the next 3-5 years. (N=55)   

In terms of the share of the operators who currently use digital technologies, most 
stakeholders who were able to provide an estimate, identified this to be below 10%, 
highlighting the urgent need for increased resources, education and possibilities for 

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the use of digital processes.    

  Q262-263 Please provide your best estimate of the proportion of 

operators in your country who use digital processes for variety 
registration, testing and certification? (N=77) 

Most stakeholders (71%, 55 out of 77 respondent) anticipate that improved 
digitalisation will decrease administrative burden and the same ratio of respondents 
(36 out of 55 respondents) believe this decrease will be significant or very significant.  

  Q264 What benefits do you expect increased digitalisation to 
bring in relation to inspection/certification and labelling? (N=77) 

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In terms of the current barriers to increasing the use of digital technologies most 
stakeholders identified:  

 

 

 
 
 

 

lack of available public finances to invest in digital technologies (32%, 25 out of 
77 respondents),  
lack of available finances for SMEs to digitalise their processes (47%, 36 out of 
77 respondents),  
lack of technical skills (53%, 41 out of 77 respondents),  
lack of available digital tools (39%, 30 out of 77 respondents),  
lack of provision explicitly allowing for the use of digital technologies (48%, 37 
out of 77 respondents),  
lack of connectivity among some operators (44%, 34 out of 77 respondents). 

Annex 9  Focus groups 

A9.1 

FRM focus group 

A9.1.1 

Introduction 

The FRM focus group session was organised on 06 April, between 14:00 – 16:00 
(CET), using MS TEAMs. The focus group was divided into three main sessions 
covering the following topics: 

  Difficulties in the supply of FRM; 

  The development of a voluntary inventory with information on FRM 

characteristics and performance; and 

  FRM for non-forestry purposes.  

A total of 10 participants were invited to the focus group. The participants were 
selected to ensure a balance between NCAs and other stakeholder groups. An initial 
list of participants was proposed by ICF and refined in partnership with DG SANTE. 
Seven participants were scheduled to join the focus group, however on the day of the 
focus group, four informed ICF that they were no longer able to join.  

Participants: 

  Finnish Food Authority 

  Federal Office for Agriculture and Food (Germany)  

  European Forest Genetic Resources Programme (EUFORGEN) 

The following note summarises the discussion points raised by participants.  

A9.1.2 

Topic 1: Difficulties in the supply of FRM 

It was agreed that there are challenges in the supply of FRM, due largely to the need 
to plan and consider supply/demand over longer timeframes. Weather conditions, 
disease and phytosanitary issues contribute to this problem. However, the problem is 
complicated and differs by Member State. It is unlikely that any changes to the 
legislation would have an impact on these problems. Discussion covered: 

Examples of challenges in supply 

Finland: there are challenges with ensuring supply in the northern parts of Finland 
(Lapland) due to the difficulty of collecting seeds. The main species are spruce and 
pine and in those conditions they only flower once in a decade. Additionally, seed 
collection can be challenging due to weather conditions (e.g. heavy snowfall), reduced 
daylight hours and the lack of labour due to a small population. It is not possible to 
select those stands beforehand, it is only possible to collect the material from felled 

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trees as collecting from standing trees is too dangerous. The material would then fulfil 
the requirements of source-identified.  

Because of these difficulties, there is a need for the long-term storage of seeds. 
Generally, the storage in Finland is good, but a lot of the collection is done by private 
companies who are not willing to store seeds for 10-20 years, meaning that seed 
security is of higher concern in the future. Because the security of supply is a concern, 
this leads to less willingness to trade with other Member States in the case of an 
extreme weather event.  

Causes of supply issues 

In addition to causes already identified, participants highlighted that long timelines are 
needed for planning in FRM (from harvest to seed production can take 2-3 years, 
sometimes more depending on species) and these timelines are not always considered 
(also by political actors) and this can also cause issues in supply. Participants also 
noted that these problems differ by Member State and region.  

In the EU, there is a strong push to plant trees for different purposes, with many 
actors in the supply chain recognising the importance of [species] diversity. However, 
since there is little planning carried out, often seeds sold by nurseries are those that 
are in good supply rather than those that are necessarily needed.  

In Italy, there are few public nurseries, most are privately owned, which has put 
pressure on the supply and amount of FRM in Italy. In general, there is much higher 
demand for than is available. This good, early planning crucial.   

In Germany, a key issue is that users of FRM do not explain their needs and wants to 
the nurseries. This includes Federal States and cities, as well as other buyers. They 
may not know what seeds they will need, how much funding they will have or the 
extent of resource to plant the seedlings in the future. Currently, a lot of actors are 
looking to purchase seeds to plant immediately and the nurseries cannot deal with the 
demand. In Germany there are over 15,000 approved seed stands, so there is 
opportunity to harvest more. However, because many nurseries are privately 
organised, it is difficult to get a common understanding across Europe of supply and 
demand.  

In some MS (such as Sweden and Finland), there is already longer-term planning in 
place. 

It is difficult to determine where the responsibility for long term planning sits. 
Nurseries and seed collectors are willing to produce seeds that are needed but for 
some private nurseries, it is not a viable option to produce seeds that are not valuable 
or will be disposed of within a year. The main focus of these nurseries is to sell their 
material. The EU market currently demands a lot of material (through tree planting 
initiatives) which is difficult to sustainably produce. This mismatch of supply and 
demand is more complex than a lack of communication in the supply chain. For 
example, sometimes there are physiological problems which make it difficult to 
determine how much harvest there will be. In addition, most available funding is for 
planting trees within a 3-year timeframe, which is challenging and can act as a 
disincentive.  

Trading/outside EU 

Participants did not have much experience of problems with trading/importing FRM 
leading to issues with supply.   

Impacts of these problems 

Participants agreed that using lower quality FRM as a replacement when there are 
supply issues can have significant impacts.  

[Finland] If lower quality material is used (i.e. from the selected category rather than 
qualified and tested category), production decreases by 10 to 15% and adaptability of 

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the forest is lower. For private owners, this means decreases in wood production and 
carbon storage. 

In some cases using the wrong provenance or lower quality FRM can lead to not just a 
decrease in production, but no production at all. This kind of failure can have a 
significant negative impact.  

In the short term, poor quality FRM can appear to be performing well, but problems 
will present over the longer term. This can be an issue when public funding wants to 
see an impact within a limited time frame – this can focus efforts on delivering short 
term achievements with insufficient regard for how things will play out over the longer 
term i.e. 80-100 years.   

A9.1.3 

Topic 2: Availability of information for buyers/users 

Both the availability of information as well as the information needed to make 
appropriate planting decisions differ by Member State.  

Buyers in the EU are becoming increasingly interested in more detailed information. 
Sometimes this might be because, for example,, funding is tied to the planting of trees 
from a particular provenance.  

The depth of information provided could be improved, however it would work better 
outside the scope of the EU legislation. Each Member State should determine the level 
and type of information needed for different material.  

When material moves between countries, it is impossible to ask suppliers to indicate 
which conditions and areas the seed will best suit because buyers would interpret this 
information differently. However, it would be possible to provide more information on 
the supplier’s document on the climatic conditions of the seed’s provenance. 

Voluntary inventory 

It was considered likely that such an inventory would increase administrative burdens. 
Furthermore, it is not possible for state officers to collect data without legislation, due 
to GDPR requirements. This would also cause issues for private producers who do not 
want to share their information publicly; in many cases this type of information would 
be considered a trade secret. Practically, it is also hard to collect this data in the field. 
Member States often do not trace where the material is planted, and so it would be 
difficult to input this information into a voluntary inventory. In addition, the overall 
willingness to provide data will vary across Member States. Ultimately, sparse or 
incomplete data will not be useful.  

Because of this, if there was a plan to develop such an inventory, it would make sense 
to start with a very small number of additional parameters, and if this works well, then 
it could be enlarged. 

One option could be the development of a provenance trials network around Europe. 
EU funding could be used to support this. It might involve planting materials outside 
the current use to determine how forests will develop in the future under changing 
climatic conditions. Instead of a large-scale inventory, it could be more targeted and 
with a scientific design, answering specific questions on how different origins will 
perform in certain conditions.   

A9.1.4 

Topic 3:  The production of FRM for non-forestry purposes 

and potential impacts of extending the scope of application of the 
FRM legislation to certain clearly defined non-forestry purposes 

Non-forestry vs forestry purposes 

Participants mostly felt the best approach would be to define non-forestry by land use 
rather than purpose. Many of the purposes included under non-forestry are 
ambiguous. For example, material planted for biodiversity purposes or for the planting 

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of 3 billion trees should be high quality material and would frequently fall under the 
scope of the FRM directive.   

The distinction between forestry and non-forestry differs across Europe and many 
‘non-forestry’ purposes are currently under the competencies of different 
administrations (e.g. agroforestry controlled by NCA responsible for agriculture). This 
means that to have a productive conversation on this and establish any distinctions, it 
is necessary to involve a broader range of stakeholders rather than just those involved 
in FRM.  

Including ornamental trees within the scope of FRM legislation would be particularly 
burdensome, in part because there are significantly more nurseries for ornamental 
trees than for FRM. They would all need to be registered, controlled and educated. 
This would require a significant amount of work.  

One suggestion to address the problem of genetic pollution would be to include buffer 
zones around forest areas where only approved FRM can be planted.  

For forestry, if there is a need to prioritise where FRM should be used, it should be 
reforestation and afforestation. Forestry in general often encompasses elements of 
biodiversity and other non-forestry purposes. 

A9.2 

Marketing to amateur gardeners focus group 

A9.2.1 

Introduction 

The focus group session was organised on 05 April, between 14:00 – 16:00 (CET), 
using MS TEAMs. The focus group was divided into three main sessions covering the 
following topics: 

  Current situation and trends in marketing to amateur gardeners 
  Impacts of potential changes to the PRM legislation for marketing to amateur 

gardeners 

The participants were selected in partnership with DG SANTE to include a mix of NCAs, 
representatives of seed growers from the commercial and amateur sector, and 
associations of amateur gardeners. The following 10 stakeholders participated in the 
event, they were representing the following organisations: PVO (DE), OEVV MAPA 
(ES), COBORU (PL), GEVES (FR), Naktuinbouw (NL), Semae (FR), UKZUZ (CZ), 
Euroseeds, ARCHE NOAH, La Fédération Nationale des Jardins Familiaux et Collectifs.  

A9.2.2 

Current situation and future trends: 

Extent of breeding and marketing varieties exclusively to amateur gardeners. 

The market is small in comparison to commercial seed market across Europe although 
it is high value. Professional companies supply the amateur market through general 
commercial production as well as specifically addressing the home and garden market. 
The market is difficult to segment out between the amateur and professional markets. 
Seeds are provided by the same breeders and producers- the difference is at the 
distribution stage. Requirements for quality is the same between amateurs and 
professionals: minimum germination quality, identity, plant health substantial freedom 
from plant pests.  

Two types of markets can be identified: professional producers selling to amateur 
gardeners and the exchange between amateur gardeners. The latter is less easy to 
control. Conservation varieties make up part of the market.  These are not necessarily 
very old- such a variety must have been out of listing for two years minimum and can 
then be reintroduced.  

Most attendees agreed that the market is not shrinking, it is not suffering from a lack 
of variety, quality or quantity available.  However, it is difficult to always provide all 
seed varieties in such a small market. 

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No participants were aware of any data on the size of the market. The EU commercial 
seed market is worth 15 billion euros and is the leading market in the world and 
supplies 125-140 million hectares of arable land in EU.  Amateur market volumes are 
tiny by comparison. However amateur seed is more expensive (per unit) due to supply 
chains and usage (packaging requirements).  

Market in Germany: One company offers 600 varieties of veg currently and this has 
increased over time- 20 of these are listed amateur varieties. One has 300 varieties of 
veg and this has increased- 10 of these are listed as amateur varieties. 60% of their 
varieties are available for commercial sales.  The smallest company had just below 
300 varieties, their numbers have decreased.  180 amateur varieties listed in 
Germany. Regularly listed- must cover all requirements in terms of DUS.  Very old 
varieties tend to only be on the market for amateur gardeners.  

Split discussion between conservation networks and professional breeders. 
Conservation networks are in a grey area and it would be preferred if they were taken 
out of the legislation.  

Market in France: Discussions with operators representing amateur gardeners 
(associations) show that markets are varied in terms of stakeholders and producers. A 
variety of operators serve the amateur market.  In France, 2700 varieties available for 
professional growers. Estimated number used by amateur at 500 varieties. Some were 
registered in the 1950 when the French catalogue opened. 300 amateur varieties 
registered. Difficult to estimate which varieties are just used by professionals or just 
used by amateurs. Varieties with heirloom/ traditional characteristics- relevant for 
rural areas. It is important to provide amateurs with quality seed which has good 
health and has assurances and can be trusted. Besides seed companies, there are 
regional associations in France which are supported / financed by regional authorities. 
Their aim is to save and develop regional heirloom varieties (vegetables, fruits) and 
give them a larger audience through variety registration and quality labels (IGP, AOP). 

Informal Market: Informal peasant markets are also part of the market for amateur 
gardeners. Large diversity available (ARCHE Noah lists 600 varieties of tomatoes 
alone). These are preserved for the future due to seed saver and peasant 
organisations which exist next to the commercial market. The participant representing 
this sector felt that these organisations are discriminated against in the current legal 
framework.  In seed saver organisations, a large majority of seeds are aimed at hobby 
gardeners.  This is a very small niche segment. Most sales and money are made 
elsewhere in the market.  

Market Czechia: Perennial plants and breeding for fruits and vines -  50-70% are 
specified for amateur gardeners. 100,000 amateur gardeners registered with 
organisations. Good opportunities already exist to propagate in terms of local 
varieties. Basic requirements are already available. There is good choice for 
consumers. Not necessary to establish new legislation.  

Varieties for amateur use can be registered with very low requirements. In NL seeds 
can be marketed without registration if turnover is lower than 500 Euros although 
plant health legislation still applies. 

Main Crop Groups identified by participants in their country were: 

  Vegetables: Important in the CZ, NL (most important), FR, DE, ES, PL, EU level 

  Seed potato: Important in the CZ FR (decrease in demand), not too important 

in PL. 

  Fruit plants: Important in the CZ, FR, DE, ES, PL. 

  Ornamentals: A very important crop group NL (not regulated), DE (but not 

regulated so not an issue), FR (most important), PL 

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  Agricultural crops: PL (buckwheat and common millet- difficult to say if this is 
professional or amateur use), in seed conservation networks there are hobby 
gardeners who grow cereals in order to preserve varieties.  

  Turf grass: Little use in FR. No interest in DE- no varieties aimed at hobby 

gardeners. Not used in PL 

  Vine: Little use in FR. Not used in PL 

  Aromatic herbs: FR, DE, EU Level (also not regulated) 

Trends: 

Seeing an increase in local and amateur varieties and conservation varieties in the 
national register in Spain.  

Fruit tree breeders (breeding varieties with more sustainability characteristics) do not 
distinguish between amateur or commercial. They just want to produce a good new 
variety- more concerned with characteristics. In the absence of future regulatory 
change, breeders would not be separating these types of markets.  There is unlikely to 
be any specific development in exclusive breeding for amateur gardeners.   

Unlikely to be intensive efforts in breeding for amateur gardeners. Breeding company 
mergers tend to reduce the scope of varieties available to amateur gardeners. If there 
is a broad portfolio of amateur material resulting from such a merger and some don't 
sell, these will be removed from the market.  While there is still significant diversity - 
it has been decreasing as a result. There may be an increase in networks / seed 
savers, depending on whether the interest in hobby gardening is further increasing, or 
will decrease. This trend of losing diversity could be furthermore accelerated by a 
changed definition of what seed marketing is (and what is not marketing) 

A9.2.3 

Impacts of potential changes to the PRM legislation for 

marketing to amateur gardeners:  

A9.2.3.1  PRM of varieties marketed exclusively to amateur 
gardeners exempted from the variety registration and PRM 
certification requirements.   

The potential effects of an exemption were discussed and are summarised below. 

Effects on users/consumers: 

  Price: Most participants thought there would be no effect on price. The relative 
share of registration costs and certification costs in the amateur gardeners is 
very small. The distribution costs have a much higher proportion and these 
wouldn’t change. One stakeholder indicated that costs would decrease for 
companies with a large amount of production e.g. those who also produce 
heterogeneous material.  

  Quality: The majority indicated that the quality of PRM would decrease. This is 
because without regulation and control from authorities there are more risks of 
fraudulent materials. It was considered that amateur gardeners want some 
guarantees about the varieties, but are less likely to complain about low 
quality, than professional users. 

  Diversity and choice: Unlikely to be much impact. National context would be 
important here- marketing is implemented differently in each Member State. 
Where marketing is defined strictly there would be the most impact on diversity 
if there was exemption. For fruit and seed potatoes- gardeners in CZ want 
homogeneity and purity of varieties.  On the other hand, heterogeneity brought 

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by old varieties such as a range of maturity is also desired by hobby 
gardeners.  

  Fraudulent PRM: Fewer controls would potentially lead to more fraudulent 

PRM.  

  Other: Plant variety rights- if there was no control of PRM there could be a 
reduction in these rights. Producers do a lot of market research in this area. 
Amateur gardeners want quality and identity.  

Conservation of genetic resources is a different thing all together. Gardeners often 
collect their own seeds from their own gardens. These often don’t produce the same 
result as they are openly pollinated.  

In France in home gardens, poorer people grow their own vegetables to supplement 
their diet and need information about the variety so they can guarantee yields.  

Effect on business/competition: 

  Investment in breeding of varieties for marketing to amateur 

gardeners: One point of view was that companies will not invest in a market 
that is not regulated and controlled, noting that these also give a minimum 
assurance of quality and health. There are already lighter rules but these 
provide sufficient reassurance to the production chains. Another participant 
disagreed, as there are many fields (outside of PRM) without regulation that 
have high levels of investment.  

  Unintended consequences on commercial operations: Variety protection 
and competitiveness between companies who would still have to adhere to the 
more stringent requirements and those who can now produce seed under the 
exemption from the rules. 

Effects on public authorities/enforcement 

  Costs: Most participants thought there would be no impact, noting that all costs 
are typically paid by producers (through cost recovery system), hence there 
would be no effect for NCAs. There is such a small amount of production that an 
exemption would not change too much.  

  Administrative burdens: All but one participant thought there would be a 

decrease in administrative burdens. However, there could also be an increased 
burden for operators due to the change in legislation, meaning that if there 
were separate rules amateur gardeners then this would need to be enforced by 
the NCA and create an increased administrative burden. 

A9.2.3.2  PRM of varieties marketed exclusively to amateur 

gardeners subject only to basic requirements in relation to defects, 
vigour and dimensions, germination, varietal identity and purity 
and substantial freedom from plant pests.  

Participants felt that there was not enough information on what the basic 
requirements would look like for a meaningful discussion.  The impacts would depend 
on what is changed. One stakeholder suggested it was difficult to answer this question 
as the idea of basic requirements could be lighter or stricter than the current 
legislation.  

Some stakeholders indicated that some of the material for amateur gardeners was 
already subject to basic requirements. Others indicated that basic requirements could 
include lesser requirements on seed quality- germination capacity, purity, etc.  

One stakeholder made the point that any reduction in plant health requirements would 
negatively impact the environment.  

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There was a discussion on the difference between amateur varieties and other 
varieties used by amateur gardeners. Amateur gardeners do not need a high level of 
regulation. But several participants thought that regulation should only be lowered 
where the final use is for amateur varieties. Regardless, amateur gardeners need to 
trust what they are buying- there should still be a minimum level of requirements 

However, one participant noted that consumer protection laws, in terms of identity, 
need to be considered i.e. sellers are required to ensure that products are what they 
say they are. There is already a basic level of protection in the plant health legislation. 
The participant also proposed that labelling requirements should be added–- hobby 
gardeners want to know if the varieties are hybrids or openly pollinated. They also 
need to know about property rights on the material.  

A majority of participants stated that basic requirements would support an increase in 
varieties and ultimately support an increase in genetic diversity.  

It was noted that assumptions were being made on what amateur gardeners wanted 
(e.g. do they want more choice) and that the results of a previous survey (carried out 
by ICF for DG SANTE) of 6000 amateur gardeners should be looked at.  

A9.2.4 

Summary of additional information provided by 

participants after the focus group from DE NCA: 

Additional information was received from DE NCA: 

For further discussions it would be necessary to clarify: 

  Seed maintained by seed conservation networks: 

Seed maintained and exchanged by seed conservation networks should not fall 
under the scope of the PRM legislation. It should be possible, that small quantities 
are sold to interested gardeners who are not member of the network. 

  Seed for hobby gardeners distributed by professional operators via garden 

centers and other shops: 

Professional operators have several hundred vegetable varieties on offer (in 
Germany 3 main operators: 600-700, ca 300, ca 280). 

Part of those varieties are also used by professional vegetable producers (ca 60 
%, ca 20 %), varieties only aimed at the hobby gardeners: old varieties, open 
pollinated varieties, niche products. Varieties listed as “amateur varieties” on 
offer: ca 20 / ca 10 varieties. 

The Professional distributors prefer, that the requirements of variety listing be 
kept in the future. Some problems were indicated, such as deletion of varieties 
without prior informing the distributing companies, and market extension is not 
granted by all MS. Problem: small packages have already been printed and have 
to be destroyed, packages are rather expensive. 

  Seed of varieties listed as amateur varieties: 

Varieties listed as amateur varieties: may be marketed in small packages only. 
Package size is big enough to provide also seed to vegetable producers who 
market the produce on local markets, which is used by organic breeders and 
organic producers. Those breeders are happy with the system, as it is an easy way 
of variety listing and costs are low. 

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Annex 10  Case study: Experience with seed and plant 

exchanges between farmers in France 

A10.1 

Introduction 

This case study has explored France’s experience with non-commercial seed and plant 
exchanges. Article 315-5 of the Code Rural provides an allowance for exchanges of 
seeds and plants not covered by plant variety rights under the framework of 
“entraide” (mutual assistance).  

The aims of the case study were to:  

  Characterise the system (e.g. number of farmers making use of the possibility, 
amounts of seed exchanged in total and per exchange, how many varieties and 
what types of varieties were exchanged).  

  Assess whether there is a measurable impact on the obligatory seed 

certification system for agricultural crops in France (i.e. marketing of certified 
seed to farmers)?  

  Assess whether there have been impacts relevant to plant health or the 

presence of noxious weeds.  

  Articulate how is this derogation applied and controlled in France. 

The case study draws on the available academic literature and interviews. Eight 
interviews were completed with the National Competent Authority, the seed exchange 
network Reseau Semences Paysannes (RSP), seed producers, representatives of 
farmers’ unions, and two researchers.  

A10.2  Background and application 

The history of the current practices of exchanging seeds and plants not covered by 
plant variety rights in France dates back to the early 2000s. These “peasant seeds” 
(semences paysannes) have been at the heart of efforts to develop agroecology and 
to recover lost knowledge and resources for an agriculture without pesticides and 
fertilisers. These efforts were institutionalised in the Réseau Semences Paysannes 
(RSP) created in 2003. RSP aimed to emulate similar efforts that had begun sooner in 
the global south (Coomes et al 2015; Demeulenaere 2014). The movement around 
peasant seeds grew in a context where incentives for organic production were 
growing, and organic producers were being increasingly asked to demonstrate that 
their seeds had been organically produced, whereas only seed companies were able to 
provide the evidence to address such requirements (Demeulenaere 2014; Mazé et al. 
2021a). At the time, a farmer’s union together with organic producers’ organisations 
protested against the threat of legal action. This threat was lifted based on the 
understanding that exchanges of seeds between organic producers were taking place 
for research purposes and were not commercial exchanges. Interviewees date the 
change of tone in relations with public authorities to around 2008. 

In 2014, a proposal from the farmers’ union Confédération Paysanne to provide a legal 
framework for non-commercial exchanges of “peasant seeds” was formalised in art. 
315-5 of the Code Rural, as part of a broader legal act on agriculture.72 In its original 
form, the allowance for such exchanges was limited to members of a Groupement 
d’Intérêt Economique et Environnemental (GIEE), a local and temporary group of 
farmers working together towards agroecological transition. These conditions suited 
the exchanges run in the context of research projects at the time (three official 

72 These dispositions echo the content of the International Treaty on Plant Genetic Resources for Food and Agriculture, 
though the legal act itself does not reference it (see also discussion in Batur et al. 2021). 

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research programmes have played a major role in the structuring of the network, 
facilitating exchanges of knowledge and seeds and the expansion of the practices), but 
also between farmers. Two years later, the terms of the legislation were changed to 
expand the allowance for seed exchanges to any farmer, sanctioning the fact that not 
all exchanges were local, and that exchanges of peasant seeds were taking place 
between farmers who were not members of GIEEs. From a broader policy perspective, 
such expansion has been linked to efforts to reduce the use of phytosanitary products 
and encouraging the use of seeds that would not require the use of such products.  

The allowance set in art.315-5 of the Code Rural provides for exchanges of seeds and 
plants that are not covered by plant variety rights. As such, the dispositions have been 
considered out of scope of the seeds marketing legislation and not in contradiction to 
it, though this has been disputed by other Member State authorities and the European 
Commission (see discussion in Batur et al. 2021). Peasant seeds are distinguished 
from “farm saved seeds” (semences de ferme), the latter being seeds multiplied by 
farmers from registered varieties bearing rights. 

As acknowledged by both the National Competent Authority (NCA) and seed users, the 
terms of art.315-5 of the Code rural acknowledge practices that predated it, without 
fundamentally altering those practices. No particular steps were taken by public 
authorities for implementing these terms or controlling the practices they correspond 
to. The legislation provides legal certainty and a framework for those exchanges, as 
requested by the RSP. The legislation borrows from the well-established, older notion 
of mutual assistance. Indeed, the concept of entraide has been mentioned in French 
law since at least 1962 (art.20 of Law 62-933), although the practices it refers to are 
much older and are typical of peasant societies (Sabourin 2011). Entraide or mutual 
assistance refers to farmers providing each other services without payment, except for 
compensation for the efforts spent (typically, labour). In the context of vegetable 
production / market gardening, it is generally not possible for a single producer to 
produce all of their seeds (due to the sheer number of varieties involved and the need 
to isolate some of them): it is therefore usual for the task to be shared between 
several producers. 

A10.3 

The scale and nature of the system 

A10.3.1 

Availability of data  

There is no systematic data on the number of farmers who have made use of the 
allowance for exchanging seeds and plants not covered by plant variety rights, the 
number of varieties they have exchanged, or the volumes exchanged. There is partial 
data from academic research (Mazé et al. 2021b) that has been conducted on the 
groups which have participated in seed exchange networks, although that evidence is 
limited to cereals and forage. There is no data on the groups that have specialised in 
exchanging vegetable seeds and plants. Interviews suggest that the latter groups are 
fewer and have fewer members. This is due to the sequence in which the 
reintroduction of landraces and ancient varieties, and the development of new breeds 
through collaborative “peer-to-peer genetics” unfolded in France. This effort started 
with cereals (particularly, wheat) and forage, and has expanded further with 
vegetables at a later stage.  

The absence of systematic data collection can be explained in four ways.  

The first and arguably main reason is the absence of interest and concern expressed 
by NCAs and commercial seed producers. There is a shared perception that the scale 
of in-kind exchanges has been, and remains, very small. There is also a shared 
perception across both NCA and commercial seed producers that these exchanges of 
“peasant seeds” are by and large without risk, either from a plant health or 
commercial perspective. This is in contrast with “farm saved seeds”, seeds from 
registered varieties covered by plant variety rights, which some farmers multiply and 
share but are outside the scope of art. 315-5. Those have been a contentious issue: 

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concerns raised by breeders that farm saved seeds were unfair to them led to a wide-
ranging tax (called initially “Contribution Volontaire Obligatoire” , then renamed 
“Contribution Innovation Recherche Variétale”) which farmers pay and benefits 
breeders. This has been widely criticised by some farmers‘ unions.73 

The second reason is the very limited interest from research institutes in these 
exchanges, even though research funding has been of very high importance to help 
develop and structure seed exchange networks in France (as noted for example by 
Demeulenaere 2014, Mazé et al. 2021b). Interviews with researchers suggest that few 
researchers have managed to secure funding for investigations on seed exchange 
networks.  

The third reason is the nature of these networks. They are local by design: their 
purpose is to facilitate peer-to-peer exchanges of seeds and know-how between 
farmers. The geographical distance between participants is not therefore large. 
Furthermore, the approach to agriculture, seed selection and variety development 
shared within these networks is one that emphasises adaptation to local circumstances 
(soil, climate). In that respect, the varieties and knowledge developed in one territory 
are not designed to be transposed to another that would be substantially different.  
Because of the local nature of these groups, they operate in idiosyncratic ways 
(exchanges are noted in “mutual assistance books”) and their formal membership may 
not reflect the actual population of participants to the exchange networks. Though 
federated into the Réseau Semences Paysannes (RSP) which predates art. 315-5, they 
are not organised in a hierarchical structure.  

The fourth and last reason is cultural in nature. Members of seed exchange networks 
are often advocates of an alternative approach to agriculture that is at odds with the 
principles and structures (market, state) underpinning industrialised agriculture. 
Though pacified nowadays, their interactions with public authorities have in the past 
sometimes been fractious. Because of this history, there remains a reluctance to share 
data. This reluctance extends even to researchers with close ties to the RSP regarding 
the development and use of a shared database that records seed lots, the peasants 
who used them, phenotyping, environmental characteristics and cultural practices (as 
noted in Mazé et al. 2021a).  

A10.3.2 

The scale of non-commercial seed exchanges 

Echoing the unanimous view of all interviewees, the number of participants to these 
exchanges in France is very small, within a range of a few hundred to the low 
thousands. Data on local seed groups involved in the Participatory Wheat Breeding 
Group (PWBG) of the RSP (Figure 238) does not cover all groups but does covers 
cereal and forage seed exchange groups, which according to all interviewees are the 
largest in terms of participants and volumes exchanged, principally for historical 
reasons (efforts to reintroduce old varieties began with wheat). 

According to Mazé et al. (2021a) and interviewees, the RSP has more than 90 local 
seed groups as of 2018, with some of them including up to 200 members, although 
others are much smaller in size (e.g. less than 20 members). The number of varieties 
in their collections varies also greatly, from 0 to 300 per group. 

73 For instance: https://www.confederationpaysanne.fr/sites/1/mots_cles/documents/Livret-CVO-Semence_web.pdf  

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  Main attributes of the local seed groups involved in PWBG 

Source: Mazé et al. 2021b 

There is no data on trends of in-kind seed and plant exchanges before or after article 
315-5 came into force. Interviews suggest that there were around 100 farmers 
exchanging seeds in a non-commercial way in the early 2000s, and that this has 
grown possibly ten-fold in the following 20 years, although this could not be confirmed 
in the absence of hard evidence. New users involve some experienced farmers 
switching to agroecology, although many new participants are newcomers to farming 
who lack professional experience and have not benefited from inter-generational 
transfer of farming knowledge. The increase in the number of participant farmers has 
been slow and has not pushed overall numbers and volumes beyond a marginal share 
of the overall farming population or of the volume of seeds used. There is a shared 
perception across all stakeholder groups that participants in non-commercial seed 
exchanges within the framework of art.315-5 are all smallholders. 

The growth of organic agriculture appears to have only mildly contributed to this 
increase, because, as interviewees noted, much of such growth is towards an intensive 
form of organic agriculture, which is at odds with the approach that underpins peasant 
seeds.  

The history of seed exchanges in France (which predates the provisions of article 315-
5 as noted above) and the converging statements of interviewees both show that 
article 315-5 has not had a noticeable impact either on the number of participants or 
on the volumes they have exchanged. In the words of one of the interviewees, those 
exchanges had been happening before and they would be taking place now even if the 
legislation did not provide a legal framework for them. 

A10.3.3 

The varieties exchanged 

The development of peasant seeds began with cabbage varieties. Producers of 
cabbage had gone only a decade or so without producing their own seeds but instead 
purchasing them from seed producers. This was much less than for other varieties. As 
such, it was an easier first candidate for the reintroduction of old varieties and work 
towards innovative seed breeding as well as cross breeds, heterogeneous crop 
populations, seed mixtures and foreign seeds (Mazé et al. 2021a). Efforts to find and 
multiply old varieties of wheat and maize began in 2002, particularly for the purpose 
of producing without irrigation. Efforts to multiply and exchange old and adapted 

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varieties of legumes and oilseeds have begun more recently. These are therefore 
areas where volumes and experience are limited at this stage.  

Exchanges in-kind as defined under art. 315-5 could in theory be of seeds that were 
covered by plant variety rights beforehand but have fallen into the public domain. 
However, the cereal and forage varieties that have been used for in-kind seed 
exchange have not usually been recent varieties that had fallen into the public 
domain. According to the RSP, this is due to the fact that recent varieties tend to have 
been selected on a few discreet traits, which makes them less able to adapt to 
changing conditions.  

By contrast, the vegetable varieties used for non-commercial seed exchanges have 
included varieties which have fallen into the public domain, old varieties and variety 
creations (recently selected varieties) which do not satisfy DUS criteria. 

A10.4 

Impacts of non-commercial seed exchanges 

A10.4.1 

Impact on the seeds market 

Both representatives of seed producers, NCA, and participants to seed exchanges 
agreed that non-commercial exchanges of peasant seeds as provided for by art.315-5 
of the Code rural have not had any impact on the marketing of seeds. That is because 
both types of exchanges exist in parallel but do not compete with one another. 
According to their proponents, the development of peasant seeds addresses a gap that 
is not filled by the offer of seeds provided on the market. Peasant seeds are all about 
local adaptation as well as associations between different seeds/varieties for the 
purpose of adaptation and resilience. These associations are not provided for on the 
market. Furthermore, exchanges happen in face-to-face interactions, they are 
therefore extremely local, small-scale, informal, and personalised and are 
fundamentally distinct from anonymous market exchanges such as those regulated by 
the EU legislation (as noted by Mazé et al. 2021a, 2021b).  

A10.4.2 

Impact on plant health 

There have been no negative impacts of exchanges of peasant seeds on plant health, 
from either the perspective of the NCA, seed manufacturers, promoters of peasant 
seeds or users. The principle of peasant seeds has been to adapt the seeds to 
agricultural practices (rather than the other way around). To prevent pests and 
diseases, practitioners of peasant seed exchanges have mixed varieties together, so 
as to act as barriers to pathogens.  

The wheat bunt has been an issue of concern, which has been managed well in 
organic production. Experience has shown the bunt is there but manifests itself as a 
result of interactions between the soil and the seed. Corn smut has also been 
observed to disappear after 2 or 3 years as a result of the plant’s strengthening. 

As noted by a representative of cereal producers who is not a member of peasant seed 
exchange networks, experimenting with the mixing of wheat varieties has shown good 
results in terms of yield and a reduction in the use of fungicides.  

Furthermore, according to their proponents, varieties exchanged through non-
commercial exchanges have included varieties that have developed resistance to 
pathogens (as noted also by Coomes et al. 2015), and are less prone to failure than 
seeds exchanged in very large volumes (the latter may be tested at one point in time 
but delivered at a much later stage, or tested after sale). 

Non-commercial seed exchanges are in small volumes, reflecting the volumes 
produced. Field trials typically involve small volumes in the interest of limiting sanitary 
risks, since those could have dire impacts in organic production systems.  

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A10.4.3 

Other impacts 

Several by-products or secondary benefits of the dispositions from article 315-5 and 
from seed exchange networks have been noted. 

  Organic certification – The ability to trace exchanges of organic seeds has 

facilitated interactions with certification bodies (since seeds must themselves be 
organically produced). Such traceability was not as easily achieved before the 
reform that led to the terms of art. 315-5 of the Code rural, since seed 
exchanges back then could not benefit from a framework that assured their 
legality. 

  Funding support – Participants to peasant seed exchanges as provided for in 

art.315-5 of the Code Rural have been able to receive support from 
organisations such as GABs (Groupements d’Agriculteurs Biologiques) or the 
Federation Nationale de l’Agriculture Biologique (FNAB), whereas this would 
have been more difficult to achieve before then. 

  Resources for seed producers – One founder of the RSP noted that seed 

producers have been increasingly interested by the varieties that have been 
selected and exchanged within the peasant seeds network, as those varieties 
may present traits that are of broader interest. 

  Resilience – The ability to exchange seeds non-commercially, locally, and for 
varieties adapted to the soil and climate has been a source of resilience for 
farmers who may be affected by drought or flooding, and which have lost their 
production and reserve of seeds as a result. 

A10.5  Conclusions 

The evidence on France’s experience with seed and plant exchanges as provided for 
under article 315-5 of the Code Rural holds three main lessons. 

Firstly, the practices of exchanging seeds from varieties that are not protected by 
plant variety rights has been a collective effort distributed within small, local groups 
linked together in non-hierarchical networks. This effort has not been driven by 
regulatory or market forces, but rather by the needs and aspirations of established 
farmers and many newcomers to farming to produce food sustainably and in a resilient 
manner. Several research projects have contributed to the further development and 
structuring of the peasant seeds network in France. 

Secondly, the recognition of these practices and the establishment of a legal 
framework to underpin them has not fundamentally had an impact on these practices, 
though it has provided secondary benefits. The legal certainty has benefited organic 
producers engaged in those exchanges in their interactions with certification bodies. It 
has also made it easier for organic producers to access funding support. There has not 
been any noticeable negative effect on any stakeholders, the commercial market, nor 
plant health. 

Thirdly, while data on the volumes exchanged and the number of farmers participating 
remain limited, the evidence suggests that they have grown progressively over the 
past 20 years, though overall numbers remain very small. Noting that the past 20 
years have brought a “proof of concept”, one academic expert expects to see an 
acceleration of the number of participants in the coming years, driven by local officials 
pushing for the development of local food production and agroecology.  

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Annex 11  Fruit and vine QCA 

This Annex summarises the evidence collected to address the following item from the 
Terms of Reference: “The contractor shall collect data on the experiences of Member 
States with the conservation and amateur varieties of fruit plants and vine. Are there 
indications that the existing national rules support the production and marketing of 
conservation and amateur varieties of fruit plants and vine?”74 

The methodology that was applied to explore this question involved a mailed short 
survey of National Competent Authorities (NCAs) from across 17 Member States (MS) 
that covered a limited set of questions, all related strictly to fruit and / or vine 
varieties. All questions were framed in a concise manner and prescribed specific 
answers (yes/no; figures) so as to obtain data specific enough to then run a 
Qualitative Comparative Analysis (QCA). The variables for which data was sought 
included first a set of indicators on the national rules for registration of conservation 
varieties and varieties with no intrinsic commercial value: 

  whether national rules provided for a separate, lighter regime for conservation 

varieties or varieties with no intrinsic commercial value 

  whether fees for registration are reduced for conservation varieties and 

varieties with no intrinsic commercial value, compared to those incurred for the 
registration of other varieties 

 

the number of such varieties registered in the MS 

The survey then sought to collect evidence on other factors that may influence 
practices of production of fruit and vine PRM of this type of varieties: 

 

the capacity to produce such varieties in the MS 

  whether there has been unmet demand for such PRM in the MS 

  whether any informal PRM exchange networks have been contributing to the 

diffusion of such varieties in the MS 

Finally the survey sought to measure actual production levels of fruit and vine 
conservation varieties and varieties with no intrinsic commercial value in the MS. The 
latter was defined as the main outcome measure. 

17 MS NCAs were approached and asked to return a partially pre-filled form, covering 
either fruit or vine, or both. 17 forms were returned. Most of them were partially 
completed. Information on production volumes, demand, and the active role of plant 
exchange networks was often missing. No consistent measure of volumes produced 
could be achieved due to a lack of data: not all MSs are tracking this information. As a 
result, it has not been possible to derive a common scoring for the MS that could then 
be used for the QCA. By contrast, some MSs (yet by any means not all of them) have 
provided indications of the number of such varieties registered in their MS. Some of 
them qualify as “commonly known varieties” as defined in article 7 of directive 
2008/90. The evidence collected on this aspect covers 13 MS only and is as follows: 

74 The requirement is linked to IA question C.1: “What are the expected economic impacts for competent 
authorities and operators, social impacts for citizens and environmental impacts of establishing a simple and 
harmonised registration system (i.e. no variety testing but officially recognised description) for conservation 
varieties and for amateur varieties and of facilitating the marketing conditions for those varieties (no 
quantitative restrictions and abolishing the region-of-origin concept)?” 

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 Number of conservation varieties and varieties without commercial 
value for fruits and vine (n=13) 

MS 

Austria 

Belgium 

Croatia 

Czechia 

Denmark 

Finland 

Germany 

Greece 

Hungary 

Netherlands 

Slovakia 

Spain 

Sweden 

Fruit varieties 

Vine varieties 

No data 

91 

No data 

15 

0 

125 

147 

78 

78 

25 

0 

9 

25 

150 

No data 

0 

6 

Exempted 

Exempted 

No data 

223 

Exempted 

0 

0 

Exempted 

Source: ICF Survey of NCAs; MSs for which no data was shared: France, Italy, Poland, 
Portugal. 

While these figures show extensive variation across the EU, the number of registered 
varieties is not necessarily an indicator of the extent to which the national rules 
contribute to production and marketing of such varieties. For example, Sweden has 15 
registered conservation varieties of fruits and 10 registered varieties of fruits with no 
intrinsic commercial value, yet there is no commercial production of PRM for any of 
these varieties. Likewise, Spain has 9 such varieties registered (all of them from 
apple), yet to the knowledge of the NCA no PRM are being produced for those 
varieties. Such discrepancy between the number of registered conservation varieties 
or varieties without intrinsic commercial value on the one hand, and the volumes 
actually produced/planted on the other hand is also noted by Batur et al. (2021) for 
Italy, although not in relation to fruit and vine specifically. They note that the 
registration for such varieties may be an indicator of the extent of conservation 
efforts, which may involve actors without any interest in production and 
commercialisation, such as research institutes. A respondent to the survey commented 
that this framework for conservation varieties may come with a strong emphasis on 
the prevention of genetic erosion of PRM, which does not provide flexibility for 
evolving varieties as seen in the fields. In that sense, as noted by another respondent, 
registered conservation varieties may be “niche varieties” restricted to marginal 
usage. 

In the absence of evidence on production volumes, the number of registered 
conservation varieties can be considered as a proxy measure, with the strong caveats 
just mentioned that, in practice, the relationship between the two is not linear. The 
data gaps prevent the completion of a truth table for all the cases and covering all the 
variables initially envisaged. However, a visualisation of the cases in an incomplete 
truth table (Table 36) can lead to a few suggested relationships between these 
variables.  

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 Incomplete truth table for the cases examined 

Countries / cases  

Registration 
rules 

Registration 
fees 

Demand 

Perceived 
support 

Registered 
varieties 

Austria (vine) 

Belgium (fruit) 

Croatia (vine) 

Czechia (fruit) 

Czechia (vine) 

Denmark (fruit) 

Finland (fruit) 

Germany (fruit) 

Greece (fruit) 

Greece (vine) 

Hungary (fruit) 

Netherlands (fruit) 

Slovakia (vine) 

Spain (fruit) 

Spain (vine) 

Sweden (fruit) 

1 

0 

1 

1 

1 

0 

0 

1 

1 

1 

0 

1 

0 

0 

0 

1 

0 

1 

0 

1 

0 

1 

1 

1 

1 

1 

1 

1 

0 

1 

0 

1 

1 

1 

1 

0 

0 

0 

0 

0 

1 

1 

No data 

0 

No data  

No data  

No data 

No data  

0.5 

0 

0.5 

0.5 

0.5 

No data 

No data 

0.5 

0.5 

0.5 

1 

0.5 

0 

1 

1 

0 

150 

91 

0 

15 

6 

0 

125 

147 

78 

223 

78 

25 

0 

9 

0 

25 

Source: ICF survey of NCAs 

Note: the table’s coding should be read as follows: “registration rules” scored 0 if conservation and amateur 
varieties are subject to the same rules as others, and 1 if they are exempt or subject to lighter rules; 
“registration fees” scored 0 if the registration fees for conservation and amateur varieties are similar to 
those applying to other varieties, and 1 if they are reduced or waived completely; “demand” scored 0 if 
there is no unmet demand for conservation and amateur varieties and 1 if there is; “perceived support” 
scored 0 if NCAs consider that the national rules do not support the production and marketing of 
conservation and amateur varieties, 0.5 if they consider they provide some support, and 1 if they consider 
they provide a lot of support; “registered varieties” is the absolute number of conservation and amateur 
varieties registered. 

Although the data gaps do not enable the QCA analysis to be carried out in full, its 
logic can be applied to highlight the following points: 

  The presence of either lighter rules or reduced fees or both across all cases 

where a non-null number of varieties have been registered suggests that those 
conditions contribute to higher registrations; the absence of either in two of the 
four cases where no registered varieties have been noted reinforces this 
observation. Additional comments provided by respondents (e.g. in Spain or 
Austria) highlight that the costs of registration and the burdens of PRM 
legislation (including the plant passport required by the plant health legislation) 
are preventing numerous amateur or traditional varieties from being produced 
and marketed. It is notable that, in Germany, fruits varieties from such 
varieties can be sold by notification, without the requirement for registration 
unless the variety was bred after 2012. The possibility to use such a regime 
appear not to have been used in Spain, and as a result it is said that a large 
number of varieties pre-2012 cannot be produced and conserved because the 
requirements for registration are too high.  

  As evidenced by the other two cases where no registered varieties have been 

noted, neither lighter rules or reduced fees are sufficient for greater registration 
of conservation and amateur varieties to happen.  

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  Both MSs with an unmet demand for such varieties and MSs without are found 
among those showing high numbers of registered varieties. This shows that 
demand is neither necessary nor sufficient for registrations to take place, as 
noted above. It is however clear that the production and marketing of such 
varieties would require demand for them to happen.  

  The perception of legislative support for conservation and amateur varieties is, 
as a whole, a poor indicator of the scale of registrations for conservation and 
amateur varieties taking place in the MSs. 

Capacity is certainly a consideration that would be relevant to the scale of production 
and marketing of such varieties taking place in the MSs, however that could not be 
documented systematically through the surveys. Nevertheless, a few qualitative 
insights highlight how that matters to the scale of production and marketing 
happening. In Austria, in response to demand, six nurseries have specialised in the 
breeding and selling of old varieties.  

This partial analysis has not explored how alternative paths to the propagation of 
conservation and amateur varieties of vine and fruits might be contributing to 
production. There are indications in survey responses that seed and plant exchange 
networks have played a role in addressing the demand for such varieties in Austria 
and Germany.  

Nevertheless, the analysis suggests that a lighter regime or a derogatory regime for 
the registration and marketing of conservation and amateur varieties of fruit plants 
and vine could contribute to increasing production and marketing volumes. That may 
not be sufficient, however. Broader experience beyond fruit and vine (Batur et al. 
2021) suggests that an emphasis on conservation objectives over other considerations 
for a lighter or derogatory regime (for instance, varieties are sought in some countries 
for the purpose of producing fruits without the use of chemicals) would be counter-
productive. It would contribute to greater registration of varieties by actors focused on 
conservation objectives such as research institutes. However, it would not 
accommodate the evolution of the varieties in interaction with local ecosystems and 
rapidly evolving and increasingly unpredictable agro-climatic conditions, which are 
core concerns of end users (FNPF 2022). In other words, a lighter regime heavily 
focused on conservation objectives and the risks of genetic erosion of varieties could 
condemn conservation and amateur varieties to a niche status and stymie greater 
production and marketing volumes. 

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Annex 13  EU legislation and other EU instruments 

A13.1  PRM/FRM Directives 

Commission Implementing Directive (EU) 2016/2109 of 1 December 2016 amending 
Council Directive 66/401/EEC as regards the inclusion of new species and the 
botanical name of the species Lolium x boucheanum Kunth (Text with EEA relevance) 
C/2016/7695 [2016] OJ L 327. 

Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant 
propagating material and fruit plants intended for fruit production (Recast version) 
[2008] OJ L 267. 

Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable 
propagating and planting material, other than seed (Codified version) (Text with EEA 
relevance) [2008] OJ L 205. 

Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed [2002] 
OJ L 193. 

Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed 
[2002] OJ L 193. 

Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes 
[2002] OJ L 193. 

Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and 
fibre plants [2002] OJ L 193. 

Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest 
reproductive material [1999] OJ L 11. 

Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material 
of ornamental plants [1998] OJ L 226. 

Council Directive 92/34/EEC of 28 April 1992 on the marketing of fruit plant 
propagating material and fruit plants intended for fruit production [1992] OJ L 157 

Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the 
vegetative propagation of the vine [1968] OJ L 93. 

Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed /* 
Codified version CF 374Y0608(03) */ [1966] OJ 125. 

Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed 
/* Codified version CF 374Y0608(02) */ [1966] OJ 125. 

A13.2  Other EU legislation 

Commission  Implementing  Directive  (EU)  2019/523  of  21  March  2019  amending 
Annexes  I  to  V  to  Council  Directive  2000/29/EC  on  protective  measures  against  the 
introduction into the Community of organisms harmful to plants or plant products and 
against their spread within the Community [2019] OJ L 86. 

Commission Implementing Directive (EU) 2017/1279 of 14 July 2017 amending Annexes 
I to V to Council Directive 2000/29/EC on protective measures against the introduction 
into the Community of organisms harmful to plants or plant products and against their 
spread within the Community [2000] OJ L 184. 

Commission  Implementing  Directive  2013/57/EU  of  20  November  2013  amending 
Directives  2003/90/EC  and  2003/91/EC  setting  out  implementing  measures  for  the 
purposes of Article 7 of Council Directive 2002/53/EC and Article 7 of Council Directive 
2002/55/EC respectively, as regards the characteristics to be covered as a minimum by 

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the  examination  and  the  minimum  conditions  for  examining  certain  varieties  of 
agricultural plant species and vegetable species. [2013] OJ L 312.  

Consolidated version of the Treaty on the Functioning of the European Union. Part Six - 
Institutional and Financial Provisions. Title I - Institutional Provisions. Chapter 2 - Legal 
acts of the Union, adoption procedures and other provisions. Section 1 - The legal acts 
of the Union. Article 288 (ex Article 249 TEC) [2012] OJ C 326. 

Commission Directive 2010/60/EU of 30 August 2010 providing for certain derogations 
for marketing of fodder plant seed mixtures intended for use in the preservation of the 
natural environment [2010] OJ L 228. 

Commission  Directive  2009/145/EC  of  26  November  2009  providing  for  certain 
derogations,  for  acceptance  of  vegetable  landraces  and  varieties  which  have  been 
traditionally  grown  in  particular  localities  and  regions  and  are  threatened  by  genetic 
erosion and of vegetable varieties with no intrinsic value for commercial crop production 
but developed for growing under particular conditions and for marketing of seed of those 
landraces and varieties  [2009] OJ L 312. 

Commission Directive 2008/62/EC of 20 June 2008 providing for certain derogations for 
acceptance  of  agricultural  landraces  and  varieties  which  are  naturally  adapted  to  the 
local  and  regional  conditions  and  threatened  by  genetic  erosion  and  for  marketing  of 
seed and seed potatoes of those landraces and varieties [2008] OJ L 162. 

Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of 
agricultural plant species [2002] OJ L 193. 

Council  Directive  2000/29/EC  of  8  May  2000  on  protective  measures  against  the 
introduction into the Community of organisms harmful to plants or plant products and 
against their spread within the Community [2000] OJ L 169. 

Council  Directive  70/457/EEC  of  29  September  1970  on  the  common  catalogue  of 
varieties of agricultural plant species/* CODIFIED VERSION CF 374Y0608(06) */ [1970] 
OJ L 225. 

Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 
2021  establishing  the  framework  for  achieving  climate  neutrality  and  amending 
Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) 

Regulation  (EU)  2018/848  of  the  European  Parliament  and  of  the  Council  of  30  May 
2018  on  organic  production  and  labelling  of  organic  products  and  repealing  Council 
Regulation (EC) No 834/2007. [2018] OJ L 150. 

Commission  Delegated  Regulation  (EU)  2021/1189  of  7  May  2021  supplementing 
Regulation (EU) 2018/848 of the European Parliament and of the Council as regards the 
production  and  marketing  of  plant  reproductive  material  of  organic  heterogeneous 
material of particular genera or species [2021] OJ L 258. 

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 
2017 on official controls and other official activities performed to ensure the application 
of  food  and  feed  law,  rules  on  animal  health  and  welfare,  plant  health  and  plant 
protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) 
No  1069/2009,  (EC)  No  1107/2009,  (EU)  No  1151/2012,  (EU)  No  652/2014,  (EU) 
2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council 
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 
1999/74/EC, 2007/43/EC,  2008/119/EC and 2008/120/EC,  and  repealing  Regulations 
(EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, 
Council  Directives  89/608/EEC,  89/662/EEC,  90/425/EEC,  91/496/EEC,  96/23/EC, 
96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation). 
[2017] OJ L 95. 

Regulation  (EU)  2016/2031  of  the  European  Parliament  of  the  Council  of  26  October 
2016  on  protective  measures  against  pests  of  plants,  amending  Regulations  (EU)  No 

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228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and 
of the  Council  and  repealing Council Directives  69/464/EEC, 74/647/EEC,  93/85/EEC, 
98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC [2016]. 

A13.3  Other EU instruments 

Communication from the Commission to the European Parliament, the Council, the 
European Economic and Social Committee and the Committee of the Regions Forging a 
climate-resilient Europe - the new EU Strategy on Adaptation to Climate Change. 
[2021] COM/2021/82 final. 

Communication from the Commission to the European Parliament, the Council, the 
European Economic and Social Committee and the Committee of the Regions A Farm 
to Fork Strategy for a fair, healthy and environmentally-friendly food system. [2020] 
COM/2020/381 final. 

Communication from the Commission to the European Parliament, the Council, the 
European Economic and Social Committee and the Committee of the Regions EU 
Biodiversity Strategy for 2030 Bringing nature back into our lives. [2020] 
COM/2020/380 final. 

Communication from the Commission to the European Parliament, the European 
Council, the Council, the European Economic and Social Committee and the 
Committee of the Regions The European Green Deal. [2019] COM/2019/640 final. 

Communication from the Commission to the European Parliament, the Council, the 
European Economic and Social Committee and the Committee of the Regions on the 
Mid-Term Review on the implementation of the Digital Single Market Strategy A 
Connected Digital Single Market for All. [2017] COM/2017/0228 final. 

Communication from the Commission to the Council, the European Parliament, the 
Economic and Social Committee and the Committee of the Regions on a forestry 
strategy for the European Union/* COM/98/0649 final */ 

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doi: 10.2875/4381
ISBN 978-92-76-99310-0