EUROPEAN COMMISSION

Brussels, 5.7.2023

SWD(2023) 414 final

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT REPORT

Accompanying the documents

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

and



Proposal for a Regulation of the European Parliament and of the Council

on the production and marketing of forest reproductive material in the Union, amending Regulations (EU) 2016/2031 and 2017/625 of the European Parliament and of the Council, and repealing Council Directive 1999/105/EC

(Regulation on forest reproductive material)

{COM(2023) 414 final} - {SEC(2023) 414 final} - {SWD(2023) 410 final} - {SWD(2023) 415 final}
{COM(2023) 415 final}

Table of Contents

1.Introduction: Political and legal context

2.Problem definition

2.1.What are the problems?

2.1.1.    Problem 1: Non-harmonised internal market (divergent conditions for the operators across Member States)    

2.1.2.    Problem 2: PRM/FRM legislation is not aligned with the objectives of the European Green Deal and related strategies    

2.2.What are the problem drivers?

2.2.1.    Regulatory drivers    

2.2.2.    New policy developments    

2.2.3.    New developments in science and technology    

2.3.How likely is the problem to persist?

3.Why should the EU act?

3.1.Legal basis

3.2.Subsidiarity: Necessity of EU action

3.3.Subsidiarity: Added value of EU action

4.Objectives: What is to be achieved?

4.1.General objectives

4.2.Specific objectives

4.3.Intervention logic

5.What are the available policy options?

5.1.What is the baseline from which options are assessed?

5.2.Description of the policy options

5.2.1.    Measures common to all options    

5.2.2.    Option 1 - Highest flexibility    

5.2.3.    Option 2 - Balancing flexibility and harmonisation    

5.2.4.    Option 3 - Highest harmonisation    

5.2.5.    Stakeholders’ views on policy options    

5.3.Options discarded at an early stage and alternative measures

6.What are the impacts of the policy options?

6.1.Economic impacts

6.1.1.    Common measures to policy options 1-3    

6.1.2.    Strengthened sustainability requirements    

6.1.3.    Official controls    

6.1.4.    Conservation and sustainable use of plant and forest genetic resources    

6.1.5.    Innovation and digitalisation    

6.1.6.    SMEs    

6.1.7.    Competitiveness    

6.2.Environmental impacts

6.2.1.    Strengthened sustainability requirements    

6.2.2.    Conservation and sustainable use of plant and forest genetic resources    

6.2.3.    Common measures for PRM to contribute to sustainability, biodiversity and climate-related challenges    

6.3.Social impacts

6.4.Sustainability

6.5.Global combined impact of the policy options

6.6.Stakeholders’ views on impact of policy options

7.How do the options compare?

7.1.Effectiveness

7.2.Efficiency

7.3.Coherence

7.4.Subsidiarity and proportionality

8.Preferred option

8.1.REFIT (simplification and improved efficiency)

8.2.Simplification and burden reduction for businesses, supporting the one-in one-out approach

9.How will actual impacts be monitored and evaluated?

Annex 1: Procedural information

1.Lead DG, Decide Planning/CWP references

2.Organisation and timing

3.Consultation of the RSB

4.Evidence, sources and quality

Annex 2: Stakeholder consultation (Synopsis report)

1.Consultation strategy

1.1.Consultation activities undertaken by DG SANTE

1.2.Consultation activities conducted in the framework of the study supporting the impact assessment

2.Stakeholder participation

3.Results of stakeholder consultation activities

4.Conclusions

Annex 3: Who is affected and how?

1.Practical implications of the initiative

1.1.Operators

1.2.National competent authorities

1.3.Users of PRM and FRM

2.Summary of costs and benefits

Annex 4: Analytical methods / Calculations

1.Global value of PRM/FRM and cost of PRM as a share of total input costs of agricultural production

2.Number of new varieties

3.PRM certification areas / certified quantities and certification under official supervision

4.Variety registration costs

5.Impact of strengthened sustainability requirements in variety registration

6.Impact of assessment of sustainability characteristics of basic material

7.Innovation and digitalisation

8.Detailed presentation of costs and benefits

8.1.Costs of common measures

8.2.Benefits of common measures

8.3.Costs per option

8.4.Benefits per option

8.5.Net benefit and cost benefit analysis

9.Reduction of administrative burdens due to simplification of administrative procedures

Annex 5: Background information

1.The PRM legislation and its development

2.Principles of the PRM legislation

2.1.Variety registration

2.1.1.    Distinctness, uniformity and stability (DUS)    

2.1.2.    Value for cultivation and use (VCU)    

2.2.Certification

2.2.1.    Official certification    

2.2.2.    Certification under official supervision    

2.3.Activities of seed conservation networks and exchange in kind

2.4.Marketing to amateur gardeners

2.5.Organic varieties suitable for organic production and organic heterogeneous material

2.6.Conservation varieties

3.Principles of the FRM legislation

4.Interaction with other EU policies and instruments

5.Interaction between FSFS, PRM/FRM and NGTs

6.Interplay between PRM/FRM and NGT initiatives as regards sustainability provisions

7.Interplay between PRM/FRM legislation and PHL

8.Innovation and digitalisation

9.Official controls

9.1.Legal analysis

9.2.Information on official controls from consultation activities

9.2.1.    Controls on operators carrying out certification under official supervision    

9.2.2.    PRM import controls    

9.2.3.    Types of import controls:    

9.2.4.    Controls on operators at production stage of PRM/FRM    

9.2.5.    PRM marketing controls    

10.Further details on option 2 (preferred option)

10.1.Current and potential future approach for variety registration and PRM certification

10.2.Potential future approach for variety registration, activities of seed conservation networks and exchange in kind of seeds

10.3.Value for sustainable cultivation and use (VSCU)

10.4.Certification under official supervision

10.5.Future regulation of RNQPs

Annex 6: Bibliography

1.General literature

2.Documents of the European Commission

3.EU Legislation (other than that listed in Section 1 of Annex 5)

Glossary

1.Introduction: Political and legal context

Plant reproductive material (PRM) is any plant material (for example seeds, tubers, cuttings, rootstocks, seedlings, young plants, fully grown trees) that is used for the reproduction of other plants. Forest reproductive material (FRM) is the PRM of tree species that is used for the creation of new forests, the reforestation of existing ones and other tree planting activities (for example, in rural areas for the purpose of climate adaptation). Thus, PRM and FRM form the starting point of agricultural and food production and forestry, respectively. In particular, the availability of, and access to, high-quality PRM are key contributors to food security. They link to the four main pillars on which food security is based: availability, access, utilisation and stability 1 . The actions taken under the Farm to Fork Strategy (F2F) including those under this initiative will help enable and contribute to the transition to sustainability, which will strengthen resilience and in turn enhance short- and long-term food security. The availability of and access to high-quality and genetically diverse FRM will contribute to more sustainable afforestation and reforestation which will in turn strengthen the resilience of forest ecosystems and ensure that forests can adapt to climate change.

The EU legislation on PRM and FRM currently includes 12 basic Directives, collectively known as ‘marketing Directives’: 10 specific for each type of crop (seed of cereals, seed of fodder plants, seed of oil and fibre plants, seed of beet, seed potatoes, vegetable seed, vegetable reproductive material other than seed, fruit plants, vine, ornamental plants), one Directive establishing the Common Catalogue of varieties of agricultural species and one on FRM (for a detailed overview see Annex 5, Section 1). The oldest of these Directives date back to 1966 2 . The legislation applies to the economically most important plant species. The aim of this legislation is to ensure the identity, quality and health of the marketed PRM and FRM for its users.

The PRM legislation has two main pillars: registration of varieties 3 and certification of PRM (Annex 5, Section 2). For the purposes of variety registration, the candidate varieties are tested in field trials for their distinctness, uniformity and stability (DUS) 4  by the National Competent Authority (NCA) of the MS where the application is submitted. DUS tests take two to three years in the case of varieties of agricultural plant species 5  and vegetable species and five to six years in the case of varieties of fruit plants and vine. For agricultural plant species the candidate varieties are also assessed by comparative field trials carried out by the NCAs for their value for cultivation and use (VCU), i.e. whether they offer a clear improvement in performance compared to reference varieties. Upon satisfactory completion of the DUS, and where applicable of the VCU examination, varieties are registered in the national catalogue of the MS and subsequently notified to the corresponding EU Common Catalogue for marketing throughout the EU. Each registered plant variety is designated a unique denomination, i.e. a name that serves to identify that variety.

Certification of PRM consists of checks (both in the field where PRM is produced, by sampling and testing the PRM lots produced and control plot testing of the varietal identity) to verify its identity, quality and health. As regards identity, it is verified that the PRM has the same characteristics as the registered plant variety to which that PRM belongs (i.e. it is true to variety description). Different marketing categories of PRM are defined depending on the quality and technical requirements (e.g. analytical purity, germination rate, absence of weeds). As regards health, it is verified that the PRM does not contain any plant pests or diseases. Certain aspects of the certification procedures can be carried out by authorised operators under the official supervision of the NCAs. For PRM that meets the certification requirements the NCAs issue an official label with which the PRM can be marketed throughout the EU 6 . The PRM legislation furthermore includes rules for marketing of PRM in homogeneous lots with reference to a lot number to assure traceability, as well as rules for packaging, sealing, labelling and documentation. The PRM legislation also sets the rules for imports of PRM into the EU. Such PRM can only be marketed in the Union if it satisfies the same requirements as the material produced and certified within the Union (EU equivalence regime). Exports are not covered by the legislation. Finally, to ensure the quality of PRM marketed throughout the EU, NCAs should carry out official controls (OCs) in order to verify compliance with the rules on the production, marketing and imports of PRM.

The FRM legislation is based on principles quite different from those of the PRM legislation, as FRM differs significantly from PRM (Annex 5, Section 3). While seeds of agricultural crops are harvested in annual cycles, for certain forestry species it takes 50-100 years before FRM can be harvested. FRM is marketed in relation to basic material (i.e. approved trees from which seed is harvested) and provenance (the place in which trees are growing). NCAs approve basic material through an official inspection following which basic material is registered in the national catalogue of the MS and subsequently in the EU Common Catalogue FOREMATIS 7 . Upon harvesting seeds and other FRM from basic material, NCAs issue a master certificate. FRM has to meet the relevant requirements (age, development, health and resistance of trees in stands to adverse climatic conditions) before the operator can issue a supplier’s document or supplier’s label. The registration of basic material, the master certificate and the supplier’s document/label are prerequisites for the marketing of FRM throughout the EU. Similar to the PRM legislation, the FRM legislation also includes rules for marketing of FRM, imports (equivalence), derogations aiming to facilitate the conservation and sustainable use of forest genetic resources, and OCs for verifying compliance with the rules on the production, marketing and imports of FRM.

The EU PRM and FRM market has an estimated annual value of over EUR 13 billion 8 . As regards the seed sector in particular, the EU is in the top three of globally exporting regions. The EU seed market covers agricultural species (e.g. wheat, maize, rice), vegetable species (e.g. tomato, carrot, lettuce). It is the third largest seed market after the USA and China and accounts for around 20% of the global market, estimated at EUR 7-10 billion (revenues from commercial seed sales, not including farm-saved seeds). There is little information available on the structure of the seed sector in the EU. The number of companies in the seed sector is about 7 000. They are very diverse in terms of size (turnover, employees), crops or geographical area covered. They may be active in one or several stages of the seed industry: plant breeding, seed production, seed conditioning, and seed marketing and distribution. The number of small and medium-sized enterprises (SMEs) is assumed to be high, but no information is available on their market share. Furthermore, it is not known how many are independent (a single company may own a large number of brands), while cross-licensing and cooperation agreements have created a network of relationships between seed companies that make the mapping of the sector extremely difficult 9 . The EU plant breeding sector is highly innovative and new varieties are constantly developed to meet the demands of farmers, industry and consumers. It spends around 15% of its annual turnover on research and development 10 . Farmers also play an important role in the seed sector as they multiply the seed of agricultural plant species in their fields on behalf of the seed companies. In 2021 the area used for production of certified seed (vegetable and ornamental seeds not included) in EU amounted to slightly more than 2 million ha 11 . As regards PRM of fruit plants, there are over 20 000 suppliers in the EU, almost all of which are SMEs 12 . As regards FRM, there are over 4 000 suppliers in the EU, almost all of which are SMEs 13 . The overwhelming majority of FRM (tree seeds and plants) are marketed within the EU and only a minority is traded with non-EU countries 14 .

Relationship with other EU policies and instruments

The PRM/FRM legislation interacts with a number of EU policies and instruments (Annex 5, Section 4). There is a close link with the European Green Deal (EGD) 15 and its related strategies:

·F2F 16 recognises that sustainable food systems rely on seed security and diversity and that farmers need to have access to a range of quality seeds for plant varieties adapted to the pressures of climate change. The initiative for the PRM/FRM revision will introduce relevant considerations in the criteria for acceptance of new varieties. It will also contribute to reaching the F2F objective of at least 25% of the EU’s agricultural land under organic farming by 2030 by introducing rules on registration of organic varieties suitable for organic production adapted to the needs of organic production.

·The initiative for the PRM/FRM revision will contribute to the objective of the EU Biodiversity Strategy for 2030 17 to reverse the decline of genetic diversity by facilitating the market access for traditional and locally adapted varieties, thus contributing to the conservation and sustainable use of plant genetic resources.

·It will also contribute to the objective of the EU Strategy on Adaptation to Climate Change 18 to help farmers and land managers tackle climate risks. Relevant criteria will be introduced in the rules for the registration of new varieties and of FRM with a view to facilitate the broadening of the supply of suitable high-quality plant reproductive material to support adaptation in agriculture, forestry, and land ecosystem management.

·It will furthermore contribute to the objectives of the EU Forest Strategy 19  for adapting forests to climate change and restoring forests following climate damages by introducing measures promoting the production of FRM suitable for future climatic conditions. It will finally contribute to meeting the target of planting at least 3 billion additional trees in the EU by 2030, by revising the scope of the FRM legislation, in order to ensure that FRM of high quality will be used for this.

There are also links and interplays with other EU legislation, notably the Plant Health Legislation (PHL) 20 , the Official Controls Regulation (OCR) 21 , the Organic Regulation 22 , the Community Plant Variety Rights (CPVR) legislation 23 and the genetically modified organisms (GMO) legislation 24  as well as the EU Digital Strategy 25 . The PRM/FRM legislation also has to be aligned or interrelates with a number of international standards or agreements 26 . 

Relationship with other ongoing initiatives

The initiative for the revision of the PRM/FRM legislation is linked to the following ongoing initiatives (for details see Annex 5, Section 5):

·The Framework for Sustainable Food System (FSFS) initiative 27  aims to introduce an overarching, horizontal legal framework (‘lex generalis’) establishing common sustainability principles and objectives for all food system related policies. The initiative for the PRM/FRM revision, which is underpinned by sustainability as an objective, will include specific rules for the PRM/FRM sectors (‘lex specialis’). FSFS will ensure the benefits of an integrated policy perspective and approach, while specific requirements introduced by the PRM/FRM initiative will accelerate the transition towards more sustainable practices in the PRM/FRM sectors.

·The New Genomic Techniques (NGT) initiative 28  concerns plants produced by genetic modification, in particular targeted mutagenesis 29 and cisgenesis 30 . These plants may contribute to the innovation and sustainability objectives of the EGD and of the F2F and Biodiversity strategies. The initiative aims at a proportionate regulatory oversight better adapted to NGTs that combines high levels of safety with clear benefits to society and the environment. Coherence will be ensured between the PRM/FRM and NGT initiatives, in particular as regards any sustainability aspects (see Annex 5, Section 6). The plant variety registration system of the PRM legislation applies to all varieties irrespective of the breeding technique. A variety obtained by genetic modification and subject to the provisions of the GMO legislation can only be registered and PRM of such variety can only be marketed if this variety complies with the requirements of the GMO legislation 31 . The same applies for FRM consisting of GMOs. Varieties and FRM with NGT traits 32 will be treated under PRM and FRM legislation in the same way as all other varieties and FRM regardless of the breeding methodology (conventional breeding, NGTs, established genetic modification techniques).

·The sustainable use of plant protection products (SUR) 33  initiative aims to reduce the use and risk of chemical pesticides. Current VCU rules (examination for resistance to plant pests and diseases) and the envisaged measures to extend these (Section 5) contribute to this objective of the SUR, as new varieties with increased resistance to plant pests may require less pesticides.

Legislative context

The PRM and FRM legislation was first evaluated in 2008 34 . In 2013, the Commission adopted a proposal for its revision 35 (‘2013 PRM proposal’) accompanied by an impact assessment 36 . That proposal was rejected by the European Parliament in 2014 37  as according to the European Parliament, one Regulation could not address the requirements of the broad range of PRM and cover FRM. The European Parliament also had concerns regarding the marketing to amateur gardeners, the unnecessary burden on operators and NCAs and insufficient biodiversity provisions. Subsequently, the proposal was withdrawn by the Commission in 2015 38 .

Following a request by the Council 39 , the Commission presented in 2021 a study on the Union’s options to update the existing legislation on the production and marketing of plant reproductive material (‘PRM study’) 40 , which was supported by an external data gathering study 41 . In 2022 another external study 42  was undertaken in support of this impact assessment. 

All concerns expressed by the European Parliament on the 2013 PRM proposal are addressed by this initiative (Table 1). The context has changed to the degree that the issues identified in 2013 are even more actual, e.g. need to modernise the legislation to allow for new technical developments, increasing demand for sustainability in agriculture, adaptation to climate change and conservation of agro-biodiversity. These issues are also relevant in view of the new political objectives.

Table 1. Overview of concerns expressed by the European Parliament in 2014 and approach taken in this initiative to address them.

2. Problem definition

2.1.What are the problems?

The PRM/FRM legislation has gradually evolved over several decades since the introduction of the first marketing Directives in the 1960s. The long history of amendments has led to a complex, incoherent and fragmented legal framework that is not up to date with the current scientific and technical developments. For certain aspects, such as the implementation of derogations and OCs, it leaves too much room for interpretation, resulting in divergent implementation across MS, thus hindering the internal market. Furthermore, the complexity and rigidity of the procedures puts a high burden on NCAs and operators alike. The basic legislation includes detailed technical requirements, making it difficult to adapt the system to new policy priorities, as well as to new developments in science and technology and demands for more sustainable agri-food production and forestry.

Figure 1. Problem tree

Development of the problems since 2013:

The 2008 evaluation and the 2013 impact assessment already identified most of these problems. Although no full-fledged evaluation of the PRM legislation was carried out after 2008, two evaluative studies were carried out. In 2021, there was an external data gathering study 43 supporting the PRM study that was requested by the Council and in 2022 another external study 44 supporting this impact assessment. The analysis and evidence of the existing problems was considered comprehensive, and the problems remain valid. The results of the feedback received on the inception impact assessment in 2021, and of extensive consultations activities have confirmed the problems and provided further elements to substantiate them. 

However, in comparison to 2008 and 2013 the overall context has changed significantly as the EGD and its related strategies have put a stronger focus on sustainability, climate change adaptation and biodiversity. Other related legislation (PHL 45 , OCR, Organic Regulation 46 ) has evolved and there have been new scientific and technological developments. Individual Directives have undergone a high number of targeted amendments in certain articles to address specific issues and to keep pace with these developments 47 . Furthermore, seven out of 11 Directives have been recast (Annex 5, Section 1). However, the majority of the provisions in the Directives have never been revised in a coherent and systematic way. Additionally, MS have adopted their own solutions in relation to new developments not covered by the legislation 48 . These scattered approaches have exacerbated the problems of incoherence between the different Directives and further increased their overall complexity.

2.1.1.Problem 1: Non-harmonised internal market (divergent conditions for the operators across Member States)

Implementation of various aspects of the legislation and therefore conditions for operators and marketed PRM and FRM differ between Member States (MS), either because the legislation is unclear and leaves room for interpretation, or MS tried to find practical solutions to overcome rigid provisions and provisions that have not followed in a timely manner new developments in science and technology.

The provisions in the marketing Directives on OCs 49  for verification of compliance with the requirements of the legislation are quite vague and do not specify minimum requirements 50 . PRM imported from third countries needs to fulfil the same requirements as PRM produced in the Union pursuant to Union rules, but there is no harmonised framework for OCs establishing the place of those OCs (at the border control post 51 or the final point of destination) and the approach (random or risk-based OCs). MS have implemented import controls in a different way and as a consequence it is easier to import PRM in some MS compared to others. There are also differences between MS as regards OCs and enforcement related to marketed PRM and FRM 52 . All operators are affected by those inconsistent and unsystematic controls and enforcement that undermine the functioning of a competitive market and increase the likelihood of lower quality PRM and FRM on the market.

Differences in controls and enforcement regarding Union regulated non-quarantine pests (RNQPs) 53  have an impact on all operators 54 producing and marketing PRM. Those difference arise because RNQPs are regulated both under the PHL 55 and under the marketing Directives as part of the certification requirements (Annex 5, Section 7). Those two frameworks are not fully coherent, as any amendments of PHL and the marketing Directives are not simultaneous. Furthermore, the PHL falls under the scope of the OCR 56 while the marketing Directives do not. Where measures on RNQPs of fruit plants and vine are regulated under the marketing Directives 57 while the RNQPs are listed in the PHL 58 , there is uncertainty as to whether RNQPs fall under the scope of the OCR (Annex 5, Section 7). The OCs on the deliberate release into the environment of Genetically Modified Organisms (GMOs) for the purpose of food and feed production falls under the scope of OCR and includes the presence of GMOs in PRM. OCs on PRM containing GMOs fall under the scope of the OCR while the identity and quality controls on that PRM in the frame of the PRM legislation are not under the OCR. This results in the doubling of OCs on the same material and subject to different approaches. This situation leads to uncertainty for all MS and operators about which legislation to adhere to 59 and consequently to differences in implementation and conditions for the operators, that could eventually undermine enforcement and the quality of controls.

The VCU examination for variety registration can only be carried out officially, but in order to overcome the limitations in resources 60  a few NCAs have introduced their own practices for taking into account breeders’ data 61 , leading to a divergence in the conditions for operators across MS 62 .

Absence of common rules on recent scientific and technical developments, namely innovative production processes, bio-molecular techniques (BMTs) 63 and digitalisation 64 , has resulted in operators not being able to market certain PRM/FRM produced by innovative processes (e.g. true potato seed 65 , the fruit plants and vine marketing Directives do not include rules for the certification of selected clones). For FRM, clones produced by in vitro propagation the current rules do not ensure traceability, because the legislation does not require reference to the production place of the clones. As regards BMTs, MS increasingly adopt national approaches (Annex 5, Section 8). For example, in Spain the use of BMTs is allowed as a self-standing tool for the identification of varieties during marketing controls without the need for observing the phenotypic characteristics of the varieties during control plot testing 66 , 67 . This leads to divergent conditions for operators across MS as well as to missed opportunities to increase the efficiency of processes and competitiveness of the PRM/FRM sectors 68 Furthermore, the absence of such rules at EU level leads to the divergence of the EU legislation from international standards where such advances are already catered for (e.g. International Union for the Protection of New Varieties of Plants (UPOV) 69 , Organization for Economic Co-operation and Development (OECD) Seed Schemes).

2.1.2.Problem 2: PRM/FRM legislation is not aligned with the objectives of the European Green Deal and related strategies

This problem concerns restrictions in relation to genetic diversity of PRM/FRM, insufficient sustainability considerations and incomplete scope of the FRM legislation. In the case of PRM, more genetically diverse varieties (e.g. conservation and organic varieties) cannot meet the existing legal requirements for variety registration. The activities of seed conservation networks and exchange in kind of seed are subject to the current rules on variety registration. There is an insufficient supply of high-quality certified FRM due to the increasing demand for FRM for non-forestry purposes 70 . The increasing occurrence of extreme weather and disasters in combination with an insufficient assessment of sustainability characteristics in the registration of new varieties and of FRM put pressure on the stability of yield in the PRM sector and on the supply of suitable FRM and thus on the resilience of agri-food production and forestry. 

First, the current variety registration system based on DUS limits the acceptance and therefore the access to the market of less uniform and more genetically diverse varieties. Such varieties are desirable for organic production 71 and other low input agricultural systems. They could contribute to more diverse agri-food systems, in particular at local level and broaden the genetic reservoir of cultivated crops 72 but are currently restricted due to the DUS requirements. The demand for organic seed in the EU vastly exceeds the supply (though with variations between the different regions and crops), resulting in a high use of derogations for untreated conventional seeds despite that these derogations are phased out by 2036 under the Organic Regulation. In the absence of sufficient quantities of certified organic seed, the use of untreated conventional seed in organic farming ranges between 18% in Central Europe and 48% in Eastern Europe 73 . The problem concerns all breeders active in the breeding of organic varieties, since those varieties have difficulties to access the market 74 as well as the organic farms across the EU. There are about 244 000 farms in the EU that have some organic area, two-thirds of which are fully organic. In 2018 the total area under organic production in the EU was 13 million hectares or 8% of the total utilised agricultural area 75 . The problem also undermines the effort to reach the objective under F2F of at least 25% of the EU’s agricultural land under organic farming by 2030.

The variety registration system has a restrictive impact on activities that are important for the conservation and sustainable use of plant genetic resources and help in addressing the biodiversity and climate change challenges. Seed conservation networks 76 aim to conserve threatened varieties 77 and prevent genetic erosion 78 , while for addressing particular local needs new locally adapted varieties 79  are bred 80 . However, most often conservation and new locally adapted varieties either do not meet the variety registration requirements (DUS) or the quantities of PRM are so low that it is unfeasible to benefit from the existing derogations for conservation varieties 81 . Due to these restrictions the availability of such varieties in the public domain often relies on exchange in kind of seed 82 , 83 , which is currently not possible as it is covered by the definition of “marketing” within the Directives 84  and therefore requires the fulfilment of variety registration and certification requirements (Annex 5, Section 2.2). Exchange in kind of seeds between farmers is currently also restricted by these requirements, although an important number of small farmers across EU save and exchange seed from their harvest, because such seed is better adapted to their local environment conditions following ongoing on-farm selection over many years. Indicatively, one of the organisations advocating for a framework for seed exchange between farmers counts over 80 000 members across EU. These restrictions also affect all operators marketing to amateur gardeners (Annex 5, Section 2.4) with the vast majority of PRM marketed to amateur gardeners belonging to registered varieties, leaving the demand for locally adapted varieties unsatisfied 85 . The derogations to the rules for acceptance of varieties and certification of seeds for agricultural and vegetable conservation varieties 86 have had some results 87 but the requirements are still considered too burdensome 88 . Furthermore, these derogations do not cater for new locally adapted varieties. MS currently have the possibility to accept conservation varieties on the basis of an official DUS examination, or an official DUS examination with increased tolerance for reduced uniformity or on the basis of other information such as historical knowledge. This leads to different conditions for operators between the MS. For example, Czechia carries out DUS, Spain carries out DUS but accepts uniformity levels of 90%, Germany accepts a variety description by applicant but carries out a DUS examination in case of doubt 89 .

Second, the current PRM/FRM rules have only a limited contribution to sustainable production. Those provisions are restricted to varieties of agricultural species (VCU) 90 in the case of PRM and the higher FRM categories 91 . Similar requirements to VCU are in place for vine under the DUS examination 92 . Currently no such provisions exist for vegetable species and fruit plants. The PRM legislation prescribes four broad criteria that must be examined in VCU testing leaving the degree to which sustainability is addressed at the discretion of the MS, thus implying that new varieties can be registered without improved performance regarding sustainability characteristics 93 .

Likewise, the FRM legislation prescribes two broad sustainability characteristics (adaptability of basic material to ecological conditions, and health and resistance of basic material to adverse climatic conditions), leaving room for manoeuvre to MS for their implementation 94 . Some MS (e.g. Estonia, France, Finland, France and Germany) have invested in tree breeding programmes to ultimately improve the sustainability of the resulting FRM. Others have paid little attention to this aspect 95 despite forests being under pressure because of climate change. This situation is inadequate for rapidly changing conditions.

Potentially all farmers and foresters in the EU (over 5 million specialist crop farms and over 500 000 persons employed in the forestry and logging sector 96 ) are at risk of not having PRM and FRM suitable for future challenges and subsequently of facing increased losses of production. The consequences will be equally detrimental for the wider society in terms of reduced food security and other indirect impacts on sectors relying on agriculture and forestry. The magnitude of the problem is already very significant. Over the period 1981-2010, the average annual crop losses caused by drought in the EU have been estimated at EUR 4.8 billion/year 97 . However, in 2018 and 2019 in Germany alone extreme drought and heat events have caused losses in agriculture of EUR 7.8 billion, including direct losses of EUR 4.4 billion across all crops (especially wheat and potato) and indirect losses of EUR 3.4 billion. Losses in forestry were EUR 17.8 billion, including losses of forestry companies of EUR 8.5 billion, indirect costs of EUR 2.8 billion from CO2 release from damaged wood (at EUR 201 per tonne of CO2) and additional indirect damages of EUR 6.5 billion along various value chains 98 .

Third, the scope of the FRM legislation is incomplete as it is restricted to the production of FRM for forestry purposes despite an increasing demand for FRM for non-forestry purposes under the EGD 99 . Moreover, temporary difficulties in the supply of FRM are increasing because of a higher incidence of adverse weather, drought and disasters caused by changing climatic conditions. This results in the need for reforestation of damaged parts of the forests. Because of the restricted scope of the legislation, the current FRM production levels are insufficient to address the higher demand for FRM. In addition, MS have interpreted in a different way the activities 100 that are considered as forestry purposes 101 causing a difference in scope between the national legislations. This problem affects all operators active in the production and marketing of FRM because an activity that is within the scope in one MS may be out of the scope of the legislation in another MS. Finally, the legislation does not contain clear rules on the information to be provided to users of FRM by the nurseries 102 , while such information is necessary for sound decision making in relation to tree planting 103 . Without prior access to this information, users of FRM may plant trees that are not suited for the regional climatic and ecological conditions in the worst-case scenario. This is likely to result in forests that are more vulnerable to drought, pest attacks and other disturbances and could in turn have a huge environmental, economic and social impact 104 .

2.2.What are the problem drivers?

2.2.1.Regulatory drivers

The long history of amendments of the legislation has led to a complex, incoherent and fragmented legal framework that is not up to date with the current scientific and technical developments. Certain provisions, as on OCs, are vague, therefore leaving significant margin for interpretation to the MS and resulting in different conditions for operators. Furthermore, there are no legal means of ensuring more coherent OCs and enforcement of the rules across MS 105 . The PRM and FRM legislation has not been fully adjusted to the evolution of closely related policies (PHL, Organic Regulation, OCR and SUR). Overlaps between the different policies create uncertainty about how to implement the respective provisions, exacerbating the possibilities for different interpretations by the MS and subsequently different conditions for operators.

2.2.2.New policy developments

At the time of its introduction, the PRM legislation focussed on productivity and good quality of the PRM in order to ensure food security 106 , while the FRM legislation prioritised the origin of the basic material and its characteristics suitable for forestry purposes. The legislation however has limited means to address the new challenges in relation to sustainability, climate change adaptation and biodiversity. This alignment is inadequate, as it does not provide the appropriate tools for meeting the commitments made under EGD strategies. Rules for variety registration are not adapted to the needs for less uniform varieties (such as the “organic varieties suitable for organic production” under the Organic Regulation) and new locally adapted varieties. The comprehensive scope of the current marketing rules restricts the activities related to conservation and sustainable use of plant and forest genetic resources. The scope of the FRM legislation is unfit for the increased demand for FRM due to climate change and the objectives of the Biodiversity Strategy. The PRM/FRM legislation has also diverged from other related legislation (PHL, Organic Regulation, OCR) that has significantly evolved over the last years.

2.2.3.New developments in science and technology

Developments in technology and new scientific knowledge lead to new processes of production of PRM/FRM. New solutions are being developed with the use of BMTs and digital tools that have the potential to simplify and render more efficient variety registration, certification of PRM and FRM and marketing controls. The PRM and FRM legislation has not kept pace with these advances, therefore leading to non-harmonised application of such techniques as MS increasingly adopt national approaches (Annex 5, Section 8).

2.3.How likely is the problem to persist?

In the absence of EU action, the differences between MS as regards the interpretation and implementation of the existing marketing Directives will persist and are likely to further increase. The lack of coherence of the PRM/FRM legislation with the PHL and OCR and resulting burdens for NCAs and stakeholders will remain, such as the duplication of RNQPs in the marketing Directives and the PHL and the uncertainty as regards the OCs on RNQPs. MS will likely continue to deploy different solutions, further aggravating the differences of conditions for operators.

Technical innovations such as digital technologies and BMTs are more likely to be taken up by big companies while there is a risk that SMEs would not invest in such technologies if there is no legal certainty around the acceptance of their use (Annex 5, Section 8) thus impacting the competitiveness of the EU industry in relation to other major international players (US, China) and in lost opportunities in related innovation and marketing.

Disproportionate burdens for activities, such as seed conservation networks and breeding for organic production and locally adapted varieties are likely to be aggravated. Without clarifying the rules, such activities will depend on MS decisions to support them, leading to increased uncertainty for the stakeholders concerned and a non-level playing field for operators. This situation is likely to lead to further loss of cultivated diversity. Differences between MS related to sustainability characteristics in the examination of new varieties and the approach for registering “organic varieties suitable for organic production” are also likely to further increase.

Activities, such as agroforestry, plantations for biomass production and the EU target of planting 3 billion additional trees by 2030 are gaining importance under the EGD. Those activities generate an increasing demand in supply of FRM. Problems in supply of appropriate FRM are likely if the scope of the FRM legislation is not adjusted accordingly.

Efforts to address the challenges around sustainability, climate change and biodiversity will be undermined. In the medium or long term there could likely be insufficient incentives to produce PRM and FRM that is adapted to new climatic conditions and could contribute to sustainable production. More frequent extreme weather events (e.g. drought, heavy winds, and flooding) may cause more regular difficulties in supply of PRM and FRM. This may in turn jeopardise the availability of crops to ensure seed and food security as well as of tree seedlings for multifunctional forestry purposes.

3.Why should the EU act?

3.1.Legal basis

The PRM legislative framework is based on Article 43(2) of the Treaty on the Functioning of the European Union (TFEU) implementing the Common Agricultural Policy. The TFEU qualifies agriculture as shared competence between the EU and its MS. All sectors of agricultural activity, as well as ancillary activities upstream and downstream, have been largely regulated at EU level. This means that in accordance with Article 2(2) TFEU, legislation in the area of agriculture is predominantly a role for the institutions of the EU. The same legal basis should also be used for the new act(s) that might be adopted as a result of this initiative.

3.2.Subsidiarity: Necessity of EU action

The introduction of the EU Directives on the marketing of PRM/FRM has been a major contributor to the creation of the internal market. The EU rules on marketing of PRM/FRM have had a generally positive impact on free movement, availability and quality of PRM/FRM 107 . If there had been no action at EU level, 27 systems instead of one would be in place today thus hindering the movement within the internal market, distorting competition and increasing the financial burden associated with registration of varieties and the necessary controls on the identity, health and quality of PRM/FRM.

3.3.Subsidiarity: Added value of EU action

Variety registration and certification and marketing of PRM and FRM rely on examinations, assessments and inspections performed by NCAs. Their results are valid in all 27 MS and follow the 'one key, several doors' principle. This ensures the quality of EU PRM and FRM while safeguarding open and fair competition on the single market. However, the different interpretation and implementation of the EU rules at national level has caused unequal conditions for operators across MS. This requires a greater harmonisation of the legislation but at the same time MS need flexibility to adapt the production process and the examination of the characteristics of the plants to local agro-ecological conditions and in the case of FRM to environmental and climatic conditions.

The unrestricted marketing of PRM and FRM throughout the EU territory is imperative to address transboundary issues such as the climate and biodiversity crises, the need for sustainable production to ensure food security and sustainable afforestation/reforestation to secure multi-functional forests for future generations. The current geopolitical situation and energy crisis have elevated the importance of securing agricultural and food production. Under the F2F, EU Adaptation and Biodiversity Strategies several commitments were made that necessitate the amendment of the PRM and FRM legislation. Those commitments mirror the demand from society for increased food security, more sustainable food production, locally produced food, diversification of production methods and multi-functional forests (e.g. timber production, biodiversity conservation, leisure activities).

4.Objectives: What is to be achieved?

4.1.General objectives

The general objective of this initiative is to ensure, for all types of users, PRM and FRM of high quality and diversity of choice, adapted to current and future projected climatic conditions that will in turn contribute to food security, protection of biodiversity and restoration of forest ecosystems. The availability and access to varieties and basic material with strengthened sustainability characteristics are essential to improve sustainability by ensuring the stability of yield of agricultural production and of the productivity of forest ecosystems.

·To ensure a level playing field for operators across the EU;

·To support innovation and competitiveness of the EU PRM/FRM industry;

·To contribute to addressing sustainability, biodiversity and climate-related challenges.

4.2.Specific objectives

·To increase clarity and coherence of the legal framework through simplified, clarified and harmonised basic rules on fundamental principles presented in a modern legal form;

·To enable the uptake of new scientific and technical developments (in particular, innovative production processes, BMTs and digital solutions);

·To ensure availability of PRM/FRM suitable for future challenges;

·To support the conservation and sustainable use of plant and forest genetic resources.

·To harmonise the framework for OCs on PRM/FRM;

·To improve coherence of PRM/FRM legislation with the PHL.

4.3.Intervention logic

Figure 2. Intervention logic

5.What are the available policy options?

5.1.What is the baseline from which options are assessed? 

The baseline is a “no policy change” scenario, in which the current EU legislation on PRM and FRM remains in force as it currently stands, while other policy initiatives (SUR and NGTs) will be adopted. As regards PRM, the current VCU requirements provide a basic common framework for the sustainability assessment of new varieties of agricultural plant species. For species not subject to VCU assessment for variety registration (vegetables and fruit plants), the breeding of new varieties depends only on the priorities set by the breeders and the degree to which they respond to market demands. Increased yield, tolerance to pests and abiotic factors and other desirable characteristics are in increasingly high demand by farmers, however present only to a certain extent in the breeding efforts of new varieties 108 . As regards FRM, some elements of sustainability assessment are in place only for the highest categories of FRM. Political priorities set by the EGD Strategies (i.e. F2F, Biodiversity, Forest and Adaptation) and regulatory developments (e.g. the initiative for a new regulation on the sustainable use of plant protection products, SUR) for reduced use of fertilisers and pesticides also provide an incentive for breeders to develop new varieties that are less dependent on such inputs and are, therefore, contributing to sustainability of agri-food systems. The F2F, EU Forest Strategy 109 and SUR 110 recognise the necessity of introducing relevant measures in the PRM/FRM legislation. Breeding of new varieties take on average over 10 years depending on the species, while the timeframe for FRM can be much longer 111 . Over the same timeframe, challenges as climate change are projected to have significant impacts on agriculture and forestry 112 . 

Efforts are made to compensate impacts of climate change by moving from south to north agronomic practices (e.g. introduction or increase of irrigation in areas where it was previously not necessary), varieties and species (e.g. cultivation of sorghum instead of maize to compensate for reduced availability of water). However, these solutions are constrained by the new agro-ecological conditions (e.g. precipitation rates, daylight, soil). In forestry there are longer cycles (several decades) than in agriculture. It is therefore not likely that foresters will change the tree species used in the mid-term period. Foresters could consider using the same tree species but from a different provenance (origin). Moving of varieties and species from south to north is not a sufficient solution in itself as there will not be enough area as soils are not always suitable for agricultural production (e.g. tundra). Targeted breeding efforts for new varieties, new species and selection for FRM are needed to overcome these constraints in order to be able to successfully move varieties and species from south to north, but also for developing new varieties adapted to new conditions in the south.

The time frame assumed for the dynamic baseline is 10 years and assumes that other relevant EU policies (SUR, NGTs and FSFS) would be implemented. Even if other initiatives would be successful in halting/limiting greenhouse gas emissions, the impacts of climate change would persist. Adaptation of new varieties and species and of FRM to those impacts would still be needed. In absence of regulatory changes for steering the breeding of new varieties for characteristics necessary to face those challenges, new varieties and FRM would gradually become unsuitable for the current and future challenges. A recent assessment suggests that current breeding programmes and variety selection practices do not sufficiently prepare for climatic uncertainty and variability 113 . The opportunity to mitigate the impacts of climate change that are already occurring would be lost (e.g. on average EUR 4.8 billion/year of crop losses caused by drought in the EU, 4.9% of canopy cover loss in Germany in 2018-2020 114 ). Similarly, opportunities would be missed to introduce varieties with improved disease resistance that could help reduce the use of pesticides.

The problems resulting from the limitation of activities that can be carried out under official supervision, incoherence and/or duplications between PRM/FRM legislation and PHL, OCR and the Organic Regulation, the use of innovative production processes, BMTs, and digital solutions will remain. They are expected to persist and gradually aggravate, as MS will continue to adopt divergent national practices.

Under the baseline there are no provisions in the EU legislation for the use of innovative production processes, BMTs and digital solutions. For this reason, an effort to resolve these issues by EU guidelines would be impossible without any revision of the EU legislation. The absence of a common EU framework will lead to further divergence of conditions for operators across the Union. In turn, the burdens for NCAs and operators are expected to increase, leading to reduced competitiveness of the EU PRM and FRM sectors. Likewise, the clarification and streamlining of existing administrative procedures cannot be resolved without changing the legislation. That clarification in most cases concerns the streamlining and/or simplification of procedures across crop groups such as the decision-making procedure for regulation/deregulation of species. In Directive 2008/90/EC on fruit plants, the decision to regulate/deregulate species is based on the Comitology procedure while in the Directives on agricultural species the co-decision procedure applies 115 .

Experience gained by temporary experiments has shown that certain aspects of the legislation can be simplified. For example, the extension of the possibility for operators to carry out certification activities for pre-basic and basic seed of agricultural species has been shown to be equally reliable as official certification but with reduced costs for the operators. However, permanent implementation of such changes is not possible under the baseline without a revision of the legislation. The legislative framework will furthermore remain cumbersome for activities linked to the conservation and sustainable use of plant and forest genetic resources. Currently the Common Catalogues contain a small number of conservation varieties 116 and no forest genetic resources 117 . The number of conservation varieties of agricultural plant species and vegetable species added to the Common Catalogues every year is negligible. There is no indication that this trend will change over the next years under the baseline.

Breeding of varieties for organic production and low-input agriculture and of varieties adapted to local agro-ecological conditions will remain under the baseline marginal activities because such varieties are often too heterogeneous to meet the uniformity requirements under DUS examination, while they are not covered by the current derogations for conservation varieties. Provisions on organic heterogeneous material recently introduced by the Organic Regulation offer a partial solution as the production of this type of material is restricted to certified organic production (Annex 5, Section 2.5).

5.2.Description of the policy options

The options were designed based on the PRM study, the supporting studies and by reassessing elements of the 2013 impact assessment. The options constitute the best options to address the problems, albeit to a different extent. Alternative measures have been reviewed but discarded at an early stage due to lack of stakeholder support (Section 5.3). There was no reason to design options that deregulate the sector as no stakeholder supported it.

The options share a common set of measures which are the same for all options (Figure 3). Some of those common measures are only for PRM and others are only for FRM. There is overall support in the PRM/FRM sector for maintaining the current regulatory system and its two basic pillars of registration of varieties/basic material and PRM/FRM certification. The policy options have therefore been designed from a spectrum of highest flexibility for MS and operators (option 1) to one of highest harmonisation with little to no room for individual flexibility (option 3) with option 2 presenting a balanced approach. The current presentation of the 3 options graded as described in terms of flexibility/harmonisation seemed to be the most coherent approach, especially given the number of issues to be addressed and taking into account their actual feasibility in relation to the interaction with various stakeholders. The design of the policy options considered the priority of the F2F to address sustainability challenges. Hence, under all options the sustainability requirements for the approval of new varieties are strengthened.

The flexibility which the MS need relates in the first place to their national agro-ecological conditions. The MS will continue to be exempted from the scope of the legislation for certain crops (e.g. vine not growing in Nordic MS). Variety testing including relevant variety characteristics needs to be adapted to the climatic conditions (e.g. cold tolerance in the North and drought tolerance in the South) or the certification requirement to combat noxious weeds (Avena fatua in certain MS).

Under all options, a transitional period will be foreseen to allow the reorientation of breeding efforts towards varieties with improved sustainability characteristics. The defining elements of the options for both PRM and FRM are:

·Strengthened sustainability requirements;

·Conservation and sustainable use of plant and forest genetic resources;

·Official controls;

·Enable uptake of BMTs, innovative production processes and digital solutions.

Figure 3. Design of options

5.2.1.Measures common to all options

Apart from the no policy change scenario all 3 options share a core of several common measures aimed at simplifying administrative procedures and a more flexible decision-making process, as this is a problem which affects the efficiency of processes.

For PRM and FRM legislation:

·All professional operators to be registered in a single register under the PHL 118 .

·All certification tasks are permitted under official supervision except the issuing of the official label (PRM) and the Master certificate (FRM).

·To avoid overlaps with PHL, PRM/FRM legislation will directly refer to PHL for the list of RNPQs and specific measures. Compliance with requirements for QPs and RNQPs will remain a prerequisite for the certification of PRM/FRM.

For PRM legislation:

·Simplification of existing administrative procedures:

-Decisions for addition of new species in, or removal of species from, the scope of the PRM legislation and Decisions on the equivalence to EU rules for third countries will be taken by means of tertiary legislation 119 .

-The transfer/notification of new varieties from national to the EU Plant Variety Portal will be managed by the MS without the need for a Commission Decision 120 .

-Allow MS to decide themselves on permitting temporarily the marketing of seed that does not satisfy the requirements in respect of minimum germination, if germination is not lower than 15 % than the required germination rate 121 .

·The requirements for the registration of organic varieties suitable for organic production (Annex 5, Section 2.5) will be adapted to the specific needs of organic production, by providing the possibility to deviate from certain DUS requirements as regards uniformity.

·The rules for conservation varieties are lighter and extended to cover new locally adapted varieties (Annex 5, Section 2.6.).

·The scope for heterogeneous material is broadened beyond organic production (Annex 5, Section 2.5.).

For FRM legislation:

·The decisions on the equivalence to EU rules for third countries will be taken by means of tertiary legislation.

·The existing empowerment to define the information to be made available to users/buyers of FRM is extended to explicitly cover suitability of FRM for climatic and ecological conditions.

5.2.2.Option 1 - Highest flexibility

Option 1 gives the highest level of flexibility to MS in relation to enabling the uptake of innovative production processes, BMTs and digital solutions, the sustainability considerations in the assessment of new varieties/FRM, OCs and the activities of seed conservation networks, marketing to amateur gardeners and exchange in kind of PRM between farmers.

Common elements for PRM and FRM:

·The uptake of innovative production processes, BMTs and digital solutions will be enabled by introducing in the PRM/FRM legal framework provisions allowing their use. Under option 1, these new possibilities will be implemented by the adoption of guidelines based on existing international standards but adjusted to the specificities of the EU legislation (Annex 5, Section 8).

-The use of BMTs will be clarified by allowing the use in variety registration process to speed up DUS testing and as a supplementary test in PRM/FRM certification and marketing controls, in those cases where the field inspection and control plot testing are inconclusive about the identity of the variety under investigation.

-The PRM/FRM legal framework will allow the certification of PRM/FRM produced by innovative production processes such as in vitro propagation of clones, true potato seeds and seed for the production of PRM of fruit plants and vines.

-The PRM/FRM legal framework will allow the use of digital technologies (e.g. digital certificates and digital labels) and digitalisation of the PRM/FRM certification system.

·Option 1 lays down minimum requirements for PRM/FRM OCs. Risk based OCs aligned with the OCR provisions will be introduced and MS will be required to prepare a multi-annual control plan, aligned with the principles of the OCR. However, all rules on OCs remain in the PRM/FRM legislation. More specifically, requirements for OCs on production, marketing and imports of PRM/FRM are introduced in the PRM/FRM legislation (e.g. delegation of OC tasks and multi-annual national control plans) but without linking these to the OCR.

For PRM legislation only:

·Sustainability considerations in the examination of new varieties are strengthened.

-The current VCU examination for agricultural plant species and vine is extended to include characteristics that contribute to sustainable production in order to better steer breeding efforts in this direction. The new examination will be called ‘Value for sustainable cultivation and use’ (‘VSCU’). For organic varieties suitable for organic production, it will be required that the VSCU examination is carried out under conditions adapted to the specific needs of organic production. 

-A new voluntary approach is adopted for the assessment of new varieties of other crop groups (i.e. fruit plants and vegetables) for characteristics that contribute to sustainable production. Applicants may submit along with their application for the registration of a new variety the results of trials that they have carried out themselves. A link to this information is published in the Common Catalogues 122 . Submission of any information is not linked to the acceptance of the varieties.

·The activities of seed conservation networks, marketing to amateur gardeners and exchange in kind of seed between farmers are exempted from the scope of the legislation to stimulate the increase in genetic diversity of PRM.

For FRM legislation only:

·“Forestry”/“non-forestry” purposes are defined but the scope of the legislation remains limited to the production of FRM for “forestry” purposes. The FRM legislation only covers the production for “forestry purposes” to ensure the availability of high-quality FRM for afforestation/reforestation.

·The sustainability requirements are extended to cover lower FRM categories (source-identified and selected material) and guidelines are adopted on sustainability requirements for all FRM categories.

·Empowerment to authorise MS to use FRM not fulfilling all requirements when there are temporary difficulties in supply is maintained and supplemented by adoption of guidelines on contingency planning in the MS to better prepare for major shortages in supply of FRM caused by extreme weather, disasters or any other event.

·Adoption of guidelines for the registration of basic material for the purposes of conservation and sustainable use of forest genetic resources.

5.2.3.Option 2 - Balancing flexibility and harmonisation

Option 2 balances the need for flexibility with a higher degree of harmonisation to overcome the problems stemming from differences in interpretation.

Common elements for PRM and FRM:

·The uptake of innovative production processes, BMTs and digital solutions will be enabled by introducing in the PRM/FRM legal framework provisions allowing their use. Under option 2, these new possibilities will be implemented by the introduction of basic principles for the use of innovative production processes, BMTs and digital solutions in the legislation (Annex 5, Section 8).

-The use of BMTs will be clarified by allowing the use in variety registration process to speed up DUS testing and as a supplementary test in PRM/FRM certification and marketing controls, in those cases where the field inspection and control plot testing are inconclusive about the identity of the variety under investigation.

-The PRM/FRM legal framework will allow the certification of PRM/FRM produced by innovative production processes such as in vitro propagation of clones, true potato seeds and seed for the production of PRM of fruit plants and vines.

-The PRM/FRM legal framework will contain rules on the use of digital technologies (e.g. digital certificates and digital labels) and foresee the possibility for digitalisation of the PRM/FRM certification system.

·Risk based OCs aligned with the OCR provisions will be introduced and MS will be required to prepare a multi-annual control plan. The OCs for PRM/FRM will be brought under the scope of the OCR, but with simplified import controls at appropriate places within the EU to ensure a more targeted and efficient enforcement of existing rules 123 . Specific rules for production, marketing and imports will be established through tertiary legislation under the OCR. OCR will apply to all OCs in the sector. Article 44(1) to Regulation (EU) 2017/625 will apply for PRM/FRM import controls, which will be performed at appropriate places within the EU 124 . The operator responsible for the PRM/FRM consignment must provide the relevant information about that consignment (e.g. quantity of PRM/FRM, type of material, category of material,…). OCs in relation to PRM/FRM certification remain in the sectoral PRM/FRM legislation.

For PRM legislation only:

·Sustainability considerations in the examination of new varieties are strengthened.

The current VCU examination for agricultural plant species and vine is extended to include additional characteristics that contribute to sustainable production in order to better steer breeding efforts in this direction. The new examination will be called Value for sustainable cultivation and use (VSCU). It will also be extended to new varieties of the other crop groups (fruit plants and vegetables).

-MS will have the flexibility to implement VSCU according to their agro-ecological conditions.

-It will be possible for operators to conduct the VSCU examination under official supervision.

-MS will be able to collaborate and accept results from MS with similar agro-ecological conditions, and/or create shared testing networks.

-An empowerment will be created to determine the minimum requirements for carrying out the VSCU examination and the accepted methodologies for assessing the individual VSCU characteristics.

-For organic varieties suitable for organic production, it will be required that the VSCU examination is carried out under conditions adapted to the specific needs of organic production.

·The activities of seed conservation networks, marketing to amateur gardeners and exchange in kind of seed between farmers are subject to lighter rules to stimulate the increase in genetic diversity of PRM but also retain traceability and guarantee a minimum level of PRM quality.

For FRM legislation only:

·The “forestry” and “non-forestry” purposes are defined and the current scope of legislation is extended to increase the FRM quality beyond afforestation/reforestation uses and include the production of FRM for specific “non-forestry” purposes.

·The sustainability requirements are extended to cover lower FRM categories (source-identified and selected material). General principles on the sustainability requirements are introduced in the legislation for all FRM categories, with flexibility for MS to implement according to their environmental conditions.

·The existing empowerment to authorise MS to use FRM not fulfilling all requirements when there are temporary difficulties in supply is supplemented by the introduction in the legislation of a general requirement for contingency planning by the MS to better prepare for major shortages in the supply of FRM caused by extreme weather, disasters or any other event.

·A derogation is introduced in the legislation for the registration of basic material for the purposes of conservation and sustainable use of forest genetic resources.

5.2.4.Option 3 - Highest harmonisation

Option 3 would entail the highest harmonisation in order to minimise differences in the implementation of the legislation.

Common elements for PRM and FRM:

·The uptake of innovative production processes, BMTs and digital solutions will be enabled by introducing in the PRM/FRM legal framework provisions allowing their use. Under option 3, these new possibilities will be implemented by the introduction of detailed and binding rules for the use of innovative production processes, BMTs and digital solutions in the legislation (Annex 5, Section 8).

-The use of BMTs will be clarified by allowing the use in variety registration process to speed up DUS testing and as a supplementary test in PRM/FRM certification and marketing controls, in those cases where the field inspection and control plot testing are inconclusive about the identity of the variety under investigation.

-The PRM/FRM legal framework will allow the certification of PRM/FRM produced by innovative production processes such as in vitro propagation of clones, true potato seeds and seed for the production of PRM of fruit plants and vines.

-The PRM/FRM legal framework will contain detailed rules on the use of digital technologies (e.g. digital certificates and digital labels) and the conditions for digitalisation of the PRM/FRM certification system.

·Risk based OCs aligned with the OCR provisions will be introduced and MS will be required to prepare a multi-annual control plan. The OCs for PRM/FRM will be brought under the scope of the OCR, with stricter import controls at border control posts requiring special import documentation pursuant to Article 47(1) to Regulation (EU) 2017/625 125 to strengthen and fully harmonise enforcement. Specific rules for production, marketing and imports will be established through tertiary legislation under the OCR. OCR will apply to all OCs in the sector. For each consignment of PRM/FRM subject to OCs at border control posts, the operator responsible for the consignment must complete the relevant part of the Common Health Entry Document (CHED), providing the information necessary for the immediate and complete identification of the consignment and its destination. Rules on fees will be laid down by MS pursuant to Article 79 of the OCR.

For PRM legislation only:

·Sustainability considerations in the examination of new varieties are strengthened.

The current VCU examination for agricultural plant species and vine is extended to include additional characteristics that contribute to sustainable production in order to better steer breeding efforts in this direction. The new examination will be called Value for sustainable cultivation and use (VSCU). It will also apply to new varieties of the other crop groups (fruit plants and vegetables).

In contrast to option 2:

-Implementation of the VSCU will be harmonised between the MS.

-Detailed rules on accepted methodologies for assessing the individual VSCU characteristics will be introduced and harmonised across MS. The VSCU examination would still be conducted in different locations that reflect the different agro-ecological conditions in each MS. However, this could result in a MS having to test for tolerance/resistance to plant pests that do not occur in their territory. This on the one hand would lead to the highest assurance regarding the variety characteristics but would on the other hand also lead to unnecessary costs.

As under option 2:

-It will be possible for operators to conduct the VSCU examination under official supervision.

-MS will be able to collaborate and accept results from MS with similar agro-ecological conditions, and/or create shared testing networks.

-For organic varieties suitable for organic production, it will be required that the VSCU examination is carried out under conditions adapted to the specific needs of organic production.

·The activities of seed conservation networks, marketing to amateur gardeners and exchange in kind of seed between farmers are subject to the general requirements of the legislation (See Annex 5, Sections 2.3. and 2.4.) to achieve homogenous rules for all market segments.

For FRM legislation only:

·The “forestry” and “non-forestry” purposes are defined and the current scope of legislation is extended to increase the FRM quality beyond afforestation/reforestation uses and include the production of FRM for specific “non-forestry” purposes.

·The sustainability requirements are extended to cover lower FRM categories (source-identified and selected material). Detailed and harmonised rules on sustainability requirements for all FRM categories are introduced in the legislation.

·The existing empowerment to authorise MS to use FRM not fulfilling all requirements when there are temporary difficulties in supply is supplemented by the introduction in the legislation of common rules for contingency planning by the MS to better prepare for major shortages in supply of FRM caused by extreme weather, disasters or any other event. A derogation is introduced in the legislation for the registration of basic material for the purposes of conservation and sustainable use of forest genetic resources.

Table 2. Overview of policy options

5.2.5.Stakeholders’ views on policy options

Stakeholder consultations showed that there is overall support in the PRM sector for maintaining the current regulatory system and its two basic pillars of variety registration (based on DUS and where applicable VCU) and PRM certification. NCAs and stakeholders, in particular the seed industry, highlighted that the current system works well and that the EU PRM industry receives international recognition for the high quality of the certified seed. Likewise, in the FRM sector there is overall support for keeping the existing regulatory system of registration of basic material and FRM certification. The majority of NCAs, a business association and an EU trade union called for maintaining the current alignment of the EU FRM legislation with the Rules and Regulations of the OECD Forest Seed and Planting Scheme. All NCAs and stakeholders emphasised that the FRM legislation should remain separate from the PRM legislation. They argued that as forest trees often have a life span of over 100 years, some rules that apply to PRM might neither be needed for FRM, nor be reasonable to implement due to the difficulty of ensuring consistency over such long periods of time.

As regards PRM, the majority of NCAs and stakeholders is in favour of option 2 with the exception of the extension of the assessment of sustainability characteristics to all crop groups including fruit plants and vegetables. A few NCAs and stakeholders express a preference for option 3. A number of stakeholder groups is in favour of option 1 as regards e.g. the exemption from the scope of certain activities. As regards FRM, most NCAs and regional forest authorities, a regional union of forest nurseries and an NGO emphasised that MS should have the flexibility to decide which FRM is best adapted to their regional climatic and ecological conditions. For this reason, several stakeholders expressed preference for maintaining a Directive (option 1). Some business associations and a trade union expressed preference for a full harmonisation of the legislation.

NCAs and stakeholders strongly agree with the set of common measures proposed (Section 5.2.1.), with the exception of permitting certification tasks to be carried out by operators under official supervision instead of being carried out directly by the NCAs. Certain stakeholders are concerned that this will be disadvantageous for SMEs that do not have sufficient resources to carry out certification tasks under official supervision. The new legislation will however oblige MS to maintain official certification in order to respond to the needs of SMEs. No other alternative solutions that would allow simplification of administrative procedures have been identified.

One main objective of the revision is to extend the assessment of characteristics contributing to sustainable agri-food production. With the exception respondents from business associations, a majority of NCAs and stakeholders agreed with the need for a set of general sustainability criteria that MS can apply taking into account their agro-ecological conditions. Several stakeholders highlighted the difficulties of harmonising VCU across MS (option 3), the need for, and implications of, new sustainability criteria as well as suggested approaches for sustainability criteria.

The seed sector’s position as regards agricultural plant species is that the sustainability assessment of new varieties can be addressed with slight modifications of the current VCU, while available information should be used before new obligations and costs are introduced for species other than agricultural plant species . The sector argues that such information is already available as other legislation and targets (organic production, reduction of pesticides and fertilisers), climate change conditions and market demand have been steering breeding towards the examination of more sustainable characteristics.

Some stakeholders call to abolish the current VCU requirement (and not to introduce a sustainability assessment) for:

·seed potatoes, using arguments similar to the vegetable sector mentioned above;

·crops for which there are very few applications for registering new varieties and where the current VCU makes it even more difficult for those varieties to reach the market. Moreover, they state that NCAs are not in a position to organise the relevant examinations every year.

The organic sector calls for a specific VCU examination adapted to organic varieties suitable for organic production. Moreover, they are of the opinion that all new plant varieties should be examined under organic and/or low input conditions. This opinion is shared by some seed saver organisations.

Several NGOs and small farmers’ organisations overall reject the principle of VCU assessment of new varieties. In their view, this examination guarantees the adaptation of new varieties to certain local and regional agro-ecological conditions but not the adaptability of the varieties to different agro-ecological conditions. In their view, the adaptability of varieties is key for the resilience of agriculture to climate change. This approach is dealt with in the options by establishing the conditions for heterogeneous material, organic varieties suitable for organic conditions and the exchange in kind of seed between farmers.

Stakeholders’ views differ regarding the measures proposed under the options to facilitate the conservation and sustainable use of plant genetic resources. NCAs and most stakeholders agree with the common measure under all options to adapt the DUS and VCU requirements for the examination of organic varieties to the specific needs of organic production. The seed sector on the contrary states that organic varieties should comply with the current DUS requirements. NCAs and stakeholders agree with lighter rules for conservation varieties and new locally adapted varieties, but the seed sector would like to maintain the current restriction related to the local marketing of those varieties in their region of origin. Stakeholders’ views are mixed as regards the activities of seed conservation networks and exchange in kind of seed between farmers. NGOs and certain academia favour an exemption of these activities from the scope of the legislation. They refer to UNDROP and the rights of peasants to freely exchange, multiply and sell seed In relation to exchange in kind of seed, the seed sector is concerned that a total exemption could be misused by farmers and calls for a quantitative restriction. As regards the activities of seed conservation networks, the seed sector is of the opinion that PRM marketed for the purposes of conserving plant genetic resources should be subject to the same rules as organic heterogeneous material. All NCAs and stakeholders agree with the broadening of the scope of heterogeneous material beyond organic production.

The majority of NCAs and stakeholders fear an increase in administrative burden upon the inclusion of OCs into the scope of the OCR (options 2 and 3). Several NCAs and businesses recognise the divergent conditions for operators and marketed PRM and FRM across MS. They prefer for OCs to be included into the scope of the OCR, albeit with simplified import controls (option 2). They see the advantages of using common IT applications for OCs such as IMSOC. Only a few stakeholders are in favour of a full inclusion into the scope of the OCR with stricter import controls at border control posts (option 3).

Most NCAs and stakeholders including SMEs want to have the possibility of using BMTs and digital solutions. Some SMEs highlight a lack of resources for being able to invest in BMTs and digitalisation. As regards the use of BMTs some stakeholders agree if their use remains optional in addition to the observation of the phenotypic characteristics. Others ask for the use of BMTs as self-standing tools for the characterisation of new plant varieties. Most NCAs call for allowing the use of innovative production processes such as the production of hybrid seed in the fruit plant sector and the use of in vitro propagation methods including somatic embryogenesis to produce PRM and FRM.

As regards FRM, stakeholders’ views were mixed regarding the extension of the scope of the legislation to include certain specific non-forestry purposes. About 50% of stakeholders from across stakeholder categories believed that the definition of FRM should be clarified in relation to the purposes for which it is produced. Most stakeholders felt that FRM production should cover wood production, afforestation, reforestation, and conservation and sustainable use of forest genetic resources. In contrast, 52% believed that tree planting in urban and peri-urban areas and plantations for protection purposes (shelter belts against the wind) should not be covered.

Most stakeholders were favourable towards the assessment of sustainability characteristics with over half of the operators stating that they already assess, either on a voluntary or mandatory basis, basic material and FRM for characteristics that contribute to sustainable afforestation and reforestation. In relation to difficulties in supply, about half of stakeholders from across stakeholder groups recognise the need for more long-term planning across the FRM supply chain. They identified potential risks in the form of using lower quality FRM, economic losses and the increasing need of import. They expect that the demand for FRM will likely increase in the next 20 years further underlying the importance of security of supply and climatic suitability of FRM. This justifies the proposed measures on national contingency plans and better informing FRM users/buyers about the FRM characteristics.

Stakeholders active in the conservation and sustainable use of forest genetic resources declared that the current FRM legislation cannot address the needs of this type of FRM. They agree with the introduction of a derogation from the requirements for the registration of basic material (option 2).

5.3.Options discarded at an early stage and alternative measures

No full policy options were discarded at an early stage. Some specific measures however have been considered and discarded as unfeasible. Total deregulation is not supported by any stakeholder. To a lesser or greater extent all agree that the current system is functional and relevant. Abolishing the legislation would lead to different regulatory approaches at MS level with the possibility to threaten the principle of the internal market and leading to a lack of transparency of the EU market.

Different fees may cause different conditions for operators in different MS. An effort was made to harmonise fees for variety registration and PRM/FRM certification was proposed in the 2013 PRM proposal. It was based on the principle of cost recovery and the exemption of microenterprises but did not receive any support. The overall opinion was that the PRM/FRM legislation should not cover fees, even by the principle of cost recovery, because the cost structures differ between MS, the level of salaries being the main difference.

In relation to FRM, the creation of a voluntary coordination group for collaborative production, pooling and exchange of FRM was considered as an alternative measure to better address potential major shortages in the supply of FRM caused by extreme weather, disasters or any other event. Stakeholder consultations revealed that the situation differs between MS with some being largely self-sufficient and not yet having experienced any events that have led to shortages. A number of respondents from across stakeholder categories informed that difficulties in FRM supply may partly be due to a lack of planning and communication across the supply chain. It was therefore decided to require that MS prepare national contingency plans.

Likewise, the creation of a voluntary inventory was considered an alternative measure for providing information to FRM users/buyers about the suitability of FRM for climatic and ecological conditions. Most respondents from across stakeholder categories were in favour of such a measure, but opinions were evenly split on whether this voluntary inventory should be organised at EU or national level. As most stakeholders fear that an EU inventory would increase the administrative burden for NCAs and operators, it was opted to make such information available through websites, planters’ guides and other appropriate means.

6.What are the impacts of the policy options?

Due to the complex nature of the options, the assessment of the impacts will be guided by the defining elements of the options 126 and a further distinction between PRM and FRM before assessing the total combined impact of each policy option. The assessment is mainly based on the data which was collected for the PRM study 127 and through two external supporting studies 128 . This was supplemented by feedback and consultation with the stakeholders as well as further in-house calculations. While the outmost effort was undertaken to collect as much as possible quantitative data e.g. by targeted questionnaires, it must be noted that a quantitative assessment of the potential economic, environmental and social impacts of each of the retained options was not always possible. This section summarises the main impacts. Details on the methodology, the limitations of the available data as well as a detailed assessment of all elements and their economic impacts are available in Section 8 of Annex 4.

6.1.Economic impacts

6.1.1.Common measures to policy options 1-3

For the common measures of policy options 1-3, the simplification of existing administrative procedures will result in a reduction of administrative burdens for NCAs and operators (same impacts for options 1-3):

·Professional operators will be required to be registered in a single register under the PHL. This measure will not result in new costs as currently professional operators are registered either under the marketing Directives, or PHL, or both. Over 20 000 duplicate registrations will be avoided and over EUR 800 000 annual savings in registration costs for operators supplying PRM of fruit plants. Over 4 000 duplicate registrations will be avoided and there will be over EUR 237 000 annual savings in registration costs for operators supplying FRM.

·Electronic notification by MS to the EU Plant Variety Portal of on average 4 000 new varieties per year will avoid the handling of those notifications (Commission Decision and publication in the Official Journal) and speed up access of those varieties to the EU market by 1 to 4 months 129 . In turn, faster market access will have a positive impact on the competitiveness of the EU PRM sector.

·Allowing MS to authorise the temporary marketing of seed that does not satisfy the requirements as regards the minimum germination rate, will avoid the handling by on average 30 notifications per year. The waiting time for operators to use this seed will be reduced by at least 15 days. Such notifications concern 50 000 tonnes of seed or 0.01% of the quantity of seed certified annually.

·Extending the possibilities for operators to carry out activities under official supervision (PRM and FRM) is not expected to have significant impacts on enforcement costs for NCAs 130  (Annex 4, Section 3). There will be no effect on the administrative burdens for operators as regards certification and variety registration, as the administrative steps remain the same. The measure is already applied by 10 MS under temporary experiments since 2012 131 . A permanent implementation would bring potential annual cost savings for operators of around EUR 1.7 million across the EU (Annex 4, Section 3).

·The possibility to deviate from certain DUS requirements as regards uniformity will be provided for the DUS examination of organic varieties suitable for organic production. The breeding period of varieties compliant with reduced uniformity requirements can be in average 2 years shorter than for varieties fully meeting the uniformity requirements. Operators making use of this possibility will therefore access the market faster, with reduced breeding costs and with varieties that up to now were restricted from the market since it was not possible to register varieties not meeting the DUS requirements. A few dozen operators across EU are likely to use this option. The number of varieties registered under these rules could be in average 100 annually. Assuming EUR 50 000 savings in breeding costs per variety, concerned operators may see savings of EUR 5 million annually.

·The scope for heterogeneous material is broadened beyond organic production. This measure creates a new market segment. Potentially a large number of operators may benefit but the quantities of PRM concerned are expected to be very limited and of insignificant market value 132 .

·The rules for conservation varieties are lighter and extended to cover new locally adapted varieties. This measure creates a new market segment. Operators would benefit from lighter procedures for access to market (no DUS/VSCU requirements for variety registration and no certification of PRM). The number of operators concerned could be in the range of several hundreds. The number of varieties marketed under these rules could be a few hundred annually. However, the quantities of PRM concerned are expected to remain limited and below 2% of the market 133 . The potential market value could be up to EUR 13.3 billion /year * 2%= EUR 266 million/year.

6.1.2.Strengthened sustainability requirements

This section examines the potential additional costs and benefits for operators, NCAs and users of PRM/FRM due to the inclusion of requirements for assessment of sustainability characteristics in the registration of new plant varieties (PRM) and basic material (FRM).

Operators

For the PRM sector, the envisaged measures for strengthening sustainability requirements in VCU for agricultural plant species and vine and for introducing sustainability requirements in the examination of new varieties of other crops (vegetables and fruit plants) will result in additional testing costs for operators due to increased fees paid to NCAs for the examination of new varieties (Table 3). The additional possibilities under options 2 and 3 for conducting the VSCU examination under official supervision and for collaboration between NCAs on these will mitigate the additional testing costs for operators. It is assumed, on the basis of a trend observed for certification under official supervision, that 44% of all VSCU examinations will be carried out under official supervision. Costs for operators are assumed to be 12% less for carrying out activities under official supervision in comparison to the costs they have under official examinations 134 . The savings will partly compensate the expected increase in the testing costs due to strengthened sustainability requirements (Table 3).

Table 3. Cost increases for operators for registration of new varieties due to the assessment of sustainability characteristics (for detailed calculations see Annex 4 Section 4).

It is important to note that these testing costs including strengthened sustainability considerations are negligible as they represent only about 1% of the total cost for developing a new plant variety 135 . The increased requirements for characteristics contributing to sustainable production could however lead to a reduction of the number of varieties being accepted. For agricultural and vegetable species up to about 4 000 varieties less could be made available in the EU market over a period of 10 years because of the strengthened sustainability requirements (Table 4), but this system will be necessary to avoid that varieties without improved characteristics contributing to sustainable production will enter the market. The position of SMEs with a small number of applications for new varieties per year could nevertheless be negatively affected in the short term, with the need to re-orient investments in varieties with improved sustainability characteristics 136 .

Table 4. Average number of new plant varieties registered per year. The baseline is the average number of new plant varieties registered annually over the period 2012-2021 as retrieved from the Common Catalogues. Details on the assumptions on which the calculations are based can be found in Annex 4 Section 2.

In the FRM sector, the extension of the assessment of sustainability characteristics is expected to lead to a negligible increase of costs for operators under all options 1-3 (Table 5) 137 . New basic material is on average registered every 5 years and the budget spent by operators on the registration of basic material is estimated to be less than 1% of their total revenue 138 .

Table 5. Estimated annual cost increase in EU27 for the registration of new basic material due to the extension of assessment of sustainability characteristics of basic material to the lower FRM categories, based on an average of 44 applications per year. Detailed calculations are available in Annex 4, Section 6.

Under option 1 non-forestry purposes will be defined in the legislation, however these would not be included in the scope of the legislation. It would be up to MS which non-forestry purposes would be included, thus increasing or decreasing the FRM covered by the scope of the legislation with a potential increase of testing costs in some MS 139 . Under options 2 and 3 the extension of the scope of FRM legislation to include the production of FRM for specific non-forestry purposes (common measure), will result in an increase in testing costs (for certification) for operators. This increase would be more pronounced in those MS where the non-forestry purposes to be added in the scope of the FRM legislation are currently not within the scope of the current national legislation 140 . While there is insufficient data and evidence to allow an estimation, it is expected that the impacts on all options will be limited 141 .

The measures contributing to sustainable production will not have an impact on administrative burden for operators, as the administrative requirements for the registration of varieties under the PRM legislation and for registration of basic material under the FRM legislation remain the same under all options in relation to the baseline.

NCAs

The measures will result in additional enforcement costs for the NCAs. In options 1-3 due to the introduction of strengthened sustainability characteristics there will be additional costs for carrying out the examination of new varieties  For agricultural species and vine, there will be no need for additional testing stations for VSCU examinations. It will only be necessary to increase the number of characteristics assessed during the VSCU examination in comparison to the current VCU examination 142 . For new varieties of fruit plants and vegetables, under options 2 and 3, NCAs will have to increase up to 50% their capacity in areas and staff, including the need for additional testing stations. The total annual cost for the NCAs would be in the range of EUR 43 to 98 million in options 2 and 3 depending on the percentage of operators that will opt for official supervision. The cost for NCAs under option 1 will be insignificant because it does not require an increase in the capacity of the existing VCU testing stations (Annex 4, Section 5).

In the FRM sector, the extension of the assessment of sustainability characteristics is expected to lead to higher enforcement costs for NCAs. These will however be negligible for options 1-3 because the measure concerns on average only 44 applications per year in EU27 for the registration of basic material.

The extension of the scope of the FRM legislation to cover non-forestry purposes (not included under option 1, but under options 2 and 3) may result in some increase of costs for NCAs (up to 10%-increase in number of applications for certification of FRM 143 ).

The requirement for MS to prepare national contingency plans aims to ensure the availability of FRM in case of major losses due to extreme weather or disasters. MS will have to set up such plan once and update it as appropriate in view of evolving conditions. The resulting costs are expected to be highest under option 3, whereby there will be common requirements on contingency planning for all MS, therefore risking that NCAs will also have to address issues that are not relevant for their MS. The additional costs would be lowest under option 1, as it will depend on the MS decision to prepare a contingency plan (voluntary approach). The costs in all options are however not considered significant as the MS already take similar measures 144 .

Users of PRM and FRM

The increased costs for operators (breeders) caused by extension of the sustainability requirements in variety registration (leading to less varieties reaching the market) is expected to result in increased prices of PRM for their users (mainly farmers). This is assumed to result in an additional increase of the prices of PRM by 1% for option 1, 3% for option 2 and 5% for option 3. Assuming other factors influencing the costs of inputs do not change, these additional costs would correspond to an increase of overall costs of inputs for farmers 145 below 0.3% every year in all options, but would gradually reduce over the years as breeding programmes would adjust to the new requirements. Therefore, cascading impacts on the competitiveness of farmers and food prices due to the above-mentioned increases in price of PRM are estimated to be marginal. Furthermore, the resulting varieties with improved characteristics should result in a more stable agricultural output under fluctuating conditions and thus contribute to food security and the competitiveness of farmers. The avoided losses of production would compensate for the increased costs of PRM, with option 2 resulting in a net benefit for farmers ranging between EUR 221 million and 2.1 billion annually, option 1 resulting in a net benefit for farmers ranging between EUR 177 and 1 110 million annually and option 3 resulting likely in benefits under an “optimistic” scenario (EUR 1 198 million annually) and in negative balance (EUR -201 million annually) under a more “conservative” scenario (Table 6 and Annex 4, Section 5). 

Table 6. Costs and benefits for farmers due to strengthened sustainability requirements for the acceptance of new varieties of PRM. Detailed calculations are presented in Annex 4 Section 5.

As the extension of the assessment of sustainability characteristics and the extension of the scope of FRM legislation to include the production of FRM for specific non-forestry purposes is expected to lead to a marginal increase of costs for operators and NCAs in the FRM sector, the impacts on FRM users in terms of price will be negligible. FRM may however experience reduced economic losses by using more suitable FRM, but these benefits cannot be quantified 146 . 

6.1.3.Official controls

Currently there are significant differences between MS as regards the total number and type of OCs carried out 147 . The impact of the harmonisation of OCs will differ between MS depending on their current implementation of OCs. 

Operators

Under options 1 and 2, the harmonisation of the current requirements 148  will not introduce new obligations for operators.

Under options 1 to 3, passing from a combination of random checks and risk-based controls to risk-based controls will allow OCs to be carried out in a more focussed and efficient way. This will be a fairer system in comparison to the baseline, because operators will be subject to OCs depending on their risk profile. As a result, individual operators could either be subject to a lower or higher number of OCs in comparison to the baseline situation, especially when currently OCs are carried out only randomly. Consequently, the overall impact on operators will be neutral.

Under option 3, operators that are importing PRM/FRM into the Union will in addition be required to submit special import documentation and be subject to OCs at border control posts. NCAs will also have increased costs under option 3 for carrying out these OCs, which most likely will be transferred to operators in the form of fees. Therefore, those operators who import PRM/FRM into the Union will face increased administrative burden and costs (fees). These cannot be calculated as there is no information available on the number of operators and transactions concerned. The overall impact under option 3 on operators is considered as moderate negative as not all operators are concerned by the OCs on imports.

NCAs

Depending on the baseline situation per MS, under options 1 to 3 the harmonisation of the requirements for OCs may lead to increased enforcement costs and administrative burden for NCAs. Such costs will be due to the obligations to draft multi-annual control plans and report annually on OCs. There can also be one-off costs linked to potential need for reallocation of resources in order to adjust to the new requirements for risk-based OCs. NCAs may also need to increase or decrease the frequencies of OCs. These impacts overall are considered to be neutral for the NCAs in total.

Option 3 however entails additional costs for the NCAs in comparison to options 1 and 2 because under option 3 OCs on imports will be carried out at border control posts. This requirement would mean that NCAs would have to equip the border control posts with additional staff to carry out the sampling of imported PRM/FRM. There are about 500 border control posts across the EU designated for phytosanitary controls under the PHL. Assuming that these would also be designated for PRM/FRM, they would need to be equipped by staff to carry out sampling of imported PRM/FRM. With 1 person in average by border control post at EUR 30 000 for salary, the total annual cost under option 3 for NCAs amounts to EUR 15 million (not occurring under options 1 and 2).

As regards benefits, under options 1 to 3, the introduction of the risk-based approach will lead to better focus the OC activities of the NCAs on where most needed, therefore there will be overall efficiency gains. Moreover, options 2 and 3 will provide additional efficiency gains in comparison to option 1 due to the inclusion the OCs on PRM/FRM in the scope of the OCR. This will allow the use of common IT applications for reporting on OC 149 and for exchanging on fraud matters 150 , as well as opportunities for training (Better Training for Safer Food programme). It will also allow to align the OCs on PRM/FRM with those under other legislative frameworks already within the scope of the OCR which might be applicable also to PRM/FRM, as the case may be (PHL, Organic Regulation and GMOs) 151 . Such efficiency gains are not possible under option 1.

Finally, measures aiming to increase the coherence between the PRM/FRM legislation and the PHL is expected to lead to a reduction of administrative burden for operators and enforcement costs for NCAs to carry out OCs (Annex 5, Section 7) depending on how the MS distribute the competences for PRM/FRM and PHL 152 .

6.1.4.Conservation and sustainable use of plant and forest genetic resources

To contribute to biodiversity and increase the genetic diversity of PRM and FRM, there will be adapted rules for activities of seed conservation networks, exchange in kind of seed and marketing to amateur gardeners in the PRM sector and for the registration of basic material in the FRM sector.

Operators and NCAs

There will be a reduction of administrative burdens under options 1 and 2 for operators involved in seed conservation networks, marketing to amateur gardeners and exchange in kind of seed between farmers due to the exemption from the scope of the legislation, but given the limited volume of seed involved 153 , the absolute magnitude of such reduction in relation to the whole seed sector is not significant. Under option 2 lighter rules still present a reduced administrative burden in comparison to the baseline. Those rules ensure a minimum level of quality and traceability which would in particular be important for marketing to amateur gardeners. They would allow for the documentation and characterisation of plant genetic resources, thus maximising their contribution to more resilient agri-food systems. Under option 3 the administrative burden remains unchanged in comparison to the baseline. Finally, it is assumed that mostly SMEs and, in particular small-scale local operators, are involved in such activities. They benefit from the exemptions and derogations to be introduced for varieties marketed exclusively to amateur gardeners, conservation varieties including locally adapted varieties, organic varieties suitable for organic production and heterogeneous material.

Exempting the marketing of PRM to amateur gardeners from the scope of the legislation could result in a lower PRM quality and lead to an increase of fraudulent practices if that PRM is marketed to professional users (option 1). Even though exchange in kind of seed between farmers is considered to be a marginal activity (see above), there could be a potential negative economic impact on seed companies if this activity is exempted from the scope of the PRM legislation (option 1). Such exemption would also allow in particular large farms and farmers’ cooperatives currently operating as seed multipliers to place on the market big quantities of seed without the obligation to meet the certification requirements and thus have an unfair competitive advantage over the companies marketing seed. There would be a negative impact on those companies, and particularly on SMEs that are most likely to work with non-hybrid varieties that can be easily multiplied. Under option 2, an overall positive economic impact is expected because lighter rules will prevent fraudulent practices, enhance traceability and ensure a minimum PRM quality. Under option 3, benefits are minimal because activities of seed conservation networks, exchange in kind of seed and marketing to amateur gardeners would be subject to variety registration and PRM certification.

In the FRM sector there will be no additional costs and administrative burden for operators and NCAs as regards the measures for the purposes of conservation and sustainable use of forest genetic resources under option 1. Options 2 and 3 will reduce the administrative burden for operators and NCAs because there will be a notification for the purposes of the conservation of forest genetic resources instead of a fully-fledged registration process.

6.1.5.Innovation and digitalisation

Operators and NCAs

BMTs can be used to speed up the characterisation of new varieties and facilitate identification in PRM placed on the market. Digitalisation will improve the efficiency, integrity and traceability of the PRM/FRM certification and labelling system, making the certification process more efficient. Setting out a framework (implemented either by guidelines in option 1, or common rules in options 2 and 3) on the use of innovative production processes, BMTs and digital solutions will create legal clarity for operators and NCAs. It is expected to encourage NCAs and operators to invest in these 154 , with a positive impact on innovation and research (Annex 5, Section 8). The measures under options 1-3 will provide new opportunities but not new obligations. Therefore, there are no costs imposed. Use of these new options however may require investments in equipment and/or staff. Any investment is expected to be recovered within few years due to efficiency gains and lower costs of operations (Annex 4, Section 7).

It is likely that initially not all SMEs would be able to benefit to the same degree as larger companies from the new opportunities given for the use of innovative production processes, BMTs and digital solutions 155 . Gradual reduction in investment costs and increase in the use of BMTs 156 and digital technologies is expected to quickly reduce this gap. The long-term benefits would anyway outweigh the initial investments. In turn, such investments are expected to reduce costs for both NCAs and operators for examinations for variety registration, PRM/FRM certification and marketing controls. Depending on the activity they specialise in and their current research and development intensity, some SMEs could be able to benefit from the new options more easily.

6.1.6.SMEs 

Most of the 7 000 enterprises active in the seed sector in the EU are assumed to be SMEs. As regards PRM of fruit plants, there are over 20 000 suppliers in the EU, almost all of which are SMEs. As regards FRM, there are over 4 000 suppliers in the EU, almost all of which are SMEs. SMEs in the PRM/FRM sectors are very diverse in their activities and the degree of R&D intensity, but there is no comprehensive information available on the breakdown between the different activities. Some are highly specialised e.g. in breeding vegetable hybrids for only a few (or even one) species, in organic varieties, or in rapidly producing FRM clones through somatic embryogenesis. Others are just multiplying seed. The evidence available for the different activities of the SMEs is insufficient for a detailed assessment of the impact of the policy options on those SMEs.

An SME survey was carried out as part of the consultation activities. This confirmed the diversity of SMEs’ activities and the variable impact that proposed measures may have on SMEs. The replies however did not indicate that SMEs could be disproportionately affected in relation to larger companies by the envisaged measures under the different options. Depending on the activity they specialise in and their current R&D intensity, some SMEs could be able to adjust more easily to the new obligations and benefit from the new opportunities. It would be however mostly SMEs that would benefit from the exemptions and derogations to be introduced for varieties marketed exclusively to amateur gardeners, conservation varieties including locally adapted varieties, organic varieties suitable for organic production and heterogeneous material, as it is mostly SMEs that are involved in such activities. Therefore option 3 that is most restrictive in these aspects can be assumed that it provides the least benefits for SMEs.

6.1.7.Competitiveness

All options are expected to improve the functioning of the internal market by increasing harmonisation and therefore more uniform application of requirements for operators across the EU, for both the PRM and FRM sectors. The highest harmonisation would be achieved in option 3 but possibly to a counter-productive degree as in option 3 most flexibility for Member States to adjust implementation to specific conditions would be lost. The policy options considered are not expected to have any significant impact on imports and exports of PRM and FRM. PRM and FRM imported from third countries is treated in the same way as the material produced in the EU. The principle remains that equivalence with EU requirements is given to third countries and imports are allowed if PRM/FRM produced in third countries meet the requirements of the EU legislation. Particularly for imported seeds, these must be of a variety already accepted in the EU Common catalogues. To be accepted, the variety has to be examined successfully by a MS according to the EU variety registration requirements. FRM can be imported from member countries of the OECD Forest Seed and Plant Scheme if the seed and planting stock fulfil the conditions set out by the EU legislation. PRM and FRM intended for export to third countries are not subject to the EU rules, while in all options the EU rules remain compatible to relevant international standards as OECD Seed Schemes, ISTA and WTO/SPS. Overall, efficiency gains from the various measures (increased coherence with PHL, OCR, a clearer framework for BMTs, innovative production processes, digitalisation) will have a positive impact on competitiveness of operators, that will be maximised under option 2.

6.2.Environmental impacts

Table 7. Environmental impact of PRM/FRM measures

The scale corresponds to the following scheme: ++ positive impact, + moderately positive impact, +/- inconclusive/uncertain impact, = no significant impact, - moderate negative impact, --significant negative impact.

6.2.1.Strengthened sustainability requirements 

The significant impact of rapidly changing conditions highlights the importance of varieties with improved sustainability characteristics. The positive environmental impact of such varieties may also contribute to the objectives of other policy initiatives (F2F, Biodiversity Strategy and Adaptation Strategy). Over the period 1981-2010, the average annual crop losses caused by drought in the EU have been estimated at EUR 4.8 billion/year 157 . Drought projections show that the maize sector may collapse at 2ºC of global warming if there would not be enough water available for irrigation. In Europe grain maize is projected to be the crop that is most affected by climate change 158 . Agro-climatic zones are moving northward and it is expected that this will further accelerate under climate change 159 . As a consequence, crops may no longer be suitable for the changing agro-climatic conditions 160 . Varieties with improved sustainability characteristics (e.g. drought tolerance 161 ) would contribute to a more sustainable yield that would in turn contribute to food security. Under option 1, the voluntary approach for the assessment of sustainability characteristics in vegetables and fruit plants, may result in PRM that is not suited for the local agro-ecological conditions. Under options 2 and 3, the mandatory assessment of sustainability characteristics in vegetables and fruit plants and the strengthened sustainability requirements of agricultural species and vine will have a positive environmental impact. The international organisation for vine and wine recommends the development of a specific examination of vine varieties present in different geographic zones with the aim to improve the knowledge about the adaptation potential of vine varieties 162 . They recognise the importance of the conservation and recuperation of genetic resources to develop new vine varieties that may contribute to adaptation to climate change.

Apart from the migration of climate zones, climate change also has an impact on the host range and geographical distribution of certain plant pests 163 . Certain pests may pose a danger for agricultural crop protection (e.g. Meloidogyne graminicola on rice) necessitating the EU to impose emergency measures 164 . Varieties with disease resistance / tolerance as a sustainability characteristic will have a positive environmental impact and may reduce the need for plant protection products. Varieties with strengthened sustainability characteristics may also contribute to the availability of PRM that is more suitable for the current and future projected climatic conditions.

The environmental impact of the strengthened sustainability considerations for FRM is interlinked with the impacts of other policy initiatives (Biodiversity Strategy, new Forest Strategy and Adaptation Strategy). By the end of the century, climate change will substantially alter the current distribution of climatically suitable areas for the majority of European trees 165 . FRM with improved sustainability characteristics can contribute to adaptation and mitigation of the already visible impact of climate change on forests such as drought, wildfires, increased vulnerability to climate-driven disturbances 166 . Strengthened sustainability requirements under options 2 and 3 will increase to the availability of FRM contributing to sustainable forest management and restoration of healthy forest ecosystems.

Option 2 overall performs very well in terms of the positive environmental impacts of strengthened sustainability requirements in the PRM and FRM sectors. Option 3 shows weaknesses because the creation of fully harmonised conditions for MS will limit possibilities for adjustments by MS to their own agro-ecological and environmental conditions, which is a key aspect in terms of contribution to sustainable agri-food production and forestry.

The extension of the scope of the FRM legislation to cover non-forestry purposes (options 2 and 3) will have a positive environmental impact especially in those MS where non-forestry purposes are significant 167 and currently not within the scope of the legislation. The long-term losses caused by the planting of lower quality FRM would be reduced 168 . Even when FRM for non-forestry purposes is planted close to certified FRM there will no longer be any risk that it will lower the quality of the certified FRM, thus resulting long-run impacts on the resilience of forests are avoided. For all of the above, evidence is insufficient to allow a quantification of the described impacts.

National contingency plans (options 2 and 3) should address difficulties in supply of FRM in a more comprehensive way. National contingency plans will reduce the need for authorising the use of lower quality FRM, which would in turn help reduce canopy cover loss and contribute to the creation of resilient forests supporting biodiversity and mitigating climate change. In the absence of a requirement for contingency planning (option 1), it is less likely that MS will develop national contingency plans, but some MS have already done so or are in the process of doing so. Therefore, under option 1 the reduction of canopy cover loss would be low, while under options 2 and 3 it would be high. Difficulties in supply of FRM combined with the use of lower quality FRM can result in delayed planting and have a negative impact on the resilience of forests and could ultimately result in a loss of 5% of the total canopy cover 169 .

More and better information on the suitability of FRM for current and future climatic conditions under all policy options will have a positive environmental impact through the selection of the right tree for the right place and thus support the resilience of future forests. It would also benefit users of FRM. Access to information about FRM characteristics would allow users to select the most appropriate FRM and reduce economic damage caused by the use of unsuitable FRM. Indicatively, incidences of entire forests disappearing due to bark beetle infestations caused by the planting of monocultures of unsuitable tree species susceptible to bark beetles could be reduced 170 .

In the PRM and FRM sectors innovative production processes also offer big potential for addressing new demands as regards sustainability and environmental objectives 171 . Positive impacts are expected to be maximised in option 2, under which general legal provisions will provide a common framework that is on the one hand reliable and on the other hand flexible enough. Under option 1 (guidelines) there is a risk that the rules will be fragmented and requirements for operators will continue to differ across MS, with less environmental benefits. Under option 3 (more detailed rules) there is a risk that the legislation will be too prescriptive and become outdated very soon in light of new technical and scientific developments, thus nullifying initial benefits.

6.2.2.Conservation and sustainable use of plant and forest genetic resources

Measures to conserve the genetic diversity of plant and forest genetic resources will alleviate the pressure on agricultural production and forests caused by increased exposure to biotic and abiotic factors. Genetically diverse PRM and FRM will have a positive environmental impact on the resilience against extreme weather conditions and disasters.

For PRM, lighter rules for the activities of seed conservation networks, marketing to amateur gardeners and exchange in kind of seed will also lead to increased genetic diversity of cultivated crops and contribute to the conservation and sustainable use of plant genetic resources. Genetic diversity of cultivated crops in turn can have benefits for resilience to a number of pressures (e.g. climate change, plant pests). Genetic diversity is also essential for future breeding efforts to develop new improved varieties 172 . A total exemption from the scope of the legislation (option 1) may cause loss of genetic diversity due to a lack of identification and traceability of the PRM concerned while the procedures in option 3 would be too cumbersome. Option 2 offers the best solution for safeguarding genetic diversity as it introduces light rules ensuring the identification and traceability of the PRM concerned.

In the FRM sector the environmental benefits regarding lighter rules for the registration of basic material will be marginal under option 1 since the effect of guidelines will be limited without changes in the requirements for the registration. By enabling the diversity of forest genetic resources, policy options 2 and 3 will have a positive environmental impact on biodiversity and adaptation to climate change. Policy option 2 will provide the strongest incentive as it allows operators to notify basic material instead of going through the official registration procedure requiring verification by the NCAs. EU forests are fragile because currently, 32.8% of EU forests have a single tree species, 49.5% have 2 to 3 tree species, 13.1% have 4-5 species and only 4.6% of forests have more than 6 tree species 173 . The measures under option 2 will ensure and conserve greater genetic diversity within a single tree species. It is estimated that the loss of canopy cover caused by the planting of a single tree species could be reduced by 5%.

6.2.3.Common measures for PRM to contribute to sustainability, biodiversity and climate-related challenges

A number of common measures under all options will have a positive environmental impact. Adapted rules on organic varieties suitable for organic production will contribute to the target of having 25% of agricultural production under organic conditions pursuant to the goals of F2F, therefore indirectly contributing to reduced use of inputs in agriculture. Simplified requirements for marketing of conservation varieties, extension of these requirements to cover new locally adapted varieties and broadening the scope of heterogeneous material beyond organic production will also reduce the administrative burdens for the operators concerned, but again not significantly in relation to the whole sector 174 . Finally, it would be mostly SMEs that would benefit from such derogations, as it is assumed that mostly SMEs and small local actors are involved in such activities.

6.3.Social impacts

Under all options, lighter rules for conservation varieties and their extension to cover new locally adapted varieties have the potential to create a new market segment. Several hundreds of operators in rural areas could benefit from employment opportunities and a market that could reach an annual value of EUR 266 million annually. Also the exemption from the scope (option 1) or lighter rules (option 2) for activities of seed conservation networks, marketing exclusively to amateur gardeners and exchange in kind of seed between farmers are expected to have a positive impact on employment in rural areas, both in relation to SMEs in the PRM sector marketing these varieties and to the development of local value chains 175 . Under all options, the harmonisation of OCs, measures to improve the coherence with the PHL and extension of the activities that can be carried out under official supervision will have marginal/neutral impacts on employment. This would be restricted to reallocation of staff within the NCAs.

6.4.Sustainability

The introduction of strengthened sustainability considerations in the examination of new varieties will support food security 176 , since better adapted varieties – future proof varieties - will result in more stable yields. Similar contributions are expected due to the availability of organic varieties suitable for organic production and new locally adapted varieties. Availability of seed of such varieties will result in more stable agricultural production and ultimately food availability. Finally, measures to support the conservation and sustainable use of plant genetic resources also contribute to sustainability by maintaining a broad genetic pool that is necessary for the breeding of improved varieties in the future. Currently food security in the short term is not an issue. However, the sustainability and resilience of the food system should be reinforced to ensure food security in the long term. The increasing frequency of extreme weather events will have a negative impact on agricultural production and risks increasing the number of pest outbreaks while all these events will potentially have an impact on food affordability 177 .

Under option 1, the reinforcement of sustainability requirements would be restricted to agricultural crops and vine and would not contribute comprehensively to sustainability of food systems. Even though this would have low economic costs in the short term, there will be a potential negative economic impact in the long term. The environmental benefits would be limited because other crop groups (vegetable species and fruit plants) would not be addressed. In the mid to long term this would lead to increased crop losses and a negative impact on society because of expected fluctuations in food availability and food prices. Option 2 would reinforce sustainability requirements also in vegetable species and fruit plants. The overall benefits in terms of sustainability would be positive. In the mid to long term crop yields would remain more stable and have a positive impact on society because of more stable food availability and food prices. Under option 3, the overall benefits in terms of sustainability would still be positive but limited by the reduced possibilities to adapt to local agro-ecological conditions.

The impact of climate change is already visible in the forest sector. Extreme weather events and disasters are becoming more frequent. Vegetation zones are moving fast and without a policy change, forests will not be able to cope with this 178 . As a result, forests will increasingly become poorly adapted to the changing climatic conditions. Large parts of forests will be increasingly destroyed by drought, storms, floodings, forest fires and heat while insufficient and poorly adapted FRM will be available for reforestation of the damaged forests. In the FRM sector, the measures to assess sustainability characteristics of basic material and the establishment of national contingency plans (options 2 and 3) will contribute to sustainable afforestation and reforestation. This will in turn result in more resilient forest ecosystems and contribute to forests that are better adapted to climate change. Similar positive contributions are expected from the obligation to provide information on FRM to users/buyers. Extending the scope of the legislation to non-forestry purposes will have a long-term positive environmental impact by avoiding failure of forest ecosystems (options 2 and 3). Measures on forest genetic resources will increase the genetic diversity of FRM and therefore also contribute to more resilient forest ecosystems (options 2 and 3). Given the uncertainty around the future projected climatic conditions and the time needed for the creation of new forests, it is important to ensure sustainable afforestation and reforestation by planting high-quality climate-adapted and genetically diverse FRM. This will ultimately result in resilient forest ecosystems that may withstand the pressures of climate change.

Under option 1, voluntary guidelines on the assessment of sustainability characteristics may result in improperly assessed FRM reaching the market. If non-forestry purposes would not be included in the scope of the legislation low-quality FRM may be planted close to high-quality certified FRM. In spite of their low economic impact in the short term, there would be a significant negative environmental impact in the long term (e.g. forests susceptible to pests or other environmental pressures). Under options 2 and 3, measures on the assessment of sustainability characteristics and the extension of the legislation to cover non-forestry purposes would have a slightly higher economic impact. Already in the mid-term the benefits would outweigh the initial costs by avoiding forest losses caused by the planting of low-quality and improperly assessed FRM. In the long-term forest ecosystems would become more resilient and less vulnerable to climate-driven disturbances. Under option 2 the benefit in terms of sustainability and contribution to genetic diversity would be positive while under option 3 those benefits, while still positive, would be more limited by the reduced possibilities for MS to adapt to their specific environmental conditions.

6.5.Global combined impact of the policy options

Option 1 presents low economic costs for operators and NCAs but also low benefits due to strengthened sustainability requirements. The increase in costs would be insignificant as few adjustments would be required both for operators and NCAs. However, the voluntary nature of the additional assessment of sustainability characteristics gives too much leeway, risking that varieties without improved sustainability characteristics enter the market. This would in turn reduce the contribution to more sustainable agri-food production and food security. Annual agricultural losses already reach up to EUR 4.8 billion because of drought only. Without additional effort for varieties better adapted to such extreme conditions this situation is expected to deteriorate even further. In the FRM sector, the voluntary approach towards contingency plans may cause major shortages of FRM in case of extreme weather and disasters. Leaving non-forestry purposes out of the scope of the FRM legislation may result in the planting of low-quality FRM in proximity of high-quality FRM, and in long-term impacts on the resilience of forests. Finally, option 1 is expected to have positive impacts on the conservation and sustainable use of plant and forest genetic resources though limited by the absence of tools for traceability and quality assurance for plant and the voluntary nature of rules for forest genetic resources.

Option 2 presents considerable economic costs for operators and NCAs due to the need for additional investments to conduct additional sustainability assessments. On the other hand, benefits due to strengthened sustainability requirements are high as the mandatory nature of the additional assessment is combined with flexibility to adapt to local agro-ecological conditions. This would in turn increase the contribution to more sustainable agri-food production and food security. In the FRM sector, the obligation for MS to establish contingency plans is expected to increase preparedness for major shortages of FRM in case of extreme weather and disasters. The inclusion of non-forestry purposes in the scope of the FRM legislation would reduce the risk of planting low-quality PRM in proximity of high-quality FRM, and negative long-term impacts on the resilience of forests. Finally, option 2 is expected to have high positive impacts on the conservation and sustainable use of plant and forest genetic resources through tools for traceability and quality assurance for plant and adapted rules for forest genetic resources.

Option 3 presents considerable economic costs for operators and NCAs due to the need for additional investments to conduct additional sustainability assessments. Benefits due to strengthened sustainability requirements are positive though limited by the lack of flexibility to adapt to local agro-ecological conditions. This would in turn limit the contribution to more sustainable agri-food production and food security. In the FRM sector, harmonised contingency plans with lack of flexibility to adapt to local climatic and ecological conditions will limit the benefits regarding increased preparedness for major shortages of FRM in case of extreme weather and disasters. The inclusion of non-forestry purposes in the scope of the FRM legislation would reduce the risk of planting low-quality PRM in proximity of high-quality FRM, and negative long-term impacts on the resilience of forests. Finally, option 3 is expected to have negative impacts on the conservation and sustainable use of plant genetic resources as measures concentrate on increased traceability and quality assurance without fully accommodating the specific needs of plant genetic resources. Harmonised rules adapted for forest genetic resources will have a positive impact on the conservation and sustainable use of forest genetic resources.

The major cost and benefit elements of each option are summarised in Table 8.

Table 8. Overview of major cost and benefit elements of each option

The amounts are for EU27 in million EUR/year. For cost and benefit elements for which monetisation is not feasible, a qualitative score is used. The scale corresponds to the following scheme: ++ positive impact, + moderately positive impact, +/- inconclusive/uncertain impact, = no significant impact, - moderate negative impact, -- significant negative impact.

6.6.Stakeholders’ views on impact of policy options

Policy option 1 would be acceptable to a majority of stakeholders and MS as the impacts/additional costs and required changes would be minimal. There would be benefits of the extension of the current VCU examination for agricultural plant species and vine to include characteristics that contribute to sustainable production (VSCU). For the other crop groups currently not subject to VCU (vegetables and fruit plants), the voluntary communication of the information coming from the pre-registration trials (before application) could enable the farmers to choose the right varieties according to their needs.

The majority of NCAs and stakeholders are of the opinion that the harmonisation of the framework for OCs outside the scope of the OCR (option 1) would have the lowest impact on the increase in cost and administrative burden. According to NGOs and certain academia the total exemption of the activities of seed conservation networks, exchange in kind of seed between farmers and marketing to amateur gardeners from the scope of the legislation would have the biggest positive impact on the conservation and sustainable use of plant genetic resources. The seed sector and some NCAs are concerned that a total exemption could be misused by farmers multiplying seed under a service contract. As regards the possibility of using BMTs and digital solutions, some stakeholders prefer that the use of BMTs and digital solutions remain optional because of a lack of resources to invest in such technologies.

Stakeholders and NCAs are concerned about the increased costs and the reduced number of varieties coming to the market under policy option 2 extending the VSCU examination to all crop groups. NCAs state that the need for, and costs of, additional testing areas would be an important limiting factor, highlighting that even official supervision may not be an adequate solution. Smaller MS have reported that there would not be enough areas for field trials. MS have already identified the lack of areas for field trials as a limiting factor for carrying out the VSCU under organic conditions. Likewise, the seed sector is concerned that the VSCU examination under option 2 would lead to disproportionate costs especially for SMEs and to the decrease of new varieties entering the market. While the main farmers’ association considers it important to assess new varieties for those criteria and have the relevant information at hand, they are concerned about the increased cost and the reduced availability of new varieties because of the compulsory VSCU assessment 179 .

The majority of NCAs and stakeholders fear an increase in administrative burden upon the inclusion of OCs into the scope of the OCR. Several NCAs and businesses are of the opinion that option 2 including OCs into the scope of the OCR with simplified import controls would contribute to more harmonised conditions for the operators and the marketing of PRM and FRM across MS. NGOs are of the opinion that the introduction of lighter rules for the activities of seed conservation networks, exchange in kind of seed between farmers and marketing to amateur gardeners would hamper those activities and have a negative impact on the conservation and sustainable use of plant genetic resources. According to the seed sector, the introduction of at least lighter rules for such activities would offer a minimum guarantee for compliance with the plant health requirements and for the traceability of such activities. Most NCAs and stakeholders including SMEs are of the opinion that the introduction of basic rules on innovative production processes, BMTs and digital solutions would have a positive impact on the uptake and advancement of such technologies.

Most stakeholders and MS are of the opinion that harmonisation of the VSCU examination under option 3 would be disproportionate and counterproductive. The majority of NCAs and stakeholders fear an increase in administrative burden upon the inclusion of OCs into the scope of the OCR. Only a few stakeholders are of the opinion that a full inclusion into the scope of the OCR with stricter import controls at border control posts (option 3) would have the highest positive impact on the creation of equal conditions for operators and marketed PRM and FRM across MS. NGOs and certain academia strongly oppose to subjecting the activities of seed conservation networks, exchange in kind of seed between farmers and marketing to amateur gardeners to the requirements of the legislation. In their view, this would undermine all efforts undertaken for the conservation and sustainable use of plant genetic resources. Most stakeholders and NCAs in favour of the use of BMTs and digital solutions are of the opinion that the introduction of detailed rules would have a negative impact on the use of such technologies and restrict scientific and technological developments.

As regards FRM, the majority of NCAs and regional forest authorities who participated in the targeted survey on FRM believe that the inclusion of the purposes for which the FRM is produced will increase the administrative burdens for NCAs and operators, increase the costs for inspections and require and additional investment by the operators. Respondents agreed that it is essential to guarantee traceability of the genetic origin for the FRM users without increasing the administrative burden and the costs.

7.How do the options compare?

This section compares the expected impacts of the policy options in relation to the baseline scenario in terms of their overall effectiveness, efficiency, coherence, subsidiarity and proportionality. It considers the effects of no policy change in the long term.

Table 9: Global comparison of the options. The scale of the score given to impacts and assessment of efficiency, coherence, subsidiarity and proportionality is based on the following scheme: ++ positive, + moderately positive, +/- inconclusive/uncertain, = not significant, - moderate negative, --significantly negative.

7.1.Effectiveness

The evaluation of effectiveness looks at the extent to which the option would achieve the objectives. Option 2 overall outranks the other policy options. Option 3 ranks second, slightly better than option 1, which however performs better than the no policy change scenario.

The common measures for simplification of administrative procedures are expected to accelerate market access of PRM/FRM produced within the EU and of imported PRM/FRM.

For innovative production processes, BMTs and the use of digital solutions, options were assessed in relation to the initial investment and the gradual reduction of costs for NCAs and operators. Option 2 performed the best on these criteria while options 1 and 3 performed equally well. Laying down a reliable framework under option 2 will create legal certainty and encourage operators and NCAs to invest in these technologies and the long-term benefits would anyway outweigh the initial investments. With option 1 (implementation by guidelines) there is a risk that the rules will be fragmented and that operators may not be inclined to invest in such technologies due to the absence of a reliable framework that will give them a perspective of a return on their initial investment. More consistent rules on innovative production processes, BMTs and digital solutions under option 3 come at the expense of the frequency for updating those rules due the rapid pace of new technical and scientific developments.

To ensure availability of PRM suitable for future challenges, options were assessed in relation to the scope of the sustainability assessment of new varieties and the level of harmonisation of that assessment. The enlarged scope of the sustainability assessment under options 2 and 3 addresses the objective of PRM contributing to more sustainable agri-food production and increased resilience to climate change conditions in the most comprehensive way. With the voluntary extension of the scope of the sustainability assessment (option 1) the increase in varieties with improved sustainability characteristics of non-regulated crop groups may be lower. An approach balancing harmonisation of the sustainability assessment with flexibility (option 2) allows for adaptation to local agro-ecological conditions. For example, the relevance of pests and climatic conditions (e.g. drought, frost) differs per region. Such adaptation would not be possible under a harmonised sustainability assessment (option 3). The risk of option 1 (most flexible approach for sustainability assessment) is that MS will diverge in relation to the approach for this sustainability assessment and that varieties without improved sustainability characteristics will reach the market.

Common measures creating a legal framework to ensure the availability of PRM suitable for the needs of organic agriculture will ensure a consistent approach for variety registration and certification of ‘organic varieties suitable for organic production’ and contribute to the target of having 25% of agricultural production under organic conditions (F2F).

To ensure availability of FRM suitable for future challenges, options were assessed in relation to the sustainability assessment of basic material, inclusion of non-forestry purposes into the scope of the legislation and contingency planning. The enlarged scope of the sustainability assessment under options 2 and 3 addresses the objective of FRM contributing to more sustainable forest management and restoration of healthy forest ecosystems and increased resilience to climate change conditions in the most comprehensive way. It cannot be guaranteed that the voluntary guidelines on the assessment of sustainability characteristics under option 1 will be taken up to the same degree as mandatory principles under options 2 and 3. Under option 1, there is the possibility that improperly assessed FRM would reach the market and this could have a significant negative environmental impact in the long term (e.g. forests susceptible to pests or other environmental pressures). An approach balancing harmonisation of the sustainability assessment with flexibility (option 2) allows MS to adapt to environmental and climatic conditions which may show quite substantial regional differences. Option 3 would not allow such adaptation. The inclusion of specific non-forestry purposes in the scope of the legislation (options 2 and 3) will avoid long-run negative impacts on the resilience of forests and perform better than keeping the current scope (option 1). In addressing temporary difficulties in supply of suitable FRM through contingency planning, option 2 is expected to be the most effective. Under option 2 the requirement to establish national contingency plans is coupled with the flexibility for MS to adapt contingency plans to their environmental and climatic conditions. The voluntary approach under option 1 risks that MS will ignore the need for such plans, while the highly harmonised approach under option 3 can prove counterproductive as needs and priorities can differ significantly across the EU. A common measure providing more and better information by nurseries to FRM users/buyers on the suitability of FRM for current and future climatic conditions will allow FRM users/buyers to buy the right tree for the right place and thus support the resilience of future forests. Overall option 2 would be more effective in securing the availability of FRM suitable for future challenges.

To support the conservation and sustainable use of plant genetic resources, options were assessed in relation to the approach towards seed conservation networks, exchange in kind of seed, and marketing exclusively to amateur gardeners. A total exemption of these activities from the scope of the legislation (option 1) will not fully meet the objective due to a lack of identification and traceability of the PRM concerned. The procedures in option 3 (general requirements of the legislation for variety registration and PRM certification) would be too cumbersome and counterproductive towards meeting the objective. Option 2 offers the best solution for safeguarding genetic diversity as it introduces lighter rules ensuring the identification and traceability of the PRM concerned. To support the conservation and sustainable use of forest genetic resources, dedicated measures under options 2 and 3 would be most effective in comparison to the adoption of guidelines that risk not to be followed by the MS (option 1). Overall, in supporting the conservation and sustainable use of plant and forest genetic resources, option 2 would be most effective, followed by option 1. Option 3 would have uncertain results as the highest harmonisation foreseen under option 3 would be effective for securing the quality of the PRM/FRM concerned but not suitable for its specific needs due to its higher genetic diversity.

For the harmonisation of the framework for OCs, common measures on OCs across MS and minimum requirements as regards the frequency and scope of OCs will provide a clear regulatory framework and contribute to a level playing field for operators. Options 2 and 3 perform equally well and better than option 1. Alignment of the OC rules outside the scope of the OCR (option 1) would have the drawback of not making use of the advantages of the OCR (existing IT applications and training). Options 2 and 3 will make use of the existing IT applications for OCs such as the Information Management System for Official Controls (IMSOC). Moreover, it will be possible to report suspected cases of PRM/FRM fraud through a secure IT portal. Training activities will be organised to train MS official inspectors. As under option 1 the PRM/FRM legislation is outside the scope of the OCR as regards risk-based OCs, it will not be possible for MS to use the aforementioned IT applications and follow training courses.

Common measures for coherence between the PRM/FRM legislation and the PHL will create clarity for NCAs and operators as regards the legal framework for OCs on PHL through the removal of the duplication of RNQP requirements in both legal frameworks and the regulation of all plant pests (QPs and RNQPs) only under the PHL.

7.2.Efficiency

The evaluation of efficiency considers the extent to which the options result in costs and benefits for NCAs, operators and other stakeholders (in the case of this initiative the users of PRM and FRM). The net benefit as well as the Benefit Cost Ratio of each option have been calculated (detailed presentation in Annex 4). Due to high uncertainty, calculations have been done for an optimistic scenario (under which the highest benefits and the lowest costs are realised) and for a conservative scenario (under which the lowest benefits and the highest costs are realised).

Table 10: Net benefit and Benefit Cost Ratio of the options

In terms of net benefits, under the optimistic scenario option 2 ranks first, followed by option 3 that only marginally outranks option 1. Under the conservative scenario option 1 ranks first, followed by option 2, while option 3 presents higher costs than benefits. In terms of Benefit Cost Ratio, under both scenarios option 1 ranks better than option 2, while option 3 is always the worst option.

These calculations cannot capture a number of non-monetised benefits described in section 6. For these, option 2 is performing better than options 1 and 3, especially as regards long-term environmental and sustainability benefits (see an overview in Table 8). As a result, the comparison of the options in terms of net benefit and benefit cost ratio is distorted in favour of option 1 against option 2.

7.3.Coherence

The initiative relates to several EU policy objectives, policy initiatives and instruments. The evaluation of coherence looks at how consistent each option is with these and identifies the extent to which they promote horizontal objectives and facilitate delivery of relevant key targets.

Table 11. Key considerations on coherence

7.4.Subsidiarity and proportionality

All three options are consistent with the EU’s right to act under the Treaty of the Functioning of the EU (agricultural production, the single market and the free movement of products within the EU).

In line with the principle of subsidiarity, the initiative is limited to aspects that can be better achieved at Union level than if they were addressed individually by MS. Without common rules for PRM (variety registration and certification), FRM (approval of basic material and certification) and OCs, there would be 27 different systems instead of one common system in place. This situation would result in obstacles to the movement of PRM/FRM in the internal market and increased costs for controls to ensure equivalence between the different systems. A common EU framework is also most appropriate in order to implement in a harmonised way the various international standards in relation to PRM/FRM quality and plant health 180 .

In line with the principle of proportionality, the envisaged measures do not exceed what is necessary for achieving the set objectives. A number of existing administrative procedures and requirements will be simplified. The options reflect a trade-off between flexibility and harmonisation. Their comparison shows that a fully harmonised system (option 3) does not perform better and that the most proportionate solution is to retain some flexibility for MS (option 2). The latter balances the need for harmonised rules for variety registration and PRM certification with the flexibility for MS to implement those rules to adapt to their local agro-ecological conditions and measures to strengthen sustainability (F2F) and respond to the call for adaptation to climate change (EU Strategy on Adaptation to Climate Change) and restoring biodiversity (Biodiversity Strategy). Likewise, in the FRM sector option 2 creates a balance between the general principles of registration and FRM certification with flexibility for MS to respond to the biodiversity and climate challenges. To achieve these needs and take account of the important differences between the PRM and FRM sectors, the current 11 basic Directives 181 will be replaced by a Regulation on PRM and a Regulation on FRM.

8.Preferred option

The assessment indicates that policy option 2 is the strongest option to effectively address all the objectives of the revision of the PRM and FRM legislation in an efficient and consistent manner. Option 1 presents the best Benefit Cost Ratio as it presents the lowest costs, but it is not the most effective option in terms of achieving the objectives. Actually, option 1 presents the risk that it will lead in the long term to increased losses due to its reduced ambition in addressing comprehensively the sustainability and climate adaptation challenges.

Stakeholder consultations showed that preferences were split between option 1 (most flexible system but also with lowest costs) and option 2 (balancing harmonisation with flexibility). A majority of stakeholders highlighted the need for some degree of flexibility for MS to adapt to their local agro-ecological (PRM) and climatic and ecological conditions (FRM). All stakeholders were in favour of a separate legal framework for FRM.

There are different stakeholders in the sector. Most stakeholders produce PRM and FRM for commercial purposes while a segment does so for non-profit purposes. Although these stakeholders have different activities and objectives, they all recognise the need to preserve and increase the genetic diversity of PRM and FRM. In fact, the work done by seed conservation networks as regards the conservation of plant genetic resources is invaluable as it gives the seed industry a wider choice of PRM from which they can develop new varieties. Currently, the activities of actors involved in conservation and sustainable use of plant and forest genetic resources, such as activities of seed conservation networks and exchange in kind of seed are restricted. A future regulatory framework needs to respond to the needs of the different stakeholders. The impact assessment investigated what would be the best approach to do so. NCAs and the seed industry value the well-functioning certification system and its importance at global level with the EU in the top three of globally exporting regions. However, they recognise that the current system has its flaws, in particular as regards the non-level playing field for operators, marketed PRM and FRM, OCs and enforcement. Concerned operators and NGOs have highlighted that the existing derogations for conservation varieties have not been successful. The organic sector has expressed the need for adapted rules for organic varieties intended for organic production. Moreover, the existing system is currently quite restrictive as regards the activities that can be carried out by operators under the official supervision of the authorities. Since 2013, scientific and technical developments have swiftly moved forward while the legislation does not have adequate provisions on innovative production processes, BMTs and digitalisation.

The current legislation does not have sufficient means to respond to sustainability and climate-related challenges addressed by the EGD and its strategies. For agricultural species sustainability characteristics have been incorporated by certain MS in the VCU examination while there are no sustainability characteristics for the other crop groups. The current experience with agricultural species shows that a voluntary approach towards extending the sustainability assessment to other crop groups will not work. The preferred option will extend and strengthen sustainability requirements. This will come with a cost for businesses in terms of increased breeding costs while NCAs may need to increase their capacity in areas and staff. Mitigating measures can be taken such as a transition period in the application of the new legislation, reduction of the adjustment cost by permitting VSCU examination under official supervision and promote collaboration between MS by creating shared testing networks and allowing delegation of activities to other MS. Therefore, strengthened sustainability requirements applicable to all crop groups show the highest effectiveness in contributing to the increase in sustainable agri-food production under F2F and the availability of climate-adapted and more resilient PRM.

The regulatory framework should leave room for flexibility for MS to adapt to their local agro-ecological conditions. Furthermore, it should proportionally regulate activities related to conservation and sustainable use of plant and forest genetic resources. The choice of legal instrument, 2 Regulations (PRM and FRM) replacing 11 Directives, will reduce divergent implementation across MS caused by national transpositions.

Under option 2, the introduction of lighter rules for registration of conservation and locally adapted varieties and for conservation activities will introduce a proportionate approach for a small market segment. This will most likely have a positive impact on employment in rural areas, both on small operators marketing these varieties and on the development of local value chains. The preferred option will also result in increased genetic diversity and contribute to the objectives of the Biodiversity Strategy. Likewise, the introduction of variety registration rules adjusted to the principles of organic production will contribute to the target of having 25% of agricultural production under organic conditions pursuant to the goals of F2F.

As regards FRM stakeholder consultations also showed a split between options 1 (most flexible approach) and 2 (balancing flexibility with harmonisation). Stakeholders were very strong on separating the FRM legislation from the PRM legislation. In fact, the inclusion of FRM in the PRM proposal was one of the reasons for rejecting the PRM proposal. FRM stakeholders recognise the challenges brought about by climate change. They are confronted with increasing forest damages caused by insects, storms and drought. Furthermore, there is an increased demand for FRM for plantations for biomass production and for responding to the target of planting 3 billion additional trees by 2030. To respond to these challenges and the higher demand in FRM there is a need for a legal framework that includes a sustainability assessment of basic material, increasing the resilience of FRM by taking measures on the conservation and sustainable use of forest genetic resources and responds to the increased demand for FRM by extending to scope of the legislation to non-forestry purposes. The FRM proposal will contain updated rules for FRM and ensure that more information about the suitability of FRM for future climatic conditions is provided by the nurseries to FRM users/buyers. National contingency plans will prepare MS for difficulties in supply of suitable FRM. Altogether these measures will result in the planting of high-quality FRM in suitable areas and contribute to the creation of resilient forests and the restoration of forest ecosystems. The impact assessment showed that option 2 combining flexibility with harmonisation was the best approach to address the problems identified in the current legislation. Option 3 does not allow taking into account the differences between MS as regards the type of forests and the activities carried out.

In the PRM and FRM proposals, the measures on the harmonisation of OCs, the coherence with the PHL, innovative production processes, BMTs and digital solutions serve to increase the efficacy and efficiency of the procedures and reduce the administrative burden for MS and businesses, overall contributing to the competitiveness of the PRM/FRM sectors.

8.1.REFIT (simplification and improved efficiency)

The revision of the PRM and FRM legislation offers the opportunity of savings for businesses as regards variety registration, certification and OCs. There will be lighter rules for the registration of conservation and locally adapted varieties as well as for the activities of seed conservation networks, the possibility of VSCU examination under official supervision (PRM), extension of certification activities possible under official supervision (PRM/FRM), increased efficiency of the registration and certification system (innovative production processes, BMTs and digital solutions) and more efficient OCs. The table below gives an overview of the main opportunities under the preferred option. Some of these serve to mitigate the increased burden caused by the extension of sustainability requirements in the PRM and FRM sectors.

Table 12: Refit cost savings – preferred option

8.2.Simplification and burden reduction for businesses, supporting the one-in one-out approach

The activities that imply significant administrative costs for businesses are the following:

·Application for acceptance of new varieties (PRM);

·Application for registration of basic material (FRM);

·Certification of PRM;

·Certification of FRM;

·OCs.

For implementing the one-in-one-out requirement, for each of these activities all cost drivers were mapped but the analysis showed that these would undergo only marginal changes. There are no administrative costs for the citizens.

9.How will actual impacts be monitored and evaluated?

Indicators for the preferred option, in relation to the core objectives of the PRM/FRM revision, with suggested data sources are presented in table below.

Table 13. Measures of success and monitoring indicators

The legislation will be considered successful if there are sufficient quantities PRM and FRM available that are suitable to address future challenges and respond to the needs of the different types of PRM and FRM users. The design of indicators that are Specific, Measurable, Achievable, Realistic and anchored within a Time Frame (SMART) is not fully possible because the number and types of varieties available in the Common Catalogues is demand driven. Farmers will plant PRM of those varieties for which there is a demand. Moreover, there is no simple relationship between the number of varieties and the quantities of certified PRM. For example, a few wheat varieties could cover the demand for wheat if planted in a large agricultural area, while it would be required to plant 100 varieties of tomatoes to cover diverse consumer demands.

The PRM and FRM legislation regulates the access to the market and the revision addresses the identified bottlenecks. For example, current variety registration rules are too restrictive for organic and conservation varieties. Rules that are adjusted to the characteristics of such varieties will be introduced in order to enable their access to the market. Accordingly, success would mean that within 10 years more organic and conservation varieties are registered and their seed/PRM is made available in the market in sufficient quantities. It cannot be anticipated how many new varieties and which quantities of PRM/seed will be marketed, as this depends on the uptake of the new opportunities by the operators and the farmers presenting a sustained demand for such varieties.

Another example is that the current rules for examination of new varieties, PRM certification and OCs do not provide for the use of new methods (BMTs) that have the potential to increase the efficiency of these procedures. The revision will remove this obstacle. Success would mean that within 10 years BMTs are widely used and lead to a reduction of costs of examination of new varieties. The revision is expected to stimulate their development and use. Genetic markers are specific to each species and variety. It cannot be anticipated if suitable markers will be available for all.

The success of the legislation will therefore be measured through the number of varieties and basic material which are successfully registered in the Common Catalogues and the quantities of certified PRM and FRM produced thereof. The Common Catalogues (as of 2023 accessed through the new EU Plant Variety Portal) will be a key source for the indicators for monitoring progress as regards the type of plant varieties (accepted under general rules on DUS and sustainability assessment or under rules for conservation/locally adapted varieties or organic varieties suitable for organic production). Other sources will be notifications and reports from MS as well as audits by the Commission.

Moreover, this approach has been chosen because it is difficult to assess the individual contributions of the PRM and FRM legislation to sustainable agri-food production and restoration of forest ecosystems, respectively. The impact of using improved varieties will be a combination of selecting the appropriate variety for the regional agro-ecological conditions and applying good agricultural practices. It will also depend on the weather conditions. Likewise, in the FRM sector the improvement is assessed through the indirect impact of using improved tree seeds on the per unit area productivity of regenerated forests. Improved tree seeds may better survive in a harsh climate or show better tolerance against damages through abiotic or biotic factors.

The number and quantities of PRM of conservation and locally adapted varieties, organic varieties suitable for organic production, heterogeneous material and FRM notifications for the purposes of forest genetic resources conservation will offer an indirect measure of contribution to increased genetic diversity.

The EU Plant Variety Portal will allow MS to fulfil their reporting obligations through online submission of the relevant data (in the long term, machine to machine). MS’ reporting obligations under the OCR as well as EU audits will be important mechanisms to check the implementation of the new PRM/FRM legislation in MS. As regards the coherence with the PHL, the use of already existing IT applications for reporting RNQP non-compliances and the submission of PRM/FRM import documents (IMSOC) will lead to efficiency gains.

The Commission will review the indicators periodically. The implementation of the national contingency plans ensuring FRM supply will be regularly monitored and compared with the data obtained from the Forest Information System for Europe 182 as regards the forest areas lost because of extreme weather, forest fires and disasters.

The proposed reference period for the monitoring framework of the new PRM and FRM legislation is 10 years as it takes 10-12 years to develop a new plant variety. Based on the time needed to obtain meaningful data through annual monitoring, it is considered appropriate to supplement this monitoring with a formal evaluation of the initiative at the earliest 10 years after the planned legal proposal becomes applicable. It should be avoided that the evaluation takes place before the impact of the new requirements for variety acceptance, lighter system for registration of conservation varieties and new locally adapted varieties and the notification of heterogeneous material and basic material for the purposes of forest genetic resources conservation becomes visible. The same holds true for the other actions that need sufficient data and monitoring information on the implementation, application and enforcement of the expected legal provisions.

Annex 1: Procedural information

1.Lead DG, Decide Planning/CWP references

The Directorate-General for Health and Food Safety (DG SANTE) is the lead DG on the initiative on Revision of the plant and forest reproductive material legislation. This initiative is in the European Commission's Work Programme for 2022, in Annex II: REFIT initiatives, under the heading “A European Green Deal”. The initiative has received the validation in the Agenda Planning on 25 September 2020 (reference PLAN/2020/7576) and the Inception Impact Assessment was published on 15 June 2021.

2.Organisation and timing

An Inter-Service Steering Group (ISSG) was set up. The following Commission services were its members: SG (Secretariat-General), SJ (Legal Service), AGRI (Directorate-General for Agriculture and Rural Development), CLIMA (Directorate-General for Climate Action), ENV (Directorate-General for Environment), JRC (Joint Research Centre) and TRADE (Directorate-General for Trade). GROW (Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs) and RTD (Directorate-General for Research and Innovation) were also invited but did not join the ISSG. The ISSG met on the following dates:

Table 14. Meetings of the ISSG.

In addition to the above meetings, the members of the ISSG were regularly informed on the progress of the initiative and consulted in written on the questionnaire of the open public consultation and the draft final report of the study supporting the impact assessment for the revision. In addition, DG SANTE consulted the Community Plant Variety Office (CPVO) on aspects of this initiative relevant to CPVO’s mandate.

3.Consultation of the RSB

An upstream meeting with the Regulatory Scrutiny Board was held on 6 May 2022. A first version of this Impact Assessment Report was submitted to the RSB on 18 January 2023, the meeting took place on 15 February 2023 and the RSB written opinion was received on 17 February 2023. The Board concluded that the DG had to revise the report in accordance with the Board’s findings before launching the interservice consultation.

Table 15. Modifications of the IA report following the comments by the RSB.

4.Evidence, sources and quality

The current PRM and FRM legislation comprises 1 Directive on the Common Catalogue and 11 marketing Directives and covers diverse crop groups from annual crops in the case of agricultural species to perennial crops in the case of fruit trees. Each crop group has its specificities in relation to the two pillars variety registration (DUS examination) and PRM/FRM certification. The consultation activities have focussed on gathering quantitative and qualitative data in relation to those two pillars and on OCs. It must be highlighted that most of the available information concerns agricultural species as this is the most important market segment. A lot of effort was put in the collection of information on the activities of seed conservation networks, exchange in kind of seed between farmers and the reasons for the limited implementation of the Directives on conservation varieties and landraces. In general, it is to be noted that because of the diversity of crop groups and the multitude of technical aspects and some marginal activities, it was not feasible to assess each aspect of the envisaged amendment of the legislation in detail.

Evidence for this Impact Assessment has been collected by two external studies and a number of other sources.

A first study 183 aimed to update the state of play since the last evaluation of the PRM/FRM legislation in 2008 184 and the 2013 impact assessment 185 , as well as to fill key knowledge gaps, in order to support the Commission to prepare the study on the Union’s options to update the existing legislation on the production and marketing of PRM 186  following a request by the Council 187 . Evidence was collected by literature review, 40 interviews (with academics, civil society organisations, public authorities, industry representatives and farmers’ organisations), a workshop with 6 FRM experts, and four targeted surveys. The targeted surveys were addressed to 1) NCAs (authorities from 25 MS responded), 2) amateur gardeners (with 6089 participants from 29 countries), 3) maintainers of registered varieties for the amateur market (81 participants) and 4) FRM stakeholders (80 participants, including both FRM users and NCAs). The limited publicly available information and the fact that it is rarely broken down per group of agricultural species (i.e. cereal seed, beet seed, etc.), the small sample size and self-selection bias (interviews and targeted surveys) were identified by the contractor as limitations to the quality of the evidence collected by this study.

A second study 188 aimed to support the Commission in the preparation of this impact assessment. This study collected evidence by literature review, a targeted survey addressing NCAs, operators and other stakeholders in the PRM and FRM sectors (99 respondents in total), 43 interviews (30 on PRM and 13 on FRM), a focus group on the topic of marketing to amateur gardeners, a focus group on FRM topics, a case study on exchange in kind of seed (based on literature review and interviews) and an analysis of MS experiences on conservation varieties and varieties for amateurs of fruit plants and vine (based on a targeted survey to 17 NCAs). The low response rates to questions aiming to collect quantitative information to fill-in knowledge gaps as regards market size and costs for NCAs and operators were identified by the contractor as limitations to the quality of the evidence collected by this study.

Despite the aforementioned limitations, the data collected by these studies allows to make assumptions (e.g. range of minimum to maximum values) and even allows for higher certainty on certain aspects where the dataset is rather complete, as NCAs from most MS have responded to the relevant questions. DG SANTE has used this data for in-house calculations additional to those carried out by the external studies, as appropriate in combination with quantitative data extracted from the Common Catalogues 189 on the numbers of registered varieties, Eurostat 190 and the farm accountancy data network (FADN) 191 on the cost of PRM and its share of the total cost of inputs in agricultural production, and the portal of the European Seed Certification Agencies Association 192 on production of certified seed (see Annex 4 for details). These sources offer the best available data for the respective topics. DG SANTE also extracted evidence from published position papers of stakeholder organisations (either published online or submitted in the context of the consultations), online documents of NCAs, articles published in scientific journals and reports of EU co-financed research projects. In particular information from official sites and articles in scientific journals (having been subject to peer review) is considered to be evidence of higher quality. Remaining data gaps have been addressed by using assumptions and calculations done in older studies 193 but in such cases the uncertainty is higher. Finally, additional evidence on views and opinions of NCAs and stakeholders were collected by extensive consultation activities undertaken by DG SANTE in the form of online questionnaires and meetings with NCAs and stakeholders (see Annex 2 for details).

Annex 2: Stakeholder consultation (Synopsis report)

1.Consultation strategy

The objectives of the consultation activities were:

·to ensure that all relevant stakeholders are identified and given the opportunity to participate in the consultation;

·to provide the opportunity for stakeholders to inform the impact assessment, in particular, offering an opportunity for them to inform the development of policy options addressing the problems identified;

·to gather stakeholders’ opinions on the potential policy options together with data and qualitative evidence concerning the relevant impacts of the policy options considered.

The consultation strategy combined different consultation methods in order to engage as much as possible all stakeholders identified:

·NCAs for variety registration, PRM certification (agriculture, horticulture, vine), FRM certification, plant and forest genetic resources

·The CPVO

·Plant breeding companies, seed and PRM multipliers and suppliers, seed and plant trading companies, nurseries, from the organic and non-organic sectors, both large and small operators, and their associations

·Professional farmers including organic farmers

·Amateur gardeners

·Foresters and forestry associations

·Scientific networks on plant and forest genetic resources

·Seed conservation networks.

1.1.Consultation activities undertaken by DG SANTE

DG SANTE consulted stakeholders by means of the publication of the inception impact assessment (IIA) for feedback, the open public consultation (OPC), targeted surveys, working groups with NCAs and stakeholders and bilateral meetings with stakeholder organisations.

The IIA was open for feedback between 15 June and 13 July 2021 on the ‘Have your say’ portal 194 and was addressed to any interested citizen or stakeholder. Feedback was provided in a free text format, while respondents also had the possibility to submit position papers. The feedback collected was taken into account for adjusting the problem description and options, the design of further consultation activities, as well as for this impact assessment.

The OPC was carried out between 21 December 2021 and 27 March 2022 on the ‘Have your say’ portal 195 and was addressed to any interested citizen or stakeholder. It included two sets of closed multiple choice questions, one for PRM and one for FRM. Respondents could also provide additional information either by a short free text or by uploading a position paper. The feedback collected was taken into account for this impact assessment.

DG SANTE also organised two targeted online consultations on EUSurvey 196 , one addressed to NCAs responsible for FRM, held from 5 April to 30 May 2022 and one addressed to SMEs, held from 2 May to 13 July 2022. The SME survey was anonymous. Furthermore, DG SANTE held meetings of working groups (online due to Covid-19 restrictions) with the NCAs and with stakeholders to discuss specific aspects of the revision. Summary reports of these meetings were published on the webpages of DG SANTE 197 . At the request of a number of stakeholders, DG SANTE held bilateral meetings with them and also attended relevant events of stakeholders. Finally, some stakeholders and NCAs submitted to DG SANTE opinions on specific matters outside the framework of the IIA and the OPC. All relevant information was taken into account for this impact assessment.

1.2.Consultation activities conducted in the framework of the study supporting the impact assessment

In the framework of the study a targeted survey, interviews and two focus groups were carried out. The targeted survey was held online between 9 March and 1 April 2022. It was open to NCAs, operators and other stakeholders in the PRM and FRM sectors, but those interested to participate had to pre-register. The interviews aimed to obtain more detailed and contextualised views. The first focus group addressed the topic of marketing to amateur gardeners and the second one the definitions of “forestry” and “non-forestry” purposes in relation to the scope of the FRM legislation and the potential measures to address temporary difficulties in supply of FRM.

2.Stakeholder participation

The feedback to IIA received 66 responses from 16 countries (15 MS and a third country). Geographic distribution was uneven, as 47 responses came from 5 MS (5 to 15 responses by each of them) and 18 responses from 10 MS (1 to 4 responses per MS). As regards type of stakeholder, the submissions were from business associations (20), NGOs (13), companies/businesses (10), public authorities (5), EU citizens (4), academic/research institutions (3), trade unions (3) and other (8). The over-representation of one MS (15 respondents from Belgium) is explained by the fact that these respondents are EU-wide associations or NGOs based in Brussels. With the exception of public authorities, the most relevant types of activities, plant breeders (conventional and organic), marketing of PRM, nurseries (FRM, ornamental), seed conservation networks and farmers, are represented in a balanced way.

The OPC received 2449 responses from 29 countries (24 MS and 5 third countries). Number of responses ranged from 1 to 1684 per MS when citizens are included and from 1 to 184 per MS when citizens are not included. There were no responses from Lithuania, Malta and Romania. All relevant types of activities as well as public authorities are represented in a balanced way. Furthermore, there were in total 15 responses from third countries. 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. 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 of the OPC 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 and only 10% of citizen participants respond to these. In total, 488 participants responded only to expert questions on PRM, 61 only to expert questions on FRM, 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. However, these have not been identified as a campaign as there was a high level of variation in the replies to 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 hobby growers. 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 where 32 respondents, mostly citizens from Germany, submitted identical additional documents supporting that DUS criteria should not be a prerequisite for variety registration, calling for extended exemptions for conservation purposes and for the implementation of the farmers’ rights defined in the International Treaty on Plant Genetic Resources for Food and Agriculture and the United Nations Declaration on the Rights of Peasants. As regards FRM 12 German stakeholders composed of regional authorities, citizens and a business association stated that; the legislation should not be substantially changed, an extension of the number of EU-regulated species is necessary, forestry and non-forestry purposes should be clearly defined, the origin of the FRM must be guaranteed in order for forests derived from that FRM to fulfil the various forest functions for the next decades and centuries, a stable and sustainable funding to minimise potential supply shortages should be prioritised through an EU regulation and that the financial impact on all forest stakeholders affected by the implementation of the legislation must be restricted to a minimum. There were 25 responses to the targeted survey addressed to NCAs responsible for FRM from 19 different MS. There were 251 responses to the targeted survey addressed to SMEs from 22 different MS (from 1 to 33 responses per MS).

The targeted survey conducted in the framework of the external study supporting the impact assessment received 99 responses from 27 countries (23 MS and 4 third countries). 8 respondents identified themselves as academic/research institute, 26 as business association, 21 as company/business, 4 as NGO, 31 as a public or NCA and 8 as “other”. There were no responses from Latvia, Lithuania, Malta and Romania. 74 respondents contributed only in relation to PRM, 18 only in relation to FRM and 7 in relation to both PRM and FRM aspects. Distribution as regards origin and type of activities is considered satisfactory.

3.Results of stakeholder consultation activities

As regards PRM, there is overall support for maintaining the current regulatory system and its two basic pillars of variety registration (based on DUS and where applicable VCU) and PRM certification. Some respondents called for maintaining the current “one-key one-door” approach (i.e. same DUS rules for the plant variety rights regime and the market access of varieties) while most NGOs called to maintain DUS only for plant variety rights, allowing the breeder to choose whether to use DUS or not for variety registration. Potato breeders in particular called for the abolishment of VCU for potato varieties and vegetable breeders called not to introduce VCU for vegetable varieties. The various actors involved in conservation activities, small-scale farmers interested in exchange in kind, the organic sector and most citizens, also called for derogations from this basic system in order to enable the availability of PRM belonging to varieties that cannot meet the DUS requirements and/or to heterogeneous material. The necessity of such derogations is agreed by all stakeholders for meeting objectives relevant to conservation and sustainable use of plant genetic resources, organic production and production in marginal areas. There is however important divergence of views in relation to the degree of such derogations, ranging from calls for a total exception of exchange in kind, conservation activities and marketing to amateur gardeners to the opinion that existing derogations are sufficient and do not need to be extended. In particular, several NGOs called for the new legislation to explicitly implement farmers’ rights as defined in the International Treaty on Plant Genetic Resources for Food and Agriculture and the United Nations Declaration on the Rights of Peasants. Main arguments against total exemption are the concerns about plant health i.e. spreading of diseases by PRM exempted from the legislation (opinion shared by conventional breeders, farmers other than small-scale ones and NCAs), the respect of plant variety rights and the avoidance of unequal competition (opinion mostly supported by conventional breeders), as well as the need to guarantee a minimum quality and traceability (opinion shared by farmers other than small-scale ones and most NCAs, also important for 50% of the citizens responded to the various consultations). As regards marketing to amateur gardeners, several stakeholders were of the view that it is not possible to separate marketing to professional users from marketing to amateur gardeners. Many operators market PRM to both professional users and amateur gardeners whereas others market exclusively to amateur gardeners. As regards organic varieties, organic breeders stressed the need for variety examination (DUS and VCU where applicable) adjusted to the needs and the principles of organic production. In contrast, conventional breeders questioned the need for such derogations for organic varieties, as currently in their view DUS varieties multiplied under organic conditions cover most of the needs of the organic sector with very good results.

In relation to sustainability, there is overall recognition of the importance of PRM as the starting point of agri-food production for achieving the relevant objectives. Conventional breeders and most NCAs supported that the current VCU requirements for agricultural plant species already contribute to these objectives, as they allow for the acceptance of varieties with characteristics that contribute to a more sustainable production as disease resistance, nutrient efficiency, drought tolerance and increased yield. Introduction of requirements of examination of new varieties of fruit plants and vegetables for such characteristics was supported, though not in the form of the current VCU for agricultural plant species, as the uses especially for vegetables are very diverse. The need for flexibility to address the different conditions across Europe was stressed by almost all respondents. Actors involved in conservation activities and organic production stressed that the contribution to sustainability of material not meeting the DUS requirements is equally important, especially for production under low-input and organic conditions and in relation to short supply chains (locally adapted varieties for local markets). Some of these actors also put in question the usefulness of examination of varieties for specific characteristics, arguing that one should rather look into the sustainability of agricultural production practices.

In relation to links to plant health requirements, the need to remove duplications on RNQPs between PHL and PRM was recognised by most NCAs and operators. For the purposes of conservation and sustainable use of genetic resources some stakeholders called for exempting operators and PRM from all plant health requirements. On the contrary, the majority of NCAs and other operators explicitly opposed to exemptions from plant health requirements, even if exemptions would be granted from the PRM rules for variety registration and PRM certification.

As regards OCs, most operators agreed that a harmonisation of requirements is desirable, noting that this however should not lead to increased administrative burdens for them. Views were also split as regards the inclusion of the PRM and FRM legislation in the scope of the OCR, due to concerns for potential increase in administrative burdens. In particular for PRM, almost all NCAs and operators were against including the certification system as such under the OCR. The majority saw benefits as regards more efficient marketing and import controls. As regards FRM, most respondents opposed to the inclusion of the FRM legislation into the scope of the OCR because of the specificity of OCs in this sector and called for OCs to remain under the control of the respective forest competent authority. Most stakeholders of all categories called for maintaining some flexibility in the organisation of OCs and keeping the costs as low as possible.

In relation to the use of BMTs and digital solutions, most PRM and FRM stakeholders agreed that these could bring benefits and called for the legal framework to allow the latest technologies to be applied, in line also with developments of international standards. There is overall agreement that the phenotype-based system of registration of varieties should be maintained. Some stakeholders even called to limit BMTs use only when these are linked to phenotypic expression. Almost all however could agree to introduce the options for use of BMTs and digital solutions, without making these an obligation.

There is overall support for extending PRM certification activities under official supervision. Above 50% of FRM stakeholders were favourable of allowing certain certification tasks to be conducted under official supervision except for the issuing of the master certificate. Some PRM and FRM stakeholders declared that SMEs might not have sufficient human and financial resources for carrying out certification under official supervision. They stressed that it should always be possible for the operators to opt for certification by the NCAs. However, views on whether VCU should become possible under official examination were split, as fears were expressed by different stakeholders that the reliability of results would be undermined and/or that it could be difficult to have comparable results. The majority of forest NCAs and regional authorities opposed to the assessment for the approval of basic material intended to produce FRM of the source-identified and tested categories by operators under the official supervision of the NCAs.

All respondents that provided comments in relation to ornamental propagating material emphasised that there is no need to change the current simple rules. There should not be any DUS tests for variety registration of ornamental crops as such tests would seriously increase costs and decrease the number of varieties on the market without having any benefits. In their opinion, the market regulates itself with a private registration system for determining the identity of varieties.

As regards FRM, there is overall support for keeping the FRM legislation separated from the legislation on other PRM. All respondents called for keeping the existing pillars of registration of basic material and FRM certification. The majority of respondents highlighted the necessity to retain flexibility allowing MS to decide which FRM is adapted to the local and regional climatic and ecological conditions. Respondents expressed mixed views on the extension of the scope of the FRM legislation to the production and marketing of FRM for certain non-forestry purposes.

4.Conclusions

The different consultation activities complemented each other to achieve a balanced evidence base covering different stakeholder categories. From all the stakeholder consultation activities organised, it emerges that option 2 would best address the concerns of all actors.

Annex 3: Who is affected and how?

1.Practical implications of the initiative

This proposal will have practical implications for all those in the private, public and non-governmental sectors who are active in the marketing of PRM and FRM. This includes operators (breeders of new varieties, seed multipliers, companies marketing PRM and FRM, organisations engaged in conservation and sustainable use of plant and forest genetic resources), NCAs responsible for the acceptance of new varieties and the certification of PRM and FRM and the relevant OCs.

1.1.Operators

Breeders and/or applicants for the registration of new varieties of the regulated species will have to meet more elaborated criteria as regards the contribution of these varieties to a more sustainable agri-food production. This may result in increased breeding costs and lower numbers of new varieties being authorised for marketing, at least in the first years after entry into force of the new requirements until breeding programmes can be adjusted to the new requirements.

Producers of FRM will have to assess FRM for characteristics contributing to sustainable production and make available to buyers/users of FRM information on the suitability of FRM for climatic and ecological conditions. Producers of FRM for specific non-forestry purposes will have to meet the requirements of the FRM legislation (approval of basic material, rules on provenance, certification of FRM).

All other measures do not result into new obligations for operators but provide them with new options (additional certification tasks possible under official supervision, VSCU examination under official supervision, digitalisation of documents, use of BMTs, use of innovative production methods). In order to make use of some of these new options, operators may have to reallocate their resources and/or carry out some investment. The extent of such investments will largely depend on the current situation, e.g. using the option for additional certification tasks will be much easier and will probably require no significant investments for operators already carrying out certification tasks under official supervision. Other measures will provide lighter conditions for accessing the market (organic varieties suitable for organic production, conservation and locally adapted varieties, heterogeneous material), without resulting into new obligations.

1.2.National competent authorities

Extension of the certification tasks that may be carried out under official supervision is expected to require that NCAs will have to reallocate staff from official certification activities to training and supervision activities. The impact of this will depend on the demand by operators to carry out additional tasks under official supervision.

Extension of the current VCU requirements for agricultural plant species and vine to better address sustainability and introduction of sustainability requirements for all other crop groups (vegetables and fruit plants) in the procedure of acceptance of new varieties will require that NCAs increase their capacity in terms of staff and testing stations. This impact will be mitigated by a transition period before these requirements enter into force, permitting these examinations to take place under official supervision at the premises of the operators and allowing the cooperation between the MS.

Harmonisation of OCs on production, marketing and imports of PRM/FRM and subjecting them to the OCR, as well as moving the lists of RNQPs and specific measures to the PHL with PRM/FRM legislation referring to them instead of duplicating them, will also require NCAs to reallocate some of their resources (depending on current allocation between PHL and PRM/FRM certification) or increase their resources in case they don’t already meet the minimum rates of OCs to be introduced. OCs subject to OCR will also mean that NCAs will have to include OCs on PRM and FRM in the multi-annual national control plan and to publish an annual report on the number of OCs carried out and the outcome of those controls, but several NCAs already follow these practices despite not being an obligation currently.

Adapted DUS and VCU requirements for the examination of organic varieties suitable for organic production will require that NCAs allocate staff and testing stations to test these.

Lighter rules for seed conservation networks, marketing to amateur gardeners and exchange in kind of seed, simplification of current rules for conservation varieties and extension of those rules to cover new locally adapted varieties and broadened scope for heterogeneous material beyond organic production on the one hand will require dedicated staff for their implementation. On the other hand, removal of some of the current requirements (variety registration and PRM certification) will mitigate this impact.

Extension of the scope of FRM legislation to include the production of FRM for specific non-forestry purposes, extension of sustainability requirements to cover lower FRM categories, and introduction of a requirement for contingency planning to ensure availability of FRM may also require an increase in the resources of the NCAs.

1.3.Users of PRM and FRM

There are no new obligations for the users of PRM and FRM resulting from this initiative as the scope of the legislation does not cover the use and the users of PRM and FRM. However, the increased sustainability assessment may lead to a marginal increase of price of inputs (seed and other PRM) for farmers, but the initiative is expected to lead to increased availability of PRM and FRM for all types of users, and to PRM and FRM being more suitable for meeting future challenges. Consequently, users of PRM and FRM will benefit from a higher stability of their income under adverse conditions.

2.Summary of costs and benefits

The estimates of costs and benefits refer to the preferred option in relation to the baseline. The main recipient of the benefit is indicated in the comments’ column.