TABLE OF CONTENT

section 1: procedural issues and consultation of interested parties

1.1. Consultations 4

1.2. Data collection 5

1.3. Inter-Service Steering Group 6

1.4. follow-up of recommendations of the impact assessment board 6

section 2: problem definition

2.1. Background 7

2.2. Problem identification 12

2.2. Related issues 20

2.2. Parties affected 21

2.4. How would the problem evolve, all things being equal? 22

2.5 Does the EU have the right to act (subsidiarity)? 22

section 3: objectives

3.1. General objectives 25

3.2. Intermediate objectives 25

3.3. Specific objectives 25

3.4. Consistency with other EU policies and horizontal objectives 26

section 4: policy options

4.1. Policy options included in the analysis 27

4.2. Discarded policy options 28

section 5: analysis of impacts

5.1. Option 1: Improve only the form and clarity of the regime 31

5.2. Option 2: Prioritise, modernise and step up prevention 31

5.3. Option 3: Prioritise, modernise, step up prevention and reinforce action 34 against outbreaks

5.4. Option 4: Prioritise, modernise, step up prevention, reinforce action 37 against outbreaks and expand the scope to IAS plants

section 6: comparing the options

6.1. Comparing options in terms of economic, social and environmental impacts 40

6.2. Comparing the options in light of the objectives 41

6.3. Highlight the trade-offs and synergies associated with each option 42

6.4. Preferred option 45

section 7: monitoring and evaluation 46

literature 48

section 8: annexes

Annex I: Executive summary of the evaluation study 51

Annex II: Legal structure of the regime and foreseen changes 74

Annex III: International Plant Protection Convention 76

Annex IV: WTO Sanitary and Phytosanitary Agreement 78

Annex V: Convention on Biological Diversity 81

Annex VI: Overview of the EU agriculture and forestry sector 85

Annex VII: Relevance of harmful organisms and invasive alien plant species to the EU 94

agriculture and forestry, environment, landscape and public and private green

Annex VIII: Costs and expected impacts of the baseline scenario 104

Annex IX: Outline of amendments to the regime in options 1-4 and foreseen impact on costs 109

Annex X: Summary of the opinions of stakeholders and member states 121

Annex XI: List of consulted stakeholders 129

Annex XII: Executive summary of the supporting economic study 131

Acronyms

BTSF Better Training for Safer Food programme

CAP Common Agriculture Policy

CBD Convention on Biodiversity

COP Conference of Parties of the CBD

COPHs Chief Officers for Plant Health

CPM Commission on Phytosanitary Matters of the IPPC

CSF Common Strategic Framework

EFSA European Food Safety Authority

EPPO European and Mediterranean Plant Protection Organisation

EU European Union

FAO Food and Agriculture Organisation of the United Nations

FCEC Food Chain Evaluation Consortium

GATT General Agreement on Tariffs and Trade

IA Impact Assessment

IAS Invasive Alien Species

IPPC International Plant Protection Convention

ISPM International Standard on Phytosanitary Measures

ISSG Inter-Service Steering Group

ISTA International Seed Testing Association

IT Information Technology

MS Member State

NGO Non-Governmental Organisation

NPPO National Plant Protection Organisation

PHD Plant Health Directive

PHR Plant Health Regime

PRA Pest Risk Analysis

PRM Plant Reproductive Material

PZ Protected Zone

RPPO Regional Plant Protection Organisation

SME Small and Medium-sized Enterprises

SPS Sanitary and Phytosanitary Agreement under the WTO

TF Task Force

TFEU Treaty on the Functioning of the European Union

TRACES Trade Control and Expert System

WPM Wood Packaging Material

WTO World Trade Organisation

Acronyms of consulted stakeholders' organisations are provided in the Annexes.

Section 1: Procedural issues and consultation of interested parties

1.1. Consultations

Member States

The Council on 21 November 2008 invited the Commission to proceed to an evaluation of the EU plant health regime (PHR) and to consider possible modifications to the existing legal framework and the impact of such modifications[1]. The Commission initiated a comprehensive evaluation of the regime from the introduction of the internal market (1993)[2] and contracted the necessary study out to an external consultant[3]. Member State (MS) experts participated in the Inter-Service Steering Group for the evaluation. A conference took place on 23-24 February 2010 to inform the stakeholders and MS on the progress of the evaluation and to consult them on the provisional options for the future developed by the consultant. The input received framed the final options and recommendations. The report of the evaluation[4] (Annex I) was presented in a second conference[5] on 28 September 2010 including stakeholders, the general public, and representatives of MS and third countries. Linked to this conference was a public consultation on the recommendations from the evaluation and the scope of the subsequent impact assessment.

In preparation for the impact assessment (IA), the options recommended by the external consultant were discussed with the MS in Council with the Chief Officers for Plant Health (COPHs)[6] and, as concerns the coherence with the Plant Reproductive Material (PRM) regime, the Heads of Service for that regime and the relevant Working Party[7]. Four task forces with MS experts and Commission were set up and twice convened[8] to further discuss the main areas of change. A fifth task force was set up[9] to discuss the inclusion of plant health controls in Regulation 882/2004/EC. Task force reports were approved by the Council Working Party of the COPHs, with whom final meetings on the foreseen changes and the impact assessment took place on 3-4 May and 7-8 June 2011. At the 3-4 May 2011 meeting, a consultation document concerning the strategic review options was launched. In addition, input for the consultations and position papers were received from several MS and data for the evaluation and IA were supplied by the MS to the external consultant. The MS were also informed on the review via the Standing Forestry Committee on 28 June 2011.

Stakeholders

Stakeholders (industry association representatives and NGOs) were consulted from the very start of the review process, prior to the initiation of the evaluation of the PHR[10], during the evaluation study and again during the preparation of the IA. An ad-hoc Working Group on Plant Health[11] was set up under the Advisory Group on the Food Chain, Animal and Plant Health. The progress was furthermore presented and discussed in the aforementioned Advisory Group itself[12], in other Advisory Groups[13] and on invitation in meetings of COPA-COGECA, EUROPATAT, ESA and UNION FLEURS[14]. Stakeholder consultation was a key element of the evaluation study and the supplementary economic study contracted out to an external consultant. The consultation concerned changes of the EU plant health regime itself as well as elements of the regime to be transferred to or from the PRM regime and the future chapeau EU regime on official controls[15] on food and feed, animal health and welfare, plant health and plant reproductive material.

The conferences organised during the review process ensured stakeholders' input and views concerning the recommendations and the scope of the impact assessment, both orally at the conferences and through the linked public consultation. A consultation on the technical change proposals was linked to the meeting of the Working Group on Plant Health on 18 February 2011 and targeted the preferred way forward for the changes with major impact. Consultations were additionally published on the dedicated web page[16] of DG SANCO. A final consultation[17] on the strategic options was launched on 13 May 2011.

Summary of the consultation of the interested parties

Throughout the evaluation, IA and policy making process interested parties' (MS and stakeholders) views have been sought in order to design the policy options and assess their potential usefulness and impacts. Annex X gives an overview of their positions and Annex XI lists the stakeholders that were consulted during the process and/or sent in opinion papers.

1.2. Data collection

The collection of data commenced with a comprehensive evaluation of the PHR by the external consultant from 2009 to 2010. The evaluation included an ex post analysis of the regime for the period 1993-2008, the collection of economic data on costs and administrative burden for competent authorities and stakeholders stemming from the regime, as well as the development ex ante of options and recommendations for the future. The evaluation report was delivered in May 2010.

The internal process to develop the IA was further supported by a second contract with the consultant. This contract concerned a study on the quantification of costs and benefits of amendments to the regime, supplementary to the data that had been collected during the evaluation. The study consisted of modules addressing the ex ante assessment of the economic impact of specific technical options for the revision of the legislation. The scope of the issues to be addressed had been subject to stakeholder consultation. The modules were set up in such a way that aggregation was possible to potential overall policy options. In July 2011, the final report of the study (Annex XII) was delivered by the consultant. Where necessary further information was gathered from the literature, study reports and queries to assess the key impacts the change in policy would have. Furthermore, the social and environmental impacts of the policy options were assessed by Commission's services.

The data gathered as described above are used and referenced throughout the IA, along with data from the scientific literature and reports of studies carried out for the Commission and the MS in relation to harmful organisms (pests of plants) and invasive alien plant species and their impacts.

1.3. Inter-Service Steering Group

A Commission Inter-Service Steering Group (ISSG) on the IA for the revision of the legislation was established. The group was led by DG SANCO with the participation of the following Commission Directorates General and Services: Agriculture and Rural Development, Budget, Environment, Enterprise and Industry, Research and Innovation, Taxation and Customs Union, Trade, Legal Service and the Secretariat-General. The group met on 6 December 2010 (planned approach and problem analysis were discussed), 15 April 2011 (report from the contractor on progress, collection of data and a first draft of the impact assessment were discussed) and 26 September 2011 (exchange of views on draft final impact assessment report). Final comments received from the ISSG members were incorporated as appropriate.

1.4. Follow-up of recommendations of the Impact Assessment Board

The IA was discussed at a meeting of the Impact Assessment Board on 14 December 2011. The recommendations of the Board prior to the meeting in its quality checklist and following the meeting in its opinion have allowed improving the report. Firstly, the revised IA report further clarifies the budgetary implications of co-financing direct operator losses due to action to tackle EU priority pests. As requested, Annex IX now provides further details on the level of those costs, the respective rules for Union co-financing and capping of those costs and the mechanisms to cope with high demand, the modalities to allow operators to obtain the financial compensation, and the interplay with the listing of priority pests. Secondly, the report further underpins the need for Union financial support for early detection and eradication of pest outbreaks. Thirdly, the report explains the extent to which smaller firms could use approaches suitable to their size. Fourthly, the differences between invasive alien plant species and harmful organisms (pests) of plants and the implications for their management are clarified.

Section 2: Problem Definition

2.1. Background

2.1.1. Rationale for the EU plant health regime

Plant health is a key factor for sustainable and competitive agriculture, horticulture and forestry. Healthy seeds and propagating material are required for profitable crops and ensuring jobs, plant innovation and food security[18]. In the case of trees and shrubs, protecting plant health is essential for the preservation of the Union's forests, landscape and public and private green. As a rule, organisms (insects, fungi, nematodes, bacteria, viruses) that are injurious to plants co-evolved with host plant species on their own continent, where they cause mild damage and can be managed by good agricultural practices such as crop diversification, rotation, resistant plant varieties and the use of plant protection products (pesticides). However, these approaches are often insufficient to address pests and diseases from other continents, against which European plants and trees usually lack genetic resistance (no co-evolution) and for which no natural enemies occur in Europe. When introduced into Europe, such pests and diseases cause severe economic damage and reduce the growth of agriculture: they jump to previously unaffected and even entirely new host species, spread fast across countries, and cause lasting yield reduction and permanently increased costs for production and control. The often severe economic losses undermine the profitability and competitiveness of agriculture and forestry and put additional burden on Member State (MS) expenditures. In addition, the establishment of new pests and diseases often elicits trade bans from third countries, causing further damage (economic, jobs) to EU exports.

Therefore, the first objective of the EU plant health regime (PHR) is to protect European agriculture and forestry by preventing the entry and spread of non-native harmful organisms (pests and pathogenic micro-organisms). The main tool hereby is Council Directive 2000/29/EC, which also reflects international trade agreements in this area. The PHR secures safe trade by the establishment of EU import requirements and intra-EU movement conditions for plants and plant products[19]. Outbreaks of the listed organisms have to be eradicated or, if that is impossible, contained to protect the rest of the EU territory. A second objective of the regime is to ensure the availability and use of healthy plant material at the beginning of the chain of plant production by preventing the spread of harmful organisms with seeds and planting material. This objective is shared with the EU regime for plant reproductive (planting) material. Healthy planting material is critical for organisms (e.g. viruses) against which no pesticides are available. Where available, pesticide use is mainly restricted to agriculture, horticulture (applications in forestry are very limited) and gardens and may bring along environmental and human health risks.

The EU PHR is unique in that it is an open regime: movements of plants and plant products into and within the EU are allowed on condition that specific restrictions and requirements are respected (e.g. provenance from a pest free area or appropriate treatment). The high volumes of imports from other continents (Annex VI) nevertheless imply a high probability of future outbreaks of alien harmful organisms. The PHR is therefore indispensable both for protecting the health, economy and competitiveness of the EU plant production sector as well as for maintaining the Union's open trade policy.

There are close analogies between the PHR and the EU animal health regime, which have similar objectives and intervention logic (stamping out)[20].

2.1.2. International legal framework

The international framework for regulatory plant health is the International Plant Protection Convention (IPPC; Annex III), to which the EU and the MS are contracting party. The WTO Sanitary and Phytosanitary Agreement (SPS; Annex IV) recognises the right of WTO members to decide on the appropriate level of protection of plant life or health, while setting out rules how that level may be achieved without undue interference with trade. The Convention for Biological Diversity (CBD; Annex V) aims to prevent the introduction and spread of invasive alien species (IAS) in general, including non-native pests of plants. Reversely, the IPPC definition of 'pest' (the equivalent for 'harmful organism' in the EU legislation) includes invasive alien plant species, i.e., a subset of the IAS covered by the CBD. Since 2004, the CBD and IPPC officially cooperate to promote synergy and avoid overlaps and unnecessary duplication. No IAS plants have been regulated so far under the PHR other than parasitic plants.

2.1.3. The Plant Health Directive

The main instrument of the PHR is Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products[21] and against their spread within the Community (hereafter: Plant Health Directive). It is a consolidation of the initial Council Directive 77/93/EEC that dates back to 1977, when the import requirements of the MS were harmonised while plant health controls were maintained for movements between MS. Major updates:

- At the creation of the internal market (1993), border controls between MS were abolished, including those for plant health. A fundamentally new system was developed to balance the free trade of plant material across the EU and the protection of parts of the EU that should remain free from harmful organisms occurring elsewhere in the EU (the 'protected zones' (PZ)). To this end, a document ('plant passport') was introduced to accompany plant material moved between MS, replacing the phytosanitary certificate foreseen under the IPPC. The passports also have to be used for movements inside a MS. Official controls on plant passports were now to be made at the source (operator premises) instead of the border or destination and a registration obligation was established for operators handling regulated plant materials;

- An EU co-financing system was put in place in 1997 for the costs of control and eradication of harmful organism outbreaks (Council Directive 97/3/EC);

- The import regime was reinforced in 2002, on which occasion the scope of plant material subject to import controls was expanded, a system for reduced frequency checks was created as well as an obligation to levy fees for import controls.

The scope of the Plant Health Directive includes requirements concerning:

- Import and intra-EU movements of plant material and harmful organisms (including plant passports and protected zones);

- Surveillance, notification, eradication and containment of outbreaks (including a framework for emergency measures);

- Financial measures.

The EU plant health regime is an open regime. Movements of plants and plant products into and within the EU are allowed on condition that specific restrictions or requirements are respected. This relates to import (prohibitions of specific high-risk plant materials; conditions to be fulfilled and attested on the phytosanitary certificate for others) and intra-EU movements (plant passporting requirements, with a special variant for protected zones). The Plant Health Directive does not cover export[22], other than setting out the format of the phytosanitary certificate (the IPPC format) that is to be used for export certification, which otherwise is the responsibility of the MS.

As concerns the harmful organisms covered, the Directive in its Annexes lists the particularly dangerous harmful organisms against which official measures shall be taken. In order to be able to take measures against outbreaks of new, as yet unlisted harmful organisms, the scope of the Directive allows covering any harmful organism if justified by its potential socio-economic and environmental impacts. National measures concerning non-listed harmful organisms shall be notified to the Commission and the other MS, justified by a Pest Risk Analysis (PRA) and subsequently harmonised at EU level or rescinded. Measures should not be taken against harmful organisms of minor importance (no justification under IPPC and SPS) or widespread harmful organisms where territorial protection is not relevant. The scope of the Plant Health Directive does not include the official control of widespread harmful organisms (for example native pests and pathogens)[23], which are to be managed by good agricultural practices such as crop diversification and rotation.

At its update on the occasion of the creation of the internal market, the Plant Health Directive was designed to focus on the movements of plants and plant products and the eradication or containment of outbreaks. The spread of harmful organisms other than by movement of consignments (natural spread) was explicitly excluded from any EU co-financing, even though the mandatory eradication and containment of outbreaks would often require acting against follow-up outbreaks resulting from natural spread.

The provisions in the Plant Health Directive impose obligations on the MS to transpose and implement the Directive and officially control compliance. The Directive imposes indirectly restrictions on private operators, subjects them to official controls for which fees may (plant passport) or shall (import) be levied and subjects them to measures upon findings of regulated harmful organisms. It does not provide incentives for compliance. Private operators may however be authorised to issue plant passports under official supervision, and private laboratories may be authorised for official analyses under official supervision.

2.1.4. The Control Directives for potato

With respect to four specific, internationally recognised regulated pests of potato, Control Directives were adopted, two of which antedate the Plant Health Directive. Control Directives for potato cyst nematodes and potato wart disease were adopted in 1969, followed by Control Directives for potato ring rot (1980) and potato brown rot (1998). These harmful organisms occur in several MS and cannot be completely eradicated from the Union territory. The objective of the Control Directives is to control (contain) the presence of the regulated harmful organisms in infested fields, thus mitigating the risk of further spread in the EU. The four harmful organisms are also listed in the Annexes of the Plant Health Directive.

2.1.5. The Marketing Directives for plant reproductive material

Plant reproductive material is the cornerstone for agricultural production. Therefore, ensuring the availability of PRM of sufficient quality and health is crucial for the production of food, feed and other agricultural commodities. The PRM legislation is based on the registration of varieties and the certification of PRM lots. It consists of a horizontal Council Directive on the Common Catalogue of varieties of agricultural plant species and 11 vertical Council Directives on the marketing of commodities of seed and propagating material. About 200 harmful organisms are regulated which may be widespread in the EU, but impact on quality and can usually not be detected visually (market failure). Some of these overlap with those regulated under the Plant Health Directive and the Control Directives for potato. Under the IPPC, these harmful organisms are called Regulated Non-Quarantine Pests.

Plant health controls are part of the certification system of the Marketing Directives, which leads to issuance of a certification label which may be combined with the plant passport issued under the Plant Health Directive. Certification is based on a systems approach consisting of field inspections during the season and inspections on lots prepared for marketing, including mandatory laboratory testing. Equivalence agreements have been concluded with specific third countries, under specific certification schemes, in which case no systematic import controls are in place. In absence of equivalence, the import into the EU is prohibited or temporarily allowed under specific requirements. For the implementation of those Directives that foresee process control, like in the Plant Health Directive, private operators have to be registered and authorised. In some MS but not in others, the competent authorities for PRM coincide with those under the Plant Health Directive. The responsibilities of operators are similar to in the PHR, although differences exist in relation to the possibilities for official delegation of tasks. Laboratory testing of seed is carried out using the protocols of the International Seed Testing Association (ISTA). The PRM regime is under review, including improvement of the coherence with the PHR. Changes in arrangements between the two regimes are addressed in this impact assessment.

2.1.6. Regulation (EC) No. 882/2004 on Official Controls

Regulation (EC) No. 882/2004 provides a harmonised framework of general rules for the official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Certain aspects of this Regulation already apply to the plant health sector and in particular those concerning the establishment of multi-annual control plans and Union inspections in MS and third countries. A recast of the Regulation is being developed which will cover fully also PHR and PRM controls. The horizontal principles of the amended Regulation will replace those in sectoral legislative acts. The present impact assessment addresses the changes in the traditional pillars of the PHR, also if specific provisions (for example fees) will be absorbed by that Regulation. This is essential since the PHR review concerns the functioning of the regime as a whole.

2.1.7 The development of an EU Strategy on invasive alien species

Invasive alien species are organisms (animals, plants, microbes) that are introduced accidentally or deliberately into the EU where they are not native. They represent a serious threat to native plants and animals in Europe which needs to be addressed if the EU is to achieve its goal of halting the decline of biodiversity by 2020. IAS cause some EUR 12.5 billion worth of damage each year in the EU[24]. The Commission published a Communication[25] "Towards an EU Strategy on Invasive Species" in December 2008 and noted that while some EU instruments exist to deal with other drivers of biodiversity loss, there is currently no comprehensive instrument at EU level to tackle IAS, although action has been taken at EU level to address certain aspects of this threat. The European Commission adopted its EU post-2010 biodiversity strategy[26] in May 2011, including a target dedicated to IAS: "By 2020, IAS and their pathways are identified and prioritised, priority species are controlled or eradicated, and pathways are managed to prevent the introduction and establishment of new IAS". Two actions have been identified to support this target (scheduled for 2012): (i) to integrate additional biodiversity concerns into the plant and animal health regimes; and (ii) to fill policy gaps in combating IAS by developing a dedicated legislative instrument. The current review of the PHR aims to reinforce the Union's protection against invasive pests and pathogens, while where possible contributing to wider biodiversity goals.

The future IAS legislation will not cover pests and pathogenic microbes of plants and animals, as these are covered already by the PHR and the EU animal health legislation, but will close the existing legislative gap for other invasive organisms such as introduced grey squirrels and tiger mosquitos (a vector of dengue and other human diseases). Depending on the outcome of the review of the PHR, the IAS legislation would or would not also cover invasive plants, such as water hyacinths and ragweed. Invasive plants differ from the harmful organisms regulated under the PHR in that they do not cause direct harm to plants, like pests and diseases do, but compete with other plants for nutrients and space. Invasive plants may affect not only terrestrial but also aquatic and marine ecosystems, which are presently not dealt with by the PHR. Both the harmful organisms currently regulated by the PHR and invasive plants require import prohibitions and restrictions to protect the EU territory. However, the strict eradication measures of the PHR ("stamping out") may not be suitable for invasive plants in natural habitats, where management by suppression may be more appropriate. Also, restricted local release of invasive plants may be justified in certain cases (for example gardening) while the release of regulated pests and pathogenic microbes should be fully prohibited. There are pros and cons for including invasive plants in the future PHR.

2.2. Problem identification

Since its creation in 1977, the PHR successfully protected the EU against the introduction and spread of many pests (e.g. potato and citrus pests). The situation has however changed due to the on-going globalisation of trade, resulting in ever increasing imports from new parts of the world. This has led to a sharply increased influx of new harmful organisms, especially in the last decade. Europe increasingly fails to stop that influx where North America succeeds relatively well (see graph below)[27]. The problems are being exacerbated by climate change, which allows new pests to establish and thrive that previously did not survive in the EU as well as higher vulnerability of EU crops and forests to alien pests (e.g. Robinet et al., 2011). The EU is thus confronted with an increased risk of entry of pests, increased opportunities for their establishment and spread, and increased vulnerability of agricultural and natural ecosystems (including forests). The enlargement of the EU has moreover resulted in a wider diversity of climates, agricultural cropping systems, forest types, landscapes and natural habitats, often differing in sensitivity or resilience to harmful organisms which leads to even more significant and wider impacts at EU level. Indeed, globalisation of trade, climate change and evolutionary adaptation of harmful organisms to new host plants are being considered major drivers of the increasing problems with plant pests and diseases (Waage et al., 2007).

Temporal changes in new records per year in Europe of alien invertebrates. (a) Total number of alien invertebrates. (b) Total number of alien insects associated with woody plants in Europe compared to North America. Source: A. Roques, Invasive patterns of alien terrestrial invertebrates in Europe (in: Pimentel, 2011).

Major outbreaks in the past decade of dangerous import-related harmful organisms affecting forestry (e.g. pine wood nematode, citrus longhorn beetle, red palm weevil) have raised societal and political awareness of the costs and impacts of inadequate protection. The evaluation of the PHR (2010) has shown that the regime has to adapt in order to be able to fully address these increased risks and recommends to modernise it through more focus on prevention, better risk targeting (prioritisation) and more solidarity (moving from a MS based to EU approach for joint action to tackle risks of EU significance). A mismatch between currently available resources and targeted objectives is reported to underpin many of the identified shortcomings and weaknesses. The need is underlined for a reinforced financial instrumentation to ensure better preparedness in case of emergency.

Pine wood nematode The pine wood nematode (PWN), Bursaphelenchus xylophilus, is a serious pest of conifers, vectored by bark beetles. It is native to north America, where it does little harm to pine trees (co-evolution). It spread to southeast Asia in the early 20th century where it caused mass mortality of forests in Japan, China, Korea and Taiwan. Its main spread to new areas is with infested wood. To offer protection against wood-vectored pests, the IPPC developed the International Standard for Phytosanitary Measures No. 15 concerning appropriate treatment of wood packaging material. An outbreak in Portugal in 1999 led to EU emergency measures for PWN eradication. Despite these, PWN spread within Portugal, the continental part of which is now considered infested as well as Madeira. Three outbreaks occurred in Spain which are being eradicated with large-scale felling (in a radius of 500-3000 m around the infested trees), monitoring and testing. The area at risk in the EU is 13 mio hectares of coniferous forest in southern Europe where 50-90% mortality is predicted (valued at EUR 39-EUR 49 billion) (FCEC, 2011). Spread of PWN would additionally impact on central European forests and on exports from Scandinavian forests.

The main problems identified relate to insufficient focus on prevention in relation to increased imports of high-risk commodities, the need for prioritising harmful organisms at EU level across all 27 MS, the need for better instruments for controlling the presence and natural spread of pests in case they eventually reach the Union territory, and a need for modernising and upgrading the instruments concerning intra-EU movements (plant passports and protected zones), and a need to foresee additional resources. The science base of the regime (research, laboratories) also needs to be reinforced. These problems should be addressed to reinforce the positive cost-benefit balance of the current regime in the long term. Failure of regulatory action against outbreaks would undermine the credibility of those actions, discourage investments in the regime and stimulate MS to give priority to short-term national interests above EU priorities (vicious circle). This would damage the EU economy as a whole.

Red palm weevil The red palm weevil, Rhynchophorus ferrugineus, is an extremely damaging pest of a wide range of productive and ornamental palm trees. The pest reached the EU with infested planting material from third countries. Red palm weevil has spread across most of the Mediterranean where it has killed thousands of palms. The impact of the pest in the EU is estimated to have reached at least EUR 50 mio in containment and eradication costs for the MS competent authorities alone and to have involved the destruction of at least 65,000 trees, which is only a fraction of those infested. On the basis of the destroyed palms alone, the value of the trees lost is estimated at EUR 65-EUR 195 mio, on the basis of the infested palms, EUR 96-EUR 288 mio (FCEC, 2011). The red palm weevil threatens the survival of three endemic, endangered palm species in Europe: Phoenix theophrasti in Crete, P. canariensis in the Canary Islands, and Chamaerops humilis in the western Mediterranean region.

2.2.1. Insufficient focus on prevention in relation to imported high-risk organisms

The evaluation has shown that the instrumentation of the regime has shortcomings as concerns prevention of the entry, establishment and spread of import-related high-risk organisms. The Plant Health Directive in its current form addresses risks related to imports from third countries by prohibitions of the import of some plant species and specific requirements for numerous other plants and plant products. Detailed rules exist on official import controls. The instrumentation for the follow-up, including surveillance, contingency planning, rapid outbreak eradication and containment, is weak should a harmful organism have gone unnoticed during import inspection. It consists mainly of the obligation to notify outbreaks and take the necessary measures, along with a possibility to adopt national and EU emergency measures. No general surveillance obligation exist. The evaluation report recommends introducing mandatory general epidemio-surveillance at EU level for priority HOs and co-financing to improve surveillance. EU co-financing is currently limited to costs for eradication and containment. For many years the EU budget was EUR 1 million per year; for 2011 EUR 12 million was allocated[28]. So far, the EU has not co-financed losses of private operators for destroyed plant material following official measures (contrary to the policy for culled animals under the EU animal health regime[29]). This is a disincentive for growers to notify outbreaks of regulated harmful organisms and comply with the measures, while eradication measures need to be taken in the very early phase of invasions when infestations are still small (Pluess et al., 2012).

Costs of late detection of outbreaks due to lack of surveillance Pine wood nematode was detected in 1999 in Portugal in the Setubal peninsula. At the time of detection, > 500 000 hectare of forest proved already infested (the PHR does not oblige MS to carry out systematic surveys for new harmful organisms). Up to 2011, the Union granted EUR > 38 million to eradicate the pest in Portugal. Eventually, eradication proved impossible and the pest is now under containment. Three isolated PWN outbreaks subsequently occurred in Spain, close to Portugal. They were immediately identified and successfully eradicated by large-scale felling of forest. This was achieved with a Union support, up to 2011, of below EUR 5 million.

Horizon scanning for emerging risks is not specifically addressed in the regime. Problems exist with high-risk trade from third countries, in particular plants for planting. Many major outbreaks of the last decade stemmed from imports of such material, carrying latent pests and diseases which could not be detected at import but only after considerable time, when the organisms had spread and eradication had become very difficult. Furthermore, passenger luggage, currently exempted from the import prohibitions and restrictions and border controls, has shown to be a source of influx of prohibited regulated harmful organisms[30].

Third countries with the largest number of interceptions in trade to the EU, 2005-2011 (Source: FVO).

Numbers of interceptions by Member States concerning the presence of harmful organisms in commodities imported from third countries, 2011 (Source: FVO).

2.2.2. Need to focus on harmful organisms of EU priority

The evaluation has shown that the PHR does not adequately allocate the available resources to the major EU risks. The Plant Health Directive classifies the 250 regulated harmful organisms in two Annexes divided into Parts and Sections in relation to the plant material covered and presence in the EU, without prioritising them according to risk or impact. In practice, MS allocate resources as they see appropriate and priority may be given to national interests[31] above EU priorities. Harmonisation can be promoted through EU emergency measures, which have been put in place for 11 organisms, or through Control Directives which only exist for harmful organisms of potato[32]. This may however be at the expense of preventive actions against organisms that may be equally dangerous but have not yet led to outbreaks.

While the PHR needs a mechanism to ensure that priority is given to the interests of the Union as a whole, it also needs a flexible system for risk-based de-prioritisation. Organisms regulated under the PHR may become established and spread to an extent that territorial protection is no longer justified. In such cases amending their status to quality pests under the PRM regime or de-listing may be appropriate. This rarely happens. The Commission in 1991 listed 24 organisms as candidates for transfer from the Plant Health Directive to the Marketing Directives, of which by 2011 only one had been deregulated[33]. A major obstacle is the coverage of harmful organisms under two EU regimes, with separate Competent Authorities at MS level and separate Standing Committees at EU level. De-listing in the Plant Health Directive simultaneously with inclusion in the Annexes of the Marketing Directives requires two Commission Decisions. The lack of a common policy on harmful organisms and joint decision making has resulted in a lack of timely status change and double listing of organisms.

2.2.3. Need for better instruments for controlling presence and natural spread of pests

If a listed harmful organism is detected in a part of MS territory in which it was unknown, the MS shall take all necessary measures to eradicate the pest or, if that is impossible, inhibit its spread. Measures taken concerning outbreaks originating from natural spread are however not eligible for EU co-financing. The emphasis on movements of host plants rather than natural spread of pests reflects the history of the regime, which was shaped to protect agriculture and horticulture while at the same time supporting the creation of the internal EU market. Natural spread of harmful organisms in relation to eradication can temporarily be addressed in EU emergency measures by Commission Decisions. Control measures to permanently contain regulated organisms that could not be eradicated have to be laid down in Council Directives, which requires considerable time, disproportionate to the urgency of the matter.

Natural spread can in practice not be separated unambiguously from spread with movements (e.g. hitch-hiking insects in an airplane or truck not carrying plant material). Excluding natural spread from EU co-financing is a disincentive to action by the competent authorities and has undermined the success of eradication and containment measures[34]. Where forests and the landscape are affected, natural spread is often even the key factor which cannot be excluded. The interests of society have moved from a private to a public good emphasis: the protection of the natural environment, landscape and public and private green (the concepts of "greening" and "ecosystem services").

2.2.4. Need to modernise and upgrade the instruments of the intra-EU movements regime

The evaluation expresses concern about the credibility of the plant passport and protected zone systems. These were at the core of the 1993 review and created to balance free trade (movement) of plants and plant products within the EU with protection of certain pest-free zones in the EU against spread of pests with such commodities coming from other MS. Plant passports were created to replace phytosanitary certificates, previously issued by the Member States, for intra-EU trade on the single internal market. Protected zones were created to accommodate the unequal presence of certain harmful organisms across the EU (regionalisation). Plant material moved into a protected zone requires a specific "Zona Protecta" plant passport linked to enhanced phytosanitary safeguards. Enterprises within protected zones have competitive advantages over operators outside those zones, which have to meet higher standards to send plant material to the protected zones, and they have competitive advantages for export to third countries as they can attest that their material originates in a pest-free area.

The problems with the plant passport relate to its limited scope, lack of harmonisation of its format, ambiguity in its use as a traceability tool and overlap in use with the certification label of the PRM regime. Operators ask for more room for self-controls and issuance of the label under official supervision and for full responsibility for ensuring traceability of lots (rather than including such information on the plant passport). This would allow them to save costs. They perceive the role of private sector in the PHR in relation to the plant passport as more restrictive than for the certification label of the PRM regime. Unnecessary burden stems from coherence problems between these regimes, e.g. the positioning of harmful organisms in two regimes, one for territorial protection and one for ensuring quality, legally prohibits the inclusion of territorially regulated pests in the EU certification schemes for quality pests, while this would enhance effectiveness and reduce burden. Finally, unequal implementation between MS (fees, room for self-control) distorts the level playing field.

Several problems with the protected zones are due to MS failure to apply the legal measures and not flaws in the concept per se. There is evidence of failure to carry out surveillance and report the results and failures in the implementation of the PZ plant passport system. This is possible because the wording of the obligations is too general and does not fix how to manage outbreaks. The status of protected zones is thus regularly maintained despite multiple outbreaks, counter to the aim of the legislation. The zones are in such cases perceived by the private sector as a distortion of competition[35].

Number of interceptions of harmful organisms in trade between Member States (EUROPHYT)[36].

2.2.5. Erosion of the science base of the regime

The PHR was developed in decades where adequate support from R&D and laboratories was available, while since then severe erosion has taken place of the science base for the regime. A major shift has occurred in the academia from classical biological disciplines (plant pathology, taxonomy) to molecular-biological sciences and biotechnology. Molecular diagnostics however cannot replace classical diagnostic expertise but are supplementary. The erosion of the science base of the PHR creates risks as concerns the continuity of the regime in terms of the technical justification of legal provisions[37] and measures and rapid and reliable diagnosis. A solid legal base for official plant health laboratories, as provided by Regulation (EC) 882/2004, is lacking. The need for scientific support for policy development and for diagnostic laboratories via the establishment of EU reference laboratories for plant health will be addressed under the review of Regulation 882/2004 and via the Horizon 2020 programme.

2.2.6. Lack of resources for the regime

The initial absence of co-financing from the regime reflects its supposed private good nature, assuming that measures against harmful organisms would be good agricultural practice and costs from such measures should therefore be considered a risk inherent to entrepreneurship. The initial private good nature of the EU plant health regime links to a low level of public awareness and a low political profile. This is reflected in a low level of resources and cuts in staff and budget of MS competent authorities. The outbreaks in forests and public and private green in the past decade have highlighted the public good aspects and demonstrated the political need for public (EU) financial compensation. Although the EU budget available to the regime has increased from EUR 1 mio to EUR 12 mio (for 2011), the level available is too low to cover the needs. Budget is lacking altogether for co-financing of mandatory EU surveillance and operator losses from destruction measures. In essence, the lack of resources is due to a lack of awareness of the benefits of short-term actions to safeguard the long-term interests of the Union (lack of recognised justification of the regime) and market failure (public goods, externalities, information asymmetry).

2.2.7. Inconsistent implementation of the regime

Implementation of the regime has been hampered by a lack of appropriate instruments and resources, resulting in failure of actions concerning outbreaks. MS may give priority to short-term national interests above EU priorities, taking the advantages and opportunities for specific harmful organisms relevant to them (e.g. protected zones) and avoiding the disadvantages and costs of action (e.g. surveillance and eradication measures) for others which are not directly relevant to them. This hampers the effectiveness, reliability and credibility of the regime and the level playing field (the unequal levying of fees being a special case, in particular for plant passports where no fee obligation exists as yet). The current Directive contains minimal obligations concerning eradication of outbreaks and none on surveys, other than for the recognition of protected zones or in the case of emergency measures. On its own, enforcement by the Commission of the implementation by the Member States of the Directive, through infraction procedures, will not address the fundamental problems of the regime. Financial incentives need to be introduced to stimulate growers to notify outbreaks and to stimulate Member States to impose the necessary eradication measures. Unnoticed outbreaks and inadequate measures will allow pests to become established and spread to an extent where eradication is either no longer feasible or extremely expensive.

2.2.8. Need for a framework to regulate invasive alien species

The economic and environmental impacts of IAS are increasingly apparent. Especially the import of new IAS is of concern to the EU. The Commission has announced that a dedicated EU legislative instrument which could tackle outstanding challenges relating inter alia to IAS pathways, early detection and response and containment and management of IAS will be developed. IAS plant species, although part of the scope of the IPPC to the extent that they are terrestrial plants, are not addressed in the Plant Health Directive (parasitic plants excepted). It should be investigated in how far IAS could be included in the scope of the plant and animal health regimes in order to optimise the use of resources and infrastructures, while avoiding duplication of requirements under the future general invasive alien species legislation.

2.3. Related issues

2.3.1. Need for modernised governance

The expectations of society as concerns governance have changed. The current regime defines obligations to stakeholders, obliges them to pay fees for the mandatory controls, but involves them only to a limited extent in the policy development and implementation. This is no longer seen as appropriate; a new balance needs to be struck as concerns costs and responsibility sharing (partnership development). In this respect, it should be noted that the Commission proposals for the CAP 2014-2020 facilitate explicitly the use of insurances and mutual funds to cover losses from outbreaks of plant pests as well as losses resulting from eradication measures pursuant to Directive 2000/29/EC.

With the Better Regulation (SMART) agenda, and exacerbated by the current financial crisis, there is a strong need to reduce unnecessary costs and administrative burden. A modernisation need furthermore exists in terms of incentives.

2.3.2. Changed emphasis on public good

When the regime was created, agricultural productivity and food security were the global objectives of the Common Agricultural Policy (CAP) of the EU. A need for "greening" of the CAP has emerged and objectives relating to the natural environment and landscape have gained importance. This impacts on the intervention logic of the PHR which is moving from a private good regime for agriculture to a mixed public/private good regime for agriculture, forestry, natural environment and landscape. The assumptions and modalities for the financing of the regime are equally impacted (from private insurances and mutual funds only to mixed public/private funding reflecting responsibilities and objectives). In the near future, the PHR will however no longer be linked financially to the CAP[38], except for access to the crisis reserve.

2.3.3. Damage incurred by the regime in the past decade

The eroding benefits of the regime and the decline of resources have partly undermined the credibility of the regime, accelerated the erosion of the regime's science base (in itself an autonomous evolution) and allowed an increasing backlog in the organisational arrangements, capacities and quality assurance systems of plant health laboratories.

2.3.4. Overly complex legislation

The current text of the Plant Health Directive, the product of 34 years of amendments to the text of 1977, is highly complex and needs simplification. Missions of the Food and Veterinary Office of the Commission have shown that misunderstandings and differences in interpretation of the Directive are an important cause of non-compliances and, therefore, failure to achieve the objectives of the regime.

2.4. Parties affected

The regime affects the private sector (farmers/growers/traders in agriculture, horticulture, forestry), which is subject to obligations, prohibitions, restrictions, official controls for which fees are levied and, in case of findings or outbreaks, official measures. The costs of the regime impact on the profitability of the sector. The impact is small to sectors with a high profit margin (such as the seed industry) but more substantial to sectors with low profit margins (such as importers of fruit and vegetables and bulk commodities).While the private sector as a whole benefits from the regime, the economic impacts of measures on individual operators in case of an outbreak may be negative (up to bankruptcies).

The regime affects landscape managers, citizens, environmental NGOs and other parties interested in the conservation of the natural environment, landscape and public and private green. The impacts of non-action for these public goods can be considerable, including the disruption of ecosystems and disappearance of forest and street tree species. The impacts of eradication and containment measures to prevent that from happening may, on a local scale, be dramatic and costly for the owners.

The regime affects citizens in case of eradication measures in case of outbreaks in so far as the measures also concerns private gardens. As small quantities of plant material intended for non-commercial use by the owner in passenger luggage are exempted from the provisions, travellers are at present not impacted by the regime.

Regulated harmful organisms of trees may be spread with wood. The regime therefore regulates wood and wood packaging material used in shipment and transport of commodities. This impacts on the wood industries, wood packaging material industries, logistics industries and industry and trade at large.

Traders and growers in third countries are affected in that they have to comply with the EU provisions and pay for export controls and issuance of phytosanitary certificates. The competent authorities in third countries are affected because they have to perform these controls prior to export to the EU.

The competent authorities of Member States are affected as they shave to ensure infrastructural and staff resources for surveillance, official controls, official laboratory analyses, registration, authorisation and supervision of operators, training of staff and research and development.

2.5. How would the problem evolve if no action was taken?

The increasing influx[39] of new harmful organisms would cause new epidemics in EU agriculture and forestry. The resulting losses would affect the economic viability of agriculture and forestry and, at longer term, the rural environment, undermining food security and damaging the landscape and natural environment. Eradication and containment would continue to fail due to lack of resources and erosion of confidence in the regime. There would be growing opposition from private sector to carry the costs of the regime, given its lack of effectiveness and the limited sharing of costs and responsibilities between competent authorities and operators. As a consequence of on-going outbreaks and spread of dangerous harmful organisms, exports of EU plants and plant products to third countries would decline due to recurrent trade bans. The negative financial impact could range up to billions of Euros per year (FCEC, 2011).

Further to the text boxes provided, cases of damaging outbreaks in agriculture and forestry in Europe and on other continents are provided in Annex VII. The no-action scenario is further elaborated in Annex VIII.

2.6. Does the EU have the right to act (subsidiarity)?

2.6.1. Right of the EU to act

The Plant Health Directive and the Control Directives were based on Article 37 of the EC Treaty, now Article 43 of the Treaty on the Functioning of the European Union, implementing the Common Agricultural Policy. The objectives of that policy are to increase agricultural productivity, to ensure a fair standard of living for the agricultural

Agricultural losses from plant pests Losses from harmful organisms have been estimated to be attributable for 30% to new pests and diseases (Pimentel, 2005), although poor agricultural practices may be responsible to a larger extent in less developed countries. On a global scale, losses would be 50–80% in the absence of control measures such as resistant cultivars, crop protection chemicals and crop rotations. Even today, ca. 40% of staple cereal crops are lost to pests, diseases and weeds worldwide, equivalent to approximately a billion tonnes. Kenis & Branco (2010; as quoted by Pimentel, 2011) estimate annual economic losses for the EU of approximately €10 billion caused by already introduced alien insects, not including control, eradication, or quarantine costs, nor costs linked to foreign trade or market aspects. This does not yet consider similar costs due to introduced viruses, bacteria, fungi and nematodes, which add up to a multiple of that figure. The FAO (2006) forecasts that global food production will need to increase by 40% by 2030 and 70% by 2050 because of increasing demand due to population growth and changing diets, while crop losses caused by pests have not decreased since the 1960s, if anything they have increased (Bruce, 2010).

Examples of damaging plant pests in agriculture Diabrotica virgifera virgifera (Western corn rootworm): the "billion dollar bug" causes US $1 billion losses annually in the United States and induces the highest insecticide use in the world. Ralstonia solanacearum (potato brown rot): the bacterium causes up to 75% losses in the tropics and up to 40% in northern Europe, threatening an EU production value of about EUR 9 million. Xanthomonas axonopodis pv. citri (citrus canker): following its introduction into Florida, the US authorities have spent EUR 800 million in their fight against the bacterium. The production value of citrus in the EU, where the pest could cause huge damage, is about EUR 3.9 billion. Examples of damaging plant pests in forestry The impact of new pests and pathogens on forests could be disastrous. Some common tree species might disappear, as happened before to other once common tree species. Invasions from China of the so-called Dutch elm disease, caused by a fungus (Ophiostoma ulmi) that was foreign to Europe, have wiped out most of Europe's and America's elms while elms used to be as common as poplars are today (Brasier & Buck, 2011). The once widespread chestnut forests in the US have disappeared due to the introduction of the chestnut blight fungus (Cryphonectria parasitica). Mortality of western Canada's pine forests due to the mountain pine beetle (Dendroctonus ponderosae) outbreaks currently approaches 80% and reversed these vast forests from carbon sink to carbon source. Scandinavian pine forests are still free from the pest but are equally susceptible (FCEC, 2011).

community, to stabilise markets, to assure the availability of supplies and to ensure that supplies reach consumers at reasonable prices. In the framework of the current review, it is considered to widen the legal basis to also include TFEU Articles 114 (internal market) and 191 (environment).

2.6.2. Necessity for the EU to act

Regulating plant health at EU level allows for coordinated and in the long run cheaper action on EU priorities, making it more effective and less expensive than actions by individual MS. For example, border controls for differing national lists of harmful organisms would be highly inefficient and ineffective, given the free movement of commodities on the single EU internal market after import. Furthermore, plant pests are mobile by themselves and cross-border effects will occur not only through intra-EU movement of commodities but also via natural spread. Inevitably therefore pests and diseases of EU significance need to be addressed jointly. Inaction in one MS may however result in spread to others. Third country trade partners might also implement restrictions on imports from the EU as a whole if an outbreak in one of the MS is not properly eradicated. The membership of the EU (not only of the individual MS) to the International Plant Protection Convention and the WTO Sanitary and Phytosanitary Agreement further implies the EU responsibility to maintain an adequate legal framework ensuring international plant health standards.

The specific added value of the EU co-financing of the PHR is that it provides incentives to MS who put in place eradication and surveillance actions which are in the long-term interest of the Union as a whole. Large-scale eradication actions by MS for outbreaks could be difficult without EU support in view of the large costs incurred by the individual MS to the benefit of the EU, even if the overall cost/benefit for the Union as a whole would be clearly positive. This requires solidarity between MS in sharing the costs and burden. The current example of the pine wood nematode outbreaks in Portugal demonstrates that EU plant health co-financing budget is crucial to implement the eradication and containment measures which cause damage to Portuguese forestry, however are essential to protect forestry in the other 26 MS.

The PHR cannot be left to the private sector because of market failures (public good interests, information asymmetry, externalities, inadequacy of market instruments to transform the large and diverse outbreak risks into marketable risks due to their potentially catastrophic size, fragmentation of the sectors involved and non-insurable cross-links between sectors).

While the EU has the right to act to harmonise intra-EU trade and trade with third countries, it should be ensured that the measures are proportionate to the objectives, do not create undue administrative burden for MS and private sector and do not distort the level playing field.

As concerns subsidiarity, the necessity for the EU to act also relates to the necessity to ensure that the regime is adequately resourced. The evaluation underlined that a lack of resources plays an important role in the regime's shortcomings. The costs of official controls (import controls, controls at the place of production for plant passport issuance, the registration of operators requiring controls) are not adequately recovered in many MS, resulting in shortages for competent authorities to implement the legislation and, from the operators' perspective, a distortion of trade. This will be further elaborated in the review of Regulation 882/2004 on official controls.

Section 3: Objectives

3.1. General objectives

The general objectives of the revision are to ensure an EU plant health regime which:

- Supports the Union's agricultural policy (TFEU Art. 43) and environment policy (TFEU Art. 191) by protective measures against harmful organisms of plants, with prevention at the source as important principle;

- Allows a smooth functioning of the Union's internal market with fair competition (TFEU Art. 114, while respecting the need for a high level of protection of health and the environment, based on scientific facts);

- Contributes to the harmonious development of world trade (TFEU Art. 206, by adopting legislation which complies with the WTO-SPS Agreement).

3.2 Intermediate objectives

- To ensure that the EU territory remains free from harmful organisms that are not yet present in the Union

- To ensure that the areas affected by harmful organisms with the most severe impacts to the Union (priority organisms) do not increase

- To modernise the regime in terms of governance and incentives

- To ensure adequate support for the regime

3.3. Specific objectives

Objective 1: Definition of EU priorities

- To recognise priority harmful organisms with large or potentially large socio-economic and environmental impact for the Union territory as a whole (versus organisms of more restricted impact).

- To improve the ability of the regime to smoothly move harmful organisms for which territorial protection is no longer justified to the PRM regime or deregulate them.

Objective 2: Improved prevention at import

- To increase the protection against high-risk trade imported into the EU and passenger transport associated risks.

- To increase preparedness and surveillance for outbreaks of harmful organisms not known to occur in the Union and of priority organisms.

Objective 3: Strengthened eradication and containment capacities

- To upgrade the instrumentation for eradication and containment (including suppression of the presence and natural spread of priority organisms).

- To incentivise the notification, eradication and containment of outbreaks of priority organisms.

Objective 4: Restoration and modernisation of the regime for intra-EU movements

- To restore the reliability and credibility of plant passports and protected zones.

- To rebalance competent authorities' and private operators' responsibilities and costs, reduce administrative burden and ensure a level playing field.

Objective 5: Improved support for the regime

- To ensure cost recovery from operators for controls by competent authorities as these costs relate to private interests, and Union co-financing of costs incurred for public interests.

- To ensure the availability and quality of diagnostic and scientific support.

- To generate public awareness of the relevance of the regime and public support.

3.4. Consistency with other EU policies and horizontal objectives

This initiative was undertaken to improve the regime in terms of effectiveness as well as with respect to the Commission's Communication on Smart Regulation in the European Union. It takes account of the requests of the private sector to improve the governance model of the regime as concerns consultation on policy development, cost and responsibility sharing in policy implementation and reduction of burden. The policy should help SMEs (the majority of growers and traders) develop in the market.

The initiative improves the coherence with three related EU policies:

- It is part of a larger initiative in which Regulation (EC) 882/2004, as appropriately amended, becomes the general framework for official controls on food and feed, animal health and welfare, plant health and plant reproductive material, allowing simplification and harmonisation of common aspects in the food chain legislation;

- It comprises re-arrangements and better linkage with the complementary PRM regime as concerns plant health requirements, allowing simplification and reduction of burden;

- The initiative has been co-ordinated with the Commission's initiative to develop a strategy and legislation concerning IAS.

The initiative helps to transform today’s challenges (such as the effects of globalisation, world demographic trends and the need to substantially increase global food production, resource depletion, climate change, competition over land use for production of food and non-food, including energy) into opportunities and improve the competitive capacities of EU agriculture. It is coherent with other important EU policies:

- Common Agricultural Policy: the Communication "The CAP towards 2020: Meeting the food, natural resources and territorial challenges of the future" underlines the importance of plant health for agriculture and food security;

- Single Market: the regime ensures a high level of protection of health, whilst ensuring the effective functioning of the internal market;

- Europe 2020 Strategy: the regime helps to deliver a more sustainable, social, greener and knowledge-based EU market economy;

- Common Strategic Framework (CSF) Horizon 2020: the Union's financial instrument for research and innovation;

- Trade policy: effective protection of plant health is a prerequisite for international trade in plant materials[40];

- Environment policy: the regime helps to protect natural ecosystems and biodiversity;

- Climate change: the regime enables mitigating the increasing plant health risks from climate change;

- Development policy: support for capacity-building activities (existing BTSF training programmes) to help inspectors in poor third countries satisfy the PHR rules.

Section 4: Policy options

4.1. Policy options included in the analysis

In light of the problems and objectives outlined above, four options were developed to improve the regime (for a description of the elements of each option, see Annex IX). In all options, the provisions on official controls in common with other Union food chain legislation are transferred to the revised Regulation (882/2004) on official controls. As said, the present impact assessment addresses the changes in the existing pillars of the PHR, whether or not specific provisions (e.g. rules on import controls, certification, fees) are absorbed by that Regulation. This is inevitable since the PHR review concerns the functioning of the entire regime and its current instrumentation; the present impact assessment would otherwise be artificial and meaningless. The introduction to the PHR of new instruments from Regulation 882/2004 (e.g. creation of EU reference laboratories, accreditation of official laboratories, use of TRACES) and modifications for setting the level of mandatory fees (plant passports, import controls) will however be dealt with in the impact assessment for the revised Regulation 882/2004.

Option 1: Improve only the legal form and clarity of the regime. The legislation would be converted from a Directive into a Regulation, and simplified and clarified. This would ensure uniform application. The status quo is maintained in terms of substance.

Option 2: Prioritise, modernise and step up prevention. Additional to Option 1, prioritisation would be improved by transforming the Directive's current Annexes I and II, which list regulated pests according to technical features irrespective of their priority for the Union, into Annexes[41] based on intervention logic and priority:

- Future Annex I: all pests requiring territorial protection (identical to current Annex I but expanded with the non-European pests listed today in Annex II, Part A, Section I and the pests listed today in Annex II, Part B for which protected zones exist);

- New Annex / list: "upgraded" Annex I pests that require priority in surveillance, contingency planning and eradication in view of the large socio-economic and environmental risks they pose to the Union as a whole. Priority pests would be identified by risk assessment based on transparent criteria;

- Future Annex II: all pests that do not require territorial protection but pest-free planting material, including "downgraded" pests from the current Annex II, Part A, Section II (pests present in the EU that in practice only require pest-free planting material), along with the pests currently regulated under the PRM regime and subject to the certification schemes currently foreseen by the PRM.

The plant passport and protected zone systems would be modernised (responsibility sharing with operators as they have requested[42]; self-certification; reliance on their traceability systems; use of their barcodes/holograms/chips) and upgraded (plant passport scope, format, mandatory cost-recovery based plant passport fees[43] as already exist for import, rules for outbreaks in protected zones). The coherence between the PHR and PRM regimes would be improved[44] to increase effectiveness and reduce costs for operators. Prevention would be reinforced by introducing a new category of high-risk plant materials that are not authorised for import until completion of a risk analysis, and by removing exemptions for passenger luggage (to be subject to low frequency controls only to minimise the cost impacts; see Annex IX).

Option 3: Prioritise, modernise, step up prevention and reinforce actions against outbreaks. Additional to Option 2, obligations would be introduced for surveillance and contingency planning. In analogy with the arrangements in the animal health regime, EU co-financing would be made available for surveillance for new organisms and priority organisms and for financial compensation of direct losses of operators for those organisms. The legal instruments for eradication and containment would be further developed. The degressivity rule for EU co-financing of eradication and containment measures and the exclusion of natural spread related measures would be removed.

The Commission proposal for the Multi-annual Financial Framework 2014-2020 clarifies that "the programme will also fund additional and much-needed action to address the plant health pests and diseases which are becoming increasingly prevalent across the EU". Evidently this option can be put in practice only if the proposal is supported by Parliament and Council.

Option 4: Prioritise, modernise, step up prevention, reinforce actions against outbreaks and expand the scope to IAS plants. Additional to Option 3, the regime would also cover IAS plants, in terms of legal provisions for measures and EU co-financing. IAS plants (other than parasitic plants) are not covered in Options 1, 2 and 3.

4.2 Discarded policy options

The status quo option (no changes at all to the current legislation) was discarded, given the outcome of the evaluation and the consultations.

In theory, the regime could be rescinded entirely (deregulation). This option was discarded because the EU and its MS are contracting party to the IPPC and have thus agreed on a legally binding obligation to regulate plant health. The impact of this option on trade from the EU to third countries would over time evolve to an unacceptable level. MS would impose trade bans on plant material from each other, at the expense of the Single Market.

In theory, the regime could also be changed into a closed system, like in many third countries, thus prohibiting all entry of plant materials unless specifically allowed through an import license system on a case-by-case basis. This option has not been recommended in the evaluation or during the consultations. It would result in huge impacts on trade to and from the EU, agriculture and the economy at large. This would also create a huge administrative burden for third countries' operators and would likely require a significant increase of human resources at EU level to manage the system. This option was therefore discarded as it appears disproportionate. An element of the closed system approach may be included in the new regime for new high-risk trade from third countries, which would not be allowed to enter the EU pending risk analysis (see Option 2).

None of the options considers the exclusion of micro-enterprises (SMEs with less than 10 employees and a turnover or balance sheet total equal to or less than €2 million). The vast majority of enterprises (growers) affected by the PHR are micro-enterprises or, if not, SMEs[45]. Micro-enterprises and SMEs trade plant material across the Union. Exempting them from the regime would fundamentally jeopardise the protection of the EU territory against the introduction and spread of harmful organisms. For the same reasons, citizens are not being exempted from the regime either. During the consultations, stakeholders did not request any exemption for micro-enterprises.

Adapted solutions and lighter regimes for micro-enterprises have been sought for. Where small enterprises sell their products exclusively on the local market, strongly limiting the phytosanitary risk of movements of plant material, certain measures (e.g. the obligation to issue a plant passport) will not apply to them. Sales to non-professional final users will also be subject to certain exemptions, in line with current legal provisions under Directive 2000/29/EC. An adapted solution for micro-enterprises for the mandatory fees for plant health controls, proposed in the revised Regulation on Official Controls[46], will also apply in relation to plant health controls.

Section 5: Analysis of impacts

This section examines the economic, social and environmental impacts of the policy options in Section 4. Each of these comprises a series of amendments of which the costs and/or burden for operators (mostly SME)[47], MS and the EU is detailed in Annex IX. Those amendments cover all areas for which public consultation[48] had identified a need for impact assessment.

Each option was assessed against the theoretical baseline of 'do nothing' and therefore the impacts outlined are the difference from the status quo (which at long term has negative impacts on the economy, employment and environment; see Annex VIII). The following criteria were used. For economic impacts: costs and burden (based on the supplementary economic study); productivity, profitability and competitiveness. For social impacts: employment; food security / safety. For environmental impacts: sustainability (including impacts on use of pesticides); biodiversity and ecosystems conservation; health of forests, landscape, and public and private green. To help comparisons between options the impacts have been rated (0: no impact; +, ++, +++: small, medium or large positive impact; ‑, ‑‑, ‑‑‑: small, medium or large negative impact). Apart from costs and burden, quantitative estimation was not possible since it cannot be known in advance what outbreaks of which harmful organisms would be prevented.

According to the evaluation report, the baseline costs of the PHR incurred in the reference year 2008 were as follows (Annex VIII):

Overall compliance costs (including administrative burden and fees) || Competent Authorities || Operators || EU budget || Total

Baseline scenario: -- Prior to levying of fees -- After levying of fees || € 96 mio € 59 mio || € 51 mio € 88 mio || € 2 mio € 2 mio || € 149 mio € 149 mio

These figures include the costs of official controls (incurred by the competent authorities but partly recovered from the operators through fees[49]) and the costs of surveillance, eradication and containment measures. It should be noted that the figure of €2 mio EU budget is based on 2008 [50]. Given the claims for 2010, 2011 and 2012, annual MS and EU expenditures will likely be EUR 20 mio higher.

5.1. Option 1 – Improve only the legal form and clarity of the regime

In Option 1, the costs and burden of the EU plant health regime would be identical to the baseline scenario after levying of fees. The increased clarity of the legal text and the form of a Regulation, avoiding "noise" during transposition, would help to uniformly understand and implement the legislation, resulting in some limited benefits for effective prevention and control of harmful organisms. No economic or social impacts are expected. None of the stakeholders or MS indicated that this option (or the status quo) was their preferred option.

® Summary of the key impacts under Option 1:

Areas || Impacts

Economic impacts Reduction of cost/burden to operators Productivity, profitability, competitiveness || 0 0

Social impacts Employment Food security and safety || 0 0

Environmental impacts Sustainability Biodiversity and ecosystems conservation Health of forests, landscape, public and private green || + 0 +

5.2. Option 2 – Prioritise, modernise and step up prevention

This option would bring along the following changes (labelled according to Annex IX and explained in more detail in that Annex) to the foreseen Regulation:

(a) Creation of a list of EU priority pests

(b) Transformation of current Annex II of Directive 2000/29/EC into an Annex, of an implementing act, listing harmful organisms for which thresholds apply

(i) Restrictions for new high-risk trade pending risk analysis

(j) Dropping the existing exemption to import requirements for passenger luggage

(l) Operators fully responsible for intra-EU traceability information

(m) Extension of plant passport scope to all business-to-business movements of all plants

(n) Simplification and harmonisation of the plant passport format

(o) Alignments with the certification label issued under the PRM regime

(p) Obligation to MS to levy cost-recovery-based fees for registration (a prerequisite for plant passport inspections)

(q) Obligation to MS to levy cost-recovery-based fees for plant passport inspections

(r) Introduction of standardised rules for eradication of outbreaks in protected zones

5.2.1. Economic impacts

Overall compliance costs (including administrative burden and fees). According to the estimates in Annex IX, no significant impacts are foreseen for changes a, b, l, m, n or r. The annual administrative burden / costs would change as follows:

Overall compliance costs (including administrative burden and fees) || Competent Authorities || Operators || EU budget || Total

Baseline scenario: -- Prior to levying of fees -- After levying of fees || € 96 mio € 59 mio || € 51 mio € 88 mio || € 2 mio € 2 mio || € 149 mio € 149 mio

Option 1 || € 59 mio || € 88 mio || € 2 mio || € 149 mio

Changes compared to Option 1:

(i) Temporary restrictions new high-risk trade[51] || + € 1 mio (AB) || + € 3.5 mio (fees) || + € 1 mio (AB) ||

(j) Passenger luggage controls || + € 1 mio (of which 5% AB) || || ||

(o) Alignment with PRM certification label || || – € 0.7 mio (fees) || ||

(p, q) Cost-recovery based registration fees and plant passport fees || – € 16 mio (fees) || + € 16 mio (fees) || ||

Option 2 total costs || € 45 mio || € 106.8 mio || € 3 mio || € 154.8 mio

Option 2 compared to the baseline scenario after levying of fees || − € 14 mio || + € 18.8 mio || + € 1 mio || + € 5.8 mio

It should be noted that the baseline figure of EUR 2 mio EU budget is based on the official figure for 2008. Given the EUR 10-20 mio higher level of claims for 2010 and 2011, annual MS expenditures will rather be EUR 55-65 mio, and EU expenditures EUR 13-23 mio.

The impact of this option on the EU budget will depend on the evolution of outbreaks, which is unpredictable. While the ceilings set for plant health expenditures in the MFF will be respected, a need may arise in extreme cases to have access to the crisis reserve for food safety.

The liberated budget for competent authorities from full cost-recovery for registration and inspection activities would be available only in those MS that do not yet have cost-recovery based fees (budget will not be liberated in all MS). Liberating budget in MS where presently no major outbreaks occur could result in budget cuts to the plant health services.

Productivity, profitability, competitiveness (including level playing field). Option 2 will provide better protection against the entry of new harmful organisms thanks to better use of resources (prioritisation and where appropriate status change of harmful organisms) and measures against new high-risk trade and passenger luggage related risks. This should have a positive impact on productivity, profitability and competitiveness as regards third countries (an improved EU plant health status results in a higher export potential). The benefits will be achieved only partially because surveillance and action against outbreaks will also need to be reinforced and this can be done in this option only in MS where today no full cost recovery for inspection and registration is in place.

The major benefit of Option 2 is that the intra-EU movement system (plant passports) will be modernised. Operators will be made fully responsible for traceability of consignments, accordingly the plant passport can and will be simplified to the essentials, and modern information carriers already used by operators (barcodes, holograms, chips) will be allowed to replace the classical lot number. However, due to the full cost-recovery for registration and inspection, the costs for operators would nevertheless go up, which would impact negatively on profitability and competitiveness. The estimated cost increase per operator is EUR 400 per year for those Member States that currently do not levy fees at cost-recovery level (Annex IX). Mandatory cost-recovery based fees across the EU would reinforce the level playing field for operators. Trade distortions due to poorly managed protected zones, providing unjustified benefits to operators within infested protected zones, would also be removed.

The impact of this option on third countries concerns the restrictions on new high-risk trade. This would affect in particular countries with emerging trade of plants to the EU.

5.2.2. Social impacts

Employment. The cost increase for operators could have negative impact on employment. Sectors with low profit margins (end products: fruits, cut flowers) would be impacted more than sectors with a high profit margin (seed industry). MS with many small operators (mainly new MS) could be more affected because such operators have lower profit margins, although on the other hand the costs would be shared between higher numbers of operators.

Food security and safety. The increased level of protection against new harmful organisms would impact positively on long-term food security. However, the positive impact would be minor since the territorial protection would be improved only partially in this option.

5.2.3. Environmental impacts

Sustainability (durability; use of pesticides). The increased protection for the EU territory against new harmful organisms would impact positively on sustainability and would mitigate pesticide use. The positive impact would be minor since the territorial protection would be improved only partially in this option. Moreover, the increased pressure on operators without compensation for losses could be a perverse incentive to cover up outbreaks.

Biodiversity and ecosystems conservation. The increased protection against new harmful organisms would impact positively on biodiversity and ecosystems conservation. However, the positive impact would be minor since the territorial protection would be improved only partially in this option (limited resources for surveillance and eradication).

Health status of forests, landscape, public and private green. The partly increased level of protection for the EU territory against new harmful organisms would impact positively on the health status of forests, landscape, public and private green. The positive impact would be minor since the territorial protection would be improved only partially in this option.

® Summary of the key impacts under Option 2:

Areas || Impacts

Economic impacts Reduction of cost/burden to operators Productivity, profitability, competitiveness || −− −

Social impacts Employment Food security and safety || − +

Environmental impacts Sustainability Biodiversity and ecosystems conservation Health of forests, landscape, public and private green || + + +

5.2.4. Views of stakeholders and Member States

One single national stakeholder organisation (PLANTUM NL) was in favour of Option 2. Another organisation (EUROPATAT) was in favour of Option 2 but found Option 3 also acceptable. The majority of the stakeholders (including the farmers' EU umbrella organisation COPA-COGECA) was in favour of the options with increased budget (Options 3 and 4). Only two of the responding Member States were in favour of Option 2, due to lack of resources and/or opposition to any increase of the EU budget. However, if the increased budget for plant health stemmed from a reallocation within the existing EU budget, they were open to this.

5.3. Option 3 – Prioritise, modernise, step up prevention and reinforce actions against outbreaks

In this option, it is assumed that the additional EU resources necessary to reinforce prevention and actions against outbreaks would indeed be made available. In addition to the changes foreseen in Options 1 and 2, this option would bring along the following further changes to the Regulation (note that no impact is foreseen for changes (d), (e) and (g) in Annex IX):

(c) Introduction of mandatory surveillance by the MS (with EU co-financing)

(d) Introduction of mandatory contingency planning

(e) Clarification of measures required for eradication and containment of outbreaks

(f) Extension of the scope of the EU co-financing "solidarity regime" to natural spread

(g) Removal of the degressivity rule (mandatory decrease of EU co-financing over time)

(h) EU co-financing to also cover MS expenditures to compensate operator losses from measures related to EU priority organisms

5.3.1. Economic impacts

Overall compliance costs (including administrative burden and fees). According to the estimates in Annex IX, the annual burden / costs would change as follows:

Overall compliance costs (including administrative burden and fees) || Competent Authorities || Operators || EU budget || Total

Baseline scenario: -- Prior to levying of fees -- After levying of fees || € 96 mio € 59 mio || € 51 mio € 88 mio || € 2 mio € 2 mio || € 149 mio € 149 mio

Option 2 || € 45 mio || € 106.8 mio || € 3 mio || € 154.8 mio

Changes compared to Option 2:

(c) Mandatory surveillance (with EU co-financing)[52] || − € 4 mio (compliance costs) || || + € 10 mio (co-financing) ||

(f) Coverage natural spread || − € 3.7 mio (compliance costs) || || + € 3.7 mio (co-financing) ||

(h) Compensation for operator losses also covered[53] || + € 7 mio (compensation) || − € 17 mio (compensation) || + €10 mio (co-financing) ||

Option 3 total costs || € 44.3 mio || € 89.8 mio || € 26.7 mio || € 160.8 mio

Option 3 compared to the baseline scenario after levying of fees || − € 14.7 mio || + € 1.8 mio || + € 24.7 mio || + € 11.8 mio

In the table above, the figures for mandatory surveillance follow the estimate of FCEC (2011) that the current level of surveillance would increase from EUR 14 mio to EUR 20 mio per year if it would become an obligation and if EU co-financing would be available. It is assumed that the MS at present already implement measures against outbreaks resulting from natural spread in line with the legal obligations, the difference being that these measures would now be co-financed by the EU. It is furthermore accounted for that certain MS at present already provide some compensation to growers for losses resulting from imposed measures, estimated in Annex IX to be EUR 3 mio per year. Assuming that operator losses from official measures would be EUR 20 mio per year, this would imply that MS costs would go up to EUR 10 mio and operator compensation would go up to EUR 20 mio per year, the differences at EU level being reflected in the table above.

It should be noted that the baseline figure of EUR 2 mio EU budget is based on the official figure for 2008. Given the EUR 10-20 mio higher level of claims for 2010 and 2011, annual MS expenditures will rather be EUR 54-64 mio, and EU expenditures EUR 37-47 mio.

The impact of this option on the EU budget will depend on the evolution of outbreaks, which is unpredictable. While the ceilings set for plant health expenditures in the MFF will be respected, a need may arise in extreme cases to have access to the crisis reserve for food safety.

Productivity, profitability, competitiveness (including level playing field). Option 3 would introduce incentives to MS and operators to better support the objectives of the regime through vigilance, immediate notification and early action (note that compensations for losses would be conditional to compliance with good bio-security practices). Budget would be available in all MS to upgrade surveillance and to reinforce eradication and containment. Thus, the full range of protective measures would be in place (prevention against high-risk trade, enhanced surveillance, reinforced early action). This would substantially limit the influx, establishment and spread of new harmful organisms into and within the EU, with a significant positive impact on productivity, profit and competitiveness with third countries (an improved, well-documented EU plant health status will result in higher export potential). Risks of trade restrictions from third countries from EU outbreaks of internationally regulated harmful organisms would be substantially mitigated.

As in Option 2, a major benefit of Option 3 would be that the intra-EU movement system (plant passports) will be modernised and cheaper for the operators. Operators would be made officially responsible for traceability of consignments, as is being requested. Due to the full cost-recovery for registration and inspection, the costs for operators would go up, but to a same extent as compensation for losses would be foreseen. Full cost recovery in all MS would reinforce the level playing field. Trade distortions due to poorly managed protected zones, providing unjustified benefits to operators within infested protected zones, would be removed in this option.

5.3.2. Social impacts

Employment. The positive impact on productivity, profit and competitiveness would imply a moderately positive impact on employment too.

Food security and safety. Achieving full positive impact on EU plant health would have a long-term positive impact on food security. As argued previously, food safety would not be affected.

5.3.3. Environmental impacts

Sustainability (durability; use of pesticides). The positive impact on EU plant health would imply a positive impact on sustainable agriculture and forestry and a mitigation of the needs for pesticide use.

Biodiversity and ecosystems conservation. The increased level of protection for the EU territory against new harmful organisms would impact positively on biodiversity and ecosystems conservation, especially but not exclusively in relation to the health status of forests and forest-related biodiversity.

Health status of forests, landscape, public and private green. The increased level of protection for the EU territory against new harmful organisms would impact very positively on the health status of forests, landscape, public and private green, which are particularly at risk in the baseline scenario. Examples of the success of this approach are the eradication of the pine wood nematode outbreak in 2008 in Spain, of red palm weevil in the Canary islands and of the citrus longhorned beetle in the Boskoop area (The Netherlands).

® Summary of the key impacts under Option 3:

Areas || Impacts

Economic impacts Reduction of cost/burden to operators Productivity, profitability, competitiveness || 0 +++

Social impacts Employment Food security and safety || ++ ++

Environmental impacts Sustainability Biodiversity and ecosystems conservation Health of forests, landscape, public and private green || +++ + +++

5.3.4. Views of stakeholders and Member States

With the two exceptions mentioned under Option 2, all stakeholders and Member States are in favour of Option 3 or its variant including IAS plants (Option 4). EFNA (representing EU forest nurseries), ENA (representing EU nurserystock producers), UFS (a seeds industry organisation) and the NATIONAL TRUST (a national heritage NGO) were in favour of Option 3. USSE (representing southern EU foresters) was in favour of Option 3 or Option 4, depending on the available EU budget.

5.4. Option 4 – Prioritise, modernise, step up prevention, reinforce actions against outbreaks and expand the scope to IAS plants

In this option, it is assumed that the additional EU resources necessary to reinforce prevention and actions against outbreaks would indeed be made available. In addition to the changes foreseen in Options 1, 2 and 3, this option would bring along the following further change to the Regulation (labelled according to the list in Annex IX):

(u) Expansion of the scope of the plant health regime to also cover IAS plants

5.4.1. Economic impacts

Overall compliance costs (including administrative burden and fees). According to the estimates in Annex IX, the annual administrative burden / costs would change as follows:

Overall compliance costs (including administrative burden and fees) || Competent Authorities || Operators || EU budget || Total

Baseline scenario: -- Prior to levying of fees -- After levying of fees || € 96 mio € 59 mio || € 51 mio € 88 mio || € 2 mio € 2 mio || € 149 mio € 149 mio

Option 3 || € 44.3 mio || € 89.8 mio || € 26.7 mio || € 160.8 mio

Changes compared to Option 3:

(u) Coverage of IAS plants[54] || + € 20.4 mio (compliance costs) || || + € 20.4 mio (co-financing) ||

Option 4 total costs || € 64.7 mio || € 89.8 mio || € 47.1 mio || € 201.6 mio

Option 4 compared to the baseline scenario || + € 5.7 mio || + € 1.8 mio || + € 45.1 mio || + € 52.6 mio

It should be noted that the baseline figure of EUR 2 mio EU budget is based on the official figure for 2008. Given the EUR 10-20 mio higher level of claims for 2010 and 2011, annual MS expenditures will rather be EUR 75-85 mio, and EU expenditures EUR 57-67 mio.

The cost estimate for including IAS plants in the scope of the PHR is an average estimate (Annex IX) for the financial "best case" (EUR 18.5 mio) and "worst case" (EUR 63 mio) scenarios, representing an increase of the total costs of the regime to minimally EUR 179 mio and maximally EUR 224 mio (an increase of 20% to 50% compared to the baseline and 12% to 39% compared to Option 3). The potential annual costs for competent authorities range from EUR 54-76 mio and for the EU expenditures from EUR 36-58 mio.

The impact of this option on the EU budget will depend on the evolution of outbreaks, which is unpredictable. While the ceilings set for plant health expenditures in the MFF will be respected, a need may arise in extreme cases to have access to the crisis reserve for food safety.

Productivity, profitability, competitiveness (including level playing field). In principle, significantly positive impacts are expected as in Option 3. Preventing the entry of future IAS weeds would result in further savings for the economy. The balance would shift from plant health proper benefits to wider benefits. However, the positive impacts could be less to the extent that the EU co-financing budget for plant health would be insufficient to cover the needs of the regime in its current scope. If the additional needs for IAS plants would be met at the expense of the current needs, this could entail in failure in both areas.

5.4.2. Social impacts

Employment. A moderately positive impact on employment would be expected, as for Option 3, however dependent on possible competition between current needs of the regime for EU co-financing budget and the needs for IAS plants.

Food security and safety. A positive long-term impact on food security would be expected, as in Option 3. Given the health problems associated with some IAS plants (allergies, skin irritation), Option 4 would also favour public health.

5.4.3. Environmental impacts

Sustainability (durability; use of pesticides). The positive impact on EU plant health would imply a positive impact on sustainable agriculture and forestry and a mitigation of the needs for pesticide use, however dependent on possible competition between current needs of the regime for EU co-financing budget and needs for IAS plants. Including terrestrial IAS weeds in the PHR would improve coherence with the PRM and plant protection products legislation managed by DG SANCO and could result in synergies (better prevention and control with minimal herbicide inputs).

Biodiversity and ecosystems conservation. The increased level of protection for the EU territory against new harmful organisms would impact positively on biodiversity and ecosystems conservation, especially but not