EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

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 for ensuring jobs, plant innovation and food security. 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. Plant health is also important for the protection of biodiversity and ecosystem services.

Pests from other continents are especially dangerous. European plants and trees usually lack adequate genetic resistance against foreign pests, which moreover often do not have natural enemies here. When introduced into Europe, foreign pests cause severe economic damage. They may jump to previously unaffected 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. The establishment of new pests may elicit trade bans from third countries, damaging EU exports. Not all pests can be controlled with pesticides and, where available, pesticide use may be undesirable.

Regulatory framework

The current EU regulatory framework for plant health aims to protect European agriculture and forestry by preventing the entry and spread of foreign pests. The main tool hereby is Council Directive 2000/29/EC[1], which also reflects international trade agreements in this area. The EU phytosanitary (plant health) regime is unique in that it is an open regime: movements of plants and plant products into and within the Union 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 nevertheless imply a high probability of future outbreaks of foreign pests.

The regime is indispensable for protecting the health, economy and competitiveness of the EU plant production sector as well as for maintaining the Union's open trade policy. However, the existing regulatory framework is being criticised for being unable to stop the increased influx of dangerous new pests caused by globalisation of trade. Moreover climate change enables those pests to survive in Europe, while they could not in the past, and renders crops and ecosystems more vulnerable to new pests. Major outbreaks in the past decade of dangerous import-related pests affecting forestry have raised societal and political awareness of the costs and impacts of inadequate protection.

Problem analysis

An evaluation of the regime (2010)[2] has shown that the basic legislation has to be amended in order to be able to fully address these increased risks. The main problems identified relate to insufficient focus on prevention in relation to increased imports of high-risk commodities, the need for prioritising pests at EU level across all 27 Member States, the need for better instruments for controlling the presence and natural spread of pests in case they eventually reach the Union territory, a need for modernising and upgrading the instruments concerning intra-EU movements (plant passports and protected zones), and a need to foresee additional resources.

A need for "greening" of the regime has furthermore emerged and objectives relating to the natural environment have gained importance. This requires changes to the intervention logic, also in terms of financing, of the regime, 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 science base of the regime (research, laboratories) needs to be reinforced. There has been a steady erosion of the classical plant pathology and pest taxonomy in universities, endangering the support from science to assess risks from new pests and to adequately diagnose those pests in the laboratory. A State of Emergency declaration has been issued in this respect by the European and Mediterranean Plant Protection Organisation.

Finally, a new balance needs to be struck as concerns costs and responsibility sharing (partnership development) and there is a need to increase effectiveness and reduce unnecessary costs and administrative burden. A need for modernisation of the regime furthermore exists in terms of incentives for compliance.

Objective of the proposal

The present revision aims to overcome these flaws and to put in place a robust, transparent and sustainable regulatory framework that is 'fit for purpose'. The proposed Regulation replaces and repeals Directive 2000/29/EC.

Relationship to other proposals in the package

The proposal is part of a package of reviews relating to the health of plants, quality of plant reproductive material, health of animals, official controls concerning plants, animals, food and feed, and Union expenditures for those policies.

The proposal reinforces the synergies with the plant reproductive material regime, while removing avoidable duplications and unnecessary burden from those duplications. This is achieved by repositioning the pests that are currently regulated under the so-called marketing Directives for seed and plant propagating material under the proposed plant health Regulation. That repositioning will introduce flexibility to change the status of widespread quarantine pests into quality pests, as requested by professional operators and Member States, so as to use the resources available to the phytosanitary authorities for true Union priorities. In the meanwhile, the proposal ensures that the existing practical arrangements in the Member States concerning the certification of plant reproductive material for quality pests can remain. Altogether, the rearrangements between the EU plant health regime and plant reproductive material regime should reinforce the coherence between those two regimes (through shared use of certification schemes, labels and registers) and thus result in reduced burden for professional operators. The proposed new arrangements will, however, require enhanced coordination between the competent authorities in the Member States for plant health and plant reproductive material.

The proposal does not contain provisions concerning official controls by the competent authorities of compliance by professional operators with the Union phytosanitary legislation, as are currently present in Directive 2000/29/EC. Those controls are now being positioned exclusively in the proposal concerning official controls (replacing Regulation (EC) 882/2004[3]). This will also allow improved coherence with the new Customs Code and allow simplified procedures at import.

The proposal does not contain provisions on expenditures eligible for a financial contribution from the Union, as exist in Directive 2000/29/EC. The provisions concerned, drafted in accordance with the preferred option of the impact assessment, are included in the accompanying legal proposal for a Regulation on food and feed expenditure, which concerns the management of Union expenditures relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material.

The proposal will be complementary to the proposal concerning Invasive Alien Species foreseen under the EU Biodiversity Strategy.

2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

Consultation process

The Council on 21 November 2008 invited the Commission to proceed to an evaluation of the EU plant health regime and to consider possible modifications to the existing legal framework and the impact of such modifications[4]. The Commission initiated a comprehensive evaluation of the regime from the introduction of the internal market (1993)[5] and contracted the necessary study out to an external consultant[6]. Member State 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[7] was presented in a second conference 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, the options recommended by the external consultant were discussed with the Member States in Council with the Chief Officers for Plant Health (COPHs) in many rounds of meetings and, as concerns the coherence with the Plant Reproductive Material (PRM) regime, the Heads of Service for that regime and the relevant Working Party. Five task forces with Member State experts and Commission were convened to further discuss the main areas of change.

Stakeholders (industry association representatives and NGOs) were consulted from the very start of the review process, prior to the initiation of the evaluation, during the evaluation study and again during the preparation of the impact assessment. An ad-hoc Working Group on Plant Health was set up under the Advisory Group on the Food Chain, Animal and Plant Health. The progress was presented and discussed in several meetings of the aforementioned Advisory Group, in other Advisory Groups[8] and on invitation in meetings of COPA-COGECA, EUROPATAT, ESA and UNION FLEURS. 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 plant reproductive material regime and the EU regime on official controls 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[9] of DG SANCO. A final consultation on the strategic options was launched on 13 May 2011.

Data collection

The collection of data commenced with a comprehensive evaluation of the regime 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 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.

Impact assessment

Four options were developed to improve the regime:

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. The status quo would be maintained in terms of substance.

Option 2: Prioritise, modernise and step up prevention. Additional to Option 1, prioritisation would be improved by transforming the current Annexes I and II, which list regulated pests according to technical features irrespective of their priority for the Union, into lists based on intervention logic and priority. The plant passport and protected zone systems would be modernised (responsibility sharing with professional operators) and upgraded (plant passport scope, format, mandatory cost-recovery based plant passport fees as already exist for import controls, rules for surveillance and outbreak eradication in protected zones). The coherence between the PHR and the plant reproductive material regime would be improved to increase effectiveness and reduce costs for professional operators. Prevention would be reinforced by introducing a new provision concerning high-risk plant reproductive materials (plants for planting) that are not authorised for introduction into the Union or subject to specific enhanced physical controls until completion of a risk analysis, and by removing exemptions for passenger luggage (to be subject to low frequency controls to minimise the cost impacts).

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 and, in certain cases, for financial compensation of direct losses of professional operators. The legal instruments for eradication and containment would be further developed. The exclusion of natural spread related measures would be removed.

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

The assessment of the impacts of the four options revealed that Option 3 provided the best way forward to achieve the objectives with the best cost-benefit level and an optimal balance of inputs from Member States, professional operators and the Union. Option 3 should have a significant positive impact on profitability and economic growth of the sectors involved; it was also the closest reflection of the outcome of the stakeholder and MS consultation.

The EU budget necessary to implement Option 3 was secured in the Commission proposal for the Multi-Annual Financial Framework (MFF) for 2014-2020. The corresponding legal provisions are included in the legal proposal for a Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material.

Small and medium-sized enterprises and micro-enterprises

The nature of the plant health regime requires that small and medium-sized enterprises (SME) are not exempted from the obligations of this Regulation. The majority of the enterprises affected by the regime are SME and exempting them a priori would fundamentally jeopardise the regime's objectives. However, the proposal exempts enterprises selling plants and plant products exclusively to the local market from the obligation to issue plant passports, which will moreover not be required for sales to final non-professional consumers anyhow. For micro-enterprises, special arrangements concerning potential refunding of fees for plant health controls, within the framework of State Aid rules, will be made possible under the new Regulation concerning official controls.

Fundamental rights

This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter on Fundamental rights of the European Union. It should be applied by the Member States in accordance with those rights and principles, implemented as appropriate in their national legislation. Certain provisions of this Regulation nevertheless limit particular rights under the Charter, however only to the extent strictly necessary for protecting the general interest of the Union concerned by this Regulation and conserving the essence of the rights at stake.

Eradication of outbreaks of foreign pests can only be successful if all sources of infestation are removed. Apart from outbreaks of quarantine pests on the premises of professional operators, outbreaks may also take place in public or private green. In those cases, the eradication measures need to include the infested and potentially infested plants in that public and private green in order to be successful at all (any remaining infested plants will act as a source of new infestations elsewhere). This implies that, in certain cases, competent authorities of Member States need to be given access to private premises for official controls, possibly followed by the imposition of treatment or eradication measures or certain restrictions or prohibitions on the use of plants. This is a limitation of Articles 7 and 17 of the Charter on Fundamental Rights concerning, respectively, the Respect for Private and Family Life and the Right to Property. That limitation is necessary to achieve an objective of general interest, being the protection of plant health in the Union. The limitation is proportionate because the objective of general interest cannot be achieved without ensuring that phytosanitary measures are respected equally by all (refraining from destruction of infested plants in private gardens would annihilate the benefits of eradication measures imposed on professional operators and carried out in public-owned green). It will be the responsibility of the Member States to provide fair compensation to affected citizens in good time for the suffered loss. The essence of the Right to Property is thus conserved.

Anybody who is aware of the presence of a quarantine pest will be obliged to notify the presence of that quarantine pest to the competent authorities, accompanied with the information concerning the origin and the nature of the material concerned. This will also apply to laboratories and research organisation encountering pests in samples provided to them. This may in some cases constitute a limitation of Article 8 of the Charter, concerning the Right to Protection of Personal Data. That limitation is necessary to achieve the public interest objective of plant health in the Union, as findings of quarantine pests need to be made known to the competent authorities in order to ensure the immediate eradication of outbreaks. The limitation is proportionate because personal data are subject to the provision only to the extent that they are indispensable for the competent authorities to locate the outbreaks and take the necessary action. The essence of the Right to Protection of Personal Data is thus conserved.

3. LEGAL ELEMENTS OF THE PROPOSAL

Chapter I: Subject matter, scope and definitions

The territorial scope of the regime does not include any non-European outermost regions of Member States, as those regions belong to other biogeographic regions of the world, where exactly those pests occur against which the European territories of the Member States require protection. The territorial scope of the regime does include part of the Macaronesian archipelago (the island of Madeira and the Azores), which forms a biogeographic region overlapping with the Mediterranean region, in particular the Iberian peninsula, in terms of natural vegetation. It is therefore appropriate to include that archipelago in the scope of the regime. Annex I lists the territories of the Member States that are covered by the Treaty on the Functioning of European Union but, for the purpose of this Regulation, are considered as third countries.

Invasive plants other than parasitic plants (physically feeding on host plants) are excluded from the scope, in line with the outcome of the impact assessment.

Definitions are provided as necessary.

Chapter II: Quarantine pests

In Directive 2000/29/EC, pests are listed in specific Annexes. The proposal, instead, sets out the conceptual nature of quarantine pests and subsequently lists them in implementing acts, either as Union quarantine pests or Protected Zone quarantine pests. Union quarantine pests require eradication measures in the entire Union territory, while for Protected Zone quarantine pests that is only the case within specified protected zones where certain pests are absent, while they are known to occur in other parts of the Union territory. The proposal empowers the Commission to list certain quarantine pests as priority pests for the Union, up to a maximum of 10% of the listed Union quarantine pests. Those pests will be subject to an enhanced level of obligations concerning preparedness and eradication, supplemented by enhanced financial support from the Union for the required actions. Criteria to decide whether a pest qualifies as a quarantine pest, Union or Protected Zone quarantine pest, or priority pest are provided in Annex II of the Regulation. A transfer is foreseen of the pests currently listed in Annexes I and II of Directive 2000/29/EC to the appropriate lists of the future implementing acts. No distinction will be made any longer between pests currently listed in Annex I and Annex II of Directive 2000/29/EC.

This chapter furthermore sets out detailed rules on notification of the presence of quarantine pests, measures to be taken for the eradication of those pests including the restriction of areas subject to eradication measures, surveys to be carried out for the presence of pests and the establishment of contingency plans and eradication plans concerning outbreaks of priority pests.

The provisions in this chapter empower the Commission to adopt implementing acts on permanent measures to manage quarantine pests that have become established in the Union territory. Those acts can also be adopted on a temporary basis for non-listed quarantine pests, if necessary using the urgency procedure established under the Lisbon Treaty. The tools developed in this chapter exist today under Directive 2000/29/EC, however the proposal develops those tools explicitly. A provision is included allowing Member States to take stricter measures against pests than foreseen in the Union legislation, on condition that those measures do not restrict in any way the free movement of plants, plant products and other regulated objects on the internal market.

The chapter also covers the provisions concerning protected zones, which maintain the existing system, however explicitly reinforced to ensure that protected zones are technically justified and that any outbreaks of the Protected Zone quarantine pests concerned are properly and timely eradicated. If not, the protected zone will be revoked. With these changes, the Union's protected zone system aligns with the pest-free area system under the International Plant Protection Convention (IPPC), as requested by the regime's stakeholders and by third countries.

Chapter III: Quality pests

Pests that affect the intended use of plants for planting, but do not require eradication, are regulated today under the marketing Directives for seed and plant propagating material and, partly, in Annex II to Directive 2000/29/EC. The proposal categorises them all as Union quality pests. It sets out the conceptual nature of such pests and subsequently lists them through implementing acts. Criteria to decide whether a pest qualifies as a Union quality pest are provided in Annex II. Quality pests will not be regulated under the legal proposal for Plant Reproductive Material, other than their inclusion, where appropriate, in certification schemes.

Schematic representation of the various types of pests in the proposal, the decision process for their qualification and the measures required against them.

Chapter IV: Measures concerning plants, plant products and other objects

Directive 2000/29/EC has Annexes listing prohibitions for certain plants, plants products and other objects (Annex III), and specific requirements for the introduction into and movement within the Union (Annex IV). The proposal empowers the Commission to adopt such lists through implementing acts. The provisions in Chapter IV furthermore concern rules for recognition of measures of third countries as equivalent to the Union measures, and derogations to the prohibitions. The respective rules concerning the movement of plants, plant products and other objects into and within protected zones are also addressed.

New to the Union plant health regime is an Article empowering the Commission to adopt implementing acts to address emerging risks from certain plants for planting from certain third countries which require precautionary measures. Listed plant materials will require intensified visual examination and testing, or subjection to a quarantine period, or will be subject to a temporary prohibition of introduction into the Union. Those measures shall apply for two years, prolongable once. During that time, a full risk assessment shall be developed, followed by a decision to regulate the material concerned on a permanent basis, or to drop the temporary measures.

New is also an article setting out the basic rules for quarantine stations, when the use of those stations is required by the Regulation or by secondary acts under the Regulation.

The introduction into the Union of regulated plants by passengers in their luggage will no longer be exempted from the respective requirements and prohibitions. This is necessary because plants in passenger luggage have been found an increasing risk for the phytosanitary status of the Union and jeopardise the success of the regime.

New is finally an Article requiring that exports of plants, plant products and other objects to third countries shall take place either in accordance to the Union rules, or, if the third country's rules so allow or the third country explicitly so agrees through bilateral agreements or otherwise, in accordance to the requirements of that third country.

Chapter V: Registration of professional operators and traceability

The proposal requires the relevant professional operators to be registered, in a register which will also contain the professional operators required to be registered under the proposed Regulation concerning plant reproductive material. This should reduce burden for professional operators. Registered operators shall fulfil certain requirements for the traceability of the plant material under their control.

Chapter VI: Certification of plants, plant products and other objects

Directive 2000/29/EC has an Annex (V) listing requirements concerning certification of plants, plant products and other objects introduced into or moved within the Union. The proposal empowers the Commission to adopt such lists through delegated acts. The respective rules concerning the certification of plants, plant products and other objects introduced into and moved within protected zones are also addressed.

The proposal foresees that all plants for planting, other than certain seeds, shall require a phytosanitary certificate for introduction into the Union and a plant passport for movement within the Union. Plant passports shall be required for all movements between professional operators, but not for sales to final non-professional users. The plant passport will be simplified and harmonised. Instead of a lot number, the plant passport may use a chip, barcode or hologram linking to the internal traceability systems of professional operators.

Examinations on plants, plant products and other objects requiring a plant passport may require the use of certification schemes with regard to certain quarantine pests and/or quality pests, where examinations in the field during the growing season are indispensable. This possibility could be created thanks to the inclusion of quality pests in the plant health Regulation. Where certification schemes are required under the plant health Regulation, it is provided that the certification schemes created under the proposed Regulation concerning plant reproductive material shall be used. This should preclude that double schemes are set up, which would result in double costs for professional operators.

Plant passports shall be issued by registered operators that are authorised so by the competent authorities, or, on their request, by the competent authorities. Where plant material requires a plant passport under the plant health Regulation and a certification label under the proposed Regulation concerning plant reproductive material, the plant passport and the certification label shall be combined in a single document. This should preclude double costs for professional operators, where the issuance is done by the competent authorities.

Rules are foreseen concerning the authorisation and supervision of professional operators issuing plant passports and for the examination of the plant material concerned, in order to ensure that that material complies with all provisions of the Regulation.

Rules are also foreseen concerning the authorisation and supervision of wood packaging material producers who apply a certain mark to that material, following its treatment according to the International Standard for Phytosanitary Measures No. 15 on Regulation of wood packaging material in international trade.

For export purposes, the proposal foresees the introduction of a pre-export certificate, for cases where plant material is exported from a Member State which is not the Member State of origin. The pre-export certificate will replace the currently used informal guidance document agreed by the Member States.

Chapter VII: Measures supporting the implementation of the Regulation

The proposal foresees the establishment of an electronic notification system for notification and reporting.

Chapter VIII: Final provisions

The proposal foresees that the Commission will be assisted by a new Standing Committee, which will include the existing Committees dealing with the food chain, animal and plant health and plant reproductive material (instead of the existing Standing Committee on Plant Health).

The proposal foresees amendments to the Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, which is foreseen to be adopted in advance of the current legal proposal. Those amendments include the possibility for the Union to co-finance measures concerning priority pests (a pest category created in the current proposal) and compensation to operators for the foregone value of plant material that is destroyed as part of eradication measures concerning priority pests.

The proposal repeals six so-called Control Directives concerning the management of certain quarantine pests (potato wart fungus, potato cyst nematodes, potato brown rot, potato ring rot, carnation leafrollers and San José scale) that are known to be present in the Union. Acts of such nature will in future be adopted as secondary acts under the proposed Regulation and not as co-decided acts. The Directives on pests of potato will be replaced by secondary acts under now proposed Regulation, without changing their substance. The Directives on carnation leafrollers and San José scale will not be replaced.

4. BUDGETARY IMPLICATION

The financial provisions and appropriations for implementing the Regulation up to 31 December 2020 will be presented in the forthcoming legal proposal for a Regulation on the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material. The current proposal does not imply any expenditures which will not be part of the financial statement of the legal proposal for that Regulation and it does not require additional human resources.

2013/0141 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on protective measures against pests of plants

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee[10],

Having regard to the opinion of the Committee of the Regions[11],

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community[12] sets out a plant health regime.

(2) On 21 November 2008, the Council invited the Commission to proceed to an evaluation of that plant health regime[13].

(3) In the light of the outcome of that evaluation and the experience gained from the application of Directive 2000/29/EC, that Directive should be replaced. To ensure uniform application of the new rules, the act replacing that Directive should take the form of a Regulation.

(4) Plant health is very important for plant production, public and private green, natural ecosystems, ecosystem services and biodiversity in the Union. Plant health is threatened by species injurious to plants and plant products, hereinafter 'pests'. To fight that threat, it is necessary to adopt measures concerning the determination of the phytosanitary risks posed by those pests and the reduction of those risks to an acceptable level.

(5) The need for such measures has long been recognised. They have formed the subject of international agreements and international conventions, including the International Plant Protection Convention (IPPC) of 6 December 1951 concluded at the United Nations Food and Agricultural Organisation (FAO) and its new revised text approved by the Food and Agriculture Organisation Conference in November 1997 at its 29th session. The Union is party to the IPPC.

(6) It has appeared that for the determination of the scope of this Regulation it is important to take into account bio-geographical factors to avoid that pests not present in the European territory of the Union spread to that territory. Consequently, non-European territories (outermost regions) of Member States referred to in Article 355(1) TFEU should be excluded from the territorial scope of this Regulation. Those territories should be listed. Where the status of such a territory or a territory referred to in Article 355(2) TFEU is amended pursuant to Article 355(6) TFEU, that list should be amended to ensure that the territorial scope of this Regulation remains confined to the European part of the Union territory. References to third countries should be read as references also to the territories included in that list.

(7) Directive 2000/29/EC sets out rules concerning official controls to be carried out by the competent authorities as regards protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community. Such rules are presently set out by Regulation (EU) No …/…. on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)[14] [Office of Publications, please insert number of Regulation on Official Controls and, in the footnote, the reference to the Official Journal] and therefore should not be part of this Regulation.

(8) Criteria should be set out in order to allow pests to be identified for which it is necessary to adopt measures of control for the entire Union territory. Such pests are referred to as 'Union quarantine pests'. Criteria should also be set out for the identification of pests for which it is necessary to adopt measures of control only as regards one or more parts of that territory. Such pests are referred to as 'protected zone quarantine pests'.

(9) In order to allow efforts for the control of Union quarantine pests to concentrate on pests whose economic, environmental or social impact is most severe for the Union territory as a whole, a restricted list of such pests, hereinafter 'priority pests', should be established.

(10) It is appropriate to provide for exemptions from the prohibition of introduction into and movement within the Union territory of Union quarantine pests for scientific purposes, trials, varietal selections, breeding and exhibitions.

(11) In order to ensure effective and timely action in case of the presence of a Union quarantine pest, notification obligations should apply to the public, professional operators and to the Member States.

(12) Where those notification obligations imply that personal data of natural or legal persons should be disclosed to the competent authorities, this may constitute a limitation of Article 8 (Protection of Personal Data) of the Charter on Fundamental Rights. However that limitation would be necessary and proportionate to achieve the public interest objective of this Regulation.

(13) A professional operator becoming aware of the presence of a Union quarantine pest in a plant, plant product or other object which is or was under its control should be under an obligation to take all measures that may be appropriate as regards the elimination of the pest, the withdrawal or recall of the plants, plant products or other objects concerned and the information of the competent authority, other persons in the trade chain and the public.

(14) Member States should take all necessary measures to eradicate Union quarantine pests, when found present in their territories. It is appropriate to set out measures which may be taken by Member States in such a case and the principles based on which they are to decide what measures to take. Those measures should include the establishment of restricted areas, consisting of an infested zone and a buffer zone.

(15) In certain cases, Member States should impose measures for the eradication of quarantine pests on plants in private premises, because eradication of pests can only be successful if all sources of infestation are removed. For this purpose, the competent authorities of Member States should have legal access to those premises. This may constitute a limitation of Article 7 (Respect for Private and Family Life) and Article 17 (Right to Property) of the Charter on Fundamental Rights. That limitation is necessary and proportionate to achieve the public interest objective of the regime, in so far as Member States ensure fair compensation in good time for the loss of private property.

(16) Early detection of the presence of pests is extremely important for timely and effective eradication. Member States should therefore conduct surveys for the presence of Union quarantine pests in the areas where those pests were not known to be present. In view of the number of Union quarantine pests and the time and resources required to carry out those surveys, Member States should establish multi-annual survey programmes.

(17) The Commission should be empowered to adopt measures in case of the suspected or confirmed presence of specific Union quarantine pests, concerning in particular their eradication and containment, and the establishment of restricted areas, surveys, contingency plans, simulation exercises and eradication plans as regards those pests.

(18) In order to ensure swift and effective action against pests which are no Union quarantine pests but which Member States consider may fulfil the conditions for inclusion in the list of Union quarantine pests, provision should be made for measures to be taken by Member States in case they become aware of the presence of such a pest. Similar provisions should be set out for the Commission.

(19) Under certain conditions Member States should be allowed to adopt more stringent eradication measures than required by Union legislation.

(20) Special provisions should apply to priority pests as regards the information of the public, surveys, contingency plans, eradication plans and co-financing of measures by the Union, in particular.

(21) Quarantine pests which are present in the Union territory but absent from specific parts of that territory designated as 'protected zones', and whose presence would have unacceptable economic, social or environmental impacts only for those protected zones, should be specifically identified and listed as 'protected zone quarantine pests'. The introduction into, movement within, and release into the respective protected zones of protected zone quarantine pests should be prohibited.

(22) Rules should be set out concerning the recognition, modification or revocation of recognition of protected zones, survey obligations for protected zones, and actions to be taken in case protected zone quarantine pests are found present in the respective protected zones. In case of findings of the presence of the protected zone quarantine pest inside the respective protected zone, strict rules should apply for the amendment and revocation of those protected zones.

(23) A pest, which is no Union quarantine pest, should be referred to as a 'Union quality pest' in case that pest is mainly transmitted through specific plants for planting, its presence on those plants for planting has an unacceptable economic impact as regards the intended use of those plants and it is listed as a Union quality pest. To limit the presence of such pests their introduction into or movement within the Union territory on the plants for planting concerned should be prohibited unless provided otherwise in that list.

(24) Certain plants, plant products and other objects pose an unacceptable phytosanitary risk by their likelihood to host a Union quarantine pest. For some of those, acceptable risk mitigation measures are available, while not for others. Depending on the availability of acceptable risk mitigation measures, their introduction into, and movement within, the Union territory should be either prohibited or subject to special requirements. Those plants, plant products and other objects should be listed.

(25) Derogations from the prohibitions or special requirements as regards the introduction of plants, plant products and other objects into the Union territory should be provided for. The Commission should be empowered to recognise certain measures of third countries as equivalent to the requirements for the movement within the Union territory of plants, plant products and other objects concerned.

(26) Those prohibitions or requirements should neither apply to small quantities of plants, plant products and other objects, other than plants for planting, for non-commercial and non-professional purposes nor to the introduction into and movement within frontier zones of plants, plant products and other objects. Nor should they apply to the introduction into and movement within the Union territory of plants, plant products and other objects for scientific purposes, trials, varietal selection, breeding and exhibitions. Proper safeguards should be set and information should be provided to those concerned.

(27) A derogation from the Union rules for introduction into and movement within the Union territory should be provided for plants, plant products and other objects in transit.

(28) The international trade of plants for planting with which there is limited phytosanitary experience can involve serious risks of the establishment of quarantine pests for which no measures have been adopted pursuant to this Regulation. In order to ensure swift and effective action against newly identified risks associated with plants for planting which are not subject to permanent requirements or prohibitions, but may qualify for such permanent measures, the Commission should have the possibility to adopt temporary measures in accordance with the precautionary principle.

(29) It is necessary to set out prohibitions and special requirements, similar to those set out for the Union territory, in respect of the introduction into and movement within protected zones of plants, plant products and other objects that would pose a phytosanitary risk of an unacceptable level by their likelihood to host the respective protected zone quarantine pest.

(30) General requirements should be adopted concerning vehicles and packaging material of plants, plant products and other objects to ensure that they are free from quarantine pests.

(31) Member States should designate quarantine stations. Requirements concerning the designation, operation and supervision of those quarantine stations as well as the release of plants, plant products or other objects from those stations should be set out. Where those requirements include the maintenance of lists of staff and visitors entering the stations, this may constitute a limitation of Article 8 (Protection of Personal Data) of the Charter on Fundamental Rights. However that limitation would be necessary and proportionate to achieve the public interest objective of this Regulation.

(32) Where so required by a bilateral agreement concluded by the Union with a third country, or by the legislation of a third country, plants, plant products and other objects moved out of the Union territory to the third country concerned should comply with those rules.

(33) Where, as regards certain plants, plant products or other objects moved out of the Union territory to third countries, no bilateral phytosanitary agreement concluded by the Union with a third country and no phytosanitary legislation of a third country applies, protection should be offered to third countries against Union quarantine pests because of their acknowledged harmful nature, except where a Union quarantine pest is officially known to be present in the third country concerned and not under official control, or where it can be reasonably assumed that that Union quarantine pest does not meet the criteria to qualify as a quarantine pest for the third country concerned.

(34) In order to ensure effective implementation of this Regulation, professional operators subject to obligations under this Regulation should be registered in registers set up by the Member States. In order to reduce administrative burden, those registers should also include professional operators falling within the ambit of Regulation (EU) No …/…. on ……[15] [Office of Publications to insert number, title and, in a footnote, the OJ reference for the Regulation on plant reproductive material].

(35) Professional operators operating at more than one premise should be given the possibility to register separately for each of those premises.

(36) To facilitate the detection of the source of an infestation by a quarantine pest, it is appropriate to require professional operators to keep records in respect of the plants, plant products and other objects supplied to them by professional operators and supplied by them to other professional operators. In view of the latency periods of some quarantine pests, and the time required for the detection of the source of infestation, records should be kept for three years.

(37) Professional operators should also have in place systems and procedures to allow identification of the movements of their plants, plant products and other objects within their own premises.

(38) A phytosanitary certificate should be required for the introduction from third countries into the Union territory, and into protected zones, of certain plants, plant products and other objects. Those plants, plant products and other objects should be listed in the interest of clarity.

(39) Those phytosanitary certificates should comply with the requirements of the IPPC and attest compliance with the requirements and measures established pursuant to this Regulation. In order to ensure the credibility of the phytosanitary certificates, rules should be established concerning the conditions of their validity and cancellation.

(40) The movement within the Union territory, and into and within protected zones, of certain plants, plant products and other objects should only be permitted if accompanied by a plant passport, attesting compliance with the requirements and measures established pursuant to the provisions of this Regulation. Those plants, plant products and other objects should be listed in the interest of clarity.

(41) Plant passports should not be required for plants, plant products and other objects intended for final users.

(42) In order to ensure the credibility of the plant passports, rules should be established concerning their contents.

(43) Plant passports should generally be issued by the professional operator. Where professional operators do not have the resources to issue plant passports, the possibility should exist that, upon their request, plant passports are issued by the competent authorities.

(44) Rules should be set out for the issuance of plant passports, the examinations required for issuance, the authorisation and supervision of professional operators issuing plant passports, the obligations of authorised operators and the withdrawal of that authorisation.

(45) In order to reduce the burden of authorised operators, examinations for issuing plant passports should be combined with the examinations required under Regulation (EU) No …/…. [Office of Publications to insert number of Regulation on plant reproductive material law], where appropriate.

(46) Authorised operators should possess the necessary knowledge concerning pests.

(47) Certain operators may desire to establish a phytosanitary risk management plan, ensuring and demonstrating a high level of competence and awareness as regards phytosanitary risks as regards critical points in their professional activities and justifying special control arrangements with the competent authorities. Union rules should be established concerning the contents of those plans.

(48) It is appropriate to provide for the replacement of plant passports and of phytosanitary certificates.

(49) In cases of non-compliance with the Union rules, plant passports should be removed, invalidated and, for reasons of traceability, kept.

(50) FAO International Standard for Phytosanitary Measures No 15 requires that wood packaging material is marked with a specific mark, applied by duly authorised and supervised professional operators. This Regulation should set out the model and contents of that mark and the authorisation and supervision of professional operators in the Union territory applying that mark.

(51) Where so required by a third country, the respective plants, plant products or other objects should move from the Union territory to that third country with a phytosanitary certificate for export or re-export. In respect of the relevant provisions of IPPC, those certificates should be issued by the competent authorities, respecting the contents of the model certificates for export and re-export set out by the IPPC.

(52) Where a plant, plant product or other object is moved through more than one Member States before it is exported to a third country, it is important that the Member State in which the plants, plant product or other objects were produced or processed exchanges information with the Member State which issues the phytosanitary certificate for export. This exchange of information is important to enable attestation of compliance with the requirements of the third country. Therefore, a harmonised 'pre-export certificate' should be established to ensure that the exchange of that information takes place in a uniform manner.

(53) The Commission should establish an electronic system for the notifications required in accordance with this Regulation.

(54) In order to ensure that the exceptions for Union quarantine pests used for scientific purposes, trials, varietal selections, breeding or exhibitions are implemented in a manner that does not pose any phytosanitary risk to the Union territory or parts of it, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules concerning the exchange of information between Member States and the Commission as regards the introduction into and movement within the Union territory of the pests concerned, the respective assessments and authorisation, and the monitoring of compliance, the action in case of non-compliance and the notification thereof.

(55) In order to ensure an effective system of notifications, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules concerning notification obligations concerning the suspected presence of particular Union quarantine pests which has not yet been officially confirmed.

(56) In order to take into account the technical and scientific developments concerning surveys on the presence of pests, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules amending or supplementing the elements to be covered by the multi-annual survey programmes.

(57) In order to ensure the effective functioning of simulation exercises, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules setting out the frequencies, contents, format and other provisions on simulation exercises.

(58) In order to ensure that protected zones are established and function in a reliable manner, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules on surveys to be carried out for purposes of the recognition of protected zones and on whether protected zones comply with the respective requirements.

(59) In order to ensure a proportionate and restricted application of the exemptions concerning the movement of plants, plant products or other objects into or within frontier zones, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules concerning the maximum width of third country frontier zones and Member State frontier zones, the maximum distance of the movement of the plants, plant products and other objects concerned within the third country frontier zones and Member State frontier zones and the procedures concerning the authorisation of the introduction into and movement within the Member State frontier zones of plants, plant products and other objects.

(60) In order to avoid phytosanitary risks during transit of plants, plant products or other objects, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules setting out the contents of a declaration concerning the passing of plants, plant products or other objects through the Union territory for the purpose of moving to a third country.

(61) In order to ensure that the registration of professional operators is proportionate to the objective of controlling phytosanitary risk, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules setting out categories of, and conditions for, professional operators to be exempted from the obligation to register in a register.

(62) In order to ensure the credibility of phytosanitary certificates of third countries which are not parties to the IPPC, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules supplementing the conditions for acceptance of phytosanitary certificates from those third countries.

(63) In order to minimise the phytosanitary risks of plants, plant products or other objects moved within the Union territory, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules setting out the maximum figure for small quantities of particular plants, plant products or other objects to be exempted from plant passports.

(64) In order to ensure the reliability of examinations of plants, plant products and other objects carried out for the issuance of plant passports, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules on visual examination, sampling and testing and the use of certification schemes.

(65) In order to enhance the credibility of plant passports, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules setting out qualification requirements to be fulfilled by the professional operators in order for them to be authorised to issue plant passports.

(66) In order to enhance the scope and utility of the phytosanitary risk management plan, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules supplementing or amending the elements covered by such plan.

(67) In order to take into account the development of international standards, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules concerning attestations for commodities of a specific nature, other than wood packaging material, which would require the application of a specific attestation of compliance with the rules of this Regulation.

(68) In order to ensure the utility and reliability of official attestations and pre-export certificates, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules setting out the contents of official attestations, the authorisation and supervision of professional operators issuing those attestations, and the contents of the pre-export certificate.

(69) In order to adapt to the technical and scientific developments, and to adapt to a decision of the European Council pursuant to Article 355(6) TFEU, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules amending the Annexes of this Regulation.

(70) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(71) In order to ensure uniform conditions for the implementation of this Regulation with respect to establishing a list of Union quarantine pests, establishing a list of the priority pests, setting out measures against specific Union quarantine pests, adopting measures for a limited time as regards the phytosanitary risks posed by pests provisionally qualifying as Union quarantine pests, recognising the protected zones recognised in accordance with the first subparagraph of Article 2(1)(h) of Directive 2000/29/EC and establishing a list of the respective protected zone quarantine pests, amending or revoking protected zones, amending the list of those protected zones, listing of Union quality pests and the plants for planting concerned, listing the plants, plant products and other objects whose introduction into and movement within the Union territory is to be prohibited, and the third countries concerned, listing the plants, plant products and other objects, and the requirements for their introduction into and movement within the Union territory, setting out equivalent requirements of third countries to the requirements for movement within the Union territory of plants, plant products or other objects, setting out specific conditions or measures concerning the introduction of particular plants, plant products and other objects into frontier zones of Member States, adoption of temporary measures as regards the introduction into and movement within the Union territory of plants for planting from third countries, listing of plants, plant products and other objects, whose introduction into, and movement within, particular protected zones is to be prohibited, listing requirements for the introduction into, and movement within, particular protected zones of plants, plant products and other objects, listing of the plants, plant products and other objects, and the respective third countries of origin or dispatch, for which a phytosanitary certificate is to be required for their introduction into the Union territory, listing of the plants, plant products and other objects, and the respective third countries of origin or dispatch, for which a phytosanitary certificate is to be required for their introduction into certain protected zones from those third countries, listing of the plants, plant products and other objects, for which a plant passport is to be required for their movement within the Union territory, listing of the plants, plant products and other objects, for which a plant passport is to be required for their introduction into certain protected zones, and setting out the format of the plant passport, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers[16].

(72) The advisory procedure should be used for the adoption of the initial list of Union quarantine pests given that that initial list should merely contain, without any modifications, the pests listed in Part A of Annex I to Directive 2000/29/EC and Section I of Part A of Annex II to that Directive, for the amendment of the scientific name of a pest, where such an amendment is justified on the basis of the development of scientific knowledge, for the adoption of the initial list of protected zones and the respective protected zone quarantine pests given that that initial list should merely contain, without any modifications, the protected zones recognised in accordance with the first subparagraph of Article 2(1)(h) of Directive 2000/29/EC and the protected zone quarantine pests listed in Part B of Annex I and Part B of Annex II to Directive 2000/29/EC, for the amendment and revocation of protected zones, for the adoption of the initial list of Union quality pests given that that initial list should merely contain, without any modifications, the pests listed in certain Directives on the production and marketing of seeds and propagating material, for the adoption of the initial list of plants, plant products and other objects whose introduction into and movement within the Union territory is to be prohibited given that that initial list should merely contain, without any modifications, the plants, plant products and other objects, and the prohibitions and the third countries concerned, as set out in Part A of Annex III to Directive 2000/29/EC, together with their Combined Nomenclature (CN) codes, for the adoption of the initial list of plants, plant products and other objects whose introduction into and movement within the Union territory is to be subject to special requirements given that that initial list should merely contain, without any modifications, the plants, plant products and other objects, and the requirements and the third countries concerned, as set out in Part A of Annex IV to Directive 2000/29/EC, together with their Combined Nomenclature (CN) codes, for the adoption of the initial list of plants, plant products and other objects whose introduction into certain protected zones is to be prohibited given that that initial list should merely contain, without any modifications, the plants, plant products and other objects, and the prohibitions and the third countries concerned, as set out in Part B of Annex III to Directive 2000/29/EC, together with their Combined Nomenclature (CN) codes, for the adoption of the initial list of plants, plant products and other objects whose introduction into, and movement within, certain protected zones is to be subject to special requirements given that that initial list should merely contain, without any modifications, the plants, plant products and other objects, and the requirements, as set out in Part B of Annex IV to Directive 2000/29/EC, together with their Combined Nomenclature (CN) codes, for the adoption of the initial list of the plants, plant products and other objects, and the respective third countries of origin or dispatch, for which a phytosanitary certificate is required for their introduction into the Union territory, given that that initial list should merely contain, without any modifications, the plants, plant products and other objects listed in Point I of Part B of Annex V to Directive 2000/29/EC, for the adoption of the initial list of the plants, plant products and other objects, and the respective third countries of origin or dispatch, for which a phytosanitary certificate is required for their introduction into certain protected zones, given that that initial list should merely contain, without any modifications, the plants, plant products and other objects listed in Point II of Part B of Annex V to Directive 2000/29/EC, for the adoption of the initial list of the plants, plant products and other objects, for which a plant passport is required for their movement within the Union territory, given that that initial list should merely contain, without any modifications, the plants, plant products and other objects listed in Point I of Part A of Annex V to Directive 2000/29/EC, and for the adoption of the initial list of the plants, plant products and other objects, for which a plant passport is required for their introduction into certain protected zones, given that that initial list should merely contain, without any modifications, the plants, plant products and other objects listed in Point II of Part A of Annex V to Directive 2000/29/EC.

(73) Council Directive 74/647/EEC of 9 December 1974 on control of carnation leaf-rollers[17] and Council Directive 69/466/EEC of 8 December 1969 on control of San José Scale[18] set out measures on the control of the respective pests. Following the entry into force of those Directives, the concerned pests have become widely spread throughout the Union territory, thus their containment is not feasible any more. Those Directives should therefore be repealed.

(74) Council Directive 69/464/EEC of 8 December 1969 on control of Potato Wart Disease[19], Council Directive 93/85/EEC of 4 October 1993 on control of Potato Ring Rot[20], Council Directive 98/57/EC of 20 July 1998 on control of Ralstonia solanacearum (Smith) Yabuuchi et al.[21] and Council Directive 2007/33/EC of 11 June 2007 on the control of potato cyst nematodes and repealing Directive 69/465/EC[22] should be repealed, as new measures on the pests concerned should be adopted in accordance with the provisions of this Regulation. In view of the time and resources required to adopt those new measures, those acts should be repealed by 2021.

(75) Regulation (EU) No …/2013 on ……[23] [Office of Publications, please insert number and title of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material and, in the footnote, the reference to the Official Journal] sets out that grants for measures against pests are to concern certain pests listed in the Annexes to Directive 2000/29/EC, and certain pests not listed in those Annexes but subject to temporary Union measures adopted with regard to them. This Regulation establishes the category of priority pests. It is appropriate that certain measures taken by the Member States as regards priority pests are to be eligible for Union grants, including compensation paid to professional operators for the value of plants, plant products and other objects, subject to destruction pursuant to the eradication measures set out in this Regulation. Regulation (EU) No XXX/2013 should therefore be amended.

(76) Since the objective of this Regulation, namely to ensure a harmonised approach with regard to protective measures against pests of plants, cannot be sufficiently achieved by the Member States and can therefore, by reason of its effect, complexity, trans-border and international character, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not exceed what is necessary in order to achieve that objective.

(77) For small and medium enterprises, this Regulation does not create disproportionate administrative burden or economic impact. Under this Regulation, based on consultation with stakeholders, the special situation of small and medium enterprises has been taken into account where possible. A potential universal exemption for micro-enterprises, which make up the majority of companies, has not been considered, in view of the public policy objective(s) to protect plant health.

(78) This Regulation respects the IPPC, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the guidelines set out under these.

(79) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably respect for private and family life, the right to property, the protection of personal data, freedom to conduct business and the freedom of art and science. This Regulation should be applied by the Member States in accordance with those rights and principles,

HAVE ADOPTED THIS REGULATION:

Chapter I Subject matter, scope and definitions

Article 1 Subject matter and scope

1. This Regulation lays down rules to determine the phytosanitary risks posed by any species, strain or biotype of pathogenic agents, animals or parasitic plants injurious to plants or plant products (hereinafter “pests”) and measures to reduce those risks to an acceptable level.

2. For the purposes of this Regulation references to third countries shall be read as references to third countries and to the territories listed in Annex I.

For the purposes of this Regulation, references to the Union territory shall be read as references to the Union territory without the territories listed in Annex I.

The Commission shall be empowered to adopt delegated acts, in accordance with Article 98, amending Annex I to ensure that the scope of this Regulation is confined to the European part of the Union territory. That amendment shall be either of the following:

(a) an addition to Annex I of one or more territories that are referred to in Article 355(1) of the Treaty;

(b) a removal from Annex I of one or more territories that are referred to in Article 355(2) of the Treaty.

Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) 'plants' means living plants and the following living parts of plants:

(a) seeds, in the botanical sense, other than those not intended for planting;

(b) fruits, in the botanical sense;

(c) vegetables;

(d) tubers, corms, bulbs, rhizomes, roots, rootstocks, stolons;

(e) shoots, stems, runners;

(f) cut flowers;

(g) branches with foliage;

(h) cut trees retaining foliage;

(i) leaves, foliage;

(j) plant tissue cultures, including cell cultures, germplasm, meristems, chimaeric clones, micro-propagated material;

(k) live pollen;

(l) buds, budwood, cuttings, scions, grafts;

(2) 'plant products' means products of plant origin, unprocessed or having undergone simple preparation, in so far as these are not plants.

Except where otherwise provided, wood shall only be considered as a 'plant product' if it has not undergone processing eliminating the phytosanitary risks, and complies with one or more of the following points:

(a) it retains all or part of its natural round surface, with or without bark;

(b) it has not retained its natural round surface due to sawing, cutting or cleaving;

(c) it is in the form of chips, particles, sawdust, wood waste, shavings or scrap, and has not undergone processing involving the use of glue, heat or pressure or a combination thereof to produce pellet, briquettes, plywood or particle board;

(d) it is, or is intended to be, used as packaging material or dunnage, whether or not it is actually in use for transport of goods;

(3) 'plants for planting' means plants, which are capable of and intended for producing entire plants, and which are destined to be planted, or replanted, or remain planted;

(4) 'other object' means any material or object, other than plants or plant products, capable of harbouring or spreading pests, including soil or growing medium;

(5) 'competent authority' means a competent authority as defined in Article 2(5) of Regulation (EU) No …/…. [Office of Publications, please insert number of Regulation on Official Controls];

(6) 'lot' means a number of units of a single commodity, identifiable for phytosanitary purposes by its homogeneity of composition and origin, forming part of a consignment;

(7) 'professional operator' means any person, governed by public or private law, involved professionally in one or more of the following activities concerning plants, plant products and other objects:

(a) planting;

(b) growing;

(c) production;

(d) introduction into, and movement within, and out of the Union territory;

(e) making available on the market;

(8) 'final user' means any person, acting for purposes which are outside its trade, business or profession, who acquires for its own use plants or plant products;

(9) 'test' means an official examination, other than visual, to determine if pests are present or to identify pests;

(10) 'treatment' means a procedure for the killing, inactivation or removal of pests, or for rendering those pests infertile or for their devitalisation.

Chapter II Quarantine pests

Section 1 QUARANTINE PESTS

Article 3 Definition of quarantine pests

A pest shall be referred to as a 'quarantine pest', with respect to a defined territory, if it fulfils all of the following conditions:

(a) its identity is established, within the meaning of point (1) of Section 1 of Annex II;

(b) it is not present in that territory, within the meaning of point (2)(a) of Section 1 of Annex II, or, if present, only distributed to a limited extent within that territory, within the meaning of points (2)(b) and (c) of Section 1 of Annex II;

(c) it is capable of entering into that territory, of perpetuating its presence in that territory for the foreseeable future after its entry into it (hereinafter: 'to establish') and of spreading within that territory, or, if present, those parts of it where it is distributed to a limited extent, in accordance with point (3) of Section 1 of Annex II;

(d) its entry, establishment and spread would, within the meaning of point (4) of Section 1 of Annex II, have an unacceptable economic, environmental or social impact for that territory, or, if present, those parts of it where it is distributed to a limited extent; and

(e) feasible and effective measures are available to prevent the entry into, establishment or spread of that pest within that territory, and mitigate its phytosanitary risks and impacts.

Section 2 Union Quarantine Pests

Article 4 Definition of Union quarantine pests

A quarantine pest shall be referred to as a Union quarantine pest if the defined territory as referred to in the introductory words of Article 3 is the Union territory and it is included in the list referred to in Article 5(2).

Article 5 Prohibition of introduction and movement of Union quarantine pests

1. A Union quarantine pest shall not be introduced into or moved within the Union territory.

No action shall be taken intentionally which may contribute to the introduction into, and establishment and spread within, the Union territory of a Union quarantine pest.

2. The Commission shall, by means of an implementing act, establish a list of pests fulfilling the conditions referred to in Article 3(b), (c) and (d) in respect of the Union territory, referred to as 'list of Union quarantine pests'.

That list shall include the pests listed in Part A of Annex I to Directive 2000/29/EC and Section I of Part A of Annex II to that Directive.

Pests which are indigenous to any part of the Union territory, whether naturally or due to their introduction from outside the Union territory, shall be marked in that list as pests known to occur in the Union territory.

Pests which are not indigenous to any part of the Union territory shall be marked in that list as pests not known to occur in the Union territory.

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 99(2).

3. The Commission shall amend the implementing act referred to in paragraph 2, where an assessment shows that a pest not listed in that act fulfils the conditions referred to in Article 3(b), (c) and (d) in respect of the Union territory, or a pest listed in that act no longer fulfils one or more of those conditions. In the first case it shall add the pest concerned to the list referred to in paragraph 2, in the second case it shall delete the pest concerned from that list.

The Commission shall make that assessment available to the Member States.

The implementing acts amending the implementing act referred to in paragraph 2 shall be adopted in accordance with the examination procedure referred to in Article 99(3). The same procedure shall apply to a repeal or a replacement of the implementing act referred to in paragraph 2.

4. The Commission shall amend the implementing act referred to in paragraph 2 by amending the scientific name of a pest, where such an amendment is justified by the development of scientific knowledge.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 99(2).

Article 6 Priority pests

1. A Union quarantine pest is a 'priority pest' if it fulfils all of the following conditions:

(a) it fulfils, as regards the Union territory, the condition set out in point (a) or in point (b) of point (2) of Section 1 of Annex II;

(b) its potential economic, environmental or social impact is most severe for the Union territory as set out in Section 2 of Annex II;

(c) it is listed in accordance with paragraph 2.

2. The Commission shall, by means of an implementing act, establish and amend a list of the priority pests, hereinafter: 'list of priority pests'.

Where the results of an assessment show that a Union quarantine pest fulfils the conditions referred to in paragraph 1, or a pest no longer fulfils one or more of those conditions, the Commission shall amend the implementing act referred to in the first subparagraph by adding the pest concerned to, or removing it from, that list.

The Commission shall make that assessment available to the Member States.

The number of priority pests shall not exceed 10% of the number of the Union quarantine pests listed pursuant to Article 5(2) and (3). Where the number of priority pests has exceeded 10% of the number of the Union quarantine pests listed pursuant to Article 5(2) and (3), the Commission shall amend the implementing act referred to in the first subparagraph by accordingly adjusting the number of pests in that list, on the basis of their potential economic, environmental or social impact as set out in Section 2 of Annex II.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 99(3).

On duly justified imperative grounds of urgency relating to a serious phytosanitary risk, the Commission shall adopt immediately applicable implementing acts, in accordance with the procedure referred to in Article 99(4), listing Union quarantine pests as priority pests.

Article 7 Amendment of Section 1 and Section 2 of Annex II

1. The Commission shall be empowered to adopt delegated acts in accordance with Article 98 amending Section 1 of Annex II on criteria to identify pests which qualify as a quarantine pest, as regards the identity of the pest, its presence, its capability of entry, establishment and spread, and its potential economic, social and environmental impact, taking into account the developments of technical and scientific knowledge.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 98 amending Section 2 of Annex II on criteria to identify Union quarantine pests which qualify as a priority pest, as regards their potential economic, social and environmental impact, taking into account the developments of technical and scientific knowledge.

Article 8 Union quarantine pests used for scientific purposes, trials, varietal selections, breeding or exhibitions

1. By way of derogation from Article 5(1), Member States may, on application, authorise the introduction into, and the movement within, their territory of Union quarantine pests for use for scientific purposes, trials, varietal selections, breeding or exhibitions if all of the following requirements are fulfilled:

(a) the introduction, movement and use of the pest concerned do not result in the establishment or spread of that pest within the Union territory if adequate restrictions are imposed;

(b) the storage facilities in which that pest is to be kept and the quarantine stations, as referred to in Article 56, in which that pest is to be used are appropriate;

(c) the scientific and technical qualifications of the personnel by whom the activity involving that pest is to be carried out are appropriate.

2. The competent authority shall assess the risk of establishment and spread of the pest concerned, as referred to in paragraph 1(a), taking into account the identity, biology and means of dispersal of the pest, the activity envisaged, the interaction with the environment and other relevant factors relating to the risk posed by that pest.

It shall assess the storage facilities in which that pest is to be kept, as referred to in paragraph 1(b), and the scientific and technical qualifications of the personnel by whom the activity involving the pest is to be carried out, as referred to in paragraph 1(c).

On the basis of those assessments the competent authority shall authorise introduction of the pest into, or movement within, the Union territory if the requirements set out in paragraph 1 are fulfilled.

3. Where an authorisation is granted, it shall include all of the following conditions:

(a) the pest is to be kept in storage facilities found to be appropriate by the competent authorities and referred to in the authorisation;

(b) the activity involving the pest is to be carried out in a quarantine station designated in accordance with Article 56 by the competent authority and referred to in the authorisation;

(c) the activity involving the pest is to be carried out by personnel whose scientific and technical qualifications are found to be appropriate by the competent authority and referred to in the authorisation;

(d) the pest is to be accompanied by the authorisation when introduced into or moved within the Union territory.

4. The authorisation shall be limited to the amount that is adequate for the activity concerned and shall not exceed the capacity of the designated quarantine station.

It shall include the restrictions necessary to adequately mitigate the risk of establishment and spread of the Union quarantine pest concerned.

5. The competent authority shall monitor compliance with the conditions referred to in paragraph 3 and the limitation and the restrictions referred to in paragraph 4 and take the necessary action in case those conditions, that limitation or those restrictions are not complied with. Where appropriate, that action shall be the revocation of the authorisation referred to in paragraph 1.

6. The Commission shall be empowered to adopt delegated acts, in accordance with Article 98, laying down detailed rules concerning:

(a) the exchange of information between Member States and the Commission concerning the introduction into, and movement within, the Union territory of the pests concerned;

(b) the assessments and authorisation referred to in paragraph 2; and

(c) the monitoring of compliance, the action in case of non-compliance and the notification thereof, as referred to in paragraph 5.

Article 9 Notification of Union quarantine pests to the competent authorities

1. Where anyone becomes aware of the presence of a Union quarantine pest or has reason to suspect such a presence, that person shall notify, in writing, the competent authority within ten calendar days.

2. If so requested by the competent authority, the person referred to in paragraph 1 shall provide that authority with the information concerning that presence which is in its possession.

Article 10 Measures in case of suspicion of the presence of a Union quarantine pest

Where a competent authority suspect the presence of a Union quarantine pest, in a part of the territory of the respective Member State where that pest was previously not known to be present, it shall immediately take any measures necessary to officially confirm whether that pest is present or not.

Article 11 Notification of Union quarantine pests to the Commission and the other Member States

1. A Member State shall notify, through the electronic notification system referred to in Article 97, the Commission and the other Member States, in case one of the following points is fulfilled:

(a) its competent authority has received a diagnosis of an official laboratory, as referred to in Article 36 of Regulation (EU) No …/…. [Office of Publications, please insert the number of the Regulation on Official Controls], confirming (hereinafter: 'officially confirming') the presence in its territory of a Union quarantine pest not known to be present in that Member State;

(b) its competent authority has officially confirmed the presence in its territory of a Union quarantine pest, if that pest is found to be present in a part of its territory where it was previously not present;

(c) its competent authority has officially confirmed the presence in its territory of a Union quarantine pest in a consignment of plants, plant products or other objects introduced into, intended to be introduced into or moved within the Union territory.

2. The notifications referred to in paragraph 1 shall be submitted within three working days following the date of the official confirmation by the competent authority of the presence of the respective Union quarantine pest.

3. The Commission shall be empowered to adopt delegated acts, in accordance with Article 98, laying down that the notification obligations referred to in paragraph 1 shall also apply to the suspected presence of particular Union quarantine pests, which has not yet been officially confirmed. Those delegated acts may also determine the time limit within which those notifications shall be submitted.

Article 12 Information on Union quarantine pests provided to professional operators by the competent authorities

Where the conditions of one of the points of Article 11(1) are fulfilled, the competent authority concerned shall ensure that professional operators, whose plants, plant products or other objects may be affected, are immediately informed of the presence of the Union quarantine pest concerned.

Article 13 Information on priority pests provided to the public by the competent authorities

Where the conditions of one of the points of Article 11(1)(a) or (b) are fulfilled as regards a priority pest, the competent authority shall inform the public about the measures taken and to be taken by that competent authority and, where applicable, to be taken by particular professional operators or other persons.

Article 14 Notification of imminent dangers

1. Where a Member State has evidence that there is an imminent danger of the entry of a Union quarantine pest into the Union territory or into a part of that territory where it is not yet present, that Member State shall immediately and in writing notify the Commission and the other Member States of that evidence.

2. Professional operators shall immediately notify the competent authorities of any evidence they may have concerning an imminent danger as referred to in paragraph 1 concerning Union quarantine pests.

Article 15 Measures to be taken immediately by professional operators

1. Where a professional operator becomes aware that a Union quarantine pest is present in plants, plant products or other objects which are under its control, it shall, immediately, and after informing and consulting with the competent authority concerned, take the phytosanitary measures necessary to eliminate that pest from the plants, plant products or other objects concerned and from its premises, where applicable, and prevent the spread of that pest.

That professional operator shall, immediately and after informing and consulting with the competent authority concerned, inform the persons in the trade chain from whom those plants, plant products or other objects had been obtained.

That competent authority shall, where appropriate, ensure that the professional operator concerned withdraws from the market the plants, plant products and other objects in which that pest may be present.

2. Where the plants, plant products or other objects referred to in paragraph 1 have left the control of the professional operator concerned, that professional operator shall, immediately and after informing and consulting with the competent authority concerned, inform the persons in the trade chain from whom those plants, plant products or other objects had been obtained and to whom those plants, plant products and other objects had been supplied, of the presence of the pest.

3. The competent authority shall, where appropriate, ensure that the professional operator concerned recalls from the market the plants, plant products and other objects in which the pest may be present and, where the plants, plant products and other objects may have reached the final user, to recall them from those final users.

4. Where paragraph 1 or 2 applies, the professional operator concerned shall provide all information which is relevant for the public to the competent authority concerned. That authority shall inform the public in case action needs to be taken with regard to the plants, plant products or other objects in which the respective pest may be present.

Article 16 Eradication of Union quarantine pests

1. Where the presence of a Union quarantine pest is officially confirmed, the competent authority shall immediately take all necessary measures to eliminate that pest in the area concerned and to prevent its spread out of that area (hereinafter: 'to eradicate'). Those measures shall be adopted in accordance with Annex IV on measures and principles for the management of the risks of pests.

2. Where the presence of the Union quarantine pest concerned may be related to movements of plants, plant products or other objects, the competent authority shall investigate the source of that presence and the possibility that the pest concerned has been spread to further plants, plant products or other objects by those movements.

3. Where the measures referred to in paragraph 1 concern the introduction into, or movement within, the Union territory of plants, plant products and other objects, the Member State concerned shall immediately notify those measures to the Commission and the other Member States.

4. Private premises of citizens shall not be exempted from the measures, referred to in paragraph 1, and the investigations, referred to in paragraph 2.

Article 17 Establishment of restricted areas

1. Following the official confirmation referred to in Article 11(1)(a), the competent authority shall immediately establish an area where the measures referred to in that Article are to be taken (hereinafter: 'restricted area').

The restricted area shall consist of an infested zone, as provided for in paragraph 2, and a buffer zone, as provided for in paragraph 3.

2. The infested zone shall contain:

(a) all plants known to be infested by the pest concerned;

(b) all plants showing signs or symptoms indicating possible infestation by that pest;

(c) all other plants liable to be infested by that pest due to their susceptibility to that pest and their close proximity to infested plants, or common source of production, if known, with infested plants, or plants grown from them.

3. The buffer zone shall be adjacent to the infested zone and shall surround it.

Its size shall be appropriate in view of the risk of the pest concerned spreading out of the infested zone naturally, or by human activities in the infested zone and its surroundings, and shall be decided in accordance with the principles set out in Section 2 of Annex IV on measures and principles for the management of the risks of pests.

However, where any risk of the pest spreading out of the infested zone is sufficiently mitigated through natural or artificial barriers, no buffer zone need be established.

4. By way of derogation from paragraph 1, where upon first sight the competent authority concludes, in view of the nature of the pest concerned and the site where it was found, that the pest concerned can be eliminated immediately, the competent authority may decide not to establish a restricted area.

In that case, it shall carry out a survey to determine whether any further plants or plant products have been infested. On the basis of that survey, the competent authority shall determine whether there is a need to establish a restricted area. The competent authority concerned shall notify to the Commission and the other Member States the conclusions of that survey.

5. Where in accordance with paragraphs 2 and 3 a restricted area is to extend into the territory of another Member State, the Member State where the pest concerned was found to be present shall immediately contact the Member State into whose territory the restricted area is to extend in order to allow that Member State to take all appropriate actions, as referred to in paragraphs 1 to 4.

6. By 31 March of each year, Member States shall notify to the Commission and the other Member States the number and locations of the restricted areas established, the pests concerned, and the respective measures taken during the preceding year.

Article 18 Surveys and modifications of restricted areas, and lifting of restrictions

1. Competent authorities shall annually carry out a survey of each restricted area as regards the development of the presence of the pest concerned.

Those surveys shall be carried out in accordance with the provisions on surveys as set out in Article 21(1) and (2).

2. Where as a result of an annual survey a competent authority finds a presence of the pest concerned in the buffer zone, the Member State concerned shall immediately notify that presence to the Commission and the other Member States specifying that the pest was found present in a buffer zone.

3. Competent authorities shall modify the boundaries of infested zones, buffer zones and restricted areas, where appropriate, in view of the results of the surveys referred to in paragraph 1.

4. Competent authorities may decide to abolish a restricted area and terminate the respective eradication measures, provided that during the surveys referred to in paragraph 1 no presence of the pest concerned has been found in that restricted area for a sufficiently long period.

5. When deciding on the modifications referred to in paragraph 3 or the abolition of the restricted area referred to in paragraph 4, the competent authority concerned shall at least take into account the biology of the pest and the vector concerned, the presence of host plants, the eco-climatic conditions and the likelihood of the eradication measures having been successful.

Article 19 Reports on measures taken in accordance with Articles 16, 17 and 18

Member States shall prepare a report on the measures taken in accordance with Articles 16, 17 and 18.

Where those measures are taken by a Member State in an area adjacent to the border with another Member State, that report shall be submitted to the latter Member State.

That report shall be submitted, on request, to the Commission and the other Member States.

Article 20 Amendment of Annex IV

The Commission shall be empowered to adopt delegated acts in accordance with Article 98, amending Section 1 of Annex IV on measures to manage the risks of quarantine pests, as regards the measures targeting prevention and elimination of infestation of cultivated and wild plants, measures targeting consignments of plants, plant products and other objects, measures targeting other pathways for quarantine pests, and amending Section 2 of that Annex on principles for the management of the risks of pests, as regards principles for the management of the risks of pests, taking into account the developments of technical and scientific knowledge.

Article 21 Surveys on Union quarantine pests and pests provisionally qualifying as Union quarantine pest

1. Member States shall conduct surveys, over specific periods of time, checking for the presence of any Union quarantine pest, and signs or symptoms of any pest provisionally qualifying as Union quarantine pest, pursuant to Section 3 of Annex II, in all areas where that pest was not known to be present.

2. Those surveys shall consist, at least, of visual examinations by the competent authority, and, where appropriate, collection of samples and performance of tests. They shall be based on sound scientific and technical principles, and shall be carried out at appropriate times with regard to the possibility to detect the pest concerned.

Those surveys shall take account of scientific and technical evidence, and any other