EN Official Journal of the European Union C 376/1

POSITION (EU) No 16/2016 OF THE COUNCIL AT FIRST READING

with a view to the adoption of a Regulation of the European Parliament and of the Council on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC

Adopted by the Council on 18 July 2016

(2016/C 376/01)

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(2) 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 (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) Council Directive 2000/29/EC (3) 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.

(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. In order 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, forests, natural and planted areas, natural ecosystems, ecosystem services and biodiversity in the Union. Plant health is threatened by species injurious to plants and plant products which now present a greater risk of being introduced into the Union territory owing to globalisation of trade and climate change. In order 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 FAO Conference in November 1997 at its 29th session. The Union and all its Member States are contracting parties to the IPPC.

(6) It has become apparent that for the determination of the scope of this Regulation it is important to take into account bio-geographical factors to avoid the introduction into and spread within the territory of the European Union of pests not present in that territory. Consequently, Ceuta, Melilla and, with the exception of Madeira and the Azores, the outermost regions of Member States referred to in Article 355(1) of the Treaty on the Functioning of the European Union (TFEU) should be excluded from the territorial scope of this Regulation. References to third countries should be read as references also to those excluded territories.

(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. It requires the Member States to carry out adequate and efficient control measures. Such adequate and efficient official controls measures should also be continued in the future. As part of the ‘Smarter Rules for Safer Food’ package, this Regulation should only provide for a limited number of provisions on official controls since those rules should be provided for in the framework of the horizontal legislation on official controls.

(8) Criteria should be set out for the identification of pests for which the adoption of measures is necessary to prevent their introduction into and spread within 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’. Where those pests are plants, the implementation of this Regulation should focus in particular on plants which are parasitic to other plants, when they are most injurious to plant health.

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

(10) In order to ensure that effective and timely action is taken where a Union quarantine pest is found to be present or suspected of being present, notification obligations should apply to the Member States, professional operators and the public.

(11) 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 of the European Union (‘the Charter’). However such a limitation would be necessary and proportionate to the achievement of the public interest objective of this Regulation.

(12) A professional operator or other person suspecting or 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 notify the competent authority of that suspicion or awareness, to take all measures that may be appropriate as regards the elimination of the pest and the withdrawal or recall of the plants, plant products or other objects concerned, and to provideto the competent authority, other persons in the trade chain and the public with information.

(13) Member States should take all necessary phytosanitary measures to eradicate Union quarantine pests, when found to be present in their territories. It is appropriate to set out measures which may be taken by Member States in such a case. It is also appropriate to set out the principles which the Member States should follow when deciding which measures should be taken. Those measures should include the establishment of demarcated areas, consisting of an infested zone and a buffer zone and, when applicable, the determination of actions which should be taken by a professional operator or other person in order to eliminate the quarantine pest or in order to prevent the spread of that pest.

(14) 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 that 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. That limitation should be necessary and proportionate to the achievement of the public interest objective of this Regulation.

(15) Prevention and early detection of the presence of pests is extremely important for timely and effective eradication. Member States should therefore carry out 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.

(16) The Commission should be empowered to adopt measures where there is a suspected or confirmed presence of specific Union quarantine pests, in particular concerning their eradication and containment and the establishment of demarcated areas, surveys, contingency plans, simulation exercises and action plans.

(17) Where a Union quarantine pest has become established in a demarcated area and cannot be eradicated, the Commission should adopt Union measures as regards the containment of that pest in that area.

(18) In order to ensure swift and effective action against pests which are not 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 the event that 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 measures than those required by Union legislation.

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

(21) Quarantine pests which are present in the Union territory but which are absent from specific parts of that territory designated as ‘protected zones’, and whose presence would have an unacceptable economic, social or environmental impact only within 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 established concerning the recognition, modification or revocation of recognition of protected zones, survey obligations for protected zones, action to be taken in the event that protected zone quarantine pests are found to be present in the respective protected zones, as well as the establishment of temporary protected zones. Strict rules should apply for the amendment of the extent, and for the revocation of recognition, of protected zones where a protected zone quarantine pest is found to be present within the respective protected zone.

(23) A pest, which is not a Union quarantine pest, should be referred to as a ‘Union regulated non-quarantine pest’ if 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 regulated non-quarantine pest. In order 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 where those pests are present at an incidence above a certain threshold.

(24) Certain plants, plant products and other objects pose an unacceptable risk due to their likelihood of hosting 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, or 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) In addition to the measures taken to manage the unacceptable risk of the plants, plant products and other objects thereof, this Regulation should provide risk-based and preventive measures to protect the Union territory from pests that a plant, plant product or other object originating from a third country might introduce, on the basis of a preliminary assessment of that high risk. That preliminary assessment should take into account specific criteria appropriate for the plant, plant product or other object concerned. For that purpose scientific opinions or studies of the IPPC, the European and Mediterranean Plant Protection Organisation (EPPO), the European Food Safety Authority (EFSA) or Member State authorities should be taken into account. On the basis of that preliminary assessment, a list of those high risk plants, plant products or other objects should be established and their introduction into the Union territory should be prohibited, pending a risk assessment carried out in accordance with IPPC standards. Those plants, plant products or other objects should not include those whose introduction in the Union territory is prohibited or subject to special and equivalent requirements, on the basis of a pest risk analysis, or which are subject to the temporary prohibitions set out in this Regulation.

(26) Provision should be made for derogations from the prohibitions or special requirements as regards the introduction of plants, plant products and other objects into the Union territory. 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.

(27) Those prohibitions or requirements should neither apply to small quantities of certain plants, plant products and other objects, other than plants for planting, for non-commercial and non-professional purposes, nor, in certain cases, to the introduction into, and movement within, frontier zones of plants, plant products and other objects.

(28) It is appropriate to provide for exemptions from the prohibition of introduction into, and movement within, the Union territory of pests, plants, plant products and other objects which are subject to those prohibitions and which are intended for certain purposes such as official testing, scientific or educational purposes, trials, varietal selection or breeding. Proper safeguards should be set and information should be provided to those concerned.

(29) Plants moving into the Union from third countries and moving through postal services are in many cases non-compliant with the phytosanitary requirements of the Union. In order to raise awareness, specific rules concerning the information to be provided to travellers and clients of postal services should be set out.

(30) A derogation from the Union rules for the introduction into, and movement within, the Union territory should be provided for plants, plant products and other objects in phytosanitary transit, subject to specific conditions.

(31) The international trade of plants, plant products and other objects with which there is limited phytosanitary experience can potentially involve unacceptable risks of the establishment of quarantine pests which are not yet listed as Union quarantine pests and for which no measures have been adopted pursuant to this Regulation. In order to ensure swift and effective action against those newly identified or suspected pest risks associated with plants, plant products and other objects 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 and identify those plants, plant products and other objects taking into account objective and established elements.

(32) 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 risk of an unacceptable level due to their likelihood of hosting the respective protected zone quarantine pest.

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

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

(35) The Commission should keep a publicly available, updated list of all notifications it has received concerning emerging pests in third countries which may pose a risk to plant health in the Union territory.

(36) In order to ensure effective implementation of this Regulation, certain professional operators subject to obligations under this Regulation should be registered in registers set up by the Member States. Requirements for registration, as well as exemptions from those requirements, should be set out.

(37) In order 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 at least three years.

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

(39) 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 transparency.

(40) Phytosanitary certificates should also be required for the introduction of other plants from third countries into the Union territory. This is important in order to ensure an appropriate level of phytosanitary safety as well as effective overview of the import of those plants into the Union and the risks thereof. Those plants should, however, not be subject to the provisions on official controls at border control posts laid down in the relevant Union legislation.

(41) Those phytosanitary certificates should comply with the requirements of the IPPC and should 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 invalidation.

(42) 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 transparency.

(43) Plant passports should not be required for plants, plant products and other objects supplied directly to final users, including home gardeners. However, certain exceptions should be set out.

(44) In order to ensure the credibility of the plant passports, rules should be established concerning their content and form.

(45) Plant passports should generally be issued by the authorised professional operator. It should be possible for competent authorities to decide to issue plant passports.

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

(47) In order to reduce the burden of authorised operators, examinations for issuing plant passports should, where appropriate, be combined with the examinations required under Council Directives 66/401/EEC (4), 66/402/EEC (5), 68/193/EEC (6), 2002/54/EC (7), 2002/55/EC (8), 2002/56/EC (9), 2002/57/EC (10), 2008/72/EC (11) and 2008/90/EC (12).

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

(49) Certain authorised operators may wish to establish a pest risk management plan, ensuring and demonstrating a high level of competence and awareness as regards pest 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.

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

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

(52) International Standard for Phytosanitary Measures No 15 Regulation of Wood Packaging Material in International Trade (ISPM15) requires wood packaging material to be marked with a specific mark, applied by duly authorised and supervised professional operators. This Regulation should set out requirements concerning the treatment, marking and repairing of wood packaging material in line with that standard. This Regulation should also set out rules for the authorisation and supervision of professional operators in the Union territory applying that mark.

(53) Where so required by a third country, the respective plants, plant products or other objects should be moved from the Union territory to that third country with a phytosanitary certificate for export or re-export. In respect of the relevant provisions of the 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. 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.

(54) 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. That exchange of information is important in order to enable compliance with the requirements of the third country to be attested. Therefore, a harmonised ‘pre-export certificate’ should be established in order to ensure that the exchange of that information takes place in a uniform manner.

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

(56) In order to take into account the most severe economic, social or environmental impact on the Union territory of certain Union quarantine pests, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of listing priority pests.

(57) In order to ensure that the exceptions for Union quarantine pests and for plants, plant products and other objects originating from third countries or territories which are prohibited from being introduced into the Union territory, used for official testing, scientific or educational purposes, trials, varietal selection or breeding are implemented in a manner that does not pose any pest 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, movement within, and holding, multiplication and use in, the Union territory of the pests and plants, plant products and other objects concerned, the procedure and conditions for granting the corresponding authorisation, and the monitoring of compliance as well as the actions to be taken in the event of non-compliance.

(58) In order to ensure the correct application of the derogations from the obligation to carry out annual surveys of demarcated areas, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of further specifying the pests concerned by those derogations and conditions for the application of those derogations.

(59) 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 detailed rules for the surveys to be carried out for purposes of the recognition of protected zones and for the preparation and the content of surveys on protected zone quarantine pests.

(60) 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.

(61) In order to ensure that the registration of professional operators is proportionate to the objective of controlling pest risk, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules setting out further categories of professional operators to be exempted from the obligation to register, particular requirements for the registration of certain categories of professional operators and the maximum figures for small quantities that the professional operators may supply to final users in order to be exempted from the obligation to register.

(62) In order to ensure the credibility of phytosanitary certificates of third countries which are not contracting 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 pest 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 cases where, for particular plants, plant products or other objects, the exemption from the requirement to issue plant passports only applies for small quantities.

(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 frequency and timing of the examinations.

(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 criteria to be fulfilled by the professional operators in order for them to be authorised to issue plant passports and procedures ensuring that those criteria are met.

(66) In order to ensure correct marking of wood packaging material and to take into account the development of international standards, and in particular of ISPM15, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending and supplementing the requirements concerning wood packaging material, including its introduction into the Union territory, and of specifying the requirements for authorisation of registered operators to apply the mark of wood packaging material in the Union territory.

(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 plants, plant products and other objects, 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, 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, as well as the elements of the export, re-export and pre-export certificate.

(69) In order to adapt to the development of scientific and technical knowledge and of international standards, in particular the standards of the IPPC and the EPPO, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules amending the Annexes to this Regulation.

(70) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(71) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission with respect to listing Union quarantine pests; setting out the format of reports on surveys, as well as instructions on how to fill in that format; establishing the format of the multiannual survey programmes and related practical arrangements; setting out measures against specific Union quarantine pests; and adopting measures for a limited time as regards the risks posed by pests not listed as Union quarantine pests.

(72) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to establishing a list of protected zones and of the respective protected zone quarantine pests; and amending the extent of, or revoking the recognition of, protected zones.

(73) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to listing of Union regulated non-quarantine pests and the plants for planting concerned; and setting out measures to prevent the presence of Union regulated non-quarantine pests on the respective plants for planting.

(74) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to: listing the plants, plant products and other objects which are prohibited from being introduced into the Union territory, and the third countries concerned; listing the plants, plant products and other objects subject to special requirements, and the special requirements concerned for their introduction into, and movement within, the Union territory; the provisional listing of the high-risk plants, plant products and other objects whose introduction into the Union territory is to be prohibited, and the third countries concerned; the procedure for risk assessment in connection with that listing; setting out, for third countries, requirements that are equivalent to the requirements for movement within the Union territory of plants, plant products or other objects; setting out arrangements for the presentation and use of posters and brochures concerning the introduction of plants, plant products and other objects into the Union territory; 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 concerning plants, plants products and other objects likely to pose newly identified pest risks or other suspected phytosanitary risks; adopting decisions on temporary measures taken by Member States concerning imminent danger; listing of plants, plant products and other objects which are prohibited from being introduced into certain protected zones; listing the plants, plant products and other objects subject to special requirements, and the special requirements concerned for their introduction into, and movement within, certain protected zones; and laying down rules concerning the requirements for quarantine stations and confinement facilities, and the release of plants, plant products and other objects from those stations and facilities.

(75) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to setting out shorter or longer minimum periods for keeping the records concerning traceability by the professional operators, and requirements as to the accessibility of those records.

(76) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to: 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, the third countries concerned, and the maximum quantity subject to be exempted from the requirement for a phytosanitary certificate when introduced in the Union territory; and setting out technical arrangements concerning the invalidation of the electronic phytosanitary certificates.

(77) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to 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, and movement within, certain protected zones; and specifying the protected zone pests, plants, plant products or other objects for which a plant passport for protected zones is required in the case of direct supply to a final user.

(78) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to setting out the format specifications of the plant passport; identifying types and species of plants for planting for which exemptions from the indication of traceability code in the format of the plant passport should not apply; and setting out technical arrangements for the issuance of electronic plant passports.

(79) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission with respect to setting out specific arrangements concerning the material, treatment and marking as regards repairing of wood packaging material; laying down the format specifications of attestations other than the mark of wood packaging material; laying down the procedures for the issuance of the pre-export certificate; and laying down specific rules concerning the submission of notifications.

(80) The implementing powers conferred on the Commission should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (14).

(81) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to measures to be adopted against specific Union quarantine pests or pests not listed as Union quarantine pests, to the prohibition of introduction of certain plants, plant products and other objects into the Union territory or a protected zone or to subjecting such introduction to specific requirements and to temporary measures concerning plants, plant products and other objects likely to pose newly identified pest risks or other suspected phytosanitary risks, imperative grounds of urgency so require.

(82) Council Directives 74/647/EEC (15) and 2006/91/EC (16) set out measures on the control of carnation leaf-rollers and San José Scale. Following the entry into force of those Directives, the pests concerned have become widespread throughout the Union territory, and their containment is thus no longer feasible. Those Directives should therefore be repealed.

(83) Council Directives 69/464/EEC (17), 93/85/EEC (18), 98/57/EC (19) and 2007/33/EC (20) should be repealed, as new measures on the pests which they concern should be adopted in accordance with this Regulation. In view of the time and resources required to adopt those new measures, those Directives should be repealed with effect from 1 January 2022.

(84) Regulation (EU) No 652/2014 of the European Parliament and of the Council (21) provides 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. In addition to the provisions of that Regulation, this Regulation establishes the category of priority pests and it is essential that certain measures taken by the Member States as regards, in particular, 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 652/2014 should therefore be amended.

(85) Technical amendments should also be made in Regulations (EU) No 228/2013 (22) and (EU) No 1143/2014 (23) of the European Parliament and of the Council.

(86) 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 but can rather, 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.

(87) For small and medium-sized enterprises (SMEs), this Regulation does not create a disproportionate administrative burden or economic impact. Under this Regulation, based on consultation with stakeholders, the special situation of SMEs 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 of protecting plant health.

(88) This Regulation takes into account the IPPC, the Agreement on the Application of Sanitary and Phytosanitary Measures and the guidelines set out under them.

(89) In accordance with the principle of ‘smart’ regulation, the implementation of this Regulation should be coordinated with that of Regulation (EU) No 1143/2014 in order to ensure that Union plant health legislation applies fully and in its entirety.

(90) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter 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 establishes 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 (‘pests’) and measures to reduce those risks to an acceptable level.

2. Where there is evidence that non-parasitic plants, other than those regulated under Article 4(1) of Regulation (EU) No 1143/2014, pose phytosanitary risks which would have a severe economic, social and environmental impact on the Union territory, those non-parasitic plants may be considered as pests for the purposes of this Regulation.

3. For the purposes of this Regulation, references to third countries shall be read as references to third countries, Ceuta, Melilla and to the territories that are referred to in Article 355(1) TFEU, with the exception of Madeira and the Azores.

For the purposes of this Regulation, references to the Union territory shall be read as references to the Union territory without Ceuta, Melilla and the territories that are referred to in Article 355(1) TFEU, other than Madeira and the Azores.

Article 2

Definitions

For the purposes of this Regulation, the following definitions 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 or without 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 and spores; (l) buds, budwood, cuttings, scions, grafts;

(2) ‘plant products’ means unmanufactured material of plant origin and those manufactured products that, by their nature or that of their processing, may create a risk of the spread of quarantine pests. Except where otherwise provided in the implementing acts adopted pursuant to Articles 28, 30 and 41, wood shall only be considered as a plant product if it fulfils one or more of the following criteria: (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, whether or not it is actually in use for transport of goods;

(3) ‘planting’ means any operation for the placing of plants in a growing medium, or by grafting or similar operations, to ensure their subsequent growth, reproduction or propagation;

(4) ‘plants for planting’ means plants intended to remain planted, to be planted or replanted;

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

(6) ‘competent authority’ means the central authority or authorities of a Member State, or, where applicable, of a third country, responsible for the organisation of official controls and of other official activities, or any other authority to which that responsibility has been conferred, in accordance with Union legislation on official controls;

(7) ‘lot’ means a number of units of a single commodity, identifiable by its homogeneity of composition, origin and other relevant elements, forming part of a consignment;

(8) ‘trade unit’ means the smallest commercial or other useable unit applicable to the marketing stage concerned, which may be the subset or the whole of a lot;

(9) ‘professional operator’ means any person, governed by public or private law, involved professionally in, and legally responsible for, one or more of the following activities concerning plants, plant products and other objects: (a) planting; (b) breeding; (c) production, including growing, multiplying and maintaining; (d) introduction into, and movement within and out of, the Union territory; (e) making available on the market; (f) storage, collection, dispatching and processing;

(10) ‘registered operator’ means a professional operator registered in accordance with Article 65;

(11) ‘authorised operator’ means a registered operator authorised by the competent authority to issue plant passports in accordance with Article 89, to apply a mark in accordance with Article 98, or to issue attestations in accordance with Article 99;

(12) ‘final user’ means any person acting for purposes which are outside that person's trade, business or profession who acquires plants or plant products for personal use;

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

(14) ‘treatment’ means a procedure, whether official or non-official, for the killing, inactivation or removal of pests, or for rendering those pests infertile, or for the devitalisation of plants or plant products;

(15) ‘incidence’ means the proportion or number of units in which a pest is present in a sample, consignment, field or other defined population;

(16) ‘establishment’ means the perpetuation, for the foreseeable future, of a pest within an area after entry;

(17) ‘eradication’ means the application of phytosanitary measures to eliminate a pest from an area;

(18) ‘containment’ means the application of phytosanitary measures in and around an infested area to prevent the spread of a pest;

(19) ‘quarantine station’ means any official station for holding pests, plants, plant products or other objects in quarantine;

(20) ‘confinement facility’ means any facility, other than quarantine stations, where pests, plants, plant products or other objects are kept under confinement conditions;

(21) ‘traceability code’ means a letter, numerical or alphanumerical code that identifies a consignment, lot or trade unit, used for traceability purposes, including codes referring to a lot, batch, series, date of production or professional operator documents;

(22) ‘phytosanitary measure’ means any official measure having the purpose to prevent the introduction or spread of quarantine pests or to limit the economic impact of regulated non-quarantine pests.

CHAPTER II

Quarantine pests

Section 1

Quarantine pests

Article 3

Definition of quarantine pests

A pest is 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 I;

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

(c) it is capable of entering into, becoming established in and spreading within the territory, or, if present in the territory, but not widely distributed, is capable of entering into, becoming established in and spreading within those parts of that territory where it is absent, within the meaning of point (3) of Section 1 of Annex I;

(d) its entry, establishment and spread would, within the meaning of point (4) of Section 1 of Annex I, have an unacceptable economic, environmental or social impact on that territory, or, if present but not widely distributed, for those parts of the territory where it is absent; and

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

Section 2

Union quarantine pests

Article 4

Definition of Union quarantine pests

A quarantine pest is a ‘Union quarantine pest’ if the defined territory referred to in the introductory part of Article 3 is the Union territory and if it is included in the list referred to in Article 5(2).

Article 5

Prohibition of introduction, movement, holding, multiplication or release of Union quarantine pests

1. A Union quarantine pest shall not be introduced into, moved within, or held, multiplied or released in, the Union territory.

2. The Commission shall, by means of an implementing act, establish a list of pests which fulfil the conditions listed in Article 3 in respect of the Union territory (‘list of Union quarantine pests’).

The list of Union quarantine pests 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, or established in, any part of the Union territory whether naturally or due to their introduction from outside the Union territory, shall be marked in the list of Union quarantine pests as pests known to occur in the Union territory.

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

3. Where the results of an assessment show that a pest not included in the list of Union quarantine pests fulfils the conditions listed in Article 3 in respect of the Union territory, or that a pest included in the list of Union quarantine pests no longer fulfils one or more of those conditions, the Commission shall, by means of implementing acts, amend the implementing act referred to in paragraph 2 of this Article accordingly by adding the pest concerned to, or removing it from, that list.

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

The Commission may, by means of implementing acts, replace the implementing act referred to in paragraph 2 of this Article for the purpose of consolidating amendments.

4. The implementing acts referred to in paragraphs 2 and 3 shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Article 6

Priority pests

1. Union quarantine pests are ‘priority pests’ if they fulfil all of the following conditions:

(a) they fulfil, as regards the Union territory, one or more of the conditions set out in point (2) of Section 1 of Annex I;

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

(c) they are listed in accordance with paragraph 2 of this Article.

2. The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by establishing a list of the priority pests (‘list of priority pests’).

Where the results of an assessment show that a Union quarantine pest fulfils the conditions referred to in paragraph 1 of this Article, or that a pest no longer fulfils one or more of those conditions, the Commission is empowered to adopt delegated acts in accordance with Article 105 amending the list referred to in the first subparagraph accordingly by adding the pest concerned to, or removing it from, that list.

The Commission shall make that assessment available to the Member States without delay.

Where, in the case of a serious pest risk, imperative grounds of urgency so require, the procedure provided for in Article 106 shall apply to delegated acts adopted pursuant to this Article.

Article 7

Amendment of Section 1 of Annex I

The Commission is empowered to adopt delegated acts in accordance with Article 105 amending Section 1 of Annex I in order to adapt it to the development of scientific and technical knowledge and of relevant international standards.

Article 8

Union quarantine pests used for official testing, scientific or educational purposes, trials, varietal selections or breeding

1. By way of derogation from Article 5(1), Member States may, on application, temporarily authorise the introduction into, the movement within, and the holding and multiplication in, their territory of Union quarantine pests or pests subject to the measures adopted pursuant to Article 30(1) for official testing, scientific or educational purposes, trials, varietal selections, or breeding.

An authorisation shall be granted for the activity concerned only if adequate restrictions are imposed to ensure that the introduction, movement, holding, multiplication or use of the pest concerned does not result in its establishment or spread within the Union territory, 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.

2. Authorisations granted pursuant to paragraph 1 shall include all of the following conditions:

(a) the pest is to be kept in a location and under conditions which: (i) the competent authorities consider to be appropriate; and (ii) are referred to in the authorisation;

(b) the activity involving the pest is to be carried out in a quarantine station or a confinement facility designated by the competent authority in accordance with Article 60 and referred to in the authorisation;

(c) the activity involving the pest is to be carried out by personnel: (i) whose scientific and technical competence is considered to be appropriate by the competent authority; and (ii) who are referred to in the authorisation;

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

3. Authorisations granted pursuant to paragraph 1 shall be limited as to the quantity of the pest that can be introduced, moved, held, multiplied or used and the length of time that are adequate for the activity concerned. Authorisations shall not exceed the capacity of the designated quarantine station or confinement facility.

Authorisations shall include the restrictions necessary to adequately eliminate the risk of establishment and spread of the respective Union quarantine pest or pest subject to the measures adopted pursuant to Article 30(1).

4. The competent authority shall monitor compliance with the conditions referred to in paragraph 2 and the limitation and the restrictions referred to in paragraph 3 and take the necessary action in the event of non-compliance. Where appropriate, that action shall be the revocation of the authorisation referred to in paragraph 1.

5. The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by laying down detailed rules concerning:

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

(b) the procedure and conditions for granting the authorisation referred to in paragraph 1; and

(c) the monitoring of compliance and the actions to be taken in the event of non-compliance, as referred to in paragraph 4.

Article 9

Notification of an imminent danger

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 it where that pest is not yet present, the Member State shall immediately notify the Commission and the other Member States of that evidence in writing.

2. Paragraph 1 shall also apply to a pest that is not included in the list of Union quarantine pests, where:

(a) the pest is subject to the measures adopted pursuant to Article 30(1); or

(b) the Member State concerned considers that the pest may fulfil the conditions for inclusion in the list of Union quarantine pests.

3. 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 or pests referred to in paragraph 2.

Article 10

Official confirmation by the competent authorities of the presence of a Union quarantine pest

Where a competent authority suspects or has received evidence concerning the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of its Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within, the Union territory, it shall immediately take the measures necessary to confirm whether that pest is present (‘to officially confirm’).

That official confirmation shall be based on a diagnosis from an official laboratory designated by the competent authority in accordance with conditions and requirements set out in Union legislation on official controls.

Pending the official confirmation of the presence of the pest, the Member State concerned shall, where appropriate, take phytosanitary measures to eliminate the risk of spread of the pest.

The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or any other source.

Article 11

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

A Member State shall notify the Commission and the other Member States where its competent authority officially confirms any of the following situations:

(a) the presence in its territory of a Union quarantine pest not known to be present there;

(b) the presence of a Union quarantine pest in a part of its territory where it was previously not present;

(c) 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.

Notification under the first paragraph shall be made by the single authority, as referred to in Union legislation on official controls, of the Member State concerned and through the electronic notification system referred to in Article 103.

Article 12

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

1. Where one of the situations referred to in Article 11 is officially confirmed, the competent authority shall ensure that professional operators whose plants, plant products or other objects may be affected are informed of the presence of the Union quarantine pest without delay.

2. The Commission shall establish and keep up to date a publicly available list of all notifications it has received concerning emerging pests in third countries which may pose a risk to plant health in the Union territory.

That list may be part of the electronic system referred to in Article 103.

Article 13

Information on priority pests to be provided to the public by the competent authorities

Where one of the situations referred to in points (a) and (b) of the first paragraph of Article 11 is officially confirmed as regards a priority pest, the competent authority shall inform the public about the measures it has taken or intends to take and about any measures to be taken by relevant categories of professional operators or other persons.

Article 14

Measures to be taken immediately by professional operators

1. Where a professional operator suspects or becomes aware that a Union quarantine pest or a pest subject to measures adopted pursuant to Article 30(1) is present in plants, plant products or other objects which are under that operator's control, it shall immediately notify the competent authority thereof, in order for that competent authority to take actions in accordance with Article 10. Where appropriate, the professional operator shall also immediately take precautionary measures to prevent the establishment and spread of that pest.

2. The competent authority may decide that the notification referred to in paragraph 1 is not required where a specific pest is known to occur in an area. In such a case, it shall inform the professional operators concerned of that decision.

3. Where a professional operator receives an official confirmation concerning the presence of a Union quarantine pest in plants, plant products or other objects which are under that operator's control, it shall consult the competent authority regarding the action to be taken and shall proceed, as applicable, with the actions referred to in paragraphs 4 to 7.

4. The professional operator shall immediately take the necessary measures to prevent the spread of that pest. Where the competent authority has provided instructions concerning those measures, the professional operator shall act in accordance with those instructions.

5. Where so instructed by the competent authority, the professional operator shall take the necessary measures to eliminate the pest from the plants, plant products or other objects concerned and from that operator's premises, land, soil, water or other infested elements which are under its control.

6. Unless otherwise instructed by the competent authority, the professional operator shall, without delay, withdraw from the market the plants, plant products and other objects which are under that operator's control and in which the pest could be present.

Where those plants, plant products or other objects have left the control of the professional operator, the professional operator shall, unless otherwise instructed by the competent authority, immediately:

(a) inform the persons in the trade chain to whom those plants, plant products and other objects have been supplied of the presence of the pest;

(b) provide those persons with guidelines on the necessary measures to be taken during shipment of the respective plants, plant products and other objects to reduce the risk of spread or escape of the pests concerned; and

(c) recall those plants, plant products or other objects.

7. Where paragraph 1, 3, 4, 5 or 6 of this Article applies, the professional operator shall, on request, provide to the competent authority all information which is relevant for the members of the public. Without prejudice to Article 13, if action is necessary with regard to the plants, plant products or other objects in which the respective pest may be present, the competent authority shall inform the public as soon as possible of that fact.

Article 15

Measures to be taken by persons other than professional operators

1. Where any person other than a professional operator becomes aware of the presence of a Union quarantine pest or has reason to suspect such a presence, that person shall immediately notify the competent authority. Where that notification is not made in writing, the competent authority shall officially record it. If so requested by the competent authority, that person shall provide that authority with the information which is in its possession concerning that presence.

2. The competent authority may decide that the notification referred to in paragraph 1 is not required where a specific pest is known to be present in an area.

3. The person who made the notification referred to in paragraph 1 shall consult the competent authority on the action to be taken and shall, in accordance with the instructions of the competent authority, take the measures necessary to prevent the spread of that pest and to eliminate it from the plants, plant products or other objects concerned and, where applicable, from that person's premises.

Article 16

Derogations to notification obligations

The notification obligations referred to in Articles 14 and 15 shall not apply where:

(a) a Union quarantine pest is found to be present in the infested zone of a demarcated area established for the containment of that pest, as referred to in Article 18(2);

(b) a Union quarantine pest is found to be present in the infested zone of a demarcated area and subject to eradication measures requiring eight years or more, during the period of those first eight years.

Article 17

Eradication of Union quarantine pests

1. Where one of the situations referred to in points (a) and (b) of the first paragraph of Article 11 is officially confirmed, the competent authority shall immediately take all necessary phytosanitary measures to eradicate the relevant Union quarantine pest from the area concerned. Those measures shall be taken in accordance with Annex II.

That obligation to eradicate shall not apply where an implementing act concerning that pest, adopted pursuant to Article 28(2), provides otherwise.

2. The competent authority shall without delay investigate the source of the presence of the Union quarantine pest concerned, in particular where that presence may be related to movements of plants, plant products or other objects, 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. The measures referred to in paragraph 1 and the investigations referred to in paragraph 2 shall be taken irrespective of whether the pest is present on public or private premises.

Article 18

Establishment of demarcated areas

1. Where one of the situations referred to in points (a) and (b) of the first paragraph of Article 11 is officially confirmed, the competent authority shall immediately establish one or more areas where the eradication measures referred to in Article 17(1) are to be taken (‘demarcated area’).

The demarcated area shall consist of an infested zone and a buffer zone.

2. The infested zone shall, as applicable, 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 have been or become contaminated or infested by that pest, including plants liable to be infested 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;

(d) land, soil, water courses or other elements infested, or liable to be infested, by the pest concerned.

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

Its extent 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 II.

However, where any risk of the pest spreading out of the infested zone is eliminated or reduced to an acceptable level through natural or artificial barriers, no buffer zone shall be required to be established.

4. By way of derogation from paragraph 1, where upon initial examination the competent authority concludes, in view of the nature of the pest, the plant, plant product or other object 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 demarcated 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 demarcated area.

5. Where, in accordance with paragraphs 2 and 3, a demarcated 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 demarcated 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. Member States shall notify the Commission and the other Member States, by 30 April of each year, of the number and locations of the demarcated areas established, the pests concerned, and the respective measures taken during the preceding calendar year.

This paragraph shall apply without prejudice to any obligation to notify demarcated areas laid down in the implementing acts referred to in Article 104.

Article 19

Surveys and modifications of demarcated areas and lifting of restrictions

1. Competent authorities shall at least annually, at appropriate times, carry out a survey of each demarcated area as regards the development of the presence of the pest concerned.

Those surveys shall be carried out in accordance with Article 22(2).

2. Where, whether or not as a result of a survey as referred to in paragraph 1, a competent authority finds a presence of the pest concerned in the buffer zone, the Member State concerned shall immediately notify the Commission and the other Member States thereof.

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

4. Competent authorities may abolish a demarcated area and terminate the respective eradication measures, where the pest-free status of that area has been verified. This will be the case where the following two conditions are fulfilled:

(a) the survey referred to in paragraph 1 shows that the area has been found to be free from the pest concerned; and

(b) the pest concerned has not been found to be present in that demarcated area for a sufficiently long period.

5. When deciding on the modifications referred to in paragraph 3 or the abolition of the demarcated area referred to in paragraph 4, the competent authority concerned shall take into account at least the following factors:

(a) the biology of the pest and the vector concerned;

(b) the presence of host plants;

(c) the ecoclimatic conditions; and

(d) the likelihood of the eradication measures having been successful.

6. By way of derogation from paragraph 1 of this Article, annual surveys shall not be required to be carried out in the infested zone of demarcated areas established for:

(a) pests subject to eradication measures requiring eight years or more;

(b) pests subject to the containment measures referred to in Article 28(2).

7. The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by further specifying the pests referred to in point (a) of paragraph 6 of this Article and in point (b) of Article 16 and conditions for the application of those derogations.

Article 20

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

1. Where measures are taken by a Member State in an area adjacent to the border with another Member State, a report on the measures taken in accordance with Articles 17, 18 and 19 shall be submitted to that other Member State.

2. Where so requested by the Commission or by any other Member State, a Member State shall submit a report on specific measures taken in accordance with Articles 17, 18 and 19.

Article 21

Amendment of Annex II

The Commission is empowered to adopt delegated acts in accordance with Article 105 amending Annex II in order to adapt it to the development of scientific and technical knowledge and of relevant international standards.

Article 22

Surveys on Union quarantine pests and pests provisionally qualifying as Union quarantine pests

1. Member States shall carry out risk-based surveys, over specific periods of time, checking at least for:

(a) the presence of any Union quarantine pest; and

(b) signs or symptoms of any pest subject to the measures referred to in Article 29 or to measures adopted pursuant to Article 30(1).

Those surveys shall take place in all areas where the pest concerned was not known to be present.

Those surveys shall not be required to be carried out for pests for which it is unequivocally concluded that they cannot become established or spread in the Member State concerned due to its ecoclimatic conditions or to the absence of the host species.

2. The design of the surveys referred to in paragraph 1 shall be based on the risk that the pest occurs in the area covered by each survey. They shall consist, at least, of visual examinations by the competent authority and, where appropriate, the collection of samples and performance of tests. Those surveys shall be carried out in all appropriate locations and shall include, where appropriate, premises, vehicles, machinery and packaging used by professional operators and other persons. 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 appropriate information, concerning the presence of the pests concerned.

3. Member States shall report to the Commission and the other Member States, by 30 April of each year, the results of the surveys referred to in paragraph 1 which were carried out in the preceding calendar year. Those reports shall include information on where the surveys were conducted, the timing of the surveys, the pests and the plants, plant products or other objects concerned, the number of inspections and samples taken, and the finding of each pest concerned.

The Commission may, by means of implementing acts, set out the format of those reports, as well as instructions on how to fill it in. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Article 23

Multi-annual survey programmes and collection of information

1. Member States shall establish multi-annual survey programmes setting out the content of the surveys to be carried out pursuant to Article 22. Those programmes shall provide for the collection and recording of the scientific and technical evidence and other information referred to in the second subparagraph of Article 22(2).

The multi-annual survey programmes shall include the following elements in conformity with Article 22(2):

(a) the specific objective of each survey;

(b) the scope of each survey as regards the area concerned and the time scale covered, as well as the pests, plants and commodities targeted;

(c) the survey methodology and quality management including a description of the procedures for visual examination, sampling and testing and their technical justification;

(d) the timing, frequency and numbers of scheduled visual examinations, samples and tests; and

(e) the methods of recording and reporting the information collected.

The multi-annual survey programmes shall be for a period of five to seven years.

2. Member States shall, on request, notify their multi-annual survey programmes upon their establishment to the Commission and the other Member States.

3. The Commission may adopt implementing acts establishing the format of the multiannual survey programmes and the practical arrangements for the application of the elements set out in paragraph 1 to specific pest risks.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Article 24

Surveys of priority pests

1. For each priority pest, Member States shall carry out a survey annually, as set out in Article 22(1) and (2). Those surveys shall include a sufficiently high number of visual examinations, sampling and testing, as appropriate for each priority pest, to ensure, as far as it is possible given the respective biology of each priority pest and the ecoclimatic conditions, with a high degree of confidence, the timely detection of those pests.

The surveys shall not be required to be carried out for pests for which it is unequivocally concluded that they cannot become established or spread in the Member State concerned due to its ecoclimatic conditions or to the absence of the host species.

2. Member States shall report to the Commission and the other Member States by 30 April of each year the results of the surveys referred to in paragraph 1 which were carried out in the preceding calendar year.

Article 25

Contingency plans for priority pests

1. Each Member State shall draw up and keep up to date for each priority pest which is capable of entering into and becoming established in its territory, or a part thereof, a separate plan containing information concerning the decision making processes, procedures and protocols to be followed, and the minimum resources to be made available and the procedures to make available further resources, in the event of an officially confirmed or suspected presence of that pest (‘the contingency plan’).

Member States shall, at an appropriate stage, consult all relevant stakeholders in the process of drawing up and keeping up to date the contingency plans.

No contingency plans shall be required to be drawn up for pests for which it is unequivocally concluded that they cannot become established or spread in the Member State concerned due to its ecoclimatic conditions or to the absence of the host species.

2. Each contingency plan shall include the following:

(a) the roles and responsibilities of the bodies involved in the execution of the plan in the event of an officially confirmed or suspected presence of the priority pest concerned, as well as the chain of command and procedures for the co-ordination of actions to be taken by competent authorities, other public authorities, delegated bodies or natural persons involved, laboratories and professional operators, including the co-ordination with neighbouring Member States and neighbouring third countries, where appropriate;

(b) access of competent authorities to premises of professional operators, other relevant operators and natural persons;

(c) access of competent authorities, where necessary, to laboratories, equipment, personnel, external expertise and resources necessary for the rapid and effective eradication or, where appropriate, containment of the priority pest concerned;

(d) measures to be taken concerning the provision of information to the Commission, the other Member States, the professional operators concerned and the public as regards the presence of the priority pest concerned and the measures taken against it in the event that the presence of the pest concerned is officially confirmed or suspected;

(e) arrangements for recording findings of the presence of the priority pest concerned;

(f) the available assessments as set out in Article 6(2) and any assessment of the Member State as regards the risk of the priority pest concerned for its territory;

(g) the risk management measures to be taken as regards the priority pest concerned, in accordance with Section 1 of Annex II, and the procedures to be followed;

(h) principles for the geographical demarcation of demarcated areas;

(i) protocols describing the methods of visual examinations, sampling and laboratory testing; and

(j) principles concerning the training of personnel of the competent authorities and, where appropriate, the bodies, public authorities, laboratories, professional operators and other persons referred to in point (a).

Where appropriate, the items referred to in points (d) to (j) of the first subparagraph shall take the form of instruction manuals.

3. Contingency plans may be combined for multiple priority pests with similar biology and range of host species. In those cases, the contingency plan shall consist of a general part common to all priority pests covered by it and of specific parts for each priority pest concerned.

4. Within four years from the date of establishment of the list of priority pests, Member States shall establish a contingency plan for the priority pests included in that list.

Within one year from the date of the inclusion of any further pest concerned in the list of priority pests, Member States shall establish a contingency plan for that priority pest.

Member States shall regularly review and, where appropriate, update their contingency plans.

5. Member States shall, on request, communicate their contingency plans to the Commission and to the other Member States, and shall inform all relevant professional operators through publication on the internet.

Article 26

Simulation exercises for priority pests

1. Member States shall carry out simulation exercises concerning the implementation of the contingency plans at intervals set according to the biology of the priority pest or pests concerned and the risk posed by that pest or those pests.

Those exercises shall take place with regard to all priority pests concerned within a reasonable period of time and with the involvement of the relevant stakeholders.

Those exercises shall not be required where the Member State concerned has recently taken measures for the eradication of the pest or pests concerned.

2. Simulation exercises concerning priority pests whose presence in one Member State could have an impact on neighbouring Member States may be carried out together by those Member States on the basis of their respective contingency plans.

Where appropriate, Member States may carry out those simulation exercises with neighbouring third countries.

3. Member States shall, on request, make available a report on the results of each simulation exercise to the Commission and to the other Member States.

Article 27

Action plans for priority pests

1. Where the presence of a priority pest is officially confirmed in the territory of a Member State pursuant to Article 10, the competent authority shall immediately adopt a plan (the ‘action plan’) setting out the measures for the eradication of that pest, as provided for in Articles 17, 18 and 19, or its containment, as provided for in Article 28(2), as well as a time schedule for the application of those measures.

The action plan shall include a description of the design and organisation of the surveys to be carried out and set out the number of visual examinations, samples to be taken and laboratory tests to be carried out, as well as the methodology to be applied for the examination, sampling and testing.

The action plan shall be based on the relevant contingency plan and shall be immediately communicated by the competent authority to the professional operators concerned.

2. Each Member State shall, on request, notify the Commission and the other Member States of the action plans it has adopted.

Article 28

Union measures for specific Union quarantine pests

1. The Commission may, by means of implementing acts, set out measures against specific Union quarantine pests. Those measures shall implement, specifically for each of the pests concerned, one or more of the following provisions:

(a) Article 10 concerning measures to be taken in the event of suspicion and official confirmation by competent authorities of the presence of that Union quarantine pest;

(b) Article 14 concerning measures to be taken immediately by professional operators;

(c) Article 15 concerning measures to be taken by persons other than professional operators;

(d) Article 17 concerning eradication of Union quarantine pests;

(e) Article 18 concerning establishment of demarcated areas;

(f) Article 19 concerning surveys and modifications of demarcated areas and lifting of restrictions;

(g) Article 22 concerning surveys on Union quarantine pests and pests provisionally qualifying as Union quarantine pests;

(h) Article 24 concerning surveys for priority pests, as regards the number of visual examinations, samples and tests for particular priority pests;

(i) Article 25 concerning contingency plans for priority pests;

(j) Article 26 concerning simulation exercises for priority pests;

(k) Article 27 concerning action plans for priority pests.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

2. By way of derogation from Article 17, where it is concluded, on the basis of the surveys referred to in Article 19 or other evidence, that the eradication of the Union quarantine pest concerned in a demarcated area is not possible, the Commission shall adopt implementing acts referred to in paragraph 1 of this Article which set out measures with the purpose of containment.

For the purpose of reaching that conclusion, the Commission shall, without delay, take the necessary actions following the submission of the relevant evidence by the Member State concerned or any other source.

3. Where the Commission concludes that prevention measures in areas outside demarcated areas are necessary to protect the part of the Union territory where the Union quarantine pest concerned is not present, it may adopt implementing acts referred to in paragraph 1 setting out such measures.

4. The measures referred to in paragraphs 1, 2 and 3 shall be taken in accordance with Annex II, taking into account the specific risks of the Union quarantine pests concerned, the specific ecoclimatic conditions and risks as regards the Member States concerned and the need to implement the necessary risk mitigation measures in a harmonised manner at Union level.

5. Until a measure has been adopted by the Commission, the Member State may maintain any measures that it has taken.

6. On duly justified imperative grounds of urgency to address a serious pest risk, the Commission shall adopt immediately applicable implementing acts, in accordance with the procedure referred to in Article 107(3). Those acts shall be adopted in accordance with Annex II, taking into account the specific risks of the Union quarantine pests concerned, the specific ecoclimatic conditions and risks as regards the Member States concerned and the need to implement the necessary risk mitigation measures in a harmonised manner at Union level.

7. Member States shall notify, through the electronic notification system referred to in Article 103, the Commission and other Member States of any cases of non-compliance with the measures adopted pursuant to this Article which create a risk of spread of Union quarantine pests.

Article 29

Measures by Member States concerning pests not listed as Union quarantine pests

1. Where the presence of a pest that is not included in the list of Union quarantine pests is officially confirmed in the territory of a Member State, and the Member State considers that that pest may fulfil the conditions for inclusion in the list of Union quarantine pests, it shall immediately assess whether the pest fulfils the criteria set out in Subsection 1 of Section 3 of Annex I. If it concludes that those criteria are fulfilled, it shall immediately take eradication measures in accordance with Annex II. Articles 17 to 20 shall apply.

Where it is concluded, on the basis of the surveys referred to in Article 19 or other evidence, that the eradication of a pest in a demarcated area is not possible, Article 28(2) shall apply mutatis mutandis.

Where the presence of a pest fulfilling the criteria referred to in the first subparagraph is officially confirmed in a consignment of plants, plant products or other objects introduced into, or moved within, the territory of a Member State, that Member State shall take the necessary measures to prevent the entry of that pest into, and its establishment and spread in, the Union territory.

Where a Member State suspects the presence in its territory of a pest fulfilling the criteria referred to in the first subparagraph, Article 10 shall apply mutatis mutandis.

Pending the official confirmation of the presence of that pest, the Member State shall, where appropriate, take phytosanitary measures to mitigate the risk of it spreading.

2. After taking the measures referred to in paragraph 1, the Member State shall assess whether the pest concerned fulfils the criteria for quarantine pests set out in Section 1 of Annex I.

3. The Member State concerned shall notify the Commission and the other Member States of the presence of the pest referred to in paragraph 1. It shall also inform the Commission and the other Member States of the assessment referred to in that paragraph, the measures taken and the evidence justifying those measures.

It shall notify the Commission of the results of the assessment referred to in paragraph 2 within two years of the official confirmation of the presence of that pest.

Notifications of the presence of that pest shall be submitted through the electronic notification system referred to in Article 103.

Article 30

Union measures concerning pests not listed as Union quarantine pests

1. Where the Commission receives a notification as referred to in the first subparagraph of Article 29(3), or has other evidence concerning the presence in, or imminent danger of entry into, or spread within, the Union territory of a pest which is not included in the list of Union quarantine pests and it considers that that pest may fulfil the conditions for inclusion in that list, it shall immediately assess whether, as regards the Union territory, that pest fulfils the criteria set out in Subsection 2 of Section 3 of Annex I.

Where the Commission concludes that those criteria are fulfilled, it shall immediately, by means of implementing acts, adopt measures for a limited time as regards the risks posed by that pest. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Those measures shall, where appropriate, implement, specifically for each of the pests concerned, one or more of the provisions referred to in points (a) to (g) of the first subparagraph of Article 28(1).

2. After adopting the measures referred to in paragraph 1, the Commission shall assess whether the pest concerned fulfils, as regards the Union territory, the criteria for quarantine pests set out in Section 1 of Annex I.

3. Where it is concluded, on the basis of surveys referred to in Articles 19 and 22 or other evidence, that the eradication of the pest concerned in a demarcated area is not possible, the implementing acts referred to in the second subparagraph of paragraph 1 of this Article may set out measures with the purpose of containment.

4. Where it is concluded that prevention measures in areas outside demarcated areas are necessary to protect the part of the Union territory where the pest concerned is not present, the implementing acts referred to in paragraph 1 may set out such measures.

5. The measures referred to in paragraphs 1, 3 and 4 shall be adopted in accordance with Annex II, taking into account the specific risks of the pests concerned and the need to implement the necessary risk mitigation measures in a harmonised manner at Union level.

6. Until measures have been adopted by the Commission, the Member State concerned may maintain the measures that it has taken pursuant to Article 29.

7. On duly justified imperative grounds of urgency to address a serious pest risk, the Commission shall adopt immediately applicable implementing acts, in accordance with the procedure referred to in Article 107(3). Those acts shall be adopted in accordance with Annex II, taking into account the specific risks of the pests concerned and the need to implement the necessary risk mitigation measures in a harmonised manner at Union level.

8. Member States shall notify, through the electronic notification system referred to in Article 103, the Commission and other Member States of any cases of non-compliance with the measures adopted pursuant to this Article which create a risk of spread of the pests referred to in paragraph 1 of this Article.

Article 31

More stringent requirements adopted by Member States

1. Member States may apply within their territories more stringent measures than those adopted pursuant to Article 28(1), (2) and (3) and Article 30(1), (3) and (4), if justified by the objective of phytosanitary protection and in accordance with the principles set out in Section 2 of Annex II.

Those more stringent measures shall not impose, or result in, any prohibitions or restrictions on the introduction into, or movement within and through, the Union territory of plants, plant products and other objects, other than those imposed by Articles 40 to 58 and 71 to 102.

2. Member States shall immediately notify the Commission and the other Member States of measures taken by them in accordance with paragraph 1.

Member States shall, on request, submit to the Commission and the other Member States an annual report on the measures taken in accordance with paragraph 1.

Section 3

Protected zone quarantine pests

Article 32

Recognition of protected zones

1. Where a quarantine pest is present in the Union territory but not in the territory of a Member State or a part thereof, and is not a Union quarantine pest, the Commission may, upon application of that Member State pursuant to paragraph 4, recognise such territory or part thereof as a protected zone in accordance with paragraph 3 as regards that quarantine pest (‘protected zone quarantine pest’).

2. A protected zone quarantine pest shall not be introduced into, moved within, or held, multiplied or released in, the respective protected zone.

Article 8 shall apply mutatis mutandis to the introduction into, movement within, and holding and multiplication in, protected zones of protected zone quarantine pests.

3. The Commission shall, by means of an implementing act, establish a list of protected zones and the respective protected zone quarantine pests. That list shall include the protected zones recognised in accordance with the first subparagraph of point (h) of Article 2(1) of Directive 2000/29/EC, the respective pests listed in Part B of Annex I and Part B of Annex II to Directive 2000/29/EC, and codes specifically attributed to those pests.

The Commission may, by means of implementing acts amending the implementing act referred to in the first subparagraph, recognise additional protected zones where the conditions provided for in paragraph 1 of this Article are fulfilled.

The Commission may, by means of implementing acts, replace the implementing act referred to in the first subparagraph of this paragraph for the purpose of consolidating amendments.

The implementing acts referred to in this paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(2).

4. With the application referred to in paragraph 1, the Member State concerned shall submit:

(a) a description of the boundaries of the proposed protected zone, including maps;

(b) the results of surveys showing that, during at least the three years preceding the application, the quarantine pest concerned was not present in the territory concerned; and

(c) evidence that the quarantine pest concerned fulfils the conditions set out in Article 3 with respect to the proposed protected zone.

5. The surveys referred to in point (b) of paragraph 4 shall be carried out at appropriate times and be of appropriate intensity with regard to the possibility of detecting the presence of the quarantine pest concerned. They shall be based on sound scientific and technical principles, and take into account the relevant international standards.

The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by laying down detailed rules for those surveys. Those acts shall be adopted in accordance with the development of scientific and technical knowledge and the applicable international standards.

6. The Commission may recognise temporary protected zones. For that purpose, the conditions set out in paragraphs 1 and 4 and the first subparagraph of paragraph 5 shall apply mutatis mutandis. By way of derogation from the requirement referred to in point (b) of paragraph 4, a survey shall have been carried out over a period of at least one year preceding the application.

The recognition of a temporary protected zone shall last no longer than three years after recognition, and shall expire automatically after three years.

7. Member States shall notify the Commission and the other Member States and inform, via publication on the official website of the competent authority, the professional operators of the boundaries of the protected zones in their territory, including by means of maps.

Article 33

General obligations concerning protected zones

1. With regard to a protected zone, the obligations set out in Articles 9 to 19 shall apply mutatis mutandis to the respective protected zone quarantine pest.

2. A plant, plant product or other object originating in a demarcated area established in a protected zone for the protected zone quarantine pest concerned, shall not be moved from that demarcated area into the remaining part of that protected zone or into any other protected zone established for that protected zone quarantine pest.

By way of derogation from the first subparagraph, that plant, plant product or other object may be moved out of that demarcated area through and out of the protected zone concerned only if it is packed and moved in such a way that there is no risk of spreading that protected zone quarantine pest within that protected zone.

3. The demarcated areas established within a protected zone and the eradication measures taken in those areas pursuant to Articles 17, 18 and 19 shall be immediately notified to the Commission and the other Member States.

Article 34

Surveys on protected zone quarantine pests

1. The competent authority shall carry out annual surveys of each protected zone as regards the presence of the protected zone quarantine pest concerned. Article 22(2) shall apply mutatis mutandis to those surveys.

The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by laying down detailed rules for the preparation and the content of those surveys.

2. Member States shall notify the Commission and the other Member States, by 30 April of each year, of the results of the surveys referred to in paragraph 1 which were carried out in the preceding calendar year.

Article 35

Amendment of extent and revocation of recognition of protected zones

1. The Commission may ame