CELEX: 
Language: en
Date: 2019-06-05
Title: COMMISSION DELEGATED REGULATION (EU) …/... supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases

EXPLANATORY MEMORANDUM
            
            
               1.CONTEXT OF THE DELEGATED ACT
            
            
               Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health ('Animal Health Law') lays down rules on transmissible animal diseases and rules for surveillance of listed diseases and emerging diseases and for eradication programmes and disease-free status for certain diseases of terrestrial and aquatic animals. The Animal Health Law empowers the Commission to adopt delegated acts, and more particularly under Chapters 2 to 4 of Part II, supplementing the aforementioned rules.
            
            
               Thus, in the interest of coherency, transparency and to avoid duplications, it is important that these rules are laid down in the same delegated act as they are all interrelated.
            
            
               The rules laid down in this Delegated Regulation are largely based on rules currently laid down in existing Union acts establishing the requirements for the surveillance of certain diseases, for eradication programme, for the granting of disease-free status at establishments, compartments, zones or Member state levels as they have proven to be effective. These rules have also been adapted to the new legal framework taking into account experience learnt from the past, update of international standards as well as scientific progresses and recent EFSA opinions.
            
            
               Accordingly, this Delegated Regulation lays down the following rules for:
            
            
               (a)the rules and conditions for surveillance conducted by the competent authority to ensure the detection of listed diseases and, when relevant, emerging disease;
            
            
               (b)the criteria used to determine which disease shall be subject to an Union surveillance programme relevant for the Union and rules setting up the requirements for these Union surveillance programmes implemented by competent authorities;
            
            
               (c)the rules for the implementation by competent authorities of compulsory and optional eradication programmes for specific listed diseases with regard to disease control strategies, intermediate and final targets of the programmes and period of application;
            
            
               (d)measures to be implemented by the competent authority and the operators under the compulsory and optional eradication programmes;
            
            
               (e)the detailed rules for granting disease-free status to , and zones thereof, and compartments;
            
            
               (f)the detailed rules for surveillance and biosecurity measures to be implemented by competent authorities and operators for maintaining disease-free status of Member States, zones thereof and compartments;
            
            
               (g)supplementary rules for the suspension, withdrawal and restoration of disease-free status;
            
            
               (h)rules necessary to ensure a smooth transition from the rules existing prior to Regulation (EU) 2016/429.
            
            
               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
            
            
               The Commission had several meetings and exchanges with the Expert Group on animal health (E00930). The draft Delegated Regulation was also made available to the European Parliament and the Council. There were no comments received from the European Parliament and the Council. A number of meetings have been held with a range of stakeholders within the framework of Animal Health Advisory Committee where the main elements of the draft act were illustrated and discussed.
            
            
               In addition, stakeholders’ comments on the draft Delegated Regulation were collected in the context of the Better Regulation feedback mechanism during the period between [xx month] 2019 and [xx month] 2019 [to be supplemented later on].
            
            
               3.LEGAL ELEMENTS OF THE DELEGATED ACT
            
            
               This Delegated Regulation is to be adopted within the framework of Regulation (EU) 2016/429, and in particular pursuant to Article 20(3), Article 29, Article 31(5), Article 32(2), Article 37(5), Article 39, Article 41(3), Article 42(6) and Article 280(4) thereof.
            
         
         
            
               COMMISSION DELEGATED REGULATION (EU) …/...
            
            
               of XXX
            
            
               supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases
            
            
               (Text with EEA relevance)
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to [Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)]
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               , and in particular , Article 29, Articles 31(5), 32(2), 37(5), Article 39, Article 41(3), Article 42 and Article 280(4) thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases transmissible to animals or to humans. The rules laid down in this Regulation are required to supplement those laid down in Chapters 2, 3 and 4 of Part II of Regulation (EU) 2016/429 as regards surveillance, eradication programmes and disease-free status, as well as those in Part IX of that Regulation, as regards transitional arrangements concerning existing surveillance or eradication programmes and existing disease-free status. 
            
            
               (2)These rules are substantially linked and many are intended to be applied in tandem. In the interest of simplicity and transparency, as well as to facilitate their application and avoid a multiplication of rules, they should therefore be laid down in a single act rather than in a number of separate acts with many cross-references and the risk of duplication.
            
            
               (3)Indeed, surveillance represents an intrinsic part of any eradication programme and disease-free status is in most cases an outcome of a successful surveillance and eradication process. Moreover, surveillance is needed, besides other measures, as a key tool for maintaining the disease-free status after its achievement. These rules often serve common purposes and refer to complementary activities of operators, veterinarians and competent authorities. Therefore, it is appropriate to group together the rules related to surveillance, eradication programmes and disease-free status, including transitional rules thereto, in a single Delegated Regulation.
            
            
               (4)In that respect, this Regulation should supplement Regulation (EU) 2016/429 by setting out criteria and conditions for surveillance conducted by the competent authorities for listed and emerging diseases, criteria and conditions for Union surveillance programmes, rules for the implementation of compulsory and optional eradication programmes, rules for disease-free status of establishments, zones and compartments and rules for the suspension and withdrawal of that status.
            
            
               (5)Surveillance is a key element of an efficient and effective disease prevention and control policy. It should be implemented jointly by operators and the competent authority. It should be designed so as to meet the objectives of early detection of outbreaks of any listed and emerging disease and demonstration of compliance with the criteria for obtaining and maintaining disease-free-status, its suspension or withdrawal.
            
            
               (6)The competent authority should design the surveillance of listed and emerging diseases of terrestrial animals by means of a basic general surveillance system based on notification and investigations of disease events in targeted animal population with the contribution of official controls. 
            
            
               (7)These general surveillance requirements for terrestrial animals should be complemented by more specific ones, as necessary according to the expected output of surveillance. They should be designed to serve different specific purposes, such as Union surveillance programme, compulsory and optional eradication programmes, demonstration of disease free status, disease control measures, in the context of approval of certain establishments as well as movements of animals and their products.
            
            
               (8)The approach to designing general surveillance requirements for aquatic animals is similar to the approach taken for terrestrial animals, although not identical. All aquaculture establishments need to implement a basic surveillance system based on notification and investigation of disease events in a targeted animal population with the contribution of official controls, as appropriate. In addition, surveillance will take into account disease control measures, when it is necessary to take such measures in aquaculture establishments.
            
            
               (9)In addition to the general surveillance requirements which apply to all aquaculture establishments, specific surveillance requirements apply to certain approved aquaculture establishments. These specific measures include the implementation of a risk based surveillance scheme which is based on an assessment of the risk that an establishment has of contracting and spreading an aquatic disease, be it listed or non-listed.
            
            
               (10)The specific surveillance requirements also relate to the implementation of eradication programmes for certain listed diseases in order to obtain disease freedom, as well as to surveillance requirements which are required to maintain that freedom once it has been achieved. 
            
            
               (11)In addition, Member States could implement surveillance, in the form of so-called surveillance programmes for Category C diseases of aquatic animals at establishment level, without opting for a disease eradication programme. Such surveillance programmes are based on a system of targeted surveillance which is comprehensive but which does not encompass all the elements of an eradication programme to achieve official disease freedom. 
            
            
               (12)These specific eradication, maintenance and surveillance programmes serve to substantiate health requirements for certain movements of animals and products of animal origin within the Union and in certain cases, of animals and products of animal origin entering the Union. 
            
         
         
            
               (13)Regulation (EU) 2016/429 foresees that rules for listed disease should apply to listed species. Surveillance may not be relevant for all categories of animals of listed species, in particular as regards wild animals or certain categories of kept animals. Therefore this regulation should provide rules to specify the relevant targeted animal population for the purpose of surveillance. It should also be possible to expand the targeted animal population to non-listed kept species to ensure early detection of emerging disease. 
            
            
               (14)On the other hand derogations should also be made possible for further limiting targeted terrestrial animal populations to the specific, targeted surveillance purposes, such as Union surveillance programmes, compulsory or optional eradication programmes, as well as surveillance based animal health requirements for movements within the Union or for entry into the Union.
            
            
               (15)Diagnostic methods and the subsequent collection of samples to perform them, techniques, validation and interpretation are key elements of surveillance. They are of a very technical nature and are subject to frequent modifications due to the evolution of scientific standards. Therefore, to ensure that they are up to date, the rules for the diagnostic methods should indicate in a flexible manner which diagnostic methods should be used and how. In the area of animal diseases, there are different possible sources of scientific standards for diagnostic methods, therefore it is important to indicate the hierarchical order into which they should be considered, taking into account the general principles laid down by Regulation (EU) 2017/625
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               . 
            
            
               (16)To ensure the optimal use of all resources and avoid unnecessary administrative burdens and costs for the operators as well as for the competent authorities the detection of listed and emerging diseases should benefit from sources of information gathered in the framework of official controls and other official activities, which are not primarily intended for the surveillance of those diseases. 
            
            
               (17)The confirmation of disease according to the case definition is the responsibility of the competent authority and should be supported by appropriate investigations to confirm or to rule out the presence of a suspected disease. Such investigations are relevant where the confirmation of the disease triggers disease control measures and in certain other circumstances depending on the consequence of the confirmation of the disease. Therefore, it is important that this regulation lays down those additional circumstances where the confirmation of the disease is necessary.
            
            
               (18)The definition of suspect case and confirmed case of listed diseases and when relevant of emerging diseases, are of key importance so that operators, veterinarians and other stakeholders involved in surveillance are able to identify the circumstances when it is necessary to notify the competent authority and for the competent authority when to apply disease control measures. Therefore it is necessary to provide general criteria for the definition of suspect case and confirmed case and when needed, depending on the specific characteristics of certain diseases, disease specific definitions.
            
            
               (19)A Union surveillance programme is a surveillance programme relevant for the Union as a whole, necessary to reach a higher level of harmonisation of surveillance of a specific disease across the Union due to its specific public or animal health concerns. Therefore, it is necessary to lay down the criteria that diseases eligible for Union surveillance programme should meet.
            
            
               (20)Commission Decision 2010/367/EC
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                lays down minimal requirements for surveillance programmes for avian influenza in poultry and in wild birds setting out in the Annexes the technical guidelines. This Regulation should provide for similar technical guidelines in an Annex. However, the level of detail in this Regulation is lower to ensure a good capacity to adapt to changes in the situation as regards surveillance of avian influenza. Therefore the technical requirements for the Union surveillance programme for avian influenza are focussing exclusively on the objectives, the scope and the methodological principles to follow. 
            
            
               (21)Regulation (EU) 2016/429 sets out rules for the application of compulsory and optional eradication programmes for category B and category C diseases in Member States. Eradication of these diseases, or a group of them, has its own characteristics and the approach is different. The eradication should be based on a disease control strategy specific for the disease in question. This should include at least the surveillance that needs to be performed in order to achieve freedom from the disease as the ultimate goal, the timeframe, a definition of the animal population that is subject to the eradication programme, the territory in which this eradication programme will apply as well as specific disease preventive and control measures that will apply to those diseases during the eradication phase.
            
            
               (22)If the territory in which an eradication programme will be implemented includes the external border of the Member State, the competent authority should make efforts to address the risk of introduction of the disease from outside its borders.
            
            
               (23)The territory under an eradication programme is the territory deemed to be finally granted a disease free status. Ideally, for terrestrial animals it should cover the whole territory of the Member State where the disease is present. If this is not possible, such territory should have a minimum defined area. The minimum surface of the area should take into account the experience gained through previous eradication programmes and allow for flexibility depending on the specific characteristics of the disease. 
            
            
               (24)The qualitative or quantitative targets of the programme should be set by the competent authority. Final targets should be based on the criteria to grant disease free status, while intermediate targets may also comprise other activities or steps important for achieving the disease free status reflecting the evolution of the programme. 
            
            
               (25)The competent authority should determine the period of application of the eradication programmes. In the case of optional eradication programmes for category C diseases, a maximum period of application of the programme is laid down in order to prevent disproportionate and long lasting disruption of movements within the Union. Nevertheless, the competent authority may start the eradication programme before its approval by the Commission without implementing restrictions to the movements within the Union. A possibility should also be provided for Member States to request the Commission for an extension of this period when justified circumstances may exist.
            
            
               (26)The disease profile and whether diseases might be eradicated at establishment level or not are the criteria to group disease specific measures that are part of a disease control strategy. Such control strategy should spell out obligations for the operators and for the competent authorities.
            
            
               (27)For compulsory and optional eradication programmes the targeted animal population and the possibility for the competent authority to include in the programme additional animal populations, should be set out. 
            
            
               (28)The primary responsibility for obtaining and maintaining the establishment disease free status is for the operator as he/she is the primary recipient of the benefits linked to the disease free status. Therefore, the operator should comply with certain obligations to be granted and to maintain the disease-free status.
            
            
               (29)Once the general and disease specific criteria for achieving the disease free status have been met by the operator, it is for the competent authority to grant the disease free status. When these specific criteria are no longer met, it is also for the competent authority to either suspend or withdraw it. 
            
            
               (30)Moreover, the obligations for operators and competent authorities in the context of the eradication programmes should be as necessary detailed further on the basis of disease specific requirements. Due to their technical nature, the measures are set down for each specific disease in an Annex to this Regulation.
            
            
               (31)Commission Implementing Regulation (EU) 2018/1882
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                lists infection with Brucella abortus, B. melitensis and B. suis and infection with Mycobacterium tuberculosis complex for compulsory eradication programmes and lists enzootic bovine leukosis, infection with Aujeszky's disease virus, infectious bovine rhinotracheitis / infectious pustular vulvovaginitis and bovine viral diarrhoea for optional eradication programmes. For these diseases eradication programmes should be based on the classification and granting of establishment disease free status.
            
            
               (32)In the case of a disease eradication programmes for terrestrial animals based on the granting of establishment disease free status, all establishments keeping targeted animal populations should be subject to the programme. Nevertheless, the competent authority should have the possibility to exclude some establishments and slaughterhouses from the programme provided surveillance and other risk mitigating measures are implemented in order to prevent the failure of the programme. 
            
         
         
            
               (33)Moreover, in the case of a disease eradication programmes for terrestrial animals based on the classification and granting of establishment disease free status, within an establishment, the competent authority should have the possibility to attribute different health status to different epidemiological units.
            
            
               (34)In the case of terrestrial animals, the requirements to demonstrate freedom from diseases at establishment level are based on absence of infection supported by testing and surveillance regime, conditions to introduce animals and germinal products in the establishments and, if necessary, restriction on the use of vaccination. When the conditions to maintain the disease free status are no longer satisfied, specific requirements apply to suspend, withdraw and restore the disease free status. Due to their technical nature, the disease specific detailed requirements and the list of diagnostic methods to be used for granting and maintenance of the status are laid down in Annexes. 
            
            
               (35)Conditions to grant, maintain, suspend and withdraw disease free status, were in legislation prior to this Regulation, defined in Council Directive 64/432/EEC
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                for bovine brucellosis and bovine tuberculosis and in Council Directive 91/68/EEC
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                for brucellosis in sheep and goats. Commission Delegated Regulation (EU) 2018/1629 of the European Parliament and the Council has aligned the scope of disease agents involved in brucellosis and bovine tuberculosis to the Terrestrial Animal Health Code of the World Organisation for Animal Health
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                (OIE) (‘the Terrestrial Code’), now being infection with Brucella abortus, Brucella melitensis and Brucella suis and infection with Mycobacterium tuberculosis complex. Therefore, it is appropriate to revise the technical requirements related to the status of these diseases in a view of alignment with OIE international standards and taking into account the experience gained in eradication programmes.
            
            
               (36)In the case of disease eradication programmes for terrestrial animals based on granting disease free status at the level of establishments, in the event of a suspicion or a confirmation, the competent authority should implement measures aiming at preventing the spread of the disease. These measures are to be implemented primarily in the establishment where the suspected case is kept but the competent authority should have the possibility to expand the measures to other animals or establishments when there is a risk of spreading the disease. 
            
            
               (37)In these cases and in applying the disease control measures in the event of suspicion and confirmation the competent authority should introduce certain prohibitions for movements of animals. However, to take account animal welfare conditions and to facilitate the sustainability of the disease control measures, the competent authority should have the possibility of allowing the movement of certain animals from the establishment where a suspect or a confirmed case is kept and such possibility should be set out in this Regulation.
            
            
               (38)Following the confirmation of a case, at least all animals recognised as confirmed cases should be removed. The competent authority should have the possibility to decide whether these animals are to be slaughtered in a slaughterhouse and their meat intended for human consumption or killed and, therefore, being their meat not intended for human consumption. 
            
            
               (39)For certain diseases that can be spread by infected products of animal origin or fomites or with a potential public health impact the competent authority should in infected establishment introduce measures to prevent the spread of those diseases through these products or fomites. Therefore, the measures to mitigate such risks should be set out in this Regulation. 
            
            
               (40)In the case of terrestrial animals, once at establishment level a disease free status has been achieved, a stepwise reduction of the level of surveillance activities after a certain period of continuous disease-freedom in this establishment is the most appropriate course of action to ensure the maintenance of the disease-free status. 
            
            
               (41)Enzootic bovine leukosis (EBL) has been subject to compulsory eradication under the Union rules in place before the date of application of this regulation. This disease is now categorised for optional eradication in accordance with Regulation (EU) 2018/1882.
            
            
               (42)Union rules in place before the date of application of this regulation contained well-established and effective principles and criteria for the recognition, maintenance, suspension and restoring of the officially EBL-free status that have been applied successfully during the implementation of past EBL eradication programmes by many Member States. For this reason, legal provisions have been reviewed and adapted considering the standards of the Terrestrial Code and included in this Regulation.
            
            
               (43)Member States or zones which have been free from EBL for several years and therefore have reached a steady animal health situation free of EBL, should continue to demonstrate the absence of infection. Risk based surveillance is an appropriate means to ensure early detection in case of reintroduction of the disease and to substantiate EBL freedom. Member States should establish a suitable system, as required, from the date of application of this Regulation. 
            
            
               (44)Additional guarantees for the intra Union trade of pigs in relation to infection with Aujeszky's disease virus (ADV) were part of Union rules in place before the date of application of this Regulation and a number of Member States has successfully eradicated the infection with ADV in the pig population kept in their territory under these rules. The strategy for the eradication of the infection with ADV in this Regulation takes account the standards of the Terrestrial Code, the previous good experience and criteria that have proven successful in eradicating the infection with ADV. 
            
            
               (45)The legal provisions for infectious bovine rhinotracheitis / Infectious pustular vulvovaginitis (IBR/IPV) are based on Union legislation related to additional guarantees for intra-Community trade of bovine animals, which includes requirements to obtain, maintain and restore bovine herpesvirus 1 (BoHV-1)-freedom at the establishment level. The rules have been developed taking into consideration the standards of the Terrestrial Code and the EFSA scientific opinion
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               .
            
            
               (46)Bovine Viral Diarrhoea (BVD) has been included in the list of diseases and categorised as a ‘category C disease’ for optional eradication following an EFSA opinion
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               .
            
            
               (47)Union rules in place before the application of this Regulation do not contain provisions for BVD with the exception of provisions related to the trade of germinal products. However, in recent years, a number of Member States have implemented national programmes for the eradication of BVD. 
            
            
               (48)The current Terrestrial Code lacks a chapter on BVD and the criteria for BVD-freedom and related animal movements. However, a BVD chapter is available in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
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                of the OIE. These diagnostic standards have been considered for the provisions related to BVD in this Regulation. 
            
            
               (49)This Regulation provides for disease specific requirements and criteria with regard to the granting, maintenance, suspension and withdrawal of the status free from BVD. These requirements and criteria are based on the experience gained by Member States in eradication of BVD within their territories. These rules they provide enough flexibility to integrate the past efforts into an eradication programme to be approved under the new rules or into an application for the granting of the disease-free status.
            
            
               (50)Regulation (EU) 2018/1882 lists infection with rabies virus as category B disease and therefore provisions for compulsory eradication programme and granting and maintenance of the infection with rabies disease free status are laid down in this Regulation. 
            
            
               (51)The main reservoir of infection with rabies virus in the Union are wild foxes. Therefore, it is appropriate that the measures of the eradication programme are primarily focused on the population of wild foxes. However, all other mammal species are susceptible and many other animal species are listed by Regulation (EU) 2018/1882 for this disease, therefore it is appropriate that the competent authorities address other animal populations when there is a risk to human or animal health.
            
            
               (52)For infection with rabies eradication programmes, the disease control strategy is primarily based on vaccination of the relevant targeted animal population supported by other important activities as surveillance, implementation of disease control measures, control of pet movements or monitoring of the effectiveness of the vaccination. As the vaccination provisions are of a very technical nature, they are laid down in an Annex. 
            
         
         
            
               (53)Regulation (EU) 2018/1882 lists infection with bluetongue virus (serotypes 1 to 24) (infection with BTV) a category C disease for optional eradication programme. This implies a change in the policy against this disease as Council Directive 2000/75/EC
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               , applicable prior to this Regulation, provided for its immediate eradication. Therefore, new provisions are laid down in this Regulation to address the new status of the disease. 
            
            
               (54)For infection with BTV, the disease control strategy is primarily based on vaccination of the relevant targeted animal population supported by other important activities as surveillance, implementation of disease control measures, control of the movements of animals and germinal products and minimising the exposure to vectors.
            
            
               (55)In the EFSA opinion
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                related to the control, surveillance and movement of animals in the case of infection with BTV, EFSA indicates that to succeed in the eradication the vaccination coverage should be at least of 95% of the susceptible bovine and ovine animals for a minimum period of five years. Therefore, it is expected that the eradication programme against infection with BTV includes a vaccination campaign, although flexibility should be provided for in this Regulation to take into account of certain circumstances. 
            
            
               (56)A Member State or zone thereof free from infection with BTV or under an eradication programme against infection with BTV should be able to protect its epidemiological situation from the risk of introduction of any BTV serotypes by the movement of kept animals or germinal products. Therefore, the requirements for introduction of kept animals or germinal products should be laid down as part of the provisions of the eradication programme and reflected in the criteria for the maintenance of the free status. The same principles apply to movements of animals through the Member States or zone free or under an eradication programme. 
            
            
               (57)This Regulation provides requirements to ensure that competent authority only allow introduction of animals of listed species and their germinal products when they are sufficiently safe. The same principles apply to movements of animals through the Member States or zone free or under an eradication programme. 
            
            
               (58)In addition, because of the diversity of the local situation that may prevail, the competent authority should have the possibility to allow the introduction of animals or germinal products based on ad hoc requirements, provided that those movements do not jeopardize the health status at destination. Therefore, it is appropriate that this Regulation provides for the requirements and conditions under which such introduction or movements may be authorised. Such requirements should reflect the status of animals or germinal products, independently of the Member State or zone of origin. 
            
            
               (59)An eradication programme for a category B or category C disease of aquatic animals will take account of the type of surveillance requirements which are required to obtain and maintain disease freedom; details of the territory to be covered by the programme; the animal population to be covered and the intermediate and final targets of the programme. The eradication programme should include the control measures to be implemented in infected establishments.
            
            
               (60)The eradication programme for aquatic diseases will include intermediate and final targets which will be used to assess progress towards the achievement of disease freedom. Where relevant, these targets should take account of the risk posed to the success of the eradication programme by wild animals. In particular, any possibility of deviation from the proposed period of application of six years, should be taken in to account when devising the intermediate and final targets for the programme. 
            
            
               (61)In the case of aquatic animals, the population which is to be included in the eradication programme consists of those species which are listed in Regulation (EU) 2018/1882. 
            
            
               (62)In certain circumstances however, the species which are listed as vectors in that implementing regulation, may be excluded from the programme if the competent authority has carried out a risk assessment which has resulted in the risk posed by those animals being deemed to be negligible because of their level of exposure to susceptible species or to water in which susceptible species are grown. 
            
            
               (63)The competent authority should have a possibility to include additional aquatic animal population when such animals pose a significant risk to the disease status. The competent authority may decide to exclude certain low risk establishments from the eradication programme if their exclusion does not jeopardise the successful completion of the programme. 
            
            
               (64)To determine the epidemiological situation in the Member State, zone or compartment in which a listed disease is to be eradicated from aquatic animals, and to estimate its starting point, intermediate targets and likely duration; the initial step is for the competent authority to classify the health status of all establishments participating in the programme. 
            
            
               (65)When a Member State has decided to participate in an eradication programme for a Category C disease, it is appropriate for operators participating in that eradication programme to comply with conditions for introductions of animals of listed species, to notify suspicion of listed disease, to comply with disease control measures when a disease is suspected or confirmed and to take any other measures that may be required by the competent authority, including vaccination.
            
            
               (66)When the presence of a listed disease of aquatic animals is suspected or confirmed, the competent authority should take appropriate measures to control the disease. These rules should therefore be laid down in this Regulation. This includes the establishment of a restricted zone when the presence of a listed disease has been confirmed in an establishment participating in the eradication programme or in an establishment which has been declared disease-free. This Regulation includes the minimum requirements which apply as regards geographical demarcation of the restricted zone and the factors affecting it.
            
            
               (67)Following the confirmation of an aquatic disease, the competent authority applies strict controls to establishments which are infected and others which are located in the restricted zone. The rules for the competent authority to apply movement restrictions and details of the level of flexibility that can be considered for certain movements should be set out in this Regulation. 
            
            
               (68)Once an aquatic disease outbreak has occurred in an establishment and this establishment remains in an eradication programme or commences an eradication programme and to ensure a successful control of the disease, it is important to remove aquatic animals that are dead, moribund or showing clinical symptoms within a time frame set by the competent authority in accordance with Regulation (EC) 1069/2009 of the European Parliament and of the Council
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               . It is possible to prepare for human consumption in a disease control aquatic food establishment healthy animals not showing disease symptoms. Alternatively, due to particular circumstances which do not favour the slaughtering for human consumption option, the competent authority should decide that killing and destruction of the animals in the establishment is the other option which must be followed. 
            
            
               (69)Regulation (EU) 2016/429 lays down the obligation for the Commission to develop detailed rules for the granting of disease free status of Member States, zones and compartments. These rules should include disease specific requirements to demonstrate the sustainable absence of the disease in the targeted animal population and the general criteria that support effective control of the health status of that targeted animal population. 
            
            
               (70)The general criteria comprise the territorial scope, the surveillance, biosecurity, disease control measures as well as the consistent implementation of other operational rules set out in Regulation (EU) 2016/429 as regards the registration and approval of establishments, traceability of animals and movement requirements. 
            
            
               (71)This Regulation lays down disease specific criteria based on the absence of listed species or based on incapacity of the disease agent or of the vector to survive as foreseen by Regulation (EU) 2016/429. These criteria should be drawn up in a flexible way to allow the competent authority to justify their case for obtaining a disease-free status based on their specific conditions. Therefore, general requirements are laid down in this Regulation to indicate on what basis and on what supporting information Member States may request the granting of disease free status for their entire territory or a zone thereof, or in the case of aquaculture animals, also for compartments.
            
            
               (72)This Regulation lays down disease specific criteria based on the outcome of eradication programme and on historical surveillance data as foreseen by Regulation (EU) 2016/429. These conditions are based on results of the surveillance, conditions to prevent introduction of the disease and, if necessary, on the use of vaccine. Because of their technical nature these criteria are laid down in Annexes, with the criteria to maintain the disease free statuses. 
            
         
         
            
               (73)It is appropriate that this Regulation lays down modernised requirements for the granting and maintenance of disease free status taking account of the Union rules in place before the date of application of this Regulation, the Terrestrial Code, the Aquatic Animal Health Code of the OIE
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                and, in the absence of existing provisions, on the best available scientific evidence. 
            
            
               (74)Regulation (EU) 2016/429 lays down empowerments for the criteria to grant disease-free status based on historical and surveillance data. Such possibility gives flexibility to recognise the health status of Member States or zones thereof without the application of an eradication programme and should be reserved for situations where the criteria are met to comply with the legal provisions contained in this Regulation or when an eradication programme was not implemented. 
            
            
               (75)Regulation (EU) 2018/1882 lists infestation with Varroa spp as a category C disease for optional eradication. This Regulation lays down provisions for the achievement and maintenance of the infestation with Varroa spp free status. 
            
            
               (76)Regulation (EU) 2018/1882 lists EU infection with Newcastle virus as a category A disease for immediate eradication measures. Therefore, this Regulation does not contain provisions for an eradication programme against infection with Newcastle disease virus and the infection with Newcastle disease virus-free status without vaccination may be granted on the basis of historical and surveillance data.
            
            
               (77)Two different types of compartments are specified for aquaculture animals. Independent compartments have a health status which is independent of the health status of surrounding waters and the water supply to which is either subjected to treatment which ensures that any pathogens which are present are inactivated, or it originates from a well, borehole or spring and is physically protected from infection until it reaches the compartment. Wild animals cannot enter the independent compartment under normal environmental conditions or under conditions such as flooding. 
            
            
               (78)Dependent compartments operate under more flexible conditions, this is why before their recognition, the competent authority assesses several epidemiological factors and where necessary, impose whatever risk mitigation measures are necessary to prevent the introduction of disease into the compartment. 
            
            
               (79)Given the lower level of risk associated with individual establishments which are independent of the surrounding waters, special provisions are laid down for such compartments when they commence aquaculture activities for the first time or when they recommence aquaculture activities after a break. In such cases, disease freedom is declared immediately provided certain conditions are met. Provisions are also laid down for independent compartments where a disease outbreak has occurred. The risk associated with these establishments is higher, therefore a sample of the animals with which the establishment has been re-populated is tested before disease freedom can be declared. 
            
            
               (80)When conditions to maintain the disease free status are no longer fulfilled because of suspicion or confirmation of the disease, the competent authority should apply disease control measures as foreseen in Regulation (EU) 2016/429, to apply during the different steps of disease control from the event of a suspicion of the disease to the resolution of the event and restoration of the disease-free status. 
            
            
               (81)If the competent authority detects a breach in the conditions required to maintain disease free status in the Member State, zone or compartment thereof, actions need to be implemented to remediate the situation. In the period where it is still possible to satisfactorily resolve the breaches and therefore not to have the disease free status withdrawn by the Commission, the competent authority has the option to suspend it. 
            
            
               (82)In the case of aquatic animal disease when a Member State wish to apply to the Commission for approval of disease free status, it will do it for its entire territory or for a zone which is greater than 75% of its territory or which is shared with another Member State or third country. In all other cases, a system of self-declaration is available, which is designed to give greater transparency to the process and which will make it easier for Member States to declare freedom for certain zones and compartments. The entire process is completed electronically unless another Member State or the Commission indicate concerns which cannot be resolved and which are brought to the Standing Committee on Plants, Animals, Food and Feed for decision in accordance with Regulation (EU) 2016/429. This Regulation contains provisions on the approval of eradication programmes of Member States or zones thereof which may differ from the rules applicable before the entry into force of Regulation (EU) 2016/429. In order to ensure a smooth transition from the existing regime with respect to eradication programmes to the new requirements, there is a need for appropriate transitional rules. 
            
            
               (83)This Regulation contains provisions on the approval of disease-free status of Member States or zones thereof which may differ from the rules applicable before the entry into force of Regulation (EU) 2016/429. In order to ensure a smooth transition from the existing regime with respect to disease-free status to the new requirements, there is a need for appropriate transitional rules.
            
            
               (84)With a view to the uniform application of Union legislation on surveillance, eradication programmes and disease-free status and to ensure that it is clear and transparent, Commission Decision 2000/428/EC
                  15
               , Commission Decision 2002/106/EC
                  16
               ; Commission Decision 2003/422
                  17
               , Commission Decision 2006/437/EC
                  18
               , Commission Regulation (EC) No 1266/2007,
                  19
               , Commission Decision 2008/896/EC
                  20
                and Commission Decision 2015/1554
                  21
                should be repealed by this Regulation. 
            
            
               (85)Regulation (EU) 2016/429 empowers the Commission to adopt delegated acts under Part II of that regulation in relation to disease notification and reporting, surveillance, eradication programmes and disease-free status. The rules contained in this regulation are linked and complement those of Regulation (EU) 2016/429 that apply from 21 April 2021. For this reason and to facilitate the application of the new animal health legal framework this Regulation also applies from 21 April 2021. 
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               PART I 
               GENERAL PROVISIONS
            
            
               Article 1
                  Subject-matter and scope
            
            
               1.This Regulation supplements the rules on surveillance, eradication programmes and disease-free status for certain listed and emerging diseases of terrestrial, aquatic and other animals as provided for in Regulation (EU) 2016/429:
            
            
               2.Chapter 1 of Part II lays down the rules for surveillance of the diseases referred to in Article 9(1) of Regulation (EU) 2016/429 and the emerging diseases as defined in Article 6(2) of that Regulation in relation to:
            
            
               (a)the design of the surveillance including the requirements, the targeted animal population, and the diagnostic methods; 
            
            
               (b)the disease confirmation and the case definition; 
            
         
         
            
               (c)Union surveillance programmes.
            
            
               3.Chapter 2 of Part II lays down the rules for eradication programmes against the diseases of terrestrial animals referred to in points (b) and (c) of Article 9(1) of Regulation (EU) 2016/429 in relation to:
            
            
               (a)the disease control strategy, the territory, the animal populations, the targets and the period of application;
            
            
               (b)the obligations of operators and competent authorities;
            
            
               (c)the disease control measures in the event of suspicion and of confirmation.
            
            
               4.Chapter 3 of Part II lays down the rules for eradication programmes against the diseases of aquatic animals referred to in points (b) and (c) Article 9(1) of Regulation (EU) 2016/429 in relation to: 
            
            
               (a)the disease control strategy, the territory, the animal populations, the targets and the period of application;
            
            
               (b)the obligations of operators and competent authorities;
            
            
               (c)the disease control measures in the event of suspicion and of confirmation.
            
            
               5.Chapter 4 of Part II lays down the rules for -disease-free status with regard to certain diseases of terrestrial and aquatic animals referred to in Article 9(1) of Regulation (EU) 2016/429 in relation to:
            
            
               (a)the criteria for the approval of the disease-free status of Member States and zones;
            
            
               (b)the criteria for the approval of the disease-free status for compartments keeping aquaculture animals;
            
            
               (c)the criteria for the maintenance of the disease-free status;
            
            
               (d)the suspension, the withdrawal and the restoration of disease-free status. 
            
            
               6.Part III lays down final and transitional provisions in relation to:
            
            
               (a)the approval of the disease-free status of Member States, zones and compartments which are recognized disease-free under the legislation in force before the date of application of this Regulation;
            
            
               (b)the approval of eradication programmes of Member States, zones and compartments which have an approved eradication or surveillance programme under the legislation in force before the date of application of this Regulation;
            
            
               Article 2
                  Definitions
            
            
               For the purpose of this Regulation, the following definitions shall apply:
            
            
               (1)'category E disease': means a listed disease for which there is a need for surveillance within the Union, as referred to in Article 9(1)(e) of Regulation (EU) 2016/429.
            
         
         
            
               (2)'targeted animal population' means the population of animals of listed species defined by species and, as appropriate, by categories, relevant for the surveillance activities, the eradication programmes or the disease-free status of a specific disease;
            
            
               (3)'additional animal population' means the population of kept or wild animals of listed species subjected to optional prevention, surveillance and disease control measures necessary to achieve or maintain disease free status of targeted animal population;
            
            
               (4)'category A disease': means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in Article 9(1)(a) of Regulation (EU) 2016/429; 
            
            
               (5)'category B disease': means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in Article 9(1)(b) of Regulation (EU) 2016/429; 
            
            
               (6)'category C disease': means a listed disease which is of relevance to some Member States and for which measures are needed to prevent it from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, as referred to in Article 9(1)(c) of Regulation (EU) 2016/429;
            
            
               (7)'control posts' means control posts as referred to in Regulation (EC) No 1255/970;]
            
            
               (8)‘disease status’ means the health status applied to a specific disease;
            
            
               (9)'bovine animal' or 'animal of the bovine species' means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species;
            
            
               (10)'ovine animal' or 'animal of the ovine species' means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;
            
            
               (11)'caprine animal' or 'animal of the caprine species' means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;
            
            
               (12)'travelling circus' means a travelling exhibition or fair that includes animals and which intends to move to another Member State;
            
            
               (13)'animal acts' means animals kept for the purpose of an exhibition or fair, and may form part of a circus;
            
            
               (14)'porcine animal' or 'animal of the porcine species' means an animal of the species of ungulates of family Suidae listed in Annex III to Regulation (EU) 2016/429;
            
            
               (15)'means of transport' means road or rail vehicle, vessels and aircrafts;
            
            
               (16)'dog' means a kept animal of the Canis lupus species;
            
            
               (17)'cat' means a kept animal of the Felis silvestris species;
            
            
               (18)'ferret' means a kept animal of the Mustela putorius furo species;
            
            
               (19)“seasonally BTV-free area’ means the whole territory of a Member State or a zone thereof where the CA has established a temporary status of freedom from infection with bluetongue virus (serotype 1-24) in accordance with Article 40(3) on the basis of a vector-free period and the demonstration of absence of the disease in listed animal species;
            
            
               (20)‘vector protected establishment’ means part or all facilities of an establishment that are protected against attacks from Culicoides by appropriate physical and management means, with a status of vector protected establishment granted by the competent authority in accordance with Article 44;
            
            
               (21)'fallowing' means, for disease management purposes, an operation where an establishment is emptied of aquaculture animals of listed species, and where feasible, of water;
            
         
         
            
               (22)“eligibility period” means the period of time before the competent authority submits the application for disease-free status or, when relevant, before the provisional declaration referred to in point 1(a) of Article 83 is published electronically;
            
            
               (23)'Non-listed species', means not listed in the Annex to Commission Implementing Regulation (EU) 2018/1882;
            
            
               (24)'flock' means all poultry or captive birds of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in housed poultry includes all birds sharing the same airspace;
            
            
               (25)‘DIVA (differentiating infected from vaccinated animals) vaccination’ means a vaccination strategy that uses a vaccine that enables in conjunction with an appropriate diagnostic method to recognise infection-specific antibodies regardless of an animal’s vaccination status;
            
            
               (26)‘DIVA vaccinated animals’ means animals that have been vaccinated using a DIVA vaccination;
            
            
               (27)‘approved germinal product establishment’ means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre, approved in accordance with Article 97 of Regulation (EU) 2016/429;
            
            
               (28)‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;
            
            
               (29)‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova;
            
            
               (30)‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;
            
            
               (31)‘vector-free period’ means in a defined area the period of inactivity of Culicoides determined in accordance with Section 5 of Part II of Annex V; 
            
            
               (32)'honeybees' means animals of the Apis mellifera species;
            
            
               (33)'breeding poultry' means poultry 72 hours old or more, intended for the production of hatching eggs; 
            
            
               PART II 
                  SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE-FREE STATUS
            
            
               Chapter 1
                  Surveillance 
            
            
               Section 1
                  Design of surveillance
            
            
               Article 3
                  Design of surveillance 
            
            
               1.The competent authority shall design the surveillance for listed and emerging diseases of terrestrial animals and other animals taking into account:
            
            
               (a)general surveillance requirements based on:
            
            
               (i)notification as provided for in Article 18(1) of Regulation (EU) 2016/429;
            
            
               (ii)appropriate veterinary investigation of abnormal mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause;
            
         
         
            
               (iii)investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease; 
            
            
               (iv)targeted animal population for surveillance as provided for in Article 4;
            
            
               (v)the contribution of official controls and other official activities as provided for in Article 7;
            
            
               (b)specific surveillance requirements:
            
            
               (i)in Union surveillance programme; 
            
            
               (ii)as a part of compulsory or optional eradication programmes; 
            
            
               (iii)for demonstrating and maintaining disease-free status;
            
            
               (iv)as a part of disease control measures;
            
            
               (v)in the context of approval of certain establishments;
            
            
               (vi)for the movements of terrestrial animals within the Union or their entry into the Union.
            
            
               2.The competent authority shall design the surveillance for listed and emerging diseases of aquatic animals taking into account:
            
            
               (a)general surveillance requirements based on:
            
            
               (i)notification as provided for in Article 18(1) of Regulation (EU) 2016/429;
            
            
               (ii)appropriate veterinary investigation of abnormal mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause;
            
            
               (iii)investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease;
            
            
               (iv)targeted animal population for surveillance as provided for in Article 4;
            
            
               (v)the contribution of official controls and other official activities as provided for in Article 7;
            
            
               (vi)disease control measures.
            
            
               (b)specific surveillance requirements:
            
            
               (i)as a part of the risk based surveillance scheme set out in Chapter 1 of Part I of Annex VI, involving a risk ranking and regular animal health visits as provided for in Chapters 2 and 3 of Part I of Annex VI; 
            
         
         
            
               (ii)as a part of the eradication programmes provided for in Chapters 1 to 6 of Part II of Annex VI; 
            
            
               (iii)for demonstrating and maintaining disease-free status;
            
            
               (iv)for demonstrating, in accordance with the surveillance programmes provided for in Chapters 1 to 6 of Part III of Annex VI, that establishments which are not participating in the eradication programme referred to in point (ii) or which have not obtained the disease-free status referred to in point (iii) are not infected;
            
            
               (v)for the movements of aquatic animals within the Union or their entry into the Union. 
            
            
               Article 4
                  Targeted animal population 
            
            
               1.The competent authority shall specify the targeted animal population relevant to the surveillance referred to in Article 3 for each listed disease and, when relevant, for each emerging disease and shall include:
            
            
               (a)kept animals of listed species; 
            
            
               (b)wild animals of listed species if:
            
            
               (i)they are subject to a Union surveillance programme, or to a compulsory or an optional eradication programme or to the granting or maintenance of a disease-free status; 
            
            
               (ii)the competent authority considers that they constitute a risk that may impair the health status of other species in a Member State, zone or compartment; or
            
            
               (iii)surveillance is necessary to assess animal health requirements for entry into the Union or movements within the Union.
            
            
               2.To ensure the early detection of an emerging disease in species other than those referred to in point (a) of paragraph 1, the competent authority shall include, in the targeted animal population, kept animals of species that are not listed for the purpose of the relevant listed disease if the following criteria apply:
            
            
               (a)they are moved to establishments in another Member State, zone or compartment; and
            
            
               (b)due to the number of animals or the frequency of the movements, the competent authority considers the animals to constitute a risk that might impair the health status of other kept animals in another Member State, zone or compartment, should a disease emerge in that species.
            
            
               Article 5
               Exclusion of certain kept terrestrial animals from the targeted animal population 
            
            
               1.By way of derogation from point (a) of Article 4(1), the competent authority may limit the targeted animal population for the surveillance of a disease other than a category A disease to the categories of kept animals of listed species that are subject, for that disease, to:
            
            
               (a)Union surveillance programmes; 
            
            
               (b)compulsory or optional eradication programmes or the granting or maintenance of a disease-free status; or
            
            
               (c)surveillance-based animal health requirements for the movements within the Union or the entry into the Union. 
            
            
               2.The categories of kept animals referred to in paragraph 1 may be based on the animals’ age, their sex, the location and type of production.
            
         
         
            
               Article 6
                  Diagnostic methods
            
            
               1.The Competent authority shall ensure that the collection of samples, the techniques, validation and interpretation of the diagnostic methods for the purposes of surveillance shall comply:
            
            
               (a)with the specific legislation adopted in accordance with Regulation (EU) 2016/429 and the relevant details and guidance made available on the website of the European Union Reference Laboratories (EURL) or of the Commission;
            
            
               (b)when not covered by the legislation, details and guidance referred to in point (a), with the collection of samples, the techniques, validation and interpretation of the diagnostic methods laid down in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (‘the Terrestrial Manual’)
                  22
                as amended or the Manual of Diagnostic Tests for Aquatic Animals of the OIE (‘the Aquatic Manual’
                  23
               ) as amended;
            
            
               (c)when not covered by points (a) and (b), with the methods laid down in point (b) of Article 34(2) and 34(3) of Regulation (EU) 2017/625.
            
            
               2.The diagnostic methods for granting and maintaining the disease-free status are laid down in:
            
            
               (a)Section 1 of Annex III for infection with Brucella abortus, B. melitensis and B.suis;
            
            
               (b)Section 2 of Annex III for infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis)(MTBC);
            
            
               (c)Section 3 of Annex III for enzootic bovine leukosis (EBL);
            
            
               (d)Section 4 of Annex III for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV);
            
            
               (e)Section 5 of Annex III for infection with Aujeszky’s disease virus (ADV);
            
            
               (f)Section 6 of Annex III for bovine viral diarrhoea (BVD);
            
            
               (g)point 2 of Section 5 of Chapter 1 of Part II of Annex VI for viral haemorrhagic septicaemia (VHS);
            
            
               (h)point 2 of Section 5 of Chapter 1 of Part II of Annex VI for infectious haematopoietic necrosis (IHN);
            
            
               (i)point 2 of Section 5 of Chapter 2 of Part II of Annex VI for infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV);
            
            
               (j)point 2 of Section 5 of Chapter 3 of Part II of Annex VI for infection with Marteilia refringens;
            
            
               (k)point 2 of Section 5 of Chapter 4 of Part II of Annex VI for infection with Bonamia exitiosa;
            
            
               (l)point 2 of Section 5 of Chapter 5 of Part II of Annex VI for infection with Bonamia ostreae;
            
            
               (m)point 2 of Section 5 of Chapter 6 of Part II of Annex VI for infection with white spot syndrome virus (WSSV).
            
            
               Article 7
                  Contribution of official controls and other official activities to animal health surveillance 
            
         
         
            
               1.The competent authority shall, if relevant, include in the surveillance referred to in Article 3 of this Regulation the outcome of the official controls and other official activities provided for in Article 2 of Regulation (EU) 2017/625. These official controls and other official activities include:
            
            
               (a)ante-mortem and post-mortem inspections;
            
            
               (b)inspections at border control posts;
            
            
               (c)official controls and other official activities at markets and assembly operations; 
            
            
               (d)official controls and other official activities during transport of live animals;
            
            
               (e)public health related inspections and sampling in establishments;
            
            
               (f)any other official controls during which establishments, animals or samples are inspected or examined.
            
            
               2.When the competent authority suspects a listed disease or an emerging disease in the context of official controls or other official activities referred to in paragraph 1, it shall ensure that all relevant authorities are informed. This shall be done:
            
            
               (a)immediately in case of a category A disease or of an emerging disease;
            
            
               (b)without delay for other diseases.
            
            
               Section 2
                  Disease confirmation and case definitions 
            
            
               Article 8
               Criteria for official confirmation of listed diseases other than category A, B or C and certain emerging diseases 
            
            
               1.The competent authority shall, on suspicion of a listed disease other than category A, B or, when appropriate a category C or an emerging disease, conduct an investigation to confirm or to rule out the presence of that disease when:
            
            
               (a)it is needed to determine the disease-status of the Member State, zone or compartment thereof; or 
            
            
               (b)it is needed to collect necessary information on its occurrence for any of the following purposes:
            
            
               (i)to implement measures to protect animal or human health; 
            
            
               (ii)to implement animal health requirements for movements of animals or products; or
            
            
               (iii)to comply with the requirements laid down for an Union surveillance programme.
            
            
               2.The competent authority shall confirm an outbreak of any of the diseases referred to in paragraph 1 when it has classified an animal or a group of animals as a confirmed case of that disease in accordance with Article 9(2).
            
            
               Article 9
               Case definitions 
            
         
         
            
               1.The competent authority shall classify an animal or a group of animals as a suspect case of a listed disease or of an emerging disease when:
            
            
               (a)clinical, post-mortem or laboratory examinations conclude that clinical sign(s), post-mortem lesion(s) or histological findings are indicative of that disease; 
            
            
               (b)result(s) from a diagnostic method are indicating the likely presence of the disease in a sample from an animal or from a group of animals; or
            
            
               (c)an epidemiological link with a confirmed case has been established.
            
            
               2.The competent authority shall classify an animal or a group of animals, as a confirmed case of a listed disease or of an emerging disease when:
            
            
               (a)the disease agent, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals;
            
            
               (b)antigen or nucleic acid specific to the disease agent, that is not a consequence of vaccination, has been identified in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspect or confirmed case; or
            
            
               (c)a positive result from an indirect diagnostic method that is not a consequence of vaccination, has been obtained in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspect or confirmed case.
            
            
               3.Disease specific definitions of a suspect case and a confirmed case of listed diseases are laid down for terrestrial animals in Annex I and for aquatic animals in point 3 of Section 5 of Chapters 1 to 6 of Part II of Annex VI.
            
            
               4.In the absence of disease specific definitions as provided for in paragraph 3, the criteria laid down in paragraphs 1 and 2 shall apply to definitions of a suspect case and a confirmed case of listed diseases and, if relevant, emerging diseases.
            
            
               Section 3
                  Union surveillance programme
            
            
               Article 10
                  Criteria for and contents of Union surveillance programmes 
            
            
               1.A category E disease shall be subject to a Union surveillance programme in accordance with Article 28 of Regulation (EU) 2016/429 if it meets all of the following criteria:
            
            
               (a)it poses a particular threat to animal and possibly human health on the whole Union territory with possible serious economic consequences for the farming community and the wider economy; 
            
            
               (b)it is susceptible to an evolution of profile, in particular with regard to the risk for human health and animal health; 
            
            
               (c)infected wild animals pose a particular threat for the introduction of the disease into a part or the whole of the Union territory; 
            
            
               (d)it is fundamental to obtain, through surveillance, regularly updated information on the evolution of its circulation and on the characterisation of the disease agent, to assess those risks and adapt mitigation measures accordingly; 
            
            
               2.The competent authority shall implement Union surveillance programmes for the relevant disease in accordance with the contents set out in Annex II.
            
            
               Article 11
                  Information to be included in the submission of Union surveillance programmes
            
            
               1.The competent authority shall, when submitting a Union surveillance programme, include in that submission at least the following information:
            
         
         
            
               (a)description of the epidemiological situation of the disease before the date of the beginning of the implementation of the programme and data on the epidemiological evolution of the disease;
            
            
               (b)targeted animal population, epidemiological units and zones of the programme;
            
            
               (c)organisation of the competent authority, supervision of the implementation of the programme and official controls to be applied during the implementation of the programme and the role of all relevant operators, animal health professionals, veterinarians, animal health laboratories and other natural or legal person concerned;
            
            
               (d)description and demarcation of the geographical and administrative areas in which the programme is to be implemented;
            
            
               (e)indicators to measure the progress of the programme;
            
            
               (f)diagnostic methods used, number of samples tested, frequency of testing and sampling patterns;
            
            
               (g)risk factors to be considered for the design of a risk based targeted surveillance.
            
            
               2.The competent authority shall, when reporting on a Union surveillance programme, include at least:
            
            
               (a)the description of the measures implemented and the results obtained from the information referred to point (b) and points (d) to (f) of paragraph 1; and
            
            
               (b)the results of the follow up of the epidemiological evolution of the disease in case of a suspected or confirmed case.
            
            
               Chapter 2
                  Eradication programmes against category B and C diseases of terrestrial animals
            
            
               Section 1
                  General provisions
            
            
               Article 12
                  Disease control strategy for the eradication of category B and C diseases of terrestrial animals
            
            
               1.The competent authority shall, when establishing a compulsory eradication programme against a category B disease or an optional eradication programme against a category C disease of terrestrial animals, base those programmes on a disease control strategy that includes for each disease:
            
            
               (a)the territory and animal population covered by the eradication programme as provided for in Article 13(1); 
            
            
               (b)the duration of the eradication programme as provided for in Article 15, including its final and intermediate targets as provided for in Article 14; and
            
            
               (c)the disease specific provisions laid down : 
            
            
               –in Articles 21 to 31 for infection with Brucella abortus, B. melitensis and B. suis, infection with MTBC, EBL, IBR/IPV, infection with ADV and BVD;
            
            
               –in Articles 35 and 36 for infection with RABV;
            
            
               –in Articles 41 to 45 for infection with BTV.
            
         
         
            
               2.The competent authority may include in the eradication programme coordinated measures at its common land or coastal border with other Member States or third countries to ensure the sustainability and achievement of the objectives of the programme.
            
            
               Where such coordination has not been established, the competent authority shall include in the eradication programme, if feasible, effective risk mitigation measures, including enhanced surveillance, and implement these measures.
            
            
               Article 13
               Territorial scope and animal populations 
            
            
               1.The competent authority shall determine the scope of the eradication programme, including: 
            
            
               (a)the territory covered; and 
            
            
               (b)the targeted animal population and, as necessary, additional animal populations.
            
            
               2.The territory covered by the eradication programme referred to in point (a) of paragraph 1 may be:
            
            
               (a)the entire territory of the Member State; or
            
            
               (b)one or several zones, provided that each zone corresponds to administrative unit(s) of at least 2000 km² and includes at least one of the regions established in accordance with Article 21 of Regulation (EU) 2016/429. 
            
            
               3.By way of derogation from paragraph 2, the competent authority may define zones smaller than 2000 km² taking into account:
            
            
               (a)a minimum surface not significantly lower than 2000 km²; or 
            
            
               (b)the existence of natural barriers relevant to the disease profile. 
            
            
               Article 14
                  Final and intermediate targets
            
            
               1.The competent authority shall include in the eradication programme qualitative and quantitative final targets that are covering all the disease specific criteria laid down for the granting of the disease-free status referred to in Article 72.
            
            
               2.The competent authority shall include in the eradication programme qualitative and quantitative intermediate annual or multiannual targets to reflect progress towards the final targets. These intermediate targets shall include:
            
            
               (a)all of the disease specific criteria referred to in paragraph 1; and 
            
            
               (b)if necessary, additional criteria that are not included in the criteria for the granting of the disease-free status to assess progress towards eradication.
            
            
               Article 15
                  Period of application
            
            
               1.The competent authority shall include in the eradication programme the period of application taking into account the initial situation and the intermediate targets indicated in Article 14(2).
            
            
               2.For category C diseases, the period of application of an eradication programme shall not exceed 6 years from the date of its initial approval by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429. In duly justified situations, following an initial approval for 6 years the Commission may, upon request of Member States, approve the eradication programme for an extended 6 years period of application.
            
         
         
            
               Section 2
               Requirements for eradication programmes based on granting disease-free status at the level of establishments
            
            
               Article 16
               Disease control strategy based on the disease-free status at establishment level 
            
            
               1.The competent authority shall design the disease control strategy of an eradication programme in the targeted animal population kept in establishments for the following diseases of terrestrial animals:
            
            
               (a)infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (b)infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, Mycobacterium caprae and Mycobacterium tuberculosis) (MTBC);
            
            
               (c)enzootic bovine leukosis (EBL);
            
            
               (d)infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV);
            
            
               (e)infection with Aujeszky's disease virus (ADV);
            
            
               (f)bovine viral diarrhoea (BVD).
            
            
               2.Disease control strategies of eradication programmes referred to in paragraph 1 shall be based on:
            
            
               (a)the implementation of disease specific measures laid down in Articles 18 to 31 until all relevant establishments reach disease-free status;
            
            
               (b)the granting, suspension and withdrawal by the competent authority of the disease-free status of all relevant establishments; 
            
            
               (c)the implementation of biosecurity and other risk mitigation measures; 
            
            
               (d)the optional implementation of vaccination programmes.
            
            
               Article 17
                  Targeted and additional animal populations for eradication programmes against certain diseases 
            
            
               1.The competent authority shall apply the compulsory eradication programme to the following targeted animal populations:
            
            
               (a)for infection with Brucella abortus, B. melitensis and B. suis, kept bovine animals, kept ovine animals and kept caprine animals;
            
            
               (b)for infection with MTBC, kept bovine animals.
            
            
               2.The competent authority shall apply the optional eradication programme to the following targeted animal populations:
            
            
               (a)for EBL, kept bovine animals;
            
         
         
            
               (b)for IBR/IPV, kept bovine animals;
            
            
               (c)for infection with ADV, kept porcine animals;
            
            
               (d)for BVD, kept bovine animals.
            
            
               3.The competent authority shall include additional animal populations where it considers that such animals pose a significant risk to the disease status of animals referred to in paragraphs 1 or 2.
            
            
               Article 18
                  Obligation of operators for the eradication programmes against certain of diseases 
            
            
               1.The operators of establishments where animals from the targeted animal populations referred to in Article 17 are kept, other than slaughterhouses, shall comply with the following general and disease specific requirements to obtain and maintain the disease-free status of the establishments:
            
            
               (a)general requirements:
            
            
               (i)surveillance of the targeted and additional animal populations for the relevant disease as provided in Article 3 to 9;
            
            
               (ii)in the case of movement of animals from the targeted animal population, ensuring that the disease status of the establishments is not jeopardised due to transport or introduction into the establishments of animals of the targeted or additional animal populations or products thereof;
            
            
               (iii)vaccination of the kept animals of targeted animal population against the relevant disease;
            
            
               (iv)disease control measures in the event the disease is suspected or confirmed;
            
            
               (v)any additional measures considered necessary by the competent authority that may include, if relevant, separation of animals according to their disease status by physical protection and management measures;
            
            
               (b)disease specific requirements laid down in:
            
            
               (i)Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (ii)Chapter 1 of Part II of Annex IV for infection with MTBC;
            
            
               (iii)Chapter 1 of Part III of Annex IV for EBL;
            
            
               (iv)Chapter 1 of Part IV of Annex IV for IBR/IPV;
            
            
               (v)Chapter 1 of Part V of Annex IV for infection with ADV;
            
            
               (vi)Chapter 1 of Part VI of Annex IV for BVD.
            
            
               2.The operators of slaughterhouses, where animals from the targeted animal population referred to in Article 17 are kept and slaughtered shall comply with the general requirements laid down in point (i), (iv) and (v) of point (a) of paragraph 1.
            
         
         
            
               Article 19
                  Derogation with regard to granting disease-free status to establishments 
            
            
               By way of derogation from Article 18 and provided that the relevant animal populations are subjected to the general requirements laid down in point (a) of Article 18(1), the competent authority may decide that the obligations for granting and maintaining disease-free status laid down in Article 18(1) do not apply to operators of the following establishments:
            
            
               (a)confined establishments; 
            
            
               (b)establishments where animals are only kept for assembly operations;
            
            
               (c)establishments where animals are only kept for the purpose of animal acts;
            
            
               (d)traveling circuses.
            
            
               Article 20
               Obligation of the competent authority to grant, suspend and withdraw disease-free status 
            
            
               1.The competent authority shall grant disease-free status at establishment level according to the compliance of the establishments’ operators with the requirements laid down in Article 18.
            
            
               2.The competent authority shall suspend or withdraw disease-free status at establishment level when the conditions for suspension or withdrawal are fulfilled. Those conditions are laid down in: 
            
            
               (a)Sections 3 and 4 of Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (b)Sections 3 and 4 of Chapter 1 of Part II of Annex IV for infection with MTBC;
            
            
               (c)Sections 3 and 4 of Chapter 1 of Part III of Annex IV for EBL;
            
            
               (d)Sections 3 and 4 of Chapter 1 of Part IV of Annex IV for IBR/IPV;
            
            
               (e)Sections 3 and 4 of Chapter 1 of Part V of Annex IV for infection with ADV;
            
            
               (f)Sections 3 and 4 of Chapter 1 of Part VI of Annex IV for BVD. 
            
            
               3.The competent authority shall specify:
            
            
               (a)the details of the testing regime, including as necessary, the disease specific requirements referred to in point (b) of Article 18(1) when the disease-free status is suspended or withdrawn; and
            
            
               (b)the maximum period of time during which disease-free status may be suspended where there is a breach of the conditions referred to in the second sentence of paragraph 2.
            
            
               4.The competent authority may attribute distinct disease status to different epidemiological units of the same establishment provided that its operator:
            
            
               (a)has submitted to the approval of the competent authority the different epidemiological units established within the establishment to be granted distinct disease status prior to any suspicion or confirmation of the disease in accordance with Articles 21 and 24; and
            
         
         
            
               (b)has set up a system, to which the competent authority has access upon request, to trace the movements of animals and germinal products to, from and between the epidemiological units; and
            
            
               (c)has separated the epidemiological units by physical and management means and complies with any risk mitigation measures requested by the competent authority for that purpose.
            
            
               Article 21
                  Disease control measures in the event of suspicion of certain diseases
            
            
               1.The competent authority shall, when it suspects a case of the relevant disease, conduct investigations, initiate an epidemiological enquiry and suspend the disease-free status of the establishment where the suspect case occurred until the investigations and the epidemiological enquiry are concluded.
            
            
               2.Pending the outcome of the investigations and the epidemiological enquiry referred to in paragraph 1, the competent authority:
            
            
               (a)shall prohibit movement of animals from the relevant targeted animal population out of the establishment unless authorised by the competent authority for the purpose of immediate slaughter;
            
            
               (b)shall, when it considers it is necessary for the control of the risk of spreading the disease:
            
            
               (i)where technically possible, order the isolation of the suspect cases in the establishment;
            
            
               (ii)restrict the introduction of animals from the relevant targeted animal population into the establishment;
            
            
               (iii)restrict the movement of products from the relevant targeted animal population from or to the establishment.
            
            
               3.The competent authority shall maintain the measures referred to in paragraphs 1 and 2 until the presence of the disease has been ruled out or confirmed.
            
            
               Article 22
                  Extension of disease control measures in the event of suspicion of certain diseases 
            
            
               1.The competent authority shall, when it considers it necessary, extend the measures laid down in Article 21 to:
            
            
               (a)relevant additional animal populations kept in the establishment;
            
            
               (b)any establishment which has an epidemiological link with the establishment where the suspect case occurred.
            
            
               2.If the presence of the disease is suspected in wild animals, the competent authority shall, when it considers it necessary, extend to the establishments that are at risk of infection the measures laid down in Article 21.
            
            
               Article 23
                  Derogation from disease control measures in the event of suspicion of certain diseases 
            
            
               1.By way of derogation from Article 21(1), based on duly justified grounds, the competent authority may decide not to suspend the disease-free status of the whole establishment when there are different epidemiological units as referred in Article 20(4).
            
            
               2.By way of derogation from point (a) of Article 21(2), the competent authority may authorize movement of animals from the relevant targeted animal population to an establishment provided that the following requirements are complied with:
            
            
               (a)the animals shall only be moved by direct transport;
            
         
         
            
               (b)in the establishment of destination, the animals shall be kept in closed facilities, with no contact with kept animals of a higher disease status or with wild animals of listed species with respect to the relevant disease; 
            
            
               (c)the establishment of destination has been authorised for that purpose by the competent authority and is under its official supervision; 
            
            
               (d)until the end of the investigations the animals may only be moved from the establishment of destination by direct transport to a slaughterhouse designated for that purpose;
            
            
               (e)after the end of the investigations in case of suspicion of infection with Brucella abortus, B. melitensis and B. suis or infection with MTBC, the animals shall only be moved from the establishment of destination by direct transport to a slaughterhouse designated for that purpose.
            
            
               3.By way of derogation from point (a) of Article 21(2), in case of a category C disease, the competent authority may authorise movement of animals from the relevant targeted animal population provided that they are moved, if necessary by direct transport, to an establishment located in an area that is neither disease-free nor covered by an optional eradication programme.
            
            
               4.Pending the outcome of the investigations referred to in Article 21(1) and when making use of the derogations laid down in paragraph 2, the competent authority shall suspend the disease-free status of the establishment of destination of the animals subject to the derogations, as relevant.
            
            
               5.The competent authority may use the derogations provided for in paragraphs 1 to 3 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogations: 
            
            
               (a)apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and
            
            
               (b)provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures are fulfilled.
            
            
               Article 24
               Official confirmation of certain diseases and disease control measures 
            
            
               1.If a case is confirmed, the competent authority shall:
            
            
               (a)withdraw the disease-free status of the infected establishment(s); 
            
            
               (b)adopt the measures laid down in Articles 25 to 31 in the infected establishment(s).
            
            
               2.By way of derogation from point(a) of paragraph 1, the competent authority may limit the withdrawal of the disease-free status to the epidemiological units where a case was confirmed.
            
            
               3.If the disease is confirmed in wild animals, the competent authority shall conduct, when relevant, an epidemiological enquiry and investigations as provided for in Article 25. If it considers it necessary to prevent the spread of the disease to targeted animal population, it shall:
            
            
               (a)order relevant disease control measures as provided for in Articles 21 to 25 and in Article 30 in establishments keeping targeted animal population and additional animal population;
            
            
               (b)conduct or order other proportionate and necessary prevention, surveillance and disease control measures in the relevant wild animal population or in its habitat.
            
            
               Article 25
                  Epidemiological enquiry in case of confirmation of certain diseases 
            
            
               1.When the disease is confirmed, the competent authority shall:
            
            
               (a)conduct an epidemiological enquiry; 
            
         
         
            
               (b)conduct investigations and apply the measures laid down in Article 21 in all epidemiologically linked establishments; and
            
            
               (c)adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry.
            
            
               2.The competent authority shall consider the need to conduct an investigation on wild animals from additional animal populations where the epidemiological enquiry reveals epidemiological links between kept and wild animals. 
            
            
               3.The competent authority shall as soon as possible inform:
            
            
               (a)operators and relevant authorities from the Member States concerned by the epidemiological links with the confirmed case; and
            
            
               (b)the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s).
            
            
               Article 26
                  Movement of animals to or from infected establishments
            
            
               1.The competent authority shall prohibit movements of animals from targeted animal populations out of infected establishment unless it authorises its immediate slaughter.
            
            
               2.When the competent authority considers it necessary to prevent the spread of the disease, it shall:
            
            
               (a)order the isolation of the suspect and confirmed cases on the establishment where technically possible;
            
            
               (b)restrict the movements of animals from targeted animal populations within the establishment; 
            
            
               (c)restrict the introduction of animals from targeted animal populations in the establishment;
            
            
               (d)restrict the movement of products of animals from targeted animal populations from and to the infected establishment.
            
            
               3.The competent authority shall, when it considers it necessary, extend the measures in paragraphs 1 and 2 to animals and products from additional animal populations to prevent the spread of the disease.
            
            
               Article 27
                  Testing and removal of animals from infected establishments 
            
            
               1.Following confirmation of the disease, the competent authority shall order in infected establishments that the following testing is conducted within a maximum period of time to be determined by the competent authority:
            
            
               (a)the testing of those animals whose testing is considered necessary to complete the epidemiological enquiry;
            
            
               (b)the testing to restore the disease-free status as laid down in:
            
            
               (i)Section 4 of Chapters 1 and 2 of Part I of Annex IV for Infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (ii)Section 4 of Chapter 1 of Part II of Annex IV for Infection with MTBC;
            
         
         
            
               (iii)Section 4 of Chapter 1 of Part III of Annex IV for EBL;
            
            
               (iv)Section 4 of Chapter 1 of Part IV of Annex IV for IBR/IPV;
            
            
               (v)Section 4 of Chapter 1 of Part V of Annex IV for Infection with ADV;
            
            
               (vi)Section 4 of Chapter 1 of Part VI of Annex IV for BVD;
            
            
               (c)in addition to the testing referred to in point (b) and as soon as technically possible following the confirmation of the disease, the testing of animals from the targeted animal populations, if necessary, to ensure the swift detection of infected animals that contribute to the spreading of the disease
            
            
               2.By way of derogation from (b) of paragraph 1 the testing shall not be ordered when disease-free status is restored in accordance with:
            
            
               (i)point 2 of Section 1 of Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (ii)point 2 of Section 1 of Chapter 1 of Part II of Annex IV for infection with MTBC;
            
            
               (iii)point 2 Section 1 of Chapter 1 of Part III of Annex IV for EBL;
            
            
               (iv)point 2 of Section 1 of Chapter 1 of Part IV of Annex IV for IBR/IPV;
            
            
               (v)point 2 of Section 1 of Chapter 1 of Part V of Annex IV for infection with ADV;
            
            
               (vi)point 2 of Section 1 of Chapter 1 of Part VI of Annex IV for BVD;
            
            
               3.The competent authority shall in all infected establishments order that all animals recognised as confirmed cases and, if necessary, suspect cases are slaughtered within a maximum period of time to be determined by the competent authority.
            
            
               4.The slaughtering of the animals referred to in paragraph 3 shall be carried out under official supervision in a designated slaughterhouse.
            
            
               5.The competent authority may order the killing and destruction of some or all of the animals referred to in paragraph 3 instead of their slaughtering.
            
            
               6.The competent authority shall extend the measures laid down in this Article to animals from additional animal populations when this is necessary to eradicate the disease in the infected establishments.
            
            
               Article 28
                  Management of products from infected establishments 
            
            
               1.The competent authority shall in all establishments infected with Brucella abortus, B. melitensis and B. suis or infected with MTBC, order that:
            
            
               (a)milk from confirmed cases may be fed only to animals on the same establishment after processing ensuring the inactivation of the disease agent, or it shall be disposed of.
            
            
               (b)manure, straw, feedstuffs or any other matter and substance which has come into contact with a confirmed case or with contaminated material shall be either collected and disposed of as soon as possible or stored and processed to reduce the risk of spreading of the disease to an acceptable level following an appropriate risk assessment.
            
         
         
            
               2.In the event of infection with Brucella abortus, B. melitensis and B. suis, the competent authority shall, in all infected establishments, order that foetuses, still-born animals, animals which have died from the disease after birth or placentae shall be collected and disposed of.
            
            
               3.In the event of infection with a category C disease, the competent authority shall when it considers it necessary, order any appropriate measures provided in paragraphs1 and 2.
            
            
               4.The competent authority shall, when it considers it necessary, order the trace-back, the processing or the disposal of any products from infected establishments that may constitute a risk of spreading the disease or affect human health.
            
            
               Article 29
                  Derogations from the restriction of movement of animals from infected establishments
            
            
               1.By way of derogation from point (a) of Article 26(1), the competent authority may authorise movement of clinically healthy animals, other than confirmed cases provided that the following requirements are complied with:
            
            
               (a)the movement does not jeopardise the disease status of animals at the place of destination or en-route to that destination; 
            
            
               (b)the animals shall only be moved by direct transport;
            
            
               (c)in the establishment of destination, the animals shall be kept, in closed facilities, with no contact with kept animals of a higher disease status or with wild animals of listed species with respect to the relevant disease; 
            
            
               (d)the establishment of destination has been authorised for that purpose by the competent authority and is under its official supervision; 
            
            
               (e)the animals may only be moved from the establishment of destination by direct transport to a slaughterhouse designated for that purpose and not later than following a maximum period of time to be determined by the competent authority; and
            
            
               (f)in case of infection with a category C disease the animals may be moved without restriction from the establishment of destination when this establishment has regained the disease-free status.
            
            
               2.By way of derogation from point (a) of Article 26(1) in the case of category C disease, the competent authority may authorize movement of clinically healthy animals from the relevant targeted animal population, other than confirmed cases, provided that:
            
            
               (a)they are moved, if necessary by direct transport, to an establishment located in an area that is neither disease-free nor covered by the optional eradication programme; and
            
            
               (b)the movement does not jeopardise the disease status of targeted or additional animal populations at the place of destination or en-route for that destination.
            
            
               3.When making use of the derogations laid down in paragraph 1, the competent authority shall withdraw the disease-free status of the establishment of destination of the animals subject to the derogation.
            
            
               4.The competent authority may use the derogations provided for in paragraphs 1 and 2 only if operators of establishments of origin and of destination and transporters of the animals subject to the derogations: 
            
            
               (a)apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and
            
            
               (b)provide the competent authority with the guarantees that all the necessary biosecurity and other risk mitigating measures are fulfilled.
            
            
               Article 30
               Cleaning and disinfection and other measures to prevent the spread of infection 
            
            
               1.The competent authority shall for all infected establishments, and those receiving animals from infected establishment, order the cleaning and disinfection or, where relevant, the safe disposal of:
            
         
         
            
               (a)all parts of the establishment that may have been contaminated after the removal of the confirmed and suspect cases and before restocking;
            
            
               (b)any feed material of plant origin, materials, substances, husbandry, medicinal and production related equipment that may have been contaminated;
            
            
               (c)any protective clothing or safety equipment used by operators and visitors;
            
            
               (d)all means of transport, containers and equipment after the transport of animals or products from an infected establishment;
            
            
               (e)loading areas for animals after each use.
            
            
               2.The competent authority shall approve the protocol for the cleaning and disinfection.
            
            
               3.The competent authority shall supervise the cleaning and disinfection, or where relevant, the safe disposal and shall not restore or grant again disease-free status to the establishment until it considers that the cleaning and disinfection, or where relevant, the safe disposal, has been completed.
            
            
               4.The competent authority may, based on a risk assessment, regard a pasture as contaminated and prohibit its use for kept animals of higher disease status from the targeted animal population or, if epidemiologically relevant, additional animal populations, for a sufficient period of time to consider the risk of persistence of the disease agent to be negligible.
            
            
               Article 31
                  Risk mitigation measures to prevent reinfection 
            
            
               Before or upon lifting of the disease control measures, the competent authority shall order proportionate risk mitigation measures to prevent the reinfection of the establishment taking into account relevant risk factors as indicated by the results of the epidemiological enquiry. These measures shall at least take account of: 
            
            
               (a)persistence of the disease agent in the environment or in wild animals; and
            
            
               (b)biosecurity measures that are adapted to the specificities of the establishment.
            
            
               Section 3
                  Provisions for rabies eradication programmes
            
            
               Article 32
                  Disease control strategy of eradication programmes against infection with rabies virus 
            
            
               1.The competent authority shall, when establishing an eradication programme against infection with rabies virus (RABV), base those programmes on a disease control strategy that includes:
            
            
               (a)vaccination of the animals from the targeted animal population that it considers relevant; 
            
            
               (b)implementation of measures to reduce the risk of contact with infected animals;
            
            
               (c)control of the risk of spread and introduction of the disease in the territory of the Member State.
            
            
               2.The competent authority shall implement the eradication programme taking into account that it shall be:
            
            
               (a)based on a risk assessment, updated as necessary according to the evolution of the epidemiological situation;
            
         
         
            
               (b)supported by public information campaigns involving all relevant stakeholders;
            
            
               (c)as necessary, coordinated with relevant authorities in charge of public health, wild animal populations or hunting;
            
            
               (d)scaled according to a territorial risk-based approach.
            
            
               3.The competent authority may, to prevent the risk of spread and introduction of RABV in the territory of the Member State, be involved in implementation of the eradication programme in a third country or territory, adopting a coordinated approach.
            
            
               Article 33
                  Animal population for the eradication programmes against infection with RABV 
            
            
               1.The competent authority shall apply the eradication programme against infection with RABV to the following targeted animal population: kept and wild animals of species of the following orders: Carnivora, Bovidae, Suidae, Equidae, Cervidae and Camelidae.
            
            
               2.The competent authority shall address the measures in the eradication programme primarily to wild foxes, being the main reservoir of RABV.
            
            
               3.The competent authority shall subject other targeted animal populations than wild foxes to the measures of the eradication programme when, it considers that such animals pose a significant risk.
            
            
               4.The competent authority may include wild animals of species of the order Chiroptera in the targeted population for surveillance referred to in Article 4.
            
            
               Article 34
               Obligations of the competent authority in the context of eradication programmes against infection with RABV 
            
            
               1.The competent authority shall: 
            
            
               (a)conduct surveillance of infection with RABV for the purposes of:
            
            
               (i)early detection of the infection; and
            
            
               (ii)follow up of the trend in the number of infected animals, which shall include, according to a risk-based approach, the collection and testing of wild foxes and other wild carnivores found dead;
            
            
               (b)carry out disease control measures in the event of suspicion or confirmation of infection with RABV as laid down in Articles 35 and 36;
            
            
               (c)apply, if necessary, risk mitigation measures to prevent the spread of RABV by movements of kept dogs, cats and ferrets. 
            
            
               2.The competent authority shall, when it considers it necessary, order:
            
            
               (a)vaccination, and the monitoring of the effectiveness of vaccination, in accordance with Section 2 of Chapter 1 of Part I of Annex V of wild foxes and, as relevant, of other animals referred to in Article 33(3); 
            
            
               (b)as relevant, the identification and registration of kept dogs, cats and ferrets;
            
            
               (c)movement restrictions of relevant kept animals of species referred to in Article 33(3) that are not vaccinated against rabies in accordance with Section 1 of Chapter 1 of Part I of Annex V;
            
         
         
            
               (d)the measures provided for in Article 35 when an animal of a listed species wounded a person or an animal without an understandable reason and in contradiction with its normal behaviour or presented an unexplained change in behaviour followed by death within 10 days.
            
            
               Article 35
               Disease control measures in the event of suspicion of infection with RABV 
            
            
               When infection with RABV is suspected, the competent authority shall:
            
            
               (a)conduct further investigations to confirm or rule out the presence of the disease;
            
            
               (b)order relevant movement restrictions or killing of suspect cases to protect humans and animals against the risk of being infected pending the results of the investigations;
            
            
               (c)order any risk mitigation measures justified to reduce the risk of further transmission of RABV to humans or to animals.
            
            
               Article 36
               Disease control measures in the event of confirmation of infection with RABV 
            
            
               When infection with RABV is confirmed, the competent authority shall take measures to prevent further transmission of the disease to animals and to humans, for which:
            
            
               (a)it shall conduct an epidemiological enquiry, which shall include the identification of the RABV strain involved, to identify the likely source of the infection and epidemiological links;
            
            
               (b)it may, when it considers it necessary, rule out an infection with RABV in epidemiological links after a minimum period of incubation of the disease of 3 months has lapsed since the epidemiological link with the confirmed case occurred, without the onset of clinical signs;
            
            
               (c)it shall, when it considers it necessary, take one or more of the measures laid down in Articles 34 and 35;
            
            
               (d)it shall ensure that carcasses of confirmed cases of infected wild animals are disposed of or processed in accordance with the rules laid down in accordance Article 12 of Regulation (EC) No 1069/2009.
            
            
               Section 4
                  Provisions for bluetongue virus (serotypes 1-24) eradication programmes 
            
            
               Article 37
               Disease control strategy of eradication programmes against infection with bluetongue virus (serotypes 1 to 24) 
            
            
               1.The competent authority shall, when establishing an optional eradication programme against infection with bluetongue virus (serotype 1 to 24) (infection with BTV), base the programme on a disease control strategy that includes: 
            
            
               (a)surveillance of BTV serotypes 1 to 24 in accordance with the requirements set out in Chapter 1 of Part II of Annex V;
            
            
               (b)vaccination of the relevant targeted animal population for eradicating the disease by means of regular vaccination campaigns to be implemented, as relevant, in accordance with a long term strategy;
            
            
               (c)movement restrictions of the targeted animal population in accordance with the requirements laid down in Articles 43 and 45; 
            
            
               (d)risk mitigation measures to minimise transmission of infection with BTV through vectors.
            
            
               2.The competent authority shall implement the eradication programme taking into account that:
            
         
         
            
               (a)it shall detect and eradicate all the serotypes present in the territory covered by the eradication programme;
            
            
               (b)the territory covered by the eradication programme shall be: 
            
            
               (i)the whole territory of the Member State; or 
            
            
               (ii)a zone or zones that include a territory within at least a 150 kilometres radius of each infected establishment.
            
            
               3.By way of derogation from point (b)(ii) of paragraph 2, the competent authority may adapt the zone(s) covered by the eradication programme in accordance with:
            
            
               (a)the geographical situation of the infected establishment(s) and the boundaries of the corresponding administrative units; 
            
            
               (b)the ecological and meteorological conditions;
            
            
               (c)the abundance, activity and distribution of the vectors present in the zone(s);
            
            
               (d)the BTV serotype involved; 
            
            
               (e)the results of the epidemiological enquiry provided for in Article 42;
            
            
               (f)the results of the surveillance activities.
            
            
               Article 38
               Targeted and additional animal populations for eradication programmes against infection with BTV 
            
            
               1.The competent authority shall apply the eradication programme against infection with BTV to the following targeted animal population: kept animals from species of families of Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae and Traguilidae.
            
            
               2.The competent authority shall, when it considers it is necessary apply the eradication programme to the following additional animal population: wild animals from species of families of Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae and Traguilidae.
            
            
               Article 39
               Obligations of operators in the context of eradication programmes against infection with BTV 
            
            
               1.The operators of establishments, other than slaughterhouses, where animals from the targeted animal population referred to in Article 38(1) are kept shall:
            
            
               (a)comply with surveillance requirements ordered by the competent authority as regards animals from the targeted animal population; 
            
            
               (b)comply with surveillance requirements ordered by the competent authority as regards the surveillance of vectors;
            
            
               (c)have their animals from targeted animal population vaccinated following the orders of the competent authority;
            
            
               (d)implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority;
            
         
         
            
               (e)implement any additional measures considered necessary by the competent authority which may include, as relevant, protection of kept animals from attacks by vectors in accordance with the animals’ disease status.
            
            
               2.The operators of slaughterhouses, where animals from the targeted animal population referred to in Article 38(1) are kept and slaughtered, shall:
            
            
               (a)comply with surveillance requirements ordered by the competent authority as regards animals from the targeted animal population; 
            
            
               (b)implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority;
            
            
               (c)implement any additional measures considered necessary by the competent authority which may include, as relevant, protection of kept animals from attacks by vectors in accordance with the animals’ disease status.
            
            
               Article 40
                  Obligations of the competent authority in the context of eradication programme against infection with BTV
            
            
               1.The competent authority shall:
            
            
               (a)map the territory covered in a set of geographical units in accordance with point 1 of Section 4 of Chapter 1 of Part II of Annex V;
            
            
               (b)conduct surveillance of infection with BTV in each geographical unit, as relevant with regard to the epidemiological situation, according to the minimum requirements laid down in Chapter 1 of Part II of Annex V;
            
            
               (c)apply the disease control measures laid down in Articles 41 to 45 in the event of suspicion or confirmation of the disease; and
            
            
               (d)order operators of kept bovine, kept ovine, kept caprine and, if necessary, other targeted animal populations to have their animals vaccinated. 
            
            
               2By way of derogation from point (d) of paragraph 1, the competent authority may decide not to order operators to have their animals vaccinated if following a risk assessment, it duly justifies that the implementation of other measures is sufficient to eradicate the disease.
            
            
               3.The competent authority shall, when it considers it necessary and if possible, establish a seasonally BTV-free area as provided for in Chapter 5 of Part II of Annex V. In that event, the competent authority shall make available to the Commission and to the other Member States:
            
            
               (a)information demonstrating the fulfilment of the specific criteria for determining the seasonally BTV free period;
            
            
               (b)the start and end dates of the period;
            
            
               (c)information demonstrating the delimitation of the area which complies with the minimum requirements laid down in Article 13.
            
            
               Article 41
               Disease control measures in the event of suspicion of infection with BTV 
            
            
               1.In the event of suspicion of infection with BTV, the competent authority shall conduct an investigation in accordance with Article 8(1).
            
            
               2.Pending the outcome of the investigations referred to in paragraph 1, the competent authority shall:
            
            
               (a)restrict movement from the establishment where they are kept of animals and germinal products from the targeted animal population unless authorised for the purpose of immediate slaughter;
            
         
         
            
               (b)order relevant risk mitigation measures, when necessary and technically feasible, to prevent or reduce exposure of animals from the targeted animal population to attacks by vectors.
            
            
               3.The competent authority shall, when it considers it necessary, extend the measures provided for in paragraphs 1 and 2 to establishments where animals from targeted animal population had similar exposure to infectious vectors to that of the suspect cases.
            
            
               4.The measures provided for in this Article may be withdrawn when the competent authority considers that they are no longer necessary to limit the risk of spreading of the disease.
            
            
               Article 42
               Disease control measures in the event of confirmation of infection with BTV 
            
            
               1.In the event of confirmation of infection with BTV, the competent authority shall:
            
            
               (a)proceed with the confirmation of the outbreak in accordance with Article 8(2) and establish or extend the zone under eradication programme as necessary;
            
            
               (b)conduct an epidemiological enquiry;
            
            
               (c)restrict movement of animals of the targeted animal population from the establishment where they are kept unless authorised for the purpose of immediate slaughter; 
            
            
               (d)restrict movement from the establishment where they are kept of germinal products of animals from the targeted animal population;
            
            
               (e)order relevant risk mitigation measures, when necessary and technically feasible, to prevent or reduce exposure of animals from the targeted animal population to attacks by vectors;
            
            
               (f)apply the disease control measures provided for in Article 41 to all establishments having an epidemiological link with the confirmed case, including those keeping animals from the targeted animal population having a similar exposure to infectious vectors to that of the confirmed case.
            
            
               2.In addition to measures laid down in paragraph 1 and in order to prevent the disease from spreading, the competent authority shall, when it considers it necessary:
            
            
               (a)order operators of kept bovine, kept ovine, kept caprine and, if necessary, other targeted animal populations to have their animals vaccinated against the infection with the relevant BTV serotype(s) as provided for in point (d) of Article 40(1);
            
            
               (b)investigate and monitor the disease status of the targeted animal populations in the proximity of the establishment where the confirmed case is kept.
            
            
               3.The measures provided for in this Article may be withdrawn when the competent authority considers that they are no longer necessary to limit the risk of spreading of disease.
            
            
               Article 43
               Movement of kept animals and germinal products from the targeted animal population to Member States or zones covered by eradication programmes against infection with BTV 
            
            
               1.The competent authority shall only authorise the introduction of animals from the targeted animal population in the territory covered by an eradication programme against infection with BTV referred to in point (b) of in Article 37(2) if they comply with at least one of the requirements set out in points 1 to 4 of Section 1 of Chapter 2 of Part II of Annex V.
            
            
               2.By way of derogation from paragraph 1, the competent authority may also allow the introduction of animals from the targeted population in the territory covered by the eradication programme against infection with BTV referred to in point (b) of Article 37(2) if:
            
            
               (a)it has assessed the risk that the introduction poses to its disease status as regards infection with BTV, taking into account possible risk mitigation measures it may adopt at the place of destination; and
            
            
               (b)in addition to any other requirements to move these animals to another Member State, it prohibits the movement of these animals to another Member State: 
            
         
         
            
               (i)for a period of 60 days after the introduction; or
            
            
               (ii)until a negative PCR test for BTV serotypes 1-24 was carried out on samples collected not before 14 days after the introduction; 
            
            
               (c)it adapts as necessary the surveillance in accordance with point 6 of Section 4 of Chapter 1 of Part II of Annex V; and
            
            
               (d)the animals comply with any of the requirements set out in points 5 to 8 of Section 1 of Chapter 2 of Part II of Annex V. 
            
            
               3.The competent authority shall only authorise the introduction of germinal products from the targeted animal population in the territory covered by an eradication programme against infection with BTV referred to in point (b) of Article 37(2) if they comply with at least one of the requirements set out in points 1 to 3 of Section 2 of Chapter 2 of Part II of Annex V.
            
            
               4.By way of derogation from paragraph 3, the competent authority may also authorise the introduction of germinal products from the targeted animal population in the territory covered by an eradication programme against infection with BTV referred to in point (b) of Article 37(2) if:
            
            
               (a)it has assessed the risk that the introduction poses to its disease status as regards infection with BTV, taking into account possible risk mitigation measures it may adopt at the place of destination;
            
            
               (b)it prohibits the movement of these germinal products to another Member State; and 
            
            
               (c)the germinal products comply with the requirement set out in point 4 of Section 2 of Chapter 2 of Part II of Annex V.
            
            
               5.When using the derogations provided for in paragraphs 2 or 4, the competent authority receiving the animals or the germinal products shall:
            
            
               (a)inform the Commission that the derogation is accepted and on the basis of which of the requirement(s) provided for in paragraphs 2 or 4 it is accepted; 
            
            
               (b)accept animals or germinal products from targeted animal population that comply with the requirements on which the derogation is accepted regardless the Member States or zones of origin;
            
            
               (c)inform the Commission as soon as possible of any changes concerning the derogations accepted. 
            
            
               Article 44
                  Vector protected establishment 
            
            
               1.The competent authority may, upon request by the operator, grant the status ‘vector protected establishment’ to establishments or facilities complying with the criteria laid down in Chapter 3 of Part II of Annex V.
            
            
               2.The competent authority shall verify at the appropriate frequency, but at least at the beginning, during and at the end of the required protection period, the effectiveness of the measures carried out by means of a vector trap inside the establishment. 
            
            
               3.The competent authority shall immediately withdraw the status vector protected establishment when the conditions referred to in paragraph 1 are no longer complied with.
            
            
               Article 45
               Movement of animals through Member States or zones covered by eradication programmes against infection with BTV
            
            
               1.The competent authority shall only authorise movement of animals from the targeted animal population through the territory covered by an eradication programme against infection with BTV referred to in point (b) of Article 37(2) if:
            
            
               (a)the animals from the targeted animal population comply with at least one of the requirements set out in points 1 to 3 of Section 1 of Chapter 2 of Part II of Annex V; or
            
         
         
            
               (b)the means of transport onto which the animals are loaded have been protected from attacks by vectors and the journey does not include the unloading of the animals for a period longer than 1 day, or the animals are unloaded for a period longer than 1 day in a vector protected establishment or during the vector-free period. 
            
            
               2.By way of derogation from paragraph 1, the competent authority may also authorise the movement of animals from targeted animal population through the territory covered by an eradication programme against infection with BTV as referred to in point (b) of Article 37(2) if the requirements laid down in points (a), (c) and (d) of Article 43(2) and Article 43(5) are complied with.
            
            
               Chapter 3
                  Eradication programmes against category B and C diseases of aquatic animals
            
            
               Section 1
                  General provisions 
            
            
               Article 46 
                  Disease control strategy for the eradication of category B and C diseases of aquatic animals
            
            
               1.The competent authority shall, when establishing a compulsory eradication programme against a category B disease or an optional eradication programme against a category C disease of aquatic animals, base those programmes on a disease control strategy that includes for each disease: 
            
            
               (a)the type of surveillance requirements necessary to achieve the conditions for granting and maintaining -disease-free status taking into account provisions of Articles 18 to 20 and 24 to 27:
            
            
               (b)the scope of the territory and animal population addressed by the eradication programme as provided for in Articles 47 and 51; 
            
            
               (c)the duration of the eradication programme provided for in Article 49 including its final and intermediate targets as provided for in Article 48;
            
            
               (d)the disease specific preventive and control measures laid down in Articles 55 to 65. 
            
            
               2.The competent authority may include in the eradication programme coordinated measures at its common land or coastal border with other Member States or third countries to ensure the sustainability and achievement of the objective of the programme.
            
            
               Where such coordination has not been established, the competent authority shall include in the eradication programme, if feasible, effective risk mitigation measures including enhanced surveillance, and shall have implemented these measures. 
            
            
               Article 47
               Territorial scope and animal population 
            
            
               1.The competent authority shall determine the scope of the eradication programme including:
            
            
               (a)the territory covered; and 
            
            
               (b)the targeted animal population and, as necessary, additional animal populations. 
            
            
               2.The territory covered by the eradication programme referred to in point (a) of paragraph 1 may be: 
            
            
               (a)the entire territory of the Member State; or
            
            
               (b)one or several zones; or
            
            
               (c)the geographical location of the establishments which comprise the compartment or compartments.
            
         
         
            
               3.All establishments located within the Member State, zone or compartment covered by the eradication programme shall be included in the eradication programme.
            
            
               4.By way of derogation from paragraph 3 of this Article, the competent authority may exclude from the eradication programme, aquaculture establishments which do not pose a significant risk to the success of that programme and which are exempted from the obligation for approval. 
            
            
               Article 48
                  Final and intermediate targets 
            
            
               1.The competent authority shall include in the eradication programme qualitative and quantitative final targets that cover all the disease specific criteria laid down for granting of the disease-free status referred to in Article 72.
            
            
               2.Where this is technically possible, the competent authority implementing an eradication programme shall also include in that programme qualitative and quantitative final targets based on the disease status of wild animal populations that constitute a threat to the achievement of disease-free status.
            
            
               3.The competent authority shall include in the eradication programme qualitative and quantitative intermediate annual or multiannual targets to reflect progress made towards the final targets. These intermediate targets shall include:
            
            
               (a)all of the disease specific criteria referred to in paragraph 1 and the targets provided for in paragraph 2; and
            
            
               (b)if necessary, additional criteria that are not included in the criteria for granting disease-free status to assess progress towards eradication. 
            
            
               Article 49
                  Period of application 
            
            
               1.The period of application of eradication programmes for the listed aquatic diseases are laid down in Part II of Annex VI, specifically, Sections 2 and 3 of:
            
            
               (a)Chapter 1 for VHS and IHN;
            
            
               (b)Chapter 2 for infection with HPR-deleted ISAV;
            
            
               (c)Chapter 3 for infection with Marteilia refringens;
            
            
               (d)Chapter 4 for infection with Bonamia exitiosa;
            
            
               (e)Chapter 5 for infection with Bonamia ostreae;
            
            
               (f)Chapter 6 for infection with WSSV.
            
            
               2.For category C diseases, the period of application of an eradication programme shall not exceed 6 years from the date of its initial approval by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429. In duly justified situations, following an initial approval for 6 years the Commission may, upon request of Member States, approve the eradication programme for an extended 6 years period of application.
            
            
               3.In duly justified situations, the Commission may, upon request of Member States, approve the eradication programme for a further 6 year period.
            
            
               Section 2
                  Requirements for Eradication programmes 
            
            
               Article 50
                  Minimum requirements for an eradication programme 
            
         
         
            
               The competent authority shall base the eradication programme for a specific category B disease or C disease in a Member State, zone, or compartment on: 
            
            
               (a)determination of the disease status of the Member State, zone or compartment by ascertaining the disease status of all establishments where animals from the listed species are kept;
            
            
               (b)the implementation of disease control measures in all establishments where suspect and confirmed cases are detected;
            
            
               (c)the implementation of biosecurity and other risk mitigation measures to reduce the risk of the listed species in an establishment becoming infected;
            
            
               (d)in certain cases, the implementation of vaccination, as a phase of the eradication programme.
            
            
               Article 51
                  Animal population to be included in eradication programmes for category B and C diseases 
            
            
               1.The competent authority shall apply the eradication programme to listed species kept in establishments within the territory of the Member State or within the zone or compartment, to which the eradication programme applies.
            
            
               2.By way of derogation from paragraph 1, the competent authority may decide to exclude from the eradication programme, based on a risk assessment, establishments keeping only vector species referred to in the table set out in the Annex to Implementing Regulation (EU) 2018/1882.
            
            
               3.Where technically feasible, the competent authority shall include in the eradication programme additional animal populations when such animals:
            
            
               (a)pose a significant risk to the disease status of animals referred to in paragraph 1;
            
            
               (b)are included due to the small number of aquaculture establishments in the eradication programme and when their inclusion is necessary to obtain a satisfactory epidemiological coverage of the Member State, zone or compartment. 
            
            
               Article 52
                  Measures to be taken in Member States, zones or compartments covered by eradication programmes 
            
            
               1.In order to monitor the progress of eradication programmes, the competent authority shall classify the disease status of all establishments where animals from the listed species are kept according to:
            
            
               (a)the known disease status of each establishment at the time the eradication programme commences;
            
            
               (b)the compliance with conditions for the introduction of animals from listed species into the establishment;
            
            
               (c)the compliance by the operator with the obligation to notify the competent authority of any suspicion or detection of disease;
            
            
               (d)the fulfilment of disease control measures to be applied if the disease is suspected or confirmed;
            
            
               (e)the vaccination regimes that may apply to animals from listed species kept in the establishment;
            
            
               (f)any additional measures considered necessary by the competent authority.
            
            
               2.The competent authority shall: 
            
         
         
            
               (a)commence, maintain, or withdraw the eradication programme according to the compliance or non-compliance of establishments with the requirements laid down in paragraph 1; 
            
            
               (b)inform the operators of the relevant establishments about the evolution of the disease status and the necessary measures for granting disease-free status.
            
            
               3.Operators shall comply with the requirements set out in points (b) to (f) of paragraph1 so that the eradication programme can be implemented until such time as it has been successfully completed or is withdrawn. 
            
            
               Article 53
                  Derogation from classification of the disease status of confined establishments 
            
            
               By way of derogation from Article 52(1), the competent authority may decide not to classify the disease status of confined establishments, if the animal population kept in these confined establishments is subjected to appropriate risk mitigation measures and disease control measures to ensure that it does not constitute a risk of spreading the disease.
            
            
               Article 54
                  Vaccination 
            
            
               The competent authority may, include in eradication programmes under its official supervision:
            
            
               (a)vaccination of listed species referred to in point (e) of Article 52(1);
            
            
               (b)vaccination of an additional animal population of kept animals;
            
            
               (c)vaccination of an additional animal population of wild animals.
            
            
               Article 55
                  Disease control measures in the event of suspicion of diseases 
            
            
               1.The competent authority shall, when it suspects a case of the relevant disease in an establishment, conduct the necessary investigation.
            
            
               2.Pending the outcome of the investigation referred to in paragraph 1, the competent authority shall:
            
            
               (a)prohibit the introduction of animals or products of animal origin into the establishment;
            
            
               (b)where technically possible, order the isolation of units on the establishment where suspect animals are kept;
            
            
               (c)prohibit the movement of animals and products of animal origin out of the establishment unless authorised by the competent authority for the purpose of immediate slaughter in a disease control aquatic food establishment;
            
            
               (d)prohibit the movement of equipment, feed material of non-animal origin and animal by products from the establishment(s) unless authorised by the competent authority.
            
            
               3.The competent authority shall maintain the measures referred to in paragraphs 1 and 2 until the presence of the disease has been ruled out or confirmed.
            
            
               Article 56
                  Extension of disease control measures in the event of suspicion of disease 
            
            
               1.The competent authority shall, when it considers it necessary, extend the measures laid down in Article 55 to:
            
         
         
            
               (a)any establishment which due to hydrodynamic conditions, has an increased risk of contracting the disease from the suspect establishment; 
            
            
               (b)any establishment which has a direct epidemiological link with the suspect establishment.
            
            
               2.If the presence of the disease is suspected in wild aquatic animals, the competent authority shall, when it considers it necessary, extend to the concerned establishments the measures laid down in Article 55.
            
            
               Article 57
                  Derogation from disease control measures in the event of suspicion of disease 
            
            
               1.By way of derogation from point (c) of Article 55(2), in the event of suspicion of disease, the competent authority may authorise movement of animals and products of animal origin provided that: 
            
            
               (a)they are moved to establishments in which they have no contact with animals of a higher health status with respect to the relevant disease, for a maximum period of time to be determined by the competent authority; and 
            
            
               (b)the establishment to which they are moved is under its official supervision; and
            
            
               (c)they are subsequently sent directly to a disease control aquatic food establishment for immediate slaughter or in the case of molluscs or crustacea which are sold live, for direct human consumption; and 
            
            
               (d)the disease status of aquatic animals at the point of destination or en-route to that destination is not jeopardised by the movement.
            
            
               2.Pending the outcome of the investigation referred to in Article 55(1), the competent authority shall, as relevant, re-classify the health status of the establishment receiving animals and products of animal origin that are subject to the derogation laid down in paragraph 1 in accordance with the criteria laid down in Article 52(1).
            
            
               3.The competent authority may use the derogations provided for in paragraph 1 only if operators of establishments of origin and of destination and transporters of the animals subject to the derogations:
            
            
               (a)apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease;
            
            
               (b)provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures are fulfilled; and
            
            
               (c)provide the competent authority with guarantees that animal by-products as defined in point (1) of Article 3 of Regulation (EC) 1069/2009 from the aquatic animals referred to in paragraph 1(c) of this Article are processed or disposed of as Category 2 material in accordance with Article 13 of that Regulation. 
            
            
               Article 58
               Official confirmation of disease and disease control measures 
            
            
               1.If a case is confirmed in accordance with Article 8, the competent authority shall:
            
            
               (a)declare the establishment(s) infected;
            
            
               (b)reclassify the disease status of the infected establishment(s);
            
            
               (c)establish a restricted zone which is of an appropriate size;
            
            
               (d)adopt the measures laid down in Articles 59 to 65 in the infected establishment.
            
         
         
            
               2.The minimum requirements that shall apply with regard to the establishment of the restricted zone are set out in Part II of Annex VI, specifically in:
            
            
               (a)point 1 of Section 3 of Chapter 1for VHS and IHN;
            
            
               (b)point 1 of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;
            
            
               (c)point 1 of Section 3 of Chapter 3 for infection with Marteilia refringens;
            
            
               (d)point 1 of Section 3 of Chapter 4 for infection with Bonamia exitiosa;
            
            
               (e)point 1 of Section 3 of Chapter 5 for infection with Bonamia ostreae;
            
            
               (f)point 1 of Section 3 of Chapter 6 for infection with WSSV.
            
            
               3.By way of derogation from paragraph 2, the competent authority may decide not to establish a restricted zone: 
            
            
               (a)when an infected establishment does not discharge untreated effluent into surrounding waters; and 
            
            
               (b)where the biosecurity measures which exist at the establishment are of a standard which ensures that infection is fully contained within it. 
            
            
               4.The competent authority may take risk mitigating measures relating to the following activities in the restricted zone:
            
            
               (a)the movement of wellboats through the restricted zone;
            
            
               (b)fishing activities;
            
            
               (c)other activities that may pose a risk of disease spread. 
            
            
               5.If the disease is confirmed in wild aquatic animals, the competent authority may:
            
            
               (a)develop and implement the prevention, surveillance and disease control measures that are necessary to prevent the spread of the disease to kept animals of listed species or to additional animal populations;
            
            
               (b)apply intensified surveillance of wild aquatic animal populations and in establishments having a direct epidemiological link with the confirmed case;
            
            
               (c)apply the disease control measures laid down in Article 55(1) and (2);
            
            
               (c)take measures to eradicate the disease from the relevant wild population, where feasible.
            
            
               Article 59
                  Epidemiological enquiry and disease control measures 
            
         
         
            
               1.When the disease is confirmed, the competent authority shall: 
            
            
               (a)conduct an epidemiological enquiry;
            
            
               (b)conduct investigations in all establishments where a direct epidemiological link with the infected establishment(s) has been demonstrated;
            
            
               (c)apply the disease control measures laid down in Article 55(2) in all establishments where a direct epidemiological link with the infected establishment(s) has been demonstrated; 
            
            
               (d)adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry. 
            
            
               2.The competent authority shall consider the need to conduct an investigation on wild animals where the epidemiological enquiry reveals epidemiological links between kept and wild animals.
            
            
               3.The competent authority shall as soon as possible inform:
            
            
               (a)operators and relevant authorities from the Member State concerned by the epidemiological links with the confirmed case; and
            
            
               (b)the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s).
            
            
               Article 60
               Movements to or from an infected establishment and any other establishment located in the restricted zone 
            
            
               1.The competent authority shall in all infected establishment(s) and any other establishment(s) located in the restricted zone:
            
            
               (a)where technically possible, order the isolation of suspect and confirmed cases;
            
            
               (b)prohibit the movement of animals or products of animal origin from the listed species for the relevant disease out of the establishment(s) unless authorised by the competent authority for immediate slaughter in a disease control aquatic food establishment;
            
            
               (c)prohibit the introduction of animals from the listed species for the relevant disease to the establishment(s) unless authorised by the competent authority on duly justified grounds;
            
            
               (d)prohibit the movement of equipment, feed material of non-animal origin and animal by products from the establishment(s) unless authorised by the competent authority.
            
            
               2.The competent authority shall extend the measures in points (a) to (c) of paragraph 1 to kept animals from additional animal populations if they present a risk of spreading the disease.
            
            
               Article 61
                  Derogation from the restriction of movement of animals and products of animal origin from infected establishments 
            
            
               1.By way of derogation from point (b) Article 60(1), the competent authority may authorise the movement of animals and products of animal origin from listed species for the relevant disease from the infected establishment and from establishments located within the restricted zone to other establishments located within the same restricted zone provided that:
            
            
               (a)only animals showing no symptoms of disease are moved; and
            
            
               (b)they are moved for further farming, for a maximum period of time to be determined by the competent authority, to an establishment in which they have no contact with animals of listed species with a higher health status with respect to the relevant disease; and
            
         
         
            
               (c)the establishment referred to in point (b) has been authorised for that purpose by the competent authority, its disease status has been reclassified where necessary and it is under its official supervision until the completion of cleaning and disinfection, following the departure of the animals and where relevant, appropriate fallowing of the establishment; and
            
            
               (d)if the animals are not slaughtered or prepared for human consumption at the infected establishment itself, they are subsequently sent directly to a disease control aquatic food establishment for immediate slaughter or for preparation for human consumption in the case of molluscs or crustacea which are sold live for that purpose. In all cases, animal by- products as referred to in Regulation (EC) 1069/2009 shall be processed or disposed of as Category 2 material in accordance with Article 13 of that Regulation; 
            
            
               2.By way of derogation from point (b) Article 60(1), the competent authority may authorise movements of animals and products of animal origin from listed species for the relevant disease from the infected establishment and from establishments located within the restricted zone for further farming in other infected establishments which are not implementing an eradication programme for that specific disease provided that:
            
            
               (a)only animals showing no symptoms of disease are moved; and
            
            
               (b)the movement does not jeopardise the disease status of aquatic animals at the place of destination or en-route to that destination; and
            
            
               (c)the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. 
            
            
               3.By way of derogation from point (b) Article 60(1), the competent authority may authorise movements of animals and products of animal origin from listed species for the relevant disease from the infected establishment and from establishments located within the restricted zone to slaughtering and processing facilities other than disease control aquatic food establishments provided that:
            
            
               (a)only animals showing no symptoms of disease are moved; and
            
            
               (b)the slaughtering and processing facility is not located in a Member State, zone or compartment which is implementing an eradication programme for that specific disease or which has been declared disease-free; and
            
            
               (c)the movement does not jeopardise the disease status of aquatic animals en-route to the slaughtering and processing facility or in its vicinity; and
            
            
               (d)the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. 
            
            
               4.By way of derogation from point (b) of Article 60(1), the competent authority may authorise the movement of animals and products of animal origin from additional animal populations from the infected establishment(s) to other establishments without further restrictions provided:
            
            
               (a)a risk assessment has been completed; 
            
            
               (b)risk mitigation measures are implemented, where necessary, to ensure that the disease status of the animals at the point of destination or en-route to that destination is not jeopardised; and
            
            
               (c)the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. 
            
            
               Article 62
                  Removal of infected animals 
            
            
               1.Following confirmation of the disease, the competent authority shall in all infected establishments, order within a maximum period of time to be determined by the competent authority, the completion of the following steps in relation to aquatic animals of listed species for the relevant disease:
            
            
               (a)removal of all dead animals;
            
            
               (b)removal and killing of all moribund animals; 
            
            
               (c)removal and killing of all animals showing symptoms of disease;
            
         
         
            
               (d)slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of the animals that remain at the establishment(s) after the measures in points (a) to (c) have been completed. 
            
            
               2.The competent authority may order, based on duly justified grounds, the slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of:
            
            
               (a)all animals from listed species for the relevant disease in the infected establishment(s), without testing these animals;
            
            
               (b)suspect animals which have an epidemiological link with a confirmed case.
            
            
               3.Slaughtering for human consumption or removal from the water of the animals referred to in paragraphs 1 shall be carried out under official supervision either in the infected establishment(s) with subsequent processing in a disease control aquatic food establishment, or in a disease control aquatic food establishment, as appropriate.
            
            
               4.The competent authority shall extend the measures laid down in this Article to aquaculture animals of additional animal populations when it is necessary to control the disease.
            
            
               5.The competent authority may order the killing and destruction of some or all the animals referred to in paragraph 1 and of non-listed species in the establishment(s) instead of their slaughter for human consumption. 
            
            
               6.All animal by-products from animals that are slaughtered or killed in compliance with this Article shall be processed or disposed of as Category 2 material in accordance with Article 13 of Regulation (EC) No 1069/2009.
            
            
               Article 63
                  Cleaning and disinfection 
            
            
               1.The competent authority shall for all infected establishments order the cleaning and disinfection of the following structures and items prior to restocking:
            
            
               (a)the establishments, in so far as this is technically possible, after the removal of the animals referred to in Article 62(1) and of all feedstuffs that may have been exposed to contamination;
            
            
               (b)any husbandry related equipment including but not limited to feeding, grading, treatment and vaccination equipment, and workboats;
            
            
               (c)any production related equipment including but not limited to cages, netting, trestles, bags and long-lines;
            
            
               (d)any protective clothing or safety equipment used by operators and visitors;
            
            
               (e)all means of transport including tanks and other equipment used to move infected animals or personnel who have been in contact with infected animals.
            
            
               2.The competent authority shall approve the protocol for the cleaning and disinfection. 
            
            
               3.The competent authority shall supervise the cleaning and disinfection and shall not restore or grant again disease-free status to the establishments until it considers that the cleaning and disinfection has been completed.
            
            
               Article 64
                  Fallowing
            
            
               1.The competent authority shall order the fallowing of all infected establishments. The fallowing shall be carried out following completion of the cleaning and disinfection process laid down in Article 63.
            
            
               2.The duration of the fallowing shall be appropriate to the relevant pathogen and to the type of production system used in the infected establishments. Certain fallowing periods are laid down in Part II of Annex VI, specifically in:
            
         
         
            
               (a)point 1 of Section 3 of Chapter 1 for VHS and IHN;
            
            
               (b)point 1 of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;
            
            
               (c)point 1 of Section 3 of Chapter 3 for infection with Marteilia refringens;
            
            
               (d)point 1 of Section 3 of Chapter 4 for infection with Bonamia exitiosa;
            
            
               (e)point 1 of Section 3 of Chapter 5 for infection with Bonamia ostreae;
            
            
               (f)point 1 of Section 3 of Chapter 6 for infection with WSSV.
            
            
               3.The competent authority shall order synchronous fallowing of the infected establishments within the protection zone or where no protection zone has been established, within the restricted zone. Synchronous fallowing may also be extended to other establishments based on risk assessment. The duration of the synchronous fallowing and the extent of the area within which such fallowing shall take place are laid down in Part II of Annex VI, specifically in: 
            
            
               (a)point 1 of Section 3 of Chapter 1for VHS and IHN;
            
            
               (b)point 1 of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;
            
            
               (c)point 1 of Section 3 of Chapter 3 for infection with Marteilia refringens;
            
            
               (d)point 1 of Section 3 of Chapter 4 for infection with Bonamia exitiosa;
            
            
               (e)point 1 of Section 3 of Chapter 5 for infection with Bonamia ostreae;
            
            
               (f)point 1 of Section 3 of Chapter 6 for infection with WSSV.
            
            
               Article 65
                  Risk mitigation measures to prevent reinfection 
            
            
               Before or upon removal of the disease control measures, the competent authority shall order proportionate risk mitigation measures to prevent the reinfection of the establishment taking into account relevant risk factors as indicated by the results of the epidemiological enquiry. These measures shall at least take account of:
            
            
               (a)persistence of the disease agent in the environment or in wild animals;
            
            
               (b)biosecurity measures that are adapted to the specificities of the establishment.
            
            
               Chapter 4
                  Disease-free status
            
            
               Section 1 
                  Approval of disease-free status of member states and zones
            
            
               Article 66
                  Criteria for the granting of disease-free status 
            
         
         
            
               The Commission may only grant the disease-free status for a category B disease or a category C disease to a Member State or to a zone thereof if the following general and specific requirements are complied with: 
            
            
               (a)general criteria:
            
            
               (i)the territorial scope complies with the requirements laid down in Article 13 and Article 47;
            
            
               (ii)the surveillance for the disease complies with requirements laid down in Articles 3 to 9;
            
            
               (iii)the obligations of the operators as regards biosecurity measures as laid down in Article 10 of Regulation (EU) 2016/429;
            
            
               (iv)the disease control measures relevant for the disease in the event of a suspicion or confirmation of the disease comply with the requirements laid down for: 
            
            
               –infection with Brucella abortus, B. melitensis and B. suis, infection with MTBC, EBL, IBR/IPV, infection with ADV and BVD in Articles 21 to 31;
            
            
               –infection with RABV in Articles 35 and 36;
            
            
               –infection with BTV in Articles 41 to 45;
            
            
               –Viral haemorrhagic septicaemia (VHS), Infectious haematopoietic necrosis (IHN), infection with HPR-deleted infectious salmon anaemia virus, infection with Marteilia refringens, infection with Bonamia exitiosa, infection with Bonamia ostreae and infection with white spot syndrome virus (WSSV) in Articles 55 to 66;
            
            
               (v)the establishments were registered or approved, as relevant for the type of establishment; 
            
            
               (vi)identification of animals of the targeted animal population and traceability of germinal products were ensured, when appropriate;
            
            
               (vii)when moved, the animals from targeted animal population or products thereof complied with the animal health requirements for the movement within the Union and entry into the Union of those animals and products thereof;
            
            
               (b)specific criteria disease-free based on the provisions of Article 67, Article 68, Article 69, Article 70 or Article 71.
            
            
               Article 67
               Disease-free status based on the absence of listed species 
            
            
               1.The criteria to recognise the disease-free status of a Member State or of a zone because of the absence of the listed species for that disease are as follows:
            
            
               (a)the general criteria laid down in point (a)(i) and (a)(ii) of Article 66 have been fulfilled for at least the past five years before the eligibility period started; and
            
            
               (b)the listed species relevant for the disease in question are absent from kept and wild animal populations.
            
            
               2.The Member State shall provide documentary evidence to substantiate the fulfilment of the criteria in paragraph 1. The documentary evidence shall demonstrate the sustainability of disease-free status considering that:
            
            
               (a)the likelihood of the presence of animals from listed species in the Member State's territory or a zone thereof was assessed and was found to be negligible; and
            
         
         
            
               (b)the likelihood of introduction of animals from listed species into the Member State's territory or a zone thereof was found to be negligible.
            
            
               Article 68
               Disease-free status based on incapacity of the disease agent to survive 
            
            
               1.The criteria to recognise the disease-free status of a Member State or of a zone because of the incapacity of the disease agent to survive are as follows:
            
            
               (a)the general criteria laid down in points (a)(i) and (a)(ii) of Article 66 have been fulfilled for at least the five past years before the eligibility period started;
            
            
               (b)the disease has never been reported or, if reported, it has been demonstrated that the disease agent did not survive;
            
            
               (c)the value of at least one critical environmental parameter that is not compatible with the survival of the disease agent is reached; 
            
            
               (d)the disease agent is exposed to that critical environmental parameter for a period of time that is sufficient to destroy it.
            
            
               2.The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:
            
            
               (a)with respect to the fulfilment of the criteria set out in points (a) and (b), documentary evidence;
            
            
               (b)with respect to the fulfilment of the criteria set out in points (c) and (d), scientific evidence. 
            
            
               Article 69
               Disease-free status of terrestrial animals based on incapacity of listed vectors for listed diseases of terrestrial animals to survive 
            
            
               1.The criteria to recognise the disease-free status of a zone or the entire territory of a Member State because of the incapacity of listed vectors for that listed disease to survive are as follows:
            
            
               (a)the general criteria laid down in points (a)(i) and (a)(ii) of Article 66 have been fulfilled for at least the past five years before the eligibility period started;
            
            
               (b)the disease has never been reported, or, if reported, it has been demonstrated that the disease agent has not been transmitted;
            
            
               (c)the transmission of the disease agent is entirely dependent on the presence of listed vectors and no other mode of natural transmission is known to occur;
            
            
               (d)the listed vectors listed are not naturally present in the zone;
            
            
               (e)the accidental or intentional introduction of listed vectors is unlikely to have occurred in the past or to occur in the future;
            
            
               (f)the value of at least one critical environmental parameter that is not compatible with the survival of the listed vector is reached; 
            
            
               (g)the listed vector is exposed to that critical environmental parameter for a period of time that is sufficient to destroy it.
            
            
               2.The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1: 
            
         
         
            
               (a)with respect to the fulfilment of the criteria set out in points (a) and (b), documentary evidence;
            
            
               (b)with respect to the fulfilment of the criteria set out in points (c) to (g), scientific evidence.
            
            
               If the disease has occurred, the Member state shall provide evidence that surveillance has demonstrated with a 95% level of confidence that the prevalence rate of the disease was lower than 1%.
            
            
               Article 70
               Disease-free status based on historical and surveillance data 
            
            
               1.The criteria to recognise the disease-free status of a zone or the entire territory of a Member State based on historical and surveillance data are as follows:
            
            
               (a)the disease has never been reported in the Member State or in the zone thereof or it has been eradicated in the Member State or the zone thereof and not reported for at least the past 25 years before the eligibility period started;
            
            
               (b)the disease has been reported in the past 25 years before the eligibility period started and the disease has been eradicated from the Member State or zone thereof and the disease specific requirements referred to in Article 72 are complied with. 
            
            
               2.A Member State wishing to obtain the approval of disease-free status for its entire territory or for a zone thereof following the provisions set out in point (a) of paragraph 1 shall have implemented for at least the past 10 years before the eligibility period started the following measures: 
            
            
               (a)disease surveillance in listed species;
            
            
               (b)prevention to control the introduction of the disease agent; 
            
            
               (c)ban on vaccination against the disease unless it is compliant with the disease specific requirements referred to in Article 72;
            
            
               (d)disease surveillance substantiating the fact that the disease is not known to be established in wild animals of listed species within the Member State or zone. 
            
            
               3.By way of derogation from point (b) of paragraph 1 the Commission may, for a period of two years following the entry of application of this Regulation, grant disease-free status to Member States or zones as regards:
            
            
               (a)infection with RABV, if it was notifiable in accordance with Article 8 of Directive 64/432/EEC and, when necessary monitoring was implemented in accordance with Article 4 of Directive (EC) 2003/99, and no case was reported in listed animals species for the past two years;
            
            
               (b)infection with BTV, if restricted zones have been lifted in accordance with Article 6 of Regulation (EC) 1266/2007 before the date of application of this Regulation.
            
            
               4.The criteria provided for in paragraphs 1, 2 and 3 to obtain disease-free status shall only apply for a maximum period of two years following:
            
            
               (a)the accession of a new Member State to the Union; or
            
            
               (b)the date of application of the implementing acts adopted supplementing Article 9(2) of Regulation (EU) 2016/429 that categorise for the first time the relevant disease as a category B or C disease. 
            
            
               5.By way of derogation from paragraph 4, the granting of disease-free status based on historical and surveillance data shall not be subject to a time limit for the following statuses:
            
            
               (a)infestation with Varroa spp. disease-free status;
            
         
         
            
               (b)infection with Newcastle disease virus-free status without vaccination; 
            
            
               6.By way of derogation from point (b) of paragraph 4, the granting of the disease-free status based on historical and surveillance data following the date of application implementing acts adopted supplementing Article 9(2) of Regulation (EU) 2016/429 that categorise for the first time the relevant disease as a category B or C disease shall not apply to the following diseases: 
            
            
               (a)Infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (b)Infection with MTBC;
            
            
               (c)EBL;
            
            
               (d)IBR/IPV;
            
            
               (e)Infection with ADV;
            
            
               (f)VHS;
            
            
               (g)IHN;
            
            
               (h)Infection with HPR-deleted ISAV; 
            
            
               (i)Infection with Bonamia ostreae;
            
            
               (j)Infection with Marteilia refringens.
            
            
               Article 71
               Disease free status based on eradication programmes 
            
            
               1.The criteria to recognise the disease-free status of a Member State or a zone based on a eradication programme are as follows:
            
            
               (a)the competent authority has been running an approved eradication programme as referred in Articles 12 or 46; and
            
            
               (b)the competent authority has completed the eradication programme and submitted to the Commission the final report that demonstrates that the disease specific requirements laid down in Article 72 are complied with.
            
            
               (2)By way of derogation from paragraph 1, in the case of aquatic animals where a zone covers less than 75% of the territory of a Member State and is not shared with another Member State or third country, disease-free status may be achieved in accordance with Article 83.
            
            
               Article 72
                  Disease specific requirements
            
            
               Disease specific requirements for the granting of disease-free status to a Member State or to a zone are provided in:
            
            
               (a)Section 1 of Chapter 3 of Part I of Annex IV for free status from infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals and Section 1 of Chapter 4 of Part I of Annex IV for free status from infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals;
            
         
         
            
               (b)Section 1 of Chapter 2 of Part II of Annex IV for free status from infection with MTBC;
            
            
               (c)Section 1 of Chapter 2 of Part III of Annex IV for free status from EBL;
            
            
               (d)Section 1 of Chapter 2 of Part IV of Annex IV for free status from IBR/IPV;
            
            
               (e)Section 1 of Chapter 2 of Part V of Annex IV for free status from infection with ADV;
            
            
               (f)Section 1 of Chapter 2 of Part VI of Annex IV for free status from BVD;
            
            
               (g)Section 1 of Chapter 2 of Part I of Annex V for free status from infection with RABV;
            
            
               (h)Section 1 of Chapter 4 of Part II of Annex V for free status from infection with BTV;
            
            
               (i)Section 1 of Part III of Annex V for free status from Infestation with Varroa spp;
            
            
               (j)Section 1 of part IV of Annex V for infection with Newcastle disease virus-free status without vaccination;
            
            
               (k)Section 2 of Chapter 1 of Part II of Annex VI for free status from VHS;
            
            
               (l)Section 2 of Chapter 1 of Part II of Annex VI for free status from IHN;
            
            
               (m)Section 2 of Chapter 2 of Part II of Annex VI for free status from infection with HPR-deleted ISAV;
            
            
               (n)Section 2 of Chapter 3 of Part II of Annex VI for free status from infection with Marteilia refringens;
            
            
               (o)Section 2 of Chapter 4 of Part II of Annex VI for free status from infection with Bonamia exitiosa;
            
            
               (p)Section 2 of Chapter 5 of Part II of Annex VI for free status from infection with Bonamia ostreae;
            
            
               (q)Section 2 of Chapter 6 of Part II of Annex VI for free status from infection with WSSV.
            
            
               Section 2
                  Approval of disease-free status for compartments keeping aquaculture animals
            
            
               Article 73
               Criteria for the granting of disease-free status for compartments keeping aquaculture animals 
            
            
               1.The Commission may only grant the disease-free status for a category B disease or a category C disease to a compartment if the following general and specific requirements are complied with: 
            
            
               (a)general criteria:
            
         
         
            
               (i)the geographical scope of the compartment and the disease for which recognition of freedom is sought complies with paragraph 2(c) of Article 47;
            
            
               (ii)the surveillance for the disease complies with requirements laid down in Articles 3 to 9;
            
            
               (iii)the obligations of the operators as regards biosecurity measures as laid down in Article 10 of Regulation (EU) 2016/429;
            
            
               (iv)the disease control measures relevant for the disease in the event of a suspicion or confirmation of the disease comply with the requirements laid down in Articles 55 to 65;
            
            
               (v)the establishments which comprise the compartment are approved;
            
            
               (vi)traceability of the animals of the targeted animal population was ensured;
            
            
               (vii)when moved, the animals from targeted animal population or products thereof complied with the animal health requirements for movement within the Union or for entry into the Union of those animals and products thereof;
            
            
               (b)specific criteria disease-free based on the provisions of Article 74, Article 75, Article 76 or Article 77. 
            
            
               2.The disease-free status referred to in paragraph 1 may be granted to: 
            
            
               (a)compartments which are independent of the disease status of the surrounding natural waters; and
            
            
               (b)compartments which are dependent on the disease status of the surrounding natural waters but where conditions exist which create an effective disease specific separation between the compartment and other aquatic populations which may be infected. 
            
            
               3.In the case of the dependent compartments referred to in point (b) of paragraph 2, the competent authority shall: 
            
            
               (a)assess at least the following epidemiological factors:
            
            
               (i)geographical location of each establishment in the compartment and the nature of the water supply;
            
            
               (ii)disease status of other aquaculture establishments on the water system;
            
            
               (iii)the location of the establishments referred to in point (ii) and their distance from the dependent compartment; 
            
            
               (iv)production volume of the establishments referred to in point (ii) as well as their method of production and the source of their animals;
            
            
               (v)presence and abundance of wild aquatic animals of relevant listed species in the water system and their disease status; 
            
            
               (vi)details of whether the species referred to in point (v) are sedentary or migratory; 
            
            
               (vii)possibility of the wild aquatic animals referred to in point (v) entering the compartment;
            
         
         
            
               (viii)general biosecurity measures in the compartment;
            
            
               (ix)general hydrological conditions in the water body;
            
            
               (b)classify all establishments in the compartment as high risk, in compliance with Chapter III of Part I of Annex VI;
            
            
               (c)impose whatever measures are found to be necessary to prevent the introduction of disease.
            
            
               Article 74
               Disease-free status based on the absence of listed species 
            
            
               1.The criteria to recognise the disease-free status of a compartment keeping aquaculture animals because of the absence of the listed species for that disease are as follows:
            
            
               (a)the general criteria laid down in point (a)(i) and (a)(ii) of paragraph 1 of Article 73 have been fulfilled for at least the past five years before the eligibility period started and;
            
            
               (b)the listed species relevant for the disease in question are absent from kept and wild animal populations.
            
            
               2.The Member State shall provide documentary evidence to substantiate the fulfilment of the criteria in paragraph 1. The documentary evidence shall demonstrate the sustainability of the disease-free status considering that:
            
            
               (a)the likelihood of the presence of animals from listed species in the compartment was assessed and found to be negligible; and
            
            
               (b)the likelihood of introduction of animals from listed species into the compartment was found to be negligible.
            
            
               Article 75
               Disease-free status based on incapacity of the disease agent to survive 
            
            
               1.The criteria to recognise the disease-free status of a compartment because of the incapacity of the disease agent to survive are as follows:
            
            
               (a)the general criteria laid down in point (a)(i) and (a)(ii) of Article 73 have been fulfilled for at least five past years before the eligibility period started;
            
            
               (b)the disease has never been reported or if reported, it has been demonstrated that the disease agent did not survive;
            
            
               (c)the value of at least one critical environmental parameter that is not compatible with the survival of the disease agent is reached;
            
            
               (d)the disease agent is exposed to that critical parameter during a sufficient period of time to destroy it.
            
            
               2.The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:
            
            
               (a)with respect to the fulfilment of the criteria set out in point 1(a) and (b), documentary evidence; 
            
            
               (b)with respect to the fulfilment of the criteria set out in point 1(c) and (d), scientific evidence. 
            
         
         
            
               Article 76
               Disease-free status based on historical and surveillance data 
            
            
               1.The criteria to recognise the disease-free status of a compartment based on historical and surveillance data are as follows:
            
            
               (a)the disease has never been reported in the compartment or it has been eradicated in the compartment and not reported for at least the past 25 years before the eligibility period started; 
            
            
               (b)the disease has been reported in the past 25 years before eligibility period started and the disease has been eradicated form the compartment and disease specific requirements referred to in Article 78 are complied with. 
            
            
               2.A Member State wishing to obtain the approval of disease-free status for the compartment following the provisions set out in point (a) of paragraph 1 shall have implemented for at least the past 10 years before the eligibility period started the following measures: 
            
            
               (a)disease surveillance in listed species;
            
            
               (b)prevention to control the introduction of the disease agent; 
            
            
               (c)ban on vaccination against the disease t unless it is compliant with the disease specific requirements referred to in Article 78;
            
            
               (d)disease surveillance substantiating the fact that the disease is not known to be established in wild animals of listed species within the compartment. 
            
            
               3.The criteria provided for in paragraph 1 and 2 to obtain disease-free status for the category B and C diseases shall only apply for a maximum period of two years following:
            
            
               (a)the accession of a new Member State to the Union; or
            
            
               (b)the date of application of the implementing acts adopted supplementing Article 9(2) of Regulation (EU) 2016/429 that categorise for the first time the relevant disease as a category B or C disease. 
            
            
               4.By way of derogation from point (b) of paragraph 3, the granting of the disease-free status based on historical and surveillance data following the date of application of the rules that categorise for the first time the relevant disease as a category B or C disease shall not apply to the following diseases: 
            
            
               (a)VHS;
            
            
               (b)IHN;
            
            
               (c)infection with HPR-deleted ISAV;
            
            
               (d)infection with Bonamia ostreae;
            
            
               (e)infection with Marteilia refringens.
            
            
               Article 77
               Disease-free status based on eradication programme 
            
            
               1.The criteria to recognise the disease-free status of a compartment keeping aquaculture animals based on eradication programmes are:
            
         
         
            
               (a)the competent authority has been running an approved eradication programme as referred to in Article 46; and
            
            
               (b)the competent authority has completed the eradication programme and submitted to the Commission the final report that demonstrates that the disease specific criteria laid down in Article 78 are complied with.
            
            
               2.By way of derogation from paragraph 1, where a compartment covers less than 75% of the territory of a Member State and is not shared with another Member State or third country, disease-free status may be achieved in accordance with Article 83.
            
            
               Article 78
                  Disease specific requirements for disease-free status 
            
            
               Disease-specific requirements for the granting of disease-free status to a compartment keeping aquaculture animals are provided in:
            
            
               (a)Section 2 of Chapter 1 of Part II of Annex VI for free status from VHS;
            
            
               (b)Section 2 of Chapter 1 of Part II of Annex VI for free status IHN;
            
            
               (c)Section 2 of Chapter 2 of Part II of Annex VI for free status from infection with HPR-deleted ISAV;
            
            
               (d)Section 2 of Chapter 3 of Part II of Annex VI for free status from infection with Marteilia refringens;
            
            
               (e)Section 2 of Chapter 4 of Part II of Annex VI for free status from infection with Bonamia exitiosa;
            
            
               (f)Section 2 of Chapter 5 of Part II of Annex VI for free status from infection with Bonamia ostreae;
            
            
               (g)Section 2 of Chapter 6 of Part II of Annex VI for free status from infection with WSSV.
            
            
               Article 79
               Specific requirements for compartments which are independent of the disease status of the surrounding natural waters 
            
            
               1.In addition to the general criteria for granting disease-free status to compartments keeping aquaculture animals as set out in Article 73(1), a compartment which comprises one or more individual establishments where the disease status regarding a specific disease is independent of the disease status of the surrounding waters as set out in paragraph 2, may obtain disease freedom if it complies with paragraphs 3 to 6.
            
            
               2.An independent compartment may comprise:
            
            
               (a)an individual establishment which may be considered a single epidemiological unit, as it is not influenced by the animal disease status of the surrounding waters; or
            
            
               (b)more than one establishment where each establishment in the compartment complies with the criteria laid down in point (a) of this paragraph and paragraphs 3 to 6 of this Article but, due to extensive movements of animals between establishments, shall be considered as a single epidemiological unit, provided that all establishments operate a common biosecurity system.
            
            
               3.An independent compartment shall be supplied with water:
            
            
               (a)Through a water treatment plant which inactivates the relevant disease agent; or
            
            
               (b)Directly from a well, a borehole or a spring. Where such water supply originates from a source outside the establishment, the water shall be supplied directly to the farm, and be channelled to the establishment by means which afford appropriate protection from infection.
            
         
         
            
               4.There shall be natural or artificial barriers that prevent aquatic animals from entering each establishment in the compartment from the surrounding natural waters.
            
            
               5.The compartment shall, where appropriate, be protected against flooding and infiltration of water from the surrounding natural waters..
            
            
               6.The compartment shall comply with disease-specific requirements referred to in Article 78.
            
            
               Article 80
               Special provisions for compartments which comprise individual establishments which commence or recommence aquaculture activities and where the disease status regarding a specific disease is independent of the disease status of the surrounding waters
            
            
               1.A new establishment which is to commence aquaculture activities is considered to be disease-free when: 
            
            
               (a)it complies with point (a) of paragraph 2 and paragraphs 3 to 6 of Article 79; and
            
            
               (b)it commences aquaculture activities with aquaculture animals from a disease-free Member State, zone or compartment. 
            
            
               2.An establishment which recommences aquaculture activities after a break and complies with paragraph 1 is considered to be disease-free without the surveillance referred to in paragraph 1 (b)(ii) of Article 73 provided:
            
            
               (a)the health history of the establishment is known to the competent authority and there has been no detection of a category B or relevant category C disease in the establishment;
            
            
               (b)the establishment is cleaned, disinfected and fallowed, if necessary, prior to re-stocking.
            
            
               3.By way of derogation from point (a) of paragraph 2, an establishment which recommences its activities after confirmation of the presence of a category B or relevant category C disease is considered to be disease-free, provided:
            
            
               (a)a representative sample of the animals which have been re-stocked into the establishment from a disease--free Member State, zone or compartment following cleaning, disinfection and fallowing is tested no sooner than 3 months and no later than 12 months after they have been exposed to conditions including water temperature, which are conducive to clinical expression of the relevant disease; 
            
            
               (b)the sampling and diagnostic tests set out in the relevant Chapter of Part II (A) of Annex VI are used and samples are taken from the number of animals that will ensure the detection of the relevant disease with a 95 % confidence if the design prevalence is 2 %; 
            
            
               (c)results of the testing described in point (b) are negative before disease-free status is declared.
            
            
               Section 3
                  Maintenance of disease-free status
            
            
               Article 81
                  Specific criteria on surveillance and biosecurity measures for the maintenance of disease-free status 
            
            
               1.The Member States, zones or compartments thereof may maintain disease-free status only if, in addition to the criteria laid down in points (a) and (c) of Article 41(1) of Regulation (EU) 2016/429, they comply with:
            
            
               (a)the undertaking of sufficient surveillance activities to enable the early detection of the disease and the demonstration of disease-free status;
            
            
               (b)the biosecurity measures ordered by the competent authority based on the risks identified to prevent the introduction of the disease due to the introduction of kept animals of the same species as the targeted animal population and the contamination by other animal species;
            
            
               (c)the operational rules as referred to in points (a)(v), a(vi) and a(vii) of Article 66. 
            
         
         
            
               2.In the case of aquatic animals, when a Member State is declared free from one or more of the listed diseases, it may discontinue targeted surveillance as referred to in points (k) to (q) of paragraph 3 and maintain its disease-free status provided that the risk of introduction of the relevant disease has been assessed and conditions conducive to clinical expression of the disease in question exist. 
            
            
               This paragraph shall not apply to disease--free zones or compartments in Member States which are not declared disease-free, or in cases where conditions are not conducive to clinical expression of the disease in question. In these cases, targeted surveillance shall be continued as referred to set out in points (k) to (q) of paragraph 3. 
            
            
               3.The disease specific requirements as regards surveillance and biosecurity measures are provided in:
            
            
               (a)Section 2 of Chapter 3 of Part I of Annex IV for free status from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals or Section 2 of Chapter 4 of Part I of Annex IV for free status from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals;
            
            
               (b)Section 2 of Chapter 2 of Part II of Annex IV for free status from infection with MTBC;
            
            
               (c)Section 2 of Chapter 2 of Part III of Annex IV for free status from infection with EBL;
            
            
               (d)Section 2 of Chapter 2 of Part IV of Annex IV for free status from infection with IBR/IPV ;
            
            
               (e)Section 2 of Chapter 2 of Part V of Annex IV for free status from infection with ADV;
            
            
               (f)Section 2 of Chapter 2 of Part VI of Annex IV for free status from infection with BVD ;
            
            
               (g)Section 2 of Chapter 2 of Part I of Annex V for free status from infection with RABV;
            
            
               (h)Section 2 of Chapter 4 of Part II of Annex V for free status from infection with BTV;
            
            
               (i)Section 2 of Part III of Annex V for free status from infestation with Varroa spp 
            
            
               (j)Section 2 of Part IV of Annex V for infection with Newcastle disease virus-free status without vaccination;
            
            
               (k)Section 4 of Chapter 1 of Part II of Annex VI for free status from VHS;
            
            
               (l)Section 4 of Chapter 1 of Part II of Annex VI for free status from IHN;
            
            
               (m)Section 4 of Chapter 2 of Part II of Annex VI for free status from infection with HPR-deleted ISAV;
            
            
               (n)Section 4 of Chapter 3 of Part II of Annex VI for free status from infection with Marteilia refringens;
            
            
               (o)Section 4 of Chapter 4 of Part II of Annex VI for free status from infection with Bonamia exitiosa;
            
            
               (p)Section 4 of Chapter 5 of Part II of Annex VI for free status from infection with Bonamia ostreae;
            
            
               (q)Section 4 of Chapter 6 of Part II of Annex VI for free status from infection with WSSV.
            
         
         
            
               Section 4
                  Suspension, withdrawal and restoration of disease-free status
            
            
               Article 82
                  Suspension, withdrawal and restoration of disease-free status 
            
            
               1.If the disease has been confirmed and therefore the conditions for maintaining the disease-free status of a Member State, a zone or compartment thereof are not fulfilled, the competent authority shall:
            
            
               (a)apply without delay the relevant disease control measures as provided for:
            
            
               (i)infection with Brucella abortus, B. melitensis and B. suis, infection with MTBC, EBL, IBR/IPV, infection with ADV and BVD in Articles 24 to 31; 
            
            
               (ii)infection with RABV in Article 36; 
            
            
               (iii)infection with BTV in Article 42;
            
            
               (iv)infestation with Varroa spp Articles 80 and 82 of Regulation (EU) 2016/429 where relevant; and
            
            
               (v)VHS, IHN, infection with HPR-deleted ISAV, infection with Marteilia refringens, infection with Bonamia exitiosa, infection with Bonamia ostreae and infection with WSSV in Articles 59 to 65.
            
            
               (b)conduct specific surveillance to assess the extent of the outbreak;
            
            
               (c)order any necessary risk mitigation measures.
            
            
               2.If the disease has not been confirmed, but there has been a breach in one of the conditions for maintaining the disease-free status of a Member State, a zone or compartment thereof, the competent authority shall take the appropriate corrective measures and assess the risk that the health situation has changed.
            
            
               3.The competent authority may where necessary, as a transitional measure, suspend the disease-free status of the Member State, a zone or a compartment thereof rather than the Commission withdrawing the disease-free status. During that suspension, the competent authority shall: 
            
            
               (a)adopt all necessary prevention, surveillance and control measures to manage the situation; and
            
            
               (b)inform without delay the Commission and the other Member State about the measures adopted; and
            
            
               (c)inform regularly the Commission and the other Member State about the evolution of the situation, of its position as regards the restoration or withdrawal of the suspended disease-free status, or the prolongation of the suspension for a new period time and the territory concerned. 
            
            
               4.Following the suspension of the disease-free status and subject to the compliance with the provisions of paragraph 3 the competent authority may restore the disease-free status of the territory concerned.
            
            
               Section 5
                  Derogations for approval by the Commission
            
            
               Article 83
               Derogations from approval by the Commission
            
            
               1.By way of derogation from the requirement to obtain approval by the Commission for disease -free status for aquatic animal diseases of zones and compartments, such approval for zones or compartments which cover less than 75% of the territory of a Member State, and which are not shared with another Member State or third country, may be gained in accordance with the following procedure:
            
         
         
            
               (a)a Member State makes a provisional declaration of freedom for the zone or compartment which fulfils the requirements for disease freedom as set out in this Regulation;
            
            
               (b)this provisional declaration is published electronically by the Member State and the Commission and Member States are alerted to the publication;
            
            
               (c)60 days after publication, the provisional declaration will become an official declaration of freedom in compliance with Article 36(4) of Regulation (EU) 2016/429.
            
            
               2.Within that 60 day period referred to in point (c) of paragraph 1, the Commission or Member States may seek clarification or additional information in relation to the supporting evidence provided by the Member State making the provisional declaration; 
            
            
               3.Where written comments are made by at least one Member State, or the Commission, within the period referred to in point (c) of paragraph 1 indicating concerns relating to the evidence which supports the declaration, the Commission, the Member State which made the declaration and where relevant, the Member State which has sought additional information or clarification, shall together examine the submitted evidence in order to resolve the concerns. In such cases, the period referred to in point (c) of paragraph 1 may be prolonged for a further 60 days from the date on which the first concern was raised; 
            
            
               4.Where the process referred to in paragraph 3 fails:
            
            
               (a)the Commission shall inform all Member States and include the point on the agenda of the next meeting of the Standing Committee on Plants, Animals, Food and Feed for decision, where appropriate, in accordance with the procedure referred to in Article 266 of Regulation (EU) 2016/429; or 
            
            
               (b)the Member State withdraws the provisional declaration of disease freedom; or
            
            
               (c)the Commission refuses to recognise the declaration of freedom without agreed revision; 
            
            
               5.Provisional declarations of disease freedom will be subject to examination by the Commission based on: 
            
            
               (a)review of selected declarations during the 60 day period referred to in point (c) of paragraph 1; 
            
            
               (b)official controls carried out by Commission services; and 
            
            
               (c)the procedure outlined in paragraph 3,where the situation so applies. 
            
            
               6.When a disease-free declaration for a dependent compartment is made to the Commission, the competent authority shall provide the assessment referred to in paragraph 3(a) of Article 73 and details of any measure which were put in place to prevent the introduction of the disease into the compartment. 
            
            
               The competent authority shall communicate to the Commission without delay any subsequent changes to the epidemiological factors set out in paragraph 3(a) of Article 73 and measures taken to mitigate their impact. 
            
            
               PART III 
               TRANSITIONAL AND FINAL PROVISIONS 
            
            
               Article 84
                  Transitional provisions concerning existing disease-free status 
            
            
               1.The Member States and zones thereof with an approved disease--free status before the date of application of this Regulation shall be deemed to have an approved disease-free status in accordance with this Regulation for the following diseases:
            
            
               (a)infection with Brucella abortus, B. melitensis, B.suis:
            
            
               (i)in bovine animal populations when the brucellosis-free status was granted in accordance with Directive 64/432/EEC;
            
         
         
            
               (ii)in ovine and caprine animal populations when the brucellosis-free (Br. Melitensis-free) status was granted in accordance with Directive 91/68/EEC;
            
            
               (b)infection with MTBC when the tuberculosis-free status was granted in accordance with Directive 64/432/EEC;
            
            
               (c)EBL, when EBL-free status was granted in accordance with Directive 64/432/EEC; 
            
            
               (d)IBR/IPV, when IBR free status was granted in accordance with Directive 64/432/EEC;
            
            
               (e)infection with ADV, when Aujeszky’s disease-free-status was granted in accordance with Directive 64/432/EEC; 
            
            
               (f)infestation with Varroa spp, when varroasis-free status was granted in accordance with Council Directive 92/65/EEC
                  24
               ; 
            
            
               (g)infection with Newcastle disease virus-free status without vaccination when Newcastle disease non-vaccination status was granted in accordance with Directive 2009/158/EC;
            
            
               (h)VHS, when VHS-free status was granted in accordance with Council Directive 2006/88/EC
                  25
               ; 
            
            
               (i)IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (j)infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (k)infection with Bonamia ostreae, when infection with Bonamia ostreae-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (l)infection with Marteilia refringens, when infection with Marteilia refringens-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (m)infection with WSSV, when white spot disease--free status was granted in accordance with Directive 2006/88/EC.
            
            
               2.The compartments in Member States with an approved disease-free status before the date of application of this Regulation shall be deemed to have an approved disease-free status in accordance with this Regulation for the following diseases:
            
            
               (a)highly pathogenic avian influenza, when the avian influenza compartment has been approved in accordance with Commission Regulation (EC) No 616/2009
                  26
               ; 
            
            
               (b)VHS, when VHS-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (c)IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (d)infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (e)infection with Bonamia ostreae, when infection with Bonamia ostreae-free status was granted in accordance with Directive 2006/88/EC;
            
            
               (f)infection with Marteilia refringens, when infection with Marteilia refringens-free status was granted in accordance with Directive 2006/88/EC;
            
         
         
            
               (g)infection with WSSV, when white spot disease--free status was granted in accordance with Directive 2006/88/EC.
            
            
               3.The Member States deemed to have an approved disease-free status in accordance with paragraph 1 or 2 shall ensure that the conditions of maintenance of the status conform with those laid down in this Regulation.
            
            
               Article 85
                  Transitional provisions concerning existing eradication or surveillance programmes 
            
            
               1.The Member States and zones thereof with an approved eradication programme or an approved surveillance programme before the date of application of this Regulation shall be deemed to have an approved eradication programme in accordance with this Regulation for the following diseases for a period of six years from the date of application of this Regulation:
            
            
               (a)IBR/IPV, the when IBR eradication programme was approved in accordance with Directive 64/432/EEC;
            
            
               (b)infection with ADV, when the Aujeszky’s disease eradication programme was approved in accordance with Directive 64/432/EEC;
            
            
               (c)VHS, when the VHS surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; 
            
            
               (d)IHN, when the IHN surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;
            
            
               (e)infection with HPR-deleted ISAV, when the infection with HPR-deleted ISAV surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;
            
            
               (f)infection with Bonamia ostreae, when the infection with Bonamia ostreae surveillance or eradication programme was approved in accordance with Directive (EC) 2006/88;
            
            
               (g)infection with Marteilia refringens, when the infection with Marteilia refringens surveillance or eradication programme was approved in accordance with Directive (EC) 2006/88;
            
            
               (h)infection with WSSV, when the white spot disease eradication programme was approved in accordance with Directive 2006/88/EC.
            
            
               2.The compartments in Member States with an approved eradication programme or an approved surveillance programme before the date of application of this Regulation shall be deemed to have an approved eradication programme in accordance with this Regulation for the following diseases for a period of six years from the date of application of this Regulation:
            
            
               (a)VHS, when the VHS surveillance or eradication programme was approved with Directive 2006/88/EC; 
            
            
               (b)IHN, when the IHN surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;
            
            
               (c)infection with HPR-deleted ISAV, when the infection with HPR-deleted ISAV surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;
            
            
               (d)infection with Bonamia ostreae, when the infection with Bonamia ostreae surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;
            
            
               (e)infection with Marteilia refringens, when the infection with Marteilia refringens surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;
            
            
               (f)infection with WSSV, when the white spot disease surveillance or eradication programme was approved in accordance with Directive 2006/88/EC.
            
            
               3.The Member States deemed to have an approved eradication programme in accordance with paragraphs 1 or 2 shall ensure that the measures in the programme conform with those laid down for eradication programmes in this Regulation. 
            
         
         
            
               Article 86
                  Repeal
            
            
               The following acts are repealed as from 21 April 2021:
            
            
               –Commission Decision 2000/428/EC;
            
            
               –Commission Decision 2002/106/EC;
            
            
               –Commission Decision 2003/422;
            
            
               –Commission Decision 2006/437/EC;
            
            
               –Commission Regulation (EC) No 1266/2007;
            
            
               –Commission Decision 2008/896/EC;
            
            
               –Commission Decision 2015/1554.
            
            
               References to the repealed acts shall be construed as references to this Regulation.
            
            
               Article 87
               Entry into force and application
            
            
               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               It shall apply from 21 April 2021.
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Jean-Claude JUNCKER
               
            
         
         
      
    ---documentbreak--- 
      
         
         
            
               ANNEX I
               SPECIFIC CASE DEFINITION OF DISEASE OF TERRESTRIAL ANIMALS
            
            
               Section 1
                  Highly pathogenic avian influenza (HPAI)
            
            
               1.An animal or a group of animals must be considered, by the competent authority, as a suspect case of HPAI when it meets the criteria laid down in Article 9(1).
            
            
               2.An animal or a group of animals must be considered, by the competent authority, as a confirmed case of HPAI when:
            
            
               (a)the disease agent responsible for HPAI, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals; or
            
            
               (b)nucleic acid specific to the disease agent for HPAI, that is not a consequence of vaccination, has been identified in a sample from an animal or from a group of animals; or
            
            
               (c)positive result to an indirect diagnostic method, that is not a consequence of vaccination, has been obtained in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or epidemiologically linked to a suspect or confirmed case.
            
            
               3.For the purposes of this case definition, the disease agent responsible for HPAI must be either
            
            
               (a)an influenza A virus of H5 and H7 subtypes or any influenza A virus with an intravenous pathogenicity index (IVPI) greater than 1.2; or
            
            
               (b)an influenza A virus of H5 and H7 subtypes with a sequence of multiple basic amino acids present at the cleavage site of the haemagglutinin molecule (HA0) that is similar to that observed for other HPAI isolates.
            
            
               Section 2
                  Infection with low pathogenic avian influenza viruses (LPAIV)
            
            
               1.An animal or a group of animals must be considered, by the competent authority, as a suspect case of infection with LPAIV when it meets the criteria laid down in Article 9(1).
            
            
               2.An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with LPAIV when:
            
            
               (a)the disease agent responsible for infection with LPAIV, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals; or
            
            
               (b)nucleic acid specific to the disease agent for infection with LPAIV, that is not a consequence of vaccination, has been identified in a sample from an animal or from a group of animals; or
            
            
               (c)positive result to an indirect diagnostic method, that is not a consequence of vaccination, has been obtained in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or epidemiologically linked to a suspect or confirmed case.
            
            
               3.For the purposes of this case definition, the disease agent of infection with LPAIV must be any influenza A virus of H5 and H7 subtypes that are not HPAI viruses.
            
            
               Section 3
               Infection with Newcastle disease virus (NDV)
            
            
               1.An animal or a group of animals must be considered, by the competent authority, as a suspect case of infection with NDV when it meets the criteria laid down in Article 9(1).
            
         
         
            
               2.An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with NDV when:
            
            
               (a)the disease agent responsible for infection with NDV, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals; or
            
            
               (b)nucleic acid specific to the disease agent for infection with NDV, that is not a consequence of vaccination, has been identified in a sample from an animal or from a group of animals; or
            
            
               (c)positive result to an indirect diagnostic method, that is not a consequence of vaccination, has been obtained in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or epidemiologically linked to a suspect or confirmed case.
            
            
               3.For the purposes of this case definition, the disease agent responsible for infection with NDV must be any isolated avian paramyxovirus type 1 (APMV-1) (avian Avulavirus type 1) that either
            
            
               (a)has an intracerebral pathogenicity index (ICPI) of 0.7 or greater; or 
            
            
               (b)presents multiple basic amino acids at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term ‘multiple basic amino acids’ refers to at least three arginine or lysine residues between residues 113 and 116. Failure to demonstrate the characteristic pattern of amino acid residues as described above would require characterisation of the isolated virus by an ICPI test. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene, 113–116 corresponds to residues –4 to –1 from the cleavage site.
            
            
               ANNEX II
               
                  UNION SURVEILLANCE PROGRAMME
            
            
               Part I
                  Avian influenza surveillance in poultry and wild birds
            
            
               Section 1
                  General approach and requirements
            
            
               1.Territorial scope:
            
            
               Surveillance in poultry and wild birds must be implemented in all Member States.
            
            
               2.Period of application:
            
            
               Until revoked.
            
            
               3.General approach:
            
            
               The surveillance system must address the objectives provided for in Section 2 and must be built on a comprehensive approach including different components of surveillance activities complementing each other in poultry and wild bird populations: 
            
            
               ·Early detection systems as provided for in Sections 3 and 4;
            
            
               ·Risk-based surveillance as provided for in Sections 5 and 6.
            
            
               Section 2
                  Objectives for surveillance in poultry and wild birds
            
            
               1.Early detection of highly pathogenic avian influenza (HPAI) in poultry.
            
         
         
            
               2.Early detection of HPAI in wild birds providing for:
            
            
               (a)an early warning for possible HPAI introduction into poultry, in particular when viruses enter the Union through migratory movements of wild birds;
            
            
               (b)information for the assessment of risks for virus spread following findings of HPAI in wild birds.
            
            
               3.Detection of HPAI in poultry species which generally do not show significant clinical signs. 
            
            
               4.Detection of circulating low pathogenic avian influenza viruses (LPAIV) that may easily spread between poultry flocks in particular in areas with a high density of poultry establishments in view of their potential to mutate to HPAI in order to:
            
            
               (a)identify clusters of infection with LPAIV; 
            
            
               (b)monitor the risk of spread of LPAIV by movements of poultry and by fomites in certain production systems at risk. 
            
            
               5.Contribution to increased knowledge on HPAI and LPAIV posing a potential zoonotic risk.
            
            
               Section 3
                  Early detection of HPAI in poultry 
            
            
               1.The early detection systems for of HPAI in poultry must be part of the general surveillance as provided for in point (a) of Article 3(1) and must be implemented throughout the poultry sector. 
            
            
               2.The surveillance referred to in point 1 must at least include the early detection and investigation in establishments located in an area identified as being at heightened risk for HPAI introduction and spread, of:
            
            
               (a)any change in normal production and health parameters such as mortality rate, feed and water intake and egg production; and 
            
            
               (b)any clinical sign or post-mortem lesion suggesting HPAI. 
            
            
               3.Regular testing of samples collected from dead and sick poultry in establishments located in an area identified as being at heightened risk for HPAI introduction and spread may also be relevant when an increased risk has been identified at national, EU or regional level due to outbreaks of HPAI in poultry and/or wild birds.
            
            
               Section 4
                  Early detection of HPAI in wild birds 
            
            
               1.The early detection of HPAI in wild birds must be based on sampling and testing of birds that have been:
            
            
               (a)found dead;
            
            
               (b)found injured or sick;
            
            
               (c)hunted with clinical signs.
            
            
               This surveillance may need to be intensified, when HPAI as been detected in wild birds, with organised patrols by monitoring systems for detecting and collecting dead and sick birds.
            
         
         
            
               2.The design of this surveillance must be risk-based, taking into account at least relevant information on ornithology, virology, epidemiology and environmental matters.
            
            
               3.The surveillance must apply to birds from targeted wild bird species, as provided for in Section 8. However, all suspect episodes of mortality in wild birds must be investigated to exclude HPAI. 
            
            
               In addition to targeted wild bird species, additional wild bird species may also be included when their specific epidemiological relevance on the Member State's territory has been assessed. 
            
            
               4.In addition, the surveillance may include, at priority locations and key sites in particular those where birds of targeted wild birds species are entering the Union during their migratory movements, at least from North-East and Eastern routes, the sampling and testing of:
            
            
               (a)birds trapped;
            
            
               (b)hunted healthy birds;
            
            
               (c)sentinel birds.
            
            
               5.Additional sources of information obtained from investigations of wild birds in the context of HPAI outbreaks in kept birds must be included in the results of the surveillance of HPAI in wild birds.
            
            
               Section 5
                  Risk-based complementary surveillance for HPAI in poultry species which generally do not show significant clinical signs
            
            
               1.The risk-based surveillance for infection with HPAI in poultry establishments keeping ducks, geese, poultry belonging to the species of Anseriformes for restocking supplies of game or quails must take into account at least the following risk factors:
            
            
               (a)the historical and current epidemiological situation of the disease and its evolution over time in poultry and wild birds;
            
            
               (b)the proximity of establishments to water bodies and other places where migratory birds, in particular water birds, may gather in higher numbers or have their stop-over places during their movements into and through the Union; 
            
            
               (c)the period of increased movements of migratory wild birds of target species into and through the Union;
            
            
               (d)the structure of poultry farming including the broader sector involved in the different production systems;
            
            
               (e)the geographical location of the establishments in an area with a high density of poultry;
            
            
               (f)the biosecurity practices on the establishments;
            
            
               (g)the type and frequency of movements of poultry, products and vehicles transporting poultry and trade patterns;
            
            
               (h)the risk assessments and scientific advice in relation to the relevance of the spread of HPAI by wild birds.
            
            
               2.Based on scientific justifications, additional risk factors than those listed in points (a) to (h) of point 1 may be included and factors that are not relevant for the specific situation of the Member State may be omitted.
            
            
               Section 6
               risk based surveillance in order to identify clusters of establishments infected with lpaiv and with continuous spread of lpaiv
            
         
         
            
               1.The risk-based surveillance for the detection of circulating low pathogenic avian influenza viruses (LPAIV) that may easily spread between poultry flocks in particular in areas with a high density of poultry establishments, as referred to in point 4 of Section 2, must apply to poultry establishments for which the competent authority has assessed that clusters of infection with LPAIV have repeatedly occurred in the past or are deemed more likely to occur.
            
            
               2.Such clusters are characterised by infection with LPAIV of groups of establishments related in time and geographical proximity. 
            
            
               3.The assessment for the selection of establishments for targeted surveillance must take into account the risk for lateral transmission of the virus due to the structure, complexity and functional connections between establishments, in particular when operating in areas with a high density of establishments. 
            
            
               4.In addition to the selection criteria for targeted sampling of establishments referred to in point 3, the following risk factors must be taken into account at the establishment level: 
            
            
               (a)the kept species;
            
            
               (b)the cycle and duration of production; 
            
            
               (c)presence of several poultry species; 
            
            
               (d)presence of multi-age flocks;
            
            
               (e)presence of long-lived poultry; 
            
            
               (f)practice of all-in all-out principle;
            
            
               (g)length of waiting period between batches;
            
            
               (h)biosecurity practices and housing conditions. 
            
            
               Section 7
                  Targeted poultry populations
            
            
               1.Early detection systems for infection with HPAI referred to in Section 3 must apply to all poultry populations. 
            
            
               2.Complementary surveillance for infection with HPAI referred to in Section 5 in poultry species that do generally not display significant signs when infected with HPAI must apply to:
            
            
               (a)breeding ducks 
            
            
               (b)breeding geese;
            
            
               (c)fattening ducks;
            
            
               (d)fattening geese;
            
            
               (e)quails;
            
         
         
            
               (f)poultry of species belonging to Anseriformes for restocking supplies of game. 
            
            
               3.In addition to the species and categories listed under point 2 the targeting of sampling and testing for infection with LPAIV referred to in Section 6 may apply to the following poultry species and production categories: 
            
            
               (a)laying hens including those kept in free-range; 
            
            
               (b)breeding turkeys; 
            
            
               (c)fattening turkeys;
            
            
               (d)the poultry of species belonging to Galliformes for restocking supplies of game.
            
            
               Section 8
                  Targeted Wild bird populations
            
            
               Targeted wild birds species, in particular migratory water birds have shown to be at higher risk of becoming infected with, and transmitting HPAI 
            
            
               The list of 'wild bird target species' compiled and updated in the light of the most recent knowledge is available on the website of the EURL. 
            
            
               Section 9
                  Sampling and laboratory testing methods
            
            
               1.The number of poultry establishments to be sampled and the number of poultry to be tested per establishment and, as appropriate, by epidemiological unit (e.g. flock, shed, etc.) on the concerned establishment must be based on a statistically valid sampling method. This method may be that used for representative sampling; i.e. an estimated prevalence to be detected according to a pre-defined level of confidence determined by the competent authority.
            
            
               2.Frequency and period for testing:
            
            
               (a)the frequency for sampling and testing of poultry establishments must be determined based on the outcome of a risk assessment by the competent authority;
            
            
               (b)the time period for sampling must coincide with seasonal production for each production category, but must not compromise the risk based surveillance approach;
            
            
               (c)when relevant, the time period for sampling must take into account the period of heightened risk as referred to in point 3 of Section 3.3. Samples must be subjected to laboratory testing by virological methods, when taken for:
            
            
               (a)early detection of HPAI in poultry referred to in Section 3;
            
            
               (b)early detection of HPAI in wild birds referred to in Section 4; 
            
            
               (c)complementary surveillance for HPAI in poultry species which generally do not show significant clinical signs of HPAI referred to in Section 5; 
            
            
               (d)follow-up of sero-positive findings referred to in point 4(b).
            
            
               For virological testing the prevalence and time window for detection of active infection must be taken into account. 
            
         
         
            
               4.Samples must be subjected to laboratory testing by serological methods, when taken for:
            
            
               (a)complementary surveillance for HPAI in poultry species which generally do not show significant clinical signs of HPAI referred to in Section 5 supplementing virological testing, as appropriate;
            
            
               (b)detection of clusters of LPAIV infected establishments referred to in Section 6. When for technical reasons or other duly justified reasons sampling for serology is not appropriate, virological testing must be performed.
            
            
               ANNEX III
            
            
               DIAGNOSTIC METHODS FOR THE GRANTING AND MAINTENANCE OF DISEASE-FREE STATUS FOR CERTAIN DISEASES OF TERRESTRIAL ANIMALS
            
            
               Section 1
                  INFECTION WITH BRUCELLA ABORTUS, B. MELITENSIS AND B. SUIS
            
            
               1.Serological tests
            
            
               (a)tests for blood samples:
            
            
               (i)buffered Brucella antigen tests; 
            
            
               (ii)complement fixation test (CFT)
            
            
               (iii)blood indirect enzyme-linked immunosorbent assay (I - ELISA)
            
            
               (iv)fluorescent polarization assay (FPA)
            
            
               (v)blood competitive enzyme-linked immunosorbent assay (C - ELISA)
            
            
               (b)tests for milk samples:
            
            
               (i)milk ring test (MRT)
            
            
               (ii)milk I-ELISA
            
            
               2.Brucellosis skin test (BST)
            
            
               For the testing as referred to in section 1 and 2 of Chapter 1 of Part I of Annex IV, Brucellosis skin test (BST) shall only be used in ovine and caprine animals.
            
            
               Section 2
                  INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX
            
            
               1.Tuberculin skin tests
            
         
         
            
               (a)the single intradermal test (SIT)
            
            
               (b)the comparative intradermal test (CIT)
            
            
               2.Gamma-interferon assay
            
            
               Section 3
                  ENZOOTIC BOVINE LEUKOSIS
            
            
               1.Serological tests
            
            
               (a)tests for blood samples:
            
            
               (i)agar gel immuno-diffusion test (AGID)
            
            
               (ii)blocking enzyme-linked immunosorbent assay (B - ELISA)
            
            
               (iii)indirect enzyme-linked immunosorbent assay (I - ELISA)
            
            
               (b)tests for milk samples:
            
            
               (i)I-ELISA
            
            
               Section 4
                  INFECTIOUS BOVINE RHINOTRACHEITIS/INFECTIOUS PUSTULAR VULVOVAGINITIS (IBR/IPV)
            
            
                     
                  
                  
                     
                        Methods:
                     
                  
                  
                     
                        Matrix:
                     
                  
               
                     
                        non-vaccinated bovine animals
                     
                  
                  
                     
                        indirect BoHV-1 ELISAa
                     
                  
                  
                     
                        individual serum samplesd
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        milk samples
                     
                  
               
                     
                  
                  
                     
                        gB blocking ELISAb
                     
                  
                  
                     
                        individual serum samplesd
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        individual meat juice/muscular exudate samples
                     
                  
               
                     
                        DIVA vaccinated bovine animals with a gE-deleted vaccine
                     
                  
                  
                     
                        gE blocking ELISAc
                     
                  
                  
                     
                        individual serum samples 
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        individual meat juice/muscular exudate samples
                     
                  
               
               aELISA for the detection of antibodies against BoHV-1 whole virus. Pools of up to 50 milk samples (individual or bulk milk) may be used in tests for granting and up to 100 milk samples (individual or bulk milk) may be used in tests for the maintenance of the status free from IBR/IPV.
            
            
               bELISA for the detection of antibodies against BoHV-1-gB protein. When referred to tests for the detection of antibodies against whole BoHV-1 in Part IV of Annex IV this method may also be used.
            
            
               cELISA for the detection of antibodies against BoHV-1-gE protein. Individual milk samples may be used when testing to proof the maintenance of the status free from IBR/IPV. The samples may be pooled whereat the number of samples per pool may be chosen based on documented evidence that the test is under all circumstances of day to day laboratory work sensitive enough to detect a single positive reaction in the pool.
            
            
               dWhen testing is carried out to proof the maintenance of the status free from IBR/IPV individually collected samples may be pooled. The number of samples per pool may be modulated based on documented evidence that the test is under all circumstances of day to day laboratory work sensitive enough to detect a single weak positive reaction in the pool of the modulated size. 
            
            
               Section 5
                   INFECTION WITH AUJESZKY'S DISEASE VIRUS (ADV)
            
            
                     
                  
                  
                     
                        Methods:
                     
                  
                  
                     
                        Matrix:
                     
                  
               
                     
                        non-vaccinated porcine animals
                     
                  
                  
                     
                        ADV ELISAa
                     
                  
                  
                     
                        individual or up to 5 pooled serum (or plasma) samples 
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        individual or up to 5 pooled filter paper samples
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        individual meat juice/muscular exudate samples
                     
                  
               
                     
                        DIVA vaccinated porcine animals with a gE-deleted vaccine
                     
                  
                  
                     
                        gE ELISAb
                     
                  
                  
                     
                        individual serum samples
                     
                  
               
               aELISA for the detection of antibodies against whole ADV, ADV-gB protein or ADV-gD protein. For batch control of ADV-gB and ADV-gD or whole ADV kits, Community reference serum ADV 1, or sub-standards, must be scored positive at the dilution of 1:2. When referred to tests for the detection of whole ADV in Part V of Annex IV either of these tests may be used.
            
         
         
            
               bELISA for the detection of antibodies against ADV-gE protein. For batch control, Community reference serum ADV 1, or sub-standards, must be scored positive at the dilution 1:8. For batch control, Community reference serum ADV 1, or sub-standards, must be scored positive at the dilution 1:8.
            
            
               Section 6
                  BOVINE VIRAL DIARRHOEA (BVD)
            
            
               1.Direct methods:
            
            
               (a)Real-time RT-PCR
            
            
               (b)BVDV antigen detection by ELISA
            
            
               2.Serological tests:
            
            
               (a)BVDV-antibody indirect ELISA
            
            
               (b)BVDV-antibody blocking ELISA 
            
            
               ANNEX IV
            
            
               Disease specific requirements for the granting, maintenance, suspension and withdrawal of the disease-free status at the level of establishments and disease specific requirements for the granting and maintenance of the disease-free status at the level of Member States or zones 
            
            
               Part I
                  Infection with Brucella abortus, B. melitensis and B. suis 
            
            
               Chapter 1
                  Establishment free from infection with Brucella abortus, B. melitensis and B. suis without vaccination
            
            
               Section 1
                  Granting of the status
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if:
            
            
               (a)during the past 12 months there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in bovine, ovine or caprine animals kept in the establishment;
            
            
               (b)during the past 3 years none of the bovine, ovine or caprine animals in the establishment has been vaccinated against infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (c)the entire bovine animals over 12 months of age and the entire ovine or caprine animals over 6 months of age present in the establishment at the time of sampling have tested negative to serological tests, on two occasions as follows:
            
            
               (i)the first test must be carried out on samples taken not earlier than 3 months after the removal of the last confirmed case and the last animal which tested positive in an immunological test;
            
            
               (ii)the second test must be carried out on samples taken not earlier than 6 months and not later than 12 months following the date of sampling referred to in point (i);
            
            
               (d)animals showing clinical signs consistent with infection with Brucella abortus, B. melitensis and B. suis, such as abortions, have been subjected to investigations with negative results ;
            
         
         
            
               (e)since the beginning of the sampling referred to in point (c)(i) all bovine, ovine or caprine animals introduced into the establishment originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated against infection with Brucella abortus, B. melitensis and B. suis during the past 3 years, and
            
            
               (i)originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;
            
            
               (ii)are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and must have tested negative in a serological test carried out on a sample taken: 
            
            
               –during the 30 days prior to their introduction into the establishment; or
            
            
               –during the 30 days following their introduction provided they have been kept isolated during this period; or
            
            
               (iii)are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition; and
            
            
               (f)since the beginning of the sampling referred to in point (c)(i) all germinal products of bovine, ovine or caprine origin introduced or used in the establishment originate from:
            
            
               (i)establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; or
            
            
               (ii)approved germinal product establishments.
            
            
               2.By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated during the past 3 years, and:
            
            
               (a)originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;
            
            
               (b)are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test carried out on a sample taken: 
            
            
               –during the 30 days prior to their introduction into the establishment; or
            
            
               –during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or
            
            
               (c)are post-parturient females kept in isolation since their introduction into the establishment until they tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition.
            
            
               Section 2
                  Maintenance of the status
            
            
               The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:
            
            
               (a)the requirements set out in points (a), (b), (d), (e) and (f) of point 1 of Section 1 continue to be fulfilled; and
            
            
               (b)serological testing is carried out with negative results on samples taken from:
            
            
               (i)all entire bovine animals over 12 months of age and entire ovine or caprine animals over 6 months of age at appropriate intervals of not more than 12 months determined by the competent authority taking into account the type of production, the situation of the disease and the identified risk factors; or
            
         
         
            
               (ii)entire bovine animals over 12 months of age and entire ovine or caprine animals over 6 months of age kept in establishments located in a Member State or in a zone free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, in accordance with a testing regime set up by the competent authority taking into account the type of production and the identified risk factors.
            
            
               Section 3
                  Suspension and restoring of the status
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if:
            
            
               (a)one or more of the requirements set out in Section 2 are not fulfilled; or 
            
            
               (b)a case of infection with Brucella abortus, B. melitensis and B. suis is suspected in a bovine, ovine or caprine animal kept in the establishment.
            
            
               2.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be restored, if:
            
            
               (a)the requirements set out in points (b), (d), (e) and (f) of point 1 of Section 1 and in point (b) of Section 2 are fulfilled;
            
            
               (b)the results of further investigations permit to rule out infection with Brucella abortus, B. melitensis and B. suis and the status of all suspect cases has been determined.
            
            
               Section 4
                  Withdrawal and regaining of the status
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if:
            
            
               (a)one or more of the requirements set out in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
            
            
               (b)the infection with Brucella abortus, B. melitensis and B. suis cannot be ruled out in accordance with point 2(b) of Section 3;
            
            
               (c)a case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in a bovine, ovine or caprine animal kept in the establishment; or
            
            
               (d)it is justified by other needs to control infection with Brucella abortus, B. melitensis, B. suis.
            
            
               2.If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. 
            
            
               3.If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out to in point 1(c) of Section 1.
            
            
               4.By way of derogation from point 3, where the infection with B. suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing, was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1.
            
            
               Chapter 2
                  Establishment free from infection with Brucella abortus, B. melitensis and B. suis with vaccination
            
            
               Section 1
                  Granting of the status
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if:
            
         
         
            
               (a)the requirements set out in points (a), (c) and (d) of Section 1 of Chapter 1 are fulfilled;
            
            
               (b)since the beginning of the sampling referred to in point (c)(i) of Section 1 of Chapter 1, all bovine, ovine, or caprine animals introduced into the establishment originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination or free from infection with Brucella abortus, B. melitensis and B. suis with vaccination and:
            
            
               (i)originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis without vaccination for the relevant animal population; 
            
            
               (ii)are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test on a sample taken 
            
            
               –during the 30 days prior to their introduction into the establishment; or
            
            
               –during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or
            
            
               (iii)are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition; and
            
            
               (c)since the beginning of the sampling referred to in point (c)(i) of Section 1 of Chapter 1, all germinal products of bovine, ovine or caprine introduced or used in the establishment originate from:
            
            
               (i)establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination or free from infection with Brucella abortus, B. melitensis and B. suis with vaccination, or
            
            
               (ii)approved germinal product establishments.
            
            
               2.By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination, and:
            
            
               (a)originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;
            
            
               (b)are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test carried out on a sample taken: 
            
            
               (i)during the 30 days prior to their introduction into the establishment; or
            
            
               (ii)during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or
            
            
               (c)are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition.
            
            
               Section 2
                  Maintenance of the status
            
            
               The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:
            
            
               (a)the requirements set out in points (b) and (c) of point 1 of Section 1 of this Chapter and in points (a) and (d) of Section 1 of point 1 of Chapter 1 continue to be fulfilled; and
            
            
               (b)serological testing is carried out with negative results on samples taken from all entire bovine animals over 12 months of age and entire ovine or caprine animals over 6 months of age at appropriate intervals of not more than 12 months determined by the competent authority taking into account the type of production, the situation of the disease and the identified risk factors.
            
         
         
            
               Section 3
                  Suspension and restoring of the status
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if:
            
            
               (a)one or more of the requirements set out in Section 2 are not fulfilled; or
            
            
               (b)a case of infection with Brucella abortus, B. melitensis and B. suis is suspected in a bovine, ovine or caprine animal kept in the establishment.
            
            
               2.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be restored, if:
            
            
               (a)the requirements set out in point 1(d) of Section 1 of Chapter 1 and points (b) and (c) of Section 1 and point (b) of Section 2 are fulfilled;
            
            
               (b)the results of further investigations permit to rule out infection with Brucella abortus, B. melitensis and B. suis and the status of all suspect cases has been determined.
            
            
               Section 4
                  Withdrawal and regaining of the status
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if:
            
            
               (a)one or more of the requirements set out in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
            
            
               (b)the infection with Brucella abortus, B. melitensis and B. suis cannot be ruled out in accordance with point 2(b) of Section 3;
            
            
               (c)a case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in a bovine, ovine or caprine animal kept in the establishment; or
            
            
               (d)it is justified by other needs to control infection with Brucella abortus, B. melitensis, B. suis.
            
            
               2.If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. 
            
            
               3.If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out in point 1(c) of Section 1 of Chapter 1.
            
            
               4.By way of derogation from point 3, where the infection with Brucella suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1 of Chapter 1.
            
            
               Chapter 3
                  Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals
            
            
               Section 1
                  Granting of the status as regards 
                  kept bovine animals 
            
            
               The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals may only be granted to a Member State or a zone if:
            
            
               (a)for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals;
            
         
         
            
               (b)general surveillance has been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals, which included at least:
            
            
               (i)the regular submission of samples from abortion cases for laboratory testing;
            
            
               (ii)the timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (c)during the past 3 years, at least 99.8% of the establishments keeping bovine animals, representing at least 99.9% of the bovine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; 
            
            
               (d)vaccination of bovine animals against Brucella abortus, B. melitensis and B. suis has not taken place at least for the past 3 years and no bovine animals introduced into the Member State or zone have been vaccinated during the past 3 years prior to introduction.
            
            
               Section 2
                  Maintenance of the status as regards 
                  kept bovine animals
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may only be maintained if:
            
            
               (a)the requirements set out in points (a), (b) and (d) of Section 1 continue to be fulfilled;
            
            
               (b)for the first 2 consecutive years following granting of the status, annual surveillance based on a representative sample of all establishments keeping bovine animals has been carried out that must allow at least the detection, with a 95% level of confidence of infection with Brucella abortus, B. melitensis and B. suis at a target prevalence rate of 0.2% of the establishments keeping bovine animals or a target prevalence rate of 0.1% of the bovine population;
            
            
               (c)if no case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in kept bovine animals for 2 consecutive years following granting of the status the surveillance must be based on:
            
            
               (i)random annual surveillance that must allow at least the detection, with a 95% level of confidence, of infection with Brucella abortus, B. melitensis and B. suis, at a target prevalence rate of 0.2% of the establishments keeping bovine animals or a target prevalence rate of 0.1% of the bovine population; or
            
            
               (ii)risk based annual surveillance to detect infection with Brucella abortus, B. melitensis and B. suis taking into account the systems of production and the risk factors identified, including spread of infection from other animals than kept bovine animals. 
            
            
               2.The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept bovine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept bovine animals.
            
            
               3.By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if:
            
            
               (a)the establishment in which the infection with Brucella abortus, B. melitensis and B. suis was detected in kept bovine animals has been immediately subjected to the relevant disease control measures laid down in Article 24;
            
            
               (b)within 60 days after the first confirmation of the infection, the competent authority has conducted an epidemiological enquiry and investigations, as laid down in Article 25, to identify the likely source and the distribution of the infection and concluded on the likely source of infection and only a limited number of establishments were infected and those establishments are epidemiologically linked to the first detected outbreak;
            
            
               (c)the relevant disease control measures laid down in Article 21 or Article 24 have been immediately implemented on each establishment identified with suspect or confirmed cases following implementation of the measures provided for in point (b) until their disease-free status is restored or regained;
            
            
               (d)the surveillance referred to in point 1 has been adapted and has demonstrated that the incident has been resolved.
            
            
               Chapter 4
                  Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals
            
            
               Section 1
                  Granting of the status as regards 
                  kept ovine and caprine animals 
            
         
         
            
               The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals may only be granted to a Member State or a zone if:
            
            
               (a)for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals;
            
            
               (b)general surveillance has been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals, which included at least:
            
            
               (i)the regular submission of samples from abortion cases for laboratory testing;
            
            
               (ii)the timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;
            
            
               (c)during the past 3 years, surveillance carried out on the ovine and caprine population and at least 99.8% of the establishments keeping ovine or caprine animals, representing at least 99.9% of the ovine and caprine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; 
            
            
               (d)vaccination of ovine and caprine animals against Brucella abortus, B. melitensis and B. suis has not taken place at least for the past 3 years and no ovine or caprine animals introduced into the Member State or zone have been vaccinated during the past 3 years prior to introduction.
            
            
               Section 2
                  Maintenance of the status as regards 
                  kept ovine and caprine animals
            
            
               1.The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may only be maintained if:
            
            
               (a)the requirements defined in points (a), (b) and (d) of Section 1 continue to be fulfilled;
            
            
               (b)for the first 2 consecutive years following granting of the status, annual surveillance based on a representative sample of all establishments where ovine or caprine animals are kept shall be carried out that must allow at least the detection, with a 95% level of confidence, of infection with Brucella abortus, B. melitensis and B. suis at a target prevalence rate of 0.2% of the establishments keeping ovine or caprine animals or a target prevalence rate of 0.1% of the ovine and caprine population;
            
            
               (c)if no case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in kept ovine and caprine animals for 2 consecutive years following granting of the status the surveillance must be based on:
            
            
               (i)random annual surveillance that must allow at least the detection, with a 95% level of confidence, of infection with Brucella abortus, B. melitensis and B. suis at a target prevalence rate of 0.2% of the establishments keeping ovine or caprine animals or a target prevalence rate of 0.1% of the ovine and caprine population; or
            
            
               (ii)risk based annual surveillance to detect infection with Brucella abortus, B. melitensis and B. suis is carried out taking into account the systems of production and the risk factors identified, including spread of infection from other animals than kept ovine and caprine animals. 
            
            
               2.The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept ovine and caprine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept ovine and caprine animals.
            
            
               3.By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if:
            
            
               (a)the establishment in which the infection with Brucella abortus, B. melitensis and B. suis was detected in kept ovine and caprine animals has been immediately subjected to the relevant disease control measures laid down in Article 24;
            
            
               (b)within 60 days after the first confirmation of the infection, the competent authority has conducted an epidemiological enquiry and investigations, as laid down in Article 25, to identify the likely source and the distribution of the infection and concluded on the likely source of infection and only a limited number of establishments were infected and those establishments are epidemiologically linked to the first detected outbreak;
            
            
               (c)the relevant disease control measures laid down in Article 21 or Article 24 have been immediately implemented on each establishment identified with suspect or confirmed cases following implementation of the measures provided for in point (b) until their disease-free status is restored or regained;
            
            
               (d)the surveillance referred to in point 1 has been adapted and has demonstrated that the incident has been resolved.
            
         
         
            
               Part II
                  Infection with Mycobacterium tuberculosis complex
            
            
               Chapter 1
                  Establishment free from infection with Mycobacterium tuberculosis complex
            
            
               Section 1
                  Granting of the status
            
            
               1.The status free from infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, Mycobacterium tuberculosis, Mycobacterium caprae) (MTBC) may only be granted to an establishment keeping bovine animals if:
            
            
               (a)during the past 12 months there has been no confirmed case of infection with MTBC in bovine animals kept in the establishment;
            
            
               (b)the bovine animals over 6 weeks of age present in the establishment at the time of testing or sampling have tested negative to immunological tests, on 2 occasions as follows:
            
            
               (i)the first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 6 months after the removal of the last confirmed case or of the last animal which tested positive in an immunological test;
            
            
               (ii)the second test must be carried out on bovine animals or on samples taken from bovine animals not earlier than 6 months and not later than 12 months following the date of testing of the bovine or taking of the samples referred to in point (i);
            
            
               (c)since the beginning of the testing or sampling referred to in point (b)(i), all bovine animals introduced into the establishment originate from establishments free from infection with MTBC and:
            
            
               (i)originate from a Member State or a zone free from infection with MTBC;
            
            
               (ii)are bovine animals over 6 weeks of age and have tested negative in an immunological test :
            
            
               –during the 30 days prior to their introduction into the establishment; or
            
            
               –during the 30 days after their introduction provided they have been kept isolated during this period; and
            
            
               (d)since the beginning of the testing or sampling referred to in point (b)(i) only germinal products of bovine origin introduced or used in the establishment originate from: 
            
            
               (i)establishments free from infection with MTBC; or
            
            
               (ii)approved germinal product establishments.
            
            
               2.By way of derogation from point 1, the status free from infection with MTBC may be granted to an establishment if all bovine animals originate from establishments free from infection with MTBC and:
            
            
               (a)originate from a Member State or a zone free from infection with MTBC; 
            
            
               (b)if they are bovine animals over 6 weeks of age, they have tested negative to an immunological test:
            
            
               (i)during the 30 days prior to their introduction into the establishment; or
            
         
         
            
               (ii)during the 30 days after their introduction provided they have been kept in isolation during this period.
            
            
               3.By way of derogation from points 1(c) and 2(b), the competent authority may not require the test if 
            
            
               (a)the bovine animals introduced into the establishment:
            
            
               (i)have tested negative in an immunological test carried out during the past 6 months; and
            
            
               (ii)originate from establishments where the bovine animals have tested negative to a testing regime as provided for in point 1(c), 1(d) or 2 of Section 2 carried out during the past 6 months; or
            
            
               (b)the bovine animals introduced into the establishment:
            
            
               (i)have tested negative in an immunological test carried out during the past 12 months; and 
            
            
               (ii)originate from establishments where the bovine animals have tested negative to a testing regime as provided for in point 2(b) or 2 (c) of Section 2 carried out during the past 12 months.
            
            
               Section 2
                  Maintenance of the status
            
            
               1.The status free from infection with MTBC of an establishment keeping bovine animals may only be maintained if:
            
            
               (a)the requirements set out in points (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled;
            
            
               (b)any suspect case of infection with MTBC on a bovine animal kept on that establishment or introduced from that establishment into a slaughterhouse is notified to the competent authority and investigated; and
            
            
               (c)an immunological test has been carried out, with negative results, on all bovine animals over 6 weeks of age, at intervals of not more than 12 months.
            
            
               2.By way of derogation from point 1(c) the competent authority may modify the testing regime as follows:
            
            
               (a)in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 1% during the last 24 months, the interval between tests may be extended to 24 months;
            
            
               (b)in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 0.2% for the last 48 months, the interval between tests may be extended to 36 months;
            
            
               (c)in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 0.1% for the last 72 months, the interval between tests may be extended to 48 months; 
            
            
               (d)in a Member State or a zone free from infection with MTBC, if the risk of transmission of MTBC from wild animals to bovine animals has been assessed by appropriate surveillance, the interval between tests may be based on the type of production and the risk factors identified, taking into account at least the following risks: 
            
            
               (i)a location associated with suspected or confirmed infection with MTBC in wild animals;
            
            
               (ii)a history of infection with MTBC within the last 5 years;
            
         
         
            
               (iii)an epidemiological link with establishments in any of the points (i) or (ii).
            
            
               Section 3
                  Suspension and restoring of the status
            
            
               1.The status free from infection with MTBC of an establishment keeping bovine animals must be suspended if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled; or
            
            
               (b)a case of infection with MTBC is suspected in a bovine animal kept in the establishment.
            
            
               2.The status free from infection with MTBC may only be restored, if:
            
            
               (a)the requirements laid down in points 1(c) and 1(d) of point 1 of Section 1, 1(b), of Section 2 and, as relevant, in point 1(c) or in 1(d) or in point 2 of Section 2 are fulfilled;
            
            
               (b)the results of further investigations permit to rule out infection with MTBC and the status of all suspect cases has been determined. In case, suspect bovine animals are slaughtered in that context, investigations must include examination of samples with direct diagnostic methods. 
            
            
               Section 4
                  Withdrawal and regaining of the status
            
            
               1.The status free from infection with MTBC of an establishment keeping bovine animals must be withdrawn if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended; 
            
            
               (b)the infection with MTBC cannot be ruled out in accordance with point 2(b) of Section 3; 
            
            
               (c)a case of infection with MTBC has been confirmed in a bovine animal kept in the establishment; or
            
            
               (d)it is justified by other needs to control infection with MTBC.
            
            
               2.If the status free from infection with MTBC has been withdrawn in accordance with point (a) of point 1, it may only be regained if the requirements laid down in Section 2 are fulfilled.
            
            
               3.If the status free from infection with MTBC has been withdrawn in accordance with point 1(b), 1(c) or 1(d) it may only be regained if: 
            
            
               (a)all confirmed cases and all animals that have tested non negative in a immunological test have been removed; and
            
            
               (b)the remaining bovine animals fulfil the requirements set out in point 1(b) of Section 1.
            
            
               4.By way of derogation from point 3(b), the status may be regained if: 
            
            
               (a)all bovine animals over 6 weeks of age present in the establishment at the time of testing have tested negative in 2 immunological tests as follows: 
            
         
         
            
               (i)the first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 2 months after the removal of the last confirmed case and of the last animal which tested positive in an immunological test; 
            
            
               (ii)the second test must be carried out on bovine animals or on samples taken from bovine animals not earlier than 2 months and not later than 12 months following the date of testing or sampling of the bovine animal as referred to in point (i); and
            
            
               (b)at least one of the following conditions apply:
            
            
               (i)the conclusion of the epidemiological enquiry indicates that the infection is due to the introduction of one or more infected animals into the establishment during the past 12 months prior to the detection of the infection with MTBC; or
            
            
               (ii)only a single case was confirmed or only a single bovine animal tested positive in an immunological test for MTBC since the detection of the infection with MTBC and the status of the establishment has not been withdrawn during the past 3 years; or
            
            
               (iii)bovine animals in the establishment have tested negative in an immunological test carried out less than 12 months prior to the detection of the infection with MTBC in accordance with point 1(c), or 2 of Section 2.
            
            
               Chapter 2
                  Member State or zone free from infection with MTBC 
            
            
               Section 1
                  Granting of the status as regards 
                  kept bovine animals 
            
            
               The status free from infection with MTBC as regards kept bovine animals may only be granted to a Member State or a zone if:
            
            
               (a)during the past 3 years at least 99.8% of the establishments keeping bovine animals, representing at least 99.9% of the bovine population, have maintained their status free from infection with MTBC and the incidence rate of establishment confirmed infected during the year did not exceed 0.1%; 
            
            
               (b)general surveillance has been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the detection of infection with MTBC in kept bovine animals and included at least:
            
            
               (i)the systematic research of lesions of infection with MTBC on all bovine animals slaughtered through ante- and post-mortem surveillance; 
            
            
               (ii)the investigations of lesions that could be due to infection with MTBC.
            
            
               Section 2
                  Maintenance of the status
            
            
               1.The status free from infection with MTBC as regards kept bovine animals of a Member State or a zone may only be maintained if:
            
            
               (a)the requirements in point (b) of Section 1 continue to be fulfilled;
            
            
               (b)for the first 2 consecutive years following granting of the status random annual surveillance based on a representative sampling of all establishments where bovine animals are kept must be carried to demonstrate yearly with a 95% level of confidence, that:
            
            
               (i)at least 99.8% of the establishments, representing at least 99.9% of the bovine population are free from infection with MTBC;
            
            
               (ii)the incidence rate of establishment confirmed infected during the year does not exceed 0.1%; 
            
            
               (c)if the conditions in point (b) were fulfilled for 2 consecutive years, the surveillance must be based on:
            
         
         
            
               (i)random annual surveillance to demonstrate at least with a confidence level of 95%, that the incidence rate of establishment confirmed infected during the year does not exceed 0.1%; or
            
            
               (ii)risk based annual surveillance is carried out to detect infection with MTBC, taking into account the systems of production, the risk factors identified, including spread of infection from other animals than kept bovine animals and intensification of surveillance in establishments associated with at least one of the specific risk referred to in point 1(d) of Section 2 of Chapter 1.
            
            
               2.The status of a Member State or a zone free from infection with MTBC is not affected by the confirmation of infection MTBC in other animal population than kept bovine animals, provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with MTBC to kept bovine animals.
            
            
               Part III
               Enzootic Bovine Leukosis
            
            
               Chapter 1
                  Establishment free from Enzootic Bovine Leukosis 
            
            
               Section 1
                  Granting of the status
            
            
               1.The status free from Enzootic Bovine Leukosis (EBL) may only be granted to an establishment keeping bovine animals if
            
            
               (a)during the past 24 months there has been no confirmed case of EBL in bovine animals kept in the establishment; 
            
            
               (b)during the past 12 months, the bovine animals older than 24 months of age kept in the establishment have tested negative to a serological test, on at least two occasions at an interval of not less than 4 months; 
            
            
               (c)since the beginning of the sampling referred to in point (b), all bovine animals introduced into the establishment: 
            
            
               (i)originate from establishments free from EBL; or
            
            
               (ii)originate from establishments where there has been no evidence of EBL either clinical, post-mortem, or as a result of a diagnostic test for EBL within the 24 months prior to their dispatch; and 
            
            
               –if over 24 months of age,
            
            
               they have been subjected to serological tests, with negative results, on two occasions at an interval of not less than 4 months while kept in isolation from the other bovine animals of the establishment; or
            
            
               they have been subjected to a serological test, with a negative result, within 30 days prior to introduction provided all bovine animals have been tested in accordance with point (b); 
            
            
               –if less than 24 months of age, 
            
            
               they were born to dams, which have been subjected to a serological test for EBL, with negative results, carried out on samples taken during the past 12 months on two occasions at an interval of not less than 4 months.
            
            
               (d)since the beginning of the sampling referred to in point (b), all germinal products of bovine animals introduced into the establishment originate from: 
            
            
               (i)establishments free from EBL; or
            
            
               (ii)approved germinal product establishments.
            
         
         
            
               2.By way of derogation from point 1, the status free from EBL may be granted to an establishment if all bovine animals originate from establishments free from EBL located either in a Member State or zone free from EBL or in a Member State or zone covered by an approved eradication programme.
            
            
               Section 2
                  Maintenance of the status
            
            
               The status free from EBL of an establishment keeping bovine animals may only be maintained if:
            
            
               (a)the requirements laid down in points (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled;
            
            
               (b)serological testing for EBL is carried out, with negative results, 
            
            
               (i)on samples taken at intervals of not more than 36 months from all bovine animals over 24 months of age; or
            
            
               (ii)if the establishment is located in a Member State or zone free from EBL in accordance with in points (b) or (c) of Section 2 of Chapter 2, as relevant. 
            
            
               Section 3
                  Suspension and restoring of the status 
            
            
               1.The status free from EBL of an establishment keeping bovine animals must be suspended if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled; 
            
            
               (b)a case of EBL in a bovine animal which is kept on the establishment is suspected.
            
            
               2.The status free from EBL may only be restored if: 
            
            
               (a)the requirements laid down in points (c) and (d) of point 1 of Section 1 and point (b) of Section 2 are fulfilled;
            
            
               (b)the results of further investigations permit to rule out the presence of EBL and the status of all suspect cases has been determined.
            
            
               Section 4
                  Withdrawal and regaining of the status 
            
            
               1.The status free from EBL of an establishment keeping bovine animals must be withdrawn if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended; or
            
            
               (b)a case of EBL has been confirmed in a bovine animal kept in the establishment.
            
            
               2.If the status free from EBL has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (c) and (d) of point 1 of Section 1 and point (b) of Section 2 are fulfilled.
            
            
               3.If the status free from EBL has been withdrawn in accordance with point 1(b), it may only be regained if:
            
         
         
            
               (a)any bovine animal presenting a positive test result for EBL and all of their offspring younger than 24 months of age have been removed;
            
            
               (b)all bovine animals over 12 months of age have been tested negative in a serological test, on two occasions at an interval of not less than 4 months, whereat the first test must be carried out on samples not taken earlier than 4 months after the removal of the last confirmed case. 
            
            
               4.By way of derogation from point (3)(a), the offspring of dams which have been tested positive in a serological test for EBL or which have shown lesions of EBL may be kept in the establishment if 
            
            
               (a)they have been separated from the dam immediately after calving and tested negative in a PCR test, on two occasions whereat the first sample must be taken within the period of 3 to 5 weeks and the second within 8 to 10 weeks postpartum; and
            
            
               (b)they remain in the establishment until they are 24 months of age and are tested negative in a serological test, or they are sent before that test directly to the slaughterhouse in accordance with the requirements laid down in Article 27(4).
            
            
               Chapter 2
               Member State or zone free from infection with EBL
            
            
               Section 1
                  Granting of the status
            
            
               The status free from EBL as regards kept bovine animals may only be granted to a Member State or a zone if:
            
            
               (a)at least 99.8% of the bovine establishments are free from EBL;
            
            
               (b)all bovine animals over 24 months of age slaughtered within this Member State or zone are subjected to an official post-mortem examination at which all tumours which could be due to the EBL are sent for laboratory examination to confirm or rule out the presence of EBL.
            
            
               Section 2
                  Maintenance of the status
            
            
               The status free from EBL as regards kept bovine animals of a Member State or a zone may only be maintained if: 
            
            
               (a)the requirement set out in point (b) of Section 1 continues to be fulfilled; 
            
            
               (b)during the first 5 years after the granting of the status free from EBL, surveillance is carried out based on:
            
            
               (i)annual random sampling to detect at least, with a 95% level of confidence, establishments infected with EBL at a target prevalence rate of 0.2%; or
            
            
               (ii)serological testing of all bovine animals over 24 months of age on at least one occasion;
            
            
               (c)following the first 5 years after the granting of the status free from EBL, surveillance is carried out to demonstrate the absence of infection, taking into account the systems of production and the risk factors identified. 
            
            
               
            
               Part IV
               Infectious bovine rhinotracheitis / infectious pustular vulvovaginitis 
            
            
               Chapter 1
                  Establishment free from infectious bovine rhinotracheitis / infectious pustular vulvovaginitis 
            
         
         
            
               Section 1
                  Granting of the status
            
            
               1.The status free from infectious bovine rhinotracheitis / infectious pustular vulvovaginitis (IBR/IPV) may only be granted to an establishment keeping bovine animals if:
            
            
               (a)during the past 12 months there has been no confirmed case of IBR/IPV in bovine animals kept in the establishment;
            
            
               (b)during the past 2 years none of the bovine animals kept in the establishment has been vaccinated against IBR/IPV; 
            
            
               (c)the bovine animals kept in the establishment have been subjected to at least one of the following testing regimes taking into account previous DIVA vaccinations whereat serological tests for the detection of antibodies against whole BoHV-1 or antibodies against BoHV-1-gE, as necessary, have been carried out on:
            
            
               (i)a blood, milk or meat juice sample taken from each bovine animal over a period of not more than 12 months; or
            
            
               (ii)blood, milk or meat juice samples taken on at least two occasions at an interval of not less than 2 and not more than 12 months from
            
            
               –all female bovine animals over 12 months of age, and 
            
            
               –all male bovine animals used or intended for breeding over 12 months of age, and
            
            
               –a random sample of male animals not intended for breeding over 12 months of age. The number of animals tested must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 10%; or
            
            
               (iii)in the case of an establishment in which at least 30 % of the bovine animals are lactating, 
            
            
               –bulk milk samples taken on at least three occasions at intervals of not less than 3 months from lactating female bovine animals representing all epidemiological units of the establishment, and 
            
            
               –blood samples taken from all non-lactating female bovine animals over 12 months of age, and from all male bovine animals used or intended for breeding over 12 months of age, and 
            
            
               –a random blood or meat juice sample taken from male bovine animals not intended for breeding older than 12 months of age. The number of animals tested must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 10%; or
            
            
               (iv)in the case of an establishment in which less than 5% of the kept bovine animals are male and at least 95 % of the female animals over 24 months are intended or used for milk production, bulk milk samples taken on at least six occasions at intervals of not less than 2 months from lactating female bovine animals representing all epidemiological units of the establishment;
            
            
               (d)since the beginning of the sampling referred to in point (c) all bovine animals introduced into the establishment:
            
            
               (i)originate from establishments free from IBR/IPV and, in case the establishments of origin are located in a Member State or zone which is neither free from IBR/IPV nor covered by an approved eradication programme, have tested negative in a serological test for the detection of antibodies against whole BoHV-1 or antibodies against BoHV-1-gE, as necessary, on a sample taken after their introduction and before the granting of the status free from IBR/IPV; or
            
            
               (ii)have been subjected to quarantine prior to their introduction and have tested negative in serological test for the detection of antibodies against whole BoHV-1 on a sample taken not earlier than 21 days after the beginning of the quarantine; and
            
            
               (e)since the beginning of the sampling referred to in point (c) all germinal products of bovine animals introduced into the establishment originate from:
            
            
               (i)establishments free from IBR/IPV; or
            
         
         
            
               (ii)approved germinal product establishments.
            
            
               2.By way of derogation from point 1, the status free from IBR/IPV may be granted to an establishment if all bovine animals originate from establishments free from IBR/IPV located either in a Member State or zone free from IBR/IPV or in a Member State or zone under an approved eradication programme, provided they fulfil the requirements set out in point (c) and (d) of Section 2, as relevant.
            
            
               Section 2
                  Maintenance of the status
            
            
               The status free from IBR/IPV may only be maintained in an establishment keeping bovine animals if:
            
            
               (a)the requirements laid down in points (a), (b) and (e) of point 1 of Section 1 continue to be fulfilled; 
            
            
               (b)serological testing for the detection of antibodies against whole BoHV-1 or antibodies against BoHV-1-gE, as necessary, is carried out, taking into account previous vaccinations with a DIVA vaccine, with negative results, 
            
            
               (i)on blood, milk or meat juice samples taken annually from all bovine animals older than 24 months of age; or
            
            
               (ii)in the case of an establishment, in which at least 30% of the bovine animals are lactating, at least annually on
            
            
               –bulk milk samples taken on at least three occasions at intervals of not less than 3 months from lactating female bovine animals representing all epidemiological units of the establishment, and 
            
            
               –blood samples taken from all breeding male bovine animals older than 24 months of age; or, 
            
            
               (iii)in the case of an establishment, in which less than 5% of the kept bovine animals are male and at least 95 % of the female animals over 24 months are intended or used for milk production, at least annually on bulk milk samples taken on at least six occasions at intervals of not less than 2 months from lactating female bovine animals representing all epidemiological units of the establishment; or 
            
            
               (iv)provided the status free from IBR/IPV has been maintained for the past consecutive 3 years, annually on blood or milk samples taken from a number of bovine animals that must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 10%; or 
            
            
               (v)if the establishment is located in a Member State or zone free from IBR/IPV, on samples taken in accordance with point 1(b) of Section 2 of Chapter 2 or point 3 of Section 2 of Chapter 2, as relevant. 
            
            
               (c)only bovine animals which have not been vaccinated against infection with IBR/IPV are introduced into the establishment if it is located in a Member State or zone:
            
            
               (i)free from IBR/IPV; or
            
            
               (ii)where a vaccination ban is in place as part of the eradication strategy under an approved eradication programme.
            
            
               (d)all bovine animals which are introduced fulfil the requirements laid down in point 1(d)(ii) of Section 1 or originate from establishments free from IBR/IPV and have tested negative in a serological test for the detection of antibodies against whole BoHV-1 or antibodies against BoHV-1-gE, as necessary, on a sample taken in the establishments of origin within 15 days prior to their dispatch, in case where:
            
            
               (i)the establishment is located in a Member State or zone free from IBR/IPV and the establishments of origin are not located in a Member State or zone free from IBR/IPV; or
            
            
               (ii)the establishment is located in a Member State or zone covered by an approved eradication programme and the establishments of origin are located in a Member State or zone which is neither free from IBR/IPV nor covered by an approved eradication programme.
            
            
               Section 3
                  Suspension and restoring of the status
            
         
         
            
               1.The status free from IBR/IPV of an establishment keeping bovine animals must be suspended if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled; 
            
            
               (b)a case of IBR/IPV is suspected in a bovine animal kept in the establishment.
            
            
               2.The status free from IBR/IPV may only be restored if: 
            
            
               (a)the requirements laid down in points (1) (b) and (e) of Section 1 and point (b), (c) and (d) of Section 2 are fulfilled.
            
            
               (b)the results of further investigations permit to rule out the presence of IBR/IPV and the status of all suspect cases has been determined.
            
            
               Section 4
                  Withdrawal and regaining of the status 
            
            
               1.The status free from IBR/IPV of an establishment keeping bovine animals must be withdrawn if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
            
            
               (b)a case of IBR/IPV has been confirmed in a bovine animal kept in the establishment.
            
            
               2.If the status free from IBR/IPV has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (b) and (e) of point 1 of Section 1 and points (b), (c) and (d) of Section 2 are fulfilled.
            
            
               3.If the status free from IBR/IPV has been withdrawn in accordance with point 1(b), it may only be regained if: 
            
            
               (a)all confirmed cases have been removed;
            
            
               (b)at least one of the testing regimes laid down in point 1(c) of Section 1 has been carried out with negative results on samples which have been taken not earlier than 30 days after the removal of the last confirmed case. 
            
            
               Chapter 2
               Member State or zone free from IBR/IPV 
            
            
               Section 1
                  Granting of the status
            
            
               The status free from IBR/IPV as regards kept bovine animals may only be granted to a Member State or a zone if
            
            
               (a)vaccination against IBR/IPV has been prohibited for kept bovine animals;
            
            
               (b)at least 99.8 % of the establishments representing at least 99.9% of the corresponding bovine population are free from IBR/IPV.
            
            
               Section 2
                  Maintenance of the status
            
         
         
            
               1.The status free from IBR/IPV as regards kept bovine animals of a Member State or a zone may only be maintained if:
            
            
               (a)the requirements laid down in Section 1 continue to be fulfilled; 
            
            
               (b)surveillance is carried out annually based on random sampling that must allow at least the detection, with a 95% level of confidence, of the infection of establishments with BoHV-1 at a target prevalence rate of 0.2% of the establishments or of BoHV-1 infected bovine animals with at a target prevalence rate of 0.1% of the bovine population.
            
            
               2.By way of derogation from point 1(a), the use of DIVA vaccination may be authorised by the competent authority in the event of an outbreak, if 
            
            
               (a)the result of the epidemiological investigation according to Article 25 has demonstrated that only a limited number of establishments were involved in the outbreak;
            
            
               (b)its use is limited to control this outbreak as deemed necessary by the competent authority;
            
            
               (c)the bovine animals are DIVA vaccinated under the supervision of the competent authority and the use of the DIVA vaccines is documented for each animal;
            
            
               (d)the DIVA vaccinated bovine animals are only moved directly to a slaughterhouse or to an establishment in another zone or Member State where no vaccination ban is in place.
            
            
               3.By way of derogation from point 1(b), surveillance may be carried out to demonstrate yearly the absence of BoHV-1 infection taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 5 consecutive years following the granting of the status free from IBR/IPV in this Member state or zone. 
            
            
               Part V
                  Infection with Aujeszky's Disease
            
            
               Chapter 1
                  Establishment free from infection with Aujeszky's disease virus 
            
            
               Section 1
                  Granting of the status
            
            
               1.The status free from infection with Aujeszky's disease virus (ADV) may only be granted to an establishment keeping porcine animals if:
            
            
               (a)during the past 12 months there has been no confirmed case of infection with ADV in porcine animals kept in the establishment; 
            
            
               (b)during the past 12 months none of the porcine animals kept in the establishment has been vaccinated against AD; 
            
            
               (c)during the past 12 months, the porcine animals kept in the establishment have been subjected to one of the following testing regimes taking into account previous DIVA vaccinations whereat serological tests for the detection of antibodies against ADV or antibodies against ADV-gE, as necessary, have been carried out, with negative results, on:
            
            
               (i)a blood or meat juice sample taken from each porcine animal; or
            
            
               (ii)blood or meat juice samples taken on two occasions at an interval of 2 to 3 months from a number of animals that must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 10%. 
            
            
               (d)since the beginning of the sampling referred to in point (c), all porcine animals introduced into the establishment:
            
            
               (i)originate from establishments free from infection with ADV and, in case the establishments of origin are located in a Member State or zone which is neither free from infection with ADV nor covered by an approved eradication programme, have tested negative in a serological test for the detection of antibodies against whole ADV or antibodies against ADV-gE, as necessary, after their introduction and before the granting of the status free from infection with ADV; or 
            
         
         
            
               (ii)have been subjected to quarantine for a period of at least 30 days prior to their introduction and have tested negative in a serological test for the detection of antibodies against whole ADV, on two occasions at an interval of not less than 30 days between collection of each sample. The sample for the last test must be taken within 15 days prior to dispatch.
            
            
               (e)since the beginning of the sampling referred to in point (c) all germinal products from porcine animal introduced in the establishmentoriginate from :
            
            
               (i)establishments free from infection with ADV; or
            
            
               (ii)approved germinal product establishments.
            
            
               2.By way of derogation from point 1, the status free from infection with ADV may be granted to an establishment if all porcine animals originate from establishments free from infection with ADV located either in a Member State or zone free from infection with ADV or in a Member State or zone covered by an approved eradication programme, provided they fulfil the requirements set out in point (d) of Section 2, as relevant.
            
            
               Section 2
                  Maintenance of the status
            
            
               The status free from infection with ADV of an establishment keeping porcine animals may only be maintained if:
            
            
               (a)the requirements laid down in points (a), (b) and (e) of point 1 of Section 1 continue to be fulfilled; 
            
            
               (b)serological testing is carried out, with negative results, on a representative number of blood or meat juice samples taken from the porcine animals kept in the establishment, to verify the absence of infection with ADV based on a testing regime that takes into account the production cycle and the risk of introduction of ADV, 
            
            
               (i)at least once a year, in case all kept porcine animals are not vaccinated against AD, with tests for the detection of antibodies against whole ADV; or 
            
            
               (ii)at least twice a year, with tests for the detection of antibodies against whole ADV and tests for the detection of antibodies against ADV-gE, as necessary;
            
            
               (c)provided the establishment is located in a Member State or zone free from ADV, the serological testing referred to in point (b) is carried out, as required, in accordance with the surveillance provided for in point 1(b) of Chapter 2 of Section 2 or point 4 of Section 2 of Chapter 2, as relevant.
            
            
               (d)all porcine animals, which are introduced 
            
            
               (i)fulfil the requirements set out in point 1(d)(ii) of Section 1; or 
            
            
               (ii)originate from establishments free from infection with ADV and have been subjected to a serological test for antibodies against whole ADV, with a negative result, on a sample collected in the establishments of origin within 15 days prior to their dispatch, in case where
            
            
               –the establishment is located in a Member State or zone free from ADV and the establishments of origin are not located in a Member State or zone free from ADV; or
            
            
               –the establishment is located in a Member State or zone covered by an approved eradication programme and the establishments of origin are located in a Member State or zone which is neither free from ADV nor covered by an approved eradication programme.
            
            
               The number of porcine animals tested must allow at least the detection, with 95% level of confidence, of seropositive animals at a target prevalence rate of 10%. 
            
            
               By way of derogation of the first subparagraph, for porcine animals less than 4 months old descending from DIVA-vaccinated mothers the serological test for the detection of antibodies against ADV-gE may be used.
            
            
               Section 3
                  Suspension and restoring of the status 
            
         
         
            
               1.The status free from infection with ADV of an establishment keeping porcine animals must be suspended if:
            
            
               (a)one or more of the requirements laid down Section 2 are no longer fulfilled; 
            
            
               (b)a case of infection with ADV is suspected in a porcine animal kept in the establishment.
            
            
               2.The status free from infection with ADV may only be restored if: 
            
            
               (a)the requirements laid down in points (b) and (e) of point 1 of Section 1 and point (b) or (c), as relevant, and (d) of Section 2 are fulfilled.
            
            
               (b)the results of further investigations permit to rule out infection with ADV and the status of all suspect cases has been determined.
            
            
               Section 4
                  Withdrawal and regaining of the status 
            
            
               1.The status free from infection with ADV of an establishment keeping porcine animals must be withdrawn if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended; 
            
            
               (b)a case of infection with ADV has been confirmed in a porcine animal kept in the establishment. 
            
            
               2.If the status free from infection with ADV has been withdrawn in accordance with point 1(a), it may only be regained if the requirements set out in points (b) and (e) of point 1 of Section 1 and point (b) or (c), as relevant, and (d) of Section 2 are fulfilled.
            
            
               3.If the status free from infection with ADV has been withdrawn in accordance with point 1(b), it may only be regained, if all porcine animals of the establishment have been removed.
            
            
               Chapter 2
               Member State or zone free from infection with Aujeszky's disease virus 
            
            
               Section 1
                  Granting of the status
            
            
               The status free from infection with ADV as regards kept porcine animals may only be granted to a Member State or a zone if:
            
            
               (a)vaccination against AD has been prohibited for kept porcine animals for the previous 12 months; 
            
            
               (b)surveillance has been carried out to demonstrate that no establishment in the respective Member State or zone has had any clinical, virological or serological evidence of infection with AD for at least the previous 24 months; 
            
            
               (c)in case, infection with ADV is known to be established in wild porcine animals, measures have been implemented to prevent any transmission of the ADV from wild to kept porcine animals.
            
            
               Section 2
                  Maintenance of the status
            
            
               1.The status free from infection with ADV as regards kept porcine animals of a Member State or a zone may only be maintained if:
            
         
         
            
               (a)the requirements defined in points (a) and (c) of Section 1 continue to be fulfilled; 
            
            
               (b)surveillance is carried out annually based on random sampling to allow at least the detection, with a 95% level of confidence, of establishments infected with ADV at a target prevalence rate of 0.2%. The number of blood or meat juice samples to be taken from the porcine animals kept in an establishment must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 20% .
            
            
               2.By way of derogation from point 1, the status free from infection with ADV in the porcine population of a Member State or zone may be maintained in the event of an outbreak, if:
            
            
               (a)all the porcine animals in the affected establishments have been removed; 
            
            
               (b)an epidemiological investigation including clinical examination and serological or virological testing has been carried out by the competent authority 
            
            
               (i)in all establishments keeping porcine animals which have been directly or indirectly in contact with the infected establishment; and
            
            
               (ii)in all establishments keeping porcine animals located at least within a 2-kilometre radius of an infected establishment, demonstrating that these establishments are not infected. The number of blood or meat juice samples to be taken from porcine animal kept in these establishments must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 10%; or
            
            
               (iii)in case DIVA vaccination has been used, a serological testing for antibodies against ADV-gE has been carried out on two occasions at an interval of 2 months within the vaccinated radius from the infected establishment to demonstrate the absence of infection. 
            
            
               (c)the result of the investigation according to point (b) has demonstrated that only a limited number of establishments were involved in the outbreak;
            
            
               (d)the relevant control measures as referred to in Article 24 have been immediately implemented on each establishment infected with ADV and including as necessary vaccination with DIVA vaccines.
            
            
               3.By way of derogation from point (a) of Section 1, the use of DIVA vaccination may be authorised by the competent authority in the event of an outbreak referred to in point 2, if 
            
            
               (a)its use is limited to control this outbreak as deemed necessary by the competent authority;
            
            
               (b)the porcine animals are DIVA vaccinated under the supervision of the competent authority and the use of the DIVA vaccines is documented for each animal; 
            
            
               (c)the DIVA vaccinated porcine animals are only moved directly to a slaughterhouse or to an establishment in another Member State or zone where no vaccination ban is in place.
            
            
               4.By way of derogation from point 1(b), surveillance may be carried out to demonstrate annually the absence of ADV infection taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 2 consecutive years following the granting of the status free from infection with ADV in this Member state or zone. 
            
            
               Part VI
               Bovine Viral Diarrhoea
            
            
               Chapter 1
                  Establishment free from Bovine Viral Diarrhoea 
            
            
               Section 1
                  Granting of the status
            
            
               1.The status free from bovine viral diarrhoea (BVD) may only be granted to an establishment keeping bovine animals if:
            
            
               (a)during the past 18 months there has been no confirmed case of BVD in a bovine animal kept in the establishment;
            
         
         
            
               (b)the bovine animals kept in the establishment have been subjected to at least one of the following testing regimes taking into account possible previous vaccinations:
            
            
               (i)tests for the detection of BVD virus (BVDV) antigen or genome have been carried out, with negative results, on samples of all bovine animals. 
            
            
               In case of calves born during at least the previous 12 months, the samples must have been taken after or at the same time as official identification, but not later than 20 days postpartum. The dams of those calves with negative test results do not need to be tested.
            
            
               (ii)serological tests for the detection of antibodies against BVDV have been carried out, with negative results, on samples taken over a period of not less than twelve months on at least three occasions at intervals of not less than four months from bovine animals which have been kept in the establishment for at least three months prior to testing. 
            
            
               The number of animals tested must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 50% and must be at least five animals or all the animals if there are fewer than five animals kept. 
            
            
               In case the bovine animals of the establishment are kept in separate groups without direct contact with each other, a respective number of samples from animals of each group must be tested.
            
            
               (iii)a combination of the testing regimes set out in point (i) and (ii) has been applied over a period of not less than 12 months. 
            
            
               The capacity of the combined testing regime to detect the disease must be equivalent to that of the testing regimes referred to in point (i) and (ii). 
            
            
               (c)since the beginning of the sampling referred to in point (1) (b) all bovine animals introduced into the establishment: 
            
            
               (i)originate from establishments free from BVD located in a Member State or zone free from BVD; or
            
            
               (ii)originate from establishments free from BVD, where
            
            
               –serological tests referred to in point 1(c) (ii) or (iii) of Section 2 of Chapter 1 have been carried out, with negative results, within the past 4 months; or 
            
            
               –they have been tested individually to exclude BVDV infection prior to their dispatch; or
            
            
               (iii)have tested negative in a test for BVDV antigen or genome, and
            
            
               –have been subjected to quarantine for a period of at least 21 days prior to their dispatch and, in case of pregnant dams, tested negative for antibodies against BVDV on samples taken after not less than 21 days of quarantine; or
            
            
               –have tested positive for antibodies against BVDV either prior to their dispatch or, in case of pregnant dams, before insemination preceding the current gestation;
            
            
               (d)since the beginning of the sampling referred to in point 1(b) only germinal products of bovine animals have been introduced into the establishment which originate:
            
            
               (i)from establishments free from BVD; or
            
            
               (ii)from approved germinal product establishments.
            
            
               2.By way of derogation from point 1 the status free from BVD may be granted to an establishment if:
            
         
         
            
               (a)all bovine animals originate from establishments free from BVD located in a Member State or zone free from BVD or in a Member State or zone covered by an approved eradication programme and fulfil the requirements laid down in point 1(c), as relevant; or
            
            
               (b)all bovine animals originate from establishments free from BVD, are not intended for breeding and the status free from BVD of the establishment is maintained in accordance with point 2 of Section 2;
            
            
               Section 2
                  Maintenance of the status
            
            
               1.The status free from BVD of an establishment keeping bovine animals may only be maintained if:
            
            
               (a)the requirements laid down in point (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled; 
            
            
               (b)no bovine animal has been vaccinated against BVD since the status free from BVD has been granted to the establishment;
            
            
               (c)at least one of the following testing regimes is carried out with negative results:
            
            
               (i)each new-born calf is tested negative for BVDV antigen or genome on a sample taken after or at the same time as official identification, but not later than 20 days postpartum; 
            
            
               (ii)serological tests for the detection of antibodies against BVDV are carried out at least annually on samples taken from bovine animals which have been kept in the establishment for at least three months prior to testing. 
            
            
               The number of animals tested must allow at least the detection, with a 95% level of confidence, of seropositive animals at a target prevalence rate of 50% and must be at least five animals or all the animals if there are fewer than five animals kept; 
            
            
               In case the bovine animals of the establishment are kept in separate groups without direct contact with each other, a respective number of samples from animals of each group must be tested.
            
            
               (iii)a combination of the testing regimes laid down in point (i) and (ii) is applied.
            
            
               The capacity of the combined testing regime to detect the disease must be equivalent to that of the testing regimes referred to in points (i) and (ii); 
            
            
               (iv)if the establishment is located in a Member State or zone free from BVD, tests are carried out on samples taken in accordance with point 1(b) of Section 2 of Chapter 2 or point 3 of Section 2 of Chapter 2, as relevant. 
            
            
               (d)only bovine animals which have not been vaccinated against BVD are introduced into the establishment if it is located in a Member State or zone free from BVD.
            
            
               2.By way of derogation from point 1, the status free from BVD of an establishment referred to in point 2(b) of Section 1 may be maintained without testing the bovine animals in accordance with point 1(c) if 
            
            
               (a)the requirements laid down in point 2(b) of Section 1 continue to be fulfilled; 
            
            
               (b)they are not used for breeding; 
            
            
               (c)they have no contact to animals which are intended or used for breeding and are moved from this establishment to a slaughterhouse, either directly, or via an assembly operation carried out in the same Member State or zone, where only animals from establishments referred to in this point are assembled.
            
            
               Section 3
                  Suspension and restoring of the status
            
         
         
            
               1.The status free from BVD of an establishment keeping bovine animals must be suspended if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled; 
            
            
               (b)a case of BVD is suspected in a bovine animal kept in the establishment.
            
            
               2.The status free from BVD may only be restored if: 
            
            
               (a)the requirements laid down in points (c) and (e) of point 1 of Section 1 and points (b), (c), (d) of point 1 and, as relevant, point 2 of Section 2 are fulfilled.
            
            
               (b)the results of further investigations permit to rule out the presence of BVD and the status of all suspect cases has been determined.
            
            
               Section 4
                  Withdrawal and regaining of the status
            
            
               1.The status free from BVD of an establishment keeping bovine animals must be withdrawn if:
            
            
               (a)one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended; 
            
            
               (b)a case of BVD has been confirmed in a bovine animal kept in the establishment.
            
            
               2.If the status free from BVD has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (c) and (e) of point 1 of Section 1 and points (b), (c), (d) of point 1 and, as relevant, point (2) of Section 2 are fulfilled.
            
            
               3.If the status free from BVD has been withdrawn in accordance with point 1(b), it may only be regained if: 
            
            
               (a)all animals tested positive for BVDV have been removed; 
            
            
               (b)the status in relation to infection with BVDV of each bovine animal kept in the establishment has been determined;
            
            
               (c)all calves which might have been infected in utero with BVDV were born and kept in isolation until tested negative for BVDV antigen or genome.
            
            
               Chapter 2
                  Member State or zone free from Bovine Viral Diarrhoea
            
            
               Section 1
                  Granting of the status
            
            
               The status free from BVD as regards kept bovine animals may only be granted to a Member State or a zone if:
            
            
               (a)vaccination against BVD has been prohibited for kept bovine animals;
            
            
               (b)no case of BVD has been confirmed in a kept bovine animal for at least the previous 18 months;
            
         
         
            
               (c)at least 99.8% of the establishments representing at least 99.9% of the bovine population are free from BVD.
            
            
               Section 2
                  Maintenance of the status
            
            
               1.The status free from BVD as regards kept bovine animals of a Member State or a zone may only maintained if:
            
            
               (a)the requirements laid down in point (a) and (c) of Section 1 continue to be fulfilled. 
            
            
               (b)surveillance is carried out annually that must allow at least the detection, with a 95% level of confidence, of establishments infected with BVDV at a target prevalence rate of 0.2% of the establishments or of BVDV infected bovine animals with a target prevalence rate of 0.1% of the bovine population.
            
            
               2.By way of derogation from point 1(a), the use of vaccination may be authorised by the competent authority in the event of an outbreak, if 
            
            
               (a)the results of the epidemiological investigation according to Article 25 have demonstrated that only a limited number of establishments were involved in the outbreak;
            
            
               (b)only a limited number of bovine animals deemed necessary by the competent authority to control this outbreak are vaccinated under the supervision of the competent authority and the use of vaccination is documented accordingly for each animal.
            
            
               3.By way of derogation from point 1(b), surveillance may be carried out to demonstrate annually the absence of BVD taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 5 consecutive years following the granting of the status free from BVD in this Member state or zone.
            
            
               ANNEX V
            
            
               DISEASE SPECIFIC REQUIREMENTS FOR THE GRANTING AND MAINTENANCE OF THE DISEASE-FREE STATUS AT THE LEVEL OF MEMBER STATES OR ZONES
            
            
               Part I
               Infection with rabies virus
            
            
               Chapter 1
                  Technical requirements for the vaccination against rabies
            
            
               Section 1
                  Vaccination of kept animals
            
            
               1.For the purpose of eradication programmes against infection with rabies virus (RABV), anti-rabies vaccination must only be carried out on pet animals that are identified and must fulfil the requirements laid down in Annex III to Regulation (EU) No 576/2013 of the European Parliament and of the Council
                  1
               .
            
            
               2.For the purpose of eradication programmes against infection with RABV, anti-rabies vaccination of kept animals, other than those referred to in the first paragraph, must be risk-based and carried out with the purpose of protecting humans from being exposed to rabies virus, using vaccines that meet the requirements laid down in points (1)(a) and (1)(b)of Annex III to Regulation (EU) No 576/2013 of the European Parliament and of the Council.
            
            
               Section 2
                  Vaccination of wild animals 
            
            
               1.For the purpose of eradication programmes against infection with RABV the oral vaccination against infection with RABV of wildlife must: 
            
            
               (a)be organised and implemented as regular planned or emergency campaigns taking into account the risk assessment provided in point (a) of Article 32(2);
            
            
               (b)be subjected to an adequate vaccine distribution in terms of density coverage in time and in size of the vaccination area, taking into account the biology of the targeted animal population, the epidemiological situation and the topography of the area;
            
         
         
            
               (c)be subjected, with the support of geographical information systems, to assessment of the correct bait distribution with a frequency that allows, if necessary, the adoption of corrective measures;
            
            
               (d)be subjected to monitoring of vaccination effectiveness, that may include the detection of the presence of biomarker and serological testing in shot animals from targeted animal population for the vaccination.
            
            
               2.For the purpose of eradication programmes against infection with RABV the vaccination against infection with RABV of stray dog populations must:
            
            
               (a)be organised and implemented, as necessary, as part of control and management measures of stray dog populations, taking into account the risk assessment provided for in point (a) of Article 32(2);
            
            
               (b)comply with the requirements of Section 1. 
            
            
               Chapter 2
                  Member State or zone free from infection with rabies virus
            
            
               Section 1
                  Granting of the status
            
            
               1.The status free from infection with RABV may only be granted to a Member State or a zone if:
            
            
               (a)surveillance has been implemented in accordance with the principles laid down in Articles 3 to 9 at least for the past 24 months; and
            
            
               (b)no case of infection with RABV has been confirmed during the past 24 months in the targeted animal population.
            
            
               2.By way of derogation from point 1(b), if a case of infection with RABV has been confirmed, the status may be granted if the infection of the case did not occur in the Member State or in the zone; and
            
            
               (a)the case has been officially confirmed in such conditions that no epidemiological link may have occurred and resulted in any additional case, which includes detection of the case at a border control post, or in a quarantine establishment or the quarantine facilities of a confined establishment; or
            
            
               (b)epidemiological link may have occurred and no additional case was detected by intensified surveillance and epidemiological investigations during the six months following the death of the case. 
            
            
               Section 2
                  Maintenance of the status
            
            
               The status free from infection with RABV of a Member State or a zone may only be maintained if
            
            
               (a)surveillance is implemented in accordance with the principles laid down in Articles 3 to 9 ; and
            
            
               (b)no case of infection with RABV has been confirmed in the targeted animal population or a case occurred and the conditions laid down in point 2 of Section 1 were complied with.
            
            
               Part II
                  Infection with Bluetongue virus (serotypes 1-24)
            
            
               Chapter 1
                  Minimum requirements for the surveillance
            
            
               Section 1
                  Surveillance for the detection of serotypes of Bluetongue virus not reported in the previous two years
            
         
         
            
               1.The surveillance of infection with Bluetongue virus (serotypes 1-24) (infection with BTV) to ensure the capacity of early detection of introduction or recurrence of infection with any serotypes 1 to 24 of BTV that were not reported during the previous 2 years must include:
            
            
               (a)the general surveillance as provided for in point (a) of Article 3(1);
            
            
               (b)the active surveillance as provided for in Section 4.
            
            
               2.The design of the surveillance provided for in point 1 must address: 
            
            
               (a)the risk of infection with limited clinical manifestations;
            
            
               (b)the risk of introduction of BTV serotypes associated with the neighbouring circulation of any serotypes 1 to 24 of BTV; 
            
            
               (c)any other identified relevant risk factor for introduction of any serotype 1 to 24 of BTV not reported in the previous 2 years.
            
            
               3.The surveillance in area(s) adjacent to any infected Member State, zone, or third country must be intensified on an area of up to 150 kilometres from the limit with the Member State, zone, or third country. The limit of the area of intensified surveillance may be adapted to relevant ecological or geographical features likely to facilitate or interrupt the transmission of BTV or disease control measures that supports a greater or lesser distance.
            
            
               4.The surveillance provided for in point 1 (b) and point 3 must have the capacity at least to detect, with a 95% level of confidence, the infection in the targeted animal population at a target prevalence rate of 5%, unless otherwise specified in Section 2 of Chapter 4.
            
            
               Section 2
               Surveillance to determine the extent of infection with BTV 
            
            
               1.The surveillance of infection with BTV to ensure the timely demarcation of the geographical extent of the infection when one or more serotypes of BTV is present and if relevant to monitor the prevalence rate must include:
            
            
               (a)the general surveillance requirements as provided for in point (a) of Article 3(1);
            
            
               (b)the active surveillance as provided for in Section 4.
            
            
               2.The design of the surveillance provided for in point 1 must take into account: all available information on the epidemiology of the disease and biology of the vector that prevail on the territory.
            
            
               3.The targeted prevalence rate of the surveillance provided for in point (1) must be adapted to the expected epidemiological situation taking into account the phase of the infection and the main risk factors such as the target animal population and the vector population.
            
            
               Section 3
               Surveillance to demonstrate absence of infection with BTV
            
            
               1.The surveillance of infection with BTV to ensure the design of the surveillance of infection with BTV to demonstrate the absence of infection with any serotypes 1 to 24 that has been previously detected in the territory must include:
            
            
               (a)the general surveillance requirements as provided for in point (a) of Article 3(1);
            
            
               (b)the active surveillance as provided for in Section 4.
            
            
               2.The design of the surveillance provided for in point 1 must address: 
            
         
         
            
               (a)the risk of infection with limited clinical manifestations;
            
            
               (b)all available information on the epidemiology of the disease and biology of the vector that prevail on the territory 
            
            
               (c)any specific risk of persistence of the infection identified. 
            
            
               3.The surveillance provided for in point 1 (b) must have the capacity at least to detect with a 95% level of confidence, the infection in the targeted animal population at a target prevalence rate of 1%.
            
            
               Section 4
                  Requirements for the active surveillance of infection with BTV
            
            
               1.The geographical units referred to in point (a) of Article 40(1) must be based on a grid of 45 km by 45 km and it can be adapted to:
            
            
               (a)the epidemiological situation, the speed of spread of the infection and the shape and size of the zones covered by eradication programme in the event of confirmation of the infection;
            
            
               (b)the zones in accordance with point (b) of Article 13(2).
            
            
               2.The active surveillance must be based on one or a combination of the following activities:
            
            
               (a)monitoring of sentinel animals using serological, or virological testing; 
            
            
               (b)structured prevalence surveys, based on a random or risk based sampling strategy, using serological or virological testing.
            
            
               3.The frequency of the sampling must:
            
            
               (a)at least be annual, in the period of the year when infection or seroconversion is most likely to be detected;
            
            
               (b)be monthly during the vector activity season where regular information is needed due to the risk of extension of the infection. 
            
            
               4.The sampled animals must:
            
            
               (a)not be vaccinated against the serotype(s) of BTV targeted for the surveillance;
            
            
               (b)no longer be covered by maternal immunity in case their mother was vaccinated or infected;
            
            
               (c)be resident for a sufficient time in the relevant geographical unit and had not been protected from exposure to the vector;
            
            
               (d)be representative for the geographical structure of the targeted animal population in the relevant geographical unit;
            
            
               (e)be initially seronegative when the surveillance is based on serological testing of sentinels.
            
         
         
            
               5.The sample size in each geographical unit must be calculated in accordance with the target prevalence rate based on the objectives assigned in Sections 1 to 3.
            
            
               6.When surveillance must be adapted as provided for in point (c) of Article 43(2), it must at least include a survey:
            
            
               (a)in the introduced animals that: 
            
            
               (i)must be based on the sampling and testing of all introduced animals;
            
            
               (ii)must take place as soon as possible after the introduction; or
            
            
               (b)in the targeted animal population the most at risk due to the eventual circulation of the virus that:
            
            
               (i)must have a capacity at least to detect, with a 95% level of confidence, infection with BTV at a target prevalence rate of 5%;
            
            
               (ii)must either: 
            
            
               –not take place before 21 days has elapsed after the introduction of animals if it is a punctual survey; or 
            
            
               –must be conducted with a frequency adapted to the frequency of the movements of the animals that may jeopardize the health status. 
            
            
               This survey is not required if the frequency of the sampling is carried out in accordance with point 3(b).
            
            
               Section 5
                  Entomological surveillance
            
            
               1.Entomological surveillance must consist of at least an active annual programme of vector catching by means of permanently sited aspiration traps intended to determine the population dynamics of the vector and, when relevant the vector-free period.
            
            
               2.Aspiration traps equipped with ultraviolet light must be used in accordance with pre-established protocols; the traps must be operated throughout the night and operate at a rate of at least:
            
            
               (a)one night per week during the month before the expected beginning and during the month before the expected end of the vector-free period;
            
            
               (b)one night per month during the vector-free period.
            
            
               On the basis of the evidence obtained in the three first years of the operation of the aspiration traps, the frequency of operation of those traps may be adjusted.
            
            
               3.At least one aspiration trap must be placed in each geographical unit referred to in point (a) of Article 40(1) all over the seasonally BTV-free zone. A proportion of the midges collected in the aspiration traps must be sent to a specialised laboratory capable of counting and identifying the suspected vector species or complex.
            
            
               4.When organised in the context of determination of a vector-free period, a maximum threshold of Culicoides species must be defined for the interpretation of the results. In the absence of sound evidence supporting the determination of the maximum threshold, total absence of Culicoides imicola specimens and less than five parous Culicoides per trap must be used.
            
            
               Chapter 2
               Movement of animals and germinal products 
            
         
         
            
               Section 1 
                  Movement of animals
            
            
               1.The animals must originate from a Member State or a zone free from infection with BTV and have not been vaccinated with a live vaccine against infection with BTV in the last 60 days before the date of movement.
            
            
               2.The animals must originate from a Member State or a zone covered by eradication programme and at least one of the following requirements must be complied with:
            
            
               (a)the animals must have been kept in a seasonally BTV-free Member State or zone established in accordance with paragraph 3 of Article 40:
            
            
               (i)for at least 60 days prior to the date of movement; 
            
            
               (ii)for at least 28 days prior to the date of movement and must have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the entry of the animal in the seasonally BTV-free Member State or zone; or
            
            
               (iii)for at least 14 days prior to the date of movement and must have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of entry of the animal in the seasonally BTV-free Member State or zone;
            
            
               (b)the animals must have been protected against attacks by the vectors during transportation to the place of destination and they must have been kept protected against attacks by vectors in a vector protected establishment:
            
            
               (i)for at least 60 days prior to the date of movement; or
            
            
               (ii)for at least 28 days prior to the date of movement and must have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the commencement of the period of protection against attacks by vectors; or
            
            
               (iii)for at least 14 days prior to the date of movement and must have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of commencement of the period of protection against attacks by vectors;
            
            
               (c)the animals must have been vaccinated against all the serotypes 1 to 24 of BTV reported during the past 2 years in that Member State or zone, the animals must be still within the immunity period of time guaranteed in the specifications of the vaccine and the animals must meet at least one of the following requirements:
            
            
               (i)they must have been vaccinated more than 60 days before the date of movement; or
            
            
               (ii)they must have been vaccinated with an inactivated vaccine and were subjected to a PCR test, with negative results on samples collected at least 14 days after the onset of the immunity protection set in the specifications of the vaccine; or
            
            
               (d)the animals must have been subjected with positive results to a serological test able to detect specific antibodies against all serotypes 1-24 of BTV reported during the past 2 years in that Member State or zone and:
            
            
               (i)the serological test must have been carried out on samples collected at least 60 days before the date of movement; or
            
            
               (ii)the serological test must have been carried out on samples collected at least 30 days before the date of the movement and the animals must have been subjected to a PCR test, with negative results, carried out on samples collected not earlier than 14 days before the date of movement.
            
            
               3.The animals must originate from a Member State or a zone neither BTV-free nor covered by an eradication programme against infection with BTV and:
            
            
               (a)they must comply with point 2(b); or
            
            
               (b)the animals must have been kept at least for the last 60 days prior to departure either in an area of at least 150 km radius from the establishment where the animals are kept, or in a Member State, where surveillance in compliance with the requirements laid down in Sections 1 and 2 of Chapter 1 must have been carried out at least for the last 60 days prior to departure and:
            
         
         
            
               (i)they must have been vaccinated in accordance with point 2(c) against all the serotypes 1-24 of BTV reported during the past 2 years in an area of at least 150 kilometres radius centred on the place where the animals were kept; or
            
            
               (ii)they must have been immunised in accordance with point 2(d) against all the serotypes 1-24 of BTV reported during the past 2 years in an area of at least 150 kilometres radius centred on the place where the animals were kept. 
            
            
               4.The animals must originate from a Member State or a zone not BTV-free, they must be destined for immediate slaughter and all the following requirements apply:
            
            
               (a)no case of infection with BTV has been reported in the establishment of origin for a period of at least 30 days prior to the date of movement;
            
            
               (b)the animals must be transported directly from the Member States or zone of origin to the slaughterhouse of destination where they must be slaughtered within 24 hours of arrival;
            
            
               (c)the operator of the establishment of origin shall have informed the operator of the slaughterhouse of destination of the movement at least 48 hours prior to the loading of the animals.
            
            
               5.The animals must originate from a Member State or a zone neither BTV-free nor covered by an eradication programme against infection with BTV and the animals must comply with the requirements set out in point 2(a). 
            
            
               6.The animals must originate from a Member State or a zone not BTV-free and: 
            
            
               (a)they must have been protected from attacks of vectors by insecticides or repellents for at least 14 days prior to the date of movement and 
            
            
               (b)they must have been subjected during that period to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of protection from attacks by vector.
            
            
               7.The animals must comply with specific animal health requirements defined by the competent authority to ensure the animals have sufficient immunological protection prior to departure.
            
            
               8.The animals must comply with any of the requirements provided for in points 2, 3 5, 6 or 7 only for the serotypes of BTV reported for the past 2 years in the Member State or zone of origin and not in the Member State or zone of destination during the same period.
            
            
               Section 2
                  Movement of germinal products
            
            
               1.The donor animals must have been kept at least for a period of 60 days prior and during collection of the germinal products in a Member State or a zone free from infection with BTV. 
            
            
               2.The germinal products must originate from a Member State or a zone covered by eradication programme against infection with BTV and at least one of the requirements set out in points (a) for semen, point (b) for in vivo derived embryos of bovine animals or point (c) for embryos other than in vivo derived embryos of bovine animals and oocytes must be complied with.
            
            
               (a)Semen must have been obtained from donor animals which comply with at least one of the following requirements: 
            
            
               (i)they must have been protected against attacks by vectors in a vector protected establishment for a period of at least 60 days before commencement of, and during, collection of the semen;
            
            
               (ii)they must have been kept in seasonally BTV-free Member State or zone thereof for a period of at least 60 days before commencement of collection and during collection of the semen;
            
            
               (iii)they must have been subjected to a serological test, with negative results, on samples collected between 28 and 60 days from the date of each collection of the semen; 
            
            
               (iv)they must have been subjected, with negative results, to a direct diagnostic method carried out on samples collected: 
            
         
         
            
               –at commencement and final collection of the semen to be consigned; and 
            
            
               –during the period of semen collection: at least every seven days, in the case of a virus isolation test, or at least every 28 days, in the case of a PCR.
            
            
               (b)In vivo derived embryos of bovine animals must have been obtained from donor animals which do not show any clinical signs of infection with BTV on the day of collection and collected, processed and stored in accordance with Part 2 of Annex III of Commission Delegated Regulation XXX (germinal products); 
            
            
               (c)Embryos other than in vivo derived embryos of bovine animals and oocytes must have been obtained from donor animals which comply with at least one of the following requirements: 
            
            
               (i)they must have been protected against attacks by vectors in a vector protected establishment for at least 60 days before commencement of, and during, collection of the embryos/oocytes; 
            
            
               (ii)they must have been subjected to a serological test, with negative results, on samples collected between 28 and 60 days from the date of each collection of the embryos/oocytes;
            
            
               (iii)they must have been subjected to a PCR test on samples collected on the day of collection of the embryos/oocytes, with negative results;
            
            
               (iv)they must have been kept in seasonally BTV-free Member State or zone thereof for a period of at least 60 days before collection of the embryos/oocytes. 
            
            
               3.The germinal products must originate from a Member State or a zone neither free nor covered by an eradication programme against infection with BTV and they must comply with the requirements set out either in point 2(a)(i), 2(a)(iii), 2(a)(iv), 2(b), 2(c)(i), 2(c)(ii) or 2(c)(iii). 
            
            
               4.The germinal products must originate from a Member State or a zone neither BTV-free nor covered by an eradication programme against infection with BTV and the germinal products must comply either with point 2(a)(ii) or 2(c)(iv). 
            
            
               Chapter 3
                  Vector protected establishment
            
            
               The status of vector protected establishment may only be granted to an establishment if:
            
            
               (a)it has appropriate physical barriers at entry and exit points;
            
            
               (b)openings must be vector screened with mesh of appropriate gauge which must be impregnated regularly with an approved insecticide according to the manufacturers’ instructions;
            
            
               (c)vector surveillance and control must be carried out within and around the vector protected establishment;
            
            
               (d)measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected establishment;
            
            
               (e)standard operating procedures must be in place, including descriptions of back-up and alarm systems, for operation of the vector protected establishment and transport of animals to the place of loading. 
            
            
               Chapter 4
                  Member State or zone free from infection with BTV
            
            
               Section 1 
               Granting of the status
            
            
               1.The status free from infection with BTV may only be granted to a Member State or to a zone, where BTV has never been reported, if:
            
         
         
            
               (a)surveillance in accordance with Section 1 of Chapter 1 has been conducted at least for the past 24 months; 
            
            
               (b)no case of infection with BTV has been confirmed during the past 24 months in the targeted animal population.
            
            
               2.The status free from infection with BTV may only be granted to a Member State or to a zone, where it has already been reported, if:
            
            
               (a)a surveillance in accordance with Section 3 of Chapter 1 has been conducted at least for the past 24 months; 
            
            
               (b)no case of infection with BTV has been confirmed during the past 24 months in the targeted animal population.
            
            
               Section 2
               Maintenance of the status
            
            
               1.The status free from infection with BTV may only be granted to a Member State or to zone may only be maintained if:
            
            
               (a)the requirements laid down in point 1 of Section 1 are complied with;
            
            
               (b)animals and germinal products from targeted animal population are only moved into or through the Member State or zone when the requirements laid down in Articles 43 and 45 are complied with.
            
            
               2.The intensity and the frequency of the surveillance referred to in point 1 of Section 1 must be timely adapted to:
            
            
               (a)the health status of neighbouring Member States, zone, or third countries, in accordance with point 3 of Section 4 of Chapter 1. 
            
            
               (b)introduction of animals from targeted animal population that may have jeopardized the health status of the Member State or zone, in accordance with point 6 of Section 4 of Chapter 1.
            
            
               3.If no circulation of the infection has been detected for 2 consecutive years following granting of the status free from infection with BTV of a Member State or of a zone, the surveillance must be based on:
            
            
               (a)random annual surveillance at least to detect, with 95% level of confidence, the infection with BTV at a target prevalence rate of 20% ; or
            
            
               (b)risk based annual surveillance to detect infection with BTV carried out taking into account the systems of production and the risk factors identified.
            
            
               Chapter 5
               Seasonally BTV-free Member State or zone 
            
            
               1.The seasonally BTV free status may only be granted to a Member State or to a zone if:
            
            
               (a)the beginning and the end of the vector-free period and therefore of the seasonally BTV-free period has been demonstrated based on an entomological surveillance in accordance with Section 5 of Chapter 1; and
            
            
               (b)the cessation of the transmission of BTV has been demonstrated by:
            
            
               (i)the implementation of a surveillance in accordance with Section 2 of Chapter 1 at least for the past 12 months including one full vector activity season; and
            
         
         
            
               (ii)the absence of new cases of infection (incident case) with any of the serotype 1 to 24 of BTV since the end of the vector activity season.
            
            
               2.By way of derogation from point 1(a), if the seasonally BTV free period has been successfully demonstrated for a period of three consecutive years, additional criteria such as temperature, may replace entomological surveillance to substantiate the beginning and the end of the seasonally BTV free period on the basis of scientific evidences.
            
            
               3.The seasonally BTV free Member State or zone must immediately stop when there is evidence of the end of the vector-free period or of circulation of the virus.
            
            
               Part III
                  Infestation with Varroa spp. 
            
            
               Section 1
               Granting of the status to a member state or zone as free from infestation with varroa spp. 
            
            
               The status free from infestation with Varroa spp. may only be granted to the relevant honeybee population of a Member State or of a zone if:
            
            
               (a)a risk assessment has been conducted, identifying all potential factors for Varroa spp. occurrence and their historic perspective;
            
            
               (b)an ongoing awareness programme has been in place for at least one year to encourage reporting of all cases suggestive of Varroa spp;
            
            
               (c)there has been no confirmed case of infestation with Varroa spp. either in kept or in wild honeybee colonies;
            
            
               (d)for at least one year, an annual surveillance has demonstrated the absence of infestations with Varroa spp on a representative sample of kept honeybees of the Member State or zone thereof that allows at least the detection, with a 95% level of confidence, of the infestation with Varroa spp. at a target prevalence rate of 1% of the apiaries and at a within-apiary target prevalence rate of 5% of the hives;
            
            
               (e)in the presence of wild self-sustaining population of the species of the genus Apis there has been in place for at least one year an ongoing surveillance programme in the wild population which demonstrates no evidence of infestation with Varroa spp.;
            
            
               (f)during the whole duration of the surveillance referred to in point (d) the competent authority makes appropriate arrangements for the survey and further handling of honeybees in any stage of their lifecycle, including honeybee brood, which are moved into that Member State or into that zone to prevent the infestation of its population from introduced honeybees of lesser health status.
            
            
               Section 2
               Maintenance of the status of a member state or zone free from infestation with varroa spp.
            
            
               Tstatus free from infestation with Varroa spp. granted to the relevant honeybee population of a Member State or of a zone may only be maintained if:
            
            
               (a)the competent authority maintains a surveillance that:
            
            
               (i)demonstrates the absence of infestations with Varroa spp. annually on a representative sample of kept honeybees of the free area;
            
            
               (ii)enables the early detection of suspicion of infestation with Varroa spp. in apiaries and hives;
            
            
               (iii)takes into consideration specifically target areas with higher likelihood of introduction of or infestation with Varroa spp., based on a risk assessment;
            
            
               (b)all the suspect cases have been investigated and no case of infestation with Varroa spp. has been confirmed, either in kept or in wild honeybee colonies;
            
            
               (c)either there is no wild self-sustaining population of the species of the genus Apis or there is an ongoing surveillance programme in the wild population which demonstrates no evidence of infestation with Varroa spp;
            
         
         
            
               (d)the honeybees in any stage of their lifecycle, including honeybee brood, are only moved into the free area when: 
            
            
               (i)they come from a Member State or zone thereof or from a third country or territory with disease-free status regarding infestation with Varroa spp.; and
            
            
               (ii)they are protected from infestation with Varroa spp. during transport.
            
            
               Part IV
               Infection with Newcastle disease virus-free status without vaccination
            
            
               Section 1
                  Granting of the infection with Newcastle disease virus-free status without vaccination 
            
            
               The infection with Newcastle disease virus (NDV)-free status without vaccination in the population of poultry and captive birds of Galliformes species may only be granted to a Member State or to a zone if for at least the past 12 months:
            
            
               (a)vaccination against infection with NDV in poultry and in captive birds of Galliformes species has been prohibited; 
            
            
               (b)no poultry and no captive birds of Galliformes species vaccinated against infection with NDV has been kept in establishments keeping poultry or captive birds of Galliformes species; 
            
            
               (c)general surveillance has been carried out in accordance with point (a) of Article 3(1) for the early detection of infection with NDV;
            
            
               (d)one of the following testing regime has applied:
            
            
               (i)all establishments keeping breeding poultry have been tested for the presence of antibodies against infection with NDV with negative results, on blood samples from at least 60 birds randomly chosen from each establishment and tested serologically by Haemagglutination inhibition (HI) test; or
            
            
               (ii)a survey has been conducted on a representative sample of establishments which has at least the capacity at least to detect, with a 95% level of confidence, the infection at a target prevalence rate of 1% in the poultry establishments and at a within-establishment prevalence rate of seropositive birds of 10%;
            
            
               (e)no case of infection with NDV has been confirmed in poultry and captive birds of Galliformes species.
            
            
               Section 2
                  Maintenance of the status
            
            
               1.The infection with NDV-free status without vaccination granted to a Member State or to a zone may only be maintained if the requirements in points (a) to (e) of Section 1 continue to be fulfilled.
            
            
               2.By way of derogation from paragraph 1, the infection with NDV-free status without vaccination granted to a Member State or to a zone may be maintained in the event of the confirmation of a case of infection with NDV if:
            
            
               (a)the relevant disease control measures have been immediately implemented on each establishment with suspect or confirmed cases until the incident has been resolved;
            
            
               (b)the competent authority has concluded that only a limited number of establishments, epidemiologically linked to the first detected outbreak, were infected;
            
            
               (c)during a period of 12 months, the disease control measures referred to in point (a) were not applied for a duration longer than three months. 
            
            
               3.The infection with NDV-free status without vaccination granted to a Member State or to a thereof is not affected by the confirmation of the infection in another bird populations, provided the competent authority has assessed, taking into account the implementation of all necessary measures to prevent transmission of infection with NDV to poultry and captive birds of Galliformes species, that the status was not jeopardized.
            
         
         
            
               ANNEX VI
            
            
               SPECIFIC REQUIREMENTS as regards diseases of aquatic animals
            
            
               Part I
            
            
               RISK BASED SURVEILLANCE
            
            
               Chapter I
               Minimum requirements for risk based surveillance in certain approved aquaculture establishments
            
            
               1.General approach
            
            
               1.1.Risk based health surveillance which includes health visits and possible sampling is applied in certain approved aquaculture establishments and in certain approved groups of aquaculture establishments in a manner that is appropriate to the nature of the production and which has the objective of detecting:
            
            
               (a)increased mortality; 
            
            
               (b)listed diseases; 
            
            
               (c)emerging diseases.
            
            
               1.2.The frequency of such visits will depend on the risk the approved aquaculture establishment or approved group of aquaculture establishments poses in relation to contracting and spreading disease. This risk applies to listed diseases and to potential emerging diseases and will therefore include aquaculture establishments and groups of aquaculture establishments keeping listed species and in certain cases, aquaculture establishments and groups of aquaculture establishments keeping non-listed species. The competent authority must determine the risk posed by each approved aquaculture establishment or approved group of aquaculture establishments and rank them as high, medium or low risk.
            
            
               Chapter II provides details of the risk factors to be taken into account during the risk ranking process. Such risk ranking will be repeated and updated if any of the risk factors outlined in points (a) to (l) indicate that the risk posed by the establishment has changed.
            
            
               1.3.Chapter III sets out the minimum frequency of health visits which must be completed, based on whether the competent authority has designated an establishment to be high, medium or low risk.
            
            
               1.4.Risk based animal health surveillance in aquaculture establishments and groups of aquaculture establishments may be combined with health visits and sampling which are carried out: 
            
            
               (a)as part of compulsory or optional eradication programmes for one or more listed diseases; or
            
            
               (b)to demonstrate and maintain disease free status for one or more listed diseases; or
            
            
               (c)as part of a surveillance programme for one or more category C diseases. 
            
            
               Chapter II
            
            
               Risk ranking to be applied in certain approved aquaculture establishments
            
            
               The risk ranking referred to in point 1.2 of Chapter I will as a minimum, take into account the risk factors referred to in points (a) and (b) of this paragraph. Where relevant, points (c) to (l) will also be considered: 
            
         
         
            
               (a)possibility of the direct spread of pathogens via water;
            
            
               (b)movements of aquaculture animals;
            
            
               (c)type of production;
            
            
               (d)species of aquaculture animals kept;
            
            
               (e)biosecurity system, including staff competence and training;
            
            
               (f)density of aquaculture establishments and processing establishments in the area around the establishment concerned; 
            
            
               (g)proximity of establishments with a lower health status than the establishment concerned;
            
            
               (h)disease history of the establishment concerned and of other local establishments;
            
            
               (i)presence of infected wild aquatic animals in the area around the establishment concerned; 
            
            
               (j)risk posed by human activities in the proximity of the establishment concerned for example angling, the presence of transport routes, ports at which ballast water is exchanged;
            
            
               (k)access to the establishment concerned by predators which may cause disease spread;
            
            
               (l)compliance track record of the establishment.
            
            
               Chapter III
            
            
               Frequency of risk based animal health visits
            
            
               The frequency of risk based health visits which must be carried out in certain approved establishments and approved groups of establishments depends upon the risk ranking referred to in paragraph 1 of Chapter II and shall be carried out as follows:
            
            
               (a)at least once per year in high risk establishments;
            
            
               (b)at least once every two years in medium risk establishments;
            
            
               (c)at least once every three years in low risk establishments.
            
            
               Part II
               DISEASE SPECIFIC REQUIREMENTS FOR DISEASE-FREE STATUS OF AQUATIC ANIMALS
            
            
               Part II covers the disease specific requirements for disease-free status as regards the following listed diseases:
            
         
         
            
                     
                        Viral haemorrhagic septicaemia (VHS)
                     
                  
                  
                     
                        Chapter 1
                     
                  
               
                     
                        Infectious haematopoietic necrosis (IHN)
                     
                  
                  
                     
                        Chapter 1
                     
                  
               
                     
                        Infection with HPR-deleted infectious salmon anaemia virus 
                     
                  
                  
                     
                        Chapter 2
                     
                  
               
                     
                        Infection with Marteilia refringens
                     
                  
                  
                     
                        Chapter 3
                     
                  
               
                     
                        Infection with Bonamia exitiosa 
                     
                  
                  
                     
                        Chapter 4
                     
                  
               
                     
                        Infection with Bonamia ostreae 
                     
                  
                  
                     
                        Chapter 5
                     
                  
               
                     
                        Infection with white spot syndrome virus (WSSV)
                     
                  
                  
                     
                        Chapter 6
                     
                  
               
               Chapter 1
                  Eradication, disease-free status and diagnostic methods for viral haemorrhagic septicaemia (VHS) and infectious hematopoietic necrosis (IHN)
            
            
               Section 1
               General requirements for health visits and sampling
            
            
               Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and, where appropriate sampling, must be carried out during the period of the year when the water temperature is below 14 °C or when temperatures below 14 °C are not reached, samples must be taken at the lowest annual temperatures;
            
            
               (b)when targeted surveillance in wild populations is required due to the small number of aquaculture establishments in an eradication programme, the number and geographical distribution of sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points must be representative of the different ecosystems where wild populations of susceptible species are located;
            
            
               (c)when establishments or wild populations are to be subject to health visits or sampled more than once per year, in accordance with Sections 2 to 4, the intervals between the health visits and between the collection of samples must be at least 4 months, or as long as possible, taking into account the temperature requirements provided for in point (a);
            
            
               (d)all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the water outlet area where weak fish tend to accumulate because of the water current;
            
            
               (e)fish of listed species to be collected as samples must be selected as follows:
            
            
               (i)if rainbow trout are present, only fish of that species must be selected for sampling, except where other susceptible species are present which show typical signs of VHS or IHN; if rainbow trout are not present, the sample must be representative of all other susceptible species which are present;
            
            
               (ii)if weak, abnormally behaving or freshly dead but not decomposed fish are present, such fish must be selected; if more than one water source is utilised for fish production, fish representing all water sources must be included in the sample;
            
            
               (iii)the fish selected must include fish collected in such a way that all production units, such as net cages, tanks and ponds, of the establishment, as well as all year classes, are proportionally represented in the sample.
            
            
               Section 2
               Granting of the status free from VHS or free from IHN in Member States, zones and compartments of unknown health status
            
            
               The status free from VHS or free from IHN may only be granted to a Member State, a zone or a compartment with an unknown disease status with regard to VHS or IHN if:
            
            
               (a)all establishments and, when required, sampling points in wild populations selected in accordance with point (b) of Section 1, have been subject to one of the following scheme:
            
            
               (i)model A — 2-year scheme:
            
            
               The establishments or sampling points must have been subject to health visits and sampled for a minimum period of 2 consecutive years as laid down in Table 1.A.
            
            
               During that 2-year period, the testing of all samples using the diagnostic methods set out in point 2 of section 5 must have produced negative results for VHS or IHN, and any suspicion of VHS or IHN must have been ruled out in accordance with the sampling and diagnostic methods set out in point 3 of Section 5;
            
            
               (ii)model B — 4-year scheme with reduced sample size:
            
            
               The establishments or sampling points must have been subject to health visits and sampled for a minimum period of 4 consecutive years as laid down in Table 1.B. During that 4-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 must have produced negative results for VHS or IHN and any suspicion of VHS or IHN must have been ruled out in accordance with the sampling and diagnostic methods set out in point 3 of Section 5;
            
         
         
            
               (b)if VHS or IHN have been detected during the surveillance referred to in point (a); before starting a new 2-year or 4-year scheme, relevant establishments in the Member State, zone or compartment must:
            
            
               (i)be subject to the minimum disease control measures laid down in Articles 58 to 65; 
            
            
               (ii)be repopulated with fish from an establishment in a Member State, zone or compartment with status free from VHS or status free from IHN or from an establishment in a Member State, zone or compartment covered by an eradication programme against VHS or IHN.
            
            
               Table 1.A
            
            
               Scheme for Member States, zones and compartments for the 2-year control period referred to in point (i) which precedes the achievement of status free from VHS and status free from IHN 
            
            
                     
                        Type of establishment
                     
                  
                  
                     
                        Number of health visits per year to each establishment
                     
                  
                  
                     
                        Number of samplings per year in each establishment
                     
                  
                  
                     
                        Number of fish in the sample(1)
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        Number of growing fish
                     
                  
                  
                     
                        Number of broodstock fish(2)
                     
                  
               
                     
                              
                                 (a)
                              
                           
                           
                              
                                 Establishments with broodstock
                              
                           
                        
                  
                  
                     
                        2
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        50 (first visit)
                     
                     
                        75 (second visit)
                     
                  
                  
                     
                        30 (first or second visit)
                     
                     
                  
               
                     
                              
                                 (b)
                              
                           
                           
                              
                                 Establishments with broodstock only
                              
                           
                        
                  
                  
                     
                        2
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        0
                     
                  
                  
                     
                        75 (first or second visit)
                     
                  
               
                     
                              
                                 (c)
                              
                           
                           
                              
                                 Establishments without broodstock
                              
                           
                        
                  
                  
                     
                        2
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        75 (first AND second visit)
                     
                  
                  
                     
                        0
                     
                  
               
                     
                        Maximum number of fish per pool: 10
                     
                  
               
               (1)In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
            
            
               (2)Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.
            
            
               Table 1.B
            
            
               Scheme for Member States, zones or compartments using a reduced sample size for the 4-year control period referred to in point (ii) which precedes the achievement of status free from VHS and status free from IHN
            
            
                     
                  
                  
                     
                              
                                 Type of establishment
                              
                           
                           
                              
                                 Number of health visits per year to each establishment
                              
                           
                           
                              
                                 Number of samplings per year in each establishment
                              
                           
                           
                              
                                 Number of fish in the sample(1)
                              
                           
                        
                              
                           
                           
                              
                           
                           
                              
                           
                           
                              
                                 Number of growing fish
                              
                           
                           
                              
                                 Number of broodstock fish(2)
                              
                           
                        
                              
                                 First 2 years
                              
                           
                        
                              
                                       
                                          (a)
                                       
                                    
                                    
                                       
                                          Establishments with broodstock
                                       
                                    
                                 
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 1
                              
                           
                           
                              
                                 30 (second visit)
                              
                           
                           
                              
                                 0
                              
                           
                        
                              
                                       
                                          (b)
                                       
                                    
                                    
                                       
                                          Establishments with broodstock only
                                       
                                    
                                 
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 1
                              
                           
                           
                              
                                 0
                              
                           
                           
                              
                                 30 (first or second visit)
                              
                           
                        
                              
                                       
                                          (c)
                                       
                                    
                                    
                                       
                                          Establishments without broodstock
                                       
                                    
                                 
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 1
                              
                           
                           
                              
                                 30 (first or second visit)
                              
                           
                           
                              
                                 0
                              
                           
                        
                              
                                 Last 2 years
                              
                           
                        
                              
                                       
                                          (a)
                                       
                                    
                                    
                                       
                                          Establishments with broodstock
                                       
                                    
                                 
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 30 (first visit)
                              
                           
                           
                              
                                 30 (second visit)
                              
                           
                        
                              
                                       
                                          (b)
                                       
                                    
                                    
                                       
                                          Establishments with broodstock only
                                       
                                    
                                 
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 2
                              
                           
                           
                              
                           
                           
                              
                                 30 (first AND second visit)
                              
                           
                        
                              
                                       
                                          (c)
                                       
                                    
                                    
                                       
                                          Establishments without broodstock
                                       
                                    
                                 
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 2
                              
                           
                           
                              
                                 30 (first AND second visit)
                              
                           
                           
                              
                           
                        
                              
                                 Maximum number of fish per pool: 10
                              
                           
                        
                  
               
               (1)In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
            
            
               (2)Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.
            
            
               Section 3
               Granting of the status free from VHS or free from IHN in Member States, zones and compartments known to be infected with either VHS or IHN
            
            
               1.The status free from VHS or free from IHN may only be granted to a Member State, a zone or a compartment known to be infected with VHS or IHN, if all establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
            
            
               (a)the minimum control measures laid down in Articles 55 to 65 must have been effectively applied and a restricted zone of an appropriate size as provided for in point (c) of Article 58(1), where appropriate, divided into a protection zone and surveillance zone; must have been established in the vicinity of the establishment(s) declared infected with VHS or IHN, taking into account the requirements set out in point 2.
            
            
               (b)all establishments keeping listed species within the protection zone, or where a protection zone has not been established, the restricted zone, not infected with VHS or IHN must be subject to an investigation comprising at least the following elements:
            
            
               (i)the collection of samples for testing of 10 fish, when clinical signs or post-mortem signs consistent with infection with VHS or IHN are observed or minimum 30 fish, when clinical or post-mortem signs are not observed;
            
            
               (ii)in those establishments where the tests referred to in (i) have produced negative results; health visits must continue once per month during the period when the water temperature is below 14 °C, except when fish ponds, tanks, raceways or net cages are covered with ice, until the protection zone is withdrawn in accordance with point (c);
            
            
               (c)relevant establishments must be emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63 and fallowed in accordance with Article 64. 
            
         
         
            
               The duration of the fallowing period referred to in point (b) of Article 64(1) must be at least 6 weeks. When all establishments infected within the same protection zone, or where a protection zone has not been established, the restricted zone, are emptied, at least 3 weeks of synchronised fallowing must be carried out. 
            
            
               When fallowing of the infected establishments is carried out, the restricted zone or the protection zone, when it has been established, must be converted into a surveillance zone until the scheme set out in Section 2 is completed;
            
            
               (d)repopulation may only take place when all infected establishments have been emptied, cleansed, disinfected and fallowed in accordance with point (c);
            
            
               (e)all establishments other than those referred to in point (f) keeping listed species within the Member State, zone or compartment covered by the eradication programme and when surveillance in wild populations is required, sampling points selected in accordance with point (b) of Section 1, must subsequently be subject to the scheme laid down in Section 2;
            
            
               (f)an individual establishment which keeps listed species and which has a health status which is independent of the health status of the surrounding waters is not required to comply with the scheme laid down in Section 2 following a disease outbreak, provided the establishment complies with the requirements set out in paragraph 3 of Article 80 and is repopulated with fish sourced from Member States, zones or compartments with status free from VHS or status free from IHN.
            
            
               2.The restricted zone must have been defined on a case-by-case basis and:
            
            
               (a)it must take into account factors influencing the risks for the spread of VHS or IHN to kept and wild fish, such as: 
            
            
               (i)the number, rate and distribution of the mortalities of fish on the establishment infected with VHS or IHN, or in other aquaculture establishments; 
            
            
               (ii)the distance and density of neighbouring establishments; 
            
            
               (iii)the proximity to slaughterhouses;
            
            
               (iv)contact establishments; 
            
            
               (v)species present at the establishments; 
            
            
               (vi)the farming practices applied in the infected establishments and the neighbouring establishments ; 
            
            
               (vii)the hydrodynamic conditions; and 
            
            
               (viii)other factors of epidemiological significance identified;
            
            
               (b)the geographical demarcation in coastal areas must comply with the following minimum requirements: 
            
            
               (i)the protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the establishment infected with VHS or IHN, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; and 
            
            
               (ii)the surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; 
            
            
               or 
            
            
               (iii)where separate protection and surveillance zones are not established, the restricted zone must consist of an area comprising both the protection zone and the surveillance zone:
            
         
         
            
               (c)the geographical demarcation in inland areas must comply with the following minimum requirements: the entire water catchment area in which the establishment infected with VHS or IHN is located. The competent authority may limit the extent of the restricted zone to parts of the water catchment area, provided this limitation does not compromise the disease control measures with respect to VHS or IHN.
            
            
               Section 4
               Maintenance of status free from VHS and status free from IHN 
            
            
               1.When targeted surveillance is required in order to maintain the status free from VHS or free from IHN of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and fish must be sampled in accordance with Table 1.C, taking into account the risk level of the establishment for the contraction of VHS or IHN.
            
            
               2.When determining the frequency of health visits required to maintain the status free from VHS or the status free from IHN of compartments, where the disease-status regarding VHS or IHN is dependent on the disease-status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of VHS or IHN must be regarded as high.
            
            
               3.Disease-free status must only be maintained as long as all samples tested, using the diagnostic methods set out in point 2 of Section 5, have produced negative results for VHS or IHN and any suspicion of VHS or IHN has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
            
            
               Table 1.C
            
            
               Scheme for Member States, zones or compartments to maintain status free from VHS or status free from IHN as referred to in point I.3 
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits per year to each establishment
                     
                  
                  
                     
                        Number of fish in the sample(2,3)
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Maximum number of fish per pool: 10
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
            
            
               (2)There shall be minimum one sample for every health visit.
            
            
               (3)In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
            
            
               Section 5
               Diagnostic and sampling methods 
            
            
               1.The organs or tissue material to be sampled and examined must be the spleen, the anterior kidney, and either heart or encephalon. When sampling broodstock, ovarian or seminal fluid may also be examined.
            
            
               In case of small fry, whole fish may be sampled. 
            
            
               Samples from a maximum of 10 fish may be pooled.
            
            
               2.The diagnostic method for the granting or the maintenance status free from VHS or status free from IHN in accordance with Sections 2 to 4 must be:
            
            
               (a)virus isolation in cell culture with subsequent identification of the virus using enzyme-linked immunosorbent assay (ELISA), indirect fluorescent antibody test (IFAT), virus neutralisation test or virus genome detection; or
            
            
               (b)
                     RT-(q)PCR detection.
            
            
               The detailed procedures to carry out these diagnostic methods must be those approved by the EURL for fish diseases.
            
            
               3.When a suspicion of VHS or IHN is required to be confirmed or ruled out in accordance with Article 55, the following health visit, sampling and testing procedures must comply with the following requirements:
            
         
         
            
               (a)the suspect establishment must be subject to at least one health visit and one sampling of 10 fish, when clinical signs or post-mortem signs consistent with infection with VHS or IHN are observed or minimum 30 fish, when clinical or post-mortem signs are not observed. Samples shall be tested using one or more of the diagnostic methods set out in points 2(a) and 2(b) in accordance with the detailed diagnostic methods and procedures approved by the EURL for fish diseases;
            
            
               (b)the presence of VHS must be considered as confirmed, if one or more of those diagnostic methods are positive for VHSV. The presence of IHN must be considered as confirmed, if one or more of those diagnostic methods are positive for IHNV. The confirmation of the first case of VHS or IHN in Member States, zones or compartments previously not infected must be based on conventional virus isolation in cell culture with subsequent immunochemical or molecular identification or with genome detection including confirmation by sequencing of the amplification (RT-PCR) product;
            
            
               (c)Suspicion of VHS or IHN may be ruled out, if cell cultivation or RT-qPCR tests reveal no further evidence of the presence of VHSV or IHNV.
            
            
               Chapter 2
               Eradication, disease-free status and diagnostic methods for infection with HPR-deleted infectious salmon anaemia virus (HPR-deleted ISAV) 
            
            
               Section 1
               General requirements for health visits and sampling
            
            
               Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
            
            
               (a)when health visits and sampling of establishments must be carried out more than once per year in accordance with Sections 2 to 4, the intervals between the health visits or collection of samples shall be as long as possible;
            
            
               (b)when targeted surveillance in wild populations is required due to the low number of aquaculture establishments in the eradication programme, the number and geographical distribution of sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment; 
            
            
               (c)the sampling points must be representative of the different ecosystems where the wild populations of susceptible species are located;
            
            
               (d)all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the edge of cages or the water outlet area as relevant, where weak fish tend to accumulate because of the water current.
            
            
               (e)fish of listed species to be collected as samples must be selected as follows:
            
            
               (i)if Atlantic salmon are present, only fish of that species must be selected for sampling, except where other susceptible species are present which show typical signs of infection with HPR- deleted ISAV. If there are no Atlantic salmon in the establishment, the sample must be representative of all other susceptible species which are present;
            
            
               (ii)if moribund or freshly dead, but not decomposed fish are present, such fish must be selected, in particular fish demonstrating anaemia, haemorrhages or other clinical signs suggesting circulatory disturbances; if more than one water source is utilised for fish production, fish representing all water sources must be included in the sample;
            
            
               (iii)the fish selected must include fish collected in such a way that all production units, such as net cages, tanks and ponds, of the establishment as well as all year classes are proportionally represented in the sample.
            
            
               Section 2
                  Granting of the status free from infection with HPR-deleted ISAV in Member States, zones and compartments of unknown health status
            
            
               The status free from infection with HPR-deleted ISAV may only be granted to a Member State, a zone or a compartment with an unknown disease status with regard to infection with HPR-deleted ISAV if all establishments and, when required, selected sampling points in wild populations selected in accordance with (b) of Section 1, have been subject to the following scheme:
            
            
               (a)the establishments or sampling points have been subject to health visits and sampled for a minimum period of 2 consecutive years as laid down in Table 2.A;
            
            
               (b)during that 2-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 must have produced negative results for HPR-deleted ISAV and any suspicion of infection must have been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5. 
            
            
               (c)If infection with HPR-deleted ISAV is detected during the surveillance referred to in point (a); before re-starting the scheme, relevant establishments within the Member State, zone or compartment must:
            
            
               (i)be subject to the minimum disease control measures laid down in Articles 58 to 65;
            
         
         
            
               (ii)be repopulated with fish from an establishment in a Member State, zone or compartment free from infection with HPR-deleted ISAV or from an establishment in a Member State, zone or compartment covered by an eradication programme against that disease.
            
            
               Table 2.A
            
            
               Scheme for Member States, zones and compartments for the 2-year control period which precedes the achievement of status free from infection with HPR-deleted ISAV 
            
            
                     
                        Year of surveillance
                     
                  
                  
                     
                        Number of health visits per year to each establishment
                     
                  
                  
                     
                        Number of laboratory examinations per year(1) 
                     
                  
                  
                     
                        Number of fish in the sample
                     
                  
               
                     
                        Year 1
                     
                  
                  
                     
                        6
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        75
                     
                  
               
                     
                        Year 2
                     
                  
                  
                     
                        6
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        75
                     
                  
               
               (1)Samples must be collected during spring and autumn each year.
            
            
               (2)Maximum number of fish per pool: 5.
            
            
               Section 3
                  Granting of the status free from infection with HPR-deleted ISAV in Member States, zones and compartments known to be infected with HPR-deleted ISAV
            
            
               1.The status free from infection with HPR-deleted ISAV may only be granted to a Member State, a zone or a compartment known to be infected with HPR-deleted ISAV if all establishments keeping listed species within the Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
            
            
               (a)the minimum control measures laid down in Articles 55 to Article 65 have been applied and a restricted zone of an appropriate size as provided for in point (c) of Article 58(1), where appropriate, divided into a protection zone and a surveillance zone, must have been established in the vicinity of the establishment(s) infected with HPR-deleted ISAV, taking into account the requirements set out in point 2.
            
            
               (b)all establishments keeping listed species within the protection zone, or where a protection zone has not been established, the restricted zone, not infected with HPR-deleted ISAV must be subject to an investigation comprising at least the following elements:
            
            
               (i)the collection of samples for testing of minimum 10 moribund fish, when clinical signs or post-mortem signs consistent with infection with HPR-deleted ISAV are observed, or minimum 30 fish when clinical or post mortem signs are not observed;
            
            
               (ii)in those establishments where the tests referred to in (i) have produced negative results, the health visits must continue once per month until the protection zone is withdrawn in accordance with point (c);
            
            
               (c)relevant establishments must be emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63 and fallowed in accordance with Article 64. 
            
            
               The duration of the fallowing period referred to in point (b) of Article 64(2) shall be at least 3 months. When all establishments infected within the same protection zone, or where a protection zone has not been established, the restricted zone, are emptied, at least 6 weeks of synchronised fallowing must be carried out. 
            
            
               When fallowing of the infected establishments is carried out, the restricted zone or the protection zone, when it has been established, must be converted into a surveillance zone until the scheme set out in Section 2 is completed;
            
            
               (d)repopulation may only take place when all infected establishments have been emptied, cleaned, disinfected and fallowed in accordance with point (c);
            
            
               (e)all establishments other than those referred to in point (f) keeping listed species within the Member State, zone or compartment covered by the eradication programme and when surveillance in wild populations is required, sampling points selected in accordance with point (b) of Section 1, must subsequently be subject to the scheme set out in Section 2;
            
            
               (f)an individual establishment which keeps listed species and which has a disease-status which is independent of the disease-status of the surrounding waters is not required to comply with the scheme set out in Section 2 following a disease outbreak provided the establishment complies with the requirements set out in paragraph 3 of Article 80 and is re-populated with fish sourced from Member States, zones or compartments with status free from infection with HPR-deleted ISAV.
            
            
               2.The restricted zone must have been defined on a case-by-case basis and:
            
            
               (a)it must take into account factors influencing the risks for the spread of infection with HPR-deleted ISAV to kept and wild fish, such as: 
            
         
         
            
               (i)the number, rate and distribution of the mortalities on the establishment infected with HPR-deleted ISAV or in other aquaculture establishments; 
            
            
               (ii)the distance and density of neighbouring establishments; 
            
            
               (iii)the proximity to slaughterhouses; 
            
            
               (iv)contact establishments; 
            
            
               (v)species present at the establishments; 
            
            
               (vi)the farming practices applied in the infected establishments and in the neighbouring establishments to the infected establishment; 
            
            
               (vii)the hydrodynamic conditions; and 
            
            
               (viii)other factors of epidemiological significance identified;
            
            
               (b)the geographical demarcation in coastal areas must comply with the following minimum requirements: 
            
            
               (i)the protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the establishment infected with HPR-deleted ISAV, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; and 
            
            
               (ii)the surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data;
            
            
               or 
            
            
               (iii)where separate protection and surveillance zones are not established, the restricted zone must consist of an area comprising both the protection zone and the surveillance zone;
            
            
               (c)the geographical demarcation in inland areas must comply with the following minimum requirements: the entire water catchment area in which the establishment infected with HPR-deleted ISAV is located. The competent authority may limit the extent of the restricted zone to parts of the water catchment area, provided this limitation does not compromise the disease control measures with respect to infection with HPR-deleted ISAV.
            
            
               Section 4
               Maintenance of status free from infection with HPR-deleted ISAV
            
            
               1.When targeted surveillance is required in order to maintain the status free from infection with HPR-deleted ISAV of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and fish must be sampled in accordance with Table 2.B, taking into account the risk level of the establishment for the contraction of infection with HPR-deleted ISAV.
            
            
               2.When determining the frequency of health visits required to maintain the status free from infection with HPR-deleted ISAV of compartments where the disease-status is dependent on the disease-status of the aquatic animal population in surrounding natural waters, the risk for the contraction of infection with HPR-deleted ISAV must be regarded as high. 
            
            
               3.Disease-free status must only be maintained as long as all samples tested, using the diagnostic methods set out in point 2 of Section 5, have produced negative results for HPR-deleted ISAV and any suspicion of infection with HPR-deleted ISAV has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
            
            
               Table 2.B
            
            
               Scheme for Member States, zones or compartments to maintain status free from infection with HPR-deleted ISAV(1)
            
         
         
            
                     
                        Risk level(2)
                     
                  
                  
                     
                        Number of health visits per year
                     
                  
                  
                     
                        Number of laboratory examinations per year(3,4)
                     
                  
                  
                     
                        Number of fish in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        30
                     
                  
               
               (1)Shall not apply to establishments rearing only rainbow trout (Oncorhynchus mykiss) or brown trout (Salmo trutta) or both rainbow trout and brown trout, and where the water supply is exclusively based on fresh water sources which are not populated with Atlantic salmon (Salmo salar).
            
            
               (2)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
            
            
               (3)Samples must be collected during spring and autumn when two samples are required each year or during spring or autumn when one sample is required each year.
            
            
               (4)Samples must be collected during spring or autumn when one sample per year is required.
            
            
               (5)Maximum number of fish per pool: 5
            
            
               Section 5
                  Diagnostic and sampling methods 
            
            
               1.The organs or tissue material to be sampled and examined must be: 
            
            
               (a)Histology: head-kidney, liver, heart, pancreas, intestine, spleen and gill;
            
            
               (b)Immunohistochemistry: mid-kidney and heart including valves and bulbus arteriosus;
            
            
               (c)RT-qPCR analysis: mid-kidney and heart;
            
            
               (d)Virus culture: mid-kidney, heart, liver and spleen.
            
            
               Organ pieces from a maximum of five fish may be pooled.
            
            
               2.The diagnostic method to be used to grant or to maintain status free from infection with HPR-deleted ISAV in accordance with Sections 2 to 4 must be RT-qPCR, followed by sequencing of positive samples in accordance with the detailed methods and procedures which must be those approved by the EURL for fish diseases. 
            
            
               In the case of a positive RT-qPCR result, further samples must be tested before the implementation of the initial control measures provided for in Articles 55 to 65.
            
            
               Those samples must be tested as follows in accordance with the detailed methods and procedures approved by the EURL for fish diseases:
            
            
               (a)screening of the samples by RT-qPCR, including sequencing of the HE-gene to verify HPR-deletion; and
            
            
               (b)detection of ISAV antigen in tissue preparations by means of specific antibodies against ISAV; or
            
            
               (c)isolation in cell culture and subsequent identification of HPR-deleted ISAV.
            
            
               3.When a suspicion of infection with HPR-deleted ISAV must be confirmed or ruled out in accordance with Article 55, the following visit, sampling and testing procedure must comply with the following requirements:
            
         
         
            
               (a)the suspect establishment must be subject to at least one health visit and one sampling of 10 moribund fish, when clinical signs or post-mortem signs consistent with infection with HPR-deleted ISAV are observed, or minimum 30 fish when clinical signs or post-mortem signs are not observed. Samples shall be tested using one or more of the diagnostic methods set out in point 2 in accordance with the detailed diagnostic methods and procedures approved by the EURL for fish diseases;
            
            
               (b)in the case of a positive result of RT-qPCR for HPR-deleted ISAV, further samples shall be tested before the implementation of the initial control measures provided in Article 58. A suspected case of infection with HPR-deleted ISAV shall be confirmed in accordance with the following criteria using the detailed methods and procedures approved by the EURL for fish diseases:
            
            
               (i)Detection of ISAV by RT-qPCR, including sequencing of the HE-gene to verify HPR-deletion, and detection of ISAV in tissue preparations by means of specific antibodies against ISAV;
            
            
               (ii)detection of ISAV by RT-qPCR, including sequencing of the HE-gene to verify HPR-deletion; and isolation and identification of ISAV in cell culture from at least one sample from any fish from the establishment;
            
            
               (c)where the presence of clinical, gross pathological changes or histopathological findings consistent with infection are observed, the findings must be corroborated by virus detection by two diagnostic methods with independent principles of detection, such as RT-qPCR and IHC, in accordance with the procedures approved by the EURL for fish diseases.
            
            
               The suspicion of HPR-deleted ISAV may be ruled out, if tests and health visits over a period of 12 months from the date of the suspicion are found to reveal no further evidence of the presence of the virus.
            
            
               Chapter 3
               Eradication, disease-free status and diagnostic methods for infection with Marteilia refringens
            
            
               Section 1
               General requirements for health visits and sampling
            
            
               Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and, where appropriate, the sampling must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling must be carried out just after the water temperature has exceeded 17°C;
            
            
               (b)when molluscs must be sampled in accordance with the requirements set out in Sections 2 to 4, the following selection criteria must apply:
            
            
               (i)if Ostrea spp. are present, only oysters of that species must be selected for sampling. If Ostrea spp are not present, the sample must be representative of all other susceptible species present;
            
            
               (ii)if weak, gaping or freshly dead but not decomposed molluscs are present in the production units, such molluscs must primarily be selected. If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
            
            
               (iii)when sampling in mollusc establishments which utilise more than one water source for mollusc production, molluscs representing all water sources must be included for sampling in such a way that all parts of the establishment are proportionally represented in the sample;
            
            
               (iv)when sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of sampling points, must be included in the sample in such a way that all parts of the establishment or group of establishments are proportionally represented in the sample. The main factors to be considered for the selection of these sampling points are previous sampling points where Marteilia refringens was detected, stocking density, water flows, presence of susceptible species, presence of vector species, bathymetry and management practices. Natural beds within or adjacent to the establishment or group of establishments must be included in the sampling.
            
            
               Section 2
                  Granting of the status free from infection with Marteilia Refringens in Member States, zones and compartments of unknown health status
            
            
               1.The status free from infection with Marteilia refringens may only be granted to a Member State, a zone or a compartment with an unknown disease status with regard to infection with Marteilia refringens if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 3-year scheme:
            
            
               (a)the establishments or groups of establishments keeping listed species have been subject to health visits and sampled for a minimum period of 3 consecutive years as laid down in Table 3.A;
            
            
               (b)during that 3-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Marteilia refringens and any suspicion of Marteilia refringens has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5;
            
            
               (c)when Ostrea edulis sourced from a Member State, zone or compartment of disease-free status are to be included in the sample, they must have been introduced into the establishment or group of establishments at least in the spring just preceding the period when the scheme is carried out.
            
         
         
            
               2.If Marteilia refringens is detected during the 3- year programme set out in point 1; before starting a new 3-year scheme, relevant establishments in the Member State, zone or compartment must:
            
            
               (a)be subject to the minimum disease control measures laid down in Articles 58 to 65;
            
            
               (b)be repopulated with molluscs from an establishment in a Member State, zone or compartment free from infection with Marteilia refringens or from an establishment in a Member State, zone or compartment covered by an eradication programme against that disease.
            
            
               Table 3.A
            
            
               Scheme for Member States, zones or compartments for the 3-year control period which precedes the achievement of status free from infection with Marteilia refringens 
            
            
                     
                        Year of surveillance
                     
                  
                  
                     
                        Number of health visits per year to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations per year
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        Year 1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Year 2
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Year 3
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
               Section 3
                  Granting of the status free from infection with Marteilia refringens in Member States, zones and compartments known to be infected with Marteilia refringens 
            
            
               1.The status free from infection with Marteilia refringens may only be granted to a Member State, a zone or a compartment known to be infected with Marteilia refringens, where the competent authority judges that eradication of this disease to be feasible, if all establishments or groups of establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
            
            
               (a)the minimum control measures laid down in Articles 55 to 65 have effectively been applied and a restricted zone of an appropriate size as provided for in point (c) of Article 58(1), where appropriate divided into a protection zone and surveillance zone, must have been established in the vicinity of the establishment(s) or group of establishments infected with Marteilia refringens, taking into account the requirements set out in point 2;
            
            
               (b)all establishments and groups of establishments keeping listed species within the protection zone, or where a protection zone has not been established, the restricted zone, not infected with Marteilia refringens must be subject to an investigation comprising at least the collection of samples for the testing of 150 molluscs after the beginning of the transmission period of Marteilia refringens. When the transmission period is not known, the sampling must begin in the period after the temperature of the water exceeds 17 °C;
            
            
               (c)relevant establishments and groups of establishments must be emptied in accordance with Articles 62, and if possible cleaned and disinfected in accordance with Article 63.
            
            
               Fallowing must be carried out in accordance with Article 64 and the duration of the fallowing period must be at least:
            
            
               (i)2 months in case of the establishments and groups of establishments which can be fully drained and thoroughly cleaned and disinfected such as hatcheries and nurseries;
            
            
               (ii)2 months in case of the establishments and groups of establishments which cannot be drained and thoroughly cleaned and disinfected provided that the infected molluscs of the listed species and those molluscs of the listed species with epidemiological links with the infected establishment or group of establishments have been harvested or removed before the period of the year when the prevalence of Marteilia refringens is known to be maximal, or when that period is not known, before the period when water temperature exceeds 17 °C;
            
            
               (iii)14 months in case of the establishments and groups of establishments which cannot be drained and thoroughly cleaned and disinfected if the infected molluscs of the listed species and those molluscs of the listed species with epidemiological links with the infected establishment or group of mollusc establishments have not been harvested or removed before the period of the year when the prevalence of Marteilia refringens is known to be maximal or when such data is not known, when molluscs of the susceptible species have not been harvested or removed before the period when water temperature exceeds 17 °C.
            
            
               When all infected establishments and infected groups of establishments are emptied, at least 4 weeks of synchronised fallowing must be carried out;
            
            
               (d)repopulation may only take place when all infected establishments or infected groups of establishments have been emptied, cleansed, disinfected and fallowed in accordance with point (c);
            
            
               (e)all establishments and groups of establishments other than those referred to in point (f) keeping listed species within the Member State, zone or compartment covered by the eradication programme, must subsequently be subject to the scheme set out in Section 2;
            
            
               (f)an individual establishment which keeps listed species and which has a disease-status which is independent of the disease-status of the surrounding waters is not required to comply with the scheme set out in Section 2 following a disease outbreak provided the establishment complies with the requirements set out in paragraph 3 of Article 80 and is re-stocked with molluscs sourced from Member States, zones or compartments with status free from infection with Marteilia refringens.
            
            
               2.The restricted zone must have been defined on a case-by-case basis and:
            
         
         
            
               (a)it must take into account factors influencing the risks for the spread of infection with Marteilia refringens including other establishments and wild molluscs, such as:
            
            
               (i)the distance and density of neighbouring establishments or groups of establishments including wild molluscs; 
            
            
               (ii)the proximity to processing establishments, contact establishments or groups of establishments; 
            
            
               (iii)the species, especially susceptible species and vector species, present at the establishments or groups of establishments; 
            
            
               (iv)the farming practices applied in the affected and neighbouring establishments and groups of establishments; 
            
            
               (v)the hydrodynamic conditions; and 
            
            
               (vi)other factors of epidemiological significance identified.
            
            
               (b)the geographical demarcation must comply with the following minimum requirements: 
            
            
               (i)the protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the establishment infected with Martellia refringens, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; and
            
            
               (ii)the surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data;
            
            
               or
            
            
               (iii)where separate protection and surveillance zones are not established, the restricted zone must consist of an area comprising both the protection zone and the surveillance zone.
            
            
               Section 4
               Maintenance of status free from infection with Marteilia refringens 
            
            
               1.When targeted surveillance is required in order to maintain the status free from infection with Marteilia refringens of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and molluscs must be sampled in accordance with Table 3.B, taking into account the risk level of the establishment for the contraction of infection with Marteilia refringens.
            
            
               2.When determining the frequency of health visits required to maintain the status free from infection with Marteilia refringens of compartments, where the disease-status regarding that disease is dependent on the disease-status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with Marteilia refringens must be regarded as high.
            
            
               3.The status free from infection with Marteilia refringens may only be maintained as long as all samples tested, using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Marteilia refringens and any suspicion of infection with Marteilia refringens has been ruled out in accordance with the diagnostic methods set out in point 3 of section 5.
            
            
               Table 3.B
            
            
               Scheme for Member States, zones or compartments to maintain disease-free status for Marteilia refringens 
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        150
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
            
         
         
            
               Section 5
                  Diagnostic and sampling methods 
            
            
               1.The whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points 2 and 3.
            
            
               2.The diagnostic methods to be used to grant or maintain status free from infection with Marteilia refringens in accordance with Sections 2 to 4 must follow the detailed diagnostic methods and procedures approved by the EURL for Mollusc Diseases and must be histopathology, tissue imprints or PCR.
            
            
               3.When a suspicion of infection with Marteilia refringens is required to be confirmed or ruled out in accordance with Article 55 the following visit, sampling and testing procedure must be complied with:
            
            
               (a)the investigation must include at least one sampling of 30 molluscs of susceptible species if the suspicion is based on a mortality report or if not, 150 molluscs of susceptible species after the beginning of the transmission period of Marteilia refringens. When the transmission period is not known, the sampling must begin in the period after the temperature of the water exceeds 17 °C;
            
            
               (b)samples must be tested using the diagnostic methods set out in point (i) following the detailed diagnostic methods and procedures approved by the EURL for Mollusc Diseases:
            
            
               (i)the presence of Marteilia refringens must be considered as confirmed when a positive result by histopathology, tissue imprints or in situ hybridisation is combined with a positive PCR result completed by sequencing. If biological material is not available for histopathology, tissue imprints or in situ hybridization, the presence of Marteilia refringens must be considered as confirmed when positive results are obtained using two PCR assays targeting different fragments of the parasite genome and completed by sequencing;
            
            
               (ii)the suspicion of infection with Marteilia refringens may be ruled out, if the tests referred to in (i) reveal no further evidence of the presence of Marteilia refringens.
            
            
               Chapter 4
                  Eradication, disease-free status and diagnostic methods for infection with Bonamia exitiosa
            
            
               Section 1
               General requirements for health visits and sampling
            
            
               Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and, where appropriate, the sampling must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out twice a year, in spring and autumn;
            
            
               (b)when molluscs are to be sampled in accordance with the requirements set out in Sections 2 to 4, the following criteria must apply:
            
            
               (i)if Ostrea spp. are present, only oysters of that species must be selected for sampling. If Ostrea spp are not present, the sample must be representative of all other susceptible species present;
            
            
               (ii)if weak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected. If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
            
            
               (iii)when sampling in establishments or groups of establishments which utilise more than one water source for mollusc production, molluscs representing all water sources must be included for sampling in such a way that all parts of the establishment are proportionally represented in the sample;
            
            
               (iv)when sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of sampling points must be included in the sample in such a way that all parts of the establishment or group of establishments are proportionally represented in the sample. The main factors to be considered for the selection of those sampling points are previous points where Bonamia exitiosa was detected, stocking density, water flows, the presence of susceptible species, the presence of vector species (e.g.Crassostrea gigas), bathymetry and management practices. Natural beds within or adjacent to the establishment or group of establishments shall be included in the sampling.
            
            
               Section 2
                  Granting of the status free from infection with Bonamia exitiosa in Member States, zones and compartments of unknown health status
            
            
               1.The status free from infection with Bonamia exitiosa may only be granted to a Member State, a zone or a compartment with an unknown disease status with regard to infection with Bonamia exitiosa if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 3-year scheme:
            
            
               (a)the establishments and groups of establishments keeping listed species have been subject to health visits and sampled for a minimum period of 3 consecutive years as laid down in Table 4.A.;
            
         
         
            
               (b)during that 3-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Bonamia exitiosa and any suspicion of Bonamia exitiosa has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5;
            
            
               (c)when Ostrea edulis sourced from a Member State, zone or compartment of disease-free status are to be included in the sample, they must have been introduced into the establishment or group of establishments at least one year before the scheme is carried out.
            
            
               2.If infection with Bonamia exitiosa is detected during the 3-year scheme referred to in point 1; before starting a new 3-year scheme, relevant establishments in the Member State, zone or compartment must:
            
            
               (a)be subject to the minimum disease control measures laid down in Articles 58 to 65;
            
            
               (b)be repopulated with molluscs from an establishment in a Member State, zone or compartment free from infection with Bonamia exitiosa or from an establishment in a Member State, zone or compartment covered by an eradication programme against that disease. 
            
            
               Table 4.A
            
            
               Scheme for Member States, zones or compartments for the 3-year control period which precedes the achievement of status free from infection with Bonamia exitiosa 
            
            
                     
                        Year of surveillance
                     
                  
                  
                     
                        Number of health visits per year to each establishment or group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations per year
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        Year 1
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Year 2
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Year 3
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        150
                     
                  
               
               Section 3
                  Granting of the status free from infection with Bonamia exitiosa in Member States, zones and compartments known to be infected with Bonamia exitiosa 
            
            
               1.The status free from infection with Bonamia exitiosa may only be granted to a Member State, a zone or a compartment known to be infected with Bonamia exitiosa, where the competent authority judges that eradication of this disease to be feasible, if all establishments or groups of establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
            
            
               (a)the minimum control measures laid down in Articles 55 to 65 must have been effectively applied, and a restricted zone of an appropriate size as provided for in point (c) of Article 58(1), where appropriate, divided into a protection zone and surveillance zone; must have been established in the vicinity of the establishment or group of establishments declared infected with Bonamia exitiosa taking into account the requirements set out in point 2;
            
            
               (b)all establishments and groups of establishments keeping listed species within the protection zone or where a protection zone has not been established, within the restricted zone, not infected with Bonamia exitiosa must be subject to an investigation comprising at least the collection of samples for testing of 150 molluscs of susceptible species after the beginning of the transmission period of Bonamia exitiosa. When the transmission period is not known, the sampling must be done on oysters which have spent at least one year within the protection zone;
            
            
               (c)relevant establishments and groups of establishments must be emptied in accordance with Article 62, and if possible, cleaned and disinfected in accordance with Article 63. 
            
            
               Fallowing must be carried out in compliance with Article 64 and the duration of the fallowing period must be at least 6 months.
            
            
               When all infected establishments or infected groups of establishments are emptied, at least 4 weeks of synchronised fallowing must be carried out;
            
            
               (d)repopulation may only take place when all infected establishments or groups of infected establishments have been emptied, cleansed, disinfected and fallowed in accordance with point (c);
            
            
               (e)all establishments and groups of establishments other than those referred to in point (f) keeping listed species within the Member State, zone or compartment covered by the eradication programme, must subsequently be subject to the scheme set out in Section 2;
            
            
               (f)an individual establishment which keeps listed species and which has a disease-status which is independent of the disease-status of the surrounding waters is not required to comply with the scheme set out in Section 2 following a disease outbreak provided the establishment complies with the requirements set out in paragraph 3 of Article 80 and is re-stocked with molluscs sourced from Member States, zones or compartments with status free from infection with Bonamia exitiosa.
            
            
               2.The restricted zone must have been defined on a case-by-case basis and:
            
            
               (a)it must take into account factors influencing the risks for the spread of infection with Bonamia exitiosa including other establishments and wild molluscs, such as:
            
         
         
            
               (i)the number, age, rate and distribution of the mortalities of molluscs on the establishment or group of establishments infected with Bonamia exitiosa including other establishments and wild molluscs;
            
            
               (ii)the distance and density of neighbouring establishments or groups of establishments including wild molluscs; 
            
            
               (iii)the proximity to processing establishments, contact establishments or groups of establishments; 
            
            
               (iv)the species, especially susceptible species and vector species, present at the establishments or groups of establishments; 
            
            
               (v)the farming practices applied in the affected and neighbouring establishments and groups of establishments; 
            
            
               (vi)the hydrodynamic conditions; and 
            
            
               (vii)other factors of epidemiological significance identified;
            
            
               (b)the geographical demarcation must comply with the following minimum requirements: 
            
            
               (i)the protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the establishment infected with Bonamia exitiosa, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; and 
            
            
               (ii)the surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data;
            
            
               or 
            
            
               (iii)where separate protection and surveillance zones are not established, the restricted zone must consist of an area comprising both the protection zone and the surveillance zone.
            
            
               Section 4
               Maintenance of status free from infection with Bonamia exitiosa 
            
            
               1.When targeted surveillance is required in order to maintain the status free from infection with Bonamia exitiosa of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and molluscs must be sampled in accordance with Table 4.B, taking into account the risk level of the establishment for the contraction of infection with Bonamia exitiosa .
            
            
               2.When determining the frequency of health visits required to maintain the status free from infection with Bonamia exitiosa of compartments where the disease-status regarding that disease is dependent on the disease-status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with Bonamia exitiosa must be regarded as high.
            
            
               3.The status free from infection with Bonamia exitiosa may only be maintained as long as all samples using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Bonamia exitiosa and any suspicion of infection with Bonamia exitiosa has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
            
            
               Table 4.B
            
            
               Scheme for Member States, zones or compartments to maintain status free from infection with Bonamia exitiosa 
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        150
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I
            
         
         
            
               Section 5
                  Diagnostic and sampling methods
            
            
               1.The whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points 2 and 3.
            
            
               2.The diagnostic methods to be used to grant or maintain status free from infection with Bonamia exitiosa, in accordance with Sections 2 to 4 must follow the detailed diagnostic methods and procedures approved by the EURL for Mollusc Diseases and must be histopathology, tissue imprints or PCR.
            
            
               3.When a suspicion of infection with Bonamia exitiosa is required to be confirmed or ruled out in accordance with Article 58, the following visit, sampling and testing procedure must be complied with:
            
            
               (a)the investigation must include at least one sampling of 30 molluscs of susceptible species if the suspicion is based on a mortality report, or if not, 150 molluscs of susceptible species after the beginning of the transmission period of Bonamia exitiosa. When the transmission period is not known, the sampling shall be carried out twice a year, in spring and autumn. 
            
            
               (b)the samples must be tested using the diagnostic methods set out in point (i) following the detailed diagnostic methods and procedures which have been approved by the EURL for Mollusc Diseases.
            
            
               (i)the presence of Bonamia exitiosa must be considered as confirmed when a positive result by histopathology, tissue imprints or in situ hybridisation is combined with a positive result by PCR followed by sequencing. If biological material is not available for histopathology, tissue imprints or in situ hybridization, the presence of Bonamia exitiosa must be considered as confirmed when positive results are obtained using two PCR assays targeting different fragments of the parasite genome and completed by sequencing;
            
            
               (ii)the suspicion of the presence of infection with Bonamia exitiosa must be ruled out, if those tests reveal no further evidence of the presence of Bonamia exitiosa.
            
            
               Chapter 5
               Eradication, disease-free status and diagnostic methods for infection with Bonamia ostreae
            
            
               Section 1
               General requirements for health visits and sampling
            
            
               Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and, where appropriate, the sampling must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling must be carried out in winter or at the beginning of spring;
            
            
               (b)when molluscs are to be sampled in accordance with the requirements set out in Sections 2 to 4, the following criteria must apply:
            
            
               (i)if Ostrea edulis are present, only oysters of that species must be selected for sampling. If Ostrea edulis are not present, the sample must be representative of all other susceptible species present;
            
            
               (ii)if weak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected. If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
            
            
               (iii)when sampling in establishments or groups of establishments which utilise more than one water source for mollusc production, molluscs representing all water sources must be included for sampling in such a way that all parts of the establishment are proportionally represented in the sample;
            
            
               (iv)when sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of sampling points must be included in the sample in such a way that all parts of the establishment or group of establishments are proportionally represented in the sample. The main factors to be considered for the selection of those sampling points are previous points where Bonamia ostreae was detected, stocking density, water flows, the presence of susceptible species, the presence of vector species, bathymetry and management practices. Natural beds within or adjacent to the establishment or group of establishments shall be included in the sampling.
            
            
               Section 2
                  Granting of the status free from infection with Bonamia ostreae in Member States, zones and compartments of unknown health status
            
            
               1.The status free from infection with Bonamia ostreae may only be granted to a Member State, a zone or a compartment with an unknown disease status with regard to infection with Bonamia ostreae if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 3-year scheme:
            
            
               (a)the establishments and groups of establishments keeping listed species have been subject to health visits and sampled for a minimum period of 3 consecutive years as laid down in Table 5.A;
            
         
         
            
               (b)during that 3-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Bonamia ostreae and any suspicion of Bonamia ostreae has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5;
            
            
               (c)when Ostrea edulis sourced from a Member State, zone or compartment of disease-free status are to be included in the sample, they must have been introduced into the establishment or group of establishments at least one year before the scheme is carried out.
            
            
               2.If infection with Bonamia ostreae is detected during the 3-year scheme referred to in point 1; before starting a new 3-year scheme, relevant establishments in the Member State, zone or compartment must:
            
            
               (a)be subject to the minimum disease control measures laid down in Articles 58 to 65;
            
            
               (b)be repopulated with molluscs from an establishment in a Member State, zone or compartment free from infection with Bonamia ostreae or from an establishment in a Member State, zone or compartment covered by an eradication programme against that disease. 
            
            
               Section 3
                  Granting of the status free from infection with Bonamia ostreae in Member States, zones and compartments known to be infected with Bonamia ostreae 
            
            
               1.The status free from infection with Bonamia ostreae may only be granted to a Member State, a zone or a compartment known to be infected with Bonamia ostreae , where the competent authority judges that eradication of this disease to be feasible, if all establishments or groups of establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
            
            
               (a)the minimum control measures laid down in Articles 55 to 65 must have been effectively applied, and a restricted zone of an appropriate size as provided for in point (c) of Article 58(1), where appropriate, divided into a protection zone and surveillance zone; must have been established in the vicinity of the establishment or group of establishments declared infected with Bonamia ostreae taking into account the requirements set out in point 2;
            
            
               (b)all establishments and groups of establishments keeping listed species within the protection zone or where a protection zone has not been established, within the restricted zone, not infected with Bonamia ostreae must be subject to an investigation comprising at least the collection of samples for testing of 150 molluscs of susceptible species after the beginning of the transmission period of Bonamia ostreae . When the transmission period is not known, the sampling must begin in winter or at the beginning of spring;
            
            
               (c)relevant establishments and groups of establishments must be emptied in accordance with Article 62, and if possible, cleaned and disinfected in accordance with Article 63. 
            
            
               Fallowing must be carried out in compliance with Article 64 and the duration of the fallowing period must be at least 6 months.
            
            
               When all infected establishments or infected groups of establishments are emptied, at least 4 weeks of synchronised fallowing must be carried out;
            
            
               (d)repopulation may only take place when all infected establishments or infected groups of establishments have been emptied, cleansed, disinfected and fallowed in accordance with point (c);
            
            
               (e)all establishments and groups of establishments other than those referred to in point (f) keeping listed species within the Member State, zone or compartment covered by the eradication programme, must subsequently be subject to the scheme set out in Section 2;
            
            
               (f)an individual establishment which keeps listed species and which has a disease-status which is independent of the disease-status of the surrounding waters is not required to comply with the surveillance scheme set out in Section 2 following a disease outbreak provided the establishment complies with the requirements set out in paragraph 3 of Article 80 and is re-stocked with molluscs sourced from Member States, zones or compartments with status free from infection with Bonamia ostreae.
            
            
               2.The restricted zone must have been defined on a case-by-case basis and:
            
            
               (a)it must take into account factors influencing the risks for the spread of infection with Bonamia ostreae including other establishments and wild molluscs, such as:
            
            
               (i)the number, age, rate and distribution of the mortalities of molluscs on the establishment or group of establishments infected with Bonamia ostreae including other establishments and wild molluscs;
            
            
               (ii)the distance and density of neighbouring establishments or groups of establishments including wild molluscs; 
            
            
               (iii)the proximity to processing establishments, contact establishments or groups of establishments; 
            
         
         
            
               (iv)the species, especially susceptible species and vector species, present at the establishments or groups of establishments; 
            
            
               (v)the farming practices applied in the affected and neighbouring establishments and groups of establishments; 
            
            
               (vi)the hydrodynamic conditions; and 
            
            
               (vii)other factors of epidemiological significance identified;
            
            
               (b)the geographical demarcation must comply with the following minimum requirements: 
            
            
               (i)the protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the establishment infected with Bonamia ostreae , or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; and 
            
            
               (ii)the surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data;
            
            
               or 
            
            
               (iii)where separate protection and surveillance zones are not established, the restricted zone must consist of an area comprising both the protection zone and the surveillance zone.
            
            
               Table 5.A
            
            
               Scheme for Member States, zones or compartments for the 3-year control period which precedes the achievement of status free from infection with Bonamia ostreae 
            
            
                     
                        Year of surveillance
                     
                  
                  
                     
                        Number of health visits per year to each establishment or group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations per year
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        Year 1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Year 2
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Year 3
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
               Section 4
               Maintenance of status free from infection with Bonamia ostreae
            
            
               1.When targeted surveillance is required in order to maintain the status free from infection with Bonamia ostreae of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and molluscs must be sampled in accordance with Table 5.B, taking into account the risk level of the establishment for the contraction of infection with Bonamia ostreae.
            
            
               2.When determining the frequency of health visits required to maintain the status free from infection with Bonamia ostreae of compartments where the disease-status regarding that disease is dependent on the disease-status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with Bonamia ostreae must be regarded as high.
            
            
               3.The status free from infection with Bonamia ostreae may only be maintained as long as all samples using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Bonamia ostreae and any suspicion of infection with Bonamia ostreae has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
            
            
               Table 5.B
            
            
               Scheme for Member States, zones or compartments to maintain status free from infection with Bonamia ostreae 
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        150
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
            
         
         
            
               Section 5
                  Diagnostic and sampling methods
            
            
               1.The whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points 2 and 3.
            
            
               2.The diagnostic methods to be used to grant or maintain status free from infection with Bonamia ostreae, in accordance with Sections 2 to 4 must follow the detailed diagnostic methods and procedures approved by the EURL for Mollusc Diseases and must be histopathology, tissue imprints or PCR.
            
            
               3.When a suspicion of infection with Bonamia ostreae is required to be confirmed or ruled out in accordance with Article 58, the following visit, sampling and testing procedure must be complied with:
            
            
               (a)the investigation must include at least one sampling of 30 molluscs of susceptible species if the suspicion is based on a mortality report, or if not, 150 molluscs of susceptible species after the beginning of the transmission period of Bonamia ostreae. When the transmission period is not known, the sampling shall begin in the winter or at the beginning of spring. 
            
            
               (b)the samples must be tested using the diagnostic methods set out in point (i) following the detailed diagnostic methods and procedures which have been approved by the EURL for Mollusc Diseases.
            
            
               (i)the presence of Bonamia ostreae must be considered as confirmed when a positive result by histopathology, tissue imprints or in situ hybridisation is combined with a positive result by PCR followed by sequencing. If biological material is not available for histopathology, tissue imprints or in situ hybridization, the presence of Bonamia ostreae must be considered as confirmed when positive results are obtained using two PCR assays targeting different fragments of the parasite genome and completed by sequencing;
            
            
               (ii)the suspicion of the presence of infection with Bonamia ostreae must be ruled out, if those tests reveal no further evidence of the presence of Bonamia ostreae .
            
            
               Chapter 6
               Eradication, disease-free status and diagnostic methods for infection with white spot syndrome virus (WSSV)
            
            
               Section 1
               General requirements for health visits and sampling
            
            
               Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
            
            
               (a)the sampling of crustaceans for laboratory examination must be carried out whenever the water temperature is likely to reach its highest annual point. That requirement concerning water temperature must also apply to health visits where these are feasible;
            
            
               (b)when farmed crustaceans must be sampled in accordance with the requirements set out in Sections 2 to 4, the following criteria must apply:
            
            
               (i)if weak or moribund crustaceans are present in the production units, such crustaceans must primarily be selected. If such crustaceans are not present, those selected must include crustaceans of different size cohorts namely juveniles and adults of the selected susceptible species, proportionally represented in the sample;
            
            
               (ii)if more than one water source is utilised for crustacean production, susceptible crustaceans representing all water sources must be included for sampling;
            
            
               (c)when targeted surveillance in wild populations is required due to the small number of establishments covered by the eradication programme, the number and geographical distribution of the sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points must also be representative of the different ecosystems where the wild populations of susceptible species are located namely marine, estuary, river and lake systems. In such situations, the crustaceans to be sampled must be selected as follows:
            
            
               (i)in marine and estuary systems areas, one or more of the following species must be selected: Carcinus maenas, Cancer pagurus, Eriocheir sinensis, Liocarcinus depurator, Liocarcinus puber, Crangon crangon, Homarus gammarus, Palaemon adspersus or penaeid shrimp species namely Penaeus japonicus, Penaeus kerathurus, Penaeus semisulcatus. If those species are not present, the sample must be representative of other susceptible decapod species present;
            
            
               (ii)in river and lake systems, one or more of the following species must be selected: Pacifastacus leniusculus, Astacus leptodactylus, Austropotamobius pallipes or Orconectes limosus. If those species are not present, the sample must be representative of other susceptible decapod species present;
            
            
               (iii)if weak or moribund crustaceans are present, such crustaceans must primarily be selected. If such crustaceans are not present, those selected must include crustaceans of different size cohorts namely juveniles and adults of the selected susceptible species, proportionally represented in the sample.
            
            
               Section 2
                  Granting of the status free from infection with WSSV in Member States, zones and compartments of unknown health status
            
         
         
            
               1.The status free from infection with WSSV may only be granted to a Member State, a zone or a compartment with an unknown disease status with regard to infection with WSSV if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 2-year scheme:
            
            
               (a)the establishments or groups of establishments or sampling points in the wild have been subject to health visits and sampled for a minimum period of 2 consecutive years as laid down in Table 6.A;
            
            
               (b)during that 2-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 have produced negative results for infection with WSSV and any suspicion of infection with WSSV has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5;
            
            
               2.If infection with WSSV is detected during the 2-year scheme referred to in point 1, before starting a new 2-year scheme, relevant establishments in the Member State, zone or compartment must:
            
            
               (a)be subject to the minimum disease control measures laid down in Articles 58 to 65;
            
            
               (b)be repopulated with crustaceans from an establishment in a Member State, zone or compartment free from infection with WSSV or from an establishment in a Member State, zone or compartment covered by an eradication programme against that disease.
            
            
               Section 3
                  Granting of the status free from infection with WSSV in Member States, zones and compartments known to be infected with WSSV
            
            
               1.The status free from infection with WSSV may only be granted to a Member State, a zone or a compartment known to be infected with WSSV if all establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
            
            
               (a)the minimum control measures laid down in Articles 55 to 65 must have been effectively applied, and a restricted zone of an appropriate size as provided for in point (c) of Article 58(1), where appropriate, divided into a protection zone and surveillance zone; must have been established in the vicinity of the establishment(s) declared infected with WSSV taking into account the requirements set out in point 2;
            
            
               (b)all establishments keeping listed species within the protection zone, or where a protection zone has not been established, the restricted zone, not infected with WSSV must be subject to an investigation comprising at least the following:
            
            
               (i)the collection of samples for testing of 10 crustaceans, when clinical signs or post-mortem signs consistent with infection WSSV are observed, or 150 crustaceans, when clinical or post-mortem signs are not observed; and
            
            
               (ii)health visits; in those establishments where the tests referred to in (i) have produced negative results, health visits must continue once per month during the season when the water temperature is likely to reach its highest annual points, until the protection zone has been withdrawn in accordance with point (c);
            
            
               (c)relevant establishments must be emptied in accordance with Articles 62, cleansed disinfected in accordance with Article 63 and fallowed in accordance with Article 64. The duration of the fallowing period must be at least 6 weeks. When all infected establishments are emptied, at least 3 weeks of synchronous fallowing shall be carried out. 
            
            
               When fallowing of the officially declared infected establishments is carried out, the protection zones shall be converted into surveillance zones.
            
            
               (d)repopulation may only take place when all infected establishments have been emptied, cleansed, disinfected and fallowed in accordance with point (c);
            
            
               (e)all establishments other than those referred to in point (f) keeping listed species within the Member State, zone or compartment covered by the eradication programme and, when surveillance in wild populations is required, sampling points selected to provide the greatest coverage of the geographical area included in the eradication programme must be subject at least to the scheme set out in Section 2;
            
            
               (f)an individual establishment which keeps listed species and which has a disease-status which is independent of the disease-status of the surrounding waters is not required to comply with the scheme set out in Section 2 following a disease outbreak provided the establishment complies with the requirements set out in paragraph 3 of Article 80 and is restocked with crustaceans sourced from Member States, zones or compartments with status free from infection with WSSV.
            
            
               2.The restricted zone must have been defined on a case-by-case basis taking into account factors influencing the risks for the spread of WSSV to farmed and wild crustaceans, such as: 
            
            
               (i)the number, age, rate and distribution of the mortalities of crustaceans on the establishment or group of establishments infected with WSSV including other establishments and wild crustaceans;
            
            
               (ii)the distance and density of neighbouring establishments or groups of establishments including wild crustaceans; 
            
         
         
            
               (iii)the proximity to processing establishments, contact establishments or groups of establishments ; 
            
            
               (iv)the species, especially susceptible species and vector species, present at the establishments or groups of establishments; 
            
            
               (v)the farming practices applied in the affected and neighbouring establishments and groups of establishments; 
            
            
               (vi)the hydrodynamic conditions; and 
            
            
               (vii)other factors of epidemiological significance identified.
            
            
               Table 6 A
            
            
               Scheme for Member States, zones and compartments for the 2-year control period which precedes the achievement of status free from infection with WSSV 
            
            
                     
                        Year of surveillance
                     
                  
                  
                     
                        Number of health visits per year to each establishment or group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations per year
                     
                  
                  
                     
                        Number of crustaceans in the sample
                     
                  
               
                     
                        Year 1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Year 2
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        150
                     
                  
               
               Section 4
               Maintenance of status free from infection with WSSV
            
            
               1.When targeted surveillance is required in order to maintain the status free from infection with WSSV of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and molluscs must be sampled in accordance with Table 6.B, taking into account the risk level of the establishment for the contraction of infection with WSSV.
            
            
               2.In Member States, zones or compartments where the number of establishments is limited and targeted surveillance in those establishments does not provide sufficient epidemiological data, the surveillance to maintain disease-free status must include sampling points selected in accordance with the requirements laid down in point (b) of Section 1.
            
            
               3.When determining the frequency of health visits required to maintain the status free from infection with WSSV of compartments where the disease-status regarding that disease is dependent on the disease-status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with WSSV must be regarded as high.
            
            
               4.The status free from infection with WSSV may only be maintained as long as all samples using the diagnostic methods set out in point 2 of Section 5 have produced negative results for WSSV and any suspicion of infection with WSSV has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
            
            
               Table 6 B
            
            
               Scheme for Member States, zones or compartments to maintain status free from infection WSSV 
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of crustaceans in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 4 years
                     
                  
                  
                     
                        150
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
            
            
               Section 5
                  Diagnostic and sampling methods
            
            
               1.Samples of integumental epidermis, either dissected or contained within walking legs, pleopods, mouthparts or gills of the test animal must be fixed in 95 % ethanol prior to the preparation of samples for PCR.
            
            
               Other samples, fixed for histology and transmission electron microscopy may be collected to support diagnostic data arising from PCR.
            
         
         
            
               2.The diagnostic method and procedures to be used to grant or to maintain disease-free status with regard to infection with WSSV must be PCR followed by sequencing. When applying these diagnostic methods, the corresponding detailed methods and procedures which have been approved by the EURL for Crustacean Diseases must be followed.
            
            
               In the case of a positive result from the PCR test, the result must be followed by sequencing of the amplicon before the initial control measures provided for in Article 63 of Regulation (EU) 2016/429 are implemented. 
            
            
               3.When a suspicion of infection with WSSV is required to be confirmed or ruled out in accordance with Article 58, the following visit, sampling and testing procedure must be complied with:
            
            
               (a)the investigation must include at least one health visit and one sampling of 10 crustaceans when clinical or post-mortem signs consistent with infection with WSSV are observed or 150 crustaceans when clinical or post-mortem signs are not observed. The samples must be tested using the diagnostic method set out in point 2;
            
            
               (b)the presence of WSSV must be considered as confirmed when PCR followed by sequencing, carried out in accordance with the detailed methods and procedures which have been approved by the EURL for Crustacean Diseases test positive for WSSV.
            
            
               The suspicion of infection with WSSV may be ruled out, if those tests reveal no further evidence of the presence of the virus.
            
            
               PART III
               REQUIREMENTS FOR DEMONSTRATING THE IMPLEMENTATION OF SURVEILLANCE PROGRAMMES FOR CATEGORY C DISEASES AND FOR RESTARTING THOSE PROGRAMMES AFTER A DISEASE OUTBREAK
            
            
               Part III covers the requirements for establishments to demonstrate the implementation of a surveillance programme for a particular disease and the requirements to restart that surveillance programme following a disease outbreak.
            
            
                     
                        Viral haemorrhagic septicaemia (VHS)
                     
                  
                  
                     
                        Chapter 1
                     
                  
               
                     
                        Infectious haematopoietic necrosis (IHN)
                     
                  
                  
                     
                        Chapter 1
                     
                  
               
                     
                        Infection with HPR-deleted infectious salmon anaemia virus 
                     
                  
                  
                     
                        Chapter 2
                     
                  
               
                     
                        Infection with Marteilia refringens
                     
                  
                  
                     
                        Chapter 3
                     
                  
               
                     
                        Infection with Bonamia exitiosa 
                     
                  
                  
                     
                        Chapter 4
                     
                  
               
                     
                        Infection with Bonamia ostreae
                     
                  
                  
                     
                        Chapter 5
                     
                  
               
                     
                        Infection with white spot syndrome virus (WSSV)
                     
                  
                  
                     
                        Chapter 6
                     
                  
               
               Chapter 1
                  Requirements for establishments to demonstrate the implementation of a surveillance programme for VHS or IHN and requirements to re-start that programme following a disease outbreak
            
            
               Section 1
                  General requirements for health visits and sampling for VHS and IHN
            
            
               The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and sampling must be carried out during the period of the year when the water temperature is below 14°C or when temperatures below 14°C are not reached, samples must be taken at the lowest annual points;
            
            
               (b)all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the water outlet area where weak fish tend to accumulate because of the water current;
            
            
               (c)fish of listed species to be collected as samples must be selected as follows:
            
            
               (i)if rainbow trout are present, only fish of that species must be selected for sampling, except where other susceptible species are present which show typical signs of VHS or IHN; if rainbow trout are not present, the sample must be representative of all other susceptible species which are present;
            
            
               (ii)if weak, abnormally behaving or freshly dead but not decomposed fish are present, such fish must be selected; if more than one water source is utilised for fish production, fish representing all water sources must be included in the sample;
            
            
               (iii)the fish selected must include fish collected in such a way that all parts of the establishment, as well as all year classes, are proportionally represented in the sample.
            
            
               Section 2
               Specific requirements to demonstrate the implementation of a surveillance programme 
            
            
               1.Health visits must be carried out and fish must be sampled in accordance with Section 1 and Table 1. 
            
         
         
            
               2.Samples which are collected in accordance with Section 1 and Table 1 must be tested using the diagnostic methods set out in point 2 of Section 5 of Chapter 1 of Part II and produce negative results for VHS or IHN.
            
            
               Section 3
                  Requirements to re-start a surveillance programme after a disease outbreak
            
            
               An establishment which has been infected with VHS or IHN, may restart a surveillance programme for these diseases provided that:
            
            
               (a)it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with point (b)(i) of Article 64(1); and
            
            
               (b)repopulation occurs using fish that originate from establishments which are: 
            
            
               (i)in a Member State, a zone or a compartment free from VHS or IHN;
            
            
               (ii)in a Member State, a zone or a compartment covered by an eradication programme against VHS or IHN; or 
            
            
               (iii)implementing a surveillance programme for VHS or IHN. 
            
            
               Table 1
            
            
               Surveillance programme for VHS/IHN
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits per year to each establishment
                     
                  
                  
                     
                        Number of fish in the sample(2)
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 3 years
                     
                  
                  
                     
                        30
                     
                  
               
               (1)In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
            
            
               (2)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I.Maximum number of fish per pool: 10
            
            
               Chapter 2
                  Requirements for establishments to demonstrate the implementation of a surveillance programme for HPR-deleted ISAV and to re-start that programme after a disease outbreak 
            
            
               Section 1
               General requirements for health visits and sampling for infection with HPR-deleted ISAV 
            
            
               The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and sampling must take into account all production units, such as ponds, tanks and net cages, to determine if dead, weak or abnormally behaving fish are present. Particular attention must be paid to the edge of cages or the water outlet area as relevant, where weak fish tend to accumulate because of the water current;
            
            
               (b)the fish to be collected as samples must be selected as follows:
            
            
               (i)only moribund or freshly dead but not decomposed fish must be selected; in particular fish demonstrating anaemia, bleeding or other clinical signs suggesting circulatory disturbances must be prioritised for collection;
            
            
               (ii)if Atlantic salmon are present, only fish of that species must be selected for sampling, except where other susceptible species are present which show typical signs of ISA. If there are no Atlantic salmon in the establishment, other listed species must be sampled;
            
         
         
            
               (iii)if more than one water source is utilised for fish production, fish representing all water sources must be included in the sample;
            
            
               (iv)the fish selected must include fish collected in such a way that all production units, such as net cages, tanks and ponds, as well as all year classes in the establishment are proportionally represented in the sample.
            
            
               Section 2
               Specific requirements to demonstrate the implementation of a surveillance programme 
            
            
               1.Health visits must be carried out and fish must be sampled in accordance with Section 1 and Table 2. 
            
            
               2.Samples which are collected in accordance with Section 1 and Table 2 must be tested using the diagnostic methods set out in point 2 of Section 5 of Chapter 2 of Part II and produce negative results for HPR-deleted ISAV.
            
            
               Table 2
            
            
               Surveillance programme for HPR-deleted ISAV
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits per year to each establishment
                     
                  
                  
                     
                        Number of laboratory examinations per year
                     
                  
                  
                     
                        Number of fish in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        2(2)
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        1(3)
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every two years
                     
                  
                  
                     
                        30
                     
                  
               
                     
                        Maximum number of fish per pool: 5
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I
            
            
               (2)Samples must be collected during spring and autumn when two samples are required each year
            
            
               (3)Samples must be collected during spring or autumn when only one sample is required per year
            
            
               Section 3
                  Requirements to re-start a surveillance programme after a disease outbreak
            
            
               An establishment which has been infected with HPR-deleted ISAV may restart a surveillance programme for that diseases provided that:
            
            
               (a)it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with point (b)(i) of Article 64(1); and
            
            
               (b)repopulation occurs using fish that originate from establishments which are: 
            
            
               (i)in a Member State, a zone or a compartment free from infection with HPR-deleted ISAV;
            
            
               (ii)in a Member State, a zone or a compartment covered by an eradication programme against infection with HPR-deleted ISAV; or 
            
            
               (iii)implementing a surveillance programme for infection with HPR-deleted ISAV. 
            
            
               Chapter 3
                  Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with Marteilia refringens and requirements to re-start that programme following a disease outbreak 
            
            
               Section 1
               General requirements for health visits and sampling for infection with Marteilia refringens 
            
         
         
            
               The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and sampling for laboratory examination must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out just after the water temperature has exceeded 17 °C;
            
            
               (b)when molluscs are to be sampled in accordance with the requirements set out in Table 3, the following criteria must apply:
            
            
               (i)Ostrea spp. must be sampled. If Ostrea spp. are not present, the sample must be representative of all other listed species present;
            
            
               (ii)if weak, gaping or freshly dead but not decomposed molluscs are present in the production units, such molluscs must primarily be selected. If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
            
            
               (iii)when sampling in mollusc establishments which utilise more than one water source for mollusc production, molluscs representing all water sources must be included for sampling in such a way that all parts of the establishment are proportionally represented in the sample;
            
            
               (iv)when sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of sampling points must be included in the sample in such a way that all parts of the establishment or group of establishments are proportionally represented in the sample. The main factors to be considered for the selection of those sampling points are stocking density, water flows, the presence of susceptible species, the presence of vector species, bathymetry and management practices. Natural beds within or adjacent to the establishment or group of establishments must be included in the sampling. Natural beds within or adjacent to the establishment or group of establishments must be included in the sampling.
            
            
               Section 2
               Specific requirements to demonstrate the implementation of a surveillance programme
            
            
               1.Health visits must be carried out and molluscs must be sampled in accordance with Section 1 and Table 3. 
            
            
               2.Samples which are collected in accordance with Section 1 and Table 3 must be tested using the diagnostic methods set out in point 2 of Section 5 of Chapter 3 of Part II and produce negative results for Marteilia refringens.
            
            
               Table 3
            
            
               Surveillance programme for Marteilia refringens
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 4 years
                     
                  
                  
                     
                        150
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I
            
            
               Section 3
                  Requirements to re-start a surveillance programme after a disease outbreak
            
            
               An establishment which has been infected with Marteilia refringens may re-start a surveillance programme for that disease provided that:
            
            
               (a)it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with point (b)(i) of Article 64(1); and
            
            
               (b)repopulation occurs using fish that originate from establishments which are: 
            
            
               (i)in a Member State, a zone or a compartment free from infection with Marteilia refringens;
            
            
               (ii)in a Member State, a zone or a compartment covered by an eradication programme against infection with Marteilia refringens; or 
            
         
         
            
               (iii)implementing a surveillance programme for infection with Marteilia refringens.
            
            
               Chapter 4
                  Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with Bonamia exitiosa and to re-start that programme following a disease outbreak 
            
            
               Section 1
                  General requirements for health visits and sampling for infection with Bonamia exitiosa 
            
            
               The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and sampling of production units must be carried out in the period of the year when prevalence of Bonamia exitiosa in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out twice a year, in spring and autumn;
            
            
               (b)when molluscs are sampled in accordance with the requirements set out in Table 4, the following criteria must apply:
            
            
               (i)if Ostrea spp. are present, only oysters of that species must be selected for sampling. If Ostrea spp. are not present, the sample must be representative of all other susceptible species present;
            
            
               (ii)if weak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected. If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
            
            
               (iii)when sampling in establishments which utilise more than one water source for mollusc production, molluscs representing all water sources must be included for sampling in such a way that all parts of the establishment are proportionally represented in the sample;
            
            
               (iv)when sampling in establishments or groups of establishments, molluscs from a sufficient number of sampling points must be included in the sample in such a way that all parts of the establishment or group of establishments are proportionally represented in the sample. The main factors to be considered for the selection of those sampling points are stocking density, water flows, the presence of susceptible species, the presence of vector species (e.g.Crassostrea gigas), bathymetry and management practices. Natural beds within or adjacent to the establishment or group of establishments must be included in the sampling.
            
            
               Section 2
               Specific requirements to demonstrate the implementation of a surveillance programme
            
            
               1.Health visits must be carried out and molluscs must be sampled in accordance with Section 1 and Table 4. 
            
            
               2.Samples which are collected in accordance with Section 1 and Table 4 must be tested using the diagnostic methods referred to in point 2 of Section 5 of Chapter 4 of Part II and produce negative results for Bonamia exitiosa.
            
            
               Table 4
            
            
               Surveillance programme for infection with Bonamia exitiosa
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 4 years
                     
                  
                  
                     
                        150
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I.
            
            
               Section 3
                  Requirements to re-start a surveillance programme after a disease outbreak
            
            
               An establishment which has been infected with Bonamia exitiosa may re-start a surveillance programme provided that:
            
            
               (a)it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with point (b)(i) of Article 64(1); and
            
         
         
            
               (b)repopulation occurs using fish that originate from establishments which are: 
            
            
               (i)in a Member State, a zone or a compartment free from infection with Bonamia exitiosa;
            
            
               (ii)in a Member State, a zone or a compartment covered by an eradication programme against infection with Bonamia exitiosa; or 
            
            
               (iii)implementing a surveillance programme for infection with Bonamia exitiosa.
            
            
               Chapter 5
                  Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with Bonamia ostreae and to re-start that programme following a disease outbreak 
            
            
               Section 1
                  General requirements for health visits and sampling for infection with Bonamia ostreae 
            
            
               The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
            
            
               (a)health visits and sampling of production units shall be carried out in the period of the year when prevalence of Bonamia ostreae in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out in winter or at the beginning of spring;
            
            
               (b)when molluscs are to be sampled in accordance with the requirements set out in Table 5, the following criteria must apply:
            
            
               (i)if Ostrea edulis are present, only oysters of that species must be selected for sampling. If Ostrea edulis are not present, the sample must be representative of all other susceptible species present;
            
            
               (ii)if weak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected. If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
            
            
               (iii)when sampling in establishments which utilise more than one water source for mollusc production, molluscs representing all water sources must be included for sampling in such a way that all parts of the establishment are proportionally represented in the sample;
            
            
               (iv)when sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of sampling points must be included in the sample. The main factors to be considered for the selection of those sampling points are stocking density, water flows, the presence of susceptible species, the presence of vector species, bathymetry and management practices. Natural beds within or adjacent to the establishment or group of establishments must be included in the sampling.
            
            
               Section 2
               Specific requirements to demonstrate the implementation of a surveillance programme
            
            
               1.Health visits must be carried out and molluscs must be sampled in accordance with Section 1 and Table 5. 
            
            
               2.Samples which are collected in accordance with Section 1 and Table 4 must be tested using the diagnostic methods referred to in point 2 of Section 5 of Chapter 5 of Part II and produce negative results for Bonamia ostreae.
            
            
               Table 5
            
            
               Surveillance programme for infection with Bonamia ostreae
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of molluscs in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 4 years
                     
                  
                  
                     
                        150
                     
                  
               
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I
            
         
         
            
               Section 3
                  Requirements to re-start a surveillance programme after a disease outbreak
            
            
               An establishment which has been infected with Bonamia ostreae may re-start the surveillance programme for that disease provided that:
            
            
               (a)it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with point (b)(i) of Article 64(1); and
            
            
               (b)repopulation occurs using fish that originate from establishments which are: 
            
            
               (i)in a Member State, a zone or a compartment free from infection with Bonamia ostreae;
            
            
               (ii)in a Member State, a zone or a compartment covered by an eradication programme against infection with Bonamia ostreae; or 
            
            
               (iii)implementing a surveillance programme for infection with Bonamia ostreae. 
            
            
               Chapter 6
                  Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with WSSV and to re-start that programme following a disease outbreak
            
            
               Section 1
                  General requirements for health visits and sampling for infection with infection with WSSV
            
            
               The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
            
            
               (a)the sampling of crustaceans for laboratory examination must be carried out whenever the water temperature is likely to reach its highest annual point. That requirement concerning water temperature must also apply to health visits where these are feasible and appropriate;
            
            
               (b)when farmed crustaceans are to be sampled in accordance with the requirements set out in Table 6, the following criteria must apply:
            
            
               (i)if weak or moribund crustaceans are present in the production units, such crustaceans must primarily be selected. If such crustaceans are not present, those selected must include crustaceans of different size cohorts namely juveniles and adults, of the selected susceptible species, proportionally represented in the sample;
            
            
               (ii)if more than one water source is utilised for crustacean production, susceptible crustaceans representing all water sources must be included for sampling.
            
            
               Section 2
               Specific requirements to demonstrate the implementation of a surveillance programme
            
            
               1.Health visits shall be carried out and crustaceans shall be sampled in accordance with Section 1 and Table 6. 
            
            
               2.Samples which are collected in accordance with Section 1 and Table 6 must be tested using the diagnostic methods referred to in point 2 of Section 5 of Chapter 6 of Part II and produce negative results for infection with WSSV.
            
            
               Table 6
            
            
               Surveillance programme for infection with WSSV
            
            
                     
                        Risk level(1)
                     
                  
                  
                     
                        Number of health visits to each establishment/ group of establishments
                     
                  
                  
                     
                        Number of laboratory examinations
                     
                  
                  
                     
                        Number of crustaceans in the sample
                     
                  
               
                     
                        High
                     
                  
                  
                     
                        1 every year
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Medium
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        150
                     
                  
               
                     
                        Low
                     
                  
                  
                     
                        1 every 2 years
                     
                  
                  
                     
                        1 every 4 years
                     
                  
                  
                     
                        150
                     
                  
               
         
            
               (1)Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter II of Part I
            
            
               Section 3
                  Requirements to re-start a surveillance programme after a disease outbreak
            
            
               An establishment which has been infected with WSSV may re-start a surveillance programme for that disease provided that:
            
            
               (a)it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with point (b)(i) of Article 64(1); and
            
            
               (b)repopulation occurs using fish that originate from establishments which are: 
            
            
               (i)in a Member State, a zone or a compartment free from infection with WSSV;
            
            
               (ii)in a Member State, a zone or a compartment covered by an eradication programme against infection with WSSV; or 
            
            
               (iii)implementing a surveillance programme for infection with WSSV. 
            
         
         
            
                  
                     (1)
                  
                        Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) N0 998/2003 (OJ L 178, 28.6.2013, p.1)