CELEX: 
Language: en
Date: 2019-12-17 00:00:00
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

EUROPEAN
                          COMMISSION
                                                    Brussels, 17.12.2019
                                                    C(2019) 4056 final
               COMMISSION DELEGATED REGULATION (EU) …/...
                                       of 17.12.2019
    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)
EN                                                                                     EN
 ---pagebreak---                                 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 (the ‘Animal Health Law’) lays down rules on transmissible animal diseases,
   specifically on: (i) the surveillance of listed diseases and emerging diseases; (ii) eradication
   programmes; and (iii) disease-free status for certain diseases of terrestrial and aquatic animals.
   The Animal Health Law, particularly under Chapters 2 to 4 of Part II empowers the
   Commission to adopt delegated acts, supplementing the aforementioned rules.
   As these rules are all interrelated, in the interests of consistency and transparency and to avoid
   duplications, it is important that they be laid down in the same delegated act.
   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 and for the granting of disease-free status at
   establishment, compartment, zone or Member State level. As the Union rules in place before
   the date of application of this Regulation have proven to be effective, they form a sound basis
   for the rules laid down in this act. These rules have also been adapted to the new legal
   framework taking into account lessons learnt from the past, the updating of international
   standards and scientific progress and recent European Food Safety Authority (EFSA)
   opinions.
   Accordingly, this Delegated Regulation lays down:
   (a)      the rules and conditions for surveillance conducted by the competent authority to
            ensure the detection of listed diseases and, where relevant, of emerging diseases;
   (b)      the criteria used to determine which disease will require a Union surveillance
            programme and rules setting up the requirements for these Union surveillance
            programmes, to be implemented by competent authorities;
   (c)      the rules setting out how competent authorities are to implement compulsory and
            optional eradication programmes for specific listed diseases focusing on their disease
            control strategies, their intermediate and final targets and their 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 Member States, and zones 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 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 the
            Animal Health Law.
EN                                                    1                                               EN
 ---pagebreak---    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 5 June and 3
   July 2019. 75 feedbacks were received in total, including opinions of the following
   stakeholders: Animal Health Ireland, Anses (FR), APCA (FR), Associazione Piscicoltori
   Italiani, Boehringer Ingelheim (DE), British Cattle Veterinary Association, British Veterinary
   Association, CIPA (FR), Copa-Cogeca, Danish Agriculture and Food Council, Department of
   Environment, Food and Rural Affairs (UK), Dibevo (NL), Dogs Trust (UK), European
   Association of Zoos And Aquaria, Federation of Veterinarians of Europe, Fédération
   Européenne pour la Santé Animale et la Sécurité Sanitaire, 25 Groupements de Defense
   Sanitaires (GDS) from French departements and regions, GDS FRANCE, Groupement de
   defense aquacole d'Aquitaine (FR), Institute of Northern Ireland Beekeepers (UK), Irish Co-
   operative Organisation Society, Irish Farmer’s Association, LTO Dutch Organisation for
   Agriculture and Horticulture, MEP Matt Carthy Sinn Féin (IE), National Farmers' Union
   (UK), National Farmers Union Scotland (UK), NFU Cymru (UK), Ornamental Fish
   International (NL), RACES DE FRANCE (FR), Scottish Association of Meat Wholesalers
   (UK), Scottish Dairy Cattle Association (UK), Syndicat de la Vitellerie Française (FR), TED
   16 (FR), Federation of Swedish Farmers, UECBV, Ulster Farmers' Union (UK),
   Vee&Logistiek Nederland, three from public authorities (IE, AT and NO) and 6 anonymous
   (FR and UK).
   The main following requests were submitted and points made:
   (a)       the request to provide for additional derogations in the eradication programmes for
             infection with Mycobacterium tuberculosis complex, particularly requesting more
             possibilities to derogate from the systematic pre-movement testing and for a quicker
             restoration of the disease-free status following an outbreak. The rules in the
             Delegated Regulation are aligned to the standards from the Terrestrial Animal Health
             Code of the World Organisation for Animal Health (OIE) (‘the Terrestrial Code’)
             and the derogations already included are based on lessons taken from success or
             failure of eradication of this disease in the Union;
   (b)       the request to lay down less prescriptive approach for optional eradication
             programmes for category C diseases of terrestrial animals, although the flexibility
             provided in many of the provisions was acknowledged. The competent authority may
             conduct its own strategy to eradicate them before seeking the Commission’s approval
             of the eradication programme. Nevertheless, as the approval of the eradication
             programme implies modifications to the requirements for the movements of animals
             between Member States, its approval and provisions should be subject to harmonised
             rules;
   (c)       the request to modify the requirements on diagnostic methods, case definitions and
             sampling patterns for certain diseases to improve clarity or to reduce constraints. The
             Delegated Regulation was amended to take into account requests that would not
             reduce the sensitivity of the surveillance;
EN                                                    2                                              EN
 ---pagebreak---    (d) the request to reduce the requirements for the granting and maintenance of disease-
       free status for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and
       for bovine viral diarrhoea. The provisions of this Delegated Regulation aim to
       achieve the disease-free status based on OIE standards, in particular as regards
       IBR/IPV, and take account of the best practices and difficulties identified by Member
       States;
   (e) the risk associated of infection with bluetongue virus (serotypes 1-24) when
       unloading animals for a period of up to one day in certain conditions was outlined.
       However, this rule exists in the Union rules in place before the date of application of
       this Delegated Regulation and there is no evidence that it resulted in the spreading of
       the disease;
   (f) the request to provide for less strict rules to reach disease-free status from infection
       with bluetongue virus (serotypes 1-24) and in particular to address each serotype
       independently. The requirements set out in this Delegated Regulation are based on
       the Terrestrial Code and certain requirements are specified considering the lessons
       taken from success or failure of eradication of this disease in the Union;
   (g) the acknowledgements for the derogation provided for in this Delegated Regulation
       as regards the possibility for the competent authority to use a risk-based approach to
       allow certain movements of animals although more flexibility as regards the situation
       of the Member State of origin was requested;
   (h) the request to maintain the rules for the recognition of dependent compartments as
       regards diseases of aquatic animals at the same level as laid down in the Union rules
       in place before the date of application of this Delegated Regulation. This Delegated
       Regulation uses the same concepts and clarifies the rules;
   (i) the request to not allow the discontinuation of targeted surveillance for the
       maintenance of disease-free status for diseases of aquatic animals. This Delegated
       Regulation limits this possibility only to certain situations;
   (j) the request to prohibit the possibility of granting disease-free status for infection with
       Bonamia exitosia based on historical and surveillance data because the signs of the
       disease are not obvious. The approach taken in this Delegated Regulation for the
       granting of the disease-free status based on historical and surveillance data for
       diseases of aquatic animals is that this pathway can be followed in the case of
       diseases that are not eligible for eradication programmes under the Union rules in
       place before the date of application of this Delegated Regulation. Eradication
       programmes for infection with Bonamia exitosia are currently not possible and thus,
       the granting of the disease-free status based on historical and surveillance data is
       possible under this Delegated Regulation;
   (k) the request to clarify that the presence of vector species of diseases of aquatic
       animals in the absence of other listed species does not hamper the possibility to grant
       disease-free status on the basis of the absence of listed species;
   (l) the request to maintain the status granted under the Union rules in place before the
       date of application of this Delegated Regulation as long as these rules are complied
       with. The objective of the transitional rules of the Animal Health Law is to facilitate
       recognition of the statuses granted under the Union rules in place before the date of
       application of this Delegated Regulation, not to perpetuate these rules after their
       repeal.
EN                                             3                                                  EN
 ---pagebreak---    3.       LEGAL ELEMENTS OF THE DELEGATED ACT
   This Delegated Regulation is to be adopted pursuant to Regulation (EU) 2016/429, and in
   particular pursuant to Article 29, Article 31(5), Article 32(2), Article 37(5), Article 39, Article
   41(3), Article 42(6) and Article 280(4) thereof.
EN                                                 4                                                   EN
 ---pagebreak---                      COMMISSION DELEGATED REGULATION (EU) …/...
                                              of 17.12.2019
       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 Law1’)], and in particular Article 29, Article 31(5),
   32(2), 37(5), Article 39, Article 41(3), Article 42(6) and Article 280(4) thereof,
   Whereas:
   (1)     The Animal Health Law 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 the
           Animal Health Law on surveillance, eradication programmes and disease-free status,
           as well as those in Part IX on transitional arrangements concerning existing
           surveillance or eradication programmes and existing disease-free status.
   (2)     These rules are substantially linked with many intended to be applied together. 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. The rules on
           surveillance, eradication programmes and disease-free status, including transitional
           rules, often serve common purposes and refer to complementary activities of
           operators, veterinarians and competent authorities. Therefore it is appropriate to group
           together these rules in a single delegated regulation.
   (4)     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 also be designed to meet the objectives of early detection of
           outbreaks of any listed and emerging disease and to demonstrate compliance with the
           criteria for the granting, maintaining, suspension or withdrawal of disease-free status.
   1
           OJ L 84, 31.3.2016, p. 1.
EN                                                   5                                                EN
 ---pagebreak---    (5)  The competent authority should put in place a basic general surveillance system for
        listed and emerging diseases of terrestrial animals based on notification and
        investigations of disease events in targeted animal population.
   (6)  These general surveillance requirements for terrestrial animals should be
        complemented by more specific requirements depending on the expected output of
        surveillance. They should be designed to serve different specific purposes such as
        Union surveillance programmes, compulsory and optional eradication programmes,
        demonstration of disease-free status, disease control measures, in the context of the
        approval of certain establishments and the movements of animals and animal products.
   (7)  The approach to designing general surveillance requirements for aquatic animals is
        similar to that 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. In addition,
        surveillance for listed and emerging diseases of aquatic animal needs to incorporate
        certain disease control measures, when it is necessary to take such measures in
        aquaculture establishments.
   (8)  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 implementing a risk-
        based surveillance scheme based on assessment of the risk that an establishment has of
        contracting and spreading an aquatic disease, be it listed or non-listed.
   (9)  The specific surveillance requirements also relate to the implementation of eradication
        programmes for certain listed diseases in order to obtain disease-free status from that
        disease and to maintain that status once achieved.
   (10) In addition, Member States should be given the possibility to implement surveillance,
        in the form of ‘surveillance programmes’ for Category C diseases of aquatic animals at
        establishment level, without opting for a disease eradication programme. Surveillance
        programmes differ from eradication programmes in that they are based on a system of
        targeted surveillance which is comprehensive but which does not encompass all the
        elements of an eradication programme. Unlike eradication programmes, surveillance
        programmes do not offer the possibility to achieve official disease-free status.
   (11) The specific eradication and surveillance programmes set out in this Regulation 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.
   (12) The Animal Health Law requires rules for listed diseases to 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 diseases.
   (13) Derogations should also make possible to further limit targeted terrestrial animal
        populations to specific surveillance purposes, namely: (i) Union surveillance
        programmes; (ii) compulsory or optional eradication programmes; and (iii)
        surveillance-based animal health requirements for movements within the Union or for
        entry into the Union.
EN                                               6                                               EN
 ---pagebreak---    (14) Diagnostic methods, together with the subsequent collection of samples to perform
        them, techniques, validation and interpretation are of a very technical nature and are
        subject to frequent modifications due to developments in scientific standards.
        Therefore to ensure that they are up to date, the rules on diagnostic methods should
        indicate in a flexible manner which methods should be used and how. In the area of
        animal diseases, there are different possible sources of scientific standards for
        diagnostic methods. It is therefore important to indicate the hierarchical order in which
        the methods should be considered, taking into account the general principles of
        sampling, analyses, tests and diagnoses laid down in Regulation (EU) 2017/6252.
   (15) To ensure optimal use of all resources and to avoid unnecessary administrative
        burdens and costs for operators and the competent authorities, the detection of listed
        and emerging diseases should draw on sources of information gathered during official
        controls and other official activities not primarily intended for the surveillance of those
        diseases.
   (16) The confirmation of a disease according to its case definition is the responsibility of
        the competent authority; it should be supported by appropriate investigations to
        confirm or rule out the presence of a suspected disease. Such investigations are
        relevant where the confirmation of the disease triggers disease control measures, as
        well as in certain other circumstances depending on the consequences of the
        confirmation of the disease. It is therefore important that this Regulation should lay
        down the additional circumstances where the confirmation of the disease is necessary.
   (17) The definitions of a suspected case and confirmed case of a listed disease and, where
        relevant, an emerging disease are of key importance. These enable operators,
        veterinarians and other stakeholders involved in surveillance to identify circumstances
        where it is necessary to notify the competent authority and for the competent authority
        to apply disease control measures. Therefore it is necessary to provide general criteria
        for the definitions of a suspected case and a confirmed case and to provide, where
        needed, disease-specific definitions, depending on the specific characteristics of
        certain diseases.
   (18) A Union surveillance programme is a surveillance programme relevant for the Union
        as a whole. This is necessary in order to achieve greater 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.
   (19) Commission Decision 2010/367/EU3 lays down minimal requirements for surveillance
        programmes for avian influenza in poultry and in wild birds and sets out technical
   2
        Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official
        controls and other official activities performed to ensure the application of food and feed law, rules on
        animal health and welfare, plant health and plant protection products, amending Regulations (EC)
        No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU)
        No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council,
        Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC,
        1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC)
        No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives
        89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council
        Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
   3
        Commission Decision 2010/367/EU of 25 June 2010 on the implementation by Member States of
        surveillance programmes for avian influenza in poultry and wild birds (OJ L 166, 1.7.2010, p. 22).
EN                                                      7                                                         EN
 ---pagebreak---         guidelines in its annexes. 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 focus exclusively on the objectives, the scope and the
        methodological principles to follow.
   (20) The Animal Health Law sets out rules for the application of compulsory and optional
        eradication programmes for category B and category C diseases in Member States.
        These diseases, or groups of them, have their own characteristics. Their eradication
        should be based on a disease control strategy specific for the disease in question. This
        should include at least: (i) the surveillance that needs to be performed in order to
        achieve disease-free status as the ultimate goal; (ii) the timeframe; (iii) a definition of
        the animal population that is subject to the eradication programme; (iv) the territory in
        which this eradication programme will apply; and (v) specific disease prevention and
        control measures that will apply to the disease during the eradication phase.
   (21) 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.
   (22) The purpose of an eradication programme is to achieve disease-free status on the
        territory covered by the programme. Ideally, for terrestrial animals it should cover the
        whole territory of the Member State where the disease is present. If this is not
        possible, the minimum area that is acceptable should be defined. 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.
   (23) The programme’s qualitative or quantitative targets should be set by the competent
        authority. Final targets should be based on the criteria for granting 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.
   (24) 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 but should not implement restrictions to the movements
        within the Union at that stage. A possibility should also be provided for Member
        States to request that the Commission extend this period where justified circumstances
        exist.
   (25) The eradication strategy of certain diseases might be based on granting disease-free
        status at establishment level. The disease-specific measures for such diseases should
        be grouped and spell out obligations for the operators and for the competent
        authorities.
   (26) The targeted animal population to be included in the disease eradication programme
        should be set out on a disease-specific basis. The possibility for the competent
        authority to include in the programme certain additional animal populations should
        also be set out on a disease-specific basis.
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 ---pagebreak---    (27) The primary responsibility for obtaining and maintaining the establishment’s disease-
        free status lies with the operator as it is the primary recipient of the benefits linked to
        the disease-free status. Therefore the operator should comply with certain obligations
        in order to be granted and maintain disease-free status.
   (28) Once the general and disease specific criteria for achieving disease-free status have
        been met by the operator, it is for the competent authority to grant that status. When
        these specific criteria are no longer met, it is also for the competent authority to either
        suspend or withdraw the status.
   (29) Moreover, the obligations for operators and competent authorities in the context of
        eradication programmes should, where necessary, be detailed considering the specific
        disease profile. The disease-specific requirements are of a technical nature and are set
        out for each specific disease in annexes to this Regulation.
   (30) Commission Implementing Regulation (EU) 2018/18824 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
        granting of establishment disease-free status.
   (31) Eradication programmes based on granting disease-free status at establishment level
        should include all establishments keeping animals from the targeted animal
        population. However, the competent authority should have the possibility to exclude
        certain specific types of establishments and slaughterhouses from the eradication
        programme provided appropriate risk mitigating measures are implemented.
   (32) In the case of eradication programmes based on granting disease-free status at
        establishment level, the competent authority should have the possibility to attribute
        different health status to different epidemiological units.
   (33) In the case of terrestrial animals, the requirements to demonstrate disease-free status at
        establishment level are based on the absence of infection supported by the testing and
        surveillance regime, by the conditions for introducing animals and germinal products
        into the establishments and, if necessary, by restrictions on the use of vaccination.
        When the conditions for maintaining the disease-free status are no longer satisfied,
        specific requirements apply to suspend, withdraw and restore this 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.
   (34) Conditions for granting, maintaining, suspending and withdrawing disease-free status
        at establishment level were set out in the following Union rules in place before the
        date of application of this Regulation: Council Directive 64/432/EEC 5 for bovine
   4
        Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of
        certain disease prevention and control rules to categories of listed diseases and establishing a list of
        species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L
        308, 4.12.2018, p. 21).
   5
        Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community
        trade in bovine animals and swine (OJ No 121, 29. 7. 1964, p. 1977/64).
EN                                                    9                                                          EN
 ---pagebreak---         brucellosis and bovine tuberculosis and Council Directive 91/68/EEC 6 for brucellosis
        in sheep and goats. The Animal Health Law repealed those provisions. Also,
        Commission Delegated Regulation (EU) 2018/16297 has aligned the scope of disease
        agents involved in brucellosis and bovine tuberculosis with the Terrestrial Animal
        Health Code of the World Organisation for Animal Health 8 (OIE) (‘the Terrestrial
        Code’). They are now infection with Brucella abortus, Brucella melitensis and
        Brucella suis and infection with Mycobacterium tuberculosis complex. It is therefore
        appropriate to revise the technical requirements related to the status of these diseases,
        so as to seek alignment with the Terrestrial Code while taking into account the
        experience gained in previous eradication programmes for these diseases.
   (35) In the case of disease eradication programmes for terrestrial animals based on granting
        disease-free status at establishment level, if a disease is suspected or confirmed, the
        competent authority should implement measures to prevent its spread. 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.
   (36) When applying the disease control measures in response to a suspected or confirmed
        case, the competent authority should introduce certain prohibitions on movements of
        animals. However, the competent authority should also have the possibility to allow
        the movement of certain animals from the establishment where a suspected or
        confirmed case is kept, to take account of animal welfare conditions and to facilitate
        the sustainability of the disease control measures.
   (37) Following the confirmation of a case, at least all animals recognised as confirmed
        cases should be removed. When these animals are put to death, the competent
        authority should have the possibility to decide whether this is done by slaughtering,
        meaning that their meat is intended to enter the food chain, or by killing, meaning that
        the meat is not intended for that purpose.
   (38) For certain diseases that can be spread by infected products of animal origin or
        fomites, or which may have a potential public health impact, the competent authority
        should introduce measures in infected establishments to prevent the spread of those
        diseases through these products or fomites. The measures to mitigate such risks should
        therefore be set out in this Regulation.
   (39) In the case of terrestrial animals, once disease-free status has been achieved at
        establishment level, for the sake of programme efficiency, it should be possible to
        carry out a stepwise reduction in the level of surveillance activities after a certain
        period of continuous disease-free status in the establishment.
   (40) Enzootic bovine leukosis (EBL) was 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 Implementing Regulation
        (EU) 2018/1882.
   6
        Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-
        Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19).
   7
        Commission Delegated Regulation (EU) 2018/1629 of 25 July 2018 amending the list of diseases set
        out in Annex II to Regulation (EU) 2016/429 of the European Parliament and of the Council on
        transmissible animal diseases and amending and repealing certain acts in the area of animal health
        (‘Animal Health Law’)(OJ L 272, 31.10.2018, p. 11)
   8
        Terrestrial Animal Health Code, World Organisation for Animal Health, 2018
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 ---pagebreak---    (41) 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 officially EBL-free status. Many Member States
        successfully applied these rules during the implementation of past EBL eradication
        programmes. The rules have been reviewed against the Terrestrial Code and included
        in this Regulation.
   (42) Member States or zones which have been free from EBL for several years and have
        therefore reached a steady animal health situation free of EBL, should continue to
        demonstrate the absence of infection. Risk-based surveillance is an appropriate means
        of ensuring early detection if the disease is reintroduced and of substantiating freedom
        from EBL. Member States should therefore establish a suitable surveillance system
        from the date of application of this Regulation.
   (43) Additional guarantees for 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. A number of Member States have successfully applied
        those rules and eradicated infection with ADV in the pig population kept in their
        territory. The strategy for the eradication of infection with ADV in this Regulation
        takes account of the Terrestrial Code and of criteria that have proven successful in
        eradicating the infection with ADV.
   (44) The rules in this Regulation on infectious bovine rhinotracheitis / Infectious pustular
        vulvovaginitis (IBR/IPV) are based on Commission Decision 2004/558/EC 9 with
        provisions on additional guarantees for intra-Community trade of bovine animals.
        These include requirements to obtain, maintain and restore freedom at establishment
        level from bovine herpesvirus 1 (BoHV-1). The rules have been developed taking into
        consideration the standards of the Terrestrial Code and the EFSA scientific opinion10.
   (45) Union rules in place before the date of application of this Regulation do not contain
        provisions for bovine viral diarrhoea (BVD) with the exception of provisions related to
        the trade of germinal products. In Implementing Regulation (EU) 2018/1882, BVD is
        now listed as a ‘category C disease’ for optional eradication. Therefore provisions on
        eradication programmes and the granting and maintenance of disease-free status with
        regard to BVD are laid down in this Regulation.
   (46) The Terrestrial Code lacks a chapter on BVD and criteria for BVD freedom and
        related animal movements. However, a chapter on BVD is available in the Manual of
        Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE. These diagnostic
        standards have been considered for the provisions related to BVD in this Regulation.
   (47) Implementing Regulation (EU) 2018/1882 lists infection with the rabies virus as a
        category B disease. Therefore this Regulation includes provisions on compulsory
        eradication programmes and the granting and maintenance of disease-free status with
        regard to infection with the rabies virus.
   9
        Commission Decision 2004/558/EC of 15 July 2004 implementing Council Directive 64/432/EEC as
        regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine
        rhinotracheitis and the approval of the eradication programmes presented by certain Member States (OJ
        L 249, 23.7.2004, p. 20)
   10
        The EFSA Journal (2006) 311, Opinion on the “Definition of a BoHV-1-free animal and a BoHV-1-free
        holding, and the procedures to verify and maintain this status”.
EN                                                     11                                                       EN
 ---pagebreak---    (48) Wild foxes constitute the main reservoir of infection with the rabies virus in the EU. It
        is therefore appropriate that the measures in eradication programmes are primarily
        focused on the wild fox population. However, all other mammal species are
        susceptible and many other animal species are listed in Regulation (EU) 2018/1882 for
        this disease. The competent authorities should address other animal populations in the
        eradication programmes when there is a risk to human or animal health.
   (49) 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 such as surveillance, implementation of disease control
        measures, the control of pet movements and monitoring of the effectiveness of the
        vaccination. As the vaccination provisions are of a very technical nature, they are laid
        down in an annex.
   (50) Implementing Regulation (EU) 2018/1882 lists infection with bluetongue virus
        (serotypes 1-24) (infection with BTV) as a category C disease for optional eradication
        programme. This implies a change in the policy against this disease as Council
        Directive 2000/75/EC11, applicable prior to this Regulation, provided for its immediate
        eradication. New provisions are laid down in this Regulation to address the new status
        of the disease.
   (51) For infection with BTV, the disease control strategy is primarily based on vaccination
        of the relevant targeted animal population supported by other activities such as
        surveillance, implementation of disease control measures, control of the movements of
        animals and germinal products, and minimising exposure to vectors.
   (52) In its opinion12 on the control, surveillance and movement of animals in the case of
        infection with BTV, EFSA indicates that for eradication to succeed, vaccination
        coverage should be at least 95% of susceptible bovine and ovine animals for a
        minimum period of 5 years. It is therefore expected that the eradication programmes
        for infection with BTV include a vaccination campaign, although flexibility should be
        provided for in this Regulation to take into account the specific circumstances of each
        case.
   (53) A Member State or zone thereof free from infection with BTV or under an eradication
        programme for infection with BTV should be protected from the introduction of any
        BTV serotypes by the movement of kept animals or germinal products. Therefore
        requirements for the introduction of kept animals or germinal products into Member
        States or zones thereof free from infection with BTV or under an eradication
        programme for infection with BTV should be part of the provisions on eradication
        programmes. This should also be reflected in the criteria for the maintenance of the
        disease-free status. The same principles should apply to movements of animals
        through the Member States or zones thereof free from infection with BTV or under an
        eradication programme for infection with BTV.
   (54) In addition, because of the diversity of the local situations 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 such introduction does
        not jeopardise the health status at the destination. It is therefore appropriate that this
   11
        Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control
        and eradication of bluetongue (OJ L 327, 22.12.2000, p. 74).
   12
        EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), 2017. Scientific opinion on
        bluetongue: control, surveillance and safe movement of animals. EFSA Journal 2017; 15(3):4698, 126
EN                                                    12                                                   EN
 ---pagebreak---         Regulation provides for the requirements and conditions under which such
        introduction may be authorised. Such requirements should be based on the status of
        animals or germinal products, independently of the Member State or zone of origin.
   (55) An eradication programme for a category B or category C disease of aquatic animals
        should take account of the type of surveillance requirements required to obtain and
        maintain disease-free status, of details of the territory and the animal population to be
        covered by the programme; and of the programme’s intermediate and final targets. The
        eradication programme should include the control measures to be implemented in
        infected establishments of aquatic animals.
   (56) The eradication programme for aquatic animal diseases should include intermediate
        and final targets which will be used to assess progress towards achieving disease-free
        status. Where relevant, these targets should take account of the risk wild animals pose
        to the success of the eradication programme. In particular, any possibility of deviation
        from the proposed period of application of 6 years should be taken in to account when
        devising the programme’s intermediate and final targets.
   (57) 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 Implementing Regulation
        (EU) 2018/1882. However, the competent authority should have the possibility to
        exclude from the programme the species listed as a vector in Implementing Regulation
        (EU) 2018/1882 if it has carried out a risk assessment which has resulted in the risk
        posed by those animals being deemed negligible.
   (58) The competent authority should have the possibility to include additional aquatic
        animal populations when such animals pose a significant risk to the health status. It
        also should be able to exclude certain low-risk establishments from the eradication
        programme if their exclusion does not jeopardise its successful completion.
   (59) When a Member State has decided to participate in an eradication programme for a
        category C disease, operators are obliged to comply with conditions for introductions
        of animals of listed species, to notify suspicion of listed diseases, 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.
   (60) When the presence of a listed disease of aquatic animals is suspected or confirmed in a
        disease-free Member State, zone or compartment, or in one which is subject to a
        eradication programme, the competent authority should take appropriate measures to
        control the disease. These rules should therefore be laid down in this Regulation.
        These include establishing 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 also includes the
        minimum requirements applying to geographical demarcation of a restricted zone and
        the factors affecting it.
   (61) Following the confirmation of a listed aquatic disease in a disease-free Member State,
        zone or compartment, or in one which is subject to a eradication programme, the
        competent authority carries out strict controls in infected establishments and in other
        establishments located in the restricted zone. The nature of the controls and the level
        of flexibility the competent authority applies to movements are set out in this
        Regulation. Where flexibility is applied, it is limited to circumstances where the health
EN                                              13                                                EN
 ---pagebreak---         status of aquatic animals at the establishment of destination or enroute to that
        destination is not jeopardised.
   (62) Once an aquatic disease outbreak has occurred in an establishment and that
        establishment remains or commences an eradication programme, it is important to
        remove aquatic animals that are dead, moribund or showing clinical signs within a
        period set by the competent authority and in accordance with Regulation (EC)
        1069/2009 of the European Parliament and of the Council13. In this way, the disease
        can be successfully controlled.
   (63) The Animal Health Law requires the Commission to develop detailed rules for the
        granting of disease-free status to Member States, zones and compartments. These rules
        should include disease-specific criteria to demonstrate the 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.
   (64) The general criteria comprise the territorial scope, surveillance, biosecurity, disease
        control measures and consistent implementation of other operational rules set out in
        the Animal Health Law as regards the registration and approval of establishments,
        traceability of animals and movement requirements.
   (65) This Regulation lays down disease-specific criteria based on the absence of listed
        species or based on the disease agent or vector’s incapacity to survive. These criteria
        should be drawn up in a flexible way to allow the competent authority to justify the
        case for obtaining disease-free status based on the specific situation. Therefore general
        requirements are laid down in this Regulation to indicate on what basis 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, for compartments.
   (66) This Regulation lays down disease-specific criteria based on the outcome of
        eradication programme and on historical and surveillance data. These criteria are
        based on results of the surveillance, the implementation of measures to prevent
        introduction of the disease and conditions for the use of vaccines.
   (67) Because of their technical nature these criteria are laid down in annexes and grouped
        by disease with the criteria for maintaining the disease-free statuses.
   (68) It is appropriate that this Regulation lay 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 and, in the absence of existing provisions, the
        best available scientific evidence.
   (69) Implementing Regulation (EU) 2018/1882 lists infestation with Varroa spp. as a
        category C disease for optional eradication. This Regulation lays down provisions for
        achieving and maintaining infestation with Varroa spp.-free status.
   (70) Regulation (EU) 2018/1882 lists infection with Newcastle disease virus as a category
        A disease for immediate eradication measures. Therefore this Regulation does not
        contain provisions for an eradication programme for infection with Newcastle disease
   13
        Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009
        laying down health rules as regards animal by-products and derived products not intended for human
        consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation (OJ L 300,
        14.11.2009, p. 1).
EN                                                  14                                                     EN
 ---pagebreak---         virus. However, it should be possible for the competent authority to grant the status
        free from infection with Newcastle disease virus without vaccination on the basis of
        historical and surveillance data.
   (71) Two different types of compartments are possible in the case of aquatic animals.
        Independent compartments operate under strictly defined conditions which ensure they
        operate independently of the health status of the surrounding waters. Dependent
        compartments on the other hand, are influenced by the health status of the surrounding
        waters and operate therefore, under more flexible conditions. Dependent
        compartments are however, only established once the competent authority has
        assessed a number of epidemiological factors and put in place whatever risk mitigating
        measures are necessary to prevent the introduction of disease into the compartment.
   (72) In the case of aquatic animals, and given the lower level of risk associated with
        individual establishments which are independent of the surrounding waters, special
        provisions are laid down in this Regulation for independent compartments when they
        commence aquaculture activities for the first time or when they recommence
        aquaculture activities after a break in production. In such cases, disease-free status
        should be declared immediately provided certain conditions are met. Provisions are
        also laid down for independent compartments where a disease outbreak has occurred.
        To ensure that such outbreaks have been successfully dealt with by the cleaning,
        disinfection and fallowing which have been carried out after de-population, a sample
        of the animals used to repopulate the compartment should be tested before disease-free
        status can be declared.
   (73) When conditions to maintain disease-free status are no longer fulfilled because of
        suspicion or confirmation of the disease, the competent authority should apply disease
        control measures. These measures should apply during the different steps of disease
        control from when an outbreak of the disease is suspected to when the event is
        resolved and the disease-free status restored.
   (74) If the competent authority detects a breach of the conditions required to maintain
        disease-free status in the Member State, zone or compartment, measures should be
        implemented to remedy the situation. The competent authority should have the option
        to suspend the disease-free status when it is still possible to satisfactorily resolve the
        breach and therefore not to have the disease-free status withdrawn by the Commission.
   (75) When a Member State wishes to obtain disease-free status for a listed aquatic disease
        for its entire territory or for a zone thereof accounting for more than 75% of its
        territory, or which is shared with another Member State or third country, it will apply
        to the Commission for approval. In all other cases, a system of self-declaration is
        followed.
   (76) Self-declaration of freedom from aquatic animal diseases for zones and compartments
        other than those which are Commission-approved follows a system which is designed
        to give transparency to the process and which will make it easier and potentially
        quicker for Member States to declare disease-free status. The entire process will be
        completed electronically unless another Member State or the Commission indicate
        concerns which cannot be resolved satisfactorily. If there are concerns that cannot be
        resolved satisfactorily, the declaration is brought to the Standing Committee on Plants,
        Animals, Food and Feed.
   (77) This Regulation contains provisions on the approval of disease-free status of Member
        States or zones thereof. These rules may differ from the rules in force before the date
EN                                               15                                                EN
 ---pagebreak---         of application of this Regulation. Appropriate transitional rules are needed to ensure a
        smooth transition from the existing regime on the approval of disease-free status to the
        new requirements.
   (78) 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/EC14, Commission Decision
        2002/106/EC15; Commission Decision 2003/422/EC16, Commission Decision
        2006/437/EC17, Commission Regulation (EC) No 1266/2007,18, Commission Decision
        2008/896/EC19 and Commission Implementing Decision (EU) 2015/155420 should be
        repealed by this Regulation.
   (79) The Animal Health Law applies from 21 April 2021. Accordingly, the rules laid down
        in this Regulation should also apply from that date.
   HAS ADOPTED THIS REGULATION:
   14
        Commission Decision 2000/428/EC of 4 July 2000 establishing diagnostic procedures, sampling
        methods and criteria for the evaluation of the results of laboratory tests for the confirmation and
        differential diagnosis of swine vesicular disease (OJ L 167, 7.7.2000, p. 22).
   15
        Commission Decision 2002/106/EC of 1 February 2002 approving a Diagnostic Manual establishing
        diagnostic procedures, sampling methods and criteria for evaluation of the laboratory tests for the
        confirmation of classical swine fever (OJ L 39, 9.2.2002, p. 71).
   16
        Commission Decision 2003/422/EC of 26 May 2003 approving an African swine fever diagnostic
        manual (OJ L 143, 11.6.2003, p. 35).
   17
        Commission Decision 2006/437/EC of 4 August 2006 approving a Diagnostic Manual for avian
        influenza as provided for in Council Directive 2005/94/EC (OJ L 237, 31.8.2006, p. 1).
   18
        Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council
        Directive 2000/75/EC as regards control, monitoring, surveillance and restrictions on movements of
        certain animals of susceptible species in relation to bluetongue (OJ L 238, 27.10.2007, p. 37).
   19
        Commission Decision 2008/896/EC of 20 November 2008 on guidelines for the purpose of the risk
        based animal health surveillance scheme provided for in Council Directive 2006/88/EC (OJ L 322,
        2.12.2008, p. 30).
   20
        Commission Implementing Decision (EU) 2015/1554 of 11 September 2015 laying down rules for the
        application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods
        (OJ L 247, 23.9.2015, p. 1).
EN                                                      16                                                  EN
 ---pagebreak---                                         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 of this Regulation 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 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 of this Regulation lays down the rules for eradication
      programmes for 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 of this Regulation lays down the rules for eradication
      programmes for 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 of this Regulation 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 of this Regulation lays down transitional and final provisions in relation to:
EN                                            17                                                EN
 ---pagebreak---             (a)    the approval of the disease-free status of Member States, zones and
                   compartments which are recognised 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 point (e) of Article 9(1) 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 the disease-free status of a 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 point (a) of Article 9(1) 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 point (b)
            of Article 9(1) 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 point (c) of Article 9(1) of Regulation (EU)
            2016/429;
   (7)      '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;
   (8)      '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;
   (9)      '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;
   (10)     'travelling circus' means an exhibition or fair that includes animals or animal acts
            which is intended to move between Member States;
   (11)     'animal acts' means any act featuring animals kept for the purpose of an exhibition or
            fair, and which may form part of a circus;
EN                                                  18                                               EN
 ---pagebreak---    (12) '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;
   (13) 'means of transport' means road or rail vehicles, vessels and aircrafts;
   (14) 'dog' means a kept animal of the Canis lupus species;
   (15) 'cat' means a kept animal of the Felis silvestris species;
   (16) 'ferret' means a kept animal of the Mustela putorius furo species;
   (17) 'seasonally BTV-free area' means the whole territory of a Member State or a zone
        thereof where the competent authority has established a temporary status of freedom
        from infection with bluetongue virus (serotype 1-24) (‘infection with BTV’) 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;
   (18) '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 being granted by
        the competent authority in accordance with Article 44;
   (19) ‘well-boat’ means a vessel used by the aquaculture industry which has a well or tank
        for the storage and transport of live fish in water;
   (20) 'fallowing' means, for disease management purposes, an operation where an
        establishment is emptied of aquaculture animals from listed species, and where
        feasible, of water;
   (21) '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 (a) of Article 83(1) is published electronically;
   (22) 'non-listed species', means an animal species or group of animal species not listed in
        the Annex to Commission Implementing Regulation (EU) 2018/1882 for a particular
        disease;
   (23) '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;
   (24) 'DIVA (differentiating infected from vaccinated animals) vaccination' means a
        vaccination using vaccines that enable in conjunction with appropriate serological
        diagnostic methods, the detection of infected animals in a vaccinated population;
   (25) 'DIVA vaccinated animals' means animals that have been vaccinated in the
        framework of a DIVA vaccination;
   (26) '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(1) of Regulation (EU) 2016/429;
   (27) 'semen' means the ejaculate of an animal or animals, either in the unaltered state or
        prepared or diluted;
   (28) 'oocytes' means the haploid stages of the ootidogenesis including secondary oocytes
        and ova;
EN                                              19                                             EN
 ---pagebreak---    (29) 'embryo' means the initial stage of development of an animal while it is capable of
        being transferred to a recipient dam;
   (30) 'vector-free period' means in a defined area the period of inactivity of Culicoides
        determined in accordance with Section 5 of Chapter 1 of Part II of Annex V;
   (31) 'honeybees' means animals of the Apis mellifera species;
   (32) 'breeding poultry' means poultry 72 hours old or more, intended for the production of
        hatching eggs;
   (33) ‘random annual surveillance’ means a surveillance consisting of at least one survey
        of a targeted animal population organised during the year for which probability-
        based sampling methods are used to select units to examine.
EN                                            20                                              EN
 ---pagebreak---                                           PART II
      SURVEILLANCE, ERADICATION PROGRAMMES,
                           DISEASE-FREE STATUS
                                          Chapter 1
                                        Surveillance
                                           SECTION 1
    DESIGN OF SURVEILLANCE, TARGETED ANIMAL POPULATION AND DIAGNOSTIC
                                           METHODS
                                             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 increased 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;
EN                                              21                                               EN
 ---pagebreak---             (ii)  appropriate veterinary investigation of increased 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 surveillance necessary for
                  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
EN                                             22                                              EN
 ---pagebreak---          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 surveillance necessary for
                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 websites
                of the European Union Reference Laboratories (EURL) and 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’21) as amended or the Manual of Diagnostic
                Tests for Aquatic Animals of the OIE (‘the Aquatic Manual’22) as amended;
         (c)    when not covered by points (a) and (b) of this paragraph, with the methods laid
                down in point (b) of Article 34(2) and Article 34(3) of Regulation (EU)
                2017/625.
   21
       http://www.oie.int/en/standard-setting/terrestrial-manual/access-online/
   22
       http://www.oie.int/en/standard-setting/aquatic-manual/access-online/
EN                                                     23                                          EN
 ---pagebreak---    2.       The diagnostic methods for granting and maintaining 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 design of the surveillance
            referred to in Article 3 of this Regulation the outcome of the official controls and
            other official activities defined 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.
EN                                                  24                                              EN
 ---pagebreak---    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 diseases, and
                certain emerging diseases and subsequent confirmation of outbreaks
   1.      The competent authority shall, on suspicion of listed diseases, other than category A
           disease, or of an emerging disease, conduct an investigation to confirm or to rule out
           the presence of that disease when:
           (a)    there is a need to determine the health status of the Member State, zone or
                  compartment thereof; or
           (b)    there is a need to collect necessary information on the occurrence of the disease
                  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 in a 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 these diseases 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 suspected
           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;
EN                                                 25                                               EN
 ---pagebreak---           (b)    an 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 suspected 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 suspected or confirmed case.
   3.     Disease specific definitions of a suspected 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 suspected 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 the disease 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 risk mitigating 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 and reporting on 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;
EN                                                26                                                 EN
 ---pagebreak---           (b)   targeted animal population, epidemiological units and zones of the programme;
          (c)   organisation of the competent authority, supervision of the implementation of
                the programme, 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 persons
                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 in that report at least the following information:
          (a)   the description of the measures implemented and the results obtained based on
                the information referred to in 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 for 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 for a category B disease or an optional eradication programme for 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 requirements laid down:
                (i)    in Articles 16 to 31 for infection with Brucella abortus, B. melitensis and
                       B. suis, infection with MTBC, EBL, IBR/IPV, infection with ADV and
                       BVD;
                (ii)   in Articles 32 to 36 for infection with rabies virus (RABV);
EN                                                 27                                              EN
 ---pagebreak---             (iii) in Articles 37 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 that the objectives of the programme are achieved and that the
      results will last.
      Where such coordination has not been established, the competent authority shall
      include in the eradication programme, if feasible, effective risk mitigating measures,
      including intensified surveillance.
                                          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 shall 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 2 000 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 2 000 km² taking into account:
      (a)   a minimum surface not significantly lower than 2 000 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 requirements laid
      down in Article 72 for granting disease-free status.
   2. 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 requirements referred to in paragraph 1; and
      (b)   if necessary, additional requirements that are not included in the criteria for
            granting disease-free status to assess progress towards eradication.
EN                                            28                                               EN
 ---pagebreak---                                               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 the 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 cases,
          the Commission may, upon request of Member States, extend the period of
          application of the eradication programme for an additional 6-year period.
                                             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 with respect to 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 MTBC;
          (c)   EBL;
          (d)   IBR/IPV;
          (e)   infection with ADV;
          (f)   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 mitigating measures;
          (d)   the optional implementation of vaccination programmes.
                                              Article 17
   Targeted and additional animal populations for eradication programmes for certain diseases
   1.     The competent authority shall apply a 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;
EN                                                29                                            EN
 ---pagebreak---           (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 health status of animals
          referred to in paragraphs 1 or 2.
                                              Article 18
      Obligations of operators with respect to eradication programmes for certain 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 ordered by the competent authority pursuant to Article
                       3(1);
                (ii)   in the case of movement of animals from the targeted animal populations,
                       ensuring that the health 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 populations 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
                       health status by physical protection measures 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.
EN                                                30                                              EN
 ---pagebreak---    2.       The operators of slaughterhouses, where animals from the targeted animal
            populations referred to in Article 17 are kept and slaughtered shall comply with the
            general requirements laid down in points (a)(i), (iv) and (v) 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 targeted animal
   populations comply with the general requirements laid down in point (a) of Article 18(1), the
   competent authority may decide that the obligations of operators to obtain and maintain
   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)      travelling 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 have been met.
            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 paragraph 2.
   4.       The competent authority may attribute distinct health status to different
            epidemiological units of the same establishment provided that its operator:
            (a)   has submitted for the consideration of the competent authority the information
                  about the different epidemiological units established within the establishment
EN                                                31                                              EN
 ---pagebreak---                to be granted distinct health status prior to any suspicion or confirmation of the
               disease in accordance with Articles 21 and 24;
        (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 mitigating 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 suspected 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 it has authorised their immediate
               slaughter in a designated slaughterhouse;
        (b)    shall, when it considers it necessary for the control of the risk of spreading the
               disease:
               (i)    where technically possible, order the isolation of the suspected 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 suspected 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.
EN                                              32                                                EN
 ---pagebreak---                                                Article 23
      Derogations 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 to in Article
          20(4).
   2.     By way of derogation from point (a) of Article 21(2), the competent authority may
          authorise movement of animals from the relevant targeted animal population to an
          establishment under its official supervision 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 health status or with wild animals
                 of listed species for the relevant disease.
   3.     By way of derogation from point (a) of Article 21(2), in the 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.     When making use of the derogation laid down in paragraph 2, the competent
          authority shall:
          (a)    suspend the disease-free status of the establishment of destination of the
                 animals that are subject to the derogations, until the end of the investigations
                 referred to in Article 21(1);
          (b)    prohibit, until the end of the investigations referred to in Article 21(1), the
                 movement of animals from that establishment, unless it has authorised their
                 direct transport to a designated slaughterhouse for immediate slaughter;
          (c)    in case of suspicion of infection with Brucella abortus, B. melitensis and B.
                 suis or with MTBC, maintain the prohibition laid down in point (b) after the
                 end of the investigation until all the animals that moved in the establishment
                 following the derogation laid down in paragraph 2 have been slaughtered.
   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 have been taken.
                                               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);
EN                                                 33                                                 EN
 ---pagebreak---           (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, if
          necessary, an epidemiological enquiry and investigations as provided for in Article
          25. If it considers it necessary in order to prevent the spread of the disease, it shall:
          (a)    order relevant disease control measures as provided for in Articles 21 to 25 and
                 in Article 30 in establishments keeping the targeted animal population and the
                 additional animal populations;
          (b)    conduct or order other proportionate and necessary prevention, surveillance
                 and disease control measures with respect to the relevant wild animal
                 population or in its habitat.
                                               Article 25
      Epidemiological enquiry and investigations 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 about the situation:
          (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
          population out of the infected establishment unless it has authorised their immediate
          slaughter in a designated slaughterhouse.
   2.     When the competent authority considers it necessary in order to prevent the spread of
          the disease, it shall:
          (a)    order the isolation of the suspected and confirmed cases in the establishment
                 where technically possible;
EN                                                 34                                               EN
 ---pagebreak---       (b)   restrict the movements of animals from targeted animal population within the
            establishment;
      (c)   restrict the introduction of animals from targeted animal population in the
            establishment;
      (d)   restrict the movement of products of animals from targeted animal population
            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 that in
      infected establishments the following testing is conducted within a maximum period
      of time to be determined by it:
      (a)   testing of those animals whose testing is considered necessary to complete the
            epidemiological enquiry;
      (b)   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; and
      (c)   any additional testing it considers necessary to ensure the swift detection of
            infected animals that may contribute to the spreading of the disease.
   2. By way of derogation from point (b) of paragraph 1, 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 of 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 order that in infected establishments all animals
      recognised as confirmed cases and, if necessary, as suspected cases are slaughtered
      within a maximum period of time it determines.
EN                                            35                                            EN
 ---pagebreak---    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 with MTBC, order that:
          (a)   milk from confirmed cases shall either be fed only to animals in the same
                establishment after it has been processed to ensure the inactivation of the
                disease agent, or it shall be disposed of;
          (b)   manure, straw, feed 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, following an appropriate risk
                assessment, stored and processed to reduce to an acceptable level the risk of
                spreading of the disease.
   2.     In the event of infection with Brucella abortus, B. melitensis and B. suis, the
          competent authority shall order that in all infected establishments foetuses, still-born
          animals, animals which have died from the disease after birth and 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 for
          paragraphs 1 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 Article 26(1), the competent authority may authorise
          movement of clinically healthy animals, other than confirmed cases, to an
          establishment under its official supervision provided that the following requirements
          are complied with:
          (a)   the movement does not jeopardise the health status of animals at the
                establishment of destination or enroute to that destination;
          (b)   the animals shall only be moved by direct transport; and
          (c)   in the establishment of destination, the animals shall be kept, in closed
                facilities, with no contact with kept animals of a higher health status or with
                wild animals of listed species for the relevant disease.
EN                                                36                                               EN
 ---pagebreak---    2.  By way of derogation from Article 26(1) in the case of a category C disease, the
       competent authority may authorise 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 an optional eradication
             programme; and
       (b)   the movement does not jeopardise the health status of targeted or additional
             animal populations at the establishment of destination or enroute to that
             destination.
   3.  When making use of the derogation laid down in paragraph 1, the competent
       authority shall withdraw the disease-free status of the establishment of destination of
       the animals that are subject to the derogation and shall:
       (a)   order the movement of the animals by direct transport, within a maximum
             period of time it determines, from the establishment of destination to a
             designated slaughterhouse for immediate slaughter; or
       (b)   in case of a category C disease order the disease control measures laid down in
             Articles 26 to 30 until the disease-free status of the establishment is regained.
   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 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 the guarantees that all the necessary
             biosecurity and other risk mitigating measures have been taken.
                                          Article 30
      Cleaning and disinfection and other measures to prevent the spread of infection
   1.  The competent authority shall order the operators of all infected establishments and
       those receiving animals from infected establishments the cleaning and disinfection
       or, where relevant, the safe disposal of:
       (a)   all parts of the establishments that may have been contaminated after the
             removal of the confirmed and suspected cases and before repopulation;
       (b)   any feed, materials, substances, husbandry related equipment, medicinal
             equipment 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 infected establishments;
       (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.
EN                                            37                                                EN
 ---pagebreak---    4.       The competent authority may, based on a risk assessment, regard a pasture as
            contaminated and prohibit its use for kept animals of higher health status than that of
            the targeted animal population or, if epidemiologically relevant, additional animal
            populations, for a period of time sufficient to consider the risk of persistence of the
            disease agent to be negligible.
                                               Article 31
                            Risk mitigating measures to prevent reinfection
   Before or upon lifting of the disease control measures, the competent authority shall order
   proportionate risk mitigating 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 ERADICATION PROGRAMMES FOR INFECTION WITH RABV
                                               Article 32
            Disease control strategy of eradication programmes for infection with RABV
   1.       The competent authority shall, when establishing an eradication programme for
            infection with RABV, base it 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
                  its 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)   coordinated, if necessary, 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 be involved in the implementation of eradication
            programmes for infection with RABV in a third country or territory, to prevent the
            risk of spread and introduction of RABV in the territory of its Member State.
EN                                                 38                                               EN
 ---pagebreak---                                                Article 33
        Targeted animal population for eradication programmes for infection with RABV
   1.      The competent authority shall apply the eradication programme for infection with
           RABV to the following targeted animal population: kept and wild animals of species
           of the following families: 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 animal population relevant to surveillance referred to in Article 4.
                                               Article 34
   Obligations of the competent authority in the context of eradication programmes for 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 mitigating measures to prevent the spread of RABV by
                 movements of 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,
                 if relevant, of other animals referred to in Article 33(3);
           (b)   the identification and registration of dogs, cats and ferrets;
           (c)   movement restrictions of relevant kept animals of species referred to in Article
                 33(3) that are not vaccinated against infection with RABV 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.
EN                                                 39                                              EN
 ---pagebreak---                                                 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 suspected cases to protect humans
            and animals against the risk of being infected pending the results of the
            investigations;
   (c)      order any risk mitigating 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 shall, unless it considers further investigations are necessary, rule out an infection
            with RABV in animals with an epidemiological link when:
                   (i)   a minimum period of 3 months has lapsed since the epidemiological link
                         with the confirmed case occurred; and
                   (ii)  no clinical signs have been detected in those animals;
   (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 Article 12 of Regulation
            (EC) No 1069/2009.
                                               SECTION 4
       PROVISIONS FOR ERADICATION PROGRAMMES FOR INFECTION WITH BTV
                                                Article 37
             Disease control strategy of eradication programmes for infection with BTV
   1.       The competent authority shall, when establishing an optional eradication programme
            for infection with BTV, base the programme on a disease control strategy that
            includes:
            (a)    surveillance of infection with BTV 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;
EN                                                  40                                                EN
 ---pagebreak---             (c)   movement restrictions of the targeted animal population in accordance with the
                  requirements laid down in Articles 43 and 45;
            (d)   risk mitigating 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 1-24 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-km 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 for infection with
                                                  BTV
   1.       The competent authority shall apply the eradication programme for 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 populations: 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 for 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 the requirements ordered by the competent authority as regards
                  the surveillance of animals from the targeted animal population;
EN                                                  41                                               EN
 ---pagebreak---            (b)    comply with the requirements ordered by the competent authority as regards
                  the entomological surveillance;
           (c)    have animals from the 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)    comply with movement requirements following the orders of the competent
                  authority;
           (f)    implement any additional measures considered necessary by the competent
                  authority which may include, if relevant, protection of kept animals from
                  attacks by vectors in accordance with the animals’ health 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 the requirements ordered by the competent authority as regards
                  the surveillance of 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, if relevant, protection of kept animals from
                  attacks by vectors in accordance with the animals’ health status.
                                               Article 40
   Obligations of the competent authority in the context of eradication programmes for infection
                                               with BTV
   1.      The competent authority shall in the territory covered by an eradication programme
           for infection with BTV referred to in point (b) of Article 37(2):
           (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
                  requirements laid down in Chapter 1 of Part II of Annex V;
           (c)    apply the disease control measures laid down in Articles 41 and 42 in the event
                  of suspicion or confirmation of the disease;
           (d)    order operators of establishments of bovine, ovine or caprine animals and, if
                  necessary, other targeted animal populations to have their animals vaccinated;
                  and
           (e)    apply the requirements laid down in Articles 43 and 45 to the movements of
                  animals from the targeted animal population.
   2.      By 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.
EN                                                 42                                               EN
 ---pagebreak---    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 cessation of the transmission of BTV in the
            area; and
      (d)   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 to confirm or rule out the disease.
   2. Pending the outcome of the investigation referred to in paragraph 1, the competent
      authority shall:
      (a)   restrict movement of animals and germinal products from the targeted animal
            population from the establishment where they are kept unless authorised for the
            purpose of immediate slaughter;
      (b)   order relevant risk mitigating 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 the targeted
      animal population had a similar exposure to infectious vectors to that of the
      suspected 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 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)   confirm the outbreak and, if necessary, establish or extend the zone under
            eradication programme;
      (b)   conduct an epidemiological enquiry, if necessary;
      (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 of germinal products of animals from the targeted animal
            population from the establishment where they are kept ;
EN                                           43                                                EN
 ---pagebreak---           (e)    order relevant risk mitigating measures, when it considers it 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 establishments of bovine, ovine or caprine animals 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 health status of the targeted animal population 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 the
          disease.
                                               Article 43
      Movement of kept animals and germinal products from the targeted animal population to
        Member States or zones covered by eradication programmes for 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 for
          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 authorise
          the introduction of animals from the targeted animal population in the territory
          covered by the eradication programme for infection with BTV if:
          (a)    it has assessed the risk that the introduction poses to the health status of the
                 place of destination as regards infection with BTV, taking into account possible
                 risk mitigating measures it may adopt at the place of destination;
          (b)    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 polymerase chain reaction (PCR) test for BTV serotypes
                        1-24 was carried out on samples collected not earlier than 14 days after
                        the introduction;
          (c)    it adapts, if 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 one 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
EN                                                 44                                              EN
 ---pagebreak---          programme for 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 for infection with BTV if:
         (a)    it has assessed the risk that the introduction poses to the health status of the
                place of destination as regards infection with BTV, taking into account possible
                risk mitigating 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 requirements set out in point 4 of
                Section 2 of Chapter 2 of Part II of Annex V.
   5.    When the competent authority receiving the animals or the germinal products uses
         the derogations provided for in paragraphs 2 or 4, it shall:
         (a)    inform the Commission thereof as soon as possible;
         (b)    accept animals or germinal products from the targeted animal population that
                comply with the requirements for the relevant derogation regardless of the
                Member State or zone of origin of the animal or germinal products.
   6.    When the competent authority receiving the animals or the germinal products no
         longer uses the derogations provided for in paragraphs 2 or 4, it shall inform the
         Commission as soon as possible.
                                             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
                                      for 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 for
         infection with BTV referred to in point (b) of Article 37(2) if:
EN                                               45                                              EN
 ---pagebreak---            (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 for infection with BTV if the requirements laid
           down in points (a), (c) and (d) of Article 43(2) are complied with.
                                            Chapter 3
   Eradication programmes for 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 for a category B disease or an optional eradication programme for 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 point (b)(ii) of
                 Article 3(2);
           (b)   the territory and animal population covered 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 that the objective of the programmes are achieved and will last.
           Where such coordination has not been established, the competent authority shall
           include in the eradication programme, if feasible, effective risk mitigating measures
           including intensified surveillance.
EN                                                46                                               EN
 ---pagebreak---                                          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, if 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;
      (b)   one or several zones; or
      (c)   the geographical location of the establishments of which the compartment or
            compartments are comprised.
   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 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 to apply 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 requirements laid down in
      Article 72 for granting disease-free status.
   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 health 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 requirements referred to in paragraph 1 and the
            targets provided for in paragraph 2; and
      (b)   if necessary, additional requirements that are not included in the requirements
            for granting disease-free status to assess progress towards eradication.
                                         Article 49
                                    Period of application
   1. The period of application of eradication programmes for listed aquatic animal
      diseases are laid down in Part II of Annex VI, specifically Sections 2 and 3 of:
      (a)   Chapter 1 for VHS and IHN;
EN                                           47                                                EN
 ---pagebreak---             (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 cases,
            the Commission may, upon request of Member States, extend the period of
            application of the eradication programme for an additional 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 or C
   disease in a Member State, zone, or compartment on:
   (a)      the determination of the health status of the Member State, zone or compartment by
            ascertaining the health status of all establishments where animals from the listed
            species are kept;
   (b)      the implementation of disease control measures in all establishments where
            suspected and confirmed cases are detected;
   (c)      the implementation of biosecurity and other risk mitigating measures to reduce the
            risk of the listed species in an establishment becoming infected;
   (d)      in certain cases, vaccination, as part 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, the zone or compartment.
   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 health 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.
EN                                                  48                                                EN
 ---pagebreak---                                                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 health status of all establishments where animals from the listed
            species are kept according to:
            (a)    the health status of each establishment as known 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 the 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
                   health 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
            paragraph 1 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 health status of confined establishments
   By way of derogation from Article 52(1), the competent authority may decide not to classify
   the health status of confined establishments, if the animal population kept in these confined
   establishments is subjected to appropriate risk mitigating 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;
   (b)      vaccination of an additional animal population of kept animals;
   (c)      vaccination of an additional animal population of wild animals.
EN                                                 49                                             EN
 ---pagebreak---                                            Article 55
            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 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 in the establishment
              where suspected 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 or processing in a disease control aquatic food
              establishment, or for direct human consumption in the case of molluscs or
              crustacea which are sold live for that purpose;
        (d)   prohibit the movement of equipment, feed and animal by-products from the
              establishment 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 certain diseases
   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 suspected establishment;
        (b)   any establishment which has a direct epidemiological link with the suspected
              establishment.
   2.   If the presence of the disease is suspected in wild aquatic animals, the competent
        authority shall, when it considers it necessary, extend the measures laid down in
        Article 55 to the concerned establishments.
                                           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) the competent authority may
        authorise the movement of aquaculture animals to an establishment under its official
        supervision provided that the following requirements are complied with:
        (a)   only animals showing no symptoms of disease are moved;
        (b)   the health status of aquaculture animals at the establishment of destination or
              aquatic animals enroute to that establishment is not jeopardised by the
              movement;
EN                                             50                                             EN
 ---pagebreak---       (c)    in the establishment of destination they have no contact with aquaculture
             animals of a higher health status with respect to the relevant disease; and
      (d)    the animals are kept in the establishment of destination for a maximum period
             of time to be determined by the competent authority.
   2. When making use of the derogation laid down in paragraph 1, the competent
      authority shall:
      (a)    re-classify the health status of the establishment of destination, if relevant, in
             accordance with the criteria laid down in Article 52(1), until the end of the
             investigation referred to in Article 55(1);
      (b)    prohibit the movement of animals from the establishment of destination until
             the end of the investigation, unless it has authorised their transport to a disease
             control aquatic food establishment for immediate slaughter or processing or for
             direct human consumption, in the case of molluscs or crustacea which are sold
             live for that purpose.
   3. The competent authority may use the derogation provided for in paragraph 1 only if
      operators of establishments of origin and of destination and transporters of the
      animals that are subject to the derogation:
      (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 have been taken; and
      (c)    provide the competent authority with guarantees that animal by-products as
             defined in point (1) of Article 3 of Regulation (EC) No 1069/2009 from the
             aquatic animals referred to in paragraph 1(c) of this Article are processed or
             disposed of as Category 1 or Category 2 material in accordance with Articles
             12 or 13 of that Regulation.
                                          Article 58
          Official confirmation of certain diseases and disease control measures
   1. If a case is confirmed, the competent authority shall:
      (a)    declare the establishment(s) infected;
      (b)    reclassify the health 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(s).
   2. The minimum requirements that shall apply with regard to the establishment(s) of the
      restricted zone are set out in Part II of Annex VI, specifically in:
      (a)    point 1(a) of Section 3 of Chapter 1 for VHS and IHN;
      (b)    point 1(a) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;
      (c)    point 1(a) of Section 3 of Chapter 3 for infection with Marteilia refringens;
      (d)    point 1(a) of Section 3 of Chapter 4 for infection with Bonamia exitiosa;
      (e)    point 1(a) of Section 3 of Chapter 5 for infection with Bonamia ostreae;
EN                                             51                                                EN
 ---pagebreak---           (f)    point 1(a) of Section 3 of Chapter 6 for infection with WSSV.
   3.     By way of derogation from point (c) of paragraph 1, 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 well-boats 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)    take measures to eradicate the disease from the relevant wild aquatic animal
                 population, where feasible.
                                               Article 59
      Epidemiological enquiry and investigations 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 55(2) in all
                 epidemiologically linked establishments;
          (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 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).
EN                                                 52                                             EN
 ---pagebreak---                                               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 suspected 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 or processing in a disease
                 control aquatic food establishment or for direct human consumption in the case
                 of molluscs or crustacea which are sold live for that purpose;
           (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 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
    Derogations 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 aquaculture animals to an establishment under its official
           supervision located within the same restricted zone provided that:
           (a)   only animals showing no symptoms of disease are moved;
           (b)   the health status of aquaculture animals at the establishment of destination or
                 aquatic animals enroute to that establishment is not jeopardised by the
                 movement;
           (c)   in the establishment of destination they have no contact with aquaculture
                 animals of a higher health status with respect to the relevant disease;
           (d)   the animals are kept in the establishment of destination for a maximum period
                 of time to be determined by the competent authority.
   2.      When making use of the derogation laid down in paragraph 1, the competent
           authority shall:
           (a)   re-classify the health status of the establishment of destination, if relevant, in
                 accordance with the criteria laid down in Article 52(1);
           (b)   prohibit the movement of animals from the establishment of destination, unless
                 it has authorised their transport to a disease control aquatic food establishment
                 for immediate slaughter or processing or for direct human consumption, in the
                 case of molluscs or crustacea which are sold live for that purpose. In all cases,
EN                                                 53                                               EN
 ---pagebreak---             animal by- products as defined in point (1) of Article 3 of Regulation (EC) No
            1069/2009 shall be processed or disposed of as Category 1 or Category 2
            material in accordance with Articles 12 or 13 of that Regulation.
      (c)   keep the establishment of destination under its official supervision until the
            completion of cleaning, disinfection and appropriate fallowing of the
            establishment.
   3. By way of derogation from point (b) Article 60(1), the competent authority may
      authorise the movement of aquaculture animals to 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;
      (b)   the health status of aquaculture animals at the establishment of destination or
            aquatic animals enroute to that establishment is not jeopardised by the
            movement; and
      (c)   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 aquaculture animals and products of animal origin to
      slaughtering and processing facilities other than disease control aquatic food
      establishments provided that:
      (a)   only animals showing no symptoms of disease are moved;
      (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;
      (c)   the health status of aquatic animals enroute for the slaughtering and processing
            facility or in its vicinity is not jeopardised by the movement;
      (d)   the movement complies with the certification requirements set out in Article
            208(2) of Regulation (EU) 2016/429.
   5. 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 that:
      (a)   a risk assessment has been completed;
      (b)   risk mitigating measures are implemented, where necessary, to ensure that the
            health status of the aquatic animals at the establishment of destination or
            enroute 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
EN                                              54                                           EN
 ---pagebreak---       competent authority, the following measures in relation to aquatic animals from
      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)    suspected 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 paragraph 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 animals of non-listed species in the infected
      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 1 or Category 2
      material in accordance with Articles 12 or 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 repopulation:
      (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 feed that may have been
             contaminated;
      (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 longlines;
      (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.
EN                                            55                                                 EN
 ---pagebreak---    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(c) of Section 3 of Chapter 1 for VHS and IHN;
            (b)   point 1(c) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;
            (c)   point 1(c) of Section 3 of Chapter 3 for infection with Marteilia refringens;
            (d)   point 1(c) of Section 3 of Chapter 4 for infection with Bonamia exitiosa;
            (e)   point 1(c) of Section 3 of Chapter 5 for infection with Bonamia ostreae;
            (f)   point 1(c) 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 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.
                                               Article 65
                           Risk mitigating measures to prevent reinfection
   Before or upon removal of the disease control measures, the competent authority shall order
   proportionate risk mitigating 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.
EN                                                 56                                                EN
 ---pagebreak---                                              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
   Disease-free status may only be granted to Member States or zones thereof when the
   following general and specific criteria are complied with:
   (a)     general criteria:
           (i)   the territorial scope complies with the requirements laid down in Articles 13 or
                 47 as relevant;
           (ii)  the surveillance for the disease complies with the requirements laid down in
                 paragraph 1 or 2 of Article 3 as relevant;
           (iii) operators comply with obligations as regards biosecurity measures as laid
                 down in Article 10 of Regulation (EU) 2016/429;
           (iv) the disease control measures relevant to 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 and 42;
                 –      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 55 to 65;
           (v)   the establishments were registered or approved, as relevant to the type of
                 establishment;
           (vi) identification of animals from the targeted animal population and traceability
                 of germinal products were ensured, as relevant for the type of animal;
           (vii) when moved, the animals from the 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 for granting disease-free status based on Articles 67 to 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:
EN                                                 57                                              EN
 ---pagebreak---            (a)   the general criteria laid down in point (a)(i) and (a)(ii) of Article 66 have been
                 fulfilled for an eligibility period of at least 5 years and the disease was not
                 detected; and
           (b)   the listed species relevant to 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 the disease agent’s incapacity to survive
   1.      The criteria to recognise the disease-free status of a Member State or of a zone
           because of the disease agent’s incapacity 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 an eligibility period of at least 5 years and the disease was not
                 detected;
           (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) of
                 paragraph 1, documentary evidence;
           (b)   with respect to the fulfilment of the criteria set out in points (c) and (d) of
                 paragraph 1, scientific evidence.
                                                Article 69
    Disease-free status of terrestrial animals based on the incapacity to survive of listed vectors
                                for listed diseases of terrestrial animals
   1.      The criteria to recognise the disease-free status of a Member State or of a zone
           because of the incapacity to survive of listed vectors for that listed disease are as
           follows:
           (a)   the general criteria laid down in points (a)(i) and (a)(ii) of Article 66 have been
                 fulfilled for an eligibility period of at least 5 years and the disease was not
                 detected;
EN                                                  58                                               EN
 ---pagebreak---       (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 are not naturally present in the Member State or zones
             thereof;
      (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 vectors is reached;
      (g)    the listed vectors are 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) of
             paragraph 1, documentary evidence;
      (b)    with respect to the fulfilment of the criteria set out in points (c) to (g) of
             paragraph 1, scientific evidence.
      If the disease has occurred, the Member state shall provide documentary 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 Member State or a zone thereof
      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 25 years;
      (b)    the disease has been reported in the past 25 years, it 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 on the basis of the provisions set out in point (a) of
      paragraph 1 shall have implemented the following measures for an eligibility period
      of at least 10 years:
      (a)    disease surveillance of kept animals of 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;
EN                                             59                                              EN
 ---pagebreak---        (d)    disease surveillance substantiating the fact that the disease is not known to be
              established in wild animals from 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 2003/99/EC23 of the European
              Parliament and of the Council, and no case was reported in listed animals
              species for the past two years;
       (b)    infection with BTV, if all 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 paragraph 1 to obtain disease-free status shall only apply:
       (a)    in a new Member State, during a maximum period of two years following its
              accession to the Union; or
       (b)    for a maximum period of two years following the date of application of the
              implementing acts adopted in accordance with 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 the maximum two-year period
       for the following statuses:
       (a)    status free from infestation with Varroa spp.;
       (b)    status free from infection with Newcastle disease virus without vaccination.
   6.  By way of derogation from point (b) of paragraph 4, the granting of disease-free
       status based on historical and surveillance data 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;
   23
      Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the
      monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing
      Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31)
EN                                               60                                                  EN
 ---pagebreak---             (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
            eradication programmes are as follows:
            (a)   the competent authority has been running an approved eradication programme
                  as referred to in Articles 12 or 46; and
            (b)   the competent authority has completed the eradication programme and
                  submitted to the Commission an application for recognition of disease-free
                  status 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 for disease-free status
   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 status free 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 status free 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 status free from infection with
            MTBC;
   (c)      Section 1 of Chapter 2 of Part III of Annex IV for status free from EBL;
   (d)      Section 1 of Chapter 2 of Part IV of Annex IV for status free from IBR/IPV;
   (e)      Section 1 of Chapter 2 of Part V of Annex IV for status free from infection with
            ADV;
   (f)      Section 1 of Chapter 2 of Part VI of Annex IV for status free from BVD;
   (g)      Section 1 of Chapter 2 of Part I of Annex V for status free from infection with
            RABV;
   (h)      Section 1 of Chapter 4 of Part II of Annex V for status free from infection with BTV;
   (i)      Section 1 of Part III of Annex V for status free from infestation with Varroa spp.;
   (j)      Section 1 of part IV of Annex V for status free from infection with Newcastle disease
            virus without vaccination;
   (k)      Section 2 of Chapter 1 of Part II of Annex VI for status free from VHS;
   (l)      Section 2 of Chapter 1 of Part II of Annex VI for status free from IHN;
EN                                                 61                                              EN
 ---pagebreak---    (m)      Section 2 of Chapter 2 of Part II of Annex VI for status free from infection with
            HPR-deleted ISAV;
   (n)      Section 2 of Chapter 3 of Part II of Annex VI for status free from infection with
            Marteilia refringens;
   (o)      Section 2 of Chapter 4 of Part II of Annex VI for status free from infection with
            Bonamia exitiosa;
   (p)      Section 2 of Chapter 5 of Part II of Annex VI for status free from infection with
            Bonamia ostreae;
   (q)      Section 2 of Chapter 6 of Part II of Annex VI for status free 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 to compartments keeping aquaculture animals
   1.       Disease-free status may only be granted to a compartment keeping aquaculture
            animals when the following general and specific criteria are complied with:
            (a)    general criteria:
                   (i)   the territorial scope complies with point (c) of Article 47(2);
                   (ii)  the surveillance for the disease complies with the requirements laid down
                         in Articles 3(2), 4 and 6 to 9;
                   (iii) operators comply with obligations as regards biosecurity measures as laid
                         down in Article 10 of Regulation (EU) 2016/429;
                   (iv) compliance with the disease control measures relevant to the disease in
                         the event of a suspicion or confirmation;
                   (v)   the establishments of which the compartment is comprised are approved;
                   (vi) traceability of the animals from the targeted animal population was
                         ensured;
                   (vii) when moved, the animals from the 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 for granting disease-free status based on the provisions of
                   Articles 74 to 77.
   2.       The disease-free status referred to in paragraph 1 may be granted to:
            (a)    compartments which are independent of the health status of the surrounding
                   natural waters; and
            (b)    compartments which are dependent on the health status of the surrounding
                   natural waters but where conditions exist which create an effective disease
EN                                                  62                                             EN
 ---pagebreak---              specific separation between the compartment and other aquatic animal
             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)   health status of other aquaculture establishments in 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 from relevant listed
                    species in the water system and their health 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 system;
      (b)    classify all establishments in the compartment as high risk, in compliance with
             Chapter 1 of Part I of Annex VI;
      (c)    impose whatever measures are found to be necessary to prevent the
             introduction of disease.
   4. When a disease-free declaration for a dependent compartment is made to the
      Commission in accordance with Article 83, the competent authority shall provide the
      assessment referred to in point (a) of paragraph 3 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 point (a) of paragraph 3
      and measures taken to mitigate their impact.
                                           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 points (a)(i) and (a)(ii) of Article 73(1) have
             been fulfilled for an eligibility period of at least 5 years and the disease was not
             detected; and
      (b)    the listed species relevant to the disease in question are absent from kept and
             wild animal populations.
EN                                             63                                                 EN
 ---pagebreak---    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 the disease agent’s incapacity to survive
   1. The criteria to recognise the disease-free status of a compartment keeping
      aquaculture animals because of the disease agent’s incapacity to survive are as
      follows:
      (a)   the general criteria laid down in points (a)(i) and (a)(ii) of Article 73(1) have
            been fulfilled for an eligibility period of at least 5 years and the disease was not
            detected;
      (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 points (a) and (b) of
            paragraph 1, documentary evidence;
      (b)   with respect to the fulfilment of the criteria set out in points (c) and (d) of
            paragraph 1, 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 keeping
      aquaculture animals 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 25 years;
      (b)   the disease has been reported in the past 25 years, it has been eradicated from
            the compartment and the 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 on the basis of the provisions set out in point (a) of paragraph 1 shall
      have implemented the following measures for an eligibility period of at least 10
      years:
      (a)   disease surveillance of kept animals of listed species;
EN                                            64                                                 EN
 ---pagebreak---            (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 78;
           (d)   disease surveillance substantiating the fact that the disease is not known to be
                 established in wild animals from listed species within the compartment.
   3.      The criteria provided for in paragraph 1 shall only apply:
           (a)   in a new Member State, during a maximum period of two years following its
                 accession to the Union; or
           (b)   for a maximum period of two years following the date of application of the
                 implementing acts adopted in accordance with 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 disease-free
           status based on historical and surveillance data 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 programmes
   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 requirements 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 the water catchment supplying the
           compartment 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 status free from VHS;
   (b)     Section 2 of Chapter 1 of Part II of Annex VI for status free from IHN;
EN                                                 65                                             EN
 ---pagebreak---    (c)       Section 2 of Chapter 2 of Part II of Annex VI for status free from infection with
             HPR-deleted ISAV;
   (d)       Section 2 of Chapter 3 of Part II of Annex VI for status free from infection with
             Marteilia refringens;
   (e)       Section 2 of Chapter 4 of Part II of Annex VI for status free from infection with
             Bonamia exitiosa;
   (f)       Section 2 of Chapter 5 of Part II of Annex VI for status free from infection with
             Bonamia ostreae;
   (g)       Section 2 of Chapter 6 of Part II of Annex VI for status free from infection with
             WSSV.
                                                Article 79
       Specific requirements for compartments which are independent of the health 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 health status regarding a
             specific disease is independent of the health status of the surrounding natural waters,
             may obtain disease-free status if it complies with paragraphs 2 to 6.
   2.        An independent compartment may comprise:
             (a)    an individual establishment which is considered a single epidemiological unit,
                    as it is not influenced by the animal health status of the surrounding natural
                    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 but due to extensive movements of animals between
                    establishments, they are 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 establishment, 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 the disease-specific requirements referred to in
             Article 78.
EN                                                  66                                                EN
 ---pagebreak---                                                  Article 80
        Special provisions for compartments which comprise individual establishments which
      commence or recommence aquaculture activities and where the health status regarding a
        specific disease is independent of the health status of the surrounding natural 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 5 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 point (a)(ii) of Article 73(1) provided:
            (a)    the health history of the establishment is known to the competent authority and
                   there has been no confirmation in the establishment of a category B or category
                   C disease;
            (b)    the establishment is cleaned, disinfected and fallowed, if necessary, prior to
                   repopulation.
   3.       An establishment which recommences its activities after the confirmation of a
            category B or category C disease is considered to be disease-free from the confirmed
            disease, provided:
            (a)    a representative sample of the animals which have been repopulated into the
                   establishment from a disease-free Member State, zone or compartment
                   following cleaning, disinfection and fallowing is tested for the relevant disease
                   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 disease;
            (b)    the sampling and diagnostic tests set out in the relevant Chapter of Part II 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
                   targeted prevalence is 2 %;
            (c)    results of the testing described in point (b) are negative.
                                               SECTION 3
       MAINTENANCE, SUSPENSION AND WITHDRAWAL 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;
EN                                                   67                                                EN
 ---pagebreak---       (b)    the biosecurity measures ordered by the competent authority based on the risks
             identified to prevent the introduction of the disease;
      (c)    the operational rules as referred to in points (a)(v), a(vi) and a(vii) of Article 66
             or points (a)(v), a(vi) and a(vii) of Article 73(1).
   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.
      In disease-free zones or compartments in Member States which are not declared
      disease-free, or in all cases where conditions conducive to clinical expression of the
      disease in question do not exist, targeted surveillance shall be continued as referred
      to 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 status free 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 status free 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 status free from infection
             with MTBC;
      (c)    Section 2 of Chapter 2 of Part III of Annex IV for status free from EBL;
      (d)    Section 2 of Chapter 2 of Part IV of Annex IV for status free from IBR/IPV;
      (e)    Section 2 of Chapter 2 of Part V of Annex IV for status free from infection
             with ADV;
      (f)    Section 2 of Chapter 2 of Part VI of Annex IV for status free from BVD;
      (g)    Section 2 of Chapter 2 of Part I of Annex V for status free from infection with
             RABV;
      (h)    Section 2 of Chapter 4 of Part II of Annex V for status free from infection with
             BTV;
      (i)    Section 2 of Part III of Annex V for status free from infestation with Varroa
             spp;
      (j)    Section 2 of Part IV of Annex V for status free from infection with Newcastle
             disease virus without vaccination;
      (k)    Section 4 of Chapter 1 of Part II of Annex VI for status free from VHS;
      (l)    Section 4 of Chapter 1 of Part II of Annex VI for status free from IHN;
      (m) Section 4 of Chapter 2 of Part II of Annex VI for status free from infection
             with HPR-deleted ISAV;
      (n)    Section 4 of Chapter 3 of Part II of Annex VI for status free from infection
             with Marteilia refringens;
EN                                             68                                                  EN
 ---pagebreak---            (o)    Section 4 of Chapter 4 of Part II of Annex VI for status free from infection
                  with Bonamia exitiosa;
           (p)    Section 4 of Chapter 5 of Part II of Annex VI for status free from infection
                  with Bonamia ostreae;
           (q)    Section 4 of Chapter 6 of Part II of Annex VI for status free from infection
                  with WSSV.
                                               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;
           (b)    conduct specific surveillance to assess the extent of the outbreak;
           (c)    order any necessary risk mitigating measures.
   2.      If the disease has not been confirmed, but there has been a breach of 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 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;
           (b)    inform without delay the Commission and the other Member States about the
                  measures adopted; and
           (c)    inform regularly the Commission and the other Member States about the
                  evolution of the situation, of its position as regards the restoration of the
                  disease-free status, the prolongation of its suspension or its withdrawal by the
                  Commission.
   4.      Subject to compliance with the provisions of paragraph 3 the competent authority
           may restore the disease-free status of the Member State, zone or compartment thereof
           by lifting the suspension.
                                             SECTION 4
                   DEROGATIONS FROM APPROVAL BY THE COMMISSION
                                               Article 83
     Derogations from approval by the Commission for certain disease-free statuses for aquatic
                                            animal diseases
   1.      By way of derogation from the requirements to obtain approval by the Commission
           for disease-free status, laid down in Articles 36(4) and 37(4) of Regulation (EU)
           2016/429, for aquatic animal diseases of zones or compartments, such approval for
EN                                                 69                                              EN
 ---pagebreak---       zones or compartments which cover less than 75% of the territory of a Member State,
      and where the water catchment supplying the zone or compartment is not shared with
      another Member State or third country, shall 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-free status 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 shall take effect and the
             zone or compartment referred to in this paragraph shall achieve the disease-free
             status.
   2. Within the 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
      clarification or additional information, 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 is prolonged
      automatically for 60 days from the date on which the first concerns were raised.
      There shall be no further prolongation of this period
   4. Where the process referred to in paragraph 3 fails, the provisions laid down in
      Articles 36(4) and 37(4) of Regulation (EU) 2016/429 shall apply.
EN                                          70                                                EN
 ---pagebreak---                                            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 statuses:
        (a)    free from 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 (B.
                      melitensis-free) status was granted in accordance with Directive
                      91/68/EEC;
        (b)    free from infection with MTBC, when the tuberculosis-free status was granted
               in accordance with Directive 64/432/EEC;
        (c)    free from EBL, when EBL-free status was granted in accordance with
               Directive 64/432/EEC;
        (d)    free from IBR/IPV, when IBR-free status was granted in accordance with
               Directive 64/432/EEC;
        (e)    free from infection with ADV, when Aujeszky’s disease-free-status was
               granted in accordance with Directive 64/432/EEC;
        (f)    free from infestation with Varroa spp., when varroasis-free status was granted
               in accordance with Council Directive 92/65/EEC24;
        (g)    free from infection with Newcastle disease virus without vaccination when
               Newcastle disease non-vaccination status was granted in accordance with
               Directive 2009/158/EC;
        (h)    free from VHS, when VHS-free status was granted in accordance with Council
               Directive 2006/88/EC25;
        (i)    free from IHN, when IHN-free status was granted in accordance with Directive
               2006/88/EC;
        (j)    free from infection with HPR-deleted ISAV, when infection with HPR-deleted
               ISAV-free status was granted in accordance with Directive 2006/88/EC;
        (k)    free from infection with Bonamia ostreae, when infection with Bonamia
               ostreae-free status was granted in accordance with Directive 2006/88/EC;
   24
      Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade
      in and imports into the Community of animals, semen, ova and embryos not subject to animal health
      requirements laid down in specific Community rules referred to in Annex A (I) to Directive
      90/425/EEC (OJ L 268, 14.9.1992, p. 54).
   25
      Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture
      animals and products thereof, and on the prevention and control of certain diseases in aquatic animals
      (OJ L 328, 24.11.2006, p. 14).
EN                                                71                                                         EN
 ---pagebreak---          (l)    free from infection with Marteilia refringens, when infection with Marteilia
                refringens-free status was granted in accordance with Directive 2006/88/EC;
         (m) free from 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 statuses:
         (a)    free from highly pathogenic avian influenza, when the compartment has been
                approved with respect to avian influenza in accordance with Commission
                Regulation (EC) No 616/200926;
         (b)    free from VHS, when VHS-free status was granted in accordance with
                Directive 2006/88/EC;
         (c)    free from IHN, when IHN-free status was granted in accordance with Directive
                2006/88/EC;
         (d)    free from infection with HPR-deleted ISAV, when infection with HPR-deleted
                ISAV-free status was granted in accordance with Directive 2006/88/EC;
         (e)    free from infection with Bonamia ostreae, when infection with Bonamia
                ostreae-free status was granted in accordance with Directive 2006/88/EC;
         (f)    free from infection with Marteilia refringens, when infection with Marteilia
                refringens-free status was granted in accordance with Directive 2006/88/EC;
         (g)    free from 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, when the IBR/IPV 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;
   26
        Commission Regulation (EC) No 616/2009 of 13 July 2009 implementing Council Directive
        2005/94/EC as regards the approval of poultry compartments and other captive birds compartments
        with respect to avian influenza and additional preventive biosecurity measures in such compartments
        (OJ L 181, 14.7.2009, p. 16).
EN                                                   72                                                     EN
 ---pagebreak---             (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 2006/88/EC;
            (g)   infection with Marteilia refringens, when the infection with Marteilia
                  refringens surveillance or eradication programme was approved in accordance
                  with Directive 2006/88/EC;
            (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 in
                  accordance 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:
   –        Decision 2000/428/EC;
EN                                                73                                           EN
 ---pagebreak---    –         Decision 2002/106/EC;
   –         Decision 2003/422/EC;
   –         Decision 2006/437/EC;
   –         Regulation (EC) No 1266/2007;
   –         Decision 2008/896/EC;
   –         Implementing Decision 2015/1554.
   References to those 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, 17.12.2019
                                                 For the Commission
                                                 The President
                                                 Ursula von der LEYEN
EN                                                 74                                               EN
 ---documentbreak---                             EUROPEAN
                            COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 4056 final
                                                     ANNEXES 1 to 6
                                          ANNEXES
                                            to the
                COMMISSION DELEGATED REGULATION (EU) .../...
   supplementing Regulation (EU) 2016/429 of the European Parliament and the Council
    laying down rules for surveillance, eradication programmes and disease freedom for
                            certain listed and emerging diseases
EN                                                                                     EN
 ---pagebreak---                                               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
          suspected 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;
          (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 a kept animal or from a group
                of kept animals showing clinical signs consistent with the disease or
                epidemiologically linked to a suspected 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
          suspected 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;
          (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 a kept animal or from a group
                of kept animals showing clinical signs consistent with the disease or
                epidemiologically linked to a suspected or confirmed case.
EN                                                1                                                EN
 ---pagebreak---    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
      suspected 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;
      (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 a kept animal or from a group
            of kept animals showing clinical signs consistent with the disease or
            epidemiologically linked to a suspected or confirmed case.
   3. For the purposes of this case definition, the disease agent responsible for infection
      with NDV must be any 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).
EN                                           2                                                EN
 ---pagebreak---                                            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; and
        (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.
EN                                              3                                            EN
 ---pagebreak---                                         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 requirements 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 increased, when HPAI has been detected in wild
      birds, by monitoring systems using organised patrols 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 suspected 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;
EN                                           4                                              EN
 ---pagebreak---            (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 supplies
           of game or quails to be released into the wild 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 targeted 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; and
           (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.
EN                                                 5                                                   EN
 ---pagebreak---    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 and
      complexity of the production system 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 surveillance 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 poultry flocks;
      (e)    presence of long-lived poultry;
      (f)    practice of all-in all-out principle;
      (g)    length of waiting period between batches; and
      (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 supplies of game to be
             released into the wild.
   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;
EN                                              6                                            EN
 ---pagebreak---             (d)   the poultry of species belonging to Galliformes for supplies of game to be
                  released into the wild.
                                             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 targeted 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. poultry
            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. Samples must be
                  subjected to laboratory testing by virological methods, when taken for:
                  (i)    early detection of HPAI in poultry referred to in Section 3;
                  (ii)   early detection of HPAI in wild birds referred to in Section 4;
                  (iii) complementary surveillance for HPAI in poultry species which generally
                         do not show significant clinical signs of HPAI referred to in Section 5;
                  (iv) 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.
EN                                                 7                                               EN
 ---pagebreak---                                            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) indirect enzyme-linked immunosorbent assay (I-ELISA)
                (iv) fluorescence polarisation assay (FPA)
                (v)    competitive enzyme-linked immunosorbent assay (C-ELISA)
          (b)   tests for milk samples
                (i)    ring test (MRT)
                (ii)   I-ELISA
   2.     Brucellin skin test (BST)
          For the testing as referred to in section 1 and 2 of Chapter 1 of Part I of Annex IV,
          Brucellin 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 tuberculin test (SITT)
          (b)   the comparative intradermal tuberculin test (CITT)
   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) I-ELISA
          (b)   tests for milk samples
                (i)    I-ELISA
EN                                               8                                              EN
 ---pagebreak---                                                           SECTION 4
   INFECTIOUS BOVINE RHINOTRACHEITIS/INFECTIOUS PUSTULAR
                                       VULVOVAGINITIS (IBR/IPV)
                                Methods:                             Matrix:
                                                                     individual serum samplesd
                                BoHV-1 I-ELISAa
     non-vaccinated                                                  milk samples
     bovine animals                              b                   individual serum samplesd
                                gB B-ELISA
                                                                     individual meat juice samples
     DIVA vaccinated                                                 individual serum samples
     bovine animals                              c
                                gE B-ELISA                           individual meat juice samples
     with a gE-deleted
     vaccine
   a
             I-ELISA 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.
   b
             B-ELISA 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.
   c
             B-ELISA 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 one single positive sample in the pool.
   d
             When 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 system is under all circumstances of day to day laboratory work sensitive enough to detect one weak
             positive sample in the pool of the modulated size.
                                                          SECTION 5
               INFECTION WITH AUJESZKY'S DISEASE VIRUS (ADV)
                                Methods:                       Matrix:
                                                               individual or up to 5 pooled serum (or plasma)
     non-vaccinated                                            samples
                                ADV ELISAa
     porcine animals                                           individual or up to 5 pooled filter paper samples
                                                               individual meat juice samples
     DIVA vaccinated
     porcine animals
                                gE ELISAb                      individual serum samples
     with a gE-deleted
     vaccine
   a
             ELISA for the detection of antibodies against whole ADV, ADV-gB protein or ADV-gD protein. For batch
             control of ADV-gB kits and ADV-gD kits 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.
   b
             ELISA 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.
EN                                                                9                                                              EN
 ---pagebreak---                                       SECTION 6
                    BOVINE VIRAL DIARRHOEA (BVD)
   1. Direct methods:
      (a)   Real-time reverse transcription PCR
      (b)   BVDV antigen detection ELISA
   2. Serological tests:
      (a)   I-ELISA
      (b)   B-ELISA
EN                                         10    EN
 ---pagebreak---                                              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 test, 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 of the last animal
                       that 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
EN                                                 11                                              EN
 ---pagebreak---             (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 into 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.
   3. 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 with the status free from infection with Brucella abortus, B. melitensis
      and B. suis with vaccination if:
      (a)   the requirements set out in points (a), (b), (d), (e) and (f) of point 1 are
            fulfilled; and
      (b)   the requirement set out in point (b)(i) of Section 2 is fulfilled.
EN                                            12                                                EN
 ---pagebreak---                                               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 all 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, 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 substantiate absence of infection with
                  Brucella abortus, B. melitensis and B. suis and the status of all suspected 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;
EN                                                 13                                                  EN
 ---pagebreak---         (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 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 point 1 of Section 1 of
               Chapter 1 are fulfilled;
        (b)    since the beginning of the sampling referred to in point (c)(i) of point 1 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 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
EN                                              14                                                  EN
 ---pagebreak---                         –      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 point 1 of
                  Section 1 of Chapter 1, all germinal products of bovine, ovine or caprine origin
                  introduced into 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 point 1 of Section 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 all 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.
EN                                                  15                                               EN
 ---pagebreak---                                         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 point 1 of Section 1 and point (b) of Section 2 are fulfilled;
      (b)    the results of further investigations substantiate absence of infection with
             Brucella abortus, B. melitensis and B. suis and the status of all suspected 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.
EN                                            16                                               EN
 ---pagebreak---                                               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 requirements have 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 animal introduced into the
            Member State or zone has been vaccinated during the past 3 years prior to its
            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; and
            (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 for 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;
EN                                                  17                                                EN
 ---pagebreak---       (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, surveillance must be based on:
            (i)    random annual surveillance that must allow at least for 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 established conclusions 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 in each establishment identified with
            suspected 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.
EN                                           18                                                EN
 ---pagebreak---                                              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 requirements have 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 has been 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; and
   (d)      vaccination of ovine and caprine animals against Brucella abortus, B. melitensis and
            B. suis has not taken place for at least the past 3 years and no ovine or caprine animal
            introduced into the Member State or zone has 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; and
            (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 for 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;
EN                                                 19                                                EN
 ---pagebreak---       (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, surveillance must be based on:
            (i)    random annual surveillance that must allow at least for 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, which takes 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 established conclusions 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 in each establishment identified with
            suspected or confirmed cases following implementation of the measures
            provided for in point (b) until their disease-free status is restored or regained;
            and
      (d)   the surveillance referred to in point 1 has been adapted and has demonstrated
            that the incident has been resolved.
EN                                           20                                                EN
 ---pagebreak---                                           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 test on two
            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 and of the last animal that 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 animal 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), all
            germinal products of bovine origin introduced into or used in the establishment
            originate from:
            (i)    establishments free from infection with MTBC; or
            (ii)   approved germinal product establishments.
EN                                             21                                                EN
 ---pagebreak---    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 points 1(c) 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 suspected case of infection with MTBC in 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;
EN                                             22                                               EN
 ---pagebreak---       (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 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 point 2 of Section 2 are
            fulfilled;
      (b)   the results of further investigations substantiate absence of infection with
            MTBC and the status of all suspected cases has been determined. In case,
            suspected 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;
EN                                           23                                               EN
 ---pagebreak---       (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 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 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 two 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 that 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.
EN                                               24                                             EN
 ---pagebreak---                                              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 establishments confirmed
            infected during the year did not exceed 0.1 %; and
   (b)      general surveillance requirements have 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 in 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; and
            (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 out to demonstrate 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, surveillance
                  is based on:
                  (i)    random annual surveillance to demonstrate at least with a confidence
                         level of 95 %, that the incidence rate of establishments confirmed
                         infected during the year does not exceed 0.1 %; or
                  (ii)   risk-based annual surveillance carried out to detect infection with MTBC,
                         taking into account the systems of production, the risk factors identified,
                         including the spread of infection from other animals than kept bovine
                         animals and increased surveillance in establishments associated with at
EN                                                 25                                                 EN
 ---pagebreak---                   least one of the specific risks referred to in point 2(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 with MTBC in the animal population other
      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.
EN                                         26                                               EN
 ---pagebreak---                                         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, 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 other bovine animals of the establishment; or
                        they have been subjected to a serological test, with a negative
                        result, within 30 days prior to their 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, that 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; and
      (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.
EN                                           27                                                EN
 ---pagebreak---                                               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; and
   (b)     serological testing for EBL is carried out, with negative results, on samples taken
           (i)    at intervals of not more than 36 months from all bovine animals over 24
                  months of age; or
           (ii)   in accordance with point (b) or (c) of Section 2 of Chapter 2, as relevant, if the
                  establishment is located in a Member State or zone free from EBL.
                                              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 that 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 substantiate absence of EBL and the status
                  of all suspected 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;
EN                                                  28                                               EN
 ---pagebreak---             (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,
                   where 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 that 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, where 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 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; and
   (b)      all bovine animals over 24 months of age slaughtered within this Member State or
            zone are subjected to an official post-mortem examination with samples from all
            animals with tumours that could be caused by EBL being subjected to 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 requirements set out in Section 1 continue to be fulfilled; and
   (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.
EN                                                 29                                                EN
 ---pagebreak---                                             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, where serological tests for the detection of antibodies against
              whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE 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 months 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
                           for 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
EN                                              30                                             EN
 ---pagebreak---                           –     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 for 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 that 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, if necessary, antibodies against
                          BoHV-1-gE 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 points (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, if
            necessary, antibodies against BoHV-1-gE 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
EN                                                   31                                               EN
 ---pagebreak---        (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 3
             consecutive years, annually on blood or milk samples taken from a number of
             bovine animals that must allow at least for 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, if relevant.
   (c) only bovine animals that 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 that 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, if necessary, antibodies against BoHV-1-gE on a sample taken in the
       establishments of origin within 15 days prior to their dispatch, in cases 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 that 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.
EN                                             32                                                EN
 ---pagebreak---    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 points (b),
                  (c) and (d) of Section 2 are fulfilled;
           (b)    the results of further investigations substantiate absence of IBR/IPV and the
                  status of all suspected 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 that 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; and
   (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; and
EN                                                 33                                               EN
 ---pagebreak---       (b)  surveillance is carried out annually based on random sampling that must allow
           at least for 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 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 enquiry and investigations according to
           Article 25 has demonstrated that only a limited number of establishments were
           involved in the outbreak;
      (b)  its use is limited to controlling 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 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 infection with BoHV-1 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.
EN                                         34                                               EN
 ---pagebreak---                                              Part V
                  Infection with Aujeszky’s disease virus
                                           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 where serological tests for the detection of
                antibodies against ADV or, if necessary, antibodies against ADV-gE 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 for 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 that 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, if necessary, antibodies
                      against ADV-gE 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 animals introduced into the establishment originate
                from:
                (i)   establishments free from infection with ADV; or
EN                                              35                                                EN
 ---pagebreak---                   (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.
                                              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, if necessary;
   (c)     provided the establishment is located in a Member State or zone free from infection
           with 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 Section 2 of Chapter
           2 or point 4 of Section 2 of Chapter 2, if relevant;
   (d)     all porcine animals, that 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 cases where:
                  –      the establishment is located in a Member State or zone free from
                         infection with ADV and the establishments of origin are not located in a
                         Member State or zone free from infection with 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 that is neither free from infection with
                         ADV nor covered by an approved eradication programme.
                  The number of porcine animals tested must allow at least for the detection,
                  with a 95 % level of confidence, of seropositive animals at a target prevalence
                  rate of 10 %.
EN                                                  36                                              EN
 ---pagebreak---                   By way of derogation from the first subparagraph, for porcine animals less than
                  4 months old born to DIVA-vaccinated dams 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 in 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), if relevant, and (d) of Section 2 are fulfilled;
            (b)   the results of further investigations substantiate absence of infection with ADV
                  and the status of all suspected 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), if 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:
EN                                                  37                                                  EN
 ---pagebreak---    (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 ADV for at least the previous 24 months; and
   (c) in case, infection with ADV is known to be established in wild porcine animals,
       measures have been implemented to prevent any transmission of 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; and
       (b)   surveillance is carried out annually based on random sampling to allow at least
             for 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 for 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 enquiry and investigations including clinical examination
             and serological or virological testing has been carried out by the competent
             authority:
             (i)    in all establishments keeping porcine animals that have been directly or
                    indirectly in contact with the infected establishment to rule out infection;
                    and
             (ii)   in all establishments keeping porcine animals located within at least a 2-
                    kilometre radius of an infected establishment, to demonstrate that these
                    establishments are not infected. The number of blood or meat juice
                    samples to be taken from porcine animals kept in these establishments
                    must allow at least for the detection, with a 95 % level of confidence, of
                    seropositive animals at a target prevalence rate of 10 %; or
             (iii) in case a DIVA vaccination has been used, serological testing for
                    antibodies against ADV-gE has been carried out on two occasions at an
                    interval of 2 months in establishments keeping porcine animals located
                    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;
EN                                            38                                                 EN
 ---pagebreak---       (d)   the relevant control measures as referred to in Article 24 have been
            immediately implemented in each establishment infected with ADV, including
            where 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 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.
EN                                            39                                             EN
 ---pagebreak---                                         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.
                  At least from all calves born in 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 12 months on at least three occasions at intervals of not less
                  than 4 months from bovine animals which have been kept in the
                  establishment for at least 3 months prior to testing.
                  The number of animals tested must allow at least for 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
                  animals of each group must be tested;
            (iii) a combination of the testing regimes set out in points (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 points (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
EN                                           40                                                 EN
 ---pagebreak---             (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
                   –      prior to their dispatch, they have been tested individually to
                          exclude BVDV transmission into the establishment of destination
                          taking into account the testing history and, if relevant, the animal’s
                          stage of gestation; 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, have 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) all germinal
            products of bovine animals introduced into the establishment originate from:
            (i)    establishments free from BVD; or
            (ii)   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), if 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 was 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;
EN                                             41                                                   EN
 ---pagebreak---             (ii)  serological tests for the detection of antibodies against BVDV are carried
                  out at least annually on samples taken from bovine animals that have
                  been kept in the establishment for at least 3 months prior to testing.
                  The number of animals tested must allow at least for 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
                  animals of each group must be tested;
            (iii) a combination of the testing regimes laid down in points (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, if relevant;
      (d)   only bovine animals that 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
      keeping bovine animals 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 with animals that are intended or used for breeding and
            are moved from this establishment to a slaughterhouse,
            (i)   directly, or;
            (ii)  via an assembly operation, which is carried out in the same Member State
                  or zone, and where only animals that comply with the requirements laid
                  down in points (b) and (c) and originate from establishments that comply
                  with the requirement laid down in point (a) 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, if relevant, point 2 of Section 2 are fulfilled.
EN                                            42                                                  EN
 ---pagebreak---             (b)   the results of further investigations substantiate absence of BVD and the status
                  of all suspected 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) and (d) of point 1 and, if 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 that might have been infected in utero with BVDV were born and
                  kept in isolation until they 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; and
   (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 be maintained if:
EN                                                  43                                              EN
 ---pagebreak---       (a)   the requirements laid down in point (a) and (c) of Section 1 continue to be
            fulfilled; and
      (b)   surveillance is carried out annually that must allow at least for 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 enquiry and investigations 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 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.
EN                                          44                                               EN
 ---pagebreak---                                              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 for 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 Council1.
   2.    For the purpose of eradication programmes for 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 for 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 timing and
                coverage 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 geographical distribution of vaccine baits with a
                frequency that allows, if necessary, the adoption of corrective measures; and
   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).
EN                                               45                                                      EN
 ---pagebreak---            (d)    be subjected to monitoring of vaccination effectiveness, that may include the
                  detection of the presence of biomarker and serological testing in dead animals
                  from the targeted animal population for the vaccination.
   2.      For the purpose of eradication programmes for infection with RABV the vaccination
           against infection with RABV of stray dog populations must:
           (a)    be organised and implemented, if 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 requirements laid
                  down in Article 3(1) 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 and 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 increased surveillance and epidemiological enquiry and investigations
                  during the 6 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 requirements laid down in Article
           3(1) with the objective of an early detection of the disease; 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.
EN                                                  46                                              EN
 ---pagebreak---                                               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 2 YEARS
   1.     The surveillance of infection with bluetongue virus (serotypes 1-24) (infection with
          BTV) to ensure early detection of introduction or recurrence of infection with any of
          the serotypes 1-24 of BTV that were not reported during the previous 2 years must
          include:
          (a)    general surveillance requirements as provided for in point (a) of Article 3(1);
          (b)    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 circulation of any
                 of the serotypes 1-24 of BTV in the vicinity; and
          (c)    any other identified relevant risk factor for introduction of any of the serotypes
                 1-24 of BTV not reported in the previous 2 years.
   3.     The surveillance in an area(s) adjacent to any infected Member State, zone or third
          country must be increased in an area of up to 150 km from the limit with the Member
          State, zone, or third country. The demarcation of the area of increased surveillance
          may be adapted to relevant ecological or geographical features likely to facilitate or
          interrupt the transmission of BTV or adapted due to the implementation of disease
          control measures that supports the choice between 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
          spread of the infection when one or more serotypes of BTV is present and, if
          necessary, to monitor the prevalence rate must include:
          (a)    general surveillance requirements as provided for in point (a) of Article 3(1);
                 and
          (b)    active surveillance as provided for in Section 4.
EN                                                47                                                EN
 ---pagebreak---    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 target prevalence rate of the surveillance provided for in point 1 must be adapted
          to the epidemiological situation, taking into the main risk factors such as the targeted
          animal population and the vector population.
                                             SECTION 3
        SURVEILLANCE TO DEMONSTRATE ABSENCE OF INFECTION WITH BTV
   1.     The surveillance of infection with BTV to demonstrate the absence of infection with
          any of the serotypes 1-24 that has been previously detected in the territory must
          include:
          (a)    general surveillance requirements as provided for in point (a) of Article 3(1);
                 and
          (b)    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; and
          (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 can be adapted to:
          (a)    the epidemiological situation, how fast the infection is spreading and the shape
                 and size of the zones covered by the eradication programme in the event of
                 confirmation of the infection; and
          (b)    the zones in accordance with point (b) of Article 13(2).
   2.     Active surveillance must be based on one or a combination of the following
          activities:
          (a)    monitoring of sentinel animals using serological or virological testing; and
          (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; and
EN                                                 48                                              EN
 ---pagebreak---       (b)    be monthly during the vector activity season where regular information is
             needed due to the risk of the infection spreading.
   4. The animals sampled must:
      (a)    not be vaccinated against the serotype(s) of BTV targeted for 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 not have
             been protected from exposure to the vector;
      (d)    be representative for the geographical distribution of the targeted animal
             population in the relevant geographical unit; and
      (e)    be initially seronegative when 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 1-3.
   6. When surveillance must be adapted as provided for in point (c) of Article 43(2), it
      must at least include a survey:
      (a)    on 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 their introduction; or
      (b)    on the targeted animal population the most at risk due to the possible
             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 one-shot 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, where 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
      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; and
EN                                             49                                             EN
 ---pagebreak---       (b)    one night per month during the vector-free period.
      On the basis of the evidence obtained in the first 3 years of operating 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) throughout 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 complexes.
   4. When entomological surveillance is 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 as maximum
      threshold.
                                        Chapter 2
              Movement of animals and germinal products
                                         SECTION 1
                                MOVEMENT OF ANIMALS
   1. The animals 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 originate from a Member State or a zone covered by the eradication
      programme and at least one of the following requirements is complied with:
      (a)    the animals 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 have been
                   subjected to a serological test, with negative results, carried out on
                   samples collected at least 28 days following the entry date of the animal
                   into the seasonally BTV-free Member State or zone; or
             (iii) for at least 14 days prior to the date of movement and have been
                   subjected to a PCR test, with negative results, carried out on samples
                   collected at least 14 days following the entry date of the animal into the
                   seasonally BTV-free Member State or zone;
      (b)    the animals have been protected against attacks by the vectors during
             transportation to the place of destination and they 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 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
EN                                             50                                             EN
 ---pagebreak---             (iii) for at least 14 days prior to the date of movement and 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 have been vaccinated against all serotypes 1-24 of BTV reported
            during the past 2 years in that Member State or zone, the animals are within the
            immunity period guaranteed in the specifications of the vaccine and meet at
            least one of the following requirements:
            (i)    they have been vaccinated more than 60 days before the date of
                   movement; or
            (ii)   they have been vaccinated with an inactivated vaccine and subjected to a
                   PCR test, with negative results on samples collected at least 14 days after
                   the onset of the immunity set in the specifications of the vaccine.
      (d)   the animals 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 have been carried out on samples collected at least 60
                   days before the date of movement; or
            (ii)   the serological test have been carried out on samples collected at least 30
                   days before the date of the movement and the animals 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 originate from a Member State or a zone neither BTV-free nor covered
      by an eradication programme for infection with BTV and:
      (a)   they comply with point 2(b); or
      (b)   the animals 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 they are kept,
            or in a Member State, where surveillance in compliance with the requirements
            laid down in Sections 1 and 2 of Chapter 1 have been carried out at least for the
            last 60 days prior to departure and:
            (i)    they have been vaccinated in accordance with point 2(c) against all
                   serotypes 1-24 of BTV reported during the past 2 years in an area of at
                   least 150 km radius centred on the place where the animals were kept; or
            (ii)   they have been immunised in accordance with point 2(d) against all
                   serotypes 1-24 of BTV reported during the past 2 years in an area of at
                   least 150 km radius centred on the place where the animals were kept.
   4. The animals originate from a Member State or a zone not BTV-free, are destined for
      immediate slaughter and 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 are transported directly from the Member State or zone of origin to
            the slaughterhouse of destination where they are slaughtered within 24 hours of
            arrival;
EN                                            51                                               EN
 ---pagebreak---       (c)   the operator of the establishment of origin 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 originate from a Member State or a zone neither BTV-free nor covered
      by an eradication programme for infection with BTV and the animals comply with
      the requirements set out in point 2(a).
   6. The animals originate from a Member State or a zone not BTV-free and:
      (a)   they have been protected from vector attacks by insecticides or repellents for at
            least 14 days prior to the date of movement; and
      (b)   they 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 vector attacks.
   7. The animals comply with specific animal health requirements defined by the
      competent authority to ensure they have sufficient immunological protection prior to
      departure.
   8. The animals 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 have been kept at least for a period of 60 days prior to and during
      the collection of germinal products in a Member State or a zone free from infection
      with BTV.
   2. The germinal products originate from a Member State or a zone covered by the
      eradication programme for infection with BTV and at least one of the requirements
      set out in point (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 is complied with:
      (a)   semen have been obtained from donor animals that comply with at least one of
            the following requirements:
            (i)    they have been protected against attacks by vectors in a vector protected
                   establishment for a period of at least 60 days before commencement of
                   collection and during collection of the semen;
            (ii)   they have been kept in a seasonally BTV-free Member State or zone for a
                   period of at least 60 days before commencement of collection and during
                   collection of the semen;
            (iii) they 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 have been subjected, with negative results, to a direct diagnostic
                   method carried out on samples collected:
EN                                           52                                               EN
 ---pagebreak---                           –      at commencement and final collection of the semen to be
                                 consigned; and
                          –      during the period of semen collection: at least every 7 days in the
                                 case of a virus isolation test, or at least every 28 days, in the case of
                                 a PCR test;
            (b)    in vivo derived embryos of bovine animals have been obtained from donor
                   animals that do not show any clinical signs of infection with BTV on the day of
                   collection and are collected, processed and stored in accordance with Part 2 of
                   Annex III of Commission Delegated Regulation (EU) 20XX/ …
                   [SANTE/7073/2018, C(2019)4055]2;
            (c)    embryos other than in vivo derived embryos of bovine animals and oocytes
                   have been obtained from donor animals that comply with at least one of the
                   following requirements:
                   (i)    they have been protected against attacks by vectors in a vector protected
                          establishment for at least 60 days before commencement of collection
                          and during collection of the embryos/oocytes;
                   (ii)   they 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 have been subjected to a PCR test, with negative results, on samples
                          collected on the day of collection of the embryos/oocytes;
                   (iv) they have been kept in a seasonally BTV-free Member State or zone for a
                          period of at least 60 days before collection of the embryos/oocytes.
   3.       The germinal products originate from a Member State or a zone neither BTV-free
            nor covered by an eradication programme for infection with BTV and 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 originate from a Member State or a zone neither BTV-free
            nor covered by an eradication programme for infection with BTV and must comply
            with either 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;
   2
          Commission Delegated Regulation (EU) 20XX/ … of ..,supplementing Regulation (EU) 2016/429 of
          the European Parliament and of the Council as regards the approval of germinal product establishments
          and the traceability and animal health requirements for movements within the Union of germinal
          products of certain kept terrestrial animals [SANTE/7073/2018, C(2019)4055]
EN                                                        53                                                    EN
 ---pagebreak---    (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; and
   (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; and
       (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 BTV has already been reported if:
       (a)   surveillance in accordance with Section 3 of Chapter 1 has been conducted at
             least for the past 24 months; and
       (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 maintained if:
       (a)   the requirements laid down in point 1 of Section 1 are complied with; and
       (b)   animals and germinal products from the 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 frequency of the surveillance referred to in point 1 of Section 1
       must be duly adapted to:
       (a)   the health status of neighbouring Member States, zones or third countries in
             accordance with point 3 of Section 4 of Chapter 1;
       (b)   the introduction of animals from the 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.
EN                                           54                                                EN
 ---pagebreak---    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,
      surveillance must be based on:
      (a)   random annual surveillance at least to detect, with a 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 established in a Member State or zone
      thereof 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 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 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 with any of the serotypes 1-24 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 3 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
      evidence.
   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.
EN                                           55                                                EN
 ---pagebreak---                                               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 its potential presence in the past;
   (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 for 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 beehives;
   (e)      in the presence of a 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.;
            and
   (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.
   The status 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 infestation with Varroa spp. in apiaries and
                  beehives;
            (iii) takes into consideration specifically target areas with higher likelihood of
                  introduction of or infestation with Varroa spp., based on a risk assessment;
EN                                                 56                                              EN
 ---pagebreak---    (b) all the suspected 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.; and
   (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.
EN                                             57                                             EN
 ---pagebreak---                                               Part IV
       Status free from infection with Newcastle disease virus-
                                    without vaccination
                                              SECTION 1
       GRANTING OF STATUS FREE FROM INFECTION WITH NEWCASTLE DISEASE
                                  VIRUS WITHOUT VACCINATION
   The status free from infection with Newcastle disease virus (NDV) 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 requirements have 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 %; and
   (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 status free from infection with NDV 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 status free from infection with NDV
            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 suspected or confirmed cases until the incident has
                  been resolved;
EN                                                 58                                             EN
 ---pagebreak---       (b)   the competent authority has concluded that only a limited number of
            establishments, epidemiologically linked to the first detected outbreak, were
            infected; and
      (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 status free from infection with NDV without vaccination granted to a Member
      State or to a zone is not affected by the confirmation of the infection in another bird
      population, 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.
EN                                          59                                                EN
 ---pagebreak---                                             ANNEX VI
     SPECIFIC REQUIREMENTS AS REGARDS DISEASES OF AQUATIC ANIMALS
                                              Part I
                                RISK-BASED SURVEILLANCE
                                           Chapter 1
      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 2 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 3 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.
EN                                               60                                                EN
 ---pagebreak---                                               Chapter 2
           Risk ranking to be applied in certain approved aquaculture establishments
   The risk ranking referred to in point 1.2 of Chapter 1 must as a minimum, take into account
   the risk factors referred to in points (a) and (b). 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)       track record of the establishment as regards compliance with the requirements of the
             competent authority.
                                              Chapter 3
                             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 Chapter 2 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.
EN                                                   61                                               EN
 ---pagebreak---                                                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
EN                                                 62                                                EN
 ---pagebreak---             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 health 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:
EN                                                  63                                                EN
 ---pagebreak---              (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 for VHS or IHN.
                                                                    Table 1.A
   Scheme for Member States, zones and compartments for the 2-year control period
   referred to in point (a)(i) which precedes the achievement of status free from VHS and
   status free from IHN
                                                                                            Number of fish in the
                                       Number of                 Number of                            sample(1)
          Type of                  health visits per           samplings per               Number
       establishment                  year to each              year in each                                 Number of
                                                                                               of
                                     establishment             establishment                                 broodstock
                                                                                           growing
                                                                                                                fish(2)
                                                                                              fish
    (a) Establishments                         2                          2               50 (first         30 (first or
         with broodstock                                                                  visit)            second visit)
                                                                                          75 (second
                                                                                          visit)
    (b) Establishments                         2                          1                      0          75 (first or
         with broodstock                                                                                    second visit)
         only
    (c) Establishments                         2                          2               75 (first                  0
         without                                                                          AND
         broodstock                                                                       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.
EN                                                             64                                                               EN
 ---pagebreak---                                                              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 (a)(ii) which precedes the achievement of
                                 status free from VHS and status free from IHN
                                                                                             Number of fish in the
                                          Number of                Number of                           sample(1)
             Type of                  health visits per          samplings per              Number
          establishment                  year to each             year in each                                Number of
                                                                                                of
                                        establishment            establishment                                broodstock
                                                                                            growing
                                                                                                                 fish(2)
                                                                                               fish
       First 2 years
        (a) Establishments                        2                         1              30 (second                 0
            with broodstock                                                                visit)
        (b) Establishments                        2                         1                     0         30 (first or
            with broodstock                                                                                 second visit)
            only
        (c) Establishments                        2                         1              30 (first or               0
            without                                                                        second
            broodstock                                                                     visit)
       Last 2 years
        (a) Establishments                        2                         2              30 (first        30 (second
            with broodstock                                                                visit)           visit)
        (b) Establishments                        2                         2                               30 (first AND
            with broodstock                                                                                 second visit)
            only
        (c) Establishments                        2                         2              30 (first
            without                                                                        AND
            broodstock                                                                     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.
EN                                                              65                                                               EN
 ---pagebreak---                                            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 lesions consistent with infection with VHS or IHN are
                       observed or minimum 30 fish, when clinical signs or post-mortem lesions
                       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 (a) of Article 64(2)
                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, cleaned, disinfected and fallowed in accordance with point (c);
          (e)   all establishments other than those referred to in point (f) which keep listed
                species within the Member State, zone or compartment covered by the
                eradication programme and when surveillance in wild populations is required,
EN                                               66                                              EN
 ---pagebreak---             all 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 to 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 comprise 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
EN                                            67                                                 EN
 ---pagebreak---                       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 health status
              regarding VHS or IHN is dependent on the health 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
       Risk             Number of health visits per year to each                           Number of fish in the
      level(1)                              establishment                                         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 Chapter 2 of Part I other than in
              the case of dependent compartments where all establishments are deemed to be high risk.
   (2)        One sample to be taken during 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.
EN                                                              68                                                                EN
 ---pagebreak---            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
                  ELISA, indirect fluorescent antibody test (IFAT), virus neutralisation test or
                  virus genome detection; or
           (b)    Reverse Transcription quantitative PCR (RT-qPCR) 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 suspected establishment must be subject to at least one health visit and one
                  sampling of 10 fish, when clinical signs or post-mortem lesions consistent with
                  infection with VHS or IHN are observed or minimum 30 fish, when clinical
                  signs or post-mortem lesions 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;
EN                                                 69                                                EN
 ---pagebreak---    (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 health 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;
EN                                                  70                                              EN
 ---pagebreak---              (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 for 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           Number of health visits                Number of laboratory Number of
     surveillance              per year to each                     examinations per   fish in the
                                 establishment                             year(1)       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 lesions consistent with infection with HPR-
                           deleted ISAV are observed, or minimum 30 fish when clinical signs or
                           post mortem lesions 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);
EN                                                           71                                       EN
 ---pagebreak---       (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) which keep listed
            species within the Member State, zone or compartment covered by the
            eradication programme and when surveillance in wild populations is required,
            all 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 health
            status which is independent of the health 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 to 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
EN                                            72                                                 EN
 ---pagebreak---                         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 comprise 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 health status is
            dependent on the health 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         Number of health          Number        of      laboratory   Number of fish in
   level(2)     visits per year           examinations per year(3,4)         the sample
   High                     2                              2                           30
   Medium                   1                              1                           30
EN                                                 73                                              EN
 ---pagebreak---    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 2 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
   (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: anterior-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 conventional RT-PCR and sequencing of the HE-gene 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, followed by conventional RT-PCR and
                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 suspected establishment must be subject to at least one health visit and one
                sampling of 10 moribund fish, when clinical signs or post-mortem lesions
                consistent with infection with HPR-deleted ISAV are observed, or minimum
                30 fish when clinical signs or post-mortem lesions 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;
EN                                                       74                                                               EN
 ---pagebreak---            (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, followed by 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 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
EN                                                 75                                                EN
 ---pagebreak---                 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 health 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 scheme 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 for that disease.
EN                                              76                                               EN
 ---pagebreak---                                                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
                                                             Number of
                      Number of health visits per                                   Number of
      Year of                                                laboratory
                      year to each establishment/                                   molluscs in
    surveillance                                          examinations per
                       group of establishments                                      the sample
                                                                 year
      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;
EN                                                 77                                                EN
 ---pagebreak---             (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, cleaned, disinfected and fallowed
            in accordance with point (c);
      (e)   all establishments and groups of establishments other than those referred to in
            point (f) which keep 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 health
            status which is independent of the health 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 repopulated 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 number, age, rate and distribution of the mortalities of molluscs on
                   the establishment or group of establishments infected with Marteilia
                   refringens;
            (ii)   the distance to and density of neighbouring establishments or groups of
                   establishments and 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;
EN                                           78                                                 EN
 ---pagebreak---              (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 Marteilia 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 health-status
       regarding that disease is dependent on the health-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.
EN                                             79                                                 EN
 ---pagebreak---                                                           Table 3.B
   Scheme for Member States, zones or compartments to maintain disease-free status for
   Marteilia refringens
      Risk        Number of health visits to each                         Number of                      Number of
    level(1)            establishment/ group of                           laboratory                  molluscs in the
                               establishments                           examinations                        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 2 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 hybridisation, 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;
EN                                                            80                                                                EN
 ---pagebreak---                   (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 health status with regard
EN                                                  81                                               EN
 ---pagebreak---            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 for 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
                                  Number of health
                                  visits per year to                               Number of
                                                       Number of laboratory
      Year of surveillance       each establishment                             molluscs in the
                                                       examinations per year
                                     or group of                                     sample
                                   establishments
             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
EN                                                82                                                EN
 ---pagebreak---       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 infected
            groups of establishments have been emptied, cleaned, disinfected and fallowed
            in accordance with point (c);
      (e)   all establishments and groups of establishments other than those referred to in
            point (f) which keep 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 health-
            status which is independent of the health-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 repopulated 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;
EN                                           83                                                 EN
 ---pagebreak---                 (ii)   the distance to and density of neighbouring establishments or groups of
                       establishments and 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 health status
          regarding that disease is dependent on the health 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
EN                                                84                                                 EN
 ---pagebreak---               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          Number of health visits to each                Number of laboratory                   Number of
     level(1)              establishment/ group of                         examinations                 molluscs in the
                                 establishments                                                               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 2 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 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 hybridisation, 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.
EN                                                             85                                                                EN
 ---pagebreak---                                             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 health 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:
EN                                                 86                                                EN
 ---pagebreak---         (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 for 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;
EN                                              87                                               EN
 ---pagebreak---       (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, cleaned, disinfected and fallowed
            in accordance with point (c);
      (e)   all establishments and groups of establishments other than those referred to in
            point (f) which keep 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 health
            status which is independent of the health 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 repopulated 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;
            (ii)   the distance to and density of neighbouring establishments or groups of
                   establishments and 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
EN                                            88                                                 EN
 ---pagebreak---                          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
                                                              Number of
                      Number of health visits per                                   Number of
      Year of                                                 laboratory
                    year to each establishment or                                  molluscs in
    surveillance                                          examinations per
                       group of establishments                                      the sample
                                                                  year
      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 health status
            regarding that disease is dependent on the health 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.
EN                                                89                                                EN
 ---pagebreak---                                                           Table 5.B
   Scheme for Member States, zones or compartments to maintain status free from
   infection with Bonamia ostreae
                  Number of health visits to each                         Number of                      Number of
      Risk
                         establishment/ group of                          laboratory                  molluscs in the
    level(1)
                               establishments                           examinations                       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 2 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 hybridisation, 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 .
EN                                                            90                                                                EN
 ---pagebreak---                                             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.
EN                                                91                                                 EN
 ---pagebreak---                                             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 health 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 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
                 for 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 lesions consistent with infection WSSV are
EN                                                92                                               EN
 ---pagebreak---                    observed, or 150 crustaceans, when clinical signs or post-mortem lesions
                   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,
            cleaned 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, cleaned, disinfected and fallowed in accordance with point (c);
      (e)   all establishments other than those referred to in point (f) which keep listed
            species within the Member State, zone or compartment covered by the
            eradication programme and, when surveillance in wild populations is required,
            all 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 health
            status which is independent of the health 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 repopulated 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 to 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
EN                                           93                                               EN
 ---pagebreak---             (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
                                                           Number of
                    Number of health visits per                                    Number of
      Year of                                              laboratory
                     year to each establishment                                  crustaceans in
    surveillance                                        examinations per
                     or group of establishments                                    the sample
                                                              year
      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 crustaceans 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 health status regarding that
            disease is dependent on the health 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.
EN                                                94                                              EN
 ---pagebreak---                                                          Table 6. B
   Scheme for Member States, zones or compartments to maintain status free from
   infection WSSV
      Risk           Number of health visits to                       Number of                        Number of
    level(1)       each establishment/ group of                       laboratory                  crustaceans in the
                              establishments                        examinations                          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 2 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 signs or post-mortem lesions consistent with
                      infection with WSSV are observed or 150 crustaceans when clinical signs or
                      post-mortem lesions 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.
EN                                                            95                                                                EN
 ---pagebreak---                                              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:
EN                                                  96                                            EN
 ---pagebreak---            (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 Article 64; 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 for VHS or IHN; or
           (iii) implementing a surveillance programme for VHS or IHN.
EN                                                97                                                EN
 ---pagebreak---                                                           Table 1
                                    Surveillance programme for VHS/IHN
         Risk          Number of health visits per year to each                   Number of fish in the
       level(1)                         establishment                                     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 2 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.
EN                                                           98                                                    EN
 ---pagebreak---                                                       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          Number of health visits per                 Number of laboratory                    Number of fish
   level(1)      year to each establishment                  examinations per year                   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 2 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 Article 64; 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 for infection with HPR-deleted ISAV; or
            (iii) implementing a surveillance programme for infection with HPR-deleted ISAV.
EN                                                           99                                                                EN
 ---pagebreak---                                               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.
                                               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.
EN                                                 100                                              EN
 ---pagebreak---    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
                  Number of health visits to each                        Number of                       Number of
      Risk
                        establishment/ group of                          laboratory                   molluscs in the
    level(1)
                              establishments                            examinations                        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 2 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 Article 64; 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 for 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:
EN                                                            101                                                               EN
 ---pagebreak---    (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
                   Number of health visits to each                                   Number of
      Risk                                                Number of laboratory
                        establishment/ group of                                    molluscs in the
     level(1)                                                 examinations
                             establishments                                            sample
EN                                                   102                                              EN
 ---pagebreak---        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 2 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 Article 64; 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 for 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;
EN                                                           103                                                               EN
 ---pagebreak---              (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 5 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        Number of health visits to each                        Number of                       Number of
    level(1)            establishment/ group of                          laboratory                   molluscs in the
                              establishments                            examinations                        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 2 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 Article 64; and
EN                                                            104                                                               EN
 ---pagebreak---    (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 for 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
EN                                                105                                              EN
 ---pagebreak---                              Surveillance programme for infection with WSSV
     Risk           Number of health visits to                        Number of                        Number of
    level(1)      each establishment/ group of                        laboratory                   crustaceans in the
                             establishments                         examinations                          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 2 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 Article 64; 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 for infection with WSSV; or
             (iii) implementing a surveillance programme for infection with WSSV.
EN                                                            106                                                               EN