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 the Council, as regards rules for the prevention and control of certain listed diseases

EUROPEAN
                            COMMISSION
                                                    Brussels, 17.12.2019
                                                    C(2019) 4057 final
                COMMISSION DELEGATED REGULATION (EU) …/...
                                        of 17.12.2019
   supplementing Regulation (EU) 2016/429 of the European Parliament and the Council,
          as regards rules for the prevention and control of certain listed 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 ('Animal Health Law') lays down rules on transmissible animal
      diseases. Chapters 1 and 2, Title II of Part III of the Animal Health Law lays down
      disease control measures for listed diseases as referred to in point (a), (b) and (c) of
      its Article 9(1) (category A, B and C diseases).
      The Animal Health Law empowers the Commission to adopt delegated acts to
      supplement these rules.
      As these rules are all interrelated, in the interest of consistency and transparency and
      to avoid duplications, they should be laid down in the same delegated act.
      This Delegated Regulation largely replicates the rules laid down in existing Union
      acts setting out disease control measures for: (i) animal diseases with serious effects
      on the livestock, (ii) the animal health status and the economy of the Union and (iii)
      human health, as they have proven to be effective in preventing the spread of those
      diseases within the Union.
      This Delegated Regulation includes rules on disease control measures for all
      category A, B and C diseases under a general and unique approach, as it takes
      account of new scientific knowledge and the experience gained through applying
      existing Union rules in this area. These rules also update the provisions in line with
      the new Union animal health policy framework and international standards. It
      therefore offers more clarity, transparency and consistency in the requirements and
      more flexibility for competent authorities in the Members States.
      Accordingly, this Delegated Regulation lays down the following supplementing rules
      to control animal diseases:
      (a)   disease control measures if there is suspicion and official confirmation of a
            category A disease in kept animals;
      (b)   rules on establishing restricted zones if there is official confirmation of a
            category A disease in kept animals;
      (c)   rules on the repopulation of the restricted zone with kept animals if there is
            official confirmation of a category A disease;
      (d)   rules on disease control measures if there is suspicion and official confirmation
            of a category A disease in wild animals;
      (e)   rules on disease control measures if there is suspicion and official confirmation
            of category B and C diseases;
      (f)   rules on disease control measures if there is suspicion and official confirmation
            of a category A disease in aquatic animals;
      (g)   rules on establishing restricted zones if there is official confirmation of a
            category A disease in aquaculture animals; and
      (h)   rules on disease control measures if there is suspicion and official confirmation
            of a category A disease in wild aquatic animals.
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 with neither institution making any
      comment. A number of meetings were held with a range of stakeholders as part of
      the Animal Health Advisory Committee, in which 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 21 June and 19 July 2019. 23 feedbacks were received in total,
      including opinions of the following stakeholders: Anses (FR), British Egg Industry
      Council (UK), European Live Poultry and Poultry Hatching Egg Association (BE),
      National Pig Association (UK), , German Equestrian Federation (DE), World Horse
      Welfare (UK), European Federation for Animal Health and Sanitary Security (BE),
      GDS-France (FR) Fédération Francaise d’Equitation (FR), , Dibevo (NL), European
      Association of Zoos And Aquaria, , Federation of Veterinarians of Europe, National
      Farmers' Union – England and Wales (UK), Nederlandse Postduivenhouders
      Organisatie (NL), European Livestock and Meat Trades Union (BE), 3 from national
      competent authorities, 3 from particular citizens and 2 anonymous (IE and UK).
      The main following requests were submitted and points made:
      –     the request to include certain definitions laid down in Regulation (EU)
            2016/429 and Regulation (EU) 2017/625 in order to ensure an identical
            understanding throughout the Union and trading partners. The definitions laid
            down in those Regulations apply by default as they are basic acts and only
            supplementary definitions must be included in the tertiary legislation.
      –     the request to keep racing pigeons out of the scope of the Delegated
            Regulation;
      –     the request to modify the definition of ‘supply chain’ in order to include
            species other than porcine animals. This change would give the possibility to
            the competent authority to grant certain derogations from the prohibitions on
            movements in the surveillance zone not only to porcine animals. The Delegated
            Regulation was amended to take into account the requests to avoid any non-
            risk based different approach;
      –     the request to lay down a less prescriptive approach for the handling of manure,
            litter and used bedding in establishments affected by category A diseases. The
            Delegated Regulation was amended to take into account the request as the
            previous approach could be, in fact, too prescriptive in certain situations;
      –     the request to include an additional derogation allowing Member States, after
            carrying out a risk assessment, to decide not to kill all susceptible animals in
            the event of the occurrence of certain category A diseases such as glanders or
            lumpy Skin disease;
      –     the acknowledgements for the derogation provided for in this Delegated
            Regulation as regards the possibility for the competent authority to postpone
            and not to kill animals kept in confined establishments after carrying out a risk
            assessment;
EN                                           2                                                EN
 ---pagebreak---       –     the request to consider to establish prohibitions to artificial insemination also in
            the event of an outbreak of avian influenza and Newcastle disease as these
            activity is carried out in certain sub-sectors (turkey production and foie
            production). The Delegated act was amended as requested and the possibility
            of derogation from such prohibition was also included;
      –     the request to include provisions on the use of vaccines in the event of an
            outbreak of category A disease as an additional tool to control the disease.
            Provisions on the use of vaccines in such situations will be laid down in a
            future delegated act under Article 47(1) of Regulation (EU) 2016/429.
   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 Articles 53, 54, 55, 58, 63, 64, 67, 68, 70, 72, 73, 74, 76,
      77 and 272 thereof.
EN                                           3                                                   EN
 ---pagebreak---                       COMMISSION DELEGATED REGULATION (EU) …/...
                                                 of 17.12.2019
     supplementing Regulation (EU) 2016/429 of the European Parliament and the Council,
             as regards rules for the prevention and control of certain listed 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 (the 'Animal Health Law')1, and in particular Article 47(1), Article
   53(2), Article 54(3), Article 55(2), Article 58(2), the first paragraph of Article 63, Article
   64(4), the first paragraph of Article 67, Article 68(3), Article 70(3), Article 72(2), Article
   73(3), Article 74(4), Article 76(5), Article 77(2) and Article 272(2) thereof,
   Whereas:
   (1)    Regulation (EU) 2016/429 lays down rules for the prevention and control of animal
          diseases which are transmissible to animals or to humans, including rules on disease
          awareness, preparedness and control. In particular, Regulation (EU) 2016/429 lays
          down disease-specific rules for the prevention and control of diseases referred to in its
          Article 5. Regulation (EU) 2016/429 also provides that those disease-specific rules
          apply to species and groups of animal species that pose a considerable risk for the
          spread of specific diseases and which are listed as such in Commission Implementing
          Regulation (EU) 2018/18822.
   (2)    It is necessary to lay down rules supplementing the rules on disease control measures
          set out in Title II of Part III of Regulation (EU) 2016/429 for certain listed diseases.
          Those supplementing rules and the rules set out in Regulation (EU) 2016/429 are
          closely linked and should be applied in tandem. In the interest of simplicity,
          transparency and ease of application, the supplementing rules should be laid down in a
          single act rather than in a number of separate acts with many cross-references and
          risks of duplication.
   (3)    Article 53, Article 54(3), Article 55(2), Article 58(2), and Articles 63, 64, 67, 68 and
          70 in Chapter 1 of Title II of Regulation (EU) No 2016/429 relate to various technical
          aspects of the measures to be taken if there is suspicion and confirmation of diseases
          referred to in Article 9(1)(a) of that Regulation. Similarly, Article 72(2), Article 73(3),
          Article 74(4), Article 76(5) and Article 77 in Chapter 2 of Title II of Regulation (EU)
          No 2016/429 relate to technical aspects of the measures to be taken if there is
   1
           OJ L 84, 31.3.2016, p. 1.
   2
           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).
EN                                                       4                                                          EN
 ---pagebreak---        suspicion and confirmation of diseases referred to in Article 9(1)(b) and (c) of that
       Regulation.
   (4) The rules to be laid down pursuant to Articles in Title II are interrelated as they apply
       to disease control measures for different categories of listed diseases in Regulation
       (EU) No 2016/429. Therefore, for the effective application of those rules and in the
       interests of clarity, they should be laid down in a single delegated act providing a
       comprehensive set of technical measures for the control of listed diseases and
       contributing to the overall simplification of the legal framework on animal disease
       control.
   (5) Previous disease control provisions were laid down in a number of directives, each of
       which contained rules for one or few animal diseases. Some of those rules have been
       replaced by Regulation (EU) 2016/429, while others need to be replaced by this
       Delegated Regulation in order to simplify and remove possible inconsistencies. This
       will provide clear, harmonised and detailed rules to control animal diseases throughout
       the Union. This will also enable the application of the relevant provisions by
       competent authorities and operators, and will increase the transparency of the rules and
       therefore will ensure a better response to animal disease risks.
   (6) To eradicate an outbreak of a category A disease as soon as possible and to ensure a
       high level of animal health and animal welfare protection, it is necessary to provide for
       disease control measures at Union level.
   (7) The scope of this Regulation should therefore include disease control measures for
       category A diseases in terrestrial and aquatic animals, as well as certain disease control
       measures for category B and C diseases. In the case of category B and C diseases,
       those disease control measures should be applied in conjunction with the rules on
       surveillance and eradication set out in the Commission Delegated Regulation (EU)
       2019/XXX [document C(2019)4056]3.
   (8) The disease control measures set out in this Delegated Regulation should apply to
       animals and to products obtained from animals, including products of animal origin,
       germinal products, animal by-products and derived products. These animal by-
       products are subject to public and animal health rules set out in Regulation (EC) No
       1069/2009 of the European Parliament and of the Council4. The rules for safe
       collection, disposal and processing of animal by-products and derived products laid
       down in that Regulation apply in the event of the onset of a category A disease.
       However, that Regulation does not include disease control measures and restrictions
       intended to apply in such events. Therefore, those rules should be provided for in this
       Delegated Regulation.
   (9) Directive 2008/68/EC of the European Parliament and of the Council5 lays down rules
       for the safe transport of dangerous goods. When transporting infected animal by-
       products or other infected material which may be considered as dangerous goods,
       competent authorities should comply with the rules laid down in that Directive.
   3
       [Commission Delegated Regulation (EU) 2019/xxx as regards rules for surveillance, eradication
       programmes, and disease-free status for certain listed and emerging diseases].
   4
       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
       L300, 14.11.2009, p.1).
   5
       Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the
       inland transport of dangerous goods (OJ L260, 30.09.2008, p. 13).
EN                                                   5                                                    EN
 ---pagebreak---    (10) It is appropriate to follow a single approach for the measures to apply in the event of a
        category A disease. However, the epidemiology of diseases should be taken into
        account to establish the appropriate moment for the competent authority to apply
        control measures and to carry out investigations if there is suspicion or confirmation of
        those diseases. Therefore ‘monitoring periods’ should be provided, as reference time
        frames for each category A disease affecting terrestrial animals based on incubation
        periods and other relevant elements that may affect the spread of the disease.
   (11) Article 54 of Regulation (EU) 2016/429 requires the competent authority to carry out
        investigations on the occurrence of a category A disease at different stages: (i) when
        the disease is suspected, (ii) when the disease is confirmed, and (iii) when it is
        necessary to rule out its spreading to epidemiologically linked establishments and
        locations as well as neighbouring establishments and zones. Those investigations
        include clinical examination and sampling for laboratory testing. It is appropriate to
        lay down general rules on sampling in order to ensure the validity of sampling
        procedures, diagnostic methods and biosecurity measures.
   (12) Article 43 of Regulation (EU) 2016/429 requires the competent authority to draw up
        and update contingency plans and, where necessary, provide detailed instruction
        manuals on implementing of measures to be taken in case of a category A disease as
        provided for in Part III of that Regulation. The measures set out in this Delegated
        Regulation supplement those laid down in Part III of Regulation (EU) 2016/429 and it
        is therefore necessary that they be implemented in accordance with the contingency
        plans provided for in Regulation (EU) 2016/429.
   (13) Articles 53 and 55 of Regulation (EU) 2016/429 lay down obligations on operators
        and competent authorities in the case of a suspicion of a category A disease. The aim
        is to prevent the spread of the disease from affected animals and establishments under
        their responsibility to unaffected animals or to humans even before the disease has
        been confirmed. The disease control and biosecurity measures provided for in
        Regulation (EU) 2016/429 should be applied at this early stage in the affected
        establishment as regards movements of animals and products from and to that
        establishment and its surroundings. It is also necessary to detail those measures in
        order to ensure their effectiveness and proportionality.
   (14) Article 54 of Regulation (EU) 2016/429 requires the competent authority to conduct
        an official investigation if there is a suspicion of a category A disease, to either
        confirm or rule out the presence of the disease. In order to establish a standard
        operating procedure for such official investigations in all Member States, it is
        necessary to detail the circumstances which justify the conduct of an investigation, the
        minimum investigation tasks to be performed by official veterinarians and the way
        those tasks should be carried out.
   (15) Regulation (EU) 2016/429 requires that, if there is a suspicion or confirmation of a
        category A disease, disease control measures be applied not only in establishments
        keeping animals but also in food and feed businesses, in animal by-products
        establishments or in other locations that may pose a risk of spreading of diseases. It is
        necessary to specify which control measures apply in those cases, in particular in the
        case of border control posts and means of transport.
   (16) Regulation (EU) 2016/429 requires that the confirmation of a category A disease is the
        starting point for the competent authority to implement stricter disease control
        measures than those applied in the suspicion phase and to carry out further
        investigations. It is therefore necessary to specify when a category A disease should be
EN                                               6                                                EN
 ---pagebreak---         considered confirmed. This confirmation should be done in accordance with Union
        acts adopted pursuant to Regulation (EU) 2016/429 on surveillance of diseases,
        eradication programmes and disease-free status.
   (17) Regulation (EU) 2016/429 lays down the basic rules on the disease control measures
        to apply in the affected establishments in the event of an outbreak of a category A
        disease. At the same time, it provides competent authorities with a certain flexibility in
        deciding which of those measures should apply. In order to allow competent
        authorities to take the most proportionate and efficient control measures and ensure a
        harmonised implementation of the measures taken by Member States, it is appropriate
        to establish detailed decision making criteria based on epidemiological circumstances,
        type and location of establishments, species and categories of animals and economic
        or social conditions of the area affected by the disease.
   (18) The competent authority should have the possibility to grant, in justified cases and
        under supplementary guarantees if necessary, derogations from certain disease control
        measures, in particular from the requirement to kill the animals in the affected
        establishment, taking into account epidemiological factors and after carrying out an
        accurate risk assessment. Such derogations could be granted for confined
        establishments, for animals kept for scientific purposes or for purposes related to
        conservation of protected or endangered species and for officially registered rare
        breeds or for animals with a justified high genetic, cultural or educational value. In
        such cases, the application of general measures could have undesirable and
        disproportioned consequences.
   (19) In order to adapt the disease control measures to each specific situation, the competent
        authority should have the possibility to apply disease control measures that are not
        specifically provided for in Regulation (EU) 2016/429 or in this Delegated Regulation,
        taking into consideration epidemiological factors and after carrying out a risk
        assessment.
   (20) Cleaning and disinfection in the affected establishment is one of the basic disease
        control measures provided for in Regulation (EU) 2016/429 to minimise the risk of
        spreading a confirmed category A disease. Preliminary cleaning and disinfection are
        the most effective measures to reduce the disease agent load in the affected
        establishment once the affected animals have been taken off. The competent authority
        should therefore have the obligation to check the performance of the immediate
        preliminary cleaning and disinfection and, when necessary, the control of insects and
        rodents. It is appropriate to detail the cleaning and disinfection procedure, specifying
        when it must be initiated and the criteria for selecting the biocidal products to be used.
   (21) Article 62 of Regulation (EU) 2016/429 requires the competent authority to extend the
        disease control measures applied in the affected establishments to other
        establishments, epidemiological units therein, food and feed businesses, or animal by-
        products establishments or any other location of relevance, including means of
        transport, where epidemiological evidences give reason to suspect the spread of the
        category A disease to, from or through them. It is necessary to specify the traceability
        investigation which the competent authority must perform, under the epidemiological
        enquiry provided for in Regulation (EU) 2016/429, in order to properly identify those
        epidemiological links.
   (22) It is also appropriate to detail the control measures to apply in identified linked
        establishments and locations. In order to be effective, those measures should be
        flexible and proportionate, without imposing unnecessary burdens on operators or
EN                                               7                                                 EN
 ---pagebreak---         competent authorities. The competent authorities should consequently be allowed to
        derogate from general provisions in exceptional circumstances, after carrying out a
        risk assessment.
   (23) Article 64 of Regulation (EU) 2016/429 requires competent authorities to establish a
        restricted zone around the affected establishment when an outbreak of a category A
        disease is confirmed, in order to prevent any further spread of the disease. The
        restricted zone may include a protection zone and a surveillance zone. It is appropriate
        to set supplementary rules on how to establish and modify, if necessary, the restricted
        zone, including details on the protection zone, on the surveillance zone and on the
        possibility to establish further restricted zones depending on the epidemiology of the
        disease. It is also appropriate to provide for specific derogations for those cases where
        the establishment of restricted zones would not contribute to control the spreading of
        the disease or would impose an unjustified burden on operators and competent
        authorities.
   (24) Article 65 of Regulation (EU) 2016/429 lists the measures that the competent authority
        may take in the restricted zone to prevent the spreading of the disease. In order to
        allow competent authorities to take the most proportionate and efficient control
        measures and ensure a harmonised implementation of the measures in all Member
        States, it is appropriate to establish detailed decision making criteria based on
        epidemiological circumstances, type and location of production establishments,
        species and categories of animals and economic or social conditions of the area
        affected by the disease.
   (25) It is necessary to specify the prohibitions of movements of animals and products
        within, from or through the protection and surveillance zone and the prohibitions of
        other activities that can pose a risk of spreading a category A disease. Those
        prohibitions should be proportional to the risk of spreading the disease linked to each
        activity and commodity. Consequently, they need to be established taking into account
        the epidemiological disease profile. This is especially important in respect of
        prohibitions concerning products since there are certain products that should be
        exempted, in particular those considered safe commodities in relation to the risk of
        spreading certain diseases.
   (26) The prohibitions of activities in the restricted zone should be limited as far as possible.
        For that reason, there should be the possibility for the competent authority to grant
        derogations from the prohibitions when certain risk-mitigating measures are taken and
        certain procedural conditions are met. Such derogations may be granted, in particular,
        when the competent authority can check the reinforcement of biosecurity measures
        and when general and specific conditions, related to the relevant animals, products
        obtained from those animals, or other substances and materials that may be
        contaminated, are fulfilled.
   (27) Movements of ungulates should be limited to transports to a slaughterhouse. Poultry
        movements should be limited to the transport to slaughterhouses and to younger
        animals such as day-old-chicks and ready-to-lay poultry. Movements of products of
        animal origin should be allowed if the products have been produced before the high-
        risk period determined for the disease. Movements of products of animal origin and
        by-products produced within or after the high risk period should be allowed if the
        products have been subjected to specific treatments that inactivate the disease agent.
        Those treatments should be in line with existing Union legislation, international
        standards and new scientific evidence.
EN                                                8                                                 EN
 ---pagebreak---    (28) The competent authority should be able to visit establishments and to examine
        animals. To prevent the further spread of the disease, requirements should be set and
        be met before the measures applying to the protection zone can be lifted. Once those
        measures are lifted, the measures applying to the surveillance zone should be
        implemented, for an additional period, in the area previously covered by the protection
        zone, to ensure that the disease is controlled.
   (29) The provisions on control measures applicable within the surveillance zone should
        include general and specific rules for animals, products obtained from those animals,
        or other substances and materials that may be contaminated.. They should also include
        derogations to allow a proportional application of the control measures. The intensity
        of the control measures and the derogations for their proportional application should
        reflect the lower risk that the surveillance zone poses for the spread of the disease but
        should ensure that the control measures are sufficient to avoid any risk of a further
        spread of the disease.
   (30) The competent authority should: (i) authorise the repopulation of the affected
        establishments with animals, (ii) ensure that a final cleaning and disinfection of the
        establishment is carried out and, if relevant, (iii) carry out a check for vectors to ensure
        that diseases do not reappear. The competent authority should have the flexibility
        needed to decide on the most appropriate repopulation measures taking into account
        epidemiological circumstances and specific risk mitigation conditions.
   (31) Wild animals of listed species could also be affected by category A diseases. Control
        measures for those wild animals are essential in preventing the spread of the diseases
        and in ensuring their eradication. As for diseases occurring in kept animals, the
        competent authority should consider control measures for diseases in wild animals as
        part of the contingency plans provided for by the Regulation (EU) 2016/429. The
        control measures should apply to suspected and confirmed cases of a disease affecting
        wild animals within an infected zone. Measures restricting the movement of kept
        animals that are listed species from the infected zone should be applied with flexibility
        in mind, based on the epidemiological situation. This is to ensure robust control
        measures while avoiding unnecessary burdens for operators and competent authorities.
   (32) The collection and safe disposal of dead bodies of wild animals contributes to
        preventing the spread of category A diseases. It is appropriate to supplement
        Regulation (EU) 2016/429 with rules ensuring the safe collection and disposal of
        animal by-products from wild terrestrial and aquatic animals affected by category A
        diseases or subject to restriction measures imposed in response to those diseases in
        line with Regulation (EC) 1069/2009.
   (33) Article 43 of Regulation (EU) 2016/429 requires the competent authority to establish
        an operational expert group as part of the contingency plans. These plans are designed
        to ensure a high level of disease awareness and preparedness and to provide a rapid
        response in case of an outbreak of a category A disease. The main task of the
        operational expert group in the case of an outbreak of diseases in terrestrial animals is
        to support the competent authority assessing the relevant measures for the control or
        eradication of the disease. The operational expert group for diseases in wild terrestrial
        animals should be multidisciplinary and have representatives of relevant government
        departments such as environmental and forests authorities, as well as stakeholders
        concerned, local authorities, police or other organisations that can provide advice to
        the competent authority on possible actions and their implementation to control or
        eradicate the category A disease.
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 ---pagebreak---    (34) Council Directive 2006/88/EC6 includes provisions on animal health requirements for
        aquaculture animals and products and on the prevention and control of certain diseases
        in aquatic animals. The provisions in this Delegated Regulation should be based on the
        provisions from previous Union legislation that have worked well and have been
        revised and aligned, as far as possible, with the knowledge and experience gained in
        the past, and updated in accordance with new evidence and international standards.
   (35) Article 61 of Regulation (EU) 2016/429 provides for the application of disease control
        measures in establishments and other locations upon confirmation of category A
        diseases. One of those measures is the killing of animals that may be contaminated or
        may contribute to the spread of the disease. The possibility to apply such preventive
        killing should be detailed in this Delegated Regulation as a disease control measure
        aimed at reducing the infective pressure of a category A disease and to facilitate its
        control.
   (36) Article 62 of Regulation (EU) 2016/429 includes criteria for extending the disease
        control measures applied in an affected establishment to epidemiologically linked
        establishments and locations. The analysis of the hydrodynamic and topographic
        conditions, including data from water catchments, barriers in watercourses or water
        flow conditions, allows predicting the possible passive spread of a category A disease
        to other establishments or locations and this prediction may contribute to minimise the
        impact of a category A disease. The result of such an analysis permits the
        implementation of better-informed disease control measures, which should avoid or
        minimise the spread of a category A disease from a high-risk to a disease free area.
   (37) The competent authority should be able to derogate from restrictions applicable upon
        confirmation of a category A disease in order to allow the use of aquaculture animals
        for human consumption, provided they do not show clinical signs of the disease and
        are processed in a way that reduces the risk of spreading the disease by infective
        material. The derogation should be aimed at reducing economic losses while
        minimising the risk of the disease spreading.
   (38) Article 37 of Regulation (EU) 2016/429 provides for the recognition of a disease-free
        status of compartments for listed diseases. Compartments include different
        establishments with common and efficient biosecurity systems permitting those
        establishments to have a distinct animal health status. Therefore, if a category A
        disease is suspected or confirmed in an aquaculture establishment within a
        compartment, the disease control measures should be extended to other establishments
        within that compartment resulting in a more efficient control of the disease.
   (39) Fallowing for aquatic animals is a disease control measure already included in
        previous Union legislation on prevention and control of diseases in aquaculture
        animals and should continue to be applied. The main objective of fallowing is to
        prevent or minimise the risk of re-infection of establishments with the category A
        disease, after cleaning and disinfection has been completed, and before introducing a
        new population of aquatic animals. Synchronous fallowing in areas with multiple
        infected establishments strengthens the disease control measures and contributes to a
        higher success rate. Different fallowing periods should be established for different
        category A diseases to reduce the fallowing time to a minimum while ensuring the
        effectiveness of this disease control measure.
   6
        Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture
        animals and products thereof, and on prevention and control of certain diseases in aquatic animals (OJ L
        328, 24.11.2006, p. 14).
EN                                                   10                                                          EN
 ---pagebreak---    (40) When an aquaculture establishment has been affected by a category A disease which
        does not pose a risk to human health, the placing on the marked of products from that
        establishment should be allowed after risk-mitigating measures have been taken. For
        fish, those measures should include slaughtering and evisceration. Crustaceans should
        be processed to non-viable products before they are dispatched. The products should
        be used for direct human consumption or undergo further processing in an
        establishment approved under Article 179 of Regulation (EU) 2016/429. Those
        measures are effective in controlling and avoiding the further spread of the disease
        while allowing those products to be used for human consumption rather than
        unnecessarily wasted.
   (41) Article 64 of Regulation (EU) 2016/429 provides that, when a category A disease
        breaks out in aquatic animals, restricted zones be established as an effective measure
        to control the disease. Restricted zones may include a protection zone around
        establishments that have an increased risk of being affected by a category A disease.
        To ensure an effective disease control and to prevent the further spread of the disease,
        the introduction of aquaculture animals for farming in establishments located in the
        protection zone should be prohibited. To avoid re-infection, the protection zone should
        to be maintained until the infected aquaculture establishments are emptied of animals,
        cleaned and disinfected and the fallowing period has been completed.
   (42) Control measures applied in a protection zone established for disease in aquatic
        animals should be lifted only if a series of conditions are met. Those conditions should
        include depopulation, cleaning, disinfection and fallowing of the affected
        establishments. Furthermore, the results of regular visits carried out in all
        establishments located in the protection zone must be satisfactory. When all those
        conditions are met, the protection zone should become a surveillance zone. That
        surveillance zone should be maintained until the surveillance period for the relevant
        category A disease has elapsed and there are no elements to suspect the presence of the
        disease.
   (43) Article 43 of Regulation (EU) 2016/429 requires the competent authority to establish
        an operational expert group as part of the contingency plans designed to ensure a high
        level of disease awareness and preparedness and to provide a rapid response in case of
        an outbreak of a category A disease. The main task of the operational expert group in
        the case of an outbreak of diseases in aquatic animals is to support the competent
        authority in assessing the relevant measures for the control or eradication of the
        disease. The operational expert group for diseases in wild aquatic animals should be
        multidisciplinary and include representatives of government departments such as
        environmental and fisheries authorities, as well as stakeholders concerned, local
        authorities, police or other organisations that can provide advice to the competent
        authority on possible actions to control or eradicate the category A disease.
   (44) Article 6 of Regulation (EC) No 1069/2009 provides for the implementation of general
        health restrictions in the case of a serious transmissible disease. When a category A
        disease is present in aquaculture animals, the competent authority may impose stricter
        rules for animal by-products originating from certain establishments. Those rules are
        intended to deal with situations where public health restrictions may not address the
        animal health risk. It is necessary, in particular, that animal by-products from such
        establishments must be processed or disposed of as category 2 material in compliance
        with Article 13 of Regulation (EC) No 1069/2009.
EN                                              11                                               EN
 ---pagebreak---    (45) Article 270 of Regulation (EU) 2016/429 repealed Council Directives 92/66/EEC7,
        2001/89/EC8, 2002/60/EC9, 2003/85/EC10 and 2005/94,11 which contained rules for
        the control of animal diseases. Article 272 of Regulation (EU) 2016/429 provides that
        the repealed Directives continue to apply for three years after the date of application of
        that Regulation or an earlier date to be determined by the Commission in a delegated
        act. In order to ensure a harmonised and simplified approach across species and
        diseases, this Regulation should apply from the date of application of Regulation (EU)
        2016/429 and the repealed Directives should cease to apply from the same date,
   HAS ADOPTED THIS REGULATION:
   7
        Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of
        Newcastle disease (OJ L 260, 5.9.1992, p. 1).
   8
        Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical
        swine fever (OJ L 316, 1.12.2001, p. 5).
   9
        Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of
        African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine
        fever (OJ L 192, 20.7.2002, p. 27).
   10
        Council Directive 2003/85/EC of 29 of September 2003 on Community measures for the control of
        foot–and–mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC
        and amending Directive 92/46/EEC (OJ L 306, 22.11.2003, p. 1).
   11
        Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian
        influenza and repealing Directive 92/40/EEC (OJ L 10, 14.1.2006, p. 16).
EN                                                    12                                                   EN
 ---pagebreak---                                               Part I
                             GENERAL PROVISIONS
                                              Article 1
                                      Subject matter and scope
   This Regulation supplements the rules on disease awareness, preparedness and control to be
   applied with regard to the listed diseases referred to in Article 9(1)(a), (b) and (c) of
   Regulation (EU) 2016/429.
   Those rules cover the following:
   (a)     Part II covers kept and wild terrestrial animals, and in particular:
           (i)   Chapter I lays down supplementing rules on disease control measures in the
                 event of suspicion and official confirmation of a category A disease in kept
                 animals as referred to in Articles 53, 54, 55, 58 and 63 of Regulation (EU)
                 2016/429;
           (ii)  Chapter II lays down supplementing rules regarding the establishment of
                 restricted zones in the event of official confirmation of a category A disease in
                 kept animals as referred to in Article 64 and 67 of Regulation (EU) 2016/429;
           (iii) Chapter III lays down supplementing rules regarding the repopulation of the
                 restricted zone with kept animals in the event of official confirmation of a
                 category A disease as referred to in Articles 63 and 68 of Regulation (EU)
                 2016/429;
           (iv) Chapter IV lays down supplementing rules regarding disease control measures
                 in the event of suspicion and official confirmation of a category A disease in
                 wild animals as referred to in Article 70 of Regulation (EU) 2016/429;
           (v)   Chapter V lays down supplementing rules on disease control measures in the
                 event of suspicion and official confirmation of category B and C diseases in
                 terrestrial animals as referred to in Article 74 and 77 of Regulation (EU)
                 2016/429.
   (b)     Part III covers kept and wild aquatic animals, and in particular:
           (i)   Chapter I lays down supplementing rules on disease control measures in the
                 event of suspicion and official confirmation of a category A disease in aquatic
                 animals as referred to in Articles 53, 54, 55, 58 and 63 of Regulation (EU)
                 2016/429;
           (ii)  Chapter II lays down supplementing rules regarding the establishment of
                 restricted zones in the event of official confirmation of a category A disease in
                 aquaculture animals as referred to in Article 64 and 67 of Regulation (EU)
                 2016/429;
           (iii) Chapter III lays down supplementing rules regarding disease control measures
                 in the event of suspicion and official confirmation of a category A disease in
                 wild aquatic animals as referred to in Article 70 of Regulation (EU) 2016/429;
           (iv) Chapter IV lays down supplementing rules on disease control measures in the
                 event of suspicion and official confirmation of category B and C diseases in
                 aquatic animals as referred to in Article 74 and 77 of Regulation (EU)
                 2016/429.
EN                                                13                                               EN
 ---pagebreak---    (c)      Part IV covers final provisions.
                                                     Article 2
                                                    Definitions
   For the purposes of this Regulation, definitions laid down in Regulation (EU) 2018/1882 and
   Annex I to Regulation (EC) 853/200412 shall apply, except where those definitions cover
   terms that are defined in the second paragraph of this Article.
   In addition, the following definitions shall also apply:
   (1)      'means of transport' means road or rail vehicle, vessels and aircrafts;
   (2)      'day-old chicks' means poultry less than 72 hours old;
   (3)      ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or
            prepared or diluted;
   (4)      ‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes
            and ova;
   (5)      ‘embryo’ means the initial stage of development of an animal while it is capable of
            being transferred to a recipient dam;
   (6)      'fresh meat' means meat, minced meat and meat preparations, including vacuum-
            wrapped or wrapped in a controlled atmosphere, which has not undergone any
            process other than chilling, freezing or quick-freezing;
   (7)      'carcass of an ungulate' means the whole body of a slaughtered or killed ungulate
            after:
            –      bleeding, in the case of slaughtered animals;
            –      evisceration;
            –      removal of the limbs at the carpus and tarsus;
            –      removal of the tail, the udder, the head and the skin, except in porcine animals.
   (8)      'offal' means fresh meat other than that of the carcass as defined in (7), even if it
            remains naturally connected to the carcass;
   (9)      'meat products' means processed products, including treated stomachs, bladders,
            intestines, rendered fats, meat extracts and blood products, resulting from the
            processing of meat or from the further processing of such processed products, so that
            the cut surface shows that the product no longer has the characteristics of fresh meat;
   (10)     'casings' means the bladders and intestines that after cleaning have been processed by
            tissue scraping, defatting and washing and have been dried after salting;
   (11)     'colostrum' means the fluid secreted by the mammary glands of kept animals up to
            five days post parturition that is rich in antibodies and minerals, and precedes the
            production of raw milk.
   (12)     'colostrum-based products' means processed products resulting from the processing
            of colostrum or from the further processing of such processed products;
   12
           Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying
           down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
EN                                                      14                                                   EN
 ---pagebreak---    (13) ‘safe commodity’ means a commodity that can be moved without the need for risk
        mitigation measures specifically directed against a particular listed disease regardless
        of the status of the Member state or zone of origin for that disease;
   (14) ‘supply chain' means an integrated production chain of a common health status as
        regards listed diseases consisting of a collaborative network of specialised
        establishments approved by the competent authority for the purpose of Article 45,
        between which animals are moved to complete the production cycle;
   (15) ‘infected zone’ means a zone in which restrictions on the movements of kept and
        wild animals or products and other disease control and biosecurity measures may be
        applied with the view to preventing the spread of a category A disease in the event of
        official confirmation of the disease in wild animals.
                                              Article 3
             Clinical examinations, sampling procedures and diagnostic methods
   1.   Where clinical examinations of animals are required pursuant to this Regulation in
        order to confirm or rule out the presence of a category A disease, the competent
        authority shall ensure that:
        (a)    the sampling of animals for clinical examination is carried out in accordance
               with:
               (i)    point A.1 of Annex I for terrestrial animals; and
               (ii)   point 1 of Annex XII for aquatic animals.
        (b)    the clinical examination comprises:
               (i)    an initial general evaluation of the animal health status of the
                      establishment which comprises all the animals of listed species kept in
                      the establishment; and
               (ii)   an individual examination of the animals included in the sample referred
                      to in point (a).
   2.   Where laboratory examinations are required pursuant to this Regulation in order to
        confirm or rule out the presence of a category A disease, the competent authority
        shall ensure that:
        (a)    the sampling of animals for laboratory examination is carried out in accordance
               with:
               (i)    point A.2 of Annex I for terrestrial animals; and
               (ii)   point 1(b), (c), (d) and (e) of Annex XII for aquatic animals.
        (b)    the diagnostic methods for laboratory examinations fulfil the requirements set
               out in:
               (i)    point B of Annex I for terrestrial animals; and
               (ii)   point 2 of Annex XII for aquatic animals.
EN                                               15                                              EN
 ---pagebreak---            (c)     the samples are sent:
                   (i)    without delay to an official laboratory designated in accordance with
                          Article 37 of Regulation (EU) 2017/62513;
                   (ii)   in accordance with point C of Annex I for terrestrial animals and point
                          1(f) of Annex XII for aquatic animals; and
                   (iii) following any other instruction from the competent authority and from
                          the laboratory regarding biosecurity and biosafety conditions to prevent
                          the spread of category A disease agents.
           (d)     in the case of kept animals:
                   (i)    an inventory of all kept animals on the establishment and their species
                          and categories is compiled; for poultry and aquaculture animals the
                          number of animals may be estimated; and
                   (ii)   an identification mark of each sampled animal of listed species, or in the
                          case of poultry and aquaculture animals the batch number, is recorded.
                                                       Article 4
                                                 Contingency plans
   The competent authority shall implement the measures laid down in this Regulation in
   accordance with the contingency plan referred to in Article 43 of Regulation (EU) 2016/429.
   13
          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 (OJ L 95;7.4.2017; p.1).
EN                                                        16                                                        EN
 ---pagebreak---                                               Part II
                             TERRESTRIAL ANIMALS
                                            Chapter I
          Disease control measures for category A diseases in kept
                                      terrestrial animals
                                             SECTION 1
    PRELIMINARY DISEASE CONTROL MEASURES IN THE EVENT OF SUSPICION OF A
                            CATEGORY A DISEASE IN KEPT ANIMALS
                                               Article 5
    Obligations on operators in the event of suspicion of a category A disease in kept animals in
                                           an establishment
   In the event of suspicion of a category A disease in kept animals, operators shall take the
   following disease control measures in order to prevent the spread of the category A disease
   from the affected animals and establishments under their responsibility to other unaffected
   animals or to humans until the competent authority rules out the presence of the category A
   disease:
   (a)      isolate all animals suspected of being infected with the category A disease;
   (b)      keep the manure, including litter and used bedding, and any product, material or
            substance likely to be contaminated with and to transmit category A diseases isolated
            and protected from insects and rodents, kept animals of non-listed species and wild
            animals to the extent technically and practically feasible;
   (c)      implement the appropriate additional biosecurity measures to avoid any risk of
            spread of the category A disease;
   (d)      cease all movements of kept animals of listed species from or to the establishment;
   (e)      prevent non-essential movements of animals of non-listed species, products,
            materials, substances, persons and means of transport from or to the establishment;
   (f)      ensure that production, health and traceability records of the establishment are
            updated;
   (g)      provide the competent authority, on its request, with any relevant information
            regarding the category A disease; and
   (h)      follow any instructions given by the competent authority regarding the control of the
            category A disease, in accordance with Regulation (EU) 2016/429 and this
            Regulation.
EN                                                17                                              EN
 ---pagebreak---                                                  Article 6
    Investigation by the competent authority in the event of suspicion of a category A disease in
                                    kept animals in an establishment
   1.       In the event of suspicion of a category A disease in kept animals in an establishment,
            in accordance with Article 9(1), (3) and (4) of Regulation 2019/XXX as regards
            rules for surveillance, eradication programmes, and disease-free status for certain
            listed and emerging diseases [document C(2019)4056], the competent authority shall
            immediately conduct an investigation to confirm or rule out the presence of the
            suspected listed disease.
   2.       In the course of the investigation referred to in paragraph 1 the competent authority
            shall ensure that official veterinarians perform at least:
            (a)    clinical examinations of kept animals of listed species at the establishment; and
            (b)    collection of samples for laboratory examinations.
                                                 Article 7
      Preliminary restriction and biosecurity measures in the event of suspicion of a category A
                               disease in kept animals in an establishment
   1.       In the event of suspicion of a category A disease in an establishment, the competent
            authority shall place the establishment under official surveillance and immediately
            impose the following preliminary restriction and biosecurity measures, in order to
            prevent the spread of the category A disease from the affected animals and the
            establishment to other unaffected animals or to humans:
            (a)    prohibition of movements of kept animals of listed species into and from the
                   establishment;
            (b)    prohibition of movements of kept animals of non-listed species into and from
                   the establishment;
            (c)    prohibition of movements of any product, material or substance likely to be
                   contaminated with or likely to transmit category A diseases from the
                   establishment;
            (d)    isolation of kept animals of listed species and protection from wild animals,
                   animals of non-listed species and, when necessary, from insects and rodents;
            (e)    prohibition of killing of animals of listed species, unless authorised by the
                   competent authority; and
            (f)    prohibition of non-essential movements of products, materials, substances,
                   persons and means of transport into the establishments.
   2.       By way of derogation from point 1(a), (b) and (c) the competent authority may
            authorise movements of animals and products from the establishment where a
            category A disease is suspected, after carrying out a risk assessment and provided
            that:
            (a)    the movements of animals and products comply with all conditions and
                   biosecurity measures necessary in order to avoid the spread of the disease;
            (b)    in the establishment of destination there are not other kept animals of listed
                   species; and
            (c)    the establishment of destination is not a slaughterhouse.
EN                                                  18                                               EN
 ---pagebreak---    3.      Where derogations provided for in paragraph 2 are granted, the competent authority
           may impose the disease control measures provided for in paragraph 1 in the
           establishment of destination.
   4.      The competent authority may order preventive killing, in accordance with Article
           12(1) and (2), of animals of listed species in the establishment where a category A
           disease is suspected when the epidemiological situation so requires.
   5.      All animal by-products from dead animals, which have died or have been killed in
           the establishment where a category A disease is suspected shall be processed or
           disposed of in accordance with Regulation (EC) 1069/2009 to ensure that the
           suspected disease agent is inactivated and to prevent the spread of the disease to
           unaffected animals or to humans.
                                               Article 8
      Inventory and records analysis in the event of suspicion of a category A disease in kept
                                     animals in an establishment
   1.      In the event of suspicion of a category A disease, the competent authority shall order
           and verify that, without delay, operators of the establishments where a category A
           disease is suspected compile and maintain an up-to-date inventory of the following:
           (a)   the species, categories and number of animals kept on the establishment; for
                 poultry, the number of animals may be estimated;
           (b)   the individual identification number of all the animals of species for which the
                 individual identification is compulsory in accordance with Regulation (EU)
                 2019/…[document(c) registration and identification]
           (c)    the species, categories and number of kept animals of listed species which have
                 been born, died, showed clinical signs or are likely to be infected or
                 contaminated with the category A disease in the establishment;
           (d)    any product, material or substance likely to be contaminated with or likely to
                 transmit the relevant category A disease in the establishment; and
           (e)    when relevant, all places likely to enable the survival of the vectors of the
                 relevant category A disease in the establishment.
   2.      Where the establishment consists of several epidemiological units, the information in
           paragraph 1 shall be specified for each epidemiological unit.
   3.      In the framework of the epidemiological enquiry, as referred to in Article 57 of
           Regulation (EU) 2016/429, the competent authority shall analyse at least the
           following records of the establishment where a category A disease is suspected:
           (a)   the inventory referred to in paragraph 1;
           (b)   the records concerning the origin and date of arrival and departure at or from
                 the establishment of kept animals of listed species;
           (c)   the records concerning the origin and date of arrival and departure at or from
                 the establishment of other relevant transport movements;
           (d)   the production records; and
           (e)   the records concerning to visits to the establishment, if available.
EN                                                19                                              EN
 ---pagebreak---    4.      The records analysis referred to in paragraph 3 shall cover, at least, the monitoring
           period set out in Annex II for the relevant disease, calculated backwards from the
           date on which the suspicion was notified.
                                               Article 9
   Temporary restricted zones in the event of suspicion of a category A disease in kept terrestrial
                                      animals in an establishment
   1.      In the event of suspicion of a category A disease in kept animals in an establishment,
           the competent authority may establish a temporary restricted zone taking into
           account the following circumstances:
           (a)    the location of the establishment in an area with a high density of kept animals
                  of listed species for which a category A disease is suspected;
           (b)    the movement of animals or persons in contact with kept animals of listed
                  species for which a category A disease is suspected;
           (c)    the delay in confirming the category A disease pursuant to Article 11;
           (d)    the insufficient information on the possible origin and routes of introduction of
                  the suspected category A disease; and
           (e)    the disease profile, in particular the routes and speed of transmission of the
                  disease and the persistence of the disease in the animal population.
   2.      In the establishments within the temporary restricted zone the competent authority
           shall apply at least the measures provided for in Article 7.
   3.      The competent authority may maintain the temporary restricted zone until the
           moment that the presence of the category A disease has been ruled out in the
           establishment where it was suspected or the presence of that disease has been
           confirmed and a restricted zone is established pursuant to Article 21.
   4.      The competent authority may order preventive killing, in accordance with Article
           12(1) and (2), or slaughtering of animals of listed species, in the temporary restricted
           zones when the epidemiological situation so requires.
                                               Article 10
        Measures to apply in the event of suspicion of a category A disease in food and feed
    businesses, border control posts, animal by-products establishments or any other location of
                               relevance, including means of transport
   1.      In the event of suspicion of a category A disease in accordance with Article 9(1), (3)
           and (4) of Regulation 2019/XXX as regards rules for surveillance, eradication
           programmes, and disease-free status for certain listed and emerging diseases
           [document C(2019)4056] in food and feed businesses, border control posts, animal
           by-products establishments or any other location of relevance, including means of
           transport, the competent authority shall apply:
           (a)    the relevant provisions laid down in Articles 5 to 9; and
           (b)    if needed, additional measures adapted to the specific situation in order to
                  prevent the spread of the category A disease to unaffected animals or to
                  humans.
EN                                                 20                                               EN
 ---pagebreak---    2.        The competent authority shall also apply provisions laid down in Articles 5 to 9 in
             the establishments of origin of the animals or products present in the establishments
             and locations referred to in paragraph 1 which are suspected to be infected.
                                               SECTION 2
    DISEASE CONTROL MEASURES IN THE EVENT OF THE OFFICIAL CONFIRMATION
                          OF A CATEGORY A DISEASE IN KEPT ANIMALS
                                                Article 11
                Official confirmation of a category A disease in kept terrestrial animals
   The competent authority shall officially confirm an outbreak of a category A disease in kept
   terrestrial animals when a case is confirmed in accordance with Article 9(2),(3) and (4) of
   Regulation 2019/XXX as regards rules for surveillance, eradication programmes, and
   disease-free status for certain listed and emerging diseases [document C(2019)4056].
                                                Article 12
    Disease control measures in the event of official confirmation of an outbreak of a category A
                               disease in kept animals in an establishment
   1.        Following the official confirmation of an outbreak of a category A disease in an
             establishment in accordance with Article 11, the competent authority shall order that,
             in addition to measures provided for in Article 7, the following disease control
             measures are immediately applied under the supervision of official veterinarians:
             (a)   all animals of listed species kept in the affected establishment shall be killed as
                   soon as possible on the spot, within the establishment, in such a way as to
                   avoid any risk of spreading the relevant category A disease agent during and
                   after killing;
             (b)   all appropriate and necessary biosecurity measures shall be taken to avoid any
                   possible spread of the category A disease to unaffected kept or wild animals or
                   to humans;
             (c)   bodies or parts of kept animals of listed species which have died or which have
                   been killed pursuant to point (a) of this paragraph shall be disposed of in
                   accordance with Regulation (EC) No 1069/2009;
             (d)   all potentially contaminated products, materials or substances present in the
                   establishment shall be isolated until:
                   (i)    they are disposed of or processed in accordance with Regulation (EC) No
                          1069/2009, in the case of animal by-products (including those resulting
                          from the killing and products of animal origin and germinal products);
                   (ii)   cleaning and disinfection measures are completed in accordance with the
                          Article 15, in the case of other materials and substances fit for cleaning
                          and disinfection;
                   (iii) disposal is completed under the supervision of official veterinarians, in
                          the case of feeding stuff and other materials unfit for cleaning and
                          disinfection.
   2.        The competent authority shall order and supervise that:
EN                                                  21                                                 EN
 ---pagebreak---       (a)   the transport from the affected establishment of animal by-products referred to
            in paragraphs 1(c) and 1(d)(i) complies with the provisions of Regulation (EC)
            No 1069/2009;
      (b)   the transport from the affected establishment of materials or substances
            referred to in paragraph 1(d)(iii) complies with its instructions regarding
            biosecurity and biosafety conditions to prevent the spread of category A
            disease agent.
   3. The competent authority shall collect samples for laboratory examination from kept
      animals of listed species, before or when they are killed or dead, for the purposes of
      the epidemiological enquiry referred to in Article 57 of Regulation (EU) 2016/429.
   4. By way of derogation of point (a) of paragraph 1, the competent authority may, after
      carrying out a risk assessment and taking into account the possibility of applying
      other risk-mitigating measures, decide:
      (a)   to order the killing of kept animals of listed species at the nearest suitable place
            in such a way as to avoid any risk of spreading the category A disease during
            killing or transport; or
      (b)   postpone the killing of kept animals of listed species, provided that those
            animals are subject to emergency vaccination as provided for in Article 69 of
            Regulation (EU) 2016/429.
                                         Article 13
                         Specific derogations from Article 12(1)(a)
   1. In the event of an outbreak of a category A disease in establishments keeping
      animals of listed species in two or more epidemiological units, the competent
      authority may grant derogation from Article 12(1)(a) to the epidemiological units in
      which the disease has not been confirmed, after carrying out a risk assessment, and,
      when necessary, after obtaining favourable results in laboratory examinations, and
      provided that:
      (a)   the epidemiological enquiry referred to in Article 57 of Regulation (EU)
            2016/429 has not revealed any epidemiological link between the
            epidemiological units in which the category A disease has been confirmed and
            those in which the disease has not been confirmed, to suspect the spread of the
            category A disease between them; and
      (b)   the competent authority has confirmed that, at least during the monitoring
            period, set out in Annex II for the relevant disease, before the confirmation of
            the category A disease, the epidemiological units in which the disease has not
            been confirmed were kept completely separated and handled by different
            personnel.
   2. The competent authority may grant derogation from Article 12(1)(a) to the following
      categories of animals provided that the conditions in paragraph 3 are fulfilled:
      (a)   animals kept in a confined establishment;
      (b)   animals kept for scientific purposes or purposes related to conservation of
            protected or endangered species;
      (c)   animals officially registered in advance as rare breeds; and
      (d)   animals with a duly justified high genetic, cultural or educational value.
EN                                           22                                                  EN
 ---pagebreak---    3.        The competent authority shall ensure that the following conditions are fulfilled when
             granting the derogation provided for in paragraph 2:
             (a)    the competent authority has carried out an assessment of the effects of granting
                    such derogation and, in particular, of the effects on the animal health status of
                    the Member State concerned and of the adjacent countries and the outcome of
                    this assessment indicated that the animal health status is not endangered;
             (b)    appropriate biosecurity measures are applied to prevent the risk of transmission
                    of the category A disease to unaffected kept animals or to wild animals or to
                    humans taking into account:
                    (i)    the disease profile; and
                    (ii)   the affected species of animals.
             (c)    the animals are subject to appropriate isolation and clinical surveillance,
                    including laboratory examinations, until the competent authority can ensure
                    that the animals do not pose a risk of transmission of the category A disease.
   4.        The competent authority may grant specific derogations from Article 12(1)(a) to
             equine animals kept in establishments where an outbreak of the category A diseases
             referred to in Annex III has been confirmed under the conditions set out in that
             Annex.
                                                  Article 14
      Additional disease control measures in the event of an outbreak of a category A disease in
                                kept terrestrial animals in an establishment
   1.        The competent authority may establish, in addition to the measures provided for in
             Article 12, sampling procedures for kept animals of non-listed species and wild
             animals of listed species, based on the information obtained from the
             epidemiological enquiry referred to in Article 57 of the Regulation (EU) 2016/429.
   2.        The competent authority may, after carrying out a risk assessment of the further
             spread of the relevant category A disease and taking into account the possibility of
             applying other risk-mitigating measures, order the killing of kept animals of non-
             listed species and wild animals in such a way as to avoid any risk of spreading the
             category A disease during killing, transport and until disposal of the entire bodies or
             parts of the dead animals.
                                                  Article 15
       Preliminary cleaning and disinfection and control of insects and rodents in the affected
                                                establishment
   1.        Immediately after the completion of the measures provided for in Article 12, and
             when relevant in Article 14, the competent authority shall order and supervise a
             preliminary cleaning and disinfection and, when relevant, control of insects and
             rodents, in the affected establishment in order to avoid spreading of the category A
             disease.
   2.        The preliminary cleaning, disinfection and control referred to in paragraph 1 shall be:
             (a)    performed in accordance with the procedures set out in points A and B of
                    Annex IV using the appropriate biocidal products to ensure destruction of the
                    relevant category A disease agent; and
EN                                                    23                                              EN
 ---pagebreak---              (b)   adequately documented.
   3.        When the competent authority grants one of the derogations provided for in Article
             13(2) and (4), it shall order the preliminary cleaning, disinfection and the control
             referred to in paragraph 1 adapting the procedures referred to in point 2(a) to the
             specific situation without detriment to the control of spreading of the category A
             disease from the affected animals and affected establishments and locations to other
             unaffected animals or to humans.
   4.        In addition to the measures referred to in paragraphs 1 and 2, the competent authority
             shall order and supervise that the means of transport used for the transport of animals
             to and from the affected establishment are properly cleaned and disinfected and,
             where relevant, subjected to measures ensuring the control of insects and rodents.
                                                Article 16
      Derogations and special rules for the preliminary cleaning and disinfection and control of
                                                 vectors
   The competent authority may grant derogation to the requirement regarding cleaning and
   disinfection and control of insects and rodents set out in Article 15 in the case of:
   (a)       pastures epidemiologically linked to the affected establishment, under specific
             procedures to ensure effective inactivation of the relevant category A disease agent
             taking into account the disease profile, the type of establishment and the climatic
             conditions; and
   (b)       manure, including litter and used bedding, from the affected establishment, under
             specific procedures to ensure effective inactivation of the relevant category A disease
             agent in accordance with scientific evidence.
                                                Article 17
      Identification of epidemiologically linked establishments and other locations of relevance,
                                      including means of transport
   1.        In the frame of the epidemiological enquiry, as referred to in Article 57 of the
             Regulation (EU) 2016/429, and in order to identify all the epidemiologically linked
             establishments and other locations of relevance, including means of transport, the
             competent authority shall trace all kept animals present in the establishment where an
             outbreak of a category A disease has been confirmed and any products, materials,
             substances, means of transport or people likely to spread the relevant category A
             disease including:
             (a)   those dispatched into and from the establishment; and
             (b)   those that have entered into contact with the establishment.
   2.        The tracing referred to in paragraph 1 shall cover at least the monitoring period, set
             out in Annex II for the relevant disease, calculated backwards from the date the
             suspicion was notified.
   3.        After carrying out a risk assessment, the competent authority may exclude from the
             tracing referred to in paragraph 1 those products considered as safe commodities, as
             provided for in Annex VII.
EN                                                  24                                               EN
 ---pagebreak---                                               Article 18
    Measures to be applied in the epidemiologically linked establishments and other locations of
                               relevance, including means of transport
   1.     When the tracing provided for in Article 17(1) demonstrates that animals of listed
          species were dispatched from or to the affected establishment during the period
          referred to in paragraph 2 of that Article, the competent authority shall:
          (a)    carry out investigations and impose restriction and biosecurity measures in
                 accordance with Article 6, Article 7 and Article 8 in the establishments of
                 destination or origin of the movement; or
          (b)    immediately extend the measures in Article 12 to the establishment of origin or
                 the establishment of destination of the movement in the case that there is
                 epidemiological evidence of spreading of the disease to, from or through that
                 establishment.
   2.     The competent authority shall apply the measures referred to in paragraph 1 in other
          establishments and locations of relevance, including means of transport, likely to be
          contaminated as a result of contact with animals, products, materials, substances,
          persons or means of transport from the affected establishment identified in the frame
          of the tracing referred to in Article 17 or based on any other relevant information
          from the epidemiological enquiry, as referred to in Article 57 of the Regulation (EU)
          2016/429.
                                              Article 19
                  Measures to be applied to the products identified by the tracing
   1.     The competent authority shall order and supervise that semen, oocytes and embryos
          identified as contaminated by the tracing referred to in Article 17 are disposed of in
          accordance with Regulation (EU) 1069/2009.
   2.     The competent authority shall order and supervise the treatment, processing or
          disposing of the products identified by the tracing referred to in Article 17, at least up
          to:
          (a)    the first food processing establishment in the case of products of animal origin;
          (b)    the hatchery or the establishment where eggs were sent for hatching, in the case
                 of hatching eggs which did not yet hatch; and
          (c)    the first establishment of processing in the case of animal by products, except
                 manure; or
          (d)    the location where it is stored, in the case of manure, including litter and used
                 bedding.
   3.     The competent authority shall establish official surveillance on poultry hatched
          during the tracing period referred to in Article 17(2) from hatching eggs originating
          from the affected establishment; this surveillance shall be established in all the
          establishments of destination of the hatching eggs and shall be maintained for a
          period of time of 21 days after hatching.
   4.     The competent authority shall order and supervise that the transport from the
          establishments of animal by-products is subject to the provisions laid down in
          Regulation (EC) No 1069/2009.
EN                                                25                                                 EN
 ---pagebreak---    5.       The competent authority shall order and supervise that materials or substances likely
            to be contaminated or likely to transmit the relevant category A disease comply with
            its instructions regarding biosecurity and biosafety conditions to prevent the spread
            of category A disease agent.
                                                Article 20
      Measures to be applied in the event of official confirmation of an outbreak of a category A
    disease in food and feed businesses, border control posts, animal by-products establishments
                  and any other location of relevance, including means of transport
   1.       In the event of official confirmation of an outbreak in accordance with Article 11 in
            food and feed businesses, border control posts, animal by-products establishments or
            any other locations of relevance, including means of transport, the competent
            authority shall apply:
            (a)    the relevant provisions laid down in Articles 12 to 19; and
            (b)    if needed, additional measures adapted to the specific situation in order to
                   prevent the spread of the category A disease from the affected animals and
                   affected establishments and locations to other unaffected animals or to humans.
   2.       The competent authority shall apply provisions laid down in Articles 12 to 19 also in
            the establishments of origin of the affected animals or products present in the
            establishments and locations referred to in paragraph 1.
                                           CHAPTER II
          Disease control measures for category A diseases of kept
                       terrestrial animals in the restricted zones
                                              SECTION 1
           GENERAL DISEASE CONTROL MEASURES IN THE RESTRICTED ZONE
                                                Article 21
                                    Establishment of a restricted zone
   1.       In the event of an outbreak of a category A disease in an establishment, food and
            feed business, animal by–products establishment or other locations, including means
            of transport, the competent authority shall immediately establish around the affected
            establishment or location a restricted zone, which comprises:
            (a)    a protection zone based on the minimum radius from the outbreak set out for
                   the relevant category A disease in Annex V;
            (b)    a surveillance zone based on the minimum radius from the outbreak set out for
                   the relevant category A disease in Annex V; and
            (c)    if necessary, on the basis of the criteria set out in paragraph 1 of Article 64 of
                   Regulation (EU) 2016/429, further restricted zones around or adjacent to the
                   protection and surveillance zones, where the competent authority shall apply
                   the same measures as those provided for in Section 3 of this Chapter for the
                   surveillance zone.
   2.       The competent authority shall adapt the boundaries of the initial restricted zone,
            including the boundaries of the protection, surveillance and the further restricted
EN                                                  26                                                EN
 ---pagebreak---       zones, in the case of the overlapping of two or more restricted zones due to further
      outbreaks of the category A disease.
   3. By way of derogation of paragraph 1, and after carrying out a risk assessment taking
      into account the disease profile, the competent authority may not establish a
      restricted zone when an outbreak of a category A disease occurs in the following
      locations:
      (a)    establishments keeping animals referred to Article 13(2);
      (b)    hatcheries;
      (c)    food and feed businesses, border control posts, animal by-products
             establishments;
      (d)    means of transport;
      (e)    locations where assembly operations or temporal exhibition or veterinary
             assistance of animals take place; and
      (f)    any other location which is not an establishment.
                                          Article 22
                        Measures to be applied in the restricted zone
   1. The competent authority shall without delay compile and keep up to date an
      inventory of all establishments keeping animals of listed species located in the
      restricted zone including the species, categories and number of animals in each
      establishment; for poultry, the number of animals may be estimated.
   2. The competent authority may, in order to prevent the spreading of the disease and
      based on epidemiological information or other evidence, implement preventive
      killing, in accordance with Article 12(1) and (2), or slaughtering of kept animals of
      listed species in the establishments located in the restricted zone.
   3. The competent authority shall order and supervise that all movements of entire
      bodies or parts of dead wild and kept animals of listed species from the restricted
      zone are destined for processing or disposal in accordance with Regulation (EC) No
      1069/2009 in a plant approved for those purposes:
      (a)    within the territory of the Member State; or
      (b)    in another Member State in accordance with Article 48(1) and (3) of
             Regulation (EC) No 1069/2009, where it is not feasible to process or dispose
             the entire bodies or parts of dead animals in an approved plant in the territory
             of the Member State where the outbreak occurred.
   4. The competent authority shall impose specific conditions for the transport of animals
      and products through the restricted zone in order to ensure that they are performed:
      (a)    without stopping or unloading in the restricted zone;
      (b)    prioritising major highways or mainline railways; and
      (c)    avoiding the vicinity of establishments keeping animals of listed species.
   5. Animal by-products originating from and moved outside the restricted zone shall be
      accompanied by an animal health certificate issued by an official veterinarian stating
      that they are allowed to be moved from the restricted zone under the conditions
      established by the competent authority in accordance with this Chapter.
EN                                            27                                              EN
 ---pagebreak---    6.       The competent authority may decide that the certificate referred to in paragraph 5
            shall not be issued for movements of animal by-products within the Member State
            concerned when that authority considers that an alternative system is in place
            ensuring that consignments of such products are traceable and that products fulfil the
            animal health requirements for such movements.
   7.       Any collection of samples in the establishments in the restricted zone keeping
            animals of listed species for purposes other than to confirm or rule out the presence
            of the relevant category A diseases must be authorised by the competent authority.
                                                Article 23
                    Derogations from measures to be applied in the restricted zone
   The competent authority may grant derogations from the provisions set out in this Chapter
   concerning the measures to be applied in restricted zones, to the extent necessary and after
   carrying out a risk assessment:
   (a)      in the further restricted zones referred to in Article 21(1)(c);
   (b)      in the case that the competent authority decides to establish a restricted zone when an
            outbreak of a category A disease occurs in establishments and locations referred to in
            Article 21(3);
   (c)      in the case that the outbreak occurs in an establishment keeping up to 50 captive
            birds; or
   (d)      in establishments and locations referred to in Article 21(3) located in a restricted
            zone.
                                                Article 24
   Requirements for the means of transport of kept animals of listed species and products thereof
   1.       The competent authority shall ensure that the means of transport used for movements
            of kept animals of listed species and products thereof within, from, to and through
            the restricted zone have been:
            (a)   constructed and maintained in such a way to avoid any leakage or escape of
                  animals, products or any item representing an animal health risk;
            (b)   cleaned and disinfected immediately after every transport of animals, products
                  or any item representing an animal health risk and, if necessary, subsequently
                  disinfected again, and in any case dried or allowed to dry, before any new
                  loading of animals or products; and
            (c)   where relevant, subjected to measures for the control of insects and rodents
                  before the transport.
   2.       The cleaning and disinfection of the means of transport referred to in paragraph 1
            shall be performed:
            (a)   in accordance with the instructions or procedures provided for by the
                  competent authority using the appropriate biocidal products to ensure the
                  destruction of the relevant category A disease agent; and
            (b)   adequately documented.
EN                                                  28                                              EN
 ---pagebreak---                                              SECTION 2
               DISEASE CONTROL MEASURES IN THE PROTECTION ZONE
                                              Article 25
    Measures to be applied in establishments keeping animals of listed species in the protection
                                                 zone
   1.     The competent authority shall order without delay the application of the following
          measures in establishments in the protection zone keeping animals of listed species,
          other than the establishment in which the category A disease has been confirmed:
          (a)    to keep animals of listed species separate from wild animals and animals of
                 non-listed species;
          (b)    to implement additional surveillance in order to identify any further spread of
                 the category A disease to the establishments, including any increased morbidity
                 or mortality or significant drop in production data; any such increase or drop
                 shall be immediately notified to the competent authority;
          (c)    when appropriate, to implement adequate means of controlling insects and
                 rodents and other disease vectors in and around the establishment;
          (d)    to use appropriate means of disinfection at the entrances and exits of the
                 establishment;
          (e)    to apply appropriate biosecurity measures to all persons in contact with kept
                 animals of listed species or entering or leaving the establishment as well as to
                 means of transport in order to avoid any risk of spread of the relevant category
                 A disease;
          (f)    to keep records of all persons visiting the establishment, maintain them up to
                 date in order to facilitate disease surveillance and control and made them
                 available to the competent authority upon request;
          (g)    to dispose entire bodies or parts of dead or killed kept animals of listed species
                 according to Article 22(3).
   2.     By way of derogation of point (f) of paragraph 1 the records on visitors are not
          required in establishments where animals referred to in Article 13(2) are kept, if
          visitors have no access to the areas where the animals are kept.
                                              Article 26
              Visits by official veterinarians in establishments in the protection zone
   1.     The competent authority shall ensure that official veterinarians carry out at least one
          visit to all the establishments referred to in Article 25, as soon as possible and
          without unjustified delay, after the official confirmation of an outbreak of a category
          A disease.
   2.     When carrying out the visits referred to in paragraph 1, official veterinarians shall
          perform at least the following activities:
          (a)    documentary checks, including production, health and traceability records
                 analysis;
EN                                                 29                                               EN
 ---pagebreak---            (a)   verification of the implementation of the measures applied to prevent the
                 introduction or spread of the relevant category A disease in accordance with
                 Article 25;
           (b)   clinical examination of kept animals of listed species; and
           (c)   if necessary, collection of samples of animals for laboratory examination in
                 order to confirm or rule out the presence of the relevant category A disease.
   3.      The competent authority may require further veterinary visits to the establishments in
           the protection zone to follow up on the situation.
   4.      The competent authority shall keep a record of activities and visits referred to in
           paragraph 1, 2 and 3 and the findings thereof.
   5.      By way of derogation from paragraph 1, where the radius of the protection zone set
           in Annex V is larger than 3 km, the competent authority may decide to require not
           the visit to all the establishments referred to in Article 25 but the visit of a
           representative number of those establishments in accordance with point A.3 of
           Annex I.
                                                Article 27
   Prohibitions in relation to activities, including movements, concerning animals, products and
                        other material within, from or to the protection zone
   1.      The competent authority shall prohibit the activities, including movements,
           concerning animals of listed species and their products and other materials within,
           from and to the protection zone in accordance with the table in Annex VI.
   2.      The competent authority may extend the prohibitions provided for in paragraph 1 to:
           (a)   animals of non-listed species and products from such animals; and
           (b)   activities, including movements, other than those set out in Annex VI.
   3.      The following products are exempted from prohibitions provided for in paragraphs 1
           and 2:
           (a)   products of animal origin considered as safe commodities, in accordance with
                 Annex VII, as regards the relevant disease;
           (b)   products of animal origin which have undergone the relevant treatment in
                 accordance with Annex VII;
           (c)   products or other materials likely to spread the disease obtained or produced
                 before the monitoring period set out in Annex II for the relevant disease
                 calculated backwards from the date on which the suspicion was notified;
           (d)   products produced in the protection zone which have been obtained from kept
                 animals of listed species:
                 (i)    kept outside the protection zone;
                 (ii)   kept and slaughtered outside the protection zone; or
                 (iii) kept outside the protection zone and slaughtered in the protection zone.
           (e)   derived products.
   4.      Prohibitions provided for in paragraph 1 and 2 shall apply to products referred to in
           paragraph 3 if:
EN                                                  30                                            EN
 ---pagebreak---        (a)   the products were not clearly separated, during the production process, storage
             and transport, from products not eligible for dispatch outside the restricted zone
             pursuant to this Regulation; or
       (b)   the competent authority has epidemiological evidences of spreading of the
             disease to, from or through those products.
                                          Article 28
      General conditions to grant derogations from prohibitions in the protection zone
   1.  By way of derogation from prohibitions provided for in Article 27, the competent
       authority may authorise movements of animals and products in the cases covered by
       Articles 29 to 38 and under the specific conditions provided for in those Articles and
       the general conditions laid down in paragraphs 2 to 7 of this Article.
       Prior to granting the authorisation, the competent authority shall assess the risks
       deriving from that authorisation and the assessment must indicate that the risk of
       spreading the category A disease is negligible.
   2.  All authorised movements must be performed:
       (a)    exclusively via designated routes,
       (b)    prioritising major highways or mainline railways,
       (c)    avoiding the vicinity of establishments keeping animals of listed species; and
       (d)    without unloading or stopping, until the unloading in the establishment of
             destination.
   3.  The competent authority of the establishment of origin shall designate the
       establishment of destination for movements from or to the protection zone. If the
       competent authority of the establishment of origin is different from the competent
       authority of the establishment of destination, it shall inform the competent authority
       of the establishment of destination about such designation.
   4.  The competent authority of the establishment of origin shall verify that the
       establishment of destination agrees to be designated and to receive each consignment
       of animals or products.
   5.  When authorising movements of animals from the protection zone, the competent
       authority shall ensure that such movements do not pose a risk of spreading of the
       category A disease based on:
       (a)    a clinical examination, with favourable results, of animals kept in the
             establishment, including those animals to be moved;
       (b)    if necessary, a laboratory examination, with favourable results, of animals kept
             in the establishment, including those animals to be moved; and
       (c)    the outcome of the visits referred to in Article 26.
   6.  When authorising the transport of products from the protection zone, the competent
       authority shall order and supervise that:
       (a)    during the whole production process and their storage, products were clearly
             separated from products not eligible for dispatch outside the restricted zone in
             accordance with this Regulation; and
EN                                            31                                                EN
 ---pagebreak---             (b)    products will not be transported with products not eligible for dispatch outside
                   the restricted zone pursuant to this Regulation.
   7.       When granting an authorisation pursuant to paragraph 1, the competent authority
            shall ensure that supplementary biosecurity measures are applied from the moment of
            loading, during all transport operations and until the unloading in the designated
            establishment of destination in accordance with its instructions.
                                                Article 29
    Specific conditions for authorising movements for slaughter of kept animals of listed species
                                          in the protection zone
   1.       The competent authority may authorise movements of kept animals of listed species
            from establishments located in the protection zone to a slaughterhouse located:
            (a)    as near as possible to the establishment of origin, within the protection zone;
            (b)    in the surveillance zone, when it is not possible to slaughter the animals in the
                   protection zone; or
            (c)    as near as possible to the surveillance zone when it is not possible to slaughter
                   the animals in the restricted zone.
   2.       The competent authority shall only grant authorisations provided for in paragraph 1
            under the following conditions:
            (a)    the means of transport must be sealed at the moment of loading by the
                   competent authority of dispatch or under its supervision;
            (b)    the competent authority of the slaughterhouse shall:
                   (i)   be informed in advance by the slaughterhouse operator of the intention to
                         receive kept animals of listed species;
                   (ii)  confirm the absence of any signs indicative of the category A disease
                         during the ante and post mortem inspections;
                   (iii) supervise the slaughterhouse operator having effective procedures in
                         place to ensure that kept animals of listed species originating in the
                         protection zone are kept separately and slaughtered separately from such
                         animals or at different times, preferably at the end of the working day of
                         arrival;
                   (iv) confirm the slaughter of the animals to the competent authority of the
                         establishment of origin of the animals;
                   (v)   supervise the slaughterhouse operator cleaning and disinfecting the
                         premises where the animals have been kept and slaughtered and the
                         completion of the cleaning and disinfection is completed before other
                         kept animals of listed species are kept or slaughtered in those premises;
                         and
                   (vi) supervise the obtaining of meat from such animals complying with the
                         conditions laid down in Article 33.
   3.       The competent authority may authorise movements of kept animals of listed species
            from establishments located outside the protection zone to a slaughterhouse located
            in the protection zone if:
EN                                                  32                                               EN
 ---pagebreak---             (a)   the animals are kept separately from other animals originating from the
                  protection zone and are slaughtered separately from those animals or at a
                  different time;
            (b)   the fresh meat obtained is cut, transported and stored separately from fresh
                  meat obtained from animals originating in the protection zone; and
            (c)   the cleaning and disinfection of the means of transport referred to in Article 24
                  takes place under official supervision after unloading the animals.
   4.       By way of derogation of Article 9 of Regulation (EC) No 1069/2009 the competent
            authority may authorise the processing and use of animal by-products, obtained from
            animals slaughtered in accordance with paragraphs 1, 2 and 3 as category 3 material
            in accordance with Regulation (EC) No 1069/2009 in a plant approved for
            processing or disposal of animal by-products, located on its territory, or in another
            Member State, where it is not feasible to process or dispose them in an approved
            plant in the territory of the Member State where the outbreak occurred.
            In case the animal by-products referred to in the first subparagraph are moved to a
            plant located in another Member State, the Member State of destination and the
            Member States of passage shall authorise such dispatch and the competent authority
            of destination shall authorise the processing and use of those animal by-products as
            category 3 material in accordance with Regulation (EC) No 1069/2009.
                                                Article 30
    Specific conditions for authorising certain movements of poultry from establishments located
                                          in the protection zone
   1.       The competent authority may authorise movements of day-old-chicks from an
            establishment located in the protection zone to an establishment located in the same
            Member State but, if possible, outside the restricted zone, provided that:
            (a)   in the case of day-old-chicks hatched from eggs originating in the restricted
                  zone:
                  (i)    the means of transport is sealed at the moment of loading by the
                         competent authority or under its supervision;
                  (ii)   the establishment of destination is placed under official surveillance by
                         the official veterinarians following the arrival of the animals; and
                  (iii) if moved outside the restricted zone, the poultry remain in the
                         establishment of destination at least for a period of 21 days.
            (b)   in the case of day-old-chicks hatched from eggs originating outside the
                  restricted zone, the hatchery of dispatch can ensure that no contact has
                  occurred between those eggs and any other hatching eggs or day-old chicks
                  originating in the restricted zone.
   2.       The competent authority may authorise movements of ready-to-lay poultry from
            establishments located in the protection zone to establishments located in the same
            Member State and, if possible, within the restricted zone, provided that:
            (a)   in the establishment of destination there is no other kept animal of listed
                  species;
            (b)   the means of transport is sealed at the moment of loading by the competent
                  authority or under its supervision;
EN                                                  33                                              EN
 ---pagebreak---              (c)    the establishment of destination is placed under official surveillance by the
                    official veterinarians following the arrival of the animals; and
             (d)    if moved outside the restricted zone, the animals remain on the establishment
                    of destination at least for a period of 21 days.
                                                  Article 31
    Specific conditions for authorising certain movements of hatching eggs in the protection zone
   1.        The competent authority may authorise movements of hatching eggs either:
             (a)    from an establishment located in the protection zone to a hatchery located in
                    the same Member State; or
             (b)    from an establishment located in the same member State to a hatchery located
                    in the protection zone.
   2.        The authorisation provided for in paragraph 1(a) shall be subject to the following
             conditions:
             (a)    the parent flocks from which the hatching eggs are derived have undergone a
                    clinical examination and have been sampled for laboratory examination with
                    favourable results;
             (b)    the hatching eggs and their packaging are disinfected before dispatch and the
                    tracing back of the hatching eggs can be ensured; and
             (c)    the hatching eggs must be transported in means of transport sealed by the
                    competent authority.
   3.        The competent authority may authorise movements of hatching eggs from an
             establishment located in the protection zone to an establishment for in-house
             hatching located in the same Member State, if:
             (a)    the parent flocks from which the hatching eggs are derived have undergone a
                    clinical examination and have been sampled for laboratory examination with
                    favourable results;
             (b)    the establishment of destination is placed under official supervision until 21
                    days following hatching of the eggs;
             (c)    the poultry must remain on the establishment of destination during the period
                    referred to in (b); and
             (d)    the requirements referred to in paragraph 2(b) and (c) are complied with.
                                                  Article 32
      Specific conditions for authorising movements of semen from approved germinal product
                                   establishments in the protection zone
   The competent authority may authorise movements of semen collected from animals of listed
   species kept in approved germinal product establishments, excluding hatcheries, located in the
   protection zone after the estimated date of earliest infection of the affected establishment
   subject to the following conditions:
   (a)       all the disease control measures relating to the category A disease have been lifted in
             the protection zone in accordance with Article 39;
EN                                                    34                                             EN
 ---pagebreak---    (b)       all kept animals of listed species in the semen collection centre have undergone a
             clinical examination and have been sampled for laboratory examination in order to
             rule out the presence of the category A disease in the semen collection centre; and
   (c)       the donor animal has been subjected with favourable result to a laboratory
             examination on a sample taken not earlier than seven days after the monitoring
             period set out in Annex II for the relevant disease, calculated forwards from the date
             on which the semen was collected.
                                                  Article 33
    Specific conditions for authorising movements of fresh meat and raw milk obtained from kept
                  animals of listed species from establishments in the protection zone
   1.        The competent authority may authorise movements of fresh meat and raw milk
             obtained from animals of listed species kept in establishments located in the
             protection zone if:
             (a)   they are moved to a processing establishment to undergo one of the relevant
                   risk-mitigating treatments set out in Annex VII; or
             (b)   in the case of fresh meat of poultry:
                   (i)     it has been marked in accordance with paragraph 1 of Annex IX from the
                           moment it was obtained in the slaughterhouse; and
                   (ii)    it is not intended to another Member State.
   2.        The competent authority shall ensure that movements to a processing establishment
             referred to in paragraph 1(a) comply with the following conditions:
             (a)   fresh meat must be marked in accordance with point 2 of Annex IX in the
                   slaughterhouse after the post-mortem inspection and must bear such mark until
                   it is treated;
             (b)   the movement of fresh meat and raw milk from the establishment of origin to
                   the processing establishment must be carried out in sealed containers; and
             (c)   the processing establishment must be located in the same restricted zone or as
                   near as possible to the restricted zone and must operate under the supervision
                   of official veterinarians.
                                                  Article 34
        Specific conditions for authorising movements of eggs for human consumption from
                                 establishments located in the protection zone
   The competent authority may authorise the movement of eggs for human consumption from
   establishments located in the protection zone to the following destinations within the same
   Member State:
   (a)       to a packing centre, provided that they are packed in:
             (i)   a disposable packaging; or
             (ii)  a packaging which can be cleaned and disinfected in such way as to destroy the
                   relevant category A disease agent.
   (b)       to an establishment for the manufacture of egg products as set out in Chapter II of
             Section X of Annex III to Regulation (EC) No 853/2004, in order to be handled and
EN                                                    35                                            EN
 ---pagebreak---               treated in accordance with Chapter XI of Annex II to Regulation (EC) No
              852/200414.
                                                     Article 35
      Specific conditions for authorising movements of manure, including litter and used bedding
                     from establishments located in the protection zone to a landfill
   The competent authority may authorise movements of manure, including litter and used
   bedding, from establishments located in the protection zone for the purpose of their disposal
   in a designated landfill located within the same Member State only after processing in
   accordance with Article 13(c) of Regulation (EU) 1069/2009.
                                                     Article 36
     Specific conditions for authorising the movement of feed materials of plant origin and straw
                                            from the protection zone
   The competent authority may authorise movements of feed materials of plant origin and straw
   produced in the protection zone provided that:
   (a)        they were produced in locations not keeping animals of listed species;
   (b)        they were produced in feed processing establishments not keeping animals of listed
              species and the raw plant material originates:
              (i)   from locations referred to in point (a); or
              (ii)  from outside the protection zone.
   (c)        they are intended for use within the protection zone; or
   (d)        they have undergone at least one of the risk-mitigating treatments in accordance with
              Annex VIII.
                                                     Article 37
    Specific conditions for authorising movements of kept animals of listed species and products
                                   to an animal by-products approved plant
   1.         The competent authority may authorise movements of kept animals of listed species
              from establishments located in the protection zone to a plant approved for processing
              or disposal of animal by-products in which:
              (a)   the kept animals are immediately killed; and
              (b)   the resulting animal by-products are disposed of in accordance with Regulation
                    (EC) No 1069/2009.
   2.         The competent authority may authorise movements of products from establishments
              and locations in the protection zone to a plant approved for processing or disposal of
              animal by-products, in which the products are disposed of or processed in accordance
              with Regulation (EC) No 1069/2009.
                                                     Article 38
    Measures to be applied in food and feed businesses, border control posts, animal by-products
   14
            Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the
            hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
EN                                                        36                                                  EN
 ---pagebreak---     establishments or any other location of relevance in the protection zone, including means of
                                                transport
   1.       The competent authority shall apply the relevant measures referred to in Article 25,
            and Articles 27 to 38 in food and feed businesses, border control posts, animal by-
            products establishments or any other location of relevance in the protection zone,
            including means of transport.
   2.       In the establishments and locations referred to in paragraph 1, the competent
            authority may apply additional measures adapted to the specific situation in order to
            prevent the spread of the category A disease within and from the protection zone.
                                                Article 39
                    Duration of the disease control measures in the protection zone
   1.       The competent authority may lift the measures provided for in Section 1 and 2 of this
            Chapter only if the minimum period set out in Annex X has elapsed and the
            following conditions are fulfilled:
            (a)    the preliminary cleaning and disinfection and, where relevant, control of
                   insects and rodents, has been performed in accordance with Article 15 in the
                   affected establishment; and
            (b)    in all establishments keeping animals of listed species in the protection zone,
                   animals of listed species have undergone, with favourable results, clinical and
                   when necessary laboratory examinations in accordance with Article 26.
   2.       Where the relevant category A disease is transmitted by a listed vector, as referred to
            in Regulation (EU) 2018/1882, the competent authority may:
            (a)    establish the duration of the measures in the protection zone on a case by case
                   basis, taking into account any factor influencing the risk of the disease
                   spreading; and
            (b)    provide for the introduction of sentinel animals.
   3.       After the lifting of the measures referred to in paragraph 1, the measures provided for
            in Section 3 of this Chapter shall apply in the protection zone for at least the
            additional period set out in Annex X.
                                              SECTION 3
      DISEASE CONTROL MEASURES IN THE SURVEILLANCE ZONE
                                                Article 40
                   Measures to be applied in establishments in the surveillance zone
   The competent authority shall order the application, without delay, of the measures provided
   for in Article 25 in all the establishments in the surveillance zone keeping animals of listed
   species.
                                                Article 41
             Visits by the official veterinarians in establishments in the surveillance zone
   The competent authority shall ensure that official veterinarians carry out visits to a sample of
   establishments keeping animals of listed species in the surveillance zone in accordance with
   Article 26 and point A.3 of Annex I.
EN                                                   37                                             EN
 ---pagebreak---                                                  Article 42
    Prohibitions in relation to activities, including movements, concerning animals, products and
                        other material within, from or to the surveillance zone
   The competent authority shall apply prohibitions, exemptions and derogations to activities,
   including movements concerning animals of listed species, the products thereof and other
   material, from and to the surveillance zone in accordance with Article 27.
                                                 Article 43
      General conditions for granting derogations from prohibitions provided for in Article 42
   1.       By way of derogation from Article 42, the competent authority may authorise
            movements of animals and products only in the cases covered by Articles 44 to 52,
            under the specific conditions provided for in those Articles and the general
            conditions laid down in paragraphs 2 to 7 of this Article.
            Prior to granting the authorisation, the competent authority shall assess the risks
            deriving from that authorisation. The assessment must indicate that the risk of
            spreading the category A disease is negligible.
   2.       All authorised movements shall be performed:
            (a)   prioritising major highways or mainline railways;
            (b)   avoiding the vicinity of establishments keeping animals of listed species; and
            (c)   without unloading or stopping, until the unloading in the establishment of
                  destination.
   3.       The competent authority of the establishment of origin shall designate the
            establishment of destination for movements from or to the surveillance zone. If the
            competent authority is not the same as in the establishment of destination, it shall
            inform the competent authority of the establishment of destination about such
            designation.
   4.       The competent authority of the establishment of origin shall verify that the
            establishment of destination agrees to be designated and to receive each consignment
            of animals or products.
   5.       When authorising movements of animals from the surveillance zone, the competent
            authority shall ensure that such movements do not pose a risk of spreading the
            category A disease based on:
            (a)   a clinical examination with favourable results of animals kept in the
                  establishment, including those animals to be moved;
            (b)   if necessary, a laboratory examination with favourable results of animals kept
                  in the establishment, including those animals to be moved; and
            (c)   the outcome of the visits referred to in Article 41, if available.
   6.       When authorising the transport of products from the surveillance zone, the competent
            authority must ensure that:
            (a)   during the whole production process and storage, products were clearly
                  separated from products not eligible for dispatch outside the restricted zone
                  pursuant this Regulation;
EN                                                   38                                           EN
 ---pagebreak---             (b)    products will not be transported with products not eligible for dispatch outside
                   the restricted zone pursuant this Regulation.
   7.       When granting derogations provided for in paragraph 1, the competent authority
            shall ensure that supplementary biosecurity measures are applied from the moment of
            loading, during all transport operations and until the unloading in the designated
            establishment of destination in accordance with its instructions.
                                                Article 44
    Specific conditions for authorising movements for slaughter of kept animals of listed species
                                within, from and to the surveillance zone
   1.       The competent authority may authorise movements of kept animals of listed species
            originating in the surveillance zone to a slaughterhouse located:
            (a)    as near as possible to the establishment of origin, within the restricted zone; or
            (b)    outside the restricted zone, as near as possible to the surveillance zone, when it
                   is not possible to slaughter the animals in the restricted zone, and after carrying
                   out a risk assessment.
   2.       The meat obtained from animals referred to in paragraph 1 shall be subject to the
            measures provided for in Article 49.
   3.       The competent authority may authorise movements of kept animals of listed species
            originating outside the surveillance zone to a slaughterhouse situated in the
            surveillance zone.
   4.       The competent authority may authorise the processing and use of animal by-
            products, obtained from animals slaughtered in accordance with paragraphs 1, 2 and
            3 as category 3 material in accordance with Regulation (EC) No 1069/2009 in a plant
            approved for processing or disposal of animal by-products, located on their territory,
            or in another Member State, where it is not feasible to process or dispose them in an
            approved plant in the territory of the Member State where the outbreak occurred.
            In case the animal by-products referred to in the first subparagraph are moved to a
            plant located in another Member State, the Member State of destination and the
            Member States of passage shall authorise such dispatch and the competent authority
            of destination shall authorise the processing and use of those animal by-products as
            category 3 material in accordance with Regulation (EC) No 1069/2009.
                                                Article 45
   Specific conditions for authorising certain movements of kept ungulates of listed species from
                                 establishments in the surveillance zone
   1.       The competent authority may authorise the movement of kept ungulates of listed
            species to pastures situated within the surveillance zone, provided that:
            (a)    a period of 15 days has elapsed after the preliminary cleaning and disinfection
                   referred to in Article 15 has been completed and approved; and
            (b)    the animals do not come into contact with animals of listed species from other
                   establishments.
   2.       The competent authority may, after carrying out a risk assessment, authorise the
            movement of kept animals of listed species of ungulates to an establishment
            belonging to the same supply chain, located in or outside the surveillance zone, to
EN                                                  39                                                 EN
 ---pagebreak---             complete the production cycle before slaughter. If the establishment of destination is
            located outside the surveillance zone, the competent authority shall apply in that
            establishment the measures provided for in Articles 40, Article 41 and Article 42 as
            long as the disease control measures in the surveillance zone of origin are maintained
            as provided for in Article 55.
                                                 Article 46
    Specific conditions for authorising certain movements of poultry from establishments located
                                         in the surveillance zone
   1.       The competent authority may authorise movements of day-old chicks originating in
            the surveillance zone:
            (a)   to establishments in the same Member State where they were hatched from
                  eggs originating from establishments within the surveillance zone, if:
                  (i)    the establishment of destination is placed under official surveillance
                         following the arrival of the animals; and
                  (ii)   if moved outside the restricted zone, the animals remain in the
                         establishments of destination for at least 21 days.
            (b)   to establishments in the same Member State where they were hatched from
                  eggs originating outside the restricted zone, if the hatchery of dispatch can
                  ensure that no contact has occurred between those eggs and any other hatching
                  eggs or day-old chicks obtained from animals kept within the restricted zone.
   2.       The competent authority may authorise movements of ready-to-lay poultry from
            establishments in the surveillance zone to establishments in the same Member State,
            if:
            (a)   in the establishment of destination there is no other kept animal of listed
                  species;
            (b)   the establishment of destination is placed under official surveillance following
                  the arrival of the ready-to-lay poultry; and
            (c)   the poultry remain on the establishment of destination for at least 21 days.
                                                 Article 47
        Specific conditions for authorising certain movements of hatching eggs to and from
                                 establishments in the surveillance zone
   1.       The competent authority may authorise movements of hatching eggs from an
            establishment located in the same Member State to :
            (a)   a hatchery located in the surveillance zone; or
            (b)   an establishment for in-house hatching located in the surveillance zone.
   2.       The competent authority may authorise movements of hatching eggs from an
            establishment located in the surveillance zone to a hatchery in the same Member
            State or to an establishment for in-house hatching located in the same Member State,
            only if the hatching eggs and their packaging are disinfected before dispatch and the
            tracing back of these eggs can be ensured.
EN                                                   40                                            EN
 ---pagebreak---                                                  Article 48
      Specific conditions for authorising movements of semen from approved germinal product
                                  establishments in the surveillance zone
   The competent authority may authorise movements of semen collected from animals of listed
   species kept in approved germinal product establishments, excluding hatcheries, located in the
   surveillance zone after the estimated date of earliest infection of the affected establishment
   provided that:
   (a)       all the disease control measures relating to the relevant category A disease have been
             lifted in the surveillance zone in accordance with Article 55;
   (b)       all the kept animals of listed species in the semen collection centre have undergone a
             clinical examination and have been sampled for laboratory examinations in order to
             rule out the presence of the category A disease in the semen collection centre;
   (c)       the donor animal has been subjected with favourable results to a laboratory
             examination on a sample taken not earlier than seven days after the monitoring
             period set out in Annex II for the relevant disease, calculated forwards from the date
             on which the semen was collected.
                                                 Article 49
    Specific conditions for authorising movements of fresh meat and raw milk obtained from kept
            animals of listed species from establishments located in the surveillance zone
   1.        The competent authority may authorise movements of fresh meat and raw milk
             obtained from animals of listed species kept in establishments located in the
             surveillance zone if, either:
             (a)    the fresh meat or the raw milk is moved to a processing establishment to
                    undergo one of the risk-mitigating treatments set out in Annex VII; or
             (b)    the fresh meat is obtained from poultry.
   2.        The competent authority shall ensure that fresh meat and the raw milk moved
             pursuant paragraph 1(a), comply with the following:
             (a)    fresh meat is marked in accordance with Annex IX when it is obtained in the
                    slaughterhouse and keeps such mark until it is treated; and
             (b)    the treatment is applied in an establishment situated in the same restricted zone
                    or as near as possible of the restricted zone, which operates under the
                    supervision of official veterinarians.
                                                 Article 50
        Specific conditions for authorising movements of eggs for human consumption from
                                  establishments in the surveillance zone
   1.        The competent authority may authorise movements of eggs for human consumption
             from establishments in the surveillance zone to a packing centre located in the same
             Member State provided that they are packed in:
             (a)    a disposable packaging; or
             (b)    a packaging which can be cleaned and disinfected in such way as to destroy the
                    category A disease agent.
EN                                                   41                                               EN
 ---pagebreak---    2.       The competent authority may authorise movements of eggs for human consumption
            from establishments located in the surveillance zone to an establishment for the
            manufacture of egg products located in the same Member State if:
            (a)   the establishment for the manufacture of egg products complies with Chapter II
                  of Section X of Annex III to Regulation (EC) No 853/2004; and
            (b)   the eggs are moved to the establishment for the manufacture of egg products in
                  order to be handled and treated in accordance with Chapter XI of Annex II to
                  Regulation (EC) No 852/2004.
                                               Article 51
    Specific conditions for authorising movements of manure, including litter and used bedding,
                             from establishments in the surveillance zone
   The competent authority may authorise the movement of manure, including litter and used
   bedding, from establishments located in the surveillance zone:
   (a)      without processing, to a landfill, previously authorised for that purpose by the
            competent authority, located in the same surveillance zone; or
   (b)      following processing, to a landfill, previously authorised for that purpose by the
            competent authority, located in the territory in the Member State.
                                               Article 52
    Specific conditions for authorising the movement of feed materials of plant origin and straw
                                      from the surveillance zone
   The competent authority may authorise movements of feed materials of plant origin or straw
   produced in the surveillance zone provided that the feed materials or the straw:
   (a)      were produced in locations not keeping animals of listed species, other than feed
            processing establishments;
   (b)      were produced in feed processing establishments not keeping animals of listed
            species and the raw plant material originates:
            (i)   from locations referred to in paragraph (a); or
            (ii)  from outside the surveillance zone.
   (c)      are intended for use within the surveillance zone;
   (d)      have undergone at least one of the risk-mitigating treatments set out in Annex VIII.
                                               Article 53
    Specific conditions for authorising movements of kept animals of listed species and products
                                         to an approved plant
   1.       The competent authority may authorise movements of kept animals of listed species
            from establishments located in the surveillance zone to a plant approved for
            processing or disposal of animal by-products where:
            (a)   the kept animals are immediately killed; and
            (b)   the resulting animal by-products are disposed of in accordance with Regulation
                  (EC) No 1069/2009.
EN                                                 42                                            EN
 ---pagebreak---    2.       The competent authority may authorise movements of products from establishments
            and other locations in the surveillance zone to a plant approved for processing or
            disposal of animal by-products where they are disposed of or processed in
            accordance with Regulation (EC) No 1069/2009.
                                               Article 54
   Measures to be applied in food and feed businesses, border control posts, animal by-products
   establishments or any other location of relevance in the surveillance zone, including means of
                                                transport
   1.       The competent authority shall apply the relevant measures referred to in Article 40,
            and Articles 42 to 53 in food and feed businesses, border control posts, animal by-
            products establishments or any other location of relevance in the surveillance zone,
            including means of transport.
   2.       In the establishments and locations referred to in paragraph 1, the competent
            authority may apply additional measures adapted to the specific situation in order to
            prevent the spread of the category A disease within and from the surveillance zone.
                                               Article 55
                  Duration of the disease control measures in the surveillance zone
   1.       The competent authority may lift the disease control measures applied in the
            surveillance zone pursuant to Sections 1 and 3 of this Chapter only if the period set
            out in Annex XI has elapsed and the following conditions are fulfilled:
            (a)    the requirements provided for in Article 39 have been met in the protection
                   zone; and
            (b)    a representative number of establishments keeping animals of listed species
                   have undergone, with favourable results, visits carried out by official
                   veterinarians, in accordance with Article 41.
   2.       Where the relevant category A disease is transmitted by a listed vector, in accordance
            with Regulation (EU) 2018/1882, the competent authority may:
            (a)    set the duration of the measures in the surveillance zone on a case by case basis
                   taking into account factors influencing the risk of spreading the disease; and
            (b)    provide for the introduction of sentinel animals.
                                             SECTION 4
        DEROGATIONS APPLICABLE IN THE RESTRICTED ZONE IN THE CASE OF
                                  FURTHER DISEASE OUTBREAKS
                                               Article 56
      Derogations from prohibitions of movements of animals within the restricted zones when
                                  restriction measures are maintained
   1.       Where prohibitions of movement of animals provided for in Articles 27 and Article
            42 are maintained beyond the period set out in Annex XI because of the official
            confirmation of further outbreaks of the category A disease, the competent authority
            may, under exceptional circumstances, authorise the movement of kept animals of
            listed species from an establishment within the restricted zone in cases not covered
            by derogations provided for in Articles 27 and Article 42, if:
EN                                                 43                                                EN
 ---pagebreak---         (a)   the operator has submitted a reasoned application for that authorisation;
        (b)   the risks derived from authorising such movements have been assessed prior to
              the authorisation and the assessment indicates that the risk of spreading of the
              category A disease is negligible;
        (c)   official veterinarians have carried out clinical examinations and have collect
              samples for laboratory examinations from animals of listed species, including
              those to be moved, which have yielded favourable results.
   2.   Where movements of animals are authorised pursuant paragraph 1, the competent
        authority shall ensure that the transport complies with the requirements laid down in
        Article 24.
                                      CHAPTER III
      REPOPULATION WITH TERRESTRIAL ANIMALS OF
            ESTABLISHMENTS IN RESTRICTED ZONES
                                            Article 57
            Conditions to authorise the repopulation of the affected establishment
   1.   The competent authority shall only authorise the repopulation of the affected
        establishment if the following requirements are met:
        (a)   a final cleaning and disinfection and, when relevant, control of insects and
              rodents has been:
              (i)    carried out, in accordance with the procedures set out in points A and C
                     of Annex IV, using the appropriate biocidal products to ensure
                     destruction of the relevant category A disease agent; and
              (ii)   adequately documented.
        (b)   the monitoring period set out in Annex II for the relevant disease, calculated
              forwards from the date on which the final cleaning and disinfection provided
              for in point (a) was carried out, has elapsed.
   2.   The competent authority shall supervise that the final cleaning and disinfection and,
        when relevant, control of insects and rodents in the affected establishment is carried
        out in compliance with the requirements in paragraph 1(a).
   3.   The competent authority shall not allow access to a pasture of kept animals of listed
        species during the period of time during which it is considered contaminated; this
        period of time shall be established after carrying out a risk assessment.
   4.   Where for duly justified reasons the final cleaning and disinfection and, when
        relevant, the control of insects and rodents referred to in paragraph 1, have not been
        entirely accomplished in the affected establishment, the competent authority may
        authorise the repopulation by way of derogation from paragraph 1, provided that:
        (a)   a period of at least 3 months has elapsed since the preliminary cleaning and
              disinfection, as referred to in Article 15, was performed; and
        (b)   prior to granting the authorisation, the competent authority has assessed the
              risks deriving from that authorisation and the assessment indicates that the risk
              of spreading the category A disease is negligible.
EN                                              44                                              EN
 ---pagebreak---                                                 Article 58
                  Derogation from the requirement provided for in Article 55(1)(b)
   In the event of the official confirmation of an outbreak of a category A disease in food and
   feed businesses, assembly centres, border control posts, animal by-products establishments or
   any other location of relevance, including means of transport, the competent authority may
   authorise the reintroduction of kept animals of listed species for slaughter, assembly
   operations, inspection or transport, 24 hours after completion of:
   (a)      the measures referred to in Articles 12, Article 14, Article 15, Article 17, Article 18
            and Article 57(1)(a); and
   (b)      any additional measure applied by the competent authority adapted to the specific
            situation.
                                                Article 59
      Requirements for the repopulation of the affected establishment with kept animals of listed
                                                 species
   1.       The competent authority shall supervise the repopulation with kept animals of listed
            species of the affected establishment complying with the provisions of this Article.
   2.       Kept animals of listed species intended for repopulation shall:
            (a)    not originate from an establishment subject to the restrictions provided for in
                   Chapter III; and
            (b)    be sampled for laboratory examination to rule out the presence of the disease
                   with favourable results prior to their introduction into the establishment.
   3.       For the purposes of paragraph 2(b), samples shall be collected from:
            (a)    a representative number of all the animals to be introduced in the
                   establishment, if they are all introduced at the same time and from the same
                   establishment of origin; or
            (b)    a representative number of animals of each consignment, if animals are all to
                   be introduced at different times or from different establishments of origin.
                   In the case of day-old-chicks, the competent authority may decide not to
                   perform the sampling for laboratory examination referred to in paragraph 2(b).
   4.       Kept animals of listed species intended for repopulation shall be introduced in the
            establishments as follows:
            (a)    in all the epidemiological units and buildings of the affected establishment;
            (b)    preferably at the same time or within the monitoring period set out in Annex II
                   for the relevant disease, calculated forwards from the date on which the first
                   animal was introduced; or
            (c)    in case of open-air farming establishments or when the requirement set out in
                   point (a) is impractical, by using sentinel animals which have been sampled for
                   laboratory examinations with favourable results for the relevant category A
                   disease before being introduced in the establishment.
   5.       Official veterinarians shall carry out at least a visit to the affected establishment on
            the last day of the monitoring period set out in Annex II for the relevant disease,
            calculated forwards from the date on which the animals were placed in the
EN                                                  45                                               EN
 ---pagebreak---             establishment, and in any case before 30 days have elapsed since that day,
            performing at least:
            (a)   documentary checks, including production, health and traceability records
                  analysis;
            (b)   clinical examination of kept animals of listed species; and
            (c)   collection of samples of animals for laboratory examination in order to confirm
                  or rule out the presence of the relevant category A disease.
   6.       Any person entering or leaving the establishment shall comply with appropriate
            biosecurity measures aimed at preventing the spread of the relevant category A
            disease.
   7.       Kept animals of listed species shall only leave the establishment under the
            authorisation of the competent authority and only after obtaining favourable results
            from the laboratory examination referred to in paragraph 5(c).
   8.       From the date that the animals were placed in the establishment until the end of the
            repopulation, in accordance with Article 61, the operator shall:
            (a)   keep up to date the records of health and production data for kept animals of
                  listed species; and
            (b)   immediately notify to the competent authority any significant change in
                  production data and any other abnormalities.
   9.       If unusual mortalities or clinical signs of the relevant category A disease are notified
            to the competent authority during the period referred to in paragraph 8, the official
            veterinarians shall without delay collect samples for laboratory examination to rule
            out the presence of the relevant category A disease.
   10.      The competent authority may exempt confined establishments from one or more of
            the provisions laid down in paragraphs 1 to 9 after assessing the risks deriving from
            that exemption and the assessment indicates that the risk of spreading the category A
            disease is negligible.
                                                Article 60
              Additional requirements for the repopulation of the affected establishment
   1.       The competent authority shall authorise the repopulation of the affected
            establishment with animals other than kept listed species taking into account the risk
            of spreading the relevant category A disease and the risk of vector persistence.
   2.       The competent authority may extend some or all the provisions provided for in
            Articles 57 and 59 if preventive killing as provided for in paragraph 4 of Articles 7
            and 9 is applied.
                                                Article 61
    End of the repopulation of the affected establishment and lifting of disease control measures
                                      in the affected establishment
   1.       The repopulation of the affected establishment shall be considered finalised when the
            measures provided in Articles 57 and 59, and when relevant in Article 60, have been
            successfully completed.
EN                                                  46                                               EN
 ---pagebreak---    2.     The competent authority shall lift all the disease control measures applied in the
          affected establishment in accordance with this Regulation when the repopulation is
          considered finalised as provided for in paragraph 1.
                                         CHAPTER IV
      DISEASE CONTROL MEASURES IN WILD ANIMALS OF
                                      LISTED SPECIES
                                              Article 62
     Measures in the event of suspicion of a category A disease in wild animals of listed species
   1.     In the event of suspicion of a category A disease in wild animals of listed species in
          accordance with Article 9(1), (3), and (4) of Regulation 2019/XXX as regards rules
          for surveillance, eradication programmes, and disease-free status for certain listed
          and emerging diseases [document C(2019)4056], the competent authority shall
          immediately conduct an investigation to confirm or rule out the presence of the
          suspected listed disease.
   2.     In the course of the investigation referred to in paragraph 1 the competent authority
          shall at least organise post-mortem examinations and the collection of samples for
          laboratory examination of wild animals of listed species shot dead or found dead to
          confirm or rule out the presence of the category A disease.
   3.     As regards the bodies of dead wild animals in which the relevant category A disease
          is suspected, whether the wild animals were killed or found dead, the competent
          authority shall ensure that:
          (a)    the entire bodies of the dead wild animals or parts thereof are disposed of or
                 processed in accordance with Regulation (EC) No 1069/2009; and
          (b)    where feasible, any material or substance likely to be contaminated by contact
                 with the bodies of dead wild animals or animal by-products obtained therefrom
                 undergoes cleaning and disinfection or is disposed of following the instructions
                 and under the supervision of official veterinarians.
                                              Article 63
   Measures in the event of an outbreak of a category A disease in wild animals of listed species
   1.     In the event of an official confirmation of an outbreak of a category A disease in wild
          animals of listed species in accordance with Article 9(2), (3) and (4) of Regulation
          (EU) 2019/XXX as regards rules for surveillance, eradication programmes, and
          disease-free status for certain listed and emerging diseases [document
          C(2019)4056], the competent authority may determine an infected zone in order to
          prevent the further spread of the disease based on:
          (a)    the disease profile;
          (b)    the estimated population of wild animals of listed species;
          (c)    the risk factors contributing to the spread of the relevant category A disease, in
                 particular, the risk of the introduction of a category A disease into
                 establishments keeping animals of listed species;
          (d)    sampling results; and
          (e)    other relevant factors.
EN                                                47                                                EN
 ---pagebreak---    2.       As regards the bodies of wild animals in which the relevant category A disease has
            been confirmed, whether the wild animals were killed or found dead, the competent
            authority shall ensure that:
            (a)    their entire bodies of the dead wild animals or parts thereof are disposed of or
                   processed in accordance with Regulation (EC) No 1069/2009; and
            (b)    where feasible, any material or substance likely to be contaminated by contact
                   with the bodies of dead wild animals or animal by-products therefrom
                   undergoes cleaning and disinfection or is disposed of following the instructions
                   and under the supervision of official veterinarians.
   3.       The competent authority may adapt the boundaries of the initial infected zone:
            (a)    in order to control the further spread of the relevant category A disease; and
            (b)    in the case of confirmation of further outbreaks of the category A disease in
                   wild animals.
   4.       The competent authority shall immediately inform operators, clinical veterinarians,
            hunters, other relevant competent authorities and any other natural or legal person
            concerned about the outbreak of the disease and the control measures adopted.
                                                Article 64
                               Measures to be applied in the infected zone
   1.       In the infected zone determined in accordance with Article 63, the competent
            authority shall organise post-mortem examinations of wild animals of listed species
            shot dead or found dead, including when necessary sampling for laboratory
            examination.
   2.       In the infected zone the competent authority shall at least:
            (a)    implement risk mitigation and reinforced biosecurity measures in order to
                   prevent the spread of the category A disease from the affected animals and
                   infected zone to unaffected animals or to humans;
            (b)    prohibit movements of wild animals of listed species and products of animal
                   origin thereof as provided for to in Regulation (EU) 2019/xxx as regards
                   animal health requirements for movements within the Union of terrestrial
                   animals and hatching eggs[document C(2019)4058; and
            (c)    ensure that all bodies of dead wild animals of listed species, whether the
                   animals were killed or found dead, or parts thereof, are disposed of or
                   processed in accordance with in Regulation (EC) No 1069/2009.
                                                Article 65
                           Additional measures to apply in the infected zone
   In order to avoid the spreading of the category A disease, in the infected zone the competent
   authority may:
   (a)      regulate movements of kept animals of listed species;
   (b)      regulate hunting activities and other outdoors activities;
   (c)      restrict the feeding of wild animals of listed species; and
EN                                                  48                                              EN
 ---pagebreak---    (d)       develop and implement an eradication plan for the category A disease in wild
             animals of listed species if the epidemiological situation so requires.
                                                Article 66
                                        Operational expert group
   In the event of an officially confirmed outbreak of a category A disease in wild animals of
   listed species and in the case that the competent authority determines an infected zone in
   accordance with Article 63, the competent authority shall establish an operational expert
   group as referred to in Article 43 of Regulation (EU) 2016/429 to assist the competent
   authority in:
   (a)       assessing the epidemiological situation and its evolution;
   (b)       defining the infected zone;
   (c)       establishing the appropriate measures to be applied in the infected zone in
             accordance with this Chapter and their duration; and
   (d)       developing an eradication plan, when relevant.
                                                Article 67
                               Duration of measures in the infected zone
   The competent authority shall maintain the measures applied in the infected zone in
   accordance with this Chapter until the epidemiological information indicates that the relevant
   wild population no longer poses a risk of introduction of a category A disease into
   establishments keeping animals of listed species and the operational group recommends
   lifting of the measures.
                                           CHAPTER VI
    DISEASE CONTROL MEASURES FOR CATEGORY B AND C
                    DISEASES OF TERRESTRIAL ANIMALS
                                                Article 68
        Preliminary disease control measures to be applied when a category B or C disease is
    suspected by the competent authority in Member States or zones that have been granted with
                                          the disease free status
   In the event of suspicion of a category B or C disease in accordance with Article 9(1), (3) or
   (4) of Regulation 2019/XXX as regards rules for surveillance, eradication programmes, and
   disease-free status for certain listed and emerging diseases [document C(2019) 4056], in
   Member States or zones that have been granted the disease free status pursuant to Article
   36(4) of Regulation (EU) 2016/429 or Article 84(1) of Regulation 2019/XXX as regards
   rules for surveillance, eradication programmes, and disease-free status for certain listed and
   emerging diseases [document C(2019) 4056], the competent authority shall apply the
   measures laid down in:
   (a)       Articles 21, 22, 23 of Regulation 2019/XXX as regards rules for surveillance,
             eradication programmes, and disease-free status for certain listed and emerging
             diseases [document C(2019) 4056] for infection with Brucella abortus, B. melitensis,
             B. suis, infection with Mycobacterium tuberculosis complex, enzootic bovine
             leucosis, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis,
             infection with Aujeszky’s disease virus and bovine viral diarrhoea;
EN                                                  49                                            EN
 ---pagebreak---    (b)      Article 35 of Regulation 2019/XXX as regards rules for surveillance, eradication
            programmes, and disease-free status for certain listed and emerging diseases
            [document C(2019) 4056] for infection with rabies virus ; and
   (c)      Article 41 of Regulation 2019/XXX as regards rules for surveillance, eradication
            programmes, and disease-free status for certain listed and emerging diseases
            [document C(2019) 4056] for infection with bluetongue virus (serotype 1-24).
                                             Article 69
        Disease control measures to be applied when a category B or C disease is confirmed
   In the event of confirmation of a category B or C disease in accordance with point (2) of
   Article 9 of of Regulation 2019/XXX as regards rules for surveillance, eradication
   programmes, and disease-free status for certain listed and emerging diseases [document
   C(2019) 4056] in Member States or zones that have been granted the disease free status in
   with paragraph 4 of article 36 of Regulation (EU) 2016/429 or paragraph 1 Article 84 of
   Regulation 2019/XXX as regards rules for surveillance, eradication programmes, and
   disease-free status for certain listed and emerging diseases [document C(2019) 4056], the
   competent authority shall apply the measures laid down in:
   (a)      Articles 24 to 31 of Regulation 2019/XXX as regards rules for surveillance,
            eradication programmes, and disease-free status for certain listed and emerging
            diseases [document C(2019) 4056] for infection with Brucella abortus, B. melitensis,
            B. suis, infection with Mycobacterium tuberculosis complex, enzootic bovine
            leucosis, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis,
            infection with Aujeszky’s disease virus and bovine viral diarrhoea;
   (b)      Article 36 of Regulation 2019/XXX as regards rules for surveillance, eradication
            programmes, and disease-free status for certain listed and emerging diseases
            [document C(2019) 4056] for infection with rabies virus; and
   (c)      Article 42 of Regulation 2019/XXX as regards rules for surveillance, eradication
            programmes, and disease-free status for certain listed and emerging diseases
            [document C(2019) 4056] for infection with bluetongue virus (serotype 1-24).
EN                                               50                                              EN
 ---pagebreak---                                             PART III
                                 AQUATIC ANIMALS
                                           CHAPTER I
         DISEASE CONTROL MEASURES FOR CATEGORY A
                   DISEASES IN AQUACULTURE ANIMALS
                                             SECTION 1
    PRELIMINARY DISEASE CONTROL MEASURES IN THE EVENT OF SUSPICION OF A
                     CATEGORY A DISEASE IN AQUACULTURE ANIMALS
                                              Article 70
       Obligations on operators in the event of suspicion of category A disease in aquaculture
                                       animals in establishments
   In the event of suspicion of a category A disease in aquaculture animals of listed species,
   operators shall take the following disease control measures in order to prevent the spread of
   the category A disease from the affected animals and aquaculture establishments under their
   responsibility to other unaffected aquatic animals until the competent authority rules out the
   presence of the category A disease:
   (a)      isolate, where technically possible, all aquaculture animals in the establishment
            suspected of being infected with the category A disease;
   (b)      prevent movements of aquaculture animals into and from the establishment;
   (c)      keep records of all visits and movements from and to the establishment;
   (d)      keep any product, piece of equipment, material or substance likely to be
            contaminated with and to transmit category A diseases isolated and as far as
            practicable protected from vectors and other aquatic animals;;
   (e)      implement the appropriate biosecurity measures to avoid spread of the category A
            disease;
   (f)      provide the competent authority, on its request, with any relevant information
            regarding the category A disease; and
   (g)      follow any instructions given by the competent authority regarding the control of
            category A disease, in accordance with Regulation (EU) 2016/429 and this
            Regulation.
                                              Article 71
         Investigation by the competent authority of the suspicion of a category A disease in
                               aquaculture animals in an establishment
   1.       In the event of the suspicion of a category A disease in aquaculture animals in an
            establishment in accordance with Article 9(1), (3) and (4) of Regulation 2019/XXX
            as regards rules for surveillance, eradication programmes, and disease-free status
            for certain listed and emerging diseases [document C(2019)4056], the competent
            authority shall immediately conduct an investigation to confirm or rule out the
            presence of the suspected listed disease.
EN                                                 51                                             EN
 ---pagebreak---    2.      In the course of the investigation referred to in paragraph 1 the competent authority
           shall ensure that the official veterinarians perform at least:
           (a)    clinical examinations of aquaculture animals; and
           (b)    the collection of samples for laboratory examination.
                                               Article 72
   Preliminary restriction and biosecurity measures to be applied in the event of the suspicion of
                             a category A disease in aquaculture animals
   1.      In the event of suspicion of a category A disease in an establishment, the competent
           authority shall place the establishment under official surveillance and immediately
           impose the following preliminary restriction and biosecurity measures, in order to
           prevent the spread of the category A disease from the affected aquaculture animals
           and the establishment to unaffected aquatic animals:
           (a)    prohibition of movements of aquaculture animals into and from the
                  establishment;
           (b)    prohibition of non-essential movements from the establishment of means of
                  transport and equipment;
           (c)    prohibition of slaughter of aquaculture animals for human consumption;
           (d)    where technically feasible and regarded necessary, order the isolation of all
                  aquaculture animals; and
           (e)    when practicable, implement adequate means and measures to control birds
                  and other predators.
   2.      The competent authority may order preventive killing of listed species at the affected
           establishment where a category A disease is suspected provided that all necessary
           biosecurity and other risk-mitigating measures are applied to prevent the spread of
           the category A disease from the establishment.
   3.      The competent authority shall by way of derogation from Article 10(i) of Regulation
           (EC) 1069/2009 and after carrying out a risk assessment, authorise movements of
           aquaculture animals for the sole purpose of immediate killing in a disease control
           aquatic food establishment or a plant approved for processing or disposal of as
           animal-by-products of category 1 or category 2 in accordance with that Regulation.
           The authorisation may only be granted when the necessary biosecurity and other
           risk-mitigating measures are applied to prevent the spread of the category A disease.
   4.      All animal by-products from dead aquaculture animals which have died or have been
           killed in accordance with this Article, including molluscs shells with meat, shall by
           way of derogation from Article 10(i) of Regulation (EC) 1069/2009 be processed or
           disposed of as category 1 or category 2 material in accordance with that Regulation
           to ensure that the relevant disease agent is inactivated and to prevent the transmission
           of the disease to other aquatic animals.
EN                                                 52                                               EN
 ---pagebreak---                                               Article 73
        Inventory and record analysis in the event of the suspicion of a category A disease in
                                         aquaculture animals
   1.       In the event of suspicion of a category A disease, the competent authority shall order
            and verify that, without delay, operators of the establishments where a category A
            disease is suspected compile and maintain an up-to-date inventory of the following:
            (a)   the species, categories and quantities (numbers, volume or weight) of all
                  aquaculture animals kept in the establishment;
            (b)   any product, material or substance likely to be contaminated with or likely to
                  transmit the category A disease; and
            (c)   the mortality in each epidemiological unit within the establishment, recorded
                  on a daily basis.
   2.       In the framework of the epidemiological enquiry, as referred to in Article 57 of
            Regulation (EU) 2016/429 and carried out in establishments where the disease is
            suspected, the official veterinarians shall analyse at least the records listed in
            paragraph 1 of Article 186 of Regulation (EU) 2016/429.
                                              Article 74
    Extension of disease control measures in the event of the suspicion of a category A disease to
                                         other establishments
   In order to prevent the spread of a category A disease the competent authority shall conduct
   an investigation as provided for in Article 71 and, after carrying out a risk assessment, extend
   the relevant measures provided for in Articles 72 and 73 to:
   (a)      establishments situated in the same compartment as the establishment where the
            disease is suspected, or which, due to distance, hydrodynamic conditions or
            topographic conditions, have an increased risk for contracting the relevant disease
            agent from the establishment where the disease is suspected;
   (b)      any establishment other than those referred to in point (a) which has a direct
            epidemiological link with the establishment where the disease is suspected.
                                              Article 75
                        Temporary restricted zones around the establishment
   The competent authority may establish a temporary restricted zone around the establishment
   where there is a suspicion of category A disease and where preliminary disease control
   measures are applied as referred to in Article 72 and Article 73 taking into account the
   following circumstances:
   (a)      the location of the establishment in an area with other establishments keeping
            aquaculture animals of listed species for which a category A disease is suspected;
   (b)      the movement of animals in the vicinity of the suspected establishment;
   (c)      the delay in confirming the category A disease pursuant to Article 77;
   (d)      the insufficient information on the possible origin and routes of introduction of the
            suspected category A disease; and
EN                                                53                                                EN
 ---pagebreak---    (e)       the disease profile, in particular the routes and speed of transmission of the disease
             and the persistence of the disease in the relevant population of aquaculture animals of
             listed species.
                                                 Article 76
        Measures to apply in the event of suspicion of a category A disease in food and feed
      businesses, purification centre, dispatch centre, border control posts, animal by-products
           establishments or any other location of relevance , including means of transport
   1.        In the event of suspicion of a category A disease in accordance with Article 9(1),(3)
             and (4) of Regulation 2019/XXX as regards rules for surveillance, eradication
             programmes, and disease-free status for certain listed and emerging diseases
             [document C(2019)4056] in food and feed businesses, purification centre, dispatch
             centre, border control posts, animal by-products establishments or any other location
             of relevance, including means of transport, the competent authority shall apply:
             (a)    the measures provided for in Articles 71 to 75; and
             (b)    if needed, additional measures adapted to the specific situation in order to
                    prevent the spread of the category A disease from the animals and
                    establishments or locations under suspicion to unaffected animals.
   2.        The competent authority shall apply provisions laid down in Articles 71 to 75 also in
             the establishments of origin of the animals or products present in the establishments
             and locations referred to in paragraph 1.
                                               SECTION 2
    DISEASE CONTROL MEASURES IN THE EVENT OF OFFICIAL CONFIRMATION OF A
                       CATEGORY A DISEASE IN AQUACULTURE ANIMALS
                                                 Article 77
                  Official confirmation of a category A disease in aquaculture animals
   The competent authority shall officially confirm an outbreak of a category A disease in
   aquaculture animals when the conditions set out in Article 9(2), (3) and (4) of Regulation
   (EU) 2019/XXX as regards rules for surveillance, eradication programmes, and disease-free
   status for certain listed and emerging diseases [document C(2019)4056] are met.
                                                 Article 78
     Disease control measures in the event of official confirmation of an outbreak of category A
                                        disease in an establishment
   1.        Following the official confirmation of an outbreak of a category A disease in
             accordance with Article 77, the competent authority shall in addition to the measures
             provided for Article 72 and Article 73, order that the following disease control
             measures are immediately applied under the supervision of the official veterinarians,
             to the establishment where the official confirmation of an outbreak of a category A
             disease has occurred:
             (a)    fish and crustaceans of listed species shall be killed as soon as possible and
                    molluscs of listed species shall be removed from water as soon as possible;
EN                                                   54                                              EN
 ---pagebreak---       (b)   animals referred to in (a) shall by way of derogation from Article 10(i) of
            Regulation (EC) 1069/2009 be disposed of as category 1 or category 2 material
            in accordance with that Regulation;
      (c)   the measures provided for in point (a) and (b) shall be carried out either:
            (i)    in the establishment where the official confirmation of an outbreak of a
                   category A disease has occurred with subsequent processing on site; or
            (ii)   in a disease control aquatic food establishment, or in a plant approved in
                   accordance with Regulation (EC) No 1069/2009 for processing or
                   disposal in a way that prevents risk of spreading the category A disease.
      (d)   aquaculture animals of non-listed species shall, as soon as possible, be killed or
            slaughtered for human consumption or, in case of molluscs, removed from
            water in accordance with paragraph 1(b);
      (e)   appropriate measures shall be applied to limit any possible spread of the
            category A disease to and from any wild aquatic animals that might be in
            epidemiological contact with the establishment;
      (f)   all potentially contaminated products, materials or substances shall be isolated
            until:
            (i)    they are disposed of in accordance with Regulation (EC) No 1069/2009,
                   in the case of animal by-products;
            (ii)   by way of derogation from Article 10(i) of Regulation (EC) 1069/2009
                   they are disposed of or processed as category 1 or category 2 material in
                   accordance with that Regulation, in the case of products of animal origin;
            (iii) cleaning and disinfection measures have been completed in accordance
                   with the provisions in Article 80, in the case of materials and substances
                   which are fit for cleaning and disinfection; and
            (iv) they are removed from the establishment and disposed of under the
                   supervision of official veterinarians, in the case of feeding stuff and other
                   materials unfit for cleaning and disinfection.
   2. The competent authority shall order and supervise:
      (a)   the transport from the affected establishment of animal by-products referred to
            in paragraph 1(f)(i) and of the products of animal origin referred to in
            paragraph 1(f)(ii) being in compliance with the provisions of Regulation (EC)
            No 1069/2009; and
      (b)   the transport from the affected establishment of materials or substances
            referred to in paragraph 1(f)(iv) being in compliance with its instructions
            regarding biosecurity and biosafety conditions to prevent the spread of
            category A disease agent.
   3. By way of derogation from paragraph 1(a), the competent authority may, after
      carrying out a risk assessment, allow slaughter of fish or crustaceans or in case of
      molluscs removal from water, for human consumption, at the establishment or in a
      disease aquatic control food establishment, provided that appropriate biosecurity and
      other necessary risk-mitigating measures to prevent the spread of the category A
      disease are taken. All animal by-products resulting from that derogation shall, by
EN                                            55                                                 EN
 ---pagebreak---             way of derogation from Article 10(i) of Regulation (EC) 1069/2009, be processed or
            disposed of as category 1 or category 2 material in accordance with that Regulation.
   4.       By way of derogation from paragraph 1(d), the competent authority may, after
            carrying out a risk assessment, decide not to kill, slaughter or remove from water
            aquaculture animals of non-listed species provided that appropriate risk-mitigating
            measures are applied to prevent any risk of spreading of the relevant category A
            disease from the establishment.
   5.       By way of derogation from paragraph 1(f)(ii), the competent authority may, after
            carrying out a risk assessment, allow the placing on the market of products of animal
            origin in accordance with Article 83.
                                               Article 79
     Specific derogations from control measures in establishments where listed species are kept
         for scientific purposes or purposes related to conservation of endangered species
   1.       The competent authority may grant derogations from the measures provided for in
            Article 78(1)(a) and (c) in the event of an official confirmation of a category A
            disease in establishments where listed species are kept for scientific purposes or
            purposes related to conservation of endangered species, provided that:
            (a)   the animal health status of the concerned Member State, or of other Member
                  States, is not jeopardised; and
            (b)   all appropriate biosecurity measures as listed in Article 78 are taken to prevent
                  any risk of spreading of the category A disease agent.
   2.       Where a derogation is granted pursuant to paragraph 1, the competent authority shall
            ensure that aquaculture animals of listed species covered by the derogation are:
            (a)   kept in premises where appropriate biosecurity measures to avoid spread of the
                  relevant category A disease are implemented; and
            (b)   subjected to further surveillance and laboratory examination and are not moved
                  from the establishment until the laboratory tests have indicated that they do not
                  pose a risk of further spread of the relevant category A disease.
                                               Article 80
                                       Cleaning and disinfection
   1.       The competent authority shall order the operators to carry out, immediately after the
            completion of the disease control measures provided for in Article 78, the cleaning
            and disinfection of:
            (a)   the establishment, as far as the competent authority considers it is technically
                  possible;
            (b)   any husbandry related equipment including but not limited to feeding, grading,
                  treatment, vaccination and workboats;
            (c)   any production related equipment including but not limited to cages, netting,
                  trestles, bags and long-lines;
            (d)   any protective clothing or safety equipment used by operators and visitors; and
            (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                                                 56                                               EN
 ---pagebreak---    2.       The cleaning and disinfection as provided for in paragraph 1 shall be carried out:
            (a)    in accordance to a protocol previously agreed between the competent authority
                   and the operator; and
            (b)    under the supervision of official veterinarians.
                                                Article 81
                                 Fallowing of the affected establishment
   The competent authority shall order operators to carry out, after the completion of the
   cleaning and disinfection provided for in in Article 80, the fallowing of the affected
   establishment for the period of time laid down in Annex XIII.
                                                Article 82
      Extension of disease control measures in the event of confirmation of a category A disease
   In order to prevent the spread of a category A disease the competent authority shall conduct
   an investigation provided for in Article 71 and after carrying out a risk assessment, extend
   some or all of the measures provided for in Articles 78, 80 and 81 to:
   (a)      establishments of the same compartment or which due to distance, hydrodynamic
            conditions or topographic conditions, have an increased risk for contracting the
            relevant disease agent from the suspected establishment where the disease is
            confirmed;
   (b)      any establishment which as a result of the enquiry provided for in article 57 of
            Regulation (EU) 2016/429, has shown a direct epidemiological link with the
            establishment where the disease is confirmed.
                                                Article 83
   Placing on the market of products of animal origin from aquaculture animals of listed species
                                   produced in infected establishments
   1.       When granting a derogation pursuant Article 78(5), the competent authority may
            allow the placing on the market of products of animal origin only if the following
            conditions are fulfilled:
            (a)    fish must be slaughtered and eviscerated before dispatch;
            (b)    molluscs and crustaceans must be fully traceable and processed to non-viable
                   products unable to survive if returned to the water, before dispatch.
            When purification is required before processing and placing on the market, it shall be
            conducted at a disease control aquatic food establishment or in a bio-secure
            purification centre.
   2.       The products of animal origin referred to in paragraph 1 shall be intended for:
            (a)    to the final consumer directly; or
            (b)    for further processing in a disease control aquatic food establishment.
EN                                                  57                                             EN
 ---pagebreak---                                                 Article 84
    Measures to be applied in the event of confirmation of category A diseases in, food and feed
    businesses, purification centre, dispatch centre, border control posts or any other location of
                                 relevance, including means of transport
   1.       In the event of confirmation of a category A disease in food and feed businesses,
            purification centre, dispatch centre, border control posts or any other location of
            relevance, including means of transport, in accordance with Article 77, the
            competent authority shall apply:
            (a)   the measures provided for in Articles 78, Article 80 and Article 81; and
            (b)   if needed, additional measures adapted to the specific situation in order to
                  prevent the spread of the category A disease from the affected animals and
                  establishments or locations to unaffected animals.
   2.       The competent authority shall apply provisions laid down in Articles 78, Article 80
            and Article 81 also in the establishments of origin of the animals or products present
            in the establishments and locations referred to in paragraph 1.
                                           CHAPTER II
     Disease control measures for category A diseases of aquaculture
                                animals in the restricted zone
                                              SECTION 1
      GENERAL DISEASE CONTROL MEASURES IN THE RESTRICTED
                                                 ZONE
                                                Article 85
                                    Establishment of a restricted zone
   1.       In the event of the official confirmation of an outbreak of a category A disease in an
            establishment, food and feed business, animal by–products establishment or any
            other location of relevance, including means of transport, the competent authority
            shall immediately establish a restricted zone around the affected establishment or
            location, including:
            (a)   a protection zone around the establishment or location where the category A
                  disease is confirmed;
            (b)   a surveillance zone around the protection zone; and
            (c)   if necessary, on the basis of the criteria set out in Article 64(1) of Regulation
                  (EU) 2016/429, further restricted zones around or adjacent to the protection
                  and surveillance zones.
   2.       The extent of the zones shall be set on a case-to-case basis, taking into account
            factors influencing the risk of spreading the disease. To that end, the the competent
            authority shall consider the following data and criteria :
            (a)   data from the epidemiological enquiry in accordance with Article 57 in
                  Regulation (EU) 2016/429;
            (b)   relevant hydrodynamic data;
            (c)   criteria listed in Article 64(1) of Regulation (EU) 2016/429; and
EN                                                  58                                              EN
 ---pagebreak---       (d)   criteria provided for in Annex XIV to this Regulation.
   3. The competent authority shall adapt the boundaries of the initial restricted zone,
      including the boundaries of the protection, surveillance and the further restricted
      zones, in the case of the overlapping of two or more restricted zones due to further
      outbreaks of the category A disease.
   4. By way of derogation from paragraph 1, the competent authority may due to specific
      geographical, hydrodynamic and epidemiological circumstances, and after carrying
      out a risk assessment taking into account the disease profile:
      (a)   not establish the restricted zone as provided for in paragraph 1 around the
            infected establishment or location;
      (b)   establish a restricted zone consisting of a protection zone without any adjacent
            surveillance zone; and
      (c)   not establish a restricted zone when a category A disease is confirmed in food
            and feed businesses, purification centre, dispatch centre, border control posts,
            animal by-products establishments or any other location of relevance, including
            means of transport.
   5. The competent authority may derogate, to the extent necessary and after carrying out
      a risk assessment taking into account geographical, hydrodynamic, epidemiological
      circumstances and the disease profile, from the provisions of this Chapter:
      (a)   in the further restricted zones; and
      (b)   in the case that the competent authority decides to establish the restricted zone
            when an outbreak of a category A disease occurs in establishments or any other
            locations of relevance referred to in paragraph 4(c).
                                         Article 86
                       Measures to be applied in the restricted zone
   1. The competent authority shall without delay compile and keep an up-to-date
      inventory of all establishments keeping aquaculture animals of listed species located
      in the restricted zone, including the species, categories and the estimated number of
      animals in each establishment.
   2. In the establishments located within the restricted zone, the competent authority may,
      on the basis of epidemiological information or other relevant evidence and after
      carrying out a risk assessment, implement preventive killing or, slaughtering for
      human consumption or, in the case of molluscs, removal from water, of aquaculture
      animals of listed species pursuant to Article 78(1)(a) and (2).
   3. Any collection of samples, in establishments in the restricted zone keeping
      aquaculture animals of listed species, for purposes other than to confirm or rule out
      the presence of the relevant category A disease, shall be authorised by the competent
      authority.
EN                                            59                                              EN
 ---pagebreak---                                             SECTION 2
      DISEASE CONTROL MEASURES IN THE PROTECTION ZONE
                                              Article 87
   Measures to be applied in establishments keeping aquaculture animals in the protection zone
   1.     The competent authority shall order operators of establishments keeping aquaculture
          animals of any species in the protection zone, other than the establishment in which
          the category A disease has been confirmed, to carry out at least the following
          measures in order to prevent and control the spread of the disease:
          (a)    without delay update the records of the inventory provided for in Article 73(1);
          (b)    when practicable, implement appropriate measures to limit any possible spread
                 of the category A disease to and from any wild aquatic animals that might be in
                 epidemiological contact with the establishment;
          (c)    prevent aquaculture animals from being removed from the establishment in
                 which they are kept unless authorised by the competent authority;
          (d)    implement appropriate biosecurity measures to any product, piece of
                 equipment, material or substance likely to spread the relevant category A
                 disease;
          (e)    reduce the number of visitors to those which are strictly necessary to operate
                 the establishment in a proper manner; and
          (f)    where practicable, implement appropriate means of cleaning and disinfection at
                 the entry and exit of the establishment.
   2.     The competent authority shall order and supervise that the operator has processed or
          disposed of as the relevant category material in accordance with Regulation (EC) No
          1069/2009 animal by-products from aquaculture animals of listed species that have
          died or have been killed, including molluscs shells with meat, in establishments
          keeping listed species within the protection zone.
   3.     The competent authority may decide after carrying out a risk assessment that Articles
          87 and 88 only apply to aquaculture animals of listed species.
                                              Article 88
              Visits by official veterinarians in establishments in the protection zone
   1.     The competent authority shall ensure that official veterinarians carry out at least one
          visit to all the establishments referred to in Article 87 as soon as possible and without
          delay after the official confirmation of an outbreak of category A disease, with
          priority directed to establishments that the competent authority has assessed as
          posing a high risk as regards contracting or spreading disease.
   2.     When carrying out the visits referred to in paragraph 1, official veterinarians shall
          perform at least the following activities:
          (a)    documentary checks and record analysis;
          (b)    verification of the implementation of the measures intended to prevent the
                 introduction or spread of the relevant category A disease in accordance with to
                 Article 87;
          (c)    clinical examination of aquaculture animals of listed species; and
EN                                                 60                                               EN
 ---pagebreak---             (d)    if necessary, collection of samples for laboratory examination in order to
                   confirm or rule out the presence of the relevant category A disease.
   3.       The competent authority may require further veterinary visits to the establishments to
            follow up on the situation.
   4.       The competent authority shall keep a record of activities and visits referred to in
            paragraph 1, 2 and 3, and the findings thereof.
                                               Article 89
      Prohibitions in relation to movements of aquaculture animals, products from aquaculture
           animals, other substances and material within, from or to the protection zone
   1.       The competent authority shall prohibit the following movements within the
            protection zone:
            (a)    movement of aquaculture animals of listed species between establishments in
                   the protection zone;
            (b)    movement of aquaculture animals of listed species from or to the protection
                   zone;
            (c)    any movements from the establishments within the protection zone of means of
                   transport and any equipment, product, material or substance likely to transmit
                   the relevant category A disease;
            (d)    transport of aquaculture animals by well-boats through the protection zone; and
            (e)    dispatch of unprocessed animal by-products from aquaculture animals of any
                   species from establishments in the protection zone.
   2.       The competent authority may, after carrying out a risk assessment, extend the
            prohibitions provided for in paragraph 1(a) to 1(d) to animals of non-listed species
            and their products.
                                               Article 90
       General conditions to grant derogations from prohibitions of movement and transport
                    concerning aquatic animals and products in the protection zone
   1.       By way of derogation from prohibitions provided for in Article 89(1), the competent
            authority may authorise the movement and transport of aquatic animals and products
            in the cases covered by Articles 91 to 94 under the specific conditions provided for in
            those Articles and the general conditions laid down in paragraph 2 of this Article.
   2.       When granting the authorisations provided for in pargraph 1, the competent authority
            shall ensure that the following conditions are met:
            (a)    all movements must be carried out exclusively via designated routes, agreed
                   with the competent authority, without unloading or stopping;
            (b)    any exchange of water and discharges of water during the transportation must
                   be carried out in areas, establishments or water exchange points approved by
                   the competent authority;
            (c)    the means of transport must be constructed and maintained in such a way that
                   they can undergo proper cleaning and disinfection;
EN                                                 61                                               EN
 ---pagebreak---             (d)   the means of transport are cleaned and disinfected:
                  (i)   prior to the transport operations; and
                  (ii)  after transport operations under the supervision of the official
                        veterinarian;
            (e)   any other supplementary biosecurity measure considered necessary by the
                  competent authority must be taken in relation to transport operations.
                                               Article 91
    Specific conditions for slaughter, and movements for slaughter or processing of aquaculture
                animals from listed species from establishments in the protection zone
   1.       Aquaculture animals from establishments keeping listed species in the protection
            zone may be:
            (a)   slaughtered within the establishment in compliance with biosecurity measures
                  provided for by the competent authority; or
            (b)   moved for immediate slaughter for human consumption in a disease control
                  aquatic food establishment; or
            (c)   in the case of molluscs, removed from water and moved to a disease control
                  aquatic food establishment for purification if necessary and further processing.
   2.       The competent authority may, after carrying out a risk assessment based on relevant
            epidemiological data, limit the application of the measures provided for in paragraph
            1 to establishments keeping solely aquaculture animals of species listed in the third
            column of the Annex to Commission Implementing Regulation (EU) 2018/1882.
   3.       When authorising the movements of aquaculture animals referred to in paragraph
            1(b), the competent authority responsible for the disease control aquatic food
            establishment shall:
            (a)   be informed of the intention to send aquaculture animals of listed species to the
                  disease control aquatic food establishment;
            (b)   agree to receive the aquaculture animals in question;
            (c)   supervise and confirm the slaughter of the animals to the competent authority
                  of dispatch;
            (e)   ensure that the aquaculture animals of listed species originating from the
                  protection zone are kept separately from aquaculture animals of listed species
                  originating from outside the protection zone, and slaughtered or processed
                  separately from those animals;
            (f)   monitor the slaughtering or processing;
            (g)   ensure that the cleaning and disinfection of the premises is completed before
                  aquaculture animals from establishments outside the protection zone are
                  slaughtered or processed;
            (i)   ensure that products of animal origin obtained from the aquaculture animals
                  comply with the specific conditions for placing on the market provided for in
                  Article 92; and
EN                                                 62                                               EN
 ---pagebreak---             (j)    ensure that animal by-products from slaughter or other processes referred to in
                   paragraph 1, are processed or disposed of in accordance with Regulation (EC)
                   No 1069/2009.
                                                Article 92
    Specific conditions for placing on the market of products of animal origin from aquaculture
       animals of listed species produced in non-affected establishments in the protection zone
   1.       The competent authority may authorise placing on the market of products of animal
            origin obtained from aquaculture animals of listed species in non-affected
            establishments in the protection zone, provided that the following conditions are
            fulfilled:
            (a)    fish must be slaughtered and eviscerated before dispatch; and
            (b)    molluscs and crustaceans must be fully traceable and processed to non viable
                   products unable to survive if returned to the water, before dispatch.
   2.       The products of animal origin referred to in paragraph 1 shall be intended:
            (a)    for direct supply to the final consumer; or
            (b)    for further processing in a disease control aquatic food establishment.
                                                Article 93
        Special conditions for authorising transport of unprocessed animal by-products from
                              establishments located in the protection zone
   The competent authority may authorise the transport of unprocessed animal by-products of
   aquaculture animals of listed species from establishments in the protection zone to a plant for
   further processing in accordance with Regulation (EC) No 1069/2009.
                                                Article 94
    Risk-mitigating measures concerning certain activities related to aquatic animals within the
                                              protection zone
   1.       The competent authority may, after carrying out a risk assessment, implement risk-
            mitigating measures as regards:
            (a)    commercial and recreational fishing activities in the protection zone;
            (b)    other activities that are related to aquatic animals in the protection zone and
                   that might pose a risk of spreading the disease; and
            (c)    transport of service boats used for maintenance activities and treatment of
                   aquatic animals in the protection zone.
   2.       In the framework of the measures provided for in paragraph 1, the competent
            authority may, as relevant, order the cleaning and disinfection of equipment, which
            has been used in waters covered by the protection zone.
EN                                                  63                                             EN
 ---pagebreak---                                               Article 95
      Measures to be applied in food and feed businesses, purification centre, dispatch centres,
   border control posts, animal by-products establishments or any other location of relevance in
                         the protection zone, including means of transport
   1.      The competent authority shall apply the measures provided for in Articles 87 to 93 in
           food and feed businesses, purification centre, dispatch centres, border control posts,
           animal by-products establishments or any other location of relevance in the
           protection zone, including means of transport.
   2.      In the establishments and locations referred to in paragraph 1, the competent
           authority may apply additional measures adapted to the specific situation in order to
           prevent the spread of the category A disease within and from the protection zone.
                                              Article 96
   Removal of aquaculture animals from affected establishments and subsequent risk- mitigating
                                              measures
   1.      The competent authority shall determine a point in time by which aquaculture
           animals in all infected establishments shall be removed.
   2.      The competent authority may decide, after carrying out a risk assessment, that
           paragraph 1 also applies to establishments in the protection zone in which the
           category A disease has not been confirmed in order to control and prevent the
           possible spread of the diseases.
   3.      After the removal of aquaculture animals as provided for in paragraph 1, cleaning,
           disinfection and fallowing shall be carried out in accordance with Articles 80 and 81.
   4.      The competent authority shall order synchronous fallowing of the affected
           establishments and the establishments selected in accordance with paragraph 2.
   5.      The synchronous fallowing referred to in paragraph 4 shall last for the period of time
           laid down in Annex XIII.
                                              Article 97
    Duration of disease control measures in the protection zone, repopulation of establishments
                                   covered by the protection zone
   1.      The competent authority shall maintain the disease control measures in the protection
           zone provided for in Section 2 of this Chapter until:
           (a)   the measures in Article 96 are carried out and completed; and
           (b)   the competent authority has, based on the outcome of the investigations
                 conducted in accordance with Article 88, ruled out any occurrence of the
                 relevant category A disease in the other establishments within the protection
                 zone.
   2.      When the conditions set out in paragraph 1 are met:
           (a)   the competent authority shall apply the measures provided for in Section 3 of
                 this Chapter in the protection zone for the period of time set out in Article 101;
                 and
           (b)   the establishments referred to in Article 96 (1) and (2) and previously covered
                 by the protection zone may be repopulated.
EN                                                64                                                EN
 ---pagebreak---                                             SECTION 3
      DISEASE CONTROL MEASURES IN THE SURVEILLANCE ZONE
                                               Article 98
                 Measures to be applied in establishments in the surveillance zone
   1.      In the surveillance zone, the competent authority shall order that the measures
           provided for in Article 87 are applied in all establishments keeping aquaculture
           animals of listed species.
   2.      Official veterinarians shall visit the establishments referred to in paragraph 1 and
           carry out the activities provided for in Article 88(2) as appropriate.
   3.      The establishments within the surveillance zone shall undergo surveillance
           comprising visits and samplings as described in point 1 of Annex XV.
   4.      The surveillance provided for in paragraph 3 shall be carried out by the competent
           authority.
                                               Article 99
   Measures in relation to the movement and transport of aquaculture animals within from or to
                                         the surveillance zone
   1.      The competent authority shall prohibit any movements of aquaculture animals from
           establishments within the surveillance zone for slaughter, further farming or release
           into the wild outside the surveillance zone.
   2.      The competent authority shall ensure that any transport of aquaculture animals of
           listed species within or into the surveillance zone shall be conducted under
           conditions as set out in Article 90(a) to (e) and in Article 91.
   3.      The competent authority may order appropriate supplementary biosecurity measures
           to be applied to transport operations, including the unloading in the designated
           establishment of destination in order to control and prevent the possible spread of the
           diseases.
   4.      By way of derogation from paragraph 1, and in agreement with the competent
           authority of the place of destination, the competent authority may authorise
           movements of aquaculture animals provided that appropriate biosecurity measures to
           prevent the spreading of the category A disease are applied.
                                              Article 100
      Measures to be applied in food and feed businesses, purification centre, dispatch centres,
   border control posts, animal by-products establishments or any other location of relevance in
                        the surveillance zone, including means of transport
   1.      The competent authority shall order without delay that the measures provided for in
           Articles 98 and 99 be applied in food and feed businesses, purification centre,
           dispatch centres, border control posts, animal by-products establishments or any
           other location of relevance in the surveillance zone, including means of transport.
   2.      In the locations referred to in paragraph 1, the competent authority may apply
           additional measures adapted to the specific situation in order to prevent the spread of
           the category A disease within and from the surveillance zone.
EN                                                 65                                              EN
 ---pagebreak---                                               Article 101
                    Duration of disease control measures in the surveillance zone
   The competent authority shall lift the disease control measures provided for in this Section
   when the period of surveillance, set out in point 2 of Annex XV, for the relevant category A
   disease has elapsed with favourable results.
                                         CHAPTER III
         DISEASE CONTROL MEASURES IN WILD AQUATIC
                                            ANIMALS
                                              Article 102
      Measures in the event of a suspect case of a category A disease in wild aquatic animals of
                                             listed species
   In the event of a suspect case of a category A disease in wild aquatic animals of listed species
   in accordance with Article 9(1),(3) and (4) in Regulation 2019/XXX as regards rules for
   surveillance, eradication programmes, and disease-free status for certain listed and emerging
   diseases [document C(2019)4056], the competent authority shall:
   (a)      immediately conduct an investigation of wild aquatic animals of listed species fished,
            caught, collected or found dead to confirm or rule out the presence of the category A
            disease in accordance with Article 71(2);
   (b)      ensure that all animal by-products obtained from the wild aquatic animals of listed
            species suspected to be infected, including molluscs shells with meat, are processed
            or disposed of as category 1 or category 2 material in accordance with Regulation
            (EC) No 1069/2009;
   (c)      ensure that, where practicable any material or substance likely to be contaminated by
            animals suspected to be affected or by the animal by-products obtained from those
            animals undergoes cleaning and disinfection or is disposed of following the
            instructions and under the supervision of official veterinarians; and
   (d)      provide relevant information to the operators or authorities in charge of the
            management of the relevant animal population.
                                              Article 103
   Measures in the event of an outbreak of a category A disease in wild aquatic animals of listed
                                                 species
   1.       In the event of an officially confirmed case of a category A disease in wild aquatic
            animals of listed species, the competent authority shall determine an infected zone on
            the basis of:
            (a)   relevant hydrodynamic, topographic and epidemiological conditions;
            (b)   the disease profile and the estimated population of aquatic animals of listed
                  species; and
            (c)   the risk factors contributing to the spread of the relevant category A disease, in
                  particular those associated with the risk of introducing the disease into
                  establishments keeping aquatic animals of listed species.
   2.       The competent authority may adapt the boundaries of the initial infected zone:
EN                                                 66                                                EN
 ---pagebreak---       (a)   in order to control the further spread of the relevant category A disease; and
      (b)   in the case of confirmation of further outbreaks of the category A disease in
            wild animals.
   3. The competent authority shall immediately inform operators, other relevant
      competent authorities, relevant veterinarians, and any other natural or legal person
      concerned, about the outbreak of the diseases and the control measures adopted.
                                         Article 104
                        Measures to be applied in the infected zone
   1. In the infected zone established in accordance with Article 103 the competent
      authority shall:
      (a)   implement risk mitigation and reinforced biosecurity measures, in order to
            prevent the spread of the category A disease from the affected animals and
            infected zone to unaffected animals and areas;
      (b)   prohibit any movement by humans of wild aquatic animals of listed species and
            products of animal origin obtained from those animals from the infected zone;
      (c)   by way of derogation from Article 10(i) of Regulation (EC) 1069/2009 ensure
            that all animal by-products obtained from the wild aquatic animals of listed
            species in the infected zone including molluscs shells, with meat are processed
            or disposed of as category 1 or category 2 material in accordance with that
            Regulation;
      (d)   ensure, where practicable, that any material or substance likely to be
            contaminated by wild aquatic animals of listed species in the infected zone or
            animal by-products obtained from those animals undergoes cleaning and
            disinfection or is disposed of following the instructions and under the
            supervision of official veterinarians; and
      (e)   prohibit bringing into establishments keeping aquaculture animals of listed
            species both within and outside the infected zone or to water catchment or
            coastal areas outside the infected zone any parts of aquatic animals of listed
            species whether, fished, caught, collected or found dead in the infected zone as
            well as any product, material or substance which is likely to be contaminated
            with a category A disease in the infected zone.
   2. By way of derogation from paragraph 1(b) and for the purpose of preserving valuable
      genetic material, the competent authority may authorise movements of wild aquatic
      animals of listed species from the infected zone to an establishment authorised by the
      competent authority for that purpose, provided that appropriate biosecurity measures
      to prevent the spread of the category A disease are applied. The establishment of
      destination shall be considered as an establishment located in the infected zone for
      the purposes of Article 108.
                                         Article 105
                 Additional measures to be applied in the infected zone.
   1. After carrying out a risk assessment, the competent authority shall determine the
      additional measures necessary to control or eradicate the relevant category A disease.
EN                                           67                                              EN
 ---pagebreak---    2.       As part of the control or eradication of the relevant category A disease the competent
            authority may:
            (a)    suspend restocking, fishing, collecting and catching activities;
            (b)    order mandatory cleaning and disinfection of fishing equipment and boats and
                   other equipment likely to be contaminated; and
            (c)    increase fishing, collecting and catching activities or implement other relevant
                   measures to eradicate the disease.
   3.       The measures provided for in paragraph 1 shall be implemented after consultations
            and in cooperation with the operational expert group referred to in Article 107 and
            other authorities and stakeholders.
                                               Article 106
                                         Extension of measures
   The competent authority may decide that relevant measures in Articles 102 to 105 also apply
   to aquatic animals of non-listed species.
                                               Article 107
                                        Operational expert group
   1.       In the event of a confirmed case of a category A disease in wild aquatic animals of
            listed species, the competent authority shall establish an operational expert group as
            referred to in Article 43(2)(d)(iii) of Regulation (EU) 2016/429.
   2.       The operational expert group shall assist the competent authority in:
            (a)    assessing the epidemiological situation and its evolution;
            (b)    determining the infected zone; and
            (c)    establishing the appropriate measures to be applied in the infected zone and
                   their duration.
                                               Article 108
                        Measures in the establishments within the infected zone
   1.       In the establishments keeping aquaculture animals of listed species within the
            infected zone, the competent authority shall apply the measures provided for in
            Article 87.
   2.       In addition to the measures provided for in Article 87, the competent authority shall
            prohibit the movement of aquaculture animals kept in establishments within the
            infected zone:
            (a)    out of the infected zone; or
            (b)    to other establishments in the infected zone.
   3.       The competent authority may, after carrying out a risk assessment, limit the
            prohibition in paragraph 2 to aquaculture animals of listed species.
   4.       By way of derogation from paragraph 2, the competent authority may authorise after
            carrying out a risk assessment and in agreement with the competent authority of the
            place of destination, the movement of animals of of listed species out of the infected
            zone or to other establishments in the infected zone.
EN                                                  68                                              EN
 ---pagebreak---                                                Article 109
                              Duration of the measures in the infected zone
   The competent authority shall maintain the measures provided for in this Chapter until the
   epidemiological information indicates that the relevant wild population no longer poses a risk
   of spreading the disease and the operational group recommends lifting the measures.
                                          CHAPTER IV
    DISEASE CONTROL MEASURES FOR CATEGORY B AND C
                         DISEASES OF AQUATIC ANIMALS
                                               Article 110
       Preliminary disease control measures to be applied when a category B or C disease is
      suspected by the competent authority in Member States, zones or compartments that have
                                   been granted a disease free status
   The competent authority shall apply the measures laid down in Articles 55, Article 56 and
   Article 57 of Regulation (EU) 2019/XXX as regards rules for surveillance, eradication
   programmes, and disease-free status for certain listed and emerging diseases [document
   C(2019)4056] in the event of suspicion of a category B or C disease in accordance with
   Article 9(1), (3) or (4) of Regulation (EU) 2019/XXX as regards rules for surveillance,
   eradication programmes, and disease-free status for certain listed and emerging diseases
   [document C(2019)4056], in Member States, zones or compartments that have been granted a
   disease free status as provided for in Article 36(4) and Article 37(4) of Regulation (EU)
   2016/429, or Article 83, Article 84 (1) (h) to (m) or Article 84(2)(b) to (g) of Regulation (EU)
   2019/XXX as regards rules for surveillance, eradication programmes, and disease-free
   status for certain listed and emerging diseases [document C(2019)4056].
                                               Article 111
        Disease control measures to be applied when a category B or C disease is confirmed
   The competent authority shall apply the measures laid down in the Articles 58 to 65 of
   Regulation (EU) 2019/XXX as regards rules for surveillance, eradication programmes, and
   disease-free status for certain listed and emerging diseases [document C(2019)4056] in the
   event of confirmation of a category B or C disease in accordance with Article 9(2), (3) or (4)
   of Regulation (EU) 2019/XXX as regards rules for surveillance, eradication programmes,
   and disease-free status for certain listed and emerging diseases [document C(2019)4056] in
   Member States or zones or compartments that have been granted the disease free status as
   provided for in Article 36(4) and Article 37(4) of Regulation (EU) 2016/429, or Article 83,
   Article 84 (1)(h) to (m) or Article 84(2)(b) to (g) of Regulation (EU) 2019/XXX as regards
   rules for surveillance, eradication programmes, and disease-free status for certain listed and
   emerging diseases [document C(2019)4056]:
EN                                                 69                                               EN
 ---pagebreak---                                                   PART IV
                                     FINAL PROVISIONS
                                                    Article 112
                                                      Repeals
   Directive 92/66/EEC, Directive 2001/89/EC, Directive 2003/85/EC and Directive 2005/9415
   as well as the acts adopted on the basis thereof, shall cease to apply with effect from 21 April
   2021.
                                                    Article 113
                                        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
   15
            Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian
            influenza and repealing Directive 92/40/EEC (OJ L 10, 14.1.2006, p. 16).
EN                                                       70                                                 EN
 ---documentbreak---                            EUROPEAN
                           COMMISSION
                                                   Brussels, 17.12.2019
                                                   C(2019) 4057 final
                                                   ANNEXES 1 to 15
                                        ANNEXES
                                           to the
                COMMISSION DELEGATED REGULATION (EU) .../...
   supplementing Regulation (EU) 2016/429 of the European Parliament and the Council
         as regards rules for the prevention and control of certain listed diseases
EN                                                                                   EN
 ---pagebreak---                                               ANNEX I
        CLINICAL EXAMINATIONS, SAMPLING PROCEDURES, DIAGNOSTIC
       METHODS OF CATEGORY A DISEASES AND TRANSPORT OF SAMPLES
                           (as referred to in Article 3 of this Regulation)
   A.     Sampling procedures
   A.1    SAMPLING OF ANIMALS FOR CLINICAL EXAMINATIONS
   1.     Clinical examinations must include, if possible:
          (a)   animals showing clinical signs of category A diseases,
          (b)   animals likely to have recently died from the suspected/confirmed disease
          (c)   animals with epidemiological link to a suspected or confirmed case; and
          (d)   animals that obtained positive or non-conclusive results in previous laboratory
                examinations.
   2.     Animals to examine must be selected at random, in a number large enough to allow
          the detection of the disease, if present, where there are no obvious signs of disease or
          post-mortem lesions suggesting category A diseases.
   3.     The animals to examine and the sampling method must be chosen in accordance with
          the instructions of the competent authority and with the relevant contingency plan as
          referred to in Article 43 of Regulation (EU) 2016/429. The animals to examine and
          the sampling method must take into account the disease profile and:
          (a)   the purpose of the sampling;
          (b)   the listed species kept in the establishment;
          (c)   the number of animals of listed species kept in the establishment;
          (d)   the category of the kept animals;
          (e)   the available production, health and traceability records of the kept animals
                relevant for the investigation;
          (f)   the type of establishment and the husbandry practices;
          (g)   the level of exposure risk:
                (i)    likelihood of exposure to the disease agent or to the vector;
                (ii)   absence of immunisation of the animals due to vaccination or maternal
                       immunity; and
                (iii) history of residence in the establishment.
          (h)   other relevant epidemiological factors.
   4.     The minimum number of animals to examine must be in accordance with the
          instructions of the competent authority and with the relevant contingency plan as
          referred to in Article 43 of Regulation (EU) 2016/429. The minimum number of
          animals to examine must take into account the disease profile and in particular:
          (a)   the expected prevalence in the establishment;
          (b)   the level of confidence desired of the survey results, which in any case must
                not be lower than 95%; and
EN                                                 1                                               EN
 ---pagebreak---             (c)    international standards and available scientific evidence.
   A.2      SAMPLING OF ANIMALS FOR LABORATORY EXAMINATIONS
   1.       Sampling for laboratory examinations must take into account the outcome of the
            clinical examinations referred to in point A.1 and, if possible, must include animals
            referred to in paragraph 1 of point A.1.
   2.       If there are no obvious signs of disease or post-mortem lesions suggesting category A
            diseases, samples must be collected at random in each epidemiological unit of the
            establishment and must allow the detection of the disease, if present.
   3.       The animals to sample, the nature of the samples to collect and the sampling method
            must be in accordance with the instructions of the competent authority and with the
            relevant contingency plan as referred to in Article 43 of the Regulation (EU)
            2016/429. The animals to sample, the nature of the samples to collect and the
            sampling method must take into account the disease profile and the criteria set out in
            paragraph 3 of point A.1.
   4.       The minimum number of animals to sample must be in accordance with the
            instructions of the competent authority and the relevant contingency plan as referred
            to in Article 43 of the Regulation (EU) 2016/429. The minimum number of animals
            to sample must take into account the criteria set out in paragraph 4 of point A.1 and
            the performance of the tests used.
   5.       In the case of wild animals, samples must be collected from animals shot, found dead
            or purposely trapped or must be obtained on the basis of non-invasive methods such
            as salt licks and chewing ropes or baits. The minimum number and the nature of the
            samples must take into account the estimated size of the wild population and the
            relevant criteria set out in paragraph 3 and 4 of point A.1.
   A.3      SAMPLING OF ESTABLISHMENTS FOR VISITS
   1.       The choice of establishments to sample and the sampling method must be in
            accordance with the instructions of the competent authority and with the relevant
            contingency plan as referred to in Article 43 of the Regulation (EU) 2016/429. The
            choice of establishments to sample and the sampling method must take into account
            the disease profile and the criteria set out in paragraph 3 of point A1.
   2.       The minimum number of establishments to visit must be in accordance with the
            instructions of the competent authority and with the relevant contingency plan, as
            referred to in Article 43 of the Regulation (EU) 2016/429.
   B.       Diagnostic methods
   The techniques, reference materials, their standardisation and the interpretation of the results
   of tests carried out using the relevant diagnostic methods for category A diseases must
   comply with Article 6 and Part III of Annex VI to Regulation (EU) xx/xxx as regards rules
   for surveillance, eradication programmes, and disease-free status for certain listed and
   emerging diseases [document C(2019)4056].
   The diagnostic methodology must aim to maximise the sensitivity of the surveillance. In
   certain circumstances this surveillance may include the use of laboratory examinations in
   order to assess previous exposure to disease.
EN                                                   2                                              EN
 ---pagebreak---    C. Transport of samples
   1. All samples taken to confirm or rule out the presence of a category A disease must be
      sent, with a proper labelling and identification, to an official laboratory which has
      been informed of their arrival. These samples must be accompanied by the
      appropriate forms, in accordance with the requirements established by the competent
      authority and the laboratory receiving the samples. These forms must include at least:
      (a)   the establishment of origin of the sampled animals;
      (b)   information on the species, age and category of the sampled animals;
      (c)   the clinical history of the animals, if available and relevant;
      (d)   the clinical signs and post-mortem findings; and
      (e)   any other relevant information.
   2. All samples must be:
      (a)   stored in watertight and unbreakable containers and packages and in
            accordance with applicable international standards;
      (b)   kept at the most appropriate temperature and other conditions during transport
            taking into account the factors that may affect the sample quality.
   3. The exterior of the package must be labelled with the address of the recipient
      laboratory and the following message must be prominently displayed:
      ‘Animal pathological material; perishable; fragile; do not open outside the
      laboratory of destination.’
   4. The person responsible in the official laboratory receiving the samples must be
      informed in due time of the arrival of the samples.
EN                                           3                                               EN
 ---pagebreak---                                     ANNEX II
                           MONITORING PERIOD
   (as referred to in Articles 8, 17, 27, 32, 48, 57 and 59 of this Regulation)
            Category A diseases                    Monitoring period
     Foot and mouth disease (FMD)                       21 days
     Infection with rinderpest virus
                                                        21 days
     (RP)
     Infection with Rift Valley fever
                                                        30 days
     virus (RVFV)
     Infection with lumpy skin
                                                        28 days
     disease virus (LSD)
     Infection with Mycoplasma
     mycoides subsp. mycoides SC
                                                        45 days
     (Contagious bovine
     pleuropneumonia) (CBPP)
     Sheep pox and goat pox (SPGP)                      21 days
     Infection with peste des petits
                                                        21 days
     ruminants virus (PPR)
     Contagious caprine
                                                        45 days
     pleuropneumonia (CCPP)
     African horse sickness (AHS)                       14 days
     Infection with Burkholderia
                                                       6 months
     mallei (Glanders)
     Classical swine fever (CSF)                        15 days
     African swine fever (ASF)                          15 days
     Highly pathogenic avian
                                                        21 days
     influenza (HPAI)
     Infection with Newcastle disease
                                                        21 days
     virus (NCD)
EN                                        4                                     EN
 ---pagebreak---                                           ANNEX III
      CONDITIONS FOR CERTAIN DEROGATIONS FROM ARTICLE 12(1)(a)
                                   IN EQUINE ANIMALS
                                (as referred to in Article 13(4))
   1.   In the event of an outbreak of African horse sickness the competent authority may
        derogate from Article 12(1)(a) the affected and the unaffected animals, provided that:
        (a)   the affected animals subject to the derogation are isolated in vector-protected
              premises which avoid any transmission of the disease agent from the animals to
              the relevant vectors until 40 days, corresponding to the infective period
              established in the relevant Chapter of the Terrestrial Animal Health Code of the
              World Organisation for Animal Health (OIE), have elapsed after the entry of
              the animals into the vector protected premises; and
        (b)   surveillance, including if needed laboratory examinations, carried out by the
              competent authority, indicates that none of the animals in the vector protected
              premises poses a risk of virus transmission.
   2.   In the event of an outbreak of infection with Burkholderia mallei (Glanders) the
        competent authority may derogate from Article 12(1)(a) the unaffected animals,
        provided that the animals subject to the derogation are quarantined until:
        (a)   the affected animals have been killed and destroyed;
        (b)   after the killing, the cleaning and disinfection of the establishment has been
              completed as provided for in Article 15; and
        (c)   the remaining animals have been subjected to a complement fixation test
              carried with negative result at a serum dilution of 1 in 5 on samples taken at
              least 6 months after the cleaning and disinfection referred to in point (b).
EN                                              5                                              EN
 ---pagebreak---                                                ANNEX IV
       PROCEDURES FOR CLEANING, DISINFECTION AND WHEN NECESSARY
                             CONTROL OF INSECTS AND RODENTS
                (as referred to in Articles 12, 15, 16, 39, 45 and 57 of this Regulation)
   A.       General requirements
   1.       The choice of biocidal products and procedures for cleaning and disinfection
            operations must take into account:
            (a)    the causal agent of infection;
            (b)    the nature of the establishments, vehicles, objects and materials which are to be
                   treated; and
            (c)    the applicable legislation.
   2.       The conditions under which biocidal products are used must ensure that their
            efficacy is not impaired. In particular technical parameters provided by the
            manufacturer, such as pressure, temperature, required contact time or storage must be
            observed. The activity of the disinfectant must not be compromised by interaction
            with other substances.
   3.       Re-contamination of the previously cleaned parts must be avoided, in particular
            where washing is carried out with liquids applied under pressure.
   4.       The water used for cleaning operations must be contained and disposed of in a way
            that avoids any risk of spreading category A disease agents.
   5.       Biocidal products must be used in a way that reduces as much as possible any
            adverse impact on the environment and on public health that may arise from their
            use.
   B.       Preliminary cleaning and disinfection
   For preliminary cleaning and disinfection under Article 15, to avoid spreading the category A
   disease:
   (a)      entire bodies or parts of dead kept animals of listed species must be sprayed with
            disinfectant and removed from the establishment, in closed and leak-proof vehicles
            or containers for processing and disposal;
   (a)      any tissue or blood which may have been spilled during killing, slaughter or post-
            mortem examination must be carefully collected and disposed of;
   (b)      as soon as the entire bodies or parts of dead kept animals of listed species have been
            removed for processing or disposal, the parts of the establishment in which these
            animals were kept and any parts of other buildings, surfaces or equipment
            contaminated during killing or post-mortem examination must be sprayed with
            disinfectant;
   (c)      manure, including litter and used bedding, must be thoroughly soaked with
            disinfectant;
   (d)      the disinfectant must remain on the treated surface for at least 24 hours;
   (e)      equipment, containers, consumption utensils, surfaces or any material likely to be
            contaminated after the washing and disinfecting must be destroyed.
EN                                                   6                                               EN
 ---pagebreak---    C.       Final cleaning and disinfection:
   For final cleaning and disinfection for the purpose of Article 57:
   1.       Manure, including litter and used bedding, must be removed and treated as follows:
            (a)   the solid phase of manure, including litter and used bedding, must either:
                  (i)    undergo a steam treatment at a temperature of at least 70°C;
                  (ii)   be destroyed by burning;
                  (iii) be buried deep enough to prevent access by animals; or
                  (iv) be stacked to heat, sprayed with disinfectant and left for at least 42 days,
                         during which the stack must be either covered or re-stacked to ensure
                         thermic treatment of all layers;
            (b)   the liquid phase of manure must be stored for at least 42 days, and in the case
                  of highly pathogenic avian influenza 60 days, after the last addition of infective
                  material.
   2.       Buildings, surfaces and equipment must be thoroughly washed and cleaned by
            removing the remaining grease and dirt and sprayed with disinfectants.
   3.       After 7 days the establishments must be cleaned and disinfected again.
EN                                                  7                                                EN
 ---pagebreak---                                                  ANNEX V
           MINIMUM RADIUS OF PROTECTION AND SURVEILLANCE ZONES
                              (as referred to in Article 21 of this Regulation)
   Indicated as radius of a circle centred on the establishment
        Category A diseases                   Protection Zone                 Surveillance Zone
   Foot and mouth disease                            3 km                           10 km
   Infection with rinderpest virus                   3 km                           10 km
   Infection with Rift Valley fever
                                                    20 km                           50 km
   virus
   Infection with lumpy skin
                                                    20 km                           50 km
   disease virus
   Infection with Mycoplasma
   mycoides subsp. mycoides SC
                                                Establishment                        3 km
   (Contagious bovine
   pleuropneumonia)
   Sheep pox and goat pox                            3 km                           10 km
   Infection with peste des petits
                                                     3 km                           10 km
   ruminants virus
   Contagious caprine
                                                Establishment                        3 km
   pleuropneumonia
   African horse sickness                          100 km                          150 km
   Infection with Burkholderia
                                                Establishment                   Establishment
   mallei (Glanders)
   Classical swine fever                             3 km                           10 km
   African swine fever                               3 km                           10 km
   Highly pathogenic avian
                                                     3 km                           10 km
   influenza
   Infection with Newcastle
                                                     3 km                           10 km
   disease virus
EN                                                     8                                        EN
 ---pagebreak---                                                                                 ANNEX VI
                                                             PROHIBITIONS IN THE RESTRICTED ZONE
                                                              (as referred to in Article 27 of this Regulation)
 Table: Prohibitions of activities concerning animals of listed species and products from those animals
                                                                                                        RVFV                                                      GLAND
     PROHIBITIONS OF ACTIVITIES CONCERNING ANIMALS AND PRODUCTS
                                                                                            FMD1   RP          LSD   CBPP   SPGP   PPR   CCPP   CSF   ASF   AHS           HPAI   NCD
 Movements of kept animals of listed species from establishments in the restricted           X     X    X      X     X      X      X     X      X     X     X     NA      X      X
 zone
 Movements of kept animals of listed species to establishments in the restricted zone        X     X    X      X     X      X      X     X      X     X     X     NA      X      X
 Restocking of game animals of listed species                                                X     X    X      X     X      X      X     X      X     X     X     NA      X      X
 Fairs, markets, shows and other gatherings of kept animals of listed species including      X     X    X      X     X      X      X     X      X     X     X     NA      X      X
 collection and dispersion of those species
 Movements of semen, oocytes and embryos obtained from kept animals of listed                X     X    X      X*    X      X      X     X      X     X     X     NA      NA     NA
 species from establishments in the restricted zone
 Collection of semen, oocytes and embryo from kept animals of listed species                 X     X    X      X     X      X      X     X      X     X     NP    NA      NA     NA
 Itinerant artificial insemination of kept animals of listed species                         X     X    X      X     X      X      X     X      X     X     X     NA      NA     NA
 1
         Disease abbreviations in accordance with Annex II
 NA = Not applicable
 X = prohibition
 NP = Not prohibited
 * only oocytes and embryo
EN                                                                                   9                                                                                            EN
 ---pagebreak---                                                                                                                                                               GLAND
     PROHIBITIONS OFACTIVITIES CONCERNING ANIMALS AND PRODUCTS (cont.)
                                                                                        FMD2   RP   RVFV   LSD   CBPP   SPGP   PPR   CCPP   CSF   ASF   AHS           HPAI   NCD
 Itinerant natural service of kept animals of listed species                            X      X    X      X     X      X      X     X      X     X     X     NA      NA     NA
 Movements of hatching eggs from establishments in the restricted zone                  NA     NA   NA     NA    NA     NA     NA    NA     NA    NA    NA    NA      X      X
 Movements of fresh meat excluding offal from kept and wild animals of listed species   X      X    X      NP    NP     X      X     NP     X     X     NP    NA      X      X
 from slaughterhouses or game handling establishments in the restricted zone
 Movements of offal from kept and wild animals of listed species from                   X      X    X      X     X      X      X     X      X     X     NP    NA      X      X
 slaughterhouses or game handling establishments in the restricted zone
 Movements of meat products obtained from fresh meat of listed species from             X      X    X      NP    NP     NP     X     NP     X     X     NP    NA      X      X
 establishments in the restricted zone
 Movement of raw milk and colostrum obtained from kept animals of listed species        X      X    X      X     NP     X      X     NP     NA    NA    NP    NA      NA     NA
 from establishments in the restricted zone
 Movement of dairy products and colostrum based products from establishments in the     X      X    X      X     NP     X      X     NP     NA    NA    NP    NA      NA     NA
 restricted zone
 Movement of eggs for human consumption from establishments in the restricted zone      NA     NA   NA     NA    NA     NA     NA    NA     NA    NA    NA    NA      X      X
 Movement of manure, including litter and used bedding from kept animals of listed      X      X    X      X     NP     X      X     NP     X     X     NP    NA      X      X
 species from establishments in the restricted zone
 Movement of hides, skins, wool, bristles and feathers from kept animals of listed      X      X    X      X     NP     X      X     NP     X     X     NP    NA      X      X
 species from establishments in the restricted zone
 Movement of feed material of plant origin and straw obtained in the protection zone*   X      X    NP     NP    NP     NP     NP    NP     NP    NP    NP    NA      NP     NP
 2
         Disease abbreviations in accordance with Annex II
EN                                                                               10                                                                                           EN
 ---pagebreak---                                                                                                        ANNEX VII
                 RISK-MITIGATING TREATMENTS FOR PRODUCTS OF ANIMAL ORIGIN FROM THE RESTRICTED ZONE
                                                                    (as referred to in Articles 27, 33 and 49 of this Regulation)
                                                                                                                                FMD3            RVFV           CBPP   SPGP           CCPP                          HPAI
                                                  Treatment
                                                                                                                                        RP             LSD                    PPR            CSF    ASF     AHS            NCD
 MEAT
                                                                                               4
 Heat treatment in an hermetically sealed container, to achieve a minimum F0 value of 3                                         x                                            X              X       X              X      X
 Heat treatment to achieve a core temperature of 80oC                                                                           X                                            X              X       X              X      X
                                                              o
 Heat treatment to achieve a core temperature of 70 C                                                                           X                                            X              X                      X      X
                                                                                                                         o
 Heat treatment (to meat previously de-boned and defatted) to achieve a core temperature of 70 C
 for a minimum of 30 minutes
                                                                                                                                X                                            X              X
 In an hermetically sealed container, applying 60°C for a minimum of 4 hours                                                    X                                            X              X       X
                                                                               5
 Core temperature of 73,9 °C for a minimum of 0,51 seconds                                                                      X                                                                                  X      X
                                                                           5
 Core temperature of 70,0 °C for a minimum of 3.5 seconds                                                                                                                                                          X      X
                                                                           5
 Core temperature of 65,0 °C for a minimum of 42 seconds                                                                                                                                                           X      X
                                                                       5
 Core temperature of 60 °C for a minimum of 507 seconds                                                                                                                                                            X      X
 Heat treatment to achieve desiccation to maximum values of Aw of 0, 93 and pH of 6
 Heat treatment to achieve a core temperature of 65 oC for a period of time to achieve a minimum
 pasteurisation value of 40
                                                                                                                                                                             X
 3
         Disease abbreviations in accordance with Annex II
 4
         F0 is the calculated killing effect on bacterial spores. An F0 value of 3 means that the coldest point in the product has been heated sufficiently to achieve the same killing effect as 121 oC (250oF) in three minutes with
         instantaneous heating and chilling
 5
         Only for poultry meat
EN                                                                                                             11                                                                                                                   EN
 ---pagebreak---                                                                                                                   FMD6        RVFV         CBPP   SPGP         CCPP                     HPAI
                                                  Treatment                                                                          LSD                 PPR          CSF   ASF   AHS          NCD
                                                                                                                         RP
 MEAT (cont.)
 Natural fermentation and maturation for bone-in meat: minimum 9 months, to achieve maximum values of
                                                                                                                  X                                                   X
 Aw of 0,93 and pH of 6
 Natural fermentation and maturation for de-boned meat: minimum 9 months, to achieve maximum values of
                                                                                                                  X                                                   X     X
 Aw of 0,93 and pH of 6
                                                                                                           7
 Natural fermentation for loins: minimum 140 days to achieve maximum values of Aw of 0,93 and pH of 6                                                                 X     X
                                                                                                           7
 Natural fermentation for hams: minimum 190 days to achieve maximum values of Aw of 0,93 and pH of 6                                                                  X     X
                                                                     7
 Drying after salting Italian style bone-in hams: minimum 313 days                                                                                                    X
                                                               7
 Drying after salting Spanish style bone-in hams and loins :
      Iberian hams: minimum 252 days
      Iberian shoulders: minimum 140 days                                                                        X                                                   X     X
      Iberian loins: minimum 126 days
      Serrano hams: minimum 140 days
 Maturation of carcasses at a minimum temperature of 2°C for a minimum of 24 hours following slaughter                        X
 Removal of offal                                                                                                                    X     X                   X
 CASINGS
 Salting with sodium chloride (NaCl) either dry or as saturated brine (Aw < 0,80), for a continuous period of
                                                                                                                  X                                      X            X     X
 30 days or longer at an ambient temperature of 20oC or above
 Salting with phosphate supplemented salt 86,5 % NaCl, 10.7 % Na2HPO4 and 2,8 % Na3PO4 either dry or as                              SC
 saturated brine (Aw < 0,80) for a continuous period of 30 days or longer at an ambient temperature of 20 oC or   X                  8                   X            X     X
 above
 Salting with sodium chloride (NaCl) minimum 30 days 9
 6
          Disease abbreviations in accordance with Annex II
 7
          Only for porcine animals
 8
          Safe commodity
 9
          Not for bovine, ovine, caprine and porcine casings
EN                                                                                                 12                                                                                                EN
 ---pagebreak---                                                  Treatment
                                                                                                   FMD10   RP   RVFV   LSD   CBPP   SPGP   PPR   CCPP   CSF   ASF   AHS   HPAI   NCD
 CASINGS (cont.)
 Bleaching 11
 Drying 11
 MILK
 Heat treatment (sterilization process) to achieve a minimum F0 value of 3                         X
 Heat treatment UHT (Ultra high temperature): Minimum 132°C for a minimum of 1 second
                                                                                                   X                                       X
 Heat treatment UHT (Ultra high temperature): Minimum 135°C for a suitable holding time            X
 Heat treatment HTST (High temperature short time pasteurisation) if milk pH is lower than 7,
 minimum 72°C for a minimum of 15 seconds
                                                                                                   X                                       X
                                                                                                                             SC                  SC
                                                                                                                             12                  12
 Heat treatment HTST (High temperature short time pasteurisation) if milk pH is 7 or higher,
                                                                                                   X                                       X
 minimum 72°C for a minimum of 15 seconds , applied twice
 Heat treatment HTST (High temperature short time pasteurisation) combined with a physical
 treatment to achieve pH value below 6 for a minimum of 1 hour or to achieve a minimum of 72oC,    X
 combined with desiccation
 Pasteurisation consisting in a single heat treatment with an effect at least equivalent to that
 achieved by applying 72oC for 15 seconds
                                                                                                   X            X      X
 10
         Disease abbreviations in accordance with Annex II
 11
         Not for bovine, ovine, caprine and porcine casings
 12
         Safe commodity
EN                                                                                    13                                                                                               EN
 ---pagebreak---                                  Treatment        HPAI   NCD
 EGGS
 Heat treatment:
    Whole egg:
         o 60,0oC - 188 sec.
         o completely cooked
    Whole egg blends:
         o 60oC - 188 sec.
         o completely cooked
         o 61,1oC - 94 sec.
    Liquid egg white:
         o 55,6oC - 870 sec.                      X
         o 56,7oC - 232 sec.
    Plain or pure egg yolk:
         o 60oC - 288 sec.
    10% salted yolk:
         o 62,2oC - 138 sec.
    Dried egg white:
         o 67oC - 20 hours
         o 54,4oC - 50,4 hours
         o 51,7oC - 73,2 hours
EN                                           14                EN
 ---pagebreak---   Heat treatment:
   Whole egg:
          o 55°C – 2 521 sec.
          o 57°C - 1596 sec.
          o 59°C - 674 sec.
          o completely cooked
   Liquid egg white:
                                 X
          o 55°C – 2 278 sec.
          o 57°C - 986 sec.
          o 59°C – 301 sec.
   10% salted egg yolk:
          o 55°C - 176 sec.
   Dried egg white:
          o 57°C - 54,0 hours
EN                            15   EN
 ---pagebreak---                                                   ANNEX VIII
       RISK-MITIGATING TREATMENTS FOR PRODUCTS NOT OF ANIMAL ORIGIN
                         FROM THE PROTECTION ZONE
                           (as referred to in Articles 36 and 52 of this Regulation)
                                             Treatment
                                                                                           FMD13   RP
     Heat treatment, minimum temperature of 80oC and for a minimum of 10 minutes,
                                                                                  X                X
     steam in a closed chamber
     Storage in package or bales under shelter at premises situated not closer than 2 km to
     the nearest outbreak and releasing from the premises do not take place before at least
                                                                                            X      X
     three months have elapsed following the completion of cleaning and disinfection
     according to Article 15
      13
             Disease abbreviations in accordance with Annex II
EN                                                       16                                             EN
 ---pagebreak---                                         ANNEX IX
        MARKING OF FRESH MEAT FROM THE PROTECTION ZONE
                 (as referred to in Articles 33 and 49 of this Regulation)
   1. The mark to be applied to fresh meat of poultry originating in the protection zone and
      not intended to another Member State pursuant to Article 33(1)(b) must comply with
      the following:
      (a)   shape and content:
            Where 'XY' means the relevant country code provided for in point 6 of Part B
            of Section I of Annex II of Regulation (EC) No 853/2004 and '1234' means the
            approval number of the establishment referred to in point 7 of Part B of Section
            I of Annex II of Regulation (EC) No 853/2004 .
      (b)   dimensions:
            –     'XY' width of 8 mm
            –     '1234' width of 11 mm
            –     width outer diameter of not less than 30 mm
            –     line thickness of square of 3 mm
   2. The mark to be applied to fresh meat intended for treatment in a processing plant
      pursuant to Article 33(2)(a) shall consist in, either:
      (a)   the identification mark provided for in Regulation (EC) No 853/2004 with an
            additional diagonal cross consisting of two straight lines intersecting at the
            centre of the stamp and enabling the information thereon to remain legible; or
      (b)   a single oval stamp, 6,5 cm wide by 4,5 cm high, in which the following
            information must appear in perfectly legible characters:
            –     on the upper part, the full name or ISO code of the Member State in
                  capitals;
            –     in the centre, the approval number of the slaughterhouse;
            –     on the lower part, one of the following sets of initials CE, EC, EF, EG,
                  EK, EY, EO, ES, EU, EB, WE or EZ;
            –     two straight lines crossing at the centre of the stamp in such a way that
                  the information is not obscured;
            –     the letters must be at least 0,8 cm high and the figures at least 1 cm high.
EN                                           17                                                EN
 ---pagebreak---                                                ANNEX X
               DURATION OF THE MEASURES IN THE PROTECTION ZONE
                            (as referred to in Article 39 of this Regulation)
                                                                              Additional period
                                                       Minimum period of        of duration of
                                                      duration of measures       surveillance
               Category A diseases
                                                      in the protection zone   measures in the
                                                           (Article 39(1))     protection zone
                                                                                 (Article 39(3))
   Foot and mouth disease                                     15 days               15 days
   Infection with rinderpest virus                            21 days                9 days
   Infection with Rift Valley fever virus                     30 days               15 days
   Infection with lumpy skin disease virus                    28 days               17 days
   Infection with Mycoplasma mycoides subsp.
   mycoides SC (Contagious bovine                             45 days           Not applicable
   pleuropneumonia)
   Sheep pox and goat pox                                     21 days                9 days
   Infection with peste des petits ruminants
                                                              21 days                9 days
   virus
   Contagious caprine pleuropneumonia                         45 days           Not applicable
   African horse sickness                                   12 months           Not applicable
   Infection with Burkholderia mallei
                                                             6 months           Not applicable
   (Glanders)
   Classical swine fever                                      15 days               15 days
   African swine fever                                        15 days               15 days
   Highly pathogenic avian influenza                          21 days                9 days
   Infection with Newcastle disease virus                     21 days                9 days
EN                                                  18                                           EN
 ---pagebreak---                                          ANNEX XI
       DURATION OF THE MEASURES IN THE SURVEILLANCE ZONE
                  (as referred to in Articles 55 and 56 of this Regulation)
                                                      Minimum period of duration of
              Category A diseases
                                                     measures in the surveillance zone
   Foot and mouth disease                                          30 days
   Infection with rinderpest virus                                 30 days
   Infection with Rift Valley fever virus                          45 days
   Infection with lumpy skin disease virus                         45 days
   Infection with Mycoplasma mycoides
   subsp. mycoides SC (Contagious bovine                           45 days
   pleuropneumonia)
   Sheep pox and goat pox                                          30 days
   Infection with peste des petits ruminants
                                                                   30 days
   virus
   Contagious caprine pleuropneumonia                              45 days
   African horse sickness                                        12 months
   Infection with Burkholderia mallei
                                                                Not applicable
   (Glanders)
   Classical swine fever                                           30 days
   African swine fever                                             30 days
   Highly pathogenic avian influenza                               30 days
   Infection with Newcastle disease virus                          30 days
EN                                            19                                       EN
 ---pagebreak---                                           ANNEX XII
     SAMPLING PROCEDURES AND DIAGNOSTIC METHODS FOR CATEGORY A
                             DISEASES IN AQUATIC ANIMALS
   1.    The following procedures apply to the clinical examination and collection of
         samples:
         (a)  the clinical examination and the sampling for laboratory examinations must
              include:
              (i)    aquaculture animals of listed species showing clinical signs of the
                     relevant category A disease; and
              (ii)   aquaculture animals likely to have recently                  died    from     the
                     suspected/confirmed category A disease; and
              (iii) aquaculture animals with an epidemiological link to a suspected or
                     confirmed case of a category A disease.
         (b)  the minimum number of samples to be collected is:
                                                               Scenario
                                   Report of    Introduction      Post-mortem or       Suspicion based
                  Type of animals  increased     of infected       clinical signs          on other
                                   mortality      animals            observed           circumstances
                     Molluscs
                    (the whole         30             30                  -                  150
                      animal)
                   Crustaceans         10                                10                  150
                       Fish             -              -                 10                   30
         (c)  the following additional criteria apply to the sampling of molluscs:
              (i)    animals suspected to be infected must be selected for sampling. If listed
                     species are present in the population of animals concerned by the
                     suspicion, those must be selected for sampling;
              (ii)   if weak, gaping or freshly dead but not decomposed molluscs are
                     present, those must be selected first. If such molluscs are not present, the
                     molluscs selected must include the oldest healthy molluscs;
              (iii) if the establishment uses more than one water source for mollusc
                     production, molluscs representing all water sources must be included for
                     sampling to ensure that all parts of the establishment are proportionally
                     represented in the sample;
              (iv) when sampling from a group of mollusc farming establishments which
                     apparently have identical epidemiological status, molluscs from a
                     representative number of sampling points must be included in the
                     sample.
                     The main factors to be considered when selecting those sampling points
                     must be stocking density, water currents, the presence of listed species,
EN                                             20                                                      EN
 ---pagebreak---              both susceptible and vector species, bathymetry and management
             practices. Natural beds within or adjacent to the mollusc farming
             establishment(s) must be included in the sample.
   (d) the following additional criteria apply when sampling crustaceans:
       (i)   if weak or moribund crustaceans of listed species are present in the
             production units, those crustaceans must be selected first. If such animals
             are not present, the crustaceans selected must include crustaceans of
             different year classes, proportionally represented in the sample;
       (ii)  if more than one water source is used for crustacean production,
             crustaceans of listed species representing all water sources must be
             included in the sample to ensure that all parts of the establishment are
             proportionally represented in the sample;
       (iii) when collection of samples from wild populations of listed species is
             required under Article 102(a) of this Regulation, the number and
             geographical distribution of the sampling points must be determined in a
             way that ensures a reasonable coverage of the area suspected to be
             infected.
             The sampling points must be representative for the different ecosystems
             where the wild populations of susceptible species are located such as
             marine, estuary, river and lake systems.
   (e) the following additional criteria apply for sampling fish:
       (i)   if weak, abnormally behaving or freshly dead but not decomposed fish
             are present, those fish must be selected. If such animals are not present,
             the fish selected must include fish of listed species, belonging to
             different year classes, proportionally represented in the sample;
       (ii)  if more than one water source is used for fish production, listed species
             representing all water sources must be included for sampling to ensure
             that all parts of the establishment are proportionally represented in the
             sample;
       (iii) if rainbow trout (Onchorynchus mykiss) or European perch (Perca
             fluviatilis) are present, only fish of those species may be selected for
             sampling. If neither rainbow trout nor European perch are present, the
             sample must be representative of all other listed species present,
             following the criteria in points (a) to (d);
       (iv) when collection of samples from wild populations of listed species is
             required under Article 102(a) of this Regulation, the number and
             geographical distribution of the sampling points must be determined in a
             way that ensures a reasonable coverage of the area suspected to be
             infected.
             The sampling points must also be representative of the different
             ecosystems where the wild populations of susceptible species are located
             such as marine, estuary, river and lake systems.
   (f) the selection of organs to be sampled, preparation, storage and shipment of the
       samples to the laboratory must be carried out in compliance with
EN                                      21                                               EN
 ---pagebreak---             recommendations from the European Union reference laboratory for the
            relevant disease.
   2. Samples must be examined in the laboratory using the diagnostic methods and
      procedures approved by the European Union reference laboratory for the relevant
      disease.
EN                                     22                                             EN
 ---pagebreak---                                                 ANNEX XIII
          MINIMUM PERIODS OF FALLOWING OF AFFECTED AQUACULTURE
                                          ESTABLISHMENTS
   Periods for the fallowing provided for in Article 81 and for the synchronous fallowing
   provided for in Article 96(4) and (5) of this Regulation
                                                             Minimum period of
                                Minimum period of
                                                         synchronised fallowing of       Supplementary
       Category A disease    fallowing of the affected
                                                          affected establishments in       requirements
                                  establishment
                                                          the same protection zone
   Infection with Mikrocytos                                                         Must include the coldest
                                     6 months                      4 weeks
             mackini                                                                    period of the year
    Infection with Perkinsus                                                         Must include the warmest
                                     6 months                       4 weeks
             marinus                                                                    period of the year
      Infection with Taura                                                           Must include the warmest
                                     6 weeks                       4 weeks
         syndrome virus                                                                 period of the year
      Infection with Yellow                                                          Must include the warmest
                                     6 weeks                       3 weeks
      head syndrome virus                                                               period of the year
   Epizootic haematopoietic                                                          Must include the warmest
                                     8 weeks                       4 weeks
             necrosis                                                                   period of the year
EN                                                     23                                                     EN
 ---pagebreak---                                         ANNEX XIV
      CRITERIA FOR ESTABLISHING RESTRICTED ZONES AS REGARDS
                  CATEGORY A DISEASES IN AQUATIC ANIMALS
   1.  Restricted zones as referred to in Article 85 must be defined on a case-by-case basis
       taking into account at least the following factors:
       (a)   the accumulated number, the accumulated percentage and the distribution of
             the mortalities of molluscs/crustaceans/fish in the establishment or group of
             farming establishments infected with category A diseases;
       (b)   relevant information regarding movements to and from the infected
             establishment(s);
       (c)   the distance to and density of neighbouring establishments;
       (d)   the presence of wild aquatic animals;
       (e)   any knowledge concerning mortalities, suspected cases or outbreaks in wild
             aquatic animals which are, or could be related to the specific category A
             disease;
       (f)   the proximity to processing establishments, and the species present at those
             establishments, especially as regards listed species;
       (g)   farming practices applied in the affected and neighbouring establishments;
       (h)   hydrodynamic conditions and other identified factors of epidemiological
             significance.
   2.  For the geographical demarcation of the protection and surveillance zones for
       category A diseases affecting molluscs and crustaceans, the following minimum
       requirements apply:
       (a)   the protection zone must be established in the immediate vicinity of an
             establishment or group of farming establishments officially confirmed as
             infected with a category A disease and must correspond to an area determined
             according to appropriate hydrodynamic and epidemiological data;
       (b)   the surveillance zone must be established outside the protection zone and must
             correspond to an area surrounding the protection zone, determined according to
             appropriate hydrodynamic or epidemiological data.
   3.  For the geographical demarcation of the protection and surveillance zones for
       category A diseases affecting fish, the following minimum requirements must apply:
       (a)   the protection zone must be established around an establishment where
             Epizootic hematopoietic necrosis (EHN) has been confirmed. This zone shall
             correspond:
             (i)   in coastal areas: to 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 in which EHN has been officially confirmed, or an
                   equivalent area determined according to appropriate hydrodynamic or
                   epidemiological data;
             (ii)  in inland areas: to the entire water catchment area of the establishment in
                   which EHN has been officially confirmed. The competent authority may
                   limit the extension of the zone to parts of the water catchment area, or the
EN                                            24                                                EN
 ---pagebreak---              area of the establishment, provided this does not compromise prevention
             of the spread of the disease;
   (b) the surveillance zone must be established by the competent authority outside
       the protection zone and must:
       (i)   in coastal areas: correspond to an area, surrounding the protection zone,
             of overlapping tidal excursion; or an area, surrounding the protection
             zone, and included in a circle of radius 10 km from the centre of the
             protection zone; or an equivalent area determined according to
             appropriate hydrodynamic or epidemiological data;
       (ii)  in inland areas: be an extended area outside the established protection
             zone.
EN                                     25                                              EN
 ---pagebreak---                                                    ANNEX XV
    SURVEILLANCE SCHEME AND DURATION OF CONTROL MEASURES IN THE
        SURVEILLANCE ZONE FOR CATEGORY ADISEASES IN AQUACULTURE
                                                   ANIMALS
                          (as referred to in Articles 98 and 101 of this Regulation)
   1.         Surveillance scheme
   The establishments and groups of aquaculture establishments keeping listed species within a
   surveillance zone must undergo surveillance as provided for in Article 98 to check for
   infection with the relevant category A disease. The surveillance must include health visits,
   including sampling from production units. Those visits must be carried out by the competent
   authority in accordance with Tables 1 and 2.
   The criteria set out in point 1 of Annex XII, as appropriate for the species, apply to sampling.
   Table 1: Scheme for surveillance comprising health visits and samplings in establishments
   and groups of establishments for category A diseases in aquatic animals, except epizootic
   hematopoietic necrosis
                                        Number of                                            Residency period
                      Number of                     Number of
     Category A                         laboratory                  Period of the year for     of the sampled
                     health visits                  animals in
       disease                        examinations                          sampling           animals in the
                       per year                     the sample
                                         per year                                              establishment
                                                                  When the prevalence of
                                                                  infection is known to be
    Infection
                                                                   maximal or April-May,
    with
                          1                  1          150       after 3-4 months period         4 months
    Mikrocytos
                                                                        when seawater
    mackini
                                                                    temperatures are less
                                                                           than 10°C
                                                                  When the prevalence of
    Infection
                                                                  infection is known to be
    with
                          1                  1          150      maximal or in the month          4 months
    Perkinsus
                                                                 of September, October or
    marinus
                                                                           November
    Infection                                                     In the period of the year
    with Taura                                                    when water temperature
                          2                  2          150                                       2 months
    syndrome                                                         is likely to reach its
    virus                                                            highest annual level
    Infection                                                     In the period of the year
    with Yellow                                                   when water temperature
    head                  2                  2          150          is likely to reach its       2 months
    syndrome                                                         highest annual level
    virus
   Table 2: Specific scheme for surveillance comprising health visits and samplings in
   establishments for epizootic haematopoietic necrosis (EHN) in aquatic animals (1)
                                     Number of       Number of     Number of fish in the sample
                  Type of              health        samplings
                                                                     Number of growing      Number of brood
               establishment       inspections per   per year (2
                                                                              fish          stock fish (2)
                                    year (2 years)     years)
                                                                         150 (first and       150 (first or
   (a) Establishments with
                                           2          2              second inspection)          second
   broodstock
                                                                                              inspection)
EN                                                      26                                                    EN
 ---pagebreak---    (b) Establishments with                                                            150 (2) (first or
                                     2              1                     0
   broodstock only                                                                  second inspection)
   (c) Establishments                                         150 (first and second
                                     2              2                                          0
   without broodstock                                              inspection)
                                     Maximum number of fish per pool: 10
   (1)
             The sampling of fish for laboratory examination must be carried out whenever the
             water temperature is between 11 and 20°C. The water temperature requirement must
             also apply to health inspections. In establishments where the water temperature does
             not reach 11°C during the year, sampling and health visits must be carried out when
             the water temperature is at its highest level.
   (2)
             Samples from broodstock must not include gonadal fluids, milt or ova as there is no
             evidence of EHN causing reproductive tract infection.
   2.        Duration of the control measures in the surveillance zone
                                      Minimum periods of
                Category A disease
                                         surveillance
                   Infection with
                                            3 years
                Mikrocytos mackini
                   Infection with
                                            3 years
                Perkinsus marinus
               Infection with Taura
                                            2 years
                  syndrome virus
               Infection with Yellow
                                            2 years
               head syndrome virus
                     Epizootic
                  haematopoietic            2 years
                      necrosis
   When the period of surveillance has elapsed and there has been no new detection of infection
   with the relevant category A disease, the measures in the surveillance zone must be lifted as
   provided for in Article 101 of this Regulation.
EN                                                    27                                                EN