CELEX: 
Language: en
Date: 2015-12-02
Title: Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on transmissible animal diseases and amending and repealing certain acts in the area of animal health ("Animal Health Law")

Council of the
                 European Union
                                                           Brussels, 2 December 2015
                                                           (OR. en)
                                                           11779/15
       Interinstitutional File:
          2013/0136 (COD)
                                                           AGRI 460
                                                           VETER 68
                                                           AGRILEG 165
                                                           ANIMAUX 40
                                                           SAN 268
                                                           CODEC 1161
LEGISLATIVE ACTS AND OTHER INSTRUMENTS
Subject:            Position of the Council at first reading with a view to the adoption of a
                    REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
                    COUNCIL on transmissible animal diseases and amending and repealing
                    certain acts in the area of animal health ("Animal Health Law")
11779/15                                                               AS/NC/ra
                                              DGB 2B                                          EN
 ---pagebreak---                                     REGULATION (EU) 2015/…
                OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
                                                    of
           on transmissible animal diseases and amending and repealing certain acts
                        in the area of animal health ("Animal Health Law")
                                      (Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular
Article 43(2), Article 114 and Article 168(4)(b) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national Parliaments,
Having regard to the opinion of the European Economic and Social Committee 1,
Having regard to the opinion of the Committee of the Regions 2,
Acting in accordance with the ordinary legislative procedure 3,
1
        OJ C,, p..
2
        OJ C,, p..
3
        Position of the European Parliament of 15 April 2014 (not yet published in the Official
        Journal) and position of the Council at the first reading of 14 September 2015 (not yet
        published in the Official Journal). Position of the European Parliament of …(not yet
        published in the Official Journal) and decision of the Council of....
11779/15                                                                 AS/NC/ra                 1
                                                 DGB 2B                                         EN
 ---pagebreak--- Whereas:
(1)     The impact of transmissible animal diseases and the measures necessary to control those
        diseases can be devastating for individual animals, animal populations, animal keepers and
        the economy.
(2)     As recent experiences have demonstrated, transmissible animal diseases may also have a
        significant impact on public health and food safety.
(3)     In addition, adverse interactive effects can be observed with regard to biodiversity, climate
        change and other environmental aspects. Climate change may influence the emergence of
        new diseases, the prevalence of existing diseases and the geographic distribution of disease
        agents and vectors, including those affecting wildlife.
(4)     In order to ensure high standards of animal and public health in the Union and the rational
        development of the agriculture and aquaculture sectors, and to increase productivity,
        animal health rules should be laid down at Union level. Those rules are necessary in order,
        inter alia, to contribute to the completion of the internal market and to avoid the spread of
        infectious diseases. Those rules should also ensure, as far as possible, that the existing
        animal health status in the Union is maintained and that consequent improvement of that
        status is supported.
11779/15                                                                AS/NC/ra                      2
                                               DGB 2B                                              EN
 ---pagebreak--- (5)     The current Union legislation on animal health consists of a series of linked and
        interrelated basic acts that lay down rules on animal health applying to intra–Union trade,
        entry into the Union of animals and products, disease eradication, veterinary controls,
        notification of diseases and financial support in relation to different animal species, but an
        overarching legal framework, laying down harmonised principles across the sector, is
        missing.
11779/15                                                                 AS/NC/ra                      3
                                               DGB 2B                                             EN
 ---pagebreak--- (6)     Financial rules relating to the support of animal health objectives are provided for in
        Regulation (EU) No 652/2014 of the European Parliament and of the Council 1 and do not
        form part of this Regulation. In addition, the rules covering the official controls of animal
        health measures provided for in Regulation (EC) No 882/2004 of the European Parliament
        and of the Council 2 and in Council Directives 89/662/EEC 3, 90/425/EEC 4, 91/496/EEC 5
        and 97/78/EC 6 should be used to regulate official controls in the area of animal health.
1
      Regulation (EU) No 652/2014 of the European Parliament and of the Council of
      15 May 2014 laying down provisions for the management of expenditure relating to the food
      chain, animal health and animal welfare, and relating to plant health and plant reproductive
      material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations
      (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament
      and of the Council, Directive 2009/128/EC of the European Parliament and of the Council
      and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and
      repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC (OJ L 189,
      27.6.2014, p. 1).
2
      Regulation (EC) No 882/2004 of the European Parliament and of the Council of
      29 April 2004 on official controls performed to ensure the verification of compliance with
      feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).
3
      Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in
      intra-Community trade with a view to the completion of the internal market (OJ L 395,
      30.12.1989, p. 13).
4
      Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical
      checks applicable in intra-Community trade in certain live animals and products with a view
      to the completion of the internal market (OJ L 224, 18.8.1990, p. 29).
5
      Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the
      organization of veterinary checks on animals entering the Community from third countries
      and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 24.9.1991,
      p. 56).
6
      Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the
      organisation of veterinary checks on products entering the Community from third countries
      (OJ L 24, 30.1.1998, p. 9).
11779/15                                                                AS/NC/ra                      4
                                               DGB 2B                                             EN
 ---pagebreak--- (7)     This Regulation does not contain provisions which regulate animal welfare. However,
        animal health and welfare are linked: better animal health promotes better animal welfare,
        and vice versa. When disease prevention and control measures are carried out in
        accordance with this Regulation, their effect on animal welfare, understood in the light of
        Article 13 of the Treaty on the Functioning of the European Union (TFEU), should be
        considered in order to spare the animals concerned any avoidable pain, distress or
        suffering. Animal welfare legislation, such as Council Regulations (EC) No 1/2005 1 and
        (EC) No 1099/2009 2, should necessarily continue to apply and should be properly
        implemented. The rules laid down in this Regulation should not duplicate, or overlap with,
        the rules laid down in that legislation.
(8)     The Commission's communication of 19 September 2007 on a new Animal Health Strategy
        for the European Union (2007-2013) where "Prevention is better than cure" aims to
        promote animal health by placing greater emphasis on preventive measures, disease
        surveillance, disease control and research, in order to reduce the incidence of animal
        diseases and minimise the impact of outbreaks when they do occur. It proposes the
        adoption of a single and simplified regulatory framework for animal health seeking
        convergence with international standards while ensuring a firm commitment to high
        standards of animal health.
1
      Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals
      during transport and related operations and amending Directives 64/432/EEC
      and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1).
2
      Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals
      at the time of killing (OJ L 303, 18.11.2009, p. 1).
11779/15                                                                AS/NC/ra                    5
                                               DGB 2B                                          EN
 ---pagebreak--- (9)     The aim of this Regulation is to implement the commitments and visions provided for in
        that Animal Health Strategy, including the "One health" principle, and to consolidate the
        legal framework for a common Union animal health policy through a single, simplified and
        flexible regulatory framework for animal health.
(10)    Animals may suffer from a broad range of infectious or non–infectious diseases. Many
        diseases can be treated, or have an impact only on the individual animal concerned, or do
        not spread to other animals or to humans. On the other hand, transmissible diseases may
        have a broader impact on animal or public health, with effects felt at population level. The
        animal health rules laid down in this Regulation should be limited to those latter diseases
        alone.
(11)    In laying down those animal health rules, it is essential that consideration be given to the
        links between animal health and public health, the environment, food and feed safety,
        animal welfare, food security, economic, social and cultural aspects.
(12)    The Sanitary and Phytosanitary Measures (SPS) Agreement, to which the Union is a party,
        regulates the use of measures necessary to protect human, animal or plant life or health so
        that they do not arbitrarily or unjustifiably discriminate between World Trade Organisation
        (WTO) members. If international standards exist, they are required to be used as a basis for
        Union measures. However, the parties to the SPS Agreement have the right to set their own
        relevant standards, provided that such standards are based on scientific evidence.
11779/15                                                                 AS/NC/ra                    6
                                                DGB 2B                                            EN
 ---pagebreak--- (13)    As regards animal health, the SPS Agreement refers to the standards of the World
        Organisation for Animal Health (OIE) relating to animal health conditions for international
        trade. In order to reduce the risk of trade disruption, Union animal health measures should
        aim at an appropriate level of convergence with OIE standards.
(14)    In specific circumstances where a significant animal or public health risk exists but
        scientific uncertainty persists, Article 5(7) of the SPS Agreement, which has been
        interpreted for the Union in the Commission communication of 2 February 2000 on the
        precautionary principle, allows members of that Agreement to adopt provisional measures
        on the basis of available pertinent information. In such circumstances, the member
        concerned is required to obtain the additional information necessary for a more objective
        assessment of risk and to review the measure accordingly within a reasonable period of
        time.
(15)    The risk assessment on the basis of which the measures under this Regulation are taken
        should be based on the available scientific evidence and undertaken in an independent,
        objective and transparent manner. Due account should also be taken of the opinions of the
        European Food Safety Authority (EFSA) established by Article 22(1) of Regulation (EC)
        No 178/2002 of the European Parliament and of the Council 1.
1
      Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January
      2002 laying down the general principles and requirements of food law, establishing the
      European Food Safety Authority and laying down procedures in matters of food safety
      (OJ L 31, 1.2.2002, p. 1).
11779/15                                                                AS/NC/ra                    7
                                                DGB 2B                                          EN
 ---pagebreak--- (16)    Regulation (EC) No 1069/2009 of the European Parliament and the Council 1 lays down
        both public and animal health rules for certain animal by–products and derived products in
        order to prevent and minimise risks to public and animal health arising from those
        products, and in particular to protect the safety of the food and feed chain. In order to avoid
        any overlap of Union legislation, this Regulation should therefore only apply to animal
        by-products and derived products where specific rules are not laid down in Regulation
        (EC) No 1069/2009, and where an animal health risk is involved. For instance, Regulation
        (EC) No 1069/2009 does not regulate how to handle animal by–products and derived
        products in the context of disease control measures, and so those issues are duly covered
        by this Regulation.
1
      Regulation (EC) No 1069/2009 of the European Parliament and the Council of 21 October
      2009 laying down health rules as regards animal by–products and derived products not
      intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal
      by-products Regulation) (OJ L 300, 14.11.2009, p. 1).
11779/15                                                                AS/NC/ra                      8
                                               DGB 2B                                             EN
 ---pagebreak--- (17)    In addition, specific rules on transmissible animal diseases, including those transmissible
        to humans ("zoonoses"), are already laid down in Regulation (EC) No 999/2001 of the
        European Parliament and of the Council 1, Directive 2003/99/EC of the European
        Parliament and of the Council 2 and Regulation (EC) No 2160/2003 of the European
        Parliament and of the Council 3, and specific rules on communicable diseases in humans
        are laid down in Decision No 1082/2013/EU of the European Parliament and of the
        Council 4. Those acts should remain in force following the adoption of this Regulation.
        Accordingly, in order to avoid any overlap of Union legislation, this Regulation should
        only apply to zoonoses to the extent that specific rules are not already laid down in those
        other Union acts. In addition, this Regulation applies without prejudice to the rules
        provided for in other Union legislative acts, such as in the fields of veterinary medicine and
        animal welfare.
1
      Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May
      2001 laying down rules for the prevention, control and eradication of certain transmissible
      spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).
2
      Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003
      on the monitoring of zoonoses and zoonotic agents, amending Council Decision
      90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31).
3
      Regulation (EC) No 2160/2003 of the European Parliament and of the Council of
      17 November 2003 on the control of salmonella and other specified food–borne zoonotic
      agents (OJ L 325, 12.12.2003, p. 1).
4
      Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October
      2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC
      (OJ L 293, 5.11.2013, p. 1).
11779/15                                                                 AS/NC/ra                    9
                                               DGB 2B                                            EN
 ---pagebreak--- (18)    Diseases occurring in animals which are kept by humans can have severe impacts on the
        agriculture and aquaculture sectors, on public health, on the environment and on
        biodiversity. However, as such animals are kept by humans, disease prevention and control
        measures are often easier to apply to them than to wild animals.
(19)    Nevertheless, diseases occurring in wild animal populations may have a detrimental effect
        on the agriculture and aquaculture sectors, on public health, on the environment and on
        biodiversity. It is therefore appropriate that the scope of this Regulation should, in such
        cases, cover wild animals, both as potential victims of those diseases and as their vectors.
        For the purposes of this Regulation, the term 'wild animals' covers all animals that are not
        kept by humans, including stray and feral animals, even if they are of species that are
        normally domesticated.
(20)    Animal diseases are not only transmitted through direct contact between animals or
        between animals and humans. They are also carried further afield through water and air
        systems, vectors such as insects, or the semen, oocytes and embryos used in artificial
        insemination, oocyte donation or embryo transfer. Disease agents may also be contained in
        food and other products of animal origin such as leather, fur, feathers, horn and any other
        material derived from the body of an animal. Moreover, various other objects such as
        transport vehicles, equipment, fodder and hay and straw may diffuse disease agents.
        Therefore, effective animal health rules need to cover all paths of infection and material
        involved therein.
11779/15                                                                  AS/NC/ra                  10
                                                DGB 2B                                            EN
 ---pagebreak--- (21)    Animal diseases may have detrimental effects on the distribution of animal species in the
        wild, and thus affect biodiversity. Microorganisms causing such animal diseases can
        therefore be considered as invasive alien species within the framework of the United
        Nations Convention on Biological Diversity. The measures provided for in this Regulation
        also take account of biodiversity and thus this Regulation should cover animal species and
        disease agents, including those defined as invasive animal species, which play a role in the
        transmission of, or are affected by, diseases covered by this Regulation.
(22)    Union legislation adopted prior to this Regulation lays down separate animal health rules
        for terrestrial and aquatic animals. Council Directive 2006/88/EC 1 lays down specific rules
        for aquatic animals. Yet in most cases, the main principles for good animal health
        governance and good animal husbandry are applicable to both groups of animal species.
        Accordingly, this Regulation should cover both terrestrial and aquatic animals and should
        align those animal health rules where applicable. However, for certain aspects, in particular
        the registration and approval of establishments and the traceability and movements of
        animals within the Union, this Regulation adheres to the approach adopted in the past,
        which was to lay down different sets of animal health rules for terrestrial and aquatic
        animals due to their different environments and accordingly different requirements to
        safeguard health.
1
      Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for
      aquaculture animals and products thereof, and on the prevention and control of certain
      diseases in aquatic animals (OJ L 328, 24.11.2006, p 14).
11779/15                                                               AS/NC/ra                    11
                                               DGB 2B                                           EN
 ---pagebreak--- (23)    Union legislation adopted prior to this Regulation, and in particular Council
        Directive 92/65/EEC 1, also lays down basic animal health rules for other animal species
        not regulated in other Union acts, such as reptiles, amphibians, marine mammals, and
        others which are not aquatic or terrestrial animals as defined in this Regulation. Usually,
        such species do not present a significant health risk for humans or other animals and
        therefore only a few animal health rules, if any, apply. In order to avoid unnecessary
        administrative burdens and costs, this Regulation should adhere to the approach adopted in
        the past, namely to provide the legal framework enabling detailed animal health rules to be
        laid down for movements of such animals and their products if the risks involved so
        require.
(24)    Humans often keep certain animals as pets in their households to keep them company. The
        keeping of such pet animals for purely private purposes, including ornamental aquatic
        animals in households, both indoors and outdoors, generally poses a lower health risk
        compared to other ways of keeping or moving animals on a broader scale, such as those
        common in agriculture, aquaculture, animal shelters and the transport of animals more
        generally. Therefore, it is not appropriate that the general requirements concerning
        registration, record keeping and movements within the Union should apply to such pet
        animals, as this would represent an unjustified administrative burden and cost. Registration
        and record keeping requirements should therefore not apply to pet keepers. In addition,
        specific rules should apply to non–commercial movements of pet animals within the
        Union.
1
      Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements
      governing trade in and imports into the Community of animals, semen, ova and embryos not
      subject to animal health requirements laid down in specific Community rules referred to in
      Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).
11779/15                                                                 AS/NC/ra                   12
                                               DGB 2B                                            EN
 ---pagebreak--- (25)    Some defined groups of animals, for which special animal health rules exist in this
        Regulation, need to be listed as species in an annex, due to the varied nature of the group
        concerned. This is the case for the group of hoofed mammals classified as ungulates. The
        list of such animals may need to be changed in the future due to reasons of changed
        taxonomy. Therefore, in order to take account of such changes, the power to adopt acts in
        accordance with Article 290 TFEU should be delegated to the Commission in respect of
        the list of ungulates set out in Annex III to this Regulation.
(26)    Not all transmissible animal diseases can or should be prevented and controlled through
        regulatory measures, for example if the disease is too widespread, if diagnostic tools are
        not available, or if the private sector can take measures to control the disease by itself.
        Regulatory measures to prevent and control transmissible animal diseases may have
        important economic consequences for the relevant sectors and may disrupt trade. It is
        therefore essential that such measures are applied only when they are proportionate and
        necessary, such as when a disease presents, or is suspected to present, a significant risk to
        animal or public health.
(27)    Furthermore, the preventive and control measures for each transmissible animal disease
        should be "tailor–made" in order to address its unique epidemiological profile, its
        consequences and its distribution within the Union. The preventive and control rules
        applying to each of them should therefore be disease-specific.
11779/15                                                                AS/NC/ra                     13
                                                DGB 2B                                              EN
 ---pagebreak--- (28)    For transmissible animal diseases, a disease condition is usually associated with clinical or
        pathological manifestation of the infection. However, for the purpose of this Regulation,
        which aims to control the spread of, and eradicate, certain transmissible animal diseases,
        the disease definition should be wider in order to include other carriers of the disease
        agent.
(29)    Some transmissible animal diseases do not easily spread to other animals or to humans and
        thus do not cause economic or biodiversity damage on a wide scale. Therefore, they do not
        represent a serious threat to animal or public health in the Union and can thus, if desired,
        be addressed by means of national rules.
(30)    For transmissible animal diseases that are not subject to measures laid down at Union
        level, but which are of some economic importance for the private sector at a local level, the
        latter should, with the assistance of the competent authorities of the Member States, take
        action to prevent or control such diseases, for instance through self–regulatory measures or
        the development of codes of practice.
(31)    In contrast to the transmissible animal diseases described in recitals 29 and 30, highly
        transmissible animal diseases may easily spread across borders and, if they are also
        zoonoses, they may also have an impact on public health and food safety. Hence highly
        transmissible animal diseases and zoonoses should be covered by this Regulation.
11779/15                                                                AS/NC/ra                     14
                                                DGB 2B                                            EN
 ---pagebreak--- (32)    Antimicrobial resistance, understood as the ability of microorganisms to survive or to grow
        in the presence of a concentration of an antimicrobial agent which is usually sufficient to
        inhibit or kill microorganisms of the same species, is increasing. Action No 5 advocated in
        the Communication from the Commission to the European Parliament and the Council
        entitled 'Action plan against the rising threats from Antimicrobial Resistance' emphasises
        the preventive role to be played by this Regulation and the consequent expected reduction
        of the use of antibiotics in animals. This resistance of microorganisms to antimicrobials to
        which they were previously responsive complicates the treatment of infectious diseases in
        humans and animals and may thus pose a threat to human or animal health. As a result,
        microorganisms that have developed resistance to antimicrobials should be treated as if
        they were transmissible diseases, and thus covered by the scope of this Regulation. This
        will enable action to be taken against anti–microbial resistant organisms where appropriate
        and necessary.
11779/15                                                                AS/NC/ra                    15
                                               DGB 2B                                           EN
 ---pagebreak--- (33)    New hazards associated with certain diseases or species may develop in particular due to
        changes in trade patterns, the environment, the climate, animal husbandry and farming
        traditions, but also as a result of social changes. Scientific progress may also lead to new
        knowledge concerning, and increased awareness of, existing diseases. Furthermore,
        diseases and species that are important today may be marginalised in the future. Therefore
        the scope of this Regulation should be broad and the rules laid down should be focused on
        diseases with high public relevance. The OIE has, with the support of the European
        Commission, produced a study on the "Listing and categorisation of priority animal
        diseases, including those transmissible to humans" and a tool for such an exercise, which
        aims to develop a system of disease prioritisation and categorisation. That tool is an
        example of a systematic approach to the collection and assessment of information about
        animal diseases.
(34)    It is necessary to establish a harmonised list of transmissible animal diseases ('listed
        diseases') which pose a risk to animal or public health in the Union, whether across the
        whole Union or only in parts. The five diseases already identified in this Regulation should
        be supplemented by a list of diseases set out in an annex. The Commission should review
        and amend that annex in accordance with a set of criteria. The power to adopt acts
        amending the annex should therefore be delegated to the Commission in accordance with
        Article 290 TFEU.
11779/15                                                                  AS/NC/ra                   16
                                                 DGB 2B                                            EN
 ---pagebreak--- (35)    Diseases with the potential to pose serious risks to public or animal health and to result in
        impacts on health, the economy or the environment may emerge in the future.
        Implementing powers to lay down disease prevention and control measures for such
        emerging diseases should be conferred on the Commission to adopt adequate measures to
        address potential negative consequences of those diseases even if they have not been fully
        assessed in view of their potential listing. Such measures are without prejudice to
        emergency measures and could continue to apply to emerging diseases pending a decision
        on their listing.
(36)    Listed diseases will require different management approaches. Some highly contagious
        diseases which are currently not present in the Union require stringent measures to
        immediately eradicate them as soon as they occur. In cases where such diseases are not
        promptly eradicated and become endemic, a long-term compulsory eradication programme
        will be required. For other diseases that may already be present in parts of the Union,
        compulsory or optional eradication is required. In these cases, it is appropriate to put in
        place restrictions on movements of animals and products, such as a prohibition of
        movements to and from affected areas, or simply to test the animals or products concerned
        prior to dispatch. In other instances it might be appropriate merely to implement a
        programme of surveillance of the distribution of the disease in question, without taking
        further measures.
11779/15                                                                AS/NC/ra                     17
                                                DGB 2B                                            EN
 ---pagebreak--- (37)    Criteria should be laid down to ensure that all relevant aspects are considered when
        determining which transmissible animal diseases should be listed for the purposes of this
        Regulation.
(38)    The rules laid down by this Regulation for the prevention and control of a specific
        transmissible animal disease should apply to species of animals which can transmit the
        disease in question, by virtue of being susceptible to it or by acting as its vector. In order to
        ensure uniform conditions for the implementation of this Regulation, it is necessary to
        establish a harmonised list of species to which the measures for specific listed diseases are
        to apply at Union level ('listed species') and implementing powers to lay down such a list
        should thus be conferred on the Commission.
(39)    The categorisation process should be based on predefined criteria such as the profile of the
        listed disease in question, the level of its impact on animal and public health, animal
        welfare and the economy of the Union, the risk of its spreading and the availability of
        disease prevention and control measures in respect of that listed disease. Implementing
        powers should be conferred on the Commission to lay down which listed diseases are to be
        subject to which rules.
11779/15                                                                 AS/NC/ra                      18
                                                DGB 2B                                              EN
 ---pagebreak--- (40)    Such rules should apply as regards listed diseases that do normally not occur in the Union
        and for which immediate eradication measures need imperatively to be taken as soon as
        they are detected, such as classical swine fever, as regards listed diseases that need to be
        controlled in all Member States with the goal of eradicating them throughout the Union,
        which could include diseases such as brucellosis, as regards listed diseases which are of
        relevance to some Member States and for which measures are needed to prevent them from
        spreading to parts of the Union that are officially free of, or that have eradication
        programmes for that, listed disease, which could include diseases such as infectious bovine
        rhinotracheitis, as regards listed diseases for which measures are needed to prevent them
        from spreading on account of their entry into the Union or movements between Member
        States, which could include diseases such as equine infectious anaemia, and as regards
        listed diseases for which there is a need for surveillance within the Union, which could
        include diseases such as anthrax.
(41)    The disease profile of a given disease may change, as well as the risks associated with the
        disease and other circumstances. For such cases, the implementing powers conferred on the
        Commission should also include the power to modify the category into which a particular
        listed disease falls, and therefore the measures to which it is subject.
(42)    Operators working with animals are in the best position to observe and ensure the health of
        the animals and to monitor products under their responsibility. They should therefore bear
        primary responsibility for carrying out measures for the prevention and control of the
        spread of diseases among animals and the monitoring of products under their
        responsibility.
11779/15                                                                  AS/NC/ra                   19
                                                DGB 2B                                            EN
 ---pagebreak--- (43)    Biosecurity is one of the key prevention tools at the disposal of operators and others
        working with animals to prevent the introduction, development and spread of transmissible
        animal diseases to, from and within an animal population. The role of biosecurity is also
        recognised in the impact assessment for the adoption of this Regulation, in which possible
        impacts are specifically assessed. The biosecurity measures adopted should be sufficiently
        flexible, suit the type of production and the species or categories of animals involved and
        take account of the local circumstances and technical developments. Implementing powers
        should be conferred on the Commission to lay down minimum requirements necessary for
        the uniform application of biosecurity measures in the Member States. Nevertheless, it
        should always remain within the power of operators, Member States or the Commission to
        promote prevention of transmissible diseases through higher biosecurity standards by
        developing their own guides to good practice. While biosecurity may require some upfront
        investment, the resulting reduction in animal disease should be a positive incentive for
        operators.
(44)    Biocidal products, such as disinfectants for veterinary hygiene or food and feed areas,
        insecticides, repellents or rodenticides, play an important role in biosecurity strategies,
        both at farm level and during animal transport. They should therefore be considered part of
        biosecurity.
11779/15                                                                AS/NC/ra                    20
                                               DGB 2B                                              EN
 ---pagebreak--- (45)    Knowledge of animal health, including of disease symptoms, consequences of diseases and
        possible means of prevention including biosecurity, treatment and control, is a prerequisite
        for efficient animal health management and essential in ensuring the early detection of
        animal diseases. Operators and animal professionals should therefore acquire such
        knowledge as appropriate. That knowledge may be acquired by different means, for
        example formal education, but also through the Farm Advisory System existing in the
        agricultural sector or by informal training to which national and Union farmer
        organisations and other organisations may be valuable contributors.
(46)    Veterinarians and aquatic animal health professionals play a crucial role in all aspects of
        animal health management, and general rules concerning their roles and responsibilities
        should be laid down in this Regulation.
(47)    Veterinarians have the education and the professional qualifications attesting to their
        having acquired the knowledge, skills and competencies necessary, inter alia, to diagnose
        diseases and treat animals. In addition, in some Member States for historical reasons, or
        due to the lack of veterinarians dealing with aquatic diseases, there exists a specialised
        profession called "aquatic animal health professionals". These professionals are
        traditionally not veterinarians but they practice aquatic animal medicine. This Regulation
        should therefore respect the decision of those Member States which recognise that
        profession. In those cases, aquatic animal health professionals should have the same
        responsibilities and obligations as veterinarians concerning their specific area of work.
        This approach is in line with the OIE Aquatic Animal Health Code.
11779/15                                                                AS/NC/ra                    21
                                               DGB 2B                                             EN
 ---pagebreak--- (48)    Member States, and in particular their competent authorities responsible for animal health,
        are amongst the key actors in the prevention and control of transmissible animal diseases.
        The competent authority for animal health plays an important role in relation to
        surveillance, eradication, disease control measures, contingency planning and raising
        disease awareness, in the facilitation of animal movements, and in international trade by
        the issuing of animal health certificates. In order to be able to perform their duties under
        this Regulation, Member States depend on having access to adequate financial,
        infrastructural and personnel resources throughout their territories, including laboratory
        capacity and scientific and other relevant know–how.
(49)    The competent authority cannot always perform all the activities required to be carried out
        by them under this Regulation due to limited resources. For that reason, it is necessary to
        provide a legal basis for the delegation of the performance of certain activities to
        veterinarians who are not official veterinarians. For the same reason, Member States
        should also be allowed to authorise natural or legal persons to perform certain activities
        under certain conditions.
(50)    In order to ensure that the necessary conditions are laid down for the general application of
        disease prevention and control measures across the Union, the power to adopt acts in
        accordance with Article 290 TFEU should be delegated to the Commission in respect of
        the delegation of the performance of other activities which the competent authority may
        delegate to veterinarians other than official veterinarians.
11779/15                                                                  AS/NC/ra                   22
                                               DGB 2B                                             EN
 ---pagebreak--- (51)    Optimal animal health management can only be achieved in cooperation with animal
        keepers, operators, veterinarians, animal health professionals, other stakeholders and
        trading partners. In order to secure their support, it is necessary to organise decision-
        making procedures and the application of the measures provided for in this Regulation in a
        clear, transparent and inclusive manner.
(52)    The competent authority should also take appropriate steps to keep the public informed,
        especially when there are reasonable grounds to suspect that animals or products may
        present a risk for animal or public health or when a case is of public interest. In those
        cases, the animals or products concerned may originate from within the Union or enter the
        Union from outside. The latter may also be brought into the Union by persons travelling
        from outside the Union with their personal luggage. Thus, the information provided to
        citizens should also cover the risks involved with such situations.
(53)    In order to avoid the release of disease agents from laboratories, institutes and other
        facilities handling disease agents, it is vital that they take appropriate biosecurity, biosafety
        and bio–containment measures. This Regulation should therefore provide for safety
        measures to be observed during the handling or transportation of such disease agents,
        vaccines and other biological products. The obligation imposed in that regard should also
        apply to any legal or natural person who is involved in such an activity. In order to ensure
        that safety standards are respected in the handling of highly contagious biological agents,
        vaccines and other biological products, the power to adopt acts in accordance with
        Article 290 TFEU should be delegated to the Commission in respect of the safety measures
        in those laboratories, institutes and facilities and for movements of disease agents.
11779/15                                                                   AS/NC/ra                    23
                                                 DGB 2B                                             EN
 ---pagebreak--- (54)    Early detection and a clear chain of disease notification and reporting are crucial for
        effective disease control. In order to achieve an efficient and quick response, Member
        States should ensure that any suspicion or confirmation of an outbreak of certain listed
        diseases should be immediately notified to the competent authority.
(55)    Veterinarians are key actors in the investigation of diseases and a key link between
        operators and the competent authority. They should therefore be notified by the operator
        concerned in cases of abnormal mortalities, other serious disease problems, or significantly
        decreased production rates with an undetermined cause.
(56)    In order to ensure the effective and efficient notification of, and to clarify different
        circumstances related to, abnormal mortalities and other signs of serious diseases, the
        power to adopt acts in accordance with Article 290 TFEU should be delegated to the
        Commission in respect of criteria to determine when relevant circumstances for
        notification occur and to lay down the rules for further investigation, where this is relevant.
(57)    For certain listed diseases, it is vital that a Member State should immediately notify the
        Commission and the other Member States about an outbreak in its territory. Such
        notification will enable neighbouring or other affected Member States to take
        precautionary measures when appropriate.
11779/15                                                                  AS/NC/ra                  24
                                                  DGB 2B                                          EN
 ---pagebreak--- (58)    On the other hand, for some diseases immediate notification and action are not necessary.
        In those cases, the gathering of information and reporting in relation to the occurrence of
        those diseases is essential in order to control the disease situation and where necessary to
        take disease prevention and control measures. This reporting requirement may also apply
        to diseases which are subject to Union-wide notification but where additional information
        is needed for the implementation of effective disease prevention and control measures. In
        order to ensure that the correct information and data needed to prevent the spread or to
        control each particular disease are collected in the right timeframe, the power to adopt acts
        in accordance with Article 290 TFEU should be delegated to the Commission concerning
        the matters to be reported.
(59)    A key purpose of disease notification and reporting is to generate reliable, transparent and
        accessible epidemiological data. A computerised interactive information system for the
        effective collection and management of surveillance data should be established at Union
        level for listed diseases and, when relevant, for emerging diseases or antimicrobial-
        resistant pathogens. That system should promote optimal data availability, facilitation of
        data exchange, and reduction of administrative burdens for the competent authorities of the
        Member States by merging disease notification and reporting within the Union and at
        international level into a single process operated through the database of the OIE. Steps
        should also be taken to ensure consistency in exchanges of information in accordance with
        Directive 2003/99/EC.
11779/15                                                                  AS/NC/ra                   25
                                                DGB 2B                                           EN
 ---pagebreak--- (60)    In order to ensure uniform conditions for the implementation of the Union disease
        notification and reporting rules, implementing powers should be conferred on the
        Commission to establish a list of diseases which are subject to Union notification and
        Union reporting rules as provided for in this Regulation and to establish the necessary
        procedures, formats, data and information exchanges regarding disease notification and
        reporting.
(61)    Surveillance is a key element of disease control policy. It should provide for the early
        detection of transmissible animal diseases and efficient notification thereof, thereby
        enabling the sector concerned and the competent authority to implement, where feasible,
        timely disease prevention and control measures, and allowing the disease in question to be
        eradicated. Furthermore, it should supply information on the animal health status of each
        Member State and of the Union, thereby substantiating certification of freedom from
        disease and facilitating trade with third countries.
(62)    Operators observe their animals on a regular basis and are best positioned to detect
        abnormal mortalities or other serious disease symptoms. Operators are therefore the
        cornerstone of any surveillance and essential for the surveillance undertaken by the
        competent authority.
11779/15                                                                AS/NC/ra                  26
                                                DGB 2B                                           EN
 ---pagebreak--- (63)    To ensure close collaboration and exchange of information between operators and
        veterinarians or aquatic animal health professionals, and to supplement the surveillance
        undertaken by operators, establishments should, as appropriate for the type of production
        concerned and other relevant factors, be subject to animal health visits. In order to ensure
        uniform conditions for the carrying-out of animal health visits, implementing powers
        should be conferred on the Commission to lay down minimum requirements.
(64)    It is essential that the competent authority have in place a system of surveillance for the
        listed diseases which are subject to surveillance. This should also apply to emerging
        diseases, where the potential health risks of the disease concerned should be assessed and
        epidemiological data collected for that assessment. In order to ensure the best use of
        resources, information should be collected, shared and used in the most effective and
        efficient manner possible.
(65)    The surveillance methodology, frequency and intensity should be adapted to each specific
        disease and should take into account the specific purpose of the surveillance, the animal
        health status in the zone concerned and any additional surveillance conducted by operators.
        The appropriate epidemiological surveillance actions could range from a simple
        notification and reporting of the occurrence or suspicion of a listed or an emerging disease,
        or other anomalies, such as abnormal mortalities and other signs of disease, to a specific
        and comprehensive surveillance programme, which would normally include additional
        sampling and testing regimes.
11779/15                                                                 AS/NC/ra                   27
                                               DGB 2B                                             EN
 ---pagebreak--- (66)    Depending on the epidemiological profile of a disease and the relevant risk factors, a
        specific surveillance programme comprising defined and structured activities may need to
        be put in place. In such cases, it is appropriate that Member States develop targeted
        surveillance programmes. Where such programmes are relevant for the Union as a whole,
        rules should be laid down providing for harmonised application of such programmes.
(67)    Such programmes should be consistent with Union objectives and therefore coordinated at
        Union level. To that end, they should be submitted to the Commission. Furthermore,
        Member States implementing such specific surveillance programmes should also submit
        regular reports on the results of those programmes to the Commission. In order to ensure
        uniform conditions for the implementation of surveillance programmes, implementing
        powers should be conferred on the Commission to establish a list of diseases subject to
        surveillance programmes and to set up harmonised procedures, formats, data, information
        exchange and criteria to be used for the evaluation of the surveillance programmes.
11779/15                                                               AS/NC/ra                  28
                                                DGB 2B                                         EN
 ---pagebreak--- (68)    It will often be necessary to provide details about the appropriate format of surveillance for
        different diseases, ranging from those diseases where surveillance can be limited to
        activities such as reporting and notification to diseases where an in–depth Union–wide
        specific surveillance programme needs to be established. Therefore, the power to adopt
        acts in accordance with Article 290 TFEU should be delegated to the Commission
        concerning the surveillance design, the criteria to establish the relevance of a disease to be
        subject to a surveillance programme relevant for the Union and for official confirmation of
        outbreaks, the case definitions of the diseases concerned and requirements for surveillance
        programmes in relation to their content, the information to be included in such programmes
        and their period of application.
(69)    Member States that are not free or are not known to be free from listed diseases which are
        subject to eradication measures as provided for in this Regulation should be required to
        establish compulsory eradication programmes to eradicate those diseases where eradication
        is compulsory in the Union.
(70)    On the other hand, there are some diseases which are of Union concern but for which it is
        not necessary to require Member States to eradicate the disease in question. It should be
        open to Member States to establish optional eradication programmes for such diseases if
        they decide that eradication is important for them. Such optional eradication programmes
        would be recognised at Union level and would entail the implementation of certain
        relevant disease control measures. They may also enable the Member State concerned,
        subject to approval by the Commission, to require certain guarantees when receiving
        animals from other Member States or from third countries.
11779/15                                                                 AS/NC/ra                    29
                                               DGB 2B                                             EN
 ---pagebreak--- (71)    In order to ensure uniform conditions for the implementation of disease eradication
        programmes, implementing powers should be conferred on the Commission to lay down
        the procedures for the submission of such programmes, performance indicators, and
        reporting.
(72)    Furthermore, a Member State should have the possibility of declaring the whole of its
        territories, zones or compartments thereof free of one or more of listed diseases which are
        subject to rules on compulsory or optional eradication programmes, in order to be
        protected against the introduction of such listed diseases from other parts of the Union or
        from third countries or territories. A clear harmonised procedure, including the necessary
        criteria for disease–free status, should be established for that purpose. In order to ensure
        uniform conditions for the implementation of the recognition of disease–free status within
        the Union, it is necessary that such a disease–free status be officially approved, and
        implementing powers to approve such status should therefore be conferred on the
        Commission.
(73)    The OIE has introduced the concept of compartmentalisation in the framework of the
        Terrestrial and Aquatic Animal Health Codes ("the OIE Codes"). In Union legislation
        adopted prior to this Regulation, that concept is recognised only for particular animal
        species and diseases specified in specific Union legislation, namely for avian influenza and
        aquatic animal diseases. This Regulation should establish the possibility of using the
        compartment system for other animal species and diseases. In order to lay down the
        detailed conditions and rules for the recognition and approval of compartments and the
        requirements relating to them, the power to adopt acts in accordance with Article 290
        TFEU should be delegated to the Commission.
11779/15                                                                  AS/NC/ra                   30
                                                DGB 2B                                            EN
 ---pagebreak--- (74)    Member States should make their disease–free territories, zones and compartments thereof
        publicly known for the purpose of informing trading partners and facilitating trade.
(75)    In order to lay down the detailed conditions for the recognition of disease–free status, the
        power to adopt acts in accordance with Article 290 TFEU should be delegated to the
        Commission in respect of the criteria and conditions for obtaining such status, the evidence
        needed to substantiate certification of freedom from disease, special disease prevention and
        control measures, including non–vaccination status, where relevant, restrictions,
        information to be provided, derogations, and conditions for the maintenance, suspension,
        withdrawal or restoration of disease–free status.
(76)    In order to ensure uniform conditions for the implementation of procedures to obtain
        disease-free status, implementing powers should be conferred on the Commission to
        establish the listed diseases which may be subject to compartmentalisation and to lay down
        detailed rules on formats for the submission of applications and exchanges of information.
(77)    The presence of an entirely non–immune population of animals, susceptible to certain
        listed diseases, requires permanent disease awareness and preparedness. Contingency plans
        have proved to be a crucial tool for the successful control of disease emergencies in the
        past. In order to ensure the availability of this effective and efficient tool for the control of
        disease emergencies, and that it is sufficiently flexible to adjust to emergency situations,
        implementing powers should be conferred on the Commission to lay down necessary rules
        for the implementation of contingency plans.
11779/15                                                                  AS/NC/ra                      31
                                                DGB 2B                                               EN
 ---pagebreak--- (78)    Past animal health crises have shown the benefits of having specific, detailed and rapid
        procedures for the management of disease emergencies. Those organisational procedures
        should ensure a rapid and effective response and should improve coordination of efforts on
        the part of all parties involved, including in particular the competent authorities and the
        stakeholders. They should also include cooperation with the competent authorities of
        neighbouring Member States and third countries and territories, where feasible and
        relevant.
(79)    To ensure the applicability of contingency plans in real emergency situations, it is essential
        to practise the systems concerned and to test that they are working. To that end, the
        competent authorities of the Member States should carry out simulation exercises, in
        cooperation with the competent authorities of the neighbouring Member States and third
        countries and territories, where feasible and relevant.
(80)    In order to ensure uniform conditions for the implementation of contingency plans and
        simulation exercises, implementing powers should be conferred on the Commission to lay
        down rules for the practical implementation of those plans and exercises.
(81)    Veterinary medicinal products such as vaccines, hyper-immune sera and antimicrobials
        play an important role in the prevention and control of transmissible animal diseases. The
        Impact Assessment for the adoption of this Regulation highlights in particular the
        importance of vaccines as a tool in the prevention, control and eradication of animal
        diseases.
11779/15                                                                 AS/NC/ra                   32
                                                DGB 2B                                            EN
 ---pagebreak--- (82)    However, control strategies for some transmissible animal diseases require prohibition or
        restriction of the use of certain veterinary medicinal products, as their use would hamper
        the effectiveness of those strategies. For example, certain veterinary medicinal products
        may mask the manifestation of a disease, make the detection of a disease agent impossible
        or render a swift and differential diagnosis difficult and thus endanger the correct detection
        of disease.
(83)    However, those control strategies may vary substantially between different listed diseases.
        This Regulation should therefore provide for rules on the use of veterinary medicinal
        products for the prevention and control of certain listed diseases and for harmonised
        criteria to be taken into consideration when determining whether or not to use, and how to
        use, vaccines, hyper–immune sera and antimicrobials. In order to ensure a flexible
        approach and to address the specificities of different listed diseases and the availability of
        effective treatments, the power to adopt acts in accordance with Article 290 TFEU should
        be delegated to the Commission in respect of the restrictions on, prohibitions of or
        obligations to use certain veterinary medicinal products within the framework of the
        control of certain listed diseases. In urgent cases and in order to address emerging risks
        with possibly devastating implications for animal or public health, the economy, society or
        the environment, it should be possible for the measures in this regard to be adopted by
        means of the urgency procedure.
11779/15                                                                 AS/NC/ra                    33
                                                DGB 2B                                             EN
 ---pagebreak--- (84)    Following the conclusions of the expert opinion on vaccine and/or diagnostic banks for
        major animal diseases, steps should also be taken to make it possible for the Union and the
        Member States to establish reserves of antigens, vaccines and diagnostic reagents for listed
        diseases that represent a serious threat to animal or public health. The establishment of a
        Union antigen, vaccine and diagnostic reagent bank would promote attainment of the
        Union's animal health objectives by permitting a quick and effective response when the
        resources of the bank are required, and would represent an efficient use of limited
        resources.
(85)    In order to ensure such a quick and effective response, the power to adopt acts in
        accordance with Article 290 TFEU should be delegated to the Commission in respect of
        the establishment and management of such banks, and safety standards and requirements
        for their operation. However, this Regulation should not provide for the adoption of rules
        on the financing of the disease prevention and control measures, including vaccination.
(86)    Criteria for priority access to the Union antigen, vaccine and diagnostic reagent banks'
        resources should be established in order to ensure their effective distribution in
        emergencies.
11779/15                                                                AS/NC/ra                    34
                                               DGB 2B                                            EN
 ---pagebreak--- (87)    For reasons of security in relation to bio–terrorism and agro–terrorism, certain detailed
        information concerning the Union antigen, vaccine and diagnostic reagent banks should be
        treated as classified information and its publication should be prohibited. As regards the
        same type of information in relation to national vaccine banks, the constitutional
        requirements of different Member States as regards freedom of information should be
        respected while ensuring that the information in question is treated as classified
        information.
(88)    In order to ensure uniform conditions for the management of the Union antigen, vaccine
        and diagnostic reagent banks, implementing powers should be conferred on the
        Commission to lay down detailed rules concerning which biological products are to be
        included in those banks and for which diseases, and detailed rules on the supply, quantities,
        storage, delivery, procedural and technical requirements for antigens, vaccines and
        diagnostic reagents and the frequency and content of submissions of information to the
        Commission.
(89)    In the event of an outbreak of a listed disease considered to represent a high risk to animal
        or public health in the Union, Member States should ensure that immediate disease control
        measures to eradicate the disease in question are taken in order to protect animal and
        public health.
(90)    The competent authority should be responsible for initiating the first investigations to
        confirm or rule out an outbreak of a highly contagious listed disease which is considered to
        represent a high risk to animal or public health in the Union.
11779/15                                                                AS/NC/ra                    35
                                               DGB 2B                                             EN
 ---pagebreak--- (91)    The competent authority should put in place preliminary disease control measures to
        prevent the possible spread of the listed disease, and should undertake an epidemiological
        enquiry.
(92)    As soon as a listed disease is confirmed, the competent authority should take the necessary
        disease control measures, if necessary including the establishment of restricted zones, to
        eradicate and prevent the further spread of that disease.
(93)    The occurrence of a listed disease in wild animals may pose a risk to public health and the
        health of kept animals. Special rules should therefore be laid down, where necessary, for
        measures to control and eradicate diseases in wild animals.
(94)    There may be cases where small populations of certain animals, such as rare breeds and
        species, may be endangered by standard disease control measures in the event of an
        occurrence of a listed disease. The protection of such breeds and species may require
        modified measures to be taken by the competent authority. However, such modification
        should not hamper the overall control of that disease.
11779/15                                                                AS/NC/ra                   36
                                               DGB 2B                                           EN
 ---pagebreak--- (95)    For listed diseases which are not highly contagious and which are subject to compulsory
        rules requiring their eradication, the disease control measures should be implemented in
        such a way as to prevent the spread of the disease in question, in particular to non–infected
        areas. However, those measures may possibly be more limited than, or may be different
        from, those applicable in relation to the most dangerous listed diseases. This Regulation
        should therefore provide for special rules for those less dangerous diseases. Member States
        that have an optional eradication programme in place should also implement such disease
        control measures. In some cases, depending on the disease profile and the epidemiological
        situation, eradication may be a long-term objective, while the short-term aim may be to
        control the disease. However, the level and intensity of disease control measures should be
        proportionate and should take into account the characteristics of the listed disease in
        question, its distribution and its significance for the Member State concerned by it and for
        the Union as a whole.
(96)    In order to ensure the effective application of the disease control measures provided for in
        this Regulation by operators, pet keepers and competent authorities, and taking into
        account the specificities of the disease control measures for particular listed diseases and
        the risk factors involved, the power to adopt acts in accordance with Article 290 TFEU
        should be delegated to the Commission in respect of the detailed disease control measures
        to be implemented in the event of suspicion or confirmation of a listed disease in
        establishments, other locations and restricted zones.
11779/15                                                                AS/NC/ra                     37
                                                DGB 2B                                            EN
 ---pagebreak--- (97)    In order to provide for the possibility for the Commission to adopt special disease control
        measures on a temporary basis in the event that the disease control measures laid down in
        this Regulation are not sufficient or appropriate to address the risk involved, implementing
        powers should be conferred on the Commission concerning the laying down of special
        disease control measures for a limited period of time.
(98)    The registration of certain transporters and establishments keeping terrestrial animals or
        handling germinal products or transporting them is necessary in order to allow the
        competent authority to perform adequate surveillance and to prevent, control and eradicate
        transmissible animal diseases.
(99)    To avoid unjustified administrative burdens and costs, Member States should be able, on a
        limited basis, to exempt from the registration obligation certain types of establishments
        posing a low risk. Implementing powers should be conferred on the Commission in order
        to achieve a harmonised approach to the granting of such exemptions. Such a harmonised
        approach is particularly necessary in order to prevent certain types of establishments from
        being excluded from the registration obligation. This is particularly relevant not only as
        regards those establishments which pose a more than insignificant risk to animal health but
        also as regards establishments which pose a more than insignificant risk to public health.
        An example of such risk is the keeping of animals that live in close contact with, or
        proximity to, humans, such as the breeding of dogs at a level involving a certain continuity
        of activities and a certain degree of organisation with the primary aim of their being sold
        for the purpose of becoming pet animals in households.
11779/15                                                                AS/NC/ra                    38
                                               DGB 2B                                            EN
 ---pagebreak--- (100)   Where a certain type of establishment keeping terrestrial animals or handling or storing
        germinal products poses a particular animal health risk, it should be subject to approval by
        the competent authority.
(101)   To avoid unjustified administrative burdens and costs, particularly to enterprises posing a
        low risk, flexibility should where possible be built into the relevant measures, making it
        possible to adapt the system of registration and approval to local and regional conditions
        and production patterns.
(102)   In some cases, harmonisation of certain conditions for registration or approval across the
        Union is desirable or necessary. For example, germinal products establishments and
        assembly operations should meet certain conditions and should be approved in order to
        comply with international standards, thereby enabling the Union to provide animal health
        guarantees to third countries when trading. Such conditions should also involve
        requirements for specific training or professional qualifications for certain very specific
        establishments or operations (e.g. for embryo collection teams), or even the obligation for
        specific supervision by the competent authority. The Commission should therefore be
        empowered to adopt delegated acts in accordance with Article 290 TFEU concerning those
        detailed requirements, in order to provide for such specific conditions.
(103)   In the interest of reducing administrative burdens, registrations and approvals should,
        where possible, be integrated into a registration or approval system which the Member
        State concerned may already have established for other purposes.
11779/15                                                                 AS/NC/ra                   39
                                               DGB 2B                                             EN
 ---pagebreak--- (104)   Operators have first–hand knowledge of the animals under their care. They should
        therefore maintain up–to–date records of information which is relevant for assessing the
        animal health status, for traceability and for an epidemiological enquiry in the event of the
        occurrence of a listed disease. Those records should be easily accessible to the competent
        authority.
(105)   In order to ensure the availability of up–to–date information concerning registered
        establishments and operators and approved establishments, competent authorities should
        establish and keep a register of such establishments and operators. The power to adopt acts
        in accordance with Article 290 TFEU should be delegated to the Commission in respect of
        the detailed information to be included in the register of establishments and operators.
(106)   In order to be approved by the competent authority, an establishment should have to fulfil
        certain requirements. Before granting the approval, the competent authority should have to
        verify by means of an on–site visit whether all requirements have been met. In some cases,
        not all conditions can be met immediately, but the remaining deficiencies do not present a
        significant risk to animal or public health. In such cases, it should be possible for the
        competent authority to grant a conditional approval, followed by another on–site visit to
        verify that progress has been made. In those cases, the competent authority should provide
        the necessary effective guidance to the operators of the establishments concerned, in order
        that the operator in question understands the deficiency and can plan for its successful
        resolution.
11779/15                                                                  AS/NC/ra                  40
                                                DGB 2B                                            EN
 ---pagebreak--- (107)   Efficient traceability is a key element of disease control policy. Identification and
        registration requirements specific to the different species of kept terrestrial animals and
        germinal products should be in place in order to facilitate the effective application of the
        disease prevention and control rules provided for in this Regulation. In addition, it is
        important to provide for the possibility of establishing an identification and registration
        system for species for which such arrangements do not exist at present, or when changing
        circumstances and risks so warrant.
(108)   For certain animal species for which it is important to be able to trace individual animals or
        groups, a physical means of identification should be required. This entails the animal in
        question being physically marked, tagged, microchipped or otherwise identified by means
        of a method which can be seen or detected on or in its body and which cannot easily be
        removed.
(109)   In order to ensure the smooth operation of the identification and registration system and to
        ensure traceability, the power to adopt acts in accordance with Article 290 TFEU should be
        delegated to the Commission in respect of obligations concerning databases, detailed
        identification and registration requirements concerning different animal species, including
        exemptions and conditions for such exemptions, and documents.
11779/15                                                                AS/NC/ra                     41
                                               DGB 2B                                             EN
 ---pagebreak--- (110)   It is appropriate to reduce administrative burdens and costs and to provide for flexibility of
        the system in circumstances where the traceability requirements can be achieved by means
        other than those set out in this Regulation. The Commission should therefore be
        empowered to adopt delegated acts in accordance with Article 290 TFEU concerning
        derogations from the identification and registration requirements.
(111)   In order to ensure uniform conditions for the implementation of the identification and
        registration system and traceability, implementing powers should be conferred on the
        Commission to lay down rules concerning the technical specifications for databases, means
        of identification, documents and formats, and deadlines.
(112)   An important tool for preventing the introduction and spread of a transmissible animal
        disease is the use of restrictions on movements of animals and products that may transmit
        that disease. However, restricting the movement of animals and products may have a
        severe economic impact and may interfere with the operation of the internal market. Such
        restrictions should therefore be applied only where necessary and proportionate to the risks
        involved. This approach is in line with the principles laid down in the SPS Agreement and
        the OIE international standards.
(113)   The general requirements laid down in this Regulation should apply to all animal
        movements, such as the prohibition of the movement of animals from an establishment
        where there are abnormal mortalities or other disease symptoms with an undetermined
        cause or disease prevention requirements during transport.
11779/15                                                               AS/NC/ra                     42
                                               DGB 2B                                            EN
 ---pagebreak--- (114)   The legal framework currently laid down in Union animal health legislation, for the
        movement of terrestrial animals and products lays down harmonised rules primarily for
        such movements between Member States, while leaving it up to the Member States to
        determine the necessary movement requirements within their territory. A comparison
        between the current situation and an option whereby rules for movements within Member
        States would also be harmonised at Union level was set out at length in the impact
        assessment for the adoption of this Regulation. It has been concluded that the current
        approach should be maintained, as complete harmonisation of all movements would be
        very complex and the benefits in terms of the facilitation of movements between Member
        States do not outweigh the negative impact this could have on the ability to control
        diseases.
(115)   For animals that are moved between Member States, a set of basic animal health
        requirements should apply. In particular, animals should not be moved from establishments
        with abnormal mortalities or signs of disease of unknown cause. However, mortalities,
        even if abnormal, which are linked to scientific procedures authorised under Directive
        2010/63/EU of the European Parliament and of the Council 1 and which are not of
        infectious origin related to listed diseases, should not be a reason to prevent movements of
        animals intended for scientific purposes.
1
      Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010
      on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
11779/15                                                                 AS/NC/ra                  43
                                                DGB 2B                                         EN
 ---pagebreak--- (116)   However, this Regulation should provide for flexibility in order to facilitate the movement
        of species and categories of terrestrial animals that pose a low risk in terms of spreading
        listed diseases between Member States. In addition, further possibilities for derogations
        should be provided for in cases where Member States or operators successfully put in place
        alternative risk-mitigating measures such as high levels of biosecurity and effective
        surveillance systems.
(117)   Ungulates and poultry are groups of animal species of high economic significance and are
        subject to specific movement requirements under Union legislation adopted prior to this
        Regulation, namely Council Directive 64/432/EEC 1, Council Directive 91/68/EEC 2,
        Council Directive 2009/156/EC 3, Council Directive 2009/158/EC 4 and, in part, Directive
        92/65/EEC. The main rules governing the movement of animals of those species should be
        laid down in this Regulation. The detailed requirements which largely depend on the
        diseases that may be transmitted by different species or categories of animals should be
        regulated in subsequent Commission acts, taking into account the specificities of the
        diseases, species and categories of animals in question.
1
      Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting
      intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977).
2
      Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing
      intra–Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19).
3
      Council Directive 2009/156/EC of 30 November 2009 on animal health conditions
      governing the movement and importation from third countries of equidae (OJ L 192,
      23.7.2010, p. 1).
4
      Council Directive 2009/158/EC of 30 November 2009 on animal health conditions
      governing intra-Community trade in, and imports from third countries of, poultry and
      hatching eggs (OJ L 343, 22.12.2009, p. 74).
11779/15                                                                AS/NC/ra                    44
                                               DGB 2B                                             EN
 ---pagebreak--- (118)   As assembly operations for ungulates and poultry pose a particularly high risk of disease, it
        is appropriate to limit the number that can be carried out in one movement between
        Member States, and to lay down specific rules in this Regulation to protect the health of
        the animals involved and prevent the spread of transmissible animal diseases. Those
        assembly operations would normally take place in an establishment approved for that
        purpose, or, when permitted by a Member State of origin, the first assembly operation, on
        one means of transport such as a lorry, through the collection of animals from different
        locations in that Member State.
(119)   Depending on the listed diseases and listed species concerned, it is necessary to lay down
        specific animal health requirements for certain animal species other than kept ungulates
        and poultry. Rules for these species were also laid down in the legal framework applicable
        prior to this Regulation and in particular in Directive 92/65/EEC. That Directive lays down
        specific rules for the movement of animal species including bees, bumble bees, apes, dogs
        and cats and this Regulation should therefore provide a legal basis for the adoption of
        delegated and implementing acts laying down specific movement rules for those animal
        species.
11779/15                                                                AS/NC/ra                  45
                                               DGB 2B                                           EN
 ---pagebreak--- (120)   Confined establishments, usually used for the keeping of laboratory animals or zoo
        animals, normally involve a high level of biosecurity and a favourable and well-controlled
        health status, and are subject to fewer movements or to movements solely within the closed
        circuits of those establishments. The status of confined establishments, for which operators
        may apply on a voluntary basis, was first introduced in Directive 92/65/EEC, which lays
        down rules and requirements for approval and movement requirements for approved
        bodies, institutes and centres. The system thereby established enables those establishments
        to exchange animals amongst themselves with fewer movement requirements, at the same
        time providing health guarantees within the circuit of confined establishments.
        Consequently, it has been broadly accepted by the operators and used as a voluntary
        option. It is therefore appropriate in this Regulation to preserve the concept of confined
        establishments and also to lay down rules for movement between those establishments.
(121)   For scientific purposes, such as research or diagnostic purposes, and in particular for those
        authorised in accordance with Directive 2010/63/EU, it may be necessary to move animals
        which do not fulfil the general animal health requirements laid down in this Regulation and
        which represent a higher animal health risk. Those kinds of movements should not be
        prohibited or unduly restricted by this Regulation, as this could impede otherwise
        authorised research activities and delay scientific progress. None the less, it is essential that
        rules be laid down in this Regulation to ensure that movements of those animals take place
        in a safe manner.
11779/15                                                                 AS/NC/ra                      46
                                                DGB 2B                                             EN
 ---pagebreak--- (122)   Movement patterns of circus animals, animals kept in zoos, animals intended for exhibition
        and certain other animals often deviate from the movement patterns of other kept species.
        In adapting Union rules on animal movements specific consideration should be given to
        such animals, taking into account specific risks and alternative risk-mitigation measures.
(123)   In order to ensure that the objectives referred to in recitals 112 to 122 of this Regulation
        are achieved, the power to adopt acts in accordance with Article 290 TFEU should be
        delegated to the Commission concerning disease prevention measures in transport
        operations, specific rules for the movement of certain animal species and special
        circumstances, such as assembly operations or rejected consignments, and special
        requirements or derogations for other types of movements, such as movement for scientific
        purposes.
(124)   In order to ensure the possibility of applying special rules for movements where the usual
        movement rules are not sufficient or appropriate to limit the spread of a certain disease,
        implementing powers should be conferred on the Commission to lay down special
        movement rules for a limited period of time.
(125)   Movements of kept terrestrial animals between Member States should comply with the
        requirements applicable to such movements. In the case of animals of species which
        present a health risk or which are of greater economic importance, they should be
        accompanied by an animal health certificate issued by the competent authority.
11779/15                                                                  AS/NC/ra                   47
                                               DGB 2B                                              EN
 ---pagebreak--- (126)   To the extent technically, practically and financially feasible, there should be recourse to
        technological developments in order to reduce the administrative burdens on operators and
        competent authorities in relation to certification and notification by using information
        technology to replace paper documentation and to facilitate notification procedures, and by
        using such technology as far as possible for multiple purposes.
(127)   In cases where there is no requirement for an animal health certificate to be issued by a
        competent authority, an operator who moves animals to another Member State should issue
        a self–declaration document which confirms that the animals meet the movement
        requirements laid down in this Regulation.
(128)   In order to ensure that the objectives referred to in recitals 125, 126 and 127 of this
        Regulation are achieved, the power to adopt acts in accordance with Article 290 TFEU
        should be delegated to the Commission concerning rules on the content of animal health
        certificates, information obligations, derogations from the animal health certification
        requirements, specific certification rules, and the obligations of official veterinarians to
        conduct appropriate checks before the signing an animal health certificate.
11779/15                                                                  AS/NC/ra                   48
                                               DGB 2B                                              EN
 ---pagebreak--- (129)   Notification of movements of animals and germinal products between Member States, and
        in some cases within the national territories of Member States, is essential in order to
        ensure the traceability of the animals and germinal products concerned, where these
        movements may be linked to a risk of spreading transmissible animal diseases. Such
        movements should therefore be notified and registered by means of an integrated
        computerised veterinary system ("TRACES"). The TRACES system integrates into a
        single architecture the computerised systems provided for in Article 20 of Directive
        90/425/EEC and in Council Decision 92/438/EEC 1 respectively, based on Commission
        Decisions 2003/24/EC 2 and 2004/292/EC 3.
(130)   In order to ensure uniform conditions for the implementation of the rules laid down in this
        Regulation on animal health certification and movement notification, implementing powers
        should be conferred on the Commission to lay down rules concerning the model animal
        health certificates, self–declaration documents, formats and deadlines for movement
        notification for both terrestrial and aquatic animals, germinal products and, where also
        relevant, products of animal origin.
1
      Council Decision 92/438/EEC of 13 July 1992 on computerization of veterinary import
      procedures (Shift project), amending Directives 90/675/EEC, 91/496/EEC, 91/628/EEC and
      Decision 90/424/EEC, and repealing Decision 88/192/EEC (OJ L 243, 25.8.1992, p. 27).
2
      Commission Decision 2003/24/EC of 30 December 2002 concerning the development of an
      integrated computerised veterinary system (OJ L 8, 14.1.2003, p. 44).
3
      Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces
      system and amending Decision 92/486/EEC (OJ L 094, 31.3.2004, p. 63).
11779/15                                                                AS/NC/ra                  49
                                                DGB 2B                                           EN
 ---pagebreak--- (131)   The specific nature of movements of pet animals represents an animal health risk which
        deviates significantly from that of other kept animals. Specific, less stringent rules for such
        movements should therefore be laid down in this Regulation. Such less stringent rules are
        only justified, however, if the pet animal genuinely accompanies its owner during the
        owner's movement, or within a limited period thereafter, and if no more than five pet
        animals as referred to in Part A of Annex I are moved together with their owner at one
        time. In order to ensure that pet animals do not pose a significant risk for the spread of
        transmissible animal diseases, and in order to clarify the exceptional situations in which
        more than five pet animals may accompany the owner, or when the pet animal is to be
        moved within a longer timeframe before or after the owner moves, the power to adopt acts
        in accordance with Article 290 TFEU should be delegated to the Commission in respect of
        the detailed rules for movements of those animals. In order to ensure uniform conditions
        for the implementation of the animal health requirements laid down in this Regulation
        concerning the movements of pet animals, implementing powers should be conferred on
        the Commission to lay down rules concerning the disease prevention and control measures
        to be taken for such movements.
11779/15                                                                AS/NC/ra                     50
                                               DGB 2B                                              EN
 ---pagebreak--- (132)   Wild animals may for various reasons represent an animal and public health risk, for
        example if they are moved into an establishment or from one environment to another
        environment. Appropriate preventive measures for movement of those animals may need
        to be taken to avoid the spread of transmissible animal diseases. In order to ensure that
        wild animals do not pose a significant risk for the spread of transmissible animal diseases,
        the power to adopt acts in accordance with Article 290 TFEU should be delegated to the
        Commission concerning the additional requirements for movements of wild terrestrial
        animals.
(133)   Germinal products can represent a similar risk of spreading transmissible animal diseases
        to live animals. In addition, there are specificities in their production which are related to
        high health demands for breeding animals and which call for stricter or particular animal
        health requirements concerning the donor animals. In order to ensure safe movements of
        germinal products, to maintain their expected high health standard and to take into account
        certain specific uses of such products, the power to adopt acts in accordance with Article
        290 TFEU should be delegated to the Commission concerning the detailed requirements
        for movement of germinal products of certain animal species, special requirements
        applicable to, for example, their movement for scientific purposes, and derogations from
        the animal health certification obligation.
11779/15                                                                   AS/NC/ra                    51
                                                DGB 2B                                             EN
 ---pagebreak--- (134)   Products of animal origin can represent a risk for the spreading of transmissible animal
        diseases. Food safety requirements for products of animal origin laid down in Union
        legislation ensure good hygiene practices and reduce the animal health risks of such
        products. However, for certain types of products, specific animal health measures, such as
        disease control and emergency measures, should be laid down in this Regulation in order
        to ensure that products of animal origin do not spread animal diseases. In order to ensure
        safe movements of products of animal origin in these particular cases, the power to adopt
        acts in accordance with Article 290 TFEU should be delegated to the Commission
        concerning the establishment of detailed rules for movements of products of animal origin
        in relation to disease control measures taken, the obligations in respect of animal health
        certification and derogations from those rules where the risk involved with such
        movements and the risk-mitigation measures in place so permit.
(135)   When Member States take national measures concerning movements of animals and
        germinal products, or decide to take national measures to limit the impact of transmissible
        animal diseases other than listed diseases within their territory, those national measures
        should not interfere with the rules on the internal market laid down in Union legislation. It
        is therefore appropriate to set the framework for such national measures and to ensure that
        they remain within the limits permitted under Union law.
11779/15                                                                 AS/NC/ra                  52
                                                DGB 2B                                           EN
 ---pagebreak--- (136)   The registration and approval of aquaculture establishments is necessary in order to allow
        the competent authority to perform adequate surveillance and to prevent, control and
        eradicate transmissible animal diseases. Directive 2006/88/EC requires all establishments
        which move aquatic animals to be authorised. That system of authorisation should be
        maintained under this Regulation, notwithstanding the fact that, in some official languages
        of the Union, this Regulation uses different terms to refer to the authorisation system from
        those used in Directive 2006/88/EC.
(137)   The slaughter and processing of aquaculture animals which are subject to disease control
        measures may spread transmissible animal diseases, for example as a result of the
        discharge from processing establishments of effluents containing pathogens. It is therefore
        necessary to approve processing establishments which fulfil the risk-mitigation measures
        for such slaughter and processing operations. This Regulation should therefore provide for
        the approval of disease control aquatic food establishments.
(138)   In order to ensure the availability to the public of up–to–date information concerning
        registered and approved establishments, the competent authority should establish and keep
        a register of such establishments. The power to adopt acts in accordance with Article 290
        TFEU should be delegated to the Commission concerning the information to be included in
        registers of aquaculture establishments and the record-keeping requirements for
        aquaculture establishments and transporters.
11779/15                                                                 AS/NC/ra                  53
                                                DGB 2B                                           EN
 ---pagebreak--- (139)   In order to ensure uniform conditions for the implementation of the rules laid down in this
        Regulation concerning the registration and approval of aquaculture establishments and
        disease control aquatic food establishments, record-keeping and registers of
        establishments, implementing powers should be conferred on the Commission to lay down
        rules concerning the information obligations, derogations and other implementing rules in
        that regard.
(140)   As it is not feasible in most cases to individually identify aquatic animals, the keeping of
        records by aquaculture establishments, disease control aquatic food establishments and
        transporters is an essential tool in ensuring the traceability of aquatic animals. Records also
        serve as a valuable tool for the surveillance of the health situation of establishments.
(141)   As in the case of terrestrial animals, it is necessary to lay down harmonised rules on the
        movement of aquatic animals, including rules on animal health certification and movement
        notification.
(142)   Directive 2006/88/EC lays down rules for movements of aquatic animals which apply
        equally to movements within and between Member States. The key determining factor in
        relation to rules on the movement of aquatic animals is the health status, as regards listed
        diseases, of the Member State, zones and compartments of destination.
11779/15                                                                  AS/NC/ra                   54
                                                DGB 2B                                            EN
 ---pagebreak--- (143)   However, Directive 2006/88/EC excludes from its scope wild aquatic animals caught or
        harvested for direct entry into the food chain. By contrast, this Regulation retains them
        within its scope, but excludes them from the definition of aquaculture animals. It should
        therefore provide for possible measures in relation to such aquatic animals where, taking
        into account their proportionality, such measures are justified by the risks involved.
(144)   Consequently, the principle explained in recital 142 should also apply to movements of
        aquatic animals that are not defined as aquaculture animals but are covered by the scope of
        this Regulation. This applies, in particular, to aquatic animals with an unknown or
        confirmed disease positive health status, regardless of their final use. As movements of live
        wild aquatic animals with an unknown or confirmed disease positive health status and
        intended for human consumption may also pose a risk of spreading listed or emerging
        diseases, the same system of rules should also apply to them. This includes those wild
        aquatic animals, harvested or caught for human consumption, which are moved and
        temporarily kept while awaiting slaughter.
(145)   However, disproportionate movement restrictions and unnecessary administrative burdens
        for establishments and operators within the commercial fisheries sector should be avoided.
        Consequently, in cases where such live wild aquatic animals are intended for human
        consumption, the rules in question should in principle apply only to movements of live
        wild aquatic animals which pose a significant risk of spreading listed or emerging diseases
        into Member States, zones or compartments which have been declared free of certain listed
        diseases or which are subject to eradication programmes with regard to those diseases.
11779/15                                                                 AS/NC/ra                  55
                                               DGB 2B                                            EN
 ---pagebreak--- (146)   To encourage Member States to enhance the health status of their aquatic populations,
        certain adjustments and added flexibility should be introduced in this Regulation.
(147)   In order to ensure control of the movement of aquatic animals, the power to adopt acts in
        accordance with Article 290 TFEU should be delegated to the Commission concerning the
        disease prevention measures applicable to transport, specific rules applicable to
        movements of certain categories of aquatic animals for different purposes, specific
        requirements or derogations in respect of certain types of movements, such as movements
        for scientific purposes, and additional requirements for movements of wild aquatic
        animals.
(148)   In order to ensure the possibility of temporary derogations and specific requirements for
        movements of aquatic animals, where the movement rules laid down in this Regulation are
        not sufficient or appropriate to limit the spread of a particular listed disease, implementing
        powers should be conferred on the Commission to lay down special movement rules or
        derogations for a limited period of time.
11779/15                                                                  AS/NC/ra                   56
                                                DGB 2B                                            EN
 ---pagebreak--- (149)   Union aquaculture production is extremely diverse as regards species and production
        systems, and this diversification is rapidly increasing. This may require the adoption at
        Member State level of national measures concerning diseases other than those regarded as
        listed diseases in accordance with this Regulation. However, such national measures
        should be justified, necessary and proportionate to the goals to be achieved. Furthermore,
        they should not affect movements between Member States unless they are necessary in
        order to prevent the introduction, or to control the spread, of disease. National measures
        affecting trade between Member States should be approved and regularly reviewed at
        Union level.
(150)   Currently, listed diseases concern animal species other than those defined by this
        Regulation as terrestrial and aquatic species, such as reptiles, amphibians, insects and
        others, only to a very limited extent. It is therefore not appropriate to require that all the
        provisions of this Regulation should apply to those animal species. However, if a disease
        which concerns species other than terrestrial and aquatic species should become listed, the
        relevant animal health requirements of this Regulation should apply to those species, in
        order to ensure that adequate and proportionate disease prevention and control measures
        may be taken.
11779/15                                                                 AS/NC/ra                      57
                                                DGB 2B                                               EN
 ---pagebreak--- (151)   In order to ensure the possibility of laying down movement rules for animals that are not
        defined as terrestrial or aquatic animals by this Regulation, and germinal products and
        products of animal origin deriving from such animals, when a risk so warrants, the power
        to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission
        concerning the registration and approval of establishments, record-keeping and registers,
        identification and registration and traceability movement requirements, animal health
        certification and self–declaration and movement notification obligations in respect of
        animals, germinal products and products of animal origin deriving from those species.
(152)   Whenever necessary in order to ensure uniform conditions for the implementation of the
        animal health requirements for those other animal species and germinal products and
        products of animal origin deriving from them, implementing powers should be conferred
        on the Commission to lay down detailed rules concerning those requirements.
(153)   In order to prevent the introduction of listed diseases and emerging diseases into the
        Union, it is necessary to have in place efficient rules on the entry into the Union of
        animals, germinal products and products of animal origin that may transmit such diseases.
(154)   In order to guarantee the health status of the Union, this Regulation lays down provisions
        concerning movements of animals and products within the Union. It is therefore
        appropriate, so as not to jeopardise that status, to impose conditions for the entry of
        animals and products into the Union that are no less strict than those applicable to
        movements within the Union.
11779/15                                                                 AS/NC/ra                 58
                                                DGB 2B                                          EN
 ---pagebreak--- (155)   In order to ensure that animals, germinal products and products of animal origin from third
        countries or territories fulfil animal health requirements that provide guarantees equivalent
        to those provided for in Union legislation, it is essential that they be subject to appropriate
        controls by the competent authority of the third country or territory from which they are
        exported to the Union. Where relevant, the health status of a third country or territory of
        origin should be verified prior to accepting entry into the Union of such animals, germinal
        products and products of animal origin. Consequently, only third countries and territories
        which can demonstrate that they meet the animal health standards for entry of the animals
        and products into the Union should be eligible to export them to the Union and be listed for
        that purpose.
(156)   For some species and categories of animals, germinal products and products of animal
        origin, the Union lists of third countries and territories from which entry into the Union is
        permitted have not been established in Union acts adopted prior to the date of adoption of
        this Regulation. In those cases, pending the adoption of rules pursuant to this Regulation,
        Member States should be permitted to determine from which countries and territories those
        animals, germinal products and products of animal origin may be permitted to enter their
        territory. In so determining, Member States should take into account the criteria laid down
        in this Regulation for the Union lists of third countries and territories.
11779/15                                                                  AS/NC/ra                    59
                                                DGB 2B                                             EN
 ---pagebreak--- (157)   In order to ensure that the animal health requirements for entry into the Union provided for
        in this Regulation are complied with, and that they are in line with the principles of the
        OIE Codes, all animals, germinal products and products of animal origin entering the
        Union should be accompanied by an animal health certificate issued by the competent
        authority of the third country or territory of origin confirming that all the animal health
        requirements for entry into the Union are complied with. However, deviation from this rule
        should be permitted in respect of commodities which pose a low animal health risk.
(158)   Animal health certificates may stand on their own, but certification is often required in
        Union legislation for other purposes, for example in order to certify that public health or
        animal welfare requirements of animals or products have been complied with. This has to
        be taken into account. In order to minimise administrative burdens and costs, those animal
        health certificates should also be permitted to include information required under other
        Union legislation concerning food and feed safety and animal welfare.
(159)   Diseases may be spread by means other than animals, germinal products, products of
        animal origin and animal by–products and derived products. For instance, vehicles,
        transport containers, hay, straw, plant products, materials that may have been in contact
        with infected animals and equipment may also spread disease. Where necessary, measures
        should be taken to prevent disease transmission by those means.
11779/15                                                                AS/NC/ra                    60
                                                DGB 2B                                             EN
 ---pagebreak--- (160)   In order to ensure the appropriate level of detail for the requirements for entry into the
        Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated
        to the Commission in respect of the adoption of supplementary rules for the approval of
        establishments in third countries and territories and derogations, animal health
        requirements for the entry into the Union of consignments from third countries and
        territories and animal health requirements for disease agents, other materials, means of
        transport and equipment which may transmit animal diseases.
(161)   In order to ensure uniform conditions for the implementation of animal health requirements
        for the entry into the Union of consignments of animals, germinal products and products of
        animal origin, implementing powers should be conferred on the Commission to lay down
        rules on, inter alia, the list of third countries and territories from which the entry into the
        Union of animals, germinal products and products of animal origin is allowed and on the
        contents and format of model animal health certificates.
11779/15                                                                     AS/NC/ra                   61
                                                  DGB 2B                                             EN
 ---pagebreak--- (162)   Past experience has shown that when an outbreak of a serious disease occurs in Member
        States or in third countries or territories from which animals or products enter the Union,
        disease prevention and control measures have to be taken immediately to prevent its
        introduction and limit its spread. Such an emergency may involve listed diseases, emerging
        diseases or other animal health hazards. In that context, it should be made clear which
        disease prevention and control measures provided for by this Regulation may be used in
        the event of the occurrence of a listed or emerging disease or hazard. In all such cases, it is
        essential that measures can be taken at very short notice and without any delay. As such
        measures would restrict movement within or into the Union, they should be implemented
        at Union level whenever possible.
(163)   In order to ensure an effective and quick reaction to emerging risks, implementing powers
        should be conferred on the Commission to lay down emergency measures.
(164)   The Commission should adopt immediately applicable implementing acts in duly justified
        cases relating to, inter alia, measures regarding emerging diseases, the stocking, supply,
        storage, delivery and other procedures of Union antigen, vaccine and diagnostic reagent
        banks, the laying down of special disease control measures and derogations for a limited
        period of time, special rules on movements for terrestrial and aquatic animals applying for
        a limited period of time, emergency measures, and the listing of third countries and
        territories for the purposes of entry into the Union.
11779/15                                                                AS/NC/ra                     62
                                                 DGB 2B                                          EN
 ---pagebreak--- (165)   This Regulation lays down general and specific rules for the prevention and control of
        transmissible animal diseases and ensures a harmonised approach to animal health across
        the Union. In some areas, such as general responsibilities for animal health, notification,
        surveillance, registration and approval or traceability, the Member States should be
        allowed or encouraged to apply additional or more stringent national measures. However,
        such national measures should be permitted only if they do not compromise the animal
        health objectives set out in this Regulation and are not inconsistent with the rules laid
        down herein, and provided that they do not hinder movements of animals and products
        between Member States, unless this is necessary in order to prevent the introduction, or to
        control the spread, of disease.
(166)   The national measures referred to in recital 165 should be subject to a simplified
        notification procedure in order to reduce the administrative burden. Experience has shown
        that the general notification procedure laid down in Directive 98/34/EC of the European
        Parliament and of the Council 1 has been an important tool for guiding and improving the
        quality of national technical regulations – in terms of increased transparency, readability
        and effectiveness – in non–harmonised or partly harmonised areas. It is therefore
        appropriate that this general notification procedure applies.
1
      Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying
      down a procedure for the provision of information in the field of technical standards and
      regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
11779/15                                                                AS/NC/ra                    63
                                                DGB 2B                                            EN
 ---pagebreak--- (167)   Currently, Union rules on animal health are laid down in the following acts of the
        European Parliament and of the Council and in subsequent Commission acts adopted
        pursuant to them:
        Directive 64/432/EEC, Council Directive 77/391/EEC 1, Council Directive 78/52/EEC 2,
        Council Directive 80/1095/EEC 3, Council Directive 82/894/EEC 4, Council Directive
        88/407/EEC 5, Council Directive 89/556/EEC 6, Council Directive 90/429/EEC 7,
1
      Council Directive 77/391/EEC of 17 May 1977 introducing Community measures for the
      eradication of brucellosis, tuberculosis and leucosis in cattle (OJ L 145, 13.6.1977, p. 44).
2
      Council Directive 78/52/EEC of 13 December 1977 establishing the Community criteria for
      national plans for the accelerated eradication of brucellosis, tuberculosis and enzootic
      leukosis in cattle (OJ L 15, 19.1.1978, p. 34).
3
      Council Directive 80/1095/EEC of 11 November 1980 laying down conditions designed to
      render and keep the territory of the Community free from classical swine fever (OJ L 325,
      1.12.1980, p. 1).
4
      Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases
      within the Community (OJ L 378, 31.12.1982, p. 58).
5
      Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements
      applicable to intra–Community trade in and imports of semen of domestic animals of the
      bovine species (OJ L 194, 22.7.1988, p. 10).
6
      Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing
      intra–Community trade in and importation from third countries of embryos of domestic
      animals of the bovine species (OJ L 302, 19.10.1989, p. 1).
7
      Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements
      applicable to intra–Community trade in and imports of semen of domestic animals of the
      porcine species (OJ L 224, 18.8.1990, p. 62).
11779/15                                                                AS/NC/ra                    64
                                              DGB 2B                                            EN
 ---pagebreak---         Directive 91/68/EEC, Council Decision 91/666/EEC 1, Council Directive 92/35/EEC 2,
        Directive 92/65/EEC, Council Directive 92/66/EEC 3, Council Directive 92/118/EEC 4,
        Council Directive 92/119/EEC 5, Council Decision 95/410/EC 6, Council Directive
        2000/75/EC 7, Council Decision 2000/258/EC 8, Council Directive 2001/89/EC 9,
1
      Council Decision 91/666/ EEC of 11 December 1991 establishing Community reserves of
      foot–and–mouth disease vaccines (OJ L 368, 31.12.1991, p. 21).
2
      Council Directive 92/35/EEC of 29 April 1992 laying down control rules and measures to
      combat African horse sickness (OJ L 157, 10.6.1992, p. 19).
3
      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).
4
      Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public
      health requirements governing trade in and imports into the Community of products not
      subject to the said requirements laid down in specific Community rules referred to in Annex
      A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (OJ L
      62, 15.3.1993, p. 49).
5
      Council Directive 92/119/EEC of 17 December 1992 introducing general Community
      measures for the control of certain animal diseases and specific measures relating to swine
      vesicular disease (OJ L 62, 15.3.1993, p. 69).
6
      Council Decision 95/410/EC of 22 June 1995 laying down the rules for testing by sampling
      in the establishment of origin of poultry for slaughter intended for Finland and Sweden (OJ
      L 243, 11.10.1995, p. 25).
7
      Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the
      control and eradication of bluetongue (OJ L 327, 22.12.2000, p. 74).
8
      Council Decision 2000/258/EC of 20 March 2000 designating a specific institute
      responsible for establishing the criteria necessary for standardising the serological tests to
      monitor the effectiveness of rabies vaccines (OJ L 79, 30.3.2000, p. 40).
9
      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).
11779/15                                                                AS/NC/ra                     65
                                               DGB 2B                                             EN
 ---pagebreak---         Council Directive 2002/60/EC 1, Council Directive 2002/99/EC 2, Council Directive
        2003/85/EC 3, Council Regulation (EC) No 21/2004 4, Council Directive 2004/68/EC 5,
        Council Directive 2005/94/EC 6, Directive 2006/88/EC, Council Directive 2008/71/EC 7,
        Directive 2009/156/EC, Directive 2009/158/EC, Regulation (EU) No 576/2013 of the
        European Parliament and of the Council 8.
1
      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).
2
      Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules
      governing the production, processing, distribution and introduction of products of animal
      origin for human consumption (OJ L 18, 23.1.2003, p. 11).
3
      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).
4
      Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the
      identification and registration of ovine and caprine animals and amending Regulation (EC)
      No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8).
5
      Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the
      importation into and transit through the Community of certain live ungulate animals,
      amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (OJ
      L 139, 30.4.2004, p. 321).
6
      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).
7
      Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs
      (OJ L 213, 8.8.2008, p. 31).
8
      Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June
      2013 on the non–commercial movement of pet animals and repealing Regulation (EC) No
      998/2003 (OJ L 178, 28.6.2013, p. 1).
11779/15                                                              AS/NC/ra                  66
                                              DGB 2B                                         EN
 ---pagebreak--- (168)   This Regulation provides for the rules on the identification and registration of bovine
        animals while rules for beef labelling remain outside of its scope. Regulation (EC) No
        1760/2000 of the European Parliament and of the Council 1 provides for the rules on the
        identification and registration of bovine animals and for the rules on beef labelling. It
        should thus be amended to repeal its provisions on the identification and registration of
        bovine animals while those concerning beef labelling would have to remain in force.
(169)   With a view to guaranteeing the reliability of the arrangements provided for in existing
        Regulations establishing systems for the identification and registration of bovine, ovine
        and caprine animals, that legislation requires the Member States to carry out adequate and
        efficient control measures. Such adequate and efficient official control measures should
        also be preserved in the future. As part of the "Smarter rules for safer food" package of
        proposals, this Regulation does not envisage provisions on official controls since those
        rules should be provided for in the framework of the proposed horizontal legislation on
        official controls. However, even if the proposed new horizontal rules on official controls
        were not to enter into force at the same time as this Regulation, the existing horizontal
        rules on official controls would allow the Commission to ensure an equivalent level of
        control.
1
      Regulation (EC) No 1760/2000 of the European Parliament and of the Council of
      17 July 2000 establishing a system for the identification and registration of bovine animals
      and regarding the labelling of beef and beef products and repealing Council Regulation (EC)
      No 820/97 (OJ L 204, 11.8.2000, p. 1).
11779/15                                                                AS/NC/ra                   67
                                               DGB 2B                                             EN
 ---pagebreak--- (170)   The rules laid down in the legislative acts referred to in recital 167 are to be replaced by
        this Regulation and by subsequent Commission acts to be adopted pursuant to this
        Regulation. Accordingly, those legislative acts should be repealed. However, to ensure
        legal clarity and avoid a legal vacuum, the repeal should in the first place take effect only
        when the relevant delegated and implementing acts are adopted pursuant to this
        Regulation. It is therefore necessary to empower the Commission to determine the dates
        when the repeal of those legislative acts is to take effect, while the legislator should set a
        deadline.
11779/15                                                                  AS/NC/ra                     68
                                               DGB 2B                                              EN
 ---pagebreak--- (171)   The following Council acts in the area of animal health are obsolete and should be
        expressly repealed in the interests of clarity of Union legislation: Council Decision
        78/642/EEC 1, Council Directive 79/110/EEC 2, Council Directive 81/6/EEC 3, Council
        Decision 89/455/EEC 4, Council Directive 90/423/EEC 5, Council Decision 90/678/EEC 6,
        Council Directive 92/36/EEC 7, Council Directive 98/99/EC 8.
1
      Council Decision 78/642/EEC of 25 July 1978 on health protection measures in respect of
      the Republic of Botswana (OJ L 213, 3.8.1978, p. 15).
2
      Council Directive 79/110/EEC of 24 January 1979 authorizing the Italian Republic to
      postpone the notification and implementation of its national plans for the accelerated
      eradication of brucellosis and tuberculosis in cattle (OJ L 29, 3.2.1979, p. 24).
3
      Council Directive 81/6/EEC of 1 January 1981 authorizing the Hellenic Republic to
      communicate and to implement its national plans for the accelerated eradication of
      brucellosis and tuberculosis in cattle (OJ L 14, 16.1.1981, p. 22).
4
      Council Decision 89/455/EEC of 24 July 1989 introducing Community measures to set up
      pilot projects for the control of rabies with a view to its eradication or prevention (OJ L 223,
      2.8.1989, p. 19).
5
      Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC
      introducing Community measures for the control of foot–and–mouth disease, Directive
      64/432/EEC on animal health problems affecting intra- Community trade in bovine animals
      and swine and Directive 72/462/EEC on health and veterinary inspection problems upon
      importation of bovine animals and swine and fresh meat or meat products from third
      countries (OJ L 224, 18.8.1990, p. 13).
6
      Council Decision 90/678/EEC of 13 December 1990 recognizing certain parts of the
      territory of the Community as being either officially swine fever free or swine fever free
      (OJ L 373, 31.12.1990, p. 29).
7
      Council Directive 92/36/EEC of 29 April 1992 amending, with regard to African horse
      sickness, Directive 90/426/EEC on animal health conditions governing the movement and
      import from third countries of equidae (OJ L 157, 10.6.1992, p. 28).
8
      Council Directive 98/99/EC of 14 December 1998 amending Directive 97/12/EC amending
      and updating Directive 64/432/EEC on health problems affecting intra–Community trade in
      bovine animals and swine (OJ L 358, 31.12.1998, p. 107).
11779/15                                                                 AS/NC/ra                   69
                                               DGB 2B                                             EN
 ---pagebreak--- (172)   The requirements set out in this Regulation should not apply until the key delegated and
        implementing acts have been adopted by the Commission pursuant to this Regulation,
        allowing a period of 24 months from the adoption of the key acts until the date when they
        start to apply, thus permitting Member States and operators to duly adapt to the new rules.
        In addition, it is appropriate to provide for a period of at least 36 months for the
        Commission to elaborate the new rules.
(173)   In order to ensure legal certainty as regards the application of rules for the identification
        and registration of animals and disease control measures for certain animal diseases and
        zoonoses, the power to adopt acts in accordance with Article 290 TFEU should be
        delegated to the Commission in respect of the date on which Regulation (EC) No 21/2004
        and Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC,
        2005/94/EC and 2008/71/EC are to cease to apply, whilst a deadline in that regard should
        be set in this Regulation.
(174)   In line with the preventive approach to animal health that is promoted by this Regulation,
        the special measures concerning salmonella that applied to live animals dispatched to
        Finland and Sweden prior to … * should continue to apply and Regulation (EC)
        No 2160/2003 should be amended accordingly.
*
      OJ: Please insert the date of the entry into force of this Regulation.
11779/15                                                                   AS/NC/ra                   70
                                                DGB 2B                                              EN
 ---pagebreak--- (175)   Considering the recent adoption of Regulation (EU) No 576/2013, it is desirable to allow
        for a long transitional period before the corresponding rules set out in this Regulation start
        to apply.
(176)   The implementing powers provided for in this Regulation should be exercised in
        accordance with Regulation (EU) No 182/2011 of the European Parliament and of the
        Council 1.
(177)   It is of particular importance that the Commission carry out appropriate consultations
        during its preparatory work, including at expert level. The Commission, when preparing
        and drawing up delegated acts, should ensure a simultaneous, timely and appropriate
        transmission of relevant documents to the European Parliament and to the Council.
(178)   This Regulation should not create a disproportionate administrative burden or economic
        impact for small and medium-sized enterprises. Under this Regulation, based on
        consultation with stakeholders, the special situation of small and medium-sized enterprises
        has been taken into account. A potential universal derogation from the requirements of this
        Regulation for such enterprises has not been considered, in view of the public policy
        objectives of protecting animal health and public health. However, a number of
        derogations for such enterprises should be provided for in relation to the different
        requirements of this Regulation, taking into account the risks involved.
1
      Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16
      February 2011 laying down the rules and general principles concerning mechanisms for
      control by the Member States of the Commission's exercise of implementing powers (OJ L
      55, 28.2.2011, p. 13).
11779/15                                                                AS/NC/ra                    71
                                                DGB 2B                                           EN
 ---pagebreak--- (179)   Since the objectives of this Regulation, namely to lay down animal health rules for
        animals, germinal products, products of animal origin, animal by–products and derived
        products to the extent that they are not covered by specific rules in other Union legislation,
        and other material that may be involved in the spread of transmissible animal diseases,
        cannot be sufficiently achieved by the Member States but can rather be better achieved at
        Union level through a common and coordinated legal framework for animal health, the
        Union may adopt measures, in accordance with the principle of subsidiarity as set out in
        Article 5 of the Treaty on European Union. In accordance with the principle of
        proportionality as set out in that Article, this Regulation does not go beyond what is
        necessary in order to achieve those objectives,
HAVE ADOPTED THIS REGULATION:
11779/15                                                                 AS/NC/ra                   72
                                                DGB 2B                                           EN
 ---pagebreak---                                               PART I
                                    GENERAL RULES
                                             Chapter 1
                     Subject matter, aim, scope and definitions
                                                Article 1
                                        Subject matter and aim
1.      This Regulation lays down rules for the prevention and control of animal diseases which
        are transmissible to animals or to humans.
        Those rules provide for:
        (a)    the prioritisation and categorisation of diseases of Union concern and for the
               establishment of responsibilities for animal health (Part I: Articles 1 to 17);
        (b)    the early detection, notification and reporting of diseases, surveillance, eradication
               programmes and disease–free status (Part II: Articles 18 to 42);
        (c)    disease awareness, preparedness and control (Part III: Articles 43 to 83);
11779/15                                                                 AS/NC/ra                     73
                                                DGB 2B                                             EN
 ---pagebreak---         (d)  the registration and approval of establishments and transporters, movements and
             traceability of animals, germinal products and products of animal origin within the
             Union (Part IV: Articles 84 to 228; and Part: VI Articles 244 to 248 and 252 to 256);
        (e)  the entry of animals, germinal products, and products of animal origin into the Union
             and the export of such consignments from the Union (Part V: Articles 229 to 243;
             and Part VI: Articles 244 to 246 and 252 to 256);
        (f)  non–commercial movements of pet animals into a Member State from another
             Member State or from a third country or territory, (Part VI: Articles 244 to 256);
        (g)  the emergency measures to be taken in the event of a disease emergency situation
             (Part VII: Articles 257 to 262).
2.      The rules referred to in paragraph 1:
        (a)  aim to ensure:
             (i)    improved animal health to support sustainable agricultural and aquaculture
                    production in the Union;
             (ii)   the effective functioning of the internal market;
11779/15                                                              AS/NC/ra                   74
                                              DGB 2B                                           EN
 ---pagebreak---             (iii) a reduction in the adverse effects on animal health, public health and the
                  environment of:
                  –     certain diseases;
                  –     the measures taken to prevent and control diseases;
        (b) take into account:
            (i)   the relationship between animal health and:
                  –     public health;
                  –     the environment, including biodiversity and valuable genetic resources,
                        as well as the impact of climate change;
                  –     food and feed safety;
                  –     animal welfare, including the sparing of any avoidable pain, distress or
                        suffering;
                  –     antimicrobial resistance;
                  –     food security;
            (ii)  the economic, social, cultural and environmental consequences arising from the
                  application of disease control and prevention measures;
            (iii) relevant international standards.
11779/15                                                             AS/NC/ra                    75
                                             DGB 2B                                           EN
 ---pagebreak---                                                Article 2
                                                Scope
1.      This Regulation shall apply to:
        (a)   kept and wild animals;
        (b)   germinal products;
        (c)   products of animal origin;
        (d)   animal by–products and derived products, without prejudice to the rules laid down in
              Regulation (EC) No 1069/2009;
        (e)   facilities, means of transport, equipment and all other paths of infection and material
              involved or potentially involved in the spread of transmissible animal diseases.
2.      This Regulation shall apply to transmissible diseases, including zoonoses, without
        prejudice to the rules laid down in:
        (a)   Decision No 1082/2013/EU;
        (b)   Regulation (EC) No 999/2001;
        (c)   Directive 2003/99/EC;
        (d)   Regulation (EC) No 2160/2003.
11779/15                                                                AS/NC/ra                   76
                                               DGB 2B                                           EN
 ---pagebreak---                                                Article 3
                                      Scope of Parts IV, V and VI
1.      Title I of Part IV (Articles 84 to 171) shall apply to:
        (a)    terrestrial animals, and animals which are not terrestrial animals but which may
               transmit diseases affecting terrestrial animals;
        (b)    germinal products from terrestrial animals;
        (c)    products of animal origin from terrestrial animals.
2.      Title II of Part IV (Articles 172 to 226) shall apply to:
        (a)    aquatic animals, and animals which are not aquatic animals but which may transmit
               diseases affecting aquatic animals;
        (b)    products of animal origin from aquatic animals.
3.      Title III of Part IV (Articles 227 and 228) shall apply to:
        (a)    other animals ;
        (b)    germinal products and products of animal origin from the other animals referred to in
               point (a).
11779/15                                                                 AS/NC/ra                 77
                                                DGB 2B                                          EN
 ---pagebreak--- 4.       Parts IV and V shall not apply to non–commercial movements of pet animals as referred to
         in paragraph 6 of this Article or to non–commercial movements of pet animals within a
         Member State.
5.       Movements of pet animals, other than non–commercial movements, shall comply with the
         animal health requirements laid down in Parts IV and V.
         The Commission shall adopt delegated acts in accordance with Article 264 concerning the
         adaptations which are necessary in order to ensure that Parts IV and V are correctly applied
         to pet animals, in particular to take account of the fact that pet animals are kept in
         households by pet keepers.
6.       Part VI shall only apply to non–commercial movements of pet animals that comply with
         the requirements laid down in Articles 245 and 246 as regards the maximum number of
         animals that may accompany their owner and the maximum number of days elapsing
         between the movement of the owner and the movement of the animal.
                                                 Article 4
                                               Definitions
For the purposes of this Regulation, the following definitions apply:
(1)      'animals' means vertebrate and invertebrate animals;
(2)      'terrestrial animals' means birds, terrestrial mammals, bees and bumble bees;
11779/15                                                                   AS/NC/ra                78
                                                 DGB 2B                                         EN
 ---pagebreak--- (3)     'aquatic animals' means animals of the following species, at all life stages, including eggs,
        sperm and gametes:
        (a)    fish belonging to the superclass Agnatha and to the classes Chondrichthyes,
               Sarcopterygii and Actinopterygii;
        (b)    aquatic molluscs belonging to the phylum Mollusca;
        (c)    aquatic crustaceans belonging to the subphylum Crustacea;
(4)     'other animals' means animals of species other than those falling within the definition of
        terrestrial or aquatic animals;
(5)     'kept animals' means animals which are kept by humans, including, in the case of aquatic
        animals, aquaculture animals;
(6)     'aquaculture' means the keeping of aquatic animals where the animals remain the property
        of one or more natural or legal persons throughout the rearing or culture stages, up to and
        including harvesting, excluding the harvesting or catching for the purposes of human
        consumption of wild aquatic animals which are subsequently temporarily kept while
        awaiting slaughter without being fed;
(7)     'aquaculture animals' means any aquatic animals subject to aquaculture,
(8)     'wild animals' means animals which are not kept animals;
11779/15                                                               AS/NC/ra                     79
                                               DGB 2B                                            EN
 ---pagebreak--- (9)     'poultry' means birds that are reared or kept in captivity for:
        (a)    the production of:
               (i)   meat;
               (ii)  eggs for consumption;
               (iii) other products;
        (b)    restocking supplies of game birds;
        (c)    the purpose of breeding of birds used for the types of production referred to in points
               (a) and (b);
(10)    'captive birds' means any birds other than poultry that are kept in captivity for any reason
        other than those referred to in point (9), including those that are kept for shows, races,
        exhibitions, competitions, breeding or selling;
(11)    'pet animal' means a kept animal of the species listed in Annex I which is kept for private
        non–commercial purposes;
(12)    'pet keeper' means a natural person, and may include a pet owner, keeping a pet animal;
(13)    'pet owner' means a natural person indicated as the owner in the identification document
        referred to in point (c) of Article 247, point (c) of Article 248(2), point (c) of
        Article 249(1) and point (c) of Article 250(2);
11779/15                                                                  AS/NC/ra                   80
                                                DGB 2B                                             EN
 ---pagebreak--- (14)    'non–commercial movement' means any movement of a pet animal accompanying its
        owner and which
        (a)    does not have as its aim either the sale of or another form of transfer of ownership of
               the pet animal concerned; and
        (b)    is part of the movement of the pet owner:
               (i)    either under his direct responsibility; or
               (ii)   under the responsibility of an authorised person, in cases where the pet animal
                      is physically separated from the pet owner;
(15)    'authorised person' means any natural person who has authorisation in writing from the pet
        owner to carry out the non–commercial movement of the pet animal on behalf of the pet
        owner;
(16)    'disease' means the occurrence of infections and infestations in animals, with or without
        clinical or pathological manifestations, caused by one or more disease agents;
(17)    'disease agent' means a pathogen transmissible to animals or to humans which is capable of
        causing a disease in animals;
(18)    'listed diseases' means diseases listed in accordance with Article 5(1);
(19)    'disease profile' means the criteria of a disease referred to in point (a) of Article 7(1);
11779/15                                                                  AS/NC/ra                   81
                                                 DGB 2B                                             EN
 ---pagebreak--- (20)    'listed species' means an animal species or group of animal species listed in accordance
        with Article 8(2), or, in the case of emerging diseases, an animal species or group of
        animal species which meets the criteria for listed species laid down in Article 8(2);
(21)    'hazard' means a disease agent in, or a condition of, an animal or product with the potential
        to have an adverse effect on the health of humans or animals;
(22)    'risk' means the likelihood of the occurrence and the likely magnitude of the biological and
        economic consequences of an adverse effect on animal or public health;
(23)    'biosecurity' means the sum of management and physical measures designed to reduce the
        risk of the introduction, development and spread of diseases to, from and within:
        (a)    an animal population, or
        (b)    an establishment, zone, compartment, means of transport or any other facilities,
               premises or location;
(24)    'operator' means any natural or legal person having animals or products under his
        responsibility, including for a limited duration of time, but excluding pet keepers and
        veterinarians;
(25)    'transporter' means an operator transporting animals on his own account or on account of a
        third party;
11779/15                                                                AS/NC/ra                   82
                                                DGB 2B                                          EN
 ---pagebreak--- (26)    'animal professional' means a natural or legal person having an occupational relationship
        with animals or products, other than operators or veterinarians;
(27)    'establishment' means any premises, structure, or, in the case of open-air farming, any
        environment or place, where animals or germinal products are kept, on a temporary or
        permanent basis, except for:
        (a)   households where pet animals are kept;
        (b)   veterinary practices or clinics;
(28)    'germinal products' means:
        (a)   semen, oocytes and embryos intended for artificial reproduction;
        (b)   hatching eggs;
(29)    'products of animal origin' means:
        (a)   food of animal origin, including honey and blood;
        (b)   live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods,
              intended for human consumption; and
        (c)   animals other than those referred to in point (b) intended to be prepared with a view
              to being supplied live to the final consumer;
11779/15                                                                AS/NC/ra                   83
                                               DGB 2B                                           EN
 ---pagebreak--- (30)    'animal by–products' means entire bodies or parts of animals, products of animal origin or
        other products obtained from animals, which are not intended for human consumption,
        excluding germinal products;
(31)    'derived products' means products obtained from one or more treatments, transformations
        or steps in the processing of animal by–products;
(32)    'products' means:
        (a)    germinal products;
        (b)    products of animal origin;
        (c)    animal by–products and derived products;
(33)    'official control' means any form of control carried out by a competent authority for the
        purpose of verifying compliance with this Regulation;
(34)    'health status' means the disease status as regards the listed diseases relevant for a
        particular listed species with respect to:
        (a)    an animal;
        (b)    animals within:
               (i)   an epidemiological unit;
11779/15                                                                  AS/NC/ra                84
                                                DGB 2B                                          EN
 ---pagebreak---               (ii)   an establishment;
              (iii) a zone;
              (iv) a compartment;
              (v)    a Member State;
              (vi) a third country or territory;
(35)    'zone' means:
        (a)   for terrestrial animals, an area of a Member State, third country or territory with a
              precise geographical delimitation, containing an animal subpopulation with a distinct
              health status with respect to a specific disease or specific diseases subject to
              appropriate surveillance, disease control and biosecurity measures;
        (b)   for aquatic animals, a contiguous hydrological system with a distinct health status
              with respect to a specific disease or specific diseases that forms an area that is
              referred to in one of the following:
              (i)    an entire water catchment from the source of a waterway to the estuary or lake;
              (ii)   more than one water catchment;
11779/15                                                                 AS/NC/ra                   85
                                                DGB 2B                                            EN
 ---pagebreak---               (iii) part of a water catchment from the source of a waterway to a barrier that
                     prevents the introduction of a specific disease or diseases;
              (iv) part of a coastal area with a precise geographical delimitation;
              (v)    an estuary with a precise geographical delimitation;
(36)    'water catchment' means an area or basin of land bounded by natural features such as hills
        or mountains, into which all run–off water flows;
(37)    'compartment' means an animal subpopulation contained in one or more establishments
        and, in the case of aquatic animals, in one or more aquaculture establishments, under a
        common biosecurity management system with a distinct health status with respect to a
        specific disease or specific diseases subject to appropriate surveillance, disease control and
        biosecurity measures;
(38)    'quarantine' means the keeping of animals in isolation with no direct or indirect contact
        with animals outside the epidemiological unit, for the purpose of ensuring that there is no
        spread of one or more specified diseases while the animals in isolation are undergoing
        observation for a specified length of time and, if appropriate, testing and treatment;
(39)    'epidemiological unit' means a group of animals with the same likelihood of exposure to a
        disease agent;
11779/15                                                                 AS/NC/ra                   86
                                               DGB 2B                                            EN
 ---pagebreak--- (40)    'outbreak' means the officially confirmed occurrence of a listed disease or an emerging
        disease in one or more animals in an establishment or other place where animals are kept
        or located;
(41)    'restricted zone' means a zone in which restrictions on the movements of certain animals or
        products and other disease control measures are applied, with a view to preventing the
        spread of a particular disease into areas where no restrictions are applied; a restricted zone
        may, when relevant, include protection and surveillance zones;
(42)    'protection zone' means a zone around and including the location of an outbreak, where
        disease control measures are applied in order to prevent the spread of the disease from that
        zone;
(43)    'surveillance zone' means a zone which is established around the protection zone, and
        where disease control measures are applied in order to prevent the spread of the disease
        from the protection zone;
(44)    'hatching eggs' means eggs, laid by poultry or captive birds, intended for incubation;
(45)    'ungulates' means the animals listed in Annex III;
(46)    'germinal product establishment' means:
        (a)    in relation to semen, an establishment where semen is collected, produced, processed
               or stored;
11779/15                                                                AS/NC/ra                     87
                                                DGB 2B                                             EN
 ---pagebreak---         (b)   in relation to oocytes and embryos, a group of professionals or structure supervised
              by a team veterinarian competent to perform the collection, production, processing
              and storage of oocytes and embryos;
        (c)   in relation to hatching eggs, a hatchery;
(47)    'hatchery' means an establishment which collects, stores, incubates and hatches eggs for the
        supply of:
        (a)   hatching eggs;
        (b)   day–old chicks or hatchlings of other species;
(48)    'confined establishment' means any permanent, geographically limited establishment,
        created on a voluntary basis and approved for the purpose of movements, where the
        animals are:
        (a)   kept or bred for the purposes of exhibitions, education, the conservation of species or
              research;
        (b)   confined and separated from the surrounding environment; and
        (c)   subject to animal health surveillance and biosecurity measures;
11779/15                                                                AS/NC/ra                   88
                                               DGB 2B                                           EN
 ---pagebreak--- (49)    'assembly operation' means the assembling of kept terrestrial animals from more than one
        establishment for a period shorter than the required residency period for the species of
        animals concerned;
(50)    'residency period' means the minimum period necessary in order to ensure that an animal
        which has been introduced into an establishment is not of a lower health status than that of
        the animals in that establishment;
(51)    'TRACES' means the integrated computerised veterinary system with a single architecture
        provided for in Decisions 2003/24/EC and 2004/292/EC;
(52)    'disease control aquatic food establishment' means a food business approved in accordance
        with Article 179;
(53)    'official veterinarian' means a veterinarian authorised by the competent authority and
        appropriately qualified to perform official activities in accordance with this Regulation;
(54)    'official veterinarian in a third country or territory' means a veterinarian in a third country
        or territory corresponding to an official veterinarian as referred to in point (53);
(55)    'competent authority' means the central veterinary authority of a Member State responsible
        for the organisation of official controls and any other official activities in accordance with
        this Regulation or any other authority to which that responsibility has been delegated;
(56)    'competent authority of a third country or territory' means the authority in a third country or
        territory corresponding to the competent authorities referred to in point (55).
11779/15                                                                  AS/NC/ra                     89
                                                DGB 2B                                              EN
 ---pagebreak---                                             Chapter 2
          Listed diseases and emerging diseases and listed species
                                               Article 5
                                          Listing of diseases
1.      The disease-specific rules for the prevention and control of diseases provided for in this
        Regulation shall apply to:
        (a)  the following listed diseases :
             (i)    foot and mouth disease;
             (ii)   classical swine fever;
             (iii) African swine fever;
             (iv) highly pathogenic avian influenza;
             (v)    African horse sickness; and
        (b)  the listed diseases set out in the list in Annex II.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        amendments to the list referred to in point (b) of paragraph 1 of this Article.
11779/15                                                               AS/NC/ra                    90
                                                DGB 2B                                          EN
 ---pagebreak--- 3.      A disease shall be included on the list referred to in point (b) of paragraph 1 of this Article
        if it has been assessed in accordance with Article 7 and it meets:
        (a)    all of the following criteria:
               (i)    scientific evidence indicates that the disease is transmissible;
               (ii)   animal species are either susceptible to the disease or vectors and reservoirs
                      thereof exist in the Union;
               (iii) the disease causes negative effects on animal health or poses a risk to public
                      health due to its zoonotic character;
               (iv) diagnostic tools are available for the disease; and
               (v)    risk-mitigating measures and, where relevant, surveillance of the disease are
                      effective and proportionate to the risks posed by the disease in the Union; and
        (b)    at least one of the following criteria:
               (i)    the disease causes or could cause significant negative effects in the Union on
                      animal health, or poses or could pose a significant risk to public health due to
                      its zoonotic character;
11779/15                                                                   AS/NC/ra                   91
                                                 DGB 2B                                            EN
 ---pagebreak---               (ii)   the disease agent has developed resistance to treatments which poses a
                     significant danger to public and/or animal health in the Union;
              (iii) the disease causes or could cause a significant negative economic impact
                     affecting agriculture or aquaculture production in the Union;
              (iv) the disease has the potential to generate a crisis or the disease agent could be
                     used for the purpose of bioterrorism; or
              (v)    the disease has or could have a significant negative impact on the environment,
                     including biodiversity, of the Union.
4.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        removal of a disease from the list referred to in point (b) of paragraph 1 of this Article
        when that disease no longer fulfils the criteria provided for in paragraph 3 of this Article.
5.      The Commission shall review the listing of each disease in the light of newly available
        significant scientific data.
                                               Article 6
                                          Emerging diseases
1.      The rules for the prevention and control of diseases shall apply to emerging diseases as
        provided for in this Regulation.
11779/15                                                                 AS/NC/ra                     92
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      A disease other than a listed disease shall be considered to be an emerging disease
        ('emerging disease') provided it has the potential to meet the criteria for listing diseases
        provided for in Article 5(3) and:
        (a)   results from the evolution or change of an existing disease agent;
        (b)   is a known disease spreading to a new geographic area, species or population;
        (c)   is diagnosed for the first time in the Union; or
        (d)   is caused by an unrecognised or a previously unrecognised disease agent.
3.      The Commission shall, by means of implementing acts, take the necessary measures
        regarding an emerging disease which fulfils the criteria set out in paragraph 2 of this
        Article. Those implementing acts shall be adopted in accordance with the examination
        procedure referred to in Article 266(2).
4.      On duly justified imperative grounds of urgency relating to a disease representing an
        emerging risk having a highly significant impact, the Commission shall adopt immediately
        applicable implementing acts in accordance with the procedure referred to in
        Article 266(3).
5.      Any obligation on operators in respect of an emerging disease, as set out in this
        Regulation, shall only apply if the Commission has adopted an implementing act for that
        disease in accordance with paragraph 3 of this Article or if the disease is covered by a
        contingency plan in accordance with Article 43.
11779/15                                                                AS/NC/ra                     93
                                                DGB 2B                                             EN
 ---pagebreak---                                                  Article 7
                            Assessment parameters for the listing of diseases
The Commission shall use the following assessment parameters in order to determine whether a
disease meets the conditions requiring it to be listed in accordance with Article 5(2):
(a)      the disease profile, which shall comprise the following:
         (i)    the animal species concerned by the disease;
         (ii)   the morbidity and mortality rates of the disease in animal populations;
         (iii) the zoonotic character of the disease;
         (iv) the resistance to treatments, including antimicrobial resistance;
         (v)    the persistence of the disease in an animal population or in the environment;
         (vi) the routes and speed of transmission of the disease between animals and, when
                relevant, between animals and humans;
         (vii) the absence or presence and distribution of the disease in the Union, and, where the
                disease is not present in the Union, the risk of its introduction into the Union;
         (viii) the existence of diagnostic and disease control tools;
11779/15                                                                    AS/NC/ra               94
                                                 DGB 2B                                           EN
 ---pagebreak--- (b)     the impact of the disease on:
        (i)    agricultural and aquaculture production and other parts of the economy, as regards:
               –     the level of presence of the disease in the Union;
               –     the loss of production due to the disease;
               –     other losses;
        (ii)   human health, as regards:
               –     transmissibility between animals and humans;
               –     transmissibility between humans;
               –     the severity of human forms of the disease;
               –     the availability of effective prevention or medical treatment in humans;
        (iii) animal welfare;
        (iv) biodiversity and the environment;
(c)     its potential to generate a crisis situation and its potential use in bioterrorism;
(d)     the feasibility, availability and effectiveness of the following disease prevention and
        control measures:
        (i)    diagnostic tools and capacities;
11779/15                                                                    AS/NC/ra              95
                                                 DGB 2B                                         EN
 ---pagebreak---         (ii)  vaccination;
        (iii) medical treatments;
        (iv) biosecurity measures;
        (v)   restrictions on the movement of animals and products;
        (vi) killing of animals;
        (vii) disposal of carcasses and other relevant animal by–products;
(e)     the impact of disease prevention and control measures, as regards:
        (i)   the direct and indirect costs for the affected sectors and the economy as a whole;
        (ii)  their societal acceptance;
        (iii) the welfare of affected subpopulations of kept and wild animals;
        (iv) the environment and biodiversity.
                                               Article 8
                                          Listing of species
1.      The disease-specific rules for listed diseases provided for in this Regulation and the rules
        adopted pursuant to this Regulation shall apply to listed species.
11779/15                                                                 AS/NC/ra                   96
                                                DGB 2B                                           EN
 ---pagebreak--- 2.      The Commission shall, by means of implementing acts, establish a list of species as
        referred to in paragraph 1 of this Article that fulfil the criteria set out in paragraph 3 of this
        Article. Those implementing acts shall be adopted in accordance with the examination
        procedure referred to in Article 266(2).
        That list shall comprise those animal species, or groups of animal species which pose a
        considerable risk for the spread of specific listed diseases, based on the following criteria:
        (a)    the susceptibility of the animal population at risk;
        (b)    the duration of the incubation period and infective period for the animals concerned;
        (c)    the capability of those animals to carry those specific diseases.
3.      Animal species or groups of animal species shall be added to the list if they are affected or
        if they pose a risk for the spread of a specific listed disease because:
        (a)    they are susceptible to a specific listed disease or scientific evidence indicates that
               such susceptibility is likely; or
        (b)    they are vector species or reservoirs for that disease, or scientific evidence indicates
               that such role is likely.
11779/15                                                                    AS/NC/ra                    97
                                                 DGB 2B                                              EN
 ---pagebreak--- 4.      The Commission shall, by means of implementing acts, remove animal species or groups
        of animal species from the list when:
        (a)   the relevant listed disease in relation to which the animal species or group of animal
              species concerned has been listed has been removed from the list of diseases; or
        (b)   scientific evidence indicates that the species or group of species concerned no longer
              fulfils the criteria set out in paragraph 3.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                                 Article 9
    Disease prevention and control rules to be applied to different categories of listed diseases
1.      Disease prevention and control rules shall apply to listed diseases as follows:
        (a)   As regards listed diseases that do not normally occur in the Union and for which
              immediate eradication measures must be taken as soon as they are detected, the
              following rules shall apply, as relevant:
              (i)    the rules for disease awareness and preparedness provided for in Title I of
                     Part III (Articles 43 to 52);
11779/15                                                                AS/NC/ra                   98
                                                 DGB 2B                                          EN
 ---pagebreak---             (ii)  the disease control measures provided for in Chapter 1 of Title II of Part III
                  (Articles 53 to 71); and
            (iii) the rules for compartmentalisation provided for in Article 37(1).
            For those listed diseases, the measures referred to in point (b), as appropriate, as well
            as points (d) and (e), shall also apply, as relevant.
        (b) As regards listed diseases which must be controlled in all Member States with the
            goal of eradicating them throughout the Union, the following rules shall apply, as
            relevant:
            (i)   the rules for compulsory eradication programmes provided for in Article 31(1);
            (ii)  the rules for disease–free Member States and zones provided for in Article 36;
            (iii) the rules for compartmentalisation provided for in Article 37(2); and
            (iv) the disease control measures provided for in Articles 72 to 75, Articles 77 to 79
                  and Articles 81 and 83.
            For those listed diseases, the measures referred to in points (d) and (e) shall also
            apply, as relevant.
11779/15                                                              AS/NC/ra                     99
                                              DGB 2B                                             EN
 ---pagebreak---         (c) As regards listed diseases which are of relevance to some Member States and for
            which measures are needed to prevent them from spreading to parts of the Union that
            are officially disease-free or that have eradication programmes for the listed disease
            concerned, the following rules shall apply, as relevant:
            (i)   the rules for optional eradication provided for in Article 31(2);
            (ii)  the rules for disease–free Member States and zones provided for in Article 36;
            (iii) the rules for compartmentalisation provided for in Article 37(2); and
            (iv) the rules for disease control measures provided for in Articles 76, 77, 78, 80,
                  82 and 83.
            For those listed diseases, the measures referred to in points (d) and (e) shall also
            apply, as relevant.
        (d) As regards listed diseases for which measures are needed to prevent them from
            spreading on account of their entry into the Union or movements between Member
            States, the following rules shall apply, as relevant:
            (i)   the rules for movement within the Union provided for in Chapters 3 to 6 of
                  Title I (Articles 124 to 169), Chapters 2 and 3of Title II of Part IV
                  (Articles 191 to 225) and Chapters 2 and 3 of Part VI (Articles 247 to 251); and
11779/15                                                              AS/NC/ra                    100
                                              DGB 2B                                             EN
 ---pagebreak---             (ii)   the rules for entry into the Union and export from the Union provided for in
                   Part V (Articles 229 to 243).
            The listed diseases referred to in points (a), (b) and (c) shall also be considered as
            listed diseases under this point, as well as those referred to in point (e), where the
            risk posed by the disease in question can be effectively and proportionately mitigated
            by measures concerning movements of animals and products.
        (e) As regards listed diseases for which there is a need for surveillance within the Union,
            the following rules shall apply, as relevant:
            (i)    the rules for notification and reporting provided for in Chapter 1 of Part II
                   (Articles 18 to 23); and
            (ii)   the rules for surveillance provided for in Chapter 2 of Part II (Articles 24
                   to 30).
            The listed diseases referred to in points (a), (b) and (c) shall also be considered as
            listed diseases under this point.
11779/15                                                                AS/NC/ra                   101
                                               DGB 2B                                            EN
 ---pagebreak--- 2.      The Commission shall, by means of implementing acts, determine the application of the
        disease prevention and control rules referred to in paragraph 1 to the respective listed
        diseases on the basis of the criteria set out in Annex IV, also in the light of newly available
        significant scientific data.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
3.      The Commission shall, by means of implementing acts, modify the application of the
        disease prevention and control rules referred to in paragraph 2 to the respective listed
        diseases when the disease in question no longer fulfils the criteria laid down in the relevant
        Section of Annex IV, also in the light of newly available significant scientific data.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
4.      On duly justified imperative grounds of urgency relating to a listed disease representing an
        emerging risk having a highly significant impact, the Commission shall adopt immediately
        applicable implementing acts in accordance with the procedure referred to in
        Article 266(3).
11779/15                                                                 AS/NC/ra                   102
                                                DGB 2B                                            EN
 ---pagebreak---                                           Chapter 3
                         Responsibilities for animal health
                                           SECTION 1
               OPERATORS, ANIMAL PROFESSIONALS AND PET KEEPERS
                                            Article 10
                   Responsibilities for animal health and biosecurity measures
1.      Operators shall:
        (a)  as regards kept animals and products under their responsibility, be responsible for:
             (i)   the health of kept animals;
             (ii)  prudent and responsible use of veterinary medicines, without prejudice to the
                   role and responsibility of veterinarians,
             (iii) minimising the risk of the spread of diseases;
             (iv) good animal husbandry;
11779/15                                                              AS/NC/ra                  103
                                              DGB 2B                                           EN
 ---pagebreak---         (b)   where appropriate, take such biosecurity measures regarding kept animals, and
              products under their responsibility, as are appropriate for:
              (i)    the species and categories of kept animals and products;
              (ii)   the type of production; and
              (iii) the risks involved, taking into account:
                     –     geographical location and climatic conditions; and
                     –     local circumstances and practices;
        (c)   where appropriate, take biosecurity measures regarding wild animals.
2.      Animal professionals shall take action to minimise the risk of the spread of diseases in the
        context of their occupational relationship with animals and products.
3.      Point (a) of paragraph 1 shall also apply to pet keepers.
4.      The biosecurity measures referred to in point (b) of paragraph 1 shall be implemented, as
        appropriate, through:
        (a)   physical protection measures, which may include:
              (i)    enclosing, fencing, roofing, netting, as appropriate;
11779/15                                                                 AS/NC/ra                 104
                                               DGB 2B                                           EN
 ---pagebreak---             (ii)  cleaning, disinfection and control of insects and rodents;
            (iii) in the case of aquatic animals, where appropriate:
                  –     measures concerning the water supply and discharge;
                  –     natural or artificial barriers to surrounding water courses that prevent
                        aquatic animals from entering or leaving the establishment concerned,
                        including measures against flooding or infiltration of water from
                        surrounding water courses;
        (b) management measures, which may include:
            (i)   procedures for entering and exiting the establishment for animals, products,
                  vehicles and persons;
            (ii)  procedures for using equipment;
            (iii) conditions for movement based on the risks involved;
            (iv) conditions for introducing animals or products into the establishment;
            (v)   quarantine, isolation or separation of newly introduced or sick animals;
            (vi) a system for safe disposal of dead animals and other animal by–products.
11779/15                                                               AS/NC/ra                  105
                                              DGB 2B                                           EN
 ---pagebreak--- 5.      Operators, animal professionals and pet keepers shall cooperate with the competent
        authority and veterinarians in the application of the disease prevention and control
        measures provided for in this Regulation.
6.      The Commission may, by means of implementing acts, lay down minimum requirements
        necessary for the uniform application of this Article.
        Such implementing acts shall reflect the matters referred to in point (b) of paragraph 1.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                             Article 11
                                    Knowledge of animal health
1.      Operators and animal professionals shall have adequate knowledge of:
        (a)   animal diseases, including those that are transmissible to humans;
        (b)   biosecurity principles;
        (c)   the interaction between animal health, animal welfare and human health;
11779/15                                                                AS/NC/ra                  106
                                              DGB 2B                                            EN
 ---pagebreak---         (d)  good practice of animal husbandry for the animal species under their care;
        (e)  resistance to treatments, including antimicrobial resistance, and its implications.
2.      The content and the level of knowledge required in accordance with paragraph 1 shall
        depend on:
        (a)  the species and categories of kept animals or products under the responsibility of the
             operators and animal professionals concerned and the nature of their occupational
             relationship with those animals or products;
        (b)  the type of production;
        (c)  the tasks performed.
3.      The knowledge provided for in paragraph 1 shall be acquired in one of the following ways:
        (a)  professional experience or training;
        (b)  existing programmes in agricultural or aquaculture sectors that are relevant for
             animal health;
        (c)  formal education;
        (d)  other experience or other training which results in the same level of knowledge as
             that covered by points (a), (b) or (c).
11779/15                                                               AS/NC/ra                   107
                                              DGB 2B                                             EN
 ---pagebreak--- 4.      Operators selling or otherwise transferring the ownership of future pet animals shall
        provide basic information to the future pet keeper, regarding the matters referred to in
        paragraph 1, as relevant for the pet animal in question.
                                             SECTION 2
            VETERINARIANS AND AQUATIC ANIMAL HEALTH PROFESSIONALS
                                              Article 12
             Responsibilities of veterinarians and aquatic animal health professionals
1.      Veterinarians shall in the course of their activities which fall within the scope of this
        Regulation:
        (a)   take all appropriate measures to prevent the introduction, development and spread of
              diseases;
        (b)   take action to ensure the early detection of diseases by carrying out proper diagnosis
              and differential diagnosis to rule out or confirm a disease;
        (c)   play an active role in:
              (i)   raising animal health awareness, and awareness of the interaction between
                    animal health, animal welfare and human health;
11779/15                                                                 AS/NC/ra                  108
                                               DGB 2B                                             EN
 ---pagebreak---               (ii)   disease prevention;
              (iii) the early detection of, and rapid response to, diseases.
              (iv) raising awareness of resistance to treatments, including antimicrobial
                     resistance, and its implications;
        (d)   cooperate with the competent authority, operators, animal professionals and pet
              keepers in the application of the disease prevention and control measures provided
              for in this Regulation.
2.      Aquatic animal health professionals may undertake activities assigned to veterinarians
        under this Regulation in relation to aquatic animals provided that they are authorised to do
        so by the Member State concerned under national law. In that event, paragraph 1 shall
        apply to those aquatic animal health professionals.
3.      Veterinarians and aquatic animal health professionals shall maintain and develop their
        professional capacities related to their areas of activities which fall within the scope of this
        Regulation.
11779/15                                                                 AS/NC/ra                    109
                                                DGB 2B                                             EN
 ---pagebreak---                                              SECTION 3
                                         MEMBER STATES
                                               Article 13
                                   Member States' responsibilities
1.      In order to ensure that the competent authority for animal health has the capability to take
        the necessary and appropriate measures, and to carry out the activities, required by this
        Regulation, each Member State shall, at the appropriate administrative level, ensure that
        competent authority has:
        (a)   qualified personnel, facilities, equipment, financial resources and an effective
              organisation covering the whole territory of the Member State;
        (b)   access to laboratories with the qualified personnel, facilities, equipment and financial
              resources needed to ensure the rapid and accurate diagnosis and differential diagnosis
              of listed diseases and emerging diseases;
        (c)   sufficiently trained veterinarians involved in performing the activities referred to in
              Article 12.
2.      Member States shall encourage operators and animal professionals to acquire, maintain and
        develop the adequate knowledge of animal health provided for in Article 11 through
        relevant programmes in agricultural or aquaculture sectors or formal education.
11779/15                                                                AS/NC/ra                    110
                                                DGB 2B                                            EN
 ---pagebreak---                                                Article 14
                      Delegation by a competent authority of official activities
1.      The competent authority may delegate one or more of the following activities to
        veterinarians other than official veterinarians:
        (a)   practical application of measures under the eradication programmes provided for in
              Article 32;
        (b)   supporting the competent authority in carrying out surveillance as provided for in
              Article 26 or in relation to surveillance programmes as provided for in Article 28;
        (c)   activities related to:
              (i)   disease awareness, preparedness and control as provided for in Part III,
                    concerning:
                    –      sampling activities and implementation of investigations and
                           epidemiological enquiries within the framework of Articles 54, points (b)
                           to (g) of Article 55(1), Article 57, Article 73 and Article 74 in the event
                           of the suspected presence of a disease, and any implementing and
                           delegated acts adopted pursuant to those Articles;
11779/15                                                                  AS/NC/ra                  111
                                                DGB 2B                                             EN
 ---pagebreak---                      –     carrying out activities relating to disease control measures in the event of
                           an outbreak of disease, as regards activities listed in Article 61, points
                           (a), (b), (e), (f) and (i) of Article 65(1), Article 70(1), Article 79(1) and
                           (2), and Article 81(1) and (2), and any implementing and delegated acts
                           adopted pursuant to those Articles;
                     –     carrying out emergency vaccination in accordance with Article 69;
               (ii)  registration, approval, traceability and movements as provided for in Part IV;
               (iii) issuing and completing the identification documents for pet animals as
                     provided for in point (c) of Article 247, point (c) of Article 248(2), point (c) of
                     Article 249(1) and point (c) of Article 250(2);
               (iv) the application and use of means of identification as referred to in point (a)(ii)
                     of Article 252(1).
2.      Member States may provide for natural or legal persons to be authorised to perform
        activities referred to in point (a) and points (b)(i), (ii) and (iv) of paragraph 1 for
        specifically identified tasks for which those persons have sufficient specific knowledge. In
        that event, paragraph 1 of this Article and the responsibilities laid down in Article 12 shall
        apply to those persons.
11779/15                                                                     AS/NC/ra                  112
                                                  DGB 2B                                              EN
 ---pagebreak--- 3.       The Commission shall be empowered to adopt delegated acts in accordance with Article
         264 concerning other activities which may be delegated to veterinarians in addition to
         those provided for in paragraph 1, and, as appropriate, to prescribe the necessary
         circumstances and conditions for such delegation.
         The Commission shall take account of the nature of those activities and of relevant
         international standards when adopting those delegated acts.
                                                Article 15
                                            Public information
Where there are reasonable grounds to suspect that animals or products originating from within the
Union or entering from outside the Union may present a risk, the competent authority shall take
appropriate steps to inform the public of the nature of the risk and the measures which are taken or
about to be taken to prevent or control that risk, taking into account the nature, seriousness and
extent of that risk and the public interest in being informed.
11779/15                                                                  AS/NC/ra                  113
                                                 DGB 2B                                            EN
 ---pagebreak---                                              SECTION 4
                    LABORATORIES, FACILITIES AND OTHER NATURAL
             AND LEGAL PERSONS HANDLING DISEASE AGENTS, VACCINES
                             AND OTHER BIOLOGICAL PRODUCTS
                                              Article 16
            Obligations of laboratories, facilities and others handling disease agents,
                               vaccines and other biological products
1.      Laboratories, facilities and other natural or legal persons handling disease agents for the
        purpose of research, education, diagnosis or the production of vaccines and other
        biological products shall, whilst taking into account any relevant international standards:
        (a)   take appropriate biosecurity, biosafety and bio–containment measures to prevent the
              escape of the disease agents and their subsequent contact with animals outside the
              laboratory or other facility handling disease agents for those purposes;
        (b)   ensure that the movement of disease agents, vaccines and other biological products
              between laboratories or other facilities does not give rise to a risk of the spread of
              listed and emerging diseases.
11779/15                                                                AS/NC/ra                     114
                                               DGB 2B                                              EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the safety measures for the prevention and control of listed and emerging
        diseases as regards laboratories, facilities and other natural or legal persons handling the
        disease agents, vaccines and other biological products in relation to:
        (a)   biosecurity, biosafety and bio–containment measures;
        (b)   movement requirements for disease agents, vaccines and other biological products.
                                               Article 17
                                      Animal health laboratories
1.      Official laboratories for animal health, consisting of Union reference laboratories, national
        reference laboratories and official animal health laboratories, shall, in fulfilling their tasks
        and responsibilities, cooperate within a network of Union animal health laboratories.
2.      The laboratories referred to in paragraph 1 shall cooperate under the coordination of the
        Union reference laboratories, to ensure that the surveillance, notification and reporting of
        diseases, eradication programmes, the definition of disease–free status, and the movements
        of animals and products within the Union, their entry into the Union and exports to third
        countries or territories provided for in this Regulation, are based on state–of–the–art, solid
        and reliable laboratory analyses, tests and diagnoses.
11779/15                                                                  AS/NC/ra                    115
                                                DGB 2B                                               EN
 ---pagebreak--- 3.      The results and reports provided by the official laboratories shall be subject to the
        principles of professional secrecy and confidentiality and the duty of notification to the
        competent authority which designated them, irrespective of the natural or legal person who
        requested the laboratory analyses, tests or diagnoses.
4.      In the event that an official laboratory in one Member State conducts diagnostic analyses
        on samples from animals originating in another Member State, that official laboratory shall
        notify the competent authority of the Member State from which the samples originated:
        (a)   immediately of any results indicating the suspicion or detection of a listed disease as
              referred to in point (a) of Article 9(1);
        (b)   without undue delay of any results indicating the suspicion or detection of a listed
              disease as referred to in point (e) of Article 9(1) other than those referred to in point
              (a) of Article 9(1).
11779/15                                                                  AS/NC/ra                   116
                                                DGB 2B                                             EN
 ---pagebreak---                                           PART II
          DISEASE NOTIFICATION AND REPORTING,
     SURVEILLANCE, ERADICATION PROGRAMMES,
                          DISEASE–FREE STATUS
                                         Chapter 1
                        Disease notification and reporting
                                            Article 18
                               Notification within Member States
1.      Member States shall ensure that operators and other relevant natural or legal persons:
        (a) immediately notify the competent authority where there are any reasons to suspect
            the presence in animals of a listed disease as referred to in point (a) of Article 9(1),
            or where the presence of such a disease is detected in animals;
        (b) as soon as practicable notify the competent authority where there are any reasons to
            suspect the presence in animals of a listed disease as referred to in point (e) of Article
            9(1) other than those referred to in point (a) of Article 9(1), or where the presence of
            such a disease is detected in animals;
11779/15                                                               AS/NC/ra                   117
                                             DGB 2B                                              EN
 ---pagebreak---         (c)  notify a veterinarian of abnormal mortalities and other signs of serious disease or
             significant decreased production rates with an undetermined cause, for further
             investigation, including sampling for laboratory examination when the situation so
             requires.
2.      Member States may decide that the notifications provided for in point (c) of paragraph 1
        may be directed to the competent authority.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)  criteria to determine whether the circumstances requiring notification described in
             point (c) of paragraph 1 occur;
        (b)  detailed rules for the further investigation provided for in point (c) of paragraph 1.
                                              Article 19
                                         Union notification
1.      Member States shall immediately notify the Commission and the other Member States of
        any outbreaks of listed diseases as referred to in point (e) of Article 9(1) for which an
        immediate notification is required in order to ensure the timely implementation of
        necessary risk management measures, taking into account the disease profile.
11779/15                                                                 AS/NC/ra                  118
                                               DGB 2B                                             EN
 ---pagebreak--- 2.      The notification provided for in paragraph 1 shall contain the following information on the
        outbreak:
        (a)   the disease agent and, where relevant, the subtype;
        (b)   the relevant dates, in particular those of the suspicion and the confirmation of the
              outbreak;
        (c)   the type and location of the outbreak;
        (d)   any related outbreaks;
        (e)   the animals involved in the outbreak;
        (f)   any disease control measures taken in relation to the outbreak;
        (g)   the possible or known origin of the listed disease;
        (h)   the diagnostic methods used.
                                              Article 20
                                           Union reporting
1.      Member States shall report to the Commission and to the other Member States the
        information on listed diseases referred to in in point (e) of Article 9(1) for which:
        (a)   immediate notification of an outbreak is not required under Article 19(1);
11779/15                                                                 AS/NC/ra                  119
                                                DGB 2B                                           EN
 ---pagebreak---         (b)   immediate notification of an outbreak is required under Article 19(1), but additional
              information is required to be reported to the Commission and the other Member
              States on:
              (i)   surveillance in accordance with the rules laid down in an implementing act
                    adopted in accordance with Article 30;
              (ii)  an eradication programme in accordance with the rules laid down in an
                    implementing act adopted in accordance with Article 35.
2.      The reports provided for in paragraph 1 shall include information on:
        (a)   the detection of the listed diseases referred to in paragraph 1;
        (b)   the results of surveillance when required in accordance with rules adopted in
              accordance with point (d)(ii) of Article 29 or point (b)(ii) of Article 30;
        (c)   the results of surveillance programmes when required in accordance with Article
              28(3) and rules adopted in accordance with point (d)(ii) of Article 29 or point (b)(ii)
              of Article 30;
        (d)   eradication programmes when required in accordance with Article 34 and rules laid
              down in an implementing act adopted in accordance with Article 35.
11779/15                                                                 AS/NC/ra                 120
                                               DGB 2B                                           EN
 ---pagebreak--- 3.        The Commission shall be empowered to adopt delegated acts in accordance with
          Article 264 concerning provisions supplementing the requirements of paragraph 2 and
          reporting on other matters concerning surveillance and eradication programmes where
          necessary in order to ensure an efficient application of the disease prevention rules and
          control rules laid down in this Regulation.
                                               Article 21
                                  Notification and reporting regions
The Member States shall establish notification and reporting regions for the purpose of the
notification and reporting provided for in Articles 19 and 20.
                                               Article 22
      Computerised information system for Union notification and Union reporting of diseases
The Commission shall set up and manage a computerised information system for the operation of
the mechanisms and tools for the notification and reporting requirements provided for in
Articles 19, 20 and 21.
11779/15                                                                  AS/NC/ra                  121
                                                 DGB 2B                                            EN
 ---pagebreak---                                                 Article 23
              Implementing powers concerning Union notification and Union reporting
                                and the computerised information system
The Commission shall, by means of implementing acts, lay down rules for the notification and
reporting requirements and the computerised information system provided for in Articles 19 to 22
with respect to:
(a)      those listed diseases referred to in point (e) of Article 9(1) which are to be subject to
         immediate notification by the Member States as well as the necessary measures relating to
         the notification, in accordance with Article 19;
(b)      the information to be provided by the Member States in the reporting provided for in
         Article 20;
(c)      procedures for the establishment and use of the computerised information system provided
         for in Article 22 and transitional measures for the migration of the data and the information
         from existing systems into the new system and its full operability;
(d)      the format and structure of the data to be entered into the computerised information system
         provided for in Article 22;
11779/15                                                                  AS/NC/ra                  122
                                                 DGB 2B                                            EN
 ---pagebreak--- (e)      the deadlines and frequencies of the notification and reporting provided for in Articles 19
         and 20, which shall be done at times and frequencies which ensure transparency and the
         timely application of the necessary risk management measures, based on the disease profile
         and the type of outbreak.
(f)      the listing of notification and reporting regions provided for in Article 21.
Those implementing acts shall be adopted in accordance with the examination procedure referred to
in Article 266(2).
                                             Chapter 2
                                            Surveillance
                                                Article 24
                                   Operators' surveillance obligation
For the purpose of detecting the presence of listed diseases and emerging diseases, operators shall:
(a)      observe the health and behaviour of animals under their responsibility;
(b)      observe any changes in the normal production parameters in the establishments, animals or
         germinal products under their responsibility that may give rise to a suspicion of being
         caused by a listed disease or emerging disease;
11779/15                                                                  AS/NC/ra                 123
                                                 DGB 2B                                          EN
 ---pagebreak--- (c)     look for abnormal mortalities and other signs of serious disease in animals under their
        responsibility.
                                              Article 25
                                         Animal health visits
1.      Operators shall ensure that establishments under their responsibility receive animal health
        visits from a veterinarian when appropriate due to the risks posed by the establishment in
        question, taking into account:
        (a)    the type of establishment;
        (b)    the species and categories of kept animals on the establishment;
        (c)    the epidemiological situation in the zone or region as regards listed and emerging
               diseases to which the animals in the establishment are susceptible;
        (d)    any other relevant surveillance, or official controls to which the kept animals and
               type of establishment are subject.
        Such animal health visits shall take place at frequencies that are proportionate to the risks
        posed by the establishment concerned.
        They may be combined with visits for other purposes.
11779/15                                                                 AS/NC/ra                   124
                                               DGB 2B                                             EN
 ---pagebreak--- 2.      The animal health visits provided for in paragraph 1 shall be made for the purpose of
        disease prevention, in particular through:
        (a)   the provision of advice to the operator concerned on biosecurity and other animal
              health matters, as relevant for the type of establishment and the species and
              categories of kept animals on the establishment.
        (b)   the detection of, and information on, signs indicative of the occurrence of listed
              diseases or emerging diseases;
3.      The Commission may, by means of implementing acts, lay down minimum requirements
        necessary for the uniform application of this Article.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                               Article 26
                          The competent authority's surveillance obligation
1.      The competent authority shall conduct surveillance to detect the presence of listed diseases
        as referred to in point (e) of Article 9(1) and relevant emerging diseases.
11779/15                                                                AS/NC/ra                  125
                                                DGB 2B                                           EN
 ---pagebreak--- 2.       The surveillance shall be designed in such a way as to ensure the timely detection of the
         presence of the listed diseases referred to in point (e) of Article 9(1) and emerging diseases
         by means of the collection, collation and analysis of relevant information relating to the
         disease situation.
3.       The competent authority shall, whenever possible and appropriate, make use of the results
         of the surveillance conducted by operators and the information obtained through animal
         health visits in accordance with Articles 24 and 25, respectively.
4.       The competent authority shall ensure that surveillance meets the requirements provided for
         in Article 27 and in any rules adopted pursuant to point (a) of Article 29.
5.       The competent authority shall ensure that the information obtained through the
         surveillance provided for in paragraph 1 is collected and used in an effective and efficient
         manner.
                                               Article 27
                         Methodology, frequency and intensity of surveillance
The design, means, diagnostic methods, frequency, intensity, targeted animal population, and
sampling patterns of the surveillance provided for in Article 26 shall be appropriate and
proportionate to the objectives of the surveillance, taking into account:
(a)      the disease profile;
11779/15                                                                   AS/NC/ra                 126
                                                DGB 2B                                             EN
 ---pagebreak--- (b)     the risk factors involved;
(c)     the health status in:
        (i)    the Member State, zone or compartment thereof subject to the surveillance;
        (ii)   the Member States and third countries or territories which either border on, or from
               which animals and products enter into, that Member State, zone or compartment
               thereof;
(d)     surveillance conducted by operators in accordance with Article 24, including animal health
        visits as referred to in Article 25, or by other public authorities.
                                                Article 28
                                   Union surveillance programmes
1.      The competent authority shall undertake surveillance as provided for in Article 26(1)
        within the framework of a surveillance programme when a disease is relevant for the
        Union in accordance with point (c) of Article 29.
2.      Member States establishing a surveillance programme in accordance with paragraph 1
        shall submit it to the Commission.
3.      Member States implementing a surveillance programme in accordance with paragraph 1
        shall submit regular reports on the results of the implementation of that programme to the
        Commission.
11779/15                                                                  AS/NC/ra                127
                                                 DGB 2B                                          EN
 ---pagebreak---                                                Article 29
                                          Delegation of powers
The Commission shall be empowered to adopt delegated acts in accordance with Article 264
concerning:
(a)     the design, means, diagnostic methods, frequency, intensity, targeted animal population,
        and sampling patterns of the surveillance provided for in Article 27;
(b)     the criteria for the official confirmation and case definitions of listed diseases as referred to
        in point (e) of Article 9(1), and, where relevant, of emerging diseases;
(c)     the criteria used to establish the relevance of a disease which is to be subject to a
        surveillance programme relevant for the Union for the purposes of point (a) of Article
        30(1), taking into account the disease profile and the risk factors involved;
(d)     requirements for surveillance programmes as provided for in Article 28(1) regarding:
        (i)   the contents of surveillance programmes;
        (ii)  the information to be included in the submission of surveillance programmes in
              accordance with Article 28(2) and regular reports in accordance with Article 28(3);
        (iii) the period of application of surveillance programmes.
11779/15                                                                 AS/NC/ra                    128
                                                DGB 2B                                              EN
 ---pagebreak---                                              Article 30
                                        Implementing powers
1.      The Commission shall, by means of implementing acts, lay down requirements concerning
        surveillance and surveillance programmes as provided for in Articles 26 and 28 and in the
        rules adopted pursuant to Article 29, as regards:
        (a)   establishing which of the listed diseases referred to in point (e) of Article 9(1) are to
              be subject to surveillance programmes in accordance with Article 28, including the
              geographical scope of such programmes;
        (b)   the format and procedure for:
              (i)   the submission of those surveillance programmes for information to the
                    Commission and other Member States;
              (ii)  the reporting to the Commission on the results of the surveillance.
2.      The Commission may, by means of implementing acts, lay down the criteria to be used for
        evaluating the surveillance programmes referred to in Article 28.
3.      The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in
        accordance with the examination procedure referred to in Article 266(2).
11779/15                                                                AS/NC/ra                     129
                                               DGB 2B                                              EN
 ---pagebreak---                                              Chapter 3
                                 Eradication programmes
                                               Article 31
                         Compulsory and optional eradication programmes
1.      Member States which are not free, or not known to be free, from one or more of the listed
        diseases referred to in point (b) of Article 9(1) throughout their territory, or in zones or
        compartments thereof, shall:
        (a)   establish a programme for the eradication of, or demonstration of freedom from, that
              listed disease, to be carried out in the animal populations concerned by that disease
              and covering the relevant parts of their territory or the relevant zones or
              compartments thereof ('compulsory eradication programme'), to apply until the
              conditions for the grant of disease–free status in the territory of the Member State or
              zone concerned, as provided for in Article 36(1), or compartment, as provided for in
              Article 37(2), are fulfilled;
        (b)   submit the draft compulsory eradication programme to the Commission for approval.
11779/15                                                                 AS/NC/ra                    130
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      Member States which are not free, or not known to be free, from one or more of the listed
        diseases referred to in point (c) of Article 9(1) and which decide to establish a programme
        for the eradication of that listed disease, to be carried out in the animal populations
        concerned by the disease in question and covering the relevant parts of their territory or
        zones or compartments thereof ("optional eradication programme"), shall submit a draft of
        that programme to the Commission for approval, where the Member State concerned asks
        for the recognition, within the Union, of animal health guarantees as regards the disease in
        question for movements of animals or products.
        Such an optional eradication programme shall apply until:
        (a)   the conditions for the grant of disease–free status in the territory of the Member State
              or zone concerned, as provided for in Article 36(1), or compartment, as provided for
              in Article 37(2), are fulfilled; or
        (b)   it is established that the conditions for the grant of disease–free status cannot be
              achieved and that the programme no longer fulfils its purpose; or
        (c)   the Member State concerned withdraws the programme.
3.      The Commission shall, by means of implementing acts, approve:
        (a)   draft compulsory eradication programmes submitted to it for approval in accordance
              with paragraph 1;
11779/15                                                                   AS/NC/ra                 131
                                                DGB 2B                                             EN
 ---pagebreak---         (b)    draft optional eradication programmes submitted to it for approval in accordance
               with paragraph 2,
        if the conditions set out in this Chapter are met.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
4.      On duly justified imperative grounds of urgency relating to a listed disease representing a
        risk having a highly significant impact, the Commission shall adopt immediately
        applicable implementing acts provided for in point (a) of paragraph 3 of this Article in
        accordance with the procedure referred to in Article 266(3).
        The Commission may, for duly justified reasons, by means of implementing acts, approve
        an amendment proposed by the Member State concerned or withdraw the approval of
        eradication programmes approved in accordance with points (a) and (b) of paragraph 3 of
        this Article. Those implementing acts shall be adopted in accordance with the examination
        procedure referred to in Article 266(2).
5.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)    the disease control strategies, intermediate and final targets for specific diseases, and
               period of application of eradication programmes;
11779/15                                                                  AS/NC/ra                    132
                                                 DGB 2B                                             EN
 ---pagebreak---         (b)  derogations from the requirement for the submission of eradication programmes for
             approval, as provided for in point (b) of paragraph 1 of this Article and in paragraph
             2 thereof, where such approval is not necessary due to the adoption of rules regarding
             those programmes in accordance with Articles 32(2) and 35;
        (c)  the information to be provided by Member States to the Commission and to the other
             Member States concerning derogations from the requirement for approval of
             eradication programmes as provided for in point (b) of this paragraph.
        The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 amending or discontinuing rules adopted pursuant to point (b) of this paragraph.
                                             Article 32
               Measures under compulsory and optional eradication programmes
1.      Eradication programmes shall consist of at least the following measures:
        (a)  disease control measures for the eradication of the disease agent from establishments,
             compartments and zones in which a disease occurs and to prevent re–infection;
        (b)  surveillance to be carried out in accordance with the rules laid down in Articles 26 to
             30 to demonstrate:
             (i)   the effectiveness of the disease control measures provided for in point (a);
             (ii)  freedom from the listed disease;
11779/15                                                               AS/NC/ra                  133
                                              DGB 2B                                            EN
 ---pagebreak---         (c)   disease control measures to be taken in the event of positive surveillance results.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        following elements to ensure the effectiveness of eradication programmes:
        (a)   disease control measures as provided for in point (a) of paragraph 1;
        (b)   disease control measures to be taken to avoid re–infection of the targeted animal
              population with the disease in question in establishments, zones and compartments;
        (c)   surveillance design, means, diagnostic methods, frequency, intensity, targeted animal
              population and sampling patterns;
        (d)   disease control measures to be taken in the event of positive surveillance results for
              the listed disease as provided for in point (c) of paragraph 1;
        (e)   criteria for vaccination, where relevant and appropriate for the disease or species in
              question.
11779/15                                                                 AS/NC/ra                  134
                                               DGB 2B                                            EN
 ---pagebreak---                                                Article 33
                    Content of compulsory and optional eradication programmes
                              submitted for approval to the Commission
Member States shall include the following information in applications for approval of compulsory
and optional eradication programmes submitted to the Commission in accordance with Article 31(1)
and (2):
(a)      a description of the epidemiological situation of the listed disease covered by the
         compulsory or optional eradication programme in question;
(b)      a description and demarcation of the geographical and administrative area or the
         compartment covered by the eradication programme;
(c)      a description of the disease control measures of the eradication programme as provided for
         in Article 32(1) and in the rules adopted pursuant to Article 32(2);
(d)      a description of the organisation, supervision and roles of the parties involved in the
         eradication programme;
(e)      the estimated duration of the eradication programme;
(f)      the intermediate targets of, and the disease control strategies for implementing, the
         eradication programme.
11779/15                                                                  AS/NC/ra                135
                                                DGB 2B                                           EN
 ---pagebreak---                                                Article 34
                                               Reporting
Member States implementing eradication programmes shall submit to the Commission:
(a)      reports enabling the Commission to monitor achievement of the intermediate targets of the
         on-going eradication programmes as referred to in point (f) of Article 33;
(b)      a final report after completion of the eradication programme in question.
                                               Article 35
                                         Implementing powers
The Commission shall, by means of implementing acts, lay down rules concerning the information,
format and procedural requirements provided for in Articles 31 to 34 as regards:
(a)      the submission of draft compulsory and draft optional eradication programmes for
         approval;
(b)      performance indicators;
(c)      reporting to the Commission and other Member States on the results of the implementation
         of compulsory or optional eradication programmes.
Those implementing acts shall be adopted in accordance with the examination procedure referred to
in Article 266(2).
11779/15                                                               AS/NC/ra                136
                                                DGB 2B                                       EN
 ---pagebreak---                                               Chapter 4
                                      Disease–free status
                                               Article 36
                                Disease–free Member States and zones
1.      A Member State may apply to the Commission for approval of disease–free status for one
        or more of the listed diseases referred to in points (b) and (c) of Article 9(1), for one or
        more of the relevant animal species, for its entire territory or for one or more zones thereof,
        provided that one or more of the following conditions are fulfilled:
        (a)   none of the listed species for the disease covered by the application for disease–free
              status is present anywhere in the territory of the Member State concerned or in the
              relevant zone or zones covered by the application;
        (b)   the disease agent is known not to be able to survive in the entire territory of the
              Member State, or in the relevant zone or zones covered by the application, according
              to the criteria referred to in point (a)(ii) of Article 39;
        (c)   in the case of listed diseases only transmitted by vectors, none of the vectors are
              present, or they are known not to be able to survive in the entire territory of the
              Member State, or in the relevant zone or zones covered by the application, according
              to the criteria referred to in point (a)(ii) of Article 39;
11779/15                                                                  AS/NC/ra                   137
                                                DGB 2B                                             EN
 ---pagebreak---         (d)    freedom from the listed disease has been demonstrated by:
               (i)    an eradication programme complying with the rules laid down in Article 32(1)
                      and rules adopted pursuant to paragraph 2 of that Article; or
               (ii)   historical and surveillance data.
2.      Applications by Member States for disease–free status shall include evidence
        demonstrating that the conditions for disease–free status laid down in paragraph 1 are
        fulfilled.
3.      A Member State may in certain specific cases apply to the Commission for approval of
        disease–free status for one or more of the listed diseases referred to in point (a) of Article
        9(1), and in particular for approval of non–vaccination status for the entire territory, or for
        one or more zones thereof, provided that the following conditions are fulfilled:
        (a)    freedom from the listed disease has been demonstrated by:
               (i)    an eradication programme complying with the rules laid down in Article 32(1)
                      and rules adopted pursuant to paragraph 2 of that Article; or
               (ii)   historical and surveillance data;
        (b)    it has been demonstrated that vaccination against the disease would lead to costs
               which would exceed those resulting from maintaining freedom from disease without
               vaccination.
11779/15                                                                AS/NC/ra                     138
                                                DGB 2B                                             EN
 ---pagebreak--- 4.      The Commission shall, by means of implementing acts, approve, subject to amendments
        where necessary, applications by Member States for disease–free status or non-vaccination
        status when the conditions referred to in paragraphs 1 and 2 and, as relevant, paragraph 3
        are fulfilled.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                              Article 37
                                            Compartments
1.      A Member State may apply to the Commission for recognition of the disease–free status of
        compartments for listed diseases referred to in point (a) of Article 9(1), and for the
        protection of the disease–free status of such a compartment in the event of an outbreak of
        one or more of those listed diseases in its territory, provided that:
        (a)   the introduction of the listed disease or listed diseases covered by the application can
              be effectively prevented at compartment level, taking into account the disease
              profile;
        (b)   the compartment covered by the application is subject to a single common
              biosecurity management system designed to ensure the disease–free status of all
              establishments forming part of it; and
11779/15                                                                 AS/NC/ra                  139
                                                DGB 2B                                            EN
 ---pagebreak---         (c)   the compartment covered by the application has been approved by the competent
              authority for the purposes of movements of animals and products thereof in
              accordance with:
              (i)   Articles 99 and 100 for compartments keeping terrestrial animals and products
                    thereof;
              (ii)  Articles 183 and 184 for compartments keeping aquaculture animals and
                    products thereof.
2.      A Member State may apply to the Commission for recognition of the disease–free status of
        compartments for one or more of the listed diseases referred to in points (b) and (c) of
        Article 9(1), provided that:
        (a)   the introduction of the listed disease or listed diseases covered by the application can
              be effectively prevented at compartment level, taking into account the disease
              profile;
        (b)   one or more of the following conditions are complied with:
              (i)   the conditions laid down in Article 36(1) are fulfilled;
              (ii)  the establishments of the compartment covered by the application have started
                    or resumed their activities and have established a common biosecurity
                    management system designed to ensure the freedom from disease of that
                    compartment;
11779/15                                                                 AS/NC/ra                  140
                                                DGB 2B                                            EN
 ---pagebreak---         (c)   the compartment covered by the application is subject to a single common
              biosecurity management system designed to ensure the disease–free status of all
              establishments forming part of it; and
        (d)   the compartment covered by the application has been approved by the competent
              authority for the purposes of movements of animals and products thereof in
              accordance with:
              (i)   Articles 99 and 100 for compartments keeping terrestrial animals and products
                    thereof;
              (ii)  Articles 183 and 184 for compartments keeping aquaculture animals and
                    products thereof.
3.      Applications by Member States for recognition of the disease–free status of compartments
        in accordance with paragraphs 1 and 2 shall include evidence demonstrating that the
        conditions laid down in those paragraphs are fulfilled.
4.      The Commission shall, by means of implementing acts:
        (a)   recognise, subject to amendments where necessary, the disease–free status of
              compartments, when the conditions laid down in paragraph 1 or paragraph 2 and in
              paragraph 3 are fulfilled;
11779/15                                                              AS/NC/ra                 141
                                             DGB 2B                                           EN
 ---pagebreak---         (b)   determine for which of the listed diseases referred to in points (a), (b) and (c) of
              Article 9(1) the disease–free compartments may be established.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
5.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning provisions supplementing those contained in this Article, on:
        (a)   the requirements for recognition of the disease-free status of compartments as
              provided for in paragraphs 1 and 2 of this Article, based on the profile of the listed
              diseases referred to in points (a), (b) and (c) of Article 9(1), concerning at least:
              (i)    surveillance results and other evidence needed to substantiate freedom from
                     disease;
              (ii)   biosecurity measures;
        (b)   the detailed rules for the approval by the competent authority of the disease–free
              status of compartments as provided for in paragraphs 1 and 2; and
        (c)   rules concerning compartments which are located in the territory of more than one
              Member State.
11779/15                                                                  AS/NC/ra                   142
                                               DGB 2B                                               EN
 ---pagebreak---                                                 Article 38
                     Lists of disease–free Member States, zones or compartments
Each Member State shall establish and maintain an up-to-date list of its territory or zones with
disease–free status as provided for in Article 36(1) and (3), and of its compartments with
disease-free status, as provided for in Article 37(1) and (2), when applicable.
Member States shall make those lists publicly available. The Commission shall assist the Member
States in making the information contained in those lists available to the public by providing on its
internet page the links to the internet–based information pages of the Member States.
                                                Article 39
        Delegation of powers concerning the disease–free status of Member States and zones
The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)      detailed rules for the disease–free status of Member States and zones thereof, based on the
         different disease profiles, concerning:
         (i)   the criteria to be used to substantiate claims by Member States that no listed species
               are present or able to survive in their territory and the evidence required to
               substantiate such claims, as provided for in point (a) of Article 36(1);
11779/15                                                                   AS/NC/ra                143
                                                 DGB 2B                                          EN
 ---pagebreak---         (ii)   the criteria to be used, and the evidence required, to substantiate claims that a disease
               agent or vector is not able to survive, as provided for in points (b) and (c) of Article
               36(1);
        (iii) the criteria to be used, and the conditions to be applied, to determine freedom from
               the disease in question, as referred to in point (d) of Article 36(1);
        (iv) surveillance results and other evidence needed to substantiate freedom from disease;
        (v)    biosecurity measures;
        (vi) restrictions and conditions for vaccination in disease-free Member States and zones
               thereof;
        (vii) the establishment of zones separating disease–free zones or zones under the
               eradication programme from restricted zones ("buffer zones");
        (viii) zones which are located in the territory of more than one Member State;
(b)     derogations from the requirement for approval by the Commission of disease–free status
        for one or more listed diseases referred to in points (b) and (c) of Article 9(1), as laid down
        in Article 36(1), where such approval is not necessary on account of detailed rules for
        freedom from disease having been laid down in rules adopted pursuant to point (a) of this
        Article;
11779/15                                                                   AS/NC/ra                  144
                                                 DGB 2B                                             EN
 ---pagebreak--- (c)      the information to be provided by Member States to the Commission and the other
         Member States to substantiate declarations of disease–free status, without the adoption of
         an implementing act in accordance with Article 36(4), as provided for in point (b) of this
         Article.
                                               Article 40
                                         Implementing powers
The Commission shall, by means of implementing acts, lay down detailed requirements concerning
the information to be provided by Member States to the Commission and the other Member States
to substantiate declarations of disease–free status of territories, zones and compartments in
accordance with Articles 36 to 39, and the format and procedures for:
(a)      applications for recognition of disease–free status of the entire territory of the Member
         State concerned, or zones and compartments thereof;
(b)      exchanges of information between the Member States and the Commission on disease-free
         Member States, or zones and compartments thereof.
Those implementing acts shall be adopted in accordance with the examination procedure referred to
in Article 266(2).
11779/15                                                                   AS/NC/ra                145
                                                DGB 2B                                            EN
 ---pagebreak---                                               Article 41
                                 Maintenance of disease–free status
1.      Member States shall only maintain disease–free status for their territories, or zones or
        compartments thereof, as long as:
        (a)  the conditions for disease–free status laid down in Article 36(1) and Article 37(1)
             and (2), and rules laid down pursuant to paragraph 3 of this Article and Article 39,
             continue to be fulfilled;
        (b)  surveillance, taking into account the requirements provided for in Article 27, is
             undertaken to verify that the territory, zone or compartment concerned continues to
             be free of the listed disease for which it was approved or recognised as having
             disease–free status;
        (c)  restrictions are applied on movements of animals, and where relevant products
             derived therefrom, of listed species for the listed disease for which the disease–free
             status was approved or recognised, into the territory, zone or compartment
             concerned, in accordance with the rules laid down in Parts IV and V;
        (d)  other biosecurity measures are applied to prevent the introduction of the listed
             disease for which it was approved or recognised as having disease–free status.
2.      A Member State shall immediately inform the Commission if the conditions referred to in
        paragraph 1 for maintaining disease–free status are no longer met.
11779/15                                                                AS/NC/ra                  146
                                               DGB 2B                                            EN
 ---pagebreak--- 3.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        following conditions for maintaining disease–free status:
        (a)   surveillance as provided for in point (b) of paragraph 1;
        (b)   biosecurity measures as provided for in point (d) of paragraph 1.
                                               Article 42
                   Suspension, withdrawal and restoration of disease–free status
1.      Where a Member State becomes aware, or has reason to suspect, that any of the conditions
        for maintaining its status as a disease–free Member State or zone or compartment thereof,
        have been breached, it shall immediately:
        (a)   where relevant, depending on the risk, suspend or restrict movements of the listed
              species, for the listed disease for which it was approved or recognised as having
              disease-free status, to other Member States, zones or compartments with a higher
              health status for that listed disease;
        (b)   where relevant for the prevention of the spread of a listed disease for which disease–
              free status has been approved or recognised, apply the disease control measures
              provided for in Title II of Part III.
11779/15                                                                AS/NC/ra                  147
                                                DGB 2B                                          EN
 ---pagebreak--- 2.      The measures provided for in paragraph 1 shall be lifted where further investigation
        confirms that:
        (a)   the suspected breach has not taken place; or
        (b)   the suspected breach has not had a significant impact and the Member State
              concerned can provide assurances that the conditions for maintaining its disease–free
              status are again fulfilled.
3.      Where further investigation by the Member State concerned confirms that there has been
        an outbreak of the listed disease for which it obtained disease–free status, or that other
        significant breaches of the conditions for maintaining disease–free status as referred to in
        Article 41(1) have occurred, or where there is a significant likelihood of this having
        occurred, the Member State shall immediately inform the Commission thereof.
4.      The Commission shall, by means of implementing acts, withdraw without undue delay the
        approval of the disease–free status of a Member State or zone granted in accordance with
        Article 36(4) or the recognition of the disease–free status of a compartment granted in
        accordance with Article 37(4) after obtaining the information from the Member State
        concerned that the conditions for maintaining the disease–free status are no longer met.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                 AS/NC/ra                   148
                                               DGB 2B                                              EN
 ---pagebreak--- 5.      On duly justified imperative grounds of extreme urgency, where the listed disease referred
        to in paragraph 3 of this Article spreads in a rapid manner, carrying with it the risk of a
        highly significant impact on animal or public health, the economy or society, the
        Commission shall adopt immediately applicable implementing acts in accordance with the
        procedure provided for in Article 266(3).
6.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning provisions supplementing the rules for the suspension, withdrawal and
        restoration of disease–free status set out in paragraphs 1 and 2 of this Article.
11779/15                                                                AS/NC/ra                    149
                                                DGB 2B                                            EN
 ---pagebreak---                                           PART III
              DISEASE AWARENESS, PREPAREDNESS
                                     AND CONTROL
                                            TITLE I
                        Disease awareness and preparedness
                                           Chapter 1
                   Contingency plans and simulation exercises
                                              Article 43
                                         Contingency plans
1.      The Member States shall, after appropriate consultation of experts and relevant
        stakeholders, draw up, and keep up to date, contingency plans and, where necessary,
        detailed instruction manuals laying down the measures to be taken in the Member State
        concerned in the event of the occurrence of a listed disease referred to in point (a) of
        Article 9(1) or, as the case may be, of an emerging disease, in order to ensure a high level
        of disease awareness and preparedness and the ability to launch a rapid response.
11779/15                                                               AS/NC/ra                   150
                                               DGB 2B                                            EN
 ---pagebreak--- 2.      Those contingency plans and, where applicable, detailed instruction manuals shall cover at
        least the following matters:
        (a)    the establishment of a chain of command within the competent authority and with
               other public authorities, to ensure a rapid and effective decision–making process at
               Member State, regional and local level;
        (b)    the framework for cooperation between the competent authority and the other public
               authorities and relevant stakeholders involved, to ensure that actions are taken in a
               coherent and coordinated manner;
        (c)    access to:
               (i)   facilities;
               (ii)  laboratories;
               (iii) equipment;
               (iv) personnel;
               (v)   emergency funds;
               (vi) all other appropriate materials and resources necessary for the rapid and
                     efficient eradication of the listed diseases referred to in point (a) of
                     Article 9(1)or of emerging diseases;
11779/15                                                                  AS/NC/ra                  151
                                                DGB 2B                                            EN
 ---pagebreak---         (d) the availability of the following centres and groups with the necessary expertise to
            assist the competent authority:
            (i)    a functional central disease control centre;
            (ii)   regional and local disease control centres, as appropriate for the administrative
                   and geographical situation of the Member State concerned;
            (iii) operational expert groups;
        (e) implementation of the disease control measures provided for in Chapter 1 of Title II
            for the listed diseases referred to in point (a) of Article 9(1) and for emerging
            diseases;
        (f) provisions on emergency vaccination, where appropriate;
        (g) principles for the geographical demarcation of the restricted zones established by the
            competent authority in accordance with Article 64(1);
        (h) coordination with neighbouring Member States and neighbouring third countries and
            territories, where appropriate.
11779/15                                                                 AS/NC/ra                 152
                                              DGB 2B                                            EN
 ---pagebreak---                                                 Article 44
                              Implementing powers for contingency plans
The Commission shall, by means of implementing acts, lay down necessary measures concerning
the implementation in the Member States of the contingency plans provided for in Article 43(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to
in Article 266(2).
                                                Article 45
                                          Simulation exercises
1.       The competent authority shall ensure that simulation exercises concerning the contingency
         plans provided for in Article 43(1) are carried out regularly or at appropriate intervals:
         (a)   to ensure a high level of disease awareness and preparedness and the ability to launch
               a rapid response in the Member State concerned;
         (b)   to verify the functionality of those contingency plans.
2.       Where feasible and appropriate, simulation exercises shall be carried out in close
         collaboration with the competent authorities of neighbouring Member States and
         neighbouring third countries and territories.
11779/15                                                                 AS/NC/ra                    153
                                                 DGB 2B                                             EN
 ---pagebreak--- 3.      Member States shall make available to the Commission and to the other Member States, on
        request, a report on the main results of the simulation exercises carried out.
4.      When appropriate and necessary, the Commission shall, by means of implementing acts,
        lay down rules concerning the practical implementation of simulation exercises in the
        Member States, relating to:
        (a)   the frequencies of simulation exercises;
        (b)   simulation exercises covering more than one listed disease referred to in point (a) of
              Article 9(1).
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                            Chapter 2
                     The use of veterinary medicinal products
                          for disease prevention and control
                                              Article 46
            The use of veterinary medicinal products for disease prevention and control
1.      The Member States may take measures concerning the use of veterinary medicinal
        products for listed diseases, to ensure the most efficient prevention or control of those
        diseases, provided that such measures are appropriate or necessary.
11779/15                                                                AS/NC/ra                   154
                                               DGB 2B                                             EN
 ---pagebreak---         Those measures may cover the following:
        (a)   prohibitions and restrictions on the use of veterinary medicinal products;
        (b)   the compulsory use of veterinary medicinal products.
2.      Member States shall take the following criteria into consideration when determining
        whether or not to use, and how to use, veterinary medicinal products as prevention and
        control measures for a specific listed disease:
        (a)   the disease profile;
        (b)   the distribution of the listed disease in:
              (i)   the Member State concerned;
              (ii)  the Union;
              (iii) where relevant, neighbouring third countries and territories;
              (iv) third countries and territories from which animals and products are brought
                    into the Union;
        (c)   the availability and effectiveness of the veterinary medicinal products in question,
              and the risks attaching to them;
        (d)   the availability of diagnostic tests for detecting infections in animals treated with the
              veterinary medicinal products concerned;
11779/15                                                                  AS/NC/ra                   155
                                                DGB 2B                                             EN
 ---pagebreak---         (e)   the economic, social, animal welfare and environmental impact of the use of the
              veterinary medicinal products concerned compared to other available disease
              prevention and control strategies.
3.      Member States shall take appropriate preventive measures concerning the use of veterinary
        medicinal products for scientific studies or for the purposes of developing and testing them
        under controlled conditions to protect animal and public health.
                                               Article 47
                 Delegation of powers for the use of veterinary medicinal products
1.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning what might constitute appropriate and necessary measures as set
        out in Article 46, in relation to:
        (a)   prohibitions and restrictions on the use of veterinary medicinal products;
        (b)   specific conditions for the use of veterinary medicinal products for a specific listed
              disease;
        (c)   risk-mitigation measures to prevent the spread of listed diseases through animals
              treated with the veterinary medicinal products or products from such animals;
        (d)   surveillance for specific listed diseases following the use of vaccines and other
              veterinary medicinal products.
11779/15                                                                AS/NC/ra                   156
                                                DGB 2B                                            EN
 ---pagebreak--- 2.      The Commission shall take into account the criteria set out in Article 46(2) when laying
        down the rules provided for in paragraph 1 of this Article.
3.      Where, in the case of emerging risks, imperative grounds of urgency so require, the
        procedure provided for in Article 265 shall apply to rules adopted pursuant to paragraph 1
        of this Article.
                                            Chapter 3
                 Antigen, vaccine and diagnostic reagent banks
                                              Article 48
            The establishment of Union antigen, vaccine and diagnostic reagent banks
1.      For listed diseases referred to in point (a) of Article 9(1) in respect of which vaccination is
        not prohibited by a delegated act adopted pursuant to Article 47, the Commission may
        establish and be responsible for managing Union antigen, vaccine and diagnostic reagent
        banks for the storage and replacement of stocks of one or more of the following biological
        products:
        (a)    antigens;
        (b)    vaccines;
        (c)    vaccine master seed–stocks;
        (d)    diagnostic reagents.
11779/15                                                                  AS/NC/ra                  157
                                               DGB 2B                                              EN
 ---pagebreak--- 2.      The Commission shall ensure that the Union antigen, vaccine and diagnostic reagent banks
        provided for in paragraph 1:
        (a)   store sufficient stocks of the appropriate type of antigens, vaccines, vaccine master
              seed–stocks and diagnostic reagents for the specific listed disease in question, taking
              into account the needs of Member States estimated in the context of the contingency
              plans provided for in Article 43(1);
        (b)   receive regular supplies and timely replacements of antigens, vaccines, vaccine
              master seed–stocks and diagnostic reagents;
        (c)   are maintained and moved in conformity with the appropriate biosecurity, biosafety
              and bio–containment requirements laid down in Article 16(1) and in accordance with
              delegated acts adopted pursuant to Article 16(2);
3.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   the management, storage and replacement of stocks of the Union antigen, vaccine
              and diagnostic reagent banks as provided for in paragraphs 1 and 2 of this Article;
        (b)   the biosecurity, biosafety and bio–containment requirements for the operation of
              those banks, respecting the requirements provided for in Article 16(1) and taking into
              account the delegated acts adopted pursuant to Article 16(2).
11779/15                                                                AS/NC/ra                   158
                                               DGB 2B                                            EN
 ---pagebreak---                                                Article 49
                Access to the Union antigen, vaccine and diagnostic reagent banks
1.      The Commission shall, upon request, provide for the delivery of the biological products
        referred to in Article 48(1) from the Union antigen, vaccine and diagnostic reagent banks,
        provided that stocks are available, to:
        (a)   in the first place, Member States; and
        (b)   third countries or territories, provided that such delivery is primarily intended to
              prevent the spread of a disease into the Union.
2.      The Commission shall, in the event of the limited availability of stocks, prioritise access to
        the stocks to be delivered pursuant to paragraph 1 based on:
        (a)   the disease circumstances under which the request is made;
        (b)   the existence of a national antigen, vaccine and diagnostic reagent bank in the
              requesting Member State or third country or territory;
        (c)   the existence of Union measures for compulsory vaccination laid down in delegated
              acts adopted pursuant to Article 47.
11779/15                                                                 AS/NC/ra                   159
                                                DGB 2B                                             EN
 ---pagebreak---                                                Article 50
    Implementing powers concerning the Union antigen, vaccine and diagnostic reagent banks
1.      The Commission shall, by means of implementing acts, lay down rules for Union antigen,
        vaccine and diagnostic reagent banks, specifying for the biological products referred to in
        Article 48(1):
        (a)   which of those biological products are to be included in the Union antigen, vaccine
              and diagnostic reagent banks and for which of the listed diseases referred to in point
              (a) of Article 9(1);
        (b)   the types of those biological products that are to be included in the Union antigen,
              vaccine and diagnostic reagent banks and in what quantities for each specific listed
              disease referred to in point (a) of Article 9(1) for which the bank in question exists;
        (c)   the requirements concerning the supply, storage and replacement of those biological
              products;
        (d)   the delivery of those biological products from the Union antigen, vaccine and
              diagnostic reagent banks to the Member States and to third countries and territories;
        (e)   procedural and technical requirements for the inclusion of those biological products
              in the Union antigen, vaccine and diagnostic reagent banks and for requesting access
              to them.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                 AS/NC/ra                  160
                                                DGB 2B                                            EN
 ---pagebreak--- 2.       On duly justified imperative grounds of urgency relating to a listed disease referred to in
         point (a) of Article 9(1) representing a risk of a highly significant impact, the Commission
         shall adopt immediately applicable implementing acts in accordance with the procedure
         provided for in Article 266(3).
                                                Article 51
Confidentiality of information concerning the Union antigen, vaccine and diagnostic reagent banks
Information on the quantities and subtypes of the biological products referred to in Article 48(1)
stored in the Union antigen, vaccine and diagnostic reagent banks shall be treated by the
Commission as classified information and shall not be published.
                                                Article 52
                       National antigen, vaccine and diagnostic reagent banks
1.       Member States that have established national antigen, vaccine and diagnostic reagent
         banks for listed diseases referred to in point (a) of Article 9(1) for which Union antigen,
         vaccine and diagnostic reagent banks exist, shall ensure that their national antigen, vaccine
         and diagnostic reagent banks comply with the biosecurity, biosafety and bio–containment
         requirements laid down in point (a) of Article 16(1) and in delegated acts adopted in
         accordance with Article 16(2) and point (b) of Article 48(3).
11779/15                                                                   AS/NC/ra                 161
                                                 DGB 2B                                           EN
 ---pagebreak--- 2.      Member States shall provide the Commission with up–to–date information on:
        (a)   the existence or the establishment of the national antigen, vaccine and diagnostic
              reagent banks referred to paragraph 1;
        (b)   the types of antigens, vaccines, vaccine master-seed stocks and diagnostic reagents
              and the quantities thereof held in such banks;
        (c)   any changes in the operation of such banks.
        That information shall be treated as classified information by the Commission and shall not
        be published.
3.      The Commission may, by means of implementing acts, lay down rules specifying the
        content, frequency and format of the submission of the information provided for in
        paragraph 2.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                               AS/NC/ra                  162
                                               DGB 2B                                           EN
 ---pagebreak---                                              TITLE II
                                 Disease control measures
                                             Chapter 1
                 Disease control measures for listed diseases as
                        referred to in point (a) of Article 9(1)
                                             SECTION 1
               DISEASE CONTROL MEASURES IN THE EVENT OF SUSPICION
                            OF A LISTED DISEASE IN KEPT ANIMALS
                                               Article 53
         Obligations on operators and other relevant natural and legal persons concerned
1.      In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept
        animals, in addition to complying with the notification obligation laid down in Article
        18(1) and pending any disease control measures being taken by the competent authority in
        accordance with Articles 54(1) and 55(1), Member States shall take measures to ensure
        that operators and other relevant natural and legal persons concerned take the appropriate
        disease control measures provided for in points (c), (d) and (e) of Article 55(1), to prevent
        the spread of that listed disease from the affected animals, establishments and locations
        under their responsibility to other unaffected animals or to humans.
11779/15                                                                  AS/NC/ra                    163
                                                DGB 2B                                              EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning detailed rules for supplementing the disease control measures provided for
        in paragraph 1 of this Article.
                                               Article 54
       Investigation by the competent authority in the event of suspicion of a listed disease
1.      In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept
        animals, the competent authority shall conduct without delay an investigation to confirm or
        rule out the presence of that listed disease.
2.      For the purpose of the investigation provided for in paragraph 1, the competent authority
        shall, when appropriate, ensure that:
        (a)    official veterinarians carry out a clinical examination of a representative sample of
               the kept animals of listed species for the listed disease in question;
        (b)    official veterinarians take appropriate samples from those kept animals of listed
               species and other samples for examination in laboratories designated for that purpose
               by the competent authority;
        (c)    such designated laboratories carry out examinations to confirm or rule out the
               presence of the listed disease in question.
11779/15                                                                  AS/NC/ra                    164
                                                DGB 2B                                              EN
 ---pagebreak--- 3.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        detailed rules supplementing the rules for investigations by competent authorities as
        provided for in paragraph 1 of this Article.
                                               Article 55
                  Preliminary disease control measures by competent authorities
1.      The competent authority shall, in the event that it suspects the presence of a listed disease
        as referred to in point (a) of Article 9(1) in kept animals, carry out the following
        preliminary disease control measures, subject to national requirements for gaining access
        to private residences, pending the results of the investigation provided for in Article 54(1)
        and the carrying-out of the disease control measures provided for in Article 61(1):
        (a)   place the establishment, food and feed business or animal by–products establishment
              concerned, or any other location where the disease is suspected of having occurred,
              including locations where the suspected disease may have originated, under official
              surveillance;
        (b)   compile an inventory of:
              (i)    the kept animals in the establishment, food and feed business, or animal by–
                     products establishment concerned, or in any other location;
11779/15                                                                  AS/NC/ra                 165
                                                DGB 2B                                            EN
 ---pagebreak---             (ii)   the products in that establishment, food and feed business, or animal by–
                   products establishment, or in any other location, where relevant for the spread
                   of that listed disease;
        (c) ensure that appropriate biosecurity measures are applied to prevent the spreading of
            that listed disease agent to other animals or to humans;
        (d) when appropriate to prevent the further spread of the disease agent, ensure that the
            kept animals of listed species for that listed disease are isolated, and that they are
            prevented from coming into contact with wildlife;
        (e) restrict the movements of kept animals, products and, if appropriate, people, vehicles
            and any material or other means by which the disease agent could have spread to or
            from the establishment, food and feed business or animal by–products establishment,
            or from any other location where that listed disease is suspected, as far as necessary
            to prevent its spread;
        (f) take any other necessary disease control measures, taking into account the disease
            control measures provided for in Section 4 of this Chapter, concerning:
            (i)    the application of the investigation by the competent authority provided for in
                   Article 54(1) and disease control measures provided for in points (a) to (d) of
                   this paragraph to other establishments, food and feed businesses, or animal by–
                   products establishments, or to any other location;
11779/15                                                                AS/NC/ra                   166
                                              DGB 2B                                             EN
 ---pagebreak---               (ii)   the establishment of any temporary restricted zones which are appropriate,
                     taking into account the disease profile;
        (g)   initiate the epidemiological enquiry provided for in Article 57(1).
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        detailed rules supplementing those laid down in paragraph 1 of this Article as regards the
        specific and detailed disease control measures to be taken depending on the listed disease
        referred to in point (a) of Article 9(1), based on the risks involved for:
        (a)   the species or category of animals concerned;
        (b)   the type of production concerned.
                                               Article 56
                 Review and extension of the preliminary disease control measures
The disease control measures provided for in Article 55(1) shall be:
(a)     reviewed by the competent authority, as appropriate, following the findings of:
        (i)   the investigation provided for in Article 54(1);
        (ii)  the epidemiological enquiry provided for in Article 57(1);
(b)     further extended to other locations as referred to in point (a) of Article 55(1), where
        necessary.
11779/15                                                                  AS/NC/ra               167
                                                DGB 2B                                          EN
 ---pagebreak---                                               SECTION 2
                                 EPIDEMIOLOGICAL ENQUIRY
                                               Article 57
                                       Epidemiological enquiry
1.      The competent authority shall carry out an epidemiological enquiry in the event of the
        confirmation of a listed disease as referred to in point (a) of Article 9(1) in animals.
2.      The epidemiological enquiry provided for in paragraph 1 shall aim to:
        (a)   identify the likely origin of the listed disease in question and the means of its spread;
        (b)   calculate the likely length of time that the listed disease has been present;
        (c)   identify establishments and epidemiological units therein, food and feed businesses
              or animal by–products establishments, or other locations, where animals of listed
              species for the suspected listed disease may have become infected, infested or
              contaminated;
        (d)   obtain information on the movements of kept animals, persons, products, vehicles,
              any material or other means by which the disease agent could have been spread
              during the relevant period preceding the notification of the suspicion or confirmation
              of the listed disease;
11779/15                                                                  AS/NC/ra                  168
                                                DGB 2B                                             EN
 ---pagebreak---         (e)   obtain information on the likely spread of the listed disease in the surrounding
              environment, including the presence and distribution of disease vectors.
                                             SECTION 3
                          DISEASE CONFIRMATION IN KEPT ANIMALS
                                               Article 58
                 Official confirmation by the competent authority of a listed disease
                               as referred to in point (a) of Article 9(1)
1.      The competent authority shall base an official confirmation of a listed disease as referred to
        in point (a) of Article 9(1) on the following information:
        (a)   the results of the clinical and laboratory examinations provided for in Article 54(2);
        (b)   the preliminary or final results of the epidemiological enquiry provided for in Article
              57(1);
        (c)   other available epidemiological data.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        requirements to be fulfilled for the official confirmation referred to in paragraph 1of this
        Article.
11779/15                                                                   AS/NC/ra                169
                                                DGB 2B                                            EN
 ---pagebreak---                                                 Article 59
                             Lifting of preliminary disease control measures
                       where the presence of the listed disease has been ruled out
The competent authority shall continue to apply the preliminary disease control measures provided
for in Article 55(1) and Article 56 until the presence of the listed disease in question, as referred to
in point (a) of Article 9(1), has been ruled out on the basis of the information referred to in Article
58(1) or rules adopted pursuant to Article 58(2).
                                               SECTION 4
                                   DISEASE CONTROL MEASURES
              IN THE EVENT OF CONFIRMATION OF DISEASE IN KEPT ANIMALS
                                                Article 60
              Immediate disease control measures to be taken by the competent authority
In the event of an official confirmation in accordance with Article 58(1) of an outbreak of a listed
disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority shall
immediately:
(a)       declare the affected establishment, food or feed business, animal by–products
          establishment or other location as officially infected with that listed disease;
(b)       establish a restricted zone appropriate for that listed disease;
11779/15                                                                   AS/NC/ra                   170
                                                 DGB 2B                                             EN
 ---pagebreak--- (c)     implement the contingency plan provided for in Article 43(1) to ensure full coordination of
        the disease control measures.
                                              Article 61
                             Affected establishments and other locations
1.      In the event of an outbreak of a listed disease as referred to in point (a) of Article 9(1) in
        kept animals, the competent authority shall immediately take one or more of the following
        disease control measures, subject to national requirements for gaining access to private
        residences, in an establishment, food or feed business, animal by–products establishment,
        or any other location referred to in point (a) of Article 60, in order to prevent the further
        spread of that listed disease:
        (a)   the imposition of restrictions on movements of persons, animals, products, vehicles
              or any other material or substance that may be contaminated and contribute to the
              spread of the listed disease;
        (b)   the killing and disposal or slaughtering of animals that may be contaminated or
              contribute to the spread of the listed disease;
        (c)   the destruction, processing, transformation or treatment of products, feed, or any
              other substances, or the treatment of equipment, means of transport, plants or plant
              products, or water which may be contaminated, as appropriate to ensure that any
              disease agent or vector of the disease agent is destroyed;
11779/15                                                                  AS/NC/ra                    171
                                               DGB 2B                                               EN
 ---pagebreak---         (d)  the vaccination or treatment with other veterinary medicinal products of kept animals
             in accordance with Article 46(1) and Article 69 and any delegated acts adopted
             pursuant to Article 47;
        (e)  the isolation, quarantine or treatment of animals and products that are likely to be
             contaminated and contribute to the spread of the listed disease;
        (f)  the cleaning, disinfection, control of insects and rodents, or other necessary
             biosecurity measures to be applied to the affected establishment, food or feed
             business, animal by–products establishment or other locations to minimise the risk of
             spread of the listed disease;
        (g)  the taking of a sufficient number of appropriate samples needed to complete the
             epidemiological enquiry provided for in Article 57(1);
        (h)  the laboratory examination of samples;
        (i)  any other appropriate measures.
2.      When determining which of the disease control measures provided for in paragraph 1 are
        appropriate to take, the competent authority shall take the following into account:
        (a)  the disease profile;
11779/15                                                                AS/NC/ra                  172
                                              DGB 2B                                            EN
 ---pagebreak---         (b)   the type of production, and epidemiological units within the affected establishment,
              food or feed business, animal by–products establishment or other location;
3.      The competent authority shall only authorise the repopulation of the establishment
        concerned, or of any other location, when:
        (a)   all appropriate disease control measures and laboratory examinations provided for in
              paragraph 1 have been successfully completed;
        (b)   a sufficient period of time has elapsed to prevent re–contamination of the affected
              establishment, food or feed business, animal by–products establishment or other
              location with the listed disease that caused the outbreak referred to in paragraph 1.
                                              Article 62
                       Epidemiologically linked establishments and locations
1.      The competent authority shall extend the disease control measures provided for in Article
        61(1) to other establishments, epidemiological units therein, food or feed businesses, or
        animal by–products establishments, or any other location, or means of transport where the
        epidemiological enquiry provided for in Article 57(1) or the results of clinical or laboratory
        investigations or other epidemiological data, give reason to suspect the spread to, from or
        through them of the listed disease referred to in point (a) of Article 9(1) in respect of which
        such measures were taken.
11779/15                                                                AS/NC/ra                    173
                                               DGB 2B                                              EN
 ---pagebreak--- 2.        If the epidemiological enquiry provided for in Article 57(1) shows that the likely origin of
          the listed disease referred to in point (a) of Article 9(1) is another Member State, or if it is
          likely that that listed disease has spread to another Member State, the competent authority
          shall inform that Member State and the Commission without delay.
3.        Should any of the events referred to in paragraph 2 occur, the competent authorities of the
          different Member States shall cooperate in a further epidemiological enquiry and in the
          application of disease control measures.
                                                 Article 63
                 Delegation of powers in respect of disease control measures in affected
                    and epidemiologically linked establishments and other locations
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed
rules on the disease control measures to be taken by the competent authority in accordance with
Articles 61 and 62 in affected and epidemiologically linked establishments, food or feed businesses,
or animal by–products establishments, and other locations in respect of any listed disease referred to
in point (a) of Article 9(1), including rules on which disease control measures referred to in Article
61(1) are to be applied in relation to each listed disease.
Those detailed rules shall cover the following matters:
(a)       the conditions and requirements for the disease control measures provided for in points (a)
          to (e) of Article 61(1);
11779/15                                                                     AS/NC/ra                   174
                                                  DGB 2B                                             EN
 ---pagebreak--- (b)     the procedures for cleaning, disinfection, control of insects and rodents, or other necessary
        biosecurity measures as provided for in point (f) of Article 61(1), specifying, where
        appropriate, the use of biocidal products for those purposes;
(c)     the conditions and requirements for sampling and laboratory examination as provided for
        in points (g) and (h) of Article 61(1);
(d)     the detailed conditions and requirements in respect of repopulation as provided for in
        Article 61(3);
(e)     the carrying-out of the necessary disease control measures provided for in Article 62 in
        epidemiologically linked establishments, other locations and means of transport.
                                               Article 64
                    Establishment of restricted zones by the competent authority
1.      The competent authority shall establish a restricted zone as referred to in point (b) of
        Article 60 around the affected establishment, food or feed business, animal by–products
        establishment or other location where the outbreak of a listed disease as referred to in point
        (a) of Article 9(1) in kept animals has occurred, where appropriate taking into account:
        (a)    the disease profile;
        (b)    the geographical situation of the restricted zone;
        (c)    the ecological and hydrological factors of the restricted zone;
11779/15                                                                 AS/NC/ra                 175
                                                DGB 2B                                           EN
 ---pagebreak---         (d)    the meteorological conditions;
        (e)    the presence, distribution and type of vectors in the restricted zone;
        (f)    the results of the epidemiological enquiry provided for in Article 57(1) and other
               studies carried out and epidemiological data;
        (g)    the results of laboratory tests;
        (h)    the disease control measures applied;
        (i)    other relevant epidemiological factors.
        The restricted zone shall include, when appropriate, a protection and surveillance zone of a
        defined size and configuration.
2.      The competent authority shall continuously assess and review the situation and, when
        appropriate in order to prevent the spread of the listed disease referred to in point (a) of
        Article 9(1), shall:
        (a)    adapt the boundaries of the restricted zone;
        (b)    establish additional restricted zones.
3.      Where restricted zones as provided for in paragraph 1 are situated in the territory of more
        than one Member State, the competent authorities of those Member States shall cooperate
        in establishing them.
11779/15                                                                  AS/NC/ra                   176
                                                DGB 2B                                             EN
 ---pagebreak--- 4.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        detailed rules for the establishment and modification of restricted zones, including
        protection or surveillance zones.
                                               Article 65
                             Disease control measures in restricted zones
1.      The competent authority shall ensure that, subject to national requirements for gaining
        access to private residences, one or more of the following disease control measures are
        taken in the restricted zone concerned, in order to prevent the further spread of a listed
        disease as referred to in point (a) of Article 9(1):
        (a)   the identification of establishments, food or feed businesses, animal by–products
              establishments or other locations with kept animals of listed species for that listed
              disease;
        (b)   visits to establishments, food or feed businesses, animal by–products establishments
              or other locations with kept animals of listed species for that listed disease, and,
              where necessary, examinations, sampling and laboratory examination of the samples
              taken;
        (c)   the imposition of conditions for the movement of persons, animals, products, feed,
              vehicles and any other material or substance that may be contaminated or contribute
              to the spread of that listed disease within and from the restricted zone and transport
              through the restricted zone;
11779/15                                                                AS/NC/ra                    177
                                                DGB 2B                                             EN
 ---pagebreak---         (d) biosecurity requirements for:
            (i)   the production, processing and distribution of products of animal origin;
            (ii)  the collection and disposal of animal by–products;
            (iii) the collection, storage and handling of germinal products;
        (e) the vaccination and treatment with other veterinary medicinal products of kept
            animals in accordance with Article 46(1) and any delegated acts adopted pursuant to
            Article 47;
        (f) cleaning, disinfection, control of insects and rodents, or other necessary biosecurity
            measures;
        (g) the designation or where relevant, approval of a food business establishment for the
            purposes of the slaughtering of animals or the treatment of products of animal origin
            originating from the restricted zone;
        (h) the identification and traceability requirements for the movement of animals,
            germinal products or products of animal origin;
        (i) other necessary biosecurity and risk-mitigating measures to minimise the risk of the
            spread of that listed disease.
11779/15                                                               AS/NC/ra                  178
                                             DGB 2B                                            EN
 ---pagebreak--- 2.      The competent authority shall:
        (a)   take all necessary measures to fully inform persons in the restricted zone of the
              restrictions in force and the nature of the disease control measures;
        (b)   impose the necessary obligations on operators in order to prevent the further spread
              of the listed disease in question.
3.      When determining which of the disease control measures provided for in paragraph 1 are
        to be taken, the competent authority shall take the following into account:
        (a)    the disease profile;
        (b)    the types of production;
        (c)    the feasibility, availability and effectiveness of those disease control measures.
                                                Article 66
                   Operators' obligations regarding movements in restricted zones
1.      In restricted zones as provided for in Article 64(1), operators shall only move the kept
        animals and products with the permission of the competent authority and in accordance
        with any instructions given by that authority.
11779/15                                                                   AS/NC/ra                179
                                                 DGB 2B                                           EN
 ---pagebreak--- 2.       Operators keeping animals and products in a restricted zone as provided for in Article
         64(1) shall notify to the competent authority intended movements of kept animals and
         products within or out of the restricted zone in question. In so far as the competent
         authority has imposed notification obligations in accordance with point (b) of Article
         65(2), the operators concerned shall notify in accordance with those obligations.
                                                   Article 67
            Delegation of powers concerning disease control measures in restricted zones
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed
rules on the disease control measures to be taken in restricted zones as provided for in Article 65(1)
for each listed disease referred to in point (a) of Article 9(1), including rules on which disease
control measures referred to in Article 65(1) are to be applied in the case of each listed disease.
Those detailed rules shall cover the following matters:
(a)      the conditions and requirements for the disease control measures provided for in points (a),
         (c), (d), (e), (g), (h) and (i) of Article 65(1);
(b)      the procedures for cleaning, disinfection, control of insects and rodents, or other necessary
         biosecurity measures as provided for in point (f) of Article 65(1), specifying, where
         appropriate, the use of biocidal products for those purposes;
11779/15                                                                   AS/NC/ra                  180
                                                    DGB 2B                                          EN
 ---pagebreak--- (c)     the necessary surveillance which is to be conducted following the application of the
        disease control measures and laboratory examinations provided for in point (b) of
        Article 65(1);
(d)     other specific disease control measures to limit the spread of specific listed diseases as
        referred to in point (a) of Article 9(1).
                                                Article 68
            Maintaining disease control measures in restricted zones and delegated acts
1.      The competent authority shall continue to apply the disease control measures provided for
        in this Section until the following conditions are met:
        (a)    the disease control measures appropriate to the listed disease referred to in point (a)
               of Article 9(1) for which they were applied have been carried out;
        (b)    the final cleaning, disinfection, control of insects and rodents, or other necessary
               biosecurity measures has been carried out as appropriate for:
               (i)    the listed disease referred to in point (a) of Article 9(1) for which the disease
                      control measures have been applied;
               (ii)   the affected species of kept animals;
               (iii) the type of production;
11779/15                                                                    AS/NC/ra                  181
                                                 DGB 2B                                              EN
 ---pagebreak---         (c)   adequate surveillance, as appropriate for the listed disease referred to in point (a) of
              Article 9(1) for which the disease control measures have been applied, and for the
              type of establishment or location concerned, has been carried out in the restricted
              zone substantiating the eradication of that listed disease.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        detailed rules for the disease control measures to be taken by the competent authority, as
        provided for in paragraph 1, in relation to:
        (a)   the final procedures for cleaning, disinfection, control of insects and rodents, or other
              necessary biosecurity measures and, where appropriate, the use of biocidal products
              for those purposes;
        (b)   the design, means, methods, frequency, intensity, targeted animal population and
              sampling patterns of surveillance aimed at the restoration of disease–free status after
              the outbreak;
        (c)   repopulation of the restricted zone concerned after the completion of the disease
              control measures provided for in paragraph 1 of this Article, taking into account the
              conditions for repopulation provided for in Article 61(3).
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning detailed rules for the disease control measures to be taken by the
        competent authority, as provided for in paragraph 1, in relation to other disease control
        measures necessary for the restoration of disease–free status.
11779/15                                                                AS/NC/ra                    182
                                               DGB 2B                                             EN
 ---pagebreak---                                              Article 69
                                      Emergency vaccination
1.      Where relevant for the effective control of a listed disease as referred to in point (a) of
        Article 9(1) for which disease control measures apply, the competent authority may:
        (a)   develop a vaccination plan;
        (b)   establish vaccination zones.
2.      When deciding on the vaccination plan and the establishment of vaccination zones as
        provided for in paragraph 1, the competent authority shall take the following into account:
        (a)   the requirements for emergency vaccination set out in the contingency plans
              provided for in Article 43;
        (b)   the requirements for the use of vaccines as provided for in Article 46(1) and any
              delegated acts adopted pursuant to Article 47.
3.      Vaccination zones as provided for in point (b) of paragraph 1 of this Article shall meet the
        requirements in respect of risk-mitigating measures to prevent the spread of listed diseases
        and surveillance as laid down in any delegated acts adopted in accordance with points (c)
        and (d) of Article 47.
11779/15                                                                 AS/NC/ra                    183
                                              DGB 2B                                                EN
 ---pagebreak---                                              SECTION 5
                                          WILD ANIMALS
                                              Article 70
                                             Wild animals
1.      Where the competent authority of an affected Member State suspects or officially confirms
        the presence of a listed disease as referred to in point (a) of Article 9(1) in wild animals, it
        shall:
        (a)    conduct, where relevant for that particular listed disease, surveillance in the wild
               animal population;
        (b)    take the necessary disease prevention and control measures.
2.      The disease prevention and control measures provided for in point (b) of paragraph 1 of
        this Article may include one or more of the measures laid down in Article 53 to 69 and
        shall take into account the disease profile and the affected wild animals and the risk of
        transmission of diseases to animals and humans.
11779/15                                                                 AS/NC/ra                    184
                                               DGB 2B                                              EN
 ---pagebreak--- 3.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   criteria and procedures for surveillance pursuant to point (a) of paragraph 1 of this
              Article in the case of official confirmation of a listed disease as referred to in
              point (a) of Article 9(1), in accordance with Article 27;
        (b)   detailed rules supplementing the disease prevention and control measures to be taken
              pursuant to point (b) of paragraph 1 of this Article in the case of official confirmation
              of a listed disease as referred to in point (a) of Article 9(1).
        When adopting those delegated acts, the Commission shall take into account the disease
        profile and the listed species for the listed disease referred to paragraph 1 of this Article.
11779/15                                                                   AS/NC/ra                  185
                                                 DGB 2B                                             EN
 ---pagebreak---                                              SECTION 6
                         ADDITIONAL DISEASE CONTROL MEASURES
            BY THE MEMBER STATES, COORDINATION BY THE COMMISSION
                    AND TEMPORARY SPECIAL DISEASE CONTROL RULES
                                              Article 71
                                 Additional disease control measures,
                coordination of measures and temporary special disease control rules
                            concerning Sections 1 to 5 (Articles 53 to 70)
1.      Member States may take disease control measures additional to those provided for in
        Article 55, Article 61(1), Article 62, Article 65(1) and (2) and Article 68(1) and in any
        delegated acts adopted pursuant to Article 63, Article 67 and Article 68(2), provided that
        such measures respect the rules laid down in this Regulation and are necessary and
        proportionate to control the spread of a listed disease as referred to in point (a) of Article
        9(1), taking into account:
        (a)    the particular epidemiological circumstances;
        (b)    the type of establishments, other locations and production concerned;
        (c)    the species and categories of animals involved;
11779/15                                                                 AS/NC/ra                    186
                                               DGB 2B                                              EN
 ---pagebreak---         (d)   economic or social conditions.
2.      Member States shall inform the Commission without delay of:
        (a)   the disease control measures taken by their competent authority as provided for in
              Articles 58, 59, 61, 62, 64 and 65, Article 68(1), Article 69 and Article 70(1) and (2)
              and in any delegated acts adopted pursuant to Articles 63 and 67 and Articles 68(2)
              and 70(3);
        (b)   any additional disease control measures taken by them as provided for in
              paragraph 1.
3.      The Commission shall review the disease situation and the disease control measures taken
        by the competent authority and any additional disease control measures taken by the
        Member State concerned, in accordance with this Chapter, and may, by means of
        implementing acts, lay down special disease control measures for a limited period of time,
        under conditions appropriate to the epidemiological situation, where:
        (a)   those disease control measures are found not to be suited to the epidemiological
              situation;
11779/15                                                                AS/NC/ra                  187
                                              DGB 2B                                             EN
 ---pagebreak---         (b)   the listed disease referred to in point (a) of Article 9(1) appears to be spreading
              despite the disease control measures taken in accordance with this Chapter.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
4.      On duly justified imperative grounds of urgency relating to a disease representing an
        emerging risk of a highly significant impact, the Commission shall adopt immediately
        applicable implementing acts in accordance with the procedure referred to in
        Article 266(3).
11779/15                                                                  AS/NC/ra                 188
                                                DGB 2B                                            EN
 ---pagebreak---                                              Chapter 2
                  Disease control measures for listed diseases as
                  referred to in points (b) and (c) of Article 9(1)
                                              SECTION 1
                                  DISEASE CONTROL MEASURES
                IN THE EVENT OF SUSPICION OF DISEASE IN KEPT ANIMALS
                                               Article 72
                        Obligations on operators and other relevant natural
                      and legal persons concerned in relation to listed diseases
                               as referred to in point (b) of Article 9(1)
1.      In the event of suspicion of a listed disease as referred to in point (b) of Article 9(1) in kept
        animals, in addition to complying with the notification obligation laid down in Article
        18(1) and pending any disease control measures being taken by the competent authority in
        accordance with Article 74(1), Member States shall take measures to ensure that operators
        and other relevant natural and legal persons concerned take disease control measures as
        referred to in point (a) of Article 74(1) and in any delegated acts adopted pursuant to
        Article 74(4), to prevent the spread of that listed disease from the affected animals,
        establishments and other locations under their responsibility to other unaffected animals or
        to humans.
11779/15                                                                   AS/NC/ra                   189
                                                DGB 2B                                              EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning detailed rules for supplementing the disease control measures as provided
        for in paragraph 1 of this Article.
                                               Article 73
       Investigation by the competent authority in the event of suspicion of a listed disease
                               as referred to in point (b) of Article 9(1)
1.      In the event of suspicion of a listed disease as referred to in point (b) of Article 9(1) in kept
        animals, the competent authority shall conduct without delay an investigation to confirm or
        rule out the presence of that listed disease.
2.      For the purpose of the investigation provided for in paragraph 1, the competent authority
        shall ensure that:
        (a)    official veterinarians carry out a clinical examination of a representative sample of
               the kept animals of listed species for the listed disease in question;
        (b)    official veterinarians take appropriate samples from those kept animals of listed
               species and other samples for examination in laboratories designated for that purpose
               by the competent authority;
        (c)    such designated laboratories carry out examinations to confirm or rule out the
               presence of the listed disease in question.
11779/15                                                                   AS/NC/ra                   190
                                                DGB 2B                                              EN
 ---pagebreak--- 3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning detailed rules supplementing the rules for investigations as provided for in
        paragraph 1 of this Article.
                                               Article 74
       Preliminary disease control measures by the competent authority for listed diseases
                               as referred to in point (b) of Article 9(1)
1.      The competent authority shall, in the event that it suspects a listed disease as referred to in
        point (b) of Article 9(1) in kept animals, carry out the following preliminary disease
        control measures, subject to national requirements for gaining access to private residences,
        pending the results of the investigation provided for in Article 73(1) and the carrying-out
        of the disease control measures provided for in Article 79(1) and (2):
        (a)   apply disease control measures to limit the spread of that listed disease from the
              affected territory, establishment, food or feed business, animal by–products
              establishment or other location;
        (b)   initiate, where necessary, an epidemiological enquiry, taking into account the rules
              for such enquiry laid down in Article 57(1).
11779/15                                                                   AS/NC/ra                 191
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      In addition to the measures referred to in paragraph 1, the competent authority may, in the
        cases referred to in that paragraph, take additional preliminary disease control measures,
        provided that those measures respect the provisions of this Regulation and are in
        accordance with Union law.
3.      The preliminary disease control measures provided for in paragraphs 1 and 2 shall be
        appropriate and proportionate to the risk posed by the listed disease in question, taking into
        account the following:
        (a)   the disease profile;
        (b)   the kept animals affected;
        (c)   the health status of the Member State, zone, compartment or establishment in which
              the listed disease is suspected;
        (d)   the preliminary disease control measures provided for in Article 55(1) and Article 56
              and in any delegated act adopted pursuant to Article 55(2).
11779/15                                                                AS/NC/ra                   192
                                               DGB 2B                                            EN
 ---pagebreak--- 4.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        rules for listed diseases as referred to in point (b) of Article 9(1) supplementing those laid
        down in paragraph 1 of this Article, while taking into account the matters referred to in
        paragraph 3, as regards:
        (a)    the preliminary disease control measures to be taken to prevent the spread of the
               listed disease, as provided for in point (a) of paragraph 1;
        (b)    the application of the preliminary disease control measures provided for in point (a)
               of paragraph 1 to other establishments, epidemiological units therein, food or feed
               businesses and animal by–products establishments or other locations;
        (c)    the establishment of temporary restricted zones which are appropriate in light of the
               disease profile.
                                                Article 75
       Review and extension of the preliminary disease control measures for listed diseases
                                as referred to in point (b) of Article 9(1)
The disease control measures provided for in Article 74(1) shall be:
(a)     reviewed by the competent authority, as appropriate, following the findings of the
        investigation provided for in Article 73(1) and, where relevant, the epidemiological
        enquiry provided for in point (b) of Article 74(1);
11779/15                                                                    AS/NC/ra                193
                                                 DGB 2B                                            EN
 ---pagebreak--- (b)     further extended to other locations, as referred to in point (b) of Article 74(4), where
        necessary.
                                                Article 76
                Obligations of operators and other relevant natural and legal persons
   and measures to be taken by the competent authority in the event of suspicion of listed diseases
                                as referred to in point (c) of Article 9(1)
1.      In the event of suspicion of a listed disease as referred to in point (c) of Article 9(1) in a
        Member State that has opted for the eradication programme covering the relevant parts of
        its territory or zones or compartments thereof, as provided for in Article 31(2), that
        Member State shall take measures to ensure that operators and other relevant natural and
        legal persons concerned take appropriate measures as provided for in Article 72(1),
        pending any disease control measures being taken by the competent authority in
        accordance with paragraph 2 of this Article.
2.      The competent authority of a Member State that has opted for the eradication of a listed
        disease as referred to in paragraph 1 shall, in the event that it suspects the disease in
        question in kept animals:
        (a)    conduct without delay an investigation to confirm or rule out the presence of that
               listed disease in accordance with Article 73(1) and (2);
11779/15                                                                    AS/NC/ra                  194
                                                 DGB 2B                                             EN
 ---pagebreak---         (b)   pending the results of the investigation provided for in point (a) and the carrying-out
              of disease control measures in accordance with Article 80(1), carry out the
              preliminary disease control measures provided for in Article 74(1) and (2).
3.      The competent authority shall review and extend the preliminary disease control measures
        referred to in point (b) of paragraph 2, in accordance with Article 75.
4.      Paragraphs 1, 2 and 3 of this Article shall also apply to Member States or zones which
        have obtained disease–free status, in order to maintain that status, in accordance with
        Article 36, or to compartments in accordance with Article 37(2).
5.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning detailed rules supplementing rules in respect of:
        (a)   the disease control measures provided for in paragraph 1;
        (b)   the investigation provided for in point (a) of paragraph 2;
        (c)   the preliminary disease control measures to be taken to prevent the spread of the
              listed disease, as provided for in point (b) of paragraph 2.
11779/15                                                                AS/NC/ra                  195
                                               DGB 2B                                            EN
 ---pagebreak---                                                 SECTION 2
                           DISEASE CONFIRMATION IN KEPT ANIMALS
                                                 Article 77
                       Official confirmation of disease by the competent authority
1.        The competent authority shall base an official confirmation of a listed disease as referred to
          in point (b) or (c) of Article 9(1) on the following information:
          (a)   the results of the clinical and laboratory examinations provided for in Article 73(2);
          (b)   the epidemiological enquiry provided for in point (b) of Article 74(1), where
                relevant;
          (c)   other available epidemiological data.
2.        The Commission shall adopt delegated acts in accordance with Article 264 concerning the
          requirements to be fulfilled for the official confirmation referred to in paragraph 1.
                                                 Article 78
     Lifting preliminary disease control measures when the occurrence of a disease is ruled out
The competent authority shall continue to apply the preliminary disease control measures provided
for in Article 74(1), Article 75 and point (b) of Article 76(2) until the presence of the listed disease
in question has been ruled out in accordance with Article 77(1) and any rules adopted pursuant to
Article 77(2).
11779/15                                                                   AS/NC/ra                   196
                                                  DGB 2B                                             EN
 ---pagebreak---                                                SECTION 3
                                  DISEASE CONTROL MEASURES
              IN THE EVENT OF CONFIRMATION OF DISEASE IN KEPT ANIMALS
                                                Article 79
               Disease control measures by the competent authority for listed diseases
                                as referred to in point (b) of Article 9(1)
In the event of an official confirmation in accordance with Article 77(1) of an outbreak of a listed
disease as referred to in point (b) of Article 9(1) in kept animals, the competent authority shall, in a
Member State, zone or compartment, as relevant for that outbreak:
(a)      apply the disease control measures laid down in the compulsory eradication programme
         provided for in Article 31(1) for that listed disease; or
(b)      where the Member State or zone, or compartment, has obtained disease–free status in
         accordance with Article 36 or Article 37 respectively:
         (i)    take one or more of the measures laid down in Articles 53 to 69 proportionate to the
                risk posed by the listed disease in question, and
         (ii)   where necessary, initiate the compulsory eradication programme for that listed
                disease.
11779/15                                                                    AS/NC/ra                 197
                                                 DGB 2B                                             EN
 ---pagebreak---                                                Article 80
       Disease control measures to be taken by the competent authority for listed diseases
                                     referred to in Article 9(1)(c)
1.      In the event of an official confirmation in accordance with Article 77(1) of an outbreak of a
        listed disease as referred to in point (c) of Article 9(1) in kept animals in a Member State
        that has opted for an eradication programme covering the relevant parts of its territory or
        zones or compartments thereof, as provided for in Article 31(2), as relevant for that listed
        disease and that outbreak, the competent authority shall apply the disease control measures
        laid down in the optional eradication programme.
2.      The competent authority may take disease control measures additional to those provided
        for in paragraph 1 which may include one or more of the measures laid down in Articles 53
        to 69 and shall be proportionate to the risk posed by the listed disease in question and shall
        take into account:
        (a)    the disease profile;
        (b)    the kept animals affected;
        (c)    economic and social impacts.
11779/15                                                                   AS/NC/ra                198
                                                DGB 2B                                           EN
 ---pagebreak--- 3.        In the event of an official confirmation in accordance with Article 77(1) of an outbreak of a
          listed disease as referred to in point (c) of Article 9(1) in kept animals in a Member State,
          zone or compartment that has obtained disease–free status in accordance with Article 36 or
          Article 37, and in order to maintain that status, the competent authority shall take one or
          more of the measures laid down in Articles 53 to 69. Those measures shall be
          proportionate to the risk posed by the listed disease in question and shall take into account:
          (a)    the disease profile;
          (b)    the kept animals affected;
          (c)    economic and social impacts.
                                                SECTION 4
                                             WILD ANIMALS
                                                 Article 81
    Disease control measures for listed diseases as referred to in point (b) of Article 9(1) in wild
                                                  animals
In the event that the competent authority of an affected Member State suspects or officially
confirms the outbreak of a listed disease as referred to in point (b) of Article 9(1) in wild animals, it
shall throughout its territory, or in the area or zone concerned, as relevant for that outbreak:
(a)       apply the disease control measures laid down in the compulsory eradication programme
          provided for in Article 30(1) for that listed disease; or
11779/15                                                                     AS/NC/ra                199
                                                  DGB 2B                                           EN
 ---pagebreak--- (b)     initiate a compulsory eradication programme, where the eradication programme provided
        for in Article 31(1) for that listed disease has not yet been applied due to the previous
        absence of that disease or freedom from it, and if measures for wild animals are necessary
        in order to control and prevent the spread of that disease.
                                                Article 82
    Disease control measures for listed diseases as referred to in point (c) of Article 9(1) in wild
                                                 animals
1.      In the event that a competent authority suspects or officially confirms a listed disease as
        referred to in point (c) of Article 9(1) in wild animals and the affected Member State has
        opted for the eradication of the disease in question, and provided that measures for wild
        animals are envisaged in the optional eradication programme provided for in Article 31(2)
        for that listed disease, the competent authority shall apply the disease control measures laid
        down in that optional eradication programme throughout the territory of the Member State,
        area or zone concerned, as relevant for that suspicion or official confirmation.
2.      The competent authority may take disease control measures additional to those provided
        for in paragraph 1, which may include one or more of the measures laid down in
        Articles 53 to 69 and shall be proportionate to the risk posed by the listed disease in
        question and shall take into account:
        (a)    the disease profile;
11779/15                                                                 AS/NC/ra                    200
                                                 DGB 2B                                            EN
 ---pagebreak---         (b)    the affected wild animals and the risk of transmission of diseases to animals and
               humans; and
        (c)    economic, social and environmental impacts.
3.      In the event of an official confirmation of an outbreak of a listed disease as referred to in
        point (c) of Article 9(1) in wild animals in a Member State, zone or compartment that has
        obtained disease–free status in accordance with Article 36 or Article 37, and in order to
        maintain that status, the competent authority shall take one or more of the measures laid
        down in Articles 53 to 69. Those measures shall be proportionate to the risk posed by the
        listed disease in question and shall take into account:
        (a)    the disease profile;
        (b)    the affected wild animals and the risk of transmission of diseases to animals and
               humans;
        (c)    the relevance of the presence of the disease in wild animals in relation to the health
               status of kept animals; and
        (d)    economic, social and environmental impacts.
11779/15                                                                 AS/NC/ra                   201
                                               DGB 2B                                             EN
 ---pagebreak---                                            SECTION 5
                         COORDINATION BY THE COMMISSION
                AND TEMPORARY SPECIAL DISEASE CONTROL RULES
                                             Article 83
                         Coordination of measures by the Commission
                    and temporary special rules concerning Sections 1 to 4
1.      Member States shall inform the Commission of:
        (a) disease control measures taken by their competent authorities in accordance with
            Articles 77(1), 78, 79 and 81 and with any delegated acts adopted pursuant to Article
            77(2) in respect of a listed disease as referred to in point (b) of Article 9(1);
        (b) disease control measures taken by their competent authorities in accordance with
            Articles 77(1), 78, 80(1) and 82 and with any delegated acts adopted pursuant to
            Article 77(2) in respect of a listed disease as referred to in point (c) of Article 9(1).
11779/15                                                                AS/NC/ra                    202
                                              DGB 2B                                              EN
 ---pagebreak--- 2.      The Commission shall review the disease situation and the disease control measures taken
        by the competent authority in accordance with this Chapter and may, by means of
        implementing acts, lay down special rules for disease control measures for a limited period
        of time in respect of a listed disease as referred to in point (b) or point (c) of Article 9(1),
        under conditions appropriate to the epidemiological situation, where:
        (a)   those disease control measures taken by the competent authority in question are
              found not to be suited to the epidemiological situation;
        (b)   that listed disease appears to be spreading despite the disease control measures taken
              in accordance with this Chapter, where relevant.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
3.      On duly justified imperative grounds of urgency relating to a listed disease as referred to in
        point (b) or point (c) of Article 9(1) representing an emerging risk of a highly significant
        impact, the Commission shall adopt immediately applicable implementing acts in
        accordance with the procedure referred to in Article 266(3).
11779/15                                                                   AS/NC/ra                   203
                                                DGB 2B                                               EN
 ---pagebreak---                                           PART IV
        REGISTRATION, APPROVAL, TRACEABILITY
                                AND MOVEMENTS
                                           TITLE I
                       Terrestrial animals, germinal products
           and products of animal origin from terrestrial animals
                                          Chapter 1
            Registration, approval, record-keeping and registers
                                           SECTION 1
      REGISTRATION OF ESTABLISHMENTS AND CERTAIN TYPES OF OPERATORS
                                             Article 84
                         Obligation of operators to register establishments
1.      Operators of establishments keeping terrestrial animals or collecting, producing,
        processing or storing germinal products shall, in order for their establishments to be
        registered in accordance with Article 93, before they commence such activities:
        (a)   inform the competent authority of any such establishment under their responsibility;
11779/15                                                                AS/NC/ra                204
                                              DGB 2B                                           EN
 ---pagebreak---         (b)   provide the competent authority with the following information:
              (i)   the name and address of the operator concerned;
              (ii)  the location of the establishment and a description of its facilities;
              (iii) the categories, species and numbers or quantities of kept terrestrial animals or
                    germinal products which they intend to keep on the establishment, and the
                    capacity of the establishment;
              (iv) the type of establishment; and
              (v)   any other aspects of the establishment which are relevant for the purpose of
                    determining the risk posed by it.
2.      Operators of establishments referred to in paragraph 1 shall inform the competent authority
        of:
        (a)   any changes in the establishment in question concerning the matters referred to in
              point (b) of paragraph 1;
        (b)   any cessation of activity by the operator or establishment concerned.
3.      Establishments which are subject to approval in accordance with Article 94(1) shall not be
        required to provide the information referred to in paragraph 1 of this Article.
11779/15                                                               AS/NC/ra                   205
                                               DGB 2B                                           EN
 ---pagebreak---                                               Article 85
               Derogations from the obligation of operators to register establishments
By way of derogation from Article 84(1), Member States may exempt from the registration
requirement certain categories of establishments posing an insignificant risk, as provided for in an
implementing act adopted in accordance with Article 86(2). Member States shall inform the
Commission of such exemptions.
                                              Article 86
       Implementing powers concerning the obligation of operators to register establishments
1.       The Commission may, by means of implementing acts, lay down rules concerning the
         information to be provided by operators for the purpose of the registration of
         establishments as provided for in Article 84(1), including the time-limits by which such
         information is to be provided.
2.       The Commission shall, by means of implementing acts, lay down rules concerning the
         types of establishments that may be exempted by the Member States from the registration
         requirement in accordance with Article 85, on the basis of:
         (a)   the species, categories and numbers of kept terrestrial animals and germinal products
               on the establishment in question and the capacity of that establishment;
11779/15                                                                AS/NC/ra                   206
                                               DGB 2B                                            EN
 ---pagebreak---         (b)   the type of establishment; and
        (c)   the movements of kept terrestrial animals or germinal products into and out of the
              establishment.
3.      The implementing acts referred to in this Article shall be adopted in accordance with the
        examination procedure referred to in Article 266(2).
                                              Article 87
            Registration obligations of transporters of kept ungulates and delegated acts
1.      Transporters of kept ungulates engaged in the transportation of those animals between
        Member States or between a Member State and a third country shall, in order to be
        registered in accordance with Article 93, before they commence such activities:
        (a)   inform the competent authority of their activity;
        (b)   provide that competent authority with information on:
              (i)    the name and address of the transporter concerned;
              (ii)   the categories, species and numbers of kept ungulates for which transportation
                     is planned;
11779/15                                                                AS/NC/ra                 207
                                               DGB 2B                                          EN
 ---pagebreak---                (iii) the type of transport;
               (iv) the means of transport.
2.       Transporters as referred to in paragraph 1 shall inform the competent authority of:
         (a)   any changes concerning the matters referred to in point (b) of paragraph 1;
         (b)   any cessation of the transport activity.
3.       The Commission shall be empowered to adopt delegated acts in accordance with Article
         264 supplementing the rules provided for in paragraph 1of this Article, requiring other
         types of transporters whose transport activity poses specific and significant risks for certain
         species or categories of animals to provide adequate information for the purposes of
         registration of their activity.
                                              Article 88
           Derogations from the registration obligation of transporters of kept ungulates
By way of derogation from Article 87(1), Member States may exempt from the registration
requirement certain categories of transporters whose transport activity poses an insignificant risk, as
provided for in an implementing act adopted in accordance with Article 89(2). Member States shall
inform the Commission of such exemptions.
11779/15                                                                AS/NC/ra                    208
                                               DGB 2B                                              EN
 ---pagebreak---                                              Article 89
            Implementing powers concerning the registration obligation of transporters
1.      The Commission may, by means of implementing acts, lay down rules concerning the
        information to be provided by transporters for the purposes of registration of their activity,
        as provided for in Article 87(1) and (3), including the time-limits by which such
        information is to be provided.
2.      The Commission shall, by means of implementing acts, lay down rules concerning the
        types of transporters that may be exempted by Member States from the registration
        requirement in accordance with Article 86, on the basis of:
        (a)   the distances over which they transport the ungulates in question; and
        (b)   the categories, species and number of ungulates which they transport.
3.      The implementing acts referred to in this Article shall be adopted in accordance with the
        examination procedure referred to in Article 266(2).
11779/15                                                                AS/NC/ra                   209
                                              DGB 2B                                             EN
 ---pagebreak---                                              Article 90
                                Registration obligation of operators
                conducting assembly operations independently of an establishment
1.      Operators conducting assembly operations for kept ungulates and poultry, independently of
        an establishment, including those who buy and sell animals, shall, in order to be registered
        in accordance with Article 93, before they commence their activities, provide the
        competent authority with information on:
        (a)   the name and address of the operator concerned;
        (b)   the species and categories of kept ungulates and poultry covered by their activity.
2.      Operators as referred to in paragraph 1 shall inform the competent authority of:
        (a)   any changes concerning the matters referred to in paragraph 1;
        (b)   any cessation of activity by the operator concerned.
11779/15                                                              AS/NC/ra                    210
                                               DGB 2B                                           EN
 ---pagebreak---                                                 Article 91
      Derogations from the registration obligation of operators conducting assembly operations
By way of derogation from Article 90(1), Member States may exempt from the registration
requirement certain categories of operators conducting assembly operations posing an insignificant
risk, as provided for in an implementing act adopted in accordance with Article 92(2). Member
States shall inform the Commission of such exemptions.
                                                Article 92
               Implementing powers concerning the registration obligation of operators
                                    conducting assembly operations
1.        The Commission may, by means of implementing acts, lay down rules concerning the
          information to be provided by operators for the purpose of registration as provided for in
          Article 90(1), including the time-limits by which such information is to be provided.
2.        The Commission shall, by means of implementing acts, lay down rules concerning the
          types of operators that may be exempted by Member States from the registration
          requirement in accordance with Article 91, provided that the activity of such operators
          poses an insignificant risk and on the basis of species, the categories and numbers of kept
          terrestrial animals covered by their activity.
3.        The implementing acts referred to in this Article shall be adopted in accordance with the
          examination procedure referred to in Article 266(2).
11779/15                                                                   AS/NC/ra                211
                                                 DGB 2B                                           EN
 ---pagebreak---                                                  Article 93
                      Obligation of the competent authority concerning registration
A competent authority shall register:
(a)      establishments in the register provided for in Article 101(1), where the operator concerned
         has provided the information required in accordance with Article 84(1);
(b)      transporters in the register provided for in Article 101(1), where the transporter concerned
         has provided the information required in accordance with Article 87(1) and (3);
(c)      operators conducting assembly operations independently of an establishment, in the
         register provided for in Article 101(1), where the operator concerned has provided the
         information required in accordance with Article 90(1).
The competent authority shall assign each establishment, transporter and operator as referred to in
points (a) to (c) of the first paragraph with a unique registration number.
11779/15                                                                 AS/NC/ra                  212
                                                  DGB 2B                                          EN
 ---pagebreak---                                              SECTION 2
                    APPROVAL OF CERTAIN TYPES OF ESTABLISHMENTS
                                              Article 94
                        Approval of certain establishments and delegated acts
1.      Operators of the following types of establishments shall apply to the competent authority
        for approval in accordance with Article 96(1) and shall not commence their activities until
        their establishment has been approved in accordance with Article 97(1):
        (a)    establishments for assembly operations of ungulates and poultry from which those
               animals are moved to another Member State or which receive animals from another
               Member State;
        (b)    germinal product establishments for bovine, porcine, ovine, caprine and equine
               animals from which germinal products of those animals are moved to another
               Member State;
        (c)    hatcheries from which hatching eggs or poultry are moved to another Member State;
        (d)    establishments keeping poultry from which poultry intended for purposes other than
               slaughter or hatching eggs are moved to another Member State;
11779/15                                                              AS/NC/ra                  213
                                               DGB 2B                                         EN
 ---pagebreak---         (e)  any other type of establishment for kept terrestrial animals which poses a significant
             risk and is required to be approved in accordance with rules laid down in a delegated
             act adopted in accordance with point (b) of paragraph 3.
2.      Operators shall cease activity at an establishment as referred to in paragraph 1 where:
        (a)  the competent authority withdraws or suspends its approval in accordance with
             Article 100(2); or
        (b)  in the event of conditional approval, granted in accordance with Article 99(3), the
             establishment in question fails to comply with the outstanding requirements referred
             to in Article 99(3) and does not obtain a final approval in accordance with
             Article 97(1).
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)  derogations from the requirement for operators of the types of establishments
             referred to in points (a) to (d) of paragraph 1 to apply to the competent authority for
             approval, where those establishments pose an insignificant risk;
        (b)  the types of establishments which must be approved in accordance with point (e) of
             paragraph 1;
        (c)  special rules for the cessation of activities for germinal product establishments as
             referred to in point (b) of paragraph 1.
11779/15                                                                AS/NC/ra                  214
                                               DGB 2B                                           EN
 ---pagebreak--- 4.      When adopting delegated acts as provided for in paragraph 3, the Commission shall base
        those acts on the following criteria:
        (a)   the species and categories of kept terrestrial animals or germinal products in an
              establishment;
        (b)   the number of species and number of kept terrestrial animals or germinal products
              kept in an establishment;
        (c)   the type of establishment and type of production; and
        (d)   the movements of kept terrestrial animals or germinal products into and out of those
              types of establishments.
                                              Article 95
                           Approval of status of confined establishments
Operators of establishments wishing to obtain the status of a confined establishment shall:
(a)     apply to the competent authority for approval in accordance with Article 96(1);
(b)     move kept animals to or from their establishment in accordance with the requirements
        provided for in Article 137(1) and any delegated acts adopted in accordance with
        Article 137(2) only after their establishment has obtained an approval of that status from
        the competent authority in accordance with Articles 97 and 99.
11779/15                                                                AS/NC/ra                  215
                                               DGB 2B                                            EN
 ---pagebreak---                                               Article 96
                           Obligation of operators to provide information
                      with a view to obtaining approval and implementing acts
1.      Operators shall, for the purposes of their application for approval of their establishment as
        provided for in Article 94(1) and point (a) of Article 95, provide the competent authority
        with the following information:
        (a)   the name and address of the operator concerned;
        (b)   the location of the establishment concerned and a description of its facilities;
        (c)   the categories, species and number of kept terrestrial animals or germinal products
              relevant for the approval which are kept on the establishment;
        (d)   the type of establishment;
        (e)   other aspects of the establishment, related to its specificity, which are relevant in
              determining the risk, if any, posed by it.
2.      Operators of establishments as referred to in paragraph 1 shall inform the competent
        authority of:
        (a)   any changes in the establishments concerning the matters referred to in points (a), (b)
              or (c) of paragraph 1;
11779/15                                                                 AS/NC/ra                   216
                                               DGB 2B                                              EN
 ---pagebreak---         (b)   any cessation of activity by the operator or establishment concerned.
3.      The Commission may, by means of implementing acts, lay down rules concerning the
        information to be provided by operators in their application for approval of their
        establishment in accordance with paragraph 1, and the time-limits by which the
        information referred to in paragraph 1 and in point (b) of paragraph 2 is to be provided.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                              Article 97
          Granting of, and conditions for, approval of establishments and delegated acts
1.      Competent authorities shall only grant approval of establishments as provided for in
        Article 94(1) and point (a) of Article 95 where such establishments:
        (a)   comply with the following requirements, where appropriate, in relation to:
              (i)    quarantine, isolation and other biosecurity measures taking into account the
                     requirements provided for in point (b) of Article 10(1) and any rules adopted
                     pursuant to Article 10(2);
              (ii)   surveillance requirements as provided for in Article 24 and, where relevant for
                     the type of establishment concerned and the risk involved, in Article 25;
11779/15                                                                AS/NC/ra                  217
                                                DGB 2B                                          EN
 ---pagebreak---              (iii) record-keeping as provided for in Articles 102 and 103 and any rules adopted
                    pursuant to Articles 106 and 107;
        (b)  have facilities and equipment that are:
             (i)    adequate to reduce the risk of the introduction and spread of diseases to an
                    acceptable level, taking into account the type of establishment concerned;
             (ii)   of a capacity adequate for the number of kept terrestrial animals or the volume
                    of germinal products concerned;
        (c)  do not pose an unacceptable risk as regards the spread of diseases, taking into
             account the risk-mitigation measures in place;
        (d)  have adequately trained personnel for the activity of the establishment concerned;
        (e)  have in place a system which enables the operator concerned to demonstrate to the
             competent authority compliance with points (a) to (d).
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)  quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of
             paragraph 1;
        (b)  surveillance as referred to in point (a)(ii) of paragraph 1;
        (c)  facilities and equipment as referred to in point (b) of paragraph 1;
11779/15                                                                AS/NC/ra                  218
                                               DGB 2B                                            EN
 ---pagebreak---         (d)  responsibilities, competence and specialised training of personnel and veterinarians
             as provided for in point (d) of paragraph 1 for the activity of germinal products
             establishments and establishments for assembly operations of ungulates and poultry;
        (e)  the necessary supervision by the competent authority of germinal products
             establishments and establishments for assembly operations of ungulates and poultry.
3.      When establishing the rules to be laid down in the delegated acts to be adopted pursuant to
        paragraph 2, the Commission shall base those rules on the following matters:
        (a)  the risks posed by each type of establishment;
        (b)  the species and categories of kept terrestrial animals relevant for the approval;
        (c)  the type of production concerned;
        (d)  typical movement patterns of the type of establishment and species and categories of
             animals kept in those establishments.
11779/15                                                               AS/NC/ra                 219
                                              DGB 2B                                           EN
 ---pagebreak---                                                 Article 98
                                 Scope of the approval of establishments
The competent authority shall expressly specify in the approval of an establishment granted
pursuant to Article 97(1), following an application made in accordance with Article 94(1) or
point (a) of Article 95:
(a)      for which of the types of establishments referred to in Article 94(1) and Article 95, and in
         the rules adopted pursuant to point (b) of Article 94(3), the approval applies;
(b)      for which species and categories of kept terrestrial animals or germinal products of those
         species the approval applies.
                                                Article 99
                  Procedures for the granting of approval by the competent authority
1.       The competent authority shall establish procedures for operators to follow when applying
         for approval of their establishments in accordance with Article 94(1), Article 95 or
         Article 96(1).
2.       Upon receipt of an application for approval from an operator, the competent authority
         shall, in accordance with Article 94(1) or point (a) of Article 95, make an on–site visit.
3.       Provided that the requirements referred to in Article 97 and paragraphs (1) and (2) of this
         Article are fulfilled, the competent authority shall grant the approval.
11779/15                                                                  AS/NC/ra                  220
                                                 DGB 2B                                           EN
 ---pagebreak--- 4.      Where an establishment does not fulfil all requirements for approval as referred to in
        Article 97, the competent authority may grant conditional approval of an establishment if it
        appears, on the basis of the application by the operator concerned and the subsequent on–
        site visit as provided for in paragraph 2 of this Article, that the establishment meets all the
        main requirements that provide sufficient guarantees that the establishment does not pose a
        significant risk.
5.      Where conditional approval has been granted by the competent authority in accordance
        with paragraph 4 of this Article, it shall grant full approval only where it appears from
        another on–site visit to the establishment, carried out within three months of the date of the
        grant of conditional approval, or from documentation provided by the operator within three
        months from that date, that the establishment meets all the requirements for approval
        provided for in Article 97(1) and the rules adopted pursuant to Article 97(2).
        Where the on–site visit or the documentation referred to in the first subparagraph shows
        that clear progress has been made but that the establishment still does not meet all of those
        requirements, the competent authority may prolong the conditional approval. However,
        conditional approval shall not be granted for a period exceeding, in total, six months.
11779/15                                                                  AS/NC/ra                   221
                                               DGB 2B                                              EN
 ---pagebreak---                                              Article 100
           Review, suspension and withdrawal of approvals by the competent authority
1.      The competent authority shall keep approvals of establishments granted in accordance with
        Articles 97 and 99 under review, at appropriate intervals based on the risk involved.
2.      Where a competent authority identifies serious deficiencies in an establishment as regards
        compliance with the requirements laid down in Article 97(1) and the rules adopted
        pursuant to Article 97(2), and the operator of that establishment is not able to provide
        adequate guarantees that those deficiencies will be eliminated, the competent authority
        shall initiate procedures to withdraw the approval of the establishment.
        However, the competent authority may merely suspend, rather than withdraw, approval of
        an establishment where the operator can guarantee that it will eliminate those deficiencies
        within a reasonable period of time.
3.      Approval shall only be granted after withdrawal or restored after suspension in accordance
        with paragraph 2 when the competent authority is satisfied that the establishment fully
        complies with all the requirements of this Regulation appropriate for that type of
        establishment.
11779/15                                                               AS/NC/ra                   222
                                              DGB 2B                                             EN
 ---pagebreak---                                              SECTION 3
                         REGISTERS OF THE COMPETENT AUTHORITY
                                              Article 101
                            Registers to be kept by the competent authority
1.      Each competent authority shall establish and keep up to date registers of:
        (a)    all establishments and operators registered with it pursuant to Article 93;
        (b)    all establishments approved by it in accordance with Articles 97 and 99.
        It shall make the registers referred to in points (a) and (b) of the first subparagraph
        available to the Commission and to the competent authorities of other Member States in so
        far as the information contained therein is relevant for movements of kept terrestrial
        animals and germinal products thereof between Member States.
        It shall make the register of approved establishments as referred to in point (b) of the first
        subparagraph available to the public in so far as the information contained therein is
        relevant for movements of kept terrestrial animals and germinal products thereof between
        Member States.
11779/15                                                                  AS/NC/ra                  223
                                                DGB 2B                                            EN
 ---pagebreak--- 2.      Where appropriate and relevant, a competent authority may combine the registration
        referred to in point (a) of the first subparagraph of paragraph 1 and the approvals referred
        to in point (b) of the first subparagraph of paragraph 1 with registration for other purposes.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the detailed information to be included in the registers provided for in
        points (a) and (b) of the first subparagraph of paragraph 1, and the availability to the public
        of the register provided for in point (b) of the first subparagraph of paragraph 1.
                                               SECTION 4
                                         RECORD-KEEPING
                                                Article 102
                      Record-keeping obligations of operators of establishments
                              other than germinal products establishments
1.      Operators of establishments subject to the requirement of registration in accordance with
        Article 93, or approval in accordance with Article 97(1), shall keep and maintain records
        containing at least the following information:
        (a)    the species, categories, number and, where applicable, identification of kept
               terrestrial animals on their establishment;
11779/15                                                                 AS/NC/ra                  224
                                                 DGB 2B                                           EN
 ---pagebreak---         (b)   movements of kept terrestrial animals into and out of their establishment, stating as
              appropriate:
              (i)    their place of origin or destination;
              (ii)   the date of such movements;
        (c)   the documents required to accompany kept terrestrial animals arriving at or leaving
              their establishment in accordance with point (b) of Article 112, point (b) of Article
              113(1), point (c) of Article114(1), point (b) of Article 115, point (b) of Article 117,
              Article 143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118
              and 120 and points (b) and (c) of Article 144(1);
        (d)   mortality of kept terrestrial animals on their establishment;
        (e)   biosecurity measures, surveillance, treatments, test results and other relevant
              information as appropriate for:
              (i)    the species and categories of kept terrestrial animals in the establishment;
              (ii)   the type of production;
              (iii) the type and size of the establishment;
        (f)   the results of any animal health visits required in accordance with Article 25(1).
        The records shall be kept and maintained in paper or electronic form.
11779/15                                                                 AS/NC/ra                  225
                                                DGB 2B                                            EN
 ---pagebreak--- 2.      Establishments presenting a low risk of spreading listed or emerging diseases may be
        exempted by the Member State concerned from the requirement to keep records of all or
        some of the information listed in paragraph 1.
3.      Operators of establishments shall keep the records provided for in paragraphs 1 and 2 on
        their establishment concerned and shall:
        (a)    make them immediately available to the competent authority on request;
        (b)    retain them for a minimum period to be prescribed by the competent authority, which
               may not be less than three years.
4.      By way of derogation from paragraph 3, operators may be exempted from the obligation to
        keep records of some or all of the matters provided for in paragraph 1 when the operator
        concerned:
        (a)    has access to the computerised database referred to in Article 109 for the relevant
               species and the database already contains the information to be included in the
               records; and
        (b)    has the up–to–date information entered directly into the computerised database.
11779/15                                                               AS/NC/ra                    226
                                              DGB 2B                                             EN
 ---pagebreak---                                                Article 103
                   Record-keeping obligations of germinal product establishments
1.      Operators of germinal product establishments shall keep and maintain records containing
        at least the following information:
        (a)    the breed, age, identification and health status of donor animals used for the
               production of germinal products;
        (b)    the time and place of collection, and the processing and storage, of germinal products
               collected, produced or processed;
        (c)    the identification of the germinal products together with details of their place of
               destination, if known;
        (d)    the documents required to accompany germinal products arriving at or leaving the
               establishment in question in accordance with Article 162 and Article 164(2) and any
               rules adopted pursuant to Article 162(3) and (4);
        (e)    where relevant, the results of clinical and laboratory tests;
        (f)    laboratory techniques used.
2.      Establishments presenting a low risk of spreading listed or emerging diseases may be
        exempted by the Member State concerned from the requirement to keep records of all or
        some of the information listed in paragraph 1.
11779/15                                                                  AS/NC/ra                  227
                                                DGB 2B                                             EN
 ---pagebreak--- 3.      Operators of germinal product establishments shall keep the records provided for in
        paragraphs 1 and 2 on their establishment and:
        (a)   make them immediately available to the competent authority on request;
        (b)   retain them for a minimum period to be prescribed by the competent authority, which
              may not be less than three years.
                                             Article 104
                             Record-keeping obligations of transporters
1.      Transporters shall keep and maintain records containing at least the following information:
        (a)   the establishments visited by them;
        (b)   the categories, species and number of kept terrestrial animals transported by them;
        (c)   the cleaning, disinfection and disinfestation of the means of transport used;
        (d)   details of the documents accompanying the animals in question, including their
              document numbers.
        The records shall be kept and maintained in paper or electronic form.
2.      Transporters presenting a low risk of spreading listed or emerging diseases may be
        exempted by the Member State concerned from the requirement to keep records of all or
        some of the information listed in paragraph 1.
11779/15                                                               AS/NC/ra                 228
                                              DGB 2B                                           EN
 ---pagebreak--- 3.      Transporters shall keep the records provided for in paragraphs 1 and 2:
        (a)   in such a manner that they can be made immediately available to the competent
              authority on request;
        (b)   for a minimum period to be prescribed by the competent authority, which may not be
              less than three years.
                                              Article 105
             Record-keeping obligations of operators conducting assembly operations
1.      Operators conducting assembly operations subject to the registration requirement laid
        down in Article 93 shall keep and maintain records containing at least the following
        information:
        (a)   the species, categories, numbers and identification of kept terrestrial animals under
              their responsibility;
        (b)   movements of kept terrestrial animals under their responsibility, stating as
              appropriate:
              (i)    their place of origin and destination;
              (ii)   the date of such movements;
11779/15                                                               AS/NC/ra                   229
                                                DGB 2B                                           EN
 ---pagebreak---         (c)   the documents required to accompany kept terrestrial animals moved under their
              responsibility in accordance with point (b) of Article 112, point (b) of Article 113(1),
              point (c) of Article 114(1), point (b) of Article 115, point (b) of Article 117, Article
              143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118
              and 120 and points (b) and (c) of Article 144(1);
        (d)   mortality of kept terrestrial animals under their responsibility; and
        (e)   biosecurity measures, surveillance, treatments, test results and other relevant
              information as appropriate for the species and categories of kept terrestrial animals
              under their responsibility.
        The records shall be kept and maintained in paper or electronic form.
2.      Operators whose activities present a low risk of spreading listed or emerging diseases may
        be exempted by the Member State concerned from the requirement to keep records of all or
        some of the information listed in paragraph 1.
3.      Operators shall:
        (a)   make the records referred to in paragraph 1 available to the competent authority on
              request;
        (b)   retain those records for a minimum period to be prescribed by the competent
              authority, which may not be less than three years.
11779/15                                                                 AS/NC/ra                   230
                                               DGB 2B                                              EN
 ---pagebreak---                                             Article 106
                         Delegation of powers concerning record-keeping
1.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning rules supplementing the record-keeping requirements provided for in
        Articles 102, 103, 104 and 105, as regards:
        (a)   information to be recorded in addition to that provided for in Articles 102(1), 103(1),
              104(1) and 105(1);
        (b)   additional requirements for record-keeping in respect of germinal products collected,
              produced or processed in a germinal products establishment after that establishment
              ceased its activities.
2.      When establishing the rules to be laid down in delegated acts as provided for in
        paragraph 1, the Commission shall base those rules on the following matters:
        (a)   the risks posed by each type of establishment or activity;
        (b)   the species and categories of kept terrestrial animals or germinal products in the
              establishment concerned, or transported to or from that establishment;
        (c)   the type of production on the establishment or the type of activity;
        (d)   the typical movement patterns and categories of the animals concerned;
11779/15                                                                AS/NC/ra                  231
                                              DGB 2B                                             EN
 ---pagebreak---           (e)    the number of kept terrestrial animals or volume of germinal products under the
                 responsibility of the operator concerned.
                                                Article 107
         Implementing powers concerning exemptions from the record-keeping requirements
The Commission may, by means of implementing acts, lay down rules concerning the types of
establishments and operators that may be exempted by Member States from the record-keeping
requirements provided for in Articles 102, 103, 104 and 105, as regards:
(a)       establishments keeping, or operators handling or transporting, a small number of kept
          terrestrial animals or a small volume or number of germinal products;
(b)       species or categories of kept terrestrial animals or germinal products.
When adopting those implementing acts, the Commission shall base those acts on the criteria laid
down in Article 106(2).
Those implementing acts shall be adopted in accordance with the examination procedure referred to
in Article 266(2).
11779/15                                                                  AS/NC/ra                232
                                                  DGB 2B                                         EN
 ---pagebreak---                                             Chapter 2
                                 Traceability requirements
              for kept terrestrial animals and germinal products
                                             SECTION 1
                                  KEPT TERRESTRIAL ANIMALS
                                              Article 108
                       Member States' responsibility for establishing a system
                  for the identification and registration of kept terrestrial animals
1.      Member States shall have in place a system for the identification and registration of those
        species of kept terrestrial animals for which such a system is required by this Regulation
        and by any rules adopted pursuant to it. Such a system shall, when appropriate, provide for
        the recording of the movements of such animals.
2.      When establishing the system referred to in paragraph 1, Member States shall take into
        account:
        (a)   the species or categories of kept terrestrial animals concerned;
        (b)   the risk posed by that species or category.
11779/15                                                                  AS/NC/ra               233
                                                DGB 2B                                          EN
 ---pagebreak--- 3.      The system provided for in paragraph 1 shall include the following elements:
        (a)  the means to identify kept terrestrial animals individually or in groups;
        (b)  identification documents, movement documents and other documents for identifying
             and tracing kept terrestrial animals as referred to in Article 110;
        (c)  up–to–date records in establishments as provided for in points (a) and (b) of Article
             102(1);
        (d)  a computer database of kept terrestrial animals as provided for in Article 109(1).
4.      The system provided for in paragraph 1 shall be designed in such a manner that it:
        (a)  ensures the efficient application of the disease prevention and control measures
             provided for in this Regulation;
        (b)  facilitates the traceability of kept terrestrial animals and their movements within and
             between Member States and their entry into the Union;
        (c)  ensures the efficient interoperability, integration and compatibility of the elements of
             that system;
11779/15                                                                 AS/NC/ra                 234
                                               DGB 2B                                            EN
 ---pagebreak---         (d) ensures that the system, to the extent appropriate, is adapted to:
            (i)   the computerised information system for Union notification and reporting
                  provided for in Article 22;
            (ii)  TRACES;
        (e) ensures a coherent approach in respect of the different animal species covered by the
            system.
5.      Member States may when appropriate:
        (a) use the whole or part of the system provided for in paragraph 1 for purposes other
            than those referred to in points (a) and (b) of paragraph 4;
        (b) integrate the identification documents, movement documents and other documents
            referred to in Article 110 with the animal health certificates or self–declaration
            document provided for in Article 143(1) and (2) and Article 151(1) and in any rules
            adopted pursuant to points (b) and (c) of Article 144(1) and Article 151(3) and (4);
        (c) designate another authority or authorise another body or a natural person to ensure
            the practical application of the identification and registration system provided for in
            paragraph 1 of this Article, including the issuing of identification documents and the
            drawing-up of models as provided for in points (a), (b) and (c) of Article 110(1).
11779/15                                                               AS/NC/ra                  235
                                              DGB 2B                                           EN
 ---pagebreak---                                                Article 109
                        Member States' obligation to establish and maintain
                            a computer database of kept terrestrial animals
1.      The Member States shall establish and maintain a computer database for the recording of at
        least:
        (a)    the following information related to kept animals of the bovine species:
               (i)   their individual identification as provided for in point (a) of Article 112;
               (ii)  the establishments keeping them;
               (iii) their movements into and from those establishments;
        (b)    the following information related to kept animals of the ovine and caprine species:
               (i)   information on their identification as provided for in point (a) of Article 113(1)
                     and the number of animals at the establishments keeping them;
               (ii)  the establishments keeping them;
               (iii) their movements into and from those establishments;
11779/15                                                                 AS/NC/ra                   236
                                                DGB 2B                                             EN
 ---pagebreak---         (c) the following information related to kept animals of the porcine species:
            (i)   information on their identification as provided for in Article 115 and the
                  number of animals at the establishments keeping them;
            (ii)  the establishments keeping them;
            (iii) their movements into and from those establishments;
        (d) the following information related to kept animals of the equine species:
            (i)   their unique code as provided for in Article 114;
            (ii)  the method of identification provided for in point (b) of Article 114(1) linking
                  the animal concerned with the identification document referred to in point (iii)
                  where relevant;
            (iii) the relevant identification details from the identification document provided for
                  in point (c) of Article 114(1), as determined in the rules adopted pursuant to
                  Articles 118 and 120;
            (iv) the establishments where those animals are habitually kept;
        (e) information related to kept terrestrial animals of species other than those referred to
            in points (a), (b), (c) and (d) of this paragraph, when this is provided for in the rules
            adopted pursuant to paragraph 2.
11779/15                                                               AS/NC/ra                    237
                                               DGB 2B                                             EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the recording of information related to animal species other than those
        referred to in points (a), (b), (c) and (d) of paragraph 1 of this Article in the computer
        database provided for in that paragraph where necessary, due to the specific and significant
        risks posed by those species, in order to:
        (a)   ensure the efficient application of the disease prevention measures and control
              measures provided for in this Regulation;
        (b)   facilitate the traceability of kept terrestrial animals, their movements between
              Member States and their entry into the Union.
                                               Article 110
            Obligation of the competent authority in respect of identification documents,
                  movement documents and other documents for the identification
                                 and tracing of kept terrestrial animals
1.      Each competent authority shall:
        (a)   issue identification documents in respect of kept terrestrial animals where those
              documents are required by point (c) of Article 114(1) and point (b) of Article 117
              and by rules adopted pursuant to Articles 118 and 120;
11779/15                                                                   AS/NC/ra                 238
                                                 DGB 2B                                            EN
 ---pagebreak---         (b)   issue identification documents in respect of bovine animals as required by point (b)
              of Article 112, unless Member States exchange electronic data with other Member
              States within the framework of an electronic exchange system from the date when
              the Commission recognises the full operability of that system;
        (c)   draw up models of movement documents and other documents for the identification
              and tracing of kept terrestrial animals, when required by point (b) of Article 113(1),
              point (b) of Article 115, point (b) of Article 117 and any rules adopted pursuant to
              Articles 118 and 120.
2.      Point (b) of paragraph (1) is without prejudice to the right of Member States to adopt
        national rules on the issuing of passports for animals not intended for movement between
        Member States.
                                              Article 111
                    Public availability of information on means of identification
Each competent authority shall inform the Commission of, and make publicly available,
information on:
(a)     contact points for the computer databases established by the Member States in accordance
        with Article 109(1);
11779/15                                                                AS/NC/ra                  239
                                                DGB 2B                                          EN
 ---pagebreak--- (b)     the authorities or bodies responsible for issuing identification documents, movement
        documents and other documents in accordance with Article 110, taking into account point
        (c) of Article 108(5);
(c)     the means of identification that are to be used for each species and category of kept
        terrestrial animals in accordance with point (a) of Article 112, point (a) of Article 113(1),
        Article 114(1), point (a) of Article 115, point (a) of Article 117 and any rules adopted
        pursuant to Articles 118 and 120;
(d)     the prescribed format for the issuing of the identification documents and other documents
        referred to in Article 110.
                                              Article 112
    Operators' obligations in respect of the identification of kept animals of the bovine species
Operators keeping animals of the bovine species shall:
(a)     ensure that those kept animals are identified individually by a physical means of
        identification;
(b)     ensure that those kept animals, when they are moved between Member States, are issued
        with an identification document from the competent authority or designated authority or
        authorised body of origin, unless the conditions laid down in point (b) of Article 110(1) are
        met;
11779/15                                                                 AS/NC/ra                  240
                                               DGB 2B                                             EN
 ---pagebreak--- (c)     ensure that that identification document:
        (i)   is kept, correctly completed and updated by the operator concerned; and
        (ii)  accompanies those kept terrestrial animals at the time of movement, when such
              document is required by point (b);
(d)     transmit the information on movements of those kept animals from and to the
        establishment concerned, and all births and deaths in that establishment, to the computer
        database provided for in Article 109(1).
                                              Article 113
               Operators' obligations in respect of the identification of kept animals
                                   of the ovine and caprine species
1.      Operators keeping kept animals of the ovine and caprine species shall:
        (a)   ensure that those kept animals are each identified by a physical means of
              identification;
        (b)   ensure that those kept animals are accompanied by a correctly completed movement
              document based on the model drawn up by the competent authority in accordance
              with Article 110 when they are moved from the establishment keeping those animals
              within the Member State concerned;
11779/15                                                                AS/NC/ra                241
                                                DGB 2B                                         EN
 ---pagebreak---         (c)   transmit the information on movements of those kept animals from and to the
              establishment to the computer database provided for in Article 109(1).
2.      Member States may exempt operators from the requirement to ensure that kept animals of
        the ovine and caprine species are accompanied by movement documents during
        movements within their territory, provided that:
        (a)   the information contained in the relevant movement document is included in the
              computer database provided for in Article 109(1);
        (b)   the system for the identification and registration of kept animals of the ovine and
              caprine species provides level of traceability equivalent to that provided by
              movement documents.
                                             Article 114
               Operators' obligations in respect of the identification and registration
                                of kept animals of the equine species
1.      Operators keeping kept animals of the equine species shall ensure that those animals are
        individually identified by:
        (a)   a unique code which is recorded in the computer database provided for in
              Article 109(1);
11779/15                                                                AS/NC/ra                  242
                                               DGB 2B                                            EN
 ---pagebreak---         (b)   a physical means of identification or other method which unequivocally links the
              kept animal with the identification document provided for in point (c) of this
              paragraph and issued by the competent authority in accordance with Article 110;
        (c)   a correctly completed single lifetime identification document.
2.      Operators of kept animals of the equine species shall ensure that the information on those
        animals is transmitted to the computer database provided for in Article 109(1).
                                              Article 115
    Operators' obligations in respect of the identification and registration of kept animals of the
                                           porcine species
Operators keeping kept animals of the porcine species shall:
(a)     ensure that those kept animals are each identified by a physical means of identification;
(b)     ensure that those kept animals are accompanied by a correctly completed movement
        document based on the model drawn up by the competent authority in accordance with
        point (b) of Article 110(1) when they are moved from the establishment keeping those
        animals within the Member State concerned;
(c)     transmit the information relating to the establishment keeping those animals to the
        computer database provided for in Article 109(1).
11779/15                                                                 AS/NC/ra                   243
                                               DGB 2B                                             EN
 ---pagebreak---                                                Article 116
              Derogations concerning movements of kept animals of the porcine species
By way of derogation from point (b) of Article 115, Member States may exempt operators from the
requirement to ensure that kept animals of the porcine species are accompanied by correctly
completed movement documents based on the model drawn up by the competent authority for
movements within the Member State concerned, provided that:
(a)      the information contained in such movement documents is included in the computer
         database established by that Member State in accordance with Article 109(1);
(b)      the system for the identification and registration of kept terrestrial animals of the porcine
         species provides a level of traceability equivalent to that provided by such movement
         documents.
                                               Article 117
           Operators' obligation in respect of the identification of kept terrestrial animals
            other than animals of the bovine, ovine, caprine, porcine and equine species
Operators shall ensure that kept terrestrial animals of species other than those of the bovine, ovine,
caprine, porcine and equine species fulfil the following requirements, when required by the rules
adopted pursuant to Articles 118 and 120:
(a)      they are identified, either individually or in groups;
11779/15                                                                  AS/NC/ra                   244
                                                 DGB 2B                                             EN
 ---pagebreak--- (b)     they are accompanied by correctly completed and updated identification documents,
        movement documents or other documents for the identification and tracing of animals, as
        appropriate for the animal species concerned.
                                              Article 118
                   Delegation of powers concerning identification and registration
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)   detailed requirements for the means and methods of identification of kept terrestrial
              animals provided for in point (a) of Article 112, point (a) of Article 113(1), Article
              114(1), point (a) of Article115 and point (a) of Article117, including their application
              and use;
        (b)   rules on the information to be included in:
              (i)    the computer databases provided for in points (a) to (d) of Article 109(1);
              (ii)   the identification and movement documents provided for in point (b) of Article
                     112, point (b) of Article 113(1), point (c) of Article 114(1), and point (b) of
                     Article 115;
        (c)   rules on the exchange of electronic data between computer databases of Member
              States as referred to in point (b) of Article 110(1).
11779/15                                                                  AS/NC/ra                   245
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   detailed requirements for alternative means and methods of identification to those
              referred to in point (a) of paragraph 1 of this Article, as well as exemptions and
              special provisions for certain categories of animals or circumstances and conditions
              for such exemptions;
        (b)   specific provisions for the identification or movement documents provided for in
              point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1),
              point (b) of Article 115 and point (b) of Article 117 that have to accompany animals
              when they are moved;
        (c)   detailed requirements for the identification and registration of kept terrestrial animals
              of species other than the bovine, ovine, caprine, porcine and equine species where
              necessary, taking into account the risks posed by the species concerned, in order to:
              (i)   ensure the efficient application of the disease prevention and control measures
                    provided for in this Regulation;
              (ii)  facilitate the traceability of kept terrestrial animals, and their movements
                    within and between Member States and their entry into the Union;
11779/15                                                                  AS/NC/ra                  246
                                                DGB 2B                                             EN
 ---pagebreak---         (d)   rules on the information to be included in:
              (i)    the computer databases provided for in point (e) of Article 109(1);
              (ii)   the identification and movement documents provided for in point (b) of
                     Article 117;
        (e)   rules on the identification and registration of kept terrestrial animals as referred to in
              Articles 112 to 117 after their entry into the Union.
3.      When establishing the rules to be laid down in the delegated acts provided for in this
        Article, the Commission shall base those rules on the considerations provided for in
        Article 119(2).
                                             Article 119
         Delegation of powers concerning derogations from the traceability requirements
1.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning derogations for operators from the identification and registration
        requirements provided for in Articles 112, 113, 114 and 115:
        (a)   in cases where one or more of the elements listed in Article 108(3) are not necessary
              in order to meet the requirements provided for in points (a) and (b) of Article 108(4);
              and
11779/15                                                                 AS/NC/ra                    247
                                               DGB 2B                                               EN
 ---pagebreak---         (b)    when other traceability measures in place in the Member States guarantee that the
               level of traceability of the animals in question is not compromised,
        as well as transitional measures required for the practical application of such derogations.
2.      When establishing the rules to be laid down in the delegated acts provided for in paragraph
        1, the Commission shall base those rules on the following considerations:
        (a)    the species and categories of kept terrestrial animals concerned;
        (b)    the risks involved for those kept terrestrial animals;
        (c)    the number of animals in the establishments concerned;
        (d)    the type of production in the establishments where those terrestrial animals are kept;
        (e)    movement patterns for the species and categories of kept terrestrial animals
               concerned;
        (f)    considerations concerning the protection and conservation of the species of kept
               terrestrial animals concerned;
        (g)    the performance of the other traceability elements of the system for the identification
               and registration of kept terrestrial animals referred to in Article 108(3).
11779/15                                                                   AS/NC/ra                248
                                                 DGB 2B                                          EN
 ---pagebreak---                                               Article 120
            Implementing powers concerning the traceability of kept terrestrial animals
1.      The Commission shall, by means of implementing acts, adopt rules:
        (a)   for uniform access to data contained in, and the technical specifications and
              operational rules of, the computer databases referred to in points (a) to (d) of
              Article 109(1);
        (b)   on the technical conditions and modalities for the exchange of electronic data
              between computer databases of Member States and the recognition of full operability
              of the data exchange systems referred to in point (b) of Article 110(1).
2.      The Commission may, by means of implementing acts, adopt rules:
        (a)   for the uniform application of the identification and registration system provided for
              in Article 108(1) for different species or categories of kept terrestrial animals, in
              order to ensure its efficient operation;
        (b)   for the uniform application of point (c) of Article 108(5) concerning the authorised
              bodies or natural persons referred to in Article 108(5) and the conditions for their
              designation;
11779/15                                                                AS/NC/ra                     249
                                               DGB 2B                                               EN
 ---pagebreak---         (c) on the technical specifications and procedures, formats, design and operational rules
            for the means and methods of identification, including:
            (i)   the time periods for the application of the means and methods of identification;
            (ii)  the removal, modification or replacement of the means and methods of
                  identification and the deadlines for such operations; and
            (iii) the configuration of the identification code;
        (d) on the technical specifications, formats and operational rules for the identification
            and movement documents provided for in point (b) of Article 112, point (b) of
            Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of
            Article117;
        (e) for uniform access to data contained in, and the technical specifications and
            operational rules of, the computer databases referred to in point (e) of Article 109(1);
        (f) on the deadlines, obligations and procedures for the transmission of information by
            operators or other natural or legal persons and for the registration of kept terrestrial
            animals in the computer databases;
        (g) on guidelines and procedures for electronic identification of animals, where relevant;
        (h) on the practical application of exemptions from the identification and registration
            requirements provided for in the rules adopted pursuant to Article 119(1).
11779/15                                                               AS/NC/ra                    250
                                             DGB 2B                                              EN
 ---pagebreak--- 3.      The implementing acts referred to in this Article shall be adopted in accordance with the
        examination procedure referred to in Article 266(2).
                                             SECTION 2
                                      GERMINAL PRODUCTS
                                              Article 121
                  Traceability requirements for germinal products of kept animals
                      of the bovine, ovine, caprine, porcine and equine species
1.      Operators producing, processing or storing germinal products shall mark germinal products
        of kept animals of the bovine, caprine, ovine, porcine and equine species in such a way that
        they can be clearly traced to:
        (a)   the donor animals;
        (b)   the date of collection; and
        (c)   the germinal product establishments where they were collected, produced, processed
              and stored.
2.      The marking provided for in paragraph 1 shall be designed in such a way as to ensure:
        (a)   the efficient application of the disease prevention and control measures provided for
              in this Regulation;
        (b)   the traceability of the germinal products, their movements within and between
              Member States and their entry into the Union.
11779/15                                                                AS/NC/ra                 251
                                                DGB 2B                                         EN
 ---pagebreak---                                               Article 122
         Delegation of powers concerning traceability requirements for germinal products
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        traceability requirements for germinal products of kept terrestrial animals of the bovine,
        caprine, ovine, porcine and equine species supplementing the rules laid down in
        Article 121;
2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning traceability requirements for germinal products of kept terrestrial animals
        of species other than of the bovine, caprine, ovine, porcine and equine species, where
        necessary for:
        (a)   the efficient application of the disease prevention and control measures provided for
              in this Regulation;
        (b)   the traceability of those germinal products, their movements within and between
              Member States and their entry into the Union.
3.      When adopting the delegated acts provided for in paragraph 1, the Commission shall base
        those acts on the following matters:
        (a)   the species of kept terrestrial animals from which the germinal products originate;
        (b)   the health status of donor animals;
11779/15                                                                AS/NC/ra                  252
                                                DGB 2B                                          EN
 ---pagebreak---          (c)   the risk involved with such germinal products;
         (d)   the type of germinal products;
         (e)   the type of collection, production, processing or storage of germinal products;
         (f)   the movement patterns for the relevant species and categories of kept terrestrial
               animals and their germinal products;
         (g)   considerations concerning the protection and conservation of species of kept
               terrestrial animals;
         (h)   other elements that may contribute to the traceability of germinal products.
                                              Article 123
          Implementing powers concerning traceability requirements for germinal products
The Commission shall, by means of implementing acts, lay down rules concerning:
(a)      technical requirements and specifications for marking as provided for in Article 121(1);
(b)      operational requirements for the traceability provided for in delegated acts adopted
         pursuant to Article 122(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to
in Article 266(2).
11779/15                                                                 AS/NC/ra                 253
                                                DGB 2B                                           EN
 ---pagebreak---                                              Chapter 3
          Movements within the Union of kept terrestrial animals
                                              SECTION 1
                         GENERAL REQUIREMENTS FOR MOVEMENTS
                                               Article 124
                   General requirements for movements of kept terrestrial animals
1.      Operators shall take appropriate preventive measures to ensure that the movement of kept
        terrestrial animals does not jeopardise the health status at the place of destination with
        regard to:
        (a)    the listed diseases referred to in point (d) of Article 9(1);
        (b)    emerging diseases.
2.      Operators shall only move kept terrestrial animals from their establishments and receive
        such animals if the animals in question fulfil the following conditions:
        (a)    they come from establishments that have been:
               (i)    registered by the competent authority in accordance with Article 93; or
11779/15                                                                   AS/NC/ra                 254
                                                 DGB 2B                                            EN
 ---pagebreak---              (ii)   approved by the competent authority in accordance with Articles 97(1) and 98,
                    when required by Article 94(1) or Article 95; or
             (iii) granted a derogation from the registration requirement laid down in Article 84;
        (b)  they fulfil the identification and registration requirements laid down in Articles 112,
             113, 114, 115 and 117 and the rules adopted pursuant to Articles 118 and 120.
                                             Article 125
                       Disease prevention measures in relation to transport
1.      Operators shall take the appropriate and necessary preventive measures to ensure that:
        (a)  the health status of kept terrestrial animals is not jeopardised during transport;
        (b)  transport operations of kept terrestrial animals do not cause the potential spread of
             listed diseases as referred to in point (d) of Article 9(1) to humans and animals;
        (c)  cleaning and disinfection of, and control of insects and rodents with respect to,
             equipment and means of transport and other adequate biosecurity measures are taken,
             as appropriate to the risks involved with the transport operations concerned.
11779/15                                                                 AS/NC/ra                 255
                                               DGB 2B                                            EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)   the conditions and requirements for cleaning and disinfection of, and control of
              insects and rodents with respect to, equipment and means of transport and the use of
              biocidal products for those purposes;
        (b)   other appropriate biosecurity measures as provided for in point (c) of paragraph 1 of
              this Article.
                                            SECTION 2
                          MOVEMENTS BETWEEN MEMBER STATES
                                             Article 126
     General requirements for movements of kept terrestrial animals between Member States
1.      Operators shall only move kept terrestrial animals to another Member State if the animals
        in question fulfil the following conditions:
        (a)   they show no disease symptoms;
        (b)   they come from a registered or approved establishment:
              (i)   where there are no abnormal mortalities with an undetermined cause;
11779/15                                                              AS/NC/ra                   256
                                               DGB 2B                                          EN
 ---pagebreak---             (ii)   which is not subject to movement restrictions affecting the species to be moved
                   in accordance with the rules laid down in Article 55(1), point (a) of Article
                   61(1), Article 62, point (c) of Article 65(1), Article 74(1) and Article 79 and
                   the rules adopted pursuant to Article 55(2), Articles 63 and 67, Articles 71(3),
                   74(4), and 83(2) or the emergency measures provided for in Articles 257
                   and 258 and any rules adopted pursuant to Article 259, unless derogations from
                   movement restrictions have been granted in accordance with those rules;
            (iii) which is not situated in a restricted zone in accordance with rules laid down in
                   point (f)(ii) of Article 55(1), Articles 64 and 65, Article 74(1), Article 79 and
                   any rules adopted pursuant to Article 67, Article 71(3), Article 74(4) and
                   Article 83(2) or the emergency measures provided for in Articles 257 and 258
                   and any rules adopted pursuant to Article 259, unless derogations have been
                   granted in accordance with those rules;
        (c) they have not been in contact with kept terrestrial animals which are subject to
            movement restrictions as referred to in point (b)(ii) and (iii) or kept terrestrial
            animals of a listed species of a lower health status, for an adequate period of time
            prior to the date of the intended movement to another Member State, thereby
            minimising the possibility of spreading disease, taking into account the following
            matters:
            (i)    the incubation period and routes of transmission of the listed diseases and
                   emerging diseases in question;
11779/15                                                                AS/NC/ra                   257
                                               DGB 2B                                             EN
 ---pagebreak---              (ii)  the type of establishment concerned;
             (iii) the species and category of kept terrestrial animals moved;
             (iv) other epidemiological factors;
        (d)  they fulfil the relevant requirements provided for in Sections 3 to 8 (Articles 124
             to 154).
2.      Operators shall take all necessary measures to ensure that kept terrestrial animals moved to
        another Member State are consigned directly to their place of destination in that other
        Member State unless they need to stop at a place of resting for animal welfare reasons.
                                             Article 127
                        Obligations of operators at the place of destination
1.      Operators of establishments and slaughterhouses receiving kept terrestrial animals from
        another Member State shall:
        (a)  check that:
             (i)   the means or methods of identification provided for in point (a) of Article 112,
                   point (a) of Article 113(1), points (a) and (b) Article 114(1), point (a) of
                   Article 115 and point (a) of Article 117 and the rules adopted pursuant to
                   Articles 118 and 120 are in place;
11779/15                                                                AS/NC/ra                 258
                                              DGB 2B                                            EN
 ---pagebreak---               (ii)   the identification documents provided for in point (b) of Article 112, point (b)
                     of Article 113(1), point (c) of Article 114(1), point (b) of Article 117 and the
                     rules adopted pursuant to Articles 118 and 120 are in place and are correctly
                     completed;
        (b)   check that the animal health certificates provided for in Article 143 and in any rules
              adopted pursuant to points (b) and (c) of Article 144(1) or the self–declaration
              documents provided for in Article 151 and the rules adopted pursuant to Article
              151(3) and (4) are in place;
        (c)   inform the competent authority of the place of destination, after checking the kept
              terrestrial animals received, of any irregularity with regard to:
              (i)    the kept terrestrial animals received;
              (ii)   the means or methods of identification referred to in point (a)(i);
              (iii) the documents referred to in points (a)(ii) and (b).
2.      In the event of any irregularity as referred to in point (c) of paragraph 1, the operator shall
        isolate the animals concerned by that irregularity until the competent authority of the place
        of destination has taken a decision regarding them.
11779/15                                                                  AS/NC/ra                  259
                                                DGB 2B                                             EN
 ---pagebreak---                                                Article 128
                        Prohibition on movements of kept terrestrial animals
              for disease eradication purposes outside the territory of a Member State
Operators shall not move kept terrestrial animals intended to be slaughtered for disease eradication
purposes as part of an eradication programme, as provided for in Article 31(1) or (2), to another
Member State unless the Member State of destination and, where relevant, the Member State of
passage authorise the movement in advance.
                                               Article 129
  General requirement applicable to operators in respect of movements of kept terrestrial animals
                       passing through Member States but intended for export
                           from the Union to third countries or territories
Operators shall ensure that kept terrestrial animals intended for export to a third country or territory
and passing through the territory of another Member State fulfil the requirements laid down in
Articles 124, 125, 126 and 128.
11779/15                                                                 AS/NC/ra                    260
                                                DGB 2B                                              EN
 ---pagebreak---                                                SECTION 3
                    SPECIFIC REQUIREMENTS IN RESPECT OF MOVEMENTS
                 TO OTHER MEMBER STATES OF UNGULATES AND POULTRY
                                                Article 130
                   Movements of kept ungulates and poultry to other Member States
Operators shall only move kept ungulates and poultry from an establishment in one Member State
to another Member State if the animals in question fulfil the following conditions as regards the
listed diseases referred to in point (d) of Article 9(1):
(a)       they show no clinical symptoms or signs of listed diseases as referred to in point (d) of
          Article 9(1) at the time of movement;
(b)       they have been subject to a residency period appropriate to those listed diseases, taking
          into account the species and category of kept ungulates and poultry to be moved;
(c)       for a period of time appropriate for those listed diseases and the species and category of
          ungulates or poultry to be moved, no kept ungulates or poultry have been introduced into
          the establishment of origin when a requirement to that effect is laid down in the rules
          adopted in accordance with Article 131 or Article 135;
11779/15                                                                  AS/NC/ra                   261
                                                  DGB 2B                                           EN
 ---pagebreak--- (d)     they are presumed not to pose a significant risk of spreading of those listed diseases at the
        place of destination, based on:
        (i)   the health status concerning relevant diseases for species or categories of kept
              ungulates and poultry moved, taking into account the health status at the place of
              destination;
        (ii)  the results of laboratory or other examinations necessary in order to provide
              guarantees regarding the health status required for the movement in question;
        (iii) the application of vaccination or other disease prevention or risk-mitigation measures
              aimed at limiting the spread of the relevant disease to the places of destination or
              passage.
                                              Article 131
Delegation of powers in respect of movements of kept ungulates and poultry to other Member States
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)   residency periods as referred to in point (b) of Article 130;
        (b)   the period of time necessary in order to limit the introduction of kept ungulates or
              poultry into establishments prior to movement as provided for in point (c) of
              Article 130;
11779/15                                                                AS/NC/ra                   262
                                               DGB 2B                                            EN
 ---pagebreak---         (c)  supplementary requirements to ensure that kept ungulates and poultry do not pose a
             significant risk for the spread of listed diseases as referred to in point (d) of
             Article 9(1), as provided for in point (d) of Article 130);
        (d)  other necessary risk-mitigation measures supplementing the requirements laid down
             in Article 130.
2.      When establishing the rules to be laid down in the delegated acts provided for in
        paragraph 1, the Commission shall base those rules on the following considerations:
        (a)  the listed diseases referred to in point (d) of Article 9(1) relevant for the listed
             species or the category of kept ungulates or poultry to be moved;
        (b)  the health status as regards listed diseases referred to in point (d) of Article 9(1) in
             the establishments, compartments, zones and Member States of origin and
             destination;
        (c)  the type of establishment concerned and the type of production at the places of origin
             and destination;
        (d)  the type of movement concerned;
        (e)  the species and categories of kept ungulates or poultry to be moved;
        (f)  the age of the kept ungulates or poultry to be moved;
        (g)  other epidemiological factors.
11779/15                                                                 AS/NC/ra                    263
                                               DGB 2B                                              EN
 ---pagebreak---                                              Article 132
     Kept ungulates and poultry moved to another Member State and intended for slaughter
1.      Operators of slaughterhouses receiving kept ungulates and poultry from another Member
        State shall slaughter those animals as soon as possible following their arrival and at the
        latest within a timeframe to be laid down in delegated acts adopted pursuant to
        paragraph 2.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        time of slaughter provided for in paragraph 1 of this Article.
                                            SECTION 4
      ASSEMBLY OPERATIONS IN RESPECT OF KEPT UNGULATES AND POULTRY
                                             Article 133
                            Derogation in respect of assembly operations
1.      By way of derogation from Article 126(2), operators may subject kept ungulates and
        poultry to a maximum of three assembly operations during a movement from a Member
        State of origin to another Member State.
11779/15                                                               AS/NC/ra                    264
                                              DGB 2B                                             EN
 ---pagebreak--- 2.      The assembly operations provided for in paragraph 1 of this Article shall only take place in
        an establishment approved for that purpose in accordance with Article 97(1) and Article
        99(3) and (4).
        However, the Member State of origin may allow an assembly operation on its territory to
        take place on a means of transport, collecting kept ungulates or poultry directly from their
        establishments of origin, provided that those animals are not unloaded again during that
        operation and before arriving:
        (a)   at the establishment or final place of destination; or
        (b)   for the subsequent assembly operation in an establishment approved for that purpose
              in accordance with Article 97(1) and Article 99(4) and (5).
                                              Article 134
                Disease prevention requirements in respect of assembly operations
Operators conducting assembly operations shall ensure that:
(a)     the kept ungulates and poultry assembled have the same health status; where they do not,
        the lower health status applies to all such animals assembled;
11779/15                                                               AS/NC/ra                  265
                                                DGB 2B                                          EN
 ---pagebreak--- (b)     the kept ungulates and poultry are assembled and moved to their final place of destination
        in another Member State as soon as possible after leaving their establishment of origin, and
        at the latest within a timeframe to be laid down in delegated acts adopted pursuant to point
        (c) of Article 135;
(c)     the necessary biosecurity measures are taken to ensure that the kept ungulates and poultry
        assembled:
        (i)    do not come into contact with kept ungulates or poultry having a lower health status;
        (ii)   do not pose a significant risk for the spread of the listed diseases referred to in point
               (d) of Article 9(1) to the kept ungulates or poultry at the place where the assembly
               operation takes place;
(d)     the kept ungulates and poultry are identified where so required by this Regulation and are
        accompanied by the following documents:
        (i)    the identification and movement documents as provided for in point (b) of Article
               112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115
               and point (b) of Article 117 and any rules adopted pursuant to Articles 118 and 120,
               unless derogations are provided for in accordance with Articles 113(2) and 119;
        (ii)   the animal health certificates as provided for in Article 143 and point (c) of
               Article 144(1), unless derogations are provided for in the rules adopted pursuant to
               point (a) of Article 144(1);
11779/15                                                                  AS/NC/ra                    266
                                                DGB 2B                                              EN
 ---pagebreak---         (iii) the self–declaration document as provided for in Article 151.
                                             Article 135
                       Delegation of powers concerning assembly operations
The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)     specific rules for assembly operations, where other risk-mitigation measures, in addition to
        those provided for in points (b) and (c) of Article 134, are in place;
(b)     criteria under which Member States of origin may allow assembly operations to take place
        on means of transport, as provided for in the second subparagraph of Article 133(2);
(c)     the timeframe between the time of departure of the kept ungulates or poultry from their
        establishment of origin and their departure from the assembly operation to their final
        destination in another Member State, as referred to in point (b) of Article 134;
(d)     detailed rules as regards the biosecurity measures provided for in point (c) of Article 134.
11779/15                                                                 AS/NC/ra                 267
                                               DGB 2B                                            EN
 ---pagebreak---                                               SECTION 5
     MOVEMENTS TO OTHER MEMBER STATES OF KEPT TERRESTRIAL ANIMALS
                       OTHER THAN KEPT UNGULATES AND POULTRY
                                              Article 136
            Movements of kept terrestrial animals other than kept ungulates and poultry
                              to other Member States and delegated acts
1.      Operators shall only move kept terrestrial animals other than kept ungulates or poultry
        from an establishment in one Member State to another Member State if the animals in
        question do not pose a significant risk for the spread of listed diseases as referred to in
        point (d) of Article 9(1) at the place of destination.
2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning detailed rules to ensure that kept terrestrial animals other than kept
        ungulates or poultry do not pose a significant risk for the spread of listed diseases as
        referred to in point (d) of Article 9(1), as provided for in paragraph 1 of this Article.
3.      When establishing the detailed rules to be laid down in the delegated acts provided for in
        paragraph 2, the Commission shall base those rules on the following considerations:
        (a)   the listed diseases referred to in point (d) of Article 9(1) relevant for the listed
              species or the category of kept terrestrial animals to be moved;
11779/15                                                                  AS/NC/ra                   268
                                                DGB 2B                                              EN
 ---pagebreak---         (b)  the health status as regards the listed diseases referred to in point (d) of Article 9(1)
             in the establishments, compartments, zones and Member States of origin and the
             place of destination;
        (c)  the types of establishment and the types of production at the place of origin and the
             place of destination;
        (d)  the types of movement in respect of the final use of animals at the place of
             destination;
        (e)  the species and categories of kept terrestrial animals to be moved;
        (f)  the age of the kept terrestrial animals to be moved;
        (g)  other epidemiological factors.
                                             SECTION 6
      DEROGATING FROM, AND SUPPLEMENTING, RISK-MITIGATION MEASURES
                   FOR MOVEMENTS OF KEPT TERRESTRIAL ANIMALS
                                             Article 137
         Kept terrestrial animals intended for confined establishments and delegated acts
1.      Operators shall only move kept terrestrial animals to a confined establishment if the
        animals in question fulfil the following conditions:
        (a)  they originate from another confined establishment;
11779/15                                                                 AS/NC/ra                   269
                                               DGB 2B                                              EN
 ---pagebreak---         (b)    they do not pose a significant risk for the spread of listed diseases as referred to in
               point (d) of Article 9(1) to listed species or to categories of animals at the confined
               establishment of destination, except where the movement in question is authorised
               for scientific purposes.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)    detailed rules for movements of kept terrestrial animals into confined establishments
               in addition to those provided for in paragraph 1 of this Article;
        (b)    specific rules for movements of kept terrestrial animals into confined establishments
               where the risk-mitigation measures in place guarantee that such movements do not
               pose a significant risk for the health of kept terrestrial animals within that confined
               establishment and the surrounding establishments.
                                                Article 138
         Movements of kept terrestrial animals for scientific purposes and delegated acts
1.      The competent authority of the place of destination may, subject to the agreement of the
        competent authority of the place of origin, authorise movements of kept terrestrial animals
        into the territory of the Member State of destination, for scientific purposes, where those
        movements do not comply with the requirements of Sections 1 to 5 (Articles 124 to 136),
        with the exception of Articles 124 and 125, point (b)(ii) of Article 126(1) and Article 127.
11779/15                                                                   AS/NC/ra                   270
                                                 DGB 2B                                             EN
 ---pagebreak--- 2.      The competent authority of the place of destination shall only grant derogations as
        provided for in paragraph 1 under the following conditions:
        (a)  the competent authorities of the places of destination and origin:
              (i)  have agreed on the conditions for such movements;
              (ii) ensure that the necessary risk-mitigation measures are in place so that those
                   movements do not jeopardise the health status in places en route and in the
                   place of destination with regard to the listed diseases referred to in point (d) of
                   Article 9(1); and
             (iii) have notified, where relevant, the competent authorities of the Member States
                   of passage of the derogation granted and of the conditions under which it is
                   granted; and
        (b)  those movements of those animals take place under the supervision of the competent
             authorities of the places of origin and destination, and where relevant, the competent
             authorities of the Member States of passage.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning rules for the granting of derogations by competent authorities,
        supplementing those provided for in paragraphs 1 and 2 of this Article.
11779/15                                                               AS/NC/ra                    271
                                              DGB 2B                                              EN
 ---pagebreak---                                               Article 139
              Derogations concerning recreational use, sporting and cultural events,
                                    work near borders and grazing
1.      The competent authority of the place of destination may grant derogations from the
        requirements of Sections 2 to 5 (Articles 126 to 136), with the exception of points (a),(b)
        and (c) of Article 126(1) and Articles 127 and 128, for intra–Union movements of kept
        terrestrial animals between Member States where such movements are for:
        (a)    recreational use near borders;
        (b)    exhibitions, and sporting, cultural and similar events, organised near borders;
        (c)    grazing of kept terrestrial animals in grazing areas shared between Member States; or
        (d)    work done by kept terrestrial animals near borders of Member States.
2.      Derogations by the competent authority of the place of destination for movements of kept
        terrestrial animals for the purposes provided for in paragraph 1 shall be agreed on between
        the Member States of origin and destination and appropriate risk-mitigation measures shall
        be taken to ensure that such movements do not pose a significant risk.
3.      The Member States referred to in paragraph 2 shall inform the Commission of the granting
        of derogations as provided for in paragraph 1.
11779/15                                                                 AS/NC/ra                 272
                                               DGB 2B                                            EN
 ---pagebreak--- 4.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning rules for the granting of derogations by the competent authority of
        the place of destination, supplementing those provided for in paragraph 1 of this Article.
                                              Article 140
    Delegation of power concerning circuses, exhibitions, sporting events and recreational use,
                          zoos, pet shops, animal shelters and wholesalers
The Commission shall be empowered to adopt delegated acts in accordance with Article 264
concerning:
(a)     specific requirements supplementing the rules laid down in Sections 2 to 5 (Articles 126 to
        136) for movements of kept terrestrial animals for the following purposes:
        (i)   circuses, zoos, pet shops, animal shelters and wholesalers;
        (ii)  exhibitions and sporting, cultural and similar events;
(b)     derogations from Sections 2 to 5 (Articles 126 to 136), with the exception of points (a), (b)
        and (c) of Article 126(1) and Articles 127 and 128, for movements of kept terrestrial
        animals as referred to in point (a) of this Article.
11779/15                                                               AS/NC/ra                   273
                                                DGB 2B                                          EN
 ---pagebreak---                                                Article 141
         Implementing power to adopt temporary rules for movements of specific species
                               or categories of kept terrestrial animals
1.      The Commission may, by means of implementing acts, lay down temporary rules, by way
        of addition or alternative to those laid down in this Chapter, for movements of specific
        species or categories of kept terrestrial animals where:
        (a)   the movement requirements provided for in Article 130, Article 132(1), Articles 133
              and 134, Articles 136(1), 137(1) and 138(1) and (2) and Article 139 and the rules
              adopted pursuant to Articles 131(1) and 132(2), Article 135, Articles 136(2), 137(2),
              138(3) and 139(4) and Article 140 are not effectively mitigating the risks posed by
              the movement of such animals; or
        (b)   a listed disease as referred to in point (d) of Article 9(1) appears to be spreading
              despite the movement requirements laid down in accordance with Sections 1 to 6
              (Articles 124 to 142).
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
2.      On duly justified imperative grounds of urgency relating to diseases representing a risk of a
        highly significant impact and taking into account the matters referred to in Article 142, the
        Commission shall adopt immediately applicable implementing acts in accordance with the
        procedure provided for in Article 266(3).
11779/15                                                                  AS/NC/ra                  274
                                                DGB 2B                                             EN
 ---pagebreak---                                                Article 142
        Matters to be taken into account in the adoption of delegated and implementing acts
                                     as provided for in this Section
When establishing the rules to be laid down in the delegated and implementing acts provided for in
Articles 137(2), 138(3) and 139(4) and Articles 140 and 141, the Commission shall base those rules
on the following matters:
(a)      the risks involved with the movements referred to in those provisions;
(b)      the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the
         places of origin, passage and destination;
(c)      listed animal species for the listed diseases referred to in point (d) of Article 9(1);
(d)      biosecurity measures in place at the places of origin, passage and destination
(e)      any specific conditions in establishments under which the kept terrestrial animals are kept;
(f)      specific movement patterns of the type of establishment and the species and category of
         kept terrestrial animals concerned;
(g)      other epidemiological factors.
11779/15                                                                   AS/NC/ra                     275
                                                 DGB 2B                                               EN
 ---pagebreak---                                                SECTION 7
                                 ANIMAL HEALTH CERTIFICATION
                                                Article 143
   Obligation of operators to ensure that animals are accompanied by an animal health certificate
1.       Operators shall only move the following species and categories of kept terrestrial animals
         to another Member State if the animals in question are accompanied by an animal health
         certificate issued by the competent authority of the Member State of origin in accordance
         with Article 149(1):
         (a)    ungulates;
         (b)    poultry;
         (c)    kept terrestrial animals other than ungulates and poultry, intended for a confined
                establishment;
         (d)    kept terrestrial animals other than those referred to in points (a), (b) and (c) of this
                paragraph, when required in accordance with delegated acts adopted pursuant to
                point (c) of Article 144(1).
11779/15                                                                   AS/NC/ra                     276
                                                 DGB 2B                                               EN
 ---pagebreak--- 2.      In cases where kept terrestrial animals are allowed to leave a restricted zone as provided
        for in point (f)(ii) of Article 55(1), Article 56 and Article 64(1) and are subject to disease
        control measures as provided for in Articles 55(1), 65(1), 74(1) or Article 79(1) and (2) or
        rules adopted pursuant to Article 55(2), Article 67, Articles 71(3) and 74(4), Article 80,
        Article 83(3) or Article 259, and the animals in question are of species subject to those
        disease control measures, operators shall only move such kept terrestrial animals within a
        Member State or from one Member State to another Member State when the animals to be
        moved are accompanied by an animal health certificate issued by the competent authority
        of the Member State of origin in accordance with Article 149(1).
        The competent authority may decide that such a certificate does not have to be issued for
        movements of kept terrestrial animals within the Member State in question when that
        authority considers that an alternative system is in place ensuring that the consignment of
        such animals is traceable and that those animals fulfil the animal health requirements for
        such movement.
3.      Operators shall take all necessary measures to ensure that the animal health certificate
        referred to in paragraph 1 of this Article accompanies the kept terrestrial animals from their
        place of origin to their final place of destination, unless specific measures are provided for
        in rules adopted pursuant to Article 147.
11779/15                                                                  AS/NC/ra                   277
                                                 DGB 2B                                             EN
 ---pagebreak---                                               Article 144
                    Delegation of powers concerning the obligation of operators
              to ensure that animals are accompanied by an animal health certificate
1.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   derogations from the animal health certification requirements provided for in
              Article 143(1), for movements of kept terrestrial animals which do not pose a
              significant risk for the spread of a disease on account of:
              (i)    the species or categories of the kept terrestrial animals that are being moved
                     and the listed diseases referred to in point (d) of Article 9(1) for which they are
                     listed species;
              (ii)   the methods of keeping and the type of production of those species and
                     categories of kept terrestrial animals;
              (iii) the intended use of the kept terrestrial animals; or
              (iv) the place of destination of the kept terrestrial animals; including those cases
                     where their place of destination is in the same Member State as their place of
                     origin but they pass through another Member State in order to reach their place
                     of destination;
11779/15                                                                  AS/NC/ra                   278
                                                DGB 2B                                             EN
 ---pagebreak---         (b) special rules for animal health certification as provided for in Article 143(1) where
            specific risk-mitigation measures concerning surveillance or biosecurity are taken,
            taking into account the matters provided for in paragraph 2 of this Article, which
            ensure:
            (i)    the traceability of the kept terrestrial animals being moved;
            (ii)   that the kept terrestrial animals being moved fulfil the animal health
                   requirements for movements provided for in Sections 1 to 6 (Articles 124
                   to 142);
        (c) the requirement for animal health certification for movements of species and
            categories of kept terrestrial animals other than those referred to in points (a), (b) and
            (c) of Article 143(1) in cases where animal health certification is imperative in order
            to ensure that the movement in question complies with the animal health
            requirements for movements provided for in Sections 1 to 6 (Articles 124 to 142).
2.      When establishing the special rules provided for in point (b) of paragraph 1, the
        Commission shall take the following matters into account:
        (a) the assessment by the competent authority of the biosecurity put in place by
            operators as provided for in point (b) of Article 10(1) and any rules adopted pursuant
            Article 10(6);
11779/15                                                                AS/NC/ra                   279
                                               DGB 2B                                            EN
 ---pagebreak---         (b)   the ability of the competent authority, in so far as may be necessary and appropriate,
              to take measures and to engage in activities required by this Regulation as provided
              for in Article 13(1);
        (c)   the level of knowledge of animal health as provided for in Article 11 and the
              encouragement thereof provided for in Article 13(2);
        (d)   the carrying-out of the animal health visits provided for in Article 25 or other
              relevant surveillance or official controls in place;
        (e)   the performance by the competent authority of its obligations under the Union
              notification and reporting system provided for in Articles 19 to 22 and in the rules
              adopted pursuant to Articles 20(3) and Article 23;
        (f)   the application of surveillance as provided for in Article 26 and surveillance
              programmes as provided for in Article 28 and in any rules adopted pursuant to
              Articles 29 and 30.
3.      The Commission shall take the matters referred to in point (a)(i) to (iv) of paragraph 1 into
        account when establishing the requirements for animal health certification provided for in
        point (c) of paragraph (1).
11779/15                                                                AS/NC/ra                  280
                                               DGB 2B                                           EN
 ---pagebreak---                                               Article 145
                                Contents of animal health certificates
1.      The animal health certificate referred to in Article 143 shall contain the following
        information:
        (a)   the establishment or place of origin, the establishment or place of destination and,
              where relevant, establishments for assembly operations or for rests, of the kept
              terrestrial animals concerned;
        (b)   the means of transport and the transporter;
        (c)   a description of the kept terrestrial animals;
        (d)   the number of kept terrestrial animals;
        (e)   the identification and registration of kept terrestrial animals, where required by
              Articles 112, 113, 114, 115 and 117 and by any rules adopted pursuant to
              Articles 118 and 120, unless derogations are provided for in accordance with
              Article 119; and
        (f)   the information needed to demonstrate that the kept terrestrial animals fulfil the
              relevant animal health requirements in respect of movements provided for in
              Sections 1 to 6 (Articles 124 to 142).
2.      The animal health certificate may include other information required under other Union
        legislation.
11779/15                                                                  AS/NC/ra                 281
                                                DGB 2B                                           EN
 ---pagebreak---                                              Article 146
                            Delegation of powers and implementing acts
                        concerning the content of animal health certificates
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)   detailed rules on the content of animal health certificates as provided for in
              Article 145(1) for different species and categories of kept terrestrial animals and for
              specific types of movements as provided for in the rules adopted pursuant to
              Article 147;
        (b)   additional information to be contained in the animal health certificate provided for in
              Article 145(1).
2.      The Commission may, by means of implementing acts, lay down rules for model forms of
        animal health certificates. Those implementing acts shall be adopted in accordance with
        the examination procedure referred to in Article 266(2).
11779/15                                                                AS/NC/ra                   282
                                               DGB 2B                                            EN
 ---pagebreak---                                                 Article 147
       Delegation of powers concerning specific types of movements of kept terrestrial animals
The Commission shall be empowered to adopt delegated acts in accordance with Article 264
concerning specific measures derogating from, or supplementing, the obligation of operators to
ensure that animals are accompanied by an animal health certificate as provided for in Article 143
and in the rules adopted pursuant to Article 144, for the following types of movements of kept
terrestrial animals:
(a)       movements of kept ungulates and poultry passing through the assembly operations
          provided for in Article 133 prior to reaching their final place of destination;
(b)       movements of kept terrestrial animals which are required to return to their place of origin
          or to be moved to a different destination, for one or more of the following reasons:
          (i)   their intended journey was unexpectedly interrupted for animal welfare reasons;
          (ii)   unforeseen accidents or events during the journey;
          (iii) they were rejected at the place of destination in a Member State or at the external
                 border of the Union;
          (iv) they were rejected at a place of assembly or resting;
          (v)    they were rejected in a third country or territory;
11779/15                                                                   AS/NC/ra                 283
                                                 DGB 2B                                           EN
 ---pagebreak--- (c)     movements of kept terrestrial animals intended for exhibitions, and sporting, cultural and
        similar events, and their subsequent return to their place of origin.
                                              Article 148
                  Operators' obligations to cooperate with the competent authority
                            for the purposes of animal health certification
Operators shall:
 (a)     provide the competent authority with all the information necessary to complete the animal
         health certificate provided for in Article 143(1) and (2) and in any rules adopted pursuant
                   to Article 146(1) or Article 147, in advance of the intended movement;
(b)     where necessary, ensure that the kept terrestrial animals in question are subjected to
        documentary, identity and physical checks as provided for in Article 149(3).
                                              Article 149
              Responsibility of the competent authority for animal health certification
1.      The competent authority shall, upon request by an operator, issue an animal health
        certificate for the movement of kept terrestrial animals, where required by Article 143 or
        by delegated acts adopted pursuant to Article 144(1), provided that the following
        movement requirements have been complied with:
        (a)    those provided for in Article 124, Article 125(1), Articles 126, 128, 129, 130, 133
               and 134, Articles 136(1) and 137(1), Article 138 and Article 139;
11779/15                                                                 AS/NC/ra                  284
                                               DGB 2B                                            EN
 ---pagebreak---         (b)   those provided for in delegated acts adopted pursuant to Articles 125(2) and 131(1),
              Article 135, Articles 136(2), 137(2), 138(4) and 139(4) and Article 140;
        (c)   those provided for in implementing acts adopted pursuant to Article 141.
2.      Animal health certificates shall:
        (a)   be verified, stamped and signed by an official veterinarian;
        (b)   remain valid for the period of time provided for in the rules adopted pursuant to point
              (c) of paragraph 4, during which the kept terrestrial animals covered by it continue to
              fulfil the animal health guarantees contained in it.
3.      Before signing an animal health certificate, the official veterinarian concerned shall verify,
        by means of documentary, identity and physical checks as provided for by delegated acts
        adopted pursuant to paragraph 4, that the kept terrestrial animals covered by it fulfil the
        requirements of this Chapter.
4.      The Commission shall adopt delegated acts in accordance with Article 264 laying down
        rules concerning:
        (a)   the types of documentary, identity and physical checks and examinations in relation
              to different species and categories of kept terrestrial animals that must be carried out
              by the official veterinarian in accordance with paragraph 3 in order to verify
              compliance with the requirements of this Chapter;
11779/15                                                                 AS/NC/ra                   285
                                               DGB 2B                                             EN
 ---pagebreak---          (b)    the timeframes for the carrying-out of such documentary, identity and physical
                checks and examinations and the issuing of animal health certificates by the official
                veterinarian prior to the movement of consignments of kept terrestrial animals;
         (c)    the duration of the validity of animal health certificates.
                                                Article 150
                                  Electronic animal health certificates
Electronic animal health certificates, produced, handled and transmitted by means of TRACES,
may replace accompanying animal health certificates as provided for in Article 149(1) where:
(a)      such electronic animal health certificates contain all the information that the model form of
         animal health certificate is required to contain in accordance with Article 145 and any rules
         adopted pursuant to Article 146;
(b)      the traceability of the kept terrestrial animals in question and the link between those
         animals and the electronic animal health certificate is ensured;
(c)      the competent authorities of the Member States of origin, passage and destination are able
         to have access to the electronic documents at all times during the transport.
11779/15                                                                    AS/NC/ra               286
                                                  DGB 2B                                          EN
 ---pagebreak---                                                Article 151
                Self–declaration by operators for movements to other Member States
1.      Operators at the place of origin shall issue a self–declaration document for movements of
        kept terrestrial animals from their place of origin in one Member State to their place of
        destination in another Member State, and shall ensure that it accompanies such animals,
        where they are not required to be accompanied by an animal health certificate as provided
        for in Article 143(1) and (2).
2.      The self–declaration document provided for in paragraph 1 shall contain the following
        information concerning the kept terrestrial animals in question:
        (a)    their place of origin, their place of destination and, when relevant, any places of
               assembly or rest;
        (b)    the means of transport and the transporter;
        (c)    a description of the kept terrestrial animals, their species, category and quantity;
        (d)    identification and registration where required in accordance with Articles 112, 113,
               114 and 115, point (a) of Article 117 and any rules adopted pursuant to Articles 118
               and 120;
        (e)    the information needed to demonstrate that the kept terrestrial animals fulfil the
               animal health requirements for movements provided for in Sections 1 to 6
               (Articles 124 to 142).
11779/15                                                                  AS/NC/ra                   287
                                                 DGB 2B                                             EN
 ---pagebreak--- 3.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   detailed rules on the content of the self–declaration document provided for in
              paragraph 2 of this Article for different species and categories of animals;
        (b)   information to be contained in the self–declaration document in addition to that
              provided for in paragraph 2 of this Article.
4.      The Commission may, by means of implementing acts, lay down rules for the model forms
        of the self–declaration document provided for in paragraph 2 of this Article. Those
        implementing acts shall be adopted in accordance with the examination procedure referred
        to in Article 266(2).
11779/15                                                                AS/NC/ra                288
                                               DGB 2B                                          EN
 ---pagebreak---                                               SECTION 8
            NOTIFICATION OF MOVEMENTS OF KEPT TERRESTRIAL ANIMALS
                                   TO OTHER MEMBER STATES
                                               Article 152
                  Obligation of operators concerning the notification of movements
                          of kept terrestrial animals to other Member States
Operators other than transporters shall notify the competent authority in their Member State of
origin in advance of intended movements of kept terrestrial animals from that Member State to
another Member State where:
(a)      the animals must be accompanied by an animal health certificate issued by the competent
         authority of the Member State of origin in accordance with Articles 149 and 150 and any
         rules adopted pursuant to Article 149(4);
(b)      the animals must be accompanied by an animal health certificate for kept terrestrial
         animals where they are being moved from a restricted zone and are subject to disease
         control measures as referred to in Article 143(2);
(c)      the animals are granted a derogation from the animal health certification requirement
         provided for in point (a) of Article 144(1) or are subject to special rules as provided for in
         point (b) of Article 144(1);
11779/15                                                                  AS/NC/ra                   289
                                                 DGB 2B                                            EN
 ---pagebreak--- (d)      notification is required in accordance with delegated acts adopted pursuant to
         Article 154(1).
For the purposes of the first paragraph of this Article, operators shall provide the competent
authority of their Member State of origin with all the necessary information to enable it to notify the
movements of the kept terrestrial animals to the competent authority of the Member State of
destination in accordance with Article 153(1).
                                              Article 153
       Responsibility of the competent authority to notify movements to other Member States
1.       The competent authority of the Member State of origin shall notify the competent authority
         of the Member State of destination of movements of kept terrestrial animals as referred to
         in Article 152.
2.       The notification referred to in paragraph 1 shall be carried out prior to the movement in
         question and, whenever possible, through TRACES.
3.       Member States shall designate regions for the management of notifications of movements
         as provided for in paragraph 1.
4.       By way of derogation from paragraph 1, the competent authority of the Member State of
         origin may authorise the operator concerned to notify, partially or completely, movements
         of kept terrestrial animals through TRACES to the competent authority of the Member
         State of destination.
11779/15                                                                  AS/NC/ra                 290
                                                DGB 2B                                            EN
 ---pagebreak---                                              Article 154
           Delegation of power and implementing acts for the notification of movements
                            by operators and by the competent authority
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)   the requirement for advance notification by operators, in accordance with Article
              152, of movements between Member States of kept terrestrial animals of species or
              categories other than those referred to in points (a) and (b) of that Article, where
              traceability of such movements of those species or categories is necessary in order to
              ensure compliance with the animal health requirements for movements laid down in
              Sections 1 to 6 (Articles 124 to 142);
        (b)   the information needed in order to notify movements of kept terrestrial animals as
              provided for in Articles 152 and 153;
        (c)   the emergency procedures for the notification of movements of kept terrestrial
              animals in the event of power cuts and other disturbances of TRACES;
        (d)   the requirements for the designation of regions by Member States for the
              management of notifications of movements, as provided for in Article 153(3).
11779/15                                                                 AS/NC/ra                   291
                                               DGB 2B                                              EN
 ---pagebreak--- 2.      The Commission may, by means of implementing acts, lay down rules concerning:
        (a)   the details concerning notifications of movements of kept terrestrial animals by:
              (i)    operators to the competent authority of their Member State of origin in
                     accordance with Article 152;
              (ii)   the competent authority of the Member State of origin to the Member State of
                     destination in accordance with Article 153;
        (b)   the deadlines for:
              (i)    the provision by the operator of the necessary information referred to in Article
                     152 to the competent authority of the Member State of origin;
              (ii)   the notification of movements of kept terrestrial animals by the competent
                     authority of the Member State of origin as referred to in Article 153(1).
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                  292
                                               DGB 2B                                           EN
 ---pagebreak---                                             Chapter 4
                       Movements of wild terrestrial animals
                                              Article 155
                                       Wild terrestrial animals
1.      Operators shall only move wild animals from a habitat in one Member State to a habitat or
        an establishment in another Member State where:
        (a)   the movements of the wild animals in question from their habitat are carried out in
              such a way that they do not pose a significant risk for the spread of listed diseases as
              referred to in point (d) of Article 9(1) or emerging diseases en route or at the place of
              destination;
        (b)   the wild animals do not come from a habitat in a restricted zone which is subject to
              movement restrictions concerning the animal species to which they belong due to the
              occurrence of a listed disease as referred to in point (d) of Article 9(1) or of an
              emerging disease, as provided for in Article 70(2) and in any rules adopted pursuant
              to point (b) of Article 70(3), Article 71(3) and Article 83(3) or the emergency
              measures provided for in Articles 257 and 258 and any rules adopted pursuant to
              Article 259, unless derogations have been granted in accordance with those rules;
11779/15                                                                 AS/NC/ra                  293
                                                DGB 2B                                            EN
 ---pagebreak---         (c)   the wild animals are accompanied by an animal health certificate or other documents
              where animal health certification is necessary in order to ensure compliance with the
              animal health requirements for movements provided for in points (a) and (b) of this
              paragraph and the rules adopted pursuant to points (c) and (d) of Article 156(1);
        (d)   the movements are notified by the competent authority of the Member State of origin
              to the competent authority of the Member State of destination, where animal health
              certification is required by the rules adopted pursuant to point (c) of Article 156(1);
              and
        (e)   the competent authority of the Member State of origin and the competent authority of
              the Member State of destination have agreed to such movement.
2.      When animal health certification is required by the rules adopted pursuant to point (c) of
        Article 156(1), the requirements provided for in Articles 145 and 148, Article 149(1), (2)
        and (3) and Article 150, and in the rules adopted pursuant to Articles 146 and 147 and
        Article 149(4) shall apply to movements of wild terrestrial animals.
3.      When notification of movements is required in accordance with point (d) of paragraph 1 of
        this Article, the requirements provided for in Articles 152 and 153 and in the delegated acts
        adopted pursuant to Article 154(1) shall apply to movements of wild terrestrial animals.
11779/15                                                                AS/NC/ra                   294
                                                DGB 2B                                            EN
 ---pagebreak---                                              Article 156
              Empowerments concerning the movement of wild terrestrial animals
1.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)  the animal health requirements for movements of wild terrestrial animals provided
             for in points (a) and (b) of Article 155(1);
        (b)  the animal health requirements for the introduction of wild terrestrial animals when
             they are moved from the wild into establishments;
        (c)  the types of movements of wild terrestrial animals for which, or the situations in
             which, an animal health certificate or other document is required to accompany such
             movements, and the requirements concerning the contents of such certificates or
             other documents;
        (d)  the notification by the competent authority of the Member State of origin to the
             competent authority of the Member State of destination in the case of movements of
             wild terrestrial animals between Member States, and the information to be included
             in such notification.
11779/15                                                             AS/NC/ra                    295
                                               DGB 2B                                           EN
 ---pagebreak--- 2.      The Commission may, by means of implementing acts, lay down rules specifying the
        requirements provided for in Article 155 and in the delegated acts adopted pursuant to
        paragraph 1 of this Article, concerning:
        (a)   model forms of animal health certificates and other documents which are required to
              accompany movements of wild terrestrial animals, when provided for in delegated
              acts adopted pursuant to point (c) of paragraph 1 of this Article;
        (b)   the details of the notification to be given by the competent authority of the Member
              State of origin and the deadlines for such notifications, when provided for in rules
              adopted pursuant to point (d) of paragraph 1 of this Article.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                  296
                                                DGB 2B                                           EN
 ---pagebreak---                                             Chapter 5
             Movements within the Union of germinal products
                                             SECTION 1
                                   GENERAL REQUIREMENTS
                                              Article 157
                     General requirements for movements of germinal products
1.      Operators shall take appropriate preventive measures to ensure that movements of
        germinal products do not jeopardise the health status of kept terrestrial animals at the place
        of destination with regard to:
        (a)   the listed diseases referred to in point (d) of Article 9(1);
        (b)   emerging diseases.
11779/15                                                                  AS/NC/ra                 297
                                                DGB 2B                                            EN
 ---pagebreak--- 2.      Operators shall only move germinal products from their establishments, and receive such
        germinal products, if the products in question fulfil the following conditions:
        (a)   they come from establishments that have been:
              (i)   entered in the register of establishments by the competent authority in
                    accordance with point (a) of Article 93 and no derogation has been granted by
                    the Member State of origin in accordance with Article 85;
              (ii)  approved by the competent authority in accordance with Article 97(1), when
                    such approval is required by Article 94(1) or Article 95;
        (b)   they fulfil the traceability requirements of Article 121(1) and any rules adopted
              pursuant to Article 122(1).
3.      Operators shall comply with the requirements of Article 125 for the transport of germinal
        products of kept terrestrial animals.
4.      Operators shall not move germinal products from an establishment in one Member State to
        an establishment in another Member State unless the competent authority of the Member
        State of destination gives its express authorisation for such movement, where those
        germinal products are required to be destroyed for disease eradication purposes as part of
        an eradication programme as provided for in Article 31(1) or (2).
11779/15                                                                AS/NC/ra                 298
                                                DGB 2B                                          EN
 ---pagebreak---                                               Article 158
                         Obligations for operators at the place of destination
1.      Operators of establishments at the place of destination receiving germinal products from an
        establishment in another Member State shall:
        (a)   check for the presence of:
              (i)    marks in accordance with Article 121 and with rules adopted pursuant to
                     Article 122;
              (ii)   animal health certificates as provided for in Article 161;
        (b)   after checking the germinal products received, inform the competent authority of the
              place of destination of any irregularity with regard to;
              (i)    the germinal products received;
              (ii)   the marks referred to in point (a)(i);
              (iii) the animal health certificates referred to in point (a)(ii).
2.      In the event of an irregularity as referred to in point (b) of paragraph 1, the operator
        concerned shall keep the germinal products stored separately until the competent authority
        has taken a decision regarding them.
11779/15                                                                  AS/NC/ra                299
                                                DGB 2B                                           EN
 ---pagebreak---                                             SECTION 2
         MOVEMENTS TO OTHER MEMBER STATES OF GERMINAL PRODUCTS
             OF KEPT ANIMALS OF THE BOVINE, OVINE, CAPRINE, PORCINE
             AND EQUINE SPECIES AND GERMINAL PRODUCTS OF POULTRY
                                             Article 159
              Operators' obligations in respect of movements to other Member States
            of germinal products of kept animals of the bovine, ovine, caprine, porcine
                        and equine species and germinal products of poultry
1.      Operators shall only move germinal products of kept animals of the bovine, ovine, caprine,
        porcine and equine species and germinal products of poultry to another Member State if
        those germinal products fulfil the following conditions:
        (a)   they are collected, produced, processed and stored in germinal product
              establishments approved for that purpose in accordance with Article 97(1) and
              Article 99;
        (b)   they have been collected from donor animals which fulfil the necessary animal health
              requirements, in order to ensure that the germinal products do not spread listed
              diseases;
11779/15                                                              AS/NC/ra                  300
                                               DGB 2B                                          EN
 ---pagebreak---         (c)   they have been collected, produced, processed, stored and transported in such a way
              as to ensure that they do not spread listed diseases as referred to in point (d) of
              Article 9(1).
2.      Operators shall not move germinal products of kept animals of the bovine, ovine, caprine,
        porcine and equine species and germinal products of poultry from a germinal product
        establishment which is subject to movement restrictions affecting the listed species in
        question in accordance with:
        (a)   points (a), (c) and (e) of Article 55(1), point (f)(ii) of Article 55(1), Article 56,
              point (a) of Article 61(1), Article 62(1), point (c) of Article 65(1) and Articles 74(1)
              and 79(1) and (2);
        (b)   rules adopted pursuant to Article 55(2), Articles 63 and 67, and Articles 71(3), 74(4)
              and 83(2); and
        (c)   emergency measures as provided for in Articles 257 and 258 and rules adopted
              pursuant to Article 259, unless derogations have been provided for in rules adopted
              pursuant to Article 258.
        The restrictions provided for in this paragraph shall not apply to cases where the germinal
        products were collected before the outbreak in question occurred and those products have
        been stored separately from other germinal products.
11779/15                                                                   AS/NC/ra                  301
                                                DGB 2B                                              EN
 ---pagebreak---                                              Article 160
               Delegation of power in respect of movements to other Member States
            of germinal products of kept animals of the bovine, porcine, ovine, caprine
                        and equine species and germinal products of poultry
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        animal health requirements for movements of germinal products of kept animals of the
        bovine, ovine, caprine, porcine and equine species and germinal products of poultry to
        other Member States as provided for in Article 159, specifying:
        (a)   rules for the collection, production, processing and storage of germinal products of
              those kept animals in approved establishments as referred to in point (a) of
              Article 159(1);
        (b)   animal health requirements as provided for in point (b) of Article 159(1) for kept
              donor animals from which germinal products were collected, and concerning
              isolation or quarantine for those animals;
        (c)   laboratory and other tests to be carried out on kept donor animals and germinal
              products;
        (d)   animal health requirements for the collection, production, processing, storage or
              other procedures and transport provided for in point (c) of Article 159(1).
11779/15                                                                AS/NC/ra                 302
                                               DGB 2B                                           EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the animal health requirements for movements of germinal products of
        kept animals of the bovine, ovine, caprine, porcine and equine species and germinal
        products of poultry to other Member States as provided for in Article 159, specifying
        derogations for operators from the rules provided for in Article 159, taking into account the
        risks attached to such germinal products and any risk-mitigation measures in place.
                                           SECTION 3
        ANIMAL HEALTH CERTIFICATION AND NOTIFICATION OF MOVEMENTS
                                            Article 161
           Operators' obligations concerning animal health certification for movements
            of germinal products of kept animals of the bovine, ovine, caprine, porcine
              and equine species and germinal products of poultry and delegated acts
1.      Operators shall only move germinal products of kept animals of the bovine, ovine, caprine,
        porcine and equine species and germinal products of poultry to another Member State
        where such products are accompanied by an animal health certificate issued by the
        competent authority of the Member State of origin in accordance with paragraph 3;
11779/15                                                               AS/NC/ra                  303
                                             DGB 2B                                            EN
 ---pagebreak--- 2.      In cases where germinal products of kept animals are allowed to leave a restricted zone
        subject to:
        (a)    disease control measures as provided for in point (f)(ii) of Article 55(1), Articles 56,
               64 and 65, Article 74(1) and Article 79, and the rules adopted pursuant to
               Article 55(2), Article 67, Articles 71(3) and 74(4), Article 83(2), or
        (b)    emergency measures as provided for in Articles 257 and 258 and the rules adopted
               pursuant to Article 259,
        and those germinal products are of species subject to those disease control or emergency
        measures, operators shall only move such germinal products within a Member State or
        from one Member State to another Member State when they are accompanied by an animal
        health certificate issued by the competent authority of the Member State of origin in
        accordance with Article 149(1), unless derogations have been granted from the animal
        health certification requirement in accordance with the rules referred in this subparagraph.
        The competent authority may decide that such a certificate does not have to be issued for
        movements of germinal products within the Member State concerned when that authority
        considers that an alternative system is in place ensuring that the consignment of such
        germinal products is traceable and that those germinal products comply with the animal
        health requirements for such movement.
3.      Operators shall take all necessary measures to ensure that the animal health certificate
        referred to in paragraph 1 accompanies the germinal products from their place of origin to
        their place of destination.
11779/15                                                                 AS/NC/ra                    304
                                                DGB 2B                                             EN
 ---pagebreak--- 4.      The competent authority shall, upon request by an operator, issue an animal health
        certificate for the movements of germinal products referred to in paragraph 1, provided that
        the relevant requirements referred to in Chapter 5 of Title I of Part IV have been complied
        with.
5.      Articles 148, 149 and 150, and the rules adopted pursuant to Articles 146 and 147 and
        Article 149(4), shall apply to the animal health certification of the germinal products
        referred to in paragraph 1 of this Article. Article 151(1) and the rules adopted pursuant to
        Article 151(3) shall apply to the self–declaration of movements of germinal products.
6.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning derogations from the animal health certificate requirements provided for in
        paragraph 1 of this Article as regards movements of germinal products of kept animals of
        the bovine, ovine, caprine, porcine and equine species and germinal products of poultry
        which do not pose a significant risk for the spread of listed diseases due to:
        (a)    the nature of the germinal products concerned or the species of animal that those
               products come from;
        (b)    the methods of production and processing at the germinal product establishment;
        (c)    the intended use of the germinal products;
        (d)    alternative risk-mitigation measures in place for the type and category of germinal
               products and the germinal product establishment;
11779/15                                                                 AS/NC/ra                  305
                                               DGB 2B                                           EN
 ---pagebreak---         (e)   the place of destination of the germinal products, when the place of destination is in
              the same Member State as the place of origin but the germinal products pass through
              another Member State in order to reach the place of destination.
                                             Article 162
                                 Content of animal health certificates
1.      The animal health certificate for the germinal products provided for in Article 161 shall
        contain at least the following information:
        (a)   the germinal product establishment of origin and the establishment or place of
              destination;
        (b)   the type of the germinal products and the species of kept donor animals;
        (c)   the volume or number of the germinal products;
        (d)   the marking of the germinal products, when required by Articles 121(1) and by any
              rules adopted pursuant to Article 122(1);
        (e)   the information needed to demonstrate that the germinal products of the consignment
              fulfil the movement requirements for the relevant species as provided for in
              Articles 157 and 159 and in any rules adopted pursuant to Article 160.
11779/15                                                               AS/NC/ra                   306
                                               DGB 2B                                           EN
 ---pagebreak--- 2.      The animal health certificate for germinal products as provided for in Article 161 may
        include other information required under other Union legislation.
3.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        information to be contained in the animal health certificate pursuant to paragraph 1 of this
        Article;
4.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning animal health certification for different types of germinal products and of
        different animal species.
5.      The Commission may, by means of implementing acts, lay down rules concerning model
        forms of animal health certificates for germinal products. Those implementing acts shall be
        adopted in accordance with the examination procedure referred to in Article 266(2).
11779/15                                                               AS/NC/ra                   307
                                              DGB 2B                                            EN
 ---pagebreak---                                                Article 163
           Notification of movements of germinal products of kept animals of the bovine,
            ovine, caprine, porcine and equine species and germinal products of poultry
                                         to other Member States
1.      Operators shall:
        (a)    inform the competent authority in their Member State of origin in advance of the
               intended movement of germinal products of kept animals of the bovine, ovine,
               caprine, porcine and equine species and germinal products of poultry to another
               Member State when:
               (i)   the germinal products in question are required to be accompanied by an animal
                     health certificate in accordance with Article 161(1) or (2);
               (ii)  notification of movement is required in accordance with delegated acts adopted
                     pursuant to point (a) of paragraph 5 of this Article for germinal products,
                     taking into account paragraph 3 of this Article;
        (b)    provide all the necessary information to enable the competent authority of the
               Member State of origin to notify the movement of the germinal products to the
               competent authority of the Member State of destination in accordance with
               paragraph 2.
11779/15                                                                 AS/NC/ra                 308
                                                 DGB 2B                                          EN
 ---pagebreak--- 2.      The competent authority of the Member State of origin shall notify, prior to the movement
        in question and whenever possible through TRACES, the competent authority of the
        Member State of destination of any movement of germinal products of kept animals of the
        bovine, ovine, caprine, porcine and equine species and germinal products of poultry in
        accordance with the rules adopted pursuant to paragraphs 5 and 6.
3.      Member States shall use, for the management of notifications, regions designated in
        accordance with Article 153(3).
4.      Article 153(4) shall apply to the notification of germinal products by operators.
5.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)   the requirement for advance notification by operators of movements of germinal
              products between Member States in accordance with point (a)(ii) of paragraph 1 of
              this Article, where traceability of such movements is necessary in order to ensure
              compliance with the animal health requirements for movements laid down in
              Sections 1 and 2 (Articles 157 to 160);
        (b)   information necessary to notify movements of germinal products as provided for in
              paragraph 1 of this Article;
        (c)   the emergency procedures for the notification of movements of germinal products in
              the event of power cuts and other disturbances of TRACES.
11779/15                                                               AS/NC/ra                  309
                                               DGB 2B                                          EN
 ---pagebreak--- 6.      The Commission may, by means of implementing acts, lay down rules concerning:
        (a)   the provision of information on movements of germinal products by operators to the
              competent authority of their Member State of origin in accordance with paragraph 1;
        (b)   notification by the competent authority of the Member State of origin to the Member
              State of destination of movements of germinal products in accordance with
              paragraph 2;
        (c)   the deadlines for:
              (i)    the provision of the information referred to in paragraph 1 by the operator to
                     the competent authority of the Member State of origin;
              (ii)   notification by the competent authority of the Member State of origin of
                     movements of germinal products as referred to in paragraph 2.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                 AS/NC/ra                  310
                                               DGB 2B                                            EN
 ---pagebreak---                                               SECTION 4
         MOVEMENTS TO OTHER MEMBER STATES OF GERMINAL PRODUCTS
     OF KEPT TERRESTRIAL ANIMALS OF SPECIES OTHER THAN BOVINE, OVINE,
   CAPRINE, PORCINE AND EQUINE SPECIES AND GERMINAL PRODUCTS OF POULTRY
                                              Article 164
                            Germinal products of kept terrestrial animals
                       other than those of the bovine, ovine, caprine, porcine
                        and equine species and germinal products of poultry
1.      Operators shall only move germinal products of kept terrestrial animals of species other
        than those of the bovine, ovine, caprine, porcine and equine species and germinal products
        of poultry to another Member State if those products do not pose a significant risk for the
        spread of listed diseases as referred to in point (d) of Article 9(1) to listed species at the
        place of destination, taking into account the health status at the place of destination.
2.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning animal health requirements, animal health certification and
        notification requirements for movements of germinal products of kept terrestrial animals of
        species other than those of the bovine, ovine, caprine, porcine and equine species and
        germinal products of poultry, taking into account the following matters:
        (a)   listed diseases as referred to in point (d) of Article 9(1) for the listed species
              concerned;
11779/15                                                                  AS/NC/ra                     311
                                                DGB 2B                                               EN
 ---pagebreak---         (b)   the species of animals from which the germinal products have been collected and the
              type of germinal product;
        (c)   the health status at the places of origin and of destination;
        (d)   the type of collection, production, processing and storage;
        (e)   other epidemiological factors.
3.      Where animal health certification and notification of movements of germinal products are
        required in accordance with paragraph 2:
        (a)   the rules provided for in Articles 161(1) to (5), 162 (1) and (2) and the rules adopted
              pursuant to Articles 161(6) and 162(3) to (5) shall apply for such certification;
        (b)   the rules provided for in Article 163(1), (2) and (4) and the rules adopted pursuant to
              Article 163(5) shall apply for notification of movements.
11779/15                                                                 AS/NC/ra                  312
                                                DGB 2B                                           EN
 ---pagebreak---                                              SECTION 5
                                          DEROGATIONS
                                              Article 165
               Germinal products intended for scientific purposes and delegated acts
1.      The competent authority of the place of destination may, subject to the agreement of the
        competent authority of the place of origin, authorise movements of germinal products into
        the territory of the Member State of destination, for scientific purposes, where those
        movements do not fulfil the requirements of Articles 159 to 164.
2.      The competent authority shall only grant derogations provided for in paragraph 1 under the
        following conditions:
        (a)    the competent authorities of the places of destination and origin:
               (i)   have agreed on the conditions for the movements proposed;
               (ii)  ensure that necessary risk-mitigation measures are in place so that those
                     movements do not jeopardise the health status en route and in the place of
                     destination with regard to the listed diseases referred to in point (d) of
                     Article 9(1);
11779/15                                                                  AS/NC/ra               313
                                               DGB 2B                                           EN
 ---pagebreak---              (iii) have notified, where relevant, the competent authorities of Member States of
                   passage of the derogation granted and of the conditions under which it is
                   granted;
        (b)  those movements take place under the supervision of the competent authorities of the
             places of origin and destination, and where relevant, of the competent authorities of
             any Member States of passage.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the rules for the granting of derogations by competent authorities,
        supplementing those provided for in paragraphs 1 and 2 of this Article.
11779/15                                                              AS/NC/ra                  314
                                              DGB 2B                                           EN
 ---pagebreak---                                             Chapter 6
                      Production, processing and distribution
                  within the Union of products of animal origin
                                              Article 166
                General animal health obligations for operators and delegated acts
1.      Operators shall take appropriate preventive measures to ensure that, during all stages of the
        production, processing and distribution of products of animal origin in the Union, such
        products do not cause the spread of:
        (a)   listed diseases as referred to in point (d) of Article 9(1), taking into account the
              health status of the place of production, processing or destination;
        (b)   emerging diseases.
2.      Operators shall ensure that products of animal origin do not come from establishments or
        food businesses, or are not obtained from animals which come from establishments, that
        are subject to:
        (a)   emergency measures as provided for in Articles 257 and 258 or any rules adopted
              pursuant to Article 259, unless derogations from the requirement provided for in
              paragraph 1 of this Article are provided for in rules adopted pursuant to Article 259;
11779/15                                                                  AS/NC/ra                  315
                                                DGB 2B                                             EN
 ---pagebreak---         (b)   movement restrictions applicable to kept terrestrial animals and products of animal
              origin, as provided for in point (c) of Article 32(1), point (e) of Article 55(1), Article
              56, point (a) of Article 61(1), Article 62(1), point (c) of Article 65(1), point (b) of
              Article 70(1), point (a) of Article 74(1), point (b) of Article 76(2), Article 76(3),
              Article 79, Article 81 and Article 82(2) and (3) and in the rules adopted pursuant to
              Article 55(2), Articles 63 and 67, Article 70(3), Article 71(3), Article 74(4), Article
              76(5) and Article 83(2), unless derogations from those movement restrictions have
              been provided for in those rules.
3.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        detailed requirements supplementing those referred to:
        (a)   in paragraph 1 of this Article on preventive measures, including risk-mitigation
              measures, and
        (b)   in paragraph 2 of this Article in relation to restrictions on movements of products of
              animal origin.
4.      When adopting the delegated acts referred to in paragraph 3, the Commission shall base
        those acts on:
        (a)   the listed disease in question, as referred to in point (d) of Article 9(1), and species
              concerned by it and
        (b)   the risks involved.
11779/15                                                                  AS/NC/ra                    316
                                               DGB 2B                                               EN
 ---pagebreak---                                                Article 167
       Operators' obligations with regard to animal health certificates and delegated acts
1.      Operators shall only move the following products of animal origin within a Member State
        or to another Member State where the products in question are accompanied by an animal
        health certificate issued by the competent authority of the Member State of origin in
        accordance with paragraph 3:
        (a)    products of animal origin that:
               (i)   are allowed to be moved from a restricted zone subject to emergency measures
                     as provided for in rules adopted pursuant to Article 259;
               (ii)  originate from animals of species subject to those emergency measures;
        (b)    products of animal origin that:
               (i)   are allowed to be moved from a restricted zone subject to disease control
                     measures in accordance with Article 32(1), point (f)(ii) of Article 55(1), Article
                     56, point (a) of Article 61(1), Article 62(1), Article 64, point (c) of Article
                     65(1), point (b) of Article 70(1), point (a) of Article 74(1) and Article79(1) and
                     any rules adopted pursuant to Article 55(2), Articles 63 and 67 and
                     Articles 71(3), 74(4) and 83(2),
11779/15                                                                  AS/NC/ra                    317
                                                DGB 2B                                               EN
 ---pagebreak---               (ii)   originate from animals of species subject to those disease control measures.
        The competent authority may decide that such a certificate does not have to be issued for
        movements of products of animal origin 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 those products fulfil the animal health requirements
        for such movements.
2.      Operators shall take all necessary measures to ensure that the animal health certificate
        referred to in paragraph 1 accompanies the products of animal origin from their place of
        origin to their place of destination.
3.      The competent authority shall, upon request by the operator concerned, issue an animal
        health certificate for movements of products of animal origin as referred to in paragraph 1,
        provided that the relevant requirements referred to in this Article have been complied with.
4.      Articles 148, 149 and 150 and the rules adopted pursuant to Articles 146 and 147 and
        Article 149(4) shall apply to the animal health certification of movements of products of
        animal origin as referred to in paragraph 1 of this Article.
11779/15                                                                AS/NC/ra                  318
                                               DGB 2B                                            EN
 ---pagebreak--- 5.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning derogations from the animal health certificate requirements provided for in
        paragraph 1 of this Article and the conditions for such derogations, in respect of
        movements of products of animal origin which do not pose a significant risk for the spread
        of diseases due to:
        (a)    the types of products of animal origin concerned;
        (b)    the risk-mitigation measures applied to the products of animal origin, thereby
               reducing the risks of the spread of diseases;
        (c)    the intended use of the products of animal origin;
        (d)    the place of destination of the products of animal origin.
                                              Article 168
            Content of animal health certificates and delegated and implementing acts
1.      The animal health certificate for products of animal origin provided for in Article 167(1)
        shall contain at least the following information:
        (a)    the establishment or place of origin and the establishment or place of destination;
        (b)    a description of the products of animal origin concerned;
11779/15                                                                AS/NC/ra                   319
                                                DGB 2B                                           EN
 ---pagebreak---         (c)    the quantity of the products of animal origin;
        (d)    the identification of the products of animal origin, when required by point (h) of
               Article 65(1) or by any rules adopted pursuant to point (a) of Article 67;
        (e)    the information needed to demonstrate that the products of animal origin fulfil the
               movement restriction requirements provided for in Article 166(2) and in any rules
               adopted pursuant to Article 166(3).
2.      The animal health certificate referred to in paragraph 1 may include other information
        required under other Union legislation.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the information to be contained in the animal health certificate provided
        for in paragraph 1 of this Article.
4.      The Commission may, by means of implementing acts, lay down rules concerning model
        forms of animal health certificates for products of animal origin referred to in paragraph 1
        of this Article. Those implementing acts shall be adopted in accordance with the
        examination procedure referred to in Article 266(2).
11779/15                                                                AS/NC/ra                   320
                                                DGB 2B                                            EN
 ---pagebreak---                                              Article 169
          Notification of movements of products of animal origin to other Member States
1.      Operators shall:
        (a)   inform the competent authority in their Member State of origin in advance of
              intended movements of products of animal origin when the consignments in question
              are required to be accompanied by an animal health certificate in accordance with
              Article 167(1);
        (b)   provide all necessary information to enable the competent authority of the Member
              State of origin to notify the movement in question to the competent authority of the
              Member State of destination in accordance with paragraph 2.
2.      The competent authority of the Member State of origin shall, prior to the movement and
        whenever possible through TRACES, notify the competent authority of the Member State
        of destination of movements of products of animal origin in accordance with the rules
        adopted pursuant to paragraphs 5 and 6.
3.      Member States shall use, for the management of notifications, regions designated in
        accordance with Article 153(3).
4.      Article 153(4) shall apply to the notification of movements of products of animal origin by
        operators.
11779/15                                                               AS/NC/ra                  321
                                               DGB 2B                                          EN
 ---pagebreak--- 5.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)  the information needed for the notification of movements of products of animal
             origin as provided for in paragraph 1 of this Article;
        (b)  the emergency procedures for the notification of movements of products of animal
             origin in the event of power cuts and other disturbances of TRACES.
6.      The Commission may, by means of implementing acts, lay down rules concerning:
        (a)  the information to be provided by operators to the competent authority of their
             Member State of origin concerning movements of products of animal origin in
             accordance with paragraph 1;
        (b)  notification of movements of products of animal origin to be given by the competent
             authority of the Member State of origin to the Member State of destination in
             accordance with paragraph 2;
        (c)  the deadlines for:
             (i)   provision of the information referred to in paragraph 1 by the operator
                   concerned to the competent authority of the Member State of origin;
11779/15                                                              AS/NC/ra                322
                                             DGB 2B                                          EN
 ---pagebreak---               (ii)   notification of movements of products of animal origin to be given by the
                     competent authority of the Member State of origin as referred to in
                     paragraph 2.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                             Chapter 7
                                Scope of national measures
                                              Article 170
  National measures concerning disease control and movements of animals and germinal products
1.      Member States shall remain free to take national measures to control listed diseases as
        referred to in points (d) and (e) of Article 9(1) with regard to movements of terrestrial
        animals and germinal products thereof within their own territories.
2.      Those national measures shall:
        (a)   take account of the rules on movements of animals and germinal products laid down
              in Chapters 3 (Articles 124 to 154), 4 (Articles 155 and 156) and 5 (Articles 157 to
              165), and shall not be inconsistent with those rules;
        (b)   not hinder the movement of animals and products between Member States;
11779/15                                                                 AS/NC/ra                  323
                                                DGB 2B                                            EN
 ---pagebreak---           (c)   not exceed the limits of what is appropriate and necessary in order to prevent the
                introduction and spread of the listed diseases referred to in points (d) and (e) of
                Article 9(1).
                                              Article 171
         National measures designed to limit the impact of diseases other than listed diseases
Where a disease other than a listed disease constitutes a significant risk for the health of kept
terrestrial animals in a Member State, the Member State concerned may take national measures to
control that disease and may restrict movements of kept terrestrial animals and germinal products,
provided those measures do not:
(a)       hinder the movement of animals and products between Member States;
(b)       exceed the limits of what is appropriate and necessary in order to control that disease.
11779/15                                                                  AS/NC/ra                   324
                                                DGB 2B                                              EN
 ---pagebreak---                                            TITLE II
 Aquatic animals and products of animal origin from aquatic animals
                                          Chapter 1
            Registration, approval, record-keeping and registers
                                           SECTION 1
                   REGISTRATION OF AQUACULTURE ESTABLISHMENTS
                                            Article 172
                  Obligation of operators to register aquaculture establishments
1.      Operators of aquaculture establishments shall, in order for their establishments to be
        registered in accordance with Article 173, before they commence such activities:
        (a)   inform the competent authority of any aquaculture establishment under their
              responsibility;
        (b)   provide the competent authority with the following information:
              (i)    the name and address of the operator concerned;
11779/15                                                               AS/NC/ra                 325
                                              DGB 2B                                           EN
 ---pagebreak---               (ii)  the location of the establishment and a description of its facilities;
              (iii) the species, categories and quantities (numbers, volume or weight) of
                    aquaculture animals which they intend to keep on the aquaculture
                    establishment and the capacity of the aquaculture establishment;
              (iv) the type of aquaculture establishment; and
              (v)   any other aspects of the establishment which are relevant for the purpose of
                    determining the risk posed by it.
2.      Operators of aquaculture establishments referred to in paragraph 1 shall inform the
        competent authority in advance of:
        (a)   any significant changes in the aquaculture establishment in question concerning the
              matters referred to in point (b) of paragraph 1;
        (b)   any cessation of activity by the operator or aquaculture establishment concerned.
3.      Aquaculture establishments which are subject to approval in accordance with
        Article 176(1) and Article 177 shall not be required to provide the information referred to
        in paragraph 1 of this Article.
11779/15                                                               AS/NC/ra                  326
                                               DGB 2B                                          EN
 ---pagebreak--- 4.      An operator may apply for registration as provided for in paragraph 1 to cover a group of
        aquaculture establishments, provided that they fulfil either of the following conditions:
        (a)   they are located in an epidemiologically linked area and all operators in that area
              operate under a common biosecurity system;
        (b)   they are under the responsibility of the same operator and operate under a common
              biosecurity system, and the aquaculture animals of the establishments concerned
              form part of a single epidemiological unit.
        Where an application for registration covers a group of establishments, the rules laid down
        in paragraphs 1 to 3 of this Article and in point (b) of Article 173, and the rules adopted
        pursuant to Article 175 which are applicable to a single aquaculture establishment, shall be
        applicable to the group of aquaculture establishments as a whole.
                                              Article 173
                               Obligations of the competent authority
                     concerning the registration of aquaculture establishments
A competent authority shall register:
(a)     aquaculture establishments in the register of aquaculture establishments provided for in
        Article 185(1), where the operator concerned has provided the information required in
        accordance with Article 172(1);
11779/15                                                                 AS/NC/ra                   327
                                               DGB 2B                                             EN
 ---pagebreak--- (b)       groups of aquaculture establishment in that register, provided that the criteria laid down in
          Article 172(4) are complied with.
The competent authority shall assign each establishment or group of establishments as referred to in
this Article with a unique registration number.
                                               Article 174
         Derogations from the obligation of operators to register aquaculture establishments
By way of derogation from Article 172(1), Member States may exempt from the registration
requirement certain aquaculture establishments posing an insignificant risk, as provided for in an
implementing act adopted in accordance with Article 175.
                                               Article 175
                   Implementing powers concerning derogations from the obligation
                                 to register aquaculture establishments
1.        The Commission may, by means of implementing acts, lay down rules concerning the
          information to be provided by operators for the purpose of the registration of aquaculture
          establishments as provided for in Article 172(1), including the time-limits by which such
          information is to be provided.
11779/15                                                                 AS/NC/ra                   328
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      The Commission shall, by means of implementing acts, lay down rules concerning the
        types of aquaculture establishments that may be exempted by Member States from the
        registration requirement in accordance with Article 174, based on:
        (a)   the species, categories and quantity (number, volume or weight) of aquaculture
              animals on the aquaculture establishment in question and the capacity of that
              establishment;
        (b)   the movements of aquaculture animals into and out of the aquaculture establishment.
3.      The implementing acts referred to in this Article shall be adopted in accordance with the
        examination procedure referred to in Article 266(2).
                                            SECTION 2
         APPROVAL OF CERTAIN TYPES OF AQUACULTURE ESTABLISHMENTS
                                            Article 176
                 Approval of certain aquaculture establishments and delegated acts
1.      Operators of the following types of aquaculture establishments shall apply to the
        competent authority for approval in accordance with Article 180(1):
        (a)   aquaculture establishments where aquaculture animals are kept with a view to their
              being moved therefrom, either alive or as products of aquaculture animal origin;
11779/15                                                               AS/NC/ra                 329
                                              DGB 2B                                           EN
 ---pagebreak---         (b)   other aquaculture establishments which pose a significant risk due to:
              (i)   the species, categories and number of aquaculture animals kept there;
              (ii)  the type of aquaculture establishment concerned;
              (iii) movements of aquaculture animals into and out of the aquaculture
                    establishment concerned.
2.      By way of derogation from paragraph 1, Member States may exempt from the obligation to
        apply for approval operators of the following types of establishment:
        (a)   aquaculture establishments producing a small quantity of aquaculture animals for
              supply for human consumption either:
              (i)   to the final consumer directly; or
              (ii)  to local retail establishments directly supplying the final consumer;
        (b)   ponds and other installations where the population of aquatic animals is maintained
              only for recreational fishing purposes, by restocking with aquaculture animals which
              are confined and unable to escape;
        (c)   aquaculture establishments keeping aquaculture animals for ornamental purposes in
              closed facilities,
        provided that the establishment in question does not pose a significant risk.
11779/15                                                                AS/NC/ra                330
                                               DGB 2B                                          EN
 ---pagebreak--- 3.      Unless a derogation has been granted under paragraph 4 of this Article, operators shall not
        commence activity at an aquaculture establishment as referred to in paragraph 1 of this
        Article until that establishment has been approved in accordance with Article 181(1), and
        shall cease such activity at an aquaculture establishment referred to in paragraph 1 of this
        Article where:
        (a)    the competent authority withdraws or suspends its approval in accordance with
               Article 184(2); or
        (b)    in the event of conditional approval, granted in accordance with Article 183(3), the
               aquaculture establishment concerned fails to comply with the outstanding
               requirements referred to in Article 183(4) and does not obtain a final approval in
               accordance with Article 183(3).
4.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning :
        (a)    derogations from the requirement for operators to apply to the competent authority
               for approval of the types of aquaculture establishments referred to in point (a) of
               paragraph 1, concerning types of establishments other than those specified in
               points (a)(i) and (ii) of paragraph 2, where those establishments do not pose a
               significant risk;
        (b)    the types of aquaculture establishments which must be approved in accordance with
               point (b) of paragraph 1.
11779/15                                                                  AS/NC/ra                 331
                                                 DGB 2B                                           EN
 ---pagebreak--- 5.      When adopting delegated acts as provided for in paragraph 4, the Commission shall base
        those acts on the following criteria:
        (a)    the species and categories of aquaculture animals kept in an aquaculture
               establishment;
        (b)    the type of aquaculture establishment and the type of production; and
        (c)    typical movement patterns of the type of aquaculture establishment concerned and of
               the species or category of aquaculture animals concerned.
6.      An operator may apply for approval of a group of aquaculture establishments, provided
        that the requirements provided for in points (a) and (b) of Article 177 are complied with.
11779/15                                                                AS/NC/ra                 332
                                               DGB 2B                                          EN
 ---pagebreak---                                                Article 177
              Approval by the competent authority of groups of aquaculture establishments
The competent authority may grant approval as provided for in Article 181(1) covering a group of
aquaculture establishments, provided that the aquaculture establishments in question comply with
either of the following conditions:
(a)       they are located in an epidemiologically linked area and all operators in that area operate
          under a common biosecurity system; however, any on–shore or off–shore establishment for
          the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live
          bivalve molluscs intended for human consumption (so-called "dispatch centres"),
          establishment with tanks fed by clean seawater in which live bivalve molluscs are placed
          for the time necessary to reduce contamination to make them fit for human consumption
          (so-called "purification centres") and similar establishments located inside such an
          epidemiologically linked area must be approved individually;
(b)       they are under the responsibility of the same operator; and
          (i)   operate under a common biosecurity system; and
          (ii)  the aquaculture animals of the establishments concerned form part of the same
                epidemiological unit.
11779/15                                                                  AS/NC/ra                  333
                                                 DGB 2B                                           EN
 ---pagebreak--- When a single approval is granted for a group of aquaculture establishments, the rules laid down in
Article 178 and Articles 180 to 184 and the rules adopted pursuant to Articles 180(2) and 181(2),
which are applicable to a single aquaculture establishment, shall be applicable to the whole group of
aquaculture establishments.
                                              Article 178
                      Approval of status of confined aquaculture establishments
Operators of aquaculture establishments wishing to obtain the status of a confined establishment
shall:
(a)      apply to the competent authority for approval in accordance with Article 180(1);
(b)      move aquaculture animals to or from their establishment in accordance with the
         requirements provided for in Article 203(1) and any delegated acts adopted in accordance
         with Article 203(2) only after their establishment has obtained an approval of that status
         from the competent authority in accordance with Article 181 or 183.
                                              Article 179
                       Approval of disease control aquatic food establishments
Operators of disease control aquatic food establishments shall:
(a)      ensure that the necessary approval in accordance with Article 4 of Regulation (EC)
         No 853/2004 of the European Parliament and of the Council 1 has been obtained; and
1
        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).
11779/15                                                                AS/NC/ra                   334
                                                DGB 2B                                           EN
 ---pagebreak--- (b)     apply to the competent authority, in accordance with Article 180(1), for approval to
        slaughter or process aquatic animals for disease control purposes in accordance with
        point (b) of Article 61(1), Article 62 and Articles 68(1), 79(1) and (2) and the rules adopted
        pursuant to Article 63 and Articles 70(3), 71(3) and 79(3).
                                              Article 180
         Obligation of operators to provide information with a view to obtaining approval
1.      Operators shall, for the purposes of their application for approval of their establishment as
        provided for in Article 176(1), Article 177, point (a) of Article 178 and Article 179,
        provide the competent authority with the following information:
        (a)   the name and address of the operator concerned;
        (b)   the location of the establishment concerned and a description of its facilities;
        (c)   the species, categories and quantities (numbers, volume or weight) of aquaculture
              animals relevant for the approval which are kept on the establishment;
        (d)   the type of aquaculture establishment;
        (e)   in cases of approval of a group of aquaculture establishments, details showing that
              the group in question complies with the conditions laid down in Article 177;
11779/15                                                                AS/NC/ra                   335
                                               DGB 2B                                            EN
 ---pagebreak---         (f)   other aspects of the mode of operation of the aquaculture establishment in question
              which are relevant for determining the risk, posed by it;
        (g)   the water supply to, and discharge of water from, the establishment;
        (h)   the establishment's biosecurity measures.
2.      Operators of establishments as referred to in paragraph 1 shall inform the competent
        authority in advance of:
        (a)   any changes in the establishments concerning the matters referred to in paragraph 1;
        (b)   any cessation of activity by the operator or establishment concerned.
3.      The Commission may, by means of implementing acts, lay down rules concerning the
        information to be provided by operators in their application for approval of their
        establishment, in accordance with paragraph 1, including the time-limits by which such
        information is to be provided.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                336
                                               DGB 2B                                          EN
 ---pagebreak---                                               Article 181
                    Granting of, and conditions for, approval and delegated acts
1.      The competent authority shall only grant approvals of aquaculture establishments as
        referred to in Article 176(1) and point (a) of Article 178, groups of aquaculture
        establishments as referred to in Article 177 and disease control aquatic food establishments
        as referred to in Article 179, where such establishments:
        (a)   comply with the following requirements, where appropriate, in relation to:
              (i)    quarantine, isolation and other biosecurity measures taking into account the
                     requirements provided for in point (b) of Article 10(1)) and any rules adopted
                     pursuant to Article 10(6);
              (ii)   surveillance requirements as provided for in Article 24, where relevant for the
                     type of establishment concerned and the risk involved, in Article 25 ;
              (iii) record-keeping as provided for in Articles 186 to 188 and any rules adopted
                     pursuant to Articles 189 and 190;
        (b)   have facilities and equipment that are:
              (i)    adequate to reduce the risk of the introduction and spread of diseases to an
                     acceptable level, taking into account the type of establishment concerned;
11779/15                                                                 AS/NC/ra                  337
                                                DGB 2B                                            EN
 ---pagebreak---              (ii)   of a capacity adequate for the species, categories and quantity (numbers,
                    volume or weight) of aquatic animals concerned;
        (c)  do not pose an unacceptable risk as regards the spread of diseases, taking into
             account the risk-mitigation measures in place;
        (d)  have in place a system which enables the operator concerned to demonstrate to the
             competent authority that the requirements laid down in points (a), (b) and (c) are
             fulfilled.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)  quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of
             paragraph 1;
        (b)  surveillance as referred to in point (a)(ii) of paragraph 1;
        (c)  facilities and equipment as referred to in point (b) of paragraph 1.
3.      When establishing the rules to be laid down in the delegated acts to be adopted pursuant to
        paragraph 2, the Commission shall base those rules on the following matters:
        (a)  the risks posed by each type of establishment;
        (b)  the species and categories of aquaculture or aquatic animals relevant for the
             approval;
11779/15                                                                AS/NC/ra                  338
                                              DGB 2B                                             EN
 ---pagebreak---          (c)    the type of production concerned;
         (d)    typical movement patterns of the type of aquaculture establishment and species and
                categories of animals kept in those establishments.
                                               Article 182
                                Scope of the approval of establishments
The competent authority shall expressly specify in the approval of an aquaculture establishment or a
disease control aquatic food establishment granted pursuant to Article 181(1) following an
application made in accordance with Article 176, Article 177, point (a) of Article 178 or
Article 179:
(a)      for which of the types of aquaculture establishments referred to in Article 176(1) and point
         (a) of Article 178, groups of aquaculture establishments referred to in Article 177 and
         disease control aquatic food establishments referred to in Article 179, and in any rules
         adopted pursuant to point (b) of Article 176(4), the approval applies;
(b)      for which species and categories of aquaculture animals the approval applies.
11779/15                                                                AS/NC/ra                   339
                                                DGB 2B                                            EN
 ---pagebreak---                                               Article 183
                Procedures for the granting of approval by the competent authority
1.      The competent authority shall establish procedures for operators to follow when applying
        for approval of their establishments in accordance with Article 176(1) and Articles 178
        and 179.
2.      Upon receipt of an application for approval from an operator in accordance with
        Article 176(1), Article 178 or Article 179, the competent authority shall make an on–site
        visit.
3.      Provided that the requirements referred to in Article 181 are fulfilled, the competent
        authority shall grant the approval.
4.      Where an establishment does not fulfil all requirements for approval as referred to in
        Article 181, the competent authority may grant conditional approval of an establishment if
        it appears, on the basis of the application by the operator concerned and the subsequent
        on-site visit provided for in paragraph 2 of this Article, that the establishment meets all the
        main requirements that provide sufficient guarantees that the establishment does not pose a
        significant risk.
11779/15                                                                  AS/NC/ra                  340
                                                DGB 2B                                            EN
 ---pagebreak--- 5.      Where conditional approval has been granted by the competent authority in accordance
        with paragraph 4 of this Article, it shall grant full approval only where it appears from
        another on–site visit to the establishment, carried out within three months from the date of
        the grant of conditional approval, or from documentation provided by the operator within
        three months from that date, that the establishment meets all the requirements for approval
        provided for in Article 181(1) and the rules adopted pursuant to Article 181(2).
        Where the on–site visit or the documentation referred to in the first subparagraph shows
        that clear progress has been made but that the establishment still does not meet all of those
        requirements, the competent authority may prolong the conditional approval. However,
        conditional approval shall not be granted for a period exceeding, in total, six months.
                                              Article 184
           Review, suspension and withdrawal of approvals by the competent authority
1.      The competent authority shall keep approvals of establishments granted in accordance with
        Article 181(1) under review, at appropriate intervals based on the risk involved.
11779/15                                                                 AS/NC/ra                  341
                                               DGB 2B                                             EN
 ---pagebreak--- 2.      Where a competent authority identifies serious deficiencies in an establishment as regards
        compliance with the requirements laid down in Article 181(1) and the rules adopted
        pursuant to Article 181(2), and the operator of that establishment is not able to provide
        adequate guarantees that those deficiencies will be eliminated, the competent authority
        shall initiate procedures to withdraw the approval of the establishment.
        However, the competent authority may merely suspend, rather than withdraw, approval of
        an establishment where the operator can guarantee that it will eliminate those deficiencies
        within a reasonable period of time.
3.      Approval shall only be granted after withdrawal or restored after suspension in accordance
        with paragraph 2 when the competent authority is satisfied that the establishment fully
        complies with all the requirements of this Regulation appropriate for that type of
        establishment.
11779/15                                                               AS/NC/ra                   342
                                              DGB 2B                                             EN
 ---pagebreak---                                             SECTION 3
                      REGISTER OF AQUACULTURE ESTABLISHMENTS
                AND DISEASE CONTROL AQUATIC FOOD ESTABLISHMENTS
                                             Article 185
     Register of aquaculture establishments and disease control aquatic food establishments
1.      Each competent authority shall establish and keep up to date a register of:
        (a)   all aquaculture establishments registered in accordance with Article 173;
        (b)   all aquaculture establishments approved in accordance with Article 181(1);
        (c)   all disease control aquatic food establishments approved in accordance with
              Article 181(1).
2.      The register of aquaculture establishments provided for in paragraph 1 shall contain the
        following information:
        (a)   the name and address of the operator and the registration number of the
              establishment in question;
        (b)   the location of the aquaculture establishment or, as the case may be, of the group of
              aquaculture establishments concerned;
11779/15                                                                AS/NC/ra                 343
                                               DGB 2B                                           EN
 ---pagebreak---         (c)   the type of production at the establishment;
        (d)   the water supply to, and discharge from, the establishment, when relevant;
        (e)   the species of aquaculture animals kept at the establishment;
        (f)   up–to–date information on the health status of the registered aquaculture
              establishment, or, as the case may be, of the group of establishments, as regards the
              listed diseases referred to in point (d) of Article 9(1).
3.      For establishments approved in accordance with Article 181(1), the competent authority
        shall make publicly available by electronic means at least the information referred to in
        points (a), (c), (e) and (f) of paragraph 2 of this Article, subject to data protection
        requirements.
4.      Where appropriate and relevant, a competent authority may combine the registration
        provided for in paragraph 1 with registration for other purposes.
5.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)   the relevant detailed information to be included in the register of aquaculture
              establishments provided for in paragraph 1 of this Article;
        (b)   the public availability of that register.
11779/15                                                                   AS/NC/ra               344
                                                DGB 2B                                          EN
 ---pagebreak---                                             SECTION 4
                          RECORD-KEEPING AND TRACEABILITY
                                             Article 186
             Record-keeping obligations of operators of aquaculture establishments
1.      Operators of aquaculture establishments subject to the requirement of registration in
        accordance with Article 173, or approval in accordance with Article 181(1), shall keep and
        maintain records containing at least the following information:
        (a)  the species, categories and quantities (numbers, volume or weight) of aquaculture
             animals on their establishment;
        (b)  movements of aquaculture animals and products of animal origin obtained from
             those animals into and out of their establishment, stating as appropriate:
             (i)   their place of origin or destination;
             (ii)  the date of such movements;
        (c)  the animal health certificates, in paper or electronic form, required to accompany
             movements of aquaculture animals arriving at the aquaculture establishment in
             accordance with Article 208 and the rules adopted pursuant to points (a) and (c) of
             Article 211(1) and Article 213(2);
11779/15                                                                AS/NC/ra                345
                                               DGB 2B                                          EN
 ---pagebreak---         (d)    mortality in each epidemiological unit and other disease problems at the aquaculture
               establishment as relevant for the type of production;
        (e)    biosecurity measures, surveillance, treatments, test results and other relevant
               information as appropriate for:
               (i)   the species and categories of the aquaculture animals on the establishment;
               (ii)  the type of production at the aquaculture establishment;
               (iii) the type and size of the aquaculture establishment;
        (f)    the results of any animal health visits required in accordance with Article 25(1).
        The records shall be kept and maintained in paper or electronic form.
2.      Aquaculture establishments presenting a low risk of spreading listed or emerging diseases
        may be exempted by the Member State concerned from the requirement to keep records of
        all or some of the information listed in points (c), (d) and (e) of paragraph 1, provided that
        traceability is ensured.
3.      Operators of aquaculture establishments shall keep the records provided for in paragraph 1
        on their aquaculture establishment concerned and shall:
        (a)    keep them in such a way that the tracing of the place of origin and destination of
               aquatic animals can be guaranteed;
11779/15                                                                  AS/NC/ra                  346
                                                DGB 2B                                            EN
 ---pagebreak---         (b)   make them available to the competent authority on request;
        (c)   retain them for a minimum period to be prescribed by the competent authority, which
              may not be less than three years.
        By way of derogation from the requirement that the records are to be kept on their
        establishment concerned, as set out in the first subparagraph, when it is physically not
        possible to keep the records on that establishment, they shall be kept in the office from
        which the business is administered.
                                             Article 187
            Record-keeping obligations of disease control aquatic food establishments
1.      Operators of disease control aquatic food establishments subject to approval in accordance
        with Article 179 shall keep and maintain records of:
        (a)   all movements into and from their establishment of aquaculture animals and products
              of animal origin obtained from such animals ;
        (b)   discharge of water and relevant biosecurity measures.
2.      Operators of disease control aquatic food establishments shall:
        (a)   keep the records provided for in paragraph 1 on their establishment and shall make
              them available to the competent authority on request;
11779/15                                                                AS/NC/ra                  347
                                              DGB 2B                                             EN
 ---pagebreak---         (b)    retain those records for a minimum period to be prescribed by the competent
               authority, which may not be less than three years.
        The records shall be kept and maintained in paper or electronic form.
                                               Article 188
                              Record-keeping obligations of transporters
1.      Transporters of aquatic animals intended for aquaculture establishments or to be released
        into the wild shall keep and maintain records in relation to:
        (a)    the species, categories and quantities (numbers, volume or weight) of aquatic animals
               transported by them;
        (b)    mortality rates of the aquaculture animals and wild aquatic animals in question
               during transport, in so far as is practicable for the type of transport and the species of
               aquaculture animals and wild aquatic animals transported;
        (c)    aquaculture establishments and disease control aquatic food establishments visited by
               the means of transport;
        (d)    any exchange of water that took place during transport, specifying the sources of new
               water and sites of release of water;
11779/15                                                                   AS/NC/ra                   348
                                                 DGB 2B                                             EN
 ---pagebreak---         (e)   the cleaning and disinfection of the means of transport.
        The records shall be kept and maintained in paper or electronic form.
2.      Transporters presenting a low risk of spreading listed or emerging diseases may be
        exempted by the Member State concerned from the requirement to keep records of all or
        some of the information listed in paragraph 1, provided that traceability is ensured.
3.      Transporters shall keep the records provided for in paragraph 1:
        (a)   in such a manner that they can be made immediately available to the competent
              authority on request;
        (b)   for a minimum period to be prescribed by the competent authority, which may not be
              less than three years.
                                             Article 189
                          Delegation of powers concerning record-keeping
1.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning rules supplementing the record-keeping requirements provided for
        in Articles 186, 187 and 188, as regards information to be recorded by operators in
        addition to that provided for in Articles 186(1), 187(1) and 188(1).
11779/15                                                               AS/NC/ra                349
                                               DGB 2B                                         EN
 ---pagebreak--- 2.       The Commission shall take the following matters into account when adopting the delegated
         acts provided for in paragraph 1:
         (a)   the risks posed by each type of aquaculture establishment or transport;
         (b)   the species and categories of aquatic animals kept on the aquaculture establishment
               concerned, or transported to or from that establishment;
         (c)   the type of production of the establishment;
         (d)   typical movement patterns for the type of aquaculture establishment or disease
               control aquatic food establishment;
         (e)   the numbers, volume or weight of aquatic animals kept on the establishment or
               transported to or from it.
                                              Article 190
        Implementing powers concerning exemptions from the record-keeping requirements
The Commission may, by means of implementing acts, lay down rules concerning the types of
aquaculture establishments and operators that may be exempted by Member States from the record-
keeping requirements provided for in Articles 186 and 188, as regards:
(a)      operators of certain categories of aquaculture establishments and transporters;
11779/15                                                                AS/NC/ra                350
                                               DGB 2B                                          EN
 ---pagebreak--- (b)      aquaculture establishments keeping, or transporters transporting, respectively, a small
         number of aquaculture animals or a small number of aquatic animals;
(c)      certain species and categories of aquatic animals.
When adopting those implementing acts, the Commission shall base those acts on the criteria
provided for in Article 189(2).
Those implementing acts shall be adopted in accordance with the examination procedure referred to
in Article 266(2).
                                             Chapter 2
                 Movements within the Union of aquatic animals
                                              SECTION 1
                         GENERAL REQUIREMENTS FOR MOVEMENTS
                                               Article 191
                       General requirements for movements of aquatic animals
1.       Operators shall take appropriate measures to ensure that the movement of aquatic animals
         does not jeopardise the health status at the place of destination with regard to:
         (a)   the listed diseases referred to in point (d) of Article 9(1);
         (b)   emerging diseases.
11779/15                                                                   AS/NC/ra               351
                                                 DGB 2B                                          EN
 ---pagebreak--- 2.      Operators shall only move aquatic animals into an aquaculture establishment or for human
        consumption purposes, or release them into the wild, if the animals in question fulfil the
        following conditions:
        (a)   they come, except in the case of wild aquatic animals, from establishments that have
              been:
              (i)   registered by the competent authority in accordance with Article 173,
              (ii)  approved by that competent authority in accordance with Articles 181 and 182,
                    when required by Article 176(1), Article 177 or Article 178, or
              (iii) granted a derogation from the registration requirement laid down in
                    Article 173.
        (b)   they are not subject to:
              (i)   movement restrictions affecting the species and categories concerned in
                    accordance with the rules laid down in Article 55(1), Article 56, Article 61(1),
                    Articles 62, 64 and 65, point (b) of Article 70(1), Article 74(1), Article 79 and
                    Article 81 and the rules adopted pursuant to Article 55(2), Articles 63 and 67
                    and Articles 70(3), 71(3), 74(4) and 83(2); or
              (ii)  the emergency measures laid down in Articles 242 and 258 and the rules
                    adopted pursuant to Article 259.
11779/15                                                                AS/NC/ra                   352
                                              DGB 2B                                              EN
 ---pagebreak---         However, operators may move those aquatic animals where derogations from the
        movement restrictions for such movements or release are provided for in Title II of Part III
        (Articles 53–83) or derogations from emergency measures are provided for in rules
        adopted pursuant to Article 259.
3.      Operators shall take all necessary measures to ensure that aquatic animals, after leaving
        their place of origin, are consigned directly to the final place of destination.
                                              Article 192
                        Disease prevention measures in relation to transport
1.      Operators shall take the appropriate and necessary disease prevention measures to ensure
        that:
        (a)    the health status of aquatic animals is not jeopardised during transport;
        (b)    transport operations of aquatic animals do not cause the potential spread of listed
               diseases as referred to in point (d) of Article 9(1) to humans or animals en route, and
               at places of destination;
        (c)    cleaning and disinfection of equipment and means of transport and other adequate
               biosecurity measures are taken, as appropriate to the risks involved with the transport
               operations concerned;
11779/15                                                                  AS/NC/ra                  353
                                                 DGB 2B                                           EN
 ---pagebreak---         (d)   any exchanges of water and discharges of water during the transport of aquatic
              animals intended for aquaculture or release into the wild are carried out at places and
              under conditions which do not jeopardise the health status with regard to the listed
              diseases referred to in point (d) of Article 9(1) of:
              (i)   the aquatic animals being transported;
              (ii)  any aquatic animals en route to the place of destination;
              (iii) aquatic animals at the place of destination.
2.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   the conditions and requirements for cleaning and disinfection of equipment and
              means of transport in accordance with point (c) of paragraph 1 of this Article and the
              use of biocidal products for such purposes;
        (b)   other appropriate biosecurity measures during transport as provided for in point (c)
              of paragraph 1 of this Article;
        (c)   water exchanges and discharges of water during transport as provided for in point (d)
              of paragraph 1 of this Article.
11779/15                                                               AS/NC/ra                   354
                                               DGB 2B                                            EN
 ---pagebreak---                                              Article 193
                                       Change of intended use
1.      Aquatic animals which are moved for destruction or slaughter in accordance with the
        following measures shall not be used for any other purpose:
        (a)   any of the disease control measures provided for in point (c) of Article 32(1) and
              Article 55(1), Articles 56, 61, 62, 64, 65 and 70, Articles 74(1) and (2) and
              Articles 79, 80, 81 and 82 and in the rules adopted pursuant to Article 55(2),
              Articles 63 and 67, Articles 70(3), 71(3) and 74(4), and Article 83(2);
        (b)   emergency measures as provided for in Articles 257 and 258 and in rules adopted
              pursuant to Article 259.
2.      Aquatic animals moved for human consumption, aquaculture, release into the wild or any
        other purpose, shall not be used for any purpose other than the intended one.
3.      By way of derogation from paragraph 2, the competent authority of the place of destination
        may authorise a change of use of aquatic animals for a purpose other than that originally
        intended, provided that the new use does not pose a higher risk to the health status of the
        aquatic animals at the place of destination than the originally intended use.
11779/15                                                                AS/NC/ra                  355
                                               DGB 2B                                            EN
 ---pagebreak---                                               Article 194
                         Obligations of operators at the place of destination
1.      Operators of aquaculture establishments and disease control aquatic food establishments
        receiving aquatic animals and operators receiving aquatic animals for release into the wild
        shall, before the aquatic animals are unloaded:
        (a)    check that, where required, one of the following documents is present:
               (i)   the animal health certificates provided for in Article 208(1), Article 209 and
                     Article 223(1) and in the rules adopted pursuant to Articles 189, 211 and 213;
               (ii)  the self–declaration documents provided for in Article 218(1) and in the rules
                     adopted pursuant to Article 218(3) and (4);
        (b)    inform the competent authority of the place of destination, after checking the aquatic
               animals received, of any irregularity with regard to:
               (i)   the aquatic animals received;
               (ii)  the documents referred to in point (a)(i) and (ii).
2.      In the event of any irregularity as referred to in point (b) of paragraph 1, the operator shall
        isolate the aquatic animals concerned by that irregularity until the competent authority of
        the place of destination has taken a decision regarding them.
11779/15                                                                  AS/NC/ra                  356
                                                DGB 2B                                             EN
 ---pagebreak---                                              Article 195
                            General requirements in respect of movements
                       of aquaculture animals passing through Member States
               but intended for export from the Union to third countries or territories
Operators shall ensure that aquaculture animals intended for export to a third country or territory
and passing through the territory of another Member State fulfil the requirements laid down in
Articles 191, 192 and 193.
                                             SECTION 2
          AQUATIC ANIMALS INTENDED FOR AQUACULTURE ESTABLISHMENTS
                                  OR RELEASE INTO THE WILD
                                             Article 196
                      Abnormal mortalities or other serious disease symptoms
1.       Operators shall only move aquatic animals from an aquaculture establishment or from the
         wild to another aquaculture establishment, or release them into the wild, if the animals in
         question:
         (a)   show no disease symptoms; and
         (b)   originate from an aquaculture establishment or environment where there are no
               abnormal mortalities with an undetermined cause.
11779/15                                                                AS/NC/ra                    357
                                              DGB 2B                                              EN
 ---pagebreak--- 2.      By way of derogation from paragraph 1, the competent authority may, on the basis of an
        evaluation of the risks involved, authorise the movement or release of aquatic animals as
        referred to in that paragraph, provided that the animals in question originate from a part of
        the aquaculture establishment or from the wild that is independent of the epidemiological
        unit where the abnormal mortalities or other disease symptoms have occurred.
        If the movement or release referred to in this paragraph is to be made to another Member
        State, it shall only be authorised by the competent authority if the competent authorities of
        the Member State of destination and, where relevant, of the Member States of passage have
        given their consent to such movement or release.
                                              Article 197
                   Movements of aquaculture animals intended for Member States,
                    zones or compartments which have been declared disease-free
               or which are subject to an eradication programme, and delegated acts
1.      Operators shall only move aquaculture animals of listed species relevant for one or more of
        the listed diseases referred to in points (b) or (c) of Article 9(1) to an aquaculture
        establishment, or for release into the wild, in a Member State, zone or compartment which
        has been declared free of those listed diseases in accordance with Article 36(4) or 37(4), if
        the animals in question originate from a Member State, or a zone or compartment thereof,
        which has been declared free of those diseases.
11779/15                                                                   AS/NC/ra               358
                                                DGB 2B                                           EN
 ---pagebreak--- 2.      Operators shall only move aquaculture animals of listed species relevant for one or more of
        the listed diseases referred to in points (b) or (c) of Article 9(1) to an aquaculture
        establishment, or for release into the wild, in a Member State, zone or compartment subject
        to an eradication programme for one or more of those listed diseases as provided for in
        Article 31(1) or (2), if the animals in question originate from a Member State, or a zone or
        compartment thereof, which has been declared free of those listed diseases.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning derogations from the movement or release requirements laid down in
        paragraphs 1 and 2 of this Article which do not pose a significant risk for the spread of
        listed diseases as referred to in point (d) of Article 9(1) on account of:
        (a)    the species, categories, and life stage of the aquaculture animals concerned;
        (b)    the type of establishment of origin and of destination;
        (c)    the intended use of the aquaculture animals;
        (d)    the place of destination of the aquaculture animals;
        (e)    treatments, processing methods and other special risk-mitigation measures applied at
               the place of origin or destination.
11779/15                                                                   AS/NC/ra               359
                                                 DGB 2B                                          EN
 ---pagebreak---                                                 Article 198
                 Derogations by Member States concerning the obligation of operators
        for movement of aquaculture animals between Member States, zones or compartments
                            which are subject to an eradication programme
By way of derogation from Article 197(1) and (2), Member States may authorise operators to move
aquaculture animals into a zone or compartment for which an eradication programme has been
established in accordance with Article 31(1) and (2) as regards the listed diseases referred to in
points (b) and (c) of Article 9(1), from another zone or compartment for which such a programme
has also been established for the same listed diseases, provided that such movement will not
jeopardise the health status of the Member State, zone or compartment of destination.
If such movements are to be made to another Member State, the competent authority shall only
authorise them if the competent authorities of the Member State of destination and, where relevant,
of the Member States of passage, have given their consent to them.
                                                Article 199
           Member States' measures concerning the release of aquatic animals into the wild
Member States may require that aquatic animals may be released into the wild only if they originate
from a Member State, or a zone or compartment thereof, which has been declared disease–free in
accordance with Article 36(1) or Article 37(1) as regards one or more of the listed diseases referred
to in points (b) and (c) of Article 9(1) for which the species of aquatic animals to be moved is a
listed species, regardless of the health status of the area where those aquatic animals are to be
released.
11779/15                                                                  AS/NC/ra                  360
                                                 DGB 2B                                            EN
 ---pagebreak---                                               Article 200
                  Movements of wild aquatic animals intended for Member States,
            or zones or compartments thereof, which have been declared disease–free
              or which are subject to an eradication programme, and delegated acts
1.      Articles 196, 197 and 198 shall apply to movements of wild aquatic animals intended for
        an aquaculture establishment or for release into the wild.
2.      Operators shall take the appropriate and necessary disease prevention measures when
        moving wild aquatic animals between habitats to ensure that:
        (a)   such movements do not pose a significant risk for the spread of listed diseases as
              referred to in point (d) of Article 9(1) to aquatic animals at the place of destination;
              and
        (b)   risk-mitigation or other adequate biosecurity measures are in place where necessary
              to ensure compliance with point (a).
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the disease prevention and risk-mitigation measures to be taken by
        operators as provided for in paragraph 2 of this Article. Pending the adoption of such
        delegated acts, the competent authority of the place of destination may decide on such
        measures.
11779/15                                                                 AS/NC/ra                   361
                                                DGB 2B                                             EN
 ---pagebreak---                                              SECTION 3
                AQUATIC ANIMALS INTENDED FOR HUMAN CONSUMPTION
                                              Article 201
   Movements of live aquaculture animals intended for human consumption in Member States,
           or in zones or compartments thereof, which have been declared disease–free
               or which are subject to an eradication programme, and delegated acts
1.      Operators shall only move live aquaculture animals of listed species relevant for listed
        diseases as referred to in points (b) or (c) of Article 9(1) intended for human consumption
        to a Member State, or to a zone or compartment thereof, which has been declared disease-
        free in accordance with Article 36(4) or Article 37(4) or for which a eradication
        programme has been established in accordance with Article 31(1) or (2), as regards one or
        more of the listed diseases referred to in points (b) and (c) of Article 9(1), if the animals in
        question originate from a Member State, or a zone or compartment thereof, which has been
        declared disease–free in accordance with Article 36(4) or Article 37(4).
2.      By way of derogation from paragraph 1 of this Article, Member States may authorise
        operators to introduce live aquaculture animals into a zone or compartment for which an
        eradication programme has been established in accordance with Article 31(1) or (2) as
        regards the listed diseases referred to in points (b) and (c) of Article 9(1), from another
        zone or compartment for which such a programme has also been established as regards the
        same diseases within that Member State, provided that such movement will not jeopardise
        the health status of the Member State or of the zone or compartment thereof.
11779/15                                                                  AS/NC/ra                   362
                                                DGB 2B                                             EN
 ---pagebreak--- 3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the derogations provided for in paragraph 2 of this Article in respect of
        movements of live aquaculture animals which do not pose a significant risk of spreading of
        diseases on account of:
        (a)   the species, categories, and live stage of the aquaculture animals concerned;
        (b)   the methods of keeping the aquaculture animals and the type of production in the
              aquaculture establishments of origin and of destination;
        (c)   the intended use of the aquaculture animals;
        (d)   the place of destination of the aquaculture animals;
        (e)   treatments, processing methods and other special risk-mitigation measures applied at
              the place of origin or the place of destination.
11779/15                                                                AS/NC/ra                 363
                                               DGB 2B                                          EN
 ---pagebreak---                                               Article 202
                Movements of live wild aquatic animals intended for Member States,
            or zones or compartments thereof, which have been declared disease–free
              or which are subject to an eradication programme, and delegated acts
1.      Article 201(1) and (2) and the rules adopted pursuant to Article 201(3) shall apply to
        movements of live wild aquatic animals intended for human consumption and which are
        intended for Member States, or zones or compartments thereof, which have been declared
        disease–free in accordance with Articles 36(4) or 37(4) or which are subject to an
        eradication programme in accordance with Article 31(1) or (2), where the measures
        adopted pursuant thereto are necessary in order to ensure that the animals in question do
        not pose a significant risk for the spread of listed diseases as referred to in point (d) of
        Article 9(1) to aquatic animals at the place of destination.
2.      Paragraph 1 of this Article shall also apply to live aquatic animals not covered by the
        definition of aquaculture animals contained in Article 4(7).
3.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning movement requirements for wild aquatic animals intended for
        human consumption, supplementing paragraphs 1 and 2 of this Article.
11779/15                                                                  AS/NC/ra                    364
                                                DGB 2B                                               EN
 ---pagebreak---                                               SECTION 4
             DEROGATIONS FROM SECTIONS 1 TO 3 (ARTICLES 191 TO 202)
                      AND ADDITIONAL RISK-MITIGATION MEASURES
                                               Article 203
    Aquatic animals intended for confined establishments for aquaculture and delegated acts
1.      Operators shall only move aquatic animals to a confined establishment for aquaculture if
        the animals in question fulfil the following conditions:
        (a)   they originate from another confined establishment for aquaculture;
        (b)   they do not pose a significant risk for the spread of listed diseases as referred to in
              point (d) of Article 9(1) to listed species of animals at the confined establishment for
              aquaculture of destination, except where the movement in question is authorised for
              scientific purposes.
2.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   detailed rules for movements of aquaculture animals to confined establishments for
              aquaculture in addition to those provided for in paragraph 1 of this Article;
11779/15                                                                  AS/NC/ra                   365
                                                DGB 2B                                             EN
 ---pagebreak---         (b)    specific rules for movements of aquaculture animals to confined establishments for
               aquaculture where the risk-mitigation measures in place guarantee that such
               movements do not pose a significant risk for the health of aquaculture animals within
               that confined establishment for aquaculture and the surrounding establishments.
                                               Article 204
              Movements of aquatic animals for scientific purposes and delegated acts
1.      The competent authority of the place of destination may, subject to the agreement of the
        competent authority of the place of origin, authorise movements of acquatic animals into
        the territory of the Member State of destination, for scientific purposes, where those
        movements do not fulfil the requirements of Sections 1 to 3 (Articles 191 to 202), with the
        exception of Article 191(1) and (3) and Articles 192, 193 and Article 194.
2.      The competent authority referred to in paragraph 1shall only grant derogations as provided
        for in that paragraph under the following conditions:
        (a)    the competent authorities of the places of destination and origin:
               (i)   have agreed on the conditions for such movements;
               (ii)  ensure that the necessary risk-mitigation measures are in place so that
                     movements of the aquatic animals in question do not jeopardise the health
                     status in places en route and in the places of destination with regard to the
                     listed diseases referred to in point (d) of Article 9(1);
11779/15                                                                   AS/NC/ra                 366
                                                DGB 2B                                             EN
 ---pagebreak---               (iii) have notified, where relevant, the competent authorities of the Member States
                     of passage of the derogation granted and of the conditions under which it is
                     granted;
        (b)   those movements take place under the supervision of the competent authorities of the
              places of origin and destination, and where relevant, the competent authorities of the
              Member States of passage.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning rules for the granting of derogations by competent authorities,
        supplementing those provided for in paragraphs 1 and 2 of this Article.
                                              Article 205
                    Other specific uses of aquatic animals, specific requirements
                              and derogations and delegation of powers
1.      Operators shall take the necessary preventive measures to ensure that movements of
        aquatic animals intended for the specific purposes or uses listed in point (a)(i) to (vi) of
        paragraph 2 of this Article do not pose a risk for the spread of listed diseases as referred to
        in point (d) of Article 9(1) to aquatic animals at the place of destination.
11779/15                                                                 AS/NC/ra                    367
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)  specific requirement supplementing the rules laid down in Sections 1 to 3 (Articles
             191 to 202) and for movements of aquatic animals for the following purposes:
             (i)   zoos, pet shops, wholesalers and garden ponds;
             (ii)  exhibitions;
             (iii) sports fishing, including fishing baits;
             (iv) cultural and similar events;
             (v)   commercial aquaria; or
             (vi) health care and other similar uses.
        (b)  derogations from Sections 1 to 3 (Articles 191 to 202) with the exception of
             Article 191(1) and (3) and Articles 192, 193 and 194 for the movements of aquatic
             animals referred to in point (a) of this paragraph, provided that adequate biosecurity
             provisions are in place to ensure that those movements do not pose a significant risk
             to the health status of the place of destination.
11779/15                                                               AS/NC/ra                  368
                                               DGB 2B                                          EN
 ---pagebreak---                                                Article 206
         Implementing power to adopt temporary rules for movements of specific species
                                   or categories of aquatic animals
1.      The Commission may, by means of implementing acts, lay down temporary rules, by way
        of addition or alternative to those laid down in this Chapter, for movements of specific
        species or categories of aquatic animals where:
        (a)   the movement requirements provided for in Article 196, Article 197(1), Articles 198
              and 199, Article 200(1) and (2), Article 201 and Articles 202(1), 203(1), 204(1) and
              (2) and the rules adopted pursuant to Articles 197(3), 200(3), 202(3), 203(2) and
              204(3) and Article 205 do not efficiently mitigate the risks posed by the movement
              of those aquatic animals; or
        (b)   a listed disease as referred to in point (d) of Article 9(1) appears to be spreading
              despite the movement requirements laid down in accordance with Sections 1 to 4
              (Articles 191 to 207).
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                  AS/NC/ra                  369
                                                DGB 2B                                             EN
 ---pagebreak--- 2.       On duly justified imperative grounds of urgency relating to a listed disease representing a
         risk of a highly significant impact and taking into account the matters referred to in Article
         205, the Commission shall adopt immediately applicable implementing acts in accordance
         with the procedure provided for in Article 266(3).
                                               Article 207
        Matters to be taken into account in the adoption of delegated and implementing acts
                                     as provided for in this Section
When establishing the rules to be laid down in the delegated and implementing acts provided for in
Article 203(2), Article 204(3) and Articles 205 and 206, the Commission shall base those rules on:
(a)      the risks involved with the movements referred to in those provisions;
(b)      the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the
         places of origin, passage and destination;
(c)      listed aquatic animal species for the listed diseases referred to in point (d) of Article 9(1);
(d)      biosecurity measures in place at the places of origin, passage and destination;
(e)      any specific conditions under which the aquaculture animals are kept;
(f)      specific movement patterns of the type of aquaculture establishment and the species or
         category of aquatic animals concerned;
(g)      other epidemiological factors.
11779/15                                                                   AS/NC/ra                     370
                                                 DGB 2B                                               EN
 ---pagebreak---                                               SECTION 5
                               ANIMAL HEALTH CERTIFICATION
                                               Article 208
                     Obligation of operators to ensure that aquaculture animals
                           are accompanied by an animal health certificate
1.      Operators shall only move aquaculture animals if they are accompanied by an animal
        health certificate issued by the competent authority of the Member State of origin in
        accordance with Article 216(1), where the animals in question are of listed species for the
        listed diseases referred to in points (b) and (c) of Article 9(1) and are intended for
        introduction into a Member State, or a zone or compartment thereof, which has been
        declared disease–free in accordance with Articles 36(4) and 37(4) or for which an
        eradication programme has been established as provided for in Article 31(1) or (2) as
        regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1).
11779/15                                                                  AS/NC/ra                  371
                                                DGB 2B                                            EN
 ---pagebreak--- 2.      Operators shall only move aquaculture animals if they are accompanied by an animal
        health certificate issued by the competent authority of the Member State of origin in
        accordance with Article 216(1), where the animals in question are of listed species for the
        relevant disease(s) referred to in points (a) and (b) of Article 9(1) and are allowed to leave
        a restricted zone subject to disease control measures as provided for in point (f)(ii) of
        Article 55(1), Articles 56 and 64 or Articles 65(1), 74(1), 79 and rules adopted pursuant to
        Article 55(2), Articles 67 and 68, Articles 71(3), 74(4) and 83(2) and Article 259 for one or
        more of the listed diseases referred to in points (a) and (b) of Article 9(1).
3.      Operators shall take all necessary measures to ensure that the animal health certificate
        accompanies the aquaculture animals from their place of origin to their final place of
        destination, unless specific measures are provided for in rules adopted pursuant to
        Article 214.
                                              Article 209
                    Obligation of operators to ensure that other aquatic animals
             are accompanied by an animal health certificate and implementing power
1.      In cases where, due to the risk involved with the movement of aquatic animals other than
        aquaculture animals, animal health certification is required in accordance with the rules
        provided for in point (a) of Article 211(1), operators shall only move those aquatic animals
        if the animals in question are accompanied by an animal health certificate issued by the
        competent authority of the Member State of origin in accordance with Article 216(1).
11779/15                                                                  AS/NC/ra                  372
                                               DGB 2B                                              EN
 ---pagebreak--- 2.       Article 208 shall also apply to aquatic animals other than aquaculture animals intended for
         an aquaculture establishment or release into the wild. Where the competent authority of the
         Member State of origin concludes that certification is not feasible due to the nature of the
         place of origin of the aquatic animals in question, it may authorise their movement without
         an animal health certificate subject to the consent of the competent authority of the place of
         destination.
3.       This Article shall not apply to wild aquatic animals harvested or caught for direct human
         consumption.
                                              Article 210
      Grant of derogations by Member States in respect of national animal health certification
By way of derogation from the animal health certification requirements laid down in Articles 208
and 209, Member States may grant derogations for movements of certain consignments of aquatic
animals without an animal health certificate within their territories provided that they have in place
an alternative system to ensure that consignments of such animals are traceable and those
consignments comply with the animal health requirements for such movements provided for in
Sections 1 to 4 (Articles 191 to 207).
11779/15                                                                 AS/NC/ra                   373
                                                DGB 2B                                            EN
 ---pagebreak---                                               Article 211
                            Delegation of powers and implementing acts
                concerning animal health certification in respect of aquatic animals
1.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   the requirement for animal heath certification for movements of aquatic animals
              other than aquaculture animals as referred to in Article 209(1), in cases where animal
              health certification is imperative in order to ensure that the movement in question
              complies with the following animal health requirements for the listed species of
              animals concerned:
              (i)   the requirements provided for in Sections 1 to 4 (Articles 191 to 207) and the
                    rules adopted pursuant to those Sections;
              (ii)  disease control measures as provided for in Article 55(1), Article 56,
                    Article 61(1), Articles 62 and 64, and Articles 65(1), 74(1) and 79(1) and (2) or
                    the rules adopted pursuant to Article 55(2), Articles 63, 67 and 68, and
                    Articles 71(3), 74(4) and 83(2);
              (iii) emergency measures as provided for in the rules adopted pursuant to
                    Article 259;
11779/15                                                                 AS/NC/ra                 374
                                               DGB 2B                                           EN
 ---pagebreak---         (b)    special rules for animal health certification as provided for in Articles 208 and 209
               where specific risk-mitigation measures are taken by the competent authority to
               ensure:
               (i)   the traceability of the aquatic animals being moved;
               (ii)  that the aquatic animals being moved fulfil the animal health requirements for
                     movements provided for in Sections 1 to 4 (Articles 191 to 207);
        (c)    derogations from the animal health certificate requirements provided for in Articles
               208 and 209 and the conditions for such derogations for movements of aquatic
               animals which do not pose a significant risk of the spread of diseases, on account of:
               (i)   species, the categories or live stage of the aquatic animals concerned;
               (ii)  the methods of keeping and the type of production of those species and
                     categories of aquaculture animals;
               (iii) the intended use of the aquatic animals; or
               (iv) the place of destination of the aquatic animals.
2.      The Commission shall, by means of implementing acts, lay down rules concerning the
        obligation of operators, as provided for in Article 209(2), to ensure that wild aquatic
        animals intended for an aquaculture establishment are accompanied by an animal health
        certificate.
11779/15                                                                  AS/NC/ra                 375
                                                DGB 2B                                            EN
 ---pagebreak---         Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                             Article 212
                                Contents of animal health certificates
1.      The animal health certificate referred to in Articles 208, 209 and 210 shall contain at least
        the following information:
        (a)   the establishment or place of origin, the establishment or place of destination and,
              where relevant for the spread of diseases, any establishment or place visited en route;
        (b)   a description, including the species and category, of the aquatic animals concerned;
        (c)   the quantity (number, volume or weight) of aquatic animals;
        (d)   the information needed to demonstrate that the aquatic animals fulfil the relevant
              animal health requirements in respect of movements provided for in Sections 1 to 4
              (Articles 191 to 207).
2.      The animal health certificate may include other information required under other Union
        legislation.
11779/15                                                                AS/NC/ra                   376
                                              DGB 2B                                             EN
 ---pagebreak---                                              Article 213
  Delegation of powers and implementing acts concerning the content of animal health certificates
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        content of animal health certificates as provided for in Article 212(1):
        (a)   detailed rules on the content of those animal health certificates provided for in
              Article 212(1) for different species and categories of aquatic animals;
        (b)   additional information to be contained in the animal health certificate provided for in
              Article 212(1).
2.      The Commission may, by means of implementing acts, lay down rules concerning the
        model forms for the animal health certificates.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                 377
                                               DGB 2B                                           EN
 ---pagebreak---                                              Article 214
                                        Delegation of powers
       concerning specific types of movements of aquatic animals to the place of destination
The Commission shall be empowered to adopt delegated acts in accordance with Article 264
concerning specific measures supplementing the requirements for animal health certification
provided for in Article 208 and 209 for the following types of movements of aquatic animals:
(a)     movements of aquatic animals which are required to return to their place of origin or to be
        moved to a different destination, for one or more of the following reasons:
        (i)    their intended journey was unexpectedly interrupted for animal welfare reasons;
        (ii)   unforeseen accidents or events during the journey;
        (iii) they were rejected at the place of the destination in another Member State or at the
               external border of the Union;
        (iv) they were rejected in a third country or territory;
(b)     movements of aquaculture animals intended for exhibitions and for sporting, cultural and
        similar events, and their subsequent return to their place of origin.
11779/15                                                                 AS/NC/ra                378
                                               DGB 2B                                           EN
 ---pagebreak---                                               Article 215
                 Operators' obligations to cooperate with the competent authorities
                            for the purposes of animal health certification
Operators shall:
(a)     provide the competent authority with all the information necessary to complete the animal
        health certificate provided for in Articles 208 and 209 and in the rules adopted pursuant to
        Articles 211, 213 and 214, in advance of the intended movement;
(b)     where necessary, ensure that the aquatic animals in question are subjected to documentary,
        identity and physical checks as provided for in Article 216(3) and in the rules adopted
        pursuant to Article 216(4).
                                              Article 216
    Responsibility of the competent authority for animal health certification and delegated acts
1.      The competent authority shall, upon request by an operator, issue an animal health
        certificate for the movement of aquatic animals, where required by Articles 208 and 209,
        or by rules adopted pursuant to Articles 211 and Article 214, provided that the following
        animal health requirements have been complied with, as relevant:
        (a)    those provided for in Article 191, Article 192(1), Articles 193, 195 and 196,
               Article197(1), Articles 198 and 199, Article 200(1) and (2), Article 201,
               Article 203(1) and Article 204(1) and (2);
11779/15                                                                 AS/NC/ra                379
                                               DGB 2B                                           EN
 ---pagebreak---         (b)    those provided for in delegated acts adopted pursuant to Articles 192(2), 197(3),
               200(3), 201(3), 202(3), 203(2) and 204(3) and Article 205;
        (c)    those provided for in implementing acts adopted pursuant to Article 206.
2.      Animal health certificates shall:
        (a)    be verified, stamped and signed by an official veterinarian;
        (b)    remain valid for the period of time, provided for in the rules adopted pursuant to
               point (c) of paragraph 4, during which the aquatic animals covered by it must
               continue to fulfil the animal health guarantees contained in it.
3.      Before signing an animal health certificate, the official veterinarian concerned shall verify,
        by means of documentary, identity and physical checks as provided for by delegated acts
        adopted pursuant to paragraph 4 where appropriate, that the aquatic animals covered by it
        fulfil the requirements of this Chapter, taking into account the species and categories of
        aquatic animals concerned and the animal health requirements.
4.      The Commission shall adopt delegated acts in accordance with Article 264 laying down
        rules concerning:
        (a)    the types of documentary, identity and physical checks and examinations in relation
               to different species and categories of aquatic animals that must be carried out by the
               official veterinarian in accordance with paragraph 3 in order to verify compliance
               with the requirements of this Chapter;
11779/15                                                                 AS/NC/ra                  380
                                                DGB 2B                                            EN
 ---pagebreak---          (b)   the timeframes for the carrying-out of such documentary, identity and physical
               checks and examinations, and the issuing of animal health certificates by the official
               veterinarian prior to the movement of consignments of aquatic animals;
         (c)   the duration of the validity of animal health certificates.
                                               Article 217
                                 Electronic animal health certificates
Electronic animal health certificates, produced, handled and transmitted by means of TRACES,
may replace accompanying animal health certificates as provided for in Article 216(1) where such
electronic animal health certificates:
(a)      contain all the information that the model form of animal health certificate is required to
         contain in accordance with Article 212(1) and the rules adopted pursuant to Article 213;
(b)      ensure the traceability of the aquatic animals in question and the link between those
         animals and the electronic animal health certificate;
(c)      ensure that the competent authorities of the Member States of origin, passage and
         destination are able to have access to the electronic documents at all times during the
         transport.
11779/15                                                                   AS/NC/ra                 381
                                                DGB 2B                                            EN
 ---pagebreak---                                              Article 218
               Self–declaration by operators for movements of aquaculture animals
                             to other Member States and delegated acts
1.      Operators at the place of origin shall issue a self–declaration document for movements of
        aquaculture animals from their place of origin in one Member State to their place of
        destination in another Member State, and shall ensure that it accompanies such aquaculture
        animals, where they are not required to be accompanied by an animal health certificate as
        provided for in Articles 208 and 209 or in any rules adopted pursuant to Articles 211 and
        Article 214.
2.      The self–declaration document provided for in paragraph 1 shall contain at least the
        following information concerning the aquaculture animals in question:
        (a)   their places of origin and destination, and, when relevant, any places en route;
        (b)   the means of transport
        (c)   a description of the aquaculture animals, and their categories, species and quantity
              (numbers, volume or weight), as relevant for the animals concerned;
        (d)   the information needed to demonstrate that the aquaculture animals fulfil the
              movement requirements provided for in Sections 1 to 4 (Articles 191 to 207).
11779/15                                                                 AS/NC/ra                 382
                                               DGB 2B                                           EN
 ---pagebreak--- 3.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning:
        (a)   detailed rules on the content of the self–declaration document provided for in
              paragraph 2 of this Article for different species and categories of aquaculture
              animals;
        (b)   additional information to be contained in the self–declaration document to the one
              provided for in paragraph 2 of this Article.
4.      The Commission may, by means of implementing acts, lay down rules for a model form of
        the self–declaration document provided for in paragraph 1.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                383
                                               DGB 2B                                          EN
 ---pagebreak---                                              SECTION 6
 NOTIFICATION OF MOVEMENTS OF AQUATIC ANIMALS TO OTHER MEMBER STATES
                                              Article 219
       Obligation of operators concerning the notification of movements of aquatic animals
                                       to other Member States
1.      Operators other than transporters shall notify the competent authority in their Member
        State of origin in advance of intended movements of aquatic animals from one Member
        State to another Member State where:
        (a)   the aquatic animals are required to be accompanied by an animal health certificate
              issued by the competent authority of the Member State of origin in accordance with
              Articles 208 and 209 and any rules adopted pursuant to Article 211 and
              Article 214(2);
        (b)   the aquatic animals are required to be accompanied by an animal health certificate
              for aquatic animals when they are being moved from a restricted zone as referred to
              in Article point (a) of 208(2);
        (c)   the aquaculture animals and wild aquatic animals being moved are intended for:
              (i)    an establishment subject to registration in accordance with Article 173 or
                     approval in accordance with Articles 176 to 179;
11779/15                                                                AS/NC/ra                 384
                                               DGB 2B                                           EN
 ---pagebreak---               (ii)  release into the wild;
        (d)   notification is required in accordance with delegated acts adopted pursuant to
              Article 221.
2.      For the purposes of the notification provided for in paragraph 1 of this Article, operators
        shall provide the competent authority of their Member State of origin with all the necessary
        information to enable it to notify the movement to the competent authority of the Member
        State of destination in accordance with Article 220(1).
                                             Article 220
                         Responsibility of the competent authority to notify
                       movements of aquatic animals to other Member States
1.      The competent authority of the Member State of origin shall notify the competent authority
        of the Member State of destination of movements of aquatic animals as referred to in
        Article 219, unless a derogation has been granted in accordance with point (c) of
        Article 221(1) as regards such notification.
2.      The notification referred to in paragraph 1 shall be carried out prior to the movement in
        question and, whenever possible, through TRACES.
3.      Member States shall designate regions for the management of notifications of movements
        as provided for in paragraph 1.
11779/15                                                                AS/NC/ra                  385
                                               DGB 2B                                            EN
 ---pagebreak--- 4.      By way of derogation from paragraph 1, the competent authority of Member State of origin
        may authorise the operator concerned to notify, partially or completely, movements of
        aquatic animals through TRACES to the competent authority of the Member State of
        destination.
                                             Article 221
          Delegation of powers and implementing acts for the notification of movements
                  of aquatic animals by operators and by the competent authority
1.      The Commission shall adopt delegated acts in accordance with Article 264 concerning:
        (a)   the requirement for advance notification by operators, in accordance with Article
              219, of movements between Member States of aquatic animals of species or
              categories other than those referred to in points (a), (b) and (c) of Article 219(1),
              where traceability of such movements is necessary in order to ensure compliance
              with the animal health requirements laid down in this Chapter;
        (b)   the information needed in order to notify movements of aquatic animals as provided
              for in Articles 219 and 220(1);
        (c)   derogations from the notification requirements provided for in point (c) of
              Article 219(1) for species and categories of aquatic animals or types of movements
              which pose an insignificant risk;
11779/15                                                                  AS/NC/ra                  386
                                              DGB 2B                                               EN
 ---pagebreak---         (d)   the emergency procedures for notification of movements of aquatic animals in the
              event of power cuts or other disturbances of TRACES;
        (e)   the requirements for the designation of regions by Member States as provided for in
              Article 220(3).
2.      The Commission may, by means of implementing acts, lay down rules concerning:
        (a)   the details of notifications by:
              (i)    operators to the competent authority of the Member State of origin of
                     movements of aquatic animals in accordance with Article 219;
              (ii)   the competent authority of the Member State of origin to the Member State of
                     destination of movements of aquatic animals in accordance with
                     Article 220(1);
        (b)   the deadlines for:
              (i)    the provision by operators of the necessary information referred to in
                     Article 219(2) to the competent authority of the Member State of origin ;
              (ii)   the notification of movements by the competent authority of the Member State
                     of origin as referred to in Article 220(1).
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                               AS/NC/ra                 387
                                                 DGB 2B                                        EN
 ---pagebreak---                                             Chapter 3
         Production, processing and distribution within the Union
             of products of animal origin from aquatic animals,
                            other than live aquatic animals
                                              Article 222
                General animal health obligations for operators and delegated acts
1.      Operators shall take appropriate preventive measures to ensure that, during all stages of the
        production, processing and distribution of products of animal origin from aquatic animals,
        other than live aquatic animals, those products do not cause the spread of:
        (a)   listed diseases as referred to in point (d) of Article 9(1), taking into account the
              health status of the place of production, processing and destination;
        (b)   emerging diseases.
11779/15                                                                  AS/NC/ra                  388
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      Operators shall ensure that products of animal origin from aquatic animals, other than live
        aquatic animals, do not come from establishments or food businesses, or are not obtained
        from animals which come from such establishments or food businesses, that are subject to:
        (a)    emergency measures as provided for in Articles 257 and 258 and any rules adopted
               pursuant to Article 259, unless derogations have been provided for in respect of those
               rules in Part VII (Articles 257 to 262);
        (b)    movement restrictions applicable to aquatic animals and products of animal origin
               from aquatic animals, as provided for in point (c) of Article 32(1), point (e) of Article
               55(1), Article 56, point (a) of Article 61(1), Article 62(1), point (c) of Article 65(1),
               point (b) of Article 70(1), point (a) of Article 74(1), point (b) of Article 76(2),
               Article 76(3), Article 79, Article 81 and Article 82(2) and (3) and the rules adopted
               pursuant to Article 55(2), Articles 63 and 67, and Articles 70(3), 71(3), 74(4), 76(5)
               and 83(2), unless derogation from those movement restrictions have been provided
               for in those rules.
3.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        detailed requirements supplementing those referred to in paragraph 2 of this Article in
        relation to movements of products of animal origin from aquatic animals other than live
        aquatic animals, as regards:
        (a)    the diseases, and species of aquatic animals concerned by the diseases, for which
               emergency measures or movement restrictions as referred to in paragraph 2 of this
               Article apply;
11779/15                                                                  AS/NC/ra                    389
                                                DGB 2B                                              EN
 ---pagebreak---         (b)    the types of products of animal origin from aquatic animals;
        (c)    the risk-mitigation measures applied to the products of animal origin from aquatic
               animals at the places of origin and destination;
        (d)    the intended use of the products of animal origin from aquatic animals;
        (e)    the place of destination of the products of animal origin from aquatic animals.
4.      This Article shall not apply to products of animal origin from wild aquatic animals
        harvested or caught for direct human consumption.
                                               Article 223
                              Animal health certificates and delegated acts
1.      Operators shall only move the following products of animal origin from aquatic animals
        other than live aquatic animals where those products are accompanied by an animal health
        certificate issued by the competent authority of the Member State of origin in accordance
        with paragraph 3:
        (a)    products of animal origin from aquatic animals that:
               (i)    are allowed to leave a restricted zone subject to emergency measures as
                      provided for in rules adopted pursuant to Article 259; and
               (ii)   originate from aquatic animals of species subject to those emergency measures;
11779/15                                                                 AS/NC/ra                390
                                                DGB 2B                                         EN
 ---pagebreak---         (b)   products of animal origin from aquatic animals that:
              (i)    are allowed to leave a restricted zone subject to disease control measures in
                     accordance with point (c) of Article 32(1), point (c) of Article 55(1), Article
                     56, point (a) of Article 61(1), Articles 62(1) and 63(1), point (c) of Article
                     65(1), point (b) of Article 70(1), point (a) of Article 74(1) and Article 79 and
                     the rules adopted pursuant to Article 55(2), Articles 63 and 67 and Articles
                     71(3), 74(4) and 83(2); and
              (ii)   originate from aquatic animals of species subject to those disease control
                     measures.
2.      By way of derogation from paragraph 1, such a certificate shall not be required for
        movements of products of animal origin from wild aquatic animals, provided that:
        (a)   alternative risk-mitigation measures authorised by the competent authority are in
              place to ensure that those movements do not pose a risk of the spread of listed
              diseases;
        (b)   consignments of such products are traceable.
3.      Operators shall take all necessary measures to ensure that the animal health certificate
        referred to in paragraph 1 accompanies the products of animal origin from their place of
        origin to their place of destination.
11779/15                                                                  AS/NC/ra                   391
                                                DGB 2B                                              EN
 ---pagebreak--- 4.      The competent authority shall, upon request by the operator concerned, issue an animal
        health certificate for movements of products of animal origin other than live aquatic
        animals as referred to in paragraph 1, provided that the relevant requirements referred to in
        this Article have been complied with.
5.      Article 212 and Articles 214 to 217 and the rules adopted pursuant to Article 213 and
        Article 216(4) shall apply to the animal health certification of movements of products of
        animal origin other than live aquatic animals as referred to in paragraph 1 of this Article.
6.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning requirements and detailed rules on the animal health certificate to
        accompany products of animal origin other than live aquatic animals, as referred to in
        paragraph 1 of this Article, taking into account:
        (a)   the types of products of animal origin concerned;
        (b)   the risk-mitigation measures applied to the products concerned which reduce the
              risks of the spread of diseases;
        (c)   the intended use of those products;
        (d)   the place of destination of those products.
11779/15                                                                AS/NC/ra                   392
                                               DGB 2B                                            EN
 ---pagebreak---                                              Article 224
            Content of animal health certificates and delegated and implementing acts
1.      The animal health certificate for products of animal origin from aquatic animals, other than
        live aquatic animals, shall contain at least the following information:
        (a)   the establishment or place of origin and the establishment or place of destination;
        (b)   a description of the products of animal origin concerned;
        (c)   the quantity (numbers, volume or weight) of the products of animal origin;
        (d)   the identification of the products of animal origin, when required by point (h) of
              Article 65(1) or by any rules adopted pursuant to Article 67;
        (e)   the information needed to demonstrate that the products concerned fulfil the
              movement restriction requirements provided for in Article 222(2) and in any rules
              adopted pursuant to Article 222(3).
2.      The animal health certificate referred to in paragraph 1 may include other information
        required under other Union legislation.
11779/15                                                                AS/NC/ra                  393
                                               DGB 2B                                            EN
 ---pagebreak--- 3.      The Commission shall adopt delegated acts in accordance with Article 264 concerning
        amending and supplementing the information to be contained in the animal health
        certificate as provided for in paragraph 1 of this Article.
4.      The Commission may, by means of implementing acts, lay down rules concerning model
        forms of animal health certificates as provided for in paragraph 1 of this Article.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                              Article 225
          Notification of movements of products of animal origin to other Member States
1.      Operators shall:
        (a)    inform the competent authority in the Member State of origin in advance of intended
               movements of products of animal origin from aquatic animals, other than live aquatic
               animals, when the consignments in question are required to be accompanied by an
               animal health certificate in accordance with Article 223(1);
        (b)    provide all necessary information to enable the competent authority of the Member
               State of origin to notify the movement in question to the Member State of destination
               in accordance with paragraph 2 of this Article.
11779/15                                                                AS/NC/ra                 394
                                                DGB 2B                                         EN
 ---pagebreak--- 2.      The competent authority of the Member State of origin shall notify the competent authority
        of the Member State of destination of movements of products of animal origin from
        aquatic animals, other than live aquatic animals, in accordance with Article 220(1).
3.      Articles 219 and 220 and any rules adopted pursuant to Article 221 shall be applicable to
        the notification of products of animal origin from aquatic animals, other than live aquatic
        animals.
                                             Chapter 4
                                      National measures
                                               Article 226
       National measures designed to limit the impact of diseases other than listed disease
1.      Where a disease other than a listed disease as referred to in point (d) of Article 9(1)
        constitutes a significant risk for the health of aquatic animals in a Member State, the
        Member State concerned may take national measures to prevent the introduction, or to
        control the spread, of that disease.
        Member States shall ensure that those national measures do not exceed the limits of what is
        appropriate and necessary in order to prevent the introduction, or to control the spread, of
        the disease in question within the Member State concerned.
11779/15                                                                 AS/NC/ra                 395
                                                DGB 2B                                          EN
 ---pagebreak--- 2.      Member States shall notify the Commission in advance of any proposed national measures
        as referred to in paragraph 1 that may affect movements of aquatic animals and products of
        animal origin from aquatic animals between Member States.
3.      The Commission shall approve and, if necessary, amend the national measures referred to
        in paragraph 2 of this Article by means of implementing acts. Those implementing acts
        shall be adopted in accordance with the examination procedure referred to in Article
        266(2).
4.      The approval referred to in paragraph 3 shall only be granted where the establishment of
        movement restrictions between Member States is necessary in order to prevent the
        introduction, or to control the spread, of the disease referred to in paragraph 1, taking into
        account the overall impact on the Union of the disease in question and of the measures
        taken.
11779/15                                                                 AS/NC/ra                   396
                                               DGB 2B                                              EN
 ---pagebreak---                                              TITLE III
                   Animals of species other than those defined as
           terrestrial and aquatic animals, and germinal products
           and products of animal origin from such other animals
                                               Article 227
           Animal health requirements concerning other animals, and germinal products
                          and products of animal origin of such other animals
Where other animals are of a listed species for a listed disease as referred to in point (d) of
Article 9(1), and those other animals or their germinal products or products of animal origin
represent a risk to public or animal health in the Union, one or more of the following requirements
shall apply:
(a)      the requirements concerning registration, approval, record-keeping and registers for
         establishments and transporters provided for in Chapter 1 of Title I and Chapter 1 of
         Title II (Articles 84 to 101 and Articles 172 to 175);
(b)      the requirements concerning traceability provided for in Articles 108 to 111 and
         Article 117 for other animals and Article 122 for germinal products;
11779/15                                                                  AS/NC/ra               397
                                                 DGB 2B                                         EN
 ---pagebreak--- (c)     movement requirements:
        (i)   as regards other animals mainly living in a terrestrial environment or that are
              normally affected by diseases of terrestrial animals, taking into account the criteria
              provided for in points (d) and (e) of Article 228(3), the requirements provided for in
              Section 1 (Articles 124 and 125) and Section 6 of Chapter 3 of Title I of Part IV
              (Articles 137 to 142) and Chapter 4 of Title I of Part IV (Articles 155 and 156);
        (ii)  as regards other animals mainly living in aquatic environment or that are normally
              affected by diseases of aquatic animals, taking into account the criteria provided for
              in points (d) and (e) of Article 228(3), the requirements provided for in Sections 1
              to 4 of Chapter 2 of Title II of Part IV (Articles 191 to 207);
        (iii) as regards germinal products, the general requirements for movements provided for
              in Articles 157 and 158 and the special requirements for movements to other
              Member States provided for in Articles 164 and 165;
        (iv) as regards products of animal origin, the general animal health obligations incumbent
              on operators in respect of the production, processing and distribution within the
              Union of products of animal origin provided for in Articles 166 and 222;
(d)     the animal health certification obligation incumbent on operators and competent authorities
        and the self–declaration incumbent on operators:
        (i)   as regards other animals, pursuant to the rules provided for in Articles 143 to 151 or
              Articles 208 to 218;
11779/15                                                                 AS/NC/ra                  398
                                                DGB 2B                                           EN
 ---pagebreak---         (ii)   as regards germinal products, pursuant to the rules provided for in Articles 161
               and 162;
        (iii) as regards products of animal origin, pursuant to the rules provided for in
               Articles 165 and 168 or Articles 223 and 224;
(e)     the obligation to notify movements incumbent on operators and competent authorities,
        taking into account the requirements provided for in Articles 152, 153, 154, 163 and 169
        and in Articles 219 to 221 and 225.
                                              Article 228
       Delegation of powers and implementing acts concerning animal health requirements
     for other animals, and germinal products and products of animal origin of other animals
1.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning any specific requirements for other animals, and their germinal
        products or products of animal origin, which are necessary in order to mitigate the risk of
        the listed diseases referred to in point (d) of Article 9(1), as provided for in Article 227.
2.      The Commission may adopt implementing acts concerning detailed rules for the
        implementation of the disease control and prevention measures provided for in
        paragraph 1.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                   AS/NC/ra                   399
                                                DGB 2B                                              EN
 ---pagebreak--- 3.      When adopting the delegated acts and implementing acts provided for in paragraphs 1
        and 2, the Commission shall base those acts on the following criteria:
        (a)   the species or categories of other animals listed in accordance with Article 8(2) as
              listed species for one or more listed diseases, for which certain disease prevention
              and control measures provided for in this Regulation apply;
        (b)   the profile of the listed disease in question, which concerns species and categories of
              other animals referred to in point (a);
        (c)   the feasibility, availability and effectiveness of disease prevention and control
              measures for the listed species concerned by those measures;
        (d)   the prevailing terrestrial or aquatic living environment of those other animals;
        (e)   the types of diseases that are affecting such other animals, which can be either
              diseases normally affecting terrestrial or aquatic animals, regardless of the prevailing
              living environment referred to in point (d).
11779/15                                                                  AS/NC/ra                 400
                                                DGB 2B                                           EN
 ---pagebreak---                                           PART V
             ENTRY INTO THE UNION AND EXPORT
                                          Chapter 1
            Entry into the Union of animals, germinal products
   and products of animal origin from third countries and territories
                                           SECTION 1
                    REQUIREMENTS FOR THE ENTRY INTO THE UNION
                                            Article 229
              Requirements for entry into the Union of animals, germinal products
                                   and products of animal origin
1.      Member States shall permit the entry into the Union of consignments of animals, germinal
        products and products of animal origin from third countries or territories only if those
        consignments fulfil the following requirements, unless such animals, germinal products or
        products of animal origin are covered by a derogation granted pursuant to Article 239(2):
        (a)  without prejudice to Article 230(2), they come from a third country or territory listed
             in accordance with Article 230(1) for the particular species and category of animals,
             or germinal products or products of animal origin concerned, or from a zone or
             compartment thereof;
11779/15                                                              AS/NC/ra                    401
                                             DGB 2B                                              EN
 ---pagebreak---         (b)   they come from establishments which are approved and listed, where such approval
              and listing is required by Article 233;
        (c)   they fulfil the animal health requirements for entry into the Union laid down in
              Article 234(1) and in any delegated acts adopted pursuant to Article 234(2), where
              such requirements are laid down for the animal, germinal product or product of
              animal origin concerned;
        (d)   they are accompanied by an animal health certificate and by declarations and other
              documents where required by Article 237(1) or by rules adopted pursuant to
              Article 237(4);
2.      The operators responsible for the consignment in question shall present consignments of
        animals, germinal products and products of animal origin from third countries or territories
        for the purposes of official control as provided for in Article 3 of Directive 91/496/EEC
        and Article 3 of Directive 97/78/EC.
11779/15                                                                 AS/NC/ra                 402
                                               DGB 2B                                           EN
 ---pagebreak---                                               SECTION 2
                      LISTING OF THIRD COUNTRIES AND TERRITORIES
                                               Article 230
      Lists of third countries and territories from which the entry into the Union of animals,
                    germinal products and products of animal origin is permitted,
                                 and implementing and delegated acts
1.      The Commission may, by means of implementing acts, draw up lists of third countries and
        territories from which the entry into the Union of specific species and categories of
        animals, germinal products and products of animal origin is to be permitted, based on the
        following criteria:
        (a)    the animal health legislation of the third country or territory concerned and the rules
               on the entry into that third country or territory of animals, germinal products and
               products of animal origin from other third countries and territories;
        (b)    the assurances provided by the competent authority of the third country or territory
               concerned as regards the efficient implementation and control of the animal health
               legislation referred to in point (a);
11779/15                                                                  AS/NC/ra                  403
                                                 DGB 2B                                           EN
 ---pagebreak---         (c) the organisation, structure, resources and legal powers of the competent authority in
            the third country or territory concerned;
        (d) the animal health certification procedures in the third country or territory concerned;
        (e) the animal health status of the third country or territory concerned, or of zones and
            compartments thereof, with regard to:
            (i)   listed diseases and emerging diseases;
            (ii)  any aspects of animal and public health or the environmental situation in the
                  third country or territory concerned, or in a zone or compartment thereof,
                  which may pose a risk to animal or public health or the environmental status of
                  the Union;
        (f) the guarantees which the competent authority of the third country or territory
            concerned can provide regarding compliance or equivalence with the relevant animal
            health requirements applicable in the Union;
        (g) the regularity and speed with which the third country or territory concerned supplies
            information concerning infectious or contagious animal diseases in its territory to the
            World Organisation for Animal Health (OIE), in particular information concerning
            the diseases listed in the OIE Codes;
        (h) the results of controls carried out by the Commission in the third country or territory
            concerned;
11779/15                                                               AS/NC/ra                  404
                                             DGB 2B                                            EN
 ---pagebreak---         (i)   any experience gathered from previous entries of animals, germinal products and
              products of animal origin from the third country or territory concerned and the results
              of official controls carried out at the point of entry into the Union on such animals,
              germinal products and products of animal origin.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
2.      Pending the adoption of the lists provided for in paragraph 1, and provided that such lists
        have not been drawn up pursuant to the Union legislation referred to in Article 270(2),
        Member States shall determine from which third countries and territories specific species
        and categories of animals, germinal products or products of animal origin may enter the
        Union.
        For the purposes of the first subparagraph of this paragraph, Member States shall take into
        account the criteria for inclusion in the lists of third countries and territories provided for in
        points (a) to (i) of paragraph 1 of this Article.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning derogations from paragraph 2 of this Article, limiting the possibility for
        Member States to decide from which third countries and territories a specific species and
        category of animal, germinal product or product of animal origin may enter the Union,
        where necessary due to the risk posed by that specific species and category of animal,
        germinal product or product of animal origin.
11779/15                                                                   AS/NC/ra                   405
                                                DGB 2B                                              EN
 ---pagebreak---                                               Article 231
                Information to be included in the lists of third countries and territories
The Commission shall specify the following information for each third country or territory in the
lists provided for in Article 230(1):
(a)       the species and categories of animals, germinal products or products of animal origin that
          may enter the Union from that third country or territory;
(b)       whether the animals, germinal products or products of animal origin specified in
          accordance with point (a) may enter the Union from the whole territory of that third
          country or territory or only from one or more zones or compartments thereof;
(c)       specific conditions and animal health guarantees concerning listed diseases.
11779/15                                                                  AS/NC/ra                406
                                                DGB 2B                                           EN
 ---pagebreak---                                               Article 232
 Suspension and withdrawal from the lists of third countries and territories and implementing acts
1.      The Commission shall, by means of implementing acts, withdraw a country or territory
        from the lists provided for in Article 230(1), or suspend the entry into the Union of
        animals, germinal products or products of animal origin from a third country or territory, or
        from a zone or compartment thereof, for any of the following reasons:
        (a)   the third country or territory concerned, or one or more zones or compartments
              thereof, no longer complies with the criteria laid down in Article 230(1), where
              relevant for the entry into the Union of a particular species and category of animal,
              germinal product or product of animal origin;
        (b)   the animal health situation in the third country or territory concerned, or in a zone or
              compartment thereof, is such that a suspension or withdrawal from the lists is
              necessary in order to protect the animal health status of the Union;
        (c)   the Commission has requested the third country or territory concerned to supply
              up-to–date information on the animal health situation and other matters referred to in
              Article 230(1), and that third country or territory has not provided such information;
        (d)   the third country or territory concerned has refused to agree to controls being carried
              out by the Commission on behalf of the Union in its territory.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                 AS/NC/ra                  407
                                               DGB 2B                                             EN
 ---pagebreak--- 2.      On duly justified imperative grounds of urgency relating to a serious risk of the
        introduction into the Union of a listed disease as referred to in point (d) of Article 9(1), the
        Commission shall adopt immediately applicable implementing acts in accordance with the
        procedure referred to in Article 266(3).
3.      The Commission may, by means of implementing acts, reinstate in the lists provided for in
        Article 230(1) a third country or territory, or a zone or compartment thereof, that has been
        withdrawn from those lists, or may re–authorise the entry into the Union of animals,
        germinal products or products of animal origin from a third country or territory, or from a
        zone or compartment thereof, from which entry into the Union has been suspended, for one
        of the following reasons:
        (a)   for the reasons referred to in point (a) or (c) of paragraph 1 of this Article, provided
              that the third country or territory concerned demonstrates that it complies with the
              listing criteria provided for in Article 230(1);
        (b)   for the reason referred to in point (b) of paragraph 1 of this Article, provided that the
              third country or territory concerned provides appropriate guarantees that the animal
              health situation that gave rise to the suspension or withdrawal has been resolved or
              no longer represents a threat to animal or public health within the Union;
        (c)   for the reason referred to in point (d) of paragraph 1 of this Article, provided that:
              (i)    the third country or territory concerned has agreed to controls being carried out
                     by the Commission on behalf of the Union in its territory; and
11779/15                                                                 AS/NC/ra                    408
                                                 DGB 2B                                            EN
 ---pagebreak---                (ii)  the results of those controls by the Commission show that the third country or
                     territory concerned, and the zones or compartments thereof, comply with the
                     listing criteria provided for in Article 230(1).
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                              SECTION 3
                        APPROVAL AND LISTING OF ESTABLISHMENTS
                            IN THIRD COUNTRIES AND TERRITORIES
                                               Article 233
                                 Approval and listing of establishments
1.      Member States shall only permit the entry into the Union of terrestrial animals and
        germinal products thereof originating from an establishment of a type for which approval
        is required in the Union in accordance with Article 94(2) and the rules adopted pursuant to
        Article 94(3) and Article 95, if the establishment in question in the third country or
        territory concerned:
        (a)    complies with animal health requirements in that third country or territory which are
               equivalent to the rules for establishments of that type applicable in the Union;
11779/15                                                                 AS/NC/ra                409
                                                DGB 2B                                          EN
 ---pagebreak---         (b)   is approved and listed by the competent authority of the third country or territory of
              dispatch, unless alternative risk-mitigation measures in place in that third country or
              territory provide equivalent guarantees for animal health within the Union.
2.      The Commission shall collect the lists of approved establishments referred to in point (b)
        of paragraph 1 received from the competent authorities of the third countries or territories
        concerned.
3.      The Commission shall provide to the Member States any new or updated lists of approved
        establishments received from the third countries or territories concerned, and shall make
        them publicly available.
4.      The Commission shall, by means of implementing acts, adopt any rules necessary in order
        to ensure uniform application of point (b) of paragraph 1.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                   410
                                               DGB 2B                                            EN
 ---pagebreak---                                              SECTION 4
         ENTRY INTO THE UNION OF SPECIES AND CATEGORIES OF ANIMALS,
                 GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN
                                              Article 234
                 Animal health requirements for the entry into the Union of species
            and categories of animals, germinal products and products of animal origin
1.      The animal health requirements for the entry into the Union of species and categories of
        animals, germinal products and products of animal origin from third countries or territories
        shall:
        (a)    be as stringent as the animal health requirements laid down in this Regulation and in
               the rules adopted pursuant thereto applicable to movements of the species and
               categories of animals, germinal products or products of animal origin in question
               within the Union; or
        (b)    offer equivalent guarantees to the animal health requirements applicable to the
               species and categories of animals, germinal products or products of animal origin
               provided for in Part IV (Articles 84 to 228) of this Regulation.
11779/15                                                                AS/NC/ra                 411
                                               DGB 2B                                           EN
 ---pagebreak--- 2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        animal health requirements for:
        (a)    the entry into the Union of species and categories of animals, germinal products and
               products of animal origin from third countries or territories;
        (b)    the movement within the Union and handling of those animals, germinal products
               and products of animal origin after their entry into the Union, where this is necessary
               in order to mitigate the risk involved.
3.      Pending the adoption of delegated acts laying down animal health requirements as regards
        a particular species and category of animal, germinal product or product of animal origin
        provided for in paragraph 1 of this Article, Members State may, following an evaluation of
        the risks involved, apply national rules, provided that those rules comply with the
        requirements laid down in that paragraph and provided that they take into account the
        matters referred to in Articles 235 and 236.
11779/15                                                                 AS/NC/ra                  412
                                                DGB 2B                                            EN
 ---pagebreak---                                                Article 235
            Matters to be taken into account in delegated acts provided for in Article 234
                           with regard to the entry into the Union of animals
The Commission shall take the following matters into account when laying down, in delegated acts
as provided for in Article 234(2), animal health requirements for the entry into the Union of
particular species and categories of animals:
(a)      the listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(b)      the health status of the Union concerning the listed diseases referred to in point (d) of
         Article 9(1) and emerging diseases;
(c)      the listed species with regard to those listed diseases referred to in point (d) of Article 9(1)
         and emerging diseases;
(d)      the age and sex of the animals concerned;
(e)      the origin of the animals concerned;
(f)      the type of establishment concerned and the type of production at the places of origin and
         of destination;
(g)      the intended place of destination;
(h)      the intended use of the animals concerned;
11779/15                                                                   AS/NC/ra                   413
                                                 DGB 2B                                              EN
 ---pagebreak--- (i)      any risk-mitigation measures in place in the third countries or territories of origin or transit,
         or after the arrival of the animals concerned into the territory of the Union;
(j)      animal health requirements applicable to movements of those animals within the Union;
(k)      other epidemiological factors;
(l)      international animal health trade standards, relevant to the species and categories of those
         animals.
                                               Article 236
          Matters to be taken into account in delegated acts as provided for in Article 234
     with regard to the entry into the Union of germinal products and products of animal origin
The Commission shall take the following matters into account when laying down, in delegated acts
as provided for in Article 234(2), the animal health requirements for the entry into the Union of
germinal products and products of animal origin:
(a)      the listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(b)      the health status of the animals from which the germinal products or products of animal
         origin originate and of the Union concerning the listed diseases referred to in point (d) of
         Article 9(1) and emerging diseases;
11779/15                                                                   AS/NC/ra                  414
                                                 DGB 2B                                             EN
 ---pagebreak--- (c)     the type and nature of particular germinal products or products of animal origin,
        treatments, processing methods and other risk-mitigation measures that have been applied
        at the places of origin, dispatch of consignment or destination;
(d)     the type of establishment and the type of production at the places of origin and of
        destination;
(e)     the intended place of destination;
(f)     the intended use of the germinal products or products of animal origin concerned;
(g)     animal health requirements applicable to movements of the germinal products and products
        of animal origin concerned within the Union;
(h)     other epidemiological factors;
(i)     international animal health trade standards, relevant for the germinal products and products
        of animal origin in question.
11779/15                                                                AS/NC/ra                415
                                               DGB 2B                                          EN
 ---pagebreak---                                              SECTION 5
     ANIMAL HEALTH CERTIFICATES, DECLARATIONS AND OTHER DOCUMENTS
                                              Article 237
      Animal health certificates, declarations and other documents for entry into the Union
1.      Member States shall only permit the entry into the Union of consignments of animals,
        germinal products and products of animal origin if such consignments are accompanied by
        one or both of the following:
        (a)   an animal health certificate issued by the competent authority of the third country or
              territory of origin, unless a derogation is provided for in point (a) of paragraph 4;
        (b)   declarations or other documents, where required by the rules adopted pursuant to
              point (b) of paragraph 4.
2.      Member States shall not permit the entry into the Union of consignments of animals,
        germinal products and products of animal origin unless the animal health certificate
        referred to in point (a) of paragraph 1 has been verified and signed by an official
        veterinarian in a third country or territory in compliance with certification requirements
        equivalent to those laid down in Article 149(3) or 216(3) and any rules adopted pursuant to
        Article 149(4) or 216(4).
11779/15                                                                 AS/NC/ra                   416
                                                DGB 2B                                            EN
 ---pagebreak--- 3.      Member States shall permit electronic animal health certificates that are produced, handled
        and transmitted by means of TRACES to replace the accompanying animal health
        certificates referred to in paragraph 1, where such electronic animal health certificates:
        (a)    contain all the information that the animal health certificate referred to in point (a) of
               paragraph 1 of this Article is required to contain in accordance with Article 238(1)
               and any rules adopted pursuant to Article 238(3);
        (b)    ensure the traceability of the consignments of animals, germinal products and
               products of animal origin concerned and link those consignments to the electronic
               animal health certificate.
4.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)    derogations from the animal health certificate requirements provided for in point (a)
               of paragraph 1 and paragraph 2 of this Article, for consignments of animals, germinal
               products and products of animal origin, and in specific rules for the animal health
               certification of those consignments, where the consignments in question pose an
               insignificant risk to animal health or public health within the Union, due to one or
               more of the following factors:
               (i)    the species and categories of animals, germinal products or products of animal
                      origin concerned;
11779/15                                                                 AS/NC/ra                     417
                                                DGB 2B                                              EN
 ---pagebreak---             (ii)  the methods of keeping and types of production of the animals, germinal
                  products and products of animal origin concerned;
            (iii) their intended use;
            (iv) alternative risk-mitigation measures which are in place in the third countries or
                  territories of origin or transit, or after their arrival into the territory of the
                  Union, affording equivalent protection of animal health and public health
                  within the Union as provided for in this Regulation;
            (v)   the provision by the third country or territory concerned of guarantees of
                  compliance with the requirements for entry into the Union, demonstrated by
                  means other than an animal health certificate;
        (b) rules requiring consignments of animals, germinal products and products of animal
            origin entering into the Union to be accompanied by declarations or other documents
            needed to demonstrate that the animals, germinal products and products of animal
            origin in question meet the animal health requirements for entry into the Union laid
            down in rules adopted pursuant to Article 234(2).
11779/15                                                                   AS/NC/ra                   418
                                              DGB 2B                                                 EN
 ---pagebreak---                                              Article 238
                                Content of animal health certificates
1.      The animal health certificate referred to in point (a) of Article 237(1) shall contain at least
        the following information:
        (a)   the name and address of:
              (i)   the establishment or place of origin;
              (ii)  the establishment or place of destination;
              (iii) where applicable, establishments for assembly operations or rest of the kept
                    animals concerned;
        (b)   a description of the animals, germinal products or products of animal origin
              concerned;
        (c)   the number or volume of the animals, germinal products or products of animal origin
              concerned;
        (d)   where applicable, the identification and registration of the animals, germinal
              products or products of animal origin concerned;
11779/15                                                                 AS/NC/ra                   419
                                              DGB 2B                                               EN
 ---pagebreak---         (e)   the information needed to demonstrate that the animals, germinal products and
              products of animal origin concerned fulfil the animal health requirements for entry
              into the Union provided for in Article 229 and Article 234(2) and in the rules adopted
              pursuant to Article 234(2) and Article 239.
2.      The animal health certificate referred to in point (a) of Article 237(1) may include other
        information required under other Union legislation.
3.      The Commission may, by means of implementing acts, lay down rules concerning:
        (a)   information to be contained in the animal health certificate referred to in point (a) of
              Article 237(1) in addition to that referred to in paragraph 1of this Article;
        (b)   information to be contained in declarations or other documents as referred to in
              point (b) of Article 237(1);
        (c)   model forms for the animal health certificates, declarations and other documents
              referred to in Article 237(1).
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
4.      Pending the establishment of rules in implementing acts adopted pursuant to paragraph 3,
        as regards a particular species and category of animal, germinal product or product of
        animal origin, Member States may, following an evaluation of the risks involved, apply
        national rules, provided those national rules comply with the conditions laid down in
        paragraph 1.
11779/15                                                                 AS/NC/ra                   420
                                               DGB 2B                                             EN
 ---pagebreak---                                              SECTION 6
                      DEROGATIONS AND ADDITIONAL REQUIREMENTS
                             IN RESPECT OF CERTAIN CATEGORIES
       OF ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN
                                              Article 239
       Derogations and additional requirements in respect of certain categories of animals,
                          germinal products and products of animal origin
1.      For certain specific types of entry of animals, germinal products and products of animal
        origin, the application of the rules set out in Article 229(1) and Articles 233 and 237 may
        not be adequate, and special rules may need to be adopted by the Commission through
        delegated acts which take into account the particular risks, the final destination, the type of
        final use and other circumstances.
2.      The Commission shall adopt delegated acts in accordance with Article 264 concerning the
        special rules referred to in paragraph 1 of this Article regarding derogations from the
        requirements provided for in Article 229(1) and Articles 233 and 237 and imposing
        additional requirements for the entry into the Union of the following:
        (a)    animals:
               (i)   intended for circuses, events, exhibitions, display, shows and confined
                     establishments;
11779/15                                                                 AS/NC/ra                   421
                                                DGB 2B                                            EN
 ---pagebreak---             (ii)  intended to be used for scientific or diagnostic purposes;
            (iii) for which the Union is not the final destination;
            (iv) which originate in the Union and which are moved to a third country or
                  territory, and are then moved back to the Union from that third country or
                  territory;
            (v)   which originate in the Union and which are transported through a third country
                  or territory en route to another part of the Union;
            (vi) which are intended for grazing purposes on a temporary basis, in the vicinity of
                  the Union's borders;
            (vii) which pose an insignificant risk to the animal health status within the Union;
        (b) products of animal origin:
            (i)   intended for personal use;
            (ii)  for consumption by the crew and passengers on means of transport arriving
                  from third countries or territories;
        (c) germinal products and products of animal origin:
            (i)   intended to be used as trade samples;
            (ii)  intended to be used as research and diagnostic samples;
11779/15                                                              AS/NC/ra                 422
                                             DGB 2B                                           EN
 ---pagebreak---               (iii) for which the Union is not the final destination;
              (iv) which originate in the Union and are moved to a third country or territory, and
                     are then moved back to the Union from that third country or territory;
              (v)    which originate in the Union and are transported through a third country or
                     territory en route to another part of the Union;
              (vi) which pose an insignificant risk to the animal health status within the Union.
        Those delegated acts shall take into account the matters referred to in Article 235 and 236.
3.      The Commission may, by means of implementing acts, lay down rules:
        (a)   concerning model forms for the animal health certificates, declarations and other
              documents for the categories of animals, germinal products and products of animal
              origin referred to in paragraph 2 of this Article;
        (b)   indicating, for the products referred to in paragraph 1 of this Article, the codes from
              the Combined Nomenclature, where such codes are not provided for by other
              relevant Union rules.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                    423
                                                DGB 2B                                             EN
 ---pagebreak---                                              Chapter 2
         Entry into the Union of certain goods other than animals,
                germinal products and products of animal origin
                          from third countries and territories
                                               Article 240
                                   Disease agents and delegated acts
1.      Operators, veterinarians, aquatic animal health professionals and animal professionals
        bringing disease agents into the Union shall:
        (a)    take appropriate measures to ensure that the entry of those disease agents into the
               Union does not pose a risk to animal health or public health within the Union with
               regard to listed diseases referred to in point (d) of Article 9(1) and emerging
               diseases;
        (b)    take appropriate disease control and preventive measures to ensure that the entry of
               those disease agents into the Union does not present a risk of bioterrorism.
        This paragraph shall also apply to any other natural or legal person bringing such agents
        into the Union intentionally.
11779/15                                                                   AS/NC/ra                424
                                                DGB 2B                                           EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 laying down requirements for the entry into the Union of disease agents
        concerning:
        (a)    the packaging of disease agents;
        (b)    other risk-mitigation measures required in order to prevent the release and spread of
               disease agents.
                                              Article 241
                         Plant material and delegated and implementing acts
1.      The Member States shall take measures to restrict the entry into the Union of consignments
        of plant material in the event of an unfavourable disease situation in third countries or
        territories concerning listed diseases as referred to in point (d) of Article 9(1) or emerging
        diseases, where this is required by the rules adopted in accordance with paragraph 3 of this
        Article.
2.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning the measures referred to in paragraph 1 of this Article, setting out:
        (a)    specific animal health requirements for the entry into the Union of plant material
               which acts as a path of transmission of listed or emerging diseases;
11779/15                                                                  AS/NC/ra                  425
                                               DGB 2B                                              EN
 ---pagebreak---         (b)   requirements in relation to:
              (i)    animal health certification, taking into account the rules provided for in point
                     (a) of Article 237(1) and Article 237(2) and (3); or
              (ii)   declarations or other documents, taking into account the rules provided for in
                     point (b) of Article 237(1).
3.      The Commission shall lay down the animal health requirements provided for in paragraph
        2 on the basis of the following criteria:
        (a)   whether a listed or emerging disease that can be transmitted by means of plant
              material represents a serious risk to animal or to human health in the Union;
        (b)   the likelihood that animals of listed species for a particular listed disease or emerging
              disease will come into direct or indirect contact with the plant material referred to in
              paragraph 2;
        (c)   the availability and effectiveness of alternative risk-mitigation measures in relation to
              that plant material, which may eliminate or minimise the risk of transmission referred
              to in point (a).
11779/15                                                                 AS/NC/ra                   426
                                               DGB 2B                                             EN
 ---pagebreak--- 4.      The Commission may, by means of implementing acts, lay down rules indicating, for the
        plant material referred to in paragraph 2 of this Article, the codes from the Combined
        Nomenclature, where such indication is not provided for by other relevant Union rules.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
                                             Article 242
          Means of transport, equipment, packaging materials, transport water and feed
                          and fodder and delegated and implementing acts
1.      Operators bringing animals and products into the Union shall take the appropriate and
        necessary disease prevention measures during transport, as provided for in Articles 125(1)
        and 192(1).
2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)   specific animal health requirements for the entry into the Union of:
              (i)    means of transport for animals and products;
              (ii)   equipment, packaging material or transport water for animals and products, or
                     feed and fodder which may transmit animal diseases;
11779/15                                                                 AS/NC/ra               427
                                               DGB 2B                                          EN
 ---pagebreak---         (b)    requirements in relation to:
               (i)    animal health certification, taking into account the rules provided for in point
                      (a) of Article 237(1) and Article 237(2) and (3); or
               (ii)   declarations or other documents, taking into account the rules provided for in
                      point (b) of Article 237(1).
3.      The Commission shall lay down the animal health requirements provided for in paragraph
        2 of this Article in the event of a unfavourable disease situation concerning one or more
        listed diseases as referred to in point (d) of Article 9(1), or emerging diseases, which
        present a serious risk to animal and human health in the Union, in:
        (a)    a neighbouring third country or territory;
        (b)    the third country or territory of origin;
        (c)    a third country or territory of transit.
4.      The Commission may, by means of implementing acts, lay down rules indicating, for the
        goods referred to in point (a) of paragraph 2 of this Article, the codes from the Combined
        Nomenclature, where such indication is not provided for by other relevant Union rules.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                  AS/NC/ra                   428
                                                 DGB 2B                                            EN
 ---pagebreak---                                              Chapter 3
                                               Export
                                              Article 243
                                         Export from the Union
1.      Member States shall take the appropriate measures to ensure that the export and re–export
        from the Union to a third country or territory of animals and products takes place in
        accordance with the rules for the movement of animals and products between Member
        States provided for in Part IV (Articles 84 to 228), while taking into account the animal
        health status within the third country or territory of destination, or the relevant zone or
        compartment thereof, with regard to the listed diseases referred to in point (d) of Article
        9(1) and emerging diseases.
2.      By way of derogation from paragraph 1, if so requested by the competent authority of a
        third country or territory importing the animals and products in question, or if established
        by the legal and administrative procedures in force in that third country or territory, export
        and re–export from the Union may take place in accordance with the provisions in force in
        that third country or territory, provided that such exports or re-exports do not jeopardise
        public or animal health.
3.      Where the provisions of a bilateral agreement concluded between the Union and a third
        country or territory are applicable, animals and products exported from the Union to that
        third country or territory shall comply with those provisions.
11779/15                                                                 AS/NC/ra                    429
                                                DGB 2B                                              EN
 ---pagebreak---                                            PART VΙ
                   NON–COMMERCIAL MOVEMENTS
           OF PET ANIMALS INTO A MEMBER STATE
                   FROM ANOTHER MEMBER STATE
       OR FROM A THIRD COUNTRY OR TERRITORY
                                            Chapter 1
                                     General provisions
                                             Article 244
                                          Scope of Part VI
1.      This Part shall apply to the non–commercial movement of pet animals into a Member State
        from another Member State or from a third country or territory.
2.      It shall apply without prejudice to:
        (a)    Council Regulation (EC) No 338/97 1;
1
      Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of
      wild fauna and flora by regulating trade therein (OJ L 61, 3.3.1997, p. 1).
11779/15                                                              AS/NC/ra             430
                                              DGB 2B                                      EN
 ---pagebreak---         (b)   any national measures adopted, published and made available to the public by
              Member States to restrict the movement of certain species or breeds of pet animals
              on the basis of considerations other than those relating to animal health.
                                              Article 245
                                          General provisions
1.      Non–commercial movements of pet animals that fulfil the animal health requirements laid
        down in this Part shall not be prohibited, restricted or impeded on animal health grounds
        other than those resulting from the application of this Part.
2.      Where the non–commercial movement of a pet animal is carried out by an authorised
        person, it may only take place within five days from the movement of the pet owner.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning requirements supplementing the rules laid down in paragraph 2 of this
        Article in relation to the following:
        (a)   documentation of the non–commercial movement of a pet animal carried out by an
              authorised person;
11779/15                                                                AS/NC/ra                431
                                               DGB 2B                                          EN
 ---pagebreak---         (b)   granting of derogations from the period referred to in paragraph 2 of this Article.
4.      The Commission may, by means of implementing acts, lay down requirements for the
        layout, languages and validity of the declaration authorising an authorised person in
        writing to carry out the non–commercial movement of a pet animal on behalf of the pet
        owner. Those implementing acts shall be adopted in accordance with the examination
        procedure referred to in Article 266(2).
                                             Article 246
                                  Maximum number of pet animals
1.      The number of pet animals of the species listed in Part A of Annex I which may be moved
        during a single non–commercial movement shall not exceed five.
2.      By way of derogation from paragraph 1, the number of pet animals of the species listed in
        part A of Annex I may exceed five if the following conditions are fulfilled:
        (a)   the non–commercial movement in question is for the purpose of participating in a
              competition, exhibition or sporting event or training for such an event;
        (b)   the pet owner or the authorised person concerned submits written evidence that the
              pet animals are registered either to attend an event as referred to in point (a), or with
              an association organising such events;
11779/15                                                                AS/NC/ra                    432
                                              DGB 2B                                               EN
 ---pagebreak---         (c)    the pet animals are more than six months old.
3.      In order to prevent commercial movements of pet animals of the species listed in Part B of
        Annex I from being fraudulently disguised as non–commercial movements, the
        Commission shall be empowered to adopt delegated acts in accordance with Article 264
        concerning rules setting the maximum number of pet animals of those species which may
        be moved during a single non–commercial movement.
                                              Chapter 2
            Conditions applicable to non–commercial movements
     of pet animals into a Member State from another Member State
                                                Article 247
        Conditions applicable to non–commercial movements of pet animals of the species
                                       listed in Part A of Annex I
Pet animals of the species listed in Part A of Annex I shall not be moved into a Member State from
another Member State unless:
(a)     they are individually identified by a physical means of identification in accordance with
        the rules adopted pursuant to point (a) of Article 252(1);
11779/15                                                               AS/NC/ra                  433
                                                 DGB 2B                                         EN
 ---pagebreak--- (b)     they fulfil the relevant prevention and risk-mitigation measures adopted pursuant to point
        (b) of Article 252(1) in relation to listed diseases as referred to in point (d) of Article 9(1);
(c)     they are accompanied by an identification document duly completed and issued in
        accordance with the rules adopted pursuant to point (d) of Article 254(1).
                                               Article 248
       Conditions applicable to non–commercial movements of pet animals of the species
                                      listed in Part B of Annex I
1.      In so far as the Commission has adopted a delegated act pursuant to point (b) of Article
        252(1) with regard to pet animals of one of the species listed in Part B of Annex I,
        non-commercial movements of pet animals of that species into a Member State from
        another Member State shall be subject to compliance with the conditions laid down in
        paragraph 2 of this Article.
2.      Pet animals of the species referred to in paragraph 1 may be moved into a Member State
        from another Member State only if:
        (a)   they are identified or described, either individually or in groups, in accordance with
              the rules adopted pursuant to point (a) of Article 252(1);
        (b)   they comply with the relevant prevention and risk-mitigation measures adopted
              pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in
              point (d) of Article 9(1);
11779/15                                                                  AS/NC/ra                    434
                                                 DGB 2B                                              EN
 ---pagebreak---         (c)   they are accompanied by an identification document duly completed and issued in
              accordance with the rules adopted pursuant to point (d) of Article 254(1);
3.      Pending the adoption of the relevant delegated acts referred to in paragraph 1, Member
        States may apply national rules to non–commercial movements of pet animals of the
        species listed in Part B of Annex I into their territory from another Member State, provided
        that such rules are:
        (a)   applied proportionately to the risk to public or animal health associated with non–
              commercial movements of pet animals of those species; and
        (b)   not stricter than those applied to movements of animals of those species in
              accordance with Part IV.
11779/15                                                                AS/NC/ra                 435
                                               DGB 2B                                           EN
 ---pagebreak---                                              Chapter 3
            Conditions applicable to non–commercial movements
                         of pet animals into a Member State
                           from a third country or territory
                                               Article 249
       Conditions applicable to non–commercial movements of pet animals of the species
                                      listed in Part A of Annex I
1.      Pet animals of the species listed in Part A of Annex I shall not be moved into a Member
        State from a third country or territory unless:
        (a)   they are individually identified by a physical means of identification in accordance
              with the rules adopted pursuant to point (a) of Article 252(1);
        (b)   they comply with the relevant prevention and risk-mitigation measures adopted
              pursuant to point (b) of Article 252(1) in respect of listed diseases as referred to in
              point (d) of Article 9(1);
        (c)   they are accompanied by an identification document duly completed and issued in
              accordance with the rules adopted pursuant to point (d) of Article 254(1).
11779/15                                                                 AS/NC/ra                    436
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      Pet animals of the species listed in Part A of Annex I may be moved into a Member State
        from a third country or territory other than those listed pursuant to Article 253(1)(d) only
        through a point of entry listed for that purpose. Each Member State shall draw up a list of
        those points of entry within its territory and shall make that list available to the public.
3.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the conditions for granting derogations from paragraph 2 of this Article.
                                               Article 250
       Conditions applicable to non–commercial movements of pet animals of the species
                                      listed in Part B of Annex I
1.      In so far as the Commission has adopted a delegated act pursuant to point (b) of Article
        252(1) with regard to pet animals of one of the species listed in Part B of Annex I, non–
        commercial movements of pet animals of that species into a Member State from a third
        country or territory shall be subject to compliance with the conditions laid down in
        paragraph 2 of this Article.
2.      Pet animals of the species referred to in paragraph 1 may be moved into a Member State
        from a third country or territory only if:
        (a)   they are identified or described, either individually or in groups, in accordance with
              the rules adopted pursuant to point (a) of Article 252(1);
11779/15                                                                  AS/NC/ra                   437
                                                DGB 2B                                              EN
 ---pagebreak---         (b)   they comply with the relevant prevention and risk-mitigation measures adopted
              pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in
              point (d) of Article 9(1);
        (c)   they are accompanied by an identification document duly completed and issued in
              accordance with the rules adopted pursuant to point (d) of Article 254;
        (d)   when coming from a third country or territory other than those listed pursuant to
              point (d) of Article 253(1), they enter through a point of entry listed for that purpose.
              Each Member State shall draw up a list of those points of entry within its territory
              and shall make that list available to the public.
3.      Pending the adoption of the relevant delegated acts referred to in paragraph 1, Member
        States may apply national rules to non–commercial movements of pet animals of the
        species listed in Part B of Annex I into their territory from a third country or territory,
        provided that such rules are:
        (a)   applied proportionately to the risk to public or animal health associated with non–
              commercial movements of pet animals of those species; and
        (b)   not stricter than those applied to the entry into the Union of animals of those species
              in accordance with Part V.
11779/15                                                                  AS/NC/ra                   438
                                               DGB 2B                                               EN
 ---pagebreak---                                                Article 251
             Derogation from the conditions applicable to non–commercial movements
                       of pet animals between certain countries and territories
By way of derogation from Articles 249 and 250, non–commercial movements of pet animals
between the following countries and territories may continue under the conditions laid down by the
national rules of those countries and territories:
(a)      San Marino and Italy;
(b)      the Vatican and Italy;
(c)      Monaco and France;
(d)      Andorra and France;
(e)      Andorra and Spain;
(f)      Norway and Sweden;
(g)      the Faeroe Islands and Denmark;
(h)      Greenland and Denmark.
11779/15                                                               AS/NC/ra                 439
                                                 DGB 2B                                       EN
 ---pagebreak---                                            Chapter 4
       Identification and prevention and risk-mitigation measures
                                             Article 252
                 Delegation of powers concerning the identification of pet animals
                           and prevention and risk-mitigation measures
1.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning:
        (a)  detailed species–specific requirements for:
             (i)    the means of identification of pet animals of the species listed in Annex I
                    provided for in point (a) of Article 247, point (a) of Article 248(2), point (a) of
                    Article 249(1) and point (a) of Article 250(2);
             (ii)   the application and use of those means of identification;
        (b)  detailed species–specific requirements for the prevention and risk-mitigation
             measures to ensure that pet animals do not pose a significant risk for the spread of
             listed diseases as referred to in point (d) of Article 9(1) due to movements of pet
             animals of the species listed in Annex I as provided for in point (b) of Article 247,
             point (b) of Article 248(2), point (b) of Article 249(1) and point (b) of Article 250(2).
11779/15                                                                 AS/NC/ra                   440
                                               DGB 2B                                             EN
 ---pagebreak--- 2.      Where, in the case of emerging risks, imperative grounds of urgency so require, the
        procedure provided for in Article 265 shall apply to rules adopted pursuant to point (b) of
        paragraph 1 of this Article.
3.      The species–specific prevention and risk-mitigation measures authorised by a delegated act
        adopted pursuant to point (b) of paragraph 1 of this Article shall be based on adequate,
        reliable and validated scientific information and applied proportionately to the risk to
        public or animal health associated with non–commercial movements of pet animals likely
        to be affected by listed diseases as referred to in point (d) of Article 9(1).
4.      The delegated acts provided for in point (b) of paragraph 1 may also comprise the
        following:
        (a)   rules for the categorisation of Member States or parts thereof according to their
              animal health status and their surveillance and reporting systems with regard to
              certain diseases that are likely to be spread by movements of pet animals of the
              species listed in Annex I;
        (b)   the conditions that Member States are to fulfil in order to remain eligible for the
              application of the prevention and risk-mitigation measures referred to in point (b) of
              paragraph 1;
        (c)   the conditions for applying and documenting the prevention and risk-mitigation
              measures referred to in point (b) of paragraph 1;
11779/15                                                                  AS/NC/ra                 441
                                                DGB 2B                                            EN
 ---pagebreak---         (d)   the criteria for granting and, where appropriate, documenting derogations in certain
              specified circumstances from the application of the prevention and risk-mitigation
              measures referred to in point (b) of paragraph 1;
        (e)   the criteria for granting and documenting derogations in certain specified
              circumstances from the conditions referred to in Articles 247 to 250.
                                              Article 253
             Implementing acts concerning prevention and risk-mitigation measures
1.      The Commission shall, by means of implementing acts, as regards pet animals of the
        species listed in Part A of Annex I:
        (a)   lay down rules on the format, layout and languages of any documents required under
              points (c) and (d) of Article 252(4);
        (b)   adopt a list of Member States that comply with the conditions referred to in point (d)
              of Article 252(4) and remove Member States from that list should any change occur
              in relation to those conditions;
        (c)   adopt a list of Member States that comply with the rules for categorisation of
              Member States or parts thereof referred to in point (a) of Article 252(4) and remove
              Member States from that list should any change occur in relation to those rules;
11779/15                                                               AS/NC/ra                  442
                                               DGB 2B                                          EN
 ---pagebreak---         (d)    adopt a list of third countries and territories that comply with the conditions referred
               to in point (d) of Article 252(4) and remove third countries or territories from that list
               should any change occur in relation to those conditions.
2.      The Commission may, by means of implementing acts, as regards pet animals of the
        species listed in Part B of Annex I, adopt a list of third countries and territories that comply
        with the conditions referred to in point (d) of Article 252(4) and remove third countries or
        territories from that list should any change occur in relation to those conditions.
3.      The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in
        accordance with the examination procedure referred to in Article 266(2).
4.      On duly justified imperative grounds of urgency relating to serious risks, the Commission
        shall adopt immediately applicable implementing acts updating the lists referred to in
        points (b) and (d) of paragraph 1 of this Article in accordance with the procedure referred
        to in Article 266(3).
11779/15                                                                  AS/NC/ra                   443
                                                 DGB 2B                                             EN
 ---pagebreak---                                              Chapter 5
                                  Identification documents
                                              Article 254
                     Delegation of powers concerning identification documents
The Commission shall be empowered to adopt delegated acts in accordance with Article 264
concerning:
(a)     entries for the insertion of the information to be included in the identification documents
        referred to in point (c) of Article 247, point (c) of Article 248(2), point (c) of
        Article 249(1) and point (c) of Article 250(2);
(b)     the distribution of blank identification documents as referred to in point (c) of Article 247;
(c)     the conditions for granting derogations in relation to the format of the identification
        documents provided for in point (c) of Article 247 and point (c) of Article 249(1);
(d)     the issue, completion and, where applicable, endorsement of the identification documents
        provided for in point (c) of Articles 247, point (c) of Article 248(2), point (c) of Article
        249(1) and point (c) of Article 250(2).
11779/15                                                                  AS/NC/ra                   444
                                                DGB 2B                                             EN
 ---pagebreak---                                               Article 255
                      Implementing acts concerning identification documents
1.      The Commission shall adopt implementing acts laying down the model for identification
        documents as referred to in point (c) of Article 247 and point (c) of Article 249(1). That
        model shall contain the respective entries referred to in point (a) of Article 254, as well as
        requirements concerning the languages, layout, validity or security features of those
        identification documents.
2.      The Commission may, by means of implementing acts, adopt:
        (a)   the model for identification documents as referred to in point (c) of Article 248(2)
              and point (c) of Article 250(2), which are to contain the respective entries referred to
              in point (a) of Article 254, as well as requirements concerning the languages, layout,
              validity or security features of those identification documents;
        (b)   the rules necessary for transition to the model identification document referred to in
              point (c) of Article 247.
3.      The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in
        accordance with the examination procedure referred to in Article 266(2).
11779/15                                                                 AS/NC/ra                   445
                                                DGB 2B                                            EN
 ---pagebreak---                                             Chapter 6
                                  Information obligations
                                             Article 256
                                       Information obligations
1.      Member States shall provide the public with clear and easily accessible information
        concerning the animal health requirements applicable to non–commercial movements of
        pet animals, including:
        (a)   conditions for the grant of certain derogations referred to in point (d) of
              Article 252(4);
        (b)   conditions for the grant of derogations referred to in point (e) of Article 252(4);
        (c)   requirements for the application of the means of identification referred to in point
              (a)(ii) of Article 252(1);
        (d)   conditions applicable to non–commercial movements into Member States' territories
              of pet animals of the species referred to in Part B of Annex I, which are laid down by
              their national rules as provided for in Articles 248(3) and 250(3);
11779/15                                                                AS/NC/ra                   446
                                               DGB 2B                                             EN
 ---pagebreak---         (e)   conditions applicable to non–commercial movements into Member States' territories
              of pet animals from certain countries and territories laid down by their national rules
              as referred to in Article 251;
        (f)   any relevant information concerning certain prevention and risk-mitigation measures
              as referred to in point (b) of Article 252(1).
2.      Member States shall establish internet–based information pages providing the information
        referred to in paragraph 1, and shall communicate the internet address of those pages to the
        Commission.
3.      The Commission shall assist the Member States in making that information available to the
        public by providing on its internet page:
        (a)   links to the internet–based information pages of the Member States;
        (b)   the information referred to in points (a) and (d) of paragraph 1, and the information
              made available to the public as referred to in point (b) of Article 244(2) in additional
              languages, as appropriate.
11779/15                                                                AS/NC/ra                   447
                                                DGB 2B                                            EN
 ---pagebreak---                                              PART VIΙ
                             EMERGENCY MEASURES
                                               SECTION 1
   EMERGENCY MEASURES CONCERNING MOVEMENTS OF ANIMALS AND PRODUCTS
       WITHIN THE UNION AND MEANS OF TRANSPORT AND OTHER MATERIAL
    THAT MAY HAVE COME INTO CONTACT WITH SUCH ANIMALS AND PRODUCTS
                                                Article 257
         Emergency measures to be taken by the competent authority of the Member State
            in the territory of which an outbreak of a listed disease or emerging disease,
                                          or a hazard occurred
1.      In the event of an outbreak of a listed disease or emerging disease, or the occurrence of a
        hazard which is likely to constitute a serious risk to animal or public health, the competent
        authority of the Member State where it occurred shall, depending on the gravity of the
        situation and the disease or hazard in question, immediately take one or more of the
        following emergency measures to prevent the spread of the disease or hazard:
        (a)    for listed diseases:
               (i)    referred to in point (a) of Article 9(1), the disease control measures laid down
                      in Chapter 1 of Title II of Part III (Articles 53 to 71);
11779/15                                                                    AS/NC/ra                 448
                                                  DGB 2B                                            EN
 ---pagebreak---             (ii)   referred to in point (b) of Article 9(1), the disease control measures laid down
                   in Articles 72 to 75 and 77 to 81 of Chapter 2 of Title II of Part III;
            (iii) referred to in point (c) of Article 9(1), the disease control measures laid down
                   in Articles 76 to 78 and Articles 80 and 82 of Chapter 2 of Title II of Part III;
        (b) for emerging diseases and hazards:
            (i)    restrictions on the movement of animals and products originating from the
                   establishments, or, where relevant, the restricted zones or compartments, where
                   the outbreak or the hazard occurred, and on means of transport and other
                   material that may have come into contact with those animals or products;
            (ii)   quarantine of animals and isolation of products;
            (iii) surveillance and traceability measures;
            (iv) any emergency disease control measures provided for in Chapter 1 of Title II
                   of Part III (Articles 53 to 71) that are appropriate;
        (c) any other emergency measure which it deems appropriate in order to effectively and
            efficiently control and prevent the spread of the disease or hazard.
11779/15                                                                 AS/NC/ra                 449
                                               DGB 2B                                            EN
 ---pagebreak--- 2.      The competent authority referred to in paragraph 1 shall inform the Commission and the
        other Member States:
        (a)    immediately of any outbreak or the occurrence of a hazard as referred to in
               paragraph 1;
        (b)    without delay of the emergency measures taken pursuant to paragraph 1.
                                             Article 258
                        Emergency measures to be taken by a Member State
                other than the Member State where the outbreak or hazard occurred
1.      The competent authority of a Member State other than the Member State where the
        outbreak or hazard referred to in Article 257(1) occurred shall, depending on the gravity of
        the situation and the disease or hazard in question, take one or more of the emergency
        measures referred to in Article 257(1) where it detects on its territory animals or products
        from the Member State referred to in Article 257(1) or means of transport or any other
        material that may have come into contact with such animals and products.
11779/15                                                                AS/NC/ra                  450
                                              DGB 2B                                             EN
 ---pagebreak--- 2.      The competent authority referred to in paragraph 1 of this Article may, where a serious risk
        exists pending the adoption of emergency measures by the Commission in accordance with
        Article 259, take the emergency measures referred to in Article 257(1) on an interim basis,
        depending on the gravity of the situation with regard to animals or products originating
        from the establishments or other locations, or where relevant from the restricted zones of
        the Member State, where the disease or hazard referred to in Article 257(1) occurred, or
        means of transport or other material that may have come into contact with such animals.
3.      A Member State may take measures as referred to in Article 257(1) in the event of an
        outbreak in a third country or territory bordering the Union of a disease referred to in point
        (a) of Article 9(1) or an emerging disease in such a third country or territory, in so far as
        those measures are necessary in order to prevent the spread of the disease into the territory
        of the Union.
4.      The competent authority referred to in paragraph 1 and the competent authority of the
        Member State referred to in paragraph 3 shall inform the Commission and other Member
        States:
        (a)    immediately of the outbreak or occurrence of a hazard referred to in paragraph 1;
        (b)    without delay of the emergency measures taken pursuant to paragraphs 1 and 2.
11779/15                                                               AS/NC/ra                      451
                                               DGB 2B                                              EN
 ---pagebreak---                                              Article 259
                                  Commission emergency measures
1.      In the event of an outbreak or the occurrence of a hazard as referred to in Article 257(1),
        and of emergency measures taken by the competent authorities of the Member States in
        accordance with Article 257(1) and Article 258(1), (2) and (3), the Commission shall
        review the situation and the emergency measures taken, and shall adopt, by means of an
        implementing act, one or more of the emergency measures provided for in Article 257(1)
        concerning the animals and products in question and means of transport and other material
        that may have come into contact with those animals or products, in any of the following
        cases:
        (a)   where the Commission has not been informed of any measures taken pursuant to
              Article 257(1) and Article 258(1), (2) and (3);
        (b)   where the Commission considers the measures taken pursuant to Article 257(1) and
              Article 258(1), (2) and (3) to be inadequate;
        (c)   where the Commission considers it necessary to approve or replace the measures
              taken by the competent authorities of the Member States pursuant to Article 257(1)
              and Article 258(1), (2) and (3) in order to avoid unjustified disruptions in the
              movement of animals and products.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                AS/NC/ra                  452
                                               DGB 2B                                            EN
 ---pagebreak--- 2.        On duly justified imperative grounds of urgency relating to serious risks of the spread of a
          disease or a hazard, the Commission may adopt immediately applicable implementing acts
          in accordance with Article 266(3).
                                              SECTION 2
            EMERGENCY MEASURES CONCERNING CONSIGNMENTS OF ANIMALS
        AND PRODUCTS ORIGINATING FROM THIRD COUNTRIES AND TERRITORIES,
                      AND MEANS OF TRANSPORT AND OTHER MATERIAL,
            THAT MAY HAVE COME INTO CONTACT WITH SUCH CONSIGNMENTS
                                               Article 260
                       Emergency measures to be taken by the competent authority
Where the competent authority of a Member State becomes aware of animals or products
originating from a third country or territory, or of means of transport or materials, which may have
come into contact with such animals and products, that are likely to constitute a serious risk in the
Union due to possible infection or contamination by listed diseases or emerging diseases or hazards,
it shall:
(a)       immediately take one or more of the following emergency measures necessary to mitigate
          that risk, depending on the gravity of the situation:
          (i)    destruction of the animals and products concerned;
11779/15                                                                 AS/NC/ra                   453
                                                 DGB 2B                                           EN
 ---pagebreak---         (ii)  quarantine of animals and isolation of products;
        (iii) surveillance and traceability measures;
        (iv) any disease control measures referred to in Chapter 1 of Title II of Part III
              (Articles 53 to 69), where appropriate;
        (v)   any other emergency measure which it deems appropriate to prevent the spread of the
              disease or hazard into the Union;
(b)     immediately inform the Commission and the other Member States of the risks associated
        with the animals and products in question and of the origin of those animals and products
        by means of TRACES, and without delay of the emergency measures taken pursuant to
        point (a).
11779/15                                                              AS/NC/ra                 454
                                              DGB 2B                                          EN
 ---pagebreak---                                               Article 261
                                  Commission emergency measures
1.      Where a listed disease, an emerging disease or a hazard that is likely to constitute a serious
        risk occurs or spreads in a third country or territory, or if any other serious animal or public
        health reason so warrants, the Commission may, by means of an implementing act and
        acting on its own initiative or at the request of a Member State, adopt one or more of the
        following emergency measures, depending on the gravity of the situation:
        (a)   suspend the entry into the Union of consignments of animals and products, and
              means of transport or other material, that may have come into contact with such
              consignments, which may spread that disease or hazard into the Union;
        (b)   establish special requirements for the entry into the Union of animals and products,
              and of means of transport and other material that may have come into contact with
              such animals and products, which may spread that disease or hazard into the Union;
        (c)   take any other appropriate emergency disease control measures to prevent the spread
              of such disease or hazard into the Union.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
11779/15                                                                  AS/NC/ra                  455
                                                DGB 2B                                             EN
 ---pagebreak--- 2.      On duly justified imperative grounds of urgency relating to serious risks, the Commission
        shall, after consulting the Member State concerned, adopt immediately applicable
        implementing acts in accordance with the procedure referred to in Article 266(3).
                                                Article 262
      Emergency measures to be taken by Member States when the Commission does not act
1.      Where a Member State has requested the Commission to take emergency measures in
        accordance with Article 261 and the Commission has not done so, that Member State:
        (a)    may, pending the adoption of emergency measures by the Commission in accordance
               with paragraph 2 of this Article, take one or more of the emergency measures
               referred to in point (a) of Article 260 on an interim basis in respect of animals and
               products, and any means of transport and other material that may have come into
               contact with such animals and products, originating from the third country or
               territory referred to in Article 261(1), depending on the gravity of the situation within
               its territory;
        (b)    shall inform the Commission and the competent authorities of the other Member
               States of such emergency measures without delay, giving the reason for their
               adoption.
11779/15                                                                 AS/NC/ra                   456
                                                 DGB 2B                                            EN
 ---pagebreak--- 2.      The Commission shall review the situation and the emergency measures taken by the
        Member State concerned in accordance with paragraph 1 of this Article and shall, where
        necessary, adopt by means of an implementing act one or more of the emergency measures
        provided for in Article 261.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 266(2).
3.      On duly justified imperative grounds of urgency relating to serious risks, the Commission
        shall adopt immediately applicable implementing acts in accordance with the procedure
        referred to in Article 266(3).
11779/15                                                              AS/NC/ra                 457
                                             DGB 2B                                           EN
 ---pagebreak---                                           PART VIIΙ
                              COMMON PROVISIONS
                                              TITLE I
                                   Procedural provisions
                                              Article 263
                                      Amendments to Annex III
The Commission shall be empowered to adopt delegated acts in accordance with Article 264
concerning amendments to Annex III, limited exclusively to taking into account changes in
taxonomy.
                                              Article 264
                                      Exercise of the delegation
1.      The power to adopt delegated acts is conferred on the Commission subject to the
        conditions laid down in this Article.
2.      It is of particular importance that the Commission carry out consultations with experts,
        including Member States' experts, before adopting those delegated acts.
11779/15                                                              AS/NC/ra                   458
                                                DGB 2B                                         EN
 ---pagebreak--- 3.      The power to adopt delegated acts referred to in Articles 3(5), 5(2) 5(4), 14(3), 16(2),
        18(3), 20(3), 29, 31(5), 32(2), 37(5), 39, 41(3), 42(6), 47, 48(3), 53(2), 54(3), 55(2), 58(2),
        63, 64(4), 67, 68(2), 68(3), 70(3), 72(2), 73(3), 74(4), 76(5), 77(2), 87(3), 94(3), 97(2),
        101(3), 106(1), 109(2), 118, 119, 122(1), 122(2), 125(2), 131(1), 132(2), 135, 136(2),
        137(2), 138(3), 139(4), 140, 144(1), 146(1), 147, 149(4), 151(3), 154(1), 156(1), 160(1),
        160(2), 161(6), 162(4), 163(5), 164(2), 165(3), 166(3), 167(5), 168(3), 169(5), 176(4),
        181(2), 185(5), 189(1), 192(2), 197(3), 200(3), 201(3), 202(3), 203(2), 204(3), 205(2),
        211(1), 213(1), 214, 216(4), 218(3), 221(1), 222(3), 223(6), 224(3), 228(1), 230(3), 234(2),
        237(4), 239(2), 240(2), 241(2), 242(2), 245(3), 246(3), 249(3), 252(1), 254, 263, 271(2),
        272(2), 279(2), and 280(4) shall be conferred on the Commission for a period of five years
        from … *.
*
      OJ: Please insert the date of entry into force of the basic legislative act or any other date set
      by the legislator.
11779/15                                                                 AS/NC/ra                    459
                                               DGB 2B                                              EN
 ---pagebreak---         The Commission shall draw up a report in respect of the delegation of power not later than
        nine months before the end of the five-year period. The delegation of power shall be tacitly
        extended for periods of an identical duration, unless the European Parliament or the
        Council opposes such extension not later than three months before the end of each period.
4.      The delegation of power referred to in paragraph 3 may be revoked at any time by the
        European Parliament or by the Council. A decision to revoke shall put an end to the
        delegation of the power specified in that decision. It shall take effect the day following the
        publication of the decision in the Official Journal of the European Union or at a later date
        specified therein. It shall not affect the validity of any delegated acts already in force.
5.      As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the
        European Parliament and to the Council.
6.      A delegated act adopted pursuant to the provisions listed in paragraph 3 shall enter into
        force only if no objection has been expressed either by the European Parliament or by the
        Council within a period of two months of notification of that act to the European
        Parliament and the Council or if, before the expiry of that period, the European Parliament
        and the Council have both informed the Commission that they will not object. That period
        shall be extended by two months at the initiative of the European Parliament or of the
        Council.
7.      The Commission shall allow a period of at least six months to elapse between the adoption
        of the respective initial delegated acts referred to in Articles 3(5), 14(3), 16(2), 20(3),
        122(2), 164(2) and 228(1) and the date on which they start to apply.
11779/15                                                                  AS/NC/ra                   460
                                                 DGB 2B                                             EN
 ---pagebreak---                                             Article 265
                                         Urgency procedure
1.      Delegated acts adopted under this Article shall enter into force without delay and shall
        apply as long as no objection is expressed in accordance with paragraph 2. The notification
        of a delegated act to the European Parliament and to the Council shall state the reasons for
        the use of the urgency procedure.
2.      Either the European Parliament or the Council may object to a delegated act in accordance
        with the procedure referred to in Article 264(6). In such a case, the Commission shall
        repeal the act without delay following the notification of the decision to object by the
        European Parliament or by the Council.
                                            Article 266
                                       Committee procedure
1.      The Commission shall be assisted by the Standing Committee on Plants, Animals, Food
        and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That committee
        shall be a committee within the meaning of Regulation (EU) No 182/2011.
2.      Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall
        apply.
11779/15                                                                AS/NC/ra                  461
                                              DGB 2B                                             EN
 ---pagebreak--- 3.      Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in
        conjunction with Article 5 thereof, shall apply.
4.      The Commission shall allow a period of at least six months to elapse between the adoption
        of the respective initial implementing acts referred to in Articles 25(3), 120, and 228(2),
        when those implementing acts relate to the implementation of Article 117, and the date on
        which they start to apply.
                                             Article 267
                                          Data protection
1.      Member States shall apply Directive 95/46/EC of the European Parliament and of the
        Council 1 to the processing of personal data carried out in the Member States pursuant to
        this Regulation.
2.      Regulation (EC) No 45/2001 of the European Parliament and of the Council 2 shall apply to
        the processing of personal data carried out by the Commission pursuant to this Regulation.
1
      Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on
      the protection of individuals with regard to the processing of personal data and on the free
      movement of such data (OJ L 281, 23.11.1995, p. 31).
2
      Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December
      2000 on the protection of individuals with regard to the processing of personal data by the
      Community institutions and bodies and on the free movement of such data (OJ L 8,
      12.1.2001, p. 1).
11779/15                                                                 AS/NC/ra                  462
                                              DGB 2B                                             EN
 ---pagebreak---                                              TITLE II
                                              Penalties
                                               Article 268
                                                Penalties
The Member States shall lay down the rules on penalties applicable to infringements of the
provisions of this Regulation and shall take all measures necessary to ensure that those rules are
implemented. The penalties provided for must be effective, proportionate and dissuasive.
The Member States shall notify those provisions to the Commission by … * at the latest and shall
notify it without delay of any subsequent amendments affecting them.
*
        OJ: Please insert the date: one year from the date of application of this Regulation.
11779/15                                                                 AS/NC/ra                  463
                                                DGB 2B                                           EN
 ---pagebreak---                                             TITLE III
                                 Member States' measures
                                              Article 269
                      Additional or more stringent measures by Member States
1.      In addition to what follows from other provisions in this Regulation, allowing the Member
        States to adopt national measures, Member States may apply within their territories
        measures that are additional to, or more stringent than, those laid down in this Regulation,
        concerning :
        (a)   responsibilities for animal health as provided for in Chapter 3 of Part I (Articles 10
              to 16);
        (b)   notification within Member States as provided for in Article 18;
        (c)   surveillance as provided for in Chapter 2 of Part II (Articles 24 to 30);
        (d)   registration, approval, record-keeping and registers as provided for in Chapter 1 of
              Title I (Articles 84 to 107), and Chapter 1 of Title II, of Part IV (Articles 172 to 190);
        (e)   traceability requirements for kept terrestrial animals and germinal products as
              provided for in Chapter 2 of Title I of Part IV (Articles 108 to 123).
11779/15                                                                  AS/NC/ra                  464
                                               DGB 2B                                              EN
 ---pagebreak--- 2.      The national measures referred to in paragraph 1 shall respect the rules laid down in this
        Regulation and shall not:
        (a)  hinder the movement of animals and products between Member States;
        (b)  be inconsistent with the rules referred to in paragraph 1.
11779/15                                                               AS/NC/ra                   465
                                              DGB 2B                                            EN
 ---pagebreak---                                           PART ΙΧ
            TRANSITIONAL AND FINAL PROVISIONS
                                             Article 270
                                              Repeals
1.      Decisions 78/642/EEC, 89/455/EEC and 90/678/EEC, and Directives 79/110/EEC,
        81/6/EEC, 90/423/EEC, 92/36/EEC and 98/99/EC are repealed.
2.      The following acts are repealed as from … *:
        –    Directive 64/432/EEC,
        –    Directive 77/391/EEC,
        –    Directive 78/52/EEC,
        –    Directive 80/1095/EEC,
        –    Directive 82/894/EEC,
        –    Directive 88/407/EEC,
        –    Directive 89/556/EEC,
*
      OJ. Please insert the date of application of this Regulation.
11779/15                                                            AS/NC/ra         466
                                              DGB 2B                                EN
 ---pagebreak---         – Directive 90/429/EEC,
        – Directive 91/68/EEC,
        – Decision 91/666/EEC,
        – Directive 92/35/EEC,
        – Directive 92/65/EEC,
        – Directive 92/66/EEC,
        – Directive 92/118/EEC,
        – Directive 92/119/EEC,
        – Decision 95/410/EC,
        – Directive 2000/75/EC,
        – Decision 2000/258/EC,
        – Directive 2001/89/EC,
        – Directive 2002/60/EC,
        – Directive 2002/99/EC,
11779/15                               AS/NC/ra  467
                                DGB 2B          EN
 ---pagebreak---         –     Directive 2003/85/EC,
        –     Regulation (EC) No 21/2004,
        –     Directive 2004/68/EC,
        –     Directive 2005/94/EC,
        –     Directive 2006/88/EC,
        –     Directive 2008/71/EC,
        –     Directive 2009/156/EC,
        –     Directive 2009/158/EC,
        –     Regulation (EU) No 576/2013.
        References to those repealed acts shall be construed as references to this Regulation and
        shall be read in accordance with the correlation table set out in Annex V hereto.
11779/15                                                                AS/NC/ra                 468
                                              DGB 2B                                            EN
 ---pagebreak---                                               Article 271
       Transitional measures related to the amendment of Regulation (EC) No 1760/2000
             and the repeal of Regulation (EC) No 21/2004 and Directive 2008/71/EC
1.      Notwithstanding Article 270(2) and Article 278 of this Regulation, Articles 1 to 10 of
        Regulation (EC) No 1760/2000, Regulation (EC) No 21/2004, and Directive 2008/71/EC,
        as well as the acts adopted on the basis thereof, shall continue to apply, instead of the
        corresponding Articles in this Regulation, until three years after the date of application of
        this Regulation or an earlier date to be determined in a delegated act adopted in accordance
        with paragraph 2 of this Article.
2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning the earlier date referred to in paragraph 1 of this Article.
        That date shall be the date of application of the corresponding rules to be adopted pursuant
        to the delegated acts provided for in Article 109(2) and Article 119 and the implementing
        acts provided for in Article 118 of this Regulation.
11779/15                                                                AS/NC/ra                   469
                                               DGB 2B                                             EN
 ---pagebreak---                                               Article 272
       Transitional measures related to the repeals of Directives 92/66/EEC, 2000/75/EC,
                      2001/89/EC, 2002/60/EC, 2003/85/EC and 2005/94/EC
1.      Notwithstanding Article 270(2) of this Regulation, Directives 92/66/EEC, 2000/75/EC,
        2001/89/EC, 2002/60/EC, 2003/85/EC and 2005/94/EC, as well as the acts adopted on the
        basis thereof, shall continue to apply, instead of the corresponding Articles in this
        Regulation, until three years after the date of application of this Regulation or an earlier
        date to be determined in a delegated act adopted in accordance with paragraph 2 of this
        Article.
2.      The Commission shall be empowered to adopt delegated acts in accordance with
        Article 264 concerning the earlier date referred to in paragraph 1 of this Article.
        That date shall be the date of application of the corresponding rules to be adopted pursuant
        to the delegated acts provided for in Article 47, Articles 48(3), 53(2), 54(3), 55(2)
        and 58(2), Article 63, Article 64(4), Article 67, and Articles 68(2) and 70(3) of this
        Regulation.
11779/15                                                                 AS/NC/ra                    470
                                               DGB 2B                                              EN
 ---pagebreak---                                                Article 273
                            Amendment of Regulation (EC) No 2160/2003
Regulation (EC) No 2160/2003 is amended as follows:
The following wording is added to the end of Article 9(3):
"Those special measures shall include measures based on the provisions contained in Decision
95/410/EC in its last version prior to its repeal and Commission Decisions 2003/644/EC* and
2004/235/EC** in the versions thereof at the time of the repeal of Directive 90/539/EEC.
____________________
*
         Commission Decision 2003/644/EC of 8 September 2003 establishing additional
         guarantees regarding salmonella for consignments to Finland and Sweden of breeding
         poultry and day-old chicks for introduction into flocks of breeding poultry or flocks of
         productive poultry (OJ L 228, 12.9.2003, p. 29).
**
         Commission Decision 2004/235/EC of 1 March 2004 establishing additional guarantees
         regarding salmonella for consignments to Finland and Sweden of laying hens (OJ L 72,
         11.3.2004, p. 86).".
11779/15                                                                AS/NC/ra                  471
                                                 DGB 2B                                          EN
 ---pagebreak---                                                 Article 274
  Transitional measures related to the date of adoption of certain delegated and implementing acts
Without prejudice to the date of application provided for in Article 283, the Commission shall adopt
the delegated acts referred to in the first subparagraph of Article 31(5), Articles 32(2), 39, 41(3),
54(3), 55(2), 58(2), 64(4), 67, 68(2), 74(4), 77(2) and 97(2), Article 122(2), and Articles 131(1),
132(2), 135, 137(2), 146(1), 149(4), 154(1), 162(3), 163(4), 166(3), 169(4), 181(2), 185(5), 213(1),
216(4), 221(1), 222(3), 224(3), 234(1), 239(1), and the implementing acts referred to in Articles 8
and 9, at the latest on … *. In accordance with Article 283, those delegated and implementing acts
shall apply from the date of application set out in that Article.
                                                Article 275
                                Prior review and amendments of Annex II
The Commission shall, at the latest by …*, review the list of diseases contained in Annex II. Should
it be apparent from that review that an application of the rules set out in this Regulation requires
amendments to be made to Annex II, by adding to or deleting from the list contained therein, such
amendments shall be adopted by the Commission at the latest by the deadline referred to in the first
sentence of this Article.
*
        OJ: Please insert the date: 24 months before the date of application provided for in
        Article 283.
11779/15                                                                  AS/NC/ra                    472
                                                 DGB 2B                                            EN
 ---pagebreak---                                                Article 276
                                                 Review
The Commission shall, by... * at the latest, review the existing legislation on the identification and
registration of kept animals of the equine species.
The Commission shall take the results of that review into account in the framework of the
application of Articles 118, 119 and 120.
                                               Article 277
      Transitional measures related to the repeal of Regulation (EU) No 576/2013 on the non–
                                  commercial movement of pet animals
Notwithstanding Article 270(2) of this Regulation, Regulation (EU) No 576/2013 shall continue to
apply until … ** in respect of non–commercial movements of pet animals, in place of Part VI of this
Regulation.
                                               Article 278
                             Amendments to Regulation (EC) No 1760/2000
Regulation (EC) No 1760/2000 is amended as follows:
(1)       Articles 1 to 10 are deleted;
*
        OJ: Please insert the date: 24 months before the date of application provided for in
        Article 283.
**
        OJ: Please insert the date: 10 years after the date of entry into force of this Regulation.
11779/15                                                                   AS/NC/ra                  473
                                                 DGB 2B                                             EN
 ---pagebreak--- (2)     Article 22 is replaced by the following:
        "Article 22
        1.    Member States shall take all the necessary measures to ensure compliance with the
              provisions of this Regulation.
              The controls provided for shall be without prejudice to any controls which the
              Commission may carry out pursuant to Article 9 of Regulation (EC, Euratom)
              No 2988/95.
              Any penalties imposed by the Member State on an operator or organisation
              marketing beef shall be effective, dissuasive and proportionate.
        2.    Notwithstanding paragraph 1, where operators and organisations marketing beef
              have labelled beef without complying with their obligations laid down in Title II,
              Member States shall, as appropriate, and in accordance with the principle of
              proportionality, require the removal of the beef from the market. In addition to the
              penalties referred to in paragraph 1, Member States may:
              (a)   if the meat concerned conforms with relevant veterinary and hygiene rules,
                    authorise that such beef:
                    (i)    be placed on the market after being properly labelled in accordance with
                           Union requirements; or
11779/15                                                               AS/NC/ra                   474
                                               DGB 2B                                           EN
 ---pagebreak---                  (ii)  be sent directly for processing into products other than those indicated in
                       point 1 of Article 12;
           (b)   order the suspension or withdrawal of the approval of the operators and
                 organisations concerned.
        3. Experts from the Commission, in conjunction with the competent authorities, shall:
           (a)   verify that Member States comply with the requirements of this Regulation;
           (b)   make on–the–spot checks to ensure that the checks are carried out in
                 accordance with this Regulation.
        4. A Member State in whose territory an on–the–spot check is carried out shall provide
           the experts from the Commission with any assistance they may require in the
           performance of their tasks. The outcome of the checks made shall be discussed with
           the competent authority of the Member State concerned before a final report is drawn
           up and circulated. That report shall, where appropriate, contain recommendations for
           Member States on the improvement of compliance with this Regulation.";
11779/15                                                            AS/NC/ra                   475
                                            DGB 2B                                            EN
 ---pagebreak--- (3)     Article 22b is replaced by the following:
        "Article 22b
        Exercise of the delegation
        1.    The power to adopt delegated acts is conferred on the Commission subject to the
              conditions under this Article.
        2.    The power to adopt delegated acts referred to in Articles 13(6), 14(4) and 15a shall
              be conferred on the Commission for a period of five years from... +. The Commission
              shall draw up a report in respect of the delegation of power not later than nine
              months before the end of the five-year period. The delegation of power shall be
              tacitly extended for periods of an identical duration, unless the European Parliament
              or the Council opposes such extension not later than three months before the end of
              each period.
        3.    The delegation of power referred to in Articles 13(6), 14(4) and 15a may be revoked
              at any time by the European Parliament or by the Council. A decision to revoke shall
              put an end to the delegation of the power specified in that decision. It shall take
              effect the day following the publication of the decision in the Official Journal of the
              European Union or at a later date specified therein. It shall not affect the validity of
              any delegated acts already in force.
        4.    As soon as it adopts a delegated act, the Commission shall notify it simultaneously to
              the European Parliament and to the Council.
+
      OJ: please insert the date of entry into force of this Regulation (the amending Regulation).
11779/15                                                                AS/NC/ra                    476
                                               DGB 2B                                              EN
 ---pagebreak---         5.    A delegated act adopted pursuant to Articles 13(6), 14(4) and 15a shall enter into
              force only if no objection has been expressed either by the European Parliament or
              the Council within a period of two months of notification of that act to the European
              Parliament and the Council or if, before the expiry of that period, the European
              Parliament and the Council have both informed the Commission that they will not
              object. That period shall be extended by two months at the initiative of the European
              Parliament or of the Council.";
(4)     Article 23 is replaced by the following:
        "Article 23
        Committee procedure
        1.    The Commission shall be assisted for the implementing acts adopted pursuant to
              Article 13(6) of this Regulation by the Standing Committee on Plants, Animals, Food
              and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the
              European Parliament and of the Council*.
              That committee shall be a committee within the meaning of Regulation (EU)
              No 182/2011 of the European Parliament and of the Council**.
        2.    Where reference is made to this paragraph, Article 5 of Regulation (EU)
              No 182/2011 shall apply.
11779/15                                                               AS/NC/ra                  477
                                              DGB 2B                                            EN
 ---pagebreak---               Where the opinion of the Committee is to be obtained by written procedure, that
              procedure shall be terminated without result when, within the time–limit for delivery
              of the opinion, the chair of the Committee so decides or a simple majority of
              committee members so requests.
        ___________
        *
              Regulation (EC) No 178/2002 of the European Parliament and of the Council
              of 28 January 2002 laying down the general principles and requirements of food law,
              establishing the European Food Safety Authority and laying down procedures in
              matters of food safety (OJ L 31, 1.2.2002, p. 1).
        **
              Regulation (EU) No 182/2011 of the European Parliament and of the Council
              of 16 February 2011 laying down the rules and general principles concerning
              mechanisms for control by Member States of the Commission's exercise of
              implementing powers (OJ L 55, 28.2.2011, p. 13).".
                                              Article 279
                               Existing operators and establishments
1.      Establishments and operators registered or approved in accordance with Directive
        64/432/EEC, Directive 88/407/EC, Directive 89/556/EC, Directive 90/429/EEC,
        Directive 91/68/EEC, Directive 92/65/EEC, Regulation (EC) No 1760/2000, Regulation
        (EC) No 21/2004, Directive 2006/88/EC, Directive 2008/71/EC, Directive 2009/156/EC or
        Directive 2009/158/EC before the date of application of this Regulation shall be deemed to
        be registered or approved, as required, in accordance with this Regulation and shall, as
        such, be subject to the relevant obligations provided for under this Regulation.
11779/15                                                               AS/NC/ra                  478
                                               DGB 2B                                           EN
 ---pagebreak--- 2.      The Commission shall be empowered to adopt delegated acts in accordance with Article
        264 concerning rules necessary to ensure a smooth transition from the rules existing prior
        to this Regulation referred to in paragraph 1 of this Article, in order in particular to protect
        acquired rights and legitimate expectations of natural and legal persons concerned.
                                               Article 280
                             Existing disease–free Member States, zones
     and compartments and existing Member State eradication and surveillance programmes
1.      Member States and zones with an approved disease–free status for one or more of the
        listed diseases referred to in points (b) and (c) of Article 9(1), for one or more of the
        relevant animal species, in accordance with Directive 64/432/EEC, Directive 91/68/EEC,
        Directive 92/65/EEC, Directive 2006/88/EC, Directive 2009/156/EC or
        Directive 2009/158/EC, shall be deemed to have an approved disease–free status in
        accordance with this Regulation and shall, as such, be subject to the relevant obligations
        provided for under this Regulation.
2.      Member States and zones with an approved eradication programme or surveillance
        programme for one or more of the listed diseases referred to in points (b) and (c) of Article
        9(1), for one or more of the relevant animal species, in accordance with Directive
        64/432/EEC, Directive 91/68/EEC, Directive 92/65/EEC, Directive 2006/88/EC, Directive
        2009/156/EC or Directive 2009/158/EC, shall be deemed to have an approved eradication
        programme in accordance with this Regulation and shall, as such, be subject to the relevant
        obligations provided for under this Regulation.
11779/15                                                                   AS/NC/ra                  479
                                                DGB 2B                                              EN
 ---pagebreak--- 3.       Approved compartments with an approved disease–free status for one or more of the listed
         diseases referred to in points (a), (b) or (c) of Article 9(1), in accordance with
         Directives 2005/94/EC and 2006/88/EC, shall be deemed to have a recognised disease-free
         status under Article 37 of this Regulation and shall, as such, be subject to the relevant
         obligations provided for under this Regulation.
4.       The Commission shall be empowered to adopt delegated acts in accordance with Article
         264 concerning rules necessary in order to ensure a smooth transition from the rules
         existing prior to this Regulation referred to in paragraphs 1, 2 and 3.
                                               Article 281
                             Relation with acts concerning official controls
In the event of any conflict between the provisions of this Regulation and the provisions of
Regulation (EC) No 882/2004, Council Directives 89/608/EEC 1, 89/662/EEC, 90/425/EEC,
91/496/EEC, 96/93/EC 2 and 97/78/EC and Decision 92/438/EEC, the provisions of this Regulation
shall prevail.
1
        Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the
        administrative authorities of the Member States and cooperation between the latter and the
        Commission to ensure the correct application of legislation on veterinary and zootechnical
        matters (OJ L 351, 2.12.1989, p. 34).
2
        Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal
        products (OJ L 13, 16.1.1997, p. 28).
11779/15                                                                     AS/NC/ra               480
                                                 DGB 2B                                            EN
 ---pagebreak---                                                 Article 282
                                                Evaluation
The Commission shall evaluate this Regulation together with the delegated acts referred to in
Article 264 and submit the results of the evaluation in a report to the European Parliament and to
the Council no later than … *.
                                                Article 283
                                     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 … **, except for Articles 270(1) and 274, which shall apply from the date of its
entry into force.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at …,
For the European Parliament                                     For the Council
The President                                                   The President
*
         OJ: Please insert the date: five years after the date of application of this Regulation.
**
         OJ: Please insert the date: five years from the date of entry into force of this Regulation.
11779/15                                                                    AS/NC/ra                  481
                                                  DGB 2B                                            EN
 ---pagebreak---                                               ANNEX I
                                        Species of pet animals
                                               PART A
Dogs (Canis lupus familiaris)
Cats (Felis silvestris catus)
Ferrets (Mustela putorius furo)
                                               PART B
Invertebrates (except bees, molluscs belonging to the phylum Mollusca and crustaceans belonging
to the subphylum Crustacea)
Ornamental aquatic animals
Amphibia
Reptiles
Birds: specimens of avian species other than fowl, turkeys, guinea fowl, ducks, geese, quails,
pigeons, pheasants, partridges and ratites (Ratitae).
Mammals: rodents and rabbits other than those intended for food production.
11779/15                                                              AS/NC/ra                   1
ANNEX I                                        DGB 2B                                          EN
 ---pagebreak---                                           ANNEX II
                                        List of diseases
–       Rinderpest (cattle plague)
–       Sheep and goat plague
–       Swine vesicular disease
–       Bluetongue
–       Teschen disease
–       Sheep pox or goat pox
–       Rift Valley fever
–       Lumpy skin disease
–       Vesicular stomatitis
–       Venezuelan equine viral encephalomyelitis
–       Haemorrhagic disease of deer
–       Contagious bovine pleuropneumonia
–       Newcastle disease
11779/15                                                 AS/NC/ra   1
ANNEX II                                    DGB 2B                EN
 ---pagebreak--- –       Bovine tuberculosis
–       Bovine brucellosis (B. abortus)
–       Ovine and caprine brucellosis (B. melitensis)
–       Anthrax
–       Rabies
–       Echinococcosis
–       Transmissible spongiform encephalopathies (TSE)
–       Campylobacteriosis
–       Listeriosis
–       Salmonellosis (zoonotic salmonella)
–       Trichinellosis
–       Verotoxigenic E. coli
–       Viral haemorrhagic septicæmia (VHS)
–       Infectious haematopoietic necrosis (IHN)
–       Epizootic haematopoietic necrosis in fish (EHN)
11779/15                                                AS/NC/ra   2
ANNEX II                                     DGB 2B              EN
 ---pagebreak--- –       Epizootic ulcerative syndrome in fish (EUS)
–       Infection with Bonamia exitiosa
–       Infection with Perkinsus marinus
–       Infection with Microcytos mackini
–       Taura syndrome in crustaceans
–       Yellowhead disease in crustaceans
–       Koi herpes virus disease (KHV)
–       Infectious salmon anaemia (ISA)
–       Infection with Marteilia refringens
–       Infection with Bonamia ostreae
–       White spot disease in crustaceans
11779/15                                            AS/NC/ra   3
ANNEX II                                     DGB 2B          EN
 ---pagebreak---                                   ANNEX III
                              Species of Ungulates
                                     Taxon
     Order           Family                        Genera/Species
Perissodactyla Equidae        Equus spp.
               Tapiridae      Tapirus spp.
               Rhinoceritidae Ceratotherium spp., Dicerorhinus spp., Diceros spp.,
                              Rhinoceros spp.
11779/15                                                  AS/NC/ra              1
ANNEX III                           DGB 2B                                   EN
 ---pagebreak---                                    Taxon
     Order         Family                          Genera/Species
Artiodactyla Antilocapridae Antilocapra ssp.
             Bovidae        Addax ssp., Aepyceros ssp., Alcelaphus ssp., Ammelaphus
                            ssp., Ammodorcas ssp., Ammotragus ssp., Antidorcas ssp.,
                            Antilope ssp., Arbitragus ssp., Beatragus ssp., Bison ssp.,
                            Bos ssp.(including Bibos, Novibos, Poephagus), Boselaphus
                            ssp., Bubalus ssp. (including Anoa), Budorcas ssp., Capra
                            ssp., Cephalophus ssp., Connochaetes ssp., Damaliscus
                            ssp.(including Beatragus), Dorcatragus ssp., Eudorcas ssp.,
                            Gazella ssp., Hemitragus ssp., Hippotragus ssp., Kobus
                            ssp., Litocranius ssp., Madoqua ssp., Naemorhedus ssp.
                            (including Nemorhaedus and Capricornis), Nanger ssp.,
                            Neotragus ssp., Nilgiritragus ssp., Oreamnos ssp.,
                            Oreotragus ssp., Oryx ssp., Ourebia ssp., Ovibos ssp., Ovis
                            ssp., Pantholops ssp., Philantomba ssp., Pelea ssp.,
                            Procapra ssp., Pseudois ssp., Pseudoryx ssp., Raphicerus
                            ssp., Redunca ssp., Rupicapra ssp., Saiga ssp., Sigmoceros–
                            Alecelaphus ssp., Strepticeros ssp., Sylvicapra ssp.,
                            Syncerus ssp., Taurotragus ssp., Tetracerus ssp.,
                            Tragelaphus ssp. (including Boocerus).
             Camelidae      Camelus ssp., Lama ssp., Vicugna ssp.
             Cervidae       Alces ssp., Axis–Hyelaphus ssp., Blastocerus ssp.,
                            Capreolus ssp., Cervus ssp., Dama ssp., Elaphodus ssp.,
                            Elaphurus ssp., Hippocamelus ssp., Hydropotes ssp.,
                            Mazama ssp., Megamuntiacus ssp., Muntiacus ssp.,
                            Odocoileus ssp., Ozotoceros ssp., Przewalskium ssp., Pudu
                            ssp., Rangifer ssp., Rucervus ssp., Rusa ssp.
             Giraffidae     Giraffa ssp., Okapia ssp.
             Hippopotamidae Hexaprotodon–Choeropsis ssp., Hippopotamus ssp.
             Moschidae      Moschus ssp.
             Suidae         Babyrousa ssp., Hylochoerus ssp., Phacochoerus ssp.,
                            Porcula ssp., Potamochoerus ssp., Sus ssp.
             Tayassuidae    Catagonus ssp., Pecari–Tayassu ssp.
             Tragulidae     Hyemoschus ssp., Tragulus–Moschiola ssp.
Proboscidea  Elephantidae   Elephas ssp., Loxodonta ssp.
11779/15                                                   AS/NC/ra                   2
ANNEX III                          DGB 2B                                         EN
 ---pagebreak---                                                  ANNEX IV
                  Criteria for the application of the disease prevention and control rules
                referred to in Article 9(1) to diseases listed in accordance with Article 5
The scope of this Annex is to detail the criteria to be considered by the Commission when
determining the disease prevention and control rules to be applied to the different categories of
diseases listed in accordance with Article 5.
The process of categorisation shall take into account the profile of the disease in question, the level
of the impact of that disease on animal and public health, animal welfare and the economy, and the
availability, feasibility and effectiveness of the diagnostic tools and different sets of disease
prevention and control measures provided for in this Regulation with respect to the disease.
                                                SECTION 1
              CRITERIA FOR THE APPLICATION OF THE DISEASE PREVENTION
             AND CONTROL RULES REFERRED TO IN POINT (A) OF ARTICLE 9(1)
The diseases for which the disease prevention and control rules referred to in point (a) of
Article 9(1) apply shall be considered to have the most severe animal health, public health,
economic, social or environmental impacts on the Union. Those diseases need to fulfil the following
criteria:
(a)       the disease in question is:
          (i)    not present in the territory of the Union;
11779/15                                                                   AS/NC/ra                     1
ANNEX IV                                           DGB 2B                                          EN
 ---pagebreak---          (ii)   present only in exceptional cases (irregular introductions); or
         (iii) present in only in a very limited part of the territory of the Union;
and
(b)      the disease in question is highly transmissible; in addition to direct and indirect
         transmission, there may also be possibilities of airborne, waterborne or vector–borne
         spread. The disease may affect multiple species of kept and wild animals, or a single
         species of kept animals of economic importance, and may result in high morbidity and
         significant mortality rates.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of
the following criteria:
(c)      the disease in question has a zoonotic potential with significant consequences for public
         health, including epidemic or pandemic potential or possible significant threats to food
         safety;
(d)      the disease in question has a significant impact on the economy of the Union, causing
         substantial costs, mainly related to its direct impact on the health and productivity of
         animals;
(e)      the disease in question has a significant impact on one or more of the following:
         (i)    society, with in particular an impact on labour markets;
11779/15                                                                    AS/NC/ra                    2
ANNEX IV                                           DGB 2B                                            EN
 ---pagebreak---          (ii)   animal welfare, by causing suffering to large numbers of animals;
         (iii) the environment, due to the direct impact of the disease or due to the measures taken
                to control it;
         (iv) in the long term, biodiversity or the protection of endangered species or breeds,
                including the possible disappearance of, or long-term damage to, those species or
                breeds.
                                              SECTION 2
              CRITERIA FOR THE APPLICATION OF THE DISEASE PREVENTION
            AND CONTROL RULES REFERRED TO IN POINT (B) OF ARTICLE 9(1)
The diseases for which the disease prevention and control rules referred to in point (b) of
Article 9(1) apply shall be controlled in all Member States with the goal of eradicating them
throughout the Union.
Those diseases need to fulfil the following criteria:
(a)      the disease in question is endemic in nature and is present in the whole or part of the Union
         territory. However, several Member States or zones of the Union are free of the disease;
         and
11779/15                                                                 AS/NC/ra                    3
ANNEX IV                                        DGB 2B                                            EN
 ---pagebreak--- (b)      the disease is moderately to highly transmissible; in addition to direct and indirect
         transmission, there may also be possibilities of airborne, waterborne or vector–borne
         spread. It may affect single or multiple animal species and may result in high morbidity,
         with in general low mortality.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of
the following criteria:
(c)      the disease in question has a zoonotic potential with significant consequences for public
         health, including epidemic potential or possible significant threats to food safety;
(d)      the disease in question has a significant impact on the economy of the Union causing
         substantial costs, mainly related to its direct impact on the health and productivity of
         animals;
(e)      the disease has a significant impact on one or more of the following:
         (i)    society, with in particular an impact on labour markets;
         (ii)   animal welfare, by causing suffering to large numbers of animals;
         (iii) the environment, due to the direct impact of the disease or due to the measures taken
                to control it;
         (iv) in the long term, biodiversity or the protection of endangered species or breeds,
                including the possible disappearance of, or long-term damage to, those species or
                breeds.
11779/15                                                                    AS/NC/ra                    4
ANNEX IV                                           DGB 2B                                            EN
 ---pagebreak--- A disease to which the measures referred to in point (a) of Article 9(1) apply, which has not been
successfully and promptly eradicated in a part of the Union, and has, in that part of the Union,
obtained an endemic character, may be subject to disease prevention and control measures under
point (b) of Article 9(1), in that part of the Union.
                                                 SECTION 3
               CRITERIA FOR THE APPLICATION OF THE DISEASE PREVENTION
             AND CONTROL RULES REFERRED TO IN POINT (C) OF ARTICLE 9(1)
The diseases for which the disease prevention and control rules referred to in point (c) of Article
9(1) apply are of relevance to some Member States and measures are needed to prevent them from
spreading to parts of the Union that are officially disease-free or that have eradication programmes
for the listed disease in question.
Those diseases need to fulfil the following criteria:
(a)       in terrestrial animals, the disease in question is endemic in nature and is present in the
          whole or part of the Union territory; or in aquatic animals, several Member States or zones
          of the Union are free of the disease; and
(b)       (i)    in terrestrial animals, the disease in question is moderately to highly transmissible,
                 mainly through direct and indirect transmission. The disease mainly affects multiple
                 or single animal species, usually does not result in high morbidity, and has a
                 negligible or no mortality rate. Often the most observed effect is production loss;
11779/15                                                                   AS/NC/ra                     5
ANNEX IV                                           DGB 2B                                            EN
 ---pagebreak---          (ii)   in aquatic animals, the disease is moderately to highly transmissible, mainly through
                direct and indirect transmission. The disease affects multiple or single animal species
                and may result in high morbidity and usually low mortality. Often the most observed
                effect is production loss.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of
the following criteria:
(c)      the disease in question has a zoonotic potential with significant consequences for public
         health, or possible threats to food safety;
(d)      the disease in question has a significant impact on the economy of parts of the Union,
         mainly related to its direct impact on certain types of animal production systems.
(e)      the disease in question has a significant impact on one or more of the following:
         (i)    society, with, in particular, an impact on labour markets;
         (ii)   animal welfare, by causing suffering to large numbers of animals;
         (iii) the environment, due to the direct impact of the disease or of the measures taken to
                control it;
         (iv) in the long term, biodiversity or the protection of endangered species or breeds,
                including the possible disappearance of, or long-term damage to, those species or
                breeds.
11779/15                                                                    AS/NC/ra                    6
ANNEX IV                                           DGB 2B                                            EN
 ---pagebreak---                                                 SECTION 4
             CRITERIA FOR THE APPLICATION OF THE DISEASE PREVENTION
            AND CONTROL RULES REFERRED TO IN POINT (D) OF ARTICLE 9(1)
The disease prevention and control rules referred to in point (d) of Article 9(1) shall apply to
diseases that fulfil the criteria set out in Section 1, 2 or 3 and to other diseases fulfilling the criteria
set out in Section 5 where the risk posed by the disease in question can be effectively and
proportionately mitigated by measures concerning movements of animals and products in order to
prevent or limit its occurrence and spread.
                                                SECTION 5
             CRITERIA FOR THE APPLICATION OF THE DISEASE PREVENTION
            AND CONTROL RULES REFERRED TO IN POINT (E) OF ARTICLE 9(1)
The disease prevention and control rules referred to in point (e) of Article 9(1) shall apply to
diseases that fulfil the criteria set out in Sections 1, 2 or 3 and to other diseases where surveillance
of the disease is necessary for reasons relating to animal health, animal welfare, human health, the
economy, society or the environment.
11779/15                                                                     AS/NC/ra                        7
ANNEX IV                                           DGB 2B                                               EN
 ---pagebreak---                                             ANNEX V
                                         Correlation table
                                   referred to in Article 270 (2)
1.        Directive 64/432/EEC
              Directive 64/432/EEC                                   This Regulation
Article 1                                          –
Article 2                                          Articles 4 (partially), 21, 153(3) and 220(3)
Article 3(1)                                       Articles 124 and 126
Article 3(2)                                       Articles 124 (2), 126(1) and 149(3) and (4)
Article 4(1)                                       Article 126(1)(c)
Article 4(2) and (3)                               Article 125(1) and (2)
Article 5(1)                                       Articles 143(1), 145 and 146
Article 5(2)                                       Article 149(3) and (4)
Article 5(2)(a)                                    Article 147(a)
Article 5(2)(b)                                    Article 144(1)(b)
Article 5(3)                                       –
Article 5(4)                                       Article 153(1) and (2)
Article 5(5)                                       Article 147(a)
Article 6                                          Articles 130, 131 and 132
Article 6a                                         –
Article 7                                          Articles 126(1)(c),132, 134(a) and 135
Article 8                                          Articles 18, 19, 20 and 23(a)
Article 9                                          Articles 31(1), (3)(a) and (5), 32, 33 and 36
Article 10                                         Articles 31(2) and (3)(b), 32, 33 and 36
Article 11(1)                                      Articles 94(1)(a), 97 and 98
Article 11(2)                                      Articles 102, 106 and 107
11779/15                                                                AS/NC/ra                   1
ANNEX V                                       DGB 2B                                             EN
 ---pagebreak---               Directive 64/432/EEC                     This Regulation
Article 11(3)                         Articles 98 and 99
Article 11(4)                         Article 100
Article 11(5) and (6)                 Article 97(1)(d) and (2)(d)
Article 12(1)                         Article 125
Article 12(2)                         Articles 104 and 106
Article 12(3)                         Article 125(1)(a) and (b)
Article 12(4)                         Article 143
Article 12(5) and (6)                 –
Article 13(1) and (2)                 Articles 90, 92, 93(c), 94, 97, 98, 99, 102, 106
                                      and 107
Article 13(3)                         Article 100
Article 13(4)                         –
Article 13(5) and (6)                 Article 101
Article 14(1) and (2)                 –
Article 14(3)A and B                  –
Article 14(3)C                        Article 109(1)(a) and (c)
Article 14(4) to (6)                  –
Article 15(1)                         Article 268
Article 15(2) to (4)                  –
Article 16                            –
Article 17                            –
Article 17a                           –
Article 18                            Article 109(1)(a) and (c)
Article 19                            –
Article 20                            –
11779/15                                                  AS/NC/ra                     2
ANNEX V                            DGB 2B                                           EN
 ---pagebreak--- 2.        Directive 77/391/EEC
              Directive 77/391/EEC                     This Regulation
Article 1                             –
Article 2(1)                          Article 31(1)
Article 2(2)                          Articles 32, 33 and 36(1)
Article 2(3)                          Article 34
Article 2(4)                          Articles 36 and 41
Article 3(1)                          Article 31(1)
Article 3(2)                          Articles 32, 33 and 36(1)
Article 3(3)                          Article 34
Article 3(4)                          Articles 36 and 41
Article 4                             Articles 31(1), 32, 33, 34, 36 and 41
Article 5                             –
Article 6                             –
Article 7                             –
Article 8                             –
Article 9                             –
Article 10                            –
Article 11                            –
Article 12                            –
Article 13                            –
Article 14                            –
Article 15                            –
11779/15                                                  AS/NC/ra            3
ANNEX V                            DGB 2B                                   EN
 ---pagebreak--- 3.        Directive 78/52/EEC
               Directive 78/52/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3(1)                          Articles 31(1) and 32
Article 3(2)                          –
Article 3(3)                          –
Article 3(4)                          Articles 31(1) and 32
Article 4                             Articles 32,35, 102(2) and (4) and 112
Article 5                             Articles 18, 46 and 47
Article 6(1)                          Articles 72 to 76
Article 6(2)                          Articles 77 and 78
Article 6(3)                          Articles 79 and 80
Article 7                             Articles 79 and 80
Article 8                             Articles 79 and 80
Article 9                             Articles 79 and 80
Article 10                            Articles 79 and 80
Article 11                            Articles 79 and 80
Article 12                            Articles 79 and 80
Article 13                            Articles 18, 46 and 47
Article 14(1)                         Articles 72 to 76
Article 14(2)                         Articles 77 and 78
Article 14(3)                         Articles 79 and 80
Article 15                            Articles 79 and 80
Article 16                            Articles 79 and 80
Article 17                            Articles 79 and 80
Article 18                            Articles 79 and 80
11779/15                                                   AS/NC/ra            4
ANNEX V                            DGB 2B                                    EN
 ---pagebreak---            Directive 78/52/EEC                     This Regulation
Article 19                        Articles 79 and 80
Article 20                        Articles 79 and 80
Article 21                        –
Article 22                        Articles 18, 19, 20, 46 and 47
Article 23                        Articles 79 and 80
Article 24                        Articles 79 and 80
Article 25                        Articles 79 and 80
Article 26                        Articles 79 and 80
Article 27                        Articles 124(1) and 126(1)(c)
Article 28                        –
Article 29                        –
Article 30                        –
11779/15                                              AS/NC/ra       5
ANNEX V                        DGB 2B                              EN
 ---pagebreak--- 4.        Directive 80/1095/EEC
              Directive 80/1095/EEC                      This Regulation
Article 1                              Articles 31(1) and 36
Article 2                              Article 4 (partially)
Article 3                              Articles 31(1) and 35
Article 3a                             Articles 31(1) and 35
Article 4                              Articles 32, 33 and 35
Article 4a                             Articles 32, 33 and 35
Article 5                              –
Article 6                              Articles 31(1)(b), 31(3) and 32
Article 7                              Articles 36, 39 and 40
Article 8                              Articles 41 and 42
Article 9                              –
Article 11                             –
Article 12                             –
Article 12a                            –
Article 13                             –
11779/15                                                    AS/NC/ra       6
ANNEX V                             DGB 2B                               EN
 ---pagebreak--- 5.        Directive 82/894/EEC
              Directive 82/894/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 19, 21, 22 and 23
Article 4                             Articles 19, 20, 21, 22 and 23
Article 5                             Article 23
Article 6                             –
Article 7                             –
Article 8                             –
11779/15                                                   AS/NC/ra       7
ANNEX V                            DGB 2B                               EN
 ---pagebreak--- 6.        Directive 88/407/EEC
              Directive 88/407/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 159 and 160
Article 4                             Article 160
Article 5                             Articles 94, 97, 100 and 101
Article 6(1)                          Articles 161 and 162
Article 6(2), (3) and (4)             Article 258
Article 8                             Articles 229(1)(a) and 230
Article 9                             Articles 229(1)(b) and 233
Article 10                            Articles 229(1)(c), 234 and 236
Article 11                            Articles 229(1)(d), 237 and 238
Article 12                            Articles 260 to 262
Article 15                            Articles 257 to 259
Article 16                            –
Article 17                            –
Article 18                            –
Article 20                            –
Article 21                            –
Article 22                            –
11779/15                                                   AS/NC/ra       8
ANNEX V                            DGB 2B                               EN
 ---pagebreak--- 7.        Directive 89/556/EEC
              Directive 89/556/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Article 159, 160, 161
Article 5(1)                          Articles 94 and 97
Article 5(2)                          Article 101
Article 5(2a) and (3)                 Articles 97, 98 and 100
Article 6                             Articles 161 and 162
Article 7                             Articles 229(1)(a) and 230
Article 8                             Articles 229(1)(b) and 233
Article 9                             Articles 229(1)(c), 234 and 236
Article 10                            Articles 229(1)(d), 237 and 238
Article 11                            Articles 260 to 262
Article 14                            Articles 257 to 259
Article 15                            –
Article 16                            –
Article 17                            –
Article 18                            –
Article 19                            –
Article 20                            –
Article 21                            –
11779/15                                                   AS/NC/ra       9
ANNEX V                            DGB 2B                               EN
 ---pagebreak--- 8.        Directive 90/429/EEC
              Directive 90/429/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 159 and 160
Article 4                             –
Article 5(1)                          Articles 94, 97, 98 and 100
Article 5(2)                          Article 101
Article 6(1)                          Articles 161 and 162
Article 6(2)                          Article 258
Article 7                             Articles 229(1)(a) and 230
Article 8                             Articles 229(1)(b) and 233
Article 9                             Articles 229(1)(c), 234 and 236
Article 10                            Article 229(1)(d), 237 and 238
Article 11(1)                         Article 229
Article 11(2) and (3)                 Article 260
Article 12                            Article 237
Article 13                            –
Article 14                            –
Article 15                            Articles 257 to 262
Article 16                            –
Article 17                            –
Article 18                            –
Article 19                            –
Article 20                            –
Article 21                            –
Article 22                            –
11779/15                                                   AS/NC/ra      10
ANNEX V                            DGB 2B                               EN
 ---pagebreak--- 9.        Directive 91/68/EEC
               Directive 91/68/EEC                      This Regulation
Article 1                             –
Article 2                             Articles 4 (partially), 21, 153(3) and 220(3)
Article 3(1), (2), (3) and (5)        Articles 126(1)(b), 130 and 131
Article 3(4)                          Article 139
Article 4(1)                          Articles 124(2)(b), 126(1), 130, 131 and 149(3)
                                      and (4)(a) and (b)
Article 4(2)                          Article 128
Article 4(3)                          Article 131
Article 4a                            Articles 130 and 131
Article 4b(1) and (2)                 Articles 130 and 131
Article 4b(3)                         Article 126(2)
Article 4b(4)                         Article 133
Article 4b(5)                         Article 132
Article 4b(6)                         Articles 124(1), 125 and 126(1)(b)
Article 4c(1) and (2)                 Articles 130 and 131
Article 4c(3)                         Articles 133 and 135
Article 5                             Article 131
Article 6                             Articles 131and 145(1)(e)
Article 7(1) to (3)                   Articles 31, 32, 33 and 35
Article 7(4)                          –
Article 8(1) to (3)                   Articles 36, 39 and 40
Article 8(4)                          –
Article 8a(1)                         Articles 94(1)(a), 97, 98 and 134
Article 8a(2)                         Article 102 and 106
Article 8a(3)                         Articles 98, 99 and 101
11779/15                                                   AS/NC/ra                  11
ANNEX V                            DGB 2B                                           EN
 ---pagebreak---                Directive 91/68/EEC                     This Regulation
Article 8a(4)                         Article 100
Article 8a(5)                         Article 97(1)(d) and (2)(d)
Article 8b(1)                         Articles 84, 90, 92, 93(c), 94(1)(a), 97, 98, 102,
                                      105 and 134
Article 8b(2)                         Articles 94(1)(a), 97 and 98
Article 8b(3)                         Article 100
Article 8b(4)                         –
Article 8c(1)                         Articles 87 and 125
Article 8c(2)                         Article 104
Article 8c(3)                         Articles 125(1)(a) and 126(1)(b)
Article 8c(4) and (5)                 –
Article 9(1) to (4)                   Articles 143, 145, 146, 147, 148, 149 and 153
Article 9(7)                          Article 153
Article 10                            –
Article 11                            –
Article 12                            Article 144(b)
Article 14                            –
Article 15                            –
Article 17                            –
Article 18                            –
11779/15                                                  AS/NC/ra                     12
ANNEX V                            DGB 2B                                           EN
 ---pagebreak--- 10.       Decision 91/666/EEC
            Decision 91/666/EEC                 This Regulation
Article 1                        Article 48(1) and (3)
Article 2                         –
Article 3                        Article 48
Article 4                        Articles 48, 49 and 50
Article 5                        Articles 48(3) and 50
Article 6                        Articles 16 and 48(2)(c) and (3)(b)
Article 7                        Articles 48(3) and 50
Article 8                        –
Article 9                        –
Article 10                       –
Article 11                       –
Article 12                       –
11779/15                                                AS/NC/ra      13
ANNEX V                         DGB 2B                               EN
 ---pagebreak--- 11.       Directive 92/35/EEC
             Directive 92/35/EEC                  This Regulation
Article 1                         –
Article 2                         Article 4 (partially)
Article 3                         Article 18
Article 4                         Articles 53 to 57 and 59
Article 5                         Articles 46 and 47
Article 6                         Articles 60 to 68
Article 7(1)                      Article 57
Article 7(2)                      Article 43(2)(d)
Article 8                         Article 64
Article 9                         Articles 65, 66 and 67
Article 10                        Articles 65, 66 and 67
Article 11                        Articles 67 and 68
Article 12                        Article 71(1)
Article 13                        Article 65(2)
Article 14                        –
Article 15                        –
Article 16                        –
Article 17                        Articles 43 and 44
Article 18                        –
Article 19                        –
Article 20                        –
Article 21                        –
Article 22                        –
11779/15                                                 AS/NC/ra  14
ANNEX V                          DGB 2B                           EN
 ---pagebreak--- 12.       Directive 92/65/EEC
               Directive 92/65/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 170, 171 and 269
Article 4                             Articles 124, 126, 18, 31, 84, 93(a) and 151
Article 5                             Articles 95, 97,136, 137, 143, 144 and 149
Article 6(A)                          Articles 124, 126, 130, 131, 137, 140 and 143 to
                                      146
Article 6(B)                          –
Article 7(A)                          Articles 124, 126, 130, 131, 137, 140 and 143 to
                                      146
Article 7(B)                          –
Article 8                             Articles 124, 126, 136 and 143 to 146
Article 9                             Articles 124, 126, 136 and 143 to 146
Article 10(1) to (4)                  Articles 124, 126, 136 and 143 to 146
Article 10(5) to (7)                  –
Article 10a                           –
Article 11(1)                         Article 157
Article 11(2) and (3)                 Articles 157, 159, 160 and 143 to 146
Article 11(4)                         Articles 97 and 101
Article 11(5)                         Article 164
Article 12(1)                         –
Article 12(2)                         Articles 257 to 259
Article 12(3)                         Articles 84, 90, 92, 93(c), 102 and 106
Article 12(4)                         Articles 143 to 149 and 152 to 154
Article 12(5)                         –
Article 12(6)                         Article 268
11779/15                                                   AS/NC/ra                 15
ANNEX V                            DGB 2B                                          EN
 ---pagebreak---                Directive 92/65/EEC                     This Regulation
Article 13(1)                         Articles 136, 143 to 149 and 151
Article 13(2)                         Articles 95, 97 and 98 to 101
Article 14                            Articles 31, 32 and 33
Article 15                            Articles 36, 39, 40 and 41
Article 16                            Articles 229(1) and 234(1)
Article 17(1)                         Article 229(1)
Article 17(2)                         Articles 229(1)(a), 230 and 233
Article 17(3)                         Articles 230, 233 and 234
Article 17(4)                         Article 230
Article 17(5) and (6)                 –
Article 18(1), first line             Article 237
Article 18(1), 2nd to 4th line        –
Article 18(2)                         Article 236(3)
Article 19                            Articles 234 and 239
Article 20                            Articles 229(2) and 260 to 262
Article 21                            Articles 144, 146, 162(4) and (5), 209, 211
                                      and 213
Article 22                            –
Article 23                            Articles 140 and 205
Article 24                            Articles 229(1)(d), 237 and 239(2)
Article 25                            –
Article 26                            –
Article 27                            –
Article 28                            –
Article 29                            –
Article 30                            –
11779/15                                                  AS/NC/ra                 16
ANNEX V                            DGB 2B                                         EN
 ---pagebreak--- 13.       Directive 92/66/EEC
               Directive 92/66/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Article 18
Article 4                             Articles 53 to 56 and 59
Article 5                             Articles 60 to 63
Article 6                             Article 63
Article 7                             Articles 57 and 43(2)(d)
Article 8                             Articles 55 and 56
Article 9(1)                          Article 64
Article 9(2) to (7)                   Articles 65 to 68
Article 10                            Articles 65, 66 and 67
Article 11                            Articles 67(b) and 68(1)(b) and (2)(a)
Article 12                            Articles 54, 61(1)(h) and 63(c)
Article 13                            Article 65(2)
Article 14                            –
Article 15                            –
Article 16                            Articles 46, 47 and 69
Article 17                            Article 47
Article 18                            Articles 65(1)(e), 67(a) and 69
Article 19(1) to (3)                  Articles 53 to 56 and 59
11779/15                                                   AS/NC/ra           17
ANNEX V                            DGB 2B                                    EN
 ---pagebreak---               Directive 92/66/EEC                     This Regulation
Article 19(4)                        Articles 57 and 60 to 63
Article 19(5)                        Article 71(2)
Article 20                           –
Article 21                           Articles 43 and 44
Article 22                           –
Article 23                           –
Article 24                           –
Article 25                           –
Article 26                           –
Article 27                           –
11779/15                                                AS/NC/ra       18
ANNEX V                           DGB 2B                              EN
 ---pagebreak--- 14.       Directive 92/118/EEC
              Directive 92/118/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 166, 222, 227(c)(iv) and 228
Article 4(1)                          Articles 166, 222, 227(c)(iv) and 228
Article 4(2)                          –
Article 5                             Articles 166 and 222
Article 6                             Article 16(1)(b) and (2)(b)
Article 7(1)                          –
Article 7(2)                          Articles 257 to 259
Article 7(3) and (4)                  –
Article 7(5)                          Article 268
Article 8                             –
Article 9                             Articles 229 and 234
Article 10(1) to (4) and (6)          Articles 229, 234, 237 and 239
Article 10(5)                         –
Article 11                            Article 239(2)(c)(ii)
Article 12                            –
Article 13                            Article 239(2)(c)(i)
Article 14                            –
Article 15                            –
Article 16                            Article 239(2)(c)(v)
Article 17                            –
Article 18                            –
Article 19                            –
Article 20                            –
11779/15                                                   AS/NC/ra          19
ANNEX V                            DGB 2B                                   EN
 ---pagebreak--- 15.       Directive 92/119/EEC
              Directive 92/119/EEC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Article 18
Article 4                             Articles 53 to 57 and 59
Article 5                             Articles 60 to 63
Article 6                             Articles 70 and 71(2)
Article 7                             Article 63
Article 8                             Articles 57 and 43(2)(d)
Article 9                             Articles 55 and 57
Article 10                            Articles 64 and 71(3)
Article 11                            Articles 65 to 68 and 71(2)
Article 12                            Articles 65 to 68 and 71(2)
Article 13                            Article 67(a)
Article 14                            Articles 65(2) and 71(1) and (3)
Article 15                            –
Article 16                            Articles 63(b), 67(b) and 68(1)(b) and (2)(a)
Article 17                            –
Article 18                            –
Article 19                            Articles 46, 47 and 69
11779/15                                                   AS/NC/ra                 20
ANNEX V                            DGB 2B                                         EN
 ---pagebreak---            Directive 92/119/EEC                     This Regulation
Article 20                         Articles 43 and 44
Article 21                         –
Article 22                         –
Article 23                         –
Article 24                         –
Article 25                         –
Article 26                         –
Article 27                         –
Article 28                         –
11779/15                                              AS/NC/ra       21
ANNEX V                         DGB 2B                              EN
 ---pagebreak--- 16.       Decision 95/410/EEC
              Decision 95/410/EEC                     This Regulation
Article 1                            Articles 130 to 132 and 273
Article 2                            Article 131(1)(c)
Article 3                            Articles 143, 145 and 146
Article 4                            –
Article 5                            –
Article 6                            –
11779/15                                                AS/NC/ra       22
ANNEX V                           DGB 2B                              EN
 ---pagebreak--- 17.       Directive 2000/75/EC
              Directive 2000/75/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Article 18
Article 4(1) and (2)                  Articles 54 and 55
Article 4(3)                          Article 53
Article 4(4)                          Article 56
Article 4(5)                          Article 70
Article 4(6)                          Article 59
Article 5                             Articles 46 and 47
Article 6                             Articles 60 to 64, 71(2) and 69
Article 7                             Article 57
Article 8                             Articles 64, 68 and 71(3)
Article 9                             Articles 65, 67, 69 and 71(3)
Article 10(1)                         Articles 65 and 67
Article 10(2)                         Articles 46 and 47
Article 11                            –
Article 12                            Article 71(3)
Article 13                            Article 71(1)
Article 14                            Article 65(2)
11779/15                                                   AS/NC/ra      23
ANNEX V                            DGB 2B                               EN
 ---pagebreak---            Directive 2000/75/EC                     This Regulation
Article 15                         –
Article 16                         –
Article 17                         –
Article 18                         Articles 43 and 44
Article 19                         –
Article 20                         –
Article 21                         –
Article 22                         –
Article 23                         –
11779/15                                              AS/NC/ra       24
ANNEX V                         DGB 2B                              EN
 ---pagebreak--- 18.       Regulation (EC) No 1760/2000
         Regulation (EC) No 1760/2000                       This Regulation
Article 1                                 Article 108
Article 2                                 Article 4 (partially)
Article 3                                 Articles 108(3) and 111
Article 4                                 Articles 112(a), 118, 119 and 120
Article 4a                                Article 118(1)(a) and (2)(a)
Article 4b                                Article 118(2)(e)
Article 4c                                Article 118(1)(a) and (2)(a)
Article 4d                                Article 118(1)(a)
Article 5                                 Articles 109(1)(a) and 118(1)(b)
Article 6                                 Articles 110(1)(b), 112(b) and118(1)(c)
Article 6a                                Article 110(2)
Article 7(1)                              Articles 102, 106, 107 and 112(d)
Article 7(2)                              Article 118(2)(a)
Article 7(3) and (4)                      Article 102(3)
Article 7(5)                              Article 102(4)
Article 7(6)                              Article 106
Article 9a                                Articles 11 and 13(2)
Article 10(a) to (c)                      Articles 118, 119 and 120
Article 10(d) and (e)                     –
Article 10(f)                             Article 270
Article 11                                –
Article 12                                –
Article 13                                –
Article 14                                –
Article 15                                –
Article 15a                               –
11779/15                                                       AS/NC/ra            25
ANNEX V                                DGB 2B                                     EN
 ---pagebreak---          Regulation (EC) No 1760/2000        This Regulation
Article 22                               –
Article 22a                              –
Article 22b                              –
Article 23                               –
Article 23a                              –
Article 23b                              –
Article 24                               –
Article 25                               –
11779/15                                       AS/NC/ra       26
ANNEX V                               DGB 2B                 EN
 ---pagebreak--- 19.       Directive 2001/89/EC
              Directive 2001/89/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 18, 19, 20 and 23
Article 4                             Articles 54 to 56 and 59
Article 5                             Articles 60 to 63 and 71(2) and (3)
Article 6                             Articles 63 and 71
Article 7                             Articles 62, 63, 65(1)(b) and 67
Article 8                             Article 57
Article 9                             Article 64
Article 10                            Articles 65 to 68
Article 11                            Articles 65 to 68
Article 12                            Articles 61(1)(f), 63(b), 65(1)(f), 67(b) and
                                      68(1)(b) and (2)(a)
Article 13                            Articles 61(3), 63(d) and 68(2)(a) and (c)
Article 14                            Articles 62 and 63
Article 15                            Article 70
Article 16                            Article 70 and Articles 31 to 35
Article 17                            Articles 16, 17(2), 54(2) and (3), 58(2), 61(1)(g)
                                      and (h), 63(c), 65(1)(b) and 67(c)
Article 18                            Articles 16, 46 47, 48 and 52
Article 19                            Articles 65(1)(e), 67 and 69
Article 20                            Article 70
Article 21                            –
Article 22                            Articles 43 and44
Article 23                            Articles 43(2)(d) and 44
Article 24                            –
Article 25                            –
11779/15                                                   AS/NC/ra                   27
ANNEX V                            DGB 2B                                           EN
 ---pagebreak---            Directive 2001/89/EC        This Regulation
Article 26                         –
Article 27                         –
Article 28                         –
Article 29                         –
Article 30                         –
Article 31                         –
Article 32                         –
11779/15                                 AS/NC/ra       28
ANNEX V                         DGB 2B                 EN
 ---pagebreak--- 20.       Directive 2002/60/EC
              Directive 2002/60/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 18, 19, 20 and 23
Article 4                             Articles 54 to 56 and 59
Article 5                             Articles 60 to 63 and 71(2) and (3)
Article 6                             Articles 63 and 71
Article 7                             Articles 62 and 63
Article 8                             Article 57
Article 9                             Article 64
Article 10                            Articles 65 to 68
Article 11                            Articles 65 to 68
Article 12                            Article 61(1)(f), 63(b), 65(1)(f), 67(b) and
                                      68(1)(b)
Article 13                            Articles 61(3), 63(d) and 68(2)(a) and (c)
Article 14                            Articles 62 and 63
Article 15                            Article 70
Article 16                            Article 70 and Articles 31 to 35
Article 17(1)                         Articles 61(f), 63, 65(1)(f) and (i), and 67(a) and
                                      (d)
Article 17(2) and (3)                 Article 71(2) and (3)
11779/15                                                   AS/NC/ra                    29
ANNEX V                            DGB 2B                                           EN
 ---pagebreak---            Directive 2002/60/EC                     This Regulation
Article 18                         Articles 16, 17(2), 54(2) and (3), 58(2), 61(1)(g)
                                   and (h), 63(c), 65(1)(b) and 67(c)
Article 19                         Articles 16, 46 and 47
Article 20                         –
Article 21                         Articles 43 and 44
Article 22                         Articles 43(2)(d) and 44
Article 23                         –
Article 24                         –
Article 25                         –
Article 26                         –
Article 27                         –
Article 28                         –
Article 29                         –
Article 30                         –
11779/15                                               AS/NC/ra                    30
ANNEX V                         DGB 2B                                          EN
 ---pagebreak--- 21.       Directive 2002/99/EC
              Directive 2002/99/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 166, 222 and 227(c)(iv)
Article 4                             Articles 65(1)(c),(d), (g),(h) and (i), 67, 166,
                                      222, 227(c)(iv) and 228(1)(d)
Article 5                             Articles 167, 168, 223, 224 and 227(d)(iii)
Article 6                             –
Article 7                             Article 234(1) and (2)
Article 8                             Articles 230, 231 and 232
Article 9                             Articles 237 and 238
Article 10                            –
Article 11                            –
Article 12                            –
Article 13                            –
Article 14                            –
Article 15                            –
Article 16                            –
11779/15                                                   AS/NC/ra                    31
ANNEX V                            DGB 2B                                            EN
 ---pagebreak--- 22.       Directive 2003/85/EC
              Directive 2003/85/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Articles 18, 19, 20 and 23
Article 4                             Articles 54 to 56
Article 5                             Article 55(1)(d),(e) and (2)
Article 6                             Articles 55(1)(f)(i) and (2), and 56(b)
Article 7                             Article 55(1)(f)(ii)
Article 8                             Article 55(1)(f) and (2)
Article 9                             Article 59
Article 10                            Articles 60, 61 and 63
Article 11                            Articles 61(1)(f), 63(b), 65(1)(f), 67(b)
                                      and 68(1)(b)
Article 12                            Article 65(1)(d), (h) and (i) and Article 67
Article 13                            Article 57
Article 14                            Articles 61 to 63
Article 15                            Articles 61 to 63, 70 and 71(2)
Article 16                            Articles 61, 62 and 63
Article 17                            Article 71
Article 18                            Articles 61 and 63
Article 19                            Articles 62 and 63
Article 20                            Article 71
11779/15                                                   AS/NC/ra                 32
ANNEX V                            DGB 2B                                          EN
 ---pagebreak---            Directive 2003/85/EC                     This Regulation
Article 21                         Articles 43(2)(d), 64, 65(1)(d), (h) and (i) and
                                   (2) and 67
Article 22                         Articles 65 to 67
Article 23                         Articles 65 to 67
Article 24                         Articles 67 and 71(1)
Article 25                         Articles 65(1)(c), (d)(i), (g), (h) and (i) and 67
Article 26                         Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and
                                   166
Article 27                         Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and
                                   166
Article 28                         Articles 65(1)(c) and (d)(iii) and Article 67
Article 29                         Articles 65(1)(c) and (d)(ii) and 67
Article 30                         Articles 65(1)(c) and (d)(ii) and (iii) and 67
Article 31                         Articles 65(1)(c) and (d)(ii) and 67
Article 32                         Articles 65(1)(c) and (d) and 67
Article 33                         Article 65(1)(c)(d)(ii) and 67
Article 34                         Articles 67, 143(2), 161(2) and 167(1)(b)
Article 35                         Article 71(1) and (2)
Article 36                         Article 68
Article 37                         Articles 65 to 67
Article 38                         Articles 65 to 67
Article 39                         Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and
                                   166
Article 40                         Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and
                                   166
Article 41                         Articles 65(1)(c) and (d)(ii) and 67
11779/15                                               AS/NC/ra                       33
ANNEX V                         DGB 2B                                              EN
 ---pagebreak---            Directive 2003/85/EC                     This Regulation
Article 42                         Articles 65(1)(c) and (d) and 67
Article 43                         Article 71(1)
Article 44                         Article 68
Article 45                         Articles 64, 67 and 71
Article 46                         Articles 65 and 67
Article 47                         Articles 65(1)(h) and 67
Article 48                         Article 66
Article 49                         Articles 16, 46 and 47
Article 50                         Articles 46,47 and 69
Article 51                         Articles 47 and 69
Article 52                         Articles 46 and 47
Article 53                         Articles 46 and 47
Article 54                         Articles 47, 65, 67 and 69(2) and(3)
11779/15                                               AS/NC/ra          34
ANNEX V                         DGB 2B                                  EN
 ---pagebreak---            Directive 2003/85/EC                     This Regulation
Article 55                         Articles 47, 65, 67, and 69(2) and (3)
Article 56                         Articles 47, 67(c), 68(1)(c) and 69(2) and (3)
Article 57                         Articles 47, 67(c), 68(1)(c) and 69(2) and (3)
Article 58                         Article 68
Article 59                         Articles 36, 38, 39, 40 and 68
Article 60                         Articles 36, 38, 39, 40 and 68
Article 61                         Articles 36, 38, 39, 40 and 68
Article 62                         Article 68
Article 63                         Articles 143(2), 161(2) and 167(1)(b)
Article 64                         Articles 65(1)(c), 67, 69(3) and 131
Article 65                         Article 16
Article 66                         –
Article 67                         –
Article 68                         –
Article 69                         –
Article 70                         Article 16
Article 71                         Articles 54(2) and (3), 58(2), 61(1)(g) and (h),
                                   63(c), 65(1)(b), 67(c) and 68(1)(c) and 2(b)
Article 72                         Article 43
Article 73                         Article 45
Article 74                         Article 43(2)(d)
Article 75                         Article 44
11779/15                                               AS/NC/ra                     35
ANNEX V                         DGB 2B                                          EN
 ---pagebreak---            Directive 2003/85/EC                     This Regulation
Article 76                         Articles 43(2)(d) and 44
Article 77                         Article 44
Article 78                         Article 43(2)(d)
Article 79                         Article 52
Article 80                         Articles 48 and 51
Article 81                         Articles 48(3) and 50
Article 82                         Articles 48(3) and 50
Article 83                         Article 49
Article 84                         Articles 48(3) and 50
Article 85                         Articles 70 and 71
Article 86                         Article 268
Article 87                         –
Article 88                         Article 71(3)
Article 89                         –
Article 90                         –
Article 91                         –
Article 92                         –
Article 93                         –
Article 94                         –
Article 95                         –
11779/15                                               AS/NC/ra      36
ANNEX V                         DGB 2B                              EN
 ---pagebreak--- 23.       Regulation (EC) No 21/2004
           Regulation (EC) No 21/2004                      This Regulation
Article 1                                Article 108
Article 2                                Article 4 (partially)
Article 3(1)                             Article 108(3)
Article 3(2)                             Article 111
Article 4(1) and (2)                     Articles 113(a), 118, 119 and 120
Article 4(3)                             Article 118(2)(a)
Article 4(4)                             Article 118(2)(e)
Article 4(5) to (7)                      Article 118(1)(a) and 2(a)
Article 4(8)                             Article 111
Article 4(9)                             Article 118(1)(a) and (2)(a)
Article 5                                Articles 102, 106, 107and 111
Article 6                                Articles 111(b), 113(1)(b) and (2), 118(1)(b)(ii),
                                         119 and 120(2)(d)
Article 7                                Article 101
Article 8(1)                             Articles 109(1)(b) and 118(1)(b)
Article 8(2)                             Article 113(1)(c)
Article 8(3) to (5)                      Articles 109 and 118(1)(b)
Article 9                                Article 118(1)(a) and 2(a)
Article 10(1)                            –
Article 10(2)                            Article 120(2)(c)
11779/15                                                      AS/NC/ra                   37
ANNEX V                               DGB 2B                                         EN
 ---pagebreak---           Regulation (EC) No 21/2004                     This Regulation
Article 11                              Articles 11 and 13(2)
Article 12(1)                           –
Article 12(2)                           Article 268
Article 12(4) to (7)                    –
Article 13                              –
Article 14                              –
Article 15                              –
Article 16                              –
Article 17                              –
11779/15                                                   AS/NC/ra       38
ANNEX V                              DGB 2B                              EN
 ---pagebreak--- 24.       Directive 2004/68/EC
              Directive 2004/68/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3(1)                          Articles 229(1)(a) and 231
Article 3(2)                          Article 232(1)
Article 4                             Article 230(1)
Article 5                             Articles 230(1) and (3) and 231
Article 6                             Articles 234 and 235
Article 7                             Articles 229(2), 234(2)(a), 235 and 238(1)(e)
Article 8                             Articles 234, 237(4)(a) and 239(2)(a)
Article 9                             Articles 234(2), 235 and 237 (4)(a)
Article 10                            Articles 234(2), 235 and 237(4)(a)
Article 11                            Articles 229(1)(d), 237 and 238
Article 12                            –
Article 13                            –
Article 14                            –
Article 16                            –
Article 17                            –
Article 18                            –
Article 19                            –
Article 20                            –
Article 21                            –
11779/15                                                   AS/NC/ra                 39
ANNEX V                            DGB 2B                                         EN
 ---pagebreak--- 25.       Directive 2005/94/EC
              Directive 2005/94/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3                             Article 10
Article 4                             Articles 26, 28 and 29
Article 5                             Articles 18, 19, 20 and 23
Article 6                             Article 57
Article 7                             Articles 54 to 56
Article 8                             Article 55(2)
Article 9                             Article 59
Article 10                            Articles 55(1)(e) and (f) and 56
Article 11                            Articles 61 and 63
Article 12                            Articles 63 and 71
Article 13                            Articles 61 and 63
Article 14                            Article 63(a)
Article 15                            Articles 62 and 63(e)
Article 16                            Article 64
Article 17                            Articles 65 to 67
Article 18                            Articles 65(1)(a) and (b) and 67
Article 19                            Articles 65 to 67
Article 20                            Articles 65(1)(d)(ii) and 67
11779/15                                                   AS/NC/ra      40
ANNEX V                            DGB 2B                               EN
 ---pagebreak---            Directive 2005/94/EC                     This Regulation
Article 21                         Articles 65(1)(c) and (i) and 67
Article 22                         Articles 65(1)(c) and (i) and 67
Article 23                         Articles 65(1)(c) and 67
Article 24                         Articles 65(1)(c) and 67
Article 25                         Articles 65(1)(c) and 67
Article 26                         Articles 65(1)(c) and 67
Article 27                         Articles 65(1)(d)(ii) and 67
Article 28                         Articles 65(1)(f) and 67(b)
Article 29                         Article 68
Article 30                         Articles 65 to 67
Article 31                         Article 68
Article 32                         Articles 65, 67 and 71(2) and (3)
Article 33                         Articles 67 and 71(3)
Article 34                         Article 71
Article 35                         Articles 54 and 61
Article 36                         Articles 61 to 63
Article 37                         Articles 61 to 63
Article 38                         Articles 61, 63, 65 and 67
Article 39                         Articles 61, 63 and 71(2)
Article 40                         Articles 61,63 and 71
Article 41                         Articles 61,63 and 71(2) and (3)
Article 42                         Articles 62 and 63(e)
11779/15                                               AS/NC/ra       41
ANNEX V                         DGB 2B                               EN
 ---pagebreak---            Directive 2005/94/EC                     This Regulation
Article 43                         Article 64
Article 44                         Articles 65 and 67
Article 45                         Article 68
Article 46                         Articles 64(4), 67 and 71(2) and (3)
Article 47                         Articles 54, 55, 61, 63 and 71
Article 48                         Article 68(1)(b) and (2)(a)
Article 49                         Articles 61(3) and 68
Article 50                         Articles 16, 54(2)(b) and (c) and (3), 58(2),
                                   61(1)(g) and (h), 63(c), 65(1)(b), 67(c), 68(1)(c)
                                   and 2(b)
Article 51                         –
Article 52                         Articles 46 and 47
Article 53                         Article 69
Article 54                         Articles 47, 65(1)(e), 67, 69 and 71(3)
Article 55                         Articles 47, 65(1)(e), 67, 69 and 71(3)
Article 56                         Articles 46 and 47
11779/15                                               AS/NC/ra                    42
ANNEX V                         DGB 2B                                           EN
 ---pagebreak---            Directive 2005/94/EC                     This Regulation
Article 57                         Article 47
Article 58                         Articles 48 to 50
Article 59                         Article 52
Article 60                         –
Article 61                         Article 268
Article 62                         Articles 43 and 44
Article 63                         –
Article 64                         –
Article 65                         –
Article 66                         –
Article 67                         –
Article 68                         –
Article 69                         –
11779/15                                              AS/NC/ra       43
ANNEX V                         DGB 2B                              EN
 ---pagebreak--- 26.       Directive 2006/88/EC
              Directive 2006/88/EC                      This Regulation
Article 1                             –
Article 2                             Articles 2 and 3(2)
Article 3                             Article 4 (partially)
Article 4(1)                          Articles 172, 173, 176 and 177
Article 4(2)                          Article 179
Article 4(3)                          Article 185(2)
Article 4(4)                          Articles 172, 173, 174 and 175
Article 4(5)                          –
Article 5                             Article 181
Article 6                             Article 185
Article 7                             –
Article 8                             Articles 186, 187, 188 and 189
Article 9                             Article 181(1)(a)(i), (2) and (3)
Article 10                            Article 181(1)(a)(ii), (2) and (3)
Article 11                            Articles 191 and 204
Article 12                            Article 191
Article 13                            Article 192
Article 14(1) and (2)                 Articles 208 and 211
Article 14(3) and (4)                 Articles 219 and 220
Article 15(1) and (2)                 Articles 196 and 197
11779/15                                                   AS/NC/ra       44
ANNEX V                            DGB 2B                                EN
 ---pagebreak---               Directive 2006/88/EC                     This Regulation
Article 15(3)                         Article 193
Article 15(4)                         Articles 196, 197 and 199
Article 16                            Article 197
Article 17                            Article 197
Article 18                            Articles 201 and 202
Article 19                            Articles 201 and 202
Article 20                            Article 200
Article 21                            Articles 200, 203, 205 and 226
Article 22                            Article 229(1)(a)
Article 23                            Articles 230and 231
Article 24                            Articles 229(1)(d) and 237
Article 25                            Articles 234, 237 and 238
Article 26                            Article 18
Article 27                            Articles 19 and 20
Article 28                            Articles 53 to 55 and 72 to 74
Article 29                            Articles 57 and 77(1)(b)
Article 30                            Articles 59 and 78
Article 31                            –
Article 32                            Articles 60, 61, 62 and 64
Article 33                            Articles 65 to 67
Article 34                            Articles 61(1)(b)and (c) and Article 63
Article 35                            Articles 61(3) and 63
Article 36                            –
11779/15                                                  AS/NC/ra             45
ANNEX V                            DGB 2B                                     EN
 ---pagebreak---            Directive 2006/88/EC                     This Regulation
Article 37                         Article 68
Article 38                         Articles 77, 79 and 80(3)
Article 39                         Articles 79 and 80
Article 40                         Article 81
Article 41                         Article 257(1)(b) and (c)
Article 42                         Article 71(3)
Article 43                         Article 226
Article 44                         Articles 27, 28, 31 and 32
Article 45                         Article 33
Article 46                         Article 31(2)
Article 47                         Articles 43 and 44
Article 48                         Article 46 and 47
Article 49                         Article 36
11779/15                                               AS/NC/ra      46
ANNEX V                         DGB 2B                              EN
 ---pagebreak---               Directive 2006/88/EC                     This Regulation
Article 50                            Article 36 and 37
Article 51                            Article 38
Article 52                            Article 41
Article 53                            Article 42
Article 54                            –
Article 55                            –
Article 56                            –
Article 57(a)                         –
Article 57(b)                         Articles 54(2)(c) and (3), 58, 61(1)(g) and (h),
                                      63(c), 65(1)(b) and 67(c)
Article 57(c)                         –
Article 58                            –
Article 59                            Articles 38 and 185 (partially)
Article 60                            Article 268
Article 61                            –
Article 62                            –
Article 63                            –
Article 64                            –
Article 65                            –
Article 66                            –
Article 67                            –
11779/15                                                  AS/NC/ra                     47
ANNEX V                            DGB 2B                                          EN
 ---pagebreak--- 27.       Directive 2008/71/EC
              Directive 2008/71/EC                      This Regulation
Article 1                             –
Article 2                             Article 4 (partially)
Article 3(1)                          Articles 101 and111
Article 3(2)                          Articles 118(2) and 119
Article 4(1)                          Articles 102, 107 and 119
Article 4(2)                          Article 102(3)
Article 5(1)                          Articles 115(a), 118(1)(a) and (2)(a) and 120
Article 5(2)                          Article 118(1)(a) and (2)(a)
Article 6(1)                          Articles 115(a), 118(1)(a) and (2)(a) and 120
Article 6(2)                          –
Article 7                             Article 109(1)(c) and (2)
Article 8                             Article 118(2)(e)
Article 9                             Article 268
Article 10                            –
Article 11                            –
Article 12                            –
Article 13                            –
11779/15                                                   AS/NC/ra                 48
ANNEX V                            DGB 2B                                         EN
 ---pagebreak--- 28.       Directive 2009/156/EC
              Directive 2009/156/EC                      This Regulation
Article 1                              –
Article 2                              Article 4 (partially)
Article 3                              Articles 126 and 139
Article 4(1)                           Articles 130 and 149(3)
Article 4(2)                           Articles 130 and 131
Article 4(3)                           Article 128
Article 4(4)                           Articles 114, 118 and 120
Article 4(5)                           Articles 126(1)(b), 130 and 131
Article 4(6)                           Articles 31 to 35
Article 5                              Articles 130 and 131
Article 6                              Articles 130, 131 and 144(1)(b)
Article 7(1)                           Articles 126(2) and 133
Article 7(2)                           Articles 131 and 132
Article 7(3)                           Article 130, 131 and 132
Article 8                              Articles 114(1)(c), 118, 120 and 143 to 146
Article 9                              Articles 257 to 259 (partially)
Article 10                             –
Article 11                             –
Article 12(1),(2) and (3)              Articles 229(1)(a), 230 and 231
11779/15                                                    AS/NC/ra                49
ANNEX V                             DGB 2B                                         EN
 ---pagebreak---              Directive 2009/156/EC                    This Regulation
Article 12(4)                         Article 234
Article 12(5)                         –
Article 13                            Articles 234 and 235
Article 14                            Article 234
Article 15                            Article 234
Article 16                            Articles 234, 235 and 237
Article 17                            Article 234
Article 18                            –
Article 19(a) to (c)                  Articles 234 and 239
Article 19(d)                         –
Article 20                            –
Article 21                            –
Article 22                            –
Article 23                            –
Article 24                            –
11779/15                                                 AS/NC/ra      50
ANNEX V                            DGB 2B                             EN
 ---pagebreak--- 29.       Directive 2009/158/EC
              Directive 2009/158/EC                      This Regulation
Article 1                              –
Article 2                              Article 4 (partially)
Article 3                              –
Article 4                              –
Article 5                              Articles 126, 130, 131, 159 and 160
Article 6                              Articles 124, 126 and 159
Article 7                              Article 101
Article 8                              Articles 159 and 160
Article 9                              Articles 130 and 131
Article 10                             Articles 130, 131 and 149(3) and (4)
Article 11                             Articles 130, 131 and 149(3) and (4)
Article 12                             Articles 130 and 131
Article 13                             Articles 131 and 273
Article 14                             Article 131
Article 15(1)(a)                       Articles 159 and 160
Article 15(1)(b) to (d)                Articles 130 and 131
Article 15(2)                          Articles 31 to 35 and 36(3)
Article 15(3)                          Article 42
Article 16                             Articles 31 to 35
Article 17                             Articles 36, 39 and 40
11779/15                                                    AS/NC/ra         51
ANNEX V                             DGB 2B                                  EN
 ---pagebreak---            Directive 2009/158/EC                     This Regulation
Article 18                          Articles 117, 118(2)(e), 122(2), 124, 125,
                                    126(1)(a) and (2), 132 and 157(3)
Article 19                          Articles 130 and 131
Article 20                          Articles 143(1)(a), 144, 145, 149, 161 and 162
Article 21                          Articles 139 and 144(1)(a) and (b)
Article 22                          –
Article 23                          Articles 229(1)(a), 230 and 231
Article 24                          Article 234
Article 25                          Article 234
Article 26                          Article 237
Article 27                          –
Article 28                          Articles 234, 235 and 236
Article 29                          Articles 234, 235 and 239
Article 30                          Article 234
Article 31                          Articles 257 to 259
Article 32                          –
Article 33                          –
Article 34                          –
Article 35                          –
Article 36                          –
Article 37                          –
Article 38                          –
11779/15                                                AS/NC/ra                  52
ANNEX V                          DGB 2B                                         EN
 ---pagebreak--- 30.       Regulation (EU) No 576/2013
          Regulation (EU) No 576/2013                      This Regulation
Article 1                                –
Article 2                                Articles 3(5) and (6) and 244
Article 3                                Article 4 (partially)
Article 4                                Article 245(1)
Article 5(1) and (2)                     Article 246(1) and (2)
Article 5(3)                             –
Article 5(4)                             Articles 3(4) to (6)
Article 5(5)                             Article 246(3)
Article 5(6)                             –
Article 6                                Articles 247 and 252(1)(a) and (b)
Article 7                                Article 252(1)(b) and (4)(d)
Article 8(1) and (3)                     Article 252(1)(b) and (d)
Article 8(2)                             Article 253(1)(b)
Article 9                                Articles 248 and 252(1)(a) and (b)
Article 10                               Articles 249 and 252(1)(a) and (b)
Article 11                               Article 252(1)(b) and (4)(d)
Article 12                               Article 252(1)(b) and (4)(d)
Article 13                               Articles 252(4)(d) and 253(1)(d)
Article 14                               Article 250 and 252(1)(a) and (b)
Article 15                               Articles 252(4) and 253(1)(d)
Article 16                               Article 251
11779/15                                                      AS/NC/ra       53
ANNEX V                               DGB 2B                                EN
 ---pagebreak---          Regulation (EU) No 576/2013                     This Regulation
Article 17                              Articles 247(a) and 252(1)(a)
Article 18                              Articles 252(1)(a)(ii) and 14(1)(b)(iv) and (2)
Article 19                              Article 252(1)(a), (2), (3) and(4)(a),(b) and(c)
Article 20                              Article 253(1)(c)
Article 21                              Articles 254(a) and 255(1) and (2)(b)
Article 22                              Article 254(d)
Article 23                              Article 254(b)
Article 24                              Article 254(c)
Article 25                              Articles 254(a) and 255(1)
Article 26                              Article 254(d)
Article 27                              Article 254(c)
Article 28                              Articles 254(a) and 255(2)(a)
Article 29                              Article 254(d)
Article 30                              Articles 254(a) and 255(2)(a)
Article 31                              Article 254(d)
Article 32                              Article 252(4)(e)
Article 33                              –
Article 34                              –
Article 35                              –
Article 36                              Articles 257 to 262
11779/15                                                    AS/NC/ra                     54
ANNEX V                              DGB 2B                                           EN
 ---pagebreak---          Regulation (EU) No 576/2013                This Regulation
Article 37                              Article 256
Article 38                              –
Article 39                              –
Article 40                              –
Article 41                              –
Article 42                              Article 268
Article 43                              –
Article 44                              –
Article 45                              –
11779/15                                              AS/NC/ra       55
ANNEX V                              DGB 2B                         EN