CELEX: 
Language: en
Date: 2020-04-28 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health and certification requirements for movements within the Union of aquatic animals and products of animal origin from aquatic animals

EUROPEAN
                           COMMISSION
                                                     Brussels, 28.4.2020
                                                     C(2020) 2568 final
                  COMMISSION DELEGATED REGULATION (EU) …/...
                                        of 28.4.2020
      supplementing Regulation (EU) 2016/429 of the European Parliament and of the
   Council, as regards animal health and certification requirements for movements within
     the Union of aquatic animals and products of animal origin from aquatic animals
                                 (Text with EEA relevance)
EN                                                                                       EN
 ---pagebreak---                               EXPLANATORY MEMORANDUM
   1.   CONTEXT OF THE DELEGATED ACT
        Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March
        2016 on transmissible animal diseases and amending and repealing certain acts in the
        area of animal health (‘Animal Health Law’)1 lays down rules on transmissible
        animal diseases and animal health requirements for movements within the Union of
        aquatic animals and products of animal origin from aquatic animals.
        Chapters 2 and 3 of Title II of Part IV of Regulation (EU) 2016/429 empower the
        Commission to adopt delegated acts supplementing the principal rules laid down in
        that basic act (the supplementing rules). Since those supplementing rules are all
        interrelated, they should be laid down in a single delegated act, in the interests of
        consistency and transparency, and to avoid duplication of Union rules.
        The supplementing rules are largely based on those laid down in Council Directive
        2006/88/EC2, and they establish animal health and certification requirements for
        movements within the Union of aquatic animals, including certain aquatic animals
        intended for human consumption, and products of animal origin from aquaculture
        animals other than live aquaculture animals. The supplementing rules have been
        adapted to suit the new legislative framework established by Regulation (EU)
        2016/429, and take account of updates of international standards and scientific
        progress as well as the experience gained through the application of Council
        Directive 2006/88/EC.
   2.   CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
        The Commission had several meetings and exchanges with the Expert Group on
        animal health (E00930)3. The draft Delegated Regulation was also made available to
        the European Parliament and the Council for comments, but no comments were
        received from those two Institutions. A number of meetings were also held with a
        range of stakeholders within the framework of the Animal Health Advisory
        Committee4, where the main elements of the draft act were illustrated and discussed.
        The Commission has taken account of the input received during these consultation
        activities.
        In addition, stakeholders’ comments on the draft Delegated Regulation were
        collected in the context of the Better Regulation feedback mechanism during the
        period between 16 January and 13 February, 2020. Feedback was received from the
        following organisations: Comité Interprofessionnel des Produits de l’Aquaculture
        (FR), Dansk Akvakultur (DK), Federation of European Aquaculture Producers
   1
      Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on
      transmissible animal diseases and amending and repealing certain acts in the area of animal health
      (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).
   2
      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).
   3
      https://ec.europa.eu/food/animals/health/expert_group_en
   4
      https://ec.europa.eu/food/animals/health/advisory_committees_en
EN                                                   1                                                       EN
 ---pagebreak---         (FEAP) (BE), European Association of Zoos and Aquaria (EAZA) (NL), Ornamental
        Fish International (OFI) (BE), ANSES (FR), Canadian Food Inspection Agency.
        The main requests and points made were as follows:
        –     the approach to determining when vector species should be regarded as vectors
              of listed diseases as set out in Annex I was questioned. It was further
              questioned why no vector species have been listed for HPR deleted-ISAV;
        –     the request to replace clinical inspections of consignments of aquatic animals
              and their eggs prior to certification with the surveillance system which pertains
              to disease-free status;
        –     the acknowledgement that the draft Delegated Regulation sets out requirements
              for movements of aquaculture animals to confined establishments, but that it
              would benefit from the addition of requirements concerning movements
              between confined establishments;
        –     the requirement for self-declaration documents will create a burden for
              businesses which trade in non-susceptible ornamental aquatic animals;
        –     the request to consider whether Esox lucius is a species that is susceptible to
              IHN as well as VHS;
        –     the request for an explanation as to why a number of derogations which apply
              to movements of aquatic animals and their products within the Union, do not
              apply to aquatic animals and their products entering the Union from third
              countries.
   3.   LEGAL ELEMENTS OF THE DELEGATED ACT
   3.1. Summary of the proposed rules
        This Delegated Regulation will supplement the rules laid down in Chapters 2 and 3
        of Title II of Part IV of Regulation (EU) 2016/429, and more particularly, it will
        include the following rules concerning category D diseases:
        (a)   biosecurity and labelling rules for the means of transport and containers
              transporting aquatic animals;
        (b)   animal health requirements for movements of aquatic animals intended for
              aquaculture establishments and for the release of aquaculture animals into the
              wild;
        (c)   animal health requirements for movements of live aquatic animals intended for
              human consumption;
        (d)   animal health requirements for movements of aquatic animals intended for
              certain specific uses or purposes;
        (e)   animal health certification and notification requirements for movements of
              aquatic animals and products of animal origin from aquaculture animals other
              than live aquaculture animals, and the roles and responsibilities of the
              competent authorities in the Member States and operators for such certification
              and notification requirements;
        (f)   the content of self-declaration documents for movements of aquaculture
              animals between Member States, including specific rules for aquaculture
EN                                              2                                               EN
 ---pagebreak---                  establishments which participate in surveillance programmes for category C
                 diseases;
          (g)    the movement conditions under which listed species referred to in column 4 of
                 the table in the Annex to Commission Implementing Regulation (EU)
                 2018/18825 are to be regarded as vectors of specific listed diseases.
   3.2.   Legal basis
          This Delegated Regulation is to be adopted pursuant to Regulation (EU) 2016/429,
          and in particular Articles 192(2), 197(3), 201(3), 202(3), 205(2), 211(1), 213(1),
          216(4), 218(3), 221(1), 222(3), 223(6), and 224(3) thereof.
   5
        Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of
        certain disease prevention and control rules to categories of listed diseases and establishing a list of
        species and groups of species posing a considerable risk for the spread of those listed diseases, (OJ L
        308, 4.12.2018, p. 21).
EN                                                    3                                                          EN
 ---pagebreak---                      COMMISSION DELEGATED REGULATION (EU) …/...
                                               of 28.4.2020
        supplementing Regulation (EU) 2016/429 of the European Parliament and of the
     Council, as regards animal health and certification requirements for movements within
       the Union of aquatic animals and products of animal origin from aquatic animals
                                       (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of
   9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the
   area of animal health (‘Animal Health Law’)6 and in particular Articles 192(2), 197(3),
   201(3), 202(3), 205(2), 211(1), 213(1), 216(4), 218(3), 221(1), 222(3), 223(6), and 224(3)
   thereof,
   Whereas:
   (1)     Regulation (EU) 2016/429 lays down rules for the prevention and control of animal
           diseases which are transmissible to animals or humans, including rules for the
           categorisation of listed diseases that are of concern at Union level. Article 5 of that
           Regulation provides that disease-specific rules for the prevention and control of
           diseases are to apply to the listed diseases, as referred to in that Article and in Annex II
           thereto. As listed diseases require different types of management measures, Article 9
           of Regulation (EU) 2016/429 provides for disease prevention and control rules, which
           take account of the potential seriousness of the impact of those various types of listed
           diseases on public and animal health, the economy, society and the environment.
   (2)     In particular, Article 9 of Regulation (EU) 2016/429 refers to the different types of
           listed diseases in points (a) to (e) of paragraph 1 thereof, taking account of the
           potential risks of cases of those listed diseases. In addition, Article 9(1)(d) of that
           Regulation provides that listed diseases referred to in Article 9(1)(a), (b), (c) thereof
           are also to be regarded as listed diseases under Article 9(1)(d), where the risk posed by
           the disease in question can be effectively and proportionately mitigated by measures
           concerning movements of animals and products. This distinction between the different
           categories of listed diseases should be taken into account for the purpose of the rules
           laid down in this Regulation regarding intra-Union movements of aquatic animals and
           products of animal origin from aquatic animals, other than live aquatic animals.
   (3)     Chapters 2 and 3 of Title II of Part IV of Regulation (EU) 2016/429 lay down disease-
           specific rules that apply to category D diseases and listed species for those diseases, as
           well as rules for emerging diseases. Those provisions also lay down the animal health
           requirements for movements within the Union of aquatic animals, including those
   6
           OJ L 84, 31.3.2016, p.1
EN                                                   4                                                  EN
 ---pagebreak---        intended for human consumption, and products of animal origin from aquatic animals,
       in order to prevent and control the spread of listed and emerging diseases in the Union.
   (4) Chapters 2 and 3 of Title II of Part IV of Regulation (EU) 2016/429 also empower the
       Commission to adopt rules to supplement certain non-essential elements of that
       Regulation by means of delegated acts. It is therefore appropriate to adopt such
       supplementing rules in order to ensure the smooth functioning of the new legislative
       framework for the control and prevention of animal diseases, established by that
       Regulation. As those supplementing rules are substantially interlinked, in the interest
       of simplicity and transparency, as well as to facilitate their application, they should be
       laid down in a single act rather than in a number of separate acts with many cross-
       references and the risk of duplication.
   (5) Commission Implementing Regulation (EU) 2018/18827 categorises the listed diseases
       referred to in Article 9(1) of Regulation (EU) 2016/429 into category A, B, C, D and E
       diseases. It also provides that the disease prevention and control rules for listed
       diseases referred to in Article 9(1) of Regulation (EU) 2016/429 are to apply to the
       categories of listed diseases for the listed species and groups of listed species referred
       to in the table set out in that Implementing Regulation. That table lists intra alia,
       species and groups of species of aquatic animals and vector species for diseases
       affecting aquatic animals.
   (6) The rules and risk mitigation measures laid down in this Regulation should
       supplement the animal health requirements laid down in Regulation (EU) 2016/429, as
       regards movements within the Union of aquatic animals, including those intended for
       human consumption, and products of animal origin from aquaculture animals, in order
       to ensure that those commodities do not pose a significant risk for the spread of the
       aquatic diseases referred to in Annex II to Regulation (EU) 2016/429, and
       subsequently defined by Commission Implementing Regulation (EU) 2018/1882 as
       category D diseases, which include as relevant, category A, category B and category C
       diseases. Commission Delegated Regulation (EU) …./…8[Publications Office please
       insert reference to SANTE/7066/2019, C(2019)4056] lays down rules concerning
       compulsory and optional eradication programmes for specific listed diseases. As
       regards category B and C diseases, certain Member States are subject to eradication
       programmes to stamp out those listed diseases or demonstrate that they have disease-
       free status as regards those listed diseases. Taking those programmes into account, it is
       appropriate to provide that movements of aquatic animals and products of animal
       origin from aquaculture animals other than live aquaculture animals, of listed species
       for the relevant category B or C disease, should therefore only be allowed, if such
       movements do not jeopardise the success of those eradication programmes, or
       disease-free status for those listed diseases, if such has been achieved.
   (7) In addition, as regards category C diseases, operators of establishments which are not
       subject to an optional eradication programme, may implement a voluntary surveillance
   7
       Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of
       certain disease prevention and control rules to categories of listed diseases and establishing a list of
       species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L
       308, 4.12.2018, p.21)
   8
       Commission Delegated Regulation (EU) 2019/… of … supplementing Regulation (EU) 2016/429 of the
       European Parliament and of the Council as regards rules on surveillance, eradication programmes and
       disease-free status for certain listed and emerging diseases (OJ L…, dd/mm/yyyy, p. […]).
EN                                                      5                                                       EN
 ---pagebreak---         programme for a specific category C disease in accordance with the rules laid down in
        Delegated Regulation (EU) xxx/xxx [Publications Office please insert reference to
        SANTE/7066/2019, C(2019)4056]. Whilst such establishments will not be declared
        disease-free, they will have the advantage of receiving only movements of aquaculture
        animals of listed species for the relevant category C disease, which do not jeopardise
        the success of the surveillance programme.
   (8)  Accordingly, this Regulation should lay down the supplementing rules regarding
        movements of aquatic animals and products of animal origin thereof, which are
        required to ensure the success of such eradication and surveillance programmes in the
        Member States, zones or compartments where they are implemented, as well as in
        Member States, zones and compartments which have achieved disease-free status.
   (9)  Article 192 of Regulation (EU) 2016/429 lays down disease preventive measures in
        relation to the transport of aquatic animals and empowers the Commission to lay down
        supplementing rules for the cleaning and disinfection of the means of transport of
        aquatic animals, water exchanges, water discharges and biosecurity measures, in order
        to mitigate the possible risks arising from the transportation of those aquatic animals
        within the Union. This Regulation should therefore lay down more detailed
        requirements for the transportation of aquatic animals, including transport by well-
        boat.
   (10) Regulation (EU) 2016/429 provides that consignments of aquatic animals of listed
        species that enter an area with disease-free status, or an area which is subject to an
        eradication programme, must be accompanied by an animal health certificate, except
        in certain very limited circumstances. As certain consignments are transported
        commercially in mixed lots that could be accompanied by different animal health
        certificates, it is critical to ensure that each consignment is unloaded at its intended
        point of destination. The labelling of consignments in such a way that the label clearly
        links the consignment of aquatic animals to the corresponding animal health certificate
        is a necessary risk-mitigating step in the interests of traceability, and to ensure that
        only consignments which are properly certified to be dispatched to disease-free areas,
        end up in those areas. Therefore, this Regulation should lay down supplementing rules
        for the labelling of such consignments.
   (11) Article 197 of Regulation (EU) 2016/429 provides that aquaculture animals of listed
        species relevant for category B and C diseases must originate from areas with disease-
        free status if they are intended for Member States, zones or compartments that are free
        of those listed diseases, or are subject to an eradication programme for such listed
        diseases. In certain situations, however, the risks to animal health do not justify such
        restrictions. This Regulation should therefore, provide for a derogation from such
        restrictions laid down in from Article 197 of Regulation (EU) 2016/429, while
        ensuring that the necessary risk-mitigating measures are in place to ensure that such
        movements of aquaculture animals do not jeopardise the health status or eradication
        programmes in place.
   (12) It is also necessary to lay down supplementing rules providing for derogations in
        relation to live aquatic animals of listed species, which are intended for human
        consumption where they are moved to a disease-free Member State, zone or
        compartment or to one which is subject to an eradication programme and where they
        have not originated from a disease-free Member State, zone or compartment. In such
        cases, those aquatic animals may be of species which are listed as vector species in
        column 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882, but
EN                                                 6                                             EN
 ---pagebreak---         they have not been in contact with the listed species susceptible to the relevant listed
        disease as set out in column 3 of that table and therefore they are not considered to be
        vectors. Another possibility is that those aquatic animals may be destined for slaughter
        and processing in a disease control aquatic food establishment, having been permitted
        by the competent authority to leave an area subject to disease control measures
        regarding a listed or emerging disease. This Regulation should provide that additional
        risk mitigating measures in relation to packaging and labelling in accordance with
        Regulation (EC) No 853/2004 of the European Parliament and of the Council9 be
        applied to molluscs and crustaceans intended for human consumption, thereby
        ensuring that such aquatic animals may be moved to an area with disease-free status
        or one which is subject to an eradication programme, without causing a risk for the
        spread of a relevant listed or emerging disease.
   (13) It is also necessary to lay down supplementing rules for movements of aquaculture
        animals of listed species into confined aquaculture establishments. Aquaculture
        animals of vector species listed in column 4 of the table in the Annex to Implementing
        Regulation (EU) 2018/1882, which have not been in contact with the susceptible
        species listed in column 3 of that table, as well as aquaculture animals which have
        been quarantined in an establishment approved in accordance with Article 15 of
        Commission Delegated Regulation (EU)……/….. [Publications Office please insert
        reference to SANTE/7208/2019, C(2020)415]10 or quarantined in another confined
        establishment, including the establishment of destination, should be permitted to be
        moved into confined establishments. As confined establishments may exchange
        aquaculture animals amongst themselves with fewer movement requirements than for
        other types of aquaculture establishments, it is important that the specific rules and
        derogations laid down in this Regulation ensure that such movements involving
        confined establishments do not pose a risk for the spread of listed or emerging
        diseases.
   (14) Wild aquatic animals are an important resource that should be protected. Accordingly,
        Article 199 of Regulation (EU) 2016/429 permits Member States to require that only
        aquatic animals from disease-free areas may be released into the wild even if the
        waters into which they are released do not have disease-free status. In addition, Article
        205(2) of that Regulation provides for the Commission to adopt delegated acts laying
        down supplementing rules for movements of aquatic animals for the purposes of sports
        fishing, including fishing baits. This Regulation should therefore, lay down
        supplementing rules on a procedure whereby that possibility for Member States can be
        successfully achieved. As Regulation (EU) 2016/429 does not require animal health
        certification for such movements of consignments of aquatic animals into areas which
        are not disease-free, this Regulation should lay down such rules in order to ensure that
        the competent authorities in both Member States are in a position to trace the
        movements of such consignments.
   (15) Live fishing baits infected with a listed or emerging aquatic disease represent a
        significant disease risk to wild aquatic animals and potentially therefore, also to
        aquaculture animals. Accordingly, in order to address that risk, this Regulation should
   9
        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).
   10
        Commission Delegated Regulation (EU) …./…. [Publications Office please insert reference to
        SANTE/7208/2019, C(2020)415]
EN                                                    7                                                   EN
 ---pagebreak---         provide that live fishing baits must only come from an area with disease-free status if
        they are to be used in a Member State, zone or compartment with disease-free status or
        in Member States which have taken the measures referred to in Article 199 of
        Regulation (EU) 2016/429.
   (16) Articles 208 and 209 of Regulation (EU) 2016/429 lay down rules in relation to the
        type of movements of aquatic animals, which must be certified. Experience gained in
        applying the rules laid down in Council Directive 2006/88/EC11 has however,
        indicated that some very limited and specific circumstances exist where a derogation
        from the application of the rules set out in Articles 208 and 209 of Regulation (EU)
        2016/429 may be applied as regards category C diseases, with the agreement of the
        Commission and relevant Member States. Therefore, this Regulation should lay down
        the conditions under which an animal health certificate should not be required to
        accompany consignments of aquatic animals of listed species when they are destined
        for disease-free Member States.
   (17) Self-declaration documents are issued by operators in accordance with Article 218 of
        Regulation (EU) 2016/429, for consignments that are to be moved between Member
        States but which are not required to be accompanied by an animal health certificate. It
        is important to lay down rules on the information that such self-declaration documents
        should contain to ensure the traceability of consignments and support safe trade. Self-
        declaration documents have an added value in relation to movements of aquaculture
        animals between aquaculture establishments which are implementing surveillance
        programmes for a category C disease or diseases. This Regulation should therefore
        provide that the self-declaration documents contain the necessary information
        confirming that the aquaculture establishment of origin is participating in a
        surveillance programme, and that there is no suspicion or confirmation of that
        category C disease or diseases in the aquaculture establishment.
   (18) To ensure compliance with the rules regarding animal health certification laid down in
        Article 216(3) of Regulation (EU) 2016/429, the official veterinarian is required to
        carry out documentary checks and a clinical inspection and where relevant, clinical
        examinations, at the aquaculture establishment of origin, before signing the animal
        health certificate. The aim of those checks is to ensure that there is no evidence to
        suggest that a listed or emerging disease is present in the aquaculture establishment
        and to facilitate safe trade. Supplementing rules concerning those checks should be
        laid down in this Regulation.
   (19) Clinical signs of disease are less obvious in certain categories of aquaculture animals,
        such as eggs and molluscs. It is therefore, an inappropriate use of resources to require
        that clinical inspections of such categories of aquaculture animals take place in
        advance of every movement from an aquaculture establishment. This Regulation
        should therefore, provide for a derogation from the requirement to carry out clinical
        inspections of eggs and molluscs every time they are required to be certified, provided
        certain checks are carried out in relation to documentation, the date of the previous
        clinical inspection of the aquaculture animals kept in the aquaculture establishment
        and details of movements to the establishment.
   11
        Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture
        animals and products thereof, and on the prevention and control of certain diseases in aquatic animals
        (OJ L 328, 24.11.2006, p.14)
EN                                                   8                                                         EN
 ---pagebreak---    (20) Experience gained in the application of Directive 2006/88/EC indicates that certain
        other derogations from the requirement to carry out a clinical inspection within 72
        hours prior to the time of dispatch should also be laid down in this Regulation. These
        derogations are intended to allow flexibility to the competent authority to carry out the
        clinical inspection within a period of 7 days before the time of dispatch in certain
        limited circumstances where the probability of disease manifestation or the risk of the
        spread of a listed or emerging disease are estimated to be low.
   (21) Articles 219 and 220 of Regulation (EU) 2016/429 lay down the obligations on
        operators other than transporters, and on the competent authorities in the Member
        States, in relation to the notification of movements of aquatic animals between
        Member States. This Regulation should lay down supplementing rules concerning the
        information, which operators should provide to the competent authority in advance of
        any such movement, as well as the information the competent authority in the Member
        State of origin should notify to the competent authority of the Member State of
        destination. This advance notification of movements between Member States should
        apply both to aquaculture animals and to wild aquatic animals.
   (22) In the case of movements of aquaculture animals of listed species between an
        establishment in one Member State which is participating in a surveillance programme
        for a certain category C disease, and an establishment in another Member State which
        is participating in a surveillance programme for the same category C disease, it is
        important to lay down rules concerning the information which must be notified in
        advance, to ensure that the establishment of destination receives aquaculture animals
        with the appropriate health status. This Regulation should therefore lay down rules
        concerning the information, which should be notified to the competent authority in the
        Member State of origin by the operator of the establishment of origin, as well as the
        information, which that competent authority should notify to the competent authority
        in the Member State of destination.
   (23) As the notification of movements between Member States is an important step in
        ensuring the traceability of aquatic animals and products of animal origin from
        aquaculture animals other than live aquaculture animals, and in supporting safe trade,
        this Regulation should lay down detailed rules concerning the requirements for
        advance notification including details of the information which should be supplied by
        operators as well as emergency procedures for such notifications. Articles 219(2),
        220(2) and 221(1) of Regulation (EU) 2016/429 and Article 46 of Commission
        Implementing Regulation (EU) 2019/171512 describe the information to be supplied by
        operators and competent authorities in relation to such notifications and the emergency
        procedures to be put place by the competent authority in the event of power cuts or
        other disturbances to TRACES.
   (24) Article 222(3) of Regulation (EU) 2016/429 provides for the Commission to adopt
        delegated acts in relation to the obligations of operators as regards movements of
        products of animal origin from aquatic animals other than live aquatic animals,
        including the risk–mitigation measures that should be applied to such products at the
        places of origin and destination. Article 222(4) of that Regulation provides that the
   12
        Commission Implementing Regulation (EU) 2019/ 1715 of 30 September 2019 laying down rules for
        the functioning of the information management system for official controls and its system components
        (‘the IMSOC Regulation’ (OJ L261,14.10.2019, p.37)
EN                                                  9                                                        EN
 ---pagebreak---            rules set out in that Article, do not apply to products of animal origin from wild
           aquatic animals harvested or caught for direct human consumption. Accordingly, the
           supplementing rules laid down in this Regulation should apply only to products of
           animal origin from aquaculture animals and should lay down measures to be taken
           when certain products of animal origin from aquaculture animals of listed species,
           other than live aquaculture animals, enter an area with disease-free status for further
           processing, or if they have been authorised by the competent authority to leave an
           establishment or zone which is subject to emergency measures or movement
           restrictions. The supplementing rules should also lay down the animal health
           certification and notification requirements which should apply to such movements in
           order to ensure the traceability of such products.
   (25)    The rules laid down in this Regulation in relation to movements of live aquatic
           animals, should refer to the species listed in columns 3 and 4 of the table in the Annex
           to Implementing Regulation (EU) 2018/1882, with certain derogations for the vector
           species set out in column 4. However, given the lower level of risk associated with
           products of animal origin from aquaculture animals other than live aquaculture
           animals, the rules laid down in this Regulation as regards the movement of such
           products should apply only to those susceptible species listed in column 3 of the table
           in the Annex to Implementing Regulation (EU) 2018/1882, and should not apply to the
           vector species set out in column 4 of the same table.
   (26)    Products of animal origin from aquaculture animals other than live aquaculture
           animals are required in certain circumstances, to be accompanied by an animal health
           certificate in accordance with Article 223 of Regulation (EU) 2016/429. Details of the
           content of such animal health certificates should be laid down in this Regulation.
   (27)    This Regulation should apply from 21 April 2021 in accordance with the date of
           application of Regulation (EU) 2016/429,
   HAS ADOPTED THIS REGULATION:
                                               PART I
         SUBJECT MATTER, SCOPE AND DEFINITIONS
                                                 Article 1
                                        Subject matter and scope
   This Regulation supplements the rules laid down in Chapters 2 and 3 of Title II of Part IV of
   Regulation (EU) 2016/429, as regards intra-Union movements of aquatic animals and
   products from aquatic animals.
   In particular, it lays down rules concerning:
   (a)       the obligations on operators, including transporters, for the transport of aquatic
             animals;
   (b)       supplementary animal health requirements for movements of aquatic animals
             intended for specific uses or purposes, including certification and notification
             requirements;
   (c)       the production, processing and distribution of products of animal origin from
             aquaculture animals, other than live aquaculture animals.
EN                                                  10                                              EN
 ---pagebreak---                                                 Article 2
                                               Definitions
   For the purposes of this Regulation, the definitions in Article 4 of Regulation (EU) 2016/429
   and in Article 2 of Delegated Regulation (EU) …./….[Publications Office please insert
   reference to SANTE/7208/2019, C(2019)415] apply.
   The following definitions also apply:
   (1)      ‘container’ means any crate, box, receptacle or other rigid structure used for the
            transport of aquatic animals or eggs of aquatic animals which is not the means of
            transport;
   (2)      ‘well-boat’ means a vessel which has a well or tank for the storage, transport or
            treatment of live aquaculture animals in water;
   (3)      ‘vector species’ means species listed in column 4 of the table set out in the Annex to
            Implementing Regulation (EU) 2018/1882, which fulfil the conditions to be regarded
            as vectors as set out in column 3 of Annex I to this Regulation;
   (4)      ‘fishing bait’ means any aquatic animal used to attract or catch another aquatic
            animal;
   (5)      ‘national measures’ means national measures designed to limit the impact of diseases
            other than listed diseases as referred to in Article 226 of Regulation (EU) 2016/429;
   (6)      ‘habitat’ means aquatic areas distinguished by geographical, abiotic and biotic
            features whether entirely natural or semi-natural;
   (7)      ‘disease-free Member State, zone or compartment’ means a Member State, zone or
            compartment thereof which has been declared disease-free in accordance with Article
            36(4) or 37(4) of Regulation (EU) 2016/429;
   (8)      ‘eradication programme’ means a compulsory eradication programme established in
            accordance with Article 31(1) of Regulation (EU) 2016/429, or an optional
            eradication programme established in accordance with Article 31(2) of that
            Regulation;
   (9)      ‘registered aquaculture establishment’ means an establishment which has been
            registered by the competent authority in accordance with Article 173 of Regulation
            (EU) 2016/429;
   (10)     ‘approved aquaculture establishment’ means an establishment which has been
            approved by the competent authority in accordance with Article 176 of Regulation
            (EU) 2016/429;
   (11)     ‘approved group of aquaculture establishments’ means a group of aquaculture
            establishments approved by the competent authority in accordance with Article 177
            of Regulation (EU) 2016/429.
                                             PART II
                 MOVEMENTS OF AQUATIC ANIMALS
                                             Chapter 1
     General requirements on operators for the transport of aquatic
                                               animals
EN                                                  11                                             EN
 ---pagebreak---                                                Article 3
      General obligations on operators as regards biosecurity requirements for the transport of
                                            aquatic animals
   1.      Operators, including transporters, shall ensure that aquatic animals are:
           (a)    loaded and transported in water which does not alter their health status;
           (b)    not transported in the same water or in the same container as aquatic animals of
                  a lower health status, from the time of loading to the time of arrival at their
                  place of destination.
   2.      Operators, including transporters, shall ensure that:
           (a)    the means of transport and containers are designed and constructed in such a
                  way that cleaning and disinfection can be carried out effectively between
                  consignments in order not to jeopardise the health status of the aquatic animals
                  during transport;
           (b)    the container, when it is not a single use item, or the vessel, as well as other
                  transport equipment, are cleaned and disinfected between consignments.
   3.      Operators, including transporters, shall ensure that the cleaning and disinfection
           required by paragraph 2(b) is carried out in accordance with a protocol agreed by the
           competent authority of the place of origin, which must include details of where and
           when the cleaning and disinfection is to take place and the type of disinfecting agents
           that must be used.
                                               Article 4
        General obligations on operators as regards requirements for water exchanges and
                         discharges during the transport of aquatic animals
   1.      Operators, including transporters, shall ensure that where water exchange is
           necessary, it only takes place as follows:
           (a)    in the case of transport on land: at exchange points where the exchange does
                  not alter the health status of the aquatic animals being transported, or those at
                  the place of destination or en route to that destination;
           (b)    in the case of transport by well-boat: at a distance of at least 10 km from any
                  aquaculture establishments which are located en route from the place of
                  loading to the place of destination.
   2.      Operators, including transporters, shall ensure that water exchanges as referred to in
           paragraph 1, do not take place in areas which are subject to movement restrictions or
           emergency measures.
                                               Article 5
   Obligations on operators as regards specific transport and labelling requirements concerning
           means of transport and containers in which aquatic animals are transported
   1.      Operators, including transporters, of consignments of aquatic animals that are
           accompanied by an animal health certificate as referred to in Article 208 or Article
           209 of Regulation (EU) 2016/429, shall ensure that the means of transport or
           containers in which those aquatic animals are transported, are identified by means of
           a legible label which must:
EN                                                 12                                               EN
 ---pagebreak---              (a)   be displayed in a visible position on the container or the means of transport, as
                   practicable;
             (b)   contain the necessary information to clearly link the consignment to the animal
                   health certificate.
   2.        By way of derogation from paragraph 1(b), in the case of transport by well-boat, the
             label may be replaced by an entry in the ship’s manifest that contains the necessary
             information to clearly link the consignment to the animal health certificate referred to
             in paragraph 1.
                                              Chapter 2
      Supplementary animal health requirements for movements of
                                         aquatic animals
                                              SECTION 1
           MOVEMENTS OF AQUATIC ANIMALS INTENDED FOR AQUACULTURE
                        ESTABLISHMENTS OR RELEASE INTO THE WILD
                                                Article 6
    Derogations from the requirement for aquaculture animals of listed species to originate from
                          a disease-free Member State, zone or compartment
   By way of derogation from Article 197(1) and (2) of Regulation (EU) 2016/429, operators,
   including transporters, may move aquaculture animals of listed species which are relevant for
   the category B diseases or category C diseases for which the Member State, zone or
   compartment of destination has obtained disease-free status, or for which it is subject to an
   eradication programme, from Member States, zones or compartments which are not free of
   those listed diseases, under the following circumstances:
EN                                                 13                                                 EN
 ---pagebreak---    (a)      the aquaculture animals are of one of the species listed in column 4 of the table in the
            Annex to Implementing Regulation (EU) 2018/1882 and they are not regarded as
            being vectors of the category B or category C diseases in question; or
   (b)      the aquaculture animals are of one of the species listed in column 4 of the table in the
            Annex to Implementing Regulation (EU) 2018/1882 and are vectors , but they are
            regarded as being free from the category B or category C diseases in question, as
            they have completed quarantine in a quarantine establishment approved in
            accordance with Article 15 of Delegated Regulation (EU) …./…. [Publications
            Office please insert reference to SANTE/7208/2019, C(2020)415], under the
            requirements set out in point (2) of Part 8 of Annex I to that Delegated Regulation; or
   (c)      the aquaculture animals are of one of the species listed in column 4 of the table in the
            Annex to Implementing Regulation (EU) 2018/1882 and are vectors , but they have
            been kept in an aquaculture establishment approved in accordance with Article 16 of
            Delegated Regulation (EU) …./…[ Publications Office please insert reference to
            SANTE/7208/2019, C(2020)415] under the requirements set out in point (2) of Part 9
            of Annex I to that Delegated Regulation, and are no longer regarded as vectors of the
            category B or category C diseases in question; or
   (d)      the aquaculture animals are destined for a confined establishment for scientific
            purposes.
                                               Article 7
      Obligations on operators as regards disease prevention and risk mitigating measures for
                  movements of wild aquatic animals to aquaculture establishments
   By way of derogation from Article 197(1) and (2) of Regulation (EU) 2016/429 in
   conjunction with Article 200(1) thereof, operators including transporters, may move wild
   aquatic animals of listed species which are relevant for the category B or category C
   diseases, for which the Member State, zone or compartment of destination has obtained
   disease-free status or for which it is subject to an eradication programme, from Member
   States, zones or compartments which are not free of those listed diseases, provided that those
   wild aquatic animals are destined for an aquaculture establishment and the following
   circumstances apply:
EN                                                14                                                 EN
 ---pagebreak---    (a)      they are regarded as being free of the category B or category C diseases in
            question, as they have completed quarantine in a quarantine establishment approved
            in accordance with Article 15 of Delegated Regulation (EU) …./…. [Publications
            Office please insert reference to SANTE/7208/2019, C(2020)415] under the
            requirements set out in point (2) of Part 8 of Annex I to that Delegated Regulation; or
   (b)      in the case of wild aquatic animals of species listed in column 4 of the table in the
            Annex to Implementing Regulation (EU) 2018/1882 and which are vectors, they
            have been kept in an aquaculture establishment approved in accordance with Article
            16 of Delegated Regulation (EU) …./…. [Publications Office please insert reference
            to SANTE/7208/2019, C(2020)415] under the requirements set out in point (2) of
            Part 9 of Annex I to that Delegated Regulation, and are no longer regarded as
            vectors.
                                              SECTION 2
           MOVEMENTS OF LIVE AQUATIC ANIMALS INTENDED FOR HUMAN
                                           CONSUMPTION
                                                Article 8
       Derogations from the movement requirements of live aquatic animals of listed species
       intended for human consumption in a Member State, zone or compartment, which has
            obtained disease-free status or which is subject to an eradication programme
   By way of derogation from Article 201(1) of Regulation (EU) 2016/429 in conjunction with
   Article 202(1) thereof, when live aquatic animals are intended for human consumption,
   Member States may authorise operators to move animals of listed species for the category B
   or category C diseases for which the Member State, zone or compartment of destination has
   obtained disease-free status, or for which it is subject to an eradication programme, when one
   or more of the following circumstances apply:
   (a)      the live aquatic animals are of one of the species listed in column 4 of the table in the
            Annex to Implementing Regulation (EU) 2018/1882 and they are not vectors of the
            category B or category C diseases in question ; or
   (b)      the live aquatic animals are destined for a disease control aquatic food establishment
            for slaughter and subsequent processing having originated from an area which is
            subject to movement restrictions or emergency measures as referred to in Article
            191(2)(b)(i) and (ii) of Regulation (EU) 2016/429, and where such movements are
            authorised by the competent authority, and take place in accordance with the
            conditions set out in that authorisation; or
   (c)      the live aquatic animals are molluscs or crustaceans which are packed and labelled
            for human consumption in accordance with the specific requirements for those
            animals as set out in Sections VII and VIII of Annex III to Regulation (EC) No
            853/2004 and they would no longer be able to survive as live animals if returned to
            the aquatic environment; or
   (d)      the live aquatic animals are molluscs or crustaceans which are packed and labelled
            for human consumption in accordance with the specific requirements for those
            animals as set out in Sections VII and VIII of Annex III to Regulation (EC) No
            853/2004 and they are intended for further processing without temporary storage at
            the place of processing; or
EN                                                  15                                                EN
 ---pagebreak---    (e)     the live aquatic animals are molluscs or crustaceans which are intended for human
           consumption without further processing, and they are packed for retail sale in
           accordance with the specific requirements for those animals as set out in Sections VII
           and VIII of Annex III to Regulation (EC) No 853/2004.
                                            SECTION 3
    MOVEMENTS OF AQUATIC ANIMALS INTENDED FOR OTHER SPECIFIC USES AND
                                             PURPOSES
                                               Article 9
   Animal health requirements for movements of aquaculture animals to confined establishments
   1.      Operators shall only move aquaculture animals of listed species from a confined
           establishment to a confined establishment in another Member State if those animals
           do not pose a significant risk of the spread of diseases for which they are listed,
           based on the results of the surveillance plan referred to in Article 9(c) of Delegated
           Regulation (EU) …./…. [Publications Office please insert reference to
           SANTE/7208/2019, C(2020)415].
   2.      Operators shall only move aquaculture animals of listed species, which are relevant
           for category D diseases, from aquaculture establishments other than a confined
           establishment into a confined establishment if those aquaculture animals comply
           with one or more of the following requirements:
           (a)   they originate from a disease-free Member State, zone or compartment;
           (b)   they are quarantined under appropriate conditions in one of the following:
                 (i)   a quarantine establishment approved in accordance with Article 15 of
                       Delegated Regulation (EU) …./…. [Publications Office please insert
                       reference to SANTE/7208/2019, C(2020)415]; or
                 (ii)  a quarantine facility in another confined establishment; or
                 (iii) the quarantine facility of the confined establishment of final destination;
           (c)   they are aquaculture animals of one of the species listed in column 4 of the
                 table in the Annex to Implementing Regulation (EU) 2018/1882 and they are
                 vectors, but they have been kept in an aquaculture establishment approved in
                 accordance with Article 16 of Delegated Regulation (EU) …./…. [Publications
                 Office please insert reference to SANTE/7208/2019, C(2020)415] under the
                 requirements set out in point (2) of Part 9 of Annex I to that Delegated
                 Regulation, and are no longer regarded as vectors.
   3.      By way of derogation from paragraph 2, operators may move aquaculture animals
           that do not comply with the requirements laid down in that paragraph into a confined
           establishment for scientific purposes.
                                              Article 10
            Supplementary requirements for the release of aquatic animals into the wild
   Operators shall only move aquatic animals for release into the wild in a Member State which
   has taken measures in accordance with Article 199 of Regulation (EU) 2016/429 and those
   aquatic animals are for sports fishing, including fishing bait as referred to in Article
EN                                                16                                               EN
 ---pagebreak---    205(2)(a)(iii) thereof, if they originate from a Member State, zone or compartment with
   disease-free status, and they comply with the following requirements:
   (a)      the Member State of destination has notified the Commission and other Member
            States that it applies measures in accordance with Article 199 of Regulation (EU)
            2016/429 for aquatic animals for sports fishing, including fishing bait as referred to
            in Article 205(2)(a)(iii) thereof;
   (b)      the competent authority in the Member State of origin has authorised the movement;
   (c)      the competent authorities in the Member State of origin and the Member State of
            destination have measures in place to ensure the traceability of the aquatic animals
            moved in accordance with this Article.
                                                Article 11
      Animal health requirements for movements of aquatic animals for use as live fishing bait
   Operators shall only move live fishing bait that are aquatic animals of listed species relevant
   for category D diseases, other than those listed in column 4 of the table in the Annex to
   Implementing Regulation (EU) 2018/1882 and which are not regarded as vectors, into a
   Member State, zone or a compartment which has disease-free status, or which is subject to an
   eradication programme to obtain disease-free status for one or more of those relevant category
   D diseases, if such live fishing baits originate from a disease-free Member State, zone or
   compartment.
                                             Chapter 3
        Animal health certificates, self-declarations and movement
                                            notification
                                               SECTION 1
             GENERAL RULES AS REGARDS ANIMAL HEALTH CERTIFICATION
                                                Article 12
   Derogations from the animal health certificate requirement for certain species of aquaculture
                                                 animals
   By way of derogation from the animal health certification requirements laid down in Article
   208(1) of Regulation (EU) 2016/429, operators may move aquaculture animals of listed
   species relevant for category C diseases without an animal health certificate, subject to
   compliance with the following conditions:
   (a)      the competent authority of the Member State of destination has notified the
            Commission and the other Member States that such movements are authorised
            subject to compliance with the conditions laid down in points (c) and (d);
   (b)      the competent authority of the Member State of origin has authorised the movement;
   (c)      the category C disease in question has never occurred in either the Member State of
            origin or the Member State of destination;
   (d)      both the competent authority of the Member State of origin and of destination have
            systems in place to ensure the traceability of the aquaculture animals moved in
            accordance with the conditions laid down in points (a), (b) and (c).
EN                                                  17                                             EN
 ---pagebreak---                                                SECTION 2
       RULES ON THE CONTENTS OF ANIMAL HEALTH CERTIFICATES AND SELF-
                      DECLARATION DOCUMENTS FOR AQUATIC ANIMALS
                                                Article 13
     Rules on the contents of animal health certificates for the various species and categories of
                                    aquatic animals of listed species
   1.       Operators shall ensure that the animal health certificates referred to in Article 208(1)
            of Regulation (EU) 2016/429 for aquaculture animals and in Article 209 thereof for
            aquatic animals other than aquaculture animals, contain the following:
            (a)    the general information specified in paragraph 1 or 2 of Part A of Annex II, as
                   relevant for aquaculture animals or wild aquatic animals;
            (b)    the specific animal health guarantees in accordance with paragraph 2 of this
                   Article as relevant for the species and category of aquatic animals in question;
            (c)    details of the purpose for which the aquatic animals are to be used in
                   accordance with paragraph 3 of Part A of Annex II.
   2.       The specific animal health guarantees for aquatic animals of relevant species referred
            to in paragraph 1(b) shall be the following:
            (a)    the aquatic animals being moved show no disease symptoms; and they
                   originate from either:
                   (i)   an aquaculture establishment or habitat where there are no increased
                         mortalities with an undetermined cause; or
                   (ii)  a part of the aquaculture establishment or habitat which is independent of
                         the epidemiological unit where increased mortalities or other disease
                         symptoms have occurred, where the competent authority of the Member
                         State of destination and where relevant, the competent authority of the
                         Member State(s) of transit, if there are any such Member States, have
                         given consent for such a movement to occur; or
                   (iii) an aquaculture establishment which is subject to the movement
                         restrictions or emergency measures set out in Article 191(2)(b)(i) and (ii)
                         of Regulation (EU) 2016/429 and a derogation from those movement
                         restrictions or emergency measures is authorised by the competent
                         authority and the movement takes place in accordance with the
                         conditions of that authorisation;
            (b)    the aquatic animals being moved originate from a Member State, zone or
                   compartment which complies with one of the following:
                   (i)   it has disease-free status for the category B or category C diseases for
                         which the Member State, zone or compartment of destination has
                         obtained disease-free status or for which it is subject to an eradication
                         programme ; or
                   (ii)  it is subject to an eradication programme for a category B disease or
                         category C disease, when the aquatic animals are destined for an
                         aquaculture establishment which is also subject to an eradication
                         programme for the same category B disease or category C disease;
EN                                                  18                                               EN
 ---pagebreak---            (c)    where the Member States of destination have taken national measures, the
                  aquatic animals of the relevant species comply with the health guarantees
                  which are necessary to comply with those national measures;
           (d)    where the aquaculture animals are moved from aquaculture establishments
                  other than those referred to in paragraph 2(a)(iii), a documentary check of the
                  mortality, movements, health and production records of the aquaculture
                  establishment has been completed and it indicates that there is no suspicion of
                  a listed disease or emerging disease in the aquaculture establishment.
                                               Article 14
   Information to be contained in self-declaration documents for different species and categories
                                        of aquaculture animals
   1.      Operators shall ensure that self-declaration documents for movements of aquaculture
           animals from their place of origin in one Member State to their place of destination
           in another Member State, issued in accordance with Article 218 of Regulation (EU)
           2016/429, contain the following information:
           (a)    the specific information referred to in paragraphs 2 and 3 of this Article, as
                  relevant for the category of aquaculture animal in question;
           (b)    the general information specified in paragraph 1 of Part B of Annex II;
           (c)    details of the purpose for which the aquaculture animals are to be used in
                  accordance with paragraph 2 of Part B of Annex II.
   2.      In addition to the requirements of paragraph 1, operators shall ensure that self-
           declaration documents for aquaculture animals of listed species include the following
           specific information:
           (a)    a declaration that the aquaculture animals being moved show no disease
                  symptoms and they originate from either:
                  (i)    an aquaculture establishment where there are no increased mortalities
                         with an undetermined cause; or
                  (ii)   a part of the aquaculture establishment which is independent of the
                         epidemiological unit where increased mortalities or other disease
                         symptoms have occurred, where the Member State of destination and the
                         Member State(s) of transit, if there are any such Member States, have
                         given consent for such a movement to occur;
           (b)    where the aquaculture animals are intended for an aquaculture establishment
                  which is participating in a surveillance programme for a specified category C
                  disease, a declaration that the aquaculture animals originate from an
                  aquaculture establishment:
                  (i)    which is participating in a surveillance programme for that specified
                         category C disease; and
                  (ii)    where there has been no suspicion or confirmation of the presence of
                         that specified category C disease and this is supported by the sampling
                         and laboratory data referred to in paragraph 1(f) of Part B of Annex II.
   3.      In addition to the requirements of paragraph 1 of this Article, operators shall ensure
           that the self-declaration documents for aquaculture animals of non-listed species and
           for aquaculture animals of species listed in column 4 of the table in the Annex to
EN                                                 19                                             EN
 ---pagebreak---             Implementing Regulation (EU) 2018/1882 which are not regarded as vectors of the
            relevant category C disease, contain information indicating that the aquaculture
            animals being moved show no disease symptoms; and they originate from either:
                   (a)    an aquaculture establishment or a habitat where there are no increased
                          mortalities with an undetermined cause; or
                   (b)    a part of the aquaculture establishment which is independent of the
                          epidemiological unit where increased mortalities or other disease
                          symptoms have occurred where the Member State of destination and the
                          Member State(s) of transit, if there are any such Member States, have
                          given consent for such a movement.
                                                SECTION 3
    RULES ON THE RESPONSIBILITY OF THE COMPETENT AUTHORITY FOR ANIMAL
                                       HEALTH CERTIFICATION
                                                 Article 15
    Rules concerning the responsibility of the competent authority for animal health certification
   1.       Before signing an animal health certificate as provided for in Article 216(2)(a) of
            Regulation (EU) 2016/429, the official veterinarian shall carry out the following
            checks and examinations in the aquaculture establishment:
            (a)    a documentary check of the mortality records, movement records and health
                   and production records kept at the aquaculture establishment; and
            (b)    a clinical inspection and where relevant, a clinical examination of:
                   (i)    the aquaculture animals to be moved;
                   (ii)   any moribund aquaculture animals which are observed in production
                          units other than those in which the aquaculture animals referred to in
                          point (i) are kept;
                   (iii) aquaculture animals from any production unit in the aquaculture
                          establishment where the documentary check has raised any suspicion of
                          the presence of a listed disease or an emerging disease.
   2.       By way of derogation from paragraph 1(b), in the case of eggs and molluscs, a
            clinical inspection may be omitted when a consignment is to be moved from the
            aquaculture establishment within a period of 4 weeks from the date on which the last
            clinical inspection was completed, provided that a documentary check as referred to
            in paragraph 1(a) is carried out within the 72 hours prior to the time the consignment
            is to be moved, and this documentary check indicates that:
            (a)    no movements of listed species have taken place to the aquaculture
                   establishment since the last clinical inspection was carried out; and
            (b)    there is no suspicion of listed or emerging diseases in the aquaculture
                   establishment.
   3.       The official veterinarian shall, after completing the checks, inspections and where
            relevant, examinations provided for in paragraph 1, issue an animal health certificate
            for the consignment of aquaculture animals or eggs within a period of 72 hours
            before the time of departure of the consignment from the establishment of origin.
EN                                                   20                                            EN
 ---pagebreak---    4.      The animal health certificate, as provided for in Article 216(2)(a) of Regulation (EU)
           2016/429, shall be valid for a period of 10 days from the date on which it is issued by
           the official veterinarian.
           By way of derogation from the first subparagraph, in the case of transport by
           waterway or sea of aquaculture animals, that period of 10 days may be extended by
           the period of the duration of the journey by waterway or sea.
                                              Article 16
    Derogations from certain requirements in relation to clinical examinations and certification
                                          prior to movement
   1.      By way of derogation from Article 15(3), the period within which the official
           veterinarian shall carry out the clinical inspection and where relevant, the clinical
           examination, and issue an animal health certificate for aquaculture animals of listed
           species other than those referred to in Article 15(2), may be extended from a period
           of 72 hours to a period of 7 days prior to the date of departure from the aquaculture
           establishment of origin, under the following circumstances:
           (a)   multiple movements of the same species of aquaculture animals occur from the
                 same aquaculture establishment of origin to the same aquaculture
                 establishment of destination and the movements take place not more than 7
                 days apart;
           (b)   a documentary check of the mortality records, movement records, health and
                 production records is made prior to the movement of each consignment, and a
                 clinical inspection and where necessary, a clinical examination, is carried out
                 within the period of 72 hours prior to the time of the first movement and at
                 least every 7 days thereafter, until such time as the last of the movements
                 referred to in point (a) have taken place;
           (c)   each consignment is fully traceable.
   2.      The official veterinarian shall issue an animal health certificate as provided for in
           Article 216(2)(a) of Regulation (EU) 2016/429, for each consignment which is
           moved during the 7 day period between clinical inspections as referred to in
           paragraph 1 of this Article, subject to compliance with the following conditions:
           (a)   no movements of listed species have taken place to the aquaculture
                 establishment since the last clinical inspection was carried out; and
           (b)   there is no suspicion of a listed disease or emerging disease in the aquaculture
                 establishment.
                                             SECTION 4
   DETAILED RULES ON THE NOTIFICATION OF MOVEMENTS OF AQUATIC ANIMALS
                                              Article 17
    Advance notification of movements to another Member State of aquaculture animals from an
      aquaculture establishment subject to a surveillance programme for a category C disease
   Operators of establishments implementing a surveillance programme for a specified category
   C disease in accordance with Article 3(2)(b)(iv) of Delegated Regulation (EU)
   …./…[Publications Office please insert reference to SANTE/7066/2019, C(2019)4056], who
   are moving aquaculture animals to another aquaculture establishment implementing a
EN                                                21                                               EN
 ---pagebreak---    surveillance programme for the same category C disease in another Member State, shall
   notify the competent authority in their Member State of origin in advance of the intended
   movement.
                                                Article 18
       Information obligation of operators concerning the notification of movements of aquatic
                                   animals to another Member State
   Operators required to notify the competent authority in their Member State of origin of
   movements of consignments of aquatic animals to another Member State, in accordance with
   Article 219 of Regulation (EU) 2016/429, shall provide that competent authority with the
   following information concerning such consignments set out in:
   (a)      paragraphs 1 and 3 of Part A of Annex II concerning aquaculture animals, other than
            those referred to in point (c) of this Article to be moved to another Member State;
   (b)      paragraphs 2 and 3 of Part A of Annex II concerning wild aquatic animals to be
            moved to another Member State;
   (c)      Part B of Annex II concerning the aquaculture animals referred to in Article 17, to be
            moved to another Member State.
                                                Article 19
   Information obligation of the competent authority concerning the notification of movements of
                               aquatic animals to another Member State
   1.       The competent authority of the Member State of origin required to notify the
            competent authority of the Member State of destination of movements of
            consignments of aquatic animals to another Member State, in accordance with
            Article 220(1) of Regulation (EU) 2016/429, shall provide the competent authority
            with the following information concerning such consignments set out in:
            (a)    paragraphs 1and 3 of Part A of Annex II concerning aquaculture animals,
                  other than those referred to in point (c) of Article 18 to be moved to another
                  Member State;
            (b)   paragraphs 2 and 3 of Part A of Annex II concerning wild aquatic animals to be
                  moved to another Member State.
   2.       The competent authority of the Member State of origin shall notify the competent
            authority of the Member State of destination of movements of the aquaculture
            animals referred to in Article 17, confirm the participation of the aquaculture
            establishment in the surveillance programme referred to in that Article and provide
            the information set out in Part B of Annex II.
                                                Article 20
    The emergency procedures for the notification of movements of aquatic animals between the
            Member States in the event of power cuts and other disturbances of TRACES
   In the event of the unavailability of TRACES, the competent authority of the Member State of
   origin of the aquatic animals to be moved to another Member State, shall comply with the
   contingency arrangements established pursuant to Article 46 of Implementing Regulation
   (EU) 2019/1715.
EN                                                  22                                             EN
 ---pagebreak---                                                Article 21
            Designation of regions for the management of notifications of movements
   Member States shall designate regions of their territory for the management of notifications of
   movements of aquatic animals to other Member States, as provided for in Articles 17, 18 and
   19.
   When designating those regions, the Member States shall ensure that:
   (a)    all parts of their territory are covered by at least one designated region;
   (b)    each designated region falls within the responsibility of a competent authority
          designated for animal health certification purposes in that designated region;
   (c)    the competent authority responsible for the designated region has access to
          TRACES;
   (d)    the personnel of the competent authority responsible for the designated region
          possess the appropriate ability and knowledge, and have received specific training, or
          have equivalent practical experiences in the use of TRACES for the production,
          handling and transmission of the information provided for in Articles 17, 18 and 19.
EN                                                 23                                              EN
 ---pagebreak---              PART III PRODUCTION, PROCESSING AND
    DISTRIBUTION OF PRODUCTS OF ANIMAL ORIGIN
       FROM AQUACULTURE ANIMALS, OTHER THAN
                       LIVE AQUACULTURE ANIMALS
                                                Article 22
     Obligations of operators moving products of animal origin from aquaculture animals other
           than live aquaculture animals, for further processing in a Member State, zone or
         compartment which has obtained disease-free status or is subject to an eradication
                                               programme
   1.        When they are intended for further processing, operators shall only move products of
             animal origin from aquaculture animals other than live aquaculture animals, of
             species listed in column 3 of the table in the Annex to Implementing Regulation
             (EU) 2018/1882 for the category B or category C diseases for which the Member
             State, zone or compartment of destination has obtained disease-free status, or for
             which it is subject to an eradication programme, if they originate from a Member
             State, zone or compartment which is free from the diseases in question.
   2.        By way of derogation from paragraph 1, the following products of animal origin
             from aquaculture animals of listed species other than live aquaculture animals, shall
             not be required to comply with that paragraph 1:
             (a)   fish intended for human consumption which are slaughtered and eviscerated
                   before the movement;
             (b)   products of animal origin which are destined for a disease control aquatic food
                   establishment.
                                                Article 23
     Obligations of operators moving products of animal origin from aquaculture animals other
                 than live aquaculture animals, from certain establishments and zones
   Operators shall only move products of animal origin from aquaculture animals other than live
   aquaculture animals, originating from establishments and zones that are subject to the
   emergency measures concerning the listed and emerging diseases referred to in Article
   222(2)(a) of Regulation (EU) 2016/429, or the movement restrictions referred to in Article
   222(2)(b) thereof, to another Member State, zone or compartment, subject to compliance with
   the following conditions:
   (a)       the movements are authorised by the competent authority of the place of destination;
             and
   (b)       the products of animal origin in question comply with the conditions attached to the
             authorisation referred to in point (a).
                                                Article 24
    Specific transport and labelling requirements for products of animal origin from aquaculture
                             animals, other than live aquaculture animals
   Operators, including transporters, shall ensure that consignments of products of animal origin
   from aquaculture animals other than live aquaculture animals, as referred to in Articles 22 and
EN                                                   24                                            EN
 ---pagebreak---    23 of this Regulation, that are required to be accompanied by an animal health certificate in
   accordance with Article 223(1) of Regulation (EU) 2016/429, comply with the following
   requirements:
   (a)      the consignments are traceable during transport;
   (b)      the consignments are identified by means of a legible label which is displayed in a
            visible position in the means of transport or container, as practicable, or in the case of
            transport by sea, by an entry in the ship’s manifest; and the label or manifest must
            contain the information necessary to link the consignment to the animal health
            certificate.
                                               Article 25
        Contents of animal health certificates for products of animal origin from aquaculture
              animals, other than live aquaculture animals, as referred to in Article 22
   The animal health certificate issued by the competent authority for movements of products of
   animal origin from aquaculture animals, other than live aquaculture animals, in accordance
   with Article 223(4) of Regulation (EU) 2016/429 shall, for the products referred to in Article
   22 of this Regulation, in addition to the information set out in Article 224 of that Regulation,
   contain the following:
   (a)      the general information specified in paragraph 1 of Annex III;
   (b)      details of the purpose for which the products of animal origin are to be used in
            accordance with paragraph 2 of Annex III;
   (c)      an attestation signed by the official veterinarian certifying that the products of animal
            origin from the aquaculture animals in question comply with the requirements laid
            down in Article 22(1).
                                               Article 26
   Contents of animal health certificates for products of animal origin from aquaculture animals
                   other than live aquaculture animals, as referred to in Article 23
   The animal health certificate issued by the competent authority of the Member State of origin
   for movements of products of animal origin from aquaculture animals other than live
   aquaculture animals, in accordance with Article 223(4) of Regulation (EU) 2016/429 shall, in
   addition to the information set out in Article 224 of that Regulation, contain:
   (a)      the general information specified in paragraph 1 of Annex III;
   (b)      details of the purpose for which the products of animal origin are to be used in
            accordance with paragraph 2 of Annex III;
   (c)      an attestation signed by the official veterinarian as referred to in paragraph 3 of
            Annex III certifying compliance with the conditions laid down in point (b) of Article
            23.
                                               Article 27
    Information obligation of operators concerning the notification of movements of products of
   animal origin from aquaculture animals other than live aquaculture animals between Member
                                                 States
   Operators, in notifications of movements of products of animal origin from aquaculture
   animals other than live aquaculture animals to other Member States, as provided for in Article
EN                                                 25                                                  EN
 ---pagebreak---    225(1) of Regulation (EU) 2016/429, shall provide the competent authority of the Member
   State of origin with the information set out in Annex III to this Regulation for each
   consignment of products of animal origin from aquaculture animals other than live
   aquaculture animals.
                                              Article 28
   Information obligation of the competent authority concerning the notification of movements of
      products of animal origin from aquaculture animals other than live aquaculture animals
                                        between Member States
   The competent authority of the Member State of origin, notifying the competent authority of
   the Member State of destination of movements of products of animal origin from aquaculture
   animals other than live aquaculture animals, in accordance with Article 225(2) of Regulation
   (EU) 2016/429, shall provide the information set out in Annex III to this Regulation for each
   consignment of products of animal origin from aquaculture animals other than live
   aquaculture animals.
                                              Article 29
                                        Emergency procedures
    In the event of the unavailability of TRACES, the competent authority of the Member State
   of origin of the products of animal origin from aquaculture animals other than live
   aquaculture animals, to be moved to another Member State, shall comply with the
   contingency arrangements established pursuant to Article 46 of Implementing Regulation
   (EU) 2019/1715.
EN                                                26                                             EN
 ---pagebreak---                          PART IV FINAL PROVISIONS
                                               Article 30
   This Regulation shall enter into force on the twentieth day following that of its publication in
   the Official Journal of the European Union.
   It shall apply from 21 April 2021.
   This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 28.4.2020
                                                 For the Commission
                                                 The President
                                                 Ursula VON DER LEYEN
EN                                                 27                                               EN
 ---documentbreak---                            EUROPEAN
                           COMMISSION
                                                     Brussels, 28.4.2020
                                                     C(2020) 2568 final
                                                     ANNEXES 1 to 3
                                        ANNEXES
                                           to the
                  COMMISSION DELEGATED REGULATION (EU) …/...
      supplementing Regulation (EU) 2016/429 of the European Parliament and of the
   Council, as regards animal health and certification requirements for movements within
     the Union of aquatic animals and products of animal origin from aquatic animals
EN                                                                                       EN
 ---pagebreak---                                                      ANNEX I
       Vector species listed in column 4 of the table in the Annex to Implementing Regulation
     (EU) 2018/18821 and the conditions under which those species shall be regarded as vectors
                                          for the purposes of movement
                                                            Conditions related to movements from the
                                                            place of origin of aquatic animals of the vector
       List of diseases             Vector species          species listed in column 4 of the table in the
                                                            Annex to Implementing Regulation (EU)
                                                            2018/1882
                                As listed in column 4
                                                            Aquatic animals of the species listed in column
                                of the table in the
   Epizootic                                                4 of the table in the Annex to Implementing
                                Annex to
   haematopoietic                                           Regulation (EU) 2018/1882 shall be regarded
                                Implementing
   necrosis                                                 as vectors of epizootic haematopoietic necrosis
                                Regulation (EU)
                                                            under all conditions.
                                2018/1882
                                                            Aquatic animals of the species listed in
                                                            column 4 of the table in the Annex to
                                                            Implementing Regulation (EU) 2018/1882 shall
                                As listed in column         be regarded as vectors of viral haemorrhagic
                                4 of the table in the       septicaemia when they originate from:
   Viral haemorrhagic           Annex to
                                                            (a) an aquaculture establishment or group of
   septicaemia                  Implementing
                                                            aquaculture establishments where species listed
                                Regulation (EU)
                                                            in column 3 of that table are kept; or
                                2018/1882
                                                            (b) the wild, where they may have been
                                                            exposed to species listed in column 3 of that
                                                            table.
                                                            Aquatic animals of the species listed in
                                                            column 4 of the table in the the Annex to
                                                            Implementing Regulation (EU) 2018/1882 shall
                                As listed in column 4       be regarded as vectors of infectious
                                of the table in the         haematopoietic necrosis when they originate
   Infectious
                                Annex to                    from:
   haematopoietic
                                Implementing
   necrosis                                                 (a) an aquaculture establishment or group of
                                Regulation (EU)
                                                            aquaculture establishments where species listed
                                2018/1882
                                                            in column 3 of that table are kept; or
                                                            (b) the wild where they may have been exposed
                                                            to species listed in column 3 of that table.
    1
             Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of
             certain disease prevention and control rules to categories of listed diseases and establishing a list of
             species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L
             308,4.12.2018, p.21).
EN                                                         1                                                          EN
 ---pagebreak---                                                 Conditions related to movements from the
                                                place of origin of aquatic animals of the vector
      List of diseases        Vector species    species listed in column 4 of the table in the
                                                Annex to Implementing Regulation (EU)
                                                2018/1882
   Infection with highly No vector species
   polymorphic region    listed for infection
   (HPR) deleted         with HPR deleted
   infectious salmon     infectious salmon
   anaemia virus         anaemia virus.
                         No vector species
   Infection with        listed for infection
   Mikrocytos mackini    with Mikrocytos
                         mackini
                         As listed in column 4  Aquatic animals of the species listed in
                         of the table in the    column 4 of the table in the Annex to
                         Annex to               Implementing Regulation (EU) 2018/1882 shall
                         Implementing           be regarded as vectors of infection with
                         Regulation (EU)        Perkinsus marinus when they originate from:
   Infection with
                         2018/1882
   Perkinsus marinus                            (a) an aquaculture establishment or group of
                                                aquaculture establishments where species listed
                                                in column 3 of that table are kept; or
                                                (b) the wild where they may have been exposed
                                                to species listed in column 3 of that table.
                                                Aquatic animals of the species listed in
                                                column 4 of the table in the Annex to
                                                Implementing Regulation (EU) 2018/1882 shall
                         As listed in column 4
                                                be regarded as vectors of infection with
                         of the table in the
                                                Bonamia ostreae when they originate from:
   Infection with        Annex to
   Bonamia ostreae       Implementing           (a) an aquaculture establishment or group of
                         Regulation (EU)        aquaculture establishments where species listed
                         2018/1882              in column 3 of that table are kept;or
                                                (b) the wild where they may have been exposed
                                                to species listed in column 3 of that table.
EN                                             2                                                 EN
 ---pagebreak---                                                Conditions related to movements from the
                                               place of origin of aquatic animals of the vector
      List of diseases      Vector species     species listed in column 4 of the table in the
                                               Annex to Implementing Regulation (EU)
                                               2018/1882
                                               Aquatic animals of the species listed in
                                               column 4 of the table in the Annex to
                                               Implementing Regulation (EU) 2018/1882 shall
                        As listed in column 4
                                               be regarded as vectors of infection with
                        of the table in the
                                               Bonamia exitiosa when they originate from:
   Infection with       Annex to
   Bonamia exitiosa     Implementing           (a) an aquaculture establishment or group of
                        Regulation (EU)        aquaculture establishments where species listed
                        2018/1882              in column 3 of that table are kept; or
                                               (b) the wild where they may have been exposed
                                               to species listed in column 3 of that table.
                                               Aquatic animals of the species listed in
                                               column 4 of the table in the Annex to
                                               Implementing Regulation (EU) 2018/1882 shall
                        As listed in column 4
                                               be regarded as vectors of infection with
                        of the table in the
                                               Marteilia refringens when they originate from:
   Infection with       Annex to
   Marteilia refringens Implementing           (a) an aquaculture establishment or group of
                        Regulation (EU)        aquaculture establishments where species listed
                        2018/1882              in column 3 of that table are kept; or
                                               (b) the wild where they may have been exposed
                                               to species listed in column 3 of that table.
                                               Aquatic animals of the species listed in column
                                               4 of the table in the Annex to Implementing
                                               Regulation (EU) 2018/1882 shall be regarded
                        As listed in column 4
                                               as vectors of infection with Taura syndrome
                        of the table in the
                                               virus when they originate from:
   Infection with Taura Annex to
   syndrome virus       Implementing           (a) an aquaculture establishment or group of
                        Regulation (EU)        aquaculture establishments where species listed
                        2018/1882              in column 3 of that table are kept; or
                                               (b) the wild where they may have been exposed
                                               to species listed in column 3 of that table.
EN                                            3                                                 EN
 ---pagebreak---                                                 Conditions related to movements from the
                                                place of origin of aquatic animals of the vector
      List of diseases       Vector species     species listed in column 4 of the table in the
                                                Annex to Implementing Regulation (EU)
                                                2018/1882
                                                Aquatic animals of the species listed in
                                                column 4 of the table in the Annex to
                                                Implementing Regulation (EU) 2018/1882 shall
                         As listed in column 4
                                                be regarded as vectors of infection with yellow
                         of the table in the
                                                head virus when they originate from:
   Infection with yellow Annex to
   head virus            Implementing           (a) an aquaculture establishment or group of
                         Regulation (EU)        aquaculture establishments where species listed
                         2018/1882              in column 3 of that table are kept; or
                                                (b) the wild where they may have been exposed
                                                to species listed in column 3 of that table.
                                                Aquatic animals of the species listed in
                                                column 4 of the table in the Annex to
                                                Implementing Regulation (EU) 2018/1882 shall
                         As listed in column 4
                                                be regarded as vectors of infection with white
                         of the table in the
                                                spot syndrome virus when they originate from:
   Infection with white  Annex to
   spot syndrome virus   Implementing           (a) an aquaculture establishment or group of
                         Regulation (EU)        aquaculture establishments where species listed
                         2018/1882              in column 3 of that table are kept; or
                                                (b) the wild where they may have been exposed
                                                to species listed in column 3 of that table.
EN                                             4                                                 EN
 ---pagebreak---                                               ANNEX II
    A. Information to be contained in the animal health certificate or notification for aquatic
                                                animals
   1.      The animal health certificate or notification for aquaculture animals shall contain at
           least the following information:
           (a)    the name and address of the consignor and the consignee;
           (b)    the name and address of the establishment of origin, and
                  (i)    where the establishment of origin is an approved establishment, the
                         unique approval number of that approved establishment; or
                  (ii)   where the establishment of origin is a registered establishment, the
                         unique registration number of that registered establishment;
           (c)    the name and address of the establishment of destination, and
                  (i)    where the establishment of destination is an approved establishment, the
                         unique approval number of that approved establishment; or
                  (ii)   where the establishment of destination is a registered establishment, the
                         unique registration number of that registered establishment;
                  (iii) where the place of destination is a habitat, the location where animals are
                         intended to be unloaded;
           (d)    the name and address of the transporter;
           (e)    the scientific name of the species and number, volume or weight of the
                  aquaculture animals, as appropriate to their life stage ;
           (f)    the date, time and place of issue, and the period of validity of the animal health
                  certificate and the name, the capacity and signature of the official veterinarian,
                  and the stamp of the competent authority of the place of origin of the
                  consignment;
           (g)    where this is relevant, confirmation that the agreement of the competent
                  authority of the receiving Member State has been obtained.
   2.      The animal health certificate or notification for movements of wild aquatic animals
           shall contain at least the following information:
           (a)    the name and address of the consignor and the consignee;
           (b)    the location where animals were caught and loaded for dispatch;
           (c)    the place of destination, and
                  (i)    where the place of destination is a habitat, the location where animals are
                         intended to be unloaded; or
                  (ii)   where the establishment of destination is a registered establishment, the
                         unique registration number of that registered establishment;
           (d)    the name and address of the transporter;
           (e)    the scientific name of the species and the number, volume or weight of the wild
                  aquatic animals, as appropriate to their life stage;
EN                                                 5                                                 EN
 ---pagebreak---            (f)   the date, time and place of issue, and the period of validity of the animal health
                 certificate and the name, capacity and signature of the official veterinarian, and
                 the stamp of the competent authority of the place of origin of the consignment;
           (g)   where this is relevant, confirmation that the agreement of the competent
                 authority of the receiving Member State has been obtained.
   3.      The animal health certificate or notification for movements of aquatic animals shall
           contain details of the purpose for which the aquatic animals are intended and specify
           one of the following purposes:
           (a)   further keeping;
           (b)   release into the wild;
           (c)   relaying;
           (d)   quarantine;
           (e)   ornamental purposes;
           (f)   fishing bait;
           (g)   destruction or slaughter having originated from an area subject to disease
                 control measures;
           (h)   slaughter and further processing;
           (i)   human consumption;
           (j)   purification centres;
           (k)   dispatch centres;
           (l)   research purposes;
           (m) other (to be specified).
    B. Information to be contained in the self-declaration document for aquaculture animals
                                  moved to another Member State
   1.      The self-declaration document for aquaculture animals including aquaculture animals
           intended for human consumption shall contain at least the following information:
           (a)   the name and address of the consignor and the consignee;
           (b)   the name and address of the establishment of origin, and
                 (i)    where the establishment of origin is an approved establishment, the
                        unique approval number of that approved establishment; or
                 (ii)   where the establishment of origin is a registered establishment, the
                        unique registration number of that registered establishment;
           (c)   the name and address of the establishment of destination, and
                 (i)    where the establishment of destination is an approved establishment, the
                        unique approval number of that approved establishment; or
                 (ii)   where the establishment of destination is a registered establishment, the
                        unique registration number of that registered establishment;
           (d)   the name and address of the transporter;
EN                                                6                                                 EN
 ---pagebreak---       (e)   the species and number, volume or weight of the aquaculture animals, as
            appropriate to their life stage;
      (f)   the date on which the last sample was taken in compliance with Part III of
            Annex VI to Commission Delegated Regulation (EU) …./….[Publications
            Office please insert reference to SANTE/7066/2019, C(2019)4056] and the
            results from the testing of that sample, when the aquaculture animals are
            destined for an establishment in another Member State which is implementing
            a surveillance program for a certain category C disease or diseases;
      (g)   the date and time of dispatch of the consignment.
   2. The self-declaration documents for movements of aquaculture animals including
      aquaculture animals intended for human consumption, shall contain details of the
      purpose for which the aquaculture animals are intended to be used and specify one of
      the following purposes:
      (a)   further keeping;
      (b)   release into the wild;
      (c)   relaying;
      (d)   quarantine;
      (e)   ornamental purposes;
      (f)   slaughter and further processing;
      (g)   human consumption;
      (h)   purification centres;
      (i)   dispatch centres;
      (j)   research purposes;
      (k)   other (to be specified).
EN                                           7                                             EN
 ---pagebreak---                                               ANNEX III
    Information to be contained in the animal health certificate or notification for products of
          animal origin from aquaculture animals other than live aquaculture animals
   1.      The animal health certificate or notification for products of animal origin from
           aquaculture animals other than live aquaculture animals shall contain at least the
           following information:
           (a)    the name and address of the consignor and the consignee;
           (b)    the name and address of the establishment or place of origin, and
                  (i)    where the establishment of origin is an approved establishment, the
                         unique approval number of that approved establishment; or
                  (ii)   where the establishment of origin is a registered establishment, the
                         unique registration number of that registered establishment;
           (c)    the name and address of the establishment or place of destination, and
                  (i)    where the establishment of destination is an approved establishment , the
                         unique approval number of that approved establishment; or
                  (ii)   where the establishment of destination is a registered establishment, the
                         unique registration number of that registered establishment;
           (d)    the scientific name of the species of aquaculture animals from which the
                  products of animal origin originate, and the number, volume or weight of the
                  products of animal origin, as appropriate;
           (e)    the date, time and place of issue, and the period of validity of the animal health
                  certificate and the name, capacity and signature of the official veterinarian, and
                  the stamp of the competent authority of the place of origin of the consignment.
   2.      The animal health certificate or notification for movements of products of animal
           origin from aquaculture animals other than live aquaculture animals shall contain
           details of the purpose for which the products are intended to be used and specify one
           of the following purposes:
           (a)    direct human consumption;
           (b)    processing at a disease control aquatic food establishment;
           (c)    other (to be specified).
   3.      The attestation to be contained in the animal health certificate for products of animal
           origin from aquaculture animals other than live aquaculture animals, which are to be
           moved from a restricted zone shall be as follows:
           “Products of animal origin complying with the conditions set out in the authorisation
           [xxx, including the name and date of publication of the relevant legal act] concerning
           disease control measures against [insert the name of the relevant disease] in [insert
           details of the restricted zone of origin]”
EN                                                 8                                                 EN