CELEX: 
Language: en
Date: 2020-01-30 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for aquaculture establishments and transporters of aquatic animals

EUROPEAN
                            COMMISSION
                                                     Brussels, 30.1.2020
                                                     C(2020) 415 final
                 COMMISSION DELEGATED REGULATION (EU) …/...
                                         of 30.1.2020
   supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as
      regards rules for aquaculture establishments and transporters of 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, including,
   inter alia, rules for the registration and approval of aquaculture establishments, record-
   keeping obligations of transporters of aquatic animals, as well as rules on the traceability of
   kept aquatic animals within the Union.
   Regulation (EU) 2016/429 also provides for the Commission to adopt delegated acts under
   Chapter 1 of Title II of Part IV thereof, supplementing those rules.
   The rules laid down in this Delegated Regulation largely replicate rules currently laid down in
   existing Union acts, in particular in Council Directive 2006/88/EC2 and rules adopted on the
   basis of that act, as they have proven to be effective in preventing the spread of listed diseases
   within the Union. However, they have been updated in certain respects to take account of
   experience gained in their application, and the new legislative framework established by
   Regulation (EU) 2016/429.
   Accordingly, this Delegated Regulation lays down the following supplementing rules for:
   (a)       the approval of certain aquaculture establishments keeping aquaculture animals
             posing a significant animal health risk;
   (b)       the information to be included in the registers of registered and approved aquaculture
             establishments to be kept by the competent authorities;
   (c)       record-keeping obligations of operators of aquaculture establishments and
             transporters of aquatic animals intended for those establishments and for release into
             the wild;
   (d)       transitional measures in order to protect the acquired rights and legitimate
             expectations of stakeholders resulting from pre-existing Union acts.
   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. No comments were received from the European
   Parliament or the Council. A number of meetings have been 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 in the context of 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 28 October
   2019 and 25 November 2019. Feedback was received from 2 citizens and the following 7
   organisations: Associazione Piscicoltori Italiani (API) (IT), Comité Interprofessionnel des
   1
           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---    Produits de L’Aquaculture (CIPA) (FR), Federation of European Aquaculture Producers
   (FEAP) (BE), European Association of Zoos and Aquaria (EAZA) (NL), Danish Aquaculture
   Organisation (DK), Ornamental Fish International (OFI) (NL), Department of Environment,
   Food and Rural Affairs (Defra) (UK).
   The main requests and points made were as follows:
            –    aquaculture establishments keeping fish for release into the wild should not be
                 derogated from the requirement to be approved;
            –    the public register of establishments should not include information relating to
                 the economic situation of the operators;
            –    the request for clarification in relation to movements between aquaria and
                 confined establishments;
            –    the request for clarification in relation to aquaculture establishments which are
                 closed facilities keeping aquaculture animals for ornamental purposes, and the
                 specific movement conditions that would require these establishments to be
                 approved;
            –    the measures to be considered in the biosecurity plan for aquaculture
                 establishments are somewhat ambitious and inflexible;
            –    the request for an implementing act to derogate certain low risk businesses
                 from the requirement to be registered.
   3.       LEGAL ELEMENTS OF THE DELEGATED ACT
   This Delegated Regulation is to be adopted within the framework of Regulation (EU)
   2016/429, and in particular pursuant to Articles 176(4), 181(2), 185(5), 189(1) and 279(2)
   thereof.
EN                                                 2                                               EN
 ---pagebreak---                     COMMISSION DELEGATED REGULATION (EU) …/...
                                                 of 30.1.2020
    supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as
       regards rules for aquaculture establishments and transporters of 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')5, and in particular Articles 176(4), 181(2),
   185(5), 189(1) and 279(2) thereof,
   Whereas:
   (1)    Regulation (EU) 2016/429 lays down rules for the prevention and control of diseases
          which are transmissible to animals or humans, including inter alia rules for
          aquaculture establishments, and for transporters of aquatic animals. Regulation (EU)
          2016/429 also provides for the Commission to adopt delegated acts in order to
          supplement certain non-essential elements of that Regulation. It is therefore necessary
          to lay down supplementing rules in order to ensure the smooth functioning of the
          system established within the new legislative framework of Regulation (EU)
          2016/429.
   (2)    More particularly, the rules laid down in this Regulation should supplement those
          already laid down in Chapter 1 of Title II of Part IV of Regulation (EU) 2016/429, as
          regards the approval of aquaculture establishments keeping aquaculture animals
          posing a significant animal health risk, the registers of aquaculture establishments to
          be kept by competent authorities, and the record-keeping obligations of operators of
          aquaculture establishments and transporters of aquatic animals.
   (3)    In addition, this Regulation takes into account the repeal of Council Directive
          2006/88/EC6 by Regulation (EU) 2016/429 with effect from 21 April 2021. Regulation
          (EU) 2016/429 provides that establishments and operators registered or approved in
          accordance with that Directive, before the date of application of Regulation (EU)
          2016/429, are to be deemed to be registered or approved, as required, in accordance
          with that Regulation, and subject to the relevant obligations laid down therein.
   (4)    Accordingly, the rules laid down in this Regulation should supplement the rules laid
          down in Part IX of Regulation (EU) 2016/429, as regards the necessary transitional
   5
          OJ L 84, 31.3.2016, p. 1.
   6
          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                                                     3                                                         EN
 ---pagebreak---        measures to protect the acquired rights and legitimate expectations of stakeholders
       resulting from pre-existing Union acts with regard to aquaculture establishments.
   (5) As the rules laid down in this Regulation all relate to aquaculture establishments and
       transporters of aquatic animals and are to be applied in tandem, they should be set out
       in a single act rather than in separate acts with numerous cross-references, in order to
       facilitate their application, in the interests of transparency, and to avoid a duplication
       of rules. This is also in keeping with the approach adopted by Regulation (EU)
       2016/429.
   (6) Article 176(1) of Regulation (EU) 2016/429 provides that operators of aquaculture
       establishments are to apply to the competent authority for approval where they keep
       aquaculture animals with a view to those animals being moved therefrom, either alive
       or as products of aquaculture animal origin. As a wide variety of aquaculture
       establishments fall within that category, Article 176(2) of Regulation (EU) 2016/429
       provides that Member States may exempt operators of specific types of aquaculture
       establishments from the requirement for approval provided that such aquaculture
       establishments do not pose a significant disease risk. In addition, Article 176(4) of that
       Regulation provides that the Commission may adopt delegated acts concerning
       derogations from the requirement for approval for certain types of aquaculture
       establishments, again on the condition that those aquaculture establishments do not
       pose a significant risk.
   (7) The level of risk posed by an aquaculture establishment, depends on the activity of
       that aquaculture establishment and the destination and intended use of the aquaculture
       animals or products of aquaculture animal origin produced therein. Some aquaculture
       establishments have already been approved for different purposes, such as aquaculture
       establishments which have been approved under the hygiene rules in accordance with
       Regulation (EC) No 853/2004 of the European Parliament and of the Council 7. In
       certain situations, aquaculture establishments such as purification and dispatch centres
       or relaying areas only receive molluscs from within the epidemiological area in which
       the aquaculture establishment is itself located. These aquaculture establishments
       therefore, pose an insignificant risk from an animal health perspective. Other
       aquaculture establishments are also engaged in low risk activities, such as keeping
       aquaculture animals solely for release into the wild after having produced them from
       broodstock which originated from the water body on which the aquaculture
       establishment is located, or keeping aquaculture animals in extensive ponds for human
       consumption or for release into the wild.
   (8) It is necessary to lay down in this Regulation, the specific conditions under which
       derogations from the requirement for approval should be permitted for aquaculture
       establishments. In certain cases, derogations should only apply to aquaculture
       establishments which move aquaculture animals within their own Member State and
       not to aquaculture establishments which move aquaculture animals between Member
       States. In all cases, however, derogations from the requirement for an aquaculture
       establishment to be approved should only be considered when the competent authority
       has completed a risk assessment which takes into account at least the risk of
       aquaculture animals on the aquaculture establishment contracting or spreading an
       aquatic disease via water or via movements and where the risk has been found to be
       insignificant. Details of additional risk factors which the competent authority may take
   7
       Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying
       down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
EN                                                   4                                                   EN
 ---pagebreak---         into account in this risk assessment are set out in Chapter 2 of Part I of Annex VI to
        Commission Delegated Regulation (EU) …/… 8 [C(2019) 4056]. Therefore, the
        supplementing rules laid down in this Regulation should be consistent with those laid
        down in that Delegated Regulation.
   (9)  At the same time, certain other types of aquaculture establishments represent a
        significant risk for the spread of aquatic animal diseases. Such types of aquaculture
        establishment should be specifically described in this Regulation, and the requirement
        for the operators of these aquaculture establishments to be approved should be detailed
        in this Regulation. These include aquaculture establishments keeping ornamental
        aquaculture animals in open facilities and also in closed facilities where the movement
        patterns are such that trade within the Union or with third countries potentially present
        a disease risk. Other types of aquaculture establishments where the risk of disease
        spread should be mitigated through the requirement for approval by the competent
        authority, are quarantine establishments, establishments which keep vector species in
        isolation until such time as they are no longer considered to be vectors, and vessels
        and other mobile premises where aquaculture animals are treated or undergo other
        husbandry related procedures.
   (10) Article 177 of Regulation (EU) 2016/429 provides for the competent authority to grant
        approval of operators for groups of aquaculture establishments. The supplementing
        rules laid down in this Regulation should therefore apply to such groups where
        appropriate, and should set out the details of how the rules should apply directly to,
        and within, the group.
   (11) Operators of all aquaculture establishments or groups of aquaculture establishments
        are required to provide information to the competent authority with a view to
        obtaining approval in compliance with Article 180 of Regulation (EU) 2016/429. In
        that regard, operators should provide the competent authority with a written
        biosecurity plan which will be considered during the approval process. This
        requirement should apply to both individual aquaculture establishments and groups of
        aquaculture establishments regardless of their size, but the complexity of the
        biosecurity plan should depend upon the specificities of the individual aquaculture
        establishment or group thereof, and on the measures which are required to mitigate the
        associated disease risks.
   (12) Certain aquaculture establishments and groups of aquaculture establishments should,
        on the basis of the rules laid down in Chapter 1 of Part I to Annex VI of Commission
        Delegated Regulation (EU) …/… [C(2019)4056], participate in a risk-based
        surveillance scheme which is put in place by the competent authority in accordance
        with Article 26 of Regulation (EU) 2016/429. Without such participation, aquaculture
        establishments or groups of aquaculture establishments should not be approved. In line
        with Article 27 of Regulation (EU) 2016/429, risk-based surveillance may take into
        account the surveillance conducted by operators themselves in accordance with Article
        24, including the animal health visits referred to in Article 25 of that Regulation. Risk-
        based surveillance may also be carried out at the same time as surveillance connected
        with particular listed diseases, in order to maximise resources.
   (13) The frequency of risk-based surveillance should be based on the ranking of the
        aquaculture establishment by the competent authority as ‘high’, ‘medium’ or ‘low’
   8
        Commission Delegated Regulation (EU) …/… supplementing Regulation (EU) 2016/429 of the
        European Parliament and of the Council as regards rules for surveillance, eradication programmes and
        disease-free status for certain listed and emerging diseases [C(2019) 4056]
EN                                                       5                                                   EN
 ---pagebreak---         risk, following an assessment of the circumstances of the establishment. Factors to be
        taken into account and considered by the competent authority when risk ranking
        establishments, as well as the frequency of surveillance which attaches to each risk
        ranking are set out in Part I of Annex VI to Commission Delegated Regulation (EU)
        …/… [C(2019)4056]. The objective of including aquaculture establishments which
        keep non-listed species but which participate in a significant amount of trade and
        which are therefore ranked as ‘high’ risk, in the risk- based surveillance scheme, is to
        maximise the chances of identifying and controlling emerging diseases, should they
        appear in aquaculture animals of those non-listed species.
   (14) As risk-based surveillance is also carried out in approved groups of aquaculture
        establishments, it is important to set out how this should be completed at group level
        so that the outcome of the surveillance is epidemiologically meaningful. Accordingly,
        this Regulation should lay down rules concerning the approach which the competent
        authority should take to carrying out such surveillance.
   (15) Apart from the requirement for operators to present a biosecurity plan to the competent
        authority as part of the approval process, and for certain aquaculture establishments to
        participate in a risk-based surveillance scheme, the aquaculture establishments that are
        required to be approved should also meet certain requirements in relation to their
        facilities and equipment. The particular combination of requirements with regard to
        biosecurity, surveillance, and facilities and equipment which apply to a specific
        category of aquaculture establishment or to a specific category of group of aquaculture
        establishments should therefore, be set out in this Regulation.
   (16) Article 178 of Regulation (EU) 2016/429 provides that operators of aquaculture
        establishments wishing to obtain the status of a confined aquaculture establishment
        may only move aquaculture animals to or from their aquaculture establishments after
        they have obtained the approval of that status from the competent authority in
        accordance with the rules laid down in that Regulation. As these aquaculture
        establishments may exchange aquaculture animals amongst themselves with fewer
        movement requirements than for other types of aquaculture establishments, it is
        appropriate that they should have a contracted veterinarian who will supervise the
        activities of the aquaculture establishment and be responsible for its health
        surveillance, so they can provide robust health guarantees to each other. Article 181(2)
        of Regulation (EU) 2016/429 provides for the Commission to adopt delegated acts
        laying down supplementing rules for the approval of such aquaculture establishments,
        and such rules should be laid down in this Regulation.
   (17) Article 179 of Regulation (EU) 2016/429 provides for the approval of disease control
        aquatic food establishments. These aquaculture establishments facilitate the sanitary
        slaughter and sanitary processing of aquatic animals, which may be infected with a
        listed or emerging disease. Therefore, they represent a significant disease risk and
        should be approved by the competent authority. During the periods when these
        aquaculture establishments are receiving aquatic animals which are infected or
        suspected of being infected with a listed or emerging disease, they should comply with
        stringent biosecurity measures with the aim of ensuring that disease agents are not
        released into open waters without appropriate treatment. Article 181(2) of that
        Regulation provides for the Commission to adopt delegated acts laying down
        supplementing rules for the approval of these aquaculture establishments and
        accordingly those supplementing rules should be laid down in this Regulation.
EN                                               6                                               EN
 ---pagebreak---    (18) Certain purification centres, relaying areas, and dispatch centres for live molluscs
        should be considered as aquaculture establishments which require approval in
        accordance with Article 176(1) of Regulation (EU) 2016/429. Those establishments
        which receive live molluscs from outside their own epidemiological area, represent a
        higher risk of spreading listed or emerging diseases and should be treated as such
        during the approval process. This Regulation should therefore lay down
        supplementing rules in that respect.
   (19) Commission Implementing Regulation (EU) 2018/18829 lays down definitions for
        categories A, B, C, D and E diseases, and it 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 the Annex to Implementing Regulation
        (EU) 2018/1882. That table provides that certain species of aquatic animals which are
        listed in column 4 thereof are only to be considered as vectors when they are kept in an
        aquaculture establishment where the species listed in column 3 thereof are also kept,
        or in the case of wild aquatic animals, when they have been exposed to species listed
        in column 3 in a wild habitat. However, if these species are subsequently kept in
        isolation from the species listed in column 3 and from infected water sources for an
        appropriate period of time, they are no longer to be regarded as vectors. If this period
        of isolation cannot be carried out in a quarantine establishment approved in
        compliance with Article 15 of this Regulation, then such aquatic animals may instead,
        be kept in another type of aquaculture establishment which does not have all of the
        biosecurity measures which are required for quarantine establishments, but where they
        are kept in isolation from potential pathogens until such time as they are no longer to
        be regarded as vectors. Article 181(2) of Regulation (EU) 2016/429 provides for the
        Commission to adopt delegated acts laying down supplementing rules for the approval
        of such aquaculture establishments taking into account those requirements.
        Accordingly, those requirements should be laid down in this Regulation.
   (20) Article 185(5) of Regulation (EU) 2016/429 empowers the Commission to adopt
        delegated acts regarding additional information to be included in the registers of
        registered and approved aquaculture establishments kept by the competent authority
        and public access to those registers. Subject to the data protection requirements laid
        down in Regulation (EU) 2016/679 of the European Parliament and of the Council10,
        the information which should be made publicly available by the competent authority
        should reflect the requirements set out in Article 185(2)(a),(c),(e) and (f) of Regulation
        (EU) 2016/429 which in turn, largely reflect the details which Member States have
        already provided in a public register in compliance with Commission Decision
        2008/392/EC11.
   9
        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).
   10
        Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the
        protection of natural persons with regard to the processing of personal data and on the free movement of
        such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016,
        p. 1.)
   11
        Commission Decision 2008/392/EC of 30 April 2008 implementing Council Directive 2006/88/EC
        as regards an Internet-based information page to make information on aquaculture production
        businesses and authorised processing establishments available by electronic means (OJ L 138,
        28.5.2008, p. 12).
EN                                                      7                                                        EN
 ---pagebreak---    (21)  More specific information should, however, also be included in the public register of
         the competent authority regarding the health status of each approved establishment in
         order to facilitate safe trade and to ensure stakeholders know whether or not a given
         aquaculture establishment is free from a specific category B or C disease, is subject to
         an eradication programme for a specific category B or C disease, is in a surveillance
         programme for a specific category C disease, or if it has none of those health statuses.
         Given the scope of the requirements which are set out in this Regulation with regard to
         the public availability of information on approved aquaculture establishments, this
         Regulation should repeal Decision 2008/392/EC.
   (22)  Articles 186 and 187 of Regulation (EU) 2016/429 lay down the minimum record-
         keeping obligations for operators of aquaculture establishments. As aquatic animals
         are generally not individually identifiable, record-keeping in relation to their
         production and movement is crucial. Whilst there are some common elements between
         the records kept by operators of different types of aquaculture establishments, specific
         types of aquaculture establishments should keep records which are particular to them
         and the type of aquaculture activity they are engaged in. As Article 189(1) of that
         Regulation provides for the Commission to adopt delegated acts laying down
         supplementing rules for the record-keeping obligations, different record-keeping
         requirements should therefore, be set out in this Regulation for each type of approved
         aquaculture establishment.
   (23)  Article 188 of Regulation (EU) 2016/429 lays down the minimum record-keeping
         obligations for transporters of aquatic animals intended for aquaculture establishments
         and of aquatic animals which are moved between habitats. Transporters of aquatic
         animals represent a particular risk for the spread of disease and it is crucial that these
         operators keep records to ensure the traceability of the aquatic animals they transport,
         as well as to provide documentary evidence that they are employing appropriate
         biosecurity measures. Accordingly, this Regulation should lay down supplementing
         rules for their record-keeping obligations.
   (24)  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
   1.      This Regulation supplements the rules laid down in Regulation (EU) 2016/429 as
           regards registered and approved aquaculture establishments keeping aquaculture
           animals and transporters of aquatic animals.
   2.      Part II lays down requirements in:
           (a)    Chapter 1 of Title I, on the approval by the competent authority of aquaculture
                  establishments posing a significant risk for diseases affecting aquatic animals,
                  and certain derogations for operators of establishments that pose an
                  insignificant risk for those diseases;
EN                                                  8                                               EN
 ---pagebreak---             (b)    Chapter 2 of Title I, on the requirements for aquaculture establishments and
                   groups thereof, and the granting of approval by the competent authority;
            (c)    Chapter 1 of Title II, on the information obligations of the competent authority
                   as regards registers of aquaculture establishments registered in accordance with
                   Article 173 of Regulation (EU) 2016/429;
            (d)    Chapter 2 of Title II, on the information obligations of the competent authority
                   as regards registers of approved aquaculture establishments;
            (e)    Chapter 1 of Title III, for the record-keeping obligations of operators of
                   aquaculture establishments and disease control aquatic food establishments
                   registered or approved by the competent authority, in addition to those
                   provided for in Articles 186(1) and 187(1) of Regulation (EU) 2016/429;
            (f)    Chapter 2 of Title III, on the record-keeping obligations of transporters of
                   aquatic animals, in addition to those provided for in Article 188(1) of
                   Regulation (EU) 2016/429.
   3.       Part III lays down certain transitional measures as regard to Directive 2006/88/EC
            and Decision 2008/392/EC in relation to the registration and approval of aquaculture
            establishments.
                                                Article 2
                                               Definitions
   For the purposes of this Regulation, the definitions set out in Article 1 of Implementing
   Regulation (EU) 2018/1882 shall apply.
   The following definitions shall also apply:
   (1)      'extensive pond' means a traditional pond or lagoon which is natural or artificial and
            where the food source for the animals kept in these ponds or lagoons is natural other
            than in exceptional circumstances, and where no measures are taken to increase the
            production beyond the natural capacity of the environment;
   (2)      'purification centre’ means an establishment with tanks fed by clean seawater in
            which molluscs are placed for the time necessary to reduce contamination to make
            them fit for human consumption;
   (3)      ‘dispatch centre’ means an on-shore or off-shore establishment for the reception,
            conditioning, washing, cleaning, grading, wrapping and packaging of molluscs
            intended for human consumption;
   (4)      ‘relaying area’ means any freshwater, sea, estuarine or lagoon area with boundaries
            clearly marked and indicated by buoys, posts or any other fixed means, and used
            exclusively for the natural purification of molluscs;
   (5)       ‘in isolation’ means keeping aquaculture animals in an aquaculture establishment
            where they do not come into contact with any other species of aquatic animals either
            directly through co-habitation or indirectly through the water supply;
   (6)      ‘closed facility’ means an aquaculture establishment, the waste water from which, is
            subjected to treatment which is capable of inactivating agents of listed diseases or
            emerging diseases, before it is discharged into open waters;
EN                                                  9                                               EN
 ---pagebreak---    (7)  ‘open facility’ means an aquaculture establishment, the waste water from which, is
        discharged directly into open waters without being treated to inactivate agents of
        listed diseases or emerging diseases;
   (8)  'epidemiological area' means a defined geographical area where the aquatic animals
        have the same health status and are exposed to the same risk of contracting a listed
        disease or an emerging disease;
   (9)  ‘biosecurity plan’ means a documented plan which identifies the routes by which a
        disease agent can enter an aquaculture establishment, spread within it and transfer
        from it; it takes account of the specificities of the establishment and identifies
        measures which will mitigate the biosecurity risks which have been identified;
   (10) 'common biosecurity measures' means the measures included in a biosecurity plan
        which has been devised for, and implemented by, each aquaculture establishment in
        a group of aquaculture establishments which has been approved by the competent
        authority in accordance with Article 177 of Regulation (EU) 2016/429;
   (11) 'unique registration number' means a number assigned to a registered aquaculture
        establishment or group of aquaculture establishments as referred to in Article 173 of
        Regulation (EU) 2016/429;
   (12) 'unique approval number' means a number assigned by the competent authority to an
        aquaculture establishment or group of aquaculture establishments approved by it in
        accordance with Article 173 of Regulation (EU) 2016/429;
   (13) 'IMO ship identification number' means a unique number assigned to sea-going
        vessels by the International Maritime Organisation (IMO);
   (14) ‘hygiene barrier’ means footbaths, hand washes, changes of clothing or other
        biosecurity measures, the effects of which are to create barriers to the spread of
        disease into, within or from an aquaculture establishment;
   (15) ‘production units’ means troughs, ponds, raceways, tanks, cages, pens, or similar
        structures which contain groups of aquaculture animals in an aquaculture
        establishment;
   (16) 'increased mortality' means unexplained mortalities above the level considered
        normal for the aquaculture establishment or group of aquaculture establishments in
        question, under prevailing conditions;
   (17) 'surveillance programme' means a voluntary programme of testing and control
        measures undertaken in relation to a category C disease at an aquaculture
        establishment which is not participating in an eradication programme to
        achieve disease-free status, but where testing indicates that the aquaculture
        establishment is not infected with that category C disease.
EN                                            10                                              EN
 ---pagebreak---                                            PART II
       REGISTRATION, APPROVAL, REGISTERS AND
                                RECORD-KEEPING
                                            TITLE I
       APPROVAL OF OPERATORS OF AQUACULTURE ESTABLISHMENTS BY THE
                                  COMPETENT AUTHORITY
                                         CHAPTER 1
   Approval of aquaculture establishments posing a significant risk for
      the spread of disease and derogations from the requirement for
                                           approval
                                             Article 3
      Derogations from the requirement on operators to apply to the competent authority for
                              approval of aquaculture establishments
   1.     By way of derogation from Article 176(1)(a) of Regulation (EU) 2016/429, operators
          of the following types of aquaculture establishments shall not be required to apply to
          the competent authority for approval of their aquaculture establishments:
          (a)   aquaculture establishments where aquaculture animals are kept solely for
                release into the wild;
          (b)   extensive ponds where aquaculture animals are kept for direct human
                consumption or for release into the wild;
          (c)   purification centres which:
                (i)   are approved in accordance with Article 4 of Regulation (EC) No
                      853/2004; and
                (ii)  receive molluscs only from within the epidemiological area in which the
                      establishment is located;
          (d)   dispatch centres which:
                (i)   are approved in accordance with Article 4 of Regulation (EC) No
                      853/2004; and
                (ii)  receive molluscs only from within the epidemiological area in which the
                      establishment is located;
          (e)   relaying areas which:
                (i)   are approved in accordance with Article 4 of Regulation (EC) No
                      853/2004; and
                (ii)  receive molluscs only from within the epidemiological area in which the
                      establishment is located.
   2.     Derogations from the requirement to apply to the competent authority for approval
          provided for in paragraph 1 of this Article shall only apply to aquaculture
          establishments from which aquaculture animals are not moved to another Member
EN                                              11                                               EN
 ---pagebreak---             State, other than molluscs for direct human consumption and when the competent
            authority has completed a risk assessment:
            (a)   taking into account at least the risk factors set out in points (a) and (b) of
                  Chapter 2 of Part I of Annex VI to Commission Delegated Regulation (EU)
                  …/… [C(2019)4056]; and
            (b)   which has found the risk of the aquaculture animals on the aquaculture
                  establishment either contracting or spreading a listed disease or an emerging
                  disease to be insignificant.
                                                Article 4
       Types of aquaculture establishments required to be approved by the competent authority
   Operators of the following types of aquaculture establishments shall apply to the competent
   authority for approval in accordance with Article 176(1)(b) of Regulation (EU) 2016/429:
   (a)      quarantine establishments for aquaculture animals;
   (b)      aquaculture establishments keeping aquaculture animals of listed species which are
            vectors in isolation, until such time as they are no longer regarded as being vectors;
   (c)      aquaculture establishments which are closed facilities keeping aquaculture animals
            for ornamental purposes, which because of their movement patterns, create a
            significant disease risk;
   (d)      aquaculture establishments keeping aquaculture animals for ornamental purposes in
            open facilities;
   (e)      vessels or other mobile premises where aquaculture animals are kept temporarily to
            be treated or to undergo another husbandry related procedure.
                                            CHAPTER 2
             Requirements and granting of approval of aquaculture
                                           establishments
                                                Article 5
         Requirement for approved aquaculture establishments and groups thereof to have a
                                            biosecurity plan
   The competent authority shall only approve aquaculture establishments referred to in Article 7
   and Articles 9 to 19, or groups of aquaculture establishments referred to in Article 8, if their
   operators have developed and documented a biosecurity plan, which complies with the
   following requirements:
   (a)      it identifies the routes whereby a disease agent can enter the aquaculture
            establishment or group of aquaculture establishments, spread within it and transfer
            from it to the environment or to other aquaculture establishments;
   (b)      it takes account of the specificities of the individual aquaculture establishment or
            group of aquaculture establishments and identifies risk-mitigation measures for each
            biosecurity risk which has been identified;
   (c)      it considers or takes into account, where appropriate, the elements set out in point
            1(a) of Parts 1 to 7 and Parts 9 to 12, and in point 1(b) of Part 8 of Annex I , when
EN                                                 12                                               EN
 ---pagebreak---             this plan for the aquaculture establishment or group of aquaculture establishments is
            being developed.
                                                 Article 6
    Requirement for approved aquaculture establishments and groups thereof to participate in a
                                     risk-based surveillance scheme
   1.       The competent authority shall only approve aquaculture establishments referred to in
            Articles 7, 17 and 18 of this Regulation if the operators comply with risk-based
            surveillance conducted by the competent authority in accordance with Article 26 of
            Regulation (EU) 2016/429, in the form of a risk-based surveillance scheme as set out
            in Part 1 and in point 1 of Part 2 of Annex II to this Regulation.
   2.       The competent authority shall only approve groups of aquaculture establishments
            referred to in Article 8 of this Regulation when operators comply with risk based
            surveillance conducted by the competent authority in accordance with Article 26 of
            Regulation (EU) 2016/429, in the form of a risk- based surveillance scheme as set
            out in Part 1 and in point 2 of Part 2 of Annex II to this Regulation.
   3.       When granting approval of aquaculture establishments or groups thereof as provided
            for in paragraphs 1 and 2, the competent authority shall take account of the following
            elements, and include them in the risk-based surveillance scheme:
            (a)    the outcome of the surveillance conducted by the operator in accordance with
                   Article 24 of Regulation (EU) 2016/429;
            (b)    the information obtained through the animal health visits carried out by a
                   veterinarian in accordance with Article 25 of Regulation (EU) 2016/429, when
                   the operators make such information available.
                                                 Article 7
        Requirements for granting approval of aquaculture establishments where aquaculture
         animals are kept with a view to being moved therefrom either alive or as products of
      aquaculture animal origin, other than those aquaculture establishments for which specific
                            requirements are laid down in Articles 12 to 19
   When granting approval, the competent authority shall ensure that aquaculture establishments
   where aquaculture animals are kept with a view to being moved therefrom either alive or as
   products of aquaculture animal origin, other than those aquaculture establishments referred to
   in Articles 12 to 19, comply with the requirements set out in:
   (a)      Article 6(1), in relation to risk-based surveillance;
   (b)      point 1 of Part 1 of Annex I, in relation to biosecurity measures;
   (c)      point 2 of Part 1 of Annex I, in relation to facilities and equipment.
                                                 Article 8
         Requirements for granting approval of groups of aquaculture establishments where
        aquaculture animals are kept with a view to being moved therefrom either alive or as
                                 products of aquaculture animal origin
   When granting approval, the competent authority shall ensure that groups of aquaculture
   establishments where aquaculture animals are kept with a view to being moved therefrom
EN                                                  13                                             EN
 ---pagebreak---    either alive or as products of aquaculture animal origin comply with the requirements set out
   in:
   (a)       Article 6(2), in relation to risk-based surveillance;
   (b)       point 1 of Part 2 of Annex I, in relation to biosecurity measures for the aquaculture
             establishments in the group;
   (c)       point 2 of Part 2 of Annex I, in relation to facilities and equipment.
                                                  Article 9
             Requirements for granting approval of confined aquaculture establishments
   When granting approval, the competent authority shall ensure that confined aquaculture
   establishments comply with the requirements set out in:
   (a)       Article 10, in relation to arrangements for facilities where post-mortem examinations
             are carried out and securing the services of an establishment veterinarian;
   (b)       point 1 of Part 3 of Annex I, in relation to biosecurity measures;
   (c)       point 2 of Part 3 of Annex I, in relation to surveillance and control;
   (d)       point 3 of Part 3 of Annex I, in relation to facilities and equipment.
                                                 Article 10
                   Obligations of operators of confined aquaculture establishments
   Before approval is granted by the competent authority, operators of confined aquaculture
   establishments shall:
   (a)       put in place arrangements to perform veterinary post-mortem examinations in
             appropriate facilities in the confined aquaculture establishment or in a laboratory;
   (b)       secure by contract or by another legal instrument, the services of an establishment
             veterinarian who shall be responsible for:
             (i)   the supervision of the activities of the confined aquaculture establishment and
                   compliance with the requirements for approval laid down in Article 9;
             (ii)  the review of the disease surveillance plan referred to in point 2(a) of Part 3 of
                   Annex I at least annually.
                                                 Article 11
         Requirements for granting approval of disease control aquatic food establishments
   When granting approval, the competent authority shall ensure that disease control aquatic
   food establishments comply with the requirements set out in:
   (a)       point 1 of Part 4 of Annex I, in relation to biosecurity measures;
   (b)       point 2 of Part 4 of Annex I, in relation to facilities and equipment.
                                                 Article 12
      Requirements for granting approval of purification centres other than those referred to in
                                               Article 3(1)(c)
   When granting approval, the competent authority shall ensure that purification centres other
   than those referred to in Article 3(1)(c) comply with the requirements set out in:
EN                                                   14                                               EN
 ---pagebreak---    (a)      point 1 of Part 5 of Annex I, in relation to biosecurity measures;
   (b)      point 2 of Part 5 of Annex I, in relation to facilities and equipment.
                                               Article 13
   Requirements for granting approval of dispatch centres other than those referred to in Article
                                                 3(1)(d)
   When granting approval, the competent authority shall ensure that dispatch centres other than
   those referred to in Article 3(1)(d) comply with the requirements set out in:
   (a)      point 1 of Part 6 of Annex I, in relation to biosecurity measures;
   (b)      point 2 of Part 6 of Annex I, in relation to facilities and equipment.
                                               Article 14
    Requirements for granting approval of relaying areas other than those referred to in Article
                                                 3(1)(e)
   When granting approval, the competent authority shall ensure that relaying areas other than
   those referred to in Article 3(1)(e) comply with the requirements set out in:
   (a)      point 1 of Part 7 of Annex I, in relation to biosecurity measures;
   (b)      point 2 of Part 7 of Annex I, in relation to facilities and equipment.
                                               Article 15
                  Requirements for granting approval of quarantine establishments
   When granting approval, the competent authority shall ensure that quarantine establishments
   comply with the requirements set out in:
   (a)      point 1 of Part 8 of Annex I, in relation to biosecurity measures;
   (b)      point 2 of Part 8 of Annex I, in relation to surveillance and control measures;
   (c)      point 3 of Part 8 of Annex I, in relation to facilities and equipment.
                                               Article 16
       Requirements for granting approval of aquaculture establishments keeping aquaculture
    animals of listed species which are vectors in isolation, until such time as they are no longer
                                          regarded as vectors
   When granting approval, the competent authority shall ensure that aquaculture establishments
   keeping aquaculture animals of listed species which are vectors in isolation, until such time
   as they are no longer regarded as vectors, comply with the requirements set out in:
   (a)      point 1 of Part 9 of Annex I, in relation to biosecurity measures;
   (b)      point 2 of Part 9 of Annex I, in relation to surveillance and control measures;
   (c)      point 3 of Part 9 of Annex I, in relation to facilities and equipment.
EN                                                 15                                               EN
 ---pagebreak---                                                  Article 17
    Requirements for granting approval of aquaculture establishments which are closed facilities
       keeping aquaculture animals for ornamental purposes which, because of their movement
                                 patterns, create a significant disease risk
   When granting approval, the competent authority shall ensure that aquaculture establishments
   which are closed facilities keeping aquaculture animals for ornamental purposes which,
   because of their movement patterns, create a significant disease risk, comply with the
   requirements set out in:
   (a)       Article 6(1), in relation to risk-based surveillance;
   (b)       point 1 of Part 10 of Annex I, in relation to biosecurity measures;
   (c)       point 2 of Part 10 of Annex I, in relation to facilities and equipment.
                                                 Article 18
    Requirements for granting approval of aquaculture establishments which are open facilities
                         keeping aquaculture animals for ornamental purposes
   When granting approval, the competent authority shall ensure that aquaculture establishments
   which are open facilities keeping aquaculture animals for ornamental purposes comply with
   the requirements set out in:
   (a)       Article 6(1), in relation to risk-based surveillance;
   (b)       point 1 of Part 11 of Annex I, in relation to biosecurity measures;
   (c)       point 2 of Part 11 of Annex I, in relation to facilities and equipment.
                                                 Article 19
     Requirements for granting approval of vessels or other mobile premises where aquaculture
         animals are kept temporarily to be treated or to undergo another husbandry-related
                                                 procedure
   When granting approval, the competent authority shall ensure that vessels or other mobile
   premises where aquaculture animals are kept temporarily to be treated or to undergo another
   husbandry-related procedure comply with the requirements set out in:
   (a)       point 1 of Part 12 of Annex I, in relation to biosecurity measures;
   (b)       point 2 of Part 12 of Annex I, in relation to facilities and equipment.
EN                                                   16                                          EN
 ---pagebreak---                                                  TITLE II
     REGISTERS TO BE KEPT BY THE COMPETENT AUTHORITY OF REGISTERED AND
                        APPROVED AQUACULTURE ESTABLISHMENTS
                                             CHAPTER 1
        Registers of aquaculture establishments kept by the competent
                                               authority
                                                 Article 20
       Information obligation of the competent authority as regards the register of registered
                                        aquaculture establishments
   In addition to the information required by Article 185(2) of Regulation (EU) 2016/429, the
   competent authority shall include the following information in the register of aquaculture
   establishments provided for in Article 185(1)(a) of that Regulation, for each aquaculture
   establishment it registers:
   (a)      the unique registration number assigned to it by the competent authority;
   (b)      the date of registration by the competent authority;
   (c)      the address and geographical coordinates (latitude and longitude) of the location of
            the aquaculture establishment;
   (d)      a description of its facilities and equipment;
   (e)      categories of aquaculture animals which are kept in the aquaculture establishment;
   (f)      the approximate number or the maximum biomass or both, of the aquaculture
            animals which may be kept in the aquaculture establishment;
   (g)      the period during which aquaculture animals are kept in the aquaculture
            establishment if it is not continuously occupied, including when relevant,
            information on seasonal occupation or occupation during particular events;
   (h)      the date of any cessation of activity when the operator has informed the competent
            authority thereof.
                                             CHAPTER 2
    Registers of aquaculture establishments approved by the competent
                                               authority
                                                 Article 21
       Information obligation of the competent authority as regards the register of approved
                                        aquaculture establishments
   1.       In addition to the information required by Article 185(2) of Regulation (EU)
            2016/429, the competent authority shall include the following information in the
            register of approved aquaculture establishments provided for in Article 185(1)(b) and
            (c) of that Regulation, for each aquaculture establishment or group of aquaculture
            establishments it approves:
            (a)   the unique approval number assigned to it by the competent authority
EN                                                   17                                           EN
 ---pagebreak---       (b)    the date of approval granted by the competent authority or of any suspension or
             withdrawal of approval by the competent authority;
      (c)    the address and geographical co-ordinates (latitude and longitude) of the
             location of the approved aquaculture establishment or group of aquaculture
             establishments;
      (d)    a description of its relevant facilities and equipment;
      (e)    categories of aquaculture animals which are kept in the aquaculture
             establishment or in the group of aquaculture establishments;
      (f)    the approximate number or the maximum biomass, or both, of the aquaculture
             animals which may be kept in the aquaculture establishment or in the group of
             aquaculture establishments;
      (g)    the period during which aquaculture animals are kept in the aquaculture
             establishment or group of aquaculture establishments if not continuously
             occupied, including when relevant, information on seasonal occupation or
             occupation during particular events;
      (h)    the date of any cessation of activity when the operator has informed the
             competent authority thereof.
   2. In addition to the information required by Article 185(3) of Regulation (EU)
      2016/429, the competent authority shall include up-to-date information on the health
      status of the aquaculture animals kept in aquaculture establishments or groups of
      aquaculture establishments which are approved in accordance with Article 181(1) of
      that Regulation, in an internet-based information page which is publicly available.
      That up-to-date health information shall at least set out the health status of the
      aquaculture establishment or group of aquaculture establishments for each relevant
      listed disease and for each relevant category thereof, as follows:
      (a)    whether it is free from a category B disease or category C disease;
      (b)    if it is in an eradication programme for a category B disease or category C
             disease;
      (c)    if it is in a voluntary surveillance programme for a category C disease; or
      (d)    any other information which pertains to a category B, category C or category D
             disease, other than the information which is set out in points (a), (b) and (c).
EN                                             18                                             EN
 ---pagebreak---                                              TITLE III
        RECORD-KEEPING OBLIGATIONS OF OPERATORS IN ADDITION TO THOSE
                        PROVIDED FOR IN REGULATION (EU) 2016/429
                                          CHAPTER 1
           Records to be kept by operators of registered or approved
                                aquaculture establishments
                                              Article 22
         Record-keeping obligations of operators of registered aquaculture establishments
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of registered aquaculture establishments shall record and keep the following
   information:
   (a)      the unique registration number assigned to the aquaculture establishment by the
            competent authority;
   (b)      details of any investigations that were carried out following the occurrence of
            increased mortality or suspicion of the presence of disease;
   (c)      self-declaration documents issued in accordance with Article 218 of Regulation (EU)
            2016/429, received with consignments of aquaculture animals which have arrived at
            the aquaculture establishment or which have been sent with such consignments
            which have been dispatched from the aquaculture establishment, as relevant;
   (d)      where relevant, any other documents accompanying aquatic animals.
                                              Article 23
       Record-keeping obligations of operators of approved aquaculture establishments where
     aquaculture animals are kept with a view to their being moved therefrom, either alive or as
   products of aquaculture animal origin other than those which are referred to in Articles 27 to
                                                  34
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved aquaculture establishments where aquaculture animals are kept with a
   view to being moved therefrom either alive or as products of aquaculture animal origin other
   than those aquaculture establishments referred to in Articles 27 to 34 of this Regulation, shall
   record and keep the following information:
   (a)      the unique approval number issued to the aquaculture establishment by the
            competent authority;
   (b)      the current risk categorisation of the aquaculture establishment, as assigned by the
            competent authority;
   (c)      details of the implementation and results of the risk-based surveillance provided for
            in Article 6(1);
   (d)      details of movements to the aquaculture establishment including:
            (i)   the unique approval or registration number of the aquaculture establishment of
                  origin of all aquaculture animals which have been received from another
                  aquaculture establishment; or
EN                                                19                                                EN
 ---pagebreak---            (ii)  the location of the habitat from which wild aquatic animals have been collected
                 before being dispatched to the aquaculture establishment;
   (e)     details of movements from the aquaculture establishment including:
           (i)   aquaculture animals and products of aquaculture animal origin and, in the case
                 of movements of aquaculture animals, including the unique registration or
                 approval number of the aquaculture establishment of destination; or
           (ii)  in the case of movements into the wild, details of the habitat into which the
                 aquaculture animals will be released;
   (f)     the name and address of transporters who deliver aquatic animals to or collect
           aquaculture animals from the establishment;
   (g)     the biosecurity plan for the approved aquaculture establishment and evidence of its
           implementation;
   (h)     self-declaration documents issued in compliance with Article 218 of Regulation (EU)
           2016/429 received with consignments of aquaculture animals which have arrived at
           the aquaculture establishment or which have been sent with consignments which
           have been dispatched from the aquaculture establishment, as relevant;
   (i)     where relevant, any other documents accompanying aquatic animals.
                                              Article 24
    Record-keeping obligations of operators of an approved group of aquaculture establishments
    where aquaculture animals are kept with a view to being moved therefrom either alive or as
                               products of aquaculture animal origin
   1.      In addition to the information required by Article 186(1) of Regulation (EU)
           2016/429, operators of aquaculture establishments in a group of aquaculture
           establishments approved in accordance with point (a) of Article 177 of Regulation
           (EU) 2016/429 shall record and keep the following information:
           (a)   the unique approval number issued to the aquaculture establishment by the
                 competent authority;
           (b)   the current risk categorisation of the group of aquaculture establishments, as
                 assigned by the competent authority;
           (c)   details of the implementation and results of the risk-based surveillance
                 provided for in Article 6(2);
           (d)   details of movements to the aquaculture establishment including:
                 (i)   the unique approval or registration number of the aquaculture
                       establishment of origin for all aquaculture animals which have been
                       received from an aquaculture establishment outside the group; or
                 (ii)  the location of the habitat from which wild aquatic animals have been
                       collected before being dispatched to the aquaculture establishment;
           (e)   details of movements from the group of aquaculture establishments including:
                 (i)   aquaculture animals and products of aquaculture animal origin from
                       aquaculture animals and, in the case of movements of aquaculture
                       animals, including the unique registration or approval number of the
EN                                                20                                             EN
 ---pagebreak---                          establishment of destination, where aquaculture animals are dispatched to
                         another establishment outside the group; or
                  (ii)   in the case of movements into the wild, details of the habitat into which
                         the aquaculture animals will be released;
            (f)   the name and address of transporters who deliver aquatic animals to, or collect
                  aquaculture animals from, the aquaculture establishment;
            (g)   details of the biosecurity plan employed and evidence of its implementation;
            (h)   self-declaration documents issued in compliance with Article 218 of
                  Regulation (EU) 2016/429, received with consignments of aquaculture animals
                  which have arrived at the aquaculture establishment or which have been sent
                  with consignments which have been dispatched from the aquaculture
                  establishment, as relevant;
            (i)   where relevant, any other documents accompanying the aquatic animals.
   2.       The operator of a group of aquaculture establishments approved in accordance with
            point (b) of Article 177 of Regulation (EU) 2016/429 shall record or keep the
            information set out in paragraph 1(a) to (i) of this Article on behalf of each
            aquaculture establishment in the group.
                                               Article 25
      Record-keeping obligations of operators of approved confined aquaculture establishments
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved confined aquaculture establishments shall record and keep the
   following information:
   (a)      the unique approval number issued to the confined aquaculture establishment by the
            competent authority;
   (b)      details of movements to and from the confined aquaculture establishment including
            the unique registration or approval number of the aquaculture establishment of origin
            or destination of all aquaculture animals received from or dispatched to another
            aquaculture establishment;
   (c)      the name and address of transporters who deliver aquaculture animals to, or collect
            aquaculture animals from, the confined aquaculture establishment;
   (d)      details of the implementation and results of the disease surveillance plan provided for
            in point 2 of Part 3 of Annex I;
   (e)      the results of clinical and laboratory tests and of post-mortem examinations
            completed when increased mortalities or suspicion of the presence of disease are
            investigated;
   (f)      where relevant, details of the vaccination or treatment of aquaculture animals
            provided for in point 2(c) of Part 3 of Annex I;
   (g)      details of isolation or quarantine of incoming aquaculture animals, instructions, if
            any, of the competent authority as regards isolation and quarantine and relevant
            observations made during any isolation or quarantine period;
   (h)      the biosecurity plan for the confined aquaculture establishment;
   (i)      where relevant, any other documents accompanying the aquaculture animals.
EN                                                 21                                               EN
 ---pagebreak---                                                Article 26
       Record-keeping obligations of operators of disease control aquatic food establishments
   In addition to the information required by Article 187(1) of Regulation (EU) 2016/429,
   operators of disease control aquatic food establishments shall record and keep the following
   information:
   (a)      the unique approval number issued to the disease control aquatic food establishment
            by the competent authority;
   (b)      the biosecurity plan for the disease control aquatic food establishment and evidence
            of its implementation;
   (c)      maintenance records for the waste water treatment system used in the disease control
            aquatic food establishment;
   (d)      records to verify the efficacy of the water treatment system;
   (e)      the name and address of transporters who deliver aquatic animals to the disease
            control aquatic food establishment;
   (f)      where relevant, any other documents accompanying the aquatic animals.
                                               Article 27
              Record-keeping obligations of operators of approved purification centres
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved purification centres shall record and keep the following information:
   (a)      the unique approval number issued to the approved purification centre by the
            competent authority;
   (b)      the biosecurity plan for the approved purification centre and evidence of its
            implementation;
   (c)      maintenance records for the waste water treatment system used in the approved
            purification centre ;
   (d)      records to verify the efficacy of the water treatment system;
   (e)      where relevant, any other documents accompanying aquatic animals.
                                               Article 28
                Record-keeping obligations of operators of approved dispatch centres
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved dispatch centres shall record and keep the following information:
   (a)      the unique approval number issued to the approved dispatch centre by the competent
            authority;
   (b)      the biosecurity plan for the approved dispatch centre and evidence of its
            implementation;
   (c)      maintenance records for the waste water treatment system used in the approved
            dispatch centre;
   (d)      records to verify the efficacy of the water treatment system;
   (e)      where relevant, any other documents accompanying aquatic animals.
EN                                                 22                                            EN
 ---pagebreak---                                                Article 29
                 Record-keeping obligations of operators of approved relaying areas
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved relaying areas shall record and keep the following information:
   (a)      the unique approval number issued to the approved relaying area by the competent
            authority;
   (b)      the biosecurity plan for the approved relaying area and evidence of its
            implementation;
   (c)      where relevant, any other documents accompanying aquatic animals.
                                               Article 30
        Record-keeping obligations of operators of approved quarantine establishments for
                                          aquaculture animals
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved quarantine establishments for aquaculture animals shall record and
   keep the following information:
   (a)      the unique approval number issued to the quarantine establishment by the competent
            authority;
   (b)      details of movements to the approved quarantine establishment including:
            (i)    the unique registration or approval number of the aquaculture establishment of
                   origin of all aquaculture animals received from another aquaculture
                   establishment; or
            (ii)   the location of the habitat from which aquatic animals have been collected
                   before being dispatched to the approved quarantine establishment;
   (c)      details of movements from the approved quarantine establishment including:
            (i)    the unique registration or approval number of the aquaculture establishment of
                   destination; or
            (ii)   the location of the habitat into which aquaculture animals have been released
                   into the wild;
   (d)      the name and address of transporters who deliver aquatic animals to, or collect
            aquaculture animals from, the approved quarantine establishment;
   (e)      details of the implementation and results of the disease surveillance provided for in
            point 2 of Part 8 of Annex I;
   (f)      the results of clinical and laboratory tests and of post-mortem examinations provided
            for in point 2 of Part 8 of Annex I;
   (g)      instructions, if any, of the competent authority as regards observations made during
            any isolation or quarantine period;
   (h)      the biosecurity plan for the approved quarantine establishment and evidence of its
            implementation;
   (i)      evidence showing that the environmental parameters in the approved quarantine
            establishment are conducive to the expression of the relevant listed or emerging
            disease(s);
EN                                                 23                                             EN
 ---pagebreak---    (j)      where relevant, any other documents accompanying the aquatic animals.
                                                 Article 31
       Record-keeping obligations of operators of approved aquaculture establishments keeping
     aquaculture animals of listed species which are vectors in isolation, until such time as they
                                     are no longer regarded as vectors
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved aquaculture establishments keeping aquaculture animals of listed
   species which are vectors in isolation, until such time as they are no longer regarded as
   vectors, shall record and keep the following information:
   (a)      the unique approval number issued to the aquaculture establishment by the
            competent authority;
   (b)      details of movements to the approved aquaculture establishment including:
            (i)     the unique registration or approval number of the aquaculture establishment of
                    origin of all aquaculture animals received from another aquaculture
                    establishment; or
            (ii)    the location of the habitat from which aquatic animals have been collected
                    before being dispatched to the approved aquaculture establishment;
   (c)      details of movements from the approved aquaculture establishment including:
            (i)     the unique registration or approval number of the aquaculture establishment of
                    destination; or
            (ii)    in the case of movements into the wild, details of the habitat into which the
                    aquaculture animals will be released;
   (d)      the name and address of transporters who deliver aquatic animals to, or collect
            aquaculture animals from, the approved aquaculture establishment;
   (e)      details of the implementation and results of the disease surveillance provided for in
            point 2 of Part 9 of Annex I;
   (f)      the results of clinical and laboratory tests and of post-mortem examinations provided
            for in point 2 of Part 9 of Annex I;
   (g)      instructions, if any, of the competent authority as regards observations made during
            the 90 day isolation period referred to in point 2 of Part 9 of Annex I;
   (h)      the biosecurity plan for the approved aquaculture establishment and evidence of its
            implementation;
   (i)      where relevant, any other documents accompanying the aquatic animals.
                                                 Article 32
    Record - keeping obligations of operators of approved aquaculture establishments which are
                 closed facilities keeping aquaculture animals for ornamental purposes
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved aquaculture establishments which are closed facilities keeping
   aquaculture animals for ornamental purposes shall record and keep the following information:
   (a)      the unique approval number issued to the aquaculture establishment by the
            competent authority;
EN                                                   24                                            EN
 ---pagebreak---    (b)      the current risk categorisation of the approved aquaculture establishment, as assigned
            by the competent authority;
   (c)      details of the implementation and results of the risk based surveillance provided for
            in Article 6(1), where relevant;
   (d)      details of movements to the approved aquaculture establishment including the unique
            registration or approval number of the aquaculture establishment of origin of all
            aquaculture animals received from another aquaculture establishment;
   (e)      details of movements from the approved aquaculture establishment, including the
            unique registration or approval number of the aquaculture establishment of
            destination other than when these movements take place to households;
   (f)      the name and address of transporters who deliver aquatic animals to, or collect
            aquaculture animals from, the approved aquaculture establishment, other than when
            these movements take place to households;
   (g)      the biosecurity plan for the approved aquaculture establishment and evidence of its
            implementation;
   (h)      self-declaration documents issued in accordance with Article 218 of Regulation (EU)
            2016/429, received with consignments of aquaculture animals which have arrived at
            the approved aquaculture establishment or which have been sent with consignments
            which have been dispatched from the approved aquaculture establishment, as
            relevant;
   (i)      where relevant, any other documents accompanying aquaculture animals.
                                               Article 33
    Record- keeping obligations of operators of approved aquaculture establishments which are
                open facilities keeping aquaculture animals for ornamental purposes
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved aquaculture establishments which are open facilities keeping
   aquaculture animals for ornamental purposes shall record and keep the following information:
   (a)      the unique approval number issued to the aquaculture establishment by the
            competent authority;
   (b)      the current risk categorisation of the approved aquaculture establishment, as assigned
            by the competent authority;
   (c)      details of the implementation and results of the risk based surveillance provided for
            in Article 6(1), where relevant;
   (d)      details of movements to the approved aquaculture establishment including the unique
            registration or approval number of the aquaculture establishment of origin of all
            aquaculture animals which have been received from another aquaculture
            establishment;
   (e)      details of movements from the approved aquaculture establishment including the
            unique registration or approval number of the aquaculture establishment of
            destination except when these movements take place to households;
   (f)      the name and address of transporters who deliver aquatic animals to, or collect
            aquaculture animals from, the approved aquaculture establishment, other than when
            these movements take place to households;
EN                                                 25                                              EN
 ---pagebreak---    (g)      the biosecurity plan for the approved aquaculture establishment and evidence of its
            implementation;
   (h)      self-declaration documents issued in accordance with Article 218 of Regulation (EU)
            2016/429, received with consignments of aquaculture animals which have arrived at
            the approved aquaculture establishment or which have been sent with consignments
            which have been dispatched from the approved aquaculture establishment, as
            relevant;
   (i)      where relevant, any other documents accompanying aquatic animals.
                                              Article 34
       Record- keeping obligations of operators of approved vessels or other approved mobile
   premises where aquaculture animals are kept temporarily to be treated or to undergo another
                                    husbandry related procedure
   In addition to the information required by Article 186(1) of Regulation (EU) 2016/429,
   operators of approved vessels or other approved mobile premises where aquaculture animals
   are kept temporarily to be treated or to undergo another husbandry related procedure, shall
   record and keep the following information:
   (a)      the unique approval number issued to the vessel or other mobile premises by the
            competent authority;
   (b)      the dates and times of loading of aquaculture animals at the approved vessel or other
            approved mobile premises;
   (c)      where relevant, the name, address and unique registration or approval number of
            each aquaculture establishment where aquaculture animals were loaded and
            unloaded;
   (d)      the dates and places at which the vessel or other mobile premises was filled with
            water before loading and where relevant, exchanged between loading and unloading;
   (e)      where relevant, details of the route taken between one aquaculture establishment and
            another;
   (f)      details of each treatment or husbandry related procedure which takes place in the
            approved vessel or other approved mobile premises;
   (g)      the biosecurity plan for the approved vessel or other approved mobile premises and
            evidence of its implementation;
   (h)      where relevant, any other documents accompanying aquaculture animals.
                                           CHAPTER 2
                            Records to be kept by transporters
                                              Article 35
                    Record-keeping obligations of transporters of aquatic animals
   In addition to the information required by Article 188 of Regulation (EU) 2016/429,
   transporters of aquatic animals shall record and keep the following information for each
   means of transport used to move aquatic animals:
EN                                                 26                                             EN
 ---pagebreak---    (a)       its licence plate number in the case of transport by land, its IMO ship identification
             number in the case of transport by sea, or any other means of identification which
             uniquely identifies other means of transport in which aquatic animals are transported;
   (b)       the dates and times of loading of aquatic animals at the aquaculture establishment or
             habitat of origin;
   (c)       the name, address and unique registration or approval number of each aquaculture
             establishment visited;
   (d)       the location of each habitat from which wild aquatic animals were collected;
   (e)       the dates and times of unloading of aquatic animals at the aquaculture establishment
             or habitat of destination;
   (f)       the dates, times and places of water exchange, when this has occurred;
   (g)       the biosecurity plan for the means of transport and evidence of its implementation;
   (h)       the reference numbers of the documents accompanying the consignments of aquatic
             animals.
                                              PART IV
              TRANSITIONAL AND FINAL PROVISIONS
                                                 Article 36
                                                  Repeal
   Decision 2008/392/EC is repealed with effect from 21 April 2021.
   References to the repealed act shall be construed as references to this Regulation.
                                                 Article 37
       Transitional measures regarding the information in the registers of existing aquaculture
                       establishments and operators kept by competent authorities
   Member States shall ensure that, for the existing aquaculture establishments and operators
   referred to in Article 279(1) of Regulation (EU) 2016/429 which fall within the scope of
   Articles 20 and 21 of this Regulation, the information required by Articles 20 and 21 has been
   included for each such aquaculture establishment and operator in the registers of registered
   and approved aquaculture establishments kept by competent authorities before 21 April 2021.
                                                 Article 38
                                     Entry into force and application
   This Regulation shall enter into force on the twentieth day following that of its publication in
   the Official Journal of the European Union.
   It shall apply from 21 April 2021.
EN                                                   27                                             EN
 ---pagebreak---    This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 30.1.2020
                                                 For the Commission
                                                 The President
                                                 Ursula von der LEYEN
EN                                                 28                                             EN
 ---documentbreak---                             EUROPEAN
                            COMMISSION
                                                    Brussels, 30.1.2020
                                                    C(2020) 415 final
                                                    ANNEXES 1 to 2
                                         ANNEXES
                                            to the
                 COMMISSION DELEGATED REGULATION (EU) …/...
   supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as
      regards rules for aquaculture establishments and transporters of aquatic animals
EN                                                                                     EN
 ---pagebreak---                                                 ANNEX I
          REQUIREMENTS FOR GRANTING APPROVAL OF AQUACULTURE
    ESTABLISHMENTS, AS REFERRED TO IN CHAPTER 2 OF TITLE I OF PART II
                                                Part 1
      Requirements for granting approval of aquaculture establishments where aquaculture
       animals are kept with a view to being moved therefrom either alive or as products of
                        aquaculture animal origin as referred to in Article 7
   1.      The requirements in relation to biosecurity measures of aquaculture establishments
           where aquaculture animals are kept with a view to being moved therefrom either
           alive or as products of aquaculture animal origin as referred to in point (b) of Article
           7, shall be the following:
           (a)   operators shall implement a biosecurity plan in accordance with Article 5,
                 which must take the following elements into consideration:
                 (i)    disinfection points must be installed at critical locations in the
                        aquaculture establishment;
                 (ii)   where the following functional units exist within the same aquaculture
                        establishment, they must be separated using appropriate hygiene
                        barriers:
                        –      hatchery units,
                        –      fattening units,
                        –      processing units,
                        –      dispatch centre;
                 (iii) work clothing and footwear for personnel must be kept solely for use at
                        the aquaculture establishment and cleaned and disinfected regularly;
                 (iv) equipment must not be shared between aquaculture establishments but
                        where this is unavoidable, an appropriate protocol for cleaning and
                        disinfection of the equipment must be followed;
                 (v)    visitors to the aquaculture establishment must be controlled in cases
                        where they pose a disease risk; these visitors must either:
                        –      wear protective clothing and footwear provided at the aquaculture
                               establishment; or
                        –      clean and disinfect any protective clothing and footwear they bring
                               onto the aquaculture establishment on arrival and in the case of
                               non-disposable clothing and footwear, on departure;
                 (vi) dead animals must be removed from all production units at a frequency
                        that ensures infective pressure is kept to a minimum but which is
                        practicable given the production method used, and disposed of in
EN                                                 1                                                EN
 ---pagebreak---                      compliance with Article 13 of Regulation (EC) No 1069/2009 of the
                     European Parliament and of the Council1;
              (vii) as far as possible, equipment in the aquaculture establishment must be
                     cleaned and disinfected at the end of each production cycle;
              (viii) where aquaculture establishments receive fertilised eggs from other
                     establishments, and where biologically feasible, these eggs must be
                     disinfected appropriately on arrival and all packaging must be disinfected
                     or disposed of in a biosecure manner;
              (ix) the cleaning and disinfection records of transporters must be verified
                     before aquatic animals are loaded or unloaded at the aquaculture
                     establishment;
        (b)   operators shall nominate a named person to be in charge of implementing the
              biosecurity plan for the aquaculture establishment with other personnel
              reporting to that individual in relation to biosecurity matters.
   2.   The requirements in relation to facilities and equipment of aquaculture
        establishments as referred to in point (c) of Article 7, shall be the following:
        (a)   suitable equipment and facilities must be available for the purpose of
              maintaining appropriate husbandry conditions for the aquaculture animals kept
              on the aquaculture establishment;
        (b)   the aquaculture establishment must provide for good standards of hygiene and
              allow adequate health monitoring to be carried out;
        (c)   as far as possible, equipment and facilities must be made from materials which
              can be appropriately cleaned and disinfected;
        (d)   appropriate predator control measures must be put in place, taking into account
              the risk of disease spread these predators pose and the environmental
              constraints of the aquaculture establishment;
        (e)   appropriate equipment must be available for the cleaning and disinfection of
              facilities, equipment and means of transport.
   1
      Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009
      laying down health rules as regards animal by-products and derived products not intended for human
      consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L
      300, 14.11.2009, p. 1).
EN                                                2                                                      EN
 ---pagebreak---                                               Part 2
      Requirements for granting approval of groups of aquaculture establishments where
      aquaculture animals are kept with a view to being moved therefrom either alive or as
                products of aquaculture animal origin as referred to in Article 8
   1.     The requirements in relation to biosecurity measures of groups of aquaculture
          establishments where aquaculture animals are kept with a view to being moved
          therefrom as referred to in point (b) of Article 8, shall be the following:
          (a)   operators shall implement a biosecurity plan in accordance with Article 5, and
                 in developing their biosecurity plan, the operators must take the following
                elements into consideration:
                (i)    disinfection points must be installed at critical locations in each
                       aquaculture establishment in the group;
                (ii)   where the following functional units exist within the same aquaculture
                       establishment, they must be separated using appropriate hygiene barriers:
                       –     hatchery units,
                       –     fattening units,
                       –     processing units,
                       –     dispatch centre;
                (iii) work clothing and footwear for personnel must be kept solely for use at
                       each aquaculture establishment and cleaned and disinfected regularly;
                (iv) equipment must not be shared between aquaculture establishments but
                       where this is unavoidable, an appropriate protocol for cleaning and
                       disinfection of the equipment must be followed;
                (v)    visitors to the aquaculture establishment must be controlled where they
                       pose a disease risk; these visitors must either:
                       –     wear protective clothing and footwear provided at each aquaculture
                             establishment; or
                       –     clean and disinfect any protective clothing and footwear they bring
                             onto the aquaculture establishment on arrival and in the case of
                             non-disposable clothing and footwear, on departure;
                (vi) dead aquaculture animals must be removed from all production units at a
                       frequency that ensures infective pressure is kept to a minimum but which
                       is practicable given the production method used, and disposed of in
                       compliance with Article 13 of Regulation (EC) No 1069/2009;
                (vii) as far as possible, equipment in each aquaculture establishment must be
                       cleaned and disinfected at the end of each production cycle;
                (viii) where aquaculture establishments receive fertilised eggs from other
                       establishments, and where biologically feasible, these eggs must be
                       disinfected appropriately on arrival and all packaging must be disinfected
                       or disposed of in a biosecure manner;
EN                                                3                                               EN
 ---pagebreak---             (ix) the cleaning and disinfection records of transporters must be verified
                  before aquaculture animals are loaded or unloaded at the aquaculture
                  establishment;
      (b)   responsibility for the implementation of the measures set out in the biosecurity
            plan shall be with:
            (i)   the operator of each individual aquaculture establishment in a group of
                  aquaculture establishments approved in accordance with point (a) of
                  Article 177 of Regulation (EU) 2016/429;
            (ii)  the operator of a group of aquaculture establishments approved in
                  accordance with point (b) of Article 177 of Regulation (EU) 2016/429.
   2. The requirements in relation to facilities and equipment of groups of aquaculture
      establishments as referred to in point (c) of Article 8, shall be the following:
      (a)   suitable equipment and facilities must be available for the purpose of
            maintaining appropriate husbandry conditions for the aquaculture animals kept
            in each aquaculture establishment in the group;
      (b)   each aquaculture establishment in the group must have good standards of
            hygiene and allow health monitoring to be carried out;
      (c)   equipment and facilities in each aquaculture establishment in the group must be
            made from materials which can be readily cleaned and disinfected;
      (d)   appropriate predator control measures must be put in place in each aquaculture
            establishment in the group, taking into account the risk of disease spread these
            predators pose and the environmental constraints of the aquaculture
            establishment;
      (e)   appropriate equipment must be available in each aquaculture establishment in
            the group for cleaning and disinfection of facilities, equipment and means of
            transport.
EN                                           4                                               EN
 ---pagebreak---                                               Part 3
    Requirements for granting approval of confined aquaculture establishments referred to in
                                               Article 9
   1.      The requirements in relation to the biosecurity measures of confined aquaculture
           establishments as referred to in point (b) of Article 9, shall be the following:
           (a)   operators shall implement the biosecurity plan in accordance with Article 5,
                 which must take the following elements into consideration:
                 (i)    disinfection points must be installed at critical locations in the confined
                        aquaculture establishment;
                 (ii)   where different functional units exist within the same confined
                        aquaculture establishment, they must be kept separate using hygiene
                        barriers;
                 (iii) work clothing and footwear for personnel must be kept at the confined
                        aquaculture establishment and cleaned and disinfected regularly;
                 (iv) visitors must wear protective clothing and footwear provided by the
                        operator;
                 (v)    equipment shall not be shared with other aquaculture establishments;
                 (vi) dead animals must be removed at a frequency that ensures infective
                        pressure is kept to a minimum, and disposed of in compliance with
                        Article 13 of Regulation (EC) No 1069/2009;
                 (vii) the equipment in the confined aquaculture establishment must be cleaned
                        and disinfected at an appropriate frequency;
                 (viii) where confined aquaculture establishments receive fertilised eggs from
                        other establishments, where biologically feasible and where it does not
                        interfere with research objectives, these eggs must be disinfected
                        appropriately on arrival, and all packaging must be disinfected or
                        disposed of in a biosecure manner;
                 (ix) the cleaning and disinfection records of transporters must be verified
                        before aquaculture animals are loaded or unloaded at the establishment;
           (b)   operators shall nominate a named person to be in charge of implementing the
                 biosecurity plan for the confined aquaculture establishment with other
                 personnel reporting to that individual in relation to biosecurity matters.
   2.      The requirements in relation to surveillance and control measures of confined
           aquaculture establishments as referred to in point (c) of Article 9, shall be the
           following:
           (a)   a disease surveillance plan must be implemented, which must include
                 appropriate controls for diseases of aquaculture animals, and it must be updated
                 according to the number and species of the aquaculture animals present in the
                 confined aquaculture establishment, and to the epidemiological situation in and
                 around the confined aquaculture establishment as regards listed and emerging
                 diseases;
EN                                                 5                                                EN
 ---pagebreak---       (b)   aquaculture animals suspected of being infected with listed or emerging disease
            agents must be subjected to clinical, laboratory or post-mortem testing;
      (c)   the vaccination and treatment of aquaculture animals against transmissible
            diseases is carried out as appropriate.
   3. The requirements in relation to facilities and equipment of confined aquaculture
      establishments as referred to in point (d) of Article 9, shall be the following:
      (a)   the boundaries of the confined aquaculture establishments must be clearly
            demarcated and the access of aquatic animals and humans to animal facilities
            must be controlled;
      (b)   where necessary, adequate facilities suited for the quarantine of aquaculture
            animals introduced from other establishments must be available;
      (c)   adequate means for isolating aquaculture animals must be available;
      (d)   tanks and other holding facilities must be of a suitable standard and constructed
            so that:
            (i)    contact with aquatic animals outside is prevented and that inspections
                   and any necessary treatments can be easily carried out;
            (ii)   floors, walls and all other material or equipment can be readily cleaned
                   and disinfected;
      (e)   suitable equipment and facilities must be available for the purpose of
            maintaining appropriate husbandry conditions for the aquaculture animals kept
            in the confined aquaculture establishment;
      (f)   the confined aquaculture establishment must provide for good standards of
            hygiene and allow adequate health monitoring to be carried out;
      (g)   appropriate equipment must be available for the cleaning and disinfection of
            facilities, equipment and means of transport;
      (h)   appropriate predator control measures must be put in place, taking into account
            the risk of disease spread these predators pose;
      (i)   appropriate disinfection equipment must be in place to ensure that all
            wastewater which is discharged from the confined aquaculture establishment is
            treated to a level which ensures that any infectious agents of listed or emerging
            diseases which are present are fully inactivated before discharge.
EN                                           6                                                EN
 ---pagebreak---                                               Part 4
   Requirements for granting approval of disease control aquatic food establishments referred
                                           to in Article 11
   1.     The requirements in relation to biosecurity measures of disease control aquatic food
          establishments as referred to in point (a) of Article 11, shall be the following:
          (a)   operators shall implement the biosecurity plan for the disease control aquatic
                food establishment in accordance with Article 5, which must take account of at
                least the following elements when animals which are infected with a listed or
                emerging disease are slaughtered or processed on the premises:
                (i)    visitors to the establishment must be avoided, but when such visits are
                       unavoidable, they must be controlled and protective clothing and
                       footwear must be provided by the operator which are safely disposed of
                       or cleaned and disinfected after use;
                (ii)   the personnel of the disease control aquatic food establishment must wear
                       work clothing and footwear which must be cleaned and disinfected at an
                       appropriate frequency;
                (iii) an appropriate disinfection system must be in place to ensure that waste
                       water from the disease control aquatic food establishment is
                       appropriately treated so that any disease agents which are present are
                       inactivated before the water is discharged;
                (iv) an appropriate system must be in place to ensure the collection and
                       appropriate disposal of animal by-products; such by-products shall be
                       processed as Category 1 or Category 2 material in compliance with
                       Article 12 or Article 13 of Regulation (EC) No 1069/2009;
                (v)    appropriate cleaning and disinfecting operations must be completed prior
                       to the arrival of any new consignment of aquatic animals for processing;
                (vi) appropriate measures must be in place to ensure that all means of
                       transport and their containers which are used to deliver aquatic animals to
                       a disease control aquatic food establishment are cleaned and disinfected
                       before they leave the establishment.
   2.     The requirements in relation to facilities and equipment of disease control aquatic
          food establishments as referred to in point (b) of Article 11, shall be the following:
          (a)   floors, walls and all other material or equipment must be easily cleaned and
                disinfected;
          (b)   appropriate disinfection equipment must be in place to ensure that all waste
                water which is discharged from the disease control aquatic food establishment
                is treated to a level which ensures that any infectious agents of listed or
                emerging diseases which are present are fully inactivated before discharge;
          (c)   appropriate equipment, compatible with the type of production activities
                conducted, must be available for the cleaning and disinfection of facilities,
                equipment and means of transport;
          (d)   appropriate predator control measures must be put in place, taking into account
                the risk of disease spread these predators pose.
EN                                                7                                                EN
 ---pagebreak---                                                Part 5
      Requirements for granting approval of purification centres as referred to in Article 12
   1.      The requirements in relation to biosecurity measures of purification centres as
           referred to in point (a) of Article 12, shall be the following
           (a)    operators shall implement the biosecurity plan in accordance with Article 5,
                 which must take the following elements into consideration:
                 (i)    disinfection points must be installed at critical locations in the
                        purification centre;
                 (ii)   the work clothing and footwear for personnel must be kept solely for use
                        at the purification centre and cleaned and disinfected regularly;
                 (iii) equipment must not be shared between establishments but where this is
                        unavoidable, an appropriate protocol for cleaning and disinfection of the
                        equipment must be put in place;
                 (iv) visitors to the purification centre must be controlled where they pose a
                        risk for the spread of disease; these visitors must either:
                        –      wear protective clothing and footwear provided at the purification
                               centre; or
                        –      clean and disinfect any protective clothing and footwear they bring
                               onto the purification centre on arrival and in the case of non-
                               disposable clothing and footwear, on departure;
                 (vi) equipment in the purification centre must be cleaned and disinfected at
                        the end of the purification cycle;
                 (vii) wastewater from the purification centre must not be discharged without
                        appropriate treatment directly into water bodies when the health status of
                        aquatic animals may be jeopardised with respect to listed or emerging
                        diseases.
   2.      The requirements in relation to facilities and equipment of purification centres as
           referred to in point (b) of Article 12, shall be the following:
           (a)   the purification centre must provide for good standards of hygiene;
           (b)   equipment and facilities must be made from materials which can be
                 appropriately cleaned and disinfected;
           (c)   appropriate equipment must be available for cleaning and disinfection of
                 facilities, equipment and means of transport;
           (d)   appropriate predator control measures must be put in place, taking into account
                 the risk of disease spread these predators pose;
           (e)   appropriate disinfection equipment must be put in place to ensure that
                 wastewater which is discharged from the purification centre is treated when
                 required to ensure that any agents of listed or emerging diseases which are
                 present are inactivated prior to discharge.
EN                                                  8                                              EN
 ---pagebreak---                                               Part 6
      Requirements for granting approval of dispatch centres as referred to in Article 13
   1.    The requirements in relation to biosecurity measures of dispatch centres as referred
         to in point (a) of Article 13, shall be the following:
         (a)    operators shall implement the biosecurity plan in accordance with Article 5,
                which must take the following elements into consideration:
                (i)    disinfection points must be installed at critical locations in the dispatch
                       centre;
                (ii)   work clothing and footwear for personnel must be kept solely for use at
                       the dispatch centre and cleaned and disinfected regularly;
                (iii) equipment must not be shared between establishments but where this is
                       unavoidable, an appropriate protocol for cleaning and disinfection of the
                       equipment must be put in place;
                (iv) visitors to the dispatch centre must be controlled in cases where they
                       pose a risk for the spread of disease; these visitors must either:
                       –      wear protective     clothing    and   footwear    provided   at  the
                              establishment; or
                       –      clean and disinfect any protective clothing and footwear they bring
                              onto the establishment on arrival and in the case of non-disposable
                              clothing and footwear, on departure;
                (v)    equipment in the dispatch centre must be cleaned and disinfected at the
                       end of the dispatch operation;
                (vi) wastewater from the dispatch centre must not be discharged without
                       appropriate treatment directly into water bodies when the health status of
                       aquatic animals may be jeopardised with respect to listed or emerging
                       diseases.
   2.    The requirements in relation to facilities and equipment of dispatch centres as
         referred to in point (b) of Article 13, shall be the following:
         (a)    the dispatch centre must provide for good standards of hygiene;
         (b)    equipment and facilities must be made from materials which can be
                appropriately cleaned and disinfected;
         (c)    appropriate equipment must be available for cleaning and disinfection of
                facilities, equipment and means of transport;
         (d)    appropriate predator control measures must be put in place, taking into account
                the risk of disease spread these predators pose;
         (e)    appropriate disinfection equipment must be in place to ensure that waste water
                which is discharged from the dispatch centre is treated when required to ensure
                that any agents of listed or emerging diseases which are present are inactivated
                prior to discharge.
EN                                                9                                                EN
 ---pagebreak---                                              Part 7
      Requirements for granting approval of relaying areas as referred to in Article 14
   1.   The requirements in relation to biosecurity measures of relaying areas as referred to
        in point (a) of Article 14, shall be the following:
        (a)    operators shall implement the biosecurity plan in accordance with Article 5,
               which must take the following elements into consideration:
               (i)    disinfection points must be installed at critical locations in the relaying
                      area;
               (ii)   work clothing and footwear for personnel must be kept solely for use at
                      the relaying area and cleaned and disinfected regularly;
               (iii) equipment must not be shared between aquaculture establishments but in
                      cases where this is unavoidable, an appropriate protocol for cleaning and
                      disinfection of the equipment must be put in place;
               (iv) visitors to the relaying area must be controlled in cases where they pose a
                      risk for the spread of disease; these visitors must either:
                      –          wear protective clothing and footwear provided at the relaying
                             area; or
                      –          clean and disinfect any protective clothing and footwear they
                             bring onto the relaying area on arrival and in the case of non-
                             disposable clothing and footwear, on departure;
               (v)    as far as possible, equipment in the relaying area must be cleaned and
                      disinfected at the end of the purification cycle.
   2.   The requirements in relation to facilities and equipment of relaying areas as referred
        to in point (b) of Article 14, shall be the following:
        (a)    as far as possible, the relaying area must provide for good standards of
               hygiene;
        (b)    as far as possible, equipment and facilities must be made from materials which
               can be appropriately cleaned and disinfected;
        (c)    appropriate equipment must be available for cleaning and disinfection of
               facilities where relevant, and equipment and means of transport;
        (d)    appropriate predator control measures must be put in place, taking into account
               the risk of disease spread these predators pose and the environmental
               constraints of the relaying area.
EN                                               10                                               EN
 ---pagebreak---                                                Part 8
    Requirements for granting approval of quarantine establishments as referred to in Article
                                                   15
   1.      The requirements in relation to biosecurity measures of quarantine establishments for
           aquatic animals as referred to in point (a) of Article 15 shall be the following:
           (a)   the quarantine establishment must be located at a secure distance from other
                 quarantine establishments, aquaculture establishments or groups of aquaculture
                 establishments by a distance specified by the competent authority on the basis
                 of a risk assessment which must take into account the epidemiology of the
                 relevant listed and emerging diseases;
           (b)   the operator shall implement the biosecurity plan which is provided for in
                 Article 5 and which must include at least the following elements:
                 (i)    disinfection points must be installed at critical locations as identified in
                        the biosecurity plan;
                 (ii)   where they exist within the same quarantine establishment, measures
                        must be taken to ensure that quarantine units remain epidemiologically
                        separate from each other;
                 (iii) work clothing and footwear for personnel must be kept at the quarantine
                        establishment and cleaned and disinfected regularly;
                 (iv) equipment must not be shared between quarantine units within the
                        quarantine establishment, but in cases where this is unavoidable, an
                        appropriate protocol for cleaning and disinfection of the equipment must
                        be put in place; equipment must not be shared with other establishments;
                 (v)    only authorised persons may enter the quarantine establishment;
                 (vi) persons entering the quarantine establishment must wear the protective
                        clothing and footwear provided and these must be safely disposed of or
                        cleaned and disinfected after use;
                 (vii) dead animals must be removed from all quarantine units at a frequency
                        that ensures infective pressure is kept to a minimum and disposed of as
                        Category 1 or Category 2 material in compliance with Article 12 or
                        Article 13 of Regulation (EC) No 1069/2009;
                 (viii) all equipment in the quarantine establishments must be cleaned and
                        disinfected at the end of each quarantine period;
                 (ix) the required quarantine period must start when the last aquatic animal in
                        the cohort to be quarantined is introduced;
                 (x)    each quarantine unit must be emptied of animals, cleaned and disinfected
                        at the end of the quarantine period and be kept free of animals for a
                        period of at least seven days before new aquatic animals are introduced;
                 (xi) precautions must be taken to prevent cross-contamination between
                        incoming and outgoing consignments of aquatic animals;
EN                                                 11                                                EN
 ---pagebreak---             (xii) animals released from the quarantine establishment must meet the
                   requirements for movements of aquaculture animals between Member
                   States;
      (c)   a named person must be in charge of implementing the biosecurity plan for the
            quarantine establishment with other personnel reporting to that individual in
            relation to biosecurity matters, where necessary.
   2. The requirements in relation to surveillance and control measures of quarantine
      establishments for aquaculture animals, as referred to in point (b) of Article 15, shall
      be the following:
      (a)   environmental conditions which are conducive to the clinical expression of the
            relevant listed or emerging disease must be kept in the quarantine
            establishment throughout the entire quarantine period;
      (b)   all aquaculture animals that die or show symptoms of disease during the
            quarantine period must be clinically inspected by a veterinarian and testing of
            samples must be carried out at a laboratory designated by the competent
            authority for that purpose;
      (c)   fish, molluscs and crustaceans of listed species must be quarantined under the
            conditions set out in point (a) for a period of at least 90 days;
      (d)   within a period of 15 days from the date of expiry of the quarantine period,
            samples must be taken from a number of aquaculture animals that will ensure
            the detection of the relevant pathogen with a 95% confidence if the target
            prevalence is 2%. These aquaculture animals may be taken from the cohort
            which is undergoing quarantine or from co-habiting sentinel aquaculture
            animals which are susceptible to the relevant listed or emerging disease and
            which are used as a diagnostic aid during the quarantine period.
   3. The requirements in relation to facilities and equipment of quarantine establishments
      for aquaculture animals, as referred to in point (c) of Article 15, shall be the
      following:
      (a)   the water supply to the quarantine establishment must be free of agents of the
            relevant listed or emerging disease;
      (b)   the waste water from the quarantine establishment must be treated
            appropriately to ensure that the infectious agent(s) of listed and emerging
            diseases are inactivated before discharge;
      (c)   the waste water treatment system must be fitted with a fail-safe backup
            mechanism to ensure its continuous operation and the complete containment of
            the relevant infectious agent(s);
      (d)   the quarantine establishments must be clearly demarcated and the access of
            animals and humans must be controlled;
      (e)   staff responsible for carrying out veterinary checks must have sufficiently
            equipped premises at their disposal, where necessary, including changing
            rooms and showers;
      (f)   adequate means for isolating aquaculture animals must be available for use
            when required;
EN                                           12                                                EN
 ---pagebreak---    (g) floors, walls and all other material or equipment must be constructed so that
       they can be adequately cleaned and disinfected;
   (h) an appropriate system must be in place to ensure the collection and appropriate
       disposal of animal by-products in compliance with Article 13 of Regulation
       (EC) No 1069/2009;
   (i) appropriate predator control measures are put in place, taking into account the
       risk of disease spread that these predators pose;
   (j) the part of the quarantine establishment accommodating the aquaculture
       animals must be of a suitable standard and so constructed that contact with
       water and animals outside is prevented and that inspection and any necessary
       husbandry procedures can be easily carried out.
EN                                      13                                             EN
 ---pagebreak---                                                  Part 9
      Requirements for granting approval of aquaculture establishments keeping aquaculture
      animals of vector species in isolation, until such time as they are no longer regarded as
                                  vectors, as referred to in Article 16
   1.       The requirements in relation to biosecurity measures of aquaculture establishments
            keeping aquaculture animals of listed species which are vectors in isolation until
            such time as they are no longer regarded as vectors, as referred to in point (a) of
            Article 16 shall be the following:
            (a)   operators shall implement the biosecurity plan in accordance Article 5, which
                  must include at least the following elements:
                  (i)    disinfection points must be installed at critical locations in the
                         aquaculture establishment;
                  (ii)   where different isolation units exist within the same aquaculture
                         establishment, appropriate measures must be taken to ensure they remain
                         epidemiologically separate from each other;
                  (iii) work clothing and footwear for personnel must be kept solely for use at
                         the aquaculture establishment and cleaned and disinfected regularly;
                  (iv) equipment must not be shared between isolation units within the
                         aquaculture establishment but where this is unavoidable, an appropriate
                         protocol for cleaning and disinfection of the equipment must be put in
                         place; equipment must not be shared with other establishments;
                  (v)    only authorised persons must enter the aquaculture establishment;
                  (vi) persons entering the aquaculture establishment must wear the protective
                         clothing and footwear provided and these must be safely disposed of or
                         cleaned and disinfected after use;
                  (vii) dead animals must be removed from all production units in the
                         establishment at a frequency that ensures infective pressure is kept to a
                         minimum, and must be disposed of in compliance with Article 13 of
                         Regulation (EC) No 1069/2009;
                  (viii) all equipment in the aquaculture establishment, or in the relevant
                         isolation unit, if the aquaculture establishment consists of more than one
                         such unit, must be cleaned and disinfected at the end of each isolation
                         period;
                  (ix) the isolation period referred to in point 2 shall only start when the last
                         animal in the cohort is introduced to the aquaculture establishment, or
                         when there are a number of isolation units in the aquaculture
                         establishment, the isolation period shall only start when the last animal
                         in the cohort is introduced to the isolation unit;
                  (x)    each isolation unit in the aquaculture establishment must be emptied of
                         animals, and cleaned and disinfected at the end of the isolation period;
                  (xi) precautions must be taken to prevent cross-contamination between
                         incoming and outgoing consignments of aquatic animals;
EN                                                  14                                              EN
 ---pagebreak---              (xii) animals released from the aquaculture establishment in which the
                    isolation period has been undergone shall meet the requirements for
                    movements of aquatic animals between Member States.
      (b)    operators shall ensure that a named person is charged with implementing the
             biosecurity plan for the aquaculture establishment with other personnel
             reporting to that individual in relation to biosecurity matters, where necessary.
   2. The requirements in relation to surveillance and control measures of establishments
      keeping aquaculture animals of listed species which are vectors in isolation until
      such time as they are no longer regarded as vectors, as referred to in point (b) of
      Article 16, shall be the following:
      (a)    fish, molluscs and crustaceans of listed species shall be kept in isolation for a
             period of at least 90 days;
      (b)    all aquaculture animals that die or show symptoms of disease during the 90 day
             isolation period must be clinically inspected by a veterinarian and testing of
             samples must be carried out at a laboratory designated by the competent
             authority for that purpose.
   3. The requirements in relation to facilities and equipment of aquaculture
      establishments keeping aquaculture animals of listed species which are vectors in
      isolation until such time as they are no longer regarded as vectors, as referred to in
      point (c) of Article 16, shall be the following:
      (a)    adequate means of keeping aquaculture animals in isolation must be available;
      (b)    the water supply to the aquaculture establishment must be free of listed species
             and of agents of the relevant listed and emerging diseases;
      (c)    where this is necessary so as not to jeopardise the health status of receiving
             waters, the waste water from the aquaculture establishment must be treated
             appropriately to ensure that the infectious agent(s) of listed and emerging
             diseases are inactivated before discharge;
      (d)    the access of animals to the aquaculture establishment is controlled;
      (e)    floors, walls and all other material or equipment are constructed so that they
             can be adequately cleaned and disinfected;
      (f)    an appropriate system is in place to ensure the collection and appropriate
             disposal of animal by-products in compliance with Article 13 of Regulation
             (EC) No 1069/2009;
      (g)    appropriate predator control measures are put in place, taking into account the
             risk of disease spread that these predators pose.
EN                                            15                                               EN
 ---pagebreak---                                                 Part 10
       Requirements for granting approval of aquaculture establishments which are closed
    facilities keeping aquaculture animals for ornamental purposes as referred to in Article 17
   1.        The requirements in relation to biosecurity measures of aquaculture establishments
             which are closed facilities keeping aquaculture animals for ornamental purposes
             which, because of their movement patterns, create a significant disease risk, as
             referred to in Article 17 shall be the following:
             (a)   the operator shall implement the biosecurity plan in accordance with Article 5,
                   which must take the following elements into consideration:
                   (i)    disinfection points must be installed at critical locations in the
                          establishment;
                   (ii)   work clothing and footwear for personnel must be kept solely for use at
                          the aquaculture establishment and cleaned and disinfected regularly;
                   (iii) visitors to the aquaculture establishment must be controlled in cases
                          where they pose a disease risk. These visitors must either:
                          –      wear protective clothing and footwear provided at the aquaculture
                                 establishment; or
                          –      clean and disinfect any protective clothing and footwear they bring
                                 onto the aquaculture establishment on arrival and in the case of
                                 non-disposable clothing and footwear, on departure;
                   (iv) dead animals must be removed from all production units at a frequency
                   that ensures infective pressure is kept to a minimum and disposed of in
                   compliance with Article 13 of Regulation (EC) No 1069/2009.
             (b)   a named person must be in charge of implementing the biosecurity plan for the
                   aquaculture establishment with other personnel reporting to that individual in
                   relation to biosecurity matters, where necessary.
   2.        The requirements in relation to facilities and equipment of the aquaculture
             establishments which are closed facilities keeping aquaculture animals for
             ornamental purposes which, because of their movement patterns, create a significant
             disease risk, as referred to in point (c) of Article 17, shall be the following:
             (a)   suitable equipment and facilities must be available for the purpose of
                   maintaining appropriate husbandry conditions for the animals kept in the
                   establishment;
             (b)   the aquaculture establishment must provide for good standards of hygiene and
                   allow health monitoring to be carried out;
             (c)   the equipment and facilities must be made from materials which can be readily
                   cleaned and disinfected;
             (d)   appropriate equipment must be available for cleaning and disinfection of
                   facilities, equipment and means of transport;
             (e)   appropriate predator control measures must be put in place, taking into account
                   the risk of disease spread that these predators pose;
EN                                                   16                                              EN
 ---pagebreak---    (f) an appropriate system must be in place to ensure the collection and appropriate
       disposal of animal by-products in compliance with Article 13 of Regulation
       (EC) No 1069/2009;
EN                                   17                                                EN
 ---pagebreak---                                                 Part 11
        Requirements for granting approval of aquaculture establishments which are open
    facilities keeping aquaculture animals for ornamental purposes as referred to in Article 18
   1.        The requirements in relation to biosecurity measures of aquaculture establishments
             which are open facilities keeping aquaculture animals for ornamental purposes as
             referred to in point (b) of Article 18, shall be the following:
             (a)   the operator shall implement the biosecurity plan in accordance with Article 5,
                   which must take the following elements into consideration:
                   (i)    disinfection points must be installed at critical locations in the
                          aquaculture establishment;
                   (ii)   where they exist within the same aquaculture establishment, functional
                          units must be kept separate using appropriate hygiene measures;
                   (iii) work clothing and footwear for personnel must be kept at the aquaculture
                          establishment and cleaned and disinfected regularly;
                   (iv) equipment must not be shared between aquaculture establishments but in
                          cases where this unavoidable, an appropriate protocol for cleaning and
                          disinfection of the equipment must be put in place;
                   (v)    visitors to the aquaculture establishment must be controlled in cases
                          where they pose a disease risk. These visitors must either:
                          –     wear protective clothing and footwear provided at the aquaculture
                                establishment; or
                          –     clean and disinfect any protective clothing and footwear they bring
                                onto the aquaculture establishment on arrival and in the case of
                                non-disposable clothing and footwear, on departure;
                   (vi) dead animals must be removed from all production units at a frequency
                          that ensures infective pressure is kept to a minimum and disposed of in
                          compliance with Article 13 of Regulation (EC) No 1069/2009;
                   (vii) as far as possible, equipment in the aquaculture establishment must be
                          cleaned and disinfected at the end of each production cycle;
                   (viii) the cleaning and disinfection records of transporters must be verified
                          before animals are loaded or unloaded at the aquaculture establishment;
             (b)   operators shall ensure that a named person is charged with implementing the
                   biosecurity plan for the aquaculture establishment with other personnel
                   reporting to that individual in relation to biosecurity matters, where necessary.
   2.        The requirements in relation to facilities and equipment of aquaculture
             establishments which are open facilities keeping aquaculture animals for ornamental
             purposes as referred to in point (c) of Article 18, shall be the following:
             (a)   suitable equipment and facilities must be available for the purpose of
                   maintaining appropriate husbandry conditions for the animals kept in the
                   aquaculture establishment;
             (b)   the establishment must provide for good standards of hygiene and allow
                   adequate health monitoring to be carried out;
EN                                                   18                                              EN
 ---pagebreak---    (c) as far as possible, equipment and facilities must be made from materials which
       can be appropriately cleaned and disinfected;
   (d) appropriate predator control measures must be put in place, taking into account
       the risk these predators pose and the environmental constraints of the
       aquaculture establishment;
   (e) appropriate equipment must be available for the cleaning and disinfection of
       facilities, equipment and means of transport;
   (f) an appropriate system is in place to ensure the collection and appropriate
       disposal of animal by-products in compliance with Article 13 of Regulation
       (EC) No 1069/2009.
EN                                    19                                               EN
 ---pagebreak---                                             Part 12
   Requirements for granting approval of vessels or other mobile premises where aquaculture
      animals are kept temporarily to be treated or to undergo another husbandry related
                              procedure as referred to in Article 19
   1.     The requirements in relation to biosecurity measures of vessels or other mobile
          premises where aquaculture animals are kept temporarily to be treated or to undergo
          another husbandry related procedure as referred to in point (a) of Article 19, shall be
          the following:
          (a)   the operator shall implement the biosecurity plan in accordance with Article 5,
                which must take the following elements into consideration:
                (i)   the vessel or mobile premises and all equipment used during the
                      treatment process must be cleaned and disinfected when a treatment has
                      been completed and before it moves to another aquaculture
                      establishment;
                (ii)  work clothing and footwear for personnel must be kept at the aquaculture
                      establishment and cleaned and disinfected regularly;
                (iii) equipment must not be shared with other aquaculture establishments but
                      in cases where this is unavoidable, an appropriate protocol for cleaning
                      and disinfection of the equipment must be put in place and evidence of its
                      implementation kept;
                (iv) visitors to the aquaculture establishment must be controlled in cases
                      where they cause a disease risk; these visitors must either:
                      –     wear protective clothing and footwear provided at the aquaculture
                            establishment; or
                      –     clean and disinfect any protective clothing and footwear they bring
                            onto the aquaculture establishment on arrival and in the case of
                            non-disposable clothing and footwear, on departure;
                (v)   the cause of any mortality which occurs during a treatment must be
                      recorded and dead animals must be removed from the aquaculture
                      establishment at a frequency that minimises infective pressure and which
                      is practicable given the treatment schedule for the aquaculture animals
                      concerned;
                (vi) dead animals are removed at a frequency that ensures infective pressure
                      is kept to a minimum and disposed of in compliance with Article 13 of
                      Regulation (EC) No 1069/2009.
          (c)   operators shall ensure that a named person is charged with implementing the
                biosecurity plan for the establishment, with other personnel reporting to that
                individual in relation to biosecurity matters, where necessary.
   2.     The requirements in relation to facilities and equipment of vessels or other mobile
          premises where aquaculture animals are kept temporarily to be treated or to undergo
          another husbandry-related procedure as referred to in point (b) of Article 19, shall be
          the following:
EN                                               20                                               EN
 ---pagebreak---    (a) suitable equipment and facilities must be available for the purpose of
       maintaining appropriate husbandry conditions for the aquaculture animals kept
       in the establishment;
   (b) as far as possible, equipment and facilities must be made from materials which
       can be readily cleaned and disinfected;
   (c) appropriate equipment must be available for cleaning and disinfection of
       facilities and equipment;
   (d) where automated cleaning and disinfection systems are used, their efficacy
       must be validated before their initial use and at appropriate frequencies
       thereafter;
   (e) an appropriate system is in place to ensure the collection and appropriate
       disposal of animal by-products in compliance with Article 13 of Regulation
       (EC) No 1069/2009.
EN                                    21                                              EN
 ---pagebreak---                                                     ANNEX II
     RISK-BASED SURVEILLANCE TO BE CARRIED OUT IN CERTAIN APPROVED
                                             ESTABLISHMENTS
                                                     Part 1
      Risk-based surveillance in aquaculture establishments and groups thereof referred to in
                                             Articles 7, 8, 17 and 18
   Risk-based surveillance shall be implemented as follows in the aquaculture establishments,
   and groups thereof, which are referred to in Articles 7, 8, 17 and 18:
   (a)      aquaculture establishments keeping listed species of aquaculture animals other than
            the species referred to in point (b)(ii) of this Part, shall implement risk-based
            surveillance according to their ranking as ‘high’, ‘medium’ or ‘low’ risk as a result of
            a risk assessment carried out in accordance with Part I of Annex VI to Commission
            Delegated Regulation (EU) …/… [C(2019) 4056]2;
   (b)      aquaculture establishments keeping the species of aquaculture animals referred to in
            points (i) and (ii) shall implement risk-based surveillance if they have been ranked as
            ‘high’ risk as a result of a risk assessment carried out in accordance with Part I of
            Annex VI to Commission Delegated Regulation (EU) …/… [C(2019) 4056] :
            (i)      non-listed species;
            (ii)     listed species referred to in the fourth column of the table set out in the Annex
                     to Implementing Regulation (EU) 2018/1882; but those listed species must be
                     in contact with the listed species referred to in the third column of that table in
                     order to be classified as vectors species, and that contact has not occurred.
   2
           Delegated Regulation (EU) …/… supplementing Regulation (EU) 2016/429 of the European Parliament
           and of the Council as regards rules for surveillance, eradication programmes and disease-free status for
           certain listed and emerging diseases [C(2019) 4056].
EN                                                       22                                                         EN
 ---pagebreak---                                             Part 2
      Content of risk-based surveillance at aquaculture establishments or groups thereof
            conducted in accordance with Article 26 of Regulation (EU) 2016/429
   1.    Record checks, clinical inspections and laboratory examinations at the approved
         aquaculture establishments referred to in Articles 7, 17 and 18 shall be carried out as
         follows:
         (a)   the relevant records kept in accordance with the record-keeping obligations of
               Article 186 of Regulation (EU) No 2016/429 and with Articles 23, 32 and 33
               of this Regulation must be examined to assess if there are any indications of
               increased mortality or the presence of a listed or emerging disease in the
               aquaculture establishment which must be taken into account during the visit by
               a veterinarian;
         (b)   all parts of the aquaculture establishment must be examined with particular
               attention being paid to those production units where increased mortalities have
               been indicated in the records referred to in point (a);
         (c)   where there are no indications of the presence of a listed or emerging disease
               either from an examination of the records or from the clinical inspection of all
               production units, there shall be no requirement to take samples for laboratory
               examination;
         (d)   where recently dead or moribund aquaculture animals are identified, a
               representative selection of these aquaculture animals must be examined
               clinically, both externally and internally, to determine if pathological changes
               are present; that examination must in particular, aim at detecting listed or
               emerging diseases;
         (e)   if the outcome of the clinical examination provided for in point (d) leads to a
               suspicion of the presence of such a listed or emerging disease in an aquaculture
               establishment in a Member State, zone or compartment in which an eradication
               programme is being implemented, or which has been declared free from that
               particular disease, a sample of aquaculture animals from that aquaculture
               establishment shall be collected and subjected to a laboratory examination in
               accordance with the relevant Chapter of Part II of Annex VI to Delegated
               Regulation (EU) …/… [C(2019) 4056];
         (f)   if the outcome of the clinical examination provided for in point (d) leads to a
               suspicion of the presence of a listed disease in an aquaculture establishment in
               which a surveillance programme is being implemented for that particular
               category C disease, a sample of aquaculture animals from the aquaculture
               establishment shall be collected and subjected to a laboratory examination in
               accordance with the relevant Chapter of Part III of Annex VI to Delegated
               Regulation (EU) …/… [C(2019) 4056];
         (g)   if the outcome of the clinical examination provided for in point (d) leads to the
               suspicion of an emerging disease, a sample of aquaculture animals from the
               aquaculture establishment shall be collected and subjected to a laboratory
               examination with the objective of identifying the emerging disease in question.
   2.    Record checks and clinical and laboratory examinations at the approved groups of
         aquaculture establishments referred to in Article 8 shall be carried out as follows:
EN                                             23                                                EN
 ---pagebreak---    (a) the relevant records kept by or on behalf of each aquaculture establishment in
       the group of aquaculture establishments in accordance with Article 186 of
       Regulation (EU) No 2016/429 and with Article 24 of this Regulation, must be
       examined to assess if there are indications of increased mortality or of the
       presence of a listed or emerging disease which must be taken into account
       when deciding which aquaculture establishment in the group is required to be
       visited for the purpose of risk-based surveillance;
   (b) when the examination of records referred to in point (a) indicates increased
       mortality or the presence of a listed or emerging disease in a particular
       aquaculture establishment within the group, that establishment must be visited
       for the purpose of risk based surveillance; the steps outlined in point 1 (b) to
       (g) must be followed during that visit;
   (c) when the examination of records referred to in point (a) does not indicate
       increased mortality or the presence of a listed or emerging disease in any
       aquaculture establishment within the group, the risk-based surveillance visit or
       visits shall be carried out either:
       (i)    after risk assessment, in the aquaculture establishment or aquaculture
              establishments within the group which pose the highest risk of disease
              introduction; or
       (ii)   to the establishment which has had the greatest number of movements of
              aquaculture animals for further farming, since the last risk-based
              surveillance visit was carried out.
       In either case, the steps outlined in point1 (c) to (g) must be followed during
       the risk-based surveillance visit.
EN                                       24                                             EN