CELEX: 51989PC0655
Language: en
Date: 1990-02-02
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) CONCERNING THE ANIMAL HEALTH CONDITIONS GOVERNING THE PLACING ON THE MARKET OF AQUACULTURE ANIMALS AND PRODUCTS

No C 84/42                                    Official Journal of the European Communities                                               2 . 4 . 90
                                                                 CHAPTER X
                                                      MARKING OF CONSIGNMENTS
              1. All parcels in a consignment of live bivalve molluscs must be provided with a health mark so enabling at all
                  times during transport and distribution until retail, the identification of their original expedition centre.
                  Without prejudice to Council Directive 79/112/EEC on the approximation of laws of the Member States
                  relating to the labelling, presentation and advertising of foodstuffs^), as last amended by Directive
                   89/395/EEC ( 2 ), the mark must contain the following information:
                  — the country of dispatch,
                  — species of bivalve mollusc (common name and scientific name),
                  — the identification of the expedition centre by the approval number granted by the competent
                      authority,
                  — the date of wrapping.
              2. The health mark may be printed on the wrapping material or be put on a separate tag which is then fixed on the
                  wrapping material or put inside the wrapping. They may also be of a twist-tie or staple design; self-adhesive
                  health marks must not be used. All types of health marks must be designed for single use and be not
                  transferable.
              3. The health mark must be durable and waterproof and the information presented as legible, indelible and in
                  easily decipherable characters.
              4. The health mark attached to consignments of live bivalve molluscs which are not wrapped as consumer size
                  parcels must be kept for at least 60 days by the retailer after splitting up the content of the consignment.
              H OJ No L 3 3 , 8. 2. 1979, p. 1.
              (2) OJ No L 186, 30. 6. 1989, p. 17.
              Proposal for a Council Regulation (EEC) concerning the animal health conditions governing the
                                     placing on the market of aquaculture animals and products
                                                             COM(89)   655     final
                                          (Submitted    by the Commission     on 9 February      1990)
                                                                (90/C 84/04)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                  Whereas the breeding and rearing of aquaculture animals,
                                                                           and the placing on the market of aquaculture animals and
Having regard to the Treaty establishing the European                     products constitutes a source of income for persons working
Economic C o m m u n i t y , and in particular Article 43                 in the fisheries sector;
thereof,
                                                                          Whereas, in order to ensure the rational development of this
                                                                           sector and to increase productivity, health rules for this
Having regard to the proposal from the Commission,                         sector must be laid d o w n at C o m m u n i t y level;
Having regard to the opinion of the European Parliament,                  Whereas in this context it is necessary to contribute to the
                                                                          completion of the internal m a r k e t , avoiding the spread of
                                                                           contagious diseases;
Having regard to the opinion of the Economic and Social
Committee,                                                                Whereas the animal health situation for aquaculture animals
                                                                           is not the same t h r o u g h o u t the territory of the C o m m u n i t y ,
Whereas aquaculture animals and products are included in                   whereas reference must therefore be m a d e to zones when
the list in Annex II to the Treaty;                                       dealing with parts of the C o m m u n i t y ;
 ---pagebreak--- 2. 4. 90                                 Official Journal of the European Communities                                   No C 84/43
Whereas there must be laid down criteria and procedures for          8. official service: means one or more services designated by
the approval, the suspension and the withdrawal of approval               the competent authority of the Member State or third
of such zones;                                                            country and responsible for carrying out the controls
                                                                         provided for in this Regulation;
Whereas it is necessary to define Community provisions
applicable to imports from third countries; whereas these           9. health inspection: means a visit by an official service or
provisions must provide for adequate safeguard measures;                  services, for the purpose of checking the health status of a
                                                                         farm or a zone.
Whereas a Community inspection system should be
established in order to verify compliance with this
Regulation;
Whereas provision should be made for a procedure
establishing close cooperation between the Commission and
the Member States within the Standing Veterinary                                                CHAPTER 2
Committee,
                                                                    Placing on the market of animals and products from
                                                                                    aquaculture from the Community
HAS ADOPTED THIS REGULATION:
                                                                                                 Article 3
                         CHAPTER 1
                                                                    1.       The placing on the market of aquaculture animals shall
                     General provisions                             be subject to the following general requirements:
                                                                    (a) they must show no clinical signs of disease on the day of
                          Article 1                                        loading;
This Regulation lays down the animal health conditions              (b) they must not be intended for destruction or slaughter
governing the placing on the market of aquaculture animals                 under a national scheme for the eradication of a
and products.                                                              contagious disease;
                                                                    (c) they must not come from a farm which is subject to a
                          Article 2                                       prohibition on animal health grounds and must not have
                                                                          been in contact with animals from such a farm;
For the purposes of this Regulation:
1. aquaculture animals: means live fish, crustaceans or             2.      Aquaculture products being placed on the market, for
    molluscs originating from a farm;                               breeding purposes (eggs and gametes) must originate from
2. aquaculture products: means products derived from                animals which satisfy the conditions laid down in
                                                                   paragraph 1.
    aquaculture animals such as eggs, gametes or products to
    be placed on the market for human consumption;
                                                                    3.      Aquaculture products being placed on the market for
3. fish, crustaceans and molluscs: means any fish,
                                                                    human consumption must originate from animals which
    crustacean and mollusc at any stage of development
                                                                    satisfy the conditions laid down in paragraph 1 (a).
    belonging to the species referred to in Annex A,
    columns 2 and 3;
4. farm: means any establishment or, in general, any
    geographically defined installation in which aquaculture                                     Article 4
    animals are reared or kept with a view to their being
    placed on the market;                                          Live aquaculture animals must be dispatched in the shortest
5. approved farm: means a farm complying, as the case may          possible period to the place of destination, using means of
    be, with the requirements of Annex C I or II, and              transport that have been cleaned and, if necessary,
    approved as such in accordance with the procedure laid         disinfected in advance with a disinfectant that is officially
    down in Article 6;                                             authorized in the Member State of dispatch.
6. approved zone: means a zone complying as the case may
                                                                   If water is used in transport, the vehicles shall be designed in
    be, with the requirements of Annex B I, II or III and
                                                                   such a way that water cannot escape from the vehicle during
    approved as such in accordance with the procedure laid
                                                                   transport. Transport shall be carried out in such a way as to
    down in Article 5;
                                                                   safeguard effectively the health of the animals, in particular
7. approved laboratory: means a laboratory located in the          by changing the water. Such a change must be carried out in
    territory of a Member State, designated by the competent       places complying with the requirements of Annex D. A list of
    authority, under its responsibility, to carry out the          these places must be notified by the Member States to the
    diagnostic tests provided for in this Regulation;              Commission and to the other Member States.
 ---pagebreak--- No C 84/44                                 Official Journal of the European Communities                                       2. 4. 90
                           Article 5                                   (a) when they are to be introduced into an approved zone,
                                                                           they must be accompanied by a movement document
 1.     In order to obtain, for the diseases referred to in                corresponding to Article 10 and to the model referred to
 Annex A, column 1, lists 1 and II, the status of approved                 in Annex E, Chapter I, certifying that they come from a
 zone, Member States shall present to the Commission:                      zone of the same health status;
 — all appropriate justifications and in particular those             (b) when they are to be introduced into a farm which,
     concerning the conditions laid down, as the case may be,               although not situated in an approved zone, fulfils the
     in Annex B under I B, under II B or under III B,                      conditions of Annex C I, they must be accompanied by a
— the national rules ensuring the respect of the conditions                movement document corresponding to Article 10 and to
     laid down, as the case may be, in Annex B under I C,                  the model referred to in Annex E, Chapter 2, certifying
     under II C or under III C.                                            that they come from a farm of the same health status as
                                                                           the farm of destination, or they must be accompanied by
2.      The Commission shall scrutinize the information                    the document referred to in (a), certifying that they come
referred to in paragraph 1. The Commission may, in                         from an approved zone.
 accordance with the procedure laid down in Article 26,
approve or re-approve zones, having regard to that                    2.     The Commission, in accordance with the procedure
information.                                                          laid down in Article 26 may adapt or delete the additional
                                                                      requirements referred to in paragraph 1, depending on the
If in accordance with Annex B under I D 5, under II D or              evolution of the animal health situation in the Community, in
under II D 5 the approval of a zone is withdrawn by the               particular in order to take account of the results of the
official service, the Commission shall revoke the decision            eradication measures for the disease mentioned in Annex A,
concerning its approval.                                              column 1, list I.
3.      The Commission shall draw up the list of approved
zones, and shall amend this list in order to take account of
new approvals or withdrawal of approvals.                                                         Article 8
                                                                      1.     The placing on the market of live molluscs belonging to
                           Article 6                                  the species referred to in Annex A, column 2, list II shall be
                                                                      subject to the following additional requirements:
1.      In order to obtain, for the diseases referred to in
Annex A, column 1, lists I and II, the status of approved             (a) if they are to be re-laid in an approved coastal zone, they
farm situated in a non-approved zone, the Member States                    must be accompanied by a movement document
shall present to the Commission:                                           complying with Article 10 and corresponding to the
                                                                           model referred to in Annex E, Chapter 3, certifying that
— all appropriate justifications and in particular those                   they come from a coastal zone of the same health
     concerning the conditions laid down, as the case may be,              status;
     in Annex C under I A or under II A,
                                                                      (b) if they are to be re-laid in a farm which, although not
— the national rules ensuring the respect of the conditions
                                                                           situated in an approved coastal zone fulfils the
     laid down in Annex C under I B or under II B.
                                                                           requirements of Annex C II, they must be accompanied
                                                                           by a movement document complying with Article 10
2.      The Commission shall scrutinize the information
                                                                           and corresponding to the model referred to in Annex E,
referred to in paragraph 1. The Commission may, in
                                                                           Chapter 4, certifying that they come from a farm of the
accordance with the procedure laid down in Article 26,
                                                                           same health status as the farm of destination, or they
approve or re-approve farms, having regard to that
                                                                           must be accompanied by the document referred to in (a),
information.
                                                                           certifying that they come from an approved coastal
                                                                           zone.
If in accordance with Annex C under I C or under II C, the
approval of a farm is withdrawn by the official service, the
Commission shall revoke the decision concerning its                   2.     The Commission, in accordance with the procedure
approval.                                                             laid down in Article 26 may adapt or delete the additional
                                                                      requirements referred to in paragraph 1, depending on the
3.      The Commission shall draw up the list of approved             evolution of the animal health situation in the
farms, and shall amend this list in order to take account of          Community.
new approvals or withdrawal of approvals.
                           Article 7                                                              Article 9
1.      The placing on the market of live fish belonging to the       The placing on the market in an approved zone of
susceptible species referred to in Annex A, column 2, lists I         aquaculture products for direct human consumption
and II, their eggs or gametes, shall be subject to the following      originating from a non-approved zone shall be subject to the
additional requirements:                                              following conditions:
 ---pagebreak--- 2. 4. 90                                  Official Journal of the European Communities                                 No C 84/45
1. fish susceptible to the diseases referred to in Annex A,          in paragraph 1 may be approved in accordance with the
     column 1, lists I and II must be slaughtered and                procedure laid down in Article 26. The additional
     eviscerated prior to expedition;                                guarantees, general or specific, which may be required for the
                                                                     introduction of aquaculture animals and products into
2. live molluscs susceptible to the diseases referred to in          officially checked farms or zones may be defined in
     Annex A, column 1, list II must be delivered directly for       accordance with the same procedure.
     human consumption and shall not be returned to
     water.
                                                                     3.     Programmes submitted by Member States may be
     The Commission, in accordance with the procedure laid           amended or supplemented in accordance with the procedure
     down in Article 27, shall lay down, when considered             laid down in Article 26. Under the same procedure, the
     necessary, the appropriate conditions necessary to              Commission may approve an amendment or addition to a
     ensure compliance with this prohibition.                        programme which has been approved or to guarantees which
                                                                     have been defined in accordance with paragraph 2.
                           Article 10
1.     The movement document referred to in Articles 7 and                                       Article 12
8 must be drawn up by the official service at the place of
origin within 48 hours before loading, in the official language      1.     Where a Member State considers that its territory or
or languages of the place of destination. It must be drawn up        part of its territory is free from one of the diseases listed in
on a single sheet of paper, be made out for a single consignee,      Annex A, column 1, list HI, it shall present to the
and shall be valid for 10 days.                                      Commission appropriate justification, setting out in
                                                                     particular:
2.     Each consignment of aquaculture animals and
products must be clearly identified in order to be able to trace     — the name of the disease and the previous history of its
back to the farm of origin, and to verify where appropriate              occurrence in that Member State,
the correlation of the animals or products with the
                                                                     — the results of surveillance testing based on serological,
information contained in the accompanying movement
                                                                         virological, microbiological or pathological findings, as
document. This information may figure directly on the
                                                                         appropriate, and on the fact that the disease must by law
container or on a label fixed to it or on the transport
                                                                         be notified to the competent authorities,
documents.
                                                                     — the period over which the surveillance was carried out,
                           Article 11                                — the control arrangements for verifying that the area
                                                                         concerned remains free from the disease.
1.     Where a Member State draws up or has drawn up a
voluntary or compulsory control programme for one of the             2.     The Commission shall examine such justification. The
diseases referred to in Annex A, column 1, list III, it shall        additional guarantees, general or specific, which may be
present the programme to the Commission, outlining in                required for the introduction of aquaculture animals and
particular:                                                          products into farms or areas may be defined in accordance
                                                                     with the procedure provided for in Article 26.
— the distribution of the disease in the Member State,
— the reasons for which the programme should be                      3.     The Member State concerned shall notify the
    implemented, including the importance of the disease and         Commission of any change in the particulars specified in
    the programme's likely benefit in relation to its cost,          paragraph 1 which relate to the disease. The guarantees
                                                                     defined as laid down in paragraph 2 may, in the light of such
— the geographical areas in which the programme will be              notification, be amended or withdrawn in accordance with
    implemented,                                                     the procedure provided for in Article 26.
— the categories of farms to be established, and the
    standards which must be achieved by the farms in each
    category, including test procedures,                                                         Article 13
— the rules applicable for entry of animals of a lower health
    status into the farm,                                            The Commission, in accordance with the procedure laid
                                                                     down in Article 26, shall lay down:
— the action to be taken if, for any reason, a farm loses its
    status,                                                          1. the conditions for the placing on the market of
                                                                          ornamental fish;
— the procedure under which the programme shall be
    monitored.                                                       2. the conditions for the placing on the market of wild
                                                                          species and products thereof; until such conditions are
2.     The Commission shall scrutinize the programmes                     established, the rules laid down in this Regulation shall
presented by the Member States. Programmes as referred to                 apply, mutatis mutandis.
 ---pagebreak--- No C 84/46                                 Official Journal of the European Communities                                        2. 4. 90
3. the conditions for the placing on the market of fish                                            Article 18
     which, although not susceptible to the diseases referred
     to in Annex A, column 1, lists I and II, can transfer by
     mechanical means those diseases.                                 1.     Aquaculture animals and products shall come from
                                                                      third countries or parts thereof appearing on a list drawn up
                                                                      by the Commission in accordance with the procedure laid
                                                                      down in Article 26. This list may be supplemented or
                           Article 14                                 amended in accordance with the same procedure.
Sampling plans and diagnostic methods to be applied for the           2.     In deciding whether a third country or part thereof may
detection and confirmation of the presence of the disease             appear on the list referred to in paragraph 1, particular
referred to in Annex A, column 1 shall be established in              account shall be taken of:
accordance with the procedure laid down in Article 26.
These sampling plans must take account of the presence of
                                                                      (a) the state of health of the aquaculture animals, particular
wild fish, wild crustaceans and wild molluscs in the aquatic
                                                                           attention being paid to exotic diseases and the
environment.
                                                                           environmental health situation in the third country
                                                                           which might endanger animal health in the
                                                                           Community;
                           Article 15
                                                                      (b) the regularity and rapidity of the information supplied
The rules laid down in Council Directive . . . concerning                  by the third country relating to the existence of
veterinary checks in intra-Community trade with a view to                  infectious or contagious diseases of aquaculture animals
the completion of the internal market (J) shall apply, in                  in its territory, in particular those diseases mentioned in
particular as regards the organization of and the action to be             list B of the International Office of Epizootic
taken following the inspections to be carried out by the                   Diseases;
Member State of destination, and the safeguard measures to
be implemented.                                                       (c) the rules of the third country on the prevention and
                                                                           control of diseases of aquaculture animals;
                                                                      (d) the structure of the official services in the third country
                           Article 16                                      and their powers;
1.     Commission veterinary experts may, where it is                 (e) the organization and implementation of measures to
necessary for the uniform application of the Regulation,                   prevent and control infectious or contagious diseases of
carry out on-site inspections. The Member State in whose                   aquaculture animals;
territory an inspection is carried out shall provide the experts
with all the assistance necessary to complete their task. The         (f)  assurances which the third country may provide
Commission shall notify the Member States of the outcome                   concerning the rules laid down in this Regulation.
of such inspections.
                                                                      3.     The list referred to in paragraph 1 and all amendments
2.     General provisions for the application of this Article         thereto shall be published in the Official Journal of the
shall be adopted in accordance with the procedure laid down           European Communities.
in Article 27.
The rules to be followed during the inspection provided for in
this Article shall be drawn up in accordance with the same
procedure.                                                                                         Article 19
                                                                      1.     For each third country, animals and products from
                                                                      aquaculture shall satisfy the health conditions adopted in
                                                                      accordance with the procedure laid down in Article 26.
                          CHAPTER 3
                                                                      2.     Depending on the animal health situation in the third
        Rules governing imports from third countries
                                                                      country concerned, the conditions may include in
                                                                      particular:
                           Article 17                                 — restriction to imports from a part of the third country,
Aquaculture animals and products imported into the                    — restriction to         certain   species  at   any   stage   of
Community shall satisfy the conditions laid down in                       development,
Articles 18 to 20.
                                                                      — the prescription of a treatment to be applied to the
(>) O J N o L . . .                                                       products such as the disinfection of eggs,
 ---pagebreak--- 2. 4. 90                                   Official Journal of the European Communities                                  No C 84/47
— prescription of the use to which these animals or products          from third countries with a view to the completion of the
    are to be put,                                                    internal market (2), shall apply.
— the measures to apply following importation, such as                2.     Importation of aquaculture animals and products shall
    quarantine or the disinfection of eggs.                           be prohibited if it is found that:
                                                                      — consignments do not originate from the territory of a
                                                                          third country, or a part thereof, appearing on the list
                             Article 20                                   drawn up in accordance with Article 18, paragraph 1,
1.     Aquaculture animals and products shall be                      — they are, or are suspected of being, infected with or
accompanied by a certificate drawn up by the official services            contaminated by a contagious disease,
of the exporting third country. This certificate must:
                                                                      — the conditions laid down in this Regulation have not been
(a) be issued on the day of loading of the consignment for                complied with by the exporting third country,
     dispatch to the Member State of destination;
                                                                      — the certificate accompanying them does not comply with
(b) accompany the consignment in the original;                            the conditions set out in Article 20.
(c) attest that the aquaculture animals and products meet
     the requirements of this Regulation and those laid down
                                                                                                  Article 23
     pursuant to this Regulation with regard to importation
     from the third country;
                                                                      1.     If an infectious or contagious disease of aquaculture
(d) be valid for 10 days;                                             animals, liable to endanger the health of livestock in a
                                                                      Member State, breaks out or spreads in a third country or if
(e) consist of a single sheet of paper;                               any other reason connected with animal health justifies it, the
                                                                      Member State concerned or the Commission shall prohibit
(f)  be made out for a single consignee.                              importation directly or indirectly from either the whole of the
                                                                      third country or from part of its territory.
2.     This certificate must comply with a model established
in accordance with the procedure laid down in Article 27.             2.     Measures taken by Member States under paragraph 1
                                                                      and notice of the withdrawal of such measures must be
                                                                      communicated immediately to the other Member States and
                                                                      the Commission, together with the reasons therefore.
                             Article 21
                                                                      3.    The measures referred to in paragraph 1 may be
Inspections shall be carried out on the spot by veterinary            amended in accordance with the procedure laid down in
experts of the Member States and the Commission to verify             Article 25, in particular in order to ensure their coordination
whether the provisions of this Regulation, and in particular          with measures adopted by the other Member States, or may
Articles 18 and 19, are being applied in practice.                    be withdrawn.
The experts from the Member States who are to be entrusted            4.     If the situation envisaged in paragraph 1 arises and if it
with the task of carrying out these inspections shall be              appears necessary that other Member States should also
appointed by the Commission, acting on a proposal from the            apply the measures taken pursuant to that paragraph,
Member States.                                                        appropriate measures shall be adopted under the procedure
                                                                      laid down in Article 25.
These inspections sh all be made on behalf of the Community,
which shall bear any expenditure incurred in this                     5.     Resumption of importation from the third country
connection.                                                           concerned shall be authorized in accordance with the same
                                                                      procedure.
The frequency of and the procedure for these inspections
shall be determined in accordance with the procedure laid
down in Article 27.
                                                                                                 CHAPTER 4
                             Article 22
                                                                                               Final provisions
1.     The rules laid down in Council Regulation (EEC)
No . . . laying down the principles relating to the
organization of veterinary control for products arising from                                      Article 24
third countries with a view to the completion of the internal
market ( l ) and No . . ., laying down the principles relating to     The Annexes to this Regulation may be amended in
the organization of veterinary control for animals arising            accordance with the procedure laid down in Article 26.
(') O J N o L . . .                                                   (2) OJ No L . . .
 ---pagebreak--- No C 84/48                                Official Journal of the European Communities                                       2. 4. 90
                          Article 25                                 States within the Committee shall be weighted in the manner
                                                                     set out in that Article. The Chairman shall not vote.
 1.    The Commission shall be assisted by the Standing
 Veterinary Committee set up by the Council Decision                 The Commission shall adopt the measures envisaged if they
 68/361/EEC (*), hereinafter called 'the Committee'.                 are in accordance with the opinion of the Committee.
2.     Where the procedure laid down in this Article is to be        If the measures envisaged are not in accordance with the
 applied, the following provisions shall apply.                      opinion of the Committee, or if no opinion is delivered, the
                                                                     Commission shall, without delay, submit to the Council a
                                                                     proposal relating to the measures to be taken. The Council
The representative of the Commission shall submit to the             shall act by a qualified majority.
Committee a draft of the measures to be taken. The
Committee shall deliver its opinion on the draft within a time
                                                                     If, on the expiry of a period of three months from the date of
limit which the Chairman may lay down according to the
                                                                     referral to the Council, the Council has not acted, the
urgency of the matter. The opinion shall be delivered by the
                                                                     proposed measures shall be adopted by the Commission.
majority laid down in Article 148 (2) of the Treaty in the case
of decisions which the Council is required to adopt on a
proposal from the Commission. The votes of the
representatives of the Member States within the Committee                                       Article 27
shall be weighted in the manner set out in that Article. The
Chairman shall not vote.                                             Where the procedure laid down in this Article is to be
                                                                     applied, the following rules shall apply.
The Commission shall adopt the measures envisaged if they
are in accordance with the opinion of the Committee.                 The representative of the Commission shall submit to the
                                                                     Committee a draft of the measures to be taken. The
If the measures envisaged are not in accordance with the             Committee shall deliver its opinion on the draft within a
opinion of the Committee, or if no opinion is delivered, the         time-limit which the Chairman may lay down according to
Commission shall, without delay, submit to the Council a             the urgency of the matter, if necessary by taking a vote.
proposal relating to the measures to be taken.
                                                                     The opinion shall be recorded in the minutes; in addition,
                                                                     each Member State shall have the right to ask to have its
The Council shall act by a qualified majority.
                                                                     position recorded in the minutes.
If, on the expiry of a period of fifteen days from the date of       The Commission shall take the utmost account of the
referral to the Council, the Council has not acted, the              opinion delivered by the Committee. It shall inform the
proposed measures shall be adopted by the Commission.                Committee of the manner in which its opinion has been taken
                                                                     into account.
                          Article 26
                                                                                                Article 28
Where the procedure laid down in this Article is to be
                                                                     This Regulation shall enter into force on the thirtieth day
applied, the following provisions shall apply.
                                                                     following that of its publication in the Official Journal of the
                                                                     European Communities.
The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The                   It shall apply from 1 January 1993.
Committee shall deliver its opinion on the draft within two
days. The opinion shall be delivered by the majority laid
down in Article 148 (2) of the Treaty in the case of decisions
which the Council is required to adopt on a proposal from the        This Regulation shall be binding in its entirety and directly
Commission. The votes of the representatives of the Member           applicable in all Member States.
(i) OJ No L . . .
 ---pagebreak--- 2. 4. 90                              Official Journal of the European Communities                          No C 84/49
                                                         ANNEX A
                               1                                      2                          3
                            Disease                          Susceptible species          Carrier species
          LIST I
         Fish                                        Salmo gairdneri
                                                     Oncorhynchus nerka
          IHN (infectious hematopoetic necrosis)     Oncorhynchus tschawytscha       • Survivors
                                                     Oncorhynchus rhodurus
                                                     Salmo salar
         LIST II
         Fish                                        Salmo gairdneri
                                                     Salmo trutta
         Viral haemorrhagic septicaemia (VHS)
                                                     Salmo salar
                                                     Thymallus thymallus            > Survivors
                                                     Coregonus sp.
                                                     Esox lucius (Fry)
         Molluscan shellfish
         Bonamia ostreae                             Ostrea edulis
         Marteilia sp.                               Ostrea edulis                 Ceratoderma edule
                                                                                   Mytilus edulis
         Haplosporidum sp.                           Ostrea edulis                 Crassostrea virginica
         Perkinsus sp.                               Ruditapes decussatus          Crassostrea virginica
         LIST HI
         Fish                                       Salmo gairdneri                Survivors
                                                    Salmo trutta
         IPN (infectious pancreatic necrosis)
                                                    Salvelinus fontinalis          All other salmonidae
                                                    Oncorhynchus (2 species)       Several cyprinidae
                                                                                   eels, perch, pike
         SVC (spring viremia of carp)               Cyprinus carpio
                                                    Ctenopharyngodon idella
                                                    Hypophtalmichtys sp.
         BKD (bacterial kidney disease)             All salmonids, Oncorhynchus
                                                    in particular                  [   Survivors
         Furunculosis in Atlantic salmon            Salmo salar and all other
                                                    salmonids                      \    Survivors
         ERM (enteric red mouth disease)            Salmonidae, Anguilla anguilla,
                                                    Psetta maxima (turbot),        1 s •
                                                    Notropis atherinoides
                                                    (bait minnow)
         Gyrodactylosis                             Salmo salar                    Y    Survivors
         (Gyrodactylus salaris)
                                                    Salmo gairdneri
         Myxobolosis Myxosomiasis                   Salmo trutta                   Salmo gairdneri
         (whirling disease)                         Salmo salar
         Crustaceans
                                                    Salvelinus fontinalis
                                                                                   } s.™
         Aphanomycosis                              Astacus sp.                    Pacifastacus Leniusculus
         (crayfish plague)                          Austropotamobius pallipes
                                                    Procambarus clarkii
 ---pagebreak--- No C 84/50                              Official Journal of the European Communities                                         2. 4. 90
                                                              ANNEX B
                                                         APPROVED ZONES
           I. Continental zones for fish
              A. A continental zone consists of a part of the territory comprising an entire catchment area from the sources
                 of the waterways to the sea, or more than one catchment area, in which fish is reared, kept or caught. The
                 size and the geographical situation of a continental zone must be such that possibilities for
                 recontamination, e.g. by migrating fish, is reduced to a minimum. This may require the establishment of a
                 bufferzone in which a monitoring programme is carried out without obtaining the status of approved
                 zone.
              B. Achievement of status
                 In order to obtain the approved status, a continental zone must meet the following requirements:
                 1. All fish are free for at least four years from any clinical or other sign of the diseases referred to in
                     Annex A, column 1, lists I and II.
                 2. All farms in the continental zone are placed under the supervision of the official services. Two health
                     inspections per year for four years must have been carried out.
                     The inspection must have been made at the times of year when the water temperature favours the
                     development of the diseases. However, rearing ponds must have been inspected only when they are
                     being emptied or filled.
                     The health inspection must consist at least of:
                     — an inspection of fish showing abnormalities,
                     — the taking of samples which are to be sent as quickly as possible to the approved laboratory to be
                          tested for the diseases referred to in Annex A, column 1, lists I and II.
                     However, zones having a historical record of absence of the diseases referred to in Annex A, column 1,
                     lists I and II, may obtain the approved status if:
                     (a) their geographical situation does not permit easy introduction of diseases;
                     (b) an official disease control system has been in place for an extended period of time of at least 20
                           years during which:
                           — there has been regular monitoring of all fish farms,
                           — a disease notification system has been applied,
                           — diseases have not been reported,
                           — no live fish from infected zones has been introduced.
                 3. If there is no farm in a continental zone to be approved the official services must have subjected fish
                     from the lower part of the catchment area to a health inspection twice a year for two years, in
                     accordance with paragraph 2.
                 4. The laboratory examinations of fish taken during health inspections have produced negative results as
                     regards the pathogens referred to in Annex A, column 1, lists I and II.
              C. Maintenance of status
                 The maintenance of the status is subject to the following requirements:
                 1. Fish introduced into the zone must come from other approved zones.
                 2. Each fish farm must undergo two health inspections annually in accordance with point B2, however,
                     samples will be taken by rotation in 50% of the fish farms in the continental zone each year.
                     In the case of zones having a historical record of absence of the diseases referred to in Annex A,
                     column 1, lists I and II, the frequency of sampling may be reduced in function of the period during
                     which such zones are free of diseases. However, this frequency shall not be less than 20 % of the farms
                     per year.
                 3. The results of the laboratory examinations on the fish sampled during the health inspections must have
                     been negative as regards the pathogens referred to in Annex A, column 1, lists I and II.
 ---pagebreak--- 2. 4. 90                                 Official Journal of the European Communities                                                No C 84/51
                 4. A register must be kept by the farmers or the persons responsible for the introducing of fish, containing
                     all the information necessary to enable the state of health of the fish to be monitored constantly.
              D. Suspension, re-establishment and withdrawal of the approval
                  1. Any abnormal death or other symptom that might constitute grounds for suspecting an outbreak of a
                     disease of Annex A, column I, lists I and II must be notified as quickly as possible to the official service.
                     The latter shall immediately suspend the approval of the zone.
                 2. A sample of at least 10 sick fish must be sent to the approved laboratory in order to be tested for the
                     diseases of Annex A, column 1, Lists I and II.
                     The results of the tests must be communicated immediately to the official service.
                 3. Where the results are negative for the pathogens in question but positive for another cause, the official
                     service shall re-establish the approval,
                 4. However, when no diagnosis can be made a further health inspection must be made within 15 days of
                     the first taking of a sample and a sufficient number of sick fish must be taken and forwarded to the
                     approved laboratory in order to be tested for the diseases of Annex A, column I, lists I and II.
                     If the results are again negative or if there are no more sick fish, the official service will re-establish the
                     approval.
                 5. Where the results are positive, approval must be withdrawn by the official service.
                 6. Re-establishment of the approval of a zone is subject to the following requirements: when an outbreak
                     occurs,
                     — all fish in the infected farms must have been slaughtered, and infected or contaminated fish must
                          have been destroyed,
                     — facilities and equipment must have been disinfected in accordance with a procedure approved by
                          the official services.
                     After elimination of the outbreak, the requirements referred to in point B must be again complied
                     with.
                 7. The central competent authority shall inform the Commission and the other Member States about the
                     suspension, re-establishment and withdrawal of the approval of zones.
          II. Coastal zones for fish
              A. A coastal zone consists of a part of the coast or an estuary with a precise geographical delimitation which
                 consists of a homogeneous hydrological system.
              B. Achievement of status of approved zone
                 In order to obtain the approved status, a coastal zone for fish must meet the requirements laid down for
                 continental zones referred to in I B.
              C. Maintenance of status
                 The maintenance of the approval for a coastal zone is subject to the requirements referred to in I C.
              D. Suspension, re-establishment and withdrawal of approval
                 The rules laid down for suspension, re-establishment or withdrawal of approval are those referred to
                 in I D .
         III. Coastal zones for molluscs
              A. A coastal zone must comply with the definition laid down in point II A.
              B. Achievement of status of approved zone
                 In order to be approved, a continental zone must meet the following requirements:
                 1. All molluscs have for at least four years shown no clinical or other sign of the diseases of Annex A,
                     column 1, list H.
 ---pagebreak--- No C 84/52                           Official Journal of the European Communities
              2. All farms in the coastal zone are placed under the supervision of the official services. Health
                 inspections are carried out at intervals adapted to the development of the pathogen in question. During
                 these inspections samples are taken and sent without delay to the approved laboratory to be tested for
                 the diseases of Annex A, column 1, list II.
              3. If there is no farm in the continental zone, the official service must have submitted molluscs to a health
                 inspection in accordance with paragraph 2, at intervals adapted to the development of the pathogens
                 in question.
              4. Laboratoy examinations of molluscs taken during health inspections by the official services have
                 produced negative results as regards the pathogens of Annex A, column 1, list II.
                 For zones having a historical record of absence of the diseases referred to in Annex A, column 1, list II,
                 this information may be taken into account for achievement of the status of approved zone.
           C. Maintenance of status
              The maintenance of approved status is subject to the following requirements:
              1. Molluscs introduced into the coastal zone must come from other approved zones.
              2. Each farm must undergo a health inspection in accordance with point B2 at intervals adapted to the
                 development of the pathogens in question.
              3. The results of the laboratory examinations on the molluscs sampled during the health inspections must
                 have been negative as regards the pathogens referred to in Annex A, column 1, Chapter II.
              4. A register must be kept by the farmers or the persons responsible for the introduction of molluscs,
                 containing all information necessary to enable the state of health of the molluscs to be monitored
                 constantly.
           D. Suspension, re-establishment and withdrawal of the approval
              1. Any abnormal death or other symptom that might constitute grounds for suspecting an outbreak of a
                 disease of Annex A, column 1, list II must be notified as quickly as possible to the official service. The
                 latter shall immediately suspend the approval of the zone.
              2. A sample of molluscs must be sent to the approved laboratory in order to be tested for the diseases of
                 Annex A, column 1, list II.
                 The results of the tests must be communicated immediately to the official service.
              3. Where the results are negative for the pathogens in question, but positive for another cause, the
                 approval shall be re-established.
              4. However, when no diagnosis can be made a further health inspection must be made within 15 days of
                 the first taking of samples and a sick mollusc must be taken and forwarded to the approved laboratory
                 in order to be tested for the diseases of Annex A, column 1, list II. If the results are again negative or if
                 there are no longer any sick molluscs, the official service will re-establish the approval.
              5. Where the results are positive, approval must be withdrawn by the official service.
              6. Re-establishment of the approval of a zone is subject to the following requirements:
                 (a) when a outbreak occurs:
                       — infected or contaminated molluscs must have been destroyed,
                       — facilities and equipment must have been disinfected in accordance with a procedure approved
                            by the official service;
                 (b) after elimination of the outbreak, the requirements referred to in B must again be complied
                       with.
              7. The central competent authority shall inform the Commission and the other Member States about the
                 suspension, re-establishment and withdrawal of the approval of zones.
 ---pagebreak--- 2. 4. 90                                 Official Journal of the European Communities                                          No C 84/53
                                                               ANNEX C
                                       APPROVED FARMS IN A NON-APPROVED ZONE
          I. Continental farms for fish
               A. Achievement of status of approved farm
                   In order to be approved, a farm must meet the following requirements:
                   1. Water must be supplied by a well or a borehole.
                   2. There must be a natural or artificial barrier for anadromic fish situated downstream.
                   3. It must comply with the relevant requirements laid down in Annex B I B .
               B. Maintenance of status
                   The maintenance of the approval shall be subject to the requirements laid down in Annex B I C . However,
                   the sampling for laboratory examination must be carried out once a year.
               C. Suspension, re-establishment and withdrawal of approval
                   The requirements laid down in Annex B I D shall apply.
         II. Continental farms for molluscs
               A. Achievement of status of approved farm
                   In order to be approved, a farm must meet the following requirements:
                   1. It must be supplied with water by means of a system which allows the killing of the pathogens of
                        Annex A, column 1, list II.
                   2. It must comply, mutatis mutandis, with the requirements for the achievement of status as laid down in
                        Annex B III B, points 1, 2 and 4.
               B. Maintenance of status
                   The maintenance of the approval shall, mutatis mutandis, be subject to the requirements for maintenance
                   of status as laid down in Annex B HI C, points 1 to 4.
               C. Suspension, re-establishment and withdrawal of approval
                   The requirements for suspension, re-establishment and withdrawal of approval as laid down in Annex B
                   III D shall apply, mutatis mutandis.
                                                               ANNEXD
         Renewal of water during the transportation of aquaculture animals shall be carried out in places which meet the
         following requirements:
         1. the hygienic properties of the water available for changing must be such as not to alter the health situation of
              the species transported with regard to the pathogens of the diseases of Annex A, column I, lists I and II.
         2. the location of these places and the facilities provided at them must be such as to prevent any contamination of
              neighbouring farms:
              — either by facilitating disinfection of the water used, for example, by collecting it in a tank where it can be
                  disinfected, or
             — by ensuring that the release of this water does not under any circumstances entail its direct discharge into
                  the open sea or free-flowing waterways.
 ---pagebreak--- No C 84/54                                Official Journal of the European Communities                                      2. 4. 90
                                                                ANNEX E
                                                               CHAPTER 1
                                                                 MODEL
             MOVEMENT DOCUMENT FOR LIVE FISH, EGGS AND GAMETES FROM AN APPROVED ZONE
           I.   Country of origin:
                Approved zone:
           II.  Farm of origin (name and address):
           III. Animals or products:
                                                            Live fish                  Eggs                  Gametes
                Species
                Quantity       Number
                               Weight
           IV. Destination
                Country of destination:
                Consignee (name and address):
           V.   Means of transport (nature and identification):
           VI. Health attestation
                I, the undersigned, certify that the animals or goods of the present consignment originate from an approved
                zone and that they satisfy the requirements of Council Regulation (EEC) No
           Done at                                , on
           Name of the official service
                                                                      Name (in capitals)
           Stamp of the official service                              Function of subscriber
                                                                      Signature:
 ---pagebreak--- 2. 4. 90                               Official Journal of the European Communities                                  No C 84/55
                                                           CHAPTER 2
                                                             MODEL
             MOVEMENT DOCUMENT FOR LIVE FISH, EGGS OR GAMETES FROM AN APPROVED FARM
         I.   Country of origin:
         II.  Farm of origin (name and address):
         III. Animals or products:
                                                        Live fish                  Eggs               Gametes
              Species
              Quantity       Number
                             Weight
         IV. Destination
              Country of destination:
              Consignee (name and address):
         V.   Means of transport (nature and identification):
         VI. Health attestation
              I, the undersigned, certifiy that the animals or products of the present consignment originate from an
              approved farm and that they satisfy the requirements of Council Regulation (EEC) No
         Done at                                 on
         Name of the official service
                                                                  Name (in capitals)
         Stamp of the official service                            Function of subscriber
                                                                  Signature:
 ---pagebreak--- No C 84/56                                Official Journal of the European Communities                                      2. 4 . 90
                                                              CHAPTER 3
                                                                 MODEL
                    MOVEMENT DOCUMENT FOR MOLLUSCS FROM AN APPROVED COASTAL ZONE
           I.   Country of origin:
                Approved zone:
           II.  Farm of origin (name and address):
           III. Animals:
                                                                                    Molluscs
                                           Species
                                           Quantity       Number
                                                         Weight
           IV. Destination
                Country of destination:
                Consignee (name and address):
           V.   Means of transport (nature and identification):
           VI. Health certification
                I, the undersigned, certify that the molluscs of the present consignment originate from an approved coastal
                zone and that they satisfy the requirements cf Council Regulation (EEC) No
           Done at                                , on
           Name of the official service
                                                                     Name (in capitals)
           Stamp of the official service                             Function of subscriber
                                                                     Signature:
 ---pagebreak--- 2. 4. 90                                Official Journal of the European Communities                                      No C 84/57
                                                             CHAPTER 4
                                                                MODEL
                                         FOR MOLLUSCS FROM AN APPROVED FARM
         I.   Country of origin:
         II.  Farm of origin (name and address):
         III. Animals:
                                                                                   Molluscs
                                          Species
                                          Quantity      Number
                                                        Weight
         IV. Destination
              Country of origin:
              Consignee (name and address):
         V.   Means of transport (nature and identification):
         VI. Health certification
              I, the undersigned, certify that the animals of the present consignment originate from an approved farm and
              that they satisfy the requirements of Council Regulation (EEC) No
         Done at                                , on
         Name of the official service
                                                                    Name (in capitals)
         Stamp of the official service                              Title of subscriber
                                                                    Signature: