CELEX: 51990PC0655
Language: en
Date: 1990-12-14
Title: PROPOSAL FOR A COUNCIL DECISION CONCERNING THE PROVISIONAL APPLICATION OF THE AGREED MINUTE AMENDING THE AGREEMENT BETWEEN THE EUROPEAN ECONOMIC COMMUNITY AND THE REPUBLIC OF HUNGARY ON TRADE IN TEXTILE PRODUCTS

COMMISSION OF THE EUROPEAN COMMUNITIES
                                        C0M(89) 655 final
                                        Brussels, 2 February 1990
                            Proposal for a
                       COUNCIL REGULATION (EEC)
   concerning the animal health conditions governing the placing
          on the market of aquaculture animals and products
                    (presented by the Commission)
 ---pagebreak---                                                            •"m,39)655 final
                                         2 -
                              EXPLANATORY MEMORANDUM
Farming of fish, crustaceans and molluscs constitutes an important source of
income for a part of the population working in the fisheries sector.  In order
to ensure a rational development of production, raise the productivity levels
and help to bring about a single market, it is essential to lay down common
health criteria regarding the production and the placing on the market of
aquaculture animals and products.
This proposal aims to achieve this goal.
For that purpose, it is intended to designate officially the regions of the
Community already having a favourable health status and to regulate for the
movement between regions having a different health status.
This proposal also provides for Community arrangements in respect of imports
from third countries and specifies the criteria to be applied to such
imports.  Such rules must be designed to safeguard the health of aquaculture
animals within the Community.
For certain applicatory decisions to be taken, the Commission opted for the
regulatory committee procedure, since it wished to avoid disrupting the
existing management machinery in the animal health sector.  More generally
however, the Commission continues to prefer the advisory committee procedure.
 ---pagebreak---                                        - 3 -
                                     Proposal
                                       for a
                       COUNCIL REGULATION (EEC) No
                     concerning the animal health conditions
                     governing the placing on the market of
                        aquaculture animals and products
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and
in particular Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas aquaculture animals and products are included in the list Annex II to
the Treaty;
Whereas the breeding and rearing of aquaculture animals, and the placing on
the market of aquaculture animals and products constitutes a source of income
for persons working in the fisheries sector;
Whereas, in order to ensure the rational development of this sector and to
increase productivity, health rules for this sector must be laid down at
Community level;
Whereas in this context it is necessary to contribute to the completion of the
internal market, avoiding the spread of contagious diseases;
Whereas the animal health situation for aquaculture animals is not the same
throughout the territory of the Community,   whereas reference must therefore
be made to zones when dealing with parts of the Community;
 ---pagebreak---                                       - 4 -
Whereas there must be laid down criteria and procedures for the approval, the
suspension and the withdrawal of approval of such zones;
Whereas it is necessary to define Community provisions applicable to imports
from third countries;  whereas these provisions must provide for adequate
safeguard measures;
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 Committee,
HAS ADOPTED THIS REGULATION :
                                    CHAPTER 1
                               GENERAL PROVISIONS
                                    Article 1
This Regulation lays down the animal health conditions governing the placing
on the market of aquaculture animals and products.
                                    Article 2
For the purposes of this Regulation :
1) aquaculture animals : means live fish, crustaceans or molluscs originating
   from a farm;
2) aquaculture products : means products derived from aquaculture animals
   such as eggs, gametes or products to be placed on the market for human
   consumption;
 ---pagebreak---                                         - 5 -
 3) fish, crustaceans and molluscs : means any fish, crustacean and mollusc at
     any stage of development 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 animals are reared or kept with a view to
    their being placed on the market;
5) approved farm : means a farm complying, as the case may be, with the
    requirements of Annex C I or II, and approved as such in accordance with
    the procedure laid down in Article 6;
6) approved zone : means a zone complying as the case may be, with the
    requirements of Annex B I, II or III and approved as such in accordance
    with the procedure laid down in Article 5;
7) approved laboratory : means a laboratory located in the territory of a
    Member State, designated by the competent authority, under its
    responsibility, to carry out the diagnostic tests provided for in this
    Regulation;
8) official service : means one or more services designated by the competent
    authority of the Member State or third country and responsible for carrying
    out the controls provided for in this Regulation;
9) health inspection : means a visit by an official service or services, for
    the purpose of checking the health status of a farm or a zone.
                                     CHAPTER 2
                   PLACING ON THE MARKET OF ANIMALS AND PRODUCTS
                        FROM AQUACULTURE FROM THE COMMUNITY
                                     Article 3
1. The placing on the market of aquaculture animals shall be subject to the
    following general requirements :
a) they must show no clinical signs of disease on the day of loading;
b) they must not be intended for destruction or slaughter under a national
   scheme for the eradication of a contagious disease;
c) they must not come from a farm which is subject to a prohibition on animal
   health grounds and must not have been in contact with animals from such a
   farm;
 ---pagebreak---                                         - 6
 2. Aquaculture products being placed on the market, for breeding purposes
     (eggs and gametes) must originate from animals which satisfy the conditions
     laid down in paragraph 1.
 3. Aquaculture products being placed on the market, for human consumption must
     originate from animals which satisfy the conditions laid down in
     paragraph 1(a).
                                      Article 4
 Live aquaculture animals must be dispatched in the shortest possible period to
 the place of destination, using means of transport that have been cleaned and,
 if necessary, disinfected in advance with a disinfectant that is officially
 authorized in the Member State of dispatch.
 If water is used in transport, the vehicles shall be designed in such a way
that water cannot escape from the vehicle during transport. Transport shall be
carried out in such a way as to safeguard effectively the health of the
animals, in particular by changing the water.    Such a change must be carried
out in places complying with the requirements of Annex D.    A list of these
places must be notified by the Member States to the Commission and to the
other Member States.
                                     Article 5
1. In order to obtain, for the diseases referred to in Annex A, column 1,
    lists I and II, the status of approved zone, Member States shall present to
    the Commission :
    - all appropriate justifications and in particular those concerning the
      conditions laid down, as the case may be, in Annex B under I B, under
      II B or under III B;
    - the national rules ensuring the respect of the conditions laid down, as
      the case may be, in Annex B under I C, under II C or under III C.
2. The Commission shall scrutinize the information referred to in
    paragraph 1.  The Commission may, in accordance with the procedure laid
    down in Article 26, approve or re-approve zones, having regard to that
    information.
 ---pagebreak---                                         - 7 -
If in accordance with Annex B under I D 5, under II D or under III D 5 the approval
of a zone is withdrawn by the official service, the Commission shall revoke the
decision concerning its approval.
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 6
1. In order to obtain, for the diseases referred to in Annex A, column 1, lists I
   and II, the status of approved farm situated in a non approved zone, the Member
   States shall present to the Commission :
   - all appropriate justifications and in particular those concerning the
     conditions laid down, as the case may be, in Annex C under I A or under II A;
   - the national rules ensuring the respect of the conditions laid down in Annex C
     under I B or under II B.
2. The Commission shall scrutinize the information referred to in paragraph 1.   The
   Commission may, in accordance with the procedure laid down in Article 26,
   approve or re-approve farms, having regard to that information.
   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 approval.
3. The Commission shall draw up the list of approved farms, and shall amend this
   list in order to take account of new approvals or withdrawal of approvals.
                                      Article 7
1. The placing on the market of live fish belonging to the susceptible species
   referred to in Annex A, column 2, lists I and II, their eggs or gametes, shall
   be subject to the following additional requirements :
   a) when they are to be introduced into an approved zone, they must be
      accompanied by a movement document corresponding to Article 10 and to the
      model referred to in Annex E, Chapter I, certifying that they come from a
      zone of the same health status;
 ---pagebreak---                                        - 8 -
    b) when they are to be introduced into a farm which, although not situated
       in an approved zone, fulfils the conditions of Annex C I, they must be
       accompanied by a movement document corresponding to Article 10 and to
       the model referred to in Annex E, Chapter 2, certifying that they come
       from a farm of the same health status as the farm of destination, or
       they must be accompanied by the document referred to in a), certifying
       that they come from an approved zone.
2. The Commission, in accordance with the procedure laid down in Article 26
   may adapt or delete the additional requirements referred to in paragraph 1,
   depending on the evolution of the animal health situation in the Community,
    in particular in order to take account of the results of the eradication
   measures for the disease mentioned in Annex A, column 1, list I.
                                     Article 8
1. The placing on the market of live molluscs belonging to the species
   referred to in Annex A, column 2, list II shall be subject to the following
   additional requirements :
   a) if they are to be relaid in an approved coastal zone, they must be
       accompanied by a movement document complying with Article 10 and
       corresponding to the model referred to in Annex E, Chapter 3, certifying
       that they come from a coastal zone of the same health status;
   b) if they are to be relaid in a farm which, although not situated in an
       approved coastal zone fulfils the requirements of Annex C II, they must
       be accompanied by a movement document complying with Article 10 and
       corresponding to the model referred to in Annex E, Chapter 4, certifying
       that they come from a farm of the same health status as the farm of
       destination, or they must be accompanied by the document referred to in
       a), certifying that they come from an approved coastal zone.
2. The Commission, in accordance with the procedure laid down in Article 26
   may adapt or delete the additional requirements referred to in paragraph 1,
   depending on the evolution of the animal health situation in the Community.
 ---pagebreak---                                        _ 9 -
                                     Article 9
The placing on the market in an approved zone of aquaculture products for
direct human consumption originating from a non approved zone shall be subject
to the following conditions :
1. fish susceptible to the diseases referred to in Annex A, column 1, lists I
    and II must be slaughtered and eviscerated prior to expedition;
2. live molluscs susceptible to the diseases referred to in Annex A, column 1,
   list II must be delivered directly for human consumption and shall not be
   returned to water.
   The Commission, in accordance with the procedure laid down in Article 27,
   shall lay down, when considered necessary, the appropriate conditions
   necessary to ensure compliance with this prohibition.
                                    Article 10
1. The movement document referred to in Articles 7 and 8 must be drawn up by
   the official service at the place of origin within 48 hours before loading,
   in the official language or languages of the place of destination.   It must
   be drawn up on a single sheet of paper, be made out for a single consignee,
   and shall be valid for 10 days.
2. Each consignment of aquaculture animals and products must be clearly
   identified in order to be able to trace back to the farm of origin, and to
   verify where appropriate the correlation of the animals or products with
   the information contained in the accompanying movement document.  This
   information may figure directly on the container or on a label fixed to it
   or on the transport documents.
                                    Article 11
1. Where a Member State draws up or has drawn up a voluntary or compulsory
   control programme for one of the diseases referred to in Annex A, column 1,
   list III, it shall present the programme to the Commission, outlining in
   particular :
 ---pagebreak---                                        10
   - the distribution of the disease in the Member State;
   - the reasons for which the programme should be implemented, including the
     importance of the disease and the programme's likely benefit in relation
     to its cost;
   - the geographical areas in which the programme will be implemented;
   - the categories of farms to be established, and the standards which must
     be achieved by the farms in each category, including test procedures;
   - the rules applicable for entry of animals of a lower health status into
     the farm;
   - the action to be taken if, for any reason, a farm loses its status;
   - the procedures under which the programm shall be monitored.
2. The Commission shall scrutinize the programmes presented by the Member
   States.  Programmes as referred to in paragraph 1 may be approved in
   accordance with the procedure laid down in Article 26.  The additional
   guarantees, general or specific, which may be required for the introduction
   of aquaculture animals and products in to officially checked farms or zones
   may be defined in accordance with the same procedure.
3. Programmes submitted by Member States may be amended or supplemented in
   accordance with the procedure laid down in Article 26.  Under the same
   procedure, the Commission may approve an amendment or addition to a
   programme which has been approved or to guarantees which have been defined
   in accordance with paragraph 2.
                                   Article 12
1. Where a Member State considers that its territory or part of its territory
   is free from one of the diseases listed in Annex A, column 1, List III, it
   shall present to the Commission appropriate justification, setting out in
   particular :
   - the name of the disease and the previous history of its occurrence in
     that Member State;
   - the results of surveillance testing based on serological, virological,
     microbiological or pathological findings, as appropriate, and on the fact
     that the disease must by law be notified to the competent authorities;
   - the period over which the surveillance was carried out;
   - the control arrangements for verifying that the area concerned remains
     free from the disease.
 ---pagebreak---                                        - 11 -
2. The Commission shall examine such justification.   The additional
   guarantees, general or specific, which may be required for the introduction
   of aquaculture animals and products into farms or areas may be defined in
    accordance with the procedure provided for in Article 26.
3. The Member State concerned shall notify the Commission of any change in the
   particulars specified in paragraph 1 which relate to the disease.   The
   guarantees defined as laid down in paragraph 2 may, in the light of such
   notification, be amended or withdrawn in accordance with the procedure
   provided for in Article 26.
                                    Article 13
The Commission, in accordance with the procedure laid down in Article 26,
shall lay down :
1. the conditions for the placing on the market of ornamental fish;
2. the conditions for the placing on the market of wild species and products
   thereof; until such conditions are established, the rules laid down in this
   Regulation shall apply, mutatis mutandis.
3. the conditions for the placing on the market of fish 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.
                                    Article 14
Sampling plans and diagnostic methods to be applied for the detection and
confirmation of the presence of the disease referred to in Annex A, column 1
shall be established in accordance with the procedure laid down in
Article 26.   These sampling plans must take account of the presence of wild
fish, wild crustaceans and wild molluscs in the aquatic environment.
 ---pagebreak---                                       - 12
                                   Article 15
The rules laid down in Council Directive               concerning veterinary
checks in intra-Community trade with a view to the completion of the internal
market (1) shall apply, in particular as regards the organization of and the
action to be taken following the inspections to be carried out by the Member
State of destination, and the safeguard measures to be implemented.
                                   Article 16
1. Commission veterinary experts may, where it is necessary for the uniform
   application of the Regulation, carry out on-site inspections.  The Member
   State in whose territory an inspection is carried out shall provide the
   experts with all the assistance necessary to complete their task.  The
   Commission shall notify the Member States of the outcome of such
   inspections.
2. General provisions for the application of this Article shall be adopted in
   accordance with the procedure laid down 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.
                                    CHAPTER 3
                  RULES GOVERNING IMPORTS FROM THIRD COUNTRIES
                                   Article 17
Aquaculture animals and products imported into the Community shall satisfy the
conditions laid down in Articles 18 to 20.
(1)
 ---pagebreak---                                       - 13
                                   Article 18
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
   amended in accordance with the same procedure.
2. In deciding whether a third country or part thereof may appear on the list
   referred to in paragraph 1, particular account shall be taken of :
   a) the state of health of the aquaculture animals, particular attention
      being paid to exotic diseases and the environmental health situation in
      the third country which might endanger animal health in the Community;
   b) the regularity and rapidity of the information supplied by the third
      country relating to the existence of infectious or contagious diseases
      of aquaculture animals in its territory, in particular those diseases
      mentioned in list B of the International Office of Epizootic Diseases;
   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 and their
      powers ;
   e) the organization and implementation of measures to prevent and control
      infectious or contagious diseases of aquaculture animals;
   f) assurances which the third country may provide concerning the rules laid
      down in this Regulation.
3. The list referred to in paragraph 1 and all amendments thereto shall be
   published in the Official Journal of the European Communities.
                                   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.
2. Depending on the animal health situation in the third country concerned,
   the conditions may include in particular :
 ---pagebreak---                                      - 14 -
   - restriction to imports from a part of the third country,
   - restriction to certain species at any stage of development,
   - the prescription of a treatment to be applied to the products such as the
     disinfection of eggs,
   - prescription of the use to which these animals or products are to be put,
   - the measures to apply following importation, such as quarantine or the
     disinfection of eggs.
                                   Article 20
1. Aquaculture animals and products shall be accompanied by a certificate
   drawn up by the official services of the exporting third country.   This
   certificate must :
   a) be issued on the day of loading of the consignment for dispatch to the
      Member State of destination;
   b) accompany the consignment in the original;
   c) attest that the aquaculture animals and products meet the requirements
      of this Regulation and those laid down pursuant to this Regulation with
      regard to importation from the third country;
   d) be valid for 10 days;
   e) consist of a single sheet of paper;
   f) be made out for a single consignee.
2. This certificate must comply with a model established in accordance with
   the procedure laid down in Article 27.
                                   Article 21
Inspections shall be carried out on the spot by veterinary experts of the
Member States and the Commission to verify whether the provisions of this
Regulation, and in particular Articles 18 and 19, are being applied in
practice.
 ---pagebreak---                                        - 15 -
The experts from the Member States who are to be entrusted with the task of
carrying out these inspections shall be appointed by the Commission, acting on
a proposal from the Member States.
These inspections shall be made on behalf of the Community, which shall bear
any expenditure incurred in this connection.
The frequency of and the procedure for these inspections shall be determined
in accordance with the procedure laid down in Article 27.
                                    Article 22
1. The rules laid down in Council Regulations (EEC) No                    laying
   down the principles relating to the organisation of veterinary control for
   products arising from third countries with a view to the completion of the
    internal market (1) and No                 laying down the principles
   relating to the organisation of veterinary control for animals arising from
   third countries with a view to the completion of the internal market (2),
   shall apply.
2. Importation of aquaculture animals and products shall 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 drawn up in accordance with
       Article 18, paragraph 1;
   -   they are, or are suspected of being, infected with or contaminated by a
       contagious disease;
   -   the conditions laid down in this Regulation have not been complied with
       by the exporting third country;
   -   the certificate accompanying them does not comply with the conditions
       set out in Article 20.
(1)
(2)
 ---pagebreak---                                       - 16 -
                                   Article 23
1. If an infectious or contagious disease of aquaculture animals, liable to
   endanger the health of livestock in a Member State, breaks out or spreads
   in a third country or if any other reason connected with animal health
   justifies it, the Member State concerned or the Commission shall prohibit
   importation directly or indirectly from either the whole of the third
   country or from part of its territory.
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.
3. The measures referred to in paragraph 1 may be amended in accordance with
   the procedure laid down in Article 25, in particular in order to ensure
   their coordination with measures adopted by the other Member States, or may
   be withdrawn.
4. If the situation envisaged in paragraph 1 arises and if it appears
   necessary that other Member States should also apply the measures taken
   pursuant to that paragraph, appropriate measures shall be adopted under the
   procedure laid down in Article 25.
5. Resumption of importation from the third country concerned shall be
   authorized in accordance with the same procedure.
                                    CHAPTER 4
                                FINAL PROVISIONS
                                   Article 24
The Annexes to this Regulation may be amended in accordance with the procedure
laid down in Article 26.
 ---pagebreak---                                       - 17 -
                                   Article 25
1. The Commission shall be assisted by the Standing Veterinary Committee set
   up by the Council Decision 68/361/EEC(l), hereinafter called "the
   Committee".
2. Where the procedure laid down in this Article is to be applied, the
   following provisions shall apply.
   The representative of the Commission shall submit to the Committee a draft
   of the measures to be taken.  The Committee shall deliver its opinion on
   the draft within a time limit which the Chairman may lay down according to
   the urgency of the matter.  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 Commission.  The
   votes of the representatives of the Member States within the Committee
   shall be weighted in the manner set out in that Article.  The Chairman
   shall not vote.
   The Commission shall adopt the measures envisaged if they are in accordance
   with the opinion of the Committee.
   If the measures envisaged are not in accordance with the 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 shall act by a qualified majority.
   If, on the expiry of a period of fifteen days from the date of referral to
   the Council, the Council has not acted, the proposed measures shall be
   adopted by the Commission.
                                   Article 26
Where the procedure laid down in this Article is to be applied, the following
provisions shall apply.
(1)
 ---pagebreak---                                                - 18 -
        The representative of the Commission shall submit to the Committee a draft of
         the measures to be taken.  The 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 requred to adopt on a proposal from the Commission.  The votes of
         the representatives fo the Member States within the Committee shall be
        weighted in the manner set out in that Article.   The Chairman shall not vote.
                               *
        The Commission shall adopt the measures envisaged if they are in accordance
        with thé opinion of the Committee.
        If the measures envisaged are not in accordance with the 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 shall act by a qualified majority.
        If, on the expiry of a period of three months from the date of referral to the
        Council, the Council has not acted, the proposed measures shall be adopted by
        the Commission.
                                            Article 27
        Where the procedure laid down in this Article is to be applied, the following
        rules shall apply.
        The representative of the Commission shall submit to the Committee a draft of
        the measures to be taken.   The Committee shall deliver its opinion on the
        draft within a time-limit which the Chairman may lay down according to the
        urgency of the matter, if necessary by taking a vote.
        The opinion shall be recorded in the minutes; in addition, each Member State
        shall have the right to ask to have its position recorded in the minutes.
        The Commission shall take the utmost account of the opinion delivered by the
        Committee.   It shall inform the Committee of the manner in which its opinion
        has been taken into account.
 ---pagebreak---                                      - 19 -
                                   Article 28
This Regulation shall enter into force on the thirtieth day following that of
its publication in the Official Journal of the European Communities.
It shall apply from 1 January 1993.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
Done at Brussels,                                For the Council
 ---pagebreak---                                 - 20 -
                                ANNEX A
          Disease                  Susceptible species    Carrier species
LIST I
Fish                               Salmo gairdneri       ) Survivors
IHN (Infectious Hematopoetic       Oncorhynchus nerka    )
Necrosis)                              "    tschawytscha )
                                       ** rhodurus       )
                                   Salmo salar           )
LIST II
Fish
Viral Haemorrhagic Septicaemia     Salmo gairdneri       ) Survivors
(VHS)                              Salmo trutta
                                   Salmo salar
                                   Thymallus thymallus
                                   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 III
Fish
IPN (Infectious pancreatic         Salmo gairdneri        Survivors
necrosis)                          Salmo trutta           All other
                                 Salvelinus fontinalis salmonidae
                                   Oncorhynchus          Several cyprinidae
                                   (2 species)            Eels, Perch, Pike
SVC (Spring viremia of carp)       Cyprinus carpio         Survivors
                                   Ctenopharyngodon
                                   idella
                                   Hypophtalmichtys sp
BKD (Bacterial Kidney Disease)     All salmonids.          Survivors
                                   Oncorhynchus in
                                   particular
Furunculosis in                    Salmo salar and all     Survivors
Atlantic salmon                    other salmonids
ERM (Enteric Red Mouth Disease)    Salmonidae, Anguilla    Survivors
                                   anguille. Psetta
                                   maxima (turbot),
                                 Notropis atherinoides
                                   (bait minnow)
Gyrodactylosis                     Salmo salar            Salmo
(Gyrodactylus salaris)                                    gairdneri
Myxobolosis (Myxosomiasis)                               ) Survivors
(Whirling disease)                 Salmo trutta          )
                                   Salmo salar           )
                                  Salvelinus fontinalis )
Crustaceans
Aphanomycosis                      Astacus sp             Pacifastacus
(crayfish plague)                  Austropotamobius       Leniusculus
                                   pallipes
                                   Procambarus clarkii
 ---pagebreak---                                      - 21 -
                                     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 programm 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.
 ---pagebreak---                                   - 22 -
      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 leats 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 zone.
   2. Each fish farm must undergo two health inspections annually in
      accordance with point B, 2, however, samples will be taken by
      rotation in 50 % of the fish farms in the continental zone each year.
 ---pagebreak---                                 - 23 -
      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.
   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 1, lists I and II.
 ---pagebreak---                                      - 24 -
             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.
 ---pagebreak---                                         25 -
     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 II.
        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. Laboratory 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.
 ---pagebreak---                                   - 26 -
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 B, 2 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.
 ---pagebreak---                                 - 27 -
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 an 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---                                        - 28 -
                                       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 III C, points 1 to 4.
    C. Suspension, re-establishment and withdrawal of approval
       The requirements for suspension, re-establishment and withdrawal of
       approval as la?.d down in Annex B III D shall apply, mutatis mutandis.
 ---pagebreak---                                      - 29 -
                                     ANNEX D
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---                                       - 30 -
                                     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)
                                        Function of subscriber
STAMP OF THE OFFICIAL SERVICE           Signature
 ---pagebreak---                                       - 31 -
                                    CHAPTER 2
                                      MODEL
                                MOVEMENT DOCUMENT
              FOR LIVE FISH. EGGS OR GAMETES FROM AM 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, certify 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)
                                        Function of subscriber
STAMP OF THE OFFICIAL SERVICE           Signature
 ---pagebreak---                                      • • * - " ; » . •
                                         MOPCL
                                MOVEMENT DOCUMENT
                   FOt MOLLBSCS FROM AN APPROVED COASTAL ZOttE
I.   Country of origin :
     Approved zone :
II.  Farm of origin (name and address :
TII. 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 of Council Regulation (EEC) No.
Done at              , on
NAME OF THE OFFICIAL SERVICE
                                     NAME (in capitals)
                                     Function of subscriber
STAMP OF THE OFFICIAL SERVICE        Signature
 ---pagebreak---                                          33 -
                                     CHAPTER 4
                                       MODEL
                        FOR MOLLUSCS FROM AN APPROVED FARM
I.   Country of origin :
TI.  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)
                                     Title of subscriber
STAMP OF THE OFFICIAL SERVICE        Signature
 ---pagebreak---                                              34 -
F I N A N C I A L   S T A T E M E N T   concerning :
Draft proposal for a Council Regulation concerning the animal health conditions
governing the placing on the market of aquaculture animals and products
1. BUDGET HEADING:                Item:                   Title:
    III B                         382 (1)                 Inspection in Agriculture
2. LEGAL BASIS: Article 43 of the Treaty
3. CLASSIFICATION: Non-compulsory expenditure
4. PURPOSE/DESCRIPTION OF THE MEASURE:
   Verification of the application of the Regulation (Art. 15 and 20)
5.   METHOD OF CALCULATION:
5.1.Form of expenditure: Mission expenses
5.2.Community contribution: 100 %
5.3.Calculâtion:
     200 mission days per year at ECU 170 per day (currant cost of inspection)
     ECU 34.000 per year
6.   FINANCIAL IMPLICATION AS REGARDS OPERATING APPROPRIATIONS
6.1.Schedule of appropriations (m ECU):
         Year
         1991                              0,034
         1992                              0,034
         1993                              0,034
         1994                              0,034
         1995                              0,034
         following years
         Total                             0.170
6.2.Financing during current year: NIL
7. OBSERVATIONS:
    (1) When the preliminary draft budget is prepared, an examination will be made to
        see where this category of expenditure is to be charged in the budget.
   This proposal also calls for 2 additional A7/6 posts.
   Staff requirements set out above must be met by redeployment within the Commission
   or by the budget procedure for the year concerned.
 ---pagebreak---                                  - 35 -
                    STATEMENT OF IMPACT ON BUSINESS
Name of the proposa
Draft proposal for a Council Regulation concerning the animal health
conditions governing the placing on the market of aquaculture animals
and products.
Object ives
In view of achieving the Internal market, to remove barriers to trade
In the fish farming sector, avoiding however the spread of contagious
diseases In particular to the regions In the Community which are free
of the disease.
 Impact on business
The proposal is expected not to have impact on business. It is
directed In first Instance to the authorities of the Member States,
who have to ensure that aquaculture animals and products do not
present a risk for the spreading of diseases.
 ---pagebreak---  ---pagebreak---                                                                      ISSN 0254-1475
                                                               COM(89) 655 final
                                                      DOCUMENTS
EN                                                                     03 04 05
                                 Catalogue number : CB-CO-90-060-EN-C
                                                             ISBN 92-77-57324-4
Office for Official Publications of the European Communities
L-2985 Luxembourg