CELEX: 51992PC0204
Language: en
Date: 1992-06-17
Title: Proposal for a COUNCIL DIRECTIVE introducing Community measures for the control of certain fish diseases

No C 172 / 16                          Official Journal of the European Communities                                            8 . 7 . 92
              Proposal for a Council Directive introducing Community measures for the control of certain
                                                          fish diseases
                                                        (92 /C 172/07)
                                                     COM(92) 204 final
                                      (Submitted by the Commission on 19 June 1992)
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,                           Whereas the prevention of these diseases in the
                                                                    Community shall be based normally on a non-vacci­
                                                                    nation policy; whereas however it is necessary to make
Having regard to the Treaty establishing the European               provision for vaccination where a serious situation
Economic Community, and in particular Article 43                    demands such action ;
thereof,
                                                                    Whereas, in order to give the necessary guarantees, the
Having regard to the proposal from the Commission,                  vaccine used must be approved for activity by a reference
                                                                    laboratory designated by the Community;
Having regard to the opinion of the European                        Whereas a thorough epidemiological enquiry is essential
Parliament,                                                         to prevent any spread of these diseases ;
Having regard to the opinion of the Economic and                    Whereas, in order to ensure an effective system of
Social Committee ,                                                  control, diagnosis of these diseases must be harmonized
                                                                    and must be carried out under the auspices of responsible
                                                                    laboratories, the coordination of which may be carried
Whereas fish are listed in Annex II to the Treaty;                  out by a reference laboratory designated by the
whereas the marketing of fish constitutes an important              Community ;                                                           4
source of revenue for the aquaculture sector;
                                                                    Whereas common measures for the control of these
Whereas it is necessary to establish at Community level             diseases form a basis for maintaining a uniform standard
the control measures to be taken in the event of                    of animal health,
outbreaks of disease, in order to ensure rational devel­
opment of the aquaculture sector and to contribute to               HAS ADOPTED THIS DIRECTIVE :
the protection of animal health in the Community;
                                                                                                 CHAPTER I
Whereas it is necessary, for the diseases to be covered, to                                  General provisions
refer to the lists laid down in Annex A to Council
                                                                                                   Article 1
Directive 91 /67/EEC of 28 January 1991 concerning the
animal health conditions governing the placing on the               This Directive defines the minimum Community control
market of aquaculture animals and products (') ;                    measures to be applied in the event of a suspected or
                                                                    confirmed outbreak of the fish diseases referred to in
                                                                    lists I and II of Annex A to Council Directive
Whereas an outbreak of such diseases can quickly take
                                                                    91 / 67 / EEC .
on epizootic proportions, causing mortality and distur­
bances on a scale liable to severely reduce the profita­
bility of aquaculture ;                                                                            Article 2
                                                                    For the purpose of this Directive, the definitions laid
Whereas control measures must be taken as soon as the               down in Article 2 of Directive 91 /67/EEC shall apply.
presence of such a disease is suspected so that immediate
and effective action can be implemented as soon as its              In addition , the following definitions shall apply :
presence is confirmed ;
                                                                     1 . list I disease : fish disease referred to in list I of Annex
                                                                         A to Directive 91 /67/EEC ;
Whereas the measures to be taken must be aimed at
preventing the spread of the disease and, in particular, by          2 . list II disease : fish disease referred to in list II of
 carefully controlling movements of fish and products                    Annex A to Directive 91 /67/EEC ;
 liable to spread the infection ;
                                                                     3 . fish suspected of being infected: fish showing clinical
                                                                         signs or post-mortem lesions or reactions in
                                                                         laboratory tests indicating the possible presence of a
 (') OJ No L 46, 19. 2. 1991 , p. 1 .                                    list I or II disease ;
 ---pagebreak--- 8 . 7 . 92                               Official Journal of the European Communities                             No C 172 / 17
4. infectedfish : fish in which the presence of a list I or II     2 . If the suspicion of infection is justified, the official
    disease has been officially confirmed as the result of a       service is responsible for the execution and supervision of
    laboratory examination ;                                       the provisions laid down in this Directive.
5. farm suspected of being infected: farm containing fish          3 . When infection is suspected on a farm, the official
    suspected of being infected ;                                  service shall have the farm placed under official
                                                                   surveillance, and shall in particular order that :
6. infectedfarm : farm containing infected fish.                   — an official census be made of all categories of fish
                                                                       and that, in respect of each of these categories, the
                                                                       estimated numbers of fish already dead, infected or
                            Article 3                                  liable to be infected be recorded ; the census must be
                                                                       kept up to date by the owner or keeper to take
All farms rearing or keeping fish susceptible to list I or II          account of the increase of the population or new
diseases must :                                                        mortality during the period of suspicion ; the infor­
                                                                       mation in the census must be produced on request
                                                                       and may be checked at each inspection,
1 . be registered by the official service ; this register must
    be constantly kept under review;                               — no fish whether alive or dead or eggs enter or leave
                                                                       the farm without the authorization of the official
                                                                       service,
2. keep a record open to scrutiny by the official service :
                                                                   — the disposal of dead fish or their offal be carried out
    (a) for live fish, eggs and gametes entering the farm,             under the supervision of the official service,
          containing the data of delivery, their number or
          weight, their source and supplies, and the size of       — the entry or exit of feedingstuffs, utensils, objects or
          the fish ;                                                   other substances such as waste liable to transmit
                                                                       disease be subject, if necessary, to authorization by
                                                                       the official service which shall lay down the
    (b) for live fish, eggs and gametes leaving farms,                 conditions in order to prevent the spread of the agent
          containing the data of dispatch, their number or             of the disease,
          weight, their destination, and the size of the fish.
                                                                   — the movement of persons to or from the farm be
                                                                       made subject to the authorization by the official
                            Article 4
                                                                       service,
1.      Any suspicion of the presence of a list I or II
disease in fish must immediately be notified to the                — the entry or exit of vehicles to or from the farm be
official service and, where appropriate, to the owner or               made subject if necessary to authorization by the
keeper of the fish by the most expeditious means                       official service which shall lay down the conditions
available .                                                            necessary in order to avoid the spread of the agent of
                                                                       the disease,
2.      Until such time as the measures laid down in               — appropriate means of disinfection be used at the
Article 5 (3) are enforced, the owner or keeper of the                 entrances and exits of the farm,
fish suspected of being infected shall take all action to
ensure compliance with the said paragraphs.
                                                                   — an epizootiological investigation be carried out in
                                                                       accordance with Article 7 ( 1 ),
                          CHAPTER II
                                                                   — all the farms situated in the same water catchment
              Control measures for list I diseases                     area or coastal area be placed under official
                            Article 5                                  surveillance, and no fish or eggs leave these farms
                                                                       without     the  authorization    of   the     competent
1.      Where information concerning fish suspected of                 authority; in the case of extensive water catchment
being infected with a list I disease is received, the official         areas, the official service may decide to limit this
service shall immediately set in motion official means of              measure to an area upstream and downstream of the
investigation to confirm or rule out the presence of the               farm suspected of being infected, if this area is
agent of the disease, in particular by clinical investigation          considered to give maximum guarantees for the
and, where necessary, by the taking of samples for                     prevention of the spread of the disease ; if necessary,
laboratory examination in an approved laboratory.                      the official services of neighbouring Member States
 ---pagebreak--- No C 172 / 18                           Official Journal of the European Communities                                      8 . 7 . 92
    or third countries must be informed about the                 (b) in the water catchment area or in the coastal zone in
    suspicion. In that event, the official services of the              which the infected farm is situated, all farms situated
    Member States involved shall take appropriate action                in the same area are submitted to health inspections ;
    to apply the measures laid down in this Article .                   if these inspections reveal positive cases, the
    Where necessary, appropriate measures are estab­                    measures as provided for under (a) shall be applied ;
    lished in accordance with the procedure laid down in
    Article 15 .
                                                                  (c) where it is considered that the infection occurs in
                                                                        fish other than on a fish farm, appropriate measures
4.    Where suspicion occurs in fish other than on a fish               equivalent to those laid down under (a) shall be
farm, the official service shall take the measures                      taken ;
necessary to prevent a possible spread of the disease, and
shall in particular order that measures equivalent to those
laid down in paragraph 3 be taken.                                (d) the repopulation of the farm shall be authorized by
                                                                        the official service, following satisfactory inspection
5 . The measures referred to in paragraphs 3 and 4                      of the cleaning and disinfection operations and after
shall not be withdrawn until the suspicion of disease has               an appropriate period has elapsed to ensure complete
been officially ruled out.                                              elimination of the agent of the disease, and the
                                                                        eradication of other possible infections in the same
                                                                        water catchment area ;
                           Article 6
1.    As soon as confirmation of infection of a list I            (e) in case the measures laid down under (a), (b), (c)
disease has taken place, in addition to the measures listed             and (d) require the cooperation of the official
in Article 5 , the official service shall introduce the                 services of other Member States , the official services
following measures :                                                    of the Member States concerned shall collaborate to
                                                                        ensure the respect of the measures laid down in this
(a) in the infected farm :                                              Article. Where necessary, appropriate measures are
                                                                        established in accordance with the procedure laid
     — the inflow and outflow of water through any                      down in Article 15 .
         land-based farm shall be stopped, and in
         cage-based farms, stock shall be removed
         immediately,                                             2 . In the case of an exceptional severity of the
                                                                  spreading of a disease, additional measures may be taken
     — all live fish and eggs must be destroyed under the         in accordance with the procedure laid down in Article
         supervision of the official service in such a way as      15 .
         to avoid all risk of spreading the agent of the
         disease ; however, the marketing or processing for
         human consumption of fish or parts thereof may                                       Article 7
         be authorized by the official service if these oper­
         ations are carried out in conditions such as to           1.     The epizootiological investigation shall deal with :
         prevent the spread of pathogens ; in that event,
         the offals of the fish must be submitted to a
         treatment    which     inactivates    disease-causing    — the likely length of time during which the disease
         agents possibly present therein,                               may have existed on the farm before being notified
                                                                        or suspected,
     — after slaughter and destruction of the fish, ponds,
         equipment and any material liable to be                  — the possible origin of the disease on the farm and the
         contaminated must be disinfected following the                 identification of other farms on which there are
         instructions established by the official service               animals of susceptible species which may have
         where necessary, in accordance with the                        become infected,
         procedure laid down in Article 15 ,
     — any substances which might be contaminated,                — the movement of fish, persons , vehicles and
         referred to in Article 5 (3), fourth indent, shall be          substances likely to have carried the agent of the
         destroyed or treated in such a way as to ensure                disease to or from the farms in question,
         the destruction of any agent of the disease
         present,
                                                                  — the possible existence of carriers of the disease, and
     — an epizootiological enquiry shall be carried out in              their distribution .
         accordance with Article 7 ( 1 ) and the provisions
         of Article 7 (4) shall be applied ; this enquiry shall
         include the taking of samples for laboratory              2.     If this epizootiological investigation reveals that the
         examination ;                                             disease     could  have   been   introduced    from   another
 ---pagebreak--- 8 . 7 . 92                                Official Journal of the European Communities                              No C 172 / 19
water catchment area or could have been transferred to              2.      If the epizootiological enquiry referred to in Article
another one as a result of the movement of fish or other            7 ( 1 ) reveals that the disease could have been introduced
animals, persons or vehicles or in any other way, the               from an approved zone or from another approved farm,
farms belonging to such water catchment area shall be               or could have been transferred to another approved farm
considered as being suspected and the measures laid                 as a result of the movement of persons, animals or
down in Article 5 shall apply. In case of confirmation of           vehicles or in any other way, those zones or farms shall
the presence of the disease, the measures laid down in              be considered as being suspected and the appropriate
Article 6 shall apply.                                              measures shall apply ;
3 . If this epizootiological investigation reveals that             3.      As a derogation from Article 6 ( 1 ) (a) second
cooperation with the official services of other Member              indent, the official service may allow a fattening period
States is required, the official services of the Member             to be applied to fish until they reach commercial size.
States concerned shall collaborate to take appropriate
steps to ensure the respect of the measures provided for
by this Directive .                                                 The requirements of this Article shall not apply to fish
                                                                    species such as tropical fish which are not carriers of
                                                                    disease .
4 . In order to provide full coordination of all
measures necessary to ensure eradication of the disease
as quickly as possible and for the purpose of carrying out
the epizootiological enquiry, a crisis unit shall be estab­                                    Article 10
lished .
                                                                    1 . The requirements of this Article shall apply in a
                                                                    non-approved farm situated in a non-approved zone.
The general rules concerning national crisis units and the
Community crisis unit fixed by Council Regulation
(EEC) No . . . O shall apply.                                       2 . Where a non-approved farm situated in a
                                                                    non-approved zone contains fish suspected of being
                                                                    infected with a list II disease, the official services shall
                           CHAPTER III
                                                                    immediately set in motion official means of investigation
             Control measures for list II diseases                  to confirm or rule out the presence of the disease ,
                                                                    involving where necessary the taking of samples for
                             Article 8                              laboratory examination in an approved laboratory.
1.       The requirements laid down in Articles 5, 6 and 7
shall apply :                                                       3 . In cases where the presence of a list II disease is
                                                                    officially confirmed, the movement of fish or eggs from
(a) in a zone approved in accordance with Article 5 of              that farm on public or private roads is prohibited .
      Directive 91 /67/EEC ;                                        However, removal of live fish or eggs from such farms
                                                                    can be permitted from being transported to another
(b) in a zone for which a programme has been approved               infected farm or to a slaughter premises for the purpose
       in accordance with Article 10 (2) of Directive               of immediate slaughter, such transport being authorized
       91 /67/EEC .                                                 by the official service. The slaughter offals must be
                                                                    submitted to a treatment enabling the destruction of
2 . The requirements of this Article shall not apply to             disease-causing agents .
fish species such as tropical fish which are not carriers of
disease .                                                                                    CHAPTER IV
                                                                                          Final arrangements
                             Article 9
1 . The requirements of Article 5 ( 1 ), (2), (3) indents 1                                    Article 11
to 8 , and (5), Article 6 ( 1 ) (a) and (d) as well as Article 7
( 1 ) shall apply :                                                  1 . Sampling and laboratory testing to detect the
                                                                    presence of list I and II diseases shall be carried out in
(a) in a farm approved in accordance with Article 6 of              accordance with the methods established in accordance
       Directive 91 /67 /EEC ; and                                  with the procedure laid down in Article 15 of Directive
                                                                    91 / 67 / EEC .
(b) in a farm for which a programme has been approved
       in accordance with Article 10, paragraph 2 of
       Directive 91 /67 / EEC .                                     2 . Laboratory testing to detect the presence of disease
                                                                    shall be carried out by a laboratory approved by the
                                                                    official service. This laboratory testing shall, if necessary
                                                                    and especially on the first appearance of the disease,
(*) OJ No L . . .                                                   show the type, sub-type or the variant of the relevant
 ---pagebreak---  No C 172 / 20                         Official Journal of the European Communities                                  8 . 7 . 92
disease-causing agent, which may be confirmed, if                The Commission shall approve the plans, if necessary
necessary, by a reference laboratory designated by the            amended, in accordance with the procedure laid down in
Community. Member States shall communicate the                   Article 15 .
names of the approved laboratories to the Commission
and the Member States .
                                                                 The plans may subsequently be amended or
                                                                 supplemented, in accordance with the same procedure,
3 . The approved laboratories in the Member States               to take into account developments in the situation.
shall, if necessary, through a national reference
laboratory appointed by the official service of the                                        Article 13
Member States , liaise with the Community reference
laboratory referred to in the Annex.                              1 . Vaccination against list II diseases in approved
                                                                 zones and in approved farms situated in non-approved
                                                                 zones is prohibited. However, if an outbreak of a list II
4. The Community reference laboratory designated in              disease occurs in an approved zone or in an approved
Annex A shall be charged with the tasks defined in               farm situated in a non-approved zone and threatens to
Annex B. The conditions under which this laboratory              become extensive, it may be decided, in accordance with
shall operate shall be established in accordance with the        the procedure laid down in Article 15 , that vaccination
procedure laid down in Article 15, in so far as these are        may be introduced subject to specified conditions . These
not yet covered by Article 28 of Council Decision                conditions may include the definition of :
90 /424 / EEC of 26 June 1990 on expenditure in the
veterinary field (1).
                                                                 — the geographical area in which the vaccination is
                                                                      carried out,
                           Article 12
                                                                 — the species and size class of the fish to be vaccinated,
 1.   Each Member State shall draw up a contingency
plan, specifying how it will implement, in the event of an
outbreak of a list I disease, the measures laid down in          — the duration of the vaccination campaign,
this Regulation .
                                                                 — the type of vaccine to be used and the way the
                                                                      vaccine has to be applied,
This plan should allow access to facilities, equipment,
personnel and all other appropriate materials necessary
for the rapid and efficient eradication of the outbreak.         — other matters appropriate to the emergency situation .
                                                                 2.     The movement of fish from such a vaccination zone
2. The criteria to be applied for drawing up those
                                                                 will be subject to any conditions laid down in accordance
plans shall be those laid down in Commission Decision            with the procedure of Article 15 .
91 /42/EEC of 8 January 1991 , laying down the criteria
to be applied when drawing up contingency plans for the
control of foot-and-mouth disease (2), which shall apply         3.     Member States shall inform the Commission of the
mutatis mutandis.                                                progress of the vaccination measures on a regular basis.
                                                                 A decision may be taken in accordance with the
The Commission may, in accordance with Article 15,               procedure laid down in Article 15, to modify, extend or
                                                                 terminate the measures .
amend or supplement those criteria taken into account
the specific nature of the disease.
                                                                                           Article 14
3.    Plans drawn up in accordance with the criteria             The Commission shall be assisted by the Standing
provided for in paragraph 2 shall be submitted to the            Veterinary Committee set up by Council Decision
Commission not later than 1 April 1993 .                         68 / 361 /EEC (3), hereinafter referred to as 'the
                                                                 committee'.
4. The Commission shall examine the plans in order
to determine whether they permit the desired objective to                                  Article 15
be attained and shall suggest to the Member State
concerned any amendments required, in particular to              Where the procedure laid down in this Article is to be
ensure that they are compatible with those of the other          used, the following rules shall apply :
Member States .
                                                                 The representative of the Commission shall submit to the
                                                                 committee a draft of the measures to be taken . The
(') OJ No L 224, 18 . 8 . 1990, p. 19.
O OJ No L 23 , 29. 1 . 1991 , p. 29.                             O OJ No L 255 , 18 . 10 . 1968 , p. 23 .
 ---pagebreak--- 8 . 7 . 92                               Official Journal of the European Communities                                  No C 172 /21
committee shall deliver its opinion on the draft within a                                       Article 16
time limit which the chairman may lay down according
to the urgency of the matter, if necessary by taking a                The Member States shall bring into force the laws, regu­
vote .
                                                                      lations and administrative provisions necessary to comply
                                                                      with the provisions of this Directive not later than
                                                                      1 January 1993 .
The opinion shall be recorded in the minutes ; in                     Where these measures are adopted by the Member States
addition, each Member State shall have the right to ask               they shall contain a reference to this Directive or shall be
to have its position recorded in the minutes.                         accompanied by such reference on the occasion of their
                                                                      official publication. The methods of making such
                                                                      reference shall be laid down by the Member States.
The Commission shall take the utmost account of the
opinion delivered by the committee. It shall inform the                                         Article 17
committee of the manner in which its opinion has been
taken into account.                                                   This Directive is addressed to the Member States .
                                                              ANNEX A
                                            Community reference laboratory for* fish diseases
             The Community reference laboratory for fish diseases is :
             Statens Veterinaere Serumlaboratorium,
             Landbrugsministeriet,
             Hangovej 2 ,
             DK-8200 Aarhus N.
                                                              ANNEX B
                        Duties to be fulfilled by the Community reference laboratory referred to in Annex A
             The Community reference laboratory shall be charged with :
             — identification of virus isolates,
             — supply of diagnostic reagents of good quality on request,
             — approval of diagnostic reagents produced by other laboratories on the basis of titration and specificity
                 testing,
             — establishment of contact with non-Community research laboratories with regard to advanced studies of
                viruses previously not identified inside the Community,
             — the organization of comparative Community tests at regular intervals,
             — hold isolates of disease-causing agents from confirmed outbreaks,
             — where necessary the approval of vaccines to be used under the conditions laid down in this Directive.