CELEX: 51982PC0505
Language: en
Date: 1982-09-09
Title: PROPOSAL FOR A COUNCIL DIRECTIVE INTRODUCING COMMUNITY MEASURES FOR THE CONTROL OF FOOD-AND-MOUTH DISEASE

22. 9. 82                        Official Journal of the European Communities                               N o C 248/3
                                                           II
                                                    (Preparatory Acts)
                                             COMMISSION
              Proposal for a Council Directive introducing Community measures for the control of
                                                foot-and-mouth disease
                          (Submitted by the Commission to the Council on 13 September 1982)
THE COUNCIL OF THE EUROPEAN                                     measures must be implemented where virus types or
COMMUNITIES,                                                    variants are detected against which the vaccines
                                                                usually used in the Community do not provide
Having regard to the Treaty establishing the
                                                                sufficient protection;
European Economic Community, and in particular
Article 43 thereof,                                             Whereas a procedure for close cooperation between
                                                                the Member States and the Commission must be
Having regard to the proposal from the Commission,
                                                                provided for,
Having regard to the opinion of the European Par-
liament,
                                                                HAS ADOPTED THIS DIRECTIVE:
Having regard to the opinion of the Economic and
Social Committee,
                                                                                          Article 1
Whereas one of the Community's tasks in the
veterinary field is to improve the state of health of           This Directive introduces Community measures for
livestock, thereby increasing the profitability of              the control of foot-and-mouth disease, whatever the
stockf arming;                                                  type of virus concerned.
Whereas such action should also help te remove those                                      Article 2
remaining barriers to trade between Member States in
live animals and fresh meat which are caused by                 For the purposes of this Directive, the following
differences in their respective animal health situations;       definitions shall apply:
                                                                (a) 'animal of a susceptible species' means           any
Whereas an outbreak of foot-and-mouth disease can
                                                                     domestic or wild ruminant or swine,
quickly take on epizootic proportions, causing
mortality and disturbances on a scale liable to reduce          (b) 'holding' means any establishment (agricultural or
sharply the profitability of farming of pigs and                     other), situated in the territory of a Member
ruminants as a whole;                                                State, in which animals of susceptible species are
                                                                     kept or bred;
Whereas action must be taken as soon as the presence
                                                                (c) 'animal suspected of being infected with foot-
of the disease is suspected so that immediate and
                                                                     and-mouth disease' means any animal of a
effective control measures can be implemented as
                                                                     susceptible species showing clinical symptoms,
soon as its presence is confirmed;
                                                                    post-mortem lesions, or reactions to laboratory
Whereas it is necessary to present any spread of the                 tests indicating the possible presence of foot-and-
disease as soon as an outbreak occurs, by carefully                  mouth disease;
monitoring movements of animals and the use of                  (d) 'animal infected with foot-and-mouth disease'
products liable to be contaminated, and, where                       means any animal of a susceptible species:
appropriate, by vaccination;                                        — in which clinical symptoms or post-mortem
Whereas diagnosis of the disease and identification of                   lesions of foot-and-mouth disease have been
the relevant virus must be carried out under the                         officially ascertained,
auspices of responsible laboratories the coordination                    or
of which must be ensured by a laboratory appointed                  — in which the presence of foot-and-mouth
by the Community;                                                        disease has been officially          ascertained
Whereas the vaccine used for emergency vaccination                       following a laboratory examination;
must be verified both for efficacy and safety under             (e) 'official veterinarian' means the veterinarian
the auspices of a laboratory appointed by the                        appointed by the competent central authority of
Community, and whereas special coordinated                           the Member State.
 ---pagebreak--- No C 248/4                           Official Journal of the European Communities                            22. 9. 82
                         Article 3                           2. The competent authority shall have power to
                                                             extend the measures provided for in paragraph 1 to
Member States shall ensure that the presence or the
                                                             holdings adjoining the relevant holding should their
suspected presence of foot-and-mouth disease are
                                                             location, their configuration, or contacts with animals
compulsorily and immediately notifiable to the
                                                             from the relevant holding give reason to suspect
competent authority.
                                                             possible contamination.
                                                             3. The measures referred to paragraphs 1 and 2
                         Article 4                           shall not be lifted until the suspicion of foot-and-
1. Where a holding contains one or more animals              mouth disease has been officially refuted.
suspected of being infected with foot-and-mouth
disease, Member States shall ensure that the official
veterinarian immediately sets in motion official means                                 Article 5
of investigation to confirm or rule out the presence of
the said disease, in particular by taking the necessary       1. In cases where the presence of foot-and-mouth
samples for laboratory examination.                          disease has been officially confirmed, Member States
                                                             shall ensure that:
As soon as the suspected infection is notified, the
competent authority shall have the holding placed            (a) the official veterinarian takes adequate samples
under official surveillance and shall in particular              for laboratory examination when the confir-
order that:                                                      mation of disease has not been preceded by a
                                                                 period of suspicion.
— a census be made of all categories of animals of
    susceptible species on the holding, and that, in         (b) the competent authority, in addition to the
    respect of each of these categories, the number of           measures listed in Article 4(1) requires that:
    animals already dead or liable to be infected be
    recorded; the census must be kept up to date to              — all animals of susceptible species of the
    take account of animals born or dying during the                 holding be killed on the spot without delay
    suspect period; the information in the census must               under official control, and in such a way as to
    be produced on request and be liable to veri-                    avoid all risk of dispersion of the foot-and-
    fication at each visit;                                          mouth virus. However, when killing on the
                                                                     spot is impossible, the animals must be
— all animals of susceptible species on the holding be               transported in specially equipped vehicles to
    kept in their living quarters or some other place                the place of slaughter, the whole operation
    where they can be isolated;                                      being carried out in such a way as to avoid all
— no animals of susceptible species enter or leave the               risk of dispersion of the foot-and-mouth
    holding;                                                         virus;
— no animals of other species enter or leave the                 — after slaughter the animals referred to above
    holding without an authorization issued by the                   be destroyed under official supervision in such
    competent authority;                                             a way that there is no risk of dispersion of the
— failing authorization issued in each case by the                   foot-and-mouth virus;
    competent authority, all dispatching from the                — meat of animals of susceptible species
    holding of meat or carcases of animals of                        slaughtered during the period between the
    susceptible species or of animal feed, utensils or               probable introduction of the disease to the
    other objects and waste liable to transmit the                   holding and the implementation of official
    disease be prohibited;                                           measures be, wherever possible, traced and
— no milk leave the holding and, where it is used on                 destroyed under official supervision in such a
    the holding, that proper heat treatment be                       way as to avoid any risk of dispersion of the
    applied;                                                         foot-and-mouth virus;
— the movement of persons to or from the holding                 — the carcases of animals of susceptible species
    be made subject to authorization by the                          which have died on the holding be destroyed
     competent authority;                                             under official supervision in such a way as to
                                                                      avoid any risk of dispersion of the foot-and-
— the movement of vehicles to or from the holding                     mouth virus;
    be made subject to authorization by the
    competent authority;                                          — all substances such as wool or waste likely to
                                                                      be contaminated, such as feedingstuffs, dung,
— appropriate means of disinfection be used at the                    etc., de destroyed or treated in such a way as
    entrances and exits of buildings housing animals                  to ensure the destruction of any foot-and-
    of susceptible species and of the holding itself;                 mouth virus present; this treatment must be
— an epizootiological inquiry be carried out in                       carried out in accordance with the instructions
    accordance with Article 7 and 8.                                  of the official veterinarian;
 ---pagebreak--- 22. 9. 82                         Official Journal of the European Communities                           No C 248/5
     — milk and milk products be destroyed in such a          — the possible origin of the foot-and-mouth disease
        way as to avoid all risk of dispersion of the             on the holding and the identification of other
         foot-and-mouth virus;                                    holdings on which there are animals of susceptible
     — after elimination of the animals of susceptible            species which may have become infected from the
         species, the buildings used for housing the              same source;
         animals, their surroundings and the vehicles         — the movement of persons, vehicles, animals,
         used for transporting them and all equipment             carcases, meat, material or agents likely to have
         likely to be contaminated be cleaned and                 carried the virus to or from the holdings.
        disinfected in accordance with Article 10;
     — no animals of susceptible species be
        reintroduced to the holding within at least                                    Article 8
         15 days after completion of the cleaning and
        disinfection    operations     carried  out    in      1.   Where the official veterinarian finds, or
         accordance with Article 10;                          considers on the basis of confirmed data, that foot-
     — an epizootiological inquiry be carried out in          and-mouth disease could have been introduced from
        accordance with Articles 7 and 8.                     other holdings on to the holding referred to in Article
                                                              4, or from the latter holding on to other holdings, as
2.    The competent authority shall have power to             a result of the movement of persons, animals, vehicles
extend the measures provided for in paragraph 1 to            or in any other way, those other holdings shall be
holdings adjoining the relevant holding should their          placed under official surveillance in accordance with
location, their configuration, or contacts with animals       paragraph 3, and this surveillance shall not be lifted
from the relevant holding give reason to suspect              until the suspicion of foot-and-mouth disease in
contamination.                                                relation to the holding referred to in Article 4 has
                         Article 6                            been officially refuted.
 1.   In the case of holdings which consist of two or         2.    Where the official veterinarian finds, or
more separate production units and in order that              considers on the basis of confirmed data, that foot-
fattening of susceptible species of animal may be             and-mouth disease could have been introduced on to
completed, the competent authority may derogate               the holding referred to in Article 5 from other
from the first and second indents of Article 5 (1) (b)        holdings as a result of the movement of persons,
as regards healthy production units on a holding              animals or vehicles or in any other way, those other
which is infected provided that the official veteri-          holdings shall be placed under official surveillance in
narian has confirmed that the structure and size of           accordance with paragraph 3.
these production units and the operations carried out
there are such that the production units provide              Where the official veterinarian finds, of considers on
completely separate facilities for housing, keeping and       the basis of confirmed data, that foot-and-mouth
feeding, so that the virus cannot spread from one             disease could have been introduced from the holding
production unit to another.                                   referred to in Article 5 on to other holdings as a
The same measures, and the possibility of derogating          result of the movement of persons, animals or vehicles
from the requirements of the sixth indent of Article          or in any other way, those other holdings shall
5 (1) (b) may be extended to holdings producing               become subject to the provisions of Article 4.
milk, provided that in addition milking in each unit is
usually carried out completely separately.                    3.    The purpose of the official surveillance shall be
                                                              to detect immediately any suspicion of foot-and-
2.    Where recourse      is had to paragraph 1, the
                                                              mouth disease, to make a census of animals of a
Member States shall        draw up detailed rules for
                                                              susceptible species, to check their movements and,
applying it in the       light of the animal health
                                                              where appropriate, to implement any or all of the
guarantees which can     be given. The shall notify the
                                                              measures provided for in Article 4(1).
Commission thereof.
3.    A decision may be taken, in accordance with the
procedure laid down in Article 16, that the measures                                   Article 9
referred to in paragraph 1 are to be amended in order
                                                               1.   Once the diagnosis of foot-and-mouth disease
to ensure their coordination with those adopted by
                                                              has been officially confirmed, the Member States shall
the Member States.
                                                              ensure that the competent authority establishes,
                         Article 7                            around the infected holding, a protection zone based
                                                              on a minimum radius of two kilometres and a sur-
The epizootiological inquiry shall deal with:                 veillance zone based on a minimum radius of ten
— the length of time during which the foot-and-               kilometres, endeavouring to include in one of the two
    mouth disease may have existed on the holding             zones a slaughterhouse capable of receiving the
    before being notified or suspected;                       animals from the protection zone. The establishment
 ---pagebreak--- No C 248/6                           Official Journal of the European Communities                               22. 9. 82
of zones must take account of natural boundaries and                 — animals of susceptible species may be
control facilities.                                                       removed from the surveillance zone only
                                                                          under official control, and during the 15
2. (a) The following measures shall be applied in the                     days following the date of establishment of
       protection zone:                                                   this zone only to a slaughterhouse for
                                                                          immediate slaughter. Such removals shall
       — a census shall be carried out of all the
                                                                          be authorized by the competent authority
           holdings having animals of a susceptible
                                                                          only after examination by the official
           species, these holdings being visited period-
                                                                          veterinarian of all the animals of
           ically;
                                                                          susceptible species on the holding has ruled
       — the movement of animals of susceptible                           out the presence of animals suspected of
           species on public or private roads,                            being    infected    with     foot-and-mouth
           excluding means of access within holdings,                     disease;
           shall be prohibited;
                                                                     — itinerant service for        breeding   shall   be
       — animals of susceptible species may be                            prohibited;
           removed from the holding on which they
                                                                     — fairs, markets, shows and other gatherings
           are kept only to be transported directly
                                                                          of animals shall be prohibited.
           under official supervision for the purpose
           of immediate slaughter to the slaugh-                 (b) The measures in the surveillance zone shall be
           terhouse defined in paragraph 1. Such                      kept in force until at least 30 days after the
           transport may be authorized by the                         elimination of all the animals of susceptible
           competent authority only after the official                species on the holding referred to in Article 5
           veterinarian has carried out an examination                and the execution on this holding of the
           of all the animals of susceptible species on               cleaning and disinfection operations in
           the holding and confirmed that none of the                 accordance with Article 10.
           animals is suspected of being infected with
           foot-and-mouth disease;                                                     Article 10
       — itinerant service for      breeding    shall be     The Member States shall ensure that:
           prohibited;
                                                             — the disinfectants          to be used and             their
       — artificial insemination shall be prohibited;             concentrations are officially approved by the
       — fairs, markets, shows or other gatherings of             competent authority,
           animals, including collection and distri-         — the cleaning and disinfection operations are
           bution of animals, shall be prohibited;                carried out under official supervision, in
       — the transport of animals of susceptible                  accordance with the instructions given by the
           species in transit is prohibited except for            official veterinarian.
           transit by major highways or main-line
           railways.                                                                   Article 11
   (b) The measures applied in the protection zone            1.    The Member States shall ensure that:
       shall be maintained until at least 15 days after      — laboratory examinations carried out in order to
       elimination of all animals of susceptible species          detect the presence of foot-and-mouth disease, if
       on the holding referred to in Article 5 and the            necessary and especially on the first appearance of
       execution on this holding of the cleaning and              disease, show the type and sub-type and, where
       disinfection operations in accordance with                 appropriate, the variant of the relevant virus;
       Article 10. However, the measures set out in
       paragraph 3 for the surveillance zone shall           — the examinations are carried out by a national
       remain in force in the protection zone.                    laboratory in accordance with Annex I;
                                                             — the type or sub-type and, where appropriate, the
                                                                  variant of the relevant virus, are confirmed, if
3. (a) The following measures shall be applied in the             necessary, by a reference laboratory assignated by
        surveillance zone:                                        the Community;
        — a census shall be made of all holdings              — liaison between the national laboratories defined
            which have animals of susceptible species;            in the second indent is ensured by a laboratory
       — the movement of animals of susceptible                   designated by the Community.
            species on public roads is prohibited;            2.    The Council, acting on a proposal from the
       — the transport of animals of susceptible              Commission, shall designate the laboratories referred
            species within the surveillance zone shall be     to in the third and fourth indents of paragraph 1 and
            subject to authorization issued by the            shall determine their powers and the conditions of
            competent authority;                              their operation.
 ---pagebreak---  22. 9. 82                         Official Journal of the European Communities                             No C 248/7
                         Article 12                                 rules established under the procedure provided
                                                                    for in Article 17;
 1.     Without prejudice to existing Community
provisions in this field, Member States shall inform           (d) the vaccine used is verified ' by the competent
the Commission and the other Member States about                    authority under the aegis of a specialized institute
the epizootiology and development of the disease in                 designated by the Community;
accordance with Annex II.                                      (e) any vaccine imported from a non-member
                                                                   country meets the requirements set out under (c)
2.     Annex II may be amended in accordance with                   and is verified as indicated under (d).
the procedure laid down in Article 17.
                                                               3.    Where types, sub-types or variants of virus are
                         Article 13                            detected against which the vaccines usually used
                                                               provide no protection or insufficient protection, the
Member States shall ensure that:                               Member State concerned shall immediately inform
— when animals of susceptible species are moved out            the Commission and the other Member States stating
     of the holding on which they are kept, they are           what emergency measures it believes necessary for the
     identified so as to enable the holding of origin, or      adaptation of vaccine formulae and their use. If the
     the holding from which they have been                     adoption of Community measures prove necessary,
     transported, and their movements to be traced             such measures shall, in the light of the national
     rapidly. However, for certain animals, and in             measures referred to above, be adopted according to
     certain circumstances, having regard to the health        the procedure provided for in Article 16.
    situation, the competent authority may authorize
                                                               4.    On a proposal from the Commission the
     other ways of rapidly identifying the holding of
                                                               Council shall designate the laboratory referred to in
     origin or the holding from which the animals have
                                                               paragraph 2(d) and shall decide upon its powers and
    been transported and of rapidly tracing the
                                                               conditions of operation.
    animals' movements. The arrangements for
    marking the animals or for identifying the
    holdings of origin shall be determined by the                                       Article 15
    competent authority,
                                                               Should foot-and-mouth disease assume alarming
— all persons engaged in the transport or marketing            proportions on the territory of a Member State, and,
    of animals of susceptible species are able to supply       despite the measures taken, particularly in application
    the competent authority with              information      of Article 14, the epidemic take on an extensive
    concerning the movements of animals which they             character and extend widely outside the limits of the
    have transported or marketed, and to furnish               vaccinated zone, it may be decided in accordance
    proper evidence concerning such information; the           with the procedure laid down in Article 16, at the
    same obligation shall be incumbent upon all                request of that Member State and where justified by
    persons keeping such animals in respect of animals         an assessment of the situation, to permit derogations
    entering or leaving their holdings.                        from certain provisions of Article 5, to the extent of a
                                                               selective reduction of the slaughter and destruction of
                         Article 14                            susceptible animals in the holdings where the disease
                                                               occurs. In this case, the conditions of application for
1.     When foot-and-mouth disease is diagnosed on a           the measures which are decided upon shall be
holding, the measures to control the disease may be            established if necessary according to the same
supplemented by the vaccination of animals of                  procedure.
susceptible species on holdings threatened with
contamination in a territorial area specified by the
                                                                                        Article 16
competent authority.
                                                               1.    Where the procedure laid down in this Article is
2.     In the case referred to in paragraph 1, the
                                                               to be followed, the matter shall without delay be
Member State shall ensure that:
                                                               referred by the chairman, either on his own initiative
(a) without prejudice to national arrangements where           or at the request of a Member State, to the Standing
      such arrangements provide for the preventive             Veterinary Committee (hereinafter referred to as 'the
      vaccination against foot-and-mouth disease of            Committee') set up by the Council Decision of 15
      any or all of the animals of susceptible species on      October 1968.
      part or all of the national territory, the vacci-
      nation or re-vaccination of animals of susceptible       2.     Within the Committee the votes of the Member
      species on the holdings referred to in Articles 4        States shall be weighted as laid down in Article
      and 5 is prohibited;                                      148 (2) of the Treaty. The chairman shall not vote.
(b) serum injection is prohibited;                             3.    The representative of the Commission shall
(c) the anti foot-and-mouth disease vaccine used and           submit a draft of the measures to be adopted. The
      the method of use are in accordance with the             Committee shall deliver its opinion on these measures
 ---pagebreak--- No C 248/8                           Official Journal of the European Communities                                  22. 9. 82
within two days. Opinions shall be delivered by a                  the matters submitted for examination. Opinions shall
majority of forty-five votes.                                      be delivered by a majority of forty-five votes.
                                                                   4.    The Commission shall adopt the measures and
4.     The Commission shall adopt the measures and
                                                                   shall implement them immediately, where they are in
shall implement them immediately, where they are in
                                                                   accordance with the opinion of the Committee.
accordance with the opinion of the Committee.
                                                                   Where the measures are not in accordance with the
Where the measures are not in accordance with the
                                                                   opinion of the Committee, or if no opinion is
opinion of the Committee, or if no opinion is
                                                                   delivered, the Commission shall without delay submit
delivered, the Commission shall without delay submit
                                                                   to the Council a proposal on the measures to be
to the Council a proposal on the measures to be
                                                                   taken. The Council shall adopt the measures by
taken. The Council shall adopt the measures by
                                                                   qualified majority.
qualified majority.
                                                                   If the Council has not adopted any measures within
If the Council has not adopted any measures within                 three months of the date on which the matter is
15 days of the date on which the matter is referred to              referred to it, the Commission shall adopt the
it, the Commission shall adopt the proposed measures                proposed measures and shall implement them
and shall implement them immediately unless the                     immediately unless the Council has voted against the
Council has voted against the said measures by a                    said measures by a simple majority.
simple majority.
                                                                                           Article 18
                        Article 17
                                                                    On the basis of a report, containing proposals where
1.     Where the procedure laid down in this Article is             appropriate, on the experience gained in controlling
to be followed, the matter shall without delay be                   foor-and-mouth disease, the Council shall review the
referred by the chairman, either on his own initiative              situation with a view to further harmonization, by
or at the request of a Member State, to the                         31 December 1985.
Committee.
                                                                                           Article 19
2.     Within the Committee the votes of the Member
States shall be weighted as laid down in Article                    Member States shall bring into force the laws, regu-
148 (2) of the Treaty. The chairman shall not vote.                 lations and administrative provisions necessary to
                                                                    comply with this Directive on 1 July 1983.
3.     The representative of the Commission shall
submit a draft of the measures to be adopted. The                                          Article 20
Committee shall deliver its opinion by a date which
the Chairman may set in the light of the urgency of                 This Directive is addressed to the Member States.
                                                           ANNEX I
                      THE NATIONAL FOOT-AND-MOUTH LABORATORIES ARE AS FOLLOWS
              BELGIUM AND LUXEMBOURG: Institut national de recherches veterinaires, Groeselenberg 99,
              1180-Bruxelles.
              DENMARK: Statens veterinaere Institut for Virusforskning, Lindholm.
              ITALY: Istituto zooprofilattico sperimentale della Lombardia e della Emilia Romagna — Brescia.
              UNITED KINGDOM AND IRELAND: Animal Virus Research Institute, Pirbright, Woking,
              Surrey.
              FRANCE: Laboratoire national de pathologie bovine, Lyon.
              GREECE: Institute for foot-and-mouth disease, Aghia Paraskevi Attikis.
              GERMANY: Bundesforschungsanstalt fiir Viruskrankheiten der Tiere, Tubingen.
              NETHERLANDS: Centraal Diergeneeskundig Instituut, Lelystad.
 ---pagebreak--- 22. 9. 82                        Official Journal of the European Communities                                  N o C 248/9
                                                         ANNEX II
                                         EPIZOOTIOLOGICAL INFORMATION
          1. Within 24 hours of notification of the first outbreak of foot-and-mouth disease, the Member
             State concerned must forward the following information to the Commission and the other
             Member States:
             — the date on which the disease was suspected;
             — the date on which the disease was confirmed:
                 type, sub-type and, as appropriate, variant of the relevant virus (where such information is
                 not yet available at the time of notification, it must be sent as soon as possible):
             — location of the holding infected, distance of the nearest livestock holdings;
             — number of animals by species on the holding;
             — for each species, number of animals found to be infected and the level of morbidity of the
                 disease.
          2. The information specified in paragraph 1 must be followed as soon as possible by a report stating
             the following:
             — the date on which the animals of susceptible species on the holding were slaughtered and
                 destroyed;
             — any available information concerning the possible origin of the disease or the origin of the
                 disease if this has been ascertained.
          3. The Member State concerned must forward the information specified in paragraph 1 to the
             Commission and the other Member States, within the time limit laid down therein, in respect of
             each subsequent outbreak of foot-and-mouth disease until the number of infected holdings and
             the dispersion of the disease show it to be extensive.