This Directive defines the general Community control measures to be applied in the event of an outbreak of one of the diseases listed in Annex I.
For the purposes of this Directive, the following definitions shall apply:
holding: any establishment (agricultural or other), situated in the territory of a Member State, in which animals are kept or bred;
animal: any domestic animal of a species liable to be directly affected by the disease in question, or any wild vertebrate animal likely to participate in the epidemiology of the disease, by acting as a carrier or reservoir of infection;
[X1vector: any vertebrate or invertebrate animal which, by mechanical or biological means, is liable to transmit and spread the agent of the disease in question;]
owner or keeper: any person or persons, either natural or legal, having ownership of the animals, or charged with keeping the said animals, whether or not for financial reward;
incubation period: the period of time likely to elapse between exposure to the agent of the disease and the onset of clinical symptoms. The duration of this period shall be that indicated in Annex I for the disease in question;
confirmation of infection: the declaration by the competent authority of the presence of any of the diseases listed in Annex I based on laboratory results; however, in the event of an epidemic, the competent authority may also confirm the presence of the disease on the basis of clinical and/or epidemiological results;
competent authority: the central authority of a Member State responsible for carrying out veterinary checks or any veterinary authority to which it has delegated that responsibility;
official veterinarian: the veterinarian appointed by the competent authority.
Editorial Information
Member States shall ensure that it is compulsory for the suspected presence of any of the diseases referred to in Annex I to be notified immediately to the competent authority.
1.When animals on a holding are suspected of being infected or contaminated with one of the diseases listed in Annex I, Member States shall ensure that the official veterinarian immediately activates official investigation arrangements to confirm or rule out the presence of the disease in question and, in particular, must take or have taken the samples necessary for laboratory examination. To that end the animals in question may be transported to the laboratories under the supervision of the competent authority, which shall take appropriate steps to prevent the disease from spreading.
2.As soon as the suspected presence of the disease is notified, the competent authority shall have the holding placed under official surveillance and shall in particular require that:
(a)a census be made of all categories of animals of susceptible species and that, in respect of each of these categories, the number of animals already dead, infected or liable to be infected or contaminated be recorded; the census must be kept up to date to take account of animals born or dying during the period of suspicion; the information in the census must be kept up to date and produced on request and may be checked at each visit;
(b)all animals of susceptible species on the holding be kept in their living quarters or confined in some other place where they can be isolated taking into account the possible role of vectors, where appropriate;
(c)no animals of susceptible species enter or leave the holding;
(d)all movement:
(d)of persons, animals of other species not susceptible to the disease and vehicles to or from the holding,
of meat or animal carcases, or of animal feed, equipment, waste, droppings, litter, manure, or anything liable to transmit the disease in question
(e)be subject to authorization by the competent authority, which shall lay down the conditions for preventing any risk of the disease spreeding; appropriate means of disinfection be installed at the entrances and exits of buildings or places housing animals of susceptible species and of the holding itself;
(f)an epizootiological inquiry be carried out in accordance with Article 8.
3.Until such time as the official measures laid down in paragraph 2 are enforced, the owner or keeper of any animal in which disease is suspected shall take every appropriate measure to ensure compliance with paragraph 2, except for subparagraph (f) thereof.
4.The competent authority may apply any of the measures provided for in paragraph 2 to other holdings should their location, their configuration or contacts with the holding where the disease is suspected give reason to suspect possible contamination.
5.The measures referred to in paragraphs 1 and 2 shall not be withdrawn until the suspicion of the presence of the disease has been ruled out by the official veterinarian.
1.Once it has been officially confirmed that one of the diseases listed in Annex I is present on a holding, Member States shall ensure that, in addition to the measures laid down in Article 4 (2), the competent authority requires application of the following measures:
(a)all animals of susceptible species on the holding shall be killed on the spot, without delay. The animals which have died or been killed shall either be burnt or buried on the spot, if possible, or destroyed in a carcase disposal plant. These operations shall be carried out in such a way as to minimize the risk of disseminating the agent of the disease;
(b)any substance or waste, such as animal feed, litter, manure or slurry, which is liable to be contaminated, shall be destroyed or treated appropriately. This treatment, carried out in accordance with the instructions of the official veterinarian, must ensure that any agent or vector of the agent of the disease is destroyed;
(c)after carrying out operations listed in subparagraphs (a) and (b), the buildings used for housing animals of susceptible species, their surroundings, the vehicles used for transport and all equipment liable to be contaminated shall be cleaned and disinfected in accordance with Article 16;
(d)an epizootiological inquiry shall be carried out in accordance with Article 8.
2.When recourse is had to burial, it must be deep enough to prevent carnivorous animals from digging up the carcases or waste referred to in paragraph 1 (a) and (b) above and must be in suitable ground so as to prevent contamination of water tables or any environmental nuisance.
3.The competent authority may extend the measures provided for in paragraph 1 to other neighbouring holdings should their location, their configuration or contacts with the holding where the presence of the disease has been confirmed give reason to suspect possible contamination.
4.The restocking of the holding shall be authorized by the competent authority, following the satisfactory inspection by the official veterinarian of the cleaning and disinfection operations carried out in accordance with Article 16.
Where animals living in the wild are infected or suspected of being infected, Member States shall ensure that appropriate action is taken. Member States shall inform the Commission and the other Member States, in the Standing Veterinary Committee set up by Decision 68/361/EEC(1), of the measures they have taken.
1.In the case of holdings which consist of two or more separate production units, the competent authority may derogate from the requirements of Article 5 (1) (a) as regards healthy production units of a holding which is infected, provided that the official veterinarian has confirmed that the structure and size of these units and the operations carried out therein are such that they are completely separate as regards housing, keeping, staff, equipment and feeding, so as to prevent the spread of the agent of the disease from one unit to another.
2.Where recourse is had to paragraph 1, the rules laid down in Commission Decision 88/397/EEC(2) shall apply mutatis mutandis. These rules may be amended for the disease in question under the procedure laid down in Article 25 in order to take account of the specific nature of the disease.
1.The epizootiological enquiry shall deal with:
(a)the length of time during which the disease may have existed on the holding before being notified or suspected;
(b)the possible origin of the disease on the holding and the identification of other holdings on which there are animals of susceptible species which may have become infected or contaminated;
(c)the movement of persons, animals, carcases, vehicles, equipment or any other substances likely to have carried the agent of the disease to or from the holdings in question;
(d)the presence and distribution of disease vectors as appropriate.
2.A crisis unit shall be established 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.
The general rules concerning national crisis units and the Community crisis unit shall be laid down by the Council, acting by a qualified majority on a proposal from the Commission.
1.Where the official veterinarian finds, or considers on the basis of confirmed data, that disease could have been introduced from other holdings onto the holding referred to in Article 4 or from the latter onto other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with Article 4; this surveillance shall not be lifted until the suspected presence of disease on the holding has been officially ruled out.
2.Where the official veterinarian finds, or considers on the basis of confirmed data, that disease could have been introduced from other holdings on to the holding referred to in Article 5 or from the latter onto other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with Article 4; this surveillance shall not be lifted until the suspected presence of disease on the holding has been officially ruled out.
3.When a holding has been subject to the provisions of paragraph 2, the competent authority shall keep the provisions of Article 4 in force on the holding for at least the maximum incubation period pertaining to each disease following the likely time of introduction of infection as established by the epizootiological enquiry carried out in accordance with Article 8.
4.Where it considers that conditions permit, the competent authority may limit the measures provided for in paragraphs 1 and 2 to a part of the holding and the animals contained therein provided that the holding can satisfy the conditions set out in Article 7, or to animals of susceptible species only.
1.Once the diagnosis of one of the diseases in question has been officially confirmed, Member States shall ensure that the competent authority establishes around the infected holding a protection zone with a minimum radius of three kilometres, itself contained in a surveillance zone with a minimum radius of 10 kilometres. The establishment of the zones must take account of geographical, administrative, ecological and epizootiological factors relating to the disease in question, and of monitoring facilities.
2.Where the zones are situated in the territory of more than one Member State, the competent authorities of the Member States concerned shall cooperate in establishing the zones referred to in paragraph 1. However, if necessary, the protection zone and the surveillance zone shall be established under the procedure provided for in Article 26.
3.At the duly substantiated request of a Member State or on the Commission's initiative, it may be decided under the procedure laid down in Article 26, to modify (in particular to reduce or increase, as appropriate) the boundaries of the zones laid down in paragraph 1 or the duration of the restriction measures, taking into account:
their geographical situation and ecological factors,
the meteorological conditions,
the presence, distribution and type of vectors,
the results of the epizootiological studies carried out in accordance with Article 8,
the results of laboratory tests,
control measures actually applied.
1.Member States shall ensure that the following measures are applied in the protection zone:
(a)all holdings within the zone having animals of susceptible species shall be identified;
(b)there shall be periodic visits to holdings having animals of susceptible species, a clinical examination of those animals including, if necessary, the collection of samples for laboratory examination; a record of visits and findings must be kept, with the frequency of visits being proportional to the seriousness of the epizootic on those holdings at greatest risk;
(c)the movement and transport of animals of susceptible species on public or private roads, excluding the service roads of holdings, shall be prohibited; the competent authority may, however, grant a derogation from that prohibition for the transit of animals by road or rail without unloading or stopping;
(d)animals of susceptible species must remain on the holding on which they are being kept, except to be transported under official supervision directly to a slaughterhouse located in that zone for emergency slaughter or, if that zone has no slaughterhouse under veterinary supervision, to a slaughterhouse in the surveillance zone designated by the competent authority. Such transport may be authorized by the competent authority only after the official veterinarian has carried out an examination of all the animals of susceptible species on the holding and confirmed that none of the animals is suspected of being infected. The competent authority responsible for the slaughterhouse shall be informed of the intention to send animals to it.
2.The measures applied in the protection zone shall be kept in force for at least the maximum incubation period pertaining to the disease in question after animals from the infected holding have been disposed of in accordance with Article 5 and cleaning and disinfection operations have been carried out in accordance with Article 16. However, where the disease is transmitted by an insect vector, the competent authority may fix the duration of the measures and lay down provisions for the possible introduction of sentinel animals. Member States shall forthwith inform the Commission and the other Member States, within the Standing Veterinary Committee, of the measures they have taken.
On expiry of the period referred to in the first subparagraph, the rules applied to the surveillance zone shall also apply to the protection zone.
1.Member States shall ensure that the following measures are applied in the surveillance zone:
(a)all holdings having animals of susceptible species shall be identified;
(b)the movement of animals of susceptible species on public roads shall be prohibited except for the purpose of leading them to pasture or animal buildings; the competent authority may, however, grant a derogation from that prohibition for the transit of animals by road or rail without unloading or stopping;
(c)the transport of animals of susceptible species within the surveillance zone shall be subject to authorization by the competent authority;
(d)animals of susceptible species must remain inside the surveillance zone for a maximum incubation period after the most recent recorded case of disease. Thereafter, animals may be removed from that zone to be transported under official supervision directly to a slaughterhouse designated by the competent authority for emergency slaugther. Such transport may be authorized by the competent authority only after the official veterinarian has carried out an examination of all the animals of the susceptible species on the holding and confirmed that none of the animals is suspected of being infected. The competent authority responsible for the slaughterhouse shall be informed of the intention to send animals to it.
2.The measures applied in the surveillance zone shall be kept in force for a period at least equal to the maximum incubation period after animals from the holding have been disposed of in accordance with Article 5 and cleaning and disinfection operations have been carried out in accordance with Article 16. However, where the disease is transmitted by an insect vector, the competent authority may fix the duration of the measures and lay down provisions for the possible introduction of sentinel animals. Member States shall forthwith inform the Commission and the other Member States, within the Standing Veterinary Committee, of the measures they have taken.
Where the prohibitions provided for in Articles 11 (1) (d) and 12 (1) (d) are maintained beyond 30 days because of the occurrence of further cases of the disease and as a result problems arise in keeping the animals, the competent authority may, following an application by the owner explaining the rounds for such application, by the owner explaining the grounds for such applications authorize the removal of the animals from a holding within the protection zone or the surveillance zone, provided that:
the official veterinarian has verified the facts;
an inspection of all animals on the holding has been carried out;
the animals to be transported have undergone a clinical examination, with negative result;
each animal has been marked by ear marking or has been identified by any other approved method;
the holding of destination is located either in the protection zone or within the surveillance zone.
All the necessary precautions must be taken, in particular by cleaning and disinfecting lorries after transport, to avoid the risk of spreading the agent of the disease in the course of such transport.
1.Member States shall ensure that the competent authority takes all the necessary measures to keep at least persons established in the protection and surveillance zones informed of the restrictions in force and makes all necessary arrangements for the appropriate implementation of those measures.
2.Where, in a given region, the epizootic in question is exceptionally serious, all the additional measures to be taken by the Member States concerned shall be adopted under the procedure laid down in Article 26.
By way of derogation from the general provisions laid down in this Directive, specific provisions relating to the control and eradication measures for each respective disease:
are, for swine vesicular disease, set out in Annex II for swine vesicular disease,
are, for each of the other diseases listed in Annex I, adopted by the Council, acting by a qualified majority on a proposal from the Commission.
1.Member States shall ensure that:
(a)the disinfectants and insecticides to be used and, where appropriate, their concentrations, are officially approved by the competent authority;
(b)the cleaning, disinfection and disinsectization operations are carried out under official supervision:
(b)in accordance with the instructions given by the official veterinarian,
(b)and
in such a way as to eliminate any risk of spread or survival of the agent of the disease;
(c)on completion of the operations in (b), the official veterinarian makes sure that the measures have been carried out properly and that an appropriate period, of not less than 21 days, has elapsed to ensure that the disease in question has been completely eliminated before animals of susceptible species are re-introduced.
2.The procedures for cleaning and disinfecting an infected holding:
are, for swine vesicular disease, those set out in Annex II,
are determined, in the context of preparation of the specific measures for each disease listed in Annex I, in accordance with the procedure laid down in the second indent of Article 15.
1.Member States shall ensure that in each Member State there is designated:
(a)a national laboratory with facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type, sub-type and variant of the relevant virus and to confirm results obtained in regional diagnostic laboratories;
(b)a national laboratory at which reagents used in regional diagnostic laboratories are tested.
2.The national laboratories designated for each of the diseases referred to shall be responsible for coordinating diagnostic standards and methods, and for the use of reagents.
3.The national laboratories designated for each of the diseases referred to shall be responsible for coordinating the diagnostic standards and methods laid down by each laboratory for diagnosis of the disease in question within the Member State. To this end, they:
(a)may provide diagnostic reagents to national laboratories;
(b)shall control the quality of all diagnostic reagents used in the Member State;
(c)shall periodically arrange comparative tests;
(d)shall hold isolates of the virus of the disease in question from cases confirmed in the Member State;
(e)shall ensure the confirmation of positive results obtained in regional diagnostic laboratories.
4.However, by way of derogation from paragraph 1, Member States which do not have a national laboratory competent as regards the disease in question, may use the services of a national laboratory with competence in the matter of another Member State.
[F15. Member States shall maintain up-to-date lists of the national laboratories referred to in paragraph 1 and make them available to the other Member States and to the public.]
6.The national laboratories designated for each of the diseases referred to shall cooperate with the respective Community reference laboratories referred to in Article 18.
7.The detailed rules for implementing this Article shall be adopted by the Commission under the procedure laid down in Article 25.
Textual Amendments
F1 Substituted by Council Directive 2008/73/EC of 15 July 2008 simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/426/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 91/496/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC and 2005/94/EC (Text with EEA relevance).
1.The Community reference laboratory for swine vesicular disease is indicated in Annex II.
2.The Community reference laboratories for each of the other diseases listed in Annex I shall be designated in accordance with the procedure laid down in the second indent of Article 15 in the context of preparation of the specific measures for each disease.
3.Without prejudice to Decision 90/424/EEC, and in particular Article 28 thereof, the functions and duties of the laboratories referred to in paragraphs 1 and 2 of this Article shall be those laid down in Annex III.
1.Vaccination against the diseases listed in Annex I may not be carried out except as a supplement to control measures taken when the disease in question broke out, in accordance with the following provisions:
(a)the decision to introduce vaccination as a supplement to control measures shall be taken by the Commission, in cooperation with the Member State concerned, under the procedure laid down in Article 26;
(b)this decision shall be based on the following criteria in particular:
(b)the concentration of animals of the species concerned in the affected zone,
the characteristics and composition of each vaccine used,
the procedures for supervision of the distribution, storage and use of vaccines,
the species and age of the animals which may or must be vaccinated,
the areas in which vaccination may or must be carried out,
the duration of the vaccination campaign.
2.In the case referred to in paragraph 1:
(a)the vaccination or re-vaccination of animals of susceptible species on the holdings referred to in Article 4 shall be prohibited;
(b)hyper-immune serum injection shall be prohibited.
3.In the event of recourse to vaccination, the following rules shall apply:
(a)all vaccinated animals must be identified by a clear and legible mark in accordance with a method approved by the procedure laid down in Article 25;
(b)all vaccinated animals must remain within the vaccination zone unless sent to a slaughterhouse designated by the competent authority for immediate slaughter, in which case the movement of animals may be authorized only after the official veterinarian has carried out an examination of all the susceptible animals on the holding and confirmed that none of the animals is suspected of being infected.
4.When the vaccination operations have been completed, movements of animals of susceptible species from the vaccination zone may be permitted under the procedure laid down in Article 26, after a period determined by the same procedure.
5.Member States shall inform the Commission on a regular basis, within the Standing Veterinary Committee, of progress as regards the vaccination measures.
6.However, by way of derogation from paragraph 1, the decision to introduce emergency vaccination may be taken by the Member State concerned, following notification of the Commission, provided that the fundamental interests of the Community are not affected. That decision, which must in particular take into account the degree of concentration of the animals in certain regions, of the need to protect individual breeds and of the geographical area in which vaccination is carried out, shall forthwith be re-examined, under the procedure laid down in Article 26, by the Standing Veterinary Committee, which may decide to retain, modify or extend the measures or to bring them to an end.
1.Each Member State shall draw up a contingency plan applicable to all the diseases listed in Annex I, specifiying the national measures to be implemented in the event of an outbreak of any of these diseases.
This plan must allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak.
2.The general criteria to be applied for drawing up the contingency plans are laid down in points 1 to 5 and 10 of Annex IV, with points 6 to 9 representing criteria to be adapted according to the disease concerned. Member States may however confine themselves to applying the criteria laid down in points 6 to 9 where the criteria in points 1 to 5 and 10 were already adopted when plans were submitted for the application of control measures for another disease.
3.Contingency plans drawn up in accordance with the criteria listed in Annex IV shall be submitted to the Commission:
no later than six months after this Directive is brought into effect as regards swine vesicular disease;
no later than six months after implementation of the specific measures for each of the other diseases listed in Annex I.
4.The Commission shall examine the contingency plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required in particular to ensure that they are compatible with those of the other Member States.
The Commission shall approve the plans, if necessary amended, in accordance with the procedure laid down in Article 25.
The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation and the specific nature of the disease in question.
By way of derogation from the conditions provided for in Articles 19 and 20 as regards the contingency measures to be adopted by the Member States and so as to take account of the natural, geographical constraints particular to the French Overseas Departments, the Azores and Madeira and their remoteness from the central part of the Community's territory, the Member State concerned shall be authorized to apply particular control measures specific to each of the diseases listed in Annex I to this Directive.
The Member State concerned shall, within the Standing Veterinary Committee, inform the Commission and the other Member States of the measures it has taken in this respect and in particular of the control measures implemented to ensure that animals from the territories in question or products from such animals are not dispatched to the other territories of the Community.
Following the information procedure referred to in the second paragraph, Article 20 shall apply mutatis mutandis.
Commission experts may, in collaboration with the competent authorities, and in so far as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do this, they may check a representative percentage of holdings to see whether the competent authorities are checking that these holdings are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out.
A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties.
The detailed rules for implementing this Article shall be determined in accordance with the procedure laid down in Article 25.
1.The conditions governing the Community's financial contribution to the measures connected with the application of this Directive are laid down in Decision 90/424/EEC.
F22.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
1.Annexes I, III and IV shall be amended, as and when required, by the Council acting by a qualified majority on a proposal from the Commission, in particular in order to take into account developments in research and in diagnostic procedures.
2.The Commission may, in accordance with the procedure laid down in Article 25, amend Annex II, in particular in order to take into account technological and scientific developments and diagnostic methods.
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up pursuant to Article 58 of Regulation (EC) No 178/2002 (3) .
2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC (4) shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its Rules of Procedure.]
Textual Amendments
F3 Substituted by Council Regulation (EC) No 806/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (qualified majority).
1.Where the procedure laid down in this Article is to be followed, the matter shall without delay be referred to the Standing Veterinary Committee by its chairman, either on his own initiative or at the request of a Member State.
[F4 [F52. 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.] ]
[F4 [F53.] ] (a)The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee.
(b)Where 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 a proposal to the Council on the measures to be taken. The Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within 15 days of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately unless the Council has voted against the measures by a simple majority.
Textual Amendments
1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1993. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2.Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
3.The setting of the deadline for transposition into national law at 1 October 1993 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 90/425/EEC.
This Directive is addressed to the Member States.