2000L0075 — EN — 01.07.2013 — 007.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:





Amended by:

A1 L 236 33 23.9.2003









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COUNCIL DIRECTIVE 2000/75/EC

of 20 November 2000

laying down specific provisions for the control and eradication of bluetongue







THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease ( 1 ), and in particular the second indent of Article 15 thereof, Having regard to the proposal from the Commission, Whereas: (1) In accordance with Article 15 of Directive 92/119/EEC, specific measures to control and eradicate bluetongue should be introduced. (2) The epidemiological characteristics of bluetongue are comparable to those of African horse sickness. (3) The Council has adopted Directive 92/35/EEC laying down control rules and measures to combat African horse sickness ( 2 ). (4) To combat bluetongue, therefore, the overall measures laid down by Directive 92/35/EEC to combat African horse sickness should be used as a model, making appropriate adjustments due to the characteristics of the rearing of species susceptible to bluetongue. (5) Rules should be laid down on the movement of susceptible species and their semen, ova and embryos from areas subject to restrictions arising from an outbreak of the disease. (6) Article 3 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field ( 3 ), applies in the event of an outbreak of bluetongue. (7) A procedure for close cooperation between the Member States and the Commission must be introduced, Whereas: HAS ADOPTED THIS DIRECTIVE:







Article 1

This Directive lays down control rules and measures to combat and eradicate bluetongue.

Article 2

For the purposes of this Directive, the following definitions shall apply:

(a) ‘holding’ : agricultural or other establishment where animals of species susceptible to bluetongue are permanently or temporarily reared or kept;

(b) ‘susceptible species’ : all ruminants;

(c) ‘animal(s)’ : animal(s) belonging to a susceptible species, excluding wild animals with regard to which specific provisions may adopted in accordance with the procedure laid down in Article 20(2);

(d) ‘owner’ or ‘holder’ : the natural or legal person(s) owning the animals or responsible for their upkeep, whether in return for payment or not;

(e) ‘vector’ : an insect of the species Culicoides imicola or any other insect of the genus Culicoides capable of transmitting bluetongue, to be identified according to the procedure laid down in Article 20(2), on the advice of the Scientific Veterinary Committee;

(f) ‘suspicion’ : appearance of any clinical sign suggesting bluetongue in a susceptible species, together with a set of epidemiological data enabling such a possibility to be reasonably envisaged;

(g) ‘confirmation’ : the declaration by the competent authority, based on laboratory results, that the bluetongue virus is circulating in a specific area; 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;

(h) ‘competent authority’ : the central authority of the Member State competent to conduct veterinary checks, or any other veterinary authority to which it has delegated this competence;

(i) ‘official veterinarian’ : the veterinarian designated by the competent authority;

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(j) ‘live attenuated vaccines’ : vaccines which are produced by adapting bluetongue virus field isolates through serial passages in tissue culture or in embryonated hens’ eggs.

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Article 3

Member States shall ensure the immediate, compulsory notification to the competent authority if circulation of the bluetongue virus is suspected or confirmed.

Article 4

1. If a holding located in a region not subject to restrictions within the meaning of this Directive has one or more animals suspected of being infected with bluetongue, Member States shall ensure that the official veterinarian immediately implements official methods of investigation to confirm or rule out the presence of the disease.

2. As soon as notification is given of suspected presence, the official veterinarian:

(a) shall place the suspect holding or holdings under official surveillance;

(b) shall: (i) compile an inventory of the animals, indicating for each species the number of animals already dead, infected or likely to be infected, and update this inventory to take account of the animals which are born or die during the period in which the disease is suspected; the data from this inventory must be produced on request and may be checked during each visit; (ii) compile an inventory of places likely to facilitate the survival of or to harbour the vector and, in particular, of the sites conducive to its reproduction; (iii) carry out an epidemiological survey in accordance with Article 7;

(c) shall make regular visits to the holding or holdings and, on each occasion, conduct a detailed clinical examination or an autopsy of animals that are dead or suspected of infection and confirm the disease, if necessary by means of laboratory tests;

(d) shall ensure that: (i) any movement of animals from or to the holding or holdings is prohibited; (ii) the animals are confined at times when the vectors are active, where he considers that the means required for implementing this measures are available; (iii) the animals, the buildings used to house them and their surroundings (in particular habitats in which the Culicoides populations thrive) are regularly treated with authorised insecticides. To prevent infestations by the vectors as far as possible, the rate of treatment shall be fixed by the competent authority, taking account of the persistence of the insecticide used and the climatic conditions; (iv) the carcases of the dead animals at the holding are destroyed, eliminated, incinerated or buried in accordance with Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedingstuffs of animal or fish origin and amending Directive 90/425/EEC ( 4 ).

3. Pending implementation of the measures referred to in paragraph 2, the owner or the holder of any animal suspected of being infected with the disease shall take all precautionary measures to comply with the provisions of paragraph 2(d)(i) and (ii).

4. The competent authority may apply the measures referred to in paragraph 2 to other holdings in the event that their location, geographical situation or contacts with the holding where the disease is suspected provides grounds for suspecting the possibility of contamination.

5. In addition to the provisions of paragraph 2, specific provisions may be laid down, according to the procedure provided for in Article 20(2), for nature reserves in which animals live freely.

6. The measures referred to in this Article shall not be lifted by the official veterinarian until the suspected presence of bluetongue has been ruled out by the competent authority.

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Article 5

1. The competent authority of a Member State may decide to allow the use of vaccines against bluetongue provided that:

(a) such decision is based on the result of a specific risk assessment carried out by the competent authority;

(b) the Commission is informed before such vaccination is carried out.

2. Whenever live attenuated vaccines are used, Member States shall ensure that the competent authority demarcates:

(a) a protection zone, consisting of at least the vaccination area;

(b) a surveillance zone, consisting of a part of the Union territory with a depth of at least 50 kilometres extending beyond the limits of the protection zone.

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Article 6

1. When the presence of bluetongue is officially confirmed, the official veterinarian shall:

(a) proceed, informing the Commission thereof, with the slaughter deemed necessary to prevent extension of the epidemic;

(b) order the destruction, elimination, incineration or burial of the carcases of those animals, in accordance with Directive 90/667/EEC;

(c) extend the measures provided for in Article 4 to holdings located within a radius of 20 kilometres (including the protection zone defined in Article 8) around the infected holding or holdings;

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(d) implement the measures adopted in accordance with the procedure laid down in Article 20(2), in particular with regard to the introduction of any vaccination programme or other alternative measures;

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(e) carry out an epidemiological survey in accordance with Article 7.

However, by way of derogation from subparagraph (c), provisions applicable to movements of animals in the zone may be adopted in accordance with the procedure laid down in Article 20(2).

2. The zone referred to in paragraph 1(c) may be extended or reduced on the basis of epidemiological, geographical, ecological or meteorological circumstances by the competent authority which shall notify the Commission thereof.

3. Where the zone referred to in paragraph 1(c) is located on the territory of more than one Member State, the competent authorities of the Member States concerned shall cooperate in order to demarcate the zone. If necessary, the zone shall be demarcated according to the procedure laid down in Article 20(2).

Article 7

1. The epidemiological survey shall concern:

(a) the duration of the period for which bluetongue may have been present at the holding;

(b) the possible origin of bluetongue at the holding and the identification of other holdings which have animals that may have been infected or contaminated from the same source;

(c) the presence and distribution of vectors of the disease;

(d) movements of animals from or to the holdings in question or any departure of animal carcases from those holdings.

2. A crisis unit shall be established to carry out the overall coordination of all the measures necessary for ensuring the eradication of bluetongue as soon as possible and to conduct the epidemiological survey.

General rules concerning the national crisis units and the Community crisis unit shall be laid down according to the procedure provided for in Article 20(2).

Article 8

1. Member States shall ensure that, in addition to the measures referred to in Article 6, the competent authority demarcates a protection zone and a surveillance zone. Demarcation of the zones must take account of geographical, administrative, ecological and epizootiological factors connected with bluetongue and of the control arrangements.

2.

(a) The protection zone shall consist of a part of the Community territory having a radius of at least 100 kilometres around the infected holding.

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(b) The surveillance zone shall consist of a part of the Union territory with a depth of at least 50 kilometres extending beyond the limits of the protection zone and in which no vaccination against bluetongue with live attenuated vaccines has been carried out during the previous 12 months.

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(c) Where the zones are located on the territory of more than one Member State, the competent authorities of the Member States concerned shall cooperate for the purpose of demarcating the zones referred to in subparagraphs (a) and (b).

(d) However, the protection and surveillance zones shall if necessary be demarcated according to the procedure laid down in Article 20(2).

3. On receipt of a duly substantiated request from a Member State, a decision may be taken, in accordance with the procedure laid down in Article 20(2), to change the demarcation of the zones defined in paragraph 2, in the light of:

(a) their geographical location and ecological factors;

(b) meteorological conditions;

(c) the presence and distribution of the vector;

(d) the results of epizootiological studies carried out pursuant to Article 7;

(e) the results of laboratory tests;

(f) the application of countermeasures, in particular disinsectisation.

Article 9

1. Member States shall ensure that the following measures are applied in the protection zone:

(a) the identification of all holdings with animals inside the zone;

(b) the implementation by the competent authority of an epidemiosurveillance programme based on the monitoring of sentinel groups of bovine animals (or, in their absence, of other species of ruminant) and vector populations; this programme may be laid down according to the procedure provided for in Article 20(2);

(c) a ban on animals leaving the zone. However, under the procedure laid down in Article 20(2), exemptions from the exit ban may be decided on in particular for animals situated in part of the zone where there is a proven absence of viral circulation or of vectors.

2. In addition to the measures laid down in paragraph 1, the vaccination of animals against bluetongue and their identification in the protection zone may be decided on according to the procedure laid down in Article 20, or on the initiative of the Member State informing the Commission.

Article 10

Member States shall ensure that:

1. the measures provided for in Article 9(1) apply in the surveillance zone;

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2. any vaccination against bluetongue using live attenuated vaccines is prohibited in the surveillance zone.

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Article 11

The measures taken pursuant to Articles 6, 8, 9 and 10 shall be amended or repealed in accordance with the procedure laid down in Article 20(2).

Article 12

By way of derogation from Articles 9 and 10, the provisions applicable to movements of animals in and from the protection and surveillance zones shall be determined in accordance with the procedure laid down in Article 20(2).

When the decision referred to in the first paragraph is adopted, the rules applicable to trade shall be determined in accordance with the same procedure.

Article 13

If, in a given region, the bluetongue epidemic is of an exceptionally serious nature, any additional measures to be taken by the Member States concerned shall be adopted in accordance with the procedure laid down in Article 20(2).

Article 14

Member States shall ensure that the competent authority takes all the necessary measures so that all persons in the protection and surveillance zones are fully informed of the restrictions in force and make any arrangements required for the proper implementation of the measures in question.

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Article 15

1. Member States shall designate a national laboratory responsible for carrying out the laboratory tests provided for by this Directive, and shall make the details of that laboratory, and any subsequent changes, available to the other Member States and to the public.

Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 20(2).

2. The tasks of the national laboratories designated in accordance with paragraph 1 are listed in Annex I.

3. The national laboratories designated in accordance with paragraph 1 of this Article shall liaise with the Community reference laboratory referred to in Article 16.

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Article 16

The Community reference laboratory for bluetongue is indicated in Annex II. Without prejudice to the provisions laid down in Decision 90/424/EEC, in particular Article 28 thereof, the tasks of this laboratory are set out in Annex II(B).

Article 17

Experts from the Commission may, where necessary in order to ensure the uniform application of this Directive and in collaboration with the competent authorities, carry out on-the-spot checks. For this purpose they may inspect a representative percentage of holdings in order to verify whether the competent authorities monitor compliance with the provisions of this Directive. The Commission shall notify the Member States of the results of the checks carried out.

The Member State on whose territory a check is carried out shall provide the experts with all the necessary assistance in the performance of their task.

The general implementing rules for this article shall be laid down in accordance with the procedure provided for in Article 20(2).

Article 18

1. Each Member State shall draw up a contingency plan indicating the means by which it applies the measures laid down in this Directive.

This plan must provide for access to plant, equipment, personnel and any other appropriate facility necessary for the swift and effective eradication of the disease.

2. The criteria to be applied for drawing up the plans referred to in paragraph 1 are set out in Annex III.

Plans drawn up pursuant to these criteria shall be submitted to the Commission no later than three months after the entry into force of this Directive.

The Commission shall examine the plans, in order to determine whether they enable the desired objective to be attained, and shall suggest to the Member State concerned any modification required, inter alia, in order to guarantee that they are compatible with those of the other Member States.

The Commission shall approve the plans, if necessary with modifications, in accordance with the procedure laid down in Article 20(2).

The plans may subsequently be modified or supplemented, in accordance with the same procedure, to take account of developments in the situation.

Article 19

This Directive may if necessary be amended by the Council, acting by a qualified majority on a proposal from the Commission.

The Annexes shall be amended in accordance with the procedure laid down in Article 20(2).

Any detailed rules necessary for the implementation of this Directive shall be adopted in accordance with the procedure laid down in Article 20(2).

Article 20

1. The Commission shall be assisted by the Standing Veterinary Committee.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC ( 5 ) shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

3. The Committee shall adopt its Rules of Procedure.

Article 21

Acting in accordance with the procedure laid down in Article 20(2), the Commission may adopt, for a period of two years, the transitional measures necessary for facilitating the changeover to the new arrangements provided for by this Directive.

Article 22

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2002. 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 reference shall be laid down by the Member States.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 23

This Directive is addressed to the Member States.









ANNEX I

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B. TASKS OF THE NATIONAL LABORATORIES FOR BLUETONGUE

The national laboratories for bluetongue are responsible for the coordination of the standards and diagnostic methods laid down by each diagnostic laboratory in the Member State, the use of reagents and the testing of vaccines. To this end:

(a) they may supply diagnostic reagents to diagnostic laboratories which request them;

(b) they check the quality of all the diagnostic reagents used in the Member State;

(c) they organise comparative tests at regular intervals;

(d) they preserve isolates of the bluetongue virus taken from confirmed cases in the Member State;

(e) they ensure confirmation of positive results obtained in regional diagnostic laboratories.









ANNEX II

A. LABORATORIO COMUNITARIO DE REFERENCIA DE LA FIEBRE CATARRAL OVINAEF-REFERENCELABORATORIUM FOR BLUETONGUEGEMEINSCHAFTLICHES REFERENZLABORATORIUM FÜR DIE BLAUZUNGENKRANKHEITΚΟΙΝΟΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΑΦΟΡΑΣ ΓΙΑ ΤΟΝ ΚΑΤΑΡΡΟΪΚΟ ΠΥΡΕΤΟ ΤΟΥ ΠΡΟΒΑΤΟΥCOMMUNITY REFERENCE LABORATORY FOR BLUETONGUELABORATOIRE COMMUNAUTAIRE DE RÉFÉRENCE POUR LA FIÈVRE CATARRHALE DU MOUTON ►M6 REFERENTNI LABORATORIJ ZAJEDNICE ZA BOLEST PLAVOG JEZIKA ◄ LABORATORIO COMUNITARIO DI RIFERIMENTO PER LA FEBBRE CATARRALE DEGLI OVINICOMMUNAUTAIR REFERENTIELABORATORIUM VOOR BLUETONGUELABORATÓRIO COMUNITÁRIO DE REFERÊNCIA EM RELAÇÃO À FEBRE CATARRAL OVINALAMPAAN BLUETONGUE-TAUTIA VARTEN NIMETTY YHTEISÖN VERTAILULABORATORIOGEMENSKAPENS REFERENSLABORATORIUM FÖR BLUETONGUE

AFRC Institute for Animal Health

Pirbright Laboratory

Ash Road

Pirbright

Woking

Surrey GU24 ONF

United Kingdom

Tel. (44-1483) 23 24 41

Fax (44-1483) 23 24 48

E-mail: philip-mellor@bbsrc.ac.uk

B. TASKS OF THE COMMUNITY REFERENCE LABORATORY FOR BLUETONGUE

The Community reference laboratory has the following tasks:

1. coordinating, in consultation with the Commission, diagnostic methods for bluetongue in the Member States, in particular by: (a) specifying, holding and supplying strains of the bluetongue virus for the purpose of serological tests and the preparation of antiserum; (b) the provision of reference sera and other reference reagents to the national reference laboratories for the purpose of standardising the tests and the reagents used in each Member State; (c) the establishment and conservation of a collection of strains and isolates of the bluetongue virus; (d) the regular organisation of Community comparative testing of diagnostic procedures; (e) the collection and collation of data and information concerning the diagnostic methods used and the results of the tests carried out in the Community; (f) the classification of isolates of the bluetongue virus, using the most advanced methods, in order to provide a better understanding of the epizootiology of bluetongue; (g) monitoring developments worldwide in the area of surveillance, epizootiology and prevention of bluetongue;

2. actively assisting in the identification of centres of bluetongue infection in the Member States by studying viral isolates sent to it for confirmation of diagnosis, classification and epizootiological studies;

3. facilitating the provision of training and refresher courses for experts in laboratory diagnostics with a view to harmonising diagnostic techniques throughout the Community;

4. mutual and reciprocal information exchange with the World Bluetongue Laboratory designated by the International Office for Epizootics (OIE), in particular concerning global developments with regard to bluetongue.









ANNEX III

MINIMUM CRITERIA APPLICABLE TO CONTINGENCY PLANS

The contingency plans must provide for at least the following:

1. the establishment at national level of a crisis unit to coordinate all emergency measures in the Member State concerned;

2. a list of local emergency centres adequately equipped for the purpose of coordinating control measures at local level;

3. detailed information on the personnel responsible for emergency measures, their qualifications and their responsibilities;

4. the possibility, for each local centre, of swiftly contacting persons or organisations directly or indirectly affected by an outbreak;

5. the availability of the equipment and materials necessary for the proper implementation of emergency measures;

6. precise instructions regarding the steps to be taken, including means of destroying carcases, when cases of infection or contamination are suspected and confirmed;

7. training programmes for updating and enhancing knowledge of procedures on the ground and administrative procedures;

8. for the diagnostic laboratories, an autopsy function, the capability required for conducting serological and histological tests, etc., and the updating of rapid diagnostic techniques (provisions on the swift transportation of samples should be laid down for this purpose);

9. information concerning the quantity of vaccines against bluetongue deemed necessary in case emergency vaccination needs to be reintroduced;

10. regulatory provisions for implementing the contingency plans.