1964L0432 — EN — 13.11.2007 — 012.001

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

►B COUNCIL DIRECTIVE of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (64/432/EEC) (OJ P 121, 29.7.1964, p.1977)

Amended by:





Amended by:





Corrected by:









▼B

COUNCIL DIRECTIVE

of 26 June 1964

on animal health problems affecting intra-Community trade in bovine animals and swine

(64/432/EEC)







THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European Parliament ( 1 ); Having regard to the Opinion of the Economic and Social Committee ( 2 ); Whereas Council Regulation No 20 on the progressive establishment of a common organisation of the market in pigmeat ( 3 ) is already in force and a similar regulation is to be adopted for beef and veal and whereas these regulations also concern trade in live animals; Whereas Regulation No 20 substitutes for the numerous traditional means of protection at the frontier a single system designed in particular to facilitate intra-Community trade; whereas the regulation to be adopted for beef and veal is also designed to eliminate obstacles to such trade; Whereas, so long as intra-Community trade in bovine animals and swine is hindered by differences between the health requirements of Member States, the implementation of the above-mentioned regulations will not have the desired effect; Whereas, to eliminate those differences, measures must be taken within the framework of the common agricultural policy and in line with regulations already adopted or in preparation on the progressive establishment of a common organisation of markets; whereas the animal health provisions of Member States must therefore be approximated; Whereas the right of Member States under Article 36 of the Treaty to continue to apply prohibitions or restrictions on imports, exports or goods in transit justified on grounds of the protection of health and life of humans and animals nevertheless does not exempt them from the obligation to approximate the provisions on which those prohibitions and restrictions are based, in so far as the differences between those provisions hinder the implementation and functioning of the common agricultural policy; Whereas, in the context of such approximation, the exporting country must be required to ensure that bovine animals and swine for breeding, production or slaughter intended for intra-Community trade, the places from which those animals come and are shipped and the means of transport used satisfy certain animal health requirements so as to ensure that the animals are not a source of contagious or infectious disease; Whereas, so that Member States may be sure that these requirements are satisfied, provision must be made for the issue by an official veterinarian of a health certificate which will accompany the animals to their destination; Whereas Member States must have the right to prohibit the introduction into their territory of bovine animals and swine if they are found to be suffering or are suspected of suffering from a contagious or infectious disease, if they may spread such disease without actually suffering from it or if they do not comply with Community animal health provisions; Whereas there is no reason to allow Member States to prohibit the introduction of bovine animals and swine into their territory for reasons other than those of animal health and whereas, therefore, the consignor should at his own request or upon request of his representative be allowed to return the animals to the country of export unless there are reasons to the contrary; Whereas, in case of prohibition or restriction, the reasons therefor should be made known to the consignor of the animals or his representative and to the competent central authority of the country of export so that they be aware of the reasons why such measures were imposed; Whereas in the event of dispute between himself and the authority of the Member State of destination as to the justification for prohibition or restriction, the consignor should be enabled to obtain the opinion of a veterinary expert whom he may select from a panel drawn up by the Commission; Whereas in some cases and for certain categories of animals it appears that the general provisions of this Directive may be relaxed without involving any health risk, by allowing consignee Member States to grant general or special derogations; Whereas, in certain fields presenting special problems, the provisions in Member States cannot be approximated until a more thorough study has been made; Whereas a simplified amendement procedure may be provided for Annexes B to D since the rules contained in those Annexes are of a technical nature and liable to change; whereas the Commission should therefore be entrusted with making such amendments after consulting the Member States; HAS ADOPTED THIS DIRECTIVE:

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Article 1

This Directive shall apply to intra-Community trade in bovine animals and swine with the exception of feral pigs as defined in Article 2 (e) of Directive 80/217/EEC ( 4 ) without prejudice to the provisions laid down in Directives 80/215/EEC ( 5 ), 85/511/EEC, 88/407/EEC ( 6 ), 89/608/EEC ( 7 ), 90/425/EEC, 90/429/EEC ( 8 ), 90/667/EEC ( 9 ), 91/496/EEC, 91/628/EEC ( 10 ), 92/102/EEC ( 11 ), 92/119/EEC and Decision 90/424/EEC ( 12 ).

Article 2

1. The definitions given in Article 2 of Directive 90/425/EEC and Article 2 of Directive 91/628/EEC shall apply.

2. In addition the following definitions apply for the purposes of this Directive:

(a) herd means an animal or group of animals kept on a holding (within the meaning of Article 2 (b) of Directive 92/102/EEC) as an epidemiological unit; if more than one herd is kept on a holding, each of these herds shall form a distinct unit and shall have the same health status;

(b) animal for slaughter means a bovine animal (including the species Bison bison and Bubalus bubalus) or swine intended to be taken to a slaughterhouse or assembly centre from which it may only move to slaughter;

(c) animals for breeding or production means bovine animals (including the species Bison bison and Bubalus bubalus) and swine other than those referred to in (b), including those intended for breeding, milk or meat production, or draft purposes, shows or exhibition with the exception of animals taking part in cultural and sporting events;

(d) officially tuberculosis-free bovine herd means a bovine herd which satisfies the conditions laid down in ► Annex A.I, paragraphs 1 and 2 ◄ ;

(e) officially tuberculosis-free Member State or region of a Member State means a Member State or part of a Member State which satisfies the conditions laid down in ► Annex A.I, paragraphs 4 and 5 ◄ ;

(f) officially brucellosis-free bovine herd means a bovine herd which satisfies the conditions laid down in ► Annex A.II, paragraphs 1 and 2 ◄ ;

(g) officially brucellosis-free region means a region of a Member State which satisfies the conditions laid down in Annex A.II, paragraphs 7, 8 and 9;

(h) officially brucellosis-free Member State means a Member State which satisfies the conditions laid down in ► Annex A.II, paragraphs 7, 8 and 9 ◄ ;

(i) brucellosis-free bovine herd means a bovine herd which satisfies the conditions laid down in ► Annex A.II, paragraphs 4 and 5 ◄ ;

(j) officially enzootic-bovine-leukosis-free herd means a herd which satisfies the conditions laid down in Annex D, Chapter I, Sections A and B;

(k) officially enzootic-bovine-leukosis-free Member State or region means a region or Member State which meets the requirements laid down in ► Annex D, Chapter I, Sections E and F ◄ ;

(l) official veterinarian means the veterinarian appointed by the competent authority of the Member State;

(m) approved veterinarian means any veterinarian approved by the competent authority in accordance with the provisions of Article 14 (3) (B);

(n) compulsorily notifiable diseases means the diseases listed in Annex E (I);

(o) assembly centre means holdings, collection centres and markets, at which bovine animals or swine originating from different holdings are grouped together to form consignments of animals intended for trade. These assembly centres must be approved for trading purposes and meet the requirements laid down in Article 11;

(p) region means that part of a Member State's territory which is at least 2 000 km2 in area and which is subject to inspection by the competent authorities and includes at least one of the following administrative regions:



— Belgium: province —provincie — Germany: Regierungsbezirk — Denmark: amt or island — France: département — Italy: provincia — Luxemburg — — Netherlands: rrv-kring — United Kingdom: England, Wales and Northern Ireland: county Scotland: district or island area — Ireland: county — Greece: νομός — Spain: provincia — Portugal: continente: distrito, and other parts of Portugal's territory: região autónoma — Austria: Bezirk — Sweden: län — Finland: lääni/län; ▼A4 — Czech Republic: kraj — Estonia: maakond — Cyprus: επαρχία (district) — Latvia: rajons — Lithuania: apskritis — Hungary: megye — Malta: — — Poland: powiat — Slovenia: območje — Slovakia: kraj; ▼M53 — Bulgaria: област — Romania: județ; ▼M42

(q) dealer means any natural or legal person who buys and sells animals commercially either directly or indirectly, who has a regular turnover of these animals and who within a maximum of 30 days of purchasing animals resells them or relocates them from the first premises to other premises not within his ownership and meets the conditions laid down in Article 13.

Article 3

1. Each Member State shall ensure that only animals that fulfil the relevant conditions laid down in this Directive are sent from its territory to that of another Member State.

2. Bovine animals and swine covered by this Directive must:

(a) be subjected: — to an identity check, and — to a clinical inspection within 24 hours of departure by an official veterinarian and show no clinical sign of disease;

(b) not have been obtained from a holding or an area which for health reasons is subject to prohibition or restriction affecting the species involved in accordance with Community and/or national legislation;

(c) be identified as provided for in Directive 92/102/EEC;

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(d) be identified in accordance with the provisions of Directive 92/102/EEC, in the case of swine and in accordance with the provisions of Regulation (EC) No 1760/2000 in the case of bovine animals;

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(e) comply with the provisions of Articles 4 and 5.

Article 4

1. Bovine animals and swine covered by this Directive must at no time between leaving the holding of origin and arriving at destination come into contact with cloven-hoofed animals other than animals that have the same health status.

2. Bovine animals and swine covered by this Directive must be transported in means of transport meeting the requirements of Directive 91/628/EEC and in addition the requirements of Article 12.

3. Rules for the approval of sites where cleansing and disinfection may be carried out shall be determined in accordance with the procedure set out in Article 17.

Article 5

1. Bovine animals and swine covered by this Directive must be accompanied during transportation to destination by a health ► certificate conforming to either model 1 or 2 set out in Annex F as appropriate ◄ . The certificate shall consist of a single sheet or, where more than one page is required, shall be in such a form that any two or more pages are part of an integrated whole and indivisible and shall contain a serial number. It shall be drawn up on the day of the health inspection, in one of the official languages of the country of destination at least. The certificate shall be valid for 10 days from the date of the health examination.

2. The health inspection for the issuing of the health certificate (including additional guarantees) for a consignment of animals may be carried out in the holding of origin or of an assembly centre. For this purpose the competent authority shall ensure that any health certificate is drawn up by the official veterinarian after inspections, visits and controls as provided by this Directive.

However as regards:

(a) animals coming from approved assembly centres, such certification shall be: — on the basis of an official document containing the necessary information completed by the official veterinarian for the holding of origin, or — in the form of the ► certificate according to either model 1 or 2 in Annex F as appropriate ◄ with Sections A and B duly completed and certified by the official veterinarian for the holding of origin;

(b) animals coming from an approved holding which is participating in the surveillance network provided for in Article 14, such certification shall be: — on the basis of an official document containing the necessary information completed by the approved veterinarian for the holding of origin, or — in the form of the ► certificate according to either model 1 or 2 in Annex F as appropriate ◄ with Sections A and B duly completed and certified by the approved veterinarian for the holding of origin.

For this purpose, the official veterinarian will ensure where appropriate that the additional guarantees provided for in Community legislation are fulfilled.

3. The official veterinarian for the assembly centre shall carry out all necessary checks on animals arriving there.

4. The official veterinarian completing ► Section C of the certificate according to either model 1 or 2 in Annex F as appropriate ◄ , shall ensure that the movement is registered on the Animo system on the day the certificate is issued.

5. The animals covered by this Directive may transit through an assembly centre which is located in one other Member State before being consigned to the Member State of destination. In this case, the ► certificate according to either model 1 or 2 in Annex F as appropriate ◄ ► (including Section C) ◄ must be completed by the official veterinarian responsible in the Member State where the animals originate. The official veterinarian responsible for the assembly centre of transit shall provide certification to the Member State of destination by completing a second ► certificate according to either model 1 or 2 in Annex F as appropriate ◄ , endorsing it with the serial number of the original and attaching it to the original certificate or to an officially endorsed copy thereof. In this case the combined validity of the certificates shall not exceed that provided for in paragraph 1.

Article 6

1. Animals for breeding or production must, in addition to the requirements of Articles 3, 4 and 5:

— have remained in a single holding of origin for a period of 30 days prior to loading, or since birth in the holding of origin where the animals are less than 30 days old. The official veterinarian must, on the basis of the official identification provided for in Article 3 (2) (c) and official records, be satisfied that the animals have complied with this condition and furthermore that the animals have originated in the Community or have been imported from a third country in compliance with Community animal health legislation. — However, in the case of animals transiting through an approved assembly centre in the Member State of origin, the period during which the assembly of these animals takes place outside the holding of origin shall not exceed six days,

— with regard to animals imported from a third country into a Member State which is not that of ultimate destination, be transported to the Member State of destination as quickly as practicable under cover of a certificate issued under Article 7 of Directive 91/496/EEC,

— with regard to animals imported from a third country upon arrival at destination and before any further movements satisfy the requirements of this Directive, and in particular the residency requirement in the first indent, and may not be brought into the herd until the veterinarian responsible for that holding has ascertained that the animals in question are not likely to jeopardize the health status of the holding. — If an animal from a third country is introduced into a holding no animal from the holding may be traded for 30 days following introduction unless the imported animal is isolated from all other animals on the holding.

2. Bovine animals for breeding and production must, in addition to the requirements in Articles 3, 4 and 5:

(a) come frome an officially tuberculosis-free bovine herd, and in the case of animals more than six weeks old, have reacted negatively to an intradermal tuberculin test carried out during the 30 days prior to leaving the herd of origin, in accordance with the provisions of Annex B point 32 (d). This intradermal tuberculin test is not required if the animals originate in a Member State or part of a Member State recognized as officially tuberculosis free or in a Member State or part of a Member State with an approved surveillance network;

(b) in the case of uncastrated animals which come from an officially brucellosis-free bovine herd and more than 12 months old, have shown a brucella count lower that 30 international units (IU) of agglutination per millilitre when given a serum agglutination test (or any test approved by Standing Veterinary Committee (SVC) procedure following the adoption of the relevant protocols) carried out during the 30 days prior the leaving the herd of origin and complying with the provisions of Annex C Section A. This serum agglutination test (or any test approved by SVC procedure following the adoption of the relevant protocols) is not required if the animals originate in a Member State or part of a Member State recognized as officially brucellosis free or in a Member State or part of a Member State with an approved surveillance network;

(c) come from an officially enzootic-bovine-leukosis-free herd and, if more than 12 months old, have reacted negatively to an individual test carried out during the 30 days prior to leaving the herd of origin and complying with the provisions of Annex D. The test is not required if the animals originate in a Member State or part of a Member State recognized as officially enzootic-bovine-leukosis free or in a Member State or part of a Member State with an approved surveillance network;

(d) at no time between leaving the holding of origin and arriving at destination come into contact with bovine animals which meet only the requirements in paragraph 3;

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(e) until 31 December 2000, not be subject to the test requirements laid down in (a) or (b) in the case of bovine animals aged less than 30 months intended for meat production which: — come from a beef holding officially tuberculosis-free and officially brucellosis-free, — are accompanied by an animal health certificate with paragraph 7 in Section A of Annex F Model 1 duly completed, — remain under supervision until their slaughter, — have not come into contact during transport with bovine animals not coming from herds officially free from those diseases, and provided that: — these arrangements are restricted to trade between Member States or regions of Member States with the same health status with regard to tuberculosis or brucellosis, — the Member State of destination takes all necessary measures to avoid any contamination of indigenous herds, — the Member States put in place a proper system of random sampling, inspections and controls designed to ensure the efficient implementation of these rules, — the Commission monitors the proper operation of this Directive so as to ensure that Member States comply fully with the rules;

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3. Bovine animals for slaughter must, in addition to the requirements in Articles 3, 4 and 5, come from herds that are officially tuberculosis free, officially enzootic-bovine-leukosis free and in the case of uncastrated bovines, from herds that are officially brucellosis free.

However, until ►M46 31 December 2000 ◄ , the destination countries may grant to Spain general or limited licences to introduce into their territories animals for slaughter from herds which are not officially free of tuberculosis, enzootic bovine leukosis and brucellosis, provided such animals:

— have in the 30 days prior to embarkation undergone the appropriate tests laid down in Annexes B, C and D, with negative results,

— are taken on arrival in the country of destination directly to a slaughterhouse and are slaughtered there as soon as possible but at least within 72 hours of arrival, in accordance with animal health requirements.

Article 7

Animals for slaughter which have been taken on arrival in the country of destination:

— to a slaughterhouse, must be slaughtered there as soon as possible but at least within 72 hours of arrival, in accordance with animal health requirements, or

— to an approved assembly centre, must be removed after the market directly to a slaughterhouse to be slaughtered as soon as possible but at the latest within three working days of arrival at the assembly centre, in accordance with animal health requirements. At no time, between their arrival at the assembly centre and their arrival at the slaughterhouse, may they come into contact with cloven-hoofed animals other than animals that fulfil the conditions laid down in this Directive.

Article 8

Member States shall ensure that the suspected presence of any of the diseases referred to in Annex E (I) is compulsorily and immediately notifiable to the competent authority.

Each Member State shall forward to the Commission by 31 May each year, and for the first time in 1999, details of the occurence of diseases listed in Annex E (I) and of any other diseases covered by the additional guarantees provided for by Community legislation in its territory in the previous calendar year including details of the monitoring and eradication programmes in operation. This information shall be based on uniform criteria to be established by the procedure provided for in Article 17. The Commission shall present this information to the Member States in the framework of the SVC and in particular may utilize it in relation to the decisions referred to in Annexes A and D.

Article 9

1. A Member State which has a compulsory national control programme for one of the contagious diseases listed in Annex E (II) for all or part of its territory may submit the said programme to the Commission, outlining in particular:

— the distribution of the disease in the Member State,

— the reasons for the programme, taking into consideration the importance of the disease and the programme's likely benefit in relation to its cost,

— the geographical area in which the programme will be implemented,

— the status categories to be applied to the animal establishments, the standards which must be attained in each category, and the test procedures to be used,

— the programme monitoring procedures, the results of which must be supplied at least annually to the Commission,

— the action to be taken if, for any reason, an establishment loses its status,

— the measures to be taken if the results of the tests carried out in accordance with the provisions of the programme are positive.

2. The Commission shall examine the programmes presented by the Member States. Programmes as referred to in paragraph 1 may be approved in compliance with the criteria laid down in paragraph 1 in accordance with the procedure provided for in Article 17. According to the same procedure, the additional guarantees, general or limited, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the programmes. Such guarantees must not exceed those which the Member State implements nationally.

3. Programmes submitted by Member States may be amended or supplemented in accordance with the procedure laid down in Article 17. Amendments or additions to programmes which have already been approved or to guarantees which have been defined in accordance with paragraph 2 may be approved under the same procedure.

Article 10

1. Where a Member State considers that its territory or part of its territory is free from one of the diseases listed in Annex E (II), it shall present to the Commission appropriate supporting documentation, setting out in particular:

— the nature of the disease and the history of its occurrence in its territory,

— the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation and on the fact that the disease must by law be notified to the competent authorities,

— the period over which the surveillance was carried out,

— where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition,

— the arrangements for verifying the absence of the disease.

2. The Commission shall examine documentation submitted by Member States. The additional guarantees, general or specific, which may be required in intra-Community trade may be defined in accordance with the procedure laid down in Article 17. Such guarantees must not exceed those which the Member State implements nationally.

3. The Member State concerned shall notify the Commission of any change in the details specified in paragraph 1 which relate to the disease, in particular regarding any new outbreaks of the disease. The guarantees defined in accordance with paragraph 2 may, in the light of such notification, be amended or withdrawn in accordance with the procedure laid down in Article 17.

Article 11

1. Member States shall ensure that, in order to be approved by the competent authority, assembly centres meet the following conditions at least. They must:

(a) be under the control of an official veterinarian who shall ensure that, in particular, the provisions of Article 4 (1) and (2) are complied with;

(b) be located in an area which is not subject to prohibiiton or restrictions in accordance with relevant Community legislation and/or national legislation;

(c) be cleaned and disinfected before use, as required by the official veterinarian;

(d) they must have, taking into account the animal capacity of the assembly centre: — a facility dedicated exclusively for this purpose when used as an assembly centre, — appropriate facilities for loading, unloading and adequate housing of a suitable standard for the animals, for watering and feeding them, and for giving them any necessary treatment; these facilities must be easy to clean and disinfect, — appropriate inspection facilities, — appropriate isolation facilities, — appropriate equipment for cleaning and disinfecting rooms and trucks, — an appropriate storage area for fodder, litter and manure, — an appropriate system for collecting waste water, — the use of an office for the official veterinarian;

(e) admit only animals that are identified and come from herds that are officially free of tuberculosis, brucellosis and leukosis or slaughter animals meeting the conditions set out in the present Directive and in particular Article 6 (3). To this end, when animals are admitted the owner or person in charge of the centre shall ensure they are properly identified and accompanied by health documents or appropriate certificates for the species and categories involved;

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(ee) comply with the provisions of Directive 98/58/EC and Regulation (EC) No 1/2005 ( 13 ) applicable to them;

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(f) be regularly inspected in order to ascertain that the requirements for approval continue to be fulfilled.

2. The owner or person in charge of the assembly centre shall be required, on the basis either of the accompanying documents for the animals or of the identification numbers or marks of the animals, to record on a register or a data base and retain for a minimum period of three years the following information:

— the name of the owner, the origin, date of entry and exit, number and identification of the bovine animals or the registration number of the holding of origin or of the herd of origin of the pigs entering the centre and their proposed destination,

— the registration number of the transporter and the licence number of the lorry delivering or collecting animals from the centre.

3. The competent authority shall issue an approval number to each approved assembly centre. Such approval may be limited to a particular species or to animals for breeding and production or to animals for slaughter. The competent authority shall notify the Commission of the list of approved assembly centres and of any updates. The Commission shall present this information to Member States in the framework of the SVC.

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4. The competent authority may suspend or withdraw approval in the event of failure to comply with this Article or other appropriate provisions of this Directive, or of Regulation (EC) No 1/2005 or other Community veterinary legislation listed in Chapter I of Annex A to Directive 90/425/EEC ( 14 ). Approval may be restored when the competent authority is satisfied that the assembly centre is in full compliance with all the appropriate provisions referred to in this paragraph.

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5. The competent authority shall ensure that when operating assembly centres have sufficient approved veterinarians to carry out all duties.

6. Any detailed rules required for uniform application of this Article shall be adopted in accordance with the procedure provided for in Article 17.

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Article 12

1. Member States shall ensure that transporters meet the following additional conditions:

(a) for the carriage of animals they must use means of transport that are: (i) constructed in such a way that the animal faeces, litter or feed can not leak or fall out of the vehicle; and (ii) cleaned and disinfected immediately after every transport of animals or of any product which could affect animal health, and if necessary before any new loading of animals, using disinfectants officially authorised by the competent authority;

(b) they must either: (i) have appropriate cleaning and disinfection facilities approved by the competent authority, including facilities for storing litter and dung; or (ii) provide documentary evidence that these operations are performed by a third party approved by the competent authority.

2. The transporter must ensure that for each vehicle used for the transport of animals a register is kept containing at least the following information which shall be retained for a minimum period of three years:

(a) places, dates and times of pick-up, and the name or business name and address of the holding or assembly centre where the animals are picked up;

(b) places, dates and times of delivery, and the name or business name and address of the consignee(s);

(c) the species and number of animals carried;

(d) date and place of disinfection;

(e) details of accompanying documentation including the number;

(f) expected duration of each journey.

3. Transporters shall ensure that the consignment or animals do not at any time, between leaving the holdings or the assembly centre of origin and arriving at their destination, come into contact with animals of a lower health status.

4. Member States shall ensure that transporters observe the provisions of this Article relating to the appropriate documentation that must accompany the animals.

5. This Article shall not apply to persons transporting animals up to a maximum distance of 65 km counted from the place of departure to the place of destination.

6. In the event of failure to comply with this Article, the provisions concerning infringements and notifications of infringements provided for in Article 26 of Regulation (EC) No 1/2005 shall apply mutatis mutandis in relation to animal health.

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Article 13

1. Member States shall ensure that all dealers are registered, approved and issued with an approval number by the competent authority and that they comply with the following conditions at least:

(a) they must deal only in animals that are identified and come from herds that are officially free of tuberculosis, brucellosis and leukosis or slaughter animals meeting the conditions set out in this Directive and in particular Article 6 (3). To this end, the dealer shall ensure that the animals are properly identified and are accompanied by health documents as appropriate for the species involved. However, the competent authority may authorize the marketing of identified animals which do not fulfil the conditions laid down in the first paragraph, in so far as they are brought direct to a slaughterhouse in the Member State of origin without passing through their facilities, for slaughter as soon as possible in order to prevent the spreading of diseases. The necessary provisions should be taken to ensure that such animals, when they reach the abattoir, cannot come into contact with other animals and that they are slaughtered apart from other animals;

(b) the dealer shall be required, either on the basis of the document accompanying the animals, or on the basis of identification numbers or marks on the animals, to keep a record or data base and to store the following data for at least three years: — the name of the owner, origin, date of purchase, categories, number and identification of bovine animals or registration number of the holding of origin or of the herd of origin of pigs purchased, — the registration number of the transporter and/or the licence number of the lorry delivering and collecting animals, — the name and address of the purchaser and the destination of the animals, — copies of route plans and/or serial number of health certificates as applicable;

(c) when the dealer keeps animals on his premises he shall ensure that: — specific training is given to the staff in charge of the animals in applying the requirements of this Directive and in the care and welfare of the animals, — controls and tests if necessary on the animals are carried out regularly by the official veterinarian and that all necessary steps are taken to prevent the spread of disease.

2. Member States shall ensure that all premises used by a dealer in connection with his business are registered and issued with an approval number by the competent authority and that they comply with the following conditions at least:

(a) they must be under the control of an official veterinarian;

(b) they must be located in an area which is not subject to prohibition or restrictions in accordance with the relevant Community legislation or national legislation;

(c) they must have: — appropriate facilities of sufficient capacity and in particular inspection facilities and isolation facilities so that all animals can be isolated in the event of an outbreak of a contagious disease, — appropriate facilities for unloading and where necessary adequate housing of a suitable standard for the animals, for watering and feeding them, and for giving them any necessary treatment; these facilities must be easy to clean and disinfect, — an appropriate reception area for litter and manure, — an appropriate system for collecting waste water;

(d) be cleaned and disinfected before use, as required by the official veterinarian.

3. The competent authority may suspend or withdraw approval in the event of failure to comply with this Article or other appropriate provisions of this Directive or other directives in respect of health restrictions. Approval may be restored when the competent authority is satisfied that the dealer is in full compliance with all the appropriate provisions of this Directive.

4. The competent authority must carry out regular inspections in order to ascertain that the requirements of this Article are fulfilled.

Article 14

1. The competent authority in a Member State may introduce a system of surveillance networks.

The surveillance network system must comprise at least the following elements:

— the herds,

— the owner or any other natural or legal person responsible for the holding,

— the approved veterinarian or the official veterinarian responsible for the holding,

— the official veterinary service of the Member State,

— the official veterinary diagnostic laboratories or any other laboratory approved by the competent authority,

— a computer database.

Official veterinarians for the slaughtering establishments and approved assembly centres will be associated with the network system.

2. The main objectives of the surveillance network system are to make the official classification of holdings, to maintain such classification by regular inspection, to collect epidemiological data and to carry out disease monitoring so as to ensure compliance with all the provisions of this Directive and other directives in respect of health restrictions.

This surveillance network system shall be mandatory on all holdings in the territory of the Member State operating such a system. However, the competent authority may authorize the establishment of such a network on part of the territory made up of one or several adjacent regions as defined in Article 2 (2) (p). Where this derogation is accorded, animal movements to that part of the territory from other regions which are not part of the network system shall be subject to the provisions of this Directive.

The competent authority shall lay down the obligations and rights incumbent upon the approved veterinarians, the persons responsible for the holdings or their owners and any other participants in the system including the persons responsible for issuing health certificates.

3. The competent authority shall ensure that the obligations referred to in paragraph 2 at least include the following:

A. Every owner of or person responsible for a holding must: (i) secure, by contract or legal instrument, the services of a veterinarian approved by the competent authority; (ii) immediately call in the approved veterinarian for the holding when he suspects the occurrence of an infectious disease or of any notifiable disease; (iii) notify the approved veterinarian of all arrivals of animals on his holding; (iv) isolate the animals before introducing them into his holding to enable the approved veterinarian to check, where appropriate by means of the required tests, whether the holding's status may be maintained.

B. The approved veterinarians as provided for by Article 2 (2) (m) shall be under the control of the competent authority and must comply with the following requirements. They must: (i) meet the conditions for pursuing the veterinary profession; (ii) have no financial interest or family links with the owner of or person responsible for the holding; (iii) possess particular knowledge in the field of animal health as it applies to animals of the species concerned. This means that they must: — regularly update their knowledge, especially as regards the relevant health regulations, — meet the requirements laid down by the competent authority to ensure the proper functioning of the network, — provide the owner of or person responsible for the holding with information and assistance in order that all steps are taken to ensure that the holding's status is maintained, particularly on the basis of programmes agreed with the competent authority, — ensure compliance with the requirements concerning: — (i) the identification and health certification of the animals of the herd, the animals introduced and those traded; (ii) compulsory reporting of infectious animal diseases and any other risk factor for animal health or welfare, and for human health; (iii) establishing as far as possible the cause of death of animals and where they are to be consigned; (iv) the hygiene conditions of the herd and of the livestock production units. — If the proper functioning of the system so requires, each Member State may limit the veterinarians' responsibility to a specific number of holdings or to a specific geographical area. — The competent authority shall draw up lists of approved veterinarians and of the approved holdings participating in the network. If the competent authority finds that a participant in the network no longer fulfils the conditions set out above, it shall suspend or withdraw approval, without prejudice to any penalties that may be applied.

C. The computer database must contain at least the following information: (1) For each animal: — identification code, — date of birth, — sex, — breed or colour of coat, — identification code of the mother or, in the case of an animal imported from a third country, the identification number given following inspection under Directive 92/102/EEC and corresponding to the identification number of origin, — identification number of the holding where born, — identification numbers of all holdings where the animal has been kept and the dates of each change of holding, — date of death or slaughter. (2) For each holding: — an identification number consisting of not more than 12 figures (apart from the country code), — name and address of the holder. (3) The database must be able to supply the following particulars at any time: — the identification number of all animals of the bovine species present on a holding, or in the case of groups of animals of the porcine species, the registration number of the holding of origin or herd of origin and the number of the health certificate where applicable, — a list of all changes of holding for each animal of the bovine species starting from the holding of birth, or the holding of importation in the case of animals imported from third countries; and for groups of pigs the registration number of the last holding or last herd and for imported animals from third countries the holding of importation. These particulars will be held on the database until three consecutive years have elapsed since the death of the bovine animal or until three consecutive years have elapsed since the record was made in the case of records for pigs. However, only points 2, 3 and 4 shall be applicable to porcine animals. ▼M45 (4) In order to ensure the operation of the national computer databases concerning porcine animals, appropriate rules of application, including the information that the national databases must contain, shall be adopted in accordance with the procedure laid down in Article 17. ▼M42

4. All participants in the surveillance network other than those provided for in 3A and B shall be accountable to the competent authority. The competent authority in each Member State shall be responsible for setting up the network and shall carry out regular checks to ensure that it operates properly.

5. Member States which introduce a system of surveillance networks as outlined in paragraphs 1 to 4, operational for a period of at least 12 months, shall apply to the Commission to have it approved under the procedure provided for in Article 17.

For this purpose the Commission shall examine documentation submitted by Member States.

The Commission experts shall validate the systems by means of a system of audits. Where the result of the audit is favourable the Commission shall within 90 days of receipt of the request for approval make a report to the SVC together with appropriate proposals.

Where repeated offences are noted, the approval of the surveillance network system can be suspended according to the procedure laid down in Article 17, at the request of the Commission or of one or more Member States.

6. Member States which have implemented in all their territory a recognized surveillance network system as laid down in this Article shall be authorized not to apply the provision referred to in Article 3 (2) (a), second indent to animal movements referred to by this Directive within their own territory.

7. Not later than 31 December 1999, acting on the basis of a report from the Commission, accompanied by proposals on which it shall act by a qualified majority, the Council shall review the provisions of this Article in the light of experience with a view to amending and updating them and, if appropriate, extending them to all Member States.

8. The financing of the surveillance network system will be covered within the framework of the revision of Annex B to Directive 85/73/EEC ( 15 ) in accordance with the provisions laid down in Article 8 of Directive 96/43/EC.

Article 15

1. Member States shall take the appropriate specific measures to penalize any infringement of this Directive whether by a natural or a legal person.

2. If it is confirmed that the provisions of this Directive are not or have not been complied with the competent authority of the place in which such a finding is made shall take all appropriate measures to safeguard animal health and to prevent the spread of disease.

Depending on the circumstances, such action by the competent authority may consist of taking the measures required to:

(a) arrange for the journey to be completed or the animals returned to their place of departure by the most direct route, providing this course of action would not further jeopardize the health or welfare of the animals;

(b) arrange for the animals to be held in suitable accommodation with appropriate care in the event of interruption of the journey;

(c) arrange for the slaughter of the animals. The destination and use of such animals after slaughter shall be regulated: — in accordance with the provisions of Directive 64/433/EEC ( 16 ), or — in accordance with the provisions of Directive 90/667/EEC where the health status of the animals cannot be established or where they are liable to be a risk to animal health or public health. However, where the provisions of Directive 90/667/EEC should apply, a regularization period may be accorded to the owner or his agent before that final possibility is invoked. In that case, the provisions of paragraph 3 of this Article shall apply.

3. The competent authority of the Member State of destination shall immediately notify the competent authority of the Member State of origin on the establishment of any infringement of this Directive.

In accordance with the provisions established by Directive 89/608/EEC, Member States shall provide mutual assistance to one another in the application of this Directive in order to ensure, in particular, compliance with the provisions laid down in this Article.

4. This Article shall not affect national rules applicable to penal sanctions.

Article 16

1. Annexes A, D (Chapter I), E and F shall be amended by the Council, acting by a qualified majority on a Commission proposal, in particular with regard to their adaptation to technological and scientific developments.

Annexes B, C and D (Chapter II) shall be amended by the Commission in accordance with the procedures provided for in Article 17.

However,

(a) before 1 July 1997, the Commission shall submit to the Council a proposal for the amendment of Annexes A and D (Chapter I), for the purpose of updating them and if necessary it will apply the same procedure to Annex F. The Council shall decide on these proposals by a qualified majority before 1 January 1998;

(b) before 30 June 1998, the Commission, in accordance with the procedure laid down in Article 17 and on the basis of the opinion of the Scientific Veterinary Committee, shall update and if necessary amend Annexes B, C and D (Chapter II) to adapt them to scientific developments.

2. Not later than 31 December 1999, acting on the basis of a report from the Commission, accompanied by suitable proposals on which it shall act by a qualified majority, the Council shall review the provisions of this Directive in the light of experience with a view to amending and updating them so that they comply with the rules laid down for completion of the internal market.

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3. Where necessary to facilitate the changeover to the new arrangements provided for in this Directive, the Commission, acting in accordance with the procedure laid down in Article 17a, may adopt transitional measures applicable for a period of not more than two years.

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Article 17

1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC (hereinafter referred to as the ‘Committee’).

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

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Article 17a

1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC (hereinafter referred to as the ‘Committee’).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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.

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Article 18

Those Member States which have not introduced an approved surveillance network system shall ensure that a computer database complying with the provisions laid down in Article 14 is fully operational as follows:

(a) for bovine animals, from 31 December 1999;

(b) for a register of holdings of porcine animals, complying with the provisions laid down in Article 14(3)(c)(2) from 31 December 2000;

(c) for movements of porcine animals, complying with the provisions laid down in Article 14(3)(c)(3): — from their holding of birth, by 31 December 2001, — from all other holdings, by 31 December 2002.

There shall be an entry in the database for each separate movement of porcine animals. The entry shall comprise at least the following: the number of porcine animals being moved, the identification number of the holding or herd of departure, the identification number of the holding or herd of arrival and the departure and arrival dates.

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Article 19

The rules laid down in Directive 90/425/EEC shall apply in particular to checks at origin, to the organization of, and follow-up to, the checks to be carried out by the country of destination, and to the safeguard measures to be implemented.

Article 20

This Directive is addressed to the Member States.

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ANNEX A

I. Officially tuberculosis-free bovine herd

For the purposes of this section ‘bovine animals’ means all bovine animals with the exception of animals taking part in cultural or sporting events.

1. A bovine herd is officially tuberculosis-free if: (a) all the animals are free from clinical signs of tuberculosis; (b) all the bovine animals over six weeks old have reacted negatively to at least two official intradermal tuberculin tests carried out in accordance with Annex B, the first six months after the elimination of any infection from the herd and the second six months later or, where the herd has been assembled solely from animals that originate in officially tuberculosis-free herds, the first test shall be carried out at least 60 days after assembly and the second shall not be required; (c) following the completion of the first test referred to in (b), no bovine animal over six weeks old has been introduced into the herd unless it has reacted negatively to an intradermal tuberculin test performed and assessed according to Annex B and carried out either in the 30 days prior to, or the 30 days after the date of its introduction into the herd; in the latter case the animal(s) must be isolated physically from the other animals of the herd in a way to avoid any direct or indirect contact with the other animals until proven negative. However, the competent authority may not require this test to be carried out for movements of animals on its own territory if the animal is from an officially tuberculosis-free herd, except in a Member State where, on 1 January 1998 and until the status of officially tuberculosis-free region is obtained, the competent authority required such tests to be carried out for animals moving between herds participating in a network system as referred to in Article 14.

2. A bovine herd will retain officially tuberculosis-free status if: (a) the conditions detailed in 1(a) and (c) continue to apply; (b) all animals entering the holding come from herds of officially tuberculosis-free status; (c) all animals on the holding, with the exception of calves under six weeks old which were born in the holding, are subjected to routine tuberculin testing in accordance with Annex B at yearly intervals. However, the competent authority of a Member State may, for the Member State or part of the Member State where all the bovine herds are subject to an official programme to combat tuberculosis, alter the frequency of the routine tests as follows: — if the average — determined at 31 December of each year — of the annual percentages of bovine herds confirmed as infected with tuberculosis is not more than 1 % of all herds within the defined area during the two most recent annual supervisory periods, the interval between routine herd tests may be increased to two years and male animals for fattening within an isolated epidemiological unit may be exempted from tuberculin testing provided that they come from officially tuberculosis-free herds and that the competent authority guarantees that the males for fattening will not be used for breeding and will go direct for slaughter, — if the average — determined at 31 December of each year — of the annual percentages of bovine herds confirmed as infected with tuberculosis is not more than 0,2 % of all herds within the defined area during the two most recent biennial supervisory periods, the interval between routine tests may be increased to three years and/or the age at which animals have to undergo these tests may be increased to 24 months, — if the average — determined at 31 December of each year — of the annual percentages of bovine herds confirmed as infected with tuberculosis is not more than 0,1 % of all herds within the defined area during the two most recent supervisory triennial periods, the interval between routine tests may be increased to four years, or, providing the following conditions are met, the competent authority may dispense with tuberculin testing of the herds: — (1) before the introduction into the herd all the bovine animals are subjected to an intradermal tuberculin test with negative results; or (2) all bovine animals slaughtered are examined for lesions of tuberculosis and any such lesions are submitted to a histopathological and bacteriological examination for evidence of tuberculosis. The competent authority may also, in respect of the Member State or a part thereof, increase the frequency of tuberculin testing if the level of the disease has increased.

3A. The officially tuberculosis-free status of a herd is to be suspended if: (a) the conditions detailed in paragraph 2 are no longer fulfilled; or (b) one or more animals are deemed to have given a positive reaction to a tuberculin test, or a case of tuberculosis is suspected at post-mortem examination. When an animal is considered to be a positive reactor it will be removed from the herd and slaughtered. Appropriate post-mortem, laboratory and epidemiological examinations shall be carried out on the positive reactor or the carcase of the suspect animal. The status of the herd will remain suspended until such time as all laboratory examinations have been completed. If the presence of tuberculosis is not confirmed, the suspension of the officially tuberculosis-free status may be lifted following a test of all animals over six weeks of age with negative results at least 42 days after the removal of the reactor animal(s); or (c) the herd contains animals of unresolved status as described in Annex B. In this case, the status of the herd is to remain suspended until the animals' status has been clarified. Such animals must be isolated from the other animals of the herd until their status has been clarified, either by a further test after 42 days or by post-mortem and laboratory examination; (d) however, by way of derogation from the requirements of paragraph (c), in a Member State where the competent authority carries out routine herd testing using the comparative tuberculin test described in Annex B, and in the case of a herd where no confirmed reactor animals have been disclosed for at least three years, the competent authority may decide not to restrict the movement of other animals in the herd, provided that the status of any inconclusive reactors is resolved by a further test after 42 days and that no animals from the holding are allowed to enter into intra-Community trade until the status of any inconclusive reactors has been resolved. If at this further test any animal either gives a positive reaction or continues to give an inconclusive reaction, then the conditions of paragraph (b) apply. If the presence of disease is subsequently confirmed, all animals leaving the holding since the time of the last clear herd test must be traced and tested.

3B. The officially tuberculosis-free status of the herd is to be withdrawn if the presence of tuberculosis is confirmed by the isolation of M. bovis on laboratory examination. The competent authority may withdraw status if: (a) the conditions detailed in point 2 are no longer fulfilled, or (b) classical lesions of tuberculosis are seen at post-mortem examination, or (c) an epidemiological enquiry establishes the likelihood of infection, (d) or for any other reasons considered necessary for the purpose of controlling bovine tuberculosis. Tracing and checking is to be undertaken by the competent authority of any herd considered to be epidemiologically related. The officially tuberculosis-free status of a herd is to remain withdrawn until cleansing and disinfection of the premises and utensils has been completed and all animals over six weeks of age have reacted negatively to at least two consecutive tuberculin tests, the first no less than 60 days and the second no less than four months and no more than 12 months after the removal of the last positive reactor.

4. On the basis of information supplied in accordance with Article 8, a Member State or part of a Member State may be declared officially tuberculosis-free according to the procedure laid down in Article 17 if it meets the following conditions: (a) the percentage of bovine herds confirmed as infected with tuberculosis has not exceeded 0,1 % per year of all herds for six consecutive years and at least 99,9 % of herds have achieved officially tuberculosis-free status each year for six consecutive years, the calculation of this latter percentage to take place on 31 December each calendar year; ▼M46 (b) each bovine animal is identified in accordance with Community legislation; ▼M44 (c) all bovine animals slaughtered are subjected to an official post-mortem examination; (d) the procedures for suspension and withdrawal of officially tuberculosis-free status are complied with.

5. The Member State or part of a Member State will retain officially tuberculosis-free status if the conditions 4(a) to (d) continue to be met. However, if there is evidence of a significant change in the situation as regards tuberculosis in a Member State or part of a Member State which has been recognised as officially tuberculosis-free, the Commission may, in accordance with the procedure laid down in Article 17, take a Decision suspending or revoking the status until the requirements of the Decision have been fulfilled.

II. Officially brucellosis-free and brucellosis-free bovine herds

For the purposes of this section ‘bovine animals’ means all bovine animals with the exception of males for fattening provided that they come from officially brucellosis-free herds and that the competent authority guarantees that the males for fattening will not be used for breeding and will go direct for slaughter.

1. A bovine herd is officially brucellosis-free if: (a) it contains no bovine animals which have been vaccinated against brucellosis, except females which have been vaccinated at least three years previously; (b) all the bovine animals have been free from clinical signs of brucellosis for at least six months; (c) all the bovine animals over 12 months old have been subjected to one of the following test regimes with negative results in accordance with Annex C: (i) two serological tests specified in paragraph 10 at an interval of more than three months and less than 12 months; (ii) three tests on milk samples at three-monthly intervals followed at least six weeks later by a serological test specified in paragraph 10; (d) any bovine animal entering the herd comes from a herd of officially brucellosis-free status and, in the case of bovine animals over 12 months old, has shown a brucella titre of less than 30 IU of agglutination per ml when given a serum agglutination test in accordance with Annex C or has reacted negatively to any other test approved in accordance with the procedure at Article 17 during the 30 days prior to or the 30 days after the date of its introduction into the herd: in the latter case, the animal(s) must be isolated physically from the other animals of the herd in such a way as to avoid direct or indirect contact with the other animals until proven negative.

2. A bovine herd will retain officially brucellosis-free status if: (a) one of the following test regimes is carried out annually with negative results in accordance with Annex C: (i) three milk ring tests carried out at intervals of at least three months; (ii) three milk ELISAs carried out at intervals of at least three months; (iii) two milk ring tests carried out at an interval of at least three months followed at least six weeks later by a serological test referred to in paragraph 10; (iv) two milk ELISAs carried out at an interval of at least three months followed at least six weeks later by a serological test referred to in paragraph 10; (v) two serological tests carried out at an interval of at least three months and not more than 12 months. However, the competent authority of a Member State may, for the Member State or part of the Member State which is not officially brucellosis-free but where all the bovine herds are subject to an official programme to combat brucellosis, alter the frequency of the routine tests as follows: — where not more than 1 % of bovine herds are infected, it may be sufficient to carry out each year two milk ring tests or two milk ELISAs at an interval of at least three months, or one serological test, — where at least 99,8 % of bovine herds have been recognised as officially brucellosis-free for at least four years, the interval between checks may be extended to two years if all animals over 12 months of age are tested, or testing may be restricted to animals over 24 months of age if herds continue to be tested each year. The checks must be carried out using one of the serological tests referred to in paragraph 10; (b) all bovine animals entering the herd come from herds of officially brucellosis-free status and, in the case of bovine animals over 12 months old, have shown a brucella titre of less than 30 IU of agglutination per ml when given a serum agglutination test in accordance with Annex C or have reacted negatively to any other test approved in accordance with the procedure at Article 17 during the 30 days prior to or the 30 days after the date of their introduction into the herd; in the latter case, the animal(s) must be isolated physically from the other animals of the herd in such a way as to avoid direct or indirect contact with the other animals until proven negative. However, the test described in point (b) need not be required in Member States, or regions of Member States, where the percentage of bovine herds infected with brucellosis has not exceeded 0,2 % for at least two years and where the animal comes from an officially brucellosis-free bovine herd within that Member State or region and has not during transportation come into contact with bovine animals of lesser status; (c) notwithstanding point (b), bovine animals from a brucellosis-free bovine herd may be introduced into an officially brucellosis-free herd if they are at least 18 months old and, if vaccinated against brucellosis, the vaccination was carried out more than a year previously. Such animals must have shown, in the 30 days prior to introduction, a brucella titre lower than 30 IU of agglutination per ml and a negative result when given a complement fixation test, or other test approved under the procedure set out in Article 17. If, however, a female bovine animal from a brucellosis-free herd is introduced into an officially brucellosis-free herd, under the provisions of the above paragraph, that herd shall be considered to be brucellosis-free for two years from the date on which the last vaccinated animal was introduced.

3A. The officially brucellosis-free status of a herd is to be suspended if: (a) the conditions detailed in paragraphs 1 and 2 are no longer fulfilled; or (b) as a result of laboratory tests or on clinical grounds one or more bovine animals is suspected of having brucellosis and the suspect animals have been slaughtered or isolated in a way to avoid any direct or indirect contact with the other animals. Where the animal has been slaughtered and is no longer available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex C on all bovine animals in the herd over 12 months old, show a titre lower than 30 IU of agglutination per ml. The first test shall be carried out at least 30 days after the removal of the animal and the second at least 60 days later. Where the animal has been isolated from the animals in the herd, it may be reintroduced into the herd and the status of the herd may be restored following: (a) a serum agglutination test which has shown a titre lower than 30 IU of agglutination per ml and has given a negative result to a complement fixation test, or (b) a negative result to any other combination of tests approved for that purpose under the procedure set out in Article 17.

3B. The officially brucellosis-free status of the herd is to be withdrawn if, as a result of laboratory tests or epidemiological investigations, brucella infection has been confirmed in the herd. The status of the herd is not to be restored until either all bovine animals present in the herd at the time of the outbreak have been slaughtered, or the herd has been subject to check testing and all animals over 12 months of age have given negative results to two consecutive tests at 60-day intervals, the first being carried out not less than 30 days after removal of the positive animal(s). In the case of bovine animals which were pregnant at the time of the outbreak, the final check must be carried out at least 21 days after the last animal pregnant at the time of the outbreak has calved.

4. A bovine herd is brucellosis-free if it complies with the conditions in 1(b) and (c) and when vaccination has been carried out as follows: (i) female bovine animals have been vaccinated: — before the age of six months old with live strain 19 vaccine, or — before the age of 15 months old with killed 45/20 adjuvant vaccine which has been officially inspected and approved, or — with other vaccines approved under the procedure laid down in Article 17; (ii) bovine animals under 30 months old which have been vaccinated with live strain 19 vaccine may give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.

5. A bovine herd will retain brucellosis-free status if: (i) it is subject to one of the testing regimes listed in 2(a); (ii) bovine animals entering the herd comply with the requirements of 2(b); or — come from herds of brucellosis-free status, and in the case of bovine animals over 12 months old, have shown, in the 30 days prior to or in isolation after introduction into the herd, less than 30 IU of agglutination per ml when given a serum agglutination test and a negative result to a complement fixation test in accordance with Annex C, or — come from herds of brucellosis-free status, are under 30 months old and have been vaccinated with live strain 19 vaccine if they give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.

6A. The brucellosis-free status of a herd is to be suspended if: (a) the conditions detailed in paragraphs 4 and 5 have not been complied with; or (b) as a result of laboratory tests or on clinical grounds one or more bovine animals over 30 months old is suspected of having brucellosis and the animal(s) under suspicion have been slaughtered, or isolated in a way to avoid any direct or indirect contact with other animals. Where the animal has been isolated, it may be reintroduced into the herd and the status of the herd may be restored, if it subsequently shows a serum agglutination titre lower than 30 IU of agglutination per ml and has given a negative result to a complement fixation test, or other test approved under the procedure set out in Article 17. Where the animals have been slaughtered and are no longer available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex C on all bovine animals in the holding over 12 months old, show a titre lower than 30 IU of agglutination per ml. The first test is to be carried out at least 30 days after the removal of the animal and the second at least 60 days later. If the animals to be tested in the previous two subparagraphs are under 30 months old and have been vaccinated with live strain 19 vaccine they may be considered to be negative if they give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.

6B. The brucellosis-free status of the herd is to be withdrawn if, as a result of laboratory tests of epidemiological investigations, brucella infection has been confirmed in a herd. The status of the herd is not to be restored until either all the bovine animals present in the herd at the time of the outbreak have been slaughtered or the herd has been subject to check testing and all unvaccinated animals over 12 months of age have given negative results to two consecutive tests at 60 day intervals, the first being carried out not less than 30 days after removal of the positive animal(s). If all the animals to be tested referred to in the preceding paragraph are less than 30 months old and have been vaccinated with live strain 19 vaccine, they may be considered negative if they show a brucella titre of more than 30 IU but less than 80 IU of agglutination per ml, provided that in the complement fixation test they show a titre of less than 30 EEC units in the case of females vaccinated less than 12 months previously or a titre of less than 20 EEC units in all other cases. In the case of bovine animals which were pregnant at the time of the outbreak, the final check must have been carried out at least 21 days after the last animal pregnant at the time of the outbreak has calved.

7. A Member State or a region of a Member State may be declared officially brucellosis-free according to the procedure laid down in Article 17 if it meets the following conditions: (a) no case of abortion due to brucella infection and no isolation of B. abortus has been recorded for at least three years and at least 99,8 % of herds have achieved officially brucellosis-free status each year for five consecutive years, the calculation of this percentage to take place on 31 December each calendar year. However, where the competent authority adopts a policy of whole herd slaughter, isolated incidents shown by epidemiological enquiry to be due to the introduction of animals from outside the Member State or part of the Member State and herds whose officially brucellosis-free status has been suspended or withdrawn for reasons other than suspicion of disease, is to be disregarded for the purpose of the above calculation provided that the central competent authority of the Member State concerned by these incidents makes an annual record and forwards them to the Commission in accordance with Article 8(2), and ▼M46 (b) each bovine animal is identified in accordance with Community legislation, and ▼M44 (c) notification of cases of abortion is mandatory and they are investigated by the competent authority.

8. Subject to paragraph 9, a Member State or a region of a Member State declared officially brucellosis-free is to retain this status if: (a) the conditions imposed by paragraph 7(a) and (b) are still fulfilled and notification of cases of abortion suspected of being due to brucellosis is mandatory and are investigated by the competent authority; (b) every year for the first five years after attaining status, all bovine animals over 24 months of age in not less than 20 % of herds have been tested and have reacted negatively to a serological test carried out in accordance with Annex C or, in the case of dairy herds, by examination of milk samples in accordance with Annex C; (c) every bovine animal suspected of being infected with brucellosis is notified to the competent authority and undergoes official epidemiological investigation for brucellosis comprising at least two serological blood tests, including the complement fixation test, and a microbiological examination of appropriate samples; (d) during the period of suspicion, which is to continue until negative results have been obtained from the tests provided for in (c), the officially brucellosis-free status of the herd of origin or transit of the suspected bovine animal and of the herds linked epidemiologically to it is to be suspended; (e) in the event of an outbreak of brucellosis that has spread, all bovine animals have been slaughtered. Animals of the remaining susceptible species will undergo appropriate tests and premises and equipment will be cleaned and disinfected.

9. A Member State or a region of a Member State declared officially brucellosis-free is to report the occurrence of all cases of brucellosis to the Commission. If there is evidence of a significant change in the situation as regards brucellosis in a Member State or part of a Member State which has been recognised as officially brucellosis-free, the Commission may according to the procedure laid down in Article 17 propose that the status be suspended or revoked until the requirements of the Decision have been fulfilled.

10. For the purposes of section II, a serological test means either a serum agglutination test, buffered brucella antigen test, complement fixation test, plasma agglutination test, plasma ring test, micro-agglutination test or individual blood ELISA, as described in Annex C. Any other diagnostic test approved under the procedure laid down in Article 17 and described in Annex C will also be accepted for the purposes of section II. A milk test means a milk ring test or a milk ELISA in accordance with Annex C.

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ANNEX B

TUBERCULOSIS

1. IDENTIFICATION OF THE AGENT

The presence of Mycobacterium bovis (M. bovis), agent of bovine tuberculosis, in clinical and post-mortem specimens may be demonstrated by examination of stained smears or immunoperoxidase techniques and confirmed by cultivation of the organism on primary isolation medium.

Pathological material for the confirmation of M. bovis should be taken from abnormal lymph nodes and parenchymatous organs such as lungs, liver, spleen, etc. In the cases where the animal does not present pathological lesions, samples from the retropharyngeal, bronchial, mediastinal, supramammary, mandibular and some mesenteric lymph nodes and liver should be collected for examination and culture.

Identification of isolates may be usually carried out by determining cultural and biochemical properties. The polymerase chain reaction (PCR) may also be employed for the detection of the M. tuberculosis complex. DNA analysis techniques may prove to be faster and more reliable than biochemical methods for the differentiation of M. bovis from other members of the M. tuberculosis complex. Genetic fingerprinting allows distinguishing between different strains of M. bovis and will enable patterns of origin, transmission and spread of M. bovis to be described.

The techniques and media used, their standardisation and the interpretation of results must conform to that specified in the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.3 (bovine tuberculosis).

2. THE TUBERCULIN SKIN TEST

Tuberculin PPD (Purified Protein Derivatives) that fulfil the standards laid down in paragraph 2.1 shall be used for carrying out official tuberculin skin test following the procedures referred to in paragraph 2.2.

2.1. Standards for tuberculin (bovine and avian)

2.1.1. Definition

Tuberculin purified protein derivative (tuberculin PPD, bovine or avian) is a preparation obtained from the heat-treated products of growth and lysis of Mycobacterium bovis or Mycobacterium avium (as appropiate) capable of revealing a delayed hypersensitivity in an animal sensitised to microorganisms of the same species.

2.1.2. Production

It is obtained from the water-soluble fractions prepared by heating in free-flowing steam and subsequently filtering cultures of M. bovis or . avium (as appropiate) grown in a liquid synthetic medium. The active fraction of the filtrate, consisting mainly of protein, is isolated by precipitation, washed and re-dissolved. An antimicrobial preservative that does not give rise to false positive reactions, such as phenol, may be added. The final sterile preparation, free from mycobacteria, is distributed aseptically into sterile tamper-proof glass containers which are then closed so as to prevent contamination. The preparation may be freeze-dried.

2.1.3. Identification of the product

Inject a range of graded doses intradermally at different sites into suitably sensitised albino guinea-pigs, each weighing not less than 250 g. After 24 h to 28 h, reactions appear in the form of oedematous swellings with erythema with or without necrosis at the points of injection. The size and severity of the reactions vary according to the dose. Unsensitised guinea-pigs show no reactions to similar injections.

2.1.4. Tests

2.1.4.1. pH: The pH is 6.5 to 7.5.

2.1.4.2. Phenol: If the preparation to be examined contains phenol, its concentration is not more than 5 g/l.

2.1.4.3. Sensitising effect: Use a group of three guinea-pigs that have not been treated with any material which will interfere with the test. On 3 occasions at intervals of five days inject intradermally into each guinea-pig a dose of the preparation to be examined equivalent to 500 IU in 0,1 ml. 15 to 21 days after the third injection inject the same dose (500 IU) intradermally into these animals and into a control group of three guinea-pigs of the same mass and which have not previously received injections of tuberculin. 24 to 28 hours after the last injections, the reactions of the two groups are not significantly different.

2.1.4.4. Toxicity: Use two guinea-pigs, each weighing not less than 250 g and which have not previously been treated with any material which will interfere with the test. Inject subcutaneously into each guinea-pig 0,5 ml of the preparation to be examined. Observe the animals for seven days. No abnormal effects occur during the observation period.

2.1.4.5. Sterility: It complies with the test for sterility prescribed in the monograph on Vaccines for veterinary use 4th Edition 2002 of the European Pharmacopoeia.

2.1.5. Potency

The potency of tuberculin purified protein derivative (bovine and avian) is determined by comparing the reactions produced in sensitised guinea-pigs by the intradermal injection of a series of dilutions of the preparation to be examined with those produced by known concentrations of a reference preparation of tuberculin (bovine or avian, as appropiate) purified protein derivative calibrated in International Units.

To test the potency, sensitise not fewer than nine albino guinea-pigs, each weighing 400 g to 600 g, by the deep intramuscular injection of 0,0001 mg of wet mass of living M. bovis of strain AN5 suspended in 0.5 ml of a 9 g/l solution of sodium chloride R for bovine tuberculin, or a suitable dose of inactivated or live M. avium for avian tuberculin. Not less than four weeks after the sensitisation of the guinea-pigs, shave their flanks to provide space for not more than four injection sites on each side. Prepare dilutions of the preparation to be examined and of the reference preparation using isotonic phosphate-buffered saline (pH 6,5-7,5) containing 0,005 g/l of polysorbate 80 R. Use not fewer than three doses of the reference preparation and not fewer than three doses of the preparation to be examined. Choose the doses such that the lesions produced have a diameter of not less than 8 mm and not more than 25 mm. Allocate the dilutions randomly to the sites using a Latin square design. Inject each dose intradermally in a constant volume of 0,1 ml or 0,2 ml. Measure the diameters of the lesions after 24 to 28 hours and calculate the result of the test using the usual statistical methods and assuming that the diameters of the lesions are directly proportional to the logarithm of the concentration of the tuberculins.

The test is not valid unless the fiducial limits of error (P = 0,95) are not less than 50 % and not more then 200 % of the estimated potency. The estimated potency is not less than 66 % and not more than 150 % of the stated potency for bovine tuberculin. The estimated potency is not less than 75 % and not more than 133 % of the stated potency for avian tuberculin. The stated potency is not less than 20 000 IU/ml for both tuberculins (bovine and avian).

2.1.6. Storage

Store protected from light, at a temperature of 5 ± 3 oC.

2.1.7. Labelling

The label states:

— the potency in International Units per millilitre,

— the name and quantity of any added substance,

— for freeze-dried preparations: — — -the name and volume of the reconstituting liquid to be added, — -that the product should be used immediately after reconstitution.

2.2. Test procedures

2.2.1. The following shall be recognised as official intradermal tuberculin tests: — the single intradermal test: this test requires a single injection of bovine tuberculin, — the intradermal comparative test: this test requires one injection of bovine tuberculin and one injection of avian tuberculin given simultaneously.

2.2.2. The dose of tuberculin injected shall be: — not less than 2 000 IU of bovine tuberculin, — not less than 2 000 IU of avian tuberculin.

2.2.3. The volume of each injection dose shall not exceed 0,2 ml.

2.2.4. Tuberculin tests shall be carried out by injecting tuberculin(s) into the skin of the neck. The injection sites shall be situated at the border of the anterior and middle thirds of the neck. When both avian and bovine tuberculins are injected in the same animal, the site for injection of avian tuberculins shall be about 10 cm from the crest of the neck and the site for the injection of bovine tuberculin about 12,5 cm lower on a line roughly parallel with the line of the shoulder or on different sides of the neck; in young animals in which there is not room to separate the sites sufficiently on one side of the neck, one injection shall be made on each side of the neck at identical sites in the centre of the middle third of the neck.

2.2.5. The technique of tuberculin testing and interpretation of reactions shall be as follows:

2.2.5.1. Technique: Injection sites shall be clipped and cleansed. A fold of skin within each clipped area shall be taken between the forefinger and thumb and measured with callipers and recorded. The dose of tuberculin shall then be injected by a method that ensures that the tuberculin is delivered intradermically. A short sterile needle, bevel edge outwards, with graduated syringe charged with tuberculin, inserted obliquely into the deeper layers of the skin may be used. A correct injection shall be confirmed by palpating a small pea-like swelling at each site of injection. The skin-fold thickness of each injection site shall be remeasured 72 hours (± 4 hours) after injection and recorded.

2.2.5.2. Interpretation of reactions The interpretation of reactions shall be based on clinical observations and the recorded increase(s) in skin-fold thickness at the sites of injection 72 hours after injection of tuberculin(s). (a) Negative reaction: if only limited swelling is observed, with an increase of not more than 2 mm in the thickness of the fold of skin without clinical signs such as diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the lymphatic ducts in that region or of the lymph nodes. (b) Inconclusive reaction: if no clinical signs such as mentioned in a) are observed and if the increase in skin-fold thickness is more than 2 mm and less than 4 mm. (c) Positive reaction: if clinical signs such as mentioned in a) are observed or there is an increase of 4 mm or more in the thickness of the fold of skin at the injection site.

2.2.5.3. The interpretation of official intradermal tuberculin tests shall be as follows:

2.2.5.3.1. Single intradermal test: (a) positive: a positive bovine reaction as defined in paragraph 2.2.5.2(c); (b) inconclusive: an inconclusive reaction as defined in paragraph 2.2.5.2(b); (c) negative: a negative bovine reaction as defined in paragraph 2.2.5.2(a). Animals inconclusive to the single intradermal test shall be subjected to another test after a minimum of 42 days. Animals which are not negative to this second test shall be deemed to be positive to the test. Animals positive to the single intradermal test may be subjected to an intradermal comparative test if false positive reaction or interference reaction is suspected.

2.2.5.3.2. Intradermal comparative test for the establishment and maintenance of officially tuberculosis-free herd status: (a) positive: a positive bovine reaction which is more than 4 mm greater than the avian reaction, or the presence of clinical signs; (b) inconclusive: a positive or inconclusive bovine reaction which is from 1 to 4 mm greater than the avian reaction, and the absence of clinical signs; (c) negative: a negative bovine reaction, or a positive or inconclusive bovine reaction but which is equal to or less than a positive or inconclusive avian reaction and the absence of clinical signs in both cases. Animals inconclusive to the intradermal comparative test shall be subjected to another test after a minimum of 42 days. Animals, which are not negative to this second test, shall be deemed to be positive to the test.

2.2.5.3.3. Officially tuberculosis-free herd status may be suspended and animals from the herd shall not be allowed to enter intra-Community trade until such time as the status of the following animals is resolved: (a) animals which have been deemed to be inconclusive to the single intradermal tuberculin test; (b) animals which have been deemed to be positive to the single intradermal tuberculin test but are awaiting retest with an intradermal comparative test; (c) animals which have been deemed to be inconclusive to the intradermal comparative test.

2.2.5.3.4. Where animals are required by Community legislation to be subjected to an intradermal test prior to movement, the test shall be interpreted so that no animal which shows an increase in skin-fold thickness greater than 2 mm or the presence of clinical signs is entered into intra-Community trade.

2.2.5.3.5. To enable detection of the maximum number of infected and diseased animals in a herd or in a region, Member States may modify the criteria for the interpretation of the test in order to achieve improved test sensitivity considering all inconclusive reactions referred in 2.2.5.3.1(b) and 2.2.5.3.2(b) as positive reactions.

3. SUPPLEMENTARY TESTING

To enable detection of the maximum number of infected and diseased animals in a herd or in a region, Member States may authorise the employ of the gamma-interferon assay referred in the OIE Manual of Standards for Diagnostic Tests and Vaccines, 4th Edition, 2000, Chapter 2.3.3. (bovine tuberculosis), in addition to the tuberculin test.

4. STATE INSTITUTES AND NATIONAL REFERENCE LABORATORIES

4.1. Tasks and responsibilities

The State Institutes and Reference Laboratories included in paragraph 3.2 shall be responsible for the official testing of tuberculins or reagents included in paragraph 2 and 3 in their respective States to ensure each of these tuberculins or reagents are adequate in relation to the standards above referred.

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4.2. List of State institutes and national reference laboratories AT AGES: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH — Institut für veterinärmedizinische Untersuchungen Mödling (Austrian Agency for Health and Consumer Protection-Institute for veterinary investigations Mödling)Robert Koch-Gasse 17A-2340 MödlingTel.: +43 (0) 505 55-38112Fax: +43 (0) 505 55-38108E-mail: vetmed.moedling@ages.at BE CODA — CERVA — VARVeterinary and Agrochemical Research CentreGroeselenberg 99B-1180 Brussels ▼M53 BG Институт за контрол на ветеринарномедицински продукти, ул. Шосе Банкя № 7, София 1331(Institute for Control of Veterinary Medicinal Products, 7, Shousse Bankia Str., 1331 Sofia) ▼M52 CY State Veterinary LaboratoryVeterinary Services1417 AthalassaNicosia CZ Státní veterinární ústavPraha – LysolajeSídlištní 136/24165 03 Praha 6 – Lysolaje ▼M54 DE Friedrich-Loeffler-InstitutBundesforschungsinstitut für TiergesundheitStandort JenaNaumburger Str. 96a07743 JenaTel. (49-3641) 804-0Fax (49-3641) 804-228E-Mail: poststelle@fli.bund.de DK National Veterinary Institute, Technical University of DenmarkBülowsvej 27DK-1790 Copenhagen V ▼M52 EE Eesti MaaülikoolMükobakteriooside laboratooriumF.H. Kreutzwaldi 6251014 TartuTel.: +372 731 3250 ES Laboratorio Central de Sanidad Animal de Santa FeCamino del Jau s/nSanta Fe 18320 (Granada)Tel.: +34 958 440 375/440 400Fax: +34 958 441 200Fulgencio Garrido AbellánE-mail: clvgr@mapya.es FI Finnish Food Safety AuthorityAnimal Diseases and Food Safety ResearchMustialankatu 3FI-00790 Helsinki, FinlandE-mail: info@evira.fiTel.: +358 20 772 003 (exchange)Fax: +358 20 772 4350 ▼M54 FR Laboratoire d’études et de recherches en pathologie animale et zoonosesAFSSA-LERPAZ23, avenue du Général-de-GaulleF-94703 Maisons-Alfort Cedex ▼M52 GB Veterinary Laboratories AgencyNew Haw, Addlestone, WeybridgeSurrey KT15 3NB, UKTel. (44-1932) 341111Fax (44-1932) 347046 GR Hellenic Ministry of Rural Development and FoodCentre of Athens Veterinary InstitutionsInstitute of infectious and parasitic diseasesDepartment of Microbiology25 Neapoleos Street15 310 Ag. ParaskeviTel.: +30 210 6010903-6399521Fax: +30 210 6399477 ▼M54 HU Mezőgazdasági Szakigazgatási Hivatal Központ, Állat-egészségügyi Diagnosztikai IgazgatóságCentral Agricultural Office, Veterinary Diagnostic DirectorateAddress: 1149 Budapest, Tábornok u. 2.Mailing Address: 1581 Budapest, 146. Pf. 2.Tel.: +36 1 460-6300Fax: +36 1 252-5177E-mail: titkarsag@oai.hu ▼M52 IE Bacteriology DivisionCentral Veterinary Research LaboratoryDepartment of Agriculture and Food LaboratoriesBackweston CampusStacumny LaneCelbridgeCo. Kildare IT Istituto Superiore di Sanità299 Viale Regina Elena00161 - Roma (I)Tel. +39 06 49 90 1Fax +39 06 49 38 71 18 LT Nacionalinė veterinarijos laboratorija,J. Kairiūkščio g. 10,LT-2021 Vilnius LU CODA — CERVA — VARVeterinary and Agrochemical Research CentreGroeselenberg 99B-1180 Brussels LV Nacionālais diagnostikas centrs(National Diagnostic Centre)Lejupes iela 3, Rīga, LV-1076Tel.: +371 7620526Fax: +371 7620434E-mail: ndc@ndc.gov.lv MT — NL Centraal Instituut voor DierziekteControleCIDC-LelystadHoofdvestiging: Houtribweg 39Nevenvestiging: Edelhertweg 15Postbus 20048203 AA Lelystad PL Laboratory Departament of MicrobiologyPaństwowy Instytut Weterynaryjny – Państwowy Instytut Badawczy,Al. Partyzantów 57, 24-100 PuławyTel.: +48.81.886 30 51Fax: +48.81.886 25 95E-mail: sekretariat@piwet.pulawy.pl PT Laboratório Nacional de Investigação Veterinária (LNIV)Estrada de Benfica, 701P-1549-011 Lisboa ▼M53 RO Institutul pentru Controlul Produselor Biologice și Medicamentelor de Uz VeterinarStrada Dudului nr. 37, sector 6codul 060603, București ▼M52 SE Statens Veterinärmedicinska AnstaltSE-751 89 Uppsala SI Univerza v LjubljaniVeterinarska fakultetaNacionalni veterinarski inštitutGerbičeva 60,SI-1000 Ljubljana SK Štátny veterinárny a potravinový ústavAkademická 3SK-949 01 Nitra

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ANNEX C

BRUCELLOSIS

1. IDENTIFICATION OF THE AGENT

The demonstration by modified acid-fast or immunospecific staining of organisms of Brucella morphology in abortion material, vaginal discharges or milk provides presumptive evidence of brucellosis, especially if supported by serological tests.

After isolation, the species and biovar should be identified by phage lysis and/or oxidative metabolism tests, cultural, biochemical and serological criteria.

The techniques and media used, their standardisation and the interpretation of results must conform to that specified in the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1 (bovine brucellosis), Chapter 2.4.2 (caprine and ovine brucellosis) and Chapter 2.6.2 (porcine brucellosis).

2. IMMUNOLOGICAL TESTS

2.1. Standards

2.1.1. The Brucella abortus biovar 1 Weybridge strain No 99 or USDA strain 1119-3 must be used for the preparation of all antigens used in the rose bengal test (RBT), serum agglutination test (SAT), complement fixation test (CFT) and the milk ring test (MRT).

2.1.2. The standard reference serum for the RBT, SAT, CFT and MRT is the OIE international reference standard serum (OIEISS) formerly named WHO second international anti-Brucella abortus Serum (ISAbS).

2.1.3. The standard reference sera for ELISAs are: — the OIEISS, — the weak positive OIE ELISA standard serum (OIEELISAWPSS), — the strong positive OIE ELISA standard serum (OIEELISASPSS), — The negative OIE ELISA standard serum (OIEELISANSS).

2.1.4. The above listed standard sera are available from the Veterinary Laboratories Agency (VLA), Weybridge, United Kingdom.

2.1.5. The OIEISS, the OIEELISAWPSS, the OIEELISASPSS and the OIEELISANSS are international primary standards from which secondary reference national standards (‘working standards’) must be established for each test in each Member State.

2.2. Enzyme-linked immunosorbent assays (ELISAs) or other binding assays for the detection of bovine brucellosis in serum or milk

2.2.1. Material and reagents

The technique used and the interpretation of results must have been validated in accordance with the principles laid down in Chapter 1.1.3 of the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, and should at least include laboratory and diagnostic studies.

2.2.2. Standardisation of the test

2.2.2.1. Standardisation of the test procedure for individual serum samples: (a) a 1/150 pre-dilution ( 17 ) of the OIEISS or a 1/2 pre-dilution of the OIEELISAWPSS or a 1/16 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) should give a positive reaction; (b) a 1/600 pre-dilution of the OIEISS or a 1/8 pre-dilution of the OIEELISAWPSS or a 1/64 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) should give a negative reaction; (c) the OIEELISANSS should always give a negative reaction.

2.2.2.2. Standardisation of the test procedure for pooled serum samples: (a) a 1/150 pre-dilution of the OIEISS or a 1/2 pre-dilution of the OIEELISAWPSS or a 1/16 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) and again diluted in negative sera by the number of samples making up the pool should give a positive reaction; (b) the OIEELISANSS should always give a negative reaction; (c) the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of serum have been pooled.

2.2.2.3. Standardisation of the test procedure for pooled milk or whey samples: (a) a 1/1000 pre-dilution of the OIEISS or a 1/16 pre-dilution of the OIEELISAWPSS or a 1/125 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) and again diluted 1/10 in negative milk should give a positive reaction; (b) the OIEELISANSS diluted 1/10 in negative milk should always give a negative reaction; (c) the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of milk or whey have been pooled.

2.2.3. Conditions for use of the ELISAs for diagnosis of bovine brucellosis:

2.2.3.1. Using the abovementioned calibrating conditions for ELISAs on serum samples, the diagnostic sensitivity of ELISA shall be equal or greater than the RBT or CFT taking into account the epidemiological situation under which it is employed.

2.2.3.2. Using the abovementioned calibrating conditions for ELISA on pooled milk samples, the diagnostic sensitivity of ELISA shall be equal or greater than the MRT taking into account not only the epidemiological situation but also the average and expected extreme husbandry systems.

2.2.3.3. Where ELISAs are used for certification purposes in accordance with Article 6(1) or for the establishment and maintenance of a herd status in accordance with Annex A(II)(10), pooling of samples of serum must be carried out in such a way that the test results can be undoubtedly related to the individual animal included in the pool. Any confirmatory test must be carried out on samples of serum taken from individual animals.

2.2.3.4. The ELISAs may be used on a sample of milk taken from the milk collected from a farm with at least 30 % of dairy cows in milk. If this method is used, measures must be taken to ensure that the samples taken for examination can be undoubtedly related to the individual animals from which the milk derived. Any confirmatory test must be carried out on samples of serum taken from individual animals.

2.3. Complement fixation test (CFT)

2.3.1. The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85 % (m/v) and phenol at 0,5 % (v/v)) or in a veronal buffer. Antigens may be delivered in the concentrated state provided the dilution factor to be used is indicated on the bottle label. The antigen must be stored at 4 oC and not frozen.

2.3.2. Serums must be inactivated as follows: — bovine serum: 56 to 60 oC for 30 to 50 minutes, — porcine serum: 60 oC for 30 to 50 minutes.

2.3.3. In order to carry out the genuine reaction within the test