L.S. 437.48(R) Regolamenti dwar Problemi ta’ Saħħa fl-Annimali li Jolqtu l-Kummerċ Intra-Komunitarju f’Annimali Bovini u Majjali Imħassrin bl-Avviż L

(1)The title of these regulations is the Animal Health Problems affecting Intra-Community Trade in Bovine Animals and Swine Regulations. Title, scope and applicability.

(2)The scope of these regulations is to implement the regulations laid down under European Union Council Directive 64/ 432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine: Provided that for the purposes of these regulations any reference made under European Union Council Directive 64/432/ EEC to Annex F has now been harmonised under Commission Regulation (EC) No 599/2004 of the 30th March 2004 concerning the adoption of a harmonised model certificate and inspection report linked to intra-Community trade in animals and products of animal origin: Provided further the certificate found under Commission Decision 599/2004 shall apply to these regulations.

(3)These regulations shall shall apply to intra-Community trade in bovine animals and swine with the exception of feral pigs as defined in Article 2(e) of the European Union Council Directive 80/217/EEC without prejudice to the provisions laid down in the European Union Council Directives 80/215/EEC, 85/511/EEC, 88/ 407/EEC, 89/608/EEC, 90/425/EEC, 90/429/EEC, 90/667/EEC, 91/ 496/EEC, 91/628/EEC, 92/102/EEC, 92/119/EEC and Decision 90/ 424/EEC.

(4)These regulations also transpose and implement Directive 2014/64/EU of the European Parliament and of the Council amending Council Directive 64/432/EEC as regards computer databases which are part of the surveillance networks in the Member States. 2.

(1)(

1. a)The definitions given in article 2 of European Union Council Directive 90/425/EEC relating to veterinary checks applicable in trade in bovine and porcine animals and in article 2 of European Union Council Directive 91/628/EEC relating to animal welfare during transport shall apply to these regulations. (
2. b)"Member States" means Member States of the *These regulations have been repealed by Legal Notice 77 of 2025. Definitions. 1 2 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE European Union; "Third Countries'' means countries which are not Member States within the European Union.

(2)In addition, the following definitions apply for the purposes of these regulations "animals for breeding or production" means bovine animals (including the species Bison bison and Bubalus bubalus) and swine other than those referred to as animals for slaughter, 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; "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; "approved veterinarian" means any veterinarian approved by the Ve t e r i n a r y S e r v i c e s , i n a c c o r d a n c e w i t h t h e p r o v i s i o n s o f regulation 14

(3)(b); "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 regulation 11; "brucellosis-free bovine herd" means a bovine herd which satisfies the conditions laid down in Annex A. II, paragraphs 4, 5 and 6 to European Union Council Directive 64/432/EEC; "competent authority'' means (

1. i)Cap. 437. for Malta: the Veterinary Services as established under article 2 of the Veterinary Services Act; (
2. ii)for a Member State: the central authority competent to carry out veterinary checks in animal health or any authority to which it has delegated that competence; "compulsorily notifiable diseases" means the diseases listed in Annex E (I) to European Union Council Directive 64/432/EEC; "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 thirty days of purchasing animals re-sells them or relocates them from the first premises to other premises not within his ownership and meets the conditions laid down in regulation 13; "herd" means an animal or group of animals kept on a holding (within the meaning of Article 2 (
3. 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; "officially brucellosis-free bovine herd'' means a bovine herd which satisfies the conditions laid down in Annex A. II, paragraphs ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 l, 2 and 3 to European Union Council Directive 64/432/EEC; "officially brucellosis-free Member State'' means a Member State which satisfies the conditions laid down in Annex A. II, paragraphs 10, 11 and 12 to European Union Council Directive 64/432/EEC; "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 to European Union Council Directive 64/432/ EEC; "officially enzootic-bovine-leukosis-free herd" means a herd which satisfies the conditions laid down in Annex D, Chapter I, Sections A and B, C and D to European Union Council Directive 64/432/EEC; "officially enzootic-bovine-leukosis-free Member State or r e g i o n " m e a n s a r e g i o n o r M e m b e r St a t e w h i c h m e e t s t h e requirements laid down in Annex D, Chapter I, Sections E and F, and G to European Union Council Directive 64/432/EEC; "officially tuberculosis-free bovine herd" means a bovine herd which satisfies the conditions laid down in Annex A. I, paragraphs l, 2 and 3 to European Union Council Directive 64/432/EEC; "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, 5 and 6 to European Union Council Directive 64/432/EEC; "official veterinarian" means the veterinarian appointed by the competent authority of a Member State; "region" means that part of a Member State’s territory which is subject to inspection by the competent authorities: (
4. i)(
5. ii)(iii) (
6. iv)(
7. v)(
8. vi)Belgium: province/provincie; Germany: Regierungsbezirk; Denmark: amt or island; France: department; Italy: provincia; Luxemburg Netherlands: rrv,-kring; (vii) United Kingdom - England, Wales and Northern Ireland: county; (viii) Scotland: district or island area; (
9. ix)Ireland: county; (
10. x)(
11. xi)(xii) Greece: Nomos; Spain: provincia; Portugal: continente: distrito, and other parts of Portugal’s territory: região autònoma; (xiii) Austria: Bezirk; (xiv) Sweden: län; (
12. xv)Finland: lääni/län. 3 4 [ S.L.437.48 Conditions to be fulfilled by animals for export. Amended by: L.N. 340 of 2020. ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE 3.

(1)Only animals that fulfil the relevant conditions laid downin these regulations may be moved from the place of birth.

(2)Bovine animals and swine covered by these regulations must (

1. a)be subjected (
2. i)to an identity check, and (
3. ii)to a clinical inspection within twenty-four hours of departure by an official veterinarian and show no clinical sign of disease; (
4. 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; (
5. c)be identified as provided for in European Union Council Directive 92/102/EEC; (
6. d)not be animals which are to be slaughtered and not be restricted under a contagious or infectious disease eradication programme in Malta; (
7. e)comply with the provisions of regulations 4 and 5. Contact between animals. 4.

(1)Bovine animals and swine covered by these regulations 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 these regulations must be transported by means of transport meeting the requirements of European Union Council Directive 91/628/EEC and in addition the requirements of regulation 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 of the European Union Council Directive 64/432/EEC. Health certificate to accompany animals during transportation. 5.

(1)Bovine animals and swine covered by these regulations must be accompanied during transportation to destination by a health certificate conforming to the 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 who le 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 ten 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 Veterinary Services shall ensure that any certificate is drawn up by the official veterinarian a f t er i n s p e c t i o n s , v i s i t s a n d c o n t r o l s a s p r o v i d e d b y t h e s e regulations. However as regards - ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 5 (

1. a)animals coming from approved assembly centres such certification shall be (
2. i)on the basis of an official document containing the necessary information completed by the official veterinarian for the holding of origin, or (
3. ii)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; (
4. b)animals coming from an approved holding which is participating in the surveillance network provided for in regulation 14, such certification shall be (
5. i)on the basis of an official document containing the necessary information completed by the approved veterinarian for the holding of origin, or (
6. ii)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 c e r t i f i c a t e a c c o r d i ng t o ei t h e r m o d e l 1 o r 2 i n A n n e x F a s appropriate, shall ensure that the movement is registered on the Animo system on the day the certificate is issued.

(5)The animals covered by these regulations 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 states where the animals originate. The official veterinary 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 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 subregulation

(1). 6.

(1)Animals for breeding or production must, in addition to the requirements of regulations 3, 4 and 5 (a) have remained in a single holding of origin for a period of thirty days prior to loading, or since birth in the holding of origin where the animals are less than Further requirements for animals for breeding or production. Amended by: L.N. 269 of 2010. 6 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE thirty days old. The official veterinarian must, on the basis of the official identification provided for in regulation 3

(2)(

1. c)and official records, be satisfied that the animals have complied with this condition and furthermore that the animals have originated in Malta or in the European Community or have been imported from a third country in compliance with European Community animal health legislation: Provided that in the case of animals transiting through an approved assembly centre in Malta or 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; (
2. b)with regard to animals imported from a third country into the territory of Malta which is not the ultimate destination, be transported to the Member State of destination as quickly as practicable under cover of a certificate issued under Article 7 of European Union Council Directive 91/496/EEC; (
3. c)with regard to animals imported from a third country upon arrival in the territory of Malta and before any further movements, satisfy the requirements of these regulations, and in particular the residency requirement in subregulation

(1)(a), 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 jeopardise the health status of the holding: Provided that if an animal from a third country is introduced into a holding no animal from the holding may be traded for thirty 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 regulation 3, 4 and 5 (

1. a)come from 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 in accordance with the provisions of point 2.2 of Schedule B either during the thirty days prior to leaving the herd of origin or in a place and under conditions to be defined in accordance with the procedure referred to in regulation 17: Provided that this intradermal tuberculin test is not required if the animals originate in a Member State or part of a Member State recognised as officially tuberculosis free or in a Member State or part of a Member State with an approved surveillance network; (
2. b)in the case of uncastrated animals which come from an officially brucellosis free bovine herd and more than twelve months old, have shown a brucella count lower ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 that thirty 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 thirty days prior the leaving the herd of origin and complying with the provisions of Annex C Section 2.2.2.1.(a): Provided that this serurn 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 bruceliosis free or in a Member State or part of a Member State with an approved surveillance network; (
3. c)come from an officially enzootic-bovine-leukosis-free herd and, if more than twelve months old, have reacted negatively to an individual test carried out during the thirty days prior to leaving the herd of origin and complying with the provisions of Schedule D: Provided that the test is not required if the animals originate in a Member State or part of a Member State recognised as officially enzootic-bovine-leukosis free or in a Member State or part of a Member State with an approved surveillance network; (
4. 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 subregulation

(3); (

1. e)until 31 December 2000, not be subject to the test requirements laid down in paragraph (
2. a)or (
3. b)in the case of bovine animals aged less than thirty months intended for meat production which (
4. i)come from a beef holding officially tuberculosis-free and officially brucellosis-free; (
5. ii)are accompanied by an animal health certificate with paragraph 7 in Section A of Annex F Model 1 duly completed; (iii) remain under supervision until their slaughter; (
6. iv)have not come into contact during transport with bovine animals not coming from herds officially free from those diseases. and provided that (
7. i)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; (
8. ii)the Member State of destination takes all necessary measures to avoid any contamination of indigenous herds; (iii) the Member States put in place a proper system 7 8 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE (
9. iv)of random sampling, inspections and controls designed to ensure the efficient implementation of these regulations; the Commission monitors the proper operation of the Directive so as to ensure that Member States comply fully with the regulations.

(3)Bovine animals for slaughter must, in addition to the requirements in regulations 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. Institutes or national laboratories to be designated by the Authority. Added by: L.N. 269 of 2010. 6A. The competent authority shall designate institutes, national reference labo ratori es o r official institu tes resp onsible f or coordinating the standards and methods of diagnosis referred to in Schedules A to D. It shall maintain updated lists thereof and make them available to other Member States and to the public. The tasks and responsibilities of such institutes, national reference laboratories and official institutes are set out in Schedules B and C and in Chapter II of Schedule D. Detailed rules for the uniform application of this rule may be adopted in accordance with the procedure referred to in rule 17. Animals for slaughter. 7. Animals for slaughter which have been taken on arrival in the territory of Malta (

1. a)to a slaughterhouse, must be slaughtered there as soon as possible but at least within seventy-two hours of arrival, in accordance with animal health requirements, or (
2. b)to an approved assembly centre, must be removed 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 these regulations. Immediate notification of suspected disease. 8. The suspected presence of any of the diseases referred to in Schedule E (I) is compulsorily and immediately notifiable to the competent authority. The competent authority shall forward to the European Commission by 31 May each year, and for the first time in 2004, details of the occurrence of diseases listed in Schedule E (I) and of any other diseases covered by the additional guarantees provided for by European Community legislation in the territory of Malta in the previous calendar year including details of the monitoring and eradication programmes in operation. This information shall be based on uniform criteria established by European Commission. 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 Schedules A and D. ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 9.

(1)On the basis of a Veterinary Services proposal, the Minister in charge of Agriculture may define, by virtue of an implementing regulation a compulsory national control programme for one of the contagious diseases listed in Annex E (II) to Directive 64/432/EEC for all of the territory of Malta. The said programme shall be submitted to the European Commission and outlined in particular: (

1. a)the distribution of the disease in the Member State, (
2. b)the reasons for the programme, taking into consideration the importance of the disease and the programme’s likely benefit in relation to its cost, (
3. c)the geographical area in which the programme will be implemented, (
4. d)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, (
5. e)the programme monitoring procedures, the results of which must be supplied at least annually to the Commission, (
6. f)the action to be taken if, for any reason, an establishment loses its status, (
7. g)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 subregulation

(1)may be approved in compliance with the criteria laid down in paragraph I in accordance with the procedure provided for in Article 17 of the European Union Council Directive 64/432/EEC. 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 l7 of the European Union Council Directive 64/432/EEC. Amendments or additions to programmes which have already been approved or to guarantees which have been defined in accordance with subregulation

(2)may be approved under the same procedure.

(4)The dispatching of pigs intended for breeding or production destined for the Member States or regions free of Aujeszky’s disease listed in Annex I of Commission Decision 2001/618/EC and coming from the territory of Malta or region not listed in that Annex is authorised subject to the following conditions: (

1. a)Aujeszky’s disease must be compulsorily notifiable in Malta or regioro of origin; (
2. b)a plan for the control and eradication of Aujeszky’s disease, fulfilling the criteria laid down in the first paragraph of this regulation, must be in place in Malta Compulsory national control programme for contagious diseases. 9 10 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE or regions of origin under the supervision of the Veterinary Services. Appropriate measures on pig transport and movements must be in place according to this plan for preventing a spread of disease between holdings of a different status; (
3. c)with regard to the holding of origin of the pigs: (
4. i)no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holding in question; (
5. ii)no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holdings located in an area of 5 km surrounding the holding of origin of the pigs; however, this provision shall not apply if, in these latter holdings, disease monitoring and eradication measures have been regularly applied under the supervision of the Veterinary Services and in accordance with the eradication plan referred to in paragraph (b), and these measures have effectively prevented any spread of disease to the holding in question; (iii) vaccination against Aujeszky's disease has not been carried out for at least twelve months; (
6. iv)the pigs have been subjected on at least two occasions at a distance of at least four months to a serological survey for the presence of ADV-gE or ADV-gB or ADV-gD antibody or to the whole Aujeszky's disease virus. This survey must have shown the absence of Aujeszky’s disease and that vaccinated pigs have been free from gE antibodies; (
7. v)no pigs have been introduced from holdings of a lower animal health status as regards Aujeszky’s disease in the previous twelve months, unless they have been tested for Aujeszky’s disease with negative results; (
8. d)the pigs to be moved: (
9. i)have not been vaccinated; (
10. ii)have been kept isolated in accommodation approved bv the Veterinary Services, during the thirty days prior to movement, and in such a way that any risk of spreading Aujeszky’s disease to these pigs is prevented; (iii) must have lived in the holding of origin or in a holding of an equivalent status since birth, and have remained in the holding of origin for at least: - thirty days, in the case of pigs intended for production; ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE - [ S.L.437.48 ninety days, in the case of pigs intended for breeding, have been subjected with negative results to at least two serological tests for ADV-gB or ADV-gD or the whole Aujeszky’s disease virus, at a distance of at least thirty days between each test. However, in case of pigs less than four months old, the serological test for ADV-gE may also be used. Sampling for the last test must be performed within fifteen days prior to shipment. The number of pigs tested in the isolation unit must be sufficient to detect: (
11. i)2% seroprevalence with 95% confidence in the isolation unit in case of pigs intended for production; (
12. ii)0,1% seroprevalence with 95% confidence in the isolation unit in case of pigs intended for breeding. However, the first of the two tests shall not be necessary if: (
13. i)in the framework of the plan referred to in paragraph (b), a serological survey has been carried out in the holding of origin between forty-five and seventeen days prior to shipment, demonstrating the absence of Aujeszky’s disease antibodies and that vaccinated pigs have been free from gE antibodies; (
14. ii)the pigs to be moved have lived in the holding of origin since birth; (iii) no pigs have moved on to the holding of origin while the pigs to be moved have been kept in isolation.

(5)The dispatching of pigs intended for slaughter destined for the Member States or regions free of Aujeszky’s disease listed in Annex I of Commission Decision 2001/618/EC and coming from Malta or region not listed in that Annex, is authorised subject to the following conditions: (

1. a)Aujeszky’s disease must be compulsorily notifiable in Malta or region of origin; (
2. b)a plan for the control and eradication of Aujeszky’s disease is in place in Malta or regions of origin of the pigs, fulfilling the criteria laid down under European Union Law; (
3. c)all the pigs in question must be transported directly to the slaughterhouse of destination and either: (
4. i)they come from a holding which fulfils the conditions required by European Union Law, or (
5. ii)they have been vaccinated against Aujeszky’s disease at least fifteen days prior to their shipment and come from a holding of origin where: 11 12 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE - - - in the framework of the plan referred to in paragraph (b), Aujeszky’s disease monitoring and eradication measures have been regularly applied under the supervision of the Veterinary Services for the previous twelve months; they had remained for at least thirty days before dispatch and where no clinical or pathological evidence of this disease has been detected at the moment of completion of the health certificate referred to in regulation 5, or they have not been vaccinated and they proceed from a holding where: 1. in the framework of the plan referred to in paragraph (b), Aujeszky’s disease monitoring and eradication measures have been regularly applied under the supervision of the Veterinary Services in the previous twelve months and no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous six months; 2. vaccination against Aujeszky’s disease and introduction of vaccinated pigs have been forbidden by the Veterinary Services, since the holding is in the process of reaching the highest status as regards Aujeszky’s disease in accordance to the plan referred to in paragraph (b); 3. they have lived for at least ninety days before dispatch.

(6)Pigs intended for breeding destined for the Member States or regions listed in Annex II of Commission Decision 2001/618/ EC, where approved Aujeszky’s disease eradication programmes are in place, must either: (

1. a)come from Member States or regions listed in Annex I of Commission Decision 2001/618/EC, or (
2. b)come from: (
3. i)Member States or regions listed in Annex II, and (
4. ii)a holding which fulfils the requirements of subregulation

(4)(c); or (

1. c)fulfil the following conditions: (
2. i)Aujeszky’s disease must be compulsorily notifiable in Malta or region where pigs are originating, (
3. ii)a plan for the control and eradication of Aujeszky’s disease is in place in Malta or region of origin, which fulfils the criteria laid down in ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 subregulation

(4)(b), (iii) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holding of origin of the pigs in question, (

1. iv)the pigs must have been isolated in accommodation approved by the Veterinary Services for the thirty days immediately prior to movement and kept isolated in such a way that any risk of spreading of Aujeszky’s disease is prevented, (
2. v)the pigs must have been subjected, with negative results, to a serological test for the presence of gE antibodies. Sampling for the last test must be performed within fifteen days prior to shipment. The number of pigs tested must be sufficient to detect 2% seroprevalence with 95% confidence in these pigs, (
3. vi)the pigs must lave lived in the holding of origin or in a holding of an equivalent status since birth, and have remained in the holding of origin for at least ninety days.

(7)Pigs intended for production destined for the Member States or regions listed in Annex II of Commission Decision 2001/ 6 1 8 / E C , w h e r e a p p r o v e d A u j e s z k y ’s d i s e a s e e r a d i c a t i o n programmes are in place, must either: (

1. a)come from Member States or regions listed in Annex 1 of Commission Decision 2001/618/EC, or (
2. b)come from: (
3. i)Member States or regions listed in Annex II Commission Decision 2001/618/EC, and (
4. ii)a holding which fulfils the requirements of subregulation

(4)(c), or (

1. c)fulfil the following conditions: (
2. i)Aujeszky’s disease must be compulsorily notifiable in Malta or region of origin; (
3. ii)a plan for the control and eradication of Aujeszky’s disease is in place in Malta or region of origin, which fulfils the criteria laid down in subregulation

(4)(b); (iii) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holding of origin of the pigs in question; (

1. iv)a serological survey for Aujeszky’s disease, demonstrating its absence and that vaccinated pigs have been free from gE antibodies, has been carried out in the holding of origin and between forty-five and one hundred and seventy days prior to shipment; 13 14 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE (
2. v)the pigs must either have lived in the holding of origin since birth or have remained in such holdings for at least thirty days after introduction from a holding of an equivalent status, where a serological survey equivalent to the one referred to in sub-paragraph (
3. iv)has been carried out.

(8)The serological tests carried out to monitor or detect Aujeszky’s disease in pigs in accordance with these regulations must meet the standards laid down in Annex III to the European Union Commission Decision 2001/618/EC.

(9)Without prejudice to Article 10

(3)of Directive 64/432/ EEC, infor mation of the occurrence of Aujeszky’s disease, including details of the monitoring and eradication programmes in operation in Malta where monitoring and eradication programmes wi ll b e in pl ace, m ust be provid ed at least annu ally b y the Veterinary Services in accordance with the uniform criteria laid down in Annex IV to Commission Decision 2001/618/EC.

(10)Without prejudice to the provisions laid down in Community legislation concerning health certificates, before the completion, for animals of the porcine species destined for Member States or regions listed in Annex I or II to Commission Decision 2001/618/EC, of section C of the health certificate required by Directive 64/432/EC, the official veterinarian shall ascertain: (

1. a)the status of the holding and of the Member State or region of origin of the pigs in question as regards Aujeszky’s disease; (
2. b)in case the pigs are not originating from a Member State or a region free of the disease, the status of the holding and of the Member State or regions of destination for the pigs in question as regards Aujeszky’s disease; (
3. c)the compliance of the pigs in question with the conditions laid down in Commission Decision 2001/ 618/EC.

(11)For animals of the porcine species destined for Member St a t e s o r r e g i o n s l i s t e d i n A n n e x I o r I I , E u r o p e a n U n i o n Commission Decision 2001/618/EC, the certification under subregulation

(10)shall be completed and supplemented as follows: (

1. a)in the first indent, after the word "disease:" the word "Aujeszky" must be added; (
2. b)in the second indent, reference shall be made to Commission Decision 2001/618/EC. In the same line, the number of the Article of Commission Decision 2001/618/EC, which is relevant for the pigs in question, shall be quoted between brackets.

(12)The Veterinary Services must ensure that when pigs destined for Member States or regions listed in Annex I or II to ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 15 Commission Decision 2001/618/EC are transported, they shall not come in contact with pigs of different or unknown status, as regards Aujeszky’s disease, during transport or transit. 10.

(1)Where the competent authority considers that the Maltese territory is free from one of the diseases listed in Annex E (II), they shall present to the European Commission appropriate supporting documentation, setting out in particular - Territory free from the diseases listed in Annex E to EU Council Directive 64/432/EEC. (

1. a)the nature of the disease and the history of its occurrence in its territory; (
2. b)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; (
3. c)the period over which the surveillance was carried out; (
4. d)where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition; (
5. e)the arrangements for verifying the absence of the disease.

(2)The documentation submitted by the competent authority shall be examined by the European Commission. The additional guarantees, general or specific, which may be required in IntraCommunity trade may be defined in accordance with Article 17 of the European Union Council Directive 64/432/EEC. Such guarantees must not exceed those which are implemented nationally.

(3)The competent authority shall notify the European Commission of any change in the details specified in subregulation

(1)which relate to the disease, in particular regarding any new outbreaks of the disease. The guarantees defined in accordance with subregulation

(2)may, in the light of such notification, be amended or withdrawn in accordance with the procedure laid down in Article 17 of the European Union Council Directive 64/432/ EEC. 11.

(1)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 regulation 4

(1)and

(2)are complied with; (

1. b)be located in an area which is not subject to prohibition or restrictions in accordance with relevant European Community legislation and, or Maltese regulations on animal diseases; (
2. c)be cleaned and disinfected before use, as required by the official veterinarian; (
3. d)they must have, taking into account the animal capacity of the assemblv centre (
4. i)a facility dedicated exclusively for this purpose Minimum conditions for assembly centres. Amended by: L.N. 269 of 2010. 16 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE when used as an assembly centre; (
5. ii)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; (iii) appropriate inspection facilities; (
6. iv)appropriate isolation facilities; (
7. v)appropriate equipment for cleaning and disinfecting rooms and trucks; (
8. vi)an appropriate storage area for fodder, litter and manure; (vii) an appropriate system for collecting waste water; (viii) the use of an office for the official veterinarian; (
9. 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 regulations and in particular regulation 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; (f) be regularly inspected 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 database and retain for a minimum period of three years the following information: (

1. a)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, (
2. b)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. Approvals of assembly centres may be limited to a particular species or to animals for breeding and production or to animals for slaughter. The competent authority shall draw up and keep updated a list of approved assembly centres and their approval numbers and make it available to other Member States and to the public.

(4)The competent authority may suspend or withdraw approval in the event of failure to comply with this regulation or other appropriate provisions of these regulations or other regulations in ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 respect of health restrictions. Approval may be restored when the competent authority is satisfied that that assembly centre is in full compliance with all the appropriate provisions of these regulations.

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

(6)Any detailed rules shall be adopted in accordance with the requirements of the European Community and under the procedure provided for in Article 17 of European Union Council Directive 64/ 432/EEC. 12.

(1)The transporters referred to in Article 5 of European Union Council Directive 91/628/EEC meet the following additional conditions (

1. a)for the carriage of animals they must use means of transport that are (
2. i)constructed in such a way that the animal faeces, litter or feed cannot leak or fall out of the vehicle; (
3. ii)cleaned and disinfected immediately after every animal transport operation or that of any product which could affect animal health and if necessary before any new loading of animals, using disinfectants officially authorised by competent authority; (
4. b)they must either have appropriate cleaning and disinfection facilities approved by the competent authority, including facilities for storing litter and dung, or they must 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 the following information at least which shall be retained for a minimum period of three years: (

1. i)places and dates of pickup, and the name or business name and address of the holding of assembly centre where the animals are picked up; (
2. ii)places and dates of delivery, and the name or business name and address of the consignee(s); (iii) species and number of animals carried; (
3. iv)date and place of disinfection; (
4. v)details of accompanying documentation, number, (serial number, etc).

(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)Transporters shall give a written undertaking stating in Additional conditions for transporters. 17 18 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE particular that (

1. i)all the measures necessary to comply with these regulations shall be taken and in particular the provisions laid down in this regulation and relating to the appropriate documentation that must accompany the animals, (
2. ii)the transport of animals is entrusted to staff who possess the necessary ability, professional competence and knowledge.

(5)In the event of failure to comply with the provisions of this regulation the requirements of Article 18 of European Union Council Directive 91/628/EEC shall apply mutatis mutandis relating to animal health. Approval number for dealers. Amended by: L.N. 269 of 2010. 13.

(1)In the territory of Malta 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 these regulations and in particular regulation 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 authorise the marketing of identified animals originating from the territory of Malta which do not fulfil the conditions laid down in this paragraph, in so far as they are brought direct to a slaughterhouse in the territory of Malta 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; (

1. 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 database and to store the following data for at least three years: (
2. i)the name of the owner, origin, date of purchase, categories, number and identification of bovine anmals or registration number of the holding of origin or of the herd of origin of pigs purchased, (
3. ii)the registration number of the transporter and, or the licence number of the lorry delivering and collecting animals, (iii) the name and address of the purchaser and the ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE (
4. iv)[ S.L.437.48 destination of the animal, copies of route plans and, or serial number of health certificates as applicable; (
5. c)when the dealer keeps animals on his premises he shall ensure that (
6. i)specific training is given to the staff in charge of the animals in applying the requirements of these regulations and in the care and welfare of the animals, (
7. ii)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)In the territory of Malta all premises used by a dealer in connection with his business shall be registered and issued with an approval number by the competent authority and that they comply with the following conditions at least (

1. a)they must be under the control of an official veterinarian; (
2. b)they must be located in an area which is not subject to prohibition or restrictions in accordance with relevant European Community legislation or Maltese legislation; (
3. c)they must have (
4. i)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, (
5. ii)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, (iii) an appropriate reception area for litter and manure, (
6. iv)an appropriate system for collecting waste water; (
7. 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 regulation or other appropriate provisions of these regulations or other regulations in respect of health restrictions. Approval may be restored when the Veterinary Services is satisfied that the dealer is in full compliance with all the appropriate provisions of these regulations.

(4)The competent authority must carry out regular inspections to ascertain that the requirements of this regulation are fulfilled.

(5)The competent authority shall draw up and keep updated a 19 20 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE list of approved dealers and registered premises used by dealers in connection with their business and their approval numbers and make that list available to other Member States and to the public. Detailed rules for the uniform application of this sub-regulation may be adopted in accordance with the procedure referred to in rule 17. Surveillance network system. Amended by: L.N. 9 of 2016. 14.

(1)The competent authority may carry out a system of surveillance network. The surveillance network system must comprise at least the following elements: (

1. i)the herds; (
2. ii)the owner or any other natural or legal person responsible for the holding; (iii) the approved veterinarian or the official veterinarian responsible for the holding; (
3. iv)the competent authority of Malta; (
4. v)the official veterinary diagnostic or any other laboratory approved by the competent authority; (
5. vi)a computer database: P r o v i d e d t h a t o ff i c i a l v e t e r i n a r i a n s f o r t h e s l a u g h t e r i n g 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 these regulations and other regulations in respect of health restrictions: Provided that this surveillance network system shall be mandatory on all holdings operating such a system in the territory of Malta. 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. 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 these regulations: Provided further that 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 subregulations

(1)and

(2)at least include the following: (

1. a)Every owner of or person responsible for a holding must (
2. i)secure, by contract or legal instrument, the services of a veterinarian approved by the ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 competent authority; (
3. 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; (
4. 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. (
5. b)The approved veterinarians shall be under the control of the competent authority and must comply with the following requirements: (
6. i)meet the conditions for pursuing the veterinary profession; (
7. 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 1. the identification and health certification of the animals of the herd, the animals introduced and those traded; 2. compulsory reporting of infectious animal diseases and any other risk factor for animal health or welfare, and for human health; 3. establishing as far as possible the cause of death of animals and where they are to be consigned; 4. the hygiene conditions of the herd and of the livestock production units: Provided that if the proper functioning of the system 21 22 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE so requires, each Member State may limit the veterinarians’ responsibility to a specific number of holdings or to a specific geographical area: Provided further that 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. (
8. c)The computer database must contain at least the following information: (
9. i)for each animal: - the unique identification code or codes, as regards the cases set out in Articles 4

(1), 4b, 4c

(1)and 4d of Regulation (EC) No 1760/ 2000 of the European Parliament and of the Council; - 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 unique identification code of the individual means of identification allocated to the animal by the Member State of destination in accordance with Regulation (EC) No 1760/2000; - 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; - the type of electronic identifier, if applied to the animal. (ii) for each holding - an identification number consisting of not more than 12 figures (apart from the country code); - name and address of the holder. (iii) 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 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 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: Provided that 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; in order to ensure the operation of the national computer databases concerning porcine animals, appropriate regulations of application, including the information that the national databases must contain, shall be adopted in accordance with the procedure laid down in Article 17 of the European Union Council Directive 64/432/EEC. - (iv)

(4)All participants in the surveillance network other than those provided for in subregulation

(3)(

1. a)and (
2. 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 subregulation

(3)(c), operational for a period of at least twelve months, shall apply to the Commission to have it approved under the procedure provided for in regulation 17: Provided that for this purpose the European Commission shall examine documentation submitted by Member States.

(6)When the competent authority has implemented throughout its jurisdiction a recognized surveillance network system as laid down in this regulation it shall be authorized not to apply the provision referred to in regulation 3

(2)(a), second indent, to animal movements referred to by this regulation within their own territory.

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

(1)Any infringement of these regulations whether by a natural or a legal person shall be penalised by the appropriate specific measures laid down in the Maltese legislation.

(2)If it is confirmed that at the arrival in Malta the provisions of these regulations are not or have not been complied with, the Penalties. 23 24 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE c om p e te nt a ut ho r it y s h a ll t a k e al l app r op r iat e m e a s u r e s t o 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 (

1. 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 jeopardise the health or welfare of the animals; (
2. b)arrange for the animals to be held in suitable accommodation with appropriate care in the event of interruption of the journey; (
3. c)arrange for the slaughter of the animals. The destination and use of such animals after slaughter shall be regulated (
4. i)in accordance with the provisions of European Union Council Directive 64/433/EEC on fresh meat; or (
5. ii)in accordance with the provisions of the European Union Council 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 European Union Council 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 subregulation

(3)shall apply;

(3)The competent authority shall immediately notity the c o m p e t e n t a u t h o r i t y o f t h e M e m b e r St a t e o f o r i g i n o n t h e e sta bl i shm e nt of an y i nfri ng em e nt of th ese r e gu l ati o ns . In accordance with the provisions established by European Union Council Directive 89/608/EEC, the competent authority shall provide mutual assistance to one another Member State in the application of these regulations in order to ensure, in particular, compliance with the provisions laid down in this regulation.

(4)This regulation shall not affect other national regulations applicable to penal sanctions. Interim period between computer database and network system. 16.

(1)Pending the introduction in Malta of an approved surveillance network system a computer database complying with the provisions laid down in regulation 14 shall be fully operational for bovine animals on the 31 December 2002 at the latest: Provided that with regards to porcine animals, there shall be an entry in the database for each separate movement of porcine animals. The entry shall comprise at least the following: (

1. i)the number of porcine animals being moved, (
2. ii)the identification number of the holding or herd of departure, (iii) the identification number of the holding or herd of ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 25 arrival, and (
3. iv)the departure and arrivals dates. The recording of all movements of porcine animals shall be fully operational on the 31 December 2003 at the latest. 17. A contract may be established between the competent authority of Malta and the laboratories or Institutes listed in the Annex B, Annex C, Annex D, chapter II of European Union Council Directive 64/432/EEC and Annex III of European Union Commission Decision 2001/618/EC, for the purpose of the tasks indicated in the relevant Annexes. Contract to be established between the Maltese competent authority and listed laboratories or Institutes. 18. The competent authority shall ensure that the regulations laid down in the European Union Council 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. Checks at origin and at destination. [ S.L.437.48 26 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE SCHEDULE Schedules A, B, C, D, E and F to the European Council Directive 64/432/EEC SCHEDULE 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 (
4. a)all the animals are free from clinical signs of tuberculosis; (
5. b)all the bovine animals over six weeks old have reacted negatively to at least two official intra-dermal tuberculin tests carried out in accordance with Schedule 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 sixty days after assembly and the second shall not be required; (
6. 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 intra-dermal tuberculin test performed and assessed according to Schedule B and carried out either in the thirty days prior to, or the thirty days after the date of its introduction into the herd; in the latter case the animal(
7. 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 regulation 14. 2. A bovine herd will retain officially tuberculosis-free status if (
8. a)the conditions detailed in 1(
9. a)and (
10. c)continue to apply; (
11. b)all animals entering the holding come from herds of officially tuberculosis-free status; (
12. 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 Schedule 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 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE - - [ S.L.437.48 27 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 twenty-four 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 intra-dermal 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 inereased. 3A. The officially tuberculosis-free status of a herd is to be suspended if (

1. a)the conditions detailed in paragraph 2 are no longer fulfilled; or (
2. b)one or more animals are deemed to have given a positive reaction to a tuberculin test, or a case oftuberculosis 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 forty-two days after the removal of the reactor animal(s);or (
3. c)the herd contains animals of unresolved status as described in Schedule 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 forty-two days or by post-mortem and laboratory examination; (
4. d)however, by way of derogation from the requirements of paragraph (c), in a Member State where the competent authority carries out routine 28 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE herd testing using the comparative tuberculin test described in Schedule 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 forty-two 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 (
5. 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 (
6. a)the conditions detailed in point 2 are no longer fulfilled, or (
7. b)classical lesions of tuberculosis are seen at post-mortem examination, or (
8. c)an epidemiological enquiry establishes the likelihood of infection, (
9. 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 sixty days and the second no less than four months and no more than twelve months after the removal of the last positive reactor. 4. On the basis of information supplied in accordance with regulation 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 of the European Union Council Directive 64/432/EEC if it meets the following conditions (
10. 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; (
11. b)an identification system making it possible to identify the herds of origin and transit for each bovine animal is in existence in accordance with European Union Regulation (EC) No. 1760/2000; (
12. c)all bovine animals slaughtered are subjected to an official post-mortem examination; (
13. d)the procedures for suspension and withdrawal of officially tuberculosisfiee status are complied with. 5. The Member State or part of a Member State will retain officially tuberculosis-free status if the conditions 4(
14. a)to (
15. 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 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 29 tuberculosis-free, the European Commission may, in accordance with the procedure laid down in Article 17 of the European Union Council Directive 64/432/EEC, take a Decision suspending or revoking the status until the requirements ofthe 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 (
16. a)it contains no bovine animals which have been vaccinated against brucellosis, except females which have been vaccinated at least three years previously; (
17. b)all the bovine animals have been free from clinical signs of brucellosis for at least six months; (
18. c)all the bovine animals over twelve months old have been subjected to one of the following test regimes with negative results in accordance with Schedule C (
19. i)two serological tests specified in paragraph 10 at an interval of more than three months and less than twelve months; (
20. ii)three tests on milk samples at three-monthly intervals followed at least six weeks later by a serological test specified in paragraph 10; (
21. d)any bovine animal entering the herd comes from a herd of officially brucellosis-free status and, in the case of bovine animals over twelve 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 Schedule C or has reacted negatively to any other test approved in accordance with the procedure at Article 17 during the thirty days prior to or the thirty days after the date of its introduction into the herd; in the latter case, the animal(
22. 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 (
23. a)one of the following test regimes is carried out annually with negative results in accordance with Schedule C: (
24. i)three milk ring tests carried out at intervals of at least three months; (
25. 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; (
26. 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; (
27. v)two serological tests carried out at an interval of at least three months and not more than twelve months. 30 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE 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 twelve months of age are tested, or testing may be restricted to animals over twenty-four 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; (
28. b)all bovine animals entering the herd come from herds of officially brucellosis-free status and, in the case of bovine animals over twelve 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 Schedule C or have reacted negatively to any other test approved in accordance with the procedure at Article 17 during the thirty days prior to or the thirty days after the date of their introduction into the herd; in the latter case, the animal(
29. 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 (
30. 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; (
31. 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 eighteen months old and, if vaccinated against brucellosis, the vaccination was carried out more than a year previously. Such animals must have shown, in the thirty 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 of the European Union Council Directive 64/432/EEC. 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 brucellosisfree 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 (
32. a)the conditions detailed in paragraphs 1 and 2 are no longer fulfilled; or (
33. 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 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 31 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 Schedule C on all bovine animals in the herd over twelve months old, show a titre lower than 30 IU of agglutination per ml. The first test shall be carried out at least thirty days after the removal of the animal and the second at least sixty 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 (
34. 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 (
35. b)a negative result to any other combination of tests approved for that purpose under the procedure set out in Article 17 of the European Union Council Directive 64/432/EEC. 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 ammals 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 twelve months of age have given negative results to two consecutive tests at sixty-day intervals, the first being carried out not less than thirty 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 twenty-one 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(
36. b)and (
37. c)and when vaccination has been carried out as follows: (
38. i)female bovine animals have been vaccinated - before the age of six months old with live strain 19 vaccine, or before the age of fifteen 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 of the European Union Council Directive 64/432/EEC; (
39. ii)bovine animals under thirty 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 twelve months previously or less than 20 EEC units in all other cases. 5. A bovine herd will retain brucellosis-free status if (
40. i)it is subject to one of the testing regimes listed in 2(a); (
41. 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 twelve months old, have shown, in the thirty 32 [ S.L.437.48 - ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE 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 Schedule C, or come from herds of brucellosis-free status, are under thirty 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 twelve 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 (
42. a)the conditions detailed in paragraphs 4 and 5 have not been complied with; or (
43. b)as a result of laboratory tests or on clinical grounds one or more bovine animals over thirty months old is suspected of having brucellosis and the animal(
44. 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 of the European Union Council Directive 64/432/EEC. 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 Schedule C on all bovine animals in the holding over twelve months old, show a titre lower than 30 IU of agglutination per ml. The first test is to be carried out at least thirty days after the removal of the animal and the second at least sixty days later. If the animals to be tested in the previous two subparagraphs are under thirty 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 twelve 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 epidemioloaical 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 twelve months of age have given negative results to two consecutive tests at sixtyday intervals, the first being carried out not less than thirty days after removal of the positive animal(s). If all the animals to be tested referred to in the preceding paragraph are less than thirty 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 twelve ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 33 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 twenty-one 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 of the European Union Council Directive 64/432/EEC if it meets the following conditions: (
45. 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 European Commission in accordance with regulation 8

(2), and (

1. b)an identification system making it possible to identify the herds of origin and transit for each bovine animal is in existence in accordance with European Union Regulation (EC) No. 820/97, and (
2. 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 (
3. a)the conditions imposed by paragraph 7(
4. a)and (
5. 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; (
6. b)every year for the first five years after attaining status, all bovine animals over twenty-four 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 Schedule C or, in the case of dairy herds, by examination of milk samples in accordance with Schedule C; (
7. 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 microbioloþical examination of appropriate samples; (
8. 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; (
9. 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. 34 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE 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 European 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 European Commission may according to the procedure laid down in Article 17 of the European Union Council Directive 64/432/EEC 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 Schedule C. Any other diagnostic test approved under the procedure laid down in in Article 17 of the European Union Council Directive 64/ 432/EEC and described in Schedule 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 Schedule C. Amended by: L.N. 269 of 2010. SCHEDULE B TUBERCULOSIS 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 carryine out official tuberculin skin test following the procedures referred to in paragraph 2.2. 2.1. Standards for tuberculin (bovine and avian) ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 35 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 M. 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/1. 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 three 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. Fifteen to twenty-one 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 guineapig 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 36 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE 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 ms 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/1 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°C. 2.1.7. Labelling The label states - the potency in Intemational Units per millilitre, - the name and quantity of any added substance, - for freeze-dried preparations: (
10. a)the name and volume ofthe reconstituting liquid to be added, (
11. b)that the product should be used immediately after reconstitution. 2.2. Test procedures 2.2.1. The following shall be recognised as official intra-dermal 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. ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 37 2.2.4. Tuberculin tests shall be carried out by injecting tuberculin(
12. s)jnto the skin of the neck. The injection sites shall be situated at the back 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 seventy-two hours (± four 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(
13. s)in skin-fold thickness at the sites of injection seventy-two hours after injection of tuberculin(s). (
14. 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. (
15. b)Inconclusive reaction: if no clinical signs such as mentioned in (
16. a)are observed and if the increase in skin-fold thickness is more than 2 mm and less than 4 mm. (
17. c)Positive reaction: if clinical signs such as mentioned in (
18. 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 (
19. a)positive: a positive bovine reaction as defined in paragraph 2.2.5.2(c); (
20. b)inconclusive: an inconclusive reaction as defined in paragraph 2.2.5.2(b); (
21. 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 forty- 38 [ S.L.437.48 2.2.5.3.2. 2.2.5.3.3. 2.2.5.3.4. 2.2.5.3.5. ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE two 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. Intradermal comparative test for the establishment and maintenance of officially tuberculosis-free herd status (
22. a)positive: a positive bovine reaction which is more than 4 mm greater than the avian reaction, or the presence of clinical signs; (
23. 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; (
24. 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 forty-two days. Animals, which are not negative to this second test, shall be deemed to be positive to the test. 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 (
25. a)animals which have been deemed to be inconclusive to the single intradermal tuberculin test; (
26. b)animals which haae been deemed to be positive to the single intradermal tuberculin test but are awaiting retest with an intradermal comparative test; (
27. c)animals which have been deemed to be inconclusive to the intradermal comparative test. Where animals are required by European 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. 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 to achieve improved test sensitivity considering all inconclusive reactions referred in 2.2.5.3.1(
28. b)and 2.2.5.3.2(
29. b)as positive reactions. SUPPLEMENTARY TESTING To enable detection of the maximum number of infected and diseased animals in a ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 39 herd or in a region, Member States may authorise the employ of the gammainterferon 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. STATE INSTITUTES AND NATIONAL REFERENCE LABORATORIES 4.1. Tasks and responsibilities Institutes, national reference laboratories or official institutes designated by the competent authority in accordance with rule 6A shall be responsible for the official testing of tuberculins or reagents referred to in paragraphs 2 and 3 respectively in Malta to ensure that each of these tuberculins or reagents is adequate in relation to the standards referred to in point 2.1 and paragraph 3 respectively. SCHEDULE C BRUCELLOSIS 1. Amended by: L.N. 269 of 2010. 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 presurnptive 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 CIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1 (bovine brucellosis), C h a pt e r 2 . 4 . 2 ( c a pr i n e an d ov i n e b r u c e l l o s i s ) a n d C h a p t e r 2 . 6 . 2 ( p o r c i n e 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 (OIEELISA SPSS), - 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. 40 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE 2.1.5. The OIEISS, the OIEELISA H,PSS, the OIEELISA,,SS 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. Enryme-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 CIE 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 (
30. a)a 1/150 pre-dilution (*) of the OIEISS or a 1/2 pre-dilution of the OIEELISA, SS or a 1/16 pre-dilution of the OIEELISA,,SS made up in a negative serum (or in a negative pool of sera) should give a positive reaction; (
31. b)a 1/600 pre-dilution of the OIEISS or a 1/8 pre-dilution of the OIEELISA,,SS or a 1/64 pre-dilution of the OIEELISA,,SS made up in a negative serum (or in a negative pool of sera) should give a negative reaction; (
32. c)the OIEELISANSS should always give a negative reaction. 2.2.2.2. Standardisation of the test procedure for pooled serum samples (
33. a)a 1/150 pre-dilution of the MISS or a 1/2 pre-dilution of the OIEELISAWpSS or a 1/16 pre-dilution of the OIEELISA srSS 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; (
34. b)the OIEELISANSS should always give a negative reaction; (
35. 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 (
36. a)a 1/1000 pre-dilution of the OIEISS or a 1/16 pre-dilution of the OIEELISA. SS or a 1/125 pre-dilution of the OIEELISAS SS 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; (
37. b)the OIEELISA NSS diluted 1/10 in negative milk should always give a negative reaction; (
38. 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 *For the purpose of this Schedule, dilutions given for making up liquid reagents are expressed as, for example, 1 150 shall mean a 1 in 150 dilution. ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 41 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 regulation 6

(1)or for the establishment and maintenance of a herd status in accordance with Schedule 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 (NaCI 0,85% (m/

1. 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°C and not frozen. 2.3.2. Serums must be inactivated as follows: - bovine serum: 56 to 60°C for 30 to 50 minutes, - porcine serum: 60°C for 30 to 50 minutes. 2.3.3. In to carry out the genuine reaction within the test procedure, a complement dose higher than the minimum necessary for total haemolysis should be used. 2.3.4. In carrying out the complement fixation test, the following controls must be made each time (
2. a)control of the anti-complementary effect of the serum; (
3. b)control of the antigen; (
4. c)control of sensitised red blood cells; (
5. d)control of the complement; (
6. e)control using a positive serum of sensitivity at the start of the reaction; (
7. f)control of the specificity of the reaction using a negative serum. 2.3.5. Calculation of results The OIEISS contains 1 000 international CFT units (ICFTU) per ml. If the OIEISS is tested in a given method the result is given as a titre ( TOIEISS). The test result for the test serum given as titre ( TTESTSERUM ) must be expressed in ICFTU per ml. In order to convert the expression of a titre into ICFTU, the factor (F) necessary to convert a titre of an unknown test serum ( TTESTSERUM ), tested by that method into the ICFTLJ expression can be found from the formula - 42 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE F = 1 000 x 1 /TOIEISS and the content of international CFT units per ml of test serum ( ICFTU, ESTSERUM ) from the formula ICFFU TESTSERU = F x TTESTSERUM 2.3.6. Interpretation of results A serum containing 20 or more ICFTU per ml is considered to be positive. 2.4. Milk ring test (MRT) 2.4.1. The antigen represents a bacterial suspension in phenol-saline (NaCI 0,85% (m/
8. v)and phenol at 0,5% (v/v)) stained with haematoxylin. The antigen must be stored at 4°C and not frozen. 2.4.2. The antigen sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces a positive reaction with a 1/500 dilution of the OIEISS in negative milk, while a 1/1 000 dilution should be negative. 2.4.3. The ring test must be made on samples representing the contents of each milk chum or the content of each bulk tank from the farm. 2.4.4. The milk samples must not have been frozen, heated or subjected to violent shaking. 2.4.5. The reaction must be carried out using one of the following methods - on a column of milk of at least 25 mm height and on a volume of milk of 1 ml to which either 0,03 ml or 0,05 ml of one of the standardised stained antigens has been added, - on a column of milk of at least 25 mm height and on a volume of milk of 2 ml to which 0,05 ml of one of the standardised stained antigens has been added, - on a volume of milk of 8 ml to which 0,08 ml of one of the standardised stained antigens has been added. 2.4.6. The mixture of milk and antigens must be incubated at 37°C for sixty minutes, together with positive and negative working standards. A subsequent 16 to 24 hour incubation at 4°C increases the sensitivity of the test. 2.4.7. Interpretation of results (
9. a)negative reaction: coloured milk, colourless cream; (
10. b)positive reaction - identically coloured milk and cream, or colourless milk and coloured cream. 2.5. Rose bengal plate Test (RBT) 2.5.1. The antigen represents a bacterial suspension in buffered Brucella antigen diluent at a pH of 3,65 i 0 05, stained by the use of rose bengal dye. The antigen shall be delivered ready for use and must be stored at 4°C and not frozen. 2.5.2. The antigen shall be prepared without reference to the cell concentration, but its sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces a positive reaction with a serum dilution of 1/45 and a negative reaction with a dilution of 1/55. 2.5.3. The RBT shall be carried out in the following manner: ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 43 (
11. a)serum (20-30
12. pd)is mixed with an equal volume of antigen on a white tile or enamel plate to produce a zone approximately 2 cm in diameter. The mixture is rocked gently for 4 minutes at ambient temperature, and then observed in a good light for agglutination; (
13. b)an automated method may be used but must be at least as sensitive and accurate as the manual method. 2.5.4. Interpretation of results Any visible reaction is considered to be positive, unless there has been excessive drying round the edges. Positive and negative working standards should be included in each series oftests. 2.6. Serum agglutination test (SAT) 2.6.1. The antigen represents a bacterial suspension in phenol-saline (NaC1 0,85% (m/
14. v)and phenol at 0,5% (v/v)). Formaldehyde must not be used. Antigens may be delivered in the concentrated state provided the dilution factor to be used is indicated on the bottle label. EDTA may be added to the antigen suspension to 5 mM final test dilution to reduce the level of false positives to the serum agglutination test. Subsequently the pH of 7,2 must be readjusted in the antigen suspension. 2.6.2. The OIEISS contains 1 000 international units of agglutination. 2.6.3. The antigen shall be prepared without reference to the cell concentration, but its sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces either a 50% agglutination with a final serum dilution of 1/600 to 1/1 000 or a 75% agglutination with a final serum dilution of 1/500 to 1/750. It may also be advisable to compare the reactivity of new and previously standardised batches of antigen using a panel of defined sera. 2.6.4. The test is performed either in tubes or in microplates. The mixture of antigen and serum dilutions should be incubated for 16 to 24 hours at 37°C. At least three dilutions must be prepared for each serum. Dilutions of suspect serum must be made in such a way that the reading of the reaction at the positivity limit is made in the median tube (or well for the microplate method). 2.6.5. Interpretation of results: The degree of Brucella agglutination in a serum must be expressed in IU per ml. A serum containing 30 or more IU per ml is considered to be positive. 3. COMPLEMENTARY TESTS 3.1. Brucellosis skin test (BST) 3.1.1. Conditions for the use of BST (
15. a)The brucellosis skin test shall not be used for the purpose of certification for Intra-Community trade. (
16. b)The brucellosis skin test is one of the most specific tests for the detection of brucellosis in unvaccinated animals, however diagnosis should not be made on the basis of positive intradermal reactions alone. (
17. c)Bovine animals, tested with negative result in one of the serological tests defined in this Annex and reacting positively to the BST shall be regarded as infected. (
18. d)Bovine animals, tested with positive result in one of the serological tests 44 [ S.L.437.48 ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE defined in this Annex may be subject to a BST in to support the interpretation of the serological test results in particular where in brucellosis free or officially free herds a cross-reaction with antibodies against other bacteria cannot be excluded. 3.1.2. The test must be carried out by use of a standardised and defined brucellosis allergen preparation that does not contain smooth lipopolysaccharide (LPS) antigen, as this may provoke non-specific inflammatory reactions or interfere with subsequent serological tests. One of such preparation is Brucellin INRA prepared from a non-smooth strain of B. melitensis. The requirements for its production are detailed in Section B2 of Chapter 2.4.2. of the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000. 3.1.3. Test procedure 3.1.3.1. A volume of 0,1 ml of brucellosis allergen is injected intradermally into the caudal fold, the skin of the flank, or the side of the neck. 3.1.3.2. The test is read after 48-72 hours. 3.1.3.3. The skin thickness at the injection site is measured with vemier callipers before injection and at re-examination. 3.1.3.4. Interpretation of results Strong reactions are easily recoþnised by local swelling and induration. Skin thickening of 1,5 to 2 mm shall be considered as positive reaction to the BST. 3.2. Competitive enzyme-linked immunosorbent assay (cELISA) 3.2.1. Conditions fon the use of cELISA (
19. a)The cELISA shall not be used for the purpose of certification for intraCommunity trade. (
20. b)The cELISA has shown to have a higher specificity than for example the indirect ELISA and may therefore be used in to support the interpretation of the serological test results. 3.2.2. Test pnocedure The test shall be carried out in accordance with the prescription in the CIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1

(2)(a). 4. NATIONAL REFERENCE LABORATORIES 4.1. Tasks and responsibilities National Reference Laboratories designated by the competent authority in accordance with rule 6A shall be responsible for: (

1. a)the approval of the results of the validation studies demonstrating the reliability of the test method used in the Member State; (
2. b)determination of the maximum number of samples to be pooled in ELISA kits used; (
3. c)calibration of the standard secondary reference national standard sera (''working standards'') against the primary international standard serum referred to in paragraph 2.1; ANIMAL HEALTH PROBLEMS AFFECTING INTRACOMMUNITY TRADE IN BOVINE ANIMALS AND SWINE [ S.L.437.48 45 (
4. d)quality checks of all antigens and ELISA kits batches used in the Member State; (
5. e)cooperation within the European Union Network of National Reference Laboratories for Brucellosis. SCHEDULE D CHAPTER I Amended by: L.N. 269 of 2010. OFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER STATES AND REGIONS A. Officially enzootic-bovine-leukosis-free herd means a herd in which (
6. i)there is no evidence, either clinical or as a result of a laboratory test, of any case of enzootic bovine leukosis in the herd and no such case has been confirmed in the previous two years; and (
7. ii)all animals over twenty-four months of age have reacted negatively during the preceding twelve months to two tests carried out in accordance with this Annex, at an interval of at least four months; or (iii) it meets the requirements of (
8. i)above and is situated in an officially enzootic-bovine-leukosis-free Member State or region. B. A herd shall retain officially enzootic-bovine-leukosis-free status provided (
9. i)the condition in A(
10. i)continues to be fulfilled; (
11. ii)any animals introduced into the herd come from an official