2008D0185 — EN — 21.08.2009 — 004.001

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

►B COMMISSION DECISION of 21 February 2008 on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease and criteria to provide information on this disease (notified under document number C(2008) 669) (Codified version) (Text with EEA relevance) (2008/185/EC) (OJ L 059, 4.3.2008, p.19)

Amended by:









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COMMISSION DECISION

of 21 February 2008

on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease and criteria to provide information on this disease

(notified under document number C(2008) 669)

(Codified version)

(Text with EEA relevance)

(2008/185/EC)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine ( 1 ), and in particular Article 8, Article 9(2) and Article 10(2) thereof, Whereas: (1) Commission Decision 2001/618/EC of 23 July 2001 on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease, criteria to provide information on this disease and repealing Decisions 93/24/EEC and 93/244/EEC ( 2 ) has been substantially amended several times ( 3 ). In the interests of clarity and rationality the said Decision should be codified. (2) The International Office of Epizootic Diseases (OIE) is the international organisation designated under the Agreement on the Application of Sanitary and Phytosanitary Measures in application of GATT 1994 which is responsible for the establishment of international animal health rules for trade in animals and animal products. These rules are published in the International Animal Health Code. (3) The chapter of the International Animal Health Code on Aujeszky’s disease has been substantially amended. (4) It is appropriate to modify the additional guarantees required in intra-Community trade of pigs in relation to Aujeszky’s disease in order to ensure their consistency with the international rules on this disease and better control in the Community. (5) Criteria must be established on the information to be provided by the Member States on Aujeszky’s disease, in accordance with Article 8 of Directive 64/432/EEC. (6) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS DECISION:







Article 1

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Pigs intended for breeding or production, dispatched to Member States or regions thereof which are free of Aujeszky’s disease and which are listed in Annex I must come from a Member State or region thereof listed in that Annex or must comply with the following additional conditions:

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1. Aujeszky’s disease must be compulsorily notifiable in the Member State of origin;

2. a plan for the control and eradication of Aujeszky’s disease, fulfilling the criteria laid down in Article 9(1) of Directive 64/432/EEC, must be in place in the Member State or regions of origin under the supervision of the competent authority. 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. with regard to the holding of origin of the pigs: (a) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous 12 months in the holding in question; (b) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous 12 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 competent authority and in accordance with the eradication plan referred to in point (2), and these measures have effectively prevented any spread of disease to the holding in question; (c) vaccination against Aujeszky’s disease has not been carried out for at least 12 months; (d) the pigs have been subjected on at least two occasions at an interval 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; (e) no pigs have been introduced from holdings of a lower animal health status as regards Aujeszky’s disease in the previous 12 months, unless they have been tested for Aujeszky’s disease with negative results;

4. the pigs to be moved: (a) have not been vaccinated; (b) have been kept isolated in accommodation approved by the competent authority, during the 30 days prior to movement, and in such a way that any risk of spreading Aujeszky’s disease to these pigs is prevented; (c) 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: (i) 30 days, in the case of pigs intended for production; (ii) 90 days, in the case of pigs intended for breeding; (d) 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 30 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 15 days prior to shipment. The number of pigs tested in the isolation unit must be sufficient to detect: (i) 2 % seroprevalence with 95 % confidence in the isolation unit in case of pigs intended for production; (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: (i) in the framework of the plan referred to in point (2), a serological survey has been carried out in the holding of origin between 45 and 170 days prior to shipment, demonstrating the absence of Aujeszky’s disease antibodies and that vaccinated pigs have been free from gE antibodies; (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.

Article 2

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Pigs intended for slaughter, dispatched to Member States or regions thereof which are free of Aujeszky’s disease and which are listed in Annex I must come from a Member State or region thereof listed in that Annex or must comply with the following additional conditions:

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1. Aujeszky’s disease must be compulsorily notifiable in the Member State of origin;

2. a plan for the control and eradication of Aujeszky’s disease is in place in the Member State or regions of origin of the pigs, fulfilling the criteria laid down in Article 1(2);

3. all the pigs in question must be transported directly to the slaughterhouse of destination and either: (a) they come from a holding which fulfils the conditions laid down in Article 1(3); or (b) they have been vaccinated against Aujeszky’s disease at least 15 days prior to their shipment and come from a holding of origin where: (i) in the framework of the plan referred to in point (2), Aujeszky’s disease monitoring and eradication measures have been regularly applied under the supervision of the competent authority for the previous 12 months; (ii) they had remained for at least 30 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 Article 7; or (c) they have not been vaccinated and they proceed from a holding where: (i) in the framework of the plan referred to in point 2, Aujeszky’s disease monitoring and eradication measures have been regularly applied under the supervision of the competent authority in the previous 12 months and no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous six months; (ii) vaccination against Aujeszky’s disease and introduction of vaccinated pigs have been forbidden by the competent authority, 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 point (2); (iii) they have lived for at least 90 days before dispatch.

Article 3

Pigs intended for breeding destined for the Member States or regions listed in Annex II, where approved Aujeszky’s disease eradication programmes are in place, must either:

1. come from Member States or regions listed in Annex I; or

2. come from: (a) Member States or regions listed in Annex II; and (b) a holding which fulfils the requirements of Article 1(3); or

3. fulfil the following conditions: (a) Aujeszky’s disease must be compulsorily notifiable in the Member State of origin; (b) a plan for the control and eradication of Aujeszky’s disease is in place in the Member States or region of origin, which fulfils the criteria laid down in Article 1(2); (c) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous 12 months in the holding of origin of the pigs in question; (d) the pigs must have been isolated in accommodation approved by the competent authority for the 30 days immediately prior to movement and kept isolated in such a way that any risk of spreading of Aujeszky’s disease is prevented; (e) 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 15 days prior to shipment. The number of pigs tested must be sufficient to detect 2 % seroprevalence with 95 % confidence in these pigs; (f) the pigs 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 90 days.

Article 4

Pigs intended for production destined for the Member States or regions listed in Annex II, where approved Aujeszky’s disease eradication programmes are in place, must either:

1. come from Member States or regions listed in Annex I; or

2. come from: (a) Member States or regions listed in Annex II; and (b) a holding which fulfils the requirements of Article 1(3); or

3. fulfil the following conditions: (a) Aujeszky’s disease must be compulsorily notifiable in the Member State of origin; (b) a plan for the control and eradication of Aujeszky’s disease is in place in the Member States or region of origin, which fulfils the criteria laid down in Article 1 point (2); (c) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous 12 months in the holding of origin of the pigs in question; (d) 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 45 and 170 days prior to shipment; (e) the pigs must either have lived in the holding of origin since birth or have remained in such holdings for at least 30 days after introduction from a holding of an equivalent status, where a serological survey equivalent to the one referred to in point (d) has been carried out.

Article 5

The serological tests carried out to monitor or detect Aujeszky’s disease in pigs in accordance with this Decision must meet the standards laid down in Annex III.

Article 6

Without prejudice to Article 10(3) of Directive 64/432/EEC, information on the occurrence of Aujeszky’s disease, including details of the monitoring and eradication programmes in operation in the Member States listed in Annex II and in the other Member States or regions not listed in that Annex where monitoring and eradication programmes are in place, must be provided at least annually by each Member State in accordance with the uniform criteria laid down in Annex IV.

Article 7

1. 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, of section C of the health certificate required by Directive 64/432/EEC, the official veterinarian shall ascertain:

(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;

(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;

(c) the compliance of the pigs in question with the conditions laid down in this Decision.

2. For animals of the porcine species destined for Member States or regions listed in Annex I or II, the certification under paragraph 4 of Section C of the health certificate referred to in paragraph 1 shall be completed and supplemented as follows:

(a) in the first indent, after the word ‘disease’ the word ‘Aujeszky’ must be added;

(b) in the second indent, reference shall be made to this Decision. In the same line, the number of the Article of this Decision, which is relevant for the pigs in question, shall be quoted between brackets.

Article 8

Member States must ensure that when pigs destined for Member States or regions listed in Annex I or II are transported, they shall not come in contact with pigs of different or unknown status, as regards Aujeszky’s disease, during transport or transit.

Article 9

Decision 2001/618/EC is repealed.

References to the repealed Decision shall be construed as references to this Decision and shall be read in accordance with the correlation table in Annex VI.

Article 10

This Decision is addressed to the Member States.

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ANNEX I







Member States or regions thereof free of Aujeszky’s disease and where vaccination is prohibited ISO code Member State Regions AT Austria All regions CY Cyprus All regions CZ Czech Republic All regions DE Germany All regions DK Denmark All regions FI Finland All regions FR France The departments of Ain, Aisne, Allier, Alpes-de-Haute-Provence, Alpes-Maritimes, Ardèche, Ardennes, Ariège, Aube, Aude, Aveyron, Bas-Rhin, Bouches-du-Rhône, Calvados, Cantal, Charente, Charente-Maritime, Cher, Corrèze, Côte-d’Or, Côtes-d’Armor, Creuse, Deux-Sèvres, Dordogne, Doubs, Drôme, Essonne, Eure, Eure-et-Loir, Finistère, Gard, Gers, Gironde, Hautes-Alpes, Hauts-de-Seine, Haute Garonne, Haute-Loire, Haute-Marne, Hautes-Pyrénées, Haut-Rhin, Haute-Saône, Haute-Savoie, Haute-Vienne, Hérault, Ille-et-Vilaine, Indre, Indre-et-Loire, Isère, Jura, Landes, Loire, Loire-Atlantique, Loir-et-Cher, Loiret, Lot, Lot-et-Garonne, Lozère, Maine-et-Loire, Manche, Marne, Mayenne, Meurthe-et-Moselle, Meuse, Morbihan, Moselle, Nièvre, Nord, Oise, Orne, Paris, Pas-de-Calais, Pyrénées-Atlantiques, Pyrénées-Orientales, Puy-de-Dôme, Réunion, Rhône, Sarthe, Saône-et-Loire, Savoie, Seine-et-Marne, Seine-Maritime, Seine-Saint-Denis, Somme, Tarn, Tarn-et-Garonne, Territoire de Belfort, Val-de-Marne, Val-d’Oise, Var, Vaucluse, Vendée, Vienne, Vosges, Yonne, Yvelines LU Luxembourg All regions NL The Netherlands All regions SK Slovakia All regions SE Sweden All regions UK United Kingdom All regions in England, Scotland and Wales

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ANNEX II







Member States or regions thereof where approved Aujeszky’s disease control programmes are in place ISO code Member State Regions BE Belgium All regions ES Spain The territory of the Autonomous Communities of Galicia, País Vasco, Asturias, Cantabria, Navarra, La Rioja The territory of the provinces of León, Zamora, Palencia, Burgos, Valladolid and Ávila in the Autonomous Community of Castilla y León The territory of the province of Las Palmas in the Canary Islands HU Hungary All regions IT Italy The province of Bolzano UK United Kingdom All regions in Northern Ireland

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ANNEX III

Standards for Aujeszky’s disease serological tests — Protocol for the enzyme linked immunosorbent assay (ELISA) for detecting antibodies to Aujeszky’s disease virus (whole virus), to glycoprotein B (ADV-gB), to glycoprotein D (ADV-gD) or to glycoprotein E (ADV-gE)

1. The institutes listed in paragraph 2(d) shall evaluate Elisa ADV-gE tests and kits against the criteria in paragraph 2(a), (b) and (c). The competent authority in each Member State shall ensure that only Elisa ADV-gE kits that meet these standards shall be registered. The examinations listed in 2(a) and (b) must be carried out prior to approval of the test and the examination in 2(c), at least, must thereafter be carried out on each batch.

2. Standardisation, sensitivity and specificity of the test. (a) The sensitivity of the test must be of such a level that the following Community reference sera are scored positive: — Community reference serum ADV 1 at 1:8 dilution, — Community reference serum ADV-gE A, — Community reference serum ADV-gE B, — Community reference serum ADV-gE C, — Community reference serum ADV-gE D, — Community reference serum ADV-gE E, — Community reference serum ADV-gE F. (b) The specificity of the test must be of such a level that the following Community reference sera are scored negative: — Community reference serum ADV-gE G, — Community reference serum ADV-gE H, — Community reference serum ADV-gE J, — Community reference serum ADV-gE K, — Community reference serum ADV-gE L, — Community reference serum ADV-gE M, — Community reference serum ADV-gE N, — Community reference serum ADV-gE O, — Community reference serum ADV-gE P, — Community reference serum ADV-gE Q. (c) For batch control, Community reference serum ADV 1 must be scored positive at 1:8 dilution and one of the Community reference sera from ADV-gE G to ADV-gE Q, as listed in point (b), must be scored negative. For batch control of ADV-gB and ADV-gD kits, Community reference serum ADV 1 must be scored positive at the dilution of 1:2 and Community reference serum Q referred to in (b) should be scored negative. (d) The institutes listed below will, in addition, be responsible for checking the quality of the ELISA method in each Member State, and in particular for producing and standardising national reference sera according to the Community reference sera.



AT AGES: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH — Institut für veterinärmedizinische Untersuchungen Mödling (Austrian Agency for Health and Consumer Protection — Institute for veterinary investigations Mödling)Robert Koch-Gasse 17A-2340 MödlingTel. +43 (0) 505 55-38112Fax +43 (0) 505 55-38108E-mail: vetmed.moedling@ages.at BE CODA — CERVA — VARVeterinary and Agrochemical Research CentreGroeselenberg 99B-1180 Brussels CY State Veterinary LaboratoryVeterinary Services1417 AthalassaNicosia CZ — DE Friedrich-Loeffler-InstitutBundesforschungsinstitut für TiergesundheitStandort WusterhausenSeestraße 55D-16868 WusterhausenTel. + 49 33979 80-0Fax + 49 33979 80-200 DK National Veterinary Institute, Technical University of DenmarkLindholmDK-4771 Kalvehave EE Veterinaar- ja ToidulaboratooriumKreutzwaldi 30, 51006 Tartu, EstoniaTel. + 372 7 386 100Faks: + 372 7 386 102E-mail: info@vetlab.ee ES Laboratorio Central de Sanidad Animal de AlgeteCarretera de Algete, km 8Algete 28110 (Madrid)Tel. +34 916 290 300Fax +34 916 290 598E-mail: lcv@mapya.es FI Finnish Food Safety AuthorityAnimal Diseases and Food Safety ResearchMustialankatu 3FI-00790 Helsinki, FinlandE-mail: info@evira.fiTel. +358 20 772 003 (exchange)Fax +358 20 772 4350 FR Laboratoire d’études et de recherches avicoles, porcines et piscicolesAFSSA site de Ploufragan/Brest —LERAPPBP 5322440 Ploufragan UK Veterinary Laboratories AgencyNew Haw, Addlestone, WeybridgeSurrey KT15 3NB, UKTel. (44-1932) 341111Fax (44-1932) 347046 GR Centre of Athens Veterinary Institutes25 Neapoleos Street,GR-153 10 Agia Paraskevi AttikiTel. +30 2106010903 HU Mezőgazdasági Szakigazgatási Hivatal Központ, Állat-egészségügyi Diagnosztikai IgazgatóságCentral Agricultural Office, Veterinary Diagnostic DirectorateAddress: 1149 Budapest, Tábornok u. 2.Mailing Address: 1581 Budapest, 146. Pf. 2.Tel. +36 1 460-6300Fax +36 1 252-5177E-mail: titkarsag@oai.hu IE Virology DivisionCentral Veterinary Research LaboratoryDepartment of Agriculture and Food LaboratoriesBackweston CampusStacumny LaneCelbridgeCo. Kildare IT Centro di referenza nazionale per la malattia di Aujeszky —Pseudorabbia c/o Istituto zooprofilattico sperimentale della Lombardia e dell’Emilia Romagna,Via Bianchi, 9;25124 Brescia LT National Veterinary Laboratory(Nacionalinė veterinarijos laboratorija)J. Kairiūkščio 10LT-08409 Vilnius LU CODA — CERVA — VARVeterinary and Agrochemical Research CentreGroeselenberg 99B-1180 Brussels LV Nacionālais diagnostikas centrs(National Diagnostic Centre)Lejupes iela 3, Rīga, LV-1076Tel. +371 7620526Fax +371 7620434E-mail: ndc@ndc.gov.lv MT — NL Centraal Instituut voor Dierziekte ControleCIDC-LelystadHoofdvestiging: Houtribweg 39Nevenvestiging: Edelhertweg 15Postbus 20048203 AA Lelystad PL Laboratory Departement of Swine DiseasesPaństwowy Instytut Weterynaryjny – Państwowy InstytutBadawczyal. Partyzantów 57, 24-100 PuławyTel. +48 81 889 30 00Fax +48 81 886 25 95E-mail: sekretariat@piwet.pulawy.pl PT Laboratório Nacional de Investigação Veterinária (LNIV)Estrada de Benfica, 701P-1549-011 Lisboa SE Statens veterinärmedicinska anstaltDepartment of VirologyS-751 89 UppsalaTel. (46-18) 67 40 00Fax (46-18) 67 44 67 SI Univerza v LjubljaniVeterinarska fakultetaNacionalni veterinarski inštitutGerbičeva 60,SI-1000 Ljubljana SK Štátny veterinárny ústavPod dráhami 918960 86 ZvolenSlovenska republika









ANNEX IV

Criteria on the information to be provided on the occurrence of Aujeszky’s disease (AD) and on plans for the monitoring and eradication of this disease, to be provided in accordance with Article 8 of Council Directive 64/432/EEC

1. Member State: …

2. Date: …

3. Reporting period: …

4. Number of holdings where AD has been detected by means of clinical, serological or virological investigations: …

5. Information on AD vaccination, serological investigations and categorisation of holdings (please complete the attached table):



Region Number of pig holdings Number of pig holdings under an AD-pogramme (1) Number of AD not-infected pig holdings (with vaccination) (2) Number of AD free pig holdings (without vaccination) (3) Total (1) Programme under the supervision of the competent authority. (2) Pig holdings where serological tests for AD have been carried out with negative results in accordance with an official AD programme and where vaccination has been applied during the previous 12 months. (3) Pig holdings which fulfil the conditions of Article 1(3).

6. Further information on serological monitoring in Artificial Insemination Centres, for export purposes, in the framework of other surveillance schemes, etc.: … … … …









ANNEX V







REPEALED DECISION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Commission Decision 2001/618/EC (OJ L 215, 9.8.2001, p. 48). Commission Decision 2001/746/EC (OJ L 278, 23.10.2001, p. 41). Only as regards the reference to Decision 2001/618/EC in Article 1 Commission Decision 2001/905/EC (OJ L 335, 19.12.2001, p. 22). Only as regards the reference to Decision 2001/618/EC in Article 2 Commission Decision 2002/270/EC (OJ L 93, 10.4.2002, p. 7). Only Article 3 Commission Decision 2003/130/EC (OJ L 52, 27.2.2003, p. 9). Commission Decision 2003/575/EC (OJ L 196, 2.8.2003, p. 41). Commission Decision 2004/320/EC (OJ L 102, 7.4.2004, p. 75). Only Article 2 and Annex II Commission Decision 2005/768/EC (OJ L 290, 4.11.2005, p. 27). Commission Decision 2006/911/EC (OJ L 346, 9.12.2006, p. 41). Only as regards the reference to Decision 2001/618/EC in Article 1 and point 12 of the Annex Commission Decision 2007/603/EC (OJ L 236, 8.9.2007, p. 7). Commission Decision 2007/729/EC (OJ L 294, 13.11.2007, p. 26). Only as regards the reference to Decision 2001/618/EC in Article 1 and point 10 of the Annex









ANNEX VI







Correlation table Decision 2001/618/EC This Decision Article 1(a) and (b) Article 1, points 1 and 2 Article 1(c) first to fifth indent Article 1, point 3(a) to (e) Article 1(d) first to fourth indent Article 1, point 4(a) to (d) Article 2(a) and (b) Article 2, points 1 and 2 Article 2(c) first to third indent Article 2, point 3(a) to (c) Article 3(a) Article 3, point 1 Article 3(b) first and second indent Article 3, point 2(a) and (b) Article 3(c) first to sixth indent Article 3, point 3(a) to (f) Article 4(a) Article 4, point 1 Article 4(b) first and second indent Article 4, point 2(a) and (b) Article 4(c) first to fifth indent Article 4, point 3(a) to (e) Articles 5 to 8 Articles 5 to 8 Article 9 — Article 10 — — Article 9 Article 11 Article 10 Annexes I to IV Annexes I to IV — Annex V — Annex VI