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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)

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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,

HAS ADOPTED THIS DECISION:

Article 1U.K.

[F1Great Britain is free of Aujeszky's disease and vaccination is prohibited in Great Britain. The member States or regions of such States that are recognised as free from the disease are listed in Annex I, and those that are not free but have EU approved Aujeszky's disease eradication plans in place are listed in Annex II. Pigs intended for breeding or production dispatched to Great Britain must come from a member State or region thereof listed in Annex I or must comply with the following additional conditions:]

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 2U.K.

[F2Pigs intended for slaughter dispatched to Great Britain must come from a member State or region thereof listed in Annex I or must comply with the following additional conditions:]

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 [F3accompanying the consignment]; 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.

F4Article 3U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5Article 4U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 5U.K.

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.

F6Article 6U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F7Article 7U.K.

In the case of pigs destined for Great Britain from a member State, it is a requirement that the official veterinarian in the country of origin has ascertained the disease status of the holding of origin and the disease-free status of the region of origin and checked the compliance of the pigs in question with the conditions laid down in this Decision.]

[F8Article 8U.K.

When pigs are transported to Great Britain, it is a requirement that the exporting member State has ensured that the pigs do not come into contact with pigs of different or unknown status, as regards Aujeszky's disease, during transport or transit.]

Article 9U.K.

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.

F9Article 10U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F10ANNEX IU.K. Member States or regions thereof free of Aujeszky’s disease and where vaccination is prohibited

ISO code Member State Regions
BE Belgium All regions
CZ Czechia All regions
DK Denmark All regions
DE Germany All regions
IE Ireland 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, Indre, Ille-et-Vilaine, 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
IT Italy

Autonomous Province of Bolzano

Region Friuli Venezia Giulia

CY Cyprus All regions
LU Luxembourg All regions
HU Hungary All regions
NL Netherlands All regions
AT Austria All regions
PL Poland Voivodship podlaskie the following powiaty: augustowski, białostocki, Białystok, bielski, hajnowski, moniecki, sejneński, siemiatycki, sokólski, suwalski, Suwałki
SI Slovenia All regions
SK Slovakia All regions
FI Finland All regions
SE Sweden All regions
F11. . .F11. . .F11. . .

ANNEX II U.K. Member States or regions thereof where approved national control programmes for the eradication of Aujeszky's disease are in place

ISO code Member State Regions
ES Spain All regions
IT Italy

Region Emilia-Romagna

Region Lombardia

Region Piemonte

Region Umbria

Region Veneto

LT Lithuania All regions
PL Poland

Voivodship dolnośląskie: all powiaty;

Voivodship kujawsko-pomorskie: all powiaty;

Voivodship lubelskie: all powiaty;

Voidodship lubuskie: all powiaty;

Voivodship łódzkie: all powiaty;

Voivodship małopolskie: all powiaty;

Voivodship mazowieckie: all powiaty;

Voivodship opolskie: all powiaty;

Voivodship podkarpackie: all powiaty;

Voivodship podlaskie the following powiaty: grajewski, kolneński, łomżyński, Łomża, wysokomazowiecki, zambrowski.

Voivodship pomorskie: all powiaty;

Voivodship śląskie: all powiaty;

Voivodship świętokrzyskie: all powiaty;

Voivodship warmińsko-mazurskie: all powiaty;

Voivodship wielkopolskie: all powiaty;

Voivodship zachodniopomorskie: all powiaty.]

ANNEX IIIU.K.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.U.K.

2.Standardisation, sensitivity and specificity of the test.U.K.

(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)

[F12The 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 17

A-2340 Mödling

Tel. +43 (0) 505 55-38112

Fax +43 (0) 505 55-38108

Email: vetmed.moedling@ages.at

BE

CODA — CERVA — VAR

Veterinary and Agrochemical Research Centre

Groeselenberg 99

B-1180 Brussels

CY

State Veterinary Laboratory

Veterinary Services

1417 Athalassa

Nicosia

CZ

Státní veterinární ústav Olomouc

Jakoubka ze Stříbra 1

779 00 Olomouc

Telefon: 585 557 111

Fax 585 222 394

email: svuolomouc@svuol.cz

DE

Friedrich-Loeffler-Institut

Bundesforschungsinstitut für Tiergesundheit

Südufer 10

D-17493 Greifswald — Insel Riems

Tel. + 49 38351 7-0

Fax + 49 38351 7-1219, 7-1151, 7-1226

DK

National Veterinary Institute

Technical University of Denmark

Lindholm Island

DK-4774 Kalvehave

Denmark

Switchboard: +45 88 60 00

Fax +45 88 79 01

Email: vet@vet.dtu.dk

EE

Veterinaar- ja Toidulaboratoorium

Kreutzwaldi 30,

51006 Tartu,

Estonia

Tel. + 372 7 386 100

Faks: + 372 7 386 102

Email: info@vetlab.ee

ES

Laboratorio Central de Sanidad Animal de Algete

Carretera de Algete, km 8

Algete 28110 (Madrid)

Tel. +34 916 290 300

Fax +34 916 290 598

Email: lcv@mapya.es

FI

Finnish Food Safety Authority

Animal Diseases and Food Safety Research

Mustialankatu 3

FI-00790 Helsinki, Finland

Email: info@evira.fi

Tel. +358 20 772 003 (exchange)

Fax +358 20 772 4350

FR

Laboratoire d'études et de recherches avicoles, porcines et piscicoles

AFSSA site de Ploufragan/Brest —

LERAPP

BP 53

22440 Ploufragan

F13. . .F13. . .
GR

Centre of Athens Veterinary Institutes

25 Neapoleos Street,

GR-153 10 Agia Paraskevi Attiki

Tel. +30 2106010903

HU

Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állat-egészségügyi Diagnosztikai Igazgatóság

Central Agricultural Office, Veterinary Diagnostic Directorate

Address: 1149 Budapest, Tábornok u. 2.

Mailing Address: 1581 Budapest, 146. Pf. 2.

Tel. +36 1 460-6300

Fax +36 1 252-5177

Email: ugyfelszolgalat@nebih.gov.hu

IE

Virology Division

Central Veterinary Research Laboratory

Department of Agriculture and Food Laboratories

Backweston Campus

Stacumny Lane

Celbridge

Co. 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 10

LT-08409 Vilnius

LU

CODA — CERVA — VAR

Veterinary and Agrochemical Research Centre

Groeselenberg 99

B-1180 Brussels

LV

Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts ‘BIOR’

(Institute of Food Safety, Animal Health and Environment BIOR)

Lejupes iela 3,

Rīga, LV-1076

Tel. +371 76205 13

Fax +371 7620434

Email: bior@bior.lv

MT

National Veterinary Laboratory

Veterinary and Phytosanitary Regulation Department

Ministry for Sustainable Development, the Environment and Climate Change,

Abattior Square, Albert Town, Triq Prince Albert,

Marsa, Malta

Tel. +356 22925389

NL

Centraal Instituut voor Dierziekte Controle

CIDC-Lelystad

Hoofdvestiging: Houtribweg 39

Nevenvestiging: Edelhertweg 15

Postbus 2004

8203 AA Lelystad

PL

Laboratory Department of Swine Diseases

Państwowy Instytut Weterynaryjny — Państwowy Instytut

Badawczy

al. Partyzantów 57, 24-100 Puławy

Tel. +48 81 889 30 00

Fax +48 81 886 25 95

Email: sekretariat@piwet.pulawy.pl

PT

Laboratório Nacional de Investigação Veterinária (LNIV)

Estrada de Benfica, 701

P-1549-011 Lisboa

RO

Laboratorul Național de Referință pentru Herpesviroze

Institutul de Diagnostic și Sănătate Animală

Str. Dr Staicovici, nr. 6, cod 050557, sector 5, București

telefon: 0374.322.015

fax 0214.113.394

email: office@idah.ro

SE

Statens veterinärmedicinska anstalt

Department of Virology

S-751 89 Uppsala

Tel. (46-18) 67 40 00

Fax (46-18) 67 44 67

SI

Univerza v Ljubljani

Veterinarska fakulteta

Nacionalni veterinarski inštitut

Gerbičeva 60,

SI-1000 Ljubljana

SK

Štátny veterinárny ústav

Pod dráhami 918

960 86 Zvolen

Slovenska republika]

F14ANNEX IVU.K.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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANNEX VU.K.

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 VIU.K.

Correlation table

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

OJ 121, 29.7.1964, p. 1977/64. Directive as last amended by Commission Decision 2007/729/EC (OJ L 294, 13.11.2007, p. 26).

(2)

OJ L 215, 9.8.2001, p. 48. Decision as last amended by Decision 2007/729/EC.

(3)

See Annex V.

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