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 swine1, and in particular Article 8, Article 9(2) and Article 10(2) thereof,
Whereas:
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/EEC2 has been substantially amended several times3. In the interests of clarity and rationality the said Decision should be codified.
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.
The chapter of the International Animal Health Code on Aujeszky’s disease has been substantially amended.
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.
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.
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 1
F6Great 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;
- (a)
- 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;
- (i)
- (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.
- (i)
- (a)
Article 2
F7Pigs 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 F8accompanying the consignment; or
- (i)
- (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.
- (i)
- (a)
F9Article 3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F10Article 4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
F11Article 6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F12Article 7
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.
F13Article 8
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 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.
F14Article 10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F2ANNEX I Member States or regions thereof free of Aujeszky’s disease and where vaccination is prohibited
Words in Annex 1 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 51(9) (with regs. 69-71)
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 |
F3. . . | F3. . . | F3. . . |
ANNEX IIMember 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 IIIStandards 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)
F1The 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
F4. . .
F4. . .
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
F5ANNEX IVCriteria 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 4 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 51(11) (with regs. 69-71)
F51.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F52.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F53.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F54.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F55.Information on AD vaccination, serological investigations and categorisation of holdings (please complete the attached table):
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F56.Further information on serological monitoring in Artificial Insemination Centres, for export purposes, in the framework of other surveillance schemes, etc.:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ANNEX V
Commission Decision 2001/618/EC | |
Commission Decision 2001/746/EC | Only as regards the reference to Decision 2001/618/EC in Article 1 |
Commission Decision 2001/905/EC | Only as regards the reference to Decision 2001/618/EC in Article 2 |
Commission Decision 2002/270/EC | Only Article 3 |
Commission Decision 2003/130/EC | |
Commission Decision 2003/575/EC | |
Commission Decision 2004/320/EC | Only Article 2 and Annex II |
Commission Decision 2005/768/EC | |
Commission Decision 2006/911/EC | Only as regards the reference to Decision 2001/618/EC in Article 1 and point 12 of the Annex |
Commission Decision 2007/603/EC | |
Commission Decision 2007/729/EC | Only as regards the reference to Decision 2001/618/EC in Article 1 and point 10 of the Annex |
ANNEX VI
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 |
Substituted by Commission Implementing Decision (EU) 2019/1970 of 26 November 2019 amending Annex II to Decision 93/52/EEC as regards the officially brucellosis (B. melitensis)-free status and Annex II to Decision 2003/467/EC as regards the officially brucellosis-free status of certain regions of Spain and Annexes I and II to Decision 2008/185/EC as regards the free status and the approval of the eradication programmes for Aujeszky’s disease for certain regions of Italy (notified under document C(2019) 8378) (Text with EEA relevance).