2001D0618 — EN — 01.04.2002 — 003.001 — 1
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►B COMMISSIONDECISION
of23July2001
onadditionalguaranteesinintra-CommunitytradeofpigsrelatingtoAujeszky'sdisease,criteria
toprovideinformationonthisdiseaseandrepealingDecisions93/24/EECand93/244/EEC
(notified under document number C(2001) 2236)
(TextwithEEArelevance)
(2001/618/EC)
(OJ L 215, 9.8.2001, p. 48)
Amended by:
Official Journal
No page date
►M1Commission Decision 2001/746/EC of 17 October 2001 L 278 41 23.10.2001
►M2Commission Decision 2001/905/EC of 18 December 2001 L 335 22 19.12.2001
►M3Commission Decision 2002/270/EC of 9 April 2002 L 93 7 10.4.2002
▼B
COMMISSIONDECISION
of23July2001
onadditionalguaranteesinintra-Communitytradeofpigsrelating
to Aujeszky's disease, criteria to provide information on this
diseaseandrepealingDecisions93/24/EECand93/244/EEC
(notified under document number C(2001) 2236)
(TextwithEEArelevance)
(2001/618/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), as last amended and updated by Directive 2000/
20/EC(2), and in particular Article 8, Article 9(2) and Article 10(2)
thereof,
Whereas:
(1)Commission Decision 93/24/EEC(3) establishes additional guar-
antees relating to Aujeszky's disease for pigs destined for
Member States or regions free of the disease.
(2)Commission Decision 93/244/EEC(4) establishes additional
guarantees relating to Aujeszky's disease for pigs destined for
certain parts of the territory of the Community where approvedprogrammes are in place for the eradication of this disease.
(3)The International Office of Epizootic Diseases (OIE) is the inter-national organisation designated under the Agreement on theApplication of Sanitary and Phytosanitary Measures in applica-tion of GATT 1994 which is responsible for the establishmentof international animal health rules for trade in animals and
animal products. These rules are published in the International
Animal HealthCode.
(4)The chapter of the International Animal Health Code onAujeszky's disease has recently been substantially amended.
(5)It is appropriate to modify the additional guarantees required inintra-Community trade of pigs in relation to Aujeszky's diseasein order to ensure their consistency with the international ruleson this disease and better control in the Community.
(6)Criteria must be established on the information to be providedby the Member States on Aujeszky's disease, in accordancewithArticle 8 of Directive 64/432/EEC.
(7)For the sake of clarity Decisions 93/24/EEC and 93/244/EECshould be repealed and a single Decision should be adopted
concerning additional guarantees in intra-Community trade of
pigs relating to Aujeszky's disease and on criteria to provideinformation on this disease.
(8)The measures provided for in this Decision are in accordancewith the opinion of the Standing Veterinary Committee,2001D0618 — EN — 01.04.2002 — 003.001 — 2
(1) OJ 121, 29.7.1964, p. 1977/64.
(2) OJ L 163, 4.7.2000, p. 35.
(3) OJ L 16, 25.1.1993, p. 18.
(4) OJ L 111, 5.5.1993, p. 21.
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HAS ADOPTED THIS DECISION:
Article 1
The dispatching of pigs intended for breeding or production destined
for the Member States or regions free of Aujeszky's disease listed inAnnex I and coming from any other Member State or region not listedin that Annex is authorised subject to 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,
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. Appro-priate measures on pig transport and movements must be in placeaccording to this plan for preventing a spread of disease betweenholdings of a different status;
(c) with regard to the holding of origin of the pigs:
— no clinical, pathological or serological evidence of Aujeszky's
disease has been recorded in the previous 12 months in theholding in question,
— no clinical, pathological or serological evidence of Aujeszky's
disease has been recorded in the previous 12 months in theholdings 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 eradicationmeasures have been regularly applied under the supervision ofthe competent authority and in accordance with the eradicationplan referred to in point (b), and these measures have effec-tively prevented any spread of disease to the holding in
question,
— vaccination against Aujeszky's disease has not been carried out
for at least 12 months,
— the pigs have been subjected on at least two occasions at a
distance of at least four months to a serological survey for thepresence of ADV-gE or ADV-gB or ADV-gD antibody or tothe 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,
— no pigs have been introduced from holdings of a lower animal
health status as regards Aujeszky's disease in the previous 12months, unless they have been tested for Aujeszky's diseasewithnegative results;
(d) the pigs to be moved:
— have not been vaccinated,
— have been kept isolated in accommodation approved by the
competent authority, during the 30 days prior to movement,and in sucha way th at any risk of spreading Aujeszky's diseaseto these pigs is prevented,
— 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,
— have been subjected with negative results to at least two serolo-
gical tests for ADV-gB or ADV-gD or the whole Aujeszky's
disease virus, at a distance of at least 30 days between eachtest. However, in case of pigs less than four months old, theserological test for ADV-gE may also be used. Sampling forthe last test must be performed within 15 days prior to ship-ment. The number of pigs tested in the isolation unit must be
sufficient to detect:
(i) 2 % seroprevalence with95 % confidence in th e isolation
unit in case of pigs intended for production;2001D0618 — EN — 01.04.2002 — 003.001 — 3
▼B
(ii) 0,1 % seroprevalence with95 % confidence in th e 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 (b), a
serological survey has been carried out in the holding oforigin between 45 and 17 days prior to shipment, demon-strating 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
The dispatching of pigs intended for slaughter destined for the Member
States or regions free of Aujeszky's disease listed in Annex I andcoming from any other Member State or region not listed in thatAnnex, is authorised subject to 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 State or regions of origin of the pigs, fulfilling
the criteria laid down in Article 1(b);
(c) all the pigs in question must be transported directly to the slaugh-
terhouse of destination and either:
— they come from a holding which fulfils the conditions laid
down in Article 1(c), or
— they have been vaccinated against Aujeszky's disease at least 15
days prior to their shipment and come from a holding of originwhere:
(i) in the framework of the plan referred to in point (b),
Aujeszky's disease monitoring and eradication measureshave 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 diseasehas been detected at the moment of completion of the
health certificate referred to in Article 7, or
— they have not been vaccinated and they proceed from a holding
where:
(i) in the framework of the plan referred to in point (b),
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 clin-ical, pathological or serological evidence of Aujeszky'sdisease has been recorded in the previous six months;
(ii) vaccination against Aujeszky's disease and introduction of
vaccinated pigs have been forbidden by the competentauthority, since the holding is in the process of reachingthe highest status as regards Aujeszky's disease in accor-dance to the plan referred to in point (b);
(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 eradicationprogrammes are in place, must either:
(a) come from Member States or regions listed in Annex I, or
(b) come from:
— Member States or regions listed in Annex II, and
— a holding which fulfils the requirements of Article 1(c); or2001D0618 — EN — 01.04.2002 — 003.001 — 4
▼B
(c) fulfil the following conditions:
— Aujeszky's disease must be compulsorily notifiable in the
Member State of origin,
— a plan for the control and eradication of Aujeszky's disease is in
place in the Member States or region of origin, which fulfils thecriteria laid down in Article 1(b),
— no clinical, pathological or serological evidence of Aujeszky's
disease has been recorded in the previous 12 months in theholding of origin of the pigs in question,
— 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 sucha way th at any risk ofspreading of Aujeszky's disease is prevented,
— the pigs must have been subjected, with negative results, to a
serological test for the presence of gE antibodies. Sampling forthe last test must be performed within 15 days prior to ship-ment. The number of pigs tested must be sufficient to detect
2 % seroprevalence with95 % confidence in th ese pigs,
— the pigs must lave lived in the bolding of origin or in a holding
of an equivalent status since birth, and have remained in theholding 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 eradicationprogrammes are in place, must either:
(a) come from Member States or regions listed in Annex I, or
(b) come from:
— Member States or regions listed in Annex II, and
— a holding which fulfils the requirements of Article 1(c); or
(c) fulfil the following conditions:
— Aujeszky's disease must be compulsorily notifiable in the
Member State of origin,
— a plan for the control and eradication of Aujeszky's disease is in
place in the Member States or region of origin, which fulfils thecriteria laid down in Article 1(b),
— 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,
— a serological survey for Aujeszky's disease, demonstrating its
absence and that vaccinated pigs have been free from gE anti-
bodies, has been carried out in the holding of origin andbetween 45 and 170 days prior to shipment,
— the pigs must either have lived in the holding of origin since
birth or have remained in such holdings for at least 30 daysafter introduction from a holding of an equivalent status, where
a serological survey equivalent to the one referred to in the
fourthindent above h as 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 laiddown in Annex III.
Article 6
Without prejudice to Article 10(3) of Directive 64/432/EEC, informa-
tion of the occurrence of Aujeszky's disease, including details of the
monitoring and eradication programmes in operation in the MemberStates listed in Annex II and in the other Member States or regionsnot listed in that Annex where monitoring and eradication prorammesare in place, must be provided at least annually by eachMember Statein accordance withth e uniform criteria laid down in Annex IV.2001D0618 — EN — 01.04.2002 — 003.001 — 5
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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 requiredby Directive 64/432/EC, 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 asregards 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 ofSection C of the health certificate referred to in paragraph 1 shall becompleted 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 isrelevant 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 incontact withpigs of different or unknown status, as regards Aujeszky's
disease, during transport or transit.
Article 9
Decisions 93/24/EEC and 93/244/EEC are repealed as from the date
laid down in Article 10.
Article 10
This Decision shall apply from 1 July 2002.
Article 11
This Decision is addressed to the Member States.2001D0618 — EN — 01.04.2002 — 003.001 — 6
▼M3
ANNEX I
Member States or regions thereof free of Aujeszky's disease and where
vaccinationisprohibited
Denmark: all regions
United Kingdom: all regions in England, Scotland and Wales
France: the départements of Aisne, Allier, Ardennes, Ariège,
Aube, Aude, Aveyron, Bas-Rhin, Bouches-du-Rhône,
Calvados, Cantal, Charente, Charente-Maritime, Cher,
Corrèze, Côte d'Or, Creuse, Deux-Sèvres, Dordogne,
Doubs, Eure, Eure-et-Loir, Gard, Gers, Gironde, Haute
Garonne, Haute-Loire, Haute-Marne, Haute-Pyrénées,
Haut-Rhin, Haute-Saône, Indre, Indre-et-Loire, Jura,
Landes, Loire, Loire-Atlantique, Loir-et-cher, Loiret,
Lot, Lot-et-Garonne, Lozère, Maine-et-Loire, Marne,
Meurthe-et-Moselle, Meuse, Moselle, Nièvre, Oise,
Pyrénées-Atlantiques, Puy-de-Dôme, Rhône, Sarthe,
Saône-et-Loire, Savoie, Seine-Maritime, Somme,
Vaucluse, Tarn, Tarn-et-Garonne, Territoire de Belfort,
Vendée, Vienne, Vosges, Yonne
Finland: all regions
Germany: the Länderof Thüringen, Sachsen, Brandenburg, Meck-
lenburg-Vorpommern, Sachsen-Anhalt, Rheinland-
Pfalz, Baden-Württemberg, Hessen, Schleswig-
Holstein, Saarland, Hamburg, Bremen, Berlin and
Bayern
Austria: all regionsSweden: all regions
Luxembourg: whole territory.2001D0618 — EN — 01.04.2002 — 003.001 — 7
▼M3
ANNEX II
Member States or regions thereof where approved Aujeszky's disease
controlprogrammesareinplace
Germany: the Länderof Niedersachsen, Nordrhein-Westfalen
Belgium: the whole territory
The Netherlands: the whole territory.2001D0618 — EN — 01.04.2002 — 003.001 — 8
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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
glycoproteinD(ADV-gD)ortoglycoprotein 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 kitsthat 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 batchcontrol, Community reference serum ADV 1 must be scored
positive at 1:8 dilution and one of the Community reference serum sera
from ADV-gE G to ADV-gE Q, as listed in point (b), must be scored
negative.
For batchcontrol of ADV-gB and ADV-gD kits, Community reference
serum ADV 1 must be scored positive at the dilution of 1:2 and Commu-
nity 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.
— Belgium — Centre de Recherches vétérinaires et agrochimiques,
1180 Bruxelles;
— Denmark — Statens veterinære Institut for Virusforsknig, Lindholm,
4771 Kalvehave;
— Germany — Bundesforschungsanstalt für Viruskrankheiten der Tiere,
16868 Wusterhausen,
— Greece — Veterinary Institute of Infectious and Parasitic Diseases,
15310 Ag. Paraskevi,
— Spain — Laboratorio Central de Veterinaria de Algete, Madrid,
— France — École nationale vétérinaire, Alfort, 94704 Maisons-Alfort,— Ireland — Veterinary ResearchLaboratory, Abbotstown, Castle-
knock, Dublin 15,
— Italy — Istituto Zooprofilattico Sperimentale della Lombardia a
dell'Emilia-Romagna, Brescia,
— Luxembourg — Laboratoire de Médecine Vétérinaire de l'État, 1020
Luxembourg,
— The Netherlands — Instituut voor Veehouderij en Diergezondheid
(ID-DLO), 8200 AB Lelystad,
— Austria — Bundesanstalt für veterinärmedizinische Untersuchungen
in Mödling, 2,40 Modling,2001D0618 — EN — 01.04.2002 — 003.001 — 9
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— Portugal — Laboratório Nacional de Investigaão Veterinária, 1500
Lisboa,
— Finland — Eläinlääkintä- ja elintarviketutkimuslaitos, 00581
Helsinki,
— Sweden — Statens veterinarmedicinska anstalt, 75189 Uppsala,
— United Kingdom — Veterinary Laboratory Agency, New Haw,
Weybridge, Surrey KT15 3NB.2001D0618 — EN — 01.04.2002 — 003.001 — 10
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ANNEX IV
2001D0618 — EN — 01.04.2002 — 003.001 — 11