2001/618/EC: Commission Decision 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 (Text with EEA relevance) (notified under document number C(2001) 2236)
Date: 2001-07-23
Institutions: European Commission
Subjects: animal disease, health certificate, intra-EU trade, swine, veterinary inspection

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COMMISSION DECISION

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

(notified under document number C(2001) 2236)

(Text with EEA relevance)

(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)

(2)

(3)

(4)

(5)

(6)

(7)

Commission Decision 93/24/EEC (3) establishes addi-
tional guarantees relating to Aujeszky's disease for pigs
destined for Member States or regions free of the disease.

Commission Decision 93/244/EEC (4) establishes addi-
tional guarantees relating to Aujeszky's disease for pigs
the
destined for certain parts of
Community where approved programmes are in place
for the eradication of this disease.

the territory of

The International Office of Epizootic Diseases (OIE) is
the
the international organisation designated under
Agreement on the Application of Sanitary and Phytosa-
nitary 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
recently been substantially
Aujeszky's disease has
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.

For the sake of clarity Decisions 93/24/EEC and 93/
244/EEC should be repealed and a single Decision
should be adopted concerning additional guarantees in

(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.

intra-Community trade of pigs relating to Aujeszky's
disease and on criteria to provide information on this
disease.

(8)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Veterinary
Committee,

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 in Annex I and coming from any other Member
State or region not listed in 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. 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;

(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 the holding in question,

— 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
the
competent authority and in accordance with the erad-
ication plan referred to in point (b), and these measures
have effectively prevented any spread of disease to the
holding in question,

supervision of

applied under

the

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— 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 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,

— 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;

(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 such a way that any risk of
spreading Aujeszky's disease to 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 produc-

tion;

(ii) 90 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 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
test must be
performed within 15 days prior to shipment. The
number of pigs tested in the isolation unit must be
sufficient to detect:

the last

(i) 2 % seroprevalence with 95 % confidence in the
isolation unit in case of pigs intended for produc-
tion;

(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
(b), a serological survey has been carried out in the
holding of origin between 45 and 17 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;

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 and coming from any other Member State or region
not listed in 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
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

slaughterhouse 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 origin 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 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

— 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 clinical, pathological
or serological evidence of Aujeszky's disease has
been recorded in the previous six months;

(ii) vaccination against Aujeszky's disease and intro-
duction 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 (b);

(iii) they have lived for at least 90 days before dispatch.

Article 3

(iii) no pigs have moved on to the holding of origin
while the pigs to be moved have been kept in
isolation.

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:

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(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 the criteria 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,

— 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,

— the pigs must have been subjected, with negative
results, to a serological test for the presence of gE
antibodies. Sampling for
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,

last

the

— the pigs must lave lived in the bolding 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

— 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, demon-
strating 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,

— 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 the fourth indent above has
been carried out.

Article 5

The serological tests carried out to monitor or detect Aujesz-
ky'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 of 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 prorammes are in place, must be
provided at least annually by each Member State in accordance
with the uniform criteria laid down in Annex IV.

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:

(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

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/EC, the offi-
cial 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;

(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 the criteria laid down in Article
1(b),

(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.

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For animals of the porcine species destined for Member
2.
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 9

Decisions 93/24/EEC and 93/244/EEC are repealed as from the
date laid down in Article 10.

This Decision shall apply from 1 July 2002.

Article 10

This Decision is addressed to the Member States.

Article 11

Article 8

Done at Brussels, 23 July 2001

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

For the Commission

David BYRNE

Member of the Commission

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Member States or regions thereof free of Aujeszky's disease and where vaccination is prohibited

ANNEX I

Denmark:

all regions

United Kingdom:

all regions in England, Scotland and Wales

France:

Finland:

Germany:

Austria:

Sweden:

the Departements 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,
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 and Yonne

Indre-et-Loire,

all regions

the Länder of Thuringia, Saxony, Brandenburg, Mecklenburg-Western Pomerania,
Saxony-Anhalt, Rheinland-Pfalz and Baden-Württemberg

all regions

all regions

Luxembourg:

whole territory.

ANNEX II

Member States or regions thereof where approved Aujeszky's disease control programmes are in place

Germany: all regions except the Länder of Thuringia, Saxony, Brandenburg, Mecklenburg-Western Pomerania, Saxony-

Anhalt, Rheinland-Pfalz, Baden-Württemberg

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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 serum 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.
— 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 Research Laboratory, Abbotstown, Castleknock, 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,
— 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.

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ANNEX IV