2004/558/EC: Commission Decision of 15 July 2004 implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradication programmes presented by certain Member States (notified under document number C(2004) 2104)(Text with EEA relevance)
Date: 2004-07-15
Institutions: European Commission
Subjects: animal disease, cattle, health certificate, health control, intra-EU trade

L 249/20

EN

Official Journal of the European Union

23.7.2004

COMMISSION DECISION

of 15 July 2004

implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community
trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradi-
cation programmes presented by certain Member States

(notified under document number C(2004) 2104)

(Text with EEA relevance)

(2004/558/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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
Articles 9(2) and 10(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

Infectious bovine rhinotracheitis is the description of the
most prominent clinical signs of the infection with the
bovine herpesvirus type 1 (BHV1). As many infections
with that virus run a subclinical course, control measures
should be directed to the eradication of the infection
rather than to the suppression of symptoms.

to Directive 64/432/EEC lists ‘infectious
Annex E (II)
bovine rhinotracheitis’ among the diseases for which
national control programmes may be approved and addi-
tional guarantees requested.

Germany had submitted a programme conducted with
the aim of eradicating the BHV1 infection in all parts
of its territory, which complies with the criteria set out in
Article 9(1) of Directive 64/432/EEC and provides for
rules for
the national movement of bovine animals
which are equivalent to those previously implemented
in Austria,
the Province of Bolzano in Italy and
Sweden which were successful in eradicating the disease
from those countries.

The programme presented by Germany and, as requested
by that Member State,
in
relation to trade in bovine animals in order to secure
that programme were approved by
the success of
Decision 2004/215/EC of 1 March 2004 implementing
Council Directive 64/432/EEC as regards additional guar-

the additional guarantees

(1) OJ 121, 29.7.1964, p. 1977/64. Directive as last amended by
Commission Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).

antees for
intra-Community trade in bovine animals
relating to infectious bovine rhinotracheitis and the
approval of the eradication programmes presented by
certain Member States (2).

Additional guarantees exist as regards Denmark, Austria,
Finland and Sweden as well as Italy, concerning the
province of Bolzano. Those Member States consider
that their territory is free from infectious bovine rhino-
tracheitis and Italy takes the same view for the Province
of Bolzano. In accordance with Article 10(1) of Directive
64/432/EEC, they submitted supporting documentation
to the Commission,
in particular substantiating that
monitoring of the situation is continued.

in

To Member States or regions thereof that are recognised
as being free of that disease and which are currently
Commission Decision
to
listed
93/42/EEC (3) only minimum requirements
the
dispatch of bovine animals for breeding and production
to other Member States should apply.

the Annex

for

For the standardisation of BHV1 tests in laboratories the
World Organisation for Animal Health (OIE) has adopted
a strong positive, a weak positive and negative serum as
OIE international standards for BHV1 tests which are
available at the OIE Reference Laboratories for infectious
bovine rhinotracheitis mentioned in the Manual of
Standards for Diagnostic Tests and Vaccines (4).

Problems have been encountered in relation to intra-
Community trade in bovine animals originating in
Member States of different
status with regard to
infectious bovine rhinotracheitis.

For reasons of clarity and in order to ensure the linguistic
consistency of the measures, it is appropriate to combine
in a single Decision the approval of
the German
programme and the additional guarantees for infectious
bovine
repeal Decision
and
2004/215/EC.

rhinotracheitis

to

(5)

(6)

(7)

(8)

(9)

(2) OJ L 67, 5.3.2004, p. 24.
(3) OJ L 16, 25.1.1993, p. 50. Decision as last amended by Decision

2000/502/EC (OJ L 200, 8.8.2000, p. 62).

(4) Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition,

August 2000.

23.7.2004

EN

Official Journal of the European Union

L 249/21

(10)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

(a)

the animals originate in a Member State listed in Annex I
and come from BHV1-free holdings meeting at least the
requirements set down in Annex III;

HAS ADOPTED THIS DECISION:

(b) the animals are intended for meat production and comply

with the following conditions:

Article 1

(i)

the animals either

The programmes presented by the Member States listed in the
first column of the table in Annex I for the control and eradi-
the infection with the bovine herpesvirus type 1
cation of
(BHV1), hereinafter referred to as ‘infectious bovine rhinotra-
cheitis’ or ‘IBR’, in regions of these Member States specified in
the second column of the table in Annex I are approved.

Article 2

1.
Bovine animals for breeding and production coming from
Member States or regions thereof other than those listed in
Annex II and destined for Member States or regions thereof
listed in Annex I, shall meet at least the following additional
guarantees:

(a)

they must come from a holding on which, according to
official information, no clinical or pathological evidence of
infectious bovine rhinotracheitis has been recorded for the
past 12 months;

(b) they must have been isolated in a facility approved by the
to
competent authority for 30 days immediately prior
movement and all bovine animals in the same isolation
facility must have remained free of clinical
signs of
infectious bovine rhinotracheitis during that period;

(c)

they and all other bovine animals in the same isolation
facility must have been subjected with negative results to
a serological test carried out on blood samples, taken not
earlier than 21 days after their arrival at
the isolation
facility, for the detection of the following antibodies:

(c)

(i)

in the case of vaccinated bovine animals, antibodies
against the gE-glycoprotein of the BHV1; or

(ii) in the case of unvaccinated bovine animals, antibodies

against the entire BHV1.

By way of derogation to paragraph 1,

2.
the competent
authorities of the Member State of origin may authorise the
dispatch to holdings situated in regions listed in Annex I of
bovine animals complying with at least one of the following
alternative conditions:

— originate in BHV1-free holdings as defined in Annex

III, or

— descend from vaccinated and regularly re-vaccinated

dams, or

— have been regularly vaccinated and re-vaccinated
according to the instructions of the manufacturer
with a gE-deleted vaccine, or

— have been subjected in the Member State of origin
with negative result to a serological test for anti-
bodies as referred to in paragraph 1(c) carried out
on a sample of blood taken within 14 days of
dispatch, and

(ii) they are transported without coming into contact with
animals of lesser health status to a holding of unknown
BHV1-status in the Member State of destination listed in
Annex I, where according to the approved national
eradication
fattened
all
indoors, and from which they can only be transported
directly to the slaughterhouse;

programme

animals

are

the animals originate from holdings on which all bovine
animals on the holding older than 15 months of age have
been vaccinated and regularly revaccinated and all animals
on the holding older than nine months have been subjected
for antibodies
with negative result
to a serological
against
intervals of
not more than 12 months and the animals have been
tested with negative results for antibodies as referred to in
paragraph 1(c)(i) on blood samples taken during the past 14
days prior to dispatch;

the gE-glycoprotein of

the BHV1 at

test

(d) the animals originate from BHV1-free holdings as defined in
Annex III which are situated in a Member State in which
infectious bovine rhinotracheitis is a compulsorily notifiable
disease and in which within an area of 5 km radius around
the holdings there was no clinical or pathological evidence
of BHV1-infection during the past 30 days and the animals
have been tested with negative results for antibodies as
referred to in paragraph 1(c) on a sample of blood taken
during the past 14 days prior to dispatch.

L 249/22

EN

Official Journal of the European Union

23.7.2004

Bovine animals for slaughter coming from Member States
3.
or regions thereof other than those listed in Annex II and
destined for Member States or regions thereof listed in Annex
I shall be transported directly to the slaughterhouse of desti-
nation or to an approved assembly centre from where they shall
be removed in accordance with Article 7, second indent, of
Directive 64/432/EEC to the slaughterhouse to be slaughtered.

4.
In point 4 of Section C of the health certificate set out in
Model 1 of Annex F to Directive 64/432/EEC accompanying
bovine animals as referred to in paragraph 1, the following
information shall be inserted:

(a) after the first indent: ‘IBR’;

(b) after the second indent:

‘Article 2, paragraph …. point ….

of Commission Decision 2004/558/EC’.

In point 4 of Section C of the health certificate set out in
3.
Model 1 of Annex F to Directive 64/432/EEC accompanying
bovine animals as referred to in paragraph 1, the following
information shall be inserted:

(a) after the first indent: ‘IBR’,

(b) after the second indent: ‘Article 3 of Commission Decision

2004/558/EC’.

Article 4

Bovine animals for breeding and production originating in a
listed in Annex II and
Member State or
region thereof
listed in
region thereof
destined for a Member State or
Annexes I or II shall comply with the conditions provided for
in Article 2(1)(a).

Article 3

Article 5

1.
Bovine animals for breeding and production coming from
Member States or regions thereof other than those listed in
Annex II and destined for Member States or regions thereof
free of infectious bovine rhinotracheitis and listed in Annex II,
shall meet the following additional guarantees:

Member States shall ensure that the serological test referred to
in Article 2(1)(c)(ii) and in Article 3(1)(b) for the detection of
antibodies against the entire BHV1 is standardised against the
strong positive, weak positive and negative serum adopted as
OIE international standards for BHV1 tests.

(a)

they shall comply with the additional guarantees provided
for in Article 2(1)(a) and (b);

(b) they and all other bovine animals in the same isolation
facility referred to in Article 2(1)(b) must have been
subjected with negative results to a serological test carried
out on blood samples taken not earlier than 21 days after
their arrival at the isolation facility, for the detection of
antibodies against the entire BHV1;

(c)

they must not have been vaccinated against
bovine rhinotracheitis.

infectious

2.
Bovine animals for slaughter coming from Member States
or regions thereof other than those listed in Annex II and
destined for Member States or regions thereof listed in Annex
II shall be transported directly to the slaughterhouse of desti-
nation to be slaughtered in accordance with Article 7,
first
indent, of Directive 64/432/EEC.

Article 6

Decision 2004/215/EC is repealed.

Article 7

This Decision shall apply from 26 July 2004.

Article 8

This Decision is addressed to the Member States.

Done at Brussels, 15 July 2004.

For the Commission

David BYRNE

Member of the Commission

23.7.2004

EN

Official Journal of the European Union

L 249/23

ANNEX I

Regions of Member State to which the additional guarantees for infectious bovine
rhinotracheitis apply in accordance with Article 9 of Directive 64/432/EEC

All regions

ANNEX II

Regions of Member State to which the additional guarantees for infectious bovine
rhinotracheitis apply in accordance with Article 10 of Directive 64/432/EEC

All regions

Province of Bolzano

All regions

All regions

All regions

Member State

Germany

Member State

Denmark

Italy

Austria

Finland

Sweden

L 249/24

EN

Official Journal of the European Union

23.7.2004

ANNEX III

BHV1-free holding

1. A holding keeping bovine animals shall be considered free of BHV1 infection if it complies with the following

conditions:

1.1. no suspicion for BHV1 infection has been recorded for the holding during the past six months and all bovine

animals on the holding are free from clinical symptoms indicative for BHV1 infection;

1.2. only bovine animals from holdings situated in Member States or regions thereof listed in Annex II or from BHV1-
free holdings have been introduced and none of the bovine animals on the holding had contact with bovine
animals other than those coming from holdings situated in Member States or regions thereof listed in Annex II or
from BHV1-free holdings;

1.3. female bovine animals are only inseminated with semen from bulls produced in accordance with Directive
88/407/EEC and which have been tested with negative result for antibodies as referred to in Article 2(1)(c)(i),
or have been serviced by bulls from holdings situated in Member States or regions thereof listed in Annex II or
from BHV1-free holdings;

1.4. At least one of the following control regimes is applied on the holding:

1.4.1. a serological investigation for antibodies as referred to in Article 2(1)(c) has been carried out with negative
results in each case on at least two samples of blood, taken with an interval of five to seven months from
all female and male bovine animals used or intended for breeding purposes older than nine months of age;

1.4.2. a serological investigation for antibodies against the BHV1 has been carried out with negative result on at
least two individual samples of milk, or a pool of milk samples taken from not more than five animals,
taken with an interval of five to seven months from all lactating animals, and a serological investigation
for antibodies as referred to in Article 2(1)(c) has been carried out with negative results in each case on at
least two samples of blood, taken with an interval of five to seven months from all non-lactating female
bovine animals and from all male bovine animals used or intended for breeding purposes older than nine
months of age;

1.4.3.

in the case of dairy farms on which at least 30 % of the bovine animals are lactating cows in milk, a
serological investigation for antibodies against the BHV1 has been carried out with negative results in each
case on at least three milk samples collected, depending on the specification of test employed, from a bulk
of not more than 50 animals taken with an interval of at least three months and a serological investigation
for antibodies as referred to in Article 2(1)(c) has been carried out with negative results in each case on at
least one sample of blood, taken from all non-lactating female bovine animals and from all male bovine
animals used or intended for breeding purposes older than nine months of age;

1.4.4. all bovine animals on the holding originate either from holdings situated in Member States or regions

thereof listed in Annex II or from BHV1-free holdings.

2. The BHV1-free status of a holding keeping bovine animals is retained if:

2.1. the conditions in paragraphs 1.1 to 1.3 continue to apply; and

2.2. at least one of the following control regimes is applied:

2.2.1. all bovine animals on the holding older than 24 months of age have reacted with negative result to a
serological test for the detection of antibodies as referred to in Article 2(1)(c) carried out on a sample of
blood taken at intervals of not more than 12 months;

23.7.2004

EN

Official Journal of the European Union

L 249/25

2.2.2. the serological investigation for antibodies against the BHV1 has been carried out with negative result on
at least one individual sample of milk, or a pool of milk samples taken from not more than five animals,
taken at intervals of not more than 12 months from all lactating animals, and all non-lactating female
bovine animals and male bovine animals on the holding older than 24 months of age have reacted with
negative result to a serological test for the detection of antibodies as referred to in Article 2(1)(c) carried
out on a sample of blood taken at intervals of not more than 12 months;

2.2.3.

in the case of dairy farms on which at least 30 % of the bovine animals are lactating cows in milk, the
serological investigation for antibodies against the BHV1 has been carried out with negative result on at
least two milk samples collected, depending on the specification of test employed, from a bulk of not
more than 50 animals taken at intervals of at least three months and not more than 12 months and a
serological investigation for antibodies as referred to in Article 2(1)(c) has been carried out with negative
results in each case on at least one sample of blood, taken from all non-lactating female bovine animals
and male bovine animals older than 24 months of age at intervals of not more than 12 months.

3. The BHV1-free status of a holding keeping bovine animals is suspended where during the investigations referred to in
paragraph 2.2.1. to 2.2.3. an animal reacted with positive result in a test for antibodies as referred to in Article 2(1)(c);

4. The BHV1-free status suspended in accordance with paragraph 3 shall only be restored after a serological investigation
has been carried out with negative result in each case on two occasions with an interval of at least two months and
commencing not earlier than 30 days after the removal of the seropositive animals which includes serological testing
for antibodies as referred to in Article 2(1)(c) of all bovine animals on the holding carried out on samples of blood, or
in the case of lactating cows, testing for antibodies against the BHV1 carried out on individual milk samples, or pools
of milk samples taken from not more than five animals.