2002/598/EC: Commission Decision of 15 July 2002 approving vaccines against bovine brucellosis within the framework of Council Directive 64/432/EEC (Text with EEA relevance) (notified under document number C(2002) 2592)
Date: 2002-07-15
Institutions: European Commission
Subjects: brucellosis, cattle, health control, vaccination, vaccine, veterinary inspection

23.7.2002

EN

Official Journal of the European Communities

L 194/45

COMMISSION DECISION

of 15 July 2002

approving vaccines against bovine brucellosis within the framework of Council Directive 64/432/
EEC

(notified under document number C(2002) 2592)

(Text with EEA relevance)

(2002/598/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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 by
Commission Regulation (EC) No 535/2002 (2), and in particular
the third indent of paragraph 4(i) in Annex A(II) thereto;

Whereas:

within

vaccines

It is therefore appropriate to approve, subject to certain
conditions, the use of live strain RB 51 and live strain
Rev.1
eradication
programmes approved pursuant to Council Decision 90/
424/EEC of 26 June 1990 on expenditure in the veter-
inary field (3), as last amended by Decision 2001/572/
EC (4), in order to take into account scientific develop-
ments and international standards.

brucellosis

(7)

The measures provided for in this Decision are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

(1)

(2)

(3)

(4)

(5)

Community rules on the use of vaccines against brucel-
losis in bovine animals are laid down in Directive 64/
432/EEC.

HAS ADOPTED THIS DECISION:

Article 1

Bovine brucellosis continues to occur in certain areas of
the Community. Vaccination is considered an effective
instrument to be employed under certain conditions in
conjunction with a test and slaughter policy, in particular
in areas with extensive livestock rearing.

For the purposes of this Decision, ‘competent authority’ means
the central authority of a Member State competent to carry out
veterinary or zootechnical checks or any authority to which it
has delegated that competence for the particular purpose of the
application of this Decision.

A newly developed vaccine offers additional advantages
to those already approved and in particular does not
interfere with the diagnostic procedures applied in the
framework of eradication programmes in force in some
Member States in accordance with Community legisla-
tion.

In certain cases brucellosis in bovine animals is linked to
sheep and goat brucellosis and eradication measures
must be
framework of
programmes for the eradication of brucellosis caused by
Brucella melitensis, including vaccination with the appro-
priate vaccine.

carried out within the

Article 2

The following vaccines against bovine brucellosis are hereby
approved for immunisation of female bovine animals under the
conditions set out in Article 3:

(a) live strain RB 51 vaccine for animals at risk of infection

with Brucella abortus;

(b) live strain Rev.1 vaccine for animals at risk of infection with

Brucella melitensis.

Article 3

The requirements for the production and recommenda-
tions for the use of live strain RB 51 and live strain
Rev.1 vaccines against bovine brucellosis are included in
for Diagnostic Tests and
the Manual of Standards
Vaccines of the Office International des Epizooties, 4th
Edition of 2000, published in August 2001.

1. Member States availing of
the vaccines
approved under Article 2 shall ensure that the conditions set
out in paragraphs 2 to 6 are met.

the use of

The storage, supply, distribution and sale of the vaccines

2.
shall be under the control of the competent authority.

(1) OJ 121, 29.7.1964, p. 1977/64.
(2) OJ L 80, 23.3.2002, p. 22.

(3) OJ L 224, 18.8.1990, p. 19.
(4) OJ L 203, 28.7.2001, p. 16.

L 194/46

EN

Official Journal of the European Communities

23.7.2002

The vaccines shall only be used by an official veterinary
3.
or a veterinary specifically authorised by the competent
authority within a brucellosis eradication programme submitted
by a Member State and approved by the Commission pursuant
to Article 24(7) of Decision 90/424/EEC.

4.
The competent authority shall submit to the Commission
and to the other Member States detailed information on the
vaccination programme, in particular on the vaccination area,
the age of the animals to be vaccinated and the test system in
place to identify vaccinated animals.

5.
The competent authority shall ensure that vaccinated
animals are not subject to intra-Community trade, in particular
by applying additional methods of marking and registration of
vaccinated animals.

The competent authority shall

inform public health
6.
services of the use of these vaccines and the available diagnostic
and therapeutic systems in place.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 15 July 2002.

For the Commission

David BYRNE

Member of the Commission