2004/226/EC: Commission Decision of 4 March 2004 approving tests for the detection of antibodies against bovine brucellosis within the framework of Council Directive 64/432/EEC (Text with EEA relevance) (notified under document number C(2004) 654)
Date: 2004-03-04
Institutions: European Commission
Subjects: analytical chemistry, brucellosis, cattle, health certificate, veterinary inspection

L 68/36

EN

Official Journal of the European Union

6.3.2004

COMMISSION DECISION

of 4 March 2004

approving tests for the detection of antibodies against bovine brucellosis within the framework of
Council Directive 64/432/EEC

(notified under document number C(2004) 654)

(Text with EEA relevance)

(2004/226/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 64/432/EEC of 26 June
1964 on health problems affecting intra-Community trade in
bovine animals and swine (1), and in particular Article 6(2)(b)
thereof,

Whereas:

(1)

(2)

(3)

(4)

Commission Decision 2000/330/EC of 18 April 2000
approving tests for the detection of antibodies against
bovine brucellosis within the framework of Council
Directive
substantially
amended (3). In the interests of clarity and rationality the
said Decision should be codified.

64/432/EEC (2)

been

has

intended for

Bovine animals
intra-Community trade
must, with regard to bovine brucellosis, come from a
holding officially free of bovine brucellosis and, in addi-
tion, be tested within 30 days of dispatch by use of
either a serum-agglutination test or any other
test
approved by the Standing Committee on the Food Chain
and Animal Health procedure following the adoption of
the relevant protocols.

In accordance with Article 16 of Directive 64/432/EEC,
the Commission, in accordance with the procedures of
Article 17 and on the basis of the opinion of the Scien-
tific Committee on Veterinary Measures
relating to
Public Health,
is to update and if necessary amend
Annexes B, C and D (Chapter II) to adapt them to scien-
tific developments.

The Commission has received the final report of the
Scientific Committee on Animal Health and Animal
Welfare on the modification of the technical Annexes to
Directive 64/432/EEC to take account of scientific devel-
opments regarding tuberculosis, brucellosis and enzootic
bovine leucosis (4).

(6)

(7)

(8)

(9)

In that report the Scientific Committee recommended
the preferential use of ELISA tests, the complement fixa-
tion test and the buffered brucella antigen tests for the
detection of antibodies against bovine brucellosis, carried
out, inter alia, on samples of blood taken from individual
bovine animals. The recommended procedures are in
line with the internationally recognised standards set out
by the Manual of standards for diagnostic tests and
vaccines, third edition, 1996, of the Office International
des Epizooties (OIE).

In August 2001 the OIE published the fourth edition
2000 of the said manual, including certain modifications
in the description of tests for brucellosis.

It was therefore necessary to amend Annex C to Direc-
tive 64/432/EEC so as to lay down test procedures
applicable for surveillance and trade purposes within the
Community which reflect as much as possible the OIE
standards but take also into account the advice of the
Scientific Committee and of
reference
laboratories in the Member States cooperating within the
framework of the European Union network of national
reference laboratories for brucellosis.

the national

the complement

It appears appropriate to recognise for certification
purposes the brucellosis test results produced by use of
ELISA tests,
fixation test and the
buffered brucella antigen tests, if the tests were carried
in accordance with the approved protocols on
out
samples of blood taken from individually identified
bovine animals within the 30 days prior to certification
of the tested animals for intra-Community trade.

Therefore, pending the update of the technical Annex D
(Chapter II) in accordance with Article 16 of Directive
64/432/EEC, the ELISA tests, as specified in the report of
the Scientific Committee, and the complement fixation
test and the buffered brucella antigen tests, as specified
in Annex C to that Directive, should be approved for
brucellosis testing for certification purposes as provided
for in Article 6(2)(b) and the animal health certificate in
Annex F, model 1.

(1) OJ 121, 29.7.1964, p. 1977/64. Directive as last amended by Regu-

lation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).

(2) OJ L 114, 13.5.2000, p. 37. Decision as amended by Regulation

(EC) No 535/2002 (OJ L 80, 23.3.2002, p. 22).

(3) See Annex I.
(4) Doc. SANCO/B3/R10/1999.

(10)

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

6.3.2004

EN

Official Journal of the European Union

L 68/37

HAS ADOPTED THIS DECISION:

Article 1

The complement fixation test, the buffered brucella antigen
tests and the ELISA tests carried out in accordance with the
provisions in Annex C to Directive 64/432/EEC are hereby
approved for certification purposes.

Article 2

Where, for the purposes referred to in Article 6(2)(b) of Direc-
tive 64/432/EEC, a test referred to in Article 1 of this Decision
is used, the test shall be specified in the column ‘Test’ of the
tables in point 3, second indent, and in point 5 of Section A in
Annex F, Model 1 (health certificate) to Directive 64/432/EEC.

Decision 2000/330/EC is repealed.

Article 3

References to the repealed Decision shall be construed as refer-
ences to this Decision and shall be read in accordance with the
correlation table in Annex II.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 4 March 2004.

For the Commission

David BYRNE

Member of the Commission

ANNEX I

Repealed Decision with its amendment

Commission Decision 2000/330/EC

Commission Regulation (EC) No 535/2002 (Article 2
only)

(OJ L 114, 13.5.2000, p. 37)

(OJ L 80, 23.3.2002, p. 22)

ANNEX II

Correlation Table

Decision 2000/330/EC

This Decision

Articles 1 and 2

Articles 1 and 2

—

Article 3

—

—

Article 3

Article 4

Annex I

Annex II