2004/564/EC: Commission Decision of 20 July 2004 concerning Community reference laboratories for the epidemiology of zoonoses and for salmonella and national reference laboratories for salmonella (notified under document number C(2004) 2781)(Text with EEA relevance)
Date: 2004-07-20
Institutions: European Commission
Subjects: Community body, food safety, research body, zoonosis

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Official Journal of the European Union

27.7.2004

COMMISSION DECISION

of 20 July 2004

concerning Community reference laboratories for the epidemiology of zoonoses and for salmonella
and national reference laboratories for salmonella

(notified under document number C(2004) 2781)

(Text with EEA relevance)

(2004/564/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 2003/99/EC of
the European
Parliament and of the Council of 17 November 2003 on the
monitoring of zoonoses and zoonotic agents, amending Council
repealing Council Directive
Decision
92/117/EEC (1), and in particular Article 10(1),
(2) and (4)
thereof,

90/424/EEC and

Having regard to Regulation (EC) No 2160/2003 of
the
the Council of 17 November
European Parliament and of
2003 on the control of salmonella and other specified food-
borne zoonotic agents (2), and in particular Article 11(1), (2)
and (4) thereof,

Whereas:

(1)

(2)

A Community reference laboratory for the epidemiology
of zoonoses and a Community reference laboratory for
salmonella were designated under Council Directive
92/117/EEC (3). Directive 2003/99/EC provides
for
Directive 92/117/EEC to be repealed with effect from
12 June 2004.

Pursuant to Directive 2003/99/EC, the European Food
tasks
Safety Authority is to become responsible for
equivalent
to those performed by the Community
reference laboratory for the epidemiology of zoonoses.
However, in order to ensure a smooth transition to the
new order, it is appropriate to maintain the designation
of the current Community reference laboratory for the
epidemiology of zoonoses for a limited period. That
laboratory should therefore temporarily be re-designated
as the Community reference laboratory for the epide-
miology of zoonoses.

compliance with feed and food law, animal health and
rules (4), designates
animal welfare
the Community
salmonella designated under
reference laboratory for
Directive 92/117/EEC as
the Community reference
laboratory for
the analysis and testing of zoonoses
(salmonella) as from 1 January 2006. Until that date,
in order to avoid a situation without such a laboratory
in the Community, that laboratory should temporarily be
re-designated as the Community reference laboratory for
salmonella.

the

that

For financial management purposes, it is appropriate to
clarify
the Community
re-designation of
reference laboratories referred to above should apply as
from the date when Directive 92/117/EEC ceases to have
effect.

corresponding national

It is appropriate to redefine precisely the responsibilities
and tasks of the Community reference laboratory for
salmonella and of
reference
laboratories within the new regulatory framework estab-
lished by Directive 2003/99/EC and Regulation (EC) No
2160/2003. The Community reference laboratory for
salmonella has developed activities essentially in the
area of live poultry and it is not appropriate to amend
its work programme for 2004. The new areas of
competence for that Community reference laboratory
and for the national reference laboratories for salmonella
should therefore apply only as from 1 January 2005.

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

in this Decision are in
Standing
the

opinion

the

of

(4)

(5)

(6)

HAS ADOPTED THIS DECISION:

(3)

Regulation (EC) No 882/2004 of
European
Parliament and of the Council of 29 April 2004 on
official controls performed to ensure the verification of

the

(1) OJ L 325, 12.12.2003, p. 31.
(2) OJ L 325, 12.12.2003, p. 1.
(3) OJ L 62, 15.3.1993, p. 38. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

Article 1

The Bundesinstitut
is
designated as the Community reference laboratory for the epide-
miology of zoonoses until 31 December 2004.

für Risikobewertung, Berlin, Germany,

(4) OJ L 165, 30.4.2004, p. 1.

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Article 2

Article 4

voor Volksgezondheid en Milieu,
1.
The Rijksinstituut
Bilthoven, Netherlands,
the Community
is designated as
reference laboratory for salmonella until 31 December 2005.

2.
The responsibilities and tasks of the Community reference
laboratory referred to in paragraph 1 are laid down in Annex I.
They shall apply with regard to areas other than live poultry as
from 1 January 2005.

This Decision shall apply from 12 June 2004.

Article 5

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 20 July 2004.

The responsibilities and tasks of the national reference labora-
tories for salmonella are laid down in Annex II. They shall apply
with regard to areas other than live poultry as from 1 January
2005.

For the Commission

David BYRNE
Member of the Commission

L 251/16

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Official Journal of the European Union

27.7.2004

ANNEX I

Responsibilities and tasks of the Community reference laboratory for salmonella, pursuant to Directive
2003/99/EC and Regulation (EC) No 2160/2003

1. Areas of competence

(a)

Identification and development of bacteriological methods for the detection and as appropriate quantification of
zoonotic salmonella in livestock, feed and food, as well as in environmental samples.

(b) Subtyping of zoonotic salmonella, in particular serotyping, and other subtyping, including with phenotypic and

genetic methods.

(c) Anti-microbial susceptibility testing on isolates of zoonotic salmonella.

(d) Identification and development of immunological methods for zoonotic salmonella.

(e)

Identification and development of sampling methods.

2. General functions and duties

(a) To provide national reference laboratories with details of analytical methods, including reference methods.

(b) To coordinate the application by the national reference laboratories of the methods referred to in (a), in particular
by organising comparative testing and by ensuring an appropriate follow-up of such comparative testing in
accordance with internationally accepted protocols, when available.

(c) To coordinate, within their area of competence, practical arrangements needed to apply new analytical methods

and informing national reference laboratories of advances in this field.

(d) To conduct initial and further training courses for the benefit of staff from national reference laboratories and of

experts from developing countries.

(e) To provide scientific and technical assistance to the Commission, especially in cases where Member States contest

the results of analyses.

(f) To collaborate with laboratories with the same area of competence in third countries.

3. Specific functions and duties

(a) To provide technical assistance to the Commission in the organisation of monitoring schemes for salmonella and

related anti-microbial resistance pursuant to in particular Articles 4, 5 and 7 of Directive 2003/99/EC.

(b) To provide technical assistance to the Commission in the framework of the setting of Community targets

pursuant to Article 4 of Regulation (EC) No 2160/2003.

(c) To advise the Commission on aspects related to salmonella vaccine strains and other specific control methods, as

appropriate.

(d) To provide technical assistance to the Commission and as appropriate, to participate in international forums
relating to the areas of competence identified in point 1 above, concerning, in particular, the standardisation of
analytical methods and their implementation.

(e) To gather data and information on the activities developed and methods used in national reference laboratories

and to inform the Commission thereof.

(f) To keep abreast of developments in salmonella epidemiology.

(g) To cooperate, as appropriate, with the Community structures involved in surveillance of salmonella, in particular
with the network for the epidemiological surveillance and control of communicable diseases in the Community,
as established under Decision No 2119/98/EC of the European Parliament and of the Council (1),
including
relevant dedicated surveillance networks.

4. The Community reference laboratory shall

implement a quality assurance system and shall be accredited in

accordance with standard EN ISO/IEC 17025 at the latest by 12 December 2005.

(1) OJ L 268, 3.10.1998, p. 1. Decision as last amended by Regulation (EC) No 1992/2003 (OJ L 284, 31.10.2003, p. 1).

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ANNEX II

Responsibilities and tasks of the national reference laboratories for salmonella, pursuant to Directive 2003/99/EC
and Regulation (EC) No 2160/2003

1.

General duties

(a) To collaborate with the Community reference laboratory in their area of competence.

(b) To coordinate, as appropriate, the activities of laboratories responsible for the analysis of samples in accordance

with, in particular, Articles 4, 5 and 7 of Directive 2003/99/EC.

(c) To coordinate the activities of laboratories responsible for the analysis of samples in accordance with Article

12(1) of Regulation (EC) No 2160/2003/EC.

(d) Where appropriate, to organise comparative tests between the laboratories referred to under (b) and (c) and to

assure an appropriate follow-up of such comparative testing.

(e) To ensure the dissemination to the competent authority and to the laboratories referred to under (b) and (c), of

the information that the Community reference laboratory supplies.

(f) To provide scientific and technical assistance to their national competent authority in their area of competence.

2.

Specific functions and duties

(a) To participate, as appropriate in the monitoring schemes for salmonella and related anti-microbial resistance
pursuant to Directive 2003/99/EC and in the analysis and testing of salmonella pursuant to Regulation (EC) No
2160/2003.

(b) To conduct, as appropriate, training courses for the benefit of staff from relevant laboratories.

(c) To inform, as appropriate, the Community reference laboratory on aspects related to salmonella vaccine strains

and other specific control methods.

(d) To gather data and information on the activities developed and methods used in relevant laboratories and to

inform the Community reference laboratory thereof.

(e) To keep abreast of developments in salmonella epidemiology.