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 establishing the European Community,

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 Decision 90/424/EEC and repealing Council Directive 92/117/EEC(1), and in particular Article 10(1), (2) and (4) thereof,

Having regard to Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 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) 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 Directive 2003/99/EC provides for Directive 92/117/EEC to be repealed with effect from 12 June 2004.

(2) Pursuant to Directive 2003/99/EC, the European Food Safety Authority is to become responsible for tasks 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 epidemiology of zoonoses.

(3) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(4), designates the Community reference laboratory for salmonella designated under 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.

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

(5) It is appropriate to redefine precisely the responsibilities and tasks of the Community reference laboratory for salmonella and of corresponding national reference laboratories within the new regulatory framework established 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.

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

HAS ADOPTED THIS DECISION:

Article 1

The Bundesinstitut für Risikobewertung, Berlin, Germany, is designated as the Community reference laboratory for the epidemiology of zoonoses until 31 December 2004.

Article 2

1. The Rijksinstituut voor Volksgezondheid en Milieu, Bilthoven, Netherlands, is designated as the Community 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.

Article 3

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

Article 4

This Decision shall apply from 12 June 2004.

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 20 July 2004.

For the Commission

David

BYRNE

Member of the Commission

(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

(4)

OJ L 165, 30.4.2004, p. 1

ANNEX I

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

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.

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

(e) Identification and development of sampling methods.

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.

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.

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

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.