BAKGRUNN (fra kommisjonsforordningen)

(1) Pursuant to Regulation (EU) 2022/2371, European Union reference laboratories (‘EU reference laboratories’) in the area of public health are to provide support to national reference laboratories and to promote good practice and alignment by Member States on diagnostics, testing methods and use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States.

(2) In accordance with Article 15(4) of Regulation (EU) 2022/2371, the Commission launched, in October 2023 (2), calls for applications for EU reference laboratories in six areas of public health, namely antimicrobial resistance (AMR) in bacteria; vector-borne viral pathogens; emerging, rodent-borne and zoonotic viral pathogens; high-risk, emerging and zoonotic bacterial pathogens; Legionella; and diphtheria and pertussis.

(3) In response to those calls, Member States submitted applications for designation by 5 January 2024, which were evaluated by a selection board set up by the Commission services.

(4) The selection board took into account the criteria for EU reference laboratories set in Article 15(5) of Regulation (EU) 2022/2371 and in the call for application.

(5) Following the completion of the selection procedure, the successful laboratories should be designated as EU reference laboratories and their responsibilities and tasks should be specified.

(6) In order to use the funding allocated in the EU4Health annual work programme 2023 (3), the designation of EU reference laboratories in the field of public health should be provided for as soon as possible.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Committee on serious cross-border threats to health,