LegalizeCommission Implementing Regulation (EU) 2025/2537 of 16 December 2025 designating a European Union reference laboratory for public health on respiratory viruses
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (1), and in particular Article 15(1) thereof,
Whereas:
(1) Pursuant to Regulation (EU) 2022/2371, European Union reference laboratories (‘EU reference laboratories’) in the area of public health or for specific areas of public health relevant for the implementation of this Regulation are to provide support to national reference laboratories and to promote good practice and alignment by Member States on a voluntary basis 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 May 2025 (2) a call for applications for the designation of an EU reference laboratory for public health in the field of respiratory viruses.
(3) In response to that call, Member States submitted applications for designation by 17 September 2025, which were evaluated by a selection board set up by the Commission services.
(4) The selection board applied the requirements for EU reference laboratories set in Article 15(5) of Regulation (EU) 2022/2371 and contained in the call for applications for the purpose of selecting the EU reference laboratory.
(5) Following the completion of the selection procedure, the successful consortium of laboratories should be designated as an EU reference laboratory and its responsibilities and tasks should be specified.
(6) In order to use the funding allocated in the EU4Health annual work programme 2025 (3) in a timely manner, the designation of the EU reference laboratory for public health in the field of respiratory viruses should occur 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,
HAS ADOPTED THIS REGULATION:
Article 1
The consortium referred to in the Annex is designated as the European Union reference laboratory for public health on respiratory viruses until 18 December 2032.
The responsibilities and tasks of that European Union reference laboratory are laid down in that Annex.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 December 2025.
For the Commission The President Ursula VON DER LEYEN
(1) OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj.
(3) https://health.ec.europa.eu/publications/2025-eu4health-work-programme_en.