22.5.2013 EN Official Journal of the European Union L 135/21
COMMISSION IMPLEMENTING DECISION
of 17 May 2013
authorising a laboratory in Croatia to carry out serological tests to monitor the effectiveness of rabies vaccines
(notified under document C(2013) 2783)
(Text with EEA relevance)
(2013/224/EU)
THE EUROPEAN COMMISSION
,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines (1), and in particular Article 3(2) thereof,
Whereas:
(1) Decision 2000/258/EC designates the Agence française de sécurité sanitaire des aliments (AFSSA) in Nancy, France (integrated since 1 July 2010 into the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, ANSES), as the specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines.
(2) That Decision provides that the ANSES is to document the appraisal of laboratories in third countries that have applied to carry out serological tests to monitor the effectiveness of rabies vaccines.
(3) By adopting Commission Implementing Decision 2012/304/EU of 11 June 2012 authorising laboratories in Croatia and in Mexico to carry out serological tests to monitor the effectiveness of rabies vaccines (2), the Commission authorised the laboratory for rabies and general virology of the Croatian Veterinary Institute to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.
(4) Following the unfavourable appraisal report established by the ANSES dated 3 September 2012, the authorisation granted to that laboratory has been withdrawn in accordance with Commission Decision 2010/436/EU of 9 August 2010 implementing Council Decision 2000/258/EC as regards proficiency tests for the purposes of maintaining authorisations of laboratories to carry out serological tests to monitor the effectiveness of rabies vaccines (3).
(5) The competent authority of Croatia has submitted an application for re-approval of the laboratory for rabies and general virology of the Croatian Veterinary Institute which is supported by a favourable appraisal report established for that laboratory by the ANSES dated 15 February 2013.
(6) The competent authority of Croatia has also officially informed the Commission that the name of the laboratory has changed.
(7) That laboratory should therefore be authorised to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.
(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
In accordance with Article 3(2) of Decision 2000/258/EC, the following laboratory is authorised to perform the serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets:
Laboratory for rabies (Croatian National Reference Laboratory for Rabies) of Croatian Veterinary Institute
Savska cesta 143
10000 Zagreb
Croatia
This Decision shall apply from 1 June 2013.
This Decision is addressed to the Member States.