Commission Implementing Decision (EU) 2020/528 of 14 April 2020 authorising laboratories in Brazil, China, South Korea, Thailand and the United States to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets (notified under document C(2020) 2103) (Text with EEA relevance)

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, as the specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines. The AFSSA has now been integrated into the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES) in France.

2. Decision 2000/258/EC provides, inter alia, that the ANSES is to appraise laboratories in third countries that have applied for approval to carry out serological tests to monitor the effectiveness of rabies vaccines.

3. The competent authority of Brazil has submitted an application for the approval of the laboratory ‘Núcleo de Pesquisas em Raiva do Laboratório de Virologia Clínica e Molecular do Instituto de Ciências Biomédicas da Universidade de São Paulo’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 24 October 2019 for this laboratory.

4. The competent authority of China has submitted an application for the approval of two laboratories: the ‘Sino Tech World Biologicals Pharmaceutical Co., Ltd (Beijing)’ and the ‘Animal Disease Diagnostic Center of the Institute of Animal Health of the Guangdong Academy of Agriculture Sciences’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 24 October 2019 for these laboratories.

5. The competent authority of China has submitted an application for re-approval of two laboratories: the ‘National Reference Laboratory for Animal Rabies (Diagnostic Laboratory for Rabies and Wildlife Associated Zoonoses)’ and the ‘Centre for Rabies Antibody Assay of the Laboratory of Epidemiology of the Military Veterinary Research Institute of the Academy of Military Medical Sciences’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 24 October 2019 for these laboratories.

6. The competent authority of South Korea has submitted an application for the approval of the laboratory ‘Rabies and Japanese encephalitis OIE reference laboratory of Animal and Plant Quarantine Agency’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 24 October 2019 for this laboratory.

7. The competent authority of Thailand has submitted an application for the approval of the laboratory ‘National Institute of Animal Health’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 24 October 2019 for this laboratory.

8. The competent authority of the the United States has submitted an application for re-approval of the laboratory ‘Centers for Disease Control and Prevention of the Rabies Laboratory’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 24 October 2019 for this laboratory.

9. These laboratories should therefore be authorised to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.

10. The measures provided for in this Decision are in accordance with the opinion of Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION: