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:

Article 1 In accordance with Article 3(2) of Decision 2000/258/EC, the following laboratories are hereby authorised to perform serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets: (a) Núcleo de Pesquisas em Raiva Laboratório de Virologia Clínica e Molecular do Instituto de Ciências Biomédicas Universidade de São Paulo Av. Prof. Lineu Prestes, 1374, room 225 05508-000 São Paulo Brazil (b) Sino Tech World Biologicals Pharmaceutical Co., Ltd (Beijing) 29 Qingfeng West Road. Biological Medicine Base, Daxing District, Beijing China (c) Animal Disease Diagnostic Center Institute of Animal Health, Guangdong Academy of Agriculture Sciences 21 Baishigang Street, Tianhe District Guangzhou, Guangdong China (d) National Reference Laboratory for Animal Rabies (Diagnostic Laboratory for Rabies and Wildlife Associated Zoonoses) Changchun Veterinary Research Institute,Chinese Academy of Agricultural Sciences 666 Liuying West Road, Jingyue Economy Development District, Changchun, Jilin, China (e) Centre for Rabies Antibody Assay, Laboratory of Epidemiology, Military Veterinary Research Institute, Academy of Military Medical Sciences 666 Liuying West Road, Jingyue Economy Development District Changchun, Jilin China (f) Rabies and Japanese encephalitis OIE reference laboratory of the Animal and Plant Quarantine Agency 177 Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do, 39660, South Korea (g) Centers for Disease Control and Prevention Rabies Laboratory 1600 Clifton Road, NE, Atlanta, GA 30333, The United States (h) The National Institute of Animal Health 50/2 Kasetklang, Ladyao, Chatuchak Bangkok 10900 Thailand

Article 2 This Decision is addressed to the Member States.

Done at Brussels, 14 April 2020. For the Commission Stella KYRIAKIDES Member of the Commission

(1) OJ L 79, 30.3.2000, p. 40.