CELEX: 32021D0545
Language: en
Date: 2021-03-26 00:00:00
Title: Commission Implementing Decision (EU) 2021/545 of 26 March 2021 authorising laboratories in Brazil, Cambodia, China, Mexico, South Africa, Tunisia, Ukraine and the United Kingdom to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets (notified under document C(2021) 1953) (Text with EEA relevance)

30.3.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 110/34
               
            
         COMMISSION IMPLEMENTING DECISION (EU) 2021/545
         of 26 March 2021
         authorising laboratories in Brazil, Cambodia, China, Mexico, South Africa, Tunisia, Ukraine and the United Kingdom to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets
         
            
               (notified under document C(2021) 1953)
            
         
         (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 nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (‘ANSES’) 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.
                  
               
                     (2)
                  
                  
                     Decision 2000/258/EC provides, among other things, 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 ‘Instituto de Tecnologia do Paraná’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for this laboratory.
                  
               
                     (4)
                  
                  
                     The competent authority of Brazil has submitted an application for re-approval of two laboratories: the ‘TECSA laboratórios LTDA’ and the ‘Instituto Pasteur ’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for these laboratories.
                  
               
                     (5)
                  
                  
                     The competent authority of Cambodia has submitted an application for the approval of the laboratory ‘Pasteur Institute of Cambodia’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for this laboratory.
                  
               
                     (6)
                  
                  
                     The competent authority of China has submitted an application for the approval of the laboratory ‘Technical Centre for animal, plant and food inspection and quarantine of Shanghai customs’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for this laboratory.
                  
               
                     (7)
                  
                  
                     The competent authority of Mexico has submitted an application for re-approval of the laboratory ‘SADER/SENASICA’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for this laboratory.
                  
               
                     (8)
                  
                  
                     The competent authority of South Africa has submitted an application for re-approval of the laboratory ‘Onderstepoort Veterinary Institute’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for this laboratory.
                  
               
                     (9)
                  
                  
                     The competent authority of Tunisia has submitted an application for the approval of the laboratory ‘Pasteur Institute of Tunis’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for this laboratory.
                  
               
                     (10)
                  
                  
                     The competent authority of Ukraine has submitted an application for the approval of the laboratory ‘State Scientific Control Institute of Biotechnology and Strains of Microorganisms’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for this laboratory.
                  
               
                     (11)
                  
                  
                     The competent authority of the United Kingdom has submitted an application for the approval of the laboratories ‘APHA Weybridge’ and ‘BioBest Laboratories Ltd’. The ANSES has established and submitted to the Commission a favourable appraisal report dated 5 January 2021 for these laboratories.
                  
               
                     (12)
                  
                  
                     These laboratories should therefore be authorised to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.
                  
               
                     (13)
                  
                  
                     In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, the authorisation of the application submitted by the competent authority of the United Kingdom does not prevent a national reference laboratory located in a Member State from fulfilling the functions of a national reference laboratory in respect of the United Kingdom (Northern Ireland).
                  
               
                     (14)
                  
                  
                     The measures provided for in this Decision are in accordance with the opinion of the 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)
                     
                     
                        
                                    Instituto de Tecnologia do Paraná
                                 
                              
                                    Rua Professor Algacyr Munhoz Mader, 3775
                                 
                              
                                    Curitiba 81350-010
                                 
                              
                                    Brazil
                                 
                              
                  
                        (b)
                     
                     
                        
                                    TECSA laboratórios LTDA
                                 
                              
                                    Avenida do Contorno, 6226 - Funcionários
                                 
                              
                                    Belo Horizonte 30110-042
                                 
                              
                                    Brazil
                                 
                              
                  
                        (c)
                     
                     
                        
                                    Instituto Pasteur
                                 
                              
                                    Avenida Paulista, 393
                                 
                              
                                    São Paulo 01311000
                                 
                              
                                    Brazil
                                 
                              
                  
                        (d)
                     
                     
                        
                                    Pasteur Institute of Cambodia
                                 
                              
                                    Laboratory of virology
                                 
                              
                                    5 Monivong Boulevard
                                 
                              
                                    BP 983
                                 
                              
                                    12200 Phnom Penh
                                 
                              
                                    Cambodia
                                 
                              
                  
                        (e)
                     
                     
                        
                                    Technical Centre for animal, plant and food inspection and quarantine of Shanghai customs
                                 
                              
                                    Laboratory of animal quarantine
                                 
                              
                                    1208 Minsheng Road
                                 
                              
                                    Pudong district
                                 
                              
                                    Shanghai 200135
                                 
                              
                                    China
                                 
                              
                  
                        (f)
                     
                     
                        
                                    SADER/SENASICA
                                 
                              
                                    Av. Centenario de la Educación s/n, (km 3,5 Carretera Federal Mexico-Pachuca)
                                 
                              
                                    Tecamac de Felipe Villanueva
                                 
                              
                                    55740 Estado de México
                                 
                              
                                    México
                                 
                              
                  
                        (g)
                     
                     
                        
                                    Onderstepoort Veterinary Institute
                                 
                              
                                    100 Old Soutpan Road
                                 
                              
                                    0110 Pretoria
                                 
                              
                                    South Africa
                                 
                              
                  
                        (h)
                     
                     
                        
                                    Pasteur Institute of Tunis
                                 
                              
                                    Rabies laboratory
                                 
                              
                                    13 place Pasteur
                                 
                              
                                    BO 74
                                 
                              
                                    1002 Tunis Belvedere
                                 
                              
                                    Tunisia
                                 
                              
                  
                        (i)
                     
                     
                        
                                    State Scientific Control Institute of Biotechnology and Strains of Microorganisms
                                 
                              
                                    Department of Biotechnology and Quality Control of Viral Preparations
                                 
                              
                                    30, Donetska str.
                                 
                              
                                    03151 Kyiv
                                 
                              
                                    Ukraine
                                 
                              
                  
                        (j)
                     
                     
                        
                                    APHA Weybridge
                                 
                              
                                    Virology Vl 1, Woodham Lane
                                 
                              
                                    New Haw, Addelestone
                                 
                              
                                    Surrey KT15 3NB
                                 
                              
                                    United Kingdom
                                 
                              
                  
                        (k)
                     
                     
                        
                                    BioBest Laboratories Ltd
                                 
                              
                                    6 Charles Darwin House
                                 
                              
                                    The Edinburgh technopole, Nr Milton Bridge
                                 
                              
                                    Penicuik
                                 
                              
                                    United Kingdom
                                 
                              
                  
         
            Article 2
            This Decision is addressed to the Member States.
         
         
            Done at Brussels, 26 March 2021.
            
               
                  For the Commission
               
               Stella KYRIAKIDES
               
                  Member of the Commission
               
            
         
         
            (1)  OJ L 79, 30.3.2000, p. 40.