ANNEX

  1. (1)

    In Annex XI, Parts A and B are replaced by the following:

    PART ANational laboratories authorised to handle live foot-and-mouth disease virus

    Member State where laboratory is located

    Laboratory

    Member States using the services of laboratory

    ISO code

    Name

    AT

    Austria

    Österreichische Agentur für Gesundheit und Ernährungssicherheit Veterinärmedizinische Untersuchungen Mödling

    Austria

    BE

    Belgium

    Veterinary and Agrochemical Research Centre CODA-CERVA-VAR, Uccle

    Belgium

    Luxembourg

    CZ

    Czech Republic

    Státní veterinární ústav Praha, Praha

    Czech Republic

    DE

    Germany

    Friedrich-Loeffler-Institut

    Bundesforschungsinstitut für Tiergesundheit, Greifswald — Insel Riems

    Germany

    Slovakia

    DK

    Denmark

    Danmarks Tekniske Universitet, Veterinærinstituttet, Afdeling for Virologi, Lindholm

    Danish Technical University, Veterinary Institute, Department of Virology, Lindholm

    Denmark

    Finland

    Sweden

    EL

    Greece

    Διεύθυνση Κτηνιατρικού Κέντρου Αθηνών, Τμήμα Μοριακής Διαγνωστικής, Αφθώδους Πυρετού, Ιολογικών και Εξωτικών Νοσημάτων, Αγία Παρασκευή Αττικής

    Greece

    ES

    Spain

    • Laboratorio Central de Sanidad Animal, Algete, Madrid

    • Centro de Investigación en Sanidad Animal (CISA), Valdeolmos, Madrid

    Spain

    FR

    France

    Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Laboratoire de santé animale de Maisons-Alfort

    France

    HU

    Hungary

    Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állategészségügyi Diagnosztikai Igazgatóság (NÉBIH-ÁDI), Budapest

    Hungary

    IT

    Italy

    Istituto zooprofilattico sperimentale della Lombardia e dell'Emilia-Romagna, Brescia

    Italy

    Cyprus

    NL

    Netherlands

    Centraal Veterinair Instituut, Lelystad (CVI- Lelystad)

    Netherlands

    PL

    Poland

    Zakład Pryszczycy Państwowego Instytutu Weterynaryjnego — Państwowego Instytutu Badawczego, Zduńska Wola

    Poland

    RO

    Romania

    Institutul de Diagnostic și Sănătate Animală, București

    Romania

    UK

    United Kingdom

    The Pirbright Institute

    United Kingdom

    Bulgaria

    Croatia

    Estonia

    Finland

    Ireland

    Latvia

    Lithuania

    Malta

    Portugal

    Slovenia

    Sweden

    PART BLaboratories authorised to handle live foot-and-mouth disease virus for vaccine production

    Member State where laboratory is located

    Laboratory

    ISO code

    Name

    DE

    Germany

    Intervet International GmbH/MSD Animal Health, Köln

    NL

    Netherlands

    Merial S.A.S., Lelystad Laboratory, Lelystad

    UK

    United Kingdom

    Merial, S.A.S., Pirbright Laboratory, Pirbright

  2. (2)

    Annex XII is replaced by the following:

    ‘ANNEX XIIBIO-SECURITY STANDARDS FOR LABORATORIES AND ESTABLISHMENTS HANDLING LIVE FOOT-AND-MOUTH DISEASE VIRUS

    1.

    The laboratories and establishments handling live foot-and-mouth disease virus must operate at least in accordance with Section I of the “Minimum biorisk management standards for laboratories working with foot-and-mouth disease virus in vitro and in vivo” in Appendix 7 to the Report adopted by the 40th General Session of the European Commission for the control of foot-and-mouth disease (EuFMD) on 22-24 April 2013 in Rome (bio-security standards)6.

    2.

    The laboratories and establishments handling live foot-and-mouth disease virus shall be subject to regular and risk-based inspections, including those carried out by and on behalf of the European Commission.

    3.

    The inspection team shall have at its disposition expertise from the Commission or a Member State in foot-and-mouth disease and bio-security in laboratories working with microbiological hazards.

    4.

    Inspection teams deployed by the European Commission shall submit a report to the Commission and the Member States in accordance with Decision 98/139/EC.

  3. (3)

    Annex XV is amended as follows:

    1. (a)

      Point 3 is replaced by the following:

      3.

      National Laboratories, designated as the National Reference Laboratories in accordance with Article 68(1)(c), must keep inactivated reference strains of all serotypes of foot-and-mouth disease virus, and immune sera against the viruses, as well as all other reagents necessary for a rapid diagnosis. Appropriate cell cultures should be in constant readiness for confirming a negative diagnosis.

    2. (b)

      Point 13 is replaced by the following:

      13.National Laboratories shall cooperate with other laboratories designated by the competent authorities, and listed in the contingency plans for foot-and-mouth disease as referred to in Article 72, for performing tests, for example serological tests, that do not involve handling of live foot-and-mouth disease virus. These laboratories shall not carry out virus isolation (by infection of cells or animals) from samples taken from suspect cases of vesicular diseases. Such laboratories must have established procedures which ensure that the possible spread of foot-and-mouth disease virus is effectively prevented, taking into account the recommendations in Section II of the “Minimum biorisk management standards for laboratories working with foot-and-mouth disease virus in vitro and in vivo” in Appendix 7 to the report adopted by the 40th General Session of the European Commission for the control of foot-and-mouth disease (EuFMD) on 22-24 April 2013 in Rome (bio-security standards)5.

      Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.