# Commission Implementing Decision (EU) 2015/1358 of 4 August 2015 amending Annexes XI, XII and XV to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus and minimum bio-security standards applicable to them (notified under document C(2015) 5341) (Text with EEA relevance), Annex Extent: E+W+S+N.I. Annexes XI, XII and XV to Directive 2003/85/EC are amended as follows: (1) In Annex XI, Parts A and B are replaced by the following: ‘PART A National 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 B Laboratories 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) Annex XII is replaced by the following: ‘ANNEX XII BIO-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). 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) Annex XV is amended as follows: (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.’ (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). Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.’. --- Source: https://www.legislation.gov.uk/eudn/2015/1358/annex (the official version) Page: https://openlegislation.uk/eu-decision-2015-1358/annex Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.