{
  "url": "https://openlegislation.uk/eu-decision-2015-1358/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2015-1358/annex.json",
  "legislation": "eudn/2015/1358",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2015-1358",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annexes XI, XII and XV to Directive 2003/85/EC are amended as follows:\n(1) In Annex XI, Parts A and B are replaced by the following:\n‘PART A\nNational laboratories authorised to handle live foot-and-mouth disease virus\nMember State where laboratory is located\nLaboratory\nMember States using the services of laboratory\nISO code\nName\nAT\nAustria\nÖsterreichische Agentur für Gesundheit und Ernährungssicherheit Veterinärmedizinische Untersuchungen Mödling\nAustria\nBE\nBelgium\nVeterinary and Agrochemical Research Centre CODA-CERVA-VAR, Uccle\nBelgium\nLuxembourg\nCZ\nCzech Republic\nStátní veterinární ústav Praha, Praha\nCzech Republic\nDE\nGermany\nFriedrich-Loeffler-Institut\nBundesforschungsinstitut für Tiergesundheit, Greifswald — Insel Riems\nGermany\nSlovakia\nDK\nDenmark\nDanmarks Tekniske Universitet, Veterinærinstituttet, Afdeling for Virologi, Lindholm\nDanish Technical University, Veterinary Institute, Department of Virology, Lindholm\nDenmark\nFinland\nSweden\nEL\nGreece\nΔιεύθυνση Κτηνιατρικού Κέντρου Αθηνών, Τμήμα Μοριακής Διαγνωστικής, Αφθώδους Πυρετού, Ιολογικών και Εξωτικών Νοσημάτων, Αγία Παρασκευή Αττικής\nGreece\nES\nSpain\nLaboratorio Central de Sanidad Animal, Algete, Madrid\nCentro de Investigación en Sanidad Animal (CISA), Valdeolmos, Madrid\nSpain\nFR\nFrance\nAgence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Laboratoire de santé animale de Maisons-Alfort\nFrance\nHU\nHungary\nNemzeti Élelmiszerlánc-biztonsági Hivatal, Állategészségügyi Diagnosztikai Igazgatóság (NÉBIH-ÁDI), Budapest\nHungary\nIT\nItaly\nIstituto zooprofilattico sperimentale della Lombardia e dell'Emilia-Romagna, Brescia\nItaly\nCyprus\nNL\nNetherlands\nCentraal Veterinair Instituut, Lelystad (CVI- Lelystad)\nNetherlands\nPL\nPoland\nZakład Pryszczycy Państwowego Instytutu Weterynaryjnego — Państwowego Instytutu Badawczego, Zduńska Wola\nPoland\nRO\nRomania\nInstitutul de Diagnostic și Sănătate Animală, București\nRomania\nUK\nUnited Kingdom\nThe Pirbright Institute\nUnited Kingdom\nBulgaria\nCroatia\nEstonia\nFinland\nIreland\nLatvia\nLithuania\nMalta\nPortugal\nSlovenia\nSweden\nPART B\nLaboratories authorised to handle live foot-and-mouth disease virus for vaccine production\nMember State where laboratory is located\nLaboratory\nISO code\nName\nDE\nGermany\nIntervet International GmbH/MSD Animal Health, Köln\nNL\nNetherlands\nMerial S.A.S., Lelystad Laboratory, Lelystad\nUK\nUnited Kingdom\nMerial, S.A.S., Pirbright Laboratory, Pirbright\n’\n(2) Annex XII is replaced by the following:\n‘ANNEX XII\nBIO-SECURITY STANDARDS FOR LABORATORIES AND ESTABLISHMENTS HANDLING LIVE FOOT-AND-MOUTH DISEASE VIRUS\n1.\nThe 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).\n2.\nThe 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.\n3.\nThe 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.\n4.\nInspection teams deployed by the European Commission shall submit a report to the Commission and the Member States in accordance with Decision 98/139/EC.\n(3) Annex XV is amended as follows:\n(a) Point 3 is replaced by the following:\n‘3.\nNational 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.’\n(b) Point 13 is replaced by the following:\n‘13.\nNational 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).\nSamples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.’.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "http://www.fao.org/fileadmin/user_upload/eufmd/Lab_guidelines/FMD_Minimumstandards_2013_Final_version.pdf’."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "http://www.fao.org/fileadmin/user_upload/eufmd/Lab_guidelines/FMD_Minimumstandards_2013_Final_version.pdf’."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2015/1358/annex",
    "retrieved_at": "2026-11-01T15:14:15.929850+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}