ANNEX
- (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)
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)
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)5.
Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.
- (a)