
Article 1 
Annexes XI, XII and XV to Directive 2003/85/EC are amended in accordance with the Annex to this Decision.
Article 2 
This Decision is addressed to the Member States.
Done at Brussels, 4 August 2015.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX

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:
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PART A 

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 BelgiumLuxembourg
CZ Czech Republic Státní veterinární ústav Praha, Praha Czech Republic
DE Germany Friedrich-Loeffler-InstitutBundesforschungsinstitut für Tiergesundheit, Greifswald — Insel Riems GermanySlovakia
DK Denmark Danmarks Tekniske Universitet, Veterinærinstituttet, Afdeling for Virologi, LindholmDanish Technical University, Veterinary Institute, Department of Virology, Lindholm DenmarkFinlandSweden
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 ItalyCyprus
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 KingdomBulgariaCroatiaEstoniaFinlandIrelandLatviaLithuaniaMaltaPortugalSloveniaSweden

PART B 

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
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((2)) Annex XII is replaced by the following:

‘ANNEX XII  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:
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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.
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((b)) Point 13 is replaced by the following:
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13. 
Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.
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