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)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC, and in particular Articles 67(2) and 87(3) thereof,
OJ L 306, 22.11.2003, p. 1.
Whereas:
(1) Directive 2003/85/EC sets out minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease and certain preventive measures aimed at increasing the awareness and preparedness of the competent authorities and the farming community concerning that disease.
(2) The preventive measures set out in Directive 2003/85/EC include the provision that Member States are to ensure that the handling of live foot-and-mouth disease virus for research, diagnosis or vaccine manufacturing is carried out only in approved laboratories listed in Annex XI to that Directive.
(3) Part A of Annex XI to Directive 2003/85/EC lists national laboratories authorised to handle live foot-and-mouth disease virus for research and diagnostic purposes. Part B of that Annex lists laboratories handling virus antigen during the manufacturing of vaccines.
(4) Croatia and Lithuania have officially informed the Commission that their respective national reference laboratories are no longer considered to meet the bio-security standards provided for in Article 65(d) of Directive 2003/85/EC. The entries for those countries should therefore be deleted from the list in Part A of Annex XI to that Directive. Greece and Hungary have requested a change of the name of its national laboratory provided for in that list due to organisational changes. The Czech Republic has requested a correction of a spelling mistake in the name of its national laboratory provided for in that list.
(5) For legal certainty, it is important to keep the list of national laboratories set out in Part A of Annex XI to Directive 2003/85/EC updated. Therefore, it is necessary to remove the entries for Croatia and Lithuania from that list of laboratories, to amend the names of the national laboratories in the Czech Republic, Greece and Hungary, as well as to specify in that list of laboratories that the Pirbright Institute provides the services of a National Reference Laboratory for Bulgaria, Croatia, Lithuania and Portugal.
(6) Germany has requested a change of the name of the laboratory listed in Part B of Annex XI to Directive 2003/85/EC due to organisational changes. At the same time, Part B of that Annex should be amended to correct the ISO-country code used for the United Kingdom.
(7) Parts A and B of Annex XI to Directive 2003/85/EC should therefore be amended accordingly.
(8) Point 1 of Annex XII to Directive 2003/85/EC sets out bio-security standards for laboratories handling live foot-and-mouth disease virus. It provides that such laboratories are to meet at least the minimum requirements laid down in the ‘Minimum standards for laboratories working with foot-and-mouth virus in vitro and in vivo’ adopted by the European Commission for the control of foot-and-mouth disease (EuFMD) at its 38th General Session on 29 April 2009 in Rome (bio-security standards). A revised edition of those bio-security standards was adopted at the 40th General Session of EuFMD on 22-24 April 2013 in Rome.
http://www.fao.org/fileadmin/user_upload/eufmd/Lab_guidelines/FMD_Minimumstandards_2013_Final_version.pdf
(9) The revised edition of the bio-security standards consists of Section I, concerning laboratories working with foot-and-mouth disease virus in vitro and in vivo, and Section II concerning laboratories undertaking diagnostic investigations for foot-and-mouth disease in the framework of a national contingency plan.
(10) Therefore the referrence to the bio-security standards in Point 1 of Annex XII to Directive 2003/85/EC should be amended in order to refer to the relevant section of their most current revised edition.
(11) From June 2009 to June 2012, the Commission carried out 19 audits in 15 Member States hosting 16 national laboratories and three vaccine production laboratories authorised to handle live foot-and-mouth disease virus and listed in Annex XI to Directive 2003/85/EC. Those audits aimed to assess the official controls and to evaluate the bio-security systems applied by those laboratories. The outcome of the audits was presented during a workshop on bio-security for laboratories handling live foot-and-mouth disease virus which took place on 27 and 28 January 2015 in Grange, Ireland. The audit report was published immediately thereafter.
Report DG(SANCO) 2012-6916. Available at: http://ec.europa.eu/food/fvo/overview_reports/details.cfm?rep_id=71
(12) Points 2 and 3 of Annex XII to Directive 2003/85/EC provide for the obligation for the inspections of the laboratories and establishments handling live foot-and-mouth disease virus, their frequency, as well as inspection team composition. Following the recommendations from the series of audits carried out by the Commission and taking into account the obligations for official controls in accordance with Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council, it is possible to provide for regular and risk-based inspections of the laboratories handling live foot-and-mouth disease virus without establishing fixed intervals and team compositions.
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).
(13) Annex XII to Directive 2003/85/EC should therefore be amended accordingly.
(14) Annex XV to Directive 2003/85/EC sets out the functions and duties of national laboratories. For the sake of clarity it is necessary to specify that the obligations detailed in point 3 of that Annex apply only to those national laboratories which are designated as national reference laboratories in accordance with Article 68(1)(c) of that Directive.
(15) In addition, one of the outcomes of the audits in Member States and of the discussion at the workshop on 27 and 28 January 2015 was that Member States should list in advance the other designated laboratories referred to in point 13 of Annex XV to Directive 2003/85/EC in their contingency plans and ensure that the measures taken to prevent the possible escape of foot-and-mouth disease virus are based on the recommendations provided for in Section II of the bio-security standards concerning laboratories undertaking diagnostic investigations for foot-and-mouth disease in the framework of a national contingency plan.
(16) Annex XV to Directive 2003/85/EC should therefore be amended accordingly.
(17) Directive 2003/85/EC should therefore be amended accordingly.
(18) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION: