Commission Implementing Decision (EU) 2018/136
of 25 January 2018
designating the European Union reference laboratory for foot-and-mouth disease and amending Annex II to Council Directive 92/119/EEC as regards the European Union reference laboratory for swine vesicular disease
(notified under document C(2018) 299)
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease, and in particular Article 24(2) thereof,
OJ L 62, 15.3.1993, p. 69.
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 Article 69(1) thereof,
OJ L 306, 22.11.2003, p. 1.
Whereas:
(1) Directive 92/119/EEC sets out the general Union control measures to be applied in the event of an outbreak of, inter alia, swine vesicular disease. Point 6 of Annex II to Directive 92/119/EEC indicates the European Union reference laboratory for swine vesicular disease which has been designated in order to carry out the functions and duties set out in Annex III thereto.
(2) Directive 2003/85/EC sets out minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease. Directive 2003/85/EC provides, inter alia, that a European Union reference laboratory for foot-and-mouth disease is to be designated in order to carry out the functions and duties set out in Annex XVI thereto. Subsequently, Commission Implementing Decision 2012/767/EU designated the European Union reference laboratory for foot-and-mouth disease.
Commission Implementing Decision 2012/767/EU of 7 December 2012 designating the EU reference laboratory for foot-and-mouth disease and repealing Decision 2006/393/EC (OJ L 337, 11.12.2012, p. 54).
(3) As a consequence of the United Kingdom's notification in accordance with Article 50 of the Treaty on European Union, the laboratory indicated in Annex II to Directive 92/119/EEC as the European Union reference laboratory for swine vesicular disease and subsequently designated by Implementing Decision 2012/767/EU as the European Union reference laboratory for foot-and-mouth disease will have to discontinue its functions as European Union reference laboratories for those two diseases.
(4) The Commission, in close collaboration with the Member States, has carried out a call for selection and designation of the European Union Reference Laboratory for Foot-and-Mouth Disease, taking into account the criteria of the technical and scientific competence of the laboratory and its staff expertise.
(5) Following completion of the selection procedure, the successful laboratory was the consortium ANSES & CODA-CERVA set up by the Laboratory for Animal Health of the Agency for Food, Environmental and Occupational Health and Safety (ANSES), Maisons-Alfort, France, and the Veterinary and Agrochemical Research Centre (CODA-CERVA), Uccle, Belgium.
(6) In order to avoid any disruption of activities of the European Union reference laboratory for foot-and-mouth disease and to allow the newly designated European Union reference laboratory sufficient time to be fully operational, it is appropriate that the measures provided for in this Decision apply as from 1 January 2019.
(7) In its Scientific Opinion on Swine Vesicular Disease and Vesicular Stomatitis, the European Food Safety Authority concluded that swine vesicular disease has no longer an epidemic potential and can be rapidly diagnosed by laboratory testing. In addition, the epidemiological situation as regards swine vesicular disease in the European Union has improved significantly and the last cases were only detected through laboratory testing of samples from a small region in a single Member State. Since 2014, swine vesicular disease is no longer listed as notifiable disease by the World Organisation for Animal Health (OIE).
EFSA Panel on Animal Health and Welfare (AHAW); Scientific Opinion on Swine Vesicular Disease and Vesicular Stomatitis. EFSA Journal 2012;10(4):2631. [97 pp.] doi:10.2903/j.efsa.2012.2631.
Resolution No 31 on Amendments to the OIE Terrestrial Animal Health Code, adopted during the 82nd General Session of the World Organisation for Animal Health (OIE), 25 - 30 May 2014, Paris, France.
(8) Although Directives 92/119/EEC and 2003/85/EC will be repealed as of 21 April 2021 in accordance with Article 270 of Regulation (EU) 2016/429 of the European Parliament and of the Council, foot-and-mouth disease is listed in Article 5(1) of that Regulation, while swine vesicular disease is listed in Annex II thereto. In accordance with Article 275 of that Regulation, the list of diseases in Annex II shall be reviewed at the latest by 20 April 2019. For the above mentioned scientific and technical reasons, swine vesicular disease does not meet the criteria for listing set out in Article 5(3) of Regulation (EU) 2016/429.
Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).
(9) Furthermore, swine vesicular disease and other vesicular diseases are included in certain functions and duties set out for the European Union reference laboratory for foot-and-mouth disease in Annex XVI to Directive 2003/85/EC, and in particular as regards the capacity of national reference laboratories and the European Union reference laboratory to carry out the differential diagnosis of foot-and-mouth disease. All these elements together allow discontinuing the designation of a European Union reference laboratory for swine vesicular disease.
(10) The reference made to the laboratory indicated in Annex II to Directive 92/119/EEC should be deleted. Annex II to Directive 92/119/EEC should therefore be amended accordingly.
(11) In the interest of clarity, Implementing Decision 2012/767/EU should be repealed with effect of 1 January 2019, the date on which the newly designated European Union reference laboratory for foot-and-mouth disease is to take up its function and duties.
(12) 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:

Article 1 The consortium ANSES & SCIENSANO set up by the Laboratory for Animal Health of the Agency for Food, Environmental and Occupational Health and Safety (ANSES), Maisons-Alfort, France, and the Laboratory for Exotic Viruses and Particular Diseases of the federal research centre Sciensano, Uccle, Belgium, is hereby designated as the European Union reference laboratory for foot-and-mouth disease for an undetermined period.
Substituted by Commission Implementing Decision (EU) 2018/1099 of 1 August 2018 amending Annex XI to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus and amending Commission Implementing Decision (EU) 2018/136 as regards the denomination of the designated European Union reference laboratory for foot-and-mouth disease (notified under document C(2018) 4987) (Text with EEA relevance).
Article 2 In Annex II to Directive 92/119/EEC, point 6 is deleted.
Article 3 Implementing Decision 2012/767/EU is repealed with effect from 1 January 2019.
References to the repealed Implementing Decision shall be construed as references to this Decision.
Article 4 This Decision shall apply from 1 January 2019.
Article 5 This Decision is addressed to the Member States.