Commission Implementing Decision (EU) 2016/1183 of 14 July 2016 approving the emergency vaccination programme against lumpy skin disease of bovine animals in Bulgaria and amending the Annex to Implementing Decision (EU) 2016/645 (notified under document C(2016) 4360) (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market⁽¹⁾, and in particular Article 9(4) thereof,

Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market⁽²⁾, and in particular Article 10(4) thereof,

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⁽³⁾, and in particular Article 14(2) and Article 19(1)(a), (3)(a) and (6) thereof,

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption⁽⁴⁾, and in particular Article 4(3) thereof,

Whereas:

1. Directive 92/119/EEC lays down general control measures to be applied in the event of an outbreak of certain animal diseases, including lumpy skin disease (LSD). Those control measures include the establishment of protection and surveillance zones around the infected holding, and they also provide for emergency vaccination in the case of an outbreak of LSD as a supplement to other control measures.

2. On 12 April 2016, Bulgaria informed the Commission of the suspicion of LSD in two bovine holdings situated, respectively, in the Voden and Chernogorovo villages in the municipality of Dimitrovgrad in the region of Haskovo in the central-southern part of Bulgaria, about 80 km from the borders with neighbouring countries. Following the confirmation of those two initial outbreaks in the Haskovo region, on 13 April 2016, Bulgaria reported outbreaks of LSD in several regions. On 20 May 2016 Bulgaria notified the Commission of the presence of 98 confirmed outbreaks of LSD of which 19 were in Haskovo, eight were in Stara Zagora, five were in Plovdiv, 54 were in Blagoevgrad, six were in Kjustendil, one was in Pernik and five were in the Smolyan region.

3. To prevent the spread of LSD to other parts of Bulgaria, to other Member States and to third countries, the Commission adopted Commission Implementing Decision (EU) 2016/645⁽⁵⁾. That Implementing Decision lays down certain protective measures in relation to the confirmation of LSD in Bulgaria and establishes, at Union level, a restricted zone which is described in the Annex thereto and which includes the area where LSD was confirmed and the protection and surveillance zones that were established by Bulgaria in accordance with Article 10 of Directive 92/119/EC.

4. During the same period, from 6 April 2016 to 19 May 2016, new outbreaks of LSD were reported in Greece and in the former Yugoslav Republic of Macedonia.

5. In accordance with the Scientific Opinion of the European Food Safety Authority on lumpy skin disease⁽⁶⁾, only live attenuated vaccines against LSD are commercially available. That Opinion describes the Neethling attenuated LSD virus vaccine as highly effective in preventing morbidity. As homologous LSD vaccines are more effective than vaccines based on attenuated sheep pox viruses, their use is recommended, subject to availability by vaccine producers which are exclusively operating outside the Union.

6. There is no vaccine against LSD with a marketing authorisation in the Union. Emergency vaccination in accordance with Article 19 of Directive 92/119/EEC may, therefore, only be carried out in accordance with Article 8 of Directive 2001/82/EC of the European Parliament and of the Council⁽⁷⁾, permitting Member States to provisionally allow the use of vaccines without a marketing authorisation in the event of a serious epizootic disease as it is the case of LSD.

7. On 25 April 2016, Bulgaria submitted to the Commission a programme for the emergency vaccination against LSD of bovine animals kept on holdings in the affected areas and also in certain adjoining areas of that Member State (‘the emergency vaccination programme’). The emergency vaccination programme contains information concerning the decision to implement the measures, the details concerning the geographical and administrative definition of the vaccination zone, the number of holdings and the animals to be vaccinated and the time when the vaccination should be completed. On 20 May 2016, Bulgaria informed the Commission of its intention to expand the emergency vaccination programme to the entire territory of Bulgaria. This requires enlarging the restricted zone as described in the Annex to Implementing Decision (EU) 2016/645. The Annex to Implementing Decision (EU) 2016/645 should therefore be amended accordingly.

8. In accordance with Article 19(6) of Directive 92/119/EEC, Bulgaria notified the Commission on 28 April 2016 of the acquisition of a sufficient number of doses of homologous LSD vaccine from the vaccine bank established by the Commission in accordance with Commission Implementing Decision of 18 December 2015⁽⁸⁾ and the start of emergency vaccination in a 20 km radius around confirmed LSD outbreaks according to the emergency vaccination programme.

9. It is necessary to lay down the conditions under which Bulgaria should apply emergency vaccination. The rapid spread of LSD in Bulgaria constitutes a risk to other parts of the territory of Bulgaria and to neighbouring countries. Therefore, it is also necessary to reinforce the control measures applied in Bulgaria by restricting the movement of unvaccinated bovine animals older than three months to other holdings within the restricted zone. That age limitation would allow the necessary movement of young calves to other holdings for further rearing during a period after birth when they cannot be effectively immunised. At the same time, it is necessary to allow the movement of unvaccinated bovine animals directly to a slaughterhouse within the restricted zone.

10. The area where vaccination against LSD is to be carried out may cover the entire restricted zone as defined in Implementing Decision (EU) 2016/645, which is set out in the Annex to that Decision.

11. The first round of emergency vaccination should be completed as soon as possible and not later than 30 June 2016. In the case of further outbreaks in other areas, the emergency vaccination in the affected areas should be completed within two months after the confirmation of the first outbreak of LSD in those areas subject to the availability of vaccines.

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: