Commission Implementing Decision (EU) 2016/2008Dangos y teitl llawn

Commission Implementing Decision (EU) 2016/2008

of 15 November 2016

concerning animal health control measures relating to lumpy skin disease in certain Member States

(notified under document C(2016) 7023)

(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), Articles 19(1)(a) and 19(3)(a), and Article 19(4) 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) Lumpy skin disease (LSD) is a vector transmitted viral disease of bovine animals. According to the Scientific Opinion of the European Food Safety Authority (the EFSA) on lumpy skin disease, adopted on 3 December 2014, (the EFSA Opinion)(5) direct and indirect transmission of LSD may occur. LSD is characterised by severe losses of livestock production and has the potential to spread very quickly, notably through live animals, vectors and certain products obtained from infected animals.

(2) Directive 92/119/EEC lays down general control measures to be applied in the event of an outbreak of certain animal diseases, including LSD. These include control measures to be taken in the event of a suspicion and the confirmation of the presence of LSD in a holding, including the establishment of protection and surveillance zones around outbreaks and other additional control measures to prevent the spread of the disease and eliminate the infection. Those control measures also provide for vaccination in the event of an outbreak of LSD as a supplement to other control measures.

(3) Commission Implementing Decisions (EU) 2015/1500(6) and (EU) 2016/645(7) lay down certain protective measures in relation to the confirmation of LSD in Greece in 2015 and in Bulgaria in 2016. Those protective measures include the establishment of an infected zone in those Member States, which is described in the Annex to each of those Implementing Decisions, and which includes the area where LSD was confirmed and the protection and surveillance zones duly established by Greece and Bulgaria in accordance with Directive 92/119/EEC. Implementing Decisions (EU) 2015/1500 and (EU) 2016/645 have been amended several times due to the evolution of the disease situation, including the extension of the infected zone in order to include additional regional units of Greece and Bulgaria. Those Implementing Decisions apply until 31 December 2016.

(4) Commission Implementing Decisions (EU) 2015/2055(8) and (EU) 2016/1183(9) provide that Greece and Bulgaria may carry out emergency vaccination of bovine animals kept on holdings in the vaccination zone as set out in Annex I to those Implementing Decisions.

(5) Apart from Greece and Bulgaria, between April and August 2016, a considerable number of third countries in South East Europe have also reported outbreaks of LSD in their territories for the first time, namely Albania, the former Yugoslav Republic of Macedonia, Kosovo(10), Montenegro and Serbia. All those third countries have notified the Commission that vaccination against LSD has been included in their current disease control policy, amongst other measures.

(6) According to the EFSA Opinion(11) only live attenuated vaccines against LSD are commercially available. The EFSA 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 to be recommended, subject to availability by vaccine producers which are exclusively operating outside the Union. Also, according to the EFSA Opinion, the causative agent of LSD may be present up to 92 days in the skin of affected animals even without visible lesions.

(7) 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(12), which permits Member States to provisionally allow the use of immunological veterinary medicinal products without a marketing authorisation in the event of a serious epizootic disease as it is the case with LSD.

(8) According to the Urgent Advice on Lumpy Skin Disease of the EFSA, adopted on 29 July 2016(13), vaccination against LSD is the most effective way to reduce the spread of that disease. In order to eradicate LSD, it is necessary to implement the vaccination of the entire susceptible population in regions at risk for the introduction of LSD and those affected by LSD in order to minimise the number of outbreaks, and high animal- and farm-level vaccination coverage should be achieved. Therefore, a ‘solid’ preventive and control policy for LSD should provide for vaccination.

(9) The risk of the spread of LSD from vaccinated animals and products thereof is different from the risks arising from non-vaccinated and possibly incubating animals. Therefore, it is necessary to lay down conditions for the dispatch of vaccinated bovine animals and of products derived from such animals. Also, the risk of the spread of LSD from animals, whether or not vaccinated, originating in an area where vaccination against LSD is applied but where no LSD outbreaks have occurred, is different from the risk posed by such animals when they originate from LSD affected areas. Therefore, specific conditions should also be laid down for these animals.

(10) Scientific knowledge about LSD is incomplete. Vaccinated bovine animals are protected from clinical signs but not necessarily from infection and not all vaccinated animals respond with a protective immunity. Therefore, in order to minimise the risk, it should only be permitted to dispatch consignments of vaccinated animals after a period of at least 28 days, which is the maximum incubation period for LSD, following vaccination.

(11) In terms of the risk of the spread of LSD, different commodities pose different levels of risk. As indicated in the EFSA Opinion, the movement of live bovine animals, bovine semen and raw hides and skins from infected bovine animals pose a higher risk in terms of exposure and consequences than other products such as milk and dairy products, treated hides and skins or fresh meat, meat preparations and meat products originating from bovine animals. However scientific or experimental evidence is lacking on their role of transmission of LSD. Therefore, the control measures provided for in this Decision should be balanced and proportionate to the risks. Similarly, the transmission of LSD through semen, ova and embryos of animals of the bovine species cannot be excluded. Therefore, certain protective measures should be provided for those commodities based on the EFSA Opinion and the relevant most updated standards and recommendations from the World Organisation for Animal Health (OIE).

(12) Skeletal muscle meat from bovine animals is considered to be a safe commodity according to the OIE Scientific Commission for Animal Diseases(14) and as indicated in Annex 36 of Part B of the Report of the OIE Terrestrial Animal Health Standards Commission meeting of February 2016(15). There is no scientific or experimental evidence suggesting that the LSD virus can be transmitted to susceptible animals through fresh meat, meat preparations or meat products. Although the EFSA Opinion indicates that the LSD virus may survive in meat for a non-indicated period of time, the existing Union ban on feeding ruminant proteins to ruminants laid down in Regulation (EC) No 1069/2009 of the European Parliament and of the Council(16) and Article 7 of Regulation (EC) No 999/2001 of the European Parliament and of the Council(17) rules out the possibility of a possible oral transmission of LSD.

(13) Milk and dairy products, as well as colostrum, may represent a risk for the spread of LSD only when destined for feeding to animals of the susceptible species. Therefore, risk mitigation measures intended to prevent the spread of LSD through such products when intended for animal feeding should be laid down.

(14) Council Directive 64/432/EEC(18) and Commission Decision 93/444/EEC(19) provide that health certificates are to accompany the movements of animals. Where derogations from the prohibition on the dispatch of live animals from the areas listed in Annex I to this Decision are applied to live animals intended for intra-Union trade or for export to a third country, those health certificates should include a reference to this Decision so to ensure that adequate and accurate health information is provided in the relevant certificates.

(15) For reasons of clarity and simplification Implementing Decisions (EU) 2015/1500, (EU) 2015/2055, (EU) 2016/645 and (EU) 2016/1183 should be repealed and replaced by this Decision which introduces amended and uniform measures for all Member States affected by LSD or implementing vaccination against LSD.

(16) The approval of the vaccination programmes submitted by the Member States concerned and now included in Implementing Decisions (EU) 2015/2055 and (EU) 2016/1183 for Greece and Bulgaria respectively, as well as the approval of the vaccination programme submitted by Croatia should be subject to another Implementing Decision to be adopted.

(17) Bulgaria has advised the Commission that the vaccination of all bovine animals against LSD was completed on 15 July 2016 and the last occurrence of LSD on its territory was confirmed on 1 August 2016. Accordingly, certain areas of Bulgaria where LSD has never occurred but where vaccination against that disease has been carried out, should be listed in Part I of the Annex Ι to this Decision as a ‘free zone with vaccination’, while the remaining part of the territory of that Member State should be listed as an ‘infected zone’.

(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:

(1)

OJ L 395, 30.12.1989, p. 13.

(2)

OJ L 224, 18.8.1990, p. 29.

(3)

OJ L 62, 15.3.1993, p. 69.

(4)

OJ L 18, 23.1.2003, p. 11.

(5)

EFSA Journal 2015; 13(1): 3986.

(6)

Commission Implementing Decision (EU) 2015/1500 of 7 September 2015 concerning certain protective measures against lumpy skin disease in Greece and repealing Implementing Decision (EU) 2015/1423 (OJ L 234, 8.9.2015, p. 19).

(7)

Commission Implementing Decision (EU) 2016/645 of 22 April 2016 concerning certain protective measures against lumpy skin disease in Bulgaria (OJ L 108, 23.4.2016, p. 61).

(8)

Commission Implementing Decision (EU) 2015/2055 of 10 November 2015 laying down the conditions for setting out the programme for emergency vaccination of bovine animals against lumpy skin disease in Greece and amending Implementing Decision (EU) 2015/1500 (OJ L 300, 17.11.2015, p. 31).

(9)

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 (OJ L 195, 20.7.2016, p. 75).

(10)

This designation is without prejudice to positions on status, and is in line with UNSCR 1244 and the ICJ Opinion on the Kosovo Declaration of Independence.

(11)

EFSA Journal 2015;13(1):3986 [73 pp.].

(12)

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

(13)

EFSA Journal 2016;14(8):4573 [27 pp.].

(14)

http://www.oie.int/fileadmin/Home/eng/Internationa_Standard_Setting/docs/pdf/SCAD/A_SCAD_Feb2016.pdf (Annex 15, Article 11.11.1-bis. Safe commodities).

(15)

http://www.oie.int/fileadmin/Home/eng/Internationa_Standard_Setting/docs/pdf/A_TAHSC_Feb_2016_Part_B.pdf

(16)

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).

(17)

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).

(18)

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121 29.7.1964, p. 1977/64).

(19)

Commission Decision 93/444/EEC of 2 July 1993 on detailed rules governing intra-Community trade in certain live animals and products intended for exportation to third countries (OJ L 208, 19.8.1993, p. 34).