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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,
Whereas:
(1) On 5 January 2011 Bulgaria reported a case of foot-and-mouth disease in a wild boar shot in Burgas region in the South-East of Bulgaria within a zone of reinforced surveillance along the border with Turkey. The Commission therefore adopted Decision 2011/8/EU of 6 January 2011 concerning certain interim protection measures against foot-and-mouth disease in Bulgaria(3).
(2) On 9 January 2011 Bulgaria reported outbreaks of foot-and-mouth disease in livestock in the same area. The new epidemiological situation requires to review the measures previously adopted, also in the light of the information provided by Bulgaria and the discussions with Member States at the meeting of the Standing Committee on the Food Chain and Animal Health of 12 January 2011.
(3) The foot-and-mouth disease situation in Bulgaria is liable to endanger the herds of other Member States in view of trade in live biungulate animals and the placing on the market of certain of their products.
(4) Bulgaria has taken measures in the framework of Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease(4), in particular the measures provided for in Section 3 of Chapter II and in Article 85(4) thereof.
(5) The whole territory of Bulgaria is subject to the restrictions of Articles 2, 4, 5, 6, 8b and 11 of Commission Decision 2008/855/EC of 3 November 2008 concerning animal health control measures relating to classical swine fever in certain Member States(5). However, being listed in Part II of the Annex to that Decision allows Bulgaria to dispatch under certain health conditions fresh pig meat and meat preparations and products produced from such meat.
(6) The disease situation in Bulgaria makes it necessary to reinforce the control measures for foot-and-mouth disease taken by the competent authorities in Bulgaria.
(7) It is appropriate to define as a permanent measure the high and low risk areas in the affected Member State and to provide for a prohibition on the dispatch of susceptible animals from the high and low risk areas and on the dispatch of products derived from susceptible animals from the high risk area. The Decision should also provide for the rules applicable to the dispatch from those areas of safe products that either had been produced before the restrictions, from raw material sourced from outside the restricted areas or that had undergone a treatment proven effective in inactivating possible foot-and-mouth disease virus.
(8) The size of the defined risk areas is a direct function of the outcome of tracing of possible contacts to the infected holding and takes into account the possibility to implement sufficient controls on the movement of animals and products. At this point of time and based on information provided by Bulgaria, the whole of Burgas region should currently remain a high risk area.
(9) The prohibition of dispatch should only cover products derived from animals of susceptible species coming from or obtained from animals originating in the high risk areas listed in Annex I and should not affect transit through these areas of such products coming from or obtained from animals originating in other areas.
(10) Council Directive 64/432/EEC(6) concerns animal health problems affecting intra-Community trade in bovine animals and swine.
(11) Council Directive 91/68/EEC(7) concerns animal health conditions governing intra-Community trade in ovine and caprine animals.
(12) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC(8) concerns, amongst others, trade in other biungulates and in semen, ova and embryos of sheep and goats, and in embryos of porcine animals.
(13) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(9) concerns, amongst others, the health conditions for the production and marketing of fresh meat, minced meat, mechanically separated meat, meat preparations, farmed game meat, meat products, including treated stomachs, bladders and intestines, and dairy products.
(14) Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption(10) concerns, amongst others, the health marking of food of animal origin.
(15) 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(11) provides for specific treatment of meat products that ensure inactivation of the foot-and-mouth disease virus in products of animal origin.
(16) Commission Decision 2001/304/EC of 11 April 2001 on marking and use of certain animal products in relation to Decision 2001/172/EC concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom(12) concerns a specific health mark to be applied to certain products of animal origin that shall be restricted to the national market. It is appropriate to lay down in a separate Annex a similar marking in the case of foot-and-mouth disease in Bulgaria.
(17) Council Directive 92/118/EEC(13) lays down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC.
(18) Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(14) provides for a range of treatments of animal by-products suitable to inactivate the foot-and-mouth disease virus.
(19) Council Directive 88/407/EEC(15) lays down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species.
(20) Council Directive 89/556/EEC(16) concerns the animal health conditions governing intra-Community trade in and imports from third countries of embryos of domestic animals of the bovine species.
(21) Council Directive 90/429/EEC(17) lays down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species.
(22) The model health certificates for trade within the Union in semen, ova and embryos of animals of the ovine and caprine species and in ova and embryos of animals of the porcine species are laid down in Commission Decision 2010/470/EU of 26 August 2010 laying down model health certificates for trade within the Union in semen, ova and embryos of animals of the equine, ovine and caprine species and in ova and embryos of animals of the porcine species(18).
(23) In so far as medicinal products defined in 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(19), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(20), and Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(21) no longer fall under the scope of Regulation (EC) No 1774/2002 they should be excluded from animal health related restrictions set up by this Decision.
(24) Article 6 of Commission Decision 2007/275/EC of 17 April 2007 concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC(22) provides for a derogation from the veterinary checks for certain products containing animal products. It is appropriate to allow dispatch from the high risk areas of such products under a simplified certification regime.
(25) The possible risk of spread of foot-and-mouth disease within the European Union through the movements of consignments of products of animal origin of a non-commercial character should be considered in view of the foot-and-mouth disease situation in Bulgaria. Therefore such movements should be prevented in order to avoid further spread of the disease. Bulgaria should ensure that compliance with the restrictions imposed by this Decision on certain products derived from animals of species susceptible to foot-and-mouth disease is also ensured as regards the non-commercial movement of these products. Member States should cooperate in monitoring personal luggage of passengers travelling in particular from the high risk areas and in information campaigns carried out to prevent introduction of products of animal origin into the territory of Member States other than Bulgaria.
(26) Member States other than Bulgaria should support the disease control measures carried out in the affected areas by ensuring that live susceptible animals are not dispatched to those areas.
(27) Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field(23) provides for a mechanism to compensate affected holdings for losses incurred as a result of disease control measures.
(28) The foot-and-mouth disease situation has been reviewed at the meeting of the Standing Committee on the Food Chain and Animal Health of 12 January 2011 and the measures provided for in Decision 2011/8/EU were adapted in the light of the information received from Bulgaria on the development of the epidemiological situation. Decision 2011/8/EU should therefore be repealed and replaced by this Decision.
(29) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
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