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
Modified by
  • Commission Regulation (EC) No 1248/2001of 22 June 2001amending Annexes III, X and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance and testing of transmissible spongiform encephalopathies, 32001R1248, June 27, 2001
  • Commission Regulation (EC) No 1326/2001of 29 June 2001laying down transitional measures to permit the changeover to the Regulation of the European Parliament and of the Council (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, and amending Annexes VII and XI to that Regulation, 32001R1326, June 30, 2001
  • Commission Regulation (EC) No 270/2002of 14 February 2002amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards specified risk material and epidemio-surveillance for transmissible spongiform encephalopathies and amending Regulation (EC) No 1326/2001 as regards animal feeding and the placing on the market of ovine and caprine animals and products thereof, 32002R0270, February 15, 2002
  • Commission Regulation (EC) No 1494/2002of 21 August 2002amending Annexes III, VII and XI to Regulation (EC) No 999/2001 of the European Parliament and the Council as regards monitoring of bovine spongiform encephalopathy, eradication of transmissible spongiform encephalopathy, removal of specified risk materials and rules for importation of live animals and products of animal origin(Text with EEA relevance), 32002R1494, August 22, 2002
  • Commission Regulation (EC) No 260/2003of 12 February 2003amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the eradication of transmissible spongiform encephalopathies in ovine and caprine animals and rules for the trade in live ovine and caprine animals and bovine embryos(Text with EEA relevance), 32003R0260, February 13, 2003
  • Commission Regulation (EC) No 650/2003of 10 April 2003amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the import of live ovine and caprine animals(Text with EEA relevance), 32003R0650, April 11, 2003
  • Commission Regulation (EC) No 1053/2003of 19 June 2003amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid tests(Text with EEA relevance), 32003R1053, June 20, 2003
  • Regulation (EC) No 1128/2003 of the European Parliament and of the Councilof 16 June 2003amending Regulation (EC) No 999/2001 as regards the extension of the period for transitional measures, 32003R1128, June 28, 2003
  • Commission Regulation (EC) No 1139/2003of 27 June 2003amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring programmes and specified risk material, 32003R1139, June 28, 2003
  • Commission Regulation (EC) No 1234/2003of 10 July 2003amending Annexes I, IV and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Regulation (EC) No 1326/2001 as regards transmissible spongiform encephalopathies and animal feeding(Text with EEA relevance), 32003R1234, July 11, 2003
  • Actconcerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, 12003T, September 23, 2003
  • Commission Regulation (EC) No 1809/2003of 15 October 2003amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rules for importation of live bovine animals and products of bovine, ovine and caprine origin from Costa Rica and New Caledonia(Text with EEA relevance), 32003R1809, October 16, 2003
  • Commission Regulation (EC) No 1915/2003of 30 October 2003amending Annexes VII, VIII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the trade and import of ovine and caprine animals and the measures following the confirmation of transmissible spongiform encephalopathies in bovine, ovine and caprine animals(Text with EEA relevance), 32003R1915, October 31, 2003
  • Commission Regulation (EC) No 2245/2003of 19 December 2003amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in ovine and caprine animals, 32003R2245, December 20, 2003
  • Commission Regulation (EC) No 876/2004of 29 April 2004amending Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards trade in ovine and caprine animals for breeding(Text with EEA relevance), 32004R0876, April 30, 2004
  • Commission Regulation (EC) No 1471/2004of 18 August 2004amending Annex XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the import of cervid products from Canada and the United States(Text with EEA relevance), 32004R1471, August 19, 2004
  • Commission Regulation (EC) No 1492/2004of 23 August 2004amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards eradication measures for transmissible spongiform encephalopathies in bovine, ovine and caprine animals, the trade and importation of semen and embryos of ovine and caprine animals and specified risk material(Text with EEA relevance), 32004R1492, August 24, 2004
  • Commission Regulation (EC) No 1993/2004of 19 November 2004amending Regulation (EC) 999/2001 of the European Parliament and of the Council as regards Portugal(Text with EEA relevance), 32004R1993, November 20, 2004
  • Commission Regulation (EC) No 36/2005of 12 January 2005amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals(Text with EEA relevance), 32005R0036, January 13, 2005
  • Commission Regulation (EC) No 214/2005of 9 February 2005amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in caprine animals(Text with EEA relevance), 32005R0214, February 10, 2005
  • Commission Regulation (EC) No 260/2005of 16 February 2005amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid tests(Text with EEA relevance), 32005R0260, February 17, 2005
  • Regulation (EC) No 932/2005 of the European Parliament and of the Councilof 8 June 2005amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies as regards the extension of the period for transitional measures(Text with EEA relevance), 32005R0932, June 23, 2005
  • Commission Regulation (EC) No 1292/2005of 5 August 2005amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards animal nutrition(Text with EEA relevance), 32005R1292, August 6, 2005
  • Commission Regulation (EC) No 1974/2005of 2 December 2005amending Annexes X and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards national reference laboratories and specified risk material(Text with EEA relevance), 32005R1974, December 3, 2005
  • Commission Regulation (EC) No 253/2006of 14 February 2006amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid tests and measures for the eradication of TSEs in ovine and caprine animals(Text with EEA relevance), 32006R0253, February 15, 2006
  • Commission Regulation (EC) No 339/2006of 24 February 2006amending Annex XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the rules for importation of live bovine animals and products of bovine, ovine and caprine origin(Text with EEA relevance), 32006R0339, February 25, 2006
  • Commission Regulation (EC) No 657/2006of 10 April 2006amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the United Kingdom and repealing Council Decision 98/256/EC and Decisions 98/351/EC and 1999/514/EC(Text with EEA relevance), 32006R0657, April 29, 2006
  • Commission Regulation (EC) No 688/2006of 4 May 2006amending Annexes III and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the monitoring of transmissible spongiform encephalopathies and specified risk material of bovine animals in Sweden(Text with EEA relevance), 32006R0688, May 5, 2006
  • Commission Regulation (EC) No 1041/2006of 7 July 2006amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in ovine animals(Text with EEA relevance), 32006R1041, July 8, 2006
  • Council Regulation (EC) No 1791/2006of 20 November 2006adapting certain Regulations and Decisions in the fields of free movement of goods, freedom of movement of persons, company law, competition policy, agriculture (including veterinary and phytosanitary legislation), transport policy, taxation, statistics, energy, environment, cooperation in the fields of justice and home affairs, customs union, external relations, common foreign and security policy and institutions, by reason of the accession of Bulgaria and Romania, 32006R1791, December 20, 2006
  • Regulation (EC) No 1923/2006 of the European Parliament and of the Councilof 18 December 2006amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32006R1923, December 30, 2006
  • Commission Regulation (EC) No 722/2007of 25 June 2007amending Annexes II, V, VI, VIII, IX and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32007R0722, June 26, 2007
  • Commission Regulation (EC) No 727/2007of 26 June 2007amending Annexes I, III, VII and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32007R0727, June 27, 2007
  • Commission Regulation (EC) No 1275/2007of 29 October 2007amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32007R1275, October 30, 2007
  • Commission Regulation (EC) No 1428/2007of 4 December 2007amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32007R1428, December 5, 2007
  • Commission Regulation (EC) No 21/2008of 11 January 2008amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the lists of rapid tests(Text with EEA relevance), 32008R0021, January 12, 2008
  • Commission Regulation (EC) No 315/2008of 4 April 2008amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the lists of rapid tests(Text with EEA relevance), 32008R0315, April 5, 2008
  • Commission Regulation (EC) No 357/2008of 22 April 2008amending Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32008R0357, April 23, 2008
  • Commission Regulation (EC) No 571/2008of 19 June 2008amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the criteria for revision of the annual monitoring programmes concerning BSE(Text with EEA relevance), 32008R0571, June 20, 2008
  • Commission Regulation (EC) No 746/2008of 17 June 2008amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32008R0746, July 31, 2008
  • Commission Regulation (EC) No 956/2008of 29 September 2008amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32008R0956, September 30, 2008
  • Commission Regulation (EC) No 103/2009of 3 February 2009amending Annexes VII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32009R0103, February 4, 2009
  • Commission Regulation (EC) No 162/2009of 26 February 2009amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32009R0162, February 27, 2009
  • Commission Regulation (EC) No 163/2009of 26 February 2009amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32009R0163, February 27, 2009
  • Regulation (EC) No 220/2009 of the European Parliament and of the Councilof 11 March 2009amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, as regards the implementing powers conferred on the Commission, 32009R0220, March 31, 2009
  • Commission Regulation (EU) No 956/2010of 22 October 2010amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the list of rapid tests(Text with EEA relevance), 32010R0956, October 23, 2010
  • Commission Regulation (EU) No 189/2011of 25 February 2011amending Annexes VII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32011R0189, February 26, 2011
  • Commission Regulation (EU) No 1064/2012of 13 November 2012amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the list of rapid tests(Text with EEA relevance), 32012R1064, November 14, 2012
  • Commission Regulation (EU) No 56/2013of 16 January 2013amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(Text with EEA relevance), 32013R0056, January 24, 2013
Regulation (EC) No 999/2001 of the European Parliament and of the Councilof 22 May 2001laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof, Having regard to the proposal from the CommissionOJ C 45, 19.2.1999, p. 2 andOJ C 120 E, 24.4.2001, p. 89., Having regard to the opinion of the Economic and Social CommitteeOJ C 258, 10.9.1999, p. 19., Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the TreatyOpinion of the European Parliament of 17 May 2000 (OJ C 59, 23.2.2001, p. 93), Common Position of the Council of 12 February 2001 (OJ C 88, 19.3.2001, p. 1) and Decision of the European Parliament of 3 May 2001., Whereas: (1)Several distinct transmissible spongiform encephalopathies (TSEs) have for a number of years been recognised as occurring separately in humans and animals. Bovine spongiform encephalopathy (BSE) was first recognised in bovine animals in 1986 and in the following years was recognised as occurring in other species of animal. A new variant of Creutzfeldt-Jakob Disease (CJD) was described in 1996. Evidence continues to grow of the similarity between the BSE agent and that of the new variant of Creutzfeld-Jakob Disease. (2)Since 1990 the Community has adopted a series of measures to protect human and animal health from the risk of BSE. Those measures have been based on the safeguard provisions of Directives on animal-health measures. It is appropriate, in view of the magnitude of the risk posed to human and animal health by certain TSEs, to adopt specific rules for their prevention, control and eradication. (3)This Regulation directly concerns public health and is relevant to the functioning of the internal market. It covers products which are included in Annex I to the Treaty as well as products which are not. Consequently, it is appropriate to choose Article 152(4)(b) of the Treaty as the legal basis. (4)The Commission has obtained scientific opinions, in particular from the Scientific Steering Committee and the Scientific Committee on Veterinary Measures relating to Public Health, on several aspects of TSEs. Those opinions include advice on measures to reduce the potential risk for humans and animals resulting from exposure to infected animal products. (5)These rules should apply to the production and placing on the market of live animals and products of animal origin. However, it is not necessary for them to apply to cosmetic or medicinal products, medical devices or their starting materials or intermediate products, for which other specific rules, in particular on the non-use of specified risk material, apply. Nor should they apply to products of animal origin which do not pose a risk to animal or human health since they are intended for purposes other than the production of food, feed or fertiliser. It is appropriate to ensure that products of animal origin excluded from the scope of this Regulation are kept separate from those covered by it unless they meet at least the same health standards as the latter. (6)Provision should be made for safeguard measures to be taken by the Commission in cases where a risk from a TSE has not been adequately addressed by the competent authority of a Member State or third country. (7)A procedure should be established for the determination of the epidemiological status of a Member State, a third country and of one of their regions, hereinafter referred to as "countries or regions" with respect to BSE, on the basis of the incident propagation and human exposure risk, using information available. Member States and third countries which choose not to apply for their status to be determined should be classified in a category by the Commission on the basis of all the information available to it. (8)Member States should institute education programmes for those involved in the prevention and control of TSEs, as well as for veterinarians, farmers and workers involved in the transportation, marketing and slaughter of farm animals. (8a)The feeding to non-ruminants of certain processed animal proteins originating from non-ruminants should be allowed taking into account the prohibition on intra-species recycling as laid down in 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 consumptionOJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006, p. 25). and the control aspects in particular linked to the differentiation of processed animal proteins specific to certain species as laid down in the Communication on the TSE Road map adopted by the Commission on 15 July 2005. (9)Member States should carry out an annual programme for monitoring BSE and scrapie and should inform the Commission and the other Member States of the results and of the emergence of any other TSE. (10)Certain ruminant tissues should be designated as specified risk material on the basis of the pathogenesis of TSEs and the epidemiological status of the country or region of origin or residence of the animal concerned. The specified risk material should be removed and disposed of in a manner which avoids any risk to human or animal health. In particular, it should not be placed on the market to be used in the production of food, feed or fertiliser. However, provision should be made for an equivalent level of health protection by means of a screening test for TSEs carried out on individual animals as soon as it has been fully validated. Slaughter techniques presenting a risk of causing brain material to contaminate other tissues should not be permitted in countries or regions other than those presenting the lowest risk of BSE. (11)Measures should be taken to prevent the transmission of TSEs to humans or animals by prohibiting the feeding of certain categories of animal protein to certain categories of animal, and by prohibiting the use of certain ruminant materials in food. Those prohibitions should be proportionate to the risks involved. (11a)In its resolution of 28 October 2004OJ C 174 E, 14.7.2005, p. 178.;, the European Parliament expressed concerns about feeding animal proteins to ruminants as they do not form part of the natural nutrition of adult cattle. In the wake of the BSE crisis and the foot-and-mouth disease crisis it has increasingly become accepted that the best way to ensure human and animal health is to keep and nourish animals in a way that respects the particularities of each species. Pursuant to the precautionary principle and in keeping with the natural diet and living conditions of ruminants, it is therefore necessary to maintain the prohibition on the feeding of animal proteins to ruminants in forms not normally constituting part of their natural diet. (11b)Mechanically separated meat is obtained by removing meat from bones in such a way that the muscle fibre structure is destroyed or modified. It can contain parts of the bones and the periosteum (bone skin). Thus, mechanically separated meat is not comparable with regular meat. Consequently its use for human consumption should be reviewed. (12)The suspected presence of any TSE in any animal should be notified to the competent authority, which should immediately take all appropriate measures, including placing the suspect animal under movement restrictions while awaiting the results of the investigation or having it slaughtered under official supervision. If the competent authority cannot exclude the possibility of a TSE, it should have the appropriate investigations carried out and should keep the carcasse under official supervision until a diagnosis has been made. (13)In the event of official confirmation of the presence of a TSE, the competent authority should take all the necessary measures, including having the carcasse destroyed, carrying out an investigation in order to identify all animals at risk and placing movement restrictions on the animals and the products of animal origin identified as such. Owners should be compensated, as soon as possible, for the loss of animals and products of animal origin destroyed pursuant to this Regulation. (14)Member States should draw up contingency plans for the national measures to be implemented in the event of an outbreak of BSE. Those plans should be approved by the Commission. Provision should be made for extending this provision to TSEs other than BSE. (15)Provisions should be laid down covering the placing on the market of certain live animals and products of animal origin. Existing Community rules on the identification and registration of bovine animals provide for a system enabling the animals to be traced back to the dam and herd of origin in accordance with international standards. Equivalent guarantees should be provided for bovine animals imported from third countries. The animals and products of animal origin covered by Community rules, moving in intra-Community trade or imported from third countries, should be accompanied by the certificates required by the said rules, supplemented as appropriate in accordance with this Regulation. (16)The placing on the market of certain products of animal origin derived from bovine animals in high risk regions should be prohibited. However, that prohibition should not apply to certain products of animal origin produced under controlled conditions from animals which can be demonstrated not to pose a high risk of infection with a TSE. (17)It is necessary, in order to ensure that the rules concerning the prevention, control and eradication of TSEs are observed, for samples to be taken for laboratory testing on the basis of an established protocol which would give a full epidemiological picture of the situation as regards TSE. In order to guarantee uniform testing procedures and results, national and Community Reference Laboratories and reliable scientific methods, including rapid tests specifically for TSEs, should be established. Rapid tests should be used as far as possible. (18)Community inspections should be carried out in the Member States in order to ensure uniform implementation of the requirements concerning the prevention, control and eradication of TSEs and provision should also be made for the implementation of audit procedures. In order to ensure that guarantees equivalent to those applied by the Community are provided by third countries upon import into the Community of live animals and products of animal origin, Community on-the-spot inspections and audits should be carried out in order to verify that the import conditions are met by exporting third countries. (19)Trade measures for TSEs should be based on international standards, guidelines or recommendations, where they exist. However, scientifically justified measures resulting in a higher level of health protection may be adopted if measures based on the relevant international standards, guidelines or recommendations would not achieve the appropriate level of health protection. (20)This Regulation should be re-examined as new scientific information becomes available. (21)The necessary transitional measures in particular for regulating the use of specified risk material should be provided for in the framework of this Regulation. (22)The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedure for the exercise of implementing powers conferred on the CommissionOJ L 184, 17.7.1999, p. 23.. (23)In order to implement this Regulation, procedures should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, the Standing Committee on Feedingstuffs, and the Standing Committee on Foodstuffs. (24)Given that the provisions for the implementation of this Regulation are general measures within the meaning of Article 2 of Decision 1999/468/EC, they should be adopted in accordance with the regulatory procedure laid down in Article 5 of that Decision, HAVE ADOPTED THIS REGULATION:
CHAPTER I GENERAL PROVISIONS
Article 1 Scope 1. This Regulation lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It shall apply to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof. 2. This Regulation shall not apply to: (a)cosmetic or medicinal products or medical devices, or to their starting materials or intermediate products; (b)products which are not intended for use in human food, animal feed or fertilisers, or to their starting materials or intermediate products; (c)products of animal origin intended for exhibition, teaching, scientific research, special studies or analysis, provided those products are not eventually consumed or used by humans or by animals other than those kept for the research projects concerned; (d)live animals used in or intended for research.
Article 2 Separation of live animals and of products of animal origin In order to avoid cross-contamination or substitution between the live animals or of the products of animal origin referred to in Article 1(1) and the products of animal origin referred to in Article 1(2)(a), (b) and (c), or the live animals referred to in Article 1(2)(d), they shall be kept separate at all times unless such live animals or products of animal origin are produced under at least the same conditions of health protection in respect of TSEs. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 3 Definitions 1. For the purposes of this Regulation the following definitions shall apply: (a)TSEs: all transmissible spongiform encephalopathies with the exception of those occurring in humans; (b)placing on the market: any operation the purpose of which is to sell live animals or products of animal origin covered by this Regulation to a third party in the Community, or any other form of supply against payment or free of charge to such a third party or storage with a view to supply to such a third party; (c)products of animal origin: any product derived from or containing a product derived from any animal covered by the provisions of Directive 89/662/EECCouncil 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 (OJ L 395, 30.12.1989, p. 13). Directive as last amended by Council Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49). or Directive 90/425/EECCouncil 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 (OJ L 224, 18.8.1990, p. 29). Directive as last amended by Council Directive 92/118/EEC.; (d)starting materials: raw materials or any other product of animal origin out of which, or with the help of which, the products referred to in Article 1(2)(a) and (b) are produced; (e)competent authority: the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which that central authority has delegated that competence, in particular for the control of feedingstuffs; it shall also include, where appropriate, the corresponding authority of a third country; (f)category: one of the classification categories referred to in Chapter C of Annex II; (g)specified risk material: the tissues specified in Annex V; unless otherwise indicated, it does not include products containing or derived from those tissues; (h)animal suspected of being infected by a TSE: live, slaughtered or dead animals, which show or have shown neurological or behavioural disorders or a progressive deterioration of the general condition linked to impairment of the central nervous system and for which the information gathered on the basis of a clinical examination, response to treatment, a post-mortem examination or an ante or post-mortem laboratory analysis do not allow an alternative diagnosis to be established. Bovine spongiform encephalopathies (BSE) shall be suspected in bovine animals which have produced a positive result from a rapid test specifically for BSE; (i)holding: any place in which animals covered by this Regulation are held, kept, bred, handled or shown to the public; (j)sampling: the taking of samples, ensuring a statistically correct representation, from animals or their environment, or from products of animal origin, for the purpose of establishing a disease diagnosis, familial relationships, for health surveillance, or for the monitoring of the absence of microbiological agents or of certain materials in products of animal origin; (k)fertilisers: any substance containing products of animal origin utilised on land to enhance growth of vegetation; it may include digestion residues from bio-gas production or composting; (l)rapid tests: the screening methods listed in Annex X, for which the results are known within 24 hours; (m)alternative test: the tests referred to in Article 8(2) which are used as an alternative to the withdrawal of specified risk material; (n)mechanically separated meat or "MSM": the product obtained by removing meat from flesh-bearing bones after boning, using mechanical means resulting in the loss or modification of the muscle fibre structure; (o)passive surveillance: the reporting of all animals suspected of being infected by a TSE and, where TSE cannot be excluded by clinical investigation, the laboratory testing of such animals; (p)active surveillance: the testing of animals not reported as suspected of being infected by a TSE, such as emergency slaughtered animals, animals with observations at ante mortem inspection, fallen stock, healthy slaughtered animals and animals culled in connection with a TSE case, in particular in order to determine the evolution and prevalence of TSE in a country or region thereof. 2. The specific definitions set out in Annex I shall also apply. 3. Where the terms in this Regulation are not defined in paragraph 1 or Annex I, the relevant definitions given in Regulation (EC) No 1760/2000Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1). and those given in or pursuant to Directives 64/432/EECCouncil 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). Directive as last amended by Directive 2000/20/EC of the European Parliament and of the Council (OJ L 163, 4.7.2000, p. 35)., 89/662/EEC, 90/425/EEC and 91/68/EECCouncil Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Commission Decision 94/953/EC (OJ L 371, 31.12.1994, p. 14). shall apply insofar as reference is made to them in this text.
Article 4 Safeguard measures 1. With regard to the implementation of safeguard measures, the principles and provisions set out in Article 9 of Directive 89/662/EEC, Article 10 of Directive 90/425/EEC, Article 18 of Directive 91/496/EECCouncil Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 24.9.1991, p. 56). Directive as last amended by Directive 96/43/EC (OJ L 162, 1.7.1996, p. 1). and Article 22 of Directive 97/78/ECCouncil Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9). shall apply. 2. The safeguard measures shall be adopted in accordance with the procedure referred to in Article 24(2) and shall be notified at the same time to the European Parliament, stating the reasons.
CHAPTER II DETERMINATION OF BSE STATUS
Article 5 Classification 1. The BSE status of Member States or third countries or regions thereof (hereinafter referred to as "countries or regions") shall be determined by classification into one of the following three categories: negligible BSE risk as defined in Annex II, controlled BSE risk as defined in Annex II, undetermined BSE risk as defined in Annex II. The BSE status of countries or regions may be determined only on the basis of the criteria set out in Annex II, Chapter A. These criteria shall include the outcome of a risk analysis on the basis of all the potential factors for the appearance of bovine spongiform encephalopathy as defined in Annex II, Chapter B, and their development over time, as well as comprehensive active and passive surveillance measures taking into account the risk category of the country or region. Member States, and third countries wishing to be retained on the list of third countries approved for the export to the Community of the live animals or of the products covered by this Regulation, shall submit to the Commission an application for their BSE status to be determined, accompanied by the relevant information on the criteria set out in Annex II, Chapter A, and on the potential risk factors specified in Annex II, Chapter B, and their development over time. 2. A decision on each application, placing the Member State or third country or region of the Member State or third country which submitted the application in one of the categories defined in Annex II, Chapter C, shall be adopted, taking account of the criteria and potential risk factors set out in paragraph 1, in accordance with the procedure referred to in Article 24(2). This decision shall be taken within six months of the submission of the application and of the relevant information referred to in the second subparagraph of paragraph 1. If the Commission finds that the supporting evidence does not include the information laid down in Annex II, Chapters A and B, it shall ask for additional information to be provided within a period to be specified. The final decision shall then be taken within six months of the submission of all information. After the International Office of Epizootic Diseases (OIE) has established a procedure for the classification of countries by category and if it has placed the applicant country in one of those categories, a re-assessment of the Community categorisation of the country concerned in accordance with the first subparagraph of this paragraph may be decided, if appropriate, in accordance with the procedure referred to in Article 24(2). 3. If the Commission finds that the information submitted by a Member State or a third country pursuant to Annex II, Chapters A and B, is insufficient or unclear, it may, in accordance with the procedure referred to in Article 24(2), determine the BSE status of the Member State or third country concerned on the basis of a full risk analysis. Such a risk analysis must include a conclusive statistical survey of the epidemiological situation regarding TSEs in the applicant Member State or third country, on the basis of the use, in a screening procedure, of rapid tests. The Commission shall take into account the classification criteria used by the OIE. The rapid tests shall be approved for that purpose in accordance with the regulatory procedure with scrutiny referred to in Article 24(3) and entered on a list set out in Annex X, Chapter C, point 4. Such screening procedure may also be used by Member States or third countries which wish to have the classification they carried out on that basis approved by the Commission — in accordance with the procedure laid down in Article 24(2). The cost of such screening procedure shall be borne by the Member State or third country concerned. 4. Member States and third countries which have not submitted an application in accordance with the third subparagraph of paragraph 1 shall, with respect to the dispatch from their territory of live animals and products of animal origin, comply with the import requirements applicable to countries with an undetermined BSE risk, until they have submitted such an application and a final decision has been taken on their BSE status. 5. Member States shall notify the Commission as soon as possible of any epidemiological evidence or other information which might lead to a change in BSE status, in particular the results of the monitoring programmes provided for in Article 6. 6. The retention of a third country on one of the lists provided for by Community rules for the purpose of being allowed to export to the Community live animals and products of animal origin for which this Regulation provides specific rules shall be decided upon under the procedure laid down in Article 24(2) and shall be made conditional — in the light of the information available or where a TSE is presumed to be present — on the information provided for in paragraph 1 being supplied. In the event of refusal to supply the said information within three months of the date of the Commission's request, the provisions of paragraph 4 of this Article shall apply until this information has been submitted and evaluated in accordance with paragraphs 2 or 3. The eligibility of third countries to export to the Community live animals, or products of animal origin for which this Regulation provides specific rules, under conditions based on their category as established by the Commission, shall be conditional upon their undertaking to notify the latter in writing as soon as possible of any epidemiological or other evidence which might lead to a change in BSE status. 7. A decision may be taken, under the procedure laid down in Article 24(2), to change the BSE classification of a Member State or third country, or of one of its regions, in accordance with the results of the checks provided for in Article 21. 8. The decisions referred to in paragraphs 2, 3, 4, 6 and 7 shall be based on a risk assessment, taking into consideration the recommended criteria set out in Annex II, Chapters A and B.
CHAPTER III PREVENTION OF TSE
Article 6 Monitoring system 1. Each Member State shall carry out an annual monitoring programme for TSEs based on active and passive surveillance in accordance with Annex III. If available for the animal species, that programme shall include a screening procedure using rapid tests. Rapid tests shall be approved for that purpose in accordance with the procedure referred to in Article 24(3) and listed in Annex X. 1a. The annual monitoring programme referred to in paragraph 1 shall cover as a minimum the following subpopulations: (a)all bovine animals above 24 months of age sent for emergency slaughter or with observations at ante mortem inspections; (b)all bovine animals above 30 months of age slaughtered normally for human consumption; (c)all bovine animals above 24 months of age not slaughtered for human consumption, which have died or been killed on the farm, during transport or in an abattoir (fallen stock). Member States may decide to derogate from the provision under point (c) in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this possibility shall inform the Commission and submit a list of the areas concerned together with a justification for the derogation. The derogation shall not cover more than 10 % of the bovine population in a Member State. 1b. After consultation of the appropriate scientific committee, the age laid down in paragraph 1a(a) and (c) may be adapted according to scientific progress in accordance with the procedure referred to in Article 24(3). At the request of a Member State which can demonstrate the improvement of the epidemiological situation of the country, according to certain criteria to be laid down in accordance with the procedure referred to in Article 24(3), the annual monitoring programmes for that particular Member State may be revised. The Member State concerned shall provide proof of its capability to determine the effectiveness of the measures in place and ensure protection of human and animal health based on a comprehensive risk analysis. In particular, the Member State shall demonstrate: (a)a clearly declining or consistently low BSE prevalence, based on up-to-date testing results; (b)that it has implemented and enforced for at least six years a full BSE testing scheme (Community legislation on traceability and identification of live animals and BSE surveillance); (c)that it has implemented and enforced for at least six years Community legislation on total feed ban for farmed animals. 2. Each Member State shall inform the Commission and the other Member States, within the Standing Veterinary Committee, of the emergence of a TSE other than BSE. 3. All official investigations and laboratory examinations shall be recorded in accordance with Annex III, Chapter B. 4. Member States shall submit an annual report to the Commission covering at least the information referred to in Annex III, Chapter B, Part I. The report for each calendar year shall be submitted at the latest by 31 March of the following year. The Commission shall present a summary of the national reports covering at least the information referred to in Annex III, Chapter B, Part II, to the Standing Veterinary Committee within three months of the receipt of the said reports. 5. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 6a Breeding Programmes 1. Member States may introduce breeding programmes to select for resistance to TSEs in their ovine populations. Those programmes shall include a framework to recognise the TSE-resistant status of certain flocks and may be extended to include other animal species based on scientific evidence corroborating the resistance to TSE of particular genotypes of those species. 2. Specific rules for the programmes provided for in paragraph 1 of this Article shall be adopted in accordance with the procedure referred to in Article 24(2). 3. Member States which introduce breeding programmes shall submit regular reports to the Commission in order to enable the programmes to be scientifically evaluated, in particular with regard to their impact on the incidence of TSEs but also on genetic diversity and variability and on the maintenance of old or rare ovine breeds or of those that are well-adapted to a particular region. The scientific results and overall consequences of the breeding programmes shall be evaluated regularly, and where necessary, those programmes shall be amended accordingly.
Article 7 Prohibitions concerning animal feeding 1. The feeding to ruminants of protein derived from animals shall be prohibited. 2. The prohibition provided for in paragraph 1 shall be extended to animals other than ruminants and restricted, as regards the feeding of those animals with products of animal origin, in accordance with Annex IV. 3. Paragraphs 1 and 2 shall apply without prejudice to the provisions laid down in Annex IV setting out the derogations from the prohibition contained in those paragraphs. The Commission may decide in accordance with the procedure referred to in Article 24(3), based on a scientific assessment of the dietary needs of young ruminants and subject to the rules adopted for the implementation of this Article provided for in paragraph 5 of this Article, and following an assessment of the control aspects of this derogation, to allow the feeding of young animals of ruminant species with proteins derived from fish. 4. Member States, or regions thereof, with an undetermined BSE risk shall not be permitted to export or store feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except feed for dogs, cats and fur animals, which contains processed protein derived from mammals. Third countries, or regions thereof, with an undetermined BSE risk shall not be permitted to export to the Community feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except feed for dogs, cats and fur animals, which contains processed protein derived from mammals. At the request of a Member State or third country a decision in accordance with the procedure referred to in Article 24(2) may be taken, following detailed criteria to be laid down in accordance with the procedure referred to in Article 24(3), to grant individual exemptions from the restrictions in this paragraph. Any exemption shall take account of the provisions provided for in paragraph 3 of this Article. 4a. Based on a favourable risk assessment taking into account at least the amount and possible source of contamination and the final destination of the consignment, a decision may be taken in accordance with the procedure referred to in Article 24(3) to introduce a tolerance level for insignificant amounts of animal proteins in feedingstuffs caused through adventitious and technically unavoidable contamination. 5. Rules for the implementation of this Article, in particular rules on the prevention of cross-contamination and on the methods of sampling and analysis required to check compliance with this Article, shall be adopted in accordance with the procedure referred to in Article 24(2). Those rules shall be based on a report of the Commission covering sourcing, processing, control and traceability of feedingstuffs of animal origin.
Article 8 Specified risk material 1. The specified risk material shall be removed and disposed of in accordance with Annex V to this Regulation and with Regulation (EC) No 1774/2002. It shall not be imported into the Community. The list of specified risk material referred to in Annex V shall include at least the brain, spinal cord, eyes and tonsils of bovine animals aged over 12 months and the vertebral column of bovine animals above an age to be determined in accordance with the procedure referred to in Article 24(3). Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b), the list of specified risk material in Annex V shall be amended accordingly. 2. Paragraph 1 of this Article shall not apply to tissues from animals which have undergone an alternative test approved for that distinct purpose in accordance with the procedure referred to in Article 24(3) provided that this test is listed in Annex X, is applied under the conditions provided for in Annex V and the test results are negative. The Member States which authorise the use of an alternative test pursuant to this paragraph shall inform the other Member States and the Commission. 3. In Member States, or regions thereof, with a controlled or undetermined BSE risk, the laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injection into the cranial cavity in connection with stunning, shall not be used on bovine, ovine or caprine animals whose meat is intended for human or animal consumption. 4. The data relating to age set out in Annex V may be adjusted. Such adjustments shall be based on the latest proven scientific findings concerning the statistical probability of the occurrence of a TSE in the relevant age groups of the Community's bovine, ovine and caprine population. 5. Rules providing for exemptions from paragraphs 1 to 4 of this Article may be adopted in accordance with the procedure referred to in Article 24(3), with regard to the date of the effective enforcement of the feeding prohibition provided for in Article 7(1) or, as appropriate for third countries or regions thereof with a controlled BSE risk, with regard to the date of the effective enforcement of the ban of mammalian protein in feed for ruminants with a view to limiting the requirements to remove and destroy specified risk material to animals born before that date in the countries or regions concerned. 6. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 9 Products of animal origin derived from or containing ruminant material 1. The products of animal origin listed in Annex VI shall be produced using production processes approved in accordance with the procedure referred to in Article 24(3). 2. Bones of bovine, ovine and caprine animals from countries or regions with a controlled or undetermined BSE risk shall not be used for the production of mechanically separated meat (MSM). Before 1 July 2008, the Member States shall submit a report to the Commission on the use and the production method of MSM in their territory. This report shall include a statement as to whether the Member State intends to continue with the production of MSM. The Commission shall thereupon present a communication to the European Parliament and the Council on the future necessity and use of MSM in the Community, including the information policy towards consumers. 3. Paragraphs 1 and 2 shall not apply, in the light of the criteria set out in point 5 of Annex V, to ruminants which have undergone an alternative test which has been recognised in accordance with the regulatory procedure with scrutiny referred to in Article 24(3), provided that this test is listed in Annex X, where the results of the test were negative. 4. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 10 Education programmes 1. Member States shall ensure that staff of the competent authority, of diagnostic laboratories and colleges of agriculture and veterinary medicine, official veterinarians, veterinary practitioners, slaughterhouse personnel and animal breeders, keepers and handlers have been given training in the clinical signs, epidemiology and, in the case of staff responsible for carrying out checks, in interpreting laboratory findings relating to TSEs. 2. To ensure effective implementation of the education programmes provided for in paragraph 1, financial assistance from the Community may be granted. The amount of such assistance shall be determined in accordance with the procedure referred to in Article 24(2).
CHAPTER IV CONTROL AND ERADICATION OF TSEs
Article 11 Notification Without prejudice to Directive 82/894/EECCouncil Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (OJ L 378, 31.12.1982, p. 58). Directive as last amended by Commission Decision 2000/556/EC (OJ L 235, 19.9.2000, p. 27)., the Member States shall ensure that any animal suspected of being infected by a TSE is notified immediately to the competent authorities. Member States shall regularly inform each other and the Commission of the cases of TSE notified. The competent authority shall without delay take the measures laid down in Article 12 of this Regulation, together with any other necessary measures.
Article 12 Measures with respect to suspect animals 1. Any animal suspected of being infected by a TSE shall be either placed under an official movement restriction until the results of a clinical and epidemiological examination carried out by the competent authority are known, or killed for laboratory examination under official control. If a TSE is officially suspected in a bovine animal at a holding in a Member State, all other bovine animals at that holding shall be placed under an official movement restriction until the results of the examination are available. If a TSE is officially suspected in an ovine or caprine animal at a holding in a Member State, all other ovine and caprine animals at that holding shall be placed under an official movement restriction until the results are available. However, if there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the competent authority may decide that only the animal suspected of being infected shall be placed under an official movement restriction. If considered necessary, the competent authority may also decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available. In accordance with the procedure referred to in Article 24(2) and by way of derogation from the official movement restrictions provided for in this paragraph, a Member State may be exempted from implementing such restrictions if it applies measures offering equivalent safeguards based on an appropriate assessment of the possible risks for human and animal health. 2. Where the competent authority decides that the possibility of infection with a TSE cannot be ruled out, the animal shall be killed, if it is still alive; its brain and all other tissues as the competent authority may determine shall be removed and sent to an officially approved laboratory, the national reference laboratory provided for in Article 19(1) or the Community reference laboratory provided for in Article 19(2), for examination in accordance with the testing methods laid down in Article 20. 3. All parts of the body of the suspect animal shall be either retained under official control until a negative diagnosis has been made, or disposed of in accordance with Regulation (EC) No 1774/2002. 4. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 13 Measures following confirmation of the presence of a TSE 1. When the presence of a TSE has been officially confirmed, the following measures shall be applied as soon as possible: (a)all parts of the body of the animal shall be disposed of in accordance with Regulation (EC) No 1774/2002 except for material retained for records in accordance with Annex III, Chapter B, of this Regulation. (b)an inquiry shall be carried out to identify all animals at risk in accordance with Annex VII, point 1; (c)all animals and products thereof at risk, as listed in Annex VII, point 2, of this Regulation, identified by the inquiry referred to in point (b) of this paragraph shall be killed and disposed of in accordance with Regulation (EC) No 1774/2002. At the request of a Member State and based on a favourable risk assessment taking particularly into account the control measures in that Member State, a decision may be taken in accordance with the procedure referred to in Article 24(2) to allow the use of bovine animals referred to in this paragraph until the end of their productive lives. By way of derogation from this paragraph, a Member State may apply other measures offering an equivalent level of protection based on a favourable risk assessment pursuant to Articles 24a and 25, taking particularly into account the control measures in that Member State, if those measures have been approved for that Member State in accordance with the regulatory procedure referred to in Article 24(2). 2. Pending the implementation of the measures referred to in paragraph 1(b) and (c), the holding on which the animal was present when the presence of a TSE was confirmed shall be placed under official control and all movement of animals susceptible to TSEs and products of animal origin derived from them from or to the holding shall be subject to authorisation by the competent authority, with a view to ensuring immediate tracing and identification of the animals and products of animal origin concerned. If there is evidence that the holding where the affected animal was present when the TSE was confirmed is not likely to be the holding where the animal was exposed to the TSE, the competent authority may decide that both holdings or only the holding of exposure shall be placed under official control. 3. Member States which have implemented a substitute scheme offering equivalent safeguards provided for in the fifth subparagraph of Article 12(1) may, by way of derogation from the requirements of paragraph 1(b) and (c), be exempted in accordance with the procedure referred to in Article 24(2) from the requirement to apply official restrictions on the movement of animals and from the requirement to kill and destroy animals. 4. Owners shall be compensated without delay for the loss of the animals that have been killed or products of animal origin destroyed in accordance with Article 12(2) and paragraph 1(a) and (c) of this Article. 5. Without prejudice to Directive 82/894/EEC, the confirmed presence of any TSE other than BSE shall be notified to the Commission on an annual basis. 6. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 14 Contingency plan 1. Member States shall draw up — in accordance with the general criteria of Community rules on the control of animal diseases — guidelines specifying the national measures to be implemented and indicating competences and responsibilities where cases of TSE are confirmed. 2. Where necessary to enable Community legislation to be applied uniformly, the guidelines may be harmonised in accordance with the procedure referred to in Article 24(2).
CHAPTER V PLACING ON THE MARKET AND EXPORT
Article 15 Live animals, their semen, embryos and ova 1. Placing on the market or, if need be, export of bovine, ovine or caprine animals and their semen, embryos and ova shall be subject to the conditions laid down in Annex VIII, or, in the case of imports, to the conditions laid down in Annex IX. The live animals and their embryos and ova shall be accompanied by the appropriate animal health certificates as required by Community legislation, in accordance with Article 17 or, in the case of imports, Article 18. 2. The placing on the market of first generation progeny, semen, embryos and ova of TSE suspect or confirmed animals shall be subject to the conditions laid down in Annex VIII, Chapter B. 3. In accordance with the procedure referred to in Article 24(3), the provisions of paragraphs 1 and 2 may be extended to other animal species. 4. Rules for implementing this Article may be adopted in accordance with the procedure referred to in Article 24(2).
Article 16 Placing on the market of products of animal origin 1. The following products of animal origin derived from healthy ruminants shall not be subject to restrictions on placing on the market or, if need be, export pursuant to this Article, to Annex VIII, Chapters C and D, and to Annex IX, Chapters A, C, F and G: (a)products of animal origin covered by Article 15, in particular semen, embryos and ova; (b)milk and dairy products, hides and skins, and gelatine and collagen derived from hides and skins. 2. Products of animal origin imported from a third country with a controlled or undetermined BSE risk shall come from healthy bovine, ovine and caprine animals which have not been subjected to a laceration of the central nervous tissue or gas injection into the cranial cavity as referred to in Article 8(3). 3. Food products of animal origin containing material obtained from bovine animals originating in a country or region with an undetermined BSE risk shall not be placed on the market unless they come from animals which: (a)were born eight years after the date from which the prohibition on the feeding to ruminants of animal protein derived from mammals was effectively enforced; and (b)were born, raised and have stayed in herds with a certified history of freedom from BSE for at least seven years. Furthermore, food products of ruminant origin shall not be dispatched from a Member State or a region thereof with an undetermined BSE risk to another Member State or be imported from a third country with an undetermined BSE risk. This prohibition shall not apply to products of animal origin listed in Annex VIII, Chapter C, and fulfilling the requirements of Annex VIII, Chapter C. They must be accompanied by an animal health certificate issued by an official veterinarian certifying that they have been produced in conformity with this Regulation. 4. When an animal is moved from a country or a region to country or region included in another category, it shall be classified in the highest category of the countries or regions in which it has stayed over twenty-four hours unless adequate guarantees can be provided certifying that the animal has not received feedingstuffs from the country or region classified in the highest category. 5. Products of animal origin for which this Article lays down specific rules shall be accompanied by the appropriate animal health certificates or commercial documents as required by Community legislation in accordance with Articles 17 and 18 or, if such certificates or documents are not provided for in Community legislation, by a health certificate or commercial document the specimens of which shall be established in accordance with the procedure referred to in Article 24(2). 6. For the purpose of import into the Community, products of animal origin shall comply with the conditions laid down in Annex IX, Chapters A, C, F and G. 7. In accordance with the regulatory procedure with scrutiny referred to in Article 24(3), the provisions of paragraphs 1 to 6 may be extended to other products of animal origin. Rules for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 24(2).
Article 17 Under the procedure referred to in Article 24(2), the health certificates referred to in Annex F to Directive 64/432/EEC, Models II and III in Annex E to Directive 91/68/EEC and the appropriate health certificates laid down by Community legislation relating to trade in the semen, embryos and ova of bovine, ovine or caprine animals shall be supplemented, where necessary, by a reference to the category specifying the classification of the Member State or region of origin given in accordance with Article 5. Appropriate commercial documents relating to trade in products of animal origin shall be supplemented, where necessary, by a reference to the category of the Member State or region of origin given by the Commission in accordance with Article 5.
Article 18 The appropriate health certificates relating to imports provided for by Community legislation shall, under the procedure referred to in Article 24(2), be supplemented in respect of third countries classified in a category pursuant to Article 5 by the specific requirements laid down in Annex IX, as soon as that classification decision has been taken.
CHAPTER VI REFERENCE LABORATORIES, SAMPLING, TESTING AND CONTROLS
Article 19 Reference laboratories 1. The national reference laboratories in each Member State and their functions and duties shall be those indicated in Annex X, Chapter A. 2. The Community reference laboratory and its functions and duties shall be those laid down in Annex X, Chapter B.
Article 20 Sampling and laboratory methods 1. Sampling and laboratory testing for the presence of a TSE shall be carried out using the methods and protocols laid down in Annex X, Chapter C. 2. Where necessary to ensure the uniform application of this Article, implementing rules shall be adopted in accordance with the regulatory procedure referred to in Article 24(2). The method to confirm BSE in ovine and caprine animals shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3).
Article 21 Community controls 1. Experts from the Commission may make on-the-spot checks in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Regulation. The Member State in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made. The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 24(2). 2. Community checks concerning third countries shall be made in accordance with Articles 20 and 21 of Directive 97/78/EC.
CHAPTER VII TRANSITIONAL AND FINAL PROVISIONS
Article 22 Transitional measures concerning specified risk material 1. The provisions of Annex XI, Part A shall apply for a period of at least six months from 1 July 2001 and shall cease to apply immediately following the date of adoption of a decision in accordance with Article 5(2) or (4), on which date Article 8 shall enter into force. 2. The results of a conclusive statistical survey carried out in accordance with Article 5(3) during the transitional period shall be used to confirm or overturn the risk analysis conclusions referred to in Article 5(1), while taking account of the classification criteria defined by the OIE. 3. After consultation of the appropriate scientific committee, detailed rules concerning that statistical survey shall be adopted in accordance with the procedure referred to in Article 24(2). 4. The minimum criteria to be met by this statistical survey shall be those laid down in Part B of Annex XI.
Article 23 Amendment of the annexes and transitional measures After consultation of the appropriate scientific committee on any question which could have an impact on public health, the annexes shall be amended or supplemented and any appropriate transitional measures shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3). In accordance with that procedure, transitional measures shall be adopted for a period ending on 1 July 2007 at the latest, to permit the change-over from the current arrangements to the arrangements established by this Regulation.
Article 23a The following measures which are designed to amend non-essential elements of this Regulation, including by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3): (a)approval of the rapid tests referred to in Article 5(3) third subparagraph, Article 6(1), Article 8(2) and Article 9(3), (b)adaptation of the age referred to in Article 6(1b), (c)criteria to demonstrate improvement of the epidemiological situation referred to in Article 6(1b), (d)decision to allow feeding of young animals of ruminant species with proteins derived from fish as referred to in Article 7(3), (e)criteria for granting exemptions from the restrictions referred to in Article 7(4), (f)decision to introduce a tolerance level as referred to in Article 7(4a), (g)decision on age as referred to in Article 8(1), (h)rules providing for exemptions from the requirement to remove and destroy specified risk material as referred to in Article 8(5), (i)approval of production processes referred to in Article 9(1), (j)decision to extend certain provisions to other animal species as referred to in Article 15(3), (k)extension to other products of animal origin of the provisions of paragraphs 1 to 6 of Article 16, (l)adoption of the method to confirm BSE in ovine and caprine animals referred to in Article 20(2), (m)amendment or addition to the annexes and adoption of any appropriate transitional measures referred to in Article 23.
Article 24 Committees 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. However, the Standing Committee on Zootechnics shall also be consulted by the Commission with regard to Article 6a. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits referred to in Article 5(6) of that Decision shall be three months and, in the case of safeguard measures referred to in Article 4(2) of this Regulation, 15 days. 3. Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 24a Decisions to be adopted in accordance with one of the procedures referred to in Article 24 shall be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Community.
Article 25 Consultation of the scientific committees The appropriate scientific committees shall be consulted on any matter within the scope of this Regulation which could have an impact on public health.
Article 26 Entry into force This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities. It shall apply from 1 July 2001.
This Regulation shall be binding in its entirety and directly applicable in all Member States. ANNEX I SPECIFIC DEFINITIONS 1. For the purpose of this Regulation, the following definitions set out in Regulation (EC) No 1069/2009 of the European Parliament and of the CouncilOJ L 300, 14.11.2009, p. 1., Commission Regulation (EU) No 142/2011OJ L 54, 26.2.2011, p. 1., Regulation (EC) No 178/2002 of the European Parliament and of the CouncilOJ L 31, 1.2.2002, p. 1., Regulation (EC) No 767/2009 of the European Parliament and of the CouncilOJ L 229, 1.9.2009, p. 1. and Council Directive 2006/88/ECOJ L 328, 24.11.2006, p. 14. shall apply: (a)the definition of "farmed animal" in Article 3(6) of Regulation (EC) No 1069/2009; (b)the following definitions in Annex I to Regulation (EU) No 142/2011: (i)"fur animals" in point 1; (ii)"blood products" in point 4; (iii)"processed animal protein" in point 5; (iv)"fishmeal" in point 7; (v)"collagen" in point 11; (vi)"gelatine" in point 12; (vii)"hydrolysed proteins" in point 14; (viii)"canned petfood" in point 16; (ix)"petfood" in point 19; (x)"processed petfood" in point 20; (c)the definition of "feed" in Article 3(4) of Regulation (EC) No 178/2002; (d)Regulation (EC) No 767/2009: (i)"feed materials" in Article 3(2)(g); (ii)"compound feed" in Article 3(2)(h); (iii)"complete feed" in Article 3(2)(i); (e)Directive 2006/88/EC: (i)"aquaculture animal" in Article 3(1)(b); (ii)"aquatic animal" in Article 3(1)(e). 2. For the purpose of this Regulation, the following definitions shall also apply: (a)"indigenous case of BSE" means a case of bovine spongiform encephalopathy which has not been clearly demonstrated to be due to infection prior to importation as a live animal; (b)"discrete adipose tissue" means internal and external body fat removed during the slaughter and cutting process, in particular fresh fat from the heart, caul and kidney of bovine animals, and fat from cutting rooms; (c)"cohort" means a group of bovine animals which includes both: (i)animals born in the same herd as the affected bovine animal, and within 12 months preceding or following the date of birth of the affected bovine animal; and (ii)animals which at any time during the first year of their lives were reared together with the affected bovine animal during the first year of its life; (d)"index case" means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed; (e)"TSE in Small Ruminants" means a transmissible spongiform encephalopathy case detected in an ovine or caprine animal following a confirmatory test for abnormal PrP protein; (f)"scrapie case" means a transmissible spongiform encephalopathy confirmed case in an ovine or caprine animal where a diagnosis of BSE has been excluded in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminantshttp://www.defra.gov.uk/corporate/vla/science/science-tse-rl-confirm.htm; (g)"classical scrapie case" means a scrapie confirmed case classified as classical in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants; (h)"atypical scrapie case" means a scrapie confirmed case which is distinguishable from classical Scrapie in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants. ANNEX II DETERMINATION OF BSE STATUS CHAPTER A Criteria The BSE status of Member States or third countries or regions thereof (hereinafter referred to as countries or regions), shall be determined on the basis of the criteria set out in points (a) to (e).In the country or region: (a)a risk analysis in accordance with the provisions of Chapter B, identifying all the potential factors for BSE occurrence and their historic perspective in the country or region, is carried out; (b)a system of continuous surveillance and monitoring of BSE relating in particular to the risks described in Chapter B and complying with the minimal surveillance requirements laid down in Chapter D is in place; (c)an on-going awareness programme for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of bovine animals, to encourage reporting of all cases showing clinical signs consistent with BSE in target sub-populations as defined in Chapter D of this Annex is in place; (d)an obligation to notify and investigate all bovine animals showing clinical signs consistent with BSE is in force; (e)the examination of brain or other tissues collected within the framework of the surveillance and monitoring system referred to in point (b) is carried out in an approved laboratory. CHAPTER B Risk analysis 1.Structure of the risk analysis The risk analyses shall comprise a release assessment and an exposure assessment. 2.Release assessment (external challenge) 2.1.The release assessment shall consist of assessing the likelihood that the BSE agent has either been introduced into the country or region via commodities potentially contaminated with a BSE agent, or is already present in the country or region. The following risk factors shall be taken into account: (a)the presence or absence of the BSE agent in the country or region and, if the agent is present, its prevalence based on the outcome of surveillance activities; (b)the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population; (c)imported meat-and-bone meal or greaves; (d)imported bovine and ovine and caprine animals; (e)imported animal feed and feed ingredients; (f)imported products of ruminant origin for human consumption, which may have contained tissues listed in point 1 of Annex V and may have been fed to bovine animals; (g)imported products of ruminant origin for in vivo use in bovine animals. 2.2.Special eradication schemes, surveillance and other epidemiological investigations (especially surveillance for BSE conducted on the bovine animals population) relevant to the risk factors listed in point 2.1 should be taken into account in carrying out the release assessment. 3.Exposure assessment The exposure assessment shall consist of assessing the likelihood of exposure of bovine animals to the BSE agent, through a consideration of the following: (a)recycling and amplification of the BSE agent through consumption by bovine animals of meat-and-bone meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with these; (b)the use of ruminant carcasses (including from fallen stock), by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of animal feed manufacture; (c)the feeding or not of ruminants with meat-and-bone meal and greaves derived from ruminants, including measures to prevent cross-contamination of animal feed; (d)the level of surveillance for BSE conducted on the bovine animals population to that time and the results of that surveillance. CHAPTER C Definition of categories I.COUNTRY OR REGION WITH A NEGLIGIBLE BSE RISK A country or region: (1)where a risk analysis in accordance with Chapter B has been conducted in order to identify the historical and existing risk factors; (2)which has demonstrated that appropriate specific measures have been taken for the relevant period of time defined below to manage each identified risk; (3)which has demonstrated that Type B surveillance, in accordance with Chapter D, is in place, and the relevant points target, in accordance with Table 2 thereof, has been met; and (4)which is: (a)either in the following situation: (i)in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed; (ii)the criteria in points (c), (d) and (e) of Chapter A of this Annex have been complied with for at least seven years; and (iii)it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants; (b)or in the following situation: (i)there has been one or more BSE indigenous cases in the country or region but every BSE indigenous case was born more than 11 years ago; (ii)the criteria in points (c), (d) and (e) of Chapter A have been complied with for at least seven years; (iii)it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants; (iv)the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed: all BSE cases, all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases. II.COUNTRY OR REGION WITH A CONTROLLED BSE RISK A country or region (1)where a risk analysis based on the information laid down in Chapter B has been conducted in order to identify the historical and existing risk factors; (2)which has demonstrated that appropriate measures are been taken to manage all identified risks, but those measures have not been taken for the relevant period of time; (3)which has demonstrated that Type A surveillance, in accordance with Chapter D, is in place and the relevant points target, in accordance with Table 2, has been met. Type B surveillance may replace Type A surveillance once the relevant points target is met; and (4)which is: (a)either in the following situation: (i)in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants; (ii)the criteria in points (c), (d) and (e) of Chapter A have been complied with for a period shorter than seven years; and/or (iii)it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for eight years; (b)or in the following situation: (i)in the country or region there has been a BSE indigenous case, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants; (ii)the criteria in points (c) to (e) of Chapter A of this Annex have been complied with for a period shorter than seven years; and/or (iii)it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for at least eight years; (iv)the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed: and all BSE cases, and all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases. III.COUNTRY OR REGION WITH UNDETERMINED BSE RISK A country or region for which the determination of BSE status has not been concluded, or which does not meet the conditions to be fulfilled by the country or region to be classified in one of the other categories. CHAPTER D Minimal surveillance requirements 1.Surveillance types For the purpose of this Annex, the following definitions shall apply: (a)Type A surveillance The application of Type A surveillance will allow the detection of BSE at a design prevalenceDesign prevalence is used to determine the size of a testing survey expressed in terms of target points. If the actual prevalence is greater than the selected design prevalence, the survey is highly likely to detect disease. of at least one case per 100000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %; (b)Type B surveillance The application of Type B surveillance will allow the detection of BSE at a design prevalence of at least one case per 50000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %.Type B surveillance may be carried out by countries or region of negligible BSE risk status to confirm the conclusions of the risk analysis, for example by demonstrating the effectiveness of the measures mitigating any risk factors identified, through surveillance targeted to maximise the likelihood of identifying failures of such measures.Type B surveillance may also be carried out by countries or regions of controlled BSE risk status, following the achievement of the relevant points target using Type A surveillance, to maintain confidence in the knowledge gained through Type A surveillance.For the purpose of this Annex, the following four sub-populations of bovine animals have been identified for surveillance purposes: (a)bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects); (b)bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter); (c)bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock); (d)bovine animals over 36 months of age at routine slaughter. 2.Surveillance strategy 2.1.The surveillance strategy shall be designed to ensure that samples are representative of the herd of the country or region, and include consideration of demographic factors such as production type and geographic location, and the potential influence of culturally unique husbandry practices. The approach used and the assumptions made shall be fully documented, and the documentation retained for seven years. 2.2.In order to implement the surveillance strategy for BSE, a country shall use documented records or reliable estimates of the age distribution of the adult bovine animals population and the number of bovine animals tested for BSE stratified by age and by sub-population within the country or region. 3.Points values and point targets Surveillance samples must meet the point targets set out in Table 2, on the basis of "point values" fixed in Table 1. All clinical suspects shall be investigated, regardless of the number of points accumulated. A country shall sample at least three out of the four sub-populations. The total points for samples collected shall be accumulated over a period of a maximum of seven consecutive years to achieve the target number of points. The total points accumulation shall be periodically compared to the target number of points for a country or region.
Table 1 Surveillance point values for samples collected from animals in the given sub-population and age category Bovine animals over 36 months of age at routine slaughter. Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock). Bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter). Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects).
Surveillance sub-population
Routine slaughter Fallen stock Casualty slaughter Clinical suspect
Age ≥ 1 year and < 2 years
0,01 0,2 0,4 N/A
Age ≥ 2 years and < 4 years (young adult)
0,1 0,2 0,4 260
Age ≥ 4 years and < 7 years (middle adult)
0,2 0,9 1,6 750
Age ≥ 7 years and < 9 years (older adult)
0,1 0,4 0,7 220
Age ≥ 9 years (aged)
0,0 0,1 0,2 45
Table 2 Points targets for different adult bovine animals population sizes in a country or region
Points targets for countries or regions
Adult bovine animals population size(24 months and older) Type A surveillance Type B surveillance
1000000 300000 150000
800000-1000000 240000 120000
600000-800000 180000 90000
400000-600000 120000 60000
200000-400000 60000 30000
100000-200000 30000 15000
50000-100000 15000 7500
25000-50000 7500 3750
4.Specific targeting Within each of the sub-populations above in a country or region, a country may target bovine animals identifiable as imported from countries or regions where BSE has been detected and bovine animals which have consumed potentially contaminated feedstuffs from countries or regions where BSE has been detected. 5.BSE surveillance model A country may choose to use the full BSurvE model or an alternative method based on the BSurvE model to estimate its BSE presence/prevalence. 6.Maintenance surveillance Once the points target has been achieved, and in order to continue to designate the status of a country or region as controlled BSE risk or negligible risk, surveillance can be reduced to Type B surveillance (provided all other indicators remain positive). However, to continue to comply with the requirements laid down in this Chapter, ongoing annual surveillance must continue to include at least three of the four prescribed sub-populations. In addition all bovine animals clinically suspected of being infected with BSE shall be investigated regardless of the number of points accumulated. The annual surveillance in a country or region following the achievement of the required points target, shall be no less than the amount required for one-seventh of its total Type B surveillancetarget.
ANNEX III MONITORING SYSTEM CHAPTER A I.MONITORING IN BOVINE ANIMALS 1.General Monitoring in bovine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3(1)(b). 2.Monitoring in animals slaughtered for human consumption 2.1. All bovine animals over 24 months of age: subject to "special emergency slaughtering" as defined in Article 2(n) of Council Directive 64/433/EECOJ 121, 29.7.1964, p. 2012/64., or slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, except animals without clinical signs of disease slaughtered in the context of a disease eradication campaign, shall be tested for BSE. 2.2. All bovine animals over 30 months of age: subject to normal slaughter for human consumption, or slaughtered in the context of a disease eradication campaign in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, but showing no clinical signs of disease, shall be tested for BSE. 2.3.By way of derogation from point 2.2, and with regard to bovine animals born, reared and slaughtered on its territory, Sweden may decide to examine only a random sample. The sample shall comprise at least 10000 animals per year. 3.Monitoring in animals not slaughtered for human consumption 3.1. All bovine animals over 24 months of age which have died or been killed but which were not: killed for destruction pursuant to Commission Regulation (EC) No 716/96OJ L 99, 20.4.1996, p. 14., killed in the framework of an epidemic, such as foot-and-mouth disease, slaughtered for human consumption, shall be tested for BSE. 3.2. Member States may decide to derogate from the provisions of point 3.1 in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and submit a list of the derogated areas. The derogation shall not cover more than 10 % of the bovine population in the Member State. 4.Monitoring in animals purchased for destruction pursuant to Regulation (EC) No 716/96 All animals born between 1 August 1995 and 1 August 1996 killed for destruction pursuant Regulation (EC) No 716/96 shall be tested for BSE. 5.Monitoring in other animals In addition to the testing referred to in points 2 to 4, Member States may on a voluntary basis decide to test other bovine animals on their territory, in particular where those animals originate from countries with indigenous BSE, have consumed potentially contaminated feedingstuffs or were born or derived from BSE infected dams. 6.Measures following testing 6.1. Where an animal slaughtered for human consumption has been selected for testing for BSE, the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC shall not be carried out on the carcase of that animal until a negative result to the rapid test has been obtained. 6.2. Member States may derogate from the provisions of point 6.1 where an official system is in place in the slaughterhouse ensuring that no parts of examined animals bearing the health mark leave the slaughterhouse until a negative result to the rapid test has been obtained. 6.3. All parts of the body of an animal tested for BSE including the hide shall be retained under official control until a negative result to the rapid test has been obtained, unless they are disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council. 6.4. All parts of the body of an animal found positive or inconclusive to the rapid test including the hide shall be disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002, apart from material to be retained in conjunction with the records provided for in Chapter B(III). 6.5. Where an animal slaughtered for human consumption is found positive or inconclusive to the rapid test, at least the carcase immediately preceding and the two carcases immediately following the tested positive or inconclusive animal on the same slaughter line shall be destroyed in accordance with point 6.4. By way of derogation, Member States may decide to destroy the aforementioned carcases only if the result of the rapid test is confirmed to be positive or inconclusive by confirmatory examinations referred to in Annex X, Chapter C, point 3.1(b). 6.6. Member States may derogate from the provisions of point 6.5 where a system is in place in the slaughterhouse preventing contamination between carcase. 7.Revision of the annual monitoring programmes concerning BSE (BSE monitoring programmes), as provided for in Article 6(1b) 7.1.Member States’ applications Applications submitted to the Commission by Member States for revision of their annual BSE monitoring programme shall include at least the following: (a)information on the annual BSE monitoring system in place during the previous six-year period within the territory of the Member State, including detailed documentation proving compliance with the epidemiological criteria set out in point 7.2; (b)information on the bovine identification and traceability system, as referred to in point (b) of the third subparagraph of Article 6(1b), in place during the previous six-year period within the territory of the Member State, including a detailed description of the functioning of the computerised database as referred to in Article 5 of Regulation (EC) No 1760/2000 of the European Parliament and of the CouncilOJ L 204, 11.8.2000, p. 1. (c)information on prohibitions concerning animal feeding during the previous six-year period within the territory of the Member State, including a detailed description of the enforcement of the feed ban for farmed animals, as referred to in point (c) of the third subparagraph of Article 6(1b), including the sampling plan and the number and type of infringements found and the follow-up results; (d)a detailed description of the proposed revised BSE monitoring programme that includes the geographical area in which the programme is to be implemented and a description of subpopulations of bovine animals to be covered by the BSE revised monitoring programme, including indications of the age limits and the sample sizes for testing; (e)the result of a comprehensive risk analysis showing that the revised BSE monitoring programme will ensure the protection of human and animal health. This risk analysis shall include a birth cohort analysis or other relevant studies aiming to demonstrate that the TSE risk reducing measures, including the feeding prohibitions as referred to in point (c) of the third subparagraph of Article 6(1b), have been implemented in an efficient way. 7.2.Epidemiological criteria Applications for revision of a BSE monitoring programme may only be accepted if the Member State concerned can demonstrate that, in addition to the requirements laid down in points (a), (b) and (c) of the third subparagraph of Article 6(1b), the following epidemiological criteria are met within its territory: (a)for a period of at least six consecutive years following the date of implementation of the Community BSE testing scheme as referred to in point (b) of the third subparagraph of Article 6(1b): either (i)the average decrease of the annual BSE incidence rate observed within the adult bovine animal population (over 24 months of age) was superior to 20 %, and the total number of BSE affected cattle born after the implementation of the Community total feed ban for farmed animals, as referred to in point (c) of the third subparagraph of Article 6(1b), did not exceed 5 % of the total number of confirmed BSE cases; or (ii)the annual observed BSE incidence rate within the adult bovine animal population (over 24 months of age) remained consistently less than 1/100000; or (iii)as a further option for a Member State with an adult bovine animal population (over 24 months of age) of less than 1000000 animals, the cumulated number of confirmed BSE cases remained under five; (b)following the six-year period referred to in point (a), there is no evidence that the BSE epidemiological situation is deteriorating. II.MONITORING IN OVINE AND CAPRINE ANIMALS 1.General Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b). 2.Monitoring in ovine and caprine animals slaughtered for human consumption (a)Member States in which the population of ewes and ewe lambs put to the ram exceeds 750000 animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of 10000 ovine animals slaughtered for human consumption; (b)Member States in which the population of goats which have already kidded and goats mated exceeds 750000 animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of 10000 caprine animals slaughtered for human consumption; (c)Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered ovine or caprine animals to reach its allotted minimum sample size established in points (a) and (b), it may choose to replace a maximum of 50 % of its minimum sample size by testing dead ovine or caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3. In addition a Member State may choose to replace a maximum of 10 % of its minimum sample size by testing ovine or caprine animals killed in the framework of a disease eradication campaign over the age of 18 months at the ratio of one to one. 3.Monitoring in ovine and caprine animals not slaughtered for human consumption Member States shall test, in accordance with the sampling rules set out in point 4 and the minimum sample sizes indicated in Table A and Table B, ovine and caprine animals which have died or been killed, but which were not: killed in the framework of a disease eradication campaign, or slaughtered for human consumption.
Table A Minimum sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets.
Member State population of ewes and ewe lambs put to the ram Minimum sample size of dead ovine animals
> 750000 10000
100000-750000 1500
40000-100000 100 % up to 500
< 40000 100 % up to 100
Table B Minimum sample sizes are set to take account of the size of the caprine population in the individual Member States and are intended to provide achievable targets.
Member State population of goats which have already kidded and goats mated Minimum sample size of dead caprine animals
> 750000 10000
250000-750000 1500
40000-250000 100 % up to 500
< 40000 100 % up to 100
4.Sampling rules applicable to the animals referred to in points 2 and 3 The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.The age of the animals shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.The sample selection shall be designed with a view to avoid the over-representation of any group as regards the origin, age, breed, production type or any other characteristic.The sampling shall be representative for each region and season. Multiple sampling in the same flock shall be avoided, wherever possible. Member States shall aim their monitoring programmes to achieve, wherever possible, that in successive sampling years all officially registered holdings with more than 100 animals and where TSE cases have never been detected are subject to TSE testing.The Member States shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling.However, Member States may decide to exclude from the sampling remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and shall submit a list of those remote areas where the derogation applies. The derogation shall not cover more than 10 % of the ovine and caprine population in the Member State concerned. 5.Monitoring in infected flocks Animals over 18 months of age or have more than two permanent incisors erupted through the gum, and which are killed for destruction in accordance with Annex VII, point 2.3(b)(i) or (ii) or point 5(a), shall be tested based on the selection of a simple random sample, in accordance with the sample size indicated in the following table.
Number of animals over 18 months of age or which have more than two permanent incisors erupted through the gum, killed for destruction in the herd or flock Minimum sample size
70 or less All eligible animals
80 68
90 73
100 78
120 86
140 92
160 97
180 101
200 105
250 112
300 117
350 121
400 124
450 127
500 or more 150
6.Monitoring in other animals In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary basis carry out monitoring in other animals, in particular: animals used for dairy production, animals originating from countries with indigenous TSEs, animals which have consumed potentially contaminated feedingstuffs, animals born or derived from TSE infected dams. 7.Measures following testing of ovine and caprine animals 7.1.Where an ovine or caprine animal slaughtered for human consumption has been selected for TSE testing in accordance with point 2, its carcase shall not be marked with the health marking provided for in Section I, Chapter III of Annex I to Regulation (EC) No 854/2004 until a negative result to the rapid test has been obtained. 7.2.Member States may derogate from point 7.1. where a system approved by the competent authority is in place in the slaughterhouse ensuring that all parts of an animal can be traced and that no parts of the animals tested bearing the health mark can leave the slaughterhouse until a negative result to the rapid test has been obtained. 7.3.All parts of the body of a tested animal, including the hide, shall be retained under official control until a negative result has been obtained to the rapid test, except for animal by-products directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002. 7.4.Except for the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, all parts of the body of an animal found positive to the rapid test, including the hide, shall be directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002. 8.Genotyping 8.1.The prion protein genotype for the codons 136, 154 and 171 shall be determined for each positive TSE case in sheep. TSE cases found in sheep of genotypes which encode alanine on both alleles at codon 136, arginine on both alleles at codon 154 and arginine on both alleles at codon 171 shall immediately be reported to the Commission. Where the positive TSE case is an atypical scrapie case the prion protein genotype for the codon 141 shall be determined. 8.2.In addition to the animals genotyped in accordance with point 8.1, the prion protein genotype for the codons 136, 141, 154 and 171 of a minimum sample of ovine animals shall be determined. In the case of Member States with an adult sheep population of more than 750000 animals, this minimum sample shall consist of at least 600 animals. In the case of other Member States the minimum sample shall consist of at least 100 animals. The samples may be chosen from animals slaughtered for human consumption, from animals dead-on-farm or from live animals. The sampling should be representative of the entire ovine population.
III.MONITORING IN OTHER ANIMAL SPECIES Member States may on a voluntary basis carry out monitoring for TSEs in animal species other than bovine, ovine and caprine animals.
CHAPTER B REPORTING AND RECORDING REQUIREMENTS I.REQUIREMENTS ON MEMBER STATES A.Information to be presented by Member States in their annual report as provided for in Article 6(4) 1.The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species. 2.The number of suspected cases subject to laboratory examination in accordance with Article 12(2), per animal species, including the results of the rapid and confirmatory tests (number of positives and negatives) and, with regard to bovine animals, an estimation of the age distribution of all tested animals. The age distribution should be grouped whenever possible as follows: "below 24 months", distribution per 12 months between 24 and 155 months, and "above 155 months" of age. 3.The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2). 4.The number of bovine animals tested within each subpopulation referred to in Chapter A, Part (I), points 2.1., 2.2., 2.3., 3.1., 4.1., 4.2., 4.3. and 5. The method for the sample selection, the results of the rapid and confirmatory tests and an estimation of the age distribution of the tested animals grouped as set out in point 2 shall be provided. 5.The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3 and 5 together with the method for sample selection and the results of the rapid and confirmatory tests. 6.The geographical distribution, including the country of origin if not the same as the reporting country, of positive cases of BSE and scrapie. The year, and where possible the month of birth shall be given for each TSE case in bovine, ovine and caprine animals. TSE cases which have been considered atypical and the reasons why shall be indicated. For scrapie cases, the results of the primary molecular testing with a discriminatory immuno-blotting, referred to in Annex X, Chapter C, point 3.2.(c)(i), shall be reported. 7.In animals other than bovine, ovine and caprine, the number of samples and confirmed TSE cases per species. 8.The genotype, and where possible the breed, of each ovine animal either found positive to TSE or sampled in accordance with Chapter A, Part II, points 8.1. and 8.2. B.Reporting periods The compilation of reports containing the information referred to in A and forwarded to the Commission on a monthly basis or, with regard to the information referred to in point 8 on a quarterly basis, may constitute the annual report as required by Article 6(4), provided that the information is updated whenever additional information becomes available. II.INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS SUMMARY The summary shall be presented in a tabled format covering at least the information referred to in part I for each Member State. III.RECORDS 1. The competent authority shall keep, for seven years, records of: the number and types of animals placed under movement restrictions as referred to in Article 12(1), the number and outcome of clinical and epidemiological investigations as referred to in Article 12(1), the number and outcome of laboratory examinations as referred to in Article 12(2), the number, identity and origin of animals sampled in the framework of the monitoring programmes as referred to in Chapter A and, where possible, age, breed and anamnestic information, the prion protein genotype of positive TSE cases in sheep. 2. The investigating laboratory shall keep, for seven years, all records of testing, in particular laboratory workbooks and, where appropriate, paraffin blocks and photographs of western blots.
ANNEX IV ANIMAL FEEDING CHAPTER I Extensions of the prohibition provided for in Article 7(1) In accordance with Article 7(2), the prohibition provided for in Article 7(1) shall be extended to the feeding: (a)to ruminants of dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing these products; (b)to non-ruminant farmed animals, other than fur animals, of: (i)processed animal protein; (ii)collagen and gelatine of ruminant origin; (iii)blood products; (iv)hydrolysed protein of animal origin; (v)dicalcium phosphate and tricalcium phosphate of animal origin; (vi)feed containing the products listed in (i) to (v). CHAPTER II Derogations from the prohibitions provided for in Article 7(1) and in Chapter I In accordance with the first subparagraph of Article 7(3), the prohibitions provided for in Article 7(1) and in Chapter I shall not apply to the feeding to: (a)ruminants of: (i)milk, milk-based products, milk-derived products, colostrum and colostrum products; (ii)eggs and egg products; (iii)collagen and gelatine derived from non-ruminants; (iv)hydrolysed proteins derived from: parts of non-ruminants, or ruminant hides and skins; (v)compound feed containing the products listed in points (i) to (iv) above; (b)non-ruminant farmed animals of the following feed materials and compound feed: (i)hydrolysed proteins derived from parts of non-ruminants or from ruminant hides and skins; (ii)fishmeal and compound feed containing fishmeal which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section A of Chapter IV; (iii)dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing such phosphates which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section B of Chapter IV; (iv)blood products derived from non-ruminants and compound feed containing such blood products which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section C of Chapter IV; (c)aquaculture animals of processed animal protein, other than fishmeal, derived from non-ruminants and compound feed containing such processed animal protein which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section D of Chapter IV; (d)unweaned ruminants of milk replacers containing fishmeal and which are produced, placed on the market and used in accordance with specific conditions laid down in Section E of Chapter IV; (e)farmed animals of feed materials of plant origin and compound feed containing such feed materials contaminated with insignificant amount of bone spicules derived from unauthorised animal species. Member States may only use this derogation if they have carried out a risk assessment beforehand which has confirmed there is a negligible risk for animal health. That risk assessment must take into account at least the following: (i)the level of the contamination; (ii)the nature and the source of the contamination; (iii)the intended use of the contaminated feed. CHAPTER III General conditions for the application of certain derogations provided for in Chapter II SECTION A Transport of feed materials and compound feed intended to be used for feeding non-ruminant farmed animals 1.The following products intended to be used for feeding non-ruminant farmed animals, shall be transported in vehicles and containers which are not used for the transport of feed intended for ruminants: (a)bulk processed animal protein, including fishmeal, derived from non-ruminants; (b)bulk dicalcium and tricalcium phosphate of animal origin; (c)bulk blood products derived from non-ruminants; (d)bulk compound feed containing the feed materials listed in (a), (b) and (c).Records detailing the type of products that were transported shall be kept available to the competent authority for a period of at least two years. 2.By way of derogation from point 1, vehicles and containers which have been previously used for the transport of the products listed in that point, may be subsequently used for the transport of feed intended for ruminants provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years. 3.Bulk processed animal protein derived from non-ruminants and bulk compound feed containing processed animal protein derived from such animals shall be transported in vehicles and containers which are not used for the transport of feed intended for non-ruminant farmed animals other than aquaculture animals. 4.By way of derogation from point 3, vehicles and containers which have been previously used for the transport of the products referred to in that point may be subsequently used for the transport of feed intended for non-ruminant farmed animals other than aquaculture animals provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years. SECTION B Production of compound feed intended to be used for feeding non-ruminant farmed animals 1.Compound feed intended to be used for feeding non-ruminant farmed animals and which contain the following feed materials, shall be produced in establishments which do not produce compound feed for ruminants, and which are authorised by the competent authority: (a)fishmeal; (b)dicalcium and tricalcium phosphate of animal origin; (c)blood products derived from non-ruminants. 2.By way of derogation from point 1, the production of compound feed for ruminants, in establishments which also produce compound feed for non-ruminant farmed animals which contains the products listed in that point, may be authorised by the competent authority, following an on-site inspection by it, subject to compliance with the following conditions: (a)compound feed intended for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminants are manufactured and kept; (b)records detailing the purchases and uses of the products listed in point 1 and the sales of compound feed containing those products must be kept available to the competent authority for a period of at least five years; (c)regular sampling and analysis of the compound feed intended for ruminants must be carried out in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Commission Regulation (EC) No 152/2009OJ L 54, 26.2.2009, p. 1.; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years. 3.By way of derogation from point 1, a specific authorisation for the production of complete feed from compound feed containing the products listed in that point shall not be required for home compounders subject to their compliance with the following conditions: (a)they must be registered by the competent authority; (b)they must keep only non-ruminant animals; (c)they must produce complete feed for use only in the same holding; (d)any compound feed containing fishmeal used in the production of the complete feed must contain less than 50 % crude protein; (e)any compound feed containing dicalcium and tricalcium phosphate of animal origin used in the production of the complete feed must contain less than 10 % total phosphorus; (f)any compound feed containing blood products derived from non- ruminants used in the production of the complete feed must contain less than 50 % total protein. SECTION C Import of feed materials and compound feed intended to be used for feeding non-ruminant farmed animals other than fur animals Before release for free circulation in the Union, importers shall ensure that each of the consignment of the following feed materials and compound feed, which are intended to be used for the feeding of non-ruminant farmed animals, other than fur animals, in accordance with Chapter II of this Annex, is analysed in accordance with the methods of analysis for the determination of constituents of animal origin for the control of feed set out Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin: (a)processed animal protein, including fishmeal, derived from non-ruminants; (b)blood products derived from non-ruminants; (c)compound feed containing the feed materials listed in (a) and (b). SECTION D Use and storage on farms of feed intended to be used for feeding non-ruminant farmed animals 1.The use and storage of the following feed shall be prohibited on farms keeping farmed animal species for which such feed is not intended: (a)processed animal protein, including fishmeal, derived from non-ruminants; (b)dicalcium and tricalcium phosphate of animal origin; (c)blood products derived from non-ruminants; (d)compound feed containing the feed materials listed in (a) to (c). 2.By way of derogation from point 1, the competent authority may authorise the use and storage of compound feed referred to in point 1(d) in farms keeping farmed animal species for which the compound feed is not intended provided that on-farm measures are implemented to prevent such compound feed being fed to an animal species for which it is not intended. CHAPTER IV Specific conditions for the application of derogations provided for in Chapter II SECTION A Specific conditions applicable to the production and the use of fishmeal and compound feed containing fishmeal intended to be used for feeding non-ruminant farmed animals other than fur animals The following specific conditions shall apply to the production and use of fishmeal and compound feed containing fishmeal intended to be used for the feeding of non-ruminant farmed animals other than fur animals: (a)the fishmeal must be produced in processing plants dedicated exclusively to the production of products derived from aquatic animals, except sea mammals; (b)the accompanying commercial document or health certificate, as appropriate, of fishmeal and compound feed containing fishmeal and any packaging containing such products must be clearly marked with the words "contains fishmeal — shall not be fed to ruminants". SECTION B Specific conditions applicable to the use of dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing such phosphates intended to be used for feeding non-ruminant farmed animals other than fur animals The accompanying commercial document or health certificate, as appropriate, of dicalcium phosphate or tricalcium phosphate of animal origin, compound feed containing such phosphates and any packaging of such products shall be clearly marked with the words "contains dicalcium/tricalcium phosphate of animal origin — shall not be fed to ruminants". SECTION C Specific conditions applicable to the production and use of blood products derived from non-ruminants and compound feed containing those products intended to be used for feeding non-ruminant farmed animals other than fur animals The following specific conditions shall apply to the production and use of blood products derived from non-ruminants and to compound feed containing such blood products, intended to be used for the feeding of non-ruminant farmed animals other than fur animals: (a)The blood intended to be used for the production of blood products shall be derived from slaughterhouses which do not slaughter ruminants and which are registered by the competent authority as not slaughtering ruminants. By way of derogation from that specific condition, the competent authority may authorise the slaughter of ruminants in a slaughterhouse producing non-ruminant blood intended for the production of blood products for use in feed for non-ruminant farmed animals. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of measures aimed to prevent cross-contamination between ruminant and non-ruminant blood.Those measures shall include the following minimum requirements: (i)the slaughtering of non-ruminants must be carried out in lines that are physically separate from lines used for the slaughtering of ruminants; (ii)the collection, storage, transport and packaging facilities for blood of non-ruminant origin must be kept separate from those used for blood of ruminant origin; (iii)a regular sampling and analysis of blood of non-ruminant origin must be carried out to detect the presence of ruminant proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis must be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles. (b)The blood intended to be used for the production of blood products for non-ruminants shall be transported to a processing plant in vehicles and containers dedicated exclusively for the transport of non-ruminant blood. By way of derogation from that specific condition, vehicles and containers which have been previously used for the transport of blood derived from ruminants may be used for the transport of non-ruminant blood provided that they have been thoroughly cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years. (c)The blood products shall be produced in processing plants exclusively processing non-ruminant blood. By way of derogation from that specific condition, the competent authority may authorise the production of blood products for use in feed for non-ruminant farmed animals in processing plants processing ruminant blood.That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of measures aimed to prevent cross-contamination.Those measures shall include the following minimum requirements: (i)the production of non-ruminant blood products must be carried out in a closed system that is kept physically separated from that used for the production of ruminant blood products; (ii)the collection, storage, transport and packaging facilities for bulk raw material and bulk finished products of non-ruminant origin must be kept separate from those for bulk raw material and bulk finished of ruminant origin; (iii)an ongoing reconciliation process between the incoming blood respectively derived from ruminants and non-ruminants and the corresponding blood products must be applied; (iv)a regular sampling and analysis of blood products of non ruminant origin must be carried out to verify the absence of cross-contamination with blood products of ruminant origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years. (d)The accompanying commercial document or health certificate, as appropriate, of the blood products, compound feed containing blood products and any packaging of these products must be clearly marked with the words "contains blood products — shall not be fed to ruminants". SECTION D Specific conditions applicable to the production and use of processed animal protein, other than fishmeal, derived from non-ruminants and compound feed containing such processed animal protein intended to be used for feeding aquaculture animals The following specific conditions shall apply to the production and use of processed animal protein, other than fishmeal, derived from non-ruminants and compound feed containing such protein intended to be used for feeding aquaculture animals: (a)The animal by-products intended to be used for the production of processed animal protein referred to in this Section shall be derived either from slaughterhouses which do not slaughter ruminants and which are registered by the competent authority as not slaughtering ruminants or from cutting plants which do not bone or cut up ruminant meat. By way of derogation from that specific condition, the competent authority may authorise the slaughter of ruminants in a slaughterhouse producing non-ruminant animal by-products intended for the production of processed animal protein referred to in this Section.That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of measures aimed to prevent cross-contamination between ruminant and non-ruminant by-products.Those measures shall include the following minimum requirements: (i)the slaughtering of non-ruminants must be carried out in lines that are physically separate from those used for the slaughtering of ruminants; (ii)the collection, storage, transport and packaging facilities for animal by-products of non-ruminant origin must be kept separate from those for animal by-products of ruminant origin; (iii)a regular sampling and analysis of animal by-products of non-ruminant origin must be carried out to detect the presence of ruminant proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles. (b)The animal by-products of non-ruminant origin intended to be used for the production of processed animal protein referred to in this Section shall be transported to a processing plant in vehicles and containers which are not used for the transport of animal by-products of ruminant origin. By way of derogation from that specific condition, they may be transported in vehicles and containers which have been previously used for the transport of animal by-products derived from ruminants, provided that those vehicles and containers have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority.Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years. (c)The processed animal protein referred to in this Section shall be produced in processing plants that are dedicated exclusively to processing non-ruminant animal by-products sourced from slaughterhouses and cutting plants referred to in point (a). By way of derogation from that specific condition, the competent authority may authorise the production of processed animal protein referred to in this Section in processing plants processing ruminant animal by-products.That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of the measures aimed to prevent cross-contamination between processed animal protein of ruminant origin and processed animal protein of non-ruminant origin.Those preventive measures shall include the following minimum requirements: (i)the production of processed animal protein derived from ruminants must be carried out in a closed system that is physically separated from that used for the production of the processed animal protein referred to in this Section; (ii)the keeping of animal by-products derived from ruminants during storage and transport in facilities that are physically separated from those for animal by-products derived from non-ruminants; (iii)the keeping of processed animal protein derived from ruminants during storage and packaging in facilities that are physically separated from those used for finished products derived from non-ruminants; (iv)regular sampling and analysis of the processed animal protein referred to in this Section must be carried out to verify the absence of cross-contamination with ruminant processed animal protein using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years. (d)Compound feed containing processed animal protein referred to in this Section shall be produced in establishments authorised for that purpose by the competent authority and which are dedicated exclusively to the production of feed for aquaculture animals. By way of derogation from that specific condition: (i)the production of compound feed for aquaculture animals in establishments which also produce compound feed intended for other farmed animals, except fur animals, may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions: compound feed destined for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminant animals are manufactured and kept; compound feed destined for aquaculture animals must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for other non-ruminant animals are manufactured and kept; records detailing the purchases and uses of processed animal protein referred to in this Section and the sales of compound feed containing such protein must be kept available to the competent authority for a period of at least five years; regular sampling and analysis of the compound feed destined for farmed animals other than aquaculture animals in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years; (ii)a specific authorisation for the production of complete feed from compound feed containing processed animal protein referred to in this Section shall not be required for home compounders that comply with the following conditions: they are registered by the competent authority, they keep only aquaculture animals, they produce complete feed for aquaculture animals for use only in the same holding, and the compound feed containing processed animal protein referred to in this Section used in their production contains less than 50 % total protein. (e)The accompanying commercial document or health certificate, as appropriate, of processed animal protein referred to in this Section and any packaging shall be clearly marked with the following words: "processed animal protein derived from non ruminants — shall not be used for the production of feed for farmed animals except aquaculture animals and fur animals". The accompanying commercial document or health certificate, as appropriate, of the compound feed for aquaculture animals containing processed animal protein referred to in this Section and any packaging shall be clearly marked the following words: "contains processed animal protein derived from non ruminants — shall not be fed to farmed animals except aquaculture animals and fur animals". SECTION E Specific conditions applicable to the production, placing on the market and use of milk replacers containing fishmeal for the feeding of unweaned ruminants The following specific conditions shall apply to the production, placing on the market and use of milk replacers containing fishmeal in the feeding of unweaned farmed animals of the ruminant species: (a)The fishmeal used in milk replacers shall be produced in processing plants dedicated exclusively to the production of products derived from aquatic animals, except sea mammals, and shall comply with general conditions laid set out in Chapter III. (b)The use of fishmeal for unweaned farmed animals of the ruminant species shall only be authorised for the production of milk replacers, distributed in dry form and administered after dilution in a given quantity of liquid, intended for the feeding of unweaned ruminants as a supplement to, or substitute for, post-colostral milk before weaning is complete. (c)Milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be produced in establishments which do not produce other compound feed for ruminants and which are authorised for this purpose by the competent authority. By way of derogation from that special condition, the production of other compound feed for ruminants in establishments which also produce milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions: (i)other compound feed destined for ruminants must be kept in facilities that are physically separate from those used for bulk fishmeal and bulk milk replacers containing fishmeal during storage, transport and packaging; (ii)other compound feed destined for ruminants must be manufactured in facilities that are physically separate from facilities where milk replacers containing fishmeal are manufactured; (iii)records detailing the purchases and uses of fishmeal and the sales of milk replacers containing fishmeal must be kept available to the competent authority for a period of at least five years; (iv)regular sampling and analysis of the other compound feed destined for ruminants must be carried out in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years. (d)Before release for free circulation in the Union, importers shall ensure that each consignment of imported milk replacers containing fishmeal is analysed in accordance with methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin. (e)The accompanying commercial document or health certificate, as appropriate, of milk replacers containing fishmeal, intended for unweaned farmed animals of the ruminant species, and any packaging containing such milk replacers, must be clearly marked with the words "contains fishmeal — shall not be fed to ruminants except unweaned ruminants". (f)Bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be transported by means of vehicles and containers which are not used for the transport of other feed intended for ruminants. By way of derogation from that special condition, vehicles and containers which will be subsequently used for the transport of other bulk feed intended for ruminants may be used for the transport of bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species provided that such vehicles and containers have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years. (g)On farms where ruminants are kept, on-farm measures shall be in place to prevent milk replacers containing fishmeal being fed to other ruminants than unweaned ruminants. The competent authority shall establish a list of farms where milk replacers containing fishmeal are used through a system of prior notification by the farm or another system thereby ensuring compliance with this specific condition. CHAPTER V General requirements SECTION A Listing Member States shall keep up-to-date and make publicly available lists of: (a)slaughterhouses from which blood produced in accordance with point (a) of Section C of Chapter IV can be sourced; (b)authorised processing plants producing blood products in accordance with point (c) of Section C of Chapter IV; (c)slaughterhouses and cutting plants from which animal by-products intended to be used for the production of processed animal protein in accordance with point (a) of Section D of Chapter IV can be sourced; (d)authorised processing plants producing processed animal protein derived from non-ruminants which operate in accordance with point (c) of Section D of Chapter IV; (e)authorised establishments referred to in Section B of Chapter III, in point (d) of Section D of Chapter IV and in point (c) of Section E of Chapter IV; (f)home compounders which have been registered and operate in accordance with the conditions laid down in Section B of Chapter III and point (d) of Section D of Chapter IV. SECTION B Transport of feed materials and compound feed containing products derived from ruminants 1.Bulk feed materials and bulk compound feed containing products derived from ruminants other than those listed in the following points (a), (b) and (c) shall be transported in vehicles and containers which are not used for the transport of feed intended for farmed animals other than fur animals: (a)milk, milk-based products, milk-derived products, colostrum and colostrum products; (b)dicalcium and tricalcium phosphate of animal origin; (c)hydrolysed proteins derived from ruminant hides and skins. 2.By way of derogation from point 1, vehicles and containers which have been previously used for the transport of bulk feed materials and bulk compound feed listed in that point, may be used for the transport of feedingstuffs intended for farmed animals other than fur animals provided that they have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of this use shall be kept available to the competent authority for a period of at least two years. SECTION C Production of compound feed containing products derived from ruminants Compound feed which contains products derived from ruminants other than those listed in points (a), (b) and (c) shall not be produced in establishments which produce feed for farmed animals other than fur animals: (a)milk, milk-based products, milk-derived products, colostrum and colostrum products; (b)dicalcium and tricalcium phosphate of animal origin; (c)hydrolysed proteins derived from ruminant hides and skins. SECTION D Use and storage on farms of feed materials and compound feed for farmed animals containing products derived from ruminants The use and storage of feed materials and compound feed for farmed animals containing products derived from ruminants other than those listed in points (a), (b) and (c) shall be prohibited in farms keeping farmed animals other than fur animals: (a)milk, milk-based products, milk-derived products, colostrum and colostrum products; (b)dicalcium and tricalcium phosphate of animal origin; (c)hydrolysed proteins derived from ruminant hides and skins. SECTION E Export of processed animal protein and products containing such protein 1.The export of processed animal protein derived from ruminants, and of products containing such protein shall be prohibited. By way of derogation, that prohibition shall not apply to processed petfood including canned petfood which contains processed animal protein derived from ruminants and which has undergone treatment and which is labelled in accordance with Union legislation. 2.The export of processed animal protein derived from non-ruminants, and of products containing such protein, shall only be authorised subject to compliance with the following conditions: (a)they are destined for uses not prohibited by Article 7 and this Annex; (b)a written agreement is concluded prior the exportation between the competent authority of the exporting Member State, or the Commission, and the competent authority of the importing third country which includes an undertaking from the importing third country to respect the intended use and not to re-export the processed animal protein or the products containing such protein for uses prohibited by Article 7 and this Annex. 3.Written agreements concluded in accordance with point 2(b) above shall be presented in the framework of the Standing Committee on the Food Chain and Animal Health. 4.Points 2 and 3 shall not apply to the export of the following: (a)fishmeal and compound feed containing fishmeal; (b)compound feed intended for aquaculture animals; (c)petfood. SECTION F Official controls 1.Official controls carried out by the competent authority in order to verify compliance with the rules laid down set out in this Annex shall include inspections and sampling for analysis on processed animal protein and feed in compliance with the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009. 2.The competent authority shall verify on a regular basis the competence of laboratories carrying out analyses for such official controls, in particular by evaluating the results of inter-proficiency tests. If the competence is considered unsatisfactory, a retraining of the laboratory staff shall be undertaken by the laboratory as the minimal corrective measure, prior to carrying out further analyses. ANNEX V SPECIFIED RISK MATERIAL 1.Definition of specified risk material The following tissues shall be designated as specified risk material if they come from animals whose origin is in a Member State or third country or of one of their region with a controlled or undetermined BSE risk: (a)as regards bovine animals: (i)the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months; (ii)the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia, of animals aged over 30 months; and (iii)the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages. (b)as regards ovine and caprine animals (i)the skull including the brain and eyes, the tonsils and the spinal cord of animals aged over 12 months or which have a permanent incisor erupted through the gum, and (ii)the spleen and ileum of animals of all ages. 2.Derogation for Member States By way of derogation from point 1, tissues listed in that point whose origin is in Member States with a negligible BSE risk shall continue to be considered as specified risk material. 3.Marking and disposal Specified risk material shall be stained with a dye or, as appropriate, otherwise marked, immediately on removal, and disposed of in accordance with the provisions laid down in Regulation (EC) No 1774/2002, and in particular in Article 4(2) thereof. 4.Removal of specified risk material 4.1.Specified risk material shall be removed at: (a)slaughterhouses, or, as appropriate, other places of slaughter; (b)cutting plants, in the case of vertebral column of bovine animals; (c)where appropriate, in intermediate plants referred to in Article 10 of Regulation (EC) No 1774/2002 or users and collection centres authorised and registered pursuant to Article 23(2)(c)(iv), (vi) and (vii) of Regulation (EC) No 1774/2002. 4.2.By way of derogation from point 4.1, the use of an alternative test to the removal of specified risk material may be authorised under the following conditions: (a)tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material; (b)no bovine, ovine or caprine product intended for human food or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them; (c)when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse is destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate. 4.3.By way of derogation from point 4.1, Member States may decide to allow: (a)the removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this purpose; (b)the removal of bovine vertebral column from carcasses or parts of carcasses in butcher shops specifically authorised, monitored and registered for this purpose; (c)the harvesting of head meat from bovine animals in cutting plants specifically authorised for this purpose in accordance with the provisions laid down in point 9. 4.4.The rules on removal of specified risk material laid down in this Chapter shall not apply to Category 1 material as defined in Regulation (EC) No 1774/2002 used under the supervision of competent authorities for feeding of endangered and protected species of necrophagous birds. 5.Measures concerning mechanically separated meat Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 9(3), it shall be prohibited in all Member States to use bones or bone-in cuts of bovine, ovine and caprine animals for the production of mechanically separated meat. 6.Measures concerning laceration of tissues Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 8(3), in all Member States, until all Member States are classified as countries with negligible BSE risk, laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity after stunning shall be prohibited in bovine, ovine or caprine animals whose meat is intended for human or animal consumption. 7.Harvesting of tongues from bovine animals Tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone. 8.Harvesting of bovine head meat 8.1.Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat with central nervous system tissue. The system shall include at least the following provisions: (a)harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline; (b)where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling; (c)head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or after slaughter, or which are otherwise damaged in a way which might result in contamination of the head with central nervous tissue; (d)head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent; (e)without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during the harvesting, in particular in the case when the seal referred to in the second indent is lost or the eyes damaged during the activity: (f)a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. 8.2.By way of derogation from the requirements of point 8.1, Member States may decide to apply at the slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. Member States using this derogation shall inform the Commission and the other Member States in the framework of the Standing Committee of the Food Chain and Animal Health of their control system and the results of the sampling. 8.3.If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and 8.2 shall not apply. 9.Harvesting of bovine head meat in authorised cutting plants By way of derogation from point 8, Member States may decide to allow the harvesting of head meat from bovine in cutting plants specifically authorised for this purpose and provided that the following conditions are complied with: (a)the heads intended for transport to the cutting plant shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the cutting plant; (b)the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling; (c)the heads which have not been properly sealed in accordance with point (b), where the eyes are damaged or lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue shall be excluded from transport to the specifically authorised cutting plants; (d)a sampling plan for the slaughterhouse using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify the proper implementation of the measures to reduce contamination; (e)the harvesting of head meat shall be carried out in accordance with a control system, recognized by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least: (i)all heads shall be visually checked for signs of contamination or damage and proper sealing before the harvesting of the head meat begins; (ii)head meat shall not be harvested from heads which have not been properly sealed, where the eyes are damaged or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue. Head meat shall also not be harvested from any head where contamination from such heads is suspected; (iii)without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during transport and harvesting, in particular where the seal is lost or the eyes damaged during the activity; (f)a sampling plan for the cutting plant using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. 10.Rules on trade and export 10.1.Member States may allow dispatch of heads or of un-split carcasses containing specified risk material to another Member State only after that Member State has agreed to receive the material and has approved the conditions of dispatch and transport. 10.2.By way of derogation from point 10.1, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be dispatched from one Member State to another without the latter's prior agreement. 10.3.Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing specified risk materials shall be prohibited. 11.Controls 11.1.Member States shall carry out frequent official controls to verify the correct application of this Annex and shall ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants or other places where specified risk material is removed, such as butcher shops or establishments referred in point 4.1 (c). 11.2.Member States shall in particular set up a system to ensure and check that specified risk material is handled and disposed of in accordance with Regulation (EC) No 999/2001 and Regulation (EC) No 1774/2002. 11.3.A control system shall be put in place for the removal of the vertebral column as specified in point 1(a). The system shall include at least the following measures: (a)when removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000; (b)specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as the number where removal of the vertebral column is not required, shall be added on the commercial document relating to consignments of meat. When applicable, the specific information shall be added to the document referred to in Article 2(1) of Commission Regulation (EC) No 136/2004OJ L 21, 28.1.2004, p. 11. in the case of imports; (c)butcher shops shall keep, for at least one year, the commercial documents referred to in (b). ANNEX VI PRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING RUMINANT MATERIAL, AS REFERRED TO IN ARTICLE 9(1)null ANNEX VII ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY CHAPTER A Measures following confirmation of the presence of a TSE 1.The inquiry referred to in Article 13(1)(b) must identify: (a)in the case of bovine animals: all other ruminants on the holding of the animal in which the disease was confirmed, where the disease was confirmed in a female animal, its progeny born within two years prior to, or after, clinical onset of the disease, all animals of the cohort of the animal in which the disease was confirmed, the possible origin of the disease, other animals on the holding of the animal in which the disease was confirmed or on other holdings which may have become infected by the TSE agent or been exposed to the same feed or contamination source, the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question; (b)in the case of ovine and caprine animals: all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed, insofar as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female animal in which the disease was confirmed, all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those referred to in the second indent, the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source, the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question. 2.The measures laid down in Article 13(1)(c) shall comprise at least: 2.1.In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide: not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal, to defer the killing and destruction of animals in the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death. 2.2.If a TSE is suspected in an ovine or caprine animal on a holding in a Member State and until the results of the confirmatory examinations are available, all other ovine and caprine animals from that holding shall be placed under an official movement restriction. If there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the competent authority may decide that other holdings or only the holding of exposure shall be placed under official control, depending on the epidemiological information available. The milk and the milk products derived from the ovine and caprine animals of the holding placed under official control, which are present on that holding from the date when the presence of the TSE is suspected until the results of the confirmatory examinations are available, shall only be used within that holding. 2.3.In the case of confirmation of TSE in an ovine or caprine animal: (a)if BSE cannot be excluded after the results of a ring trial carried out in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b). The milk and the milk products derived from the animals to be destroyed, which were present on the holding between the date of confirmation that BSE cannot be excluded and the date of complete destruction of the animals, shall be destroyed. (b)if BSE is excluded in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), pursuant to the decision of the competent authority: either (i)the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). In case the confirmed TSE is classical scrapie, the milk and milk products derived from the animals to be destroyed and which were present on the holding between the date of confirmation of the classical scrapie case and the date of the complete destruction of the animals shall not be used for the feeding of ruminants, except for the feeding of ruminants within that holding. The placing on the market of such products as feed for non-ruminants shall be limited to the territory of the Member State concerned. The commercial document accompanying consignments of such products and any packaging containing such consignments must be clearly marked with the words: "shall not be fed to ruminants". The use and the storage of feedingstuffs containing such products shall be prohibited on farms where ruminants are kept. Bulk feedingstuffs containing such products shall be transported by means of vehicles which do not transport feedingstuffs for ruminants at the same time. If such vehicles are subsequently used for the transport of feedingstuffs intended for ruminants, they shall be thoroughly cleaned in order to avoid cross-contamination, in accordance with a procedure approved by the competent authority. The conditions set out in point 3 shall apply to the holding;or (ii)the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of: breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph, sheep carrying at least one ARR allele which are intended solely for slaughter, if the competent authority so decides, sheep and goats less than three months old which are intended solely for slaughter.In case the confirmed TSE is classical scrapie, the milk and milk products derived from the animals to be destroyed and which were present on the holding between the date of confirmation of the classical scrapie case and the date of the complete destruction of the animals shall not be used for the feeding of ruminants, except for the feeding of ruminants within that holding. The placing on the market of such products as feed for non-ruminants shall be limited to the territory of the Member State concerned. The commercial document accompanying consignments of such products and any packaging containing such consignments must be clearly marked with the words: "shall not be fed to ruminants". The use and the storage of feedingstuffs containing such products shall be prohibited on farms where ruminants are kept. Bulk feedingstuffs containing such products shall be transported by means of vehicles which do not transport feedingstuffs for ruminants at the same time. If such vehicles are subsequently used for the transport of feedingstuffs intended for ruminants, they shall be thoroughly cleaned in order to avoid cross-contamination, in accordance with a procedure approved by the competent authority.The conditions set out in point 3 shall apply to the holding; (iii)a Member State may decide not to kill and destroy the animals, identified by the inquiry referred to in the second and third indents of point 1(b) where it is difficult to obtain replacement ovine animals of a known genotype or where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, or based on a reasoned consideration of all the epidemiological factors. The conditions set out in point 4 shall apply to the holding; (c)by way of derogation from the measures set out in point (b), and only where the TSE case confirmed on a holding is an atypical scrapie case, the Member State may decide to apply the measures laid down in point 5; (d)Member States may decide: (i)to replace the killing and complete destruction of all animals referred to in b(i) by slaughtering for human consumption; (ii)to replace the killing and complete destruction of animals referred to in b(ii) by slaughtering for human consumption provided that: the animals are slaughtered within the territory of the concerned Member State, all animals which are over 18 months of age or have more than two permanent incisors erupted through the gum and are slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2 (b); (e)the prion protein genotype of ovine animals, up to a maximum of 50, killed and destroyed or slaughtered for human consumption in accordance with points (b)(i) and (iii) shall be determined; (f)where the frequency of the ARR allele within the breed or holding is low or absent, or where it is deemed necessary in order to avoid inbreeding, a Member State may decide to delay the killing and complete destruction of the animals referred to in point 2.3(b)(i) and (ii) for a period not exceeding 5 breeding years from the date of confirmation of the index case provided that no breeding rams other than those of the ARR/ARR genotype are present on the holding. However, in the case of ovine and caprine animals kept for the production of milk with a view to placing it on the market, the killing and complete destruction of the animals may only be delayed for a maximum period of 18 months from the date of confirmation of the index case, except for caprine animals where the killing and complete destruction may be delayed until 31 December 2012 if the index case is confirmed before 1 July 2011. 2.4.If the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed; in the case of land used for common grazing by more than one flock, Member States may decide to limit the application of those measures to a single flock, based on a reasoned consideration of all the epidemiological factors; where more than one flock is kept on a single holding, Member States may decide to limit the application of the measures to the flock in which the TSE has been confirmed, provided it has been verified that the flocks have been kept isolated from each other and that the spread of infection between the flocks through either direct or indirect contact is unlikely. 2.5.Pending the killing and complete destruction of the animals referred to in points 2.3(b) (i) and (ii), including animals for which the killing and complete destruction has been delayed as provided for in point 2.3(f), the measures set out in point 3.1(a) and (b), point 3.2 and point 3.3(a), (b) first indent and (d) shall apply on the holding(s). 3.Following the application on a holding of the measures referred to in point 2.3 (a) and (b)(i) and (ii): 3.1.Only the following animals may be introduced to the holding(s): (a)male sheep of the ARR/ARR genotype; (b)female sheep carrying at least one ARR allele and no VRQ allele; (c)caprine animals, provided that: (i)no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present on the holding; (ii)thorough cleaning and disinfection of all animal housing on the premises has been carried out following destocking. 3.2.Only the following ovine germinal products may be used in the holding(s): (a)semen from rams of the ARR/ARR genotype; (b)embryos carrying at least one ARR allele and no VRQ allele. 3.3.Movement of the animals from the holding shall be subject to the following conditions: (a)movement of ARR/ARR sheep from the holding shall not be subject to any restriction; (b)sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human consumption or for the purposes of destruction; however, ewes carrying one ARR allele and no VRQ allele may be moved to other holdings which are restricted following the application of measures in accordance with point 2.3 (b)(ii) or 4, if the competent authority so decides, lambs and kids may be moved to one other holding solely for the purposes of fattening prior to slaughter; the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter within the territory of the concerned Member State; (c)caprine animals may be moved provided that the holding is subjected to intensified TSE monitoring, including the testing of all caprine animals which are over the age of 18 months and: (i)are slaughtered for human consumption at the end of their productive lives; or (ii)have died or been killed on the holding, and meet the conditions set out to in Annex III, Chapter A, Part II, point 3; (d)if the Member State so decides, lambs and kids less than three months old may be moved from the holding to go directly for slaughter for human consumption. 3.4.The restrictions set out in points 3.1, 3.2 and 3.3 shall continue to apply to the holding for a period of two years from: (a)the date of attainment of ARR/ARR status by all ovine animals on the holding; or (b)the last date when any ovine or caprine animal was kept on the premises; or (c)the date when the intensified TSE monitoring set out in 3.3 (c) commenced; or (d)the date when all breeding rams on the holding are of ARR/ARR genotype and all breeding ewes carry at least one ARR allele and no VRQ allele, provided that during the two-year period, negative results are obtained from TSE testing of the following animals over the age of 18 months: an annual sample of ovine animals slaughtered for human consumption at the end of their productive lives in accordance with the sample size referred to in the Table in Annex III, Chapter A, Part II, point 5, and all ovine animals referred to in Annex III, Chapter A, Part II, point 3 which have died or been killed on the holding. 4.Following the application on a holding of the measures set out in point 2.3 (b)(iii) and for a period of two breeding years following the detection of the last TSE case: (a)all ovine and caprine animals on the holding shall be identified; (b)all ovine and caprine animals on the holding, may be moved only within the territory of the concerned Member State for slaughter for human consumption or for the purposes of destruction; all animals over the age of 18 months slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b); (c)the competent authority shall ensure that embryos and ova are not dispatched from the holding; (d)only the semen from rams of the ARR/ARR genotype and embryos carrying at least one ARR allele and no VRQ allele may be used in the holding; (e)all ovine and caprine animals which are over the age of 18 months which have died or been killed on the holding shall be subject to TSE testing; (f)only male sheep of the ARR/ARR genotype and female ovine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions set out in point 3.4 may be introduced in the holding; (g)only caprine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions of point 3.4 may be introduced in the holding; (h)all ovine and caprine animals in the holding shall be subject to common grazing restrictions to be determined by the competent authority, based on a reasoned consideration of all the epidemiological factors; (i)by way of derogation of point (b) if the competent authority so decides, lambs and kids may be moved to another holding within the same Member State solely for the purposes of fattening prior to slaughter; provided that the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter within the territory of the concerned Member State. 5.Following the application of the derogation provided for in point 2.3 (c) the following measures shall apply: (a)either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). Member States may decide to determine the prion protein genotype of ovine animals which have been killed and destroyed; (b)or, for a period of two breeding years following the detection of the last TSE case, at least the following measures: (i)all ovine and caprine animals in the holding shall be identified; (ii)the holding must be subject to intensified TSE monitoring for a period of two years, including the testing of all ovine and caprine animals which are over the age of 18 months and slaughtered for human consumption and all ovine and caprine animals over the age of 18 which have died or been killed on the holding; (iii)the competent authority shall ensure that live ovine and caprine animals, embryos and ova from the holding are not dispatched to other Member States or third countries. 6.Member States applying the measures set out in point 2.3(b)(iii) or the derogations provided for in points 2.3(c) and (d) shall notify to the Commission an account of the conditions and criteria used for granting them. Where additional TSE cases are detected in flocks where derogations are applied, the conditions for granting such derogations shall be reassessed. CHAPTER B Minimum requirements for a breeding programme for resistance to TSEs in sheep in accordance with Article 6a PART 1 General requirements 1.The breeding programme shall concentrate on flocks of high genetic merit. 2.A database shall be established containing at least the following information: (a)the identity, breed and number of animals in all flocks participating in the breeding programme; (b)the identification of the individual animals sampled under the breeding programme; (c)the results of any genotyping tests. 3.A system of uniform certification shall be established in which the genotype of each animal sampled under the breeding programme is certified by reference to its individual identification number. 4.A system for the identification of animals and samples, the processing of samples and the delivery of results shall be established which minimises the possibility of human error. The effectiveness of that system shall be subject to regular random checking. 5.Genotyping of blood or other tissues collected for the purposes of the breeding programme shall be carried out in laboratories that have been approved under that programme. 6.The competent authority of the Member State may assist breed societies, to establish genetic banks consisting of semen, ova and/or embryos representative of prion protein genotypes which are likely to become rare as a result of the breeding programme. 7.Breeding programmes shall be drawn up for each breed, taking account of: (a)frequencies of the different alleles within the breed; (b)rarity of the breed; (c)avoidance of inbreeding or genetic drift. PART 2 Specific rules for participating flocks 1.The breeding programme shall be aimed at increasing the frequency of the ARR allele within the sheep flock, while reducing the prevalence of those alleles which have been shown to contribute to susceptibility to TSEs. 2.The minimum requirements for participating flocks shall be the following: (a)all animals in the flock that are to be genotyped shall be individually identified using secure means; (b)all rams intended for breeding within the flock to shall be genotyped before being used for breeding; (c)any male animal carrying the VRQ allele shall be slaughtered or castrated, within six months following the determination of its genotype; any such animal shall not leave the holding except for slaughter; (d)female animals that are known to carry the VRQ allele shall not leave the holding except for slaughter; (e)male animals, including semen donors used for artificial insemination, other than those certified under the breeding programme, shall not be used for breeding within the flock. 3.Member States may decide to grant derogations from the requirements set out in point 2(c) and (d) for the purposes of protection of breeds and production traits. 4.Member States shall inform the Commission of derogations granted under point 3 and of the criteria used. PART 3 The framework for the recognition of the TSE-resistant status of flocks of sheep 1.The framework shall recognise the TSE-resistant status of flocks of sheep that as a result of participation in the breeding programme as provided for in Article 6a, satisfy the criteria required in the programme. This recognition shall be granted on at least the following two levels: (a)level I flocks shall be flocks composed entirely of sheep of the ARR/ARR genotype; (b)level II flocks shall be flocks whose progeny have been sired exclusively by rams of the ARR/ARR genotype.Member States may decide to grant recognition on further levels to suit national requirements. 2.Regular random sampling of sheep from TSE-resistant flocks shall be carried out: (a)on the farm or at the slaughterhouse to verify their genotype; (b)in the case of level I flocks, in animals over 18 months of age at the slaughterhouse, for TSE testing in accordance with Annex III. PART 4 Reports to be provided to the Commission by the Member States Member States introducing national breeding programmes to select for resistance to TSE in their ovine populations shall notify to the Commission the requirements for such programmes and shall provide an annual report on their progress. The report for each calendar year shall be submitted at the latest by 31 March of the following year. ANNEX VIII PLACING ON THE MARKET AND EXPORT CHAPTER A Conditions for intra-Community trade in live animals, semen and embryos I.CONDITIONS WHICH APPLY TO OVINE.AND CAPRINE.ANIMALS AND SEMEN AND EMBRYOS TREREOF The following conditions shall apply to trade in ovine and caprine animals: (a)ovine and caprine animals for breeding shall either be sheep of the ARR/ARR prion protein genotype, as defined in Annex I of Commission Decision 2002/1003/ECOJ L 349, 24.12.2002, p. 105., or they shall have been kept continuously since birth or for the last three years on a holding or holdings which have satisfied the following requirements for at least three years: (i)until 30 June 2007: it is subject to regular official veterinary checks, the animals are marked, no case of scrapie has been confirmed, checking by sampling of old female animals intended for slaughter is carried out, females, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.From 1 July 2004 at the latest, the holding or holdings shall begin to satisfy the following additional requirements: all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding shall be examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b), and ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, shall be introduced into the holding only if they come from a holding which complies with the same requirements. (ii)from 1 July 2007: it is subject to regular official veterinary checks, the animals are identified in conformity with Community legislation, no case of scrapie has been confirmed, all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding have been examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b), ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c), ovine and caprine animals for breeding shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2). (b)a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory: (i)may submit the said program to the Commission, outlining in particular: the distribution of the disease in the Member State, the reasons for the program, taking into consideration the importance of the disease and the cost/benefit ratio, the geographical area in which the program will be implemented, the status categories defined for holdings and the standards which must be attained in each such category, the test procedures to be used, the program monitoring procedures, the action to be taken if, for any reason, a holding loses its status, the measures to be taken if the results of checks carried out in accordance with the provisions of the program are positive, (ii)the program referred to in point (i) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2). The additional guarantees, general or specific, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the program in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally, (iii)amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2). Amendments to the guarantees which have been defined in accordance with point (ii) may be approved in accordance with that procedure, (c)where a Member State considers that its territory or part of its territory is free from scrapie: (i)it is to submit to the Commission appropriate supporting documentation, setting out in particular: the history of the occurrence of the disease in its territory, the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation, the period over which the surveillance was carried out, the arrangements for verifying the absence of the disease, (ii)the additional guarantees, general or specific, which may be required in intra-Community trade are to be defined in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally, (iii)the Member State concerned is to notify the Commission of any change in the details specified in point (i) which relate to the disease. The guarantees defined in accordance with point (ii) may, in the light of such notification, be amended or withdrawn in accordance with the procedure referred to in Article 24(2), (d)from 1 January 2005 semen and embryos of ovine and caprine animals shall: (i)be collected from animals which have been kept continuously since birth or for the last three years of their life on a holding or holdings which have satisfied the requirements of subparagraph (a)(i) or, as appropriate, (a)(ii) for three years or (ii)in the case of ovine semen, be collected from male animals of the ARR/ARR prion protein genotype as defined in Annex I to Commission Decision 2002/1003/ECOJ L 349, 24.12.2002, p. 105.or (iii)in the case of ovine embryos, be of the ARR/ARR prion protein genotype as defined in Annex I to Decision 2002/1003/EC. II.CONDITIONS WICH APPLY TO BOVINE ANIMALS The United Kingdom shall ensure that bovine animals born or reared on its territory before 1 August 1996 are not dispatched from its territory to other Member States or third countries. CHAPTER B Conditions relating to progeny of TSE suspect or confirmed animals referred to in Article 15(2) It shall be prohibited to place on the market the last-born progeny to which female bovine animals infected with a TSE or BSE-confirmed ovine or caprine animals gave birth during the preceding two-year period or during the period that followed the appearance of the first clinical signs of the onset of the disease. CHAPTER C Conditions for intra-Community trade in certain products of animal origin SECTION A Products The following products of animal origin are exempt from the prohibition referred to in Article 16(3), provided that they are derived from bovine, ovine and caprine animals that satisfy the requirements of Section B: fresh meat, minced meat, meat preparations, meat products. SECTION B Requirements The products referred to in Section A must satisfy the following requirements: (a)the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections; (b)the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity; (c)the products of bovine, ovine and caprine animal origin are not derived from: (i)specified risk material as defined in Annex V; (ii)nervous and lymphatic tissues exposed during the deboning process; and (iii)mechanically separated meat obtained from bones of bovine, ovine or caprine animals. CHAPTER D Conditions applicable to exports Live bovine animals and products of animal origin derived therefrom are to be subject — as regards exports to third countries — to the rules laid down in this Regulation for intra-Community trade. ANNEX IX IMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS, EMBRYOS, OVA AND PRODUCTS OF ANIMAL ORIGIN CHAPTER A When importing from countries or regions placed in category 1, the competent authority is, for bovine animals and all commodities of bovine origin for which this Regulation lays down specific rules, to take account of the presentation of an international animal health certificate attesting that the country or region complies with the conditions in Annex II, Chapter C, to be placed in that category. CHAPTER B Imports of bovine animals SECTION A Imports from a country or a region with a negligible BSE risk Imports of bovine animals from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a)the animals were born and continuously reared in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk; (b)the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II; and (c)if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban. SECTION B Imports from a country or a region with a controlled BSE risk Imports of bovine animals from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a)the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk; (b)the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II; (c)the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban. SECTION C Imports from a country or a region with undetermined BSE risk Imports of bovine animals from a country or a region with an undetermined BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a)the country or region has not been categorized in accordance with Article 5(2) of Regulation (EC) No 999/2001 or has been categorized as a country or region with undetermined BSE risk; (b)the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II; (c)the animals were born at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban. CHAPTER C Imports of products of animal origin from bovine, ovine or caprine animals SECTION A Products The following products of bovine, ovine and caprine origin, as defined by points 1.10, 1.13, 1.15, 7.1, 7.5, 7.6, 7.7 and 7.9 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the CouncilOJ L 139, 30.4.2004, p. 55., shall be subject to the conditions laid down in Sections B, C and D of this Chapter depending on the BSE risk category of the country of origin: fresh meat, minced meat, meat preparations, meat products, rendered animal fat, greaves, gelatine other than gelatine derived from hides and skins, treated intestines. SECTION B Imports from a country or a region with a negligible BSE risk Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a)the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk; (b)the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections; (c)if in the country or region there have been BSE indigenous cases: (i)the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or (ii)the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals. SECTION C Imports from a country or a region with a controlled BSE risk 1.Imports of products of bovine, ovine and caprine animal origin referred to in section A from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a)the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk; (b)the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections; (c)animals from which the products of bovine, ovine and caprine animal origin destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity; (d)the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals. 2.By way of derogation from point 1(d) carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported. 3.When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a blue stripe on the label referred to in Regulation (EC) No 1760/2000. 4.The number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as he number where removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports. 5.In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that: (a)the country or region is classified in accordance with Article 5(2) as a country or region posing a controlled BSE risk; (b)the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections; (c)if the intestines are sourced from a country or region where there have been BSE indigenous cases: (i)the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or (ii)the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V. SECTION D Imports from a country or a region with an undetermined BSE risk 1.Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with an undetermined BSE risk, shall be subject to the presentation of an animal health certificate attesting that: (a)the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections; (b)the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity; (c)the products of bovine, ovine and caprine animal origin are not derived from: (i)specified risk material as defined in Annex V; (ii)nervous and lymphatic tissues exposed during the deboning process; (iii)mechanically separated meat obtained from bones of bovine, ovine or caprine animals. 2.By way of derogation from point 1(c), carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported. 3.When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000. 4.Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required and from which removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports. 5.In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that: (a)the country or region is classified in accordance with Article 5(2) as a country or region posing an undetermined BSE risk; (b)the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections; (c)if the intestines are sourced from a country or region where there have been BSE indigenous cases: (i)the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or (ii)the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V. CHAPTER D Imports of animal by-products and processed products derived therefrom from bovine, ovine and caprine animal origin SECTION A Animal by-products This Chapter shall apply to the following animal by-products and derived products, as defined in points (1) and (2) of Article 3 of Regulation (EC) No 1069/2009 of the European Parliament and of the CouncilOJ L 300, 14.11.2009, p. 1., provided that those products are of bovine, ovine and caprine animal origin: (a)rendered fats derived from Category 2 material, which are intended to be used as organic fertilisers or soil improvers, as defined in point 22 of Article 3 of Regulation (EC) No 1069/2009, or their starting materials or intermediate products; (b)bones and bone products derived from Category 2 material; (c)rendered fats derived from Category 3 material which are intended to be used as organic fertilisers or soil improvers or as feed, as defined in points 22 and 25 of Article 3 of Regulation (EC) No 1069/2009, or their starting materials or intermediate products; (d)pet food including dog chews; (e)blood products; (f)processed animal protein; (g)bones and bone products derived from Category 3 material; (h)gelatine derived from materials other than hides and skins; (i)category 3 material and derived products other than those referred to in points (c) to (h) excluding: (i)fresh hides and skins, treated hides and skins; (ii)gelatine derived from hides and skins; (iii)fat derivatives; (iv)collagen. SECTION B Health certificate requirements Imports of the animal by-products and derived products of bovine, ovine and caprine animal origin referred to in Section A shall be subject to the presentation of a health certificate which has been completed with the following attestation: (a)the animal by-product or derived product does not contain and is not derived from specified risk material or mechanically separated meat obtained from bones of bovine, ovine or caprine animals and the animals from which this animal by-product or derived product is derived, have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity; or (b)the animal by-product or derived product does not contain and is not derived from bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2). In addition to points (a) and (b), imports of the animal by-products and derived products referred to in Section A, containing milk or milk products of ovine or caprine animal origin and intended for feeding ruminants, shall be subject to the presentation of a health certificate which has been completed with the following attestation: (c)the ovine and caprine animals from which those products are derived must have been kept continuously since birth or for the last 3 years on a holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last 3 years: (i)it has been subject to regular official veterinary checks; (ii)no classical scrapie case has been diagnosed or, following the confirmation of a classical scrapie case: all animals in which classical scrapie was confirmed have been killed and destroyed, and all ovine and caprine animals on the holding have been killed and destroyed, except for breeding rams of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele; (iii)ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the requirements set out in points (i) and (ii);or (d)for animal by-products or derived products destined for a Member State listed in the Annex to Commission Regulation (EC) No 546/2006OJ L 94, 1.4.2006, p. 28., the ovine and caprine animals from which these products are derived must have been kept continuously since birth or for the last 7 years on a holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last 7 years: (i)it has been subject to regular official veterinary checks; (ii)no classical scrapie case has been diagnosed or, following the confirmation of a classical scrapie case: all animals in which classical scrapie was confirmed have been killed and destroyed, and all ovine and caprine animals on the holding have been killed and destroyed, except for breeding rams of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele; (iii)ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the requirements set out in points (i) and (ii). CHAPTER E Imports of ovine and caprine animals Ovine and caprine animals imported into the Community after 1 October 2003 are to be subject to the presentation of an animal health certificate attesting that: (a)either they were born in and continuously reared on holdings in which a case of scrapie has never been diagnosed, and, in the case of ovine and caprine animals for breeding, they satisfy the requirements of subparagraph (i) of point (a) of Chapter A(I) of Annex VIII; (b)or they are sheep of the ARR/ARR prion protein genotype, as defined in Annex I to Commission Decision 2002/1003/EC, coming from a holding where no case of scrapie has been reported in the last six months. If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII, they shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2). CHAPTER F Imports of products of animal origin from farmed and wild cervid animals 1.When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC) No 853/2004, derived from farmed cervid animals, are imported into the Community from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: "This product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected." 2.When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC) No 853/2004, derived from wild cervid animals, are imported into the Community from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: "This product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected." CHAPTER G When importing products of animal origin from third countries or regions thereof which are not placed in category 1, the appropriate certificates, as required by Community legislation, are to be supplemented by a declaration signed by the competent authority of the country of production, worded as follows: "The product of animal origin does not contain, and is not derived from, specified risk material as defined in Annex V to 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 or mechanically recovered meat obtained from bones of the head or vertebral column of bovine animals. The animals have not been slaughtered after stunning by means of a gas injected into the cranial cavity or killed instantaneously by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity." CHAPTER H Import of ovine and caprine semen and embryos Semen and embryos of ovine and caprine animals imported into the Community from 1 January 2005 shall satisfy the requirements of Annex VIII, Chapter A(I)(d). ANNEX X REFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODS CHAPTER A National reference laboratories 1.The designated national reference laboratory is to: (a)have at its disposal facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type and strain of the agent of TSE, and to confirm results obtained by regional diagnostic laboratories. Where it is not capable of identifying the strain-type of the agent, it shall set up a procedure to ensure that the identification of the strain is referred to the Community reference laboratory; (b)verify diagnostic methods used in regional diagnostic laboratories; (c)be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it: may provide diagnostic reagents to laboratories approved by the Member State; is to control the quality of all diagnostic reagents used in the Member State; is to periodically arrange comparative tests; is to hold isolates of the agents of the disease in question, or corresponding tissues containing such agents, coming from cases confirmed in the Member State; is to ensure confirmation of results obtained in diagnostic laboratories designated by the Member State; (d)is to cooperate with the Community reference laboratory. 2.However, by way of derogation from point 1, Member States which do not have a national reference laboratory are to use the services of the Community reference laboratory or of national reference laboratories in other Member States. 3.The national reference laboratories are:
Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Institut für veterinärmedizinische Untersuchungen MödlingRobert Koch Gasse 17A-2340 Mödling
Belgium: CERVA -CODA-VARCentre d'Étude et de Recherches Vétérinaires et AgrochimiquesCentrum voor Onderzoek in Diergeneeskunde en AgrochemieVeterinary and Agrochemical Research CentreGroeselenberg 99B-1180 Bruxelles
Bulgaria: Национален диагностичен научноизследователски ветеринарномедицински институт "Проф. Д-р Георги Павлов"Национална референтна лаборатория "Tрансмисивни спонгиформни енцефалопатии"бул. "Пенчо Славейков"София 1606(National Diagnostic Veterinary Research Institute "Prof. Dr. Georgi Pavlov" National Reference Laboratory for Transmissible Spongiform Encephalopathies15, Pencho Slaveykov Blvd.1606 Sofia)
Cyprus: State Veterinary LaboratoriesVeterinary ServicesCY-1417 AthalassaNicosia
Czech Republic: Státní veterinární ústav JihlavaRantířovská 93586 05 Jihlava
Denmark: Danmarks FødevareforskningBülowsvej 27DK-1790 København V
Estonia: Veterinaar- ja ToidulaboratooriumKreutzwaldi 30Tartu 51006
Finland: Eläinlääkintä- ja elintarvikelaitosHämeentie 57FIN-00550 Helsinki
France: Agence française de sécurité sanitaire des alimentsLaboratoire de pathologie bovine31, avenue Tony Garnier69 364 LYON CEDEX 07
Germany: Friedrich-Loeffler-Institut, Bundesforschungsinstitut für TiergesundheitAnstaltsteil Insel Riems Boddenblick 5AD-17498 Insel Riems
Greece: Ministry of Agriculture — Veterinary Laboratory of Larisa7th km of Larisa — Trikala HighwayGR-411 10 Larisa
Hungary: Országos Állategészségügyi Intézet (OÁI)Pf. 2.Tábornok u. 2.H-1581 Budapest
Ireland: Central Veterinary Research LaboratoryYoung's CrossCelbridgeCo. Kildare
Italy: Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d’Aosta — CEAVia Bologna, 148I-10154 Torino
Latvia: State Veterinary Medicine Diagnostic CentreLejupes Str. 3Riga LV 1076
Lithuania: Nacionalinė veterinarijos laboratorijaJ. Kairiūkščio g. 10LT-08409 Vilnius
Luxembourg: CERVA -CODA-VARCentre d'Étude et de Recherches Vétérinaires et AgrochimiquesCentrum voor Onderzoek in Diergeneeskunde en AgrochemieVeterinary and Agrochemical Research CentreGroeselenberg 99B-1180 Bruxelles
Malta: National Veterinary LaboratoryAlbert Town Marsa
Netherlands: Centraal Instituut voor Dierziektecontrole-LelystadHoutribweg 3g8221 RA LelystadPostbus 20048203 AA Lelystad
Poland: Państwowy Instytut Weterynaryjny (PIWet)24-100 Puławyal. Partyzantów 57
Portugal: Laboratório Nacional de Investigação Veterinária Estrada de Benfica701 P-1500 Lisboa
Romania: Institutul de Diagnostic și Sănătate AnimalăStrada Dr. Staicovici nr. 63, sector 5codul 050557, București.
Slovakia: State Veterinary Institute ZvolenPod dráhami 918SK-960 86, Zvolen
Slovenia: National Veterinary InstituteGerbičeva 601000 Ljubljana
Spain: Laboratorio Central de Veterinaria (Algete)Ctra. de Algete km. 828110 Algete (Madrid)
Sweden: National Veterinary InstituteS-751 89 Uppsala
United Kingdom: Veterinary Laboratories AgencyWoodham LaneNew Haw Addlestone Surrey KT15 3NB
CHAPTER B Community reference laboratory 1.The Community reference laboratory for TSEs is: The Veterinary Laboratories AgencyWoodham LaneNew HawAddlestoneSurrey KT15 3NBUnited Kingdom 2.The functions and duties of the Community reference laboratory are: (a)to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing BSE, specifically by: storing and supplying corresponding tissues containing the agent, for the development or production of the relevant diagnostic tests or for typing strains of the agent; supplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States; building up and retaining a collection of corresponding tissues containing the agents and strains of TSEs; organising periodic comparative tests of diagnostic procedures at Community level; collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community; characterising isolates of the TSE agent by the most up-to-date methods to allow greater understanding of the epidemiology of the disease; keeping abreast of trends in surveillance, epidemiology and prevention of TSEs throughout the world; maintaining expertise on prion diseases to enable rapid differential diagnosis; acquiring a thorough knowledge of the preparation and use of diagnostic methods used to control and eradicate TSEs; (b)to assist actively in the diagnosis of outbreaks of TSEs in Member States by studying samples from TSE-infected animals sent for confirmatory diagnosis, characterisation and epidemiological studies; (c)to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community. CHAPTER C Sampling and laboratory testing 1.Sampling Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the International Office for Epizooties (IOE/OIE) (the Manual). In addition, or in the absence, of OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the Community Reference Laboratory. In particular the competent authority shall collect the appropriate tissues, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE in small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid test is negative. Where the result is positive or inconclusive the residual tissues must be processed in accordance with the Community reference laboratory guidelines.The samples shall be correctly marked as to the identity of the sampled animal. 2.Laboratories Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose by the competent authority. 3.Methods and protocols 3.1.Laboratory testing for the presence of BSE in bovine animals (a)Suspect cases Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual: (i)the immunohistochemical (IHC) method; (ii)SAF-immunoblot or OIE approved alternative; (iii)the demonstration of characteristic fibrils by electron microscopy; (iv)the histopathological examination; (v)the combination of rapid tests as laid down in the third subparagraph. In case the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.Rapid tests may be used for both primary screening of suspect cases and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the Community reference laboratory and provided that: (i)the confirmation is carried out in a national reference laboratory for TSEs; and (ii)one of the two rapid tests is a Western blot; and (iii)the second rapid test used: includes a negative tissue control and a bovine BSE sample as positive tissue control, is of a different type than the test used for the primary screening; and (iv)if a rapid Western blot is used as the first test, the result of that test must be documented and submitted to the national reference laboratory for TSEs; and (v)where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods; in case the histopathological examination is used for that purpose but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols. If the result of one of the confirmatory examinations referred to in points (i) to (v) of the first subparagraph is positive, the animals shall be regarded a positive BSE cases. (b)BSE monitoring Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I shall be examined by a rapid test.When the result of the rapid test is inconclusive or positive, the sample shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual: (i)the immunohistochemical (IHC) method; (ii)SAF-immunoblot or OIE approved alternative; (iii)the demonstration of characteristic fibrils by electron microscopy; (iv)the histopathological examination; (v)the combination of rapid tests as laid down in the fourth subparagraph. In case the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.Rapid tests may be used for both primary screening and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the Community reference laboratory and provided that: (i)the confirmation is carried out in a national reference laboratory for TSEs; and (ii)one of the two rapid tests is a Western blot; and (iii)the second rapid test used: includes a negative tissue control and a bovine BSE sample as positive tissue control, is of a different type than the test used for the primary screening; and (iv)if a rapid Western blot is used as the first test, the result of that test must be documented and submitted to the national reference laboratory for TSEs; and (v)where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods; in case the histopathological examination is used for that purpose but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols. An animal shall be regarded a positive BSE case if the result of the rapid test is inconclusive or positive, and at least one of the confirmatory examinations referred to in points (i) to (v) of the first subparagraph is positive. 3.2.Laboratory testing for the presence of TSE in ovine and caprine animals (a)Suspect cases Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual: (i)the immunohistochemical (IHC) method; (ii)SAF-immunoblot or OIE approved alternative; (iii)the demonstration of characteristic fibrils by electron microscopy; (iv)the histopathological examination. In case the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.Rapid tests may be used for primary screening of suspect cases. Such tests may not be used for subsequent confirmation. Where the result of the rapid test used for primary screening of suspect cases is positive or inconclusive, the sample shall be subjected to an examination by one of the confirmatory examinations referred to in points (i) to (iv) of the first subparagraph. In case the histopathological examination is used for that purpose but proves to be inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.If the result of one of the confirmatory examinations referred to in point (i) to (iv) of the first subparagraph is positive, the animals shall be regarded positive TSE cases and further examination as referred to in point (c) shall be performed. (b)TSE monitoring Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test using the appropriate methods and protocols, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE.When the result of the rapid test is inconclusive or positive, the sampled tissues shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in (a). If the result of the confirmatory examination is negative or inconclusive, additional confirmatory testing shall be carried out according the guidelines of the Community reference laboratory.If the result of one of the confirmatory examination is positive, the animal shall be regarded a positive TSE case. (c)Further examination of positive TSE cases (i)Primary molecular testing with a discriminatory immuno-blotting Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive TSE cases but which are not atypical scrapie cases, following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be forwarded for further examination by a primary molecular typing method to: Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31 avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom, or to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community reference laboratory for the use of a molecular typing method. (ii)Ring trial with additional molecular testing methods Samples from TSE cases in which the presence of BSE cannot be excluded according to the guidelines issued by the Community Reference Laboratory by the primary molecular testing referred to in (i), shall be forwarded immediately to the laboratories listed in point (d) after consultation with the Community Reference Laboratory, and with all the relevant information available. They shall be submitted to a ring trial with at least: a second discriminatory immuno-blotting, a discriminatory immunocytochemistry, and a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)carried out in the laboratories approved for the relevant method as listed in point (d). Where samples are unsuitable for immunocytochemistry, the Community Reference Laboratory will direct appropriate alternative testing within the ring trial. The results shall be interpreted by the Community Reference Laboratory assisted by a panel of experts including a representative of the relevant National Reference Laboratory. The Commission shall be informed immediately about the outcome of that interpretation. Samples indicative for BSE by three different methods and samples inconclusive in the ring trial shall be further analysed by a mouse bioassay for final confirmation. Further testing of positive TSE samples detected in infected flocks on the same holding shall be carried out at least on the first two positive TSE cases detected every year following the index case. (d)Laboratories approved for performing further examination by molecular typing methods The laboratories approved for further molecular typing are: Agence Française de Sécurité Sanitaire des AlimentsLaboratoire de pathologie bovine31, avenue Tony GarnierBP 7033F-69342 Lyon Cedex Centre CEA Fontenay-aux-Roses, BP 6F-92265 Fontenay-aux-Roses Cedex Service de Pharmacologie et d’ImmunologieCentre CEA Saclay, bâtiment 136F-91191 Gif-sur-Yvette Cedex Veterinary Laboratories AgencyWoodham LaneNew HawAddlestoneSurrey KT15 3NBUnited Kingdom 3.3.Laboratory testing for the presence of TSEs in species other than those referred to in points 3.1. and 3.2. Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunocytochemistry, immuno-blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein. In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive. At least three different examinations shall be carried out in the event of the first appearance of the disease.In particular, where BSE is suspected in a species other than bovine animals, samples shall be submitted for strain-typing, where possible. 4.Rapid tests For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals: the immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test), the chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation), the microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3), the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test), the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test), the immunoassay using a chemical polymer for selective PrP Sc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA & IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA), the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP), the two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrP Sc (Roboscreen Beta Prion BSE EIA Test Kit), the sandwich ELISA for the detection of Proteinase K-resistant PrP Sc (Roche Applied Science PrionScreen). For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals: the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test), the sandwich immunoassay for PrPRes detection with the TeSeE Sheep/Goat Detection kit carried out following denaturation and concentration steps with the TeSeE Sheep/Goat Purification kit (Bio-Rad TeSeE Sheep/Goat rapid test), the immunoassay using a chemical polymer for selective PrP Sc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA), the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (rapid test Prionics - Check PrioSTRIP SR, visual reading protocol). In all rapid tests, sample tissue on which the test must be applied must comply with the manufacturer’s instructions for use.Producers of rapid tests must have a quality assurance system in place that has been approved by the European Union Reference Laboratory and ensures that the test performance does not change. Producers must provide the European Union Reference Laboratory with the test protocols.Changes to rapid tests and to test protocols may only be made after prior notification to the European Union Reference Laboratory and provided that the European Union Reference Laboratory finds that the change does not alter the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories. 5.Alternative tests (To be defined)
ANNEX XI TRANSITIONAL MEASURES REFERRED TO IN ARTICLES 22 AND 23 A.Concerning specified risk material, mechanically recovered meat and slaughtering techniques 1. The following tissues are designated as specified risk material: (i)the skull excluding the mandible and including the brain and eyes, and the spinal cord of bovine animals aged over 12 months, the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia of bovine animals aged over 24 months, and the tonsils, the intestines from the duodenum to the rectum and the mesentery of bovine animals of all ages; (ii)the skull including the brain and eyes, the tonsils and the spinal cord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen and ileum of ovine and caprine animals of all ages.The age specified in (i) for the removal of the bovine vertebral column may be adjusted by amending this Regulation in the light of the statistical probability of the occurrence of BSE in the relevant age groups of the Community's bovine population, based on the results of BSE monitoring as established by Chapter A.I of Annex III. 2. By way of derogation from point 1 (i), a decision may be taken in accordance with the procedure referred to in Article 24(2) to allow the use of the vertebral column and dorsal root ganglia from bovine animals: (a)born, continuously reared and slaughtered in Member States for which a scientific evaluation established that the occurrence of BSE in native bovine animals is highly unlikely, or unlikely but not excluded; or (b)born after the date of effective enforcement of the prohibition on the feeding of mammalian protein to ruminants in Member States with reported BSE in native animals or for which a scientific evaluation established that the occurrence of BSE in native bovine animals is likely. Member States may apply for this derogation by submitting conclusive supporting evidence to the Commission regarding point (a) or (b), as appropriate. Member States benefiting from this derogation shall, in addition to the requirements laid down in Annex III, Chapter A, Section I, ensure that one of the approved rapid tests listed in Annex X, Chapter C, point 4, is applied to all bovine animals over 30 months of age which: (i)have died on the farm or in transport, but which have not been slaughtered for human consumption, with the exception of those dead animals in remote areas with a low animal density situated in Member States where the occurrence of BSE is unlikely; (ii)were subject to normal slaughter for human consumption.Experts from the Commission may carry out on-the-spot checks to further verify the submitted evidence in accordance with Article 21. 3. Bones of bovine, ovine and caprine animals shall not be used for the production of mechanically recovered meat. 4. Laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity after stunning shall not be carried out on bovine, ovine or caprine animals whose meat is intended for human or animal consumption. 5. Specified risk material shall be removed at: (a)slaughterhouses, or, as appropriate, other places of slaughter; (b)cutting plants, in the case of vertebral column of bovine animals; (c)where appropriate, in intermediate plants referred to in Regulation (EC) No 1774/2002 of the European Parliament and of the CouncilOJ L 273, 10.10.2002, p. 1., Article 10 or users and collection centres authorised and registered pursuant to Regulation (EC) No 1774/2002, Article 23(2)(c)(iv), (vi) and (vii). The above provisions shall not apply to category 1 material for feeding of necrophagous birds in accordance with Article 23(2)(d) of Regulation (EC) No 1774/2002. 6. Tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone. 7. Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat with central nervous system tissue. The system shall include at least the following provisions: harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline, where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling, head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or after slaughter, or which are otherwise damaged in a way which might result in contamination of the head with central nervous tissue, head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent, without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during the harvesting, in particular in the case when the seal referred to in the second indent is lost or the eyes damaged during the activity, a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. 8. By way of derogation from the requirements of point 7, Member States may decide to apply at the slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. Member States using this derogation shall inform the Commission and the other Member States in the framework of the Standing Committee of the Food Chain and Animal Health of their control system and the results of the sampling. 9. The provisions of point 7 and 8 shall not apply to the harvesting of the tongue in accordance with point 6 nor to the harvesting of cheek meat in the slaughterhouse if performed without removing the bovine head from the conveyor or hooks. 10. By way of derogation from point 5 and 7, Member States may decide to allow: (a)removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this purpose; (b)removal of vertebral column from carcases or parts of carcases in butcher shops specifically authorised, monitored and registered for this purpose; (c)harvesting of head meat from bovine in cutting plants specifically authorised for this purpose in accordance with the following provisions: bovine heads intended for transport to cutting plants specifically authorised for the harvesting of head meat, shall comply with the following provisions: the heads shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the specifically authorised cutting plant, the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling, the heads which have not been properly sealed in accordance with the second indent, where the eyes are damaged or lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue shall be excluded from transport to the specifically authorised cutting plants, a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify the proper implementation of the measures to reduce contamination; the harvesting of head meat from bovine heads in cutting plants specifically authorised for this purpose shall be in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least: all heads shall be visually controlled for signs of contamination or damage and proper sealing before the commencement of the harvesting of the head meat, head meat shall not be harvested from heads which have not been properly sealed, where the eyes are damaged or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue. Head meat shall also not be harvested from any head where contamination from such heads is suspected, without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during transport and harvesting, in particular where the seal is lost or the eyes damaged during the activity, a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. 11. All specified risk material shall be stained with a dye or, as appropriate, marked immediately on removal, and disposed of in accordance with the provisions laid down in Regulation (EC) No 1774/2002, and in particular Article 4(2). 12. Member States shall carry out frequent official inspections to verify the correct application of this part and shall ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants or other places where specified risk material is removed, such as butcher shops or establishments referred in point 5(c).Member States shall in particular set up a system to ensure and check that: (a)specified risk material used for purposes authorised pursuant to Article 1(2) and to Regulation (EC) No 1774/2002 are used solely for authorised purposes; (b)specified risk material is disposed of in accordance with Regulation (EC) No 1774/2002. 13. Member States may decide to allow dispatch of heads or of un-split carcases containing specified risk material to another Member State, only after that other Member State has agreed to receive the material and has approved the specific dispatching conditions applicable to such transport.However, carcases, half carcases or half carcases cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported from a third country into a Member State, or may be dispatched to another Member State without the latter's prior agreement.Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing specified risk materials shall be prohibited. 14. A control system shall be put in place for the removal of the vertebral column as specified in point 1(a)(i). The system shall include at least the following measures: (a)when removal of the vertebral column is not required, carcases or wholesale cuts of carcases of bovine animals containing vertebral column, shall be identified by a blue stripe on the label referred to in Regulation (EC) No 1760/2000; (b)a specific indication of the number of bovine carcases or wholesale cuts of carcases, from which removal of the vertebral column is required and from which removal of the vertebral column is not required, shall be added to the commercial document referred to in Article 3(1)(A)(f)(ii) of Directive 64/433/EEC or to the document referred to in Article 1(2) of Commission Decision 93/13/EECOJ L 9, 15.1.1993, p. 3., as applicable; (c)butcher shops shall keep, for at least one year, the commercial documents referred to in (b). 15. (a)The products of animal origin listed below shall be subject to the conditions laid down in (b) on import into the Community: the specified risk material referred to in point 1(a), fresh meat: the meat defined by Directive 64/433/EEC, minced meat and meat preparations: the minced meat and meat preparations defined by Directive 94/65/ECCouncil Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations (OJ L 368, 31.12.1994, p. 10)., meat products: the meat products defined by Directive 77/99/EECCouncil Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat products (OJ L 26, 31.1.1977, p. 85). Directive as last amended by Council Directive 97/76/EC (OJ L 10, 16.1.1998, p. 25)., other products of animal origin: other products of animal origin as defined by Directive 77/99/EEC, rendered fats as referred to in Regulation (EC) No 1774/2002, gelatine as referred to by Directive 92/118/EEC and Regulation (EC) No 1774/2002, pet food as referred to in Regulation (EC) No 1774/2002, blood products as referred to in Regulation (EC) No 1774/2002 the processed animal protein referred to in Regulation (EC) No 1774/2002, bones and bone products as referred to in Regulation (EC) No 774/2002, category 3 material as referred to in Regulation (EC) No 1774/2002.Any reference to "products of animal origin" designates products of animal origin listed in this point and does not concern other products of animal origin containing or derived from those products of animal origin. (b)When the abovementioned products of animal origin, containing material from bovine, ovine or caprine animals are imported into the Community from third countries or regions thereof, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: "This product does not contain and is not derived from: eitherDelete one of these as appropriate." specified risk material as defined in Annex XI, section A, to Regulation (EC) No 999/2001 produced after 31 March 2001, or mechanically recovered meat obtained from bones of bovine, ovine or caprine animals produced after 31 March 2001. After 31 March 2001 the bovine, ovine and caprine animals, from which this product is derived, have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity. Carcases, half carcases and quarter carcases may contain vertebral column on import; or (1) bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in the following countries: Argentina Australia Iceland Nouvelle Calédonie New-Zealand Panama Paraguay Singapore Uruguay Vanuatu.
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Delete one of these as appropriate."
B.Concerning statistical surveys 1. The statistical survey referred to in Article 22 must cover: the animals sampled pursuant to the provisions of Annex III, Chapter A, Section I, points 2.1 and 4.1, all the animals in the subpopulation referred to in Annex III, Chapter A, Section I, point 3, instead of a random sample. This provision, applicable for a period of one year, may be reviewed in the light of experience gained in the first six months. 2. Sweden may decide to derogate from the provisions of point 1, second indent, in remote areas with low animal density. C.Concerning prohibitions on animal feeding Council Decision 2000/766/EC concerning certain protection measures with regard to transmissible spongiform encephalopathies and the feeding of animal protein, and Commission Decision 2001/9/EC concerning control measures required for the implementation of Council Decision 2000/766/EC, remain in force.A decision may be taken in accordance with the procedure referred to in Article 24(2) to adapt Decision 2000/766/EC to the situation of each Member State in the light of the results of Commission inspections and the incidence of BSE, based on the results of BSE monitoring, with particular reference to testing of bovine animals, as established by Annex III. D.Concerning placing on the market and export 1. The following provisions remain in force as transitional measures: Commission Decision 92/290/EEC of 14 May 1992 concerning certain protection measures relating to bovine embryos in respect of bovine spongiform encephalopathy (BSE) in the United Kingdom. Council Decision 98/256/EC of 16 March 1998 concerning emergency measures to protect against bovine spongiform encephalopathy, amending Decision 94/474/EC and repealing Decision 96/239/EC. Commission Decision 98/351/EC of 29 May 1998 setting the date on which dispatch from Northern Ireland of bovine products under the Export Certified Herds Scheme may commence by virtue of Article 6(5) of Council Decision 98/256/EC. Commission Decision 1999/514/EC of 23 July 1999 setting the date on which dispatch from the United Kingdom of bovine products under the date-based export scheme may commence by virtue of Article 6(5) of Council Decision 98/256/EC. Commission Decision 2000/345/EC of 22 May 2000 setting the date on which dispatch from Portugal to Germany of certain products for the purpose of incineration may commence by virtue of Article 3(6) of Decision 98/653/EC. Commission Decision 2000/371/EC of 6 June 2000 setting the date on which dispatch of fighting bulls from Portugal to France may commence by virtue of Article 3(7) of Decision 98/653/EC. Commission Decision 2000/372/EC of 6 June 2000 setting the date on which dispatch of fighting bulls from Portugal to Spain may commence by virtue of Article 3(7) of Decision 98/653/EC. Commission Decision 2001/376/EC of 18 April 2001 concerning measures made necessary by the occurrence of bovine spongiform encephalopathy in Portugal and implementing a date-based export scheme. 2. Imports of bovine animals are to be subject to the presentation of an international animal health certificate attesting that: (a)the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; (b)the bovine animals intended for export to the Community are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspected females. 3. Point 2 shall not apply to imports of bovine animals born and continuously reared in the following countries: Argentina Australia Iceland Nouvelle Calédonie New-Zealand Panama Paraguay Singapore Uruguay Vanuatu. 4. Points 2 and 3 shall not apply to imports of bovine animals born and continuously reared in the following countries and to imports of embryos and ova derived from such animals: Argentina Australia Botswana Brazil Chile Costa Rica El Salvador Namibia New Zealand Nicaragua Panama Paraguay Uruguay Singapore Swaziland. 4. (a)When the farmed game meat defined by Council Directive 91/495/EECOJ L 268 24.9.1991, p. 41., meat preparations defined by Council Directive 94/65/ECOJ L 368, 31.12.1994, p. 10., and meat products defined by Council Directive 77/99/EECOJ L 26, 31.1.1977, p. 85., derived from farmed cervid animals, are imported into the Community from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: "This product contains or is derived exclusively from meat, excluding offal and spinal cord, of cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authority with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected." (b)When game meat as defined by Council Directive 92/45/EECOJ L 268, 14.9.1992, p. 35., meat preparations defined by Council Directive 94/65/EC, and meat products defined by Council Directive 77/99/EEC, derived from wild cervid animals, is imported into the Community from Canada or the United States of America, the health certificate shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: "This product contains or is derived exclusively from meat, excluding offal and spinal cord, of cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authority with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected." 5. (a)Without prejudice to Commission Decision 2005/598/EC the United Kingdom shall ensure that bovine animals born or reared on its territory before 1 August 1996 are not dispatched from its territory to other Member States or third countries. (b)The United Kingdom shall ensure that no meat and products derived from bovine animals born or reared in the United Kingdom after 31 July 1996 and slaughtered before 15 June 2005 are dispatched from its territory to other Member States and third countries. (c)The United Kingdom shall ensure that vertebral column from bovine animals born or reared in the United Kingdom after 31 July 1996 and slaughtered before the coming into force of this Regulation and products derived from such vertebral column shall not be dispatched from its territory to other Member States or third countries.