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(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.
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
- Council Regulation (EU) No 517/2013of 13 May 2013adapting certain regulations and decisions in the fields of free movement of goods, freedom of movement for persons, company law, competition policy, agriculture, food safety, veterinary and phytosanitary policy, transport policy, energy, taxation, statistics, trans-European networks, judiciary and fundamental rights, justice, freedom and security, environment, customs union, external relations, foreign, security and defence policy and institutions, by reason of the accession of the Republic of Croatia, 32013R0517, June 10, 2013
- Commission Regulation (EU) No 630/2013of 28 June 2013amending the Annexes 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), 32013R0630, June 29, 2013
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(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/EEC Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (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 ).Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (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.
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negligible BSE risk as defined in Annex II, controlled BSE risk as defined in Annex II, undetermined BSE risk as defined in Annex II.
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(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).
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(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.
(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.
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(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.
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(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.
(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.
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(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;
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(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);
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(e) Directive 2006/88/EC: -
(i) "aquaculture animal" in Article 3(1)(b); (ii) "aquatic animal" in Article 3(1)(e).
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(a) "BSE indigenous case" 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) "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;
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(c) "index case" means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed; (d) "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; (e) "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 European Union reference laboratory’s technical handbook on TSE strain characterisation in small ruminants http://vla.defra.gov.uk/science/docs/sci_tse_rl_handbookv4jan10.pdf (f) "classical scrapie case" means a scrapie confirmed case classified as classical in accordance with the criteria laid down in the European Union reference laboratory’s technical handbook on TSE strain characterisation in small ruminants; (g) "atypical scrapie case" means a scrapie confirmed case which is distinguishable from classical scrapie in accordance with the criteria laid down in the European Union reference laboratory’s technical handbook on TSE strain characterisation in small ruminants; (h) "Prion protein genotype" in ovine animals means a combination of two alleles as described in point 1 of Annex I to Commission Decision 2002/1003/EC OJ L 349, 24.12.2002, p. 105 .(i) "BSE case" means a case of BSE confirmed in a national reference laboratory according to the methods and protocols in point 3.1.(a) and (b) of Chapter C of Annex X; (j) "classical BSE case" means a BSE case classified as such in accordance with the criteria laid down in the European Union reference laboratory’s method for the classification of bovine TSE isolates http://vla.defra.gov.uk/science/docs/sci_tse_rl_2blot.pdf (k) "atypical BSE case" means a BSE case which cannot be classified as a classical BSE case in accordance with the criteria laid down in the European Union reference laboratory’s method for the classification of bovine TSE isolates; (l) "ovine and caprine animals over 18 months of age" means ovine and caprine animals: -
(i) whose age is confirmed by the registers or movement documents referred to in point 1(b), (c) and (d) of Article 3 of Council Regulation (EC) No 21/2004 OJ L 5, 9.1.2004, p. 8 . (ii) which have more than two permanent incisors erupted through the gum.
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(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.
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(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.
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(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.
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(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;
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(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.
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(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;
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(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.
-
-
-
-
(a) Type A surveillance The application of Type A surveillance will allow the detection of BSE at a design prevalence Design 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. 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.
-
| Surveillance sub-population | |||
|---|---|---|---|
| Routine slaughter |
Fallen stock |
Casualty slaughter |
Clinical suspect |
| Age ≥ 1 year and < 2 years | |||
| N/A | |||
| Age ≥ 2 years and < 4 years (young adult) | |||
| Age ≥ 4 years and < 7 years (middle adult) | |||
| Age ≥ 7 years and < 9 years (older adult) | |||
| Age ≥ 9 years (aged) | |||
| Points targets for countries or regions | ||
|---|---|---|
| Type A surveillance | Type B surveillance | |
| ≥ |
||
-
emergency slaughter in accordance with point 1 of Chapter VI of Section I of Annex III to Regulation (EC) No 853/2004 OJ L 139, 30.4.2004, p. 55 . an ante mortem inspection with observations concerning accidents, or serious physiological and functional problems, or signs in accordance with point 2 of Part B of Chapter II of Section I of Annex I to Regulation (EC) No 854/2004 OJ L 139, 30.4.2004, p. 206 .
-
killed for destruction pursuant to Commission Regulation (EC) No 716/96 OJ L 99, 20.4.1996, p. 14 . killed in the framework of an epidemic, such as foot-and-mouth disease, slaughtered for human consumption,
-
(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 Council OJ 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.
-
(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.
-
50 % of its minimum sample size of ovine and caprine animals slaughtered for human consumption set out in points (a) and (b) 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; 10 % of its minimum sample size set out in points (a) and (b) 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.
-
killed in the framework of a disease eradication campaign, or slaughtered for human consumption.
| Member State population of ewes and ewe lambs put to the ram | Minimum sample size of dead ovine animals |
|---|---|
| > |
|
| 100 % up to 500 | |
| < |
100 % up to 100 |
| Member State population of goats which have already kidded and goats mated | Minimum sample size of dead caprine animals |
|---|---|
| > |
|
| 100 % up to 500 | |
| < |
100 % up to 100 |
| Number of animals over 18 months of age killed for destruction in the herd or flock | Minimum sample size |
|---|---|
| 70 or less | All eligible animals |
| 500 or more |
-
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.
-
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.
-
(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).
-
-
(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.
-
-
(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).
-
(a) fishmeal; (b) dicalcium and tricalcium phosphate of animal origin; (c) blood products derived from non-ruminants.
-
(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 152/2009 OJ L 54, 26.2.2009, p. 1 .
-
(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.
-
(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).
-
(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).
-
(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".
-
(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".
-
(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".
-
(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.
-
(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.
-
(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.
-
(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.
-
(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.
-
(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.
-
(a) fishmeal and compound feed containing fishmeal; (b) compound feed intended for aquaculture animals; (c) petfood.
-
(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.
-
-
(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.
-
(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.
-
(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.
-
(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.
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(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;
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(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.
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(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 136/2004 OJ L 21, 28.1.2004, p. 11 .(c) butcher shops shall keep, for at least one year, the commercial documents referred to in (b).
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(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 a period of two years prior to, or after, the 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;
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(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.
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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 of 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.
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2.2. In the case of confirmation of TSE in an ovine or caprine animal: -
2.2.1. In cases where BSE cannot be excluded If BSE cannot be excluded after the results of a ring trial carried out in accordance with the methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2(c), the killing and complete destruction, without delay, of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b). The animals over 18 months of age killed for destruction shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. The prion protein genotype of all ovine animals, up to a maximum of 50, shall be determined. 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 disposed of in accordance with Article 12 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council OJ L 300, 14.11.2009, p. 1 .Following the killing and complete destruction of all animals, the conditions set out in point 3 shall apply to the holding. 2.2.2. In cases where BSE and atypical scrapie can be excluded If BSE and atypical scrapie are excluded in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2(c), the holding shall be subject to the conditions set out in point (a) and, pursuant to the decision of the Member State responsible for the holding, to the conditions of either option 1 set out at point (b), or option 2 set out at point (c), or option 3 set out at point (d): -
(a) The milk and milk products derived from the animals to be destroyed or slaughtered and which were present on the holding between the date of confirmation of the case of TSE and the date of the completion of the measures to be applied in the holding as laid down in point (b) and (c), or derived from the infected flock/herd until all the restrictions laid down in point (d) and point 4 are lifted, 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 milk and milk products as feed for non-ruminants shall be limited to the territory of the Member State responsible for the holding. The commercial document accompanying consignments of such milk and milk products and any packaging containing such consignments shall be clearly marked with the words: "shall not be fed to ruminants". The use and the storage of feedingstuffs containing such milk and milk products shall be prohibited on holdings where ruminants are kept. Bulk feedingstuffs containing such milk and milk products shall be transported by means of vehicles which do not transport feedingstuffs for ruminants at the same time. If those 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 Member State responsible for the holding. (b) Option 1 — killing and complete destruction of all animals The killing and complete destruction, without delay, of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). The animals over 18 months of age killed for destruction shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. The prion protein genotype of all ovine animals, up to a maximum of 50, shall be determined. By way of derogation from the conditions set out in the first paragraph of option 1, Member States may decide instead to carry out the measures listed in (i) or (ii): -
(i) to replace the killing and complete destruction of all animals, without delay, by their slaughtering for human consumption, without delay, provided that: -
the animals are slaughtered for human consumption within the territory of the Member State responsible for the holding; all animals which are over 18 months of age slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.
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(ii) to exempt the lambs and kids less than three months old from killing and complete destruction without delay, provided that they are slaughtered for human consumption not later than when they are three months of age.
Pending the killing and complete destruction or slaughtering for human consumption of all animals, the measures set out in point 2.2.2.(a) and point 3.4.(b) third and fourth indents shall apply on the holding where it has been decided to apply option 1. Following the killing and complete destruction or slaughtering for human consumption of all animals the conditions set out in point 3 shall apply to the holding where it has been decided to apply option 1. -
(c) Option 2 — killing and complete destruction of the susceptible animals only The prion protein genotyping of all ovine animals present on the holding followed by the killing and complete destruction, without delay, 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, ovine animals carrying at least one ARR allele which are intended solely for slaughter for human consumption, if the Member State responsible for the holding so decides, lambs and kids less than three months old provided that they are slaughtered for human consumption not later than when they are three months of age. These lambs and kids shall be exempted from the genotyping.
The animals over 18 months of age killed for destruction shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. By way of derogation from the conditions set out in the first paragraph of option 2, Member States may decide instead to carry out the measures listed in (i), (ii) and (iii): -
(i) to replace the killing and complete destruction of the animals referred to in the first paragraph of option 2 by their slaughtering for human consumption, provided that: -
the animals are slaughtered for human consumption within the territory of the Member State responsible for the holding; all animals which are over 18 months of age slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.
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(ii) to delay the genotyping and subsequent killing and complete destruction or slaughtering for human consumption of the animals referred to in the first paragraph of option 2 for a period not exceeding three months in situations where the index case is confirmed close to the commencement of the lambing season, provided that the ewes, goats and their new-born are kept isolated from ovine and caprine animals of other holdings during the whole period; (iii) to delay the killing and complete destruction or slaughtering for human consumption of the animals referred to in the first paragraph of option 2 for a maximum period of three years from the date of confirmation of the index case, in ovine flocks and holdings where ovine and caprine animals are kept together. The application of the derogation set out in the present paragraph shall be limited to cases where the Member State responsible for the holding considers that the epidemiological situation cannot be handled without killing the relevant animals, but that this cannot be carried out immediately due to the low level of resistance in the ovine population of the holding coupled with other considerations, including economic factors. Breeding rams other than those of the ARR/ARR genotype shall be killed or castrated without delay and all possible measures to quickly build up genetic resistance in the ovine population of the holding, including by reasoned breeding and culling of ewes to increase the frequency of the ARR allele and eliminate the VRQ allele, shall be implemented. The Member State responsible for the holding shall ensure that the number of animals to be killed at the end of the period of delay is not greater than immediately after the index case was confirmed.
Pending the killing and complete destruction or slaughtering for human consumption of the animals referred to in the first paragraph of option 2, the following measures shall apply on the holding where it has been decided to apply option 2: point 2.2.2.(a), point 3.1., point 3.2.(a) and (b), point 3.3. and point 3.4.(a) first and second indents, (b) first, third and fourth indents, and (c). However, where the Member State responsible for the holding decides to delay the killing and complete destruction or slaughtering for human consumption of the animals in accordance with point (iii), the following measures shall instead apply on the holding: point 2.2.2.(a) and points 4.1. to 4.6. Following the killing and complete destruction, or slaughtering for human consumption of the animals referred to in the first paragraph of option 2 the conditions set out in point 3 shall apply to the holding where it has been decided to apply option 2. -
(d) Option 3 — no mandatory killing and complete destruction of animals A Member State may decide not to kill and completely destroy the animals identified by the inquiry referred to in the second and third indents of point 1(b) where the criteria laid down in at least one of the following four indents are met: -
it is difficult to obtain replacement ovine animals of genotypes allowed under point 3.2.(a) and (b), the frequency of the ARR allele within the breed or holding is low, it is deemed necessary in order to avoid inbreeding, it is deemed necessary by the Member State based on a reasoned consideration of all the epidemiological factors.
The Member States allowing recourse to option 3 in the management of classical scrapie outbreaks shall keep records of the reasons and criteria founding each individual application decision. When additional classical scrapie cases are detected in a holding where option 3 is being applied, the relevance of the reasons and criteria founding the decision to apply option 3 to this holding shall be reassessed by the Member State. If it is concluded that applying option 3 does not ensure a proper control of the outbreak, the Member State shall switch the management of this holding from option 3 to either option 1 or option 2, as laid down in points (b) and (c). The prion protein genotype of all ovine animals, up to a maximum of 50, shall be determined within a period of three months from the date of confirmation of the index case of classical scrapie. The conditions set out in point 2.2.2.(a) and point 4 shall immediately apply to a holding where it has been decided to apply option 3. -
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2.2.3. In cases where atypical scrapie is confirmed Where the TSE case confirmed on a holding is an atypical scrapie case, the holding shall be subject to the following intensified TSE monitoring protocol for a period of two years from the date of the detection of the last atypical scrapie case: 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 months which have died or been killed on the holding shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2. If a case of TSE other than atypical scrapie is confirmed during the intensified TSE monitoring period of two years referred to in the first paragraph, the holding shall be subject to the measures referred to in point 2.2.1 or point 2.2.2.
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2.3. If an animal infected with TSE has been introduced from another holding: -
(a) a Member State may decide, based on the history of the infected animal, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed; (b) in the case of land used for common grazing by more than one flock or herd, Member States may decide to limit the application of eradication measures to a single flock or herd, based on a reasoned consideration of all the epidemiological factors; (c) where more than one flock or herd is kept on a single holding, Member States may decide to limit the application of the eradication measures to the flock or herd in which the TSE has been confirmed, provided it has been verified that the flocks or herds have been kept isolated from each other and that the spread of infection between the flocks or herds through either direct or indirect contact is unlikely.
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3.1. The holding shall be subjected to an intensified TSE monitoring protocol including the testing for the presence of TSE, in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype: -
(a) animals which were kept in the holding at the time when the TSE case was confirmed, in accordance with point 2.2.2.(c), and which have been slaughtered for human consumption; (b) animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.
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3.2. Only the following animals may be introduced to the holding: -
(a) male ovine animals of the ARR/ARR genotype; (b) female ovine animals carrying at least one ARR allele and no VRQ allele; (c) caprine animals, provided that a cleaning and disinfection of all animal housing on the premises has been carried out following destocking.
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3.3. Only the following breeding rams and ovine germinal products may be used in the holding: -
(a) male ovine animals of the ARR/ARR genotype; (b) semen from rams of the ARR/ARR genotype; (c) embryos carrying at least one ARR allele and no VRQ allele.
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3.4. Movement of animals from the holding shall either be allowed for the purposes of destruction, or shall be subject to the following conditions: -
(a) the following animals may be moved from the holding for all purposes, including breeding: -
ARR/ARR ovine animals; ewes carrying one ARR allele and no VRQ allele, provided that they are moved to other holdings which are restricted following the application of measures in accordance with point 2.2.2.(c) or 2.2.2.(d); caprine animals, provided that they are moved to other holdings which are restricted following the application of measures in accordance with point 2.2.2.(c) or 2.2.2.(d);
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(b) the following animals may be moved from the holding to go directly for slaughter for human consumption: -
ovine animals carrying at least one ARR allele; caprine animals; if the Member State so decides, lambs and kids less than three months old on the date of slaughter; all animals when the Member State has decided to apply the derogations laid down in point 2.2.2.(b)(i) and point 2.2.2.(c)(i);
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(c) if the Member State so decides, lambs and kids may be moved to one other holding located within its territory solely for the purposes of fattening prior to slaughter subject to compliance with the following conditions: -
the holding of destination does not contain any ovine or caprine animals other than those being fattened prior to slaughter; at the end of the fattening period, the lambs and kids originating from the holdings subject to the eradication measures shall be transported directly to a slaughterhouse located within the territory of the same Member State to be slaughtered not later than when they are 12 months of age.
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3.5. The restrictions set out in points 3.1 to 3.4 shall continue to apply to the holding: -
(a) until the date of attainment of ARR/ARR status by all ovine animals on the holding, provided that no caprine animals are kept on the holding; or (b) for a period of two years from the date when all the measures referred to in point 2.2.1., point 2.2.2.(b) or point 2.2.2.(c) have been completed, provided that no TSE case other than atypical scrapie is detected during this two-year period. If a case of atypical scrapie is confirmed during this two-year period the holding shall also be subject to the measures referred to in point 2.2.3.
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4.1. The holding shall be subjected to an intensified TSE monitoring protocol including the testing for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype: -
(a) animals which have been slaughtered for human consumption; (b) animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.
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4.2. Only the following ovine animals may be introduced to the holding: -
(a) male ovine animals of the ARR/ARR genotype; (b) female ovine animals carrying at least one ARR allele and no VRQ allele. However, by way of derogation from points (a) and (b), a Member State may allow the animals referred to in points (c) and (d) to be introduced to the holding where the breed reared in the holding is listed by the Member State as a local breed in danger of being lost to farming in accordance with Annex IV to Commission Regulation (EC) No 1974/2006 OJ L 368, 23.12.2006, p. 15 .(c) male ovine animals carrying at least one ARR allele and no VRQ allele; (d) female ovine animals carrying no VRQ allele.
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4.3. Only the following breeding rams and ovine germinal products may be used in the holding: -
(a) male ovine animals of the ARR/ARR genotype; (b) semen from rams of the ARR/ARR genotype; (c) embryos carrying at least one ARR allele and no VRQ allele. However, by way of derogation from points (a), (b) and (c), a Member State may allow the breeding rams and ovine germinal products referred to in points (d), (e) and (f) to be used in the holding where the breed reared in the holding is listed by the Member State as a local breed in danger of being lost to farming in accordance with Annex IV to Commission Regulation (EC) No 1974/2006, and where the frequency of the ARR allele within the breed is low: (d) male ovine animals carrying at least one ARR allele and no VRQ allele; (e) semen from male ovine animals carrying at least one ARR allele and no VRQ allele; (f) embryos carrying no VRQ allele.
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4.4. Movement of animals from the holding shall be allowed for the purposes of destruction, or shall be subject to the following conditions: -
(a) rams and ewes of the ARR/ARR genotype may be moved from the holding for all purposes, including breeding, provided that they are moved to other holdings which are subject to the application of measures in accordance with point 2.2.2.(c) or 2.2.2.(d); (b) the following animals may be moved from the holding to go directly for slaughter for human consumption: -
either ovine animals carrying at least one ARR allele and, if the Member State so decides, lambs and kids less than three months old on the date of slaughter; or all animals when the Member State has decided to apply the derogation from option 2 laid down in point 2.2.2.(c)(iii) or option 3 laid down in point 2.2.2.(d).
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(c) if the Member State so decides, lambs and kids may be moved to one other holding located within its territory solely for the purposes of fattening prior to slaughter subject to compliance with the following conditions: -
the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter; at the end of the fattening period, the lambs and kids originating from the holdings subject to the eradication measures shall be transported directly to a slaughterhouse located within the territory of the same Member State to be slaughtered not later than when they are 12 months of age.
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4.5. Movement of germinal products from the holding shall be subject to the following conditions: the Member State shall ensure that no semen, embryo and ova are dispatched from the holding. 4.6. Common grazing of all ovine and caprine animals in the holding with ovine and caprine animals of other holdings shall be prohibited during the lambing and kidding period. Outside of the lambing and kidding period, common grazing shall be subject to restrictions to be determined by the Member State, based on a reasoned consideration of all the epidemiological factors. 4.7. The restrictions set out in point 2.2.2.(a) and in points 4.1 to 4.6 shall continue to apply for a period of two years following the detection of the last TSE case, other than atypical scrapie, on the holdings where option 3 laid down in point 2.2.2.(d) has been implemented. If a case of atypical scrapie is confirmed during this two-year period the holding shall also be subject to the measures referred to in point 2.2.3. In holdings where the derogation from option 2 provided for in point 2.2.2.(c)(iii) has been implemented, the restrictions set out in point 2.2.2.(a) and in points 4.1 to 4.6 shall apply until the complete destruction or slaughtering for human consumption of the animals identified for killing in accordance with point 2.2.2.(c), after which the restrictions laid out in point 3 shall be applicable.
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(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, including breeding rams sampled in flocks not participating in the breeding programme; (c) the results of any genotyping tests.
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(a) frequencies of the different alleles within the breed; (b) rarity of the breed; (c) avoidance of inbreeding or genetic drift.
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(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 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.
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(a) level I flocks shall be flocks composed entirely of ovine animals 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.
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(a) on the holding 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.
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1. notify to the Commission the requirements for such programmes; 2. submit to the Commission an annual report on their progress.
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(a) ovine and caprine animals are permanently identified and records are maintained, to enable them to be traced back to their holding of birth; (b) records of movements of ovine and caprine animals in and out of the holding are maintained; (c) only the following ovine and caprine animals may be introduced: -
(i) ovine and caprine animals from holdings with a negligible risk of classical scrapie; (ii) ovine and caprine animals from holdings which have met the conditions laid down in points (a) to (i) for a minimum of seven years or for at least the same period of time as the holding where they are to be introduced; (iii) ovine animals of the ARR/ARR prion protein genotype.
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(d) the holding is subject to regular checks to verify compliance with the provisions set out in point (a) to (i) by an official veterinarian or a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an annual basis from 1 January 2014 ;(e) no case of classical scrapie has been confirmed; (f) all ovine and caprine animals over 18 months of age slaughtered for human consumption are inspected by an official veterinarian, and all those exhibiting wasting signs, neurological signs or sent for emergency slaughter are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2. Until 31 December 2013 , all ovine and caprine animals referred to in Annex III, Chapter A, Part II, point 3 over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.From 1 January 2014 , all ovine and caprine animals over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption shall be tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.By way of derogation from the conditions set out in the second and third paragraphs of point (f), Member States may decide to apply the provisions of the first paragraph of point (f) to the ovine and caprine animals over 18 months of age with no commercial value culled at the end of their productive life instead of being slaughtered for human consumption.
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(g) only the following ovine and caprine embryos/oocytes may be introduced: -
(i) embryos/oocytes from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which meet the following requirements: -
they are permanently identified to enable trace back to their holding of birth; they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency; they showed no clinical sign of classical scrapie at the time of embryo/oocyte collection;
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(ii) ovine embryos/oocytes of the ARR/ARR prion protein genotype.
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(h) only the following ovine and caprine semen may be introduced: -
(i) semen from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible risk or a controlled risk of classical scrapie, or which meet the following requirements: -
they are permanently identified to enable trace back to their holding of birth; they showed no clinical sign of classical scrapie at the time of semen collection;
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(ii) ovine semen from a ram of the ARR/ARR prion protein genotype;
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(i) ovine and caprine animals on the holding have no direct or indirect contact, including sharing grazing, with ovine and caprine animals from holdings of a lower status.
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(a) ovine and caprine animals are permanently identified and records are maintained, to enable them to be traced back to their holding of birth; (b) records of movements of ovine and caprine animals in and out of the holding are maintained; (c) only the following ovine and caprine animals may be introduced: -
(i) ovine and caprine animals from holdings with a negligible or a controlled risk of classical scrapie; (ii) ovine and caprine animals from holdings which have met the conditions laid down in points (a) to (i) for a minimum of three years or for at least the same period of time as the holding where they are to be introduced; (iii) ovine animals of the ARR/ARR prion protein genotype.
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(d) the holding is subject to regular checks to verify compliance with the provisions set out in point (a) to (i) by an official veterinarian or a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an annual basis from 1 January 2014 ;(e) no case of classical scrapie has been confirmed; (f) all ovine and caprine animals over 18 months of age slaughtered for human consumption are inspected by an official veterinarian, and all those exhibiting wasting signs, neurological signs or sent for emergency slaughter are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2. Until 31 December 2013 , all ovine and caprine animals referred to in Annex III, Chapter A, Part II, point 3 over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.From 1 January 2014 , all ovine and caprine animals over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption shall be tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.By way of derogation from the conditions set out in the second and third paragraphs of point (f), Member States may decide to apply the provisions of the first paragraph of point (f) to the ovine and caprine animals over 18 months of age with no commercial value culled at the end of their productive life instead of being slaughtered for human consumption.
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(g) only the following ovine and caprine embryos/oocytes may be introduced: -
(i) embryos/oocytes from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible risk or with a controlled risk of classical scrapie, or which meet the following requirements: -
they are permanently identified to enable trace back to their holding of birth; they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency; they showed no clinical sign of classical scrapie at the time of embryo/oocyte collection;
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(ii) ovine embryos/oocytes of the ARR/ARR prion protein genotype.
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(h) only the following ovine and caprine semen may be introduced: -
(i) semen from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible risk or with a controlled risk of classical scrapie, or which meet the following requirements: -
they are permanently identified to enable trace back to their holding of birth; they showed no clinical sign of classical scrapie at the time of semen collection;
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(ii) ovine semen from a ram of the ARR/ARR prion protein genotype;
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(i) ovine and caprine animals of the holding have no direct or indirect contact, including sharing grazing, with ovine and caprine animals from holdings of lower status.
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(a) a risk assessment has been conducted, and it has demonstrated that appropriate measures are currently in place and have been taken for the relevant period of time to manage any risk identified. This risk assessment shall identify all potential factors for classical scrapie occurrence and their historic perspective, in particular the: -
(i) importation or introduction of ovine and caprine animals or their semen and embryos potentially infected with classical scrapie; (ii) extent of knowledge of the population structure and husbandry practices of ovine and caprine animals; (iii) feeding practices, including consumption of meat-and-bone meal or greaves derived from ruminants; (iv) importation of milk and milk products of ovine and caprine animals origin intended for use in feeding of ovine and caprine animals;
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(b) for a period of at least seven years, ovine and caprine animals displaying clinical signs compatible with classical scrapie have been tested; (c) for a period of at least seven years, a sufficient number of ovine and caprine animals over 18 months of age, representative of slaughtered, culled or found dead on farm, have been tested annually, to provide a 95 percent level of confidence of detecting classical scrapie if it is present in that population at a prevalence rate exceeding 0,1 percent and no case of classical scrapie has been reported during that period; (d) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin has been banned and effectively enforced in the whole Member State for a period of at least seven years; (e) introductions from other Member States of ovine and caprine animals and semen and embryos thereof are carried out in accordance with point 4.1.(b) or point 4.2.; (f) introductions from third countries of ovine and caprine animals and semen and embryos thereof are carried out in accordance with Chapter E or Chapter H of Annex IX.
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(a) may submit its national control programme to the Commission, outlining in particular: -
the distribution of classical scrapie in the Member State, the reasons for national control programme, taking into consideration the importance of the disease and the cost/benefit ratio, the status categories defined for holdings and the standards which must be attained in each such category, the test procedures to be used, the national control programme 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 national control programme programme are positive,
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(b) the programme referred to in point (a) 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); amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2).
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Denmark Austria Finland Sweden.
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4.1. ovine and caprine animals: -
(a) ovine and caprine animals for breeding intended for Member States other than those with a negligible risk of classical scrapie or with an approved national scrapie control programme shall: -
(i) come from a holding or holdings with a negligible risk or a controlled risk of classical scrapie; however ovine and caprine animals for breeding coming from a holding or holdings which have complied with all the requirements laid down in point 1.3. (a) to (f), for a period of at least three years may be subject to intra-Union trade until 31 December 2014 ; or (ii) come from a Member State or zone of a Member State with a negligible risk of classical scrapie; or (iii) in the case of ovine animals, be of the ARR/ARR prion protein genotype, provided they do not come from a holding subject to the restrictions laid down in Annex VII, Chapter B, points 3 and 4.
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(b) ovine and caprine animals for all intended use except immediate slaughter intended for the Member States with a negligible risk of classical scrapie or with an approved national scrapie control programme shall: -
(i) come from a holding or holdings with a negligible risk of classical scrapie; however ovine and caprine animals coming from a holding or holdings which have complied with all the requirements laid down in point 1.2. (a) to (i), for a period of at least seven years may be subject to intra-Union trade until 31 December 2014 ; or (ii) come from a Member State or zone of a Member State with a negligible risk of classical scrapie; or (iii) in the case of ovine animals, be of the ARR/ARR prion protein genotype, provided they do not come from a holding subject to the restrictions laid down in Annex VII, Chapter B, points 3 and 4.
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4.2. semen and embryos of ovine and caprine animals shall: -
(a) be collected from animals which have been kept continuously since birth on a holding or holdings with a negligible risk or a controlled risk of classical scrapie; or (b) be collected from animals which have been kept continuously for the last three years before the collection on a holding or holdings which have complied with all the requirements laid down in Part 1, point 1.3. (a) to (f) for three years; or (c) be collected from animals which have been kept continuously since birth in a country or zone with a negligible risk of classical scrapie; or (d) in the case of ovine semen, be collected from male animals of the ARR/ARR prion protein genotype; or (e) in the case of ovine embryos, be of the ARR/ARR prion protein genotype.
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fresh meat, minced meat, meat preparations, meat products.
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(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.
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(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.
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(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.
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(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.
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fresh meat, minced meat, meat preparations, meat products, rendered animal fat, greaves, gelatine and collagen other than derived from hides and skins, treated intestines.
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(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.
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(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.
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(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 andpost-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.
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(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.
-
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(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 andpost-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.
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(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 and collagen 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 and collagen derived from hides and skins; (iii) fat derivatives.
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(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, except for 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), 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).
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(c) the ovine and caprine animals from which those products are derived have been kept continuously since birth in a country where the following conditions are fulfilled: -
(i) classical scrapie is compulsorily notifiable; (ii) an awareness, surveillance and monitoring system is in place; (iii) official restrictions apply to holdings of ovine or caprine animals in case of a suspicion of TSE or a confirmation of classical scrapie; (iv) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin has been banned and effectively enforced in the whole country for a period at least seven years;
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(d) the milk and milk products of ovine or caprine animals derive from holdings where no official restriction is imposed due to a suspicion of TSE; (e) the milk and milk products of ovine or caprine animals derive from holdings where no case of classical scrapie has been diagnosed for the last seven years or, following the confirmation of a case of classical scrapie: -
(i) all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele; or (ii) all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for two years at least since the confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype: -
animals which have been slaughtered for human consumption; and animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.
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-
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1. classical scrapie is compulsorily notifiable; 2. an awareness, surveillance and monitoring system is in place; 3. ovine and caprine animals affected with classical scrapie are killed and completely destroyed; 4. the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin has been banned and effectively enforced in the whole country for a period of at least seven years;
5. For ovine and caprine animals for breeding imported into the Union and intended for Member States other than those with a negligible risk of classical scrapie or those with an approved national scrapie control programme listed in point 3.2 of Section A of Chapter A of Annex VIII, the following conditions shall be complied with: -
the imported ovine and caprine animals come from a holding or holdings that have complied with the conditions of point 1.3 of Section A of Chapter A of Annex VIII; or they are ovine animals of the ARR/ARR prion protein genotype and they come from a holding where no official movement restriction has been imposed due to BSE or classical scrapie during the last two years.
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6. For ovine and caprine animals for all uses except immediate slaughter imported into the Union and intended for a Member State with a negligible risk of classical scrapie or with an approved national scrapie control programme listed in point 3.2 of Section A of Chapter A of Annex VIII, the following conditions shall be complied with: -
they come from a holding or holdings that have complied with the conditions of point 1.2 of Section A of Chapter A of Annex VIII; or they are ovine animals of the ARR/ARR prion protein genotype and they come from a holding where no official movement restriction has been imposed due to BSE or classical scrapie during the last two years.
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1. have been kept continuously since birth in a country where the following conditions are fulfilled: -
(i) classical scrapie is compulsorily notifiable; (ii) an awareness, surveillance and monitoring system is in place; (iii) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (iv) the feeding to ovine and caprine animals of meat-and-bone meal, or greaves of ruminant origin has been banned and effectively enforced in the whole country for a period of at least seven years;
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2. have been kept continuously for the last three years before the collection of the exported semen or embryos in a holding or holdings which have been satisfying for the last three years at least all the requirements laid down in point 1.3. (a) to (f) of Section A of Chapter A of Annex VIII, or: -
(i) in the case of ovine semen, the semen has been collected from male animals of the ARR/ARR prion protein genotype. (ii) in the case of ovine embryos, the embryos are of the ARR/ARR prion protein genotype.
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(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;
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(d) is to cooperate with the Community reference laboratory.
| Austria: | |
| Belgium: | |
| Bulgaria: | |
| Cyprus: | |
| Czech Republic: | |
| Denmark: | |
| Estonia: | |
| Finland: | |
| France: | |
| Croatia | |
| Germany: | |
| Greece: | |
| Hungary: | |
| Ireland: | |
| Italy: | |
| Latvia: | |
| Lithuania: | |
| Luxembourg: | |
| Malta: | |
| Netherlands: | |
| Poland: | |
| Portugal: | |
| Romania: | |
| Slovakia: | |
| Slovenia: | |
| Spain: | |
| Sweden: | |
| United Kingdom: |
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(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;
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(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.
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(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.
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(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
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(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.
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(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.
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(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
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(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.
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(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.
(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 , orto 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.
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(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. -
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Agence Française de Sécurité Sanitaire des Aliments Laboratoire de pathologie bovine 31, avenue Tony Garnier BP 7033 F-69342 Lyon Cedex Centre CEA Fontenay-aux-Roses, BP 6 F-92265 Fontenay-aux-Roses Cedex Service de Pharmacologie et d’Immunologie Centre CEA Saclay, bâtiment 136 F-91191 Gif-sur-Yvette Cedex Veterinary Laboratories Agency Woodham Lane New Haw Addlestone Surrey KT15 3NB United Kingdom
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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 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),
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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).
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(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.
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(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.
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(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.
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(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 Council OJ L 273, 10.10.2002, p. 1 .
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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, theforamen 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.
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(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, theforamen 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;
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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.
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(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.
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(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/EEC OJ L 9, 15.1.1993, p. 3 .(c) butcher shops shall keep, for at least one year, the commercial documents referred to in (b).
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(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/EC Council 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/EEC Council 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: -
either Delete 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 after31 March 2001 . After31 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;
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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." -
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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.
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.
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(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.
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Argentina Australia Iceland Nouvelle Calédonie New-Zealand Panama Paraguay Singapore Uruguay Vanuatu.
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Argentina Australia Botswana Brazil Chile Costa Rica El Salvador Namibia New Zealand Nicaragua Panama Paraguay Uruguay Singapore Swaziland.
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(a) When the farmed game meat defined by Council Directive 91/495/EEC OJ L 268 24.9.1991, p. 41 .OJ L 368, 31.12.1994, p. 10 .OJ L 26, 31.1.1977, p. 85 ."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/EEC OJ L 268, 14.9.1992, p. 35 ."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."
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(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 before15 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.