(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/ACT, 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
- Commission Regulation (EU) No 1148/2014of 28 October 2014amending Annexes II, VII, VIII, IX 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), 32014R1148, October 29, 2014
- Commission Regulation (EU) 2015/728of 6 May 2015amending the definition of specified risk material set out in 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), 32015R0728, May 7, 2015
- Commission Regulation (EU) 2015/1162of 15 July 2015amending 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), 32015R1162, July 16, 2015
- Commission Regulation (EU) 2016/27of 13 January 2016amending Annexes III 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, 32016R0027, January 14, 2016
- Commission Regulation (EU) 2016/1396of 18 August 2016amending certain Annexes to Regulation (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), 32016R1396, August 19, 2016
- Commission Regulation (EU) 2017/110of 23 January 2017amending Annexes IV 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), 32017R0110, January 24, 2017
- Commission Implementing Regulation (EU) 2017/736of 26 April 2017amending Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the approval of Slovenia's national control programme for classical scrapie(Text with EEA relevance), 32017R0736, April 27, 2017
- Commission Regulation (EU) 2017/893of 24 May 2017amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annexes X, XIV and XV to Commission Regulation (EU) No 142/2011 as regards the provisions on processed animal protein(Text with EEA relevance), 32017R0893, May 25, 2017
- Commission Regulation (EU) 2017/894of 24 May 2017amending Annexes III and VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the genotyping of ovine animals(Text with EEA relevance), 32017R0894, May 25, 2017
- Commission Regulation (EU) 2017/1972of 30 October 2017amending Annexes I and III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards a surveillance programme for chronic wasting disease in cervids in Estonia, Finland, Latvia, Lithuania, Poland and Sweden and repealing Commission Decision 2007/182/EC(Text with EEA relevance), 32017R1972, October 31, 2017
- Commission Regulation (EU) 2018/221of 15 February 2018amending Regulation (EC) No 999/2001 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the European Union reference laboratory for transmissible spongiform encephalopathies(Text with EEA relevance), 32018R0221, February 16, 2018
- Commission Regulation (EU) 2018/969of 9 July 2018amending Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the requirements for the removal of specified risk materials from small ruminants(Text with EEA relevance), 32018R0969, July 10, 2018
- Commission Regulation (EU) 2019/319of 6 February 2019amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annex XV to Commission Regulation (EU) No 142/2011 as regards health certification at import into the Union concerning transmissible spongiform encephalopathies(Text with EEA relevance), 32019R0319, February 28, 2019
- Commission Regulation (EU) 2019/1091of 26 June 2019amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the requirements for export of products containing processed animal protein derived from ruminants and non-ruminants(Text with EEA relevance), 32019R1091, June 27, 2019
(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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