(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, 301R1248, 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, 301R1326, 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, 302R0270, 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), 302R1494, 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), 303R0260, 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), 303R0650, 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), 303R1053, 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, 303R1128, 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, 303R1139, 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), 303R1234, 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, 103T, 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), 303R1809, 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), 303R1915, 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, 303R2245, 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), 304R0876, 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), 304R1471, 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), 304R1492, 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), 304R1993, November 20, 2004
(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 analysis methods referred to in Annex X, Chapter C, point 4, and 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.
(a) all parts of the body of the animal shall be completely destroyed in accordance with Annex V apart from material retained for records in accordance with Annex III, Chapter B, III, 2; (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 of animal origin referred to in Annex VII, point 2, that have been identified as being at risk by the inquiry referred to in (b), shall be killed and completely destroyed in accordance with Annex V, points 3 and 4.
(a) products of animal origin covered by Article 15, in particular semen, embryos and ova; (b) (i) raw milk within the meaning of Directive 92/46/EEC Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (OJ L 268, 14.9.1992, p. 1 ). Directive as last amended by Directive 96/23/EC (JO L 23.5.1996, p. 10 ).(ii) milk for the manufacture of milk-based products within the meaning of Directive 92/46/EEC; (iii) heat-treated drinking milk within the meaning of Directive 92/46/EEC; (iv) di-calcium phosphate (without any trace of protein or fat); (v) hides and skins within the meaning of Directive 92/118/EEC Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(1) to Directive 89/662/EEC and, as regards pathogens, in Directive 90/425/EEC (OJ L 62, 15.3.1993, p. 49 ). Directive as last amended by Commission Decision 1999/724/EC (OJ L 290, 12.11.1999, p. 32 ).(vi) gelatine within the meaning of Directive 92/118/EEC, derived from the hides and skins referred to in point (v); (vii) collagen derived from the hides and skins referred to in point (v).
(a) animals born after the date from which the prohibition on the feeding to ruminants of animal protein derived from mammals was effectively enforced; or (b) animals which were born, raised and have stayed in herds with a certified history of freedom from BSE for at least seven years.
(a) Regulation (EC) No 1774/2002: (i) "farmed animal" in Article 2(1)(f); (ii) "petfood" in point 41 of Annex I; (iii) "processed animal protein" in point 42 of Annex I; (iv) "gelatine" in point 26 of Annex I; (v) "blood products" in point 4 of Annex I; (vi) "bloodmeal" in point 6 of Annex I; and (vii) "fishmeal" in point 24 of Annex I.
(b) the definition of "feedingstuff" in Article 3(4) of Regulation (EC) No 178/2002; (c) the definition of "complete feedingstuff" in Article 2(d) of Directive 79/373/EEC.
(a) "indigenous case of BSE" means a case of bovine spongiform encephalopathy which has not been clearly demonstrated to be due to infection prior to importation as a live animal; (b) "discrete adipose tissue" means internal and external body fat removed during the slaughter and cutting process, in particular fresh fat from the heart, caul and kidney of bovine animals, and fat from cutting rooms; (c) "cohort" means a group of bovine animals which includes both: (i) animals born in the same herd as the affected bovine animal, and within 12 months preceding or following the date of birth of the affected bovine animal; and (ii) animals which at any time during the first year of their lives were reared together with the affected bovine animal during the first year of its life;
(d) "index case" means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed.
(a) the outcome of a risk analysis identifying all the potential factors for the appearance of BSE referred to in Chapter B and their development over time; (b) an education programme for veterinarians, breeders and those who transport, trade in and slaughter bovine animals, which seeks to encourage them to report all cases of neurological manifestations in adult bovine animals; (c) the compulsory reporting and examination of all bovine animals showing clinical signs of BSE; (d) a system of continuous surveillance and monitoring of BSE with particular reference to the risks described in Chapter B, taking account of the guidelines in the table of Chapter A of Annex III or in accordance with the appropriate international standards; reports on the number of examinations carried out and the results thereof must be kept for at least seven years; (e) the examination in an approved laboratory of samples of encephala or other tissues collected under the surveillance system mentioned in point (d).
the consumption by bovine animals of meat and bone meal or greaves derived from ruminants; the importation of meat and bone meal or greaves potentially contaminated by a TSE or animal feed containing meat and bone meal or greaves; the importation of animals or ova/embryos potentially infected by a TSE; the epidemiological status of the country or region in regard to animal TSEs; the extent of knowledge about the structure of the bovine, ovine and caprine population in the country or region; the source of animal waste, the parameters of the processes for treating such waste and the methods of producing animal feed.
1. EITHER no BSE case has been recorded and: (i) the criteria in Chapter A(b) to (e) have been complied with for at least seven years, or (ii) the criteria in Chapter A(c) have been complied with for at least seven years and it has been demonstrated that for at least eight years no meat and bone meal or greaves derived from ruminants or mammals has been fed to ruminants;
2. OR where all cases of BSE have been clearly demonstrated to originate directly from the importation of live bovine animals or bovine embryos/ova, and all the affected bovine animals as well as, if these are females, their last progeny born within two years prior to, or after, the first clinical signs of onset of the disease, if alive in the country or region, have been killed and completely destroyed and, either (i) the criteria in Chapter A(b) to (e) have been complied with for at least seven years, or (ii) the criteria in Chapter A(c) have been complied with for at least seven years and it has been demonstrated that for at least eight years no meat and bone meal or greaves have been fed to ruminants;
3. OR where the last indigenous case of BSE was reported more than seven years ago, the criteria in Chapter A(b) to (e) have been complied with for at least seven years and the feeding of ruminants with meat and bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced for at least eight years.
1. EITHER where there has been no case of BSE and: (i) the criteria in Chapter A(b) to (e) are complied with, but have not been complied with for seven years, or (ii) it has been demonstrated that for at least eight years no meat and bone meal or greaves has been fed to ruminants, but the criteria in Chapter A(c) have not been complied with for seven years;
2. OR where all cases of BSE have been clearly demonstrated to originate directly from the importation of live bovine animals or bovine embryos/ova, and all the affected bovine animals as well as, if these are females, their last progeny born within two years prior to, or after, the first clinical signs of onset of the disease, if alive in the country or region, have been killed and completely destroyed, and either: (i) the criteria in Chapter A(b) to (e) are complied with, but have not been complied with for seven years, or (ii) it has been demonstrated that for at least eight years no meat and bone meal or greaves has been fed to ruminants, but the criteria in Chapter A(c) have not been complied with for seven years.
1. EITHER the last indigenous case of BSE was reported more than seven years ago, the criteria in Chapter A(b) to (e) are complied with and the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants is effectively enforced, but: (i) the criteria in Chapter A(b) to (e) have not been complied with for seven years, or (ii) the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants has not been effectively enforced for eight years;
2. OR where the last indigenous case has been reported less than seven years ago, the BSE incidence rate, calculated on the basis of indigenous cases, has been less than one case per million during each of the last four consecutive twelve-month periods within the bovine animal population over 24 months of age in the country or region or — when in a country or a region the bovine animal population over 24 months of age is less than 1 million animals — one case per real number of this population (calculated on the basis of Eurostat statistics), and where: (i) the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants has been effectively enforced for at least eight years; (ii) the criteria in Chapter A(b) to (e) have been complied with for at least seven years; (iii) the affected bovine animals as well as: if these are females, their last progeny born within two years prior to, or after, clinical onset of the disease; all bovine animals from the cohort,
are killed and completely destroyed if they are still alive in the country or region concerned. For this classification account may be taken, by way of derogation from point (iii), of the existence of other measures offering an equivalent level of protection in relation to the killing of animals at risk.
1. the criteria listed in Chapter A are complied with, and the BSE incidence rate, calculated over the past 12 months, has been greater than or equal to one indigenous case per million and less than or equal to one hundred cases per million within the bovine animal population over 24 months of age in the country or region; or 2. the criteria listed in Chapter A are complied with and the BSE incidence rate, calculated as specified in point 1 has been less than one indigenous case per million for less than four consecutive 12 month periods and the affected cattle as well as: if these are females, their last progeny born within two years prior to, or after the first clinical signs of onset of the disease, all bovine animals from the cohort,
if alive in the country or region, are killed and completely destroyed. For this classification account may be taken, by way of derogation from this point, of the existence of other measures offering an equivalent level of protection in relation to the killing of animals at risk. Countries or regions where the BSE incidence rate, calculated over the past 12 months, has been less than one indigenous case per million within the cattle population over 24 months of age in the country or region, but where a risk analysis as described in Chapter A has been conducted which demonstrates that at least one of the criteria enabling the country or region to be classified in category 2 or 3 is not complied with, must be regarded as countries or regions belonging to category 4.
1. the criteria listed in Chapter A are complied with, and the BSE incidence rate, calculated over the past 12 months, has been greater than one hundred cases per million within the bovine animal population over 24 months of age in the country or region; or 2. the BSE incidence rate, calculated over the past 12 months, has been greater than or equal to one case per million and less than or equal to one hundred cases per million within the bovine animal population over 24 months of age in the country or region, and at least one of the criteria listed in Chapter A is not complied with.
subject to "special emergency slaughtering" as defined in Article 2(n) of Council Directive 64/433/EEC OJ 121, 29.7.1964, p. 2012/64 .slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, except animals without clinical signs of disease slaughtered in the context of a disease eradication campaign,
subject to normal slaughter for human consumption, or slaughtered in the context of a disease eradication campaign in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, but showing no clinical signs of disease,
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,
killed in the framework of a disease eradication campaign, slaughtered for human consumption,
| Member State population of ewes and ewe lambs put to the ram | Minimum sample size of dead ovine animals |
|---|---|
| > | |
| 500 | |
| < | 100 |
| Member State population of goats which have already kidded and goats mated | Minimum sample size of dead caprine animals |
|---|---|
| > | |
| 500 | |
| < | 50 |
| Number of culled animals over 12 months in the herd or flock | Minimum sample size |
|---|---|
| 70 or less | All eligible animals |
| 80 | 68 |
| 90 | 73 |
| 100 | 78 |
| 120 | 86 |
| 140 | 92 |
| 160 | 97 |
| 180 | 101 |
| 200 | 105 |
| 250 | 112 |
| 300 | 117 |
| 350 | 121 |
| 400 | 124 |
| 450 | 127 |
| 500 or more | 150 |
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 farmed animals, with the exception of the feeding of carnivorous fur producing animals, of: (a) processed animal protein; (b) gelatine of ruminant origin; (c) blood products; (d) hydrolysed protein; (e) dicalcium phosphate and tricalcium phosphate of animal origin; (f) feedingstuffs containing the proteins listed in points (a) to (e);
(b) to ruminants of animal protein and feedingstuffs containing such protein.
(a) the feeding to non-ruminants of the proteins referred to in (i), (ii) and (iii), and of feedingstuffs derived from such proteins, provided that those proteins have been processed where applicable in accordance with Article 19 of Regulation (EC) No 1774/2002: (i) fishmeal, in accordance with the conditions laid down in point B; (ii) hydrolysed proteins derived from non-ruminants and ruminant hides and skins, in accordance with the conditions laid down in point C; (iii) dicalcium phosphate and tricalcium phosphate, in accordance with the conditions laid down in point D;
(b) the feeding to ruminants of the proteins referred to in (i), (ii) and (iii), and of products derived from such proteins, provided that the proteins have been processed where applicable in accordance with the provisions in Article 19 of Regulation (EC) No 1774/2002: (i) milk, milk-based products and colostrum; (ii) eggs and egg products; (iii) gelatine derived from non-ruminants;
(c) the feeding to fish of blood products and bloodmeal derived from non-ruminants, provided that they have been processed where applicable in accordance with Article 19 of Regulation (EC) No 1774/2002 and of feedingstuffs derived from such proteins, in accordance with the conditions laid down in point E.
(a) The fishmeal shall be produced in processing plants dedicated exclusively to the production of fish derived products, which shall be approved for this purpose by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002. (b) Before release for free circulation in the Community, each consignment of imported fishmeal shall be analysed in accordance with Commission Directive 98/88/EC OJ L 318, 27.11.1998, p. 45 .(c) Feedingstuffs containing fishmeal shall be produced in establishments which do not produce feedingstuffs for ruminants and which are authorised for this purpose by the competent authority. However, by way of derogation from that condition: (i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing fishmeal is not required for home compounders: registered by the competent authority, keeping only non-ruminants, producing complete feedingstuffs for use only in the same holding, and provided that the feedingstuffs containing fishmeal used in the production contain less than 50 % crude protein;
(ii) the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing fishmeal for other animal species may be authorised by the competent authority subject to the following conditions: bulk and packaged feedingstuffs destined for ruminants are manufactured in facilities physically separate from facilities where feedingstuffs containing fishmeal are manufactured, bulk feedingstuffs destined for ruminants are kept in facilities physically separate from facilities where bulk fishmeal and bulk feedingstuffs containing fishmeal are kept during storage, transport and packaging, records detailing the purchases and uses of fishmeal and the sales of feedingstuffs containing fishmeal are kept available to the competent authority for at least five years, and routine tests are carried out on feedingstuffs destined to ruminants to ensure that prohibited proteins including fishmeal are not present.
(d) The label and accompanying document of feedingstuffs containing fishmeal shall clearly indicate the words "contains fishmeal — cannot be fed to ruminants". (e) Bulk feedingstuffs containing fishmeal shall be transported by means of vehicles which do not transport at the same time feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination. (f) The use and storage of feedingstuffs containing fishmeal shall be prohibited in farms where ruminants are kept. By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing fishmeal in farms where ruminants are kept, if they are satisfied that on-farm measures are implemented to prevent that feedingstuffs containing fishmeal are fed to ruminants.
(a) The hydrolysed proteins shall be produced in a processing plant approved by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002. (b) Feedingstuffs containing hydrolysed proteins shall be produced in establishments which do not prepare feedingstuffs for ruminants and which are authorised for this purpose by the competent authority. However, by way of derogation from that condition: (i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing hydrolysed proteins is not required for home compounders: registered by the competent authority, keeping only non-ruminants, producing complete feedingstuffs for use only in the same holding, and provided that the feedingstuffs containing hydrolysed proteins used in the production contain less than 50 % crude protein;
(ii) the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing hydrolysed proteins for other animal species may be authorised by the competent authority subject to the following conditions: bulk and packaged feedingstuffs destined for ruminants are manufactured in facilities physically separate from facilities where feedingstuffs containing hydrolysed proteins are manufactured, bulk feedingstuffs destined for ruminants are kept in facilities physically separate from facilities where bulk hydrolysed proteins and bulk feedingstuffs containing hydrolysed proteins are kept during storage, transport and packaging, records detailing the purchases and uses of hydrolysed proteins, and the sales of feedingstuffs containing hydrolysed proteins are kept available to the competent authority for at least five years.
(c) The label and the accompanying document of the feedingstuffs containing hydrolysed proteins shall clearly indicate the words "contains hydrolysed proteins — cannot be fed to ruminants". (d) Bulk feedingstuffs containing hydrolysed proteins shall be transported by mean of vehicles which do not transport at the same time feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination. (e) The use and storage of feedingstuffs containing hydrolysed proteins shall be prohibited in farms where ruminants are kept. By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing hydrolysed proteins in farms where ruminants are kept, if they are satisfied that on-farm measures are implemented to prevent the feeding of feedingstuffs containing hydrolysed proteins to ruminants.
(a) Dicalcium phosphate and tricalcium phosphate shall be produced in a processing plant approved by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002. (b) Feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be produced in establishments which do not prepare feedingstuffs for ruminants and which are authorised for this purpose by the competent authority. However, by way of derogation from that condition: (i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing dicalcium phosphate or tricalcium phosphate is not required for home compounders: registered by the competent authority, keeping only non-ruminants, producing complete feedingstuffs for use only in the same holding, and provided that the feedingstuffs containing dicalcium phosphate or tricalcium phosphate used in the production contain less than 10 % total phosphorus;
(ii) the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing dicalcium phosphate or tricalcium phosphate for other animal species may be authorised by the competent authority subject to the following conditions: bulk and packaged feedingstuffs destined for ruminants are manufactured in facilities physically separate from facilities where feedingstuffs containing dicalcium phosphate or tricalcium phosphate are manufactured, bulk feedingstuffs destined for ruminants are kept in facilities physically separate from facilities where bulk dicalcium phosphate and bulk tricalcium phosphate and bulk feedingstuffs containing dicalcium phosphate and tricalcium phosphate are kept during storage, transport and packaging, records detailing the purchases and uses of dicalcium phosphate or tricalcium phosphate and the sales of feedingstuff containing dicalcium phosphate or tricalcium phosphate are kept available to the competent authority for at least five years.
(c) The label and accompanying document of the feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall clearly indicate the words "contains dicalcium/tricalcium phosphate of animal origin — cannot be fed to ruminants". (d) Bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be transported by mean of vehicles which do not transport at the same time feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination. (e) The use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be prohibited in farms where ruminants are kept. By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate in farms where ruminants are kept, if they are satisfied that on-farm measures are implemented to prevent that feedingstuffs containing dicalcium phosphate or tricalcium phosphate are fed to ruminants.
(a) the blood shall be derived from EU approved slaughterhouses not slaughtering ruminants which are registered as not slaughtering ruminants and shall be transported directly to the processing plant in vehicles dedicated exclusively to the transport of non-ruminant blood. If the vehicle was used for the transport of ruminant blood, it shall be, following cleaning, inspected by the competent authority before the transport of non-ruminant blood. By way of derogation from that condition, the competent authority may permit the slaughter of ruminants in slaughterhouses collecting non-ruminant blood intended for the production of blood meal and blood products for use in fish feed if these slaughterhouses have a recognised control system. The control system shall at least include: the slaughtering of non-ruminants physically separate from the slaughtering of ruminants, collection, storage, transport and packaging of blood from non-ruminant origin in facilities physically separate from facilities where blood of ruminant origin is collected, stored, transported and packaged, and regular sampling and analysis of blood from non-ruminant origin for the presence of ruminant proteins;
(b) the blood products and the bloodmeal shall be produced in an establishment exclusively processing non-ruminant blood and approved by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002. By way of derogation from that condition, the competent authority may permit the production of blood products for use in fish feed in establishments processing ruminant blood, which have a recognised control system in place preventing cross-contamination. The control system shall at least include: processing of non-ruminant blood in a closed system physically separate from the processing of ruminant blood, transport, storage and packaging of bulk raw material and bulk finished blood products of non-ruminant origin in facilities physically separate from facilities where bulk raw material and bulk finished products of ruminant origin are kept during storage, transport and packaging, and regular sampling and analysis of non-ruminant blood products for the presence of ruminant proteins;
(c) feedingstuffs containing blood products or bloodmeal shall be produced in establishments manufacturing fish feed which do not prepare feedingstuffs for other farmed animals, with the exception of carnivorous fur producing animals, and which are authorised for that purpose by the competent authority; (d) the label, accompanying commercial document or health certificate, as appropriate, of the feedingstuffs containing blood products or bloodmeal shall clearly indicate the words "contains blood products — shall only be fed to fish" or "contains bloodmeal — shall only be fed to fish", as appropriate; (e) transport vehicles used for the transport of bulk fish feed containing blood products or bloodmeal shall not be used for the transport of feedingstuffs for other farmed animals, with the exception of carnivorous fur producing animals, unless the transport vehicle, following cleaning, has been inspected by the competent authority; (f) the use and storage of fish feed containing blood products or bloodmeal shall be prohibited in farms where other farmed animals, with the exception of carnivorous fur producing animals, are kept.
(a) Bulk processed animal protein, with the exception of fishmeal, and bulk feedingstuffs containing such proteins, shall be stored and transported in dedicated facilities. The store or vehicle can only be used for other purposes, following cleaning, after having been inspected by the competent authority. (b) Bulk fishmeal, bulk hydrolysed proteins referred to in point A(a)(ii) of part I, bulk dicalcium phosphate and bulk tricalcium phosphate referred to in point A(a)(iii) of part I, and bloodmeal and blood products referred to in point A(c) of part I shall be stored and transported in stores and vehicles dedicated to that purpose. (c) By way of derogation from point (b): (i) stores or vehicles may be used for the storage and transport of feedingstuffs containing the same protein; (ii) stores or vehicles, following cleaning, may be used for other purposes after having been inspected by the competent authority; and (iii) vehicles transporting fishmeal may be used for other purposes if the company has a control system in place, recognised by the competent authority, to prevent cross-contamination. The control system shall at least include: records on material transported and cleaning of the vehicle, and regular sampling and analysis of feedingstuffs transported for the presence of fishmeal.
The competent authority shall carry out frequent spot checks to verify the correct application of the control plan.
they are destined for uses not prohibited by Article 7, a written agreement with the third country is made prior to exportation, which includes an undertaking from the third country to respect the final use and not to re-export the processed animal protein, blood products and products containing such proteins for uses prohibited by Article 7.
CATEGORIES 1 AND 2 None. CATEGORIES 3 AND 4 (a) the skull including the brain and eyes, the tonsils and the spinal cord of bovine animals aged over 12 months, and the intestines from the duodenum to the rectum of bovine animals of all ages; (b) 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 of ovine and caprine animals of all ages.
CATEGORY 5 (a) the entire head (excluding the tongue), including the brain, eyes, trigeminal ganglia and tonsils; the thymus; the spleen and the spinal cord of bovine animals aged over six months, and the intestines from the duodenum to the rectum of animals of all ages; (b) the vertebral column, including dorsal root ganglia, of bovine animals aged over 30 months; (c) the skull including the brain and eyes, the tonsils, 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 of ovine and caprine animals of all ages.
(a) slaughterhouses; (b) cutting plants, high-risk processing plants or premises referred to in Articles 3 and 7 of Directive 90/667/EEC Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (OJ L 363, 27.12.1990, p. 51 ). Directive as last amended by the 1994 Act of Accession.
(a) by incineration without pre-processing; or, (b) provided that the dye or marker remains detectable, after pre-processing: (i) in accordance with the systems described in Chapters I to IV, VI and VII of the Annex to Decision 92/562/EEC Commission Decision 92/562/EEC of 17 November 1992 on the approval of alternative heat treatment systems for processing high-risk material (OJ L 359, 9.12.1992, p. 23 ). Decision as amended by the 1994 Act of Accession.by incineration; by co-incineration;
(ii) in accordance with at least the standards referred to in Annex I to Decision 1999/534/EC Council Decision 1999/534/EC of 19 July 1999 on measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies and amending Commission Decision 97/735/EC (OJ L 204, 4.8.1999, p. 37 ).
(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) specified risk material used in the production of products referred to in Article 1(2) are used solely for the authorised purpose; (b) where bovine, ovine or caprine animals enter a Member State placed in a numerically lower category, indicating a better BSE status, than that of the animals that enter, those animals remain under official supervision until slaughter or dispatch from its territory; (c) specified risk material, in particular where disposal takes place at establishments or premises other than slaughterhouses, is completely separated from other waste not destined for incineration, is collected separately and is disposed of in accordance with points 2, 3 and 4. Member States may allow dispatch of heads or carcasses containing specified risk material to another Member State after agreement with that other Member State both to receive the material and to apply the specific conditions applicable to such movements.
(a) mechanically recovered meat; (b) dicalcium phosphate intended as feedingstuffs for livestock; (c) gelatine, unless it is produced from ruminant hides; (d) derivatives made from rendered ruminant fat; (e) rendered ruminant fat, unless it was produced from: (i) discrete adipose tissue declared fit for human consumption; (ii) raw materials which were processed in accordance with the standards referred to in Directive 90/667/EEC.
(a) in the case of bovine animals: all other ruminants on the holding of the animal in which the disease was confirmed, where the disease was confirmed in a female animal, its progeny born within two years prior to, or after, clinical onset of the disease, all animals of the cohort of the animal in which the disease was confirmed, the possible origin of the disease, other animals on the holding of the animal in which the disease was confirmed or on other holdings which may have become infected by the TSE agent or been exposed to the same feed or contamination source, the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;
(b) in the case of ovine and caprine animals: all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed, in so far 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 BSE agent to or from the holding in question.
(a) in the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide: not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal, to defer the killing and destruction of animals in the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death;
(b) in the case of confirmation of TSE in an ovine or caprine animal, from 1 October 2003 , according to the decision of the competent authority:(i) either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b) or (ii) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of: breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph, sheep carrying at least one ARR allele which are intended solely for slaughter, if the competent authority so decides, sheep and goats less than two months old which are intended solely for slaughter;
(iii) if the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed; in the case of land used for common grazing by more than one flock, Member States may decide to limit the application of those measures to a single flock, based on a reasoned consideration of all the epidemiological factors; where more than one flock is kept on a single holding, Member States may decide to limit the application of the measures to the flock in which scrapie has been confirmed, provided it has been verified that the flocks have been kept isolated from each other and that the spread of infection between the flocks through either direct or indirect contact is unlikely;
(c) in the case of confirmation of BSE in an ovine or caprine animal, killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b).
(a) male sheep of the ARR/ARR genotype; (b) female sheep carrying at least one ARR allele and no VRQ allele; (c) caprine animals, provided that: (i) no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present on the holding, (ii) thorough cleaning and disinfection of all animal housing on the premises has been carried out following destocking, (iii) the holding shall be subjected to intensified TSE monitoring, including the testing of all caprine animals which are over the age of 18 months and: either are slaughtered for human consumption at the end of their productive lives, or which have died or been killed on the holding, and which meet the criteria referred to in Annex III, Chapter A, Part II, point 3.
(a) semen from rams of the ARR/ARR genotype; (b) embryos carrying at least one ARR allele and no VRQ allele.
(a) movement of ARR/ARR sheep from the holding shall not be subject to any restriction; (b) sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human consumption or for the purposes of destruction; however, ewes carrying one ARR allele and no VRQ allele may be moved to other holdings which are restricted following the application of measures in accordance with point 2(b)(ii), if the competent authority so decides, lambs carrying one ARR allele and no VRQ allele may be moved to one other holding solely for the purposes of fattening prior to slaughter; the destination holding shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter;
(c) if the Member State so decides, sheep and goats less than two months old may be moved from the holding to go directly for slaughter for human consumption; the head and organs of the abdominal cavity of such animals shall however be disposed of in accordance with Article 4(2)(a), (b) or (c) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council OJ L 273, 10.10.2002, p. 1 .(d) without prejudice to subparagraph (c), sheep of genotypes not referred to in subparagraphs (a) and (b) may only be moved from the holding for the purposes of destruction.
(a) the date of attainment of ARR/ARR status by all ovine animals on the holding or (b) the last date when any ovine or caprine animal was kept on the premises or (c) in the case of point 4(c), the date when the intensified TSE monitoring commenced or (d) the date when all breeding rams on the holding are of ARR/ARR genotype and all breeding ewes carry at least one ARR allele and no VRQ allele, provided that during the three-year period, negative results are obtained from TSE testing of the following animals over the age of 18 months: an annual sample of ovine animals slaughtered for human consumption at the end of their productive lives in accordance with the sample size indicated in the table in Annex III, Chapter A, Part II, point 4; and all ovine animals referred to in Annex III, Chapter A, Part II, point 3 which have died or been killed on the holding.
(a) delay the destruction of animals as referred to in point 2(b)(i) and (ii) for up to five breeding years; (b) allow ovine animals other than those referred to in point 4 to be introduced to the holdings referred to in point 2(b)(i) and (ii), provided that they do not carry a VRQ allele.
(a) ovine and caprine animals for breeding shall either be sheep of the ARR/ARR prion protein genotype, as defined in Annex I of Commission Decision 2002/1003/EC OJ L 349, 24.12.2002, p. 105 .(i) until 30 June 2007 :it is subject to regular official veterinary checks, the animals are marked, no case of scrapie has been confirmed, checking by sampling of old female animals intended for slaughter is carried out, females, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.
From 1 July 2004 at the latest, the holding or holdings shall begin to satisfy the following additional requirements:all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding shall be examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b), and ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, shall be introduced into the holding only if they come from a holding which complies with the same requirements.
(ii) from 1 July 2007 :it is subject to regular official veterinary checks, the animals are identified in conformity with Community legislation, no case of scrapie has been confirmed, all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding have been examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b), ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.
If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c), ovine and caprine animals for breeding shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2). (b) a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory: (i) may submit the said program to the Commission, outlining in particular: the distribution of the disease in the Member State, the reasons for the program, taking into consideration the importance of the disease and the cost/benefit ratio, the geographical area in which the program will be implemented, the status categories defined for holdings and the standards which must be attained in each such category, the test procedures to be used, the program monitoring procedures, the action to be taken if, for any reason, a holding loses its status, the measures to be taken if the results of checks carried out in accordance with the provisions of the program are positive,
(ii) the program referred to in point (i) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2). The additional guarantees, general or specific, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the program in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally, (iii) amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2). Amendments to the guarantees which have been defined in accordance with point (ii) may be approved in accordance with that procedure,
(c) where a Member State considers that its territory or part of its territory is free from scrapie: (i) it is to submit to the Commission appropriate supporting documentation, setting out in particular: the history of the occurrence of the disease in its territory, the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation, the period over which the surveillance was carried out, the arrangements for verifying the absence of the disease,
(ii) the additional guarantees, general or specific, which may be required in intra-Community trade are to be defined in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally, (iii) the Member State concerned is to notify the Commission of any change in the details specified in point (i) which relate to the disease. The guarantees defined in accordance with point (ii) may, in the light of such notification, be amended or withdrawn in accordance with the procedure referred to in Article 24(2),
(d) from 1 January 2005 semen and embryos of ovine and caprine animals shall:(i) be collected from animals which have been kept continuously since birth or for the last three years of their life on a holding or holdings which have satisfied the requirements of subparagraph (a)(i) or, as appropriate, (a)(ii) for three years or (ii) in the case of ovine semen, be collected from male animals of the ARR/ARR prion protein genotype as defined in Annex I to Commission Decision 2002/1003/EC OJ L 349, 24.12.2002, p. 105 .(iii) in the case of ovine embryos, be of the ARR/ARR prion protein genotype as defined in Annex I to Decision 2002/1003/EC.
CATEGORIES 3 AND 4 The animals must have: (a) been born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years; or (b) been born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
CATEGORY 5 The animals must have: (a) been born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals has been effectively enforced; and (b) been born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equivalent status.
fresh meat; minced meat; meat preparations; meat products; petfood which is destined for domestic carnivores.
(a) the animal has been clearly identifiable throughout its life, enabling it to be traced back to its dam and herd of origin; its unique eartag number, date and holding of birth and all movements after birth are recorded either in the animal's official passport or in an official computerised identification and tracing system; the identity of its dam is known; (b) the animal is more than six months but less than 30 months of age, determined by reference to an official computer record of its date of birth, or to the animal's official passport; (c) the competent authority has obtained and verified positive evidence that the dam of the animal has lived for at least six months after the birth of the eligible animal; (d) the dam of the animal has not developed BSE and is not suspected of having contracted BSE.
(a) tracing and controls prior to slaughter; (b) controls during slaughter; (c) controls during processing of petfood; (d) all labelling and certification requirements after slaughter to the point of sale.
(a) A herd is a group of animals forming a separate and distinct unit, that is a group of animals which is managed, housed and kept separately from any other group of animals and which is identified with unique herd and animal identification numbers. (b) A herd is eligible when for at least seven years there has been no confirmed case of BSE, nor a suspect case for which the diagnosis of BSE has not been ruled out, in any animal which was still in or had moved through or from the herd. (c) As an exception to the provisions in point (b), a herd that has been in existence for less than seven years may be considered eligible, after a thorough investigation by the competent veterinary authority, on condition that: (i) all animals born or moved into the newly established herd complied with the conditions set out in point (2)(a), (d) and (e); and, (ii) the herd has complied with the conditions set out in point (b) during its entire existence.
(d) If a herd is newly established on a holding which experienced a confirmed case of BSE in any animal which was still in or had moved through or from a herd on that holding, the newly established herd can only be eligible after a thorough investigation by the competent veterinary authority, certifying compliance with each of the following conditions to the satisfaction of that authority: (i) all animals of the affected herd previously held on the same holding have been removed or killed; (ii) all feed has been removed and destroyed and all feed containers thoroughly cleansed; (iii) all buildings have been emptied and thoroughly cleansed before the new animals were admitted; (iv) all conditions set out in point (c) have been complied with.
(a) all records of the animal's birth, identity and movements are recorded on an official computerised tracing system; (b) the animal is more than six months but less than 30 months of age, determined by reference to an official computer record of its date of birth; (c) its dam has lived for at least six months after its birth; (d) its dam has not developed BSE and is not suspected of having contracted BSE; (e) the herd of birth of the animal and all herds through which it has moved are eligible.
(a) tracing and controls prior to slaughter; (b) controls during slaughter; (c) controls during processing of petfood; (d) all labelling and certification requirements after slaughter to the point of sale.
(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.
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. 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 making it possible to establish that they are not the progeny of BSE suspect or confirmed females; were born, raised and had remained in herds in which no case of BSE had been confirmed for at least seven years; or were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. bovine animals intended for export to the Community: (a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and making it possible to establish that they are not the progeny of BSE suspect or confirmed females; and (b) were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years; or (c) were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
1. the feeding of farmed animals with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. the affected bovine animals are killed and completely destroyed as well as: (a) if these are females, their last progeny born within two years prior to, or after the first clinical signs of the onset of the disease; (b) all bovine animals from the same cohort
if such animals are still alive in the country or region; 3. the animals intended for export to the Community: (a) were born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals was effectively enforced; (b) 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 suspect or confirmed females; AND (c) either were born, raised and have remained in herds in which no case of BSE has ever been confirmed, and which contain only bovine animals born on the farm or coming from a herd of equal health status; or (d) were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equal health status.
(a) the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; (b) the fresh meat and products of bovine animal origin intended for export to the Community do not contain or are not derived from specified risk material referred to in Annex V or mechanically recovered meat obtained from the bone of the head or vertebral column.
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. the fresh meat and products of bovine animal origin intended for export to the Community do not contain or are not derived from specified risk material referred to in Annex V or mechanically recovered meat obtained from the head or vertebral column.
1. they fulfil the conditions of Article 16(2) and those set out in sections II or III of Chapter C of Annex VIII; 2. the meat products intended for export to the Community do not contain or are not derived from any product referred to in Chapter F, nor from any specified risk material as defined in Annex V; 3. a system is in operation enabling the fresh meat and products of bovine animal origin intended for export to the Community to be traced back to the establishments from which they are derived; 4. the bovine animals from which the meat or meat products intended for export to the Community originate: (a) were identified by a permanent identification system enabling them to be traced back to the dam and herd of origin; (b) are not the progeny of BSE-suspect or confirmed females; and either: were born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals was effectively enforced; or were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years;
5. the feeding of farmed animals with proteins derived from mammals has been banned and the ban has been effectively enforced; 6. the affected bovine animals are slaughtered and completely destroyed as well as: (a) if these are females, their last progeny born within two years prior to, or after, the first clinical signs of the onset of the disease; (b) all bovine animals from the same cohort
if they are still alive in the country or region.
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. the embryos/ova were collected, processed and stored in conformity with the provisions of Annexes A and B to Directive 89/556/EC Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1 ). Directive as last amended by Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23 ).
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. ova/embryos destined for export to the Community are derived from females which: (a) 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-confirmed females; (b) are not the progeny of BSE-suspect or confirmed females; (c) were not suspected of being affected by BSE at the time of embryo collection;
3. the ova/embryos were collected, processed and stored in accordance with the provisions of Annexes A and B to Directive 89/556/EEC.
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. the ova/embryos intended for export to the Community are derived from females which: (a) 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 or affected females; (b) are not affected with BSE; (c) were not suspected of being affected with BSE at the time of embryo collection; and (i) either were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals was effectively enforced; or (ii) were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years;
3. the ova/embryos were collected, processed and stored in conformity with the provisions of Annexes A and B to Directive 89/556/EEC.
1. the feeding of animals for breeding with proteins derived from mammals has been banned and the ban has been effectively enforced; 2. the affected bovine animals, and, if these are females, their last progeny born within two years prior to, or after, clinical onset of the disease, if alive in the country or region, are killed and completely destroyed; 3. ova/embryos intended for export to the Community are derived from females which: (a) 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 or confirmed females; (b) are not affected with BSE; (c) were not suspected of being affected with BSE at the time of embryo collection; and (i) either were born after the date from which the ban on the feeding of animals for breeding with proteins derived from mammals was effectively enforced; (ii) or have never been fed with proteins derived from mammals and were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equal health status;
4. the ova/embryos were collected, processed and stored strictly in conformity with the provisions of Annexes A and B to Directive 89/556/EEC.
(a) either they were born in and continuously reared on holdings in which a case of scrapie has never been diagnosed, and, in the case of ovine and caprine animals for breeding, they satisfy the requirements of subparagraph (i) of point (a) of Chapter A(I) of Annex VIII; (b) or they are sheep of the ARR/ARR prion protein genotype, as defined in Annex I to Commission Decision 2002/1003/EC, coming from a holding where no case of scrapie has been reported in the last six months.
mechanically recovered meat; dicalcium phosphate intended for feeding livestock; gelatine unless produced from hides or skins; rendered ruminant fat and derivatives made from it unless they were produced from discrete adipose tissue which was itself declared fit for human consumption, or from raw materials which were processed in accordance with the standards referred to in Decision 1999/534/EC.
(a) have at its disposal facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type and strain of the agent of TSE, and to confirm results obtained by regional diagnostic laboratories. Where it is not capable of identifying the strain-type of the agent, it shall set up a procedure to ensure that the identification of the strain is referred to the Community reference laboratory; (b) verify diagnostic methods used in regional diagnostic laboratories; (c) be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it: may provide diagnostic reagents to laboratories approved by the Member State; is to control the quality of all diagnostic reagents used in the Member State; is to periodically arrange comparative tests; is to hold isolates of the agents of the disease in question, or corresponding tissues containing such agents, coming from cases confirmed in the Member State; is to ensure confirmation of results obtained in diagnostic laboratories designated by the Member State;
(d) is to cooperate with the Community reference laboratory.
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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;
(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.
(a) Suspect cases Tissues from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy). However, rapid tests cannot be used for this purpose. If the result of one of the above examinations is positive, the animals shall be regarded a positive BSE case. (b) BSE monitoring Tissues from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Section I (Monitoring in bovine animals) shall be examined by a rapid test. When the result of the rapid test is inconclusive or positive, the tissues shall immediately be subject to confirmatory examinations in an official laboratory. The confirmatory examination shall start by a histopathological examination of the brainstem as laid down in the latest edition of the Manual, except where the material is autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods mentioned under (a). An animal shall be regarded a positive BSE case if the result of the rapid test is positive or inconclusive, and the result of the subsequent histopathological examination is positive, or the result of another diagnostic method mentioned under (a) is positive.
(a) Suspect cases Tissues from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by immunocytochemistry or immuno-blotting, as laid down in the Manual. However, rapid tests cannot be used for this purpose. If the result of one of the above examinations is positive, the animal shall be regarded a positive scrapie case. (b) Scrapie monitoring Tissues from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Section II (Monitoring in ovine and caprine animals) shall be examined by a rapid test. When the result of the rapid test is inconclusive or positive, the brainstem shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry or immuno-blotting, as referred to under (a). An animal shall be regarded a positive scrapie case if the result of the confirmatory examination is positive.
immuno-blotting test based on a Western blotting procedure for the detection of the protease-resistant fragment PrP Res (Prionics-Check Western test),chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test), sandwich immunoassay for PrP Res carried out following denaturation and concentration steps (Bio-Rad TeSeE test, the former Bio-Rad Platelia test). However, existing stocks bearing the name "Bio-Rad Platelia test" may be used within nine months from the date of entry into force of this Regulation,microplate based immunoassay (ELISA) which detects protease-resistant PrP Res with monoclonal antibodies (Prionics-Check LIA test),automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the protease-sensitive and protease-resistant forms of PrP Sc (some fraction of the protease-resistant PrPSc is equivalent to PrPRes ) and to PrPC (InPro CDI-5 test).
(a) The following tissues are designated as specified risk material: (i) the skull excluding the mandible and including the brain and eyes, 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, and the spinal cord of bovine animals aged over 12 months, and the tonsils, the intestines from the duodenum to the rectum and the mesentery of bovine animals of all ages; (ii) the skull including the brain and eyes, the tonsils and the spinal cord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen and ileum of ovine and caprine animals of all ages.
The age specified in (i) for the removal of the bovine vertebral column may be adjusted by amending this Regulation in the light of the statistical probability of the occurrence of BSE in the relevant age groups of the Community's bovine population, based on the results of BSE monitoring as established by Chapter A.I of Annex III. (b) In addition to the specified risk material listed in (a), the following tissues must be designated as specified risk material in the United Kingdom of Great Britain and Northern Ireland: the entire head excluding the tongue, including the brain, eyes and trigeminal ganglia; the thymus, the spleen and the spinal cord of bovine animals aged over six months.
(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. The United Kingdom and Sweden may benefit from this derogation on the basis of previously submitted and evaluated evidence. Other Member States may apply for this derogation by submitting conclusive supporting evidence to the Commission regarding point (a) or (b), as appropriate. Member States benefiting from this derogation shall, in addition to the requirements laid down in Annex III, Chapter A, Section I, ensure that one of the approved rapid tests listed in Annex X, Chapter C, point 4, is applied to all bovine animals over 30 months of age which: (i) have died on the farm or in transport, but which have not been slaughtered for human consumption, with the exception of those dead animals in remote areas with a low animal density situated in Member States where the occurrence of BSE is unlikely; (ii) were subject to normal slaughter for human consumption.
This derogation shall not be granted to allow the use of vertebral column and dorsal root ganglia from bovine animals aged over 30 months from the United Kingdom. Experts from the Commission may carry out on-the-spot checks to further verify the submitted evidence in accordance with Article 21.
(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 .
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.
(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;
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.
(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.
(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).
(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;
or ( 1 )bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in the following countries: Argentina Australia Botswana Brazil Chile El Salvador Iceland Namibia Territoire français de la Nouvelle Calédonie New Zealand Nicaragua Panama Paraguay Singapore Swaziland Uruguay Vanuatu.
----------------------Delete one of these as appropriate."
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.
(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.
Argentina Australia Botswana Brazil Chile El Salvador Iceland Namibia Territoire français de la Nouvelle Calédonie New Zealand Nicaragua Panama Paraguay Singapore Swaziland Uruguay Vanuatu.
Argentina Australia Botswana Brazil Chile Costa Rica El Salvador Namibia New Zealand Nicaragua Panama Paraguay Uruguay Singapore Swaziland.
(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."