Proposal for a Council Decision concerning emergency measures to protect against bovine spongiform encephalopathy, amending Decision 94/474/EC and repealing Decision 96/239/EC
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 09. 03. 1998 COM(1998) 161 final Proposal for a COUNCIL DECISION concerning emergency measures to protect against bovine spongiform encephalopathy, amending Decision 94/474/EC and repealing Decision 96/239/EC (presented by the Commission) KXI'LANATOKYMKMORANDIJM Aller announcement by the UK authorities of a |>ossible link between BSE and (Ml), the Commission adopted on the 27th of March 19%, the Decision 96/239/EC which prohibits dispatch from the United Kingdom of live bovine animals and bovine products. In the Council of 22 June 1996, leading to the Florence Agreement, the preconditions for the step by step lifting of the prohibitions were set out. The implementation of an effective disease eradication plan, including selective slaughter of potentially exposed animals and culling of animals over 30 months of age and their destruction, is central in the preconditions. One of the main steps within the framework of is a gradual removing of the export ban for animals and meat from certified herds, i. e. without a history of BSE and no exposure to infected meat and bone meal. At the end of June 1996 the plan to eradicate BSE of the United Kingdom was adopted. Satisfactory progress to eradicate the disease has been made. At the peak of the epidemic, in 1992, 37. 280 BSE cases were confirmed, last year a substantially reduced number of 3. 396 BSE cases were confirmed. To date over 3 million cattle have been slaughtered and destroyed under the various programmes of the eradication plan. The United Kingdom first put forward in February 1997 a proposal for an Export Certified Herds Scheme, with a view to lifting the restrictions. Following rejection by the Scientific Veterinary Committee in June, the United Kingdom put forward a modified proposal in July. In the summer of 1997 new information on a large scale fraud with UK beef emerged. Investigations by the UCLAF and the FVO showed deficiencies in the official control of production of beef in the United Kingdom for dispatch from their territory, following this information the strategy on reinforcing veterinary controls in order to prevent fraud has been decided, and was communicated through the (fourth) progress report to the temporary Committee of the European Parliament on the follow-up of ± recommendations on BSE in October. These conditions for a reinforced veterinary control system have been incorporated in the proposal. l'art of the proposal was already presented to the Member States in June 1997. At that stage only the withdrawal for the exemption for dispatch of gelatine from cattle slaughtered in the UK and some clarifications were proposed. The reinforced controls, the partial lifting of the prohibitions and further clarifications became opportune only recently, and therefore, were included in the present proposal. This proposal was first discussed in a working group of the standing veterinary committee on 29 January 1998, where it was generally commended. To the contrary it met strong opposition in the Standing Veterinary Committee itself. The crucial element in the discussion was the acceptance of non-eligible animals in eligible herds. This is endorsed by the Scientific Veterinary Committee on condition that non- eligible animals cannot enter the scheme. It is justified by the assumption that transmission from animal to animal does not take place. In the proposal non-eligible animals are accepted in eligible herds, these non-eligible animals cannot enter the scheme. In the Standing Veterinary Committee meeting of 4 March Denmark, Greece, Ireland, Italy, The Netherlands, Austria, Portugal, Finland, Sweden and, of-course, the United Kingdom supported the proposal. Belgium, Germany, Spain and Luxembourg voted against because they object to the possibility in the Export Certified Herds Scheme for export from eligible herds to which ineligible animals have been added. France abstained, not because they reject the proposal in principle, but because they feel that there are too many outstanding technical issues still to settle. The Commission not having received a favourable opinion from the Standing Veterinary Committee, is required under Article 17 of Directive 89/662 to submit a proposal to the Council without delay. 1. PROPOSAI, for a COUNCIL DECISION of concerning emergency measures ui^rotecl against bovine spongiform encephalopathy, amending Decision 94/474/EC and repealing Decision 96/239/EC THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and xoolechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market1, as last amended by Directive 92/118/EEC, and in particular Article 10(4) thereof, Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market3, as last amended by Directive 92/118/EEC, and in particular Article 9(4) thereof, I laving regard the proposal of the Commission, i OJ No L 224, 18. 8. 1990, p. 29. OJ No L 62, 15. 3. 1993, p. 49. OJ No L 395, 30. 12. 1989, p. 13. ( I ) Whereas new information has been published in the I Initctl Kingdom further supporting the hypothesis that exposure to the bovine spongiform encephalopathy (BSE!) agent is linked to the new variant of Creulzfcldl Jacob Disease (CJD) in humans; whereas on 16 September 1997 the Spongiform Encephalopathy Advisory Committee (SEAC) of the United Kingdom concluded that recent research provided compelling new evidence that the agent which causes BSE is identical to the agent which causes the new variant of CJD in humans; whereas on 18 September 1997 the Advisory Committee on Dangerous Pathogens (ACDP) concluded that the BSE agent should now be classified as a human pathogen; (2) Whereas, in those circumstances and as an emergency measure, it is appropriate to prohibit temporarily the dispatch to the other Member States of all bovine animals from the United Kingdom and of all products consisting entirely or in part of, or incorporating materials derived from, bovine animals slaughtered in the United Kingdom which are liable to enter the human food or animal feed chains or are destined for use in cosmetic, pharmaceutical or medical products; whereas in order to prevent deflections of trade, the same prohibitions should also apply to exports to third countries; (3) Whereas, in order to protect animal and human health in the Community, the Commission adopted Decision 94/474/EC of 27 July 1994 concerning certain protection measures relating to bovine spongiform encephalopathy and repealing Decisions 89/469/1 -EC and 90/200/1 «EC, as last amended by Decision 95/287/EC\ 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 Kingdom6, as amended by the Act of Accession of Austria, Finland and Sweden, Decision 94/381/EC of 27 June 1994 concerning certain protection measures with regard to bovine spongiform encephalopathy and the feeding of mammalian derived 4 5 6 O J N oL 194, 29. 7. 1994, p. 96. O J N oL 181, 1. 8. 1995, p. 40. O J N oL 152,4. 6. 1992, p. 37. protein7, as amended by Decision 95/60/EC8, and Decision 96/449/EC of 18 July 1996 on the approval of alternative heat treatment systems for processing animal waste with a view to the inactivation of spongiform encephalopathy agents"; (4) Whereas the United Kingdom has taken measures as a result of the publication of information on certain cases of CJD in that Member State; (5) Whereas the United Kingdom has banned the use of mammalian meat-and-bone meal, regardless of ils origin, for feeding farm animals; whereas it is necessary to provide that mammalian meat-and-bone meal and farm animal feed and fertilizers containing mammalian meat-and-bone meal, which by their nature could enter the farm animal feed chain, may not be dispatched from the United Kingdom; (6) Whereas the risk of transmissible spongiform encephalopathies (TSEs) entering the human food or animal feed chains through the consumption of protein derived from domestic carnivores is considered low; whereas that risk can be further reduced by requiring that domestic carnivores are not fed mammalian meat-and-bone meal originating in the United Kingdom; whereas it is therefore appropriate to provide that food for domestic carnivores which is produced in the United Kingdom but contains no mammalian meat-and-bone meal originating in that country may be dispatched from its territory to other Member Slates or to third countries; (7) Whereas the United Kingdom has taken measures to destroy certain bovine tissues; (8) Whereas Commission Decision 96/239/EC of 27 March 1996 on emergency measures to protect against bovine spongiform encephalopathy10, prior to its amendment by Decision 96/362/EC", prohibited the dispatch from the United Kingdom to other O J N o l, 172, 7. 7. 1994, p. 23. O J N oL 55, 11. 3. 1995, p. 43. OJNoL 184, 24. 7. 1996, p. 43. O J N oL 78, 28. 3. 1996, p. 47. OJ No LI 39, 12. 6. 1996, p. 17. 10 li Member Slates and to third countries, in particular, of bovine semen, and certain other products from the United Kingdom obtained from bovine animals slaughtered in Ihe United Kingdom which are liable to enter the animal feed or human food chains and materials destined for use in medicinal products, cosmetics or pharmaceutical products; (9) Whereas the Scientific Veterinary Committee was consulted on 18 April 1996 and on 26 April 1996; whereas in the opinion of that Committee, bovine semen is considered to be safe for animal health with respect to BSE!; (10) Whereas the Scientific Committee on Cosmetology was consulted on Ihe safety of certain bovine products on 11 April 1996; whereas the Liaison Committee of F!uropean Associations of the Perfume, Cosmetic Products and Toiletries Industries (Colipa) has recommended its members not to use source materials from United Kingdom bovine animals; whereas that Committee has declared that its members follow that recommendation; whereas Commission Directive 97/1/EC of 10 January 1997 adapting to technical progress Annexes II, III, VI, and VII of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products l2, has provisionally prohibited the placing on the market of cosmetic products containing certain tissues and fluids; (11) Whereas the Scientilic Committee for Food was consulted on the safety of certain bovine products on 15 April 1996; (12) Whereas the Committee for Proprietary Medicinal Products was consulted on 16 April 1996; whereas the pharmaceutical sector had already introduced measures relating to the sourcing of materials and their treatment; whereas every medicinal product undergoes a pre-marketing approval before it is placed on the market by virtue of which the treatment process of any raw material is evaluated; whereas at the request of the F!uropean Medicines Evaluation Agency, all Community marketing authorization holders, or applicants with a positive opinion from the Committee for Proprietary 12 O J N oL 16, 18. 1. 1997, p. 85. Medicinal Products or the Committee for Veterinary Medicinal Products, have continued that the products concerned do not contain bovine tissue of United Kingdom origin; (13) Whereas subsequently, additional information was made available in order to facilitate a more complete risk assessment; whereas, on that basis, the Scientific Veterinary Committee on 26 April 1996 concluded that a combination of appropriate sourcing of bovine materials used and the application of minimum processing standards which have been shown effectively to inactivate the BSE agent together give good reassurances about the safety of those materials for food or cosmetic use; whereas, consequently, the Scientific Veterinary Committee has recommended safety parameters for the production of those materials which are therefore considered to be safe; (14) Whereas the Commission accordingly considered that certain products, such as gelatin and tallow, were safe; (15) Whereas in 1988 the United Kingdom introduced a requirement for animals affected with BSE to be completely destroyed; whereas the Council, at its meeting on 1, 2 and 3 April 1996, concluded that bovine animals over the age of 30 months should not enter the human food or animal feed chains or be used for cosmetic or pharmaceutical products; whereas such animals should not be used as source materials for certain bovine products; (16) Whereas furthermore, certain bovine tissues should not be used as source materials for those products; (17) Whereas Decision 96/362/EC amended Decision 96/239/EC to exempt certain products, such as gelatin, tallow and bovine semen, from the prohibition; (18) Whereas the Scientific Veterinary Committee at its meeting on 17 July 1996 endorsed the report of the sub-Group for BSE of 26 June 1996, where it recommended that the risk assessment for gelatin established by the Scientific Veterinary Committee on 26 April 1996 be reappraised in the light of the uncertainties as to the inactivation of the BSE agent, due note being taken of the requirements of Decision 96/362/EEC; (19) Whereas Decision 96/362/EC laid down certain preconditions which had to be met before the United Kingdom could dispatch from its territory gelatin made from raw materials from bovine animals; whereas those preconditions have not been fulfilled and such dispatch has not been authorized; whereas, however, in order to regularize the situation, pending further scientific knowledge and advice, it is appropriate to withdraw the possibility of dispatch of gelatin made from raw materials from bovine animals slaughtered in the United Kingdom for human food, animal feed, cosmetics, pharmaceutical and medical purposes; whereas that is in conformity with the advice from the Multi-disciplinary Scientific Committee of 3 April 1997, according to which no production can be considered safe if the base material used for gelatin production is potentially infectious; (20) Whereas the United Kingdom should be permitted to dispatch from its territory gelatin and di-calcium phosphate for technical purposes made from raw material from bovine animals slaughtered in the United Kingdom, provided that it is suitably labelled; (21) Whereas the United Kingdom should also be permitted to dispatch from its territory gelatin produced from raw material from bovine animals not slaughtered in the United Kingdom; whereas the United Kingdom has introduced a system of traceability for such gelatin to ensure that the origin of the raw material is identifiable; whereas the Community rules should be supplemented by formally introducing a system of traceability; whereas such a system should be introduced for other products which are exempted from the overall ban; whereas a system of labelling should also be introduced; (22) Whereas it is necessary to provide that products from bovine animals not slaughtered in the United Kingdom should come from approved establishments under official veterinary control which have a system in place to ensure traceability to the origin of the raw materials; whereas, however, dispatch of those products from the United Kingdom may take place immediately, without prior inspection by the Commission; (23) Whereas it is necessary to lay down appropriate guarantees for the dispatch from the United Kingdom of certain products obtained from bovine animals which were not slaughtered in the United Kingdom; (24) Whereas a reliable system of controls throughout the Community is a pre-condition for the smooth functioning of the beef market; whereas it is clear from the investigations by the Unit on Coordination of Fraud Prevention (UCLAF) and the Food and Veterinary OHice of the Commission that there are deficiencies in official controls on production of beef in the United Kingdom for dispatch to other Member States and third countries; whereas it is, therefore, necessary to reinforce the system of veterinary checks in order to prevent fraud; (25) Whereas reinforced checks should apply to all commercial consignments of fresh meat of bovine animals moving into, through or from the territory of the United Kingdom; whereas it is appropriate to require that all such consignments be sealed and unsealed by the competent authority and accompanied by veterinary certificates and, in the case of intra-Community trade, to require an official notification of the dispatch of a consignment by means of the ANIMO system as referred to in Commission Decision 91/398/EEC of 19 July 1991 on a computerised network linking veterinary authorities (ANIMO)" or by fax; (26) Whereas the veterinary supervision of the processing of meat derived from bovine animals slaughtered elsewhere than in the United Kingdom should also be reinforced; (27) Whereas the United Kingdom put forward a first proposal for an Export Certified Herds Scheme to the Commission on 25 February 1997; whereas the Scientific Veterinary 13 OJ No L 221, 9. 8. 1991, p. 30. Committee concluded at its meeting of II June 1997 that that proposal was not adequate; whereas the United Kingdom put forward a modified proposal dated 1 July 1997; whereas the Scientific Veterinary Committee issued an opinion on that revised proposal on 17 September 1997 stating that the major obstacle to approving the scheme for the entire territory of the United Kingdom was the lack of a comprehensive computerised movement and tracing system and associated database for live cattle in Great Britain but that an adequate system did appear to exist in Northern Ireland; whereas the Committee concluded furthermore that small modifications could be made to minor aspects of the scheme at the request of the competent Commission departments in order to comply with certification or control requirements; whereas the Food and Veterinary Office conducted a feasibility inspection in Northern Ireland from 3 to 7 November 1997; whereas the United Kingdom has agreed to further improvements in line with the recommendations made following that inspection; whereas, therefore, a partial lifting of the prohâwtion <m the dispatch of products from bovine animals slaughtered in Northern Ireland is appropriate; {28) Whereas inspections carried out by the Commission services have shown that the system of veterinary checks m Northern Ireland is more effective; whereas, therefore, a stcp4>y-s1ep approach is -appropriate, starting; with the ïiftiag of the prohibrtfons on the dispatch of products from bovine animals slaughtered, cut, processed ^tnd stored in estaMisbments exclusively used for products destined for dispatch to oilier Member States and third countries, located in Northern Ireland; whereas subsequent steps will include the lifting of the prohibition on the processing of oligible meat from Northern Ireland in Great Britain, under conditions which wiîl be laid down at a later stage; wliereas the Commission will immediately start investigating, with the authorities of the United Kingdom, by what means and under what conditions those restrictions may be farther relaxed; (29) Whereas in order to prevent fraud meat derived from bovine animals slaughtered in the United Kingdom should bear, in addition to the health mark provided for in Article 3(l)(A)(e) of Council Directive 64/433/JvlvC of 26 June 1964 on health conditions for (he production and marketing of fresh meat , as last amended by Directive 95/23/EC15, a distinct mark which cannot be confused with the Community health mark; (30) Whereas most of the provisions of Decision 94/474/EC are no longer in conformity with the opinion of the Scientific Veterinary Committee of 17 September 1997 and should therefore be deleted; (31) Whereas Decision 96/239/1 {C required the United Kingdom to provide reports on the BSE situation every two weeks; whereas that period has been found to be too short and should be extended to one month; (32) Whereas the Commission should continue to carry out Community inspections in the United Kingdom to verify the application of the measures provided for in this Decision; (33) Whereas the foregoing entails a fundamental reworking of Decision 96/239/EC; whereas, in the interests of clarity, that Decision should be repealed; (34) Whereas this Decision will be reviewed in the light of new scientific information; (35) Whereas the Standing Veterinary Committee has not given a favourable opinion, 14 '• OJ 121,29. 7. 1964, p. 2012/64 OJ L 2 4 3, 11. 10. 1995, p. 7. 10 HAS AIXXPTED THIS DECISION: (TIAI'TKKI Live bovine animals, bovine embryos, mcat-and-bonc meal and related products Article 1 Pending an overall examination of the situation, and notwithstanding Community provisions adopted to protect against USE, the United Kingdom shall ensure that the following are not dispatched from its territory to other Member States or to third countries: (a) live bovine animals and bovine embryos; (b) (e) meat meal, bone meal, and meat-and-bone meal of mammalian origin; animal feed and fertilizers containing material referred to in (b). Aâ3cje_2 By way of derogation from Article 1, food destined for domestic carnivores containing material referred to in Article I (b) may be dispatched to other Member Slates or to third countries provided that those materials did not originate from the United Kingdom and that the conditions laid down in Articles 9 and 10 are complied with. li CHAPTER II Materials derived from bovine animals slaughtered in the United Kingdom Article 3 Pending an overall examination of the situation, and notwithstanding Community provisions adopted to protect against BSE, the United Kingdom shall ensure that the following are not dispatched from its territory to other Member States or to third countries, when derived from bovine animals slaughtered in the United Kingdom: (a) (b) (e) meal; products which arc liable to enter the human food or animal feed chains; materials which are destined for use in cosmetics or medical or pharmaceutical products. Article 4 I. By way of derogation from Article 3, the United Kingdom may authorize the production and the dispatch from its territory to other Member States or to third countries of: (a) amino acids, peptides and tallow, which have been produced in establishments under official veterinary supervision which have been shown to be operating in accordance with the conditions set out in Annex I; (b) tallow products and products derived from tallow by saponification, transesterification or hydrolysis, where these are manufactured from tallow produced in accordance with this Article. 12 2. The United Kingdom shall ensure that the products referred to in paragraph 1 are labelled or otherwise identified to show the establishment of production and to indicate that they are suitable for use in human food, animal feed, cosmetics or medical or pharmaceutical products. 3. I he United Kingdom shall ensure that products referred to in paragraph 1 (a) which are dispatched to other Member States in accordance with this Article are accompanied by a health certificate issued by an official veterinarian stating that they conform to the conditions laid down in this Decision and attesting to the frequency of official controls carried out. 4. Before an establishment may commence or recommence the dispatch of products pursuant to this Article, the United Kingdom shall forward to the Commission and the other Member States the list of the establishments referred to in paragraph 1 (a), identifying for each establishment the purpose for which it has been approved. It shall notify the Commission and the other Member States immediately of any amendments to that list. 5. Community inspections shall be carried out on the implementation of official controls in respect of each of the products referred to in paragraph 1 before the dispatch of those products may commence or recommence. 6. The Commission, after having consulted the Member States in the framework of the Standing Veterinary Committee, shall set the date on which establishments may commence or recommence dispatch of the products referred to in paragraph 1 (a). Article 5 he United Kingdom shall ensure that gelatin, di-calcium phosphate, collagen, tallow, tallow products and products derived from tallow by saponification, transesterilication or hydrolysis which are produced for technical use from raw materials derived from bovine animals slaughtered in the United Kingdom are 13 labelled or otherwise identified to show the establishment of production and their unsuilability for use in human food, animal feed, cosmetics or medical or pharmaceutical products. Article 6 1. By way of derogation from Article 3, the United Kingdom may authorize the dispatch to other Member Slates or to third countries of the following products derived from bovine animals born and reared in Northern Ireland which have been slaughtered in Northern Ireland in slaughterhouses exclusively used for that purpose, in accordance with the conditions laid down in this Article, Article 7, Articles 9 to 12 and Annex II: (a) kfresh meat' as defined by Directive 64/433/EEC; (b) 'minced meal1 and 'meat preparations' as defined by Council Directive 94/65/1 •C"'; (c) 'meat products' as defined by Council Directive 77/99/EEC'7; 2. The fresh meat referred to in paragraph 1 (a) shall be deboned and all adherent tissues, including obvious nervous and lymphatic tissues shall be removed in cutting plants in Northern Ireland, exclusively used for eligible products. Cold storage shall take place in Northern Ireland in chambers exclusively used for eligible products. Cutting, storage and transport shall be carried out in accordance with the conditions laid down in this Article, Article 7, Articles 9 to 12 and Annex II. 3. The fresh meal referred to in paragraph 1 (a) may be used for the production of products referred to in paragraph 1 (b) and (c) in establishments in Northern Ireland 16 17 OJ No L 368, 31. 12. 1994, p. 10. OJ No L 26, 31. 1. 1977, p. 85. 14 exclusively used for eligible products, in accordance with the conditions laid down in this Article, in Article 7, Articles 9 to 12 and Annex II. 4. l'or the purposes of this Article, eligible products means products referred to in paragraph 1 and products derived from bovine animals not slaughtered in the United Kingdom which comply with the conditions laid down in Article 9 to 13. 5. The Commission, after having carried out Community inspections and after having informed the Member States, shall set the date on which dispatch of the products referred to in paragraph 1 may commence. 6. The Commission shall review the provisions of this Article at least every three months and shall take appropriate measures in accordance with the procedure laid down in Article 18 of Directive 89/662/EEC. Article 7 1. The meat and products referred to in Article 6(1) shall be marked or labelled with an additional distinct mark which cannot be confused with the Community health mark. 2. Meat and products as referred to in Article 6(1) which are destined for placing on the market in the I Jnited Kingdom shall not bear the additional mark referred to in paragraph 1 of this Arlicle. Where such a mark is present, it shall be cancelled or removed from the meal or cancelled from the label at the time that meat or those products leave the establishment. The Community health mark shall not be removed except where that is unavoidable in the cutting process. 3. The United Kingdom shall forward to the Commission and the other Member States the model of the additional mark referred to in paragraph 1 before dispatch commences. CHAPTER HI Materials derived from bovine animals not slaughtered in the United Kingdom Article 8 The United Kingdom shall ensure that the provisions of Articles 9 to 13 are complied with when the following products derived from bovine animals not slaughtered in the United Kingdom are dispatched from its territory to other Member Stales or to third countries: (a) 'fresh meat' as defined by Directive 64/433/EEC; (b) 'minced meat' and 'meat preparations' as defined by Council Directive 94/65/1 vC; (c) 'meat products" and 'other products of animal origin' as defined by Council Directive 77/99/EEC; (d)food which is destined for domestic carnivores; (e) gelatin and di-calcium phosphate, tallow, tallow products, and products derived from tallow by saponification, transesterification or hydrolysis, amino acids, peptides and collagen which are liable to enter the human food or animal feed chains, or are destined for use in cosmetics or medical or pharmaceutical products. 16 Article 9 I. The products referred to in Article 8 shall come from and, as appropriate, have passed through, establishments in the United Kingdom: (a) which have been approved by the competent authority; (b) which are under official veterinary supervision or, in the case of products derived from tallow by saponification, Iranscslerifixation or hydrolysis, under the supervision of the competent authority; (e) which have put in place a system of tracing of the raw material which will guarantee the origin of the material throughout the whole production chain; (d) which have put in place a registration system of amounts of incoming and outgoing materials to allow for cross-checking consignments entering or leaving; (e) in which the products are unloaded, processed, stored, handled, loaded and transported separately from, or at different times from, products which do not comply with the conditions laid down in this Article and Articles 10, 11 and 12. 2. The United Kingdom shall forward to the Commission and the other Member States the list of establishments which meet the conditions referred to in paragraph 1, identifying for each establishment the purpose for which it has been approved. It shall notify the Commission and the Member States immediately of any amendments to that list. 17 Article K> 1. Products referred to in Article 8 (a) to (d) shall come from and, as appropriate, have passed through establishments in the United Kingdom: (a) in which all unloading, processing, storage or other handling and loading of products takes place under official supervision; (b) in which the products are stored in cold stores in chambers which are not used at the same time for storing any bovine products which do not comply with the conditions laid down in this Article, in Articles 9, 11, 12 and 13 and are kept locked under the seal of the competent authority when the latter is not present; (c) in which the products, with the exception of the products referred to in Article 8 (d), are marked or labelled with an additional distinct mark which cannot be confused with the Community health mark; (d) in which the products eligible for dispatch from the United Kingdom under this Article and Articles 9, 11, 12 and 13, but destined for placing on the market in the United Kingdom do not bear the additional mark referred to in point (c). Where such a mark is present, it shall be cancelled or removed from the meat or cancelled from the label at the time that meat or those products leave the establishment. The United Kingdom shall forward to the Commission and the other Member States the model of the additional mark. 18 2. lor the purposes of the health marking and application of additional marks provided for in Community legislation, the competent authority shall keep and maintain under its responsibility: (a) the instruments intended for meat health marking and application of additional marks, which may be handed over to auxiliaries only at time of marking and for the length of time required for that purpose; (b) any labels bearing a health mark or an additional mark. Those labels shall be serially numbered and the requisite quantity shall may be given to auxiliaries at the time when they are to be used. 3. The products referred to in paragraph 1 shall be transported in means of transport that are sealed by the competent authority. When those products are dispatched to other Member States, they shall be accompanied by a health certificate issued by an official veterinarian staling that the conditions referred to in this Article and Articles 9, II, 12 and 13 are met, identifying all establishments where they were obtained, processed, handled or stored and identifying all labels and their serial numbers in the consignment. Meat shall be accompanied by the health certificate referred to in Annex IV to Directive 64/43 3/EEC identifying in the "Identification of Meat" section of the certificate all labels and their serial numbers in the consignment. The following words shall be added to all certificates: 'produced in accordance with Commission Decision [98/. /I. ÏC]' 4. The United Kingdom shall inform the competent authority of the place of destination of each consignment by means of the ANIMO system or by fax. 19 Article Without prejudice to Article 7 (2) and Article 10(1) (d), where products referred to in Article 8 (a) come from and, as appropriate, have passed through establishments in the United Kingdom, (he health marks shall not be removed except where that is unavoidable in the cutting process. Article 12 The products referred to in Article 8 (e) which are dispatched to other Member States shall be labelled in order to identify the establishment of production and to indicate that they have been produced in accordance with this Decision and, as appropriate, that they are suitable for use in human food, animal Iced, cosmetics or medical or pharmaceutical products. Article 13 1. A Member State which dispatches meat as referred to in Article 8 (a) from an establishment or Community approved border inspection post in its territory through the territory of the United Kingdom or to an establishment approved in accordance with Article 9 shall ensure that the meat is accompanied by a veterinary certificate issued by an official veterinarian or the certificate issued by the competent authority of the border inspection post. The originals of all certificates shall accompany the consignment to the establishment of its destination. 2. The meat as referred to in Article 8 (a) shall be transported in an officially sealed vehicle. 20 The seal may be broken only for official inspection purposes. 3. A Member Stale which dispatches products referred to in Article 8 (e) or any raw materials for use in the production of those products to an establishment approved in accordance with Article 9 shall ensure that they are labelled or otherwise identified to show the establishment and Member State in which they were produced. 21 UIAI'TKK IV Final provisions Article 14 The Commission shall carry out Community inspections on-the-spot in the United Kingdom to verify the application of the provisions of this Decision, in particular in relation to the implementation of official controls. Artklc 15 The United Kingdom shall send the Commission every month a report on the application of the protective measures taken against BSE, in accordance with national and Community provisions. Article 16 This Decision shall be reviewed regularly in the light of new scientific information. This Decision shall be amended, where appropriate, after consultation of the appropriate Scientific Committee, in accordance with the procedure laid down in Article 18 of Directive 89/662/EEC. Article 17 Member States shall adopt the necessary measures to comply with this Decision. They shall immediately inform the Commission thereof. 7. 2 Article 18 Decision 94/474/EC is hereby amended as follows: ( I ) Article 1 shall be deleted. (2) In Article 3, paragraphs I and 2 shall be deleted. (3) Article 4 shall be deleted. Decision 96/239/EC is hereby repealed. Article 19 Article 20 This Decision is addressed to the Member States. Done at Brussels, For the Council 23 ANNEX I Chapter 1 1. The following products may be exported from the United Kingdom in application of the provisions of Articles 4 to 7: (a) amino acids and peptides produced from hides and skins by a process which involves exposure of the material to a pH of 1 to 2, followed by a pH of >11, followed by heat treatment at 140°C for 30 minutes at 3 bar; (b) tallow and tallow products produced from material from animals lit for human consumption which has been subjected to one of the processes described in Chapter 2; (c) products derived from tallow by one of the processes described in Chapter 3. Products referred to in point I must be filtered after production. Bovine animals which are showing signs of BSE and animals over 30 months of age may not be used as source materials (as provided for by Commission Regulation (EC) No 716/96) for production of the products referred to in point 1 The following tissues may not be used for production of products referred to in point 1 skull, vertebral column, brain, spinal cord, eye, tonsil, thymus, intestine or spleen. 2. 3. 4. OJL 99, 20. 4. 1996, p. 14 o2V Chapter 2 Production standards for tallow produced in the United Kingdom from material A. derived from bovine animals slaughtered in the United Kingdom I. the Annex to the Annex to Commission Decision 92/562/EEC are achieved: fallow may be produced only in systems described in Chapters I to IV, VI and VII of 7 I , in which the following minimum conditions CHAPTER I (Batch/Atmospheric/Natural Fat) 150 mm particle size maximum Temperature Time >100°C 125 min >110°C 120 min >120°C 50min CHAPTER II (Batch/Pressure/Natural Pat) 50 mm particle size minimum Temperature lime Pressure (absolute) MX)°C 25 min 133°C 20 min 3 bar CHAPTER III (Continuous/Atmospheric/Natural Pat) 30 mm particle size maximum Temperature Time >100°C 95 min >110°C 55 min >120°C 13 min CHAPTER IV (Continuous/Atmospheric/Added Fat and Continuous/Pressure/Added Fat) A ND VI 30 mm particle size maximum Temperature rime > 100°C 16 min > 110°C 13 min > 120°C 8 min > 130°C 3 min CHAPTER VII(Continuou. s/Atnu>spheric/Defatted) 20 mm particle size maximum Temperature Time >80°C 120 min >100°C 60 min 21 O JL 359,9. 12. 1992, p. 23. 25 The above temperature/lime requirements may run concurrently. The United Kingdom may authorize plants only if they have been shown by 2. methods laid down in Section B to be operating in accordance with the conditions set out in point 1. Batch systems which achieve the parameters laid down in point 2 for continuous 3. systems operating in accordance with Chapters III, IV, VI or VII may also be authorized. B. Procedures for the validation of plants for the processing of animal waste of ruminant origin for the production of tallow in the United Kingdom, using methods described in the Annex to Decision 92/562/EEC 1. Temperature - continuous and batch systems Temperature monitoring devices must be situated regularly throughout the equipment in order to record temperature at different stages in the process. Records should be kept and calibrations completed at regular intervals. 2. Pressure (Chapter II only) Pressure monitoring devices must be installed in order to record pressure at stages in the process. Records must be kept and calibrations completed at regular intervals. 3. Particle size - all systems Jlo Chapter 3 Human food, animal feed, medical or pharmaceutical products, their starting materials or intermediate products fallow derivatives may be used provided that they are produced by an appropriate, validated and strictly certified method such as: 1. T ransesterilication or hydrolysis at not less than 200°C for not less than 20 minutes under pressure (glycerol, fatty acids and fatty acid esters production); or, 2. Saponification with NaOH 12 M (glycerol and soap production): in a batch process: at not less than 95"C for not less than 3 hours; or, in a continuous process: at not less than 140°C, 2 bars for not less than 8 minutes, or equivalent. Cosmetic products, starting materials or intermediate products fallow derivatives may be used provided that the following methods have been used and strictly certified by the producer: 1. 'I ransesterilication or I Iydrolysis at at least 200°C, 40 bars for 20 minutes (glycerol and fatty acids and esters); or, 2. Saponification with NaOH 12M (glycerol and soap): in a batch process: at 95°C for 3 hours; or, in a continuous process: at 140°C, 2 bars for 8 minutes or equivalent. n A1NNKX II 1. I )choncd fresh meat and products referred to in Article 6 ( I ) (b) and (c) from thai meal derived from bovine animals slaughtered in Northern Ireland may be dispatched from Northern Ireland in application of the provisions of Article 6 when obtained from eligible animals which originate from eligible herds. Eligible herds 2. A herd is a group of animals forming a separate and distinct unit, that is a group of animals which were managed, housed and kept separately from any other group of animals and which were identilied with unique herd and animal identification numbers. 3. A herd is eligible when for at least 8 years, there has been no confirmed case of BSK, nor a suspect ease for which the diagnosis of BSli has not been ruled out, in any animal which was still in or had moved through or from the herd. 4. As an exception to the provisions in point 2, a herd that has been in existence for less than 8 years may be considered eligible, after a thorough epidemiological investigation by the competent veterinary authority, on condition that: (a) all animals born or moved into the newly established herd complied with the conditions set out in point 6 (a), (c), (d) and (e); and, (b) the herd has complied with the conditions set out in point 3 during its entire existence. 5. If a herd is newly established on a holding which experienced a confirmed case of BSK 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 epidemiological investigation by the competent veterinary authority, taking into account compliance with each of the following conditions to the satisfaction of the competent veterinary authority: âr (a) all animals of the affected herd have been removed or killed; (b) all feed has been removed and destroyed and all feed containers thoroughly cleansed; (c) all buildings have been emptied and thoroughly cleansed before the new animals were admitted; (d) all conditions set out in point 4 have been complied with. Eligible animals 6. A bovine animal is eligible if it has been born and reared in Northern Ireland and at the time of slaughter: (a) all records of its birth, identity and movements arc recorded on an official computerised tracing system; (b) it is more than 6 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 6 months after its birth; (d) its dam has not developed BSE and is not suspected of having contracted BSli; (e) the herd of birth of the animal and all herds through which it has ever moved are eligible. 7. The official computerised tracing system referred to in point 6 (a) will be accepted only where it has been in operation for sufficient lime to contain all the information relating to the lifetime and movements of the animals needed to check compliance with the requirements of this Decision, and only in respect of animals born after the system came into operation. Historical data loaded into a computer for any period before the system was operational will not be accepted for this purpose. Controls 8. If any animal presented for slaughter or any circumstance surrounding its slaughter does not meet all of the requirements of this Decision, the animal must be J9 automatically rejected. If that information becomes available after slaughter, the competent authority must immediately cease issuing certificates, and cancel issued certificates. If dispatch has already taken place, the competent authority must notify the competent authority of the place ol destination. The competent authority of the place of destination must take the appropriate measures. (). Slaughter of eligible animals must take place in slaughterhouses exclusively used for that purpose. Cutting, deboning and processing must take place in establishments exclusively used for products which are eligible for dispatch to other Member Slates or third countries. Cold storage must lake place in chambers, exclusively used for products which are eligible for dispatch to other Member States or third countries. All establishments through which the products pass before such dispatch must be situated in Northern Ireland. 10. The competent authority must ensure that procedures used in the cutting plants ensure thai the following lymph nodes have been removed: Popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral iliac, renal prefemoral, lumbar, costocervical, sternal, prescapular, axilliary and caudal deep cervical. 11. Meat must be traceable back to the herd of the eligible animal by means of the computerised tracing system until the time of slaughter. After slaughter, labels must be capable of tracing fresh meat and products referred to in Article 6 ( 1 ) (b) and (c) back to the herd to enable the consignment concerned to be recalled. 12. All approved eligible carcasses must have individual numbers correlated with the ear tag number. 13. The I Inited Kingdom must have detailed protocols in place covering: (a) tracing and controls prior to slaughter; (b) controls during slaughter; (c) all labelling and certification requirements after slaughter to the point of sale. i o 14. The competent authority must set up a system for recording checks on compliance so that control can be demonstrated. The establishment 15. To obtain approval, the establishment must, in addition to all other requirements of this Decision, devise and implement a system whereby the eligible meat and/or eligible product is identifiable and all meat or products can be traced back to its herds of origin. The system must facilitate lull traceability oflhe meal or products at all stages and records must be retained for at least two years. Details of the system to be employed must be given, in writing, by the management oflhe establishment to the competent authority. 16. The competent authority must assess, approve and monitor the system provided by the establishment in order to ensure that it provides full segregation and traceability both backwards and forwards. 3i ISSN 0254-1475 COM(98) 161 final DOCUMENTS EN 03 05 02 15 Catalogue number : CB-CO-98-153-EN-C ISBN 92-78-31965-1 Office foi Official Publications of the European Communities L-2985 Luxembourg 2SL