2001R0999 — EN — 09.03.2005 — 016.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:





Amended by:









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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







THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof, Having regard to the proposal from the Commission ( 1 ), Having regard to the opinion of the Economic and Social Committee ( 2 ), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 3 ), Whereas: (1) Several distinct transmissible spongiform encephalopathies (TSEs) have for a number of years been recognised as occurring separately in humans and animals. Bovine spongiform encephalopathy (BSE) was first recognised in bovine animals in 1986 and in the following years was recognised as occurring in other species of animal. A new variant of Creutzfeldt-Jakob Disease (CJD) was described in 1996. Evidence continues to grow of the similarity between the BSE agent and that of the new variant of Creutzfeld-Jakob Disease. (2) Since 1990 the Community has adopted a series of measures to protect human and animal health from the risk of BSE. Those measures have been based on the safeguard provisions of Directives on animal-health measures. It is appropriate, in view of the magnitude of the risk posed to human and animal health by certain TSEs, to adopt specific rules for their prevention, control and eradication. (3) This Regulation directly concerns public health and is relevant to the functioning of the internal market. It covers products which are included in Annex I to the Treaty as well as products which are not. Consequently, it is appropriate to choose Article 152(4)(b) of the Treaty as the legal basis. (4) The Commission has obtained scientific opinions, in particular from the Scientific Steering Committee and the Scientific Committee on Veterinary Measures relating to Public Health, on several aspects of TSEs. Those opinions include advice on measures to reduce the potential risk for humans and animals resulting from exposure to infected animal products. (5) These rules should apply to the production and placing on the market of live animals and products of animal origin. However, it is not necessary for them to apply to cosmetic or medicinal products, medical devices or their starting materials or intermediate products, for which other specific rules, in particular on the non-use of specified risk material, apply. Nor should they apply to products of animal origin which do not pose a risk to animal or human health since they are intended for purposes other than the production of food, feed or fertiliser. It is appropriate to ensure that products of animal origin excluded from the scope of this Regulation are kept separate from those covered by it unless they meet at least the same health standards as the latter. (6) Provision should be made for safeguard measures to be taken by the Commission in cases where a risk from a TSE has not been adequately addressed by the competent authority of a Member State or third country. (7) A procedure should be established for the determination of the epidemiological status of a Member State, a third country and of one of their regions, hereinafter referred to as ‘countries or regions’ with respect to BSE, on the basis of the incident propagation and human exposure risk, using information available. Member States and third countries which choose not to apply for their status to be determined should be classified in a category by the Commission on the basis of all the information available to it. (8) Member States should institute education programmes for those involved in the prevention and control of TSEs, as well as for veterinarians, farmers and workers involved in the transportation, marketing and slaughter of farm animals. (9) Member States should carry out an annual programme for monitoring BSE and scrapie and should inform the Commission and the other Member States of the results and of the emergence of any other TSE. (10) Certain ruminant tissues should be designated as specified risk material on the basis of the pathogenesis of TSEs and the epidemiological status of the country or region of origin or residence of the animal concerned. The specified risk material should be removed and disposed of in a manner which avoids any risk to human or animal health. In particular, it should not be placed on the market to be used in the production of food, feed or fertiliser. However, provision should be made for an equivalent level of health protection by means of a screening test for TSEs carried out on individual animals as soon as it has been fully validated. Slaughter techniques presenting a risk of causing brain material to contaminate other tissues should not be permitted in countries or regions other than those presenting the lowest risk of BSE. (11) Measures should be taken to prevent the transmission of TSEs to humans or animals by prohibiting the feeding of certain categories of animal protein to certain categories of animal, and by prohibiting the use of certain ruminant materials in food. Those prohibitions should be proportionate to the risks involved. (12) The suspected presence of any TSE in any animal should be notified to the competent authority, which should immediately take all appropriate measures, including placing the suspect animal under movement restrictions while awaiting the results of the investigation or having it slaughtered under official supervision. If the competent authority cannot exclude the possibility of a TSE, it should have the appropriate investigations carried out and should keep the carcasse under official supervision until a diagnosis has been made. (13) In the event of official confirmation of the presence of a TSE, the competent authority should take all the necessary measures, including having the carcasse destroyed, carrying out an investigation in order to identify all animals at risk and placing movement restrictions on the animals and the products of animal origin identified as such. Owners should be compensated, as soon as possible, for the loss of animals and products of animal origin destroyed pursuant to this Regulation. (14) Member States should draw up contingency plans for the national measures to be implemented in the event of an outbreak of BSE. Those plans should be approved by the Commission. Provision should be made for extending this provision to TSEs other than BSE. (15) Provisions should be laid down covering the placing on the market of certain live animals and products of animal origin. Existing Community rules on the identification and registration of bovine animals provide for a system enabling the animals to be traced back to the dam and herd of origin in accordance with international standards. Equivalent guarantees should be provided for bovine animals imported from third countries. The animals and products of animal origin covered by Community rules, moving in intra-Community trade or imported from third countries, should be accompanied by the certificates required by the said rules, supplemented as appropriate in accordance with this Regulation. (16) The placing on the market of certain products of animal origin derived from bovine animals in high risk regions should be prohibited. However, that prohibition should not apply to certain products of animal origin produced under controlled conditions from animals which can be demonstrated not to pose a high risk of infection with a TSE. (17) It is necessary, in order to ensure that the rules concerning the prevention, control and eradication of TSEs are observed, for samples to be taken for laboratory testing on the basis of an established protocol which would give a full epidemiological picture of the situation as regards TSE. In order to guarantee uniform testing procedures and results, national and Community Reference Laboratories and reliable scientific methods, including rapid tests specifically for TSEs, should be established. Rapid tests should be used as far as possible. (18) Community inspections should be carried out in the Member States in order to ensure uniform implementation of the requirements concerning the prevention, control and eradication of TSEs and provision should also be made for the implementation of audit procedures. In order to ensure that guarantees equivalent to those applied by the Community are provided by third countries upon import into the Community of live animals and products of animal origin, Community on-the-spot inspections and audits should be carried out in order to verify that the import conditions are met by exporting third countries. (19) Trade measures for TSEs should be based on international standards, guidelines or recommendations, where they exist. However, scientifically justified measures resulting in a higher level of health protection may be adopted if measures based on the relevant international standards, guidelines or recommendations would not achieve the appropriate level of health protection. (20) This Regulation should be re-examined as new scientific information becomes available. (21) The necessary transitional measures in particular for regulating the use of specified risk material should be provided for in the framework of this Regulation. (22) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedure for the exercise of implementing powers conferred on the Commission ( 4 ). (23) In order to implement this Regulation, procedures should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, the Standing Committee on Feedingstuffs, and the Standing Committee on Foodstuffs. (24) Given that the provisions for the implementation of this Regulation are general measures within the meaning of Article 2 of Decision 1999/468/EC, they should be adopted in accordance with the regulatory procedure laid down in Article 5 of that Decision, Whereas: HAVE ADOPTED THIS REGULATION:







CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It shall apply to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof.

2. This Regulation shall not apply to:

(a) cosmetic or medicinal products or medical devices, or to their starting materials or intermediate products;

(b) products which are not intended for use in human food, animal feed or fertilisers, or to their starting materials or intermediate products;

(c) products of animal origin intended for exhibition, teaching, scientific research, special studies or analysis, provided those products are not eventually consumed or used by humans or by animals other than those kept for the research projects concerned;

(d) live animals used in or intended for research.

Article 2

Separation of live animals and of products of animal origin

In order to avoid cross-contamination or substitution between the live animals or of the products of animal origin referred to in Article 1(1) and the products of animal origin referred to in Article 1(2)(a), (b) and (c), or the live animals referred to in Article 1(2)(d), they shall be kept separate at all times unless such live animals or products of animal origin are produced under at least the same conditions of health protection in respect of TSEs.

Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 3

Definitions

1. For the purposes of this Regulation the following definitions shall apply:

(a) TSEs: all transmissible spongiform encephalopathies with the exception of those occurring in humans;

(b) placing on the market: any operation the purpose of which is to sell live animals or products of animal origin covered by this Regulation to a third party in the Community, or any other form of supply against payment or free of charge to such a third party or storage with a view to supply to such a third party;

(c) products of animal origin: any product derived from or containing a product derived from any animal covered by the provisions of Directive 89/662/EEC ( 5 ) or Directive 90/425/EEC ( 6 );

(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.

2. The specific definitions set out in Annex I shall also apply.

3. Where the terms in this Regulation are not defined in paragraph 1 or Annex I, the relevant definitions given in Regulation (EC) No 1760/2000 ( 7 ) and those given in or pursuant to Directives 64/432/EEC ( 8 ), 89/662/EEC, 90/425/EEC and 91/68/EEC ( 9 ) shall apply insofar as reference is made to them in this text.

Article 4

Safeguard measures

1. With regard to the implementation of safeguard measures, the principles and provisions set out in Article 9 of Directive 89/662/EEC, Article 10 of Directive 90/425/EEC, Article 18 of Directive 91/496/EEC ( 10 ) and Article 22 of Directive 97/78/EC ( 11 ) shall apply.

2. The safeguard measures shall be adopted in accordance with the procedure referred to in Article 24(2) and shall be notified at the same time to the European Parliament, stating the reasons.







CHAPTER II

DETERMINATION OF BSE STATUS

Article 5

Classification

1. The BSE status of a Member State, of a third country, or of one of their regions (hereinafter referred to as ‘countries or regions’) may be determined only on the basis of the criteria set out in Annex II, Chapter A, and the outcome of a risk analysis on the basis of all the potential factors for the appearance of bovine spongiform encephalopathy as defined in Annex II, Chapter B, and their development over time.

Member States, and third countries wishing to be retained on the list of third countries approved for the export to the Community of the live animals or of the products covered by this Regulation, shall submit to the Commission an application for their BSE status to be determined, accompanied by the relevant information on the criteria set out in Annex II, Chapter A, and on the potential risk factors specified in Annex II, Chapter B, and their development over time.

2. A decision on each application, placing the Member State or third country or region of the Member State or third country which submitted the application in one of the categories defined in Annex II, Chapter C, shall be adopted, taking account of the criteria and potential risk factors set out in paragraph 1, in accordance with the procedure referred to in Article 24(2).

This decision shall be taken within six months of the submission of the application and of the relevant information referred to in the second subparagraph of paragraph 1. If the Commission finds that the supporting evidence does not include the information laid down in Annex II, Chapters A and B, it shall ask for additional information to be provided within a period to be specified. The final decision shall then be taken within six months of the submission of all information.

After the International Office of Epizootic Diseases (OIE) has established a procedure for the classification of countries by category and if it has placed the applicant country in one of those categories, a re-assessment of the Community categorisation of the country concerned in accordance with the first subparagraph of this paragraph may be decided, if appropriate, in accordance with the procedure referred to in Article 24(2).

3. If the Commission finds that the information submitted by a Member State or a third country pursuant to Annex II, Chapters A and B, is insufficient or unclear, it may, in accordance with the procedure referred to in Article 24(2), determine the BSE status of the Member State or third country concerned on the basis of a full risk analysis.

Such a risk analysis must include a conclusive statistical survey of the epidemiological situation regarding TSEs in the applicant Member State or third country, on the basis of the use, in a screening procedure, of rapid tests. The Commission shall take into account the classification criteria used by the OIE.

The rapid tests shall be approved for that purpose in accordance with the procedure referred to in Article 24(2) and entered on a list set out in Annex X, Chapter C, point 4.

Such screening procedure may also be used by Member States or third countries which wish to have the classification they carried out on that basis approved by the Commission — in accordance with the procedure laid down in Article 24(2).

The cost of such screening procedure shall be borne by the Member State or third country concerned.

4. Member States or third countries which have not submitted an application in accordance with paragraph 1 within six months of 1 July 2001 shall, with respect to the dispatch from their territory of live animals and products of animal origin, be considered as countries in category 5, referred to in Annex II, Chapter C, until they have submitted such an application.

5. Member States shall notify the Commission as soon as possible of any epidemiological evidence or other information which might lead to a change in BSE status, in particular the results of the monitoring programmes provided for in Article 6.

6. The retention of a third country on one of the lists provided for by Community rules for the purpose of being allowed to export to the Community live animals and products of animal origin for which this Regulation provides specific rules shall be decided upon under the procedure laid down in Article 24(2) and shall be made conditional — in the light of the information available or where a TSE is presumed to be present — on the information provided for in paragraph 1 being supplied. In the event of refusal to supply the said information within three months of the date of the Commission's request, the provisions of paragraph 4 of this Article shall apply until this information has been submitted and evaluated in accordance with paragraphs 2 or 3.

The eligibility of third countries to export to the Community live animals, or products of animal origin for which this Regulation provides specific rules, under conditions based on their category as established by the Commission, shall be conditional upon their undertaking to notify the latter in writing as soon as possible of any epidemiological or other evidence which might lead to a change in BSE status.

7. A decision may be taken, under the procedure laid down in Article 24(2), to change the BSE classification of a Member State or third country, or of one of its regions, in accordance with the results of the checks provided for in Article 21.

8. The decisions referred to in paragraphs 2, 3, 4, 6 and 7 shall be based on a risk assessment, taking into consideration the recommended criteria set out in Annex II, Chapters A and B.







CHAPTER III

PREVENTION OF TSE

Article 6

Monitoring system

1. Each Member State shall carry out an annual programme for monitoring BSE and scrapie in accordance with Annex III, Chapter A. That programme shall include a screening procedure using rapid tests.

Rapid tests shall be approved for that purpose in accordance with the procedure referred to in Article 24(2) and listed in Annex X, Chapter C, point 4.

2. Each Member State shall inform the Commission and the other Member States, within the Standing Veterinary Committee, of the emergence of a TSE other than BSE.

3. All official investigations and laboratory examinations shall be recorded in accordance with Annex III, Chapter B.

4. Member States shall submit an annual report to the Commission covering at least the information referred to in Annex III, Chapter B, Part I. The report for each calendar year shall be submitted at the latest by 31 March of the following year. The Commission shall present a summary of the national reports covering at least the information referred to in Annex III, Chapter B, Part II, to the Standing Veterinary Committee within three months of the receipt of the said reports.

Article 7

Prohibitions concerning animal feeding

1. The feeding to ruminants of protein derived from mammals is prohibited.

2. Furthermore, the prohibition referred to in paragraph 1 shall be extended to animals and products of animal origin in accordance with point 1 of Annex IV.

3. Paragraphs 1 and 2 shall apply without prejudice to the provisions set out in point 2 of Annex IV.

4. Member States, or regions thereof, in category 5 shall not be permitted to export or store feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except for dogs and cats, which contains processed protein derived from mammals.

Third countries, or regions thereof, in category 5 shall not be permitted to export to the Community feed intended for livestock which contains protein derived from mammals or feed intended for mammals, except for dogs and cats, which contains processed protein derived from mammals.

5. Detailed rules for the implementation of this Article, in particular rules on the prevention of cross-contamination and on the methods of sampling and analysis required to check compliance with this Article, shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 8

Specified risk material

1. The specified risk material shall be removed and destroyed in accordance with points 2, 3, 4 and 8 of Annex V.

That specified risk material or the material processed therefrom may be placed on the market or, if need be, exported only for final destruction in accordance with points 3 and 4 or as appropriate 7(c) or 8 of Annex V. It may not be imported into the Community. Transit of specified risk material through Community territory must take place in accordance with the requirements of Article 3 of Directive 91/496/EEC.

2. Paragraph 1 shall not apply to tissues from animals which have undergone an alternative test approved for that distinct purpose in accordance with the procedure referred to in Article 24(2) and listed in Annex X, Chapter C, point 5, and applied under the conditions listed in point 5 of Annex V — and where the results of the test were negative.

The Member States which authorise that alternative test must inform the other Member States and the Commission.

3. In Member States, or regions thereof, which are placed in categories 2, 3, 4 and 5 referred to in Annex II, Chapter C, the laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity shall not be used on bovine, ovine or caprine animals whose meat is destined for human or animal consumption.

4. The data relating to age set out in Annex V shall be adjusted regularly. Such adjustments shall be based on the latest proven scientific findings concerning the statistical probability of the occurrence of a TSE in the relevant age groups of the Community's bovine, ovine and caprine population.

5. By way of derogation from paragraphs 1 to 4, a decision may be adopted, in accordance with the procedure referred to in Article 24(2), with regard to the date of effective enforcement of Article 7(1) or, as appropriate, in the third countries, the date of banning the use of mammalian protein in feed for ruminants in each country or region placed in category 3 or 4, in order to limit the application of this Article to animals born before that date in those countries or regions.

Similarly, by way of derogation from paragraphs 1 to 4, after consultation of the appropriate scientific committee and on the basis of an assessment of the incident, propagation and human exposure risk, a decision may be adopted in accordance with the procedure referred to in Article 24(2) to allow the use for food, feed and fertilisers of vertebral column and dorsal root ganglia from bovine animals in or coming from each country or region thereof placed in category 5.

6. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 9

Products of animal origin derived from or containing ruminant material

1. The products of animal origin listed in Annex VI shall not be produced from ruminant material from countries or regions thereof which are placed in category 5 unless they are produced in accordance with the production processes approved in accordance with the procedure referred to in Article 24(2).

2. Bones of the head, and vertebral columns of bovine, ovine and caprine animals from countries, or regions thereof, which are placed in categories 2, 3, 4 or 5, shall not be used for the production of mechanically recovered meat.

3. Paragraphs 1 and 2 shall not apply, in the light of the criteria set out in point 5 of Annex V, to ruminants which have undergone an alternative test which has been recognised in accordance with the procedure referred to in Article 24(2), where the results of the test were negative.

4. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 10

Education programmes

1. Member States shall ensure that staff of the competent authority, of diagnostic laboratories and colleges of agriculture and veterinary medicine, official veterinarians, veterinary practitioners, slaughterhouse personnel and animal breeders, keepers and handlers have been given training in the clinical signs, epidemiology and, in the case of staff responsible for carrying out checks, in interpreting laboratory findings relating to TSEs.

2. To ensure effective implementation of the education programmes provided for in paragraph 1, financial assistance from the Community may be granted. The amount of such assistance shall be determined in accordance with the procedure referred to in Article 24(2).







CHAPTER IV

CONTROL AND ERADICATION OF TSEs

Article 11

Notification

Without prejudice to Directive 82/894/EEC ( 12 ), the Member States shall ensure that any animal suspected of being infected by a TSE is notified immediately to the competent authorities.

Member States shall regularly inform each other and the Commission of the cases of TSE notified.

The competent authority shall without delay take the measures laid down in Article 12 of this Regulation, together with any other necessary measures.

Article 12

Measures with respect to suspect animals

1. Any animal suspected of being infected by a TSE shall be placed under an official movement restriction until the results of a clinical and epidemiological examination carried out by the competent authority are known, or killed for laboratory examination under official control.

If BSE is suspected in a bovine animal at a holding in a Member State, all other bovine animals from that holding shall be placed under an official movement restriction until the results of the examination are available.

If BSE is suspected in an ovine or caprine animal at a holding in a Member State on the basis of objective evidence such as the results of tests capable of differentiating in a practical way between the various TSEs, all other ovine and caprine animals from that holding shall be placed under an official movement restriction until the results of the examination are available.

If there is evidence that the holding where the animal was present when BSE was suspected is not likely to be the holding where the animal could have been exposed to BSE, the competent authority may decide that only the animal suspected of being infected shall be placed under an official movement restriction. If considered necessary, the competent authority may also decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available.

Under the procedure referred to in Article 24(2) and by way of derogation from the requirements of the second, third and fourth subparagraphs of this paragraph, a Member State may be exempted from the application of official restrictions on the movement of animals if it applies measures offering equivalent safeguards.

2. Where the competent authority decides that the possibility of infection with a TSE cannot be ruled out, the animal shall be killed, if it is still alive; its brain and all other tissues as the competent authority may determine shall be removed and sent to an officially approved laboratory, the national reference laboratory provided for in Article 19(1) or the Community reference laboratory provided for in Article 19(2), for examination in accordance with the testing methods laid down in Article 20.

3. All parts of the body of the suspect animal including the hide shall be retained under official control until a negative diagnosis has been made or shall be destroyed in accordance with Annex V, point 3 or 4.

4. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 13

Measures following confirmation of the presence of a TSE

1. When the presence of a TSE has been officially confirmed, the following measures shall be applied as soon as possible:

(a) all parts of the body of the animal shall be 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.

By way of derogation from this paragraph, Member States may apply other measures offering an equivalent level of protection, if those measures have been approved in accordance with the procedure referred to in Article 24(2).

2. Pending the implementation of the measures referred to in paragraph 1(b) and (c), the holding on which the animal was present when the presence of a TSE was confirmed shall be placed under official control and all movement of animals susceptible to TSEs and products of animal origin derived from them from or to the holding shall be subject to authorisation by the competent authority, with a view to ensuring immediate tracing and identification of the animals and products of animal origin concerned.

If there is evidence that the holding where the affected animal was present when the TSE was confirmed is not likely to be the holding where the animal was exposed to the TSE, the competent authority may decide that both holdings or only the holding of exposure shall be placed under official control.

3. Member States which have implemented a substitute scheme offering equivalent safeguards provided for in the fifth subparagraph of Article 12(1) may, by way of derogation from the requirements of paragraph 1(b) and (c), be exempted in accordance with the procedure referred to in Article 24(2) from the requirement to apply official restrictions on the movement of animals and from the requirement to kill and destroy animals.

4. Owners shall be compensated without delay for the loss of the animals that have been killed or products of animal origin destroyed in accordance with Article 12(2) and paragraph 1(a) and (c) of this Article.

5. Without prejudice to Directive 82/894/EEC, the confirmed presence of any TSE other than BSE shall be notified to the Commission on an annual basis.

6. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 14

Contingency plan

1. Member States shall draw up — in accordance with the general criteria of Community rules on the control of animal diseases — guidelines specifying the national measures to be implemented and indicating competences and responsibilities where cases of TSE are confirmed.

2. Where necessary to enable Community legislation to be applied uniformly, the guidelines may be harmonised in accordance with the procedure referred to in Article 24(2).







CHAPTER V

PLACING ON THE MARKET AND EXPORT

Article 15

Live animals, their semen, embryos and ova

1. Placing on the market or, if need be, export of bovine, ovine or caprine animals and their semen, embryos and ova shall be subject to the conditions laid down in Annex VIII, or, in the case of imports, to the conditions laid down in Annex IX. The live animals and their embryos and ova shall be accompanied by the appropriate animal health certificates as required by Community legislation, in accordance with Article 17 or, in the case of imports, Article 18.

2. The placing on the market of first generation progeny, semen, embryos and ova of TSE suspect or confirmed animals shall be subject to the conditions laid down in Annex VIII, Chapter B.

3. Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 16

Placing on the market of products of animal origin

1. The following products of animal origin derived from healthy ruminants shall not be subject to restrictions on placing on the market or, if need be, export pursuant to this Article, to Annex VIII, Chapters C and D, and to Annex IX, Chapters A, C, F and G:

(a) products of animal origin covered by Article 15, in particular semen, embryos and ova;

(i) raw milk within the meaning of Directive 92/46/EEC ( 13 ); (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 ( 14 ); (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). (b)

2. Products of animal origin imported from a third country placed in categories 2, 3, 4 and 5 must come from healthy bovine, ovine and caprine animals which have not been subjected to a laceration of the central nervous tissue as referred to in Article 8(3) or killed by means of a gas injected into the cranial cavity.

3. Products of animal origin containing materials obtained from bovine animals originating in a Member State, a region of a Member State or a third country classified in category 5 shall not be placed on the market unless they come from:

(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.

Furthermore, products of animal origin shall not be despatched from a Member State or a region of a Member State classified in category 5 to another Member State or be imported from a third country classified in category 5. That prohibition shall not apply to products of animal origin listed in Annex VIII, Chapter C, and fulfilling the requirements of Annex VIII, Chapter C. They must be accompanied by an animal health certificate issued by an official veterinarian certifying that they have been produced in conformity with this Regulation.

4. When an animal is moved from a country or a region to country or region included in another category, it shall be classified in the highest category of the countries or regions in which it has stayed over twenty-four hours unless adequate guarantees can be provided certifying that the animal has not received feedingstuffs from the country or region classified in the highest category.

5. Products of animal origin for which this Article lays down specific rules shall be accompanied by the appropriate animal health certificates or commercial documents as required by Community legislation in accordance with Articles 17 and 18 or, if such certificates or documents are not provided for in Community legislation, by a health certificate or commercial document the specimens of which shall be established in accordance with the procedure referred to in Article 24(2).

6. For the purpose of import into the Community, products of animal origin shall comply with the conditions laid down in Annex IX, Chapters A, C, F and G.

7. In accordance with the procedure referred to in Article 24(2), the provisions of paragraphs 1 to 6 may be extended to other products of animal origin. Rules for the implementation of this Article shall be adopted by the same procedure.

Article 17

Under the procedure referred to in Article 24(2), the health certificates referred to in Annex F to Directive 64/432/EEC, Models II and III in Annex E to Directive 91/68/EEC and the appropriate health certificates laid down by Community legislation relating to trade in the semen, embryos and ova of bovine, ovine or caprine animals shall be supplemented, where necessary, by a reference to the category specifying the classification of the Member State or region of origin given in accordance with Article 5.

Appropriate commercial documents relating to trade in products of animal origin shall be supplemented, where necessary, by a reference to the category of the Member State or region of origin given by the Commission in accordance with Article 5.

Article 18

The appropriate health certificates relating to imports provided for by Community legislation shall, under the procedure referred to in Article 24(2), be supplemented in respect of third countries classified in a category pursuant to Article 5 by the specific requirements laid down in Annex IX, as soon as that classification decision has been taken.







CHAPTER VI

REFERENCE LABORATORIES, SAMPLING, TESTING AND CONTROLS

Article 19

Reference laboratories

1. The national reference laboratories in each Member State and their functions and duties shall be those indicated in Annex X, Chapter A.

2. The Community reference laboratory and its functions and duties shall be those laid down in Annex X, Chapter B.

Article 20

Sampling and laboratory methods

1. Sampling and laboratory testing for the presence of a TSE shall be carried out using the methods and protocols laid down in Annex X, Chapter C.

2. Where necessary to ensure the uniform application of this Article, implementing rules, including the method to confirm BSE in ovine and caprine animals, shall be adopted in accordance with the procedure referred to in Article 24(2).

Article 21

Community controls

1. Experts from the Commission may make on-the-spot checks in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Regulation. The Member State in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.

The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 24(2).

2. Community checks concerning third countries shall be made in accordance with Articles 20 and 21 of Directive 97/78/EC.







CHAPTER VII

TRANSITIONAL AND FINAL PROVISIONS

Article 22

Transitional measures concerning specified risk material

1. The provisions of Annex XI, Part A shall apply for a period of at least six months from 1 July 2001 and shall cease to apply immediately following the date of adoption of a decision in accordance with Article 5(2) or (4), on which date Article 8 shall enter into force.

2. The results of a conclusive statistical survey carried out in accordance with Article 5(3) during the transitional period shall be used to confirm or overturn the risk analysis conclusions referred to in Article 5(1), while taking account of the classification criteria defined by the OIE.

3. After consultation of the appropriate scientific committee, detailed rules concerning that statistical survey shall be adopted in accordance with the procedure referred to in Article 24(2).

4. The minimum criteria to be met by this statistical survey shall be those laid down in Part B of Annex XI.

Article 23

Amendment of the annexes and transitional measures

After consultation of the appropriate scientific committee on any question which could have an impact on public health, the annexes shall be amended or supplemented and any appropriate transitional measures shall be adopted in accordance with the procedure referred to in Article 24(2).

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In accordance with that procedure, transitional measures shall be adopted for a period ending on 1 July 2005 at the latest, to permit the changeover from the current arrangements to the arrangements established by this Regulation.

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Article 24

Committees

1. The Commission shall be assisted by the Standing Veterinary Committee. However, for matters exclusively concerning animal feedingstuffs, the Commission shall be assisted by the Standing Committee on Feedingstuffs and, for matters exclusively concerning foodstuffs, by the Standing Committee on Foodstuffs.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, in compliance with Article 8 thereof.

The period referred to in Article 5(6) of that Decision shall be three months and, in the case of safeguard measures referred to in Article 4(2) of this Regulation, 15 days.

3. Each Committee shall adopt its rules of procedure.

Article 25

Consultation of the scientific committees

The appropriate scientific committees shall be consulted on any matter within the scope of this Regulation which could have an impact on public health.

Article 26

Entry into force

This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities.

It shall apply from 1 July 2001.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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ANNEX I

SPECIFIC DEFINITIONS

1. For the purpose of this Regulation, the following definitions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council ( 15 ), Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 16 ) and Council Directive 79/373/EEC ( 17 ) shall apply: (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.

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2. For the purpose of this Regulation, the following (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.

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ANNEX II

DETERMINATION OF BSE STATUS

CHAPTER A

The BSE status of a Member State or a third country or of one of their regions, hereinafter referred to as ‘country or region’, shall be determined on the basis of the following criteria:

(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).

CHAPTER B

The risk analysis referred to in Chapter A(a) shall be based on the following factors:

— 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.

CHAPTER C

Definition of categories

The BSE status of Member States or third countries or one of the regions thereof shall be determined by classification into the following categories:

A. CATEGORY 1 : Country or region free of BSE A country or region where a risk analysis based on the information laid down in Chapter B has been conducted which demonstrated that appropriate measures have been taken for the relevant period of time, to manage any risk identified and 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.

B. CATEGORY 2 : BSE provisionally free country or region where no indigenous case has been reported Country or region where a risk analysis as described in Chapter B has been conducted which demonstrates that appropriate measures have been taken for the relevant period of time to manage any risk identified, and 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.

C. CATEGORY 3 : BSE provisionally free country or region where at least one indigenous case has been reported Any country or region where a risk analysis based on the information referred to in Chapter B has been conducted which demonstrates that appropriate measures have been taken for the relevant period of time to manage any risk identified and: 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.

D. CATEGORY 4 : Country or region with low incidence of BSE Any country or region where: 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.

E. CATEGORY 5 : Country or region with high incidence of BSE Any country or region where: 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.

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ANNEX III

MONITORING SYSTEM

CHAPTER A

I. MONITORING IN BOVINE ANIMALS

1. General

Monitoring in bovine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3(1)(b).

2. Monitoring in animals slaughtered for human consumption

2.1. All bovine animals over 24 months of age: — subject to ‘special emergency slaughtering’ as defined in Article 2(n) of Council Directive 64/433/EEC ( 18 ), or — slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, except animals without clinical signs of disease slaughtered in the context of a disease eradication campaign, shall be tested for BSE.

2.2. All bovine animals over 30 months of age: — subject to normal slaughter for human consumption, or — slaughtered in the context of a disease eradication campaign in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, but showing no clinical signs of disease, shall be tested for BSE.

2.3. By way of derogation from point 2.2, and with regard to bovine animals born, reared and slaughtered on its territory, Sweden may decide to examine only a random sample. The sample shall comprise at least 10 000 animals per year.

3. Monitoring in animals not slaughtered for human consumption

3.1. All bovine animals over 24 months of age which have died or been killed but which were not: — killed for destruction pursuant to Commission Regulation (EC) No 716/96 ( 19 ), — killed in the framework of an epidemic, such as foot-and-mouth disease, — slaughtered for human consumption, shall be tested for BSE.

3.2. Member States may decide to derogate from the provisions of point 3.1 in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and submit a list of the derogated areas. The derogation shall not cover more than 10 % of the bovine population in the Member State.

4. Monitoring in animals purchased for destruction pursuant to Regulation (EC) No 716/96

4.1. All animals subject to casualty slaughter or found sick at ante mortem inspection shall be tested for BSE.

4.2. All animals over 42 months of age born after 1 August 1996 shall be tested for BSE.

4.3. A random sample comprising at least 10 000 animals annually of animals not covered by point 4.1 or 4.2 shall be tested for BSE.

5. Monitoring in other animals

In addition to the testing referred to in points 2 to 4, Member States may on a voluntary basis decide to test other bovine animals on their territory, in particular where those animals originate from countries with indigenous BSE, have consumed potentially contaminated feedingstuffs or were born or derived from BSE infected dams.

6. Measures following testing

6.1. Where an animal slaughtered for human consumption has been selected for testing for BSE, the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC shall not be carried out on the carcase of that animal until a negative result to the rapid test has been obtained.

6.2. Member States may derogate from the provisions of point 6.1 where an official system is in place in the slaughterhouse ensuring that no parts of examined animals bearing the health mark leave the slaughterhouse until a negative result to the rapid test has been obtained.

6.3. All parts of the body of an animal tested for BSE including the hide shall be retained under official control until a negative result to the rapid test has been obtained, unless they are disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council ( 20 ).

6.4. All parts of the body of an animal found positive to the rapid test including the hide shall be disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002, apart from material to be retained in conjunction with the records provided for in Chapter B(III).

6.5. Where an animal slaughtered for human consumption is found positive to the rapid test, at least the carcase immediately preceding the test-positive carcase and two carcases immediately following the test-positive carcase on the same slaughterline shall be destroyed in accordance with point 6.4, in addition to the test-positive carcase.

6.6. Member States may derogate from the provisions of point 6.5 where a system is in place in the slaughterhouse preventing contamination between carcase.

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II. MONITORING IN OVINE AND CAPRINE ANIMALS

1. General

Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2.(b).

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2. Monitoring in ovine and caprine animals slaughtered for human consumption

(a) Ovine animals Member States, in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals, shall test a minimum annual sample of 10 000 ovine animals slaughtered for human consumption in accordance with the sampling rules set out in point 4 ( 21 ).

(b) Caprine animals Member States shall test healthy slaughtered caprine animals in accordance with the sampling rules set out in point 4 and the minimum sample sizes listed in Table A. Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered caprine animals to reach its allotted minimum sample size, it may choose to replace a maximum of 50 % of its minimum sample size by testing dead caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3.



Table A Member State Minimum sample size in healthy slaughtered caprine animals (1) Spain 125 500 France 93 000 Italy 60 000 Greece 20 000 Cyprus 5 000 Austria 5 000 Other Member States all (1) Minimum sample sizes are set to take account of the size of the number of healthy slaughtered caprine animals and the prevalence of BSE in the individual Member State. They are also intended to provide achievable targets. The minimum sample sizes above 60 000 allow the detection of a prevalence of 0,0017 % with a 95 % confidence.

3. Monitoring in ovine and caprine animals not slaughtered for human consumption

Member States shall test in accordance with the sampling rules set out in point 4 and the minimum sample sizes indicated in table B and table C, ovine and caprine animals which have died or been killed, but which were not:

— killed in the framework of a disease eradication campaign, or

— slaughtered for human consumption.







Table B Member State population of ewes and ewe lambs put to the ram Minimum sample size of dead ovine animals (1) >750 000 10 000 100 000-750 000 1 500 40 000-100 000 500 <40 000 100 (1) Minimum sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets. The minimum sample sizes of 10 000, 1 500, 500 and 100 animals will allow the detection of a prevalence of 0,03 %, 0,2 %, 0,6 % and 3 % respectively with a 95 % confidence.







Table C Member State population of goats which have already kidded and goats mated Minimum sample size of dead caprine animals (1) >750 000 10 000 250 000-750 000 3 000 40 000-250 000 1 000 <40 000 100 % up to 200 (1) Minimum sample sizes are set to take account of the size of the caprine populations in the individual Member States and are intended to provide achievable targets. The minimum sample sizes of 10 000, 3 000, 1 000 and 200 animals will allow the detection of a prevalence of 0,03 %, 0,1 %, 0,3 % and 1,5 % respectively with a 95 % confidence.

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4. Sampling rules applicable to the animals referred to in points 2 and 3

The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.

The age of the animals shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.

The sample selection shall be designed with a view to avoid the over-representation of any group as regards the origin, age, breed, production type or any other characteristic.

Multiple sampling in the same flock shall be avoided, wherever possible.

The Member States shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling.

The sampling shall be representative for each region and season.

However, Member States may decide to exclude from the sampling remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and shall submit a list of those remote areas where the derogation applies. The derogation shall not cover more than 10 % of the ovine and caprine population in the Member State concerned.

5. Monitoring in infected flocks

From 1 October 2003, animals over 12 months or which have a permanent incisor erupted through the gum, and which are killed for destruction in accordance with the provisions of Annex VII, point 2(b)(i) or (ii) or point 2(c), shall be tested based on the selection of a simple random sample, in accordance with the sample size indicated in the following table.







Number of animals over 12 months or which have a permanent incisor erupted through the gum, killed for destruction in the herd or flock Minimum sample size 70 or less All eligible animals 80 68 90 73 100 78 120 86 140 92 160 97 180 101 200 105 250 112 300 117 350 121 400 124 450 127 500 or more 150

Where possible, the killing and subsequent sampling shall be delayed until the result of primary molecular testing carried out for the further examination of positive scrapie cases under the provisions of Annex X, Chapter C, point 3.2.(c)(i) is known.

6. Monitoring in other animals

In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary basis carry out monitoring in other animals, in particular:

— animals used for dairy production,

— animals originating from countries with indigenous TSEs,

— animals which have consumed potentially contaminated feedingstuffs,

— animals born or derived from TSE infected dams.

7. Measures following testing of ovine and caprine animals

7.1. Where an ovine or caprine animal slaughtered for human consumption has been selected for TSE testing in accordance with point 2, its carcase shall not be marked with the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC until a negative result to the rapid test has been obtained.

7.2. Member States may derogate from point 7.1. where a system approved by the competent authority is in place in the slaughterhouse ensuring that all parts of an animal can be traced and that no parts of the animals tested bearing the health mark can leave the slaughterhouse until a negative result to the rapid test has been obtained.

7.3. All parts of the body of a tested animal, including the hide, shall be retained under official control until a negative result has been obtained to the rapid test, except for animal by-products directly disposed of in accordance with Articles 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.

7.4. Except for the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, all parts of the body of an animal found positive to the rapid test, including the hide, shall be directly disposed of in accordance with Articles 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.

8. Genotyping

8.1. The prion protein genotype shall be determined for each positive TSE case in sheep. TSE cases found in resistant genotypes (sheep of genotypes which encode alanine on both alleles at codon 136, arginine on both alleles at codon 154 and arginine on both alleles at codon 171) shall immediately be reported to the Commission. Where possible, such cases shall be submitted for strain-typing. Where strain-typing of such cases is not possible, the herd of origin and all other herds where the animal has been kept shall be subjected to enhanced monitoring with a view to finding other TSE cases for strain-typing.

8.2. In addition to the animals genotyped under the provisions of point 8.1., the prion protein genotype of a minimum sample of ovine animals shall be determined. In the case of Member States with an adult sheep population of more than 750 000 adult animals, this minimum sample shall consist of at least 600 animals. In the case of other Member States the minimum sample shall consist of at least 100 animals. The samples may be chosen from animals slaughtered for human consumption, from animals dead-on farm or from live animals. The sampling should be representative of the entire ovine population.

III. MONITORING IN OTHER ANIMAL SPECIES

Member States may on a voluntary basis carry out monitoring for TSEs in animal species other than bovine, ovine and caprine animals.

CHAPTER B

Reporting and recording requirements

I. REQUIREMENTS ON MEMBER STATES

A. Information to be presented by Member States in their annual report as provided for in Article 6(4)

1. The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species.

2. The number of suspected cases subject to laboratory examination in accordance with Article 12(2), per animal species, including the results of the rapid and confirmatory tests (number of positives and negatives) and, with regard to bovine animals, an estimation of the age distribution of all tested animals. The age distribution should be grouped whenever possible as follows: ‘below 24 months’, distribution per 12 months between 24 and 155 months, and ‘above 155 months’ of age.

3. The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2).

4. The number of bovine animals tested within each subpopulation referred to in Chapter A, Part (I), points 2.1., 2.2., 2.3., 3.1., 4.1., 4.2., 4.3. and 5. The method for the sample selection, the results of the rapid and confirmatory tests and an estimation of the age distribution of the tested animals grouped as set out in point 2 shall be provided.

5. The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3 and 5 together with the method for sample selection and the results of the rapid and confirmatory tests.

6. The geographical distribution, including the country of origin if not the same as the reporting country, of positive cases of BSE and scrapie. The year, and where possible the month of birth shall be given for each TSE case in bovine, ovine and caprine animals. TSE cases which have been considered atypical and the reasons why shall be indicated. For scrapie cases, the results of the primary molecular testing with a discriminatory immuno-blotting, referred to in Annex X, Chapter C, point 3.2.(c)(i), shall be reported.

7. In animals other than bovine, ovine and caprine, the number of samples and confirmed TSE cases per species.

8. The genotype, and where possible the breed, of each ovine animal either found positive to TSE or sampled in accordance with Chapter A, Part II, points 8.1. and 8.2.

B. Reporting periods

The compilation of reports containing the information referred to in A and forwarded to the Commission on a monthly basis or, with regard to the information referred to in point 8 on a quarterly basis, may constitute the annual report as required by Article 6(4), provided that the information is updated whenever additional information becomes available.

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II. INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS SUMMARY

The summary shall be presented in a tabled format covering at least the information referred to in part I for each Member State.

III. RECORDS

1. The competent authority shall keep, for seven years, records of: — the number and types of animals placed under movement restrictions as referred to in Article 12(1), — the number and outcome of clinical and epidemiological investigations as referred to in Article 12(1), — the number and outcome of laboratory examinations as referred to in Article 12(2), — the number, identity and origin of animals sampled in the framework of the monitoring programmes as referred to in Chapter A and, where possible, age, breed and anamnestic information, — the prion protein genotype of positive TSE cases in sheep.

2. The investigating laboratory shall keep, for seven years, all records of testing, in particular laboratory workbooks and, where appropriate, paraffin blocks and photographs of western blots.

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ANNEX IV

ANIMAL FEEDING

Extension of the prohibition provided for in Article 7(1)

1. The prohibition provided for in Article 7(1) shall be extended to the feeding: (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.

2. I. Derogations from the prohibitions provided for in Article 7(1) and (2), and specific conditions for the application of such derogations. A. The prohibitions provided for in Article 7(1) and (2) shall not apply to: (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. B. Conditions for the use of fishmeal and feedingstuffs containing fishmeal in the feeding of non-ruminant farmed animals with the exception of carnivorous fur producing animals. (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 ( 22 ). (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. C. Conditions for the use of hydrolysed proteins derived from non-ruminants or from ruminant hides and skins, and feedingstuffs containing such proteins, in the feeding of non-ruminant farmed animals, with the exception of the feeding of carnivorous fur producing animals. (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. D. Conditions for the use of dicalcium phosphate, tricalcium phosphate and feedingstuffs containing such proteins in the feeding of non-ruminant farmed animals with the exception of the feeding of carnivorous fur producing animals. (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. E. Conditions for the use of blood products, bloodmeal and feedingstuffs containing such proteins of non-ruminant origin in the feeding of farmed fish: (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.

3. II. General implementing conditions A. Member States shall make available to the other Member States and to the Commission an up-to-date list of EU approved slaughterhouses registered as not slaughtering ruminants and approved processing establishments producing hydrolysed proteins, dicalcium phosphate, tricalcium phosphate, fishmeal, blood products or bloodmeal and establishments, with the exception of home compounders, authorised for manufacturing feedingstuffs containing these proteins, which operate in accordance with the conditions laid down by this Regulation within 60 days from the date of entry into force of this Regulation. Any amendments to the list shall immediately be made available to the other Member States and to the Commission. B. (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. C. Feedingstuffs, including petfood, which contain processed animal proteins, other than fishmeal or bloodmeal of non-ruminant origin, or blood products of ruminant origin shall not be manufactured in establishments which produce feedingstuffs for farmed animals, with the exception of carnivorous fur producing animals. Petfood and feedingstuffs intended for carnivorous fur producing animals containing fishmeal, hydrolysed proteins referred to in point A(a)(ii) of part I, dicalcium phosphate and 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 manufactured and transported in accordance with the provisions referred to in points B(c) and (e), C(b) and (d), D(b) and (d) and E(c) and (e), respectively of part I. D. The export to third countries of processed animal proteins derived from ruminants, and of products containing such processed animal proteins, shall be prohibited. The export of other processed animal proteins and blood products and products containing such proteins shall only be permitted subject to the following conditions: — 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. Member States which allow such exportation shall inform the Commission and the other Member States of all terms and conditions as agreed with the third country concerned, for the effective implementation of this Regulation, in the context of the Standing Committee on the Food Chain and Animal Health. The measures in this point shall not apply to fishmeal, provided it fulfils the conditions set out in point B, products containing such fishmeal, and petfood. E. The competent authority shall carry out documentary and physical checks including tests on feedingstuffs throughout the production and distribution chain in accordance with Council Directive 95/53/EC ( 23 ), to control compliance with its provisions and the provisions of this Regulation. Where any presence of prohibited animal protein is detected, Council Directive 95/53/EC shall apply. F. The provisions on the production and the use of processed animal protein of Regulation (EC) No 1774/2002 shall apply to the feedingstuffs covered by this Annex.

▼B









ANNEX V

SPECIFIED RISK MATERIAL

1. The following tissues shall be designated as specified risk material depending on the category of the Member State or third country of origin or residence of the animal, determined in accordance with Article 5: 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.

2. Specified risk material must be removed at: (a) slaughterhouses; (b) cutting plants, high-risk processing plants or premises referred to in Articles 3 and 7 of Directive 90/667/EEC ( 24 ), under the supervision of a designated agent appointed by the competent authority. Those establishments shall be approved for that purpose by the competent authority. However, the vertebral column may be removed at points of sale to the consumer situated in the territory of the Member State concerned. Where specified risk material is not removed from dead animals which have not been slaughtered for human consumption, the parts of the body containing specified risk material or the entire body will be treated as specified risk material.

3. All specified risk material must be stained with a dye and, as appropriate, marked with a marker immediately on removal, and completely destroyed: (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 ( 25 ): — by incineration; — by co-incineration; (ii) in accordance with at least the standards referred to in Annex I to Decision 1999/534/EC ( 26 ), by burial in an approved landfill site.

4. Member States may derogate from the provisions of points 2 and 3 to allow the incineration or burial of specified risk material or entire bodies, without prior staining, or, as appropriate, removal of the specified risk materials, in the circumstances set out in Article 3(2) of Directive 90/667/EEC and by a method which precludes all risk of transmission of a TSE and is authorised and supervised by the competent authority, in particular where animals have died or have been killed in the context of disease control measures and without prejudice to Articles 12 and 13.

5. The use of an alternative test to the removal of specified risk material may be authorised under the following conditions: (a) tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material; (b) no bovine, ovine or caprine product intended for human food or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them; (c) when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse is destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate.

6. Member States are to carry out frequent official inspections to verify the correct application of this Annex and ensure that measures are taken to avoid contamination, particularly in slaughterhouses, cutting plants, animal waste processing plants, high risk processing plants or premises authorised by the Member States in accordance with Article 7 of Directive 90/667/EEC, points of sale to the consumer, landfill sites and other facilities for storage or incineration.

7. Member States shall in particular set up a system to ensure and check that: (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.

8. Member States may send specified risk material or the material processed therefrom to other Member States for incineration only under the conditions laid down in Article 4(2) of Decision 97/735/EC ( 27 ), where applicable. These points may be amended at the request of a Member State to allow the dispatch of specified risk material or the material processed therefrom to third countries for incineration. The conditions governing export shall be adopted at the same time, by the same procedure.









ANNEX VI

STANDARDS FOR CERTAIN PRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING RUMINANT MATERIAL

The use of ruminant material for the production of the following products of animal origin is prohibited as referred to in Article 9(1):

(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 produce