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,
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;
(b) (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).
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).
In accordance with that procedure, transitional measures shall be adopted for a maximum period of two years to permit the change-over from the current arrangements to the arrangements established by this Regulation.
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.
Done at Brussels, 22 May 2001.