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Regulation (EC) No 999/2001 of the European Parliament and of the CouncilShow full title

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

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  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Scope

    2. Article 2.Separation of live animals and of products of animal origin

    3. Article 3.Definitions

    4. Article 4.Safeguard measures

  3. CHAPTER II DETERMINATION OF BSE STATUS

    1. Article 5.Classification

  4. CHAPTER III PREVENTION OF TSE

    1. Article 6.Monitoring system

    2. Article 6a. Breeding Programmes

    3. Article 7.Prohibitions concerning animal feeding

    4. Article 8.Specified risk material

    5. Article 9.Products of animal origin derived from or containing ruminant material

    6. Article 10.Education programmes

  5. CHAPTER IV CONTROL AND ERADICATION OF TSEs

    1. Article 11.Notification

    2. Article 12.Measures with respect to suspect animals

    3. Article 13.Measures following confirmation of the presence of a TSE

    4. Article 14.Contingency plan

  6. CHAPTER V PLACING ON THE MARKET AND EXPORT

    1. Article 15.Live animals, their semen, embryos and ova

    2. Article 16.Placing on the market of products of animal origin

    3. Article 17.Under the procedure referred to in Article 24(2), the health...

    4. Article 18.The appropriate health certificates relating to imports provided for by...

  7. CHAPTER VI REFERENCE LABORATORIES, SAMPLING, TESTING AND CONTROLS

    1. Article 19.Reference laboratories

    2. Article 20.Sampling and laboratory methods

    3. Article 21.Community controls

  8. CHAPTER VII TRANSITIONAL AND FINAL PROVISIONS

    1. Article 22.Transitional measures concerning specified risk material

    2. Article 23.Amendment of the annexes and transitional measures

    3. Article 23a.The following measures which are designed to amend non-essential elements...

    4. Article 24. Committees

    5. Article 24a.Decisions to be adopted in accordance with one of the...

    6. Article 25.Consultation of the scientific committees

    7. Article 26.Entry into force

  9. Signature

    1. ANNEX I

      SPECIFIC DEFINITIONS

      1. 1. For the purpose of this Regulation, the following definitions set...

      2. 2. For the purpose of this Regulation, the following definitions shall...

    2. ANNEX II

      DETERMINATION OF BSE STATUS

      1. CHAPTER A Criteria

      2. CHAPTER B Risk analysis

        1. 1. Structure of the risk analysis

        2. 2. Release assessment (external challenge)

          1. 2.1. The release assessment shall consist of assessing the likelihood that...

          2. 2.2. Special eradication schemes, surveillance and other epidemiological investigations (especially surveillance...

        3. 3. Exposure assessment

      3. CHAPTER C Definition of categories

        1. I. COUNTRY OR REGION WITH A NEGLIGIBLE BSE RISK

        2. II. COUNTRY OR REGION WITH A CONTROLLED BSE RISK

        3. III. COUNTRY OR REGION WITH UNDETERMINED BSE RISK

      4. CHAPTER D Minimal surveillance requirements

        1. 1. Surveillance types

        2. 2. Surveillance strategy

          1. 2.1. The surveillance strategy shall be designed to ensure that samples...

          2. 2.2. In order to implement the surveillance strategy for BSE, a...

        3. 3. Points values and point targets

        4. 4. Specific targeting

        5. 5. BSE surveillance model

        6. 6. Maintenance surveillance

    3. ANNEX III

      MONITORING SYSTEM

      1. CHAPTER A

        1. I. MONITORING IN BOVINE ANIMALS

          1. 1. General

          2. 2. Monitoring in animals slaughtered for human consumption

            1. 2.1. All bovine animals over 24 months of age:

            2. 2.2. All bovine animals over 30 months of age:

            3. 2.3. . . . . . . . . . ....

          3. 3. Monitoring in animals not slaughtered for human consumption

            1. 3.1. All bovine animals over 24 months of age which have...

            2. 3.2. Member States may decide to derogate from the provisions of...

          4. 4. Monitoring in animals purchased for destruction pursuant to Regulation (EC)...

          5. 5. Monitoring in other animals

          6. 6. Measures following testing

            1. 6.1. Where an animal slaughtered for human consumption has been selected...

            2. 6.2. Member States may derogate from the provisions of point 6.1...

            3. 6.3. All parts of the body of an animal tested for...

            4. 6.4. All parts of the body of an animal found positive...

            5. 6.5. Where an animal slaughtered for human consumption is found positive...

            6. 6.6. Member States may derogate from the provisions of point 6.5...

          7. 7. Revision of the annual monitoring programmes concerning BSE (BSE monitoring...

            1. 7.1. Member States’ applications

            2. 7.2. Epidemiological criteria

        2. II. MONITORING IN OVINE AND CAPRINE ANIMALS

          1. 1. General

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

            1. (a) Member States in which the population of ewes and ewe...

            2. (b) Member States in which the population of goats which have...

            3. (c) Where a Member State experiences difficulty in collecting sufficient numbers...

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

          4. 4. Sampling rules applicable to the animals referred to in points...

          5. 5. Monitoring in infected flocks

          6. 6. Monitoring in other animals

          7. 7. Measures following testing of ovine and caprine animals

            1. 7.1. Where an ovine or caprine animal slaughtered for human consumption...

            2. 7.2. Member States may derogate from point 7.1. where a system...

            3. 7.3. All parts of the body of a tested animal, including...

            4. 7.4. Except for the material to be retained in conjunction with...

          8. 8. Genotyping

            1. 8.1. The prion protein genotype for the codons 136, 154 and...

            2. 8.2. In addition to the animals genotyped in accordance with point...

        3. III. MONITORING IN OTHER ANIMAL SPECIES

      2. CHAPTER B REPORTING AND RECORDING REQUIREMENTS

        1. I. REQUIREMENTS ON MEMBER STATES

          1. A. Information to be presented by Member States in their annual...

            1. 1. The number of suspected cases placed under official movement restrictions...

            2. 2. The number of suspected cases subject to laboratory examination in...

            3. 3. The number of flocks where suspected cases in ovine and...

            4. 4. The number of bovine animals tested within each subpopulation referred...

            5. 5. The number of ovine and caprine animals and flocks tested...

            6. 6. The geographical distribution, including the country of origin if not...

            7. 7. In animals other than bovine, ovine and caprine, the number...

            8. 8. The genotype, and where possible the breed, of each ovine...

          2. B. Reporting periods

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

        3. III. RECORDS

          1. 1. The competent authority shall keep, for seven years, records of:...

          2. 2. The investigating laboratory shall keep, for seven years, all records...

    4. ANNEX IV

      ANIMAL FEEDING

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

      2. II. Derogations from the prohibitions provided for in Article 7(1) and...

      3. III. General implementing conditions

    5. ANNEX V

      SPECIFIED RISK MATERIAL

      1. 1. Definition of specified risk material

      2. 2. Derogation for Member States

      3. 3. Marking and disposal

      4. 4. Removal of specified risk material

        1. 4.1. Specified risk material shall be removed at:

        2. 4.2. By way of derogation from point 4.1, the use of...

        3. 4.3. By way of derogation from point 4.1, Member States may...

        4. 4.4. The rules on removal of specified risk material laid down...

      5. 5. Measures concerning mechanically separated meat

      6. 6. Measures concerning laceration of tissues

      7. 7. Harvesting of tongues from bovine animals

      8. 8. Harvesting of bovine head meat

        1. 8.1. Head meat of bovine animals above 12 months of age...

        2. 8.2. By way of derogation from the requirements of point 8.1,...

        3. 8.3. If the harvesting is performed without removing the bovine head...

      9. 9. Harvesting of bovine head meat in authorised cutting plants

      10. 10. Rules on trade and export

        1. 10.1. Member States may allow dispatch of heads or of un-split...

        2. 10.2. By way of derogation from point 10.1, carcasses, half carcasses...

        3. 10.3. Exports outside the Community of heads and of fresh meat...

      11. 11. Controls

        1. 11.1. Member States shall carry out frequent official controls to verify...

        2. 11.2. Member States shall in particular set up a system to...

        3. 11.3. A control system shall be put in place for the...

    6. ANNEX VI

      PRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING RUMINANT MATERIAL, AS REFERRED TO IN ARTICLE 9(1)

      1. The use of ruminant material for the production of the...

      2. mechanically recovered meat; dicalcium phosphate intended as feedingstuffs for livestock;...

    7. ANNEX VII

      ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY

      1. CHAPTER A Measures following confirmation of the presence of a TSE

        1. 1. The inquiry referred to in Article 13(1)(b) must identify:

        2. 2. The measures laid down in Article 13(1)(c) shall comprise at...

        3. 3. Following the application on a holding of the measures referred...

        4. 4. Following the application on a holding of the measures set...

        5. 5. Following the application of the derogation provided for in point...

        6. 6. Member States applying the measures set out in point 2.3(b)(iii)...

      2. CHAPTER B Minimum requirements for a breeding programme for resistance to TSEs...

        1. PART 1 General requirements

          1. 1. The breeding programme shall concentrate on flocks of high genetic...

          2. 2. A database shall be established containing at least the following...

          3. 3. A system of uniform certification shall be established in which...

          4. 4. A system for the identification of animals and samples, the...

          5. 5. Genotyping of blood or other tissues collected for the purposes...

          6. 6. The competent authority of the Member State may assist breed...

          7. 7. Breeding programmes shall be drawn up for each breed, taking...

        2. PART 2 Specific rules for participating flocks

          1. 1. The breeding programme shall be aimed at increasing the frequency...

          2. 2. The minimum requirements for participating flocks shall be the following:...

          3. 3. Member States may decide to grant derogations from the requirements...

          4. 4. Member States shall inform the Commission of derogations granted under...

        3. PART 3 The framework for the recognition of the TSE-resistant status of...

          1. 1. The framework shall recognise the TSE-resistant status of flocks of...

          2. 2. Regular random sampling of sheep from TSE-resistant flocks shall be...

        4. PART 4 Reports to be provided to the Commission by the Member...

    8. ANNEX VIII

      PLACING ON THE MARKET AND EXPORT

      1. CHAPTER A Conditions for intra-Community trade in live animals, semen and embryos

        1. I. CONDITIONS WHICH APPLY TO OVINE.AND CAPRINE.ANIMALS AND SEMEN AND EMBRYOS...

        2. II. CONDITIONS WICH APPLY TO BOVINE ANIMALS

      2. CHAPTER B

        1. Conditions relating to progeny of TSE suspect or confirmed animals...

      3. CHAPTER C Conditions for intra-Community trade in certain products of animal origin

        1. SECTION A Products

        2. SECTION B Requirements

      4. CHAPTER D

        1. Conditions applicable to exports

    9. ANNEX IX

      IMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS, EMBRYOS, OVA AND PRODUCTS OF ANIMAL ORIGIN

      1. CHAPTER A

      2. CHAPTER B Imports of bovine animals

        1. SECTION A Imports from a country or a region with a negligible BSE risk

        2. SECTION B Imports from a country or a region with a controlled BSE risk

        3. SECTION C Imports from a country or a region with undetermined BSE risk

      3. CHAPTER C Imports of products of animal origin from bovine, ovine or caprine animals

        1. SECTION A Products

        2. SECTION B Imports from a country or a region with a negligible BSE risk

        3. SECTION C Imports from a country or a region with a controlled BSE risk

          1. 1. Imports of products of bovine, ovine and caprine animal origin...

          2. 2. By way of derogation from point 1(d) carcasses, half carcasses...

          3. 3. When removal of the vertebral column is not required, carcasses...

          4. 4. The number of bovine carcasses or wholesale cuts of carcasses,...

          5. 5. In the case of intestines originally sourced from a country...

        4. SECTION D Imports from a country or a region with an undetermined BSE risk

          1. 1. Imports of products of bovine, ovine and caprine animal origin...

          2. 2. By way of derogation from point 1(c), carcasses, half carcasses...

          3. 3. When removal of the vertebral column is not required, carcasses...

          4. 4. Specific information on the number of bovine carcasses or wholesale...

          5. 5. In the case of intestines originally sourced from a country...

      4. CHAPTER D Imports of animal by-products and processed products derived therefrom from bovine, ovine and caprine animal origin

        1. SECTION A Animal by-products

        2. SECTION B Health certificate requirements

      5. CHAPTER E Imports of ovine and caprine animals

      6. CHAPTER F Imports of products of animal origin from farmed and wild cervid animals

        1. 1. When fresh meat, minced meat, meat preparations and meat products...

        2. 2. When fresh meat, minced meat, meat preparations and meat products...

      7. CHAPTER G

      8. CHAPTER H Import of ovine and caprine semen and embryos

    10. ANNEX X

      REFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODS

      1. CHAPTER A National reference laboratories

        1. 1. The designated national reference laboratory is to:

        2. 2. However, by way of derogation from point 1, Member States...

        3. 3. The national reference laboratories are:

      2. CHAPTER B Community reference laboratory

        1. 1. The Community reference laboratory for TSEs is:

        2. 2. The functions and duties of the Community reference laboratory are:...

      3. CHAPTER C Sampling and laboratory testing

        1. 1. Sampling

        2. 2. Laboratories

        3. 3. Methods and protocols

          1. 3.1. Laboratory testing for the presence of BSE in bovine animals...

            1. (a) Suspect cases

            2. (b) BSE monitoring

          2. 3.2. Laboratory testing for the presence of TSE in ovine and...

            1. (a) Suspect cases

            2. (b) TSE monitoring

            3. (c) Further examination of positive scrapie cases

            4. (d) Laboratories approved for performing further examination by molecular typing methods...

          3. 3.3. Laboratory testing for the presence of TSEs in species other...

        4. 4. Rapid tests

        5. 5. Alternative tests

    11. ANNEX XI

      TRANSITIONAL MEASURES REFERRED TO IN ARTICLES 22 AND 23

      1. A. Concerning specified risk material, mechanically recovered meat and slaughtering techniques...

        1. 1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

        3. 3. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

        5. 5. . . . . . . . . . ....

        6. 6. . . . . . . . . . ....

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        10. 10. . . . . . . . . . ....

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        13. 13. . . . . . . . . . ....

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      2. B. Concerning statistical surveys

        1. 1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

      3. C. Concerning prohibitions on animal feeding

      4. D. Concerning placing on the market and export

        1. 1. . . . . . . . . . ....

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        3. 3. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

        5. 4. . . . . . . . . . ....

        6. 5. . . . . . . . . . ....

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