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  1. Introductory Text

  2. Article 1.This Directive shall apply to intra-Community trade in bovine animals...

  3. Article 2.(1) The definitions given in Article 2 of Directive 90/425/EEC...

  4. Article 3.(1) Each Member State shall ensure that only animals that...

  5. Article 4.(1) Bovine animals and swine covered by this Directive must...

  6. Article 5.(1) Bovine animals and swine covered by this Directive must...

  7. Article 6.(1) Animals for breeding or production must, in addition to...

  8. Article 6a.Member States shall designate State institutes, national reference laboratories or...

  9. Article 7.Animals for slaughter which have been taken on arrival in...

  10. Article 8.Member States shall ensure that the suspected presence of any...

  11. Article 9.(1) A Member State which has a compulsory national control...

  12. Article 10.(1) Where a Member State considers that its territory or...

  13. Article 11.(1) Member States shall ensure that, in order to be...

  14. Article 12.(1) Member States shall ensure that transporters meet the following...

  15. Article 13.(1) Member States shall ensure that all dealers are registered,...

  16. Article 14.(1) The competent authority in a Member State may introduce...

  17. Article 15.(1) Member States shall take the appropriate specific measures to...

  18. Article 16.Annexes A and D (Chapter I) shall be amended by...

  19. Article 17.(1) The Commission shall be assisted by the Standing Veterinary...

  20. Article 17a.(1) The Commission shall be assisted by the Standing Veterinary...

  21. Article 18.Those Member States which have not introduced an approved surveillance...

  22. Article 19.The rules laid down in Directive 90/425/EEC shall apply in...

  23. Article 20.This Directive is addressed to the Member States.

    1. ANNEX A

      1. I. Officially tuberculosis-free bovine herd

        1. 1. A bovine herd is officially tuberculosis-free if:

        2. 2. A bovine herd will retain officially tuberculosis-free status if:

        3. 3A. The officially tuberculosis-free status of a herd is to be...

        4. 3B. The officially tuberculosis-free status of the herd is to be...

        5. 4. On the basis of information supplied in accordance with Article...

        6. 5. The Member State or part of a Member State will...

      2. II. Officially brucellosis-free and brucellosis-free bovine herds

        1. 1. A bovine herd is officially brucellosis-free if:

        2. 2. A bovine herd will retain officially brucellosis-free status if:

        3. 3A. The officially brucellosis-free status of a herd is to be...

        4. 3B. The officially brucellosis-free status of the herd is to be...

        5. 4. A bovine herd is brucellosis-free if it complies with the...

        6. 5. A bovine herd will retain brucellosis-free status if:

        7. 6A. The brucellosis-free status of a herd is to be suspended...

        8. 6B. The brucellosis-free status of the herd is to be withdrawn...

        9. 7. A Member State or a region of a Member State...

        10. 8. Subject to paragraph 9, a Member State or a region...

        11. 9. A Member State or a region of a Member State...

        12. 10. For the purposes of section II, a serological test means...

    2. ANNEX B

      TUBERCULOSIS

      1. 1. IDENTIFICATION OF THE AGENT

      2. 2. THE TUBERCULIN SKIN TEST

        1. 2.1. Standards for tuberculin (bovine and avian)

          1. 2.1.1. Definition

          2. 2.1.2. Production

          3. 2.1.3. Identification of the product

          4. 2.1.4. Tests

            1. 2.1.4.1. pH: The pH is 6.5 to 7.5.

            2. 2.1.4.2. Phenol: If the preparation to be examined contains phenol, its...

            3. 2.1.4.3. Sensitising effect: Use a group of three guinea-pigs that have...

            4. 2.1.4.4. Toxicity: Use two guinea-pigs, each weighing not less than 250...

            5. 2.1.4.5. Sterility: It complies with the test for sterility prescribed in...

          5. 2.1.5. Potency

          6. 2.1.6. Storage

          7. 2.1.7. Labelling

        2. 2.2. Test procedures

          1. 2.2.1. The following shall be recognised as official intradermal tuberculin tests:...

          2. 2.2.2. The dose of tuberculin injected shall be:

          3. 2.2.3. The volume of each injection dose shall not exceed 0,2...

          4. 2.2.4. Tuberculin tests shall be carried out by injecting tuberculin(s) into...

          5. 2.2.5. The technique of tuberculin testing and interpretation of reactions shall...

          6. 2.2.5.1. Technique:

          7. 2.2.5.2. Interpretation of reactions

          8. 2.2.5.3. The interpretation of official intradermal tuberculin tests shall be as...

          9. 2.2.5.3.1. Single intradermal test:

          10. 2.2.5.3.2. Intradermal comparative test for the establishment and maintenance of officially...

          11. 2.2.5.3.3. Officially tuberculosis-free herd status may be suspended and animals from...

          12. 2.2.5.3.4. Where animals are required by Community legislation to be subjected...

          13. 2.2.5.3.5. To enable detection of the maximum number of infected and...

      3. 3. SUPPLEMENTARY TESTING

      4. 4. STATE INSTITUTES AND NATIONAL REFERENCE LABORATORIES

        1. 4.1. Tasks and responsibilities

    3. ANNEX C

      BRUCELLOSIS

      1. 1. IDENTIFICATION OF THE AGENT

      2. 2. IMMUNOLOGICAL TESTS

        1. 2.1. Standards

          1. 2.1.1. The Brucella abortus biovar 1 Weybridge strain No 99 or...

          2. 2.1.2. The standard reference serum for the RBT, SAT, CFT and...

          3. 2.1.3. The standard reference sera for enzyme-linked immunosorbent assays (ELISAs) shall...

          4. 2.1.4. The standard reference sera for fluorescence polarisation assays (FPAs) shall...

          5. 2.1.5. The standard sera listed in 2.1.3 and 2.1.4 are available...

          6. 2.1.6. The OIEISS, the OIEELISA WP SS, the OIEELISA SP SS...

        2. 2.2. Enzyme-linked immunosorbent assays (ELISAs) or other binding assays for the...

          1. 2.2.1. Material and reagents

          2. 2.2.2. Standardisation of the test

            1. 2.2.2.1. Standardisation of the test procedure for individual serum samples:

            2. 2.2.2.2. Standardisation of the test procedure for pooled serum samples:

            3. 2.2.2.3. Standardisation of the test procedure for pooled milk or whey...

          3. 2.2.3. Conditions for use of the ELISAs for diagnosis of bovine...

            1. 2.2.3.1. Using the calibrating conditions for ELISAs set out in point...

            2. 2.2.3.2. Using the calibrating conditions for ELISA set out in point...

            3. 2.2.3.3. Where ELISAs are used for certification purposes in accordance with...

            4. 2.2.3.4. The ELISAs may be used on a sample of milk...

        3. 2.3. Complement fixation test (CFT)

          1. 2.3.1. The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85...

          2. 2.3.2. Serums must be inactivated as follows:

          3. 2.3.3. In order to carry out the genuine reaction within the...

          4. 2.3.4. In carrying out the complement fixation test, the following controls...

          5. 2.3.5. Calculation of results

          6. 2.3.6. Interpretation of results

        4. 2.4. Milk ring test (MRT)

          1. 2.4.1. The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85...

          2. 2.4.2. The antigen sensitivity must be standardised in relation to the...

          3. 2.4.3. The ring test must be made on samples representing the...

          4. 2.4.4. The milk samples must not have been frozen, heated or...

          5. 2.4.5. The reaction must be carried out using one of the...

          6. 2.4.6. The mixture of milk and antigens must be incubated at...

          7. 2.4.7. Interpretation of results:

        5. 2.5. Buffered Brucella antigen test (Rose Bengal test (RBT))

          1. 2.5.1. The antigen represents a bacterial suspension in buffered Brucella antigen...

          2. 2.5.2. The antigen shall be prepared without reference to the cell...

          3. 2.5.3. The RBT shall be carried out in the following manner:...

          4. 2.5.4. Interpretation of results

        6. 2.6. Serum agglutination test (SAT)

          1. 2.6.1. The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85...

          2. 2.6.2. The OIEISS contains 1 000 international units of agglutination.

          3. 2.6.3. The antigen shall be prepared without reference to the cell...

          4. 2.6.4. The test shall be performed either in tubes or in...

          5. 2.6.5. Interpretation of results:

        7. 2.7. Fluorescence polarisation assay (FPA)

          1. 2.7.1. The FPA can be performed in glass tubes or a...

          2. 2.7.2. Standardisation of the test

      3. 3. COMPLEMENTARY TESTS

        1. 3.1. Brucellosis skin test (BST)

          1. 3.1.1. Conditions for the use of BST

            1. (a) The brucellosis skin test shall not be used for the...

            2. (b) The brucellosis skin test is one of the most specific...

            3. (c) Bovine animals, tested with negative result in one of the...

            4. (d) Bovine animals, tested with positive result in one of the...

          2. 3.1.2. The test must be carried out by use of a...

          3. 3.1.3. Test procedure

            1. 3.1.3.1. A volume of 0.1 ml of brucellosis allergen shall be...

            2. 3.1.3.2. The test shall be read after 48- to 72-hours.

            3. 3.1.3.3. The skin thickness at the injection site shall be measured...

            4. 3.1.3.4. Interpretation of results:

        2. 3.2. Competitive enzyme-linked immunosorbent assay (cELISA)

          1. 3.2.1. Conditions for the use of cELISA

          2. 3.2.2. Test procedure

      4. 4. NATIONAL REFERENCE LABORATORIES

        1. 4.1. Tasks and responsibilities

    4. ANNEX D

      1. CHAPTER I OFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER STATES AND REGIONS

        1. A. Officially enzootic-bovine-leukosis-free herd means a herd in which:

        2. B. A herd shall retain officially enzootic-bovine-leukosis-free status provided:

        3. C. The officially leukosis-free status of a herd is to be...

        4. D. The status is to remain suspended until the following requirements...

        5. E. In accordance with the procedure in Article 17 and on...

        6. F. A Member State or a region of a Member State...

        7. G. The officially enzootic-bovine-leukosis-free status of a Member State or part...

      2. CHAPTER II TESTS FOR ENZOOTIC BOVINE LEUKOSIS

        1. A. Agar gel immuno-diffusion test for enzootic bovine leukosis

          1. 1. The antigen to be used in the test shall contain...

          2. 2. The State institutes, national reference laboratories or official institutes designated...

          3. 3. The standard antigens used in the laboratory shall be submitted...

          4. 4. The reagents of the tests shall consist of:

          5. 5. A test pattern of seven moisture-free wells shall be cut...

          6. 6. The central well shall be filled with the standard antigen....

          7. 7. This results in the following quantities being obtained:

          8. 8. Incubation shall be for 72 hours at room temperature (20...

          9. 9. The test may be read at 24 and 48 hours...

          10. 10. Any other well configuration or pattern may be utilised provided...

        2. B. Method for antigen standardisation

          1. 1. Solutions and materials required:

          2. 2. Procedure:

          3. 3. Addition of antigen:

          4. 4. Additional instructions:

        3. C. Enzyme-linked immunosorbent assay (ELISA) for detecting enzootic bovine leukosis

          1. 1. The material and reagents to be used shall be as...

          2. 2. Standardisation and sensitivity of test

          3. 3. Conditions for use of the ELISA for enzootic bovine leukosis...

    5. ANNEX E (I)

      1. (a) Bovine diseases

      2. (b) Swine diseases

    6. ANNEX E (II)

      1. Aujeszky's disease Infectious bovine rhinotracheitis Brucella suis infection Transmissible gastro-enteritis...

    7. ANNEX F

      1. Model 1 Animal health certificate for animals of the bovine species for...

      2. Model 2 Animal health certificate for swine for breeding/production/slaughter