I.Officially tuberculosis-free bovine herd 1.A bovine herd is officially tuberculosis-free if: 2.A bovine herd will retain officially tuberculosis-free status if: 3A.The officially tuberculosis-free status of a herd is to be...3B.The officially tuberculosis-free status of the herd is to be...4.On the basis of information supplied in accordance with Article...5.The Member State or part of a Member State will...II.Officially brucellosis-free and brucellosis-free bovine herds 1.A bovine herd is officially brucellosis-free if: 2.A bovine herd will retain officially brucellosis-free status if: 3A.The officially brucellosis-free status of a herd is to be...3B.The officially brucellosis-free status of the herd is to be...4.A bovine herd is brucellosis-free if it complies with the...5.A bovine herd will retain brucellosis-free status if: 6A.The brucellosis-free status of a herd is to be suspended...6B.The brucellosis-free status of the herd is to be withdrawn...7.A Member State or a region of a Member State...8.Subject to paragraph 9, a Member State or a region...9.A Member State or a region of a Member State...10.For the purposes of section II, a serological test means...1.IDENTIFICATION OF THE AGENT 2.THE TUBERCULIN SKIN TEST 2.1.Standards for tuberculin (bovine and avian) 2.1.1.Definition 2.1.2.Production 2.1.3.Identification of the product 2.1.4.Tests 2.1.4.1.pH: The pH is 6.5 to 7.5. 2.1.4.2.Phenol: If the preparation to be examined contains phenol, its...2.1.4.3.Sensitising effect: Use a group of three guinea-pigs that have...2.1.4.4.Toxicity: Use two guinea-pigs, each weighing not less than 250...2.1.4.5.Sterility: It complies with the test for sterility prescribed in...2.1.5.Potency 2.1.6.Storage 2.1.7.Labelling 2.2.Test procedures 2.2.1.The following shall be recognised as official intradermal tuberculin tests:...2.2.2.The dose of tuberculin injected shall be: 2.2.3.The volume of each injection dose shall not exceed 0,2...2.2.4.Tuberculin tests shall be carried out by injecting tuberculin(s) into...2.2.5.The technique of tuberculin testing and interpretation of reactions shall...2.2.5.1.Technique: 2.2.5.2.Interpretation of reactions 2.2.5.3.The interpretation of official intradermal tuberculin tests shall be as...2.2.5.3.1.Single intradermal test: 2.2.5.3.2.Intradermal comparative test for the establishment and maintenance of officially...2.2.5.3.3.Officially tuberculosis-free herd status may be suspended and animals from...2.2.5.3.4.Where animals are required by Community legislation to be subjected...2.2.5.3.5.To enable detection of the maximum number of infected and...3.SUPPLEMENTARY TESTING 4.STATE INSTITUTES AND NATIONAL REFERENCE LABORATORIES 4.1.Tasks and responsibilities 1.IDENTIFICATION OF THE AGENT 2.IMMUNOLOGICAL TESTS 2.1.Standards 2.1.1.The Brucella abortus biovar 1 Weybridge strain No 99 or...2.1.2.The standard reference serum for the RBT, SAT, CFT and...2.1.3.The standard reference sera for enzyme-linked immunosorbent assays (ELISAs) shall...2.1.4.The standard reference sera for fluorescence polarisation assays (FPAs) shall...2.1.5.The standard sera listed in 2.1.3 and 2.1.4 are available...2.1.6.The OIEISS, the OIEELISA WP SS, the OIEELISA SP SS...2.2.Enzyme-linked immunosorbent assays (ELISAs) or other binding assays for the...2.2.1.Material and reagents 2.2.2.Standardisation of the test 2.2.2.1.Standardisation of the test procedure for individual serum samples: 2.2.2.2.Standardisation of the test procedure for pooled serum samples: 2.2.2.3.Standardisation of the test procedure for pooled milk or whey...2.2.3.Conditions for use of the ELISAs for diagnosis of bovine...2.2.3.1.Using the calibrating conditions for ELISAs set out in point...2.2.3.2.Using the calibrating conditions for ELISA set out in point...2.2.3.3.Where ELISAs are used for certification purposes in accordance with...2.2.3.4.The ELISAs may be used on a sample of milk...2.3.Complement fixation test (CFT) 2.3.1.The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85...2.3.2.Serums must be inactivated as follows: 2.3.3.In order to carry out the genuine reaction within the...2.3.4.In carrying out the complement fixation test, the following controls...2.3.5.Calculation of results 2.3.6.Interpretation of results 2.4.Milk ring test (MRT) 2.4.1.The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85...2.4.2.The antigen sensitivity must be standardised in relation to the...2.4.3.The ring test must be made on samples representing the...2.4.4.The milk samples must not have been frozen, heated or...2.4.5.The reaction must be carried out using one of the...2.4.6.The mixture of milk and antigens must be incubated at...2.4.7.Interpretation of results: 2.5.Buffered Brucella antigen test (Rose Bengal test (RBT)) 2.5.1.The antigen represents a bacterial suspension in buffered Brucella antigen...2.5.2.The antigen shall be prepared without reference to the cell...2.5.3.The RBT shall be carried out in the following manner:...2.5.4.Interpretation of results 2.6.Serum agglutination test (SAT) 2.6.1.The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85...2.6.2.The OIEISS contains 1 000 international units of agglutination. 2.6.3.The antigen shall be prepared without reference to the cell...2.6.4.The test shall be performed either in tubes or in...2.6.5.Interpretation of results: 2.7.Fluorescence polarisation assay (FPA) 2.7.1.The FPA can be performed in glass tubes or a...2.7.2.Standardisation of the test 3.COMPLEMENTARY TESTS 3.1.Brucellosis skin test (BST) 3.1.1.Conditions for the use of BST (a)The brucellosis skin test shall not be used for the...(b)The brucellosis skin test is one of the most specific...(c)Bovine animals, tested with negative result in one of the...(d)Bovine animals, tested with positive result in one of the...3.1.2.The test must be carried out by use of a...3.1.3.Test procedure 3.1.3.1.A volume of 0.1 ml of brucellosis allergen shall be...3.1.3.2.The test shall be read after 48- to 72-hours. 3.1.3.3.The skin thickness at the injection site shall be measured...3.1.3.4.Interpretation of results: 3.2.Competitive enzyme-linked immunosorbent assay (cELISA) 3.2.1.Conditions for the use of cELISA 3.2.2.Test procedure 4.NATIONAL REFERENCE LABORATORIES 4.1.Tasks and responsibilities CHAPTER I OFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER STATES AND REGIONS A.Officially enzootic-bovine-leukosis-free herd means a herd in which: B.A herd shall retain officially enzootic-bovine-leukosis-free status provided: C.The officially leukosis-free status of a herd is to be...D.The status is to remain suspended until the following requirements...E.In accordance with the procedure in Article 17 and on...F.A Member State or a region of a Member State...G.The officially enzootic-bovine-leukosis-free status of a Member State or part...CHAPTER II TESTS FOR ENZOOTIC BOVINE LEUKOSIS A.Agar gel immuno-diffusion test for enzootic bovine leukosis 1.The antigen to be used in the test shall contain...2.The State institutes, national reference laboratories or official institutes designated...3.The standard antigens used in the laboratory shall be submitted...4.The reagents of the tests shall consist of: 5.A test pattern of seven moisture-free wells shall be cut...6.The central well shall be filled with the standard antigen....7.This results in the following quantities being obtained: 8.Incubation shall be for 72 hours at room temperature (20...9.The test may be read at 24 and 48 hours...10.Any other well configuration or pattern may be utilised provided...B.Method for antigen standardisation 1.Solutions and materials required: 2.Procedure: 3.Addition of antigen: 4.Additional instructions: C.Enzyme-linked immunosorbent assay (ELISA) for detecting enzootic bovine leukosis 1.The material and reagents to be used shall be as...2.Standardisation and sensitivity of test 3.Conditions for use of the ELISA for enzootic bovine leukosis...(a)Bovine diseases (b)Swine diseases Model 1Animal health certificate for animals of the bovine species for...Model 2Animal health certificate for swine for breeding/production/slaughter

Council Directive

of 26 June 1964

on animal health problems affecting intra-Community trade in bovine animals and swine

(64/432/EEC)

THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY,

Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof;

Having regard to the proposal from the Commission;

Having regard to the Opinion of the European Parliament1;

Having regard to the Opinion of the Economic and Social Committee2;

Whereas Council Regulation No 20 on the progressive establishment of a common organisation of the market in pigmeat3 is already in force and a similar regulation is to be adopted for beef and veal and whereas these regulations also concern trade in live animals;

Whereas Regulation No 20 substitutes for the numerous traditional means of protection at the frontier a single system designed in particular to facilitate intra-Community trade; whereas the regulation to be adopted for beef and veal is also designed to eliminate obstacles to such trade;

Whereas, so long as intra-Community trade in bovine animals and swine is hindered by differences between the health requirements of Member States, the implementation of the above-mentioned regulations will not have the desired effect;

Whereas, to eliminate those differences, measures must be taken within the framework of the common agricultural policy and in line with regulations already adopted or in preparation on the progressive establishment of a common organisation of markets; whereas the animal health provisions of Member States must therefore be approximated;

Whereas the right of Member States under Article 36 of the Treaty to continue to apply prohibitions or restrictions on imports, exports or goods in transit justified on grounds of the protection of health and life of humans and animals nevertheless does not exempt them from the obligation to approximate the provisions on which those prohibitions and restrictions are based, in so far as the differences between those provisions hinder the implementation and functioning of the common agricultural policy;

Whereas, in the context of such approximation, the exporting country must be required to ensure that bovine animals and swine for breeding, production or slaughter intended for intra-Community trade, the places from which those animals come and are shipped and the means of transport used satisfy certain animal health requirements so as to ensure that the animals are not a source of contagious or infectious disease;

Whereas, so that Member States may be sure that these requirements are satisfied, provision must be made for the issue by an official veterinarian of a health certificate which will accompany the animals to their destination;

Whereas Member States must have the right to prohibit the introduction into their territory of bovine animals and swine if they are found to be suffering or are suspected of suffering from a contagious or infectious disease, if they may spread such disease without actually suffering from it or if they do not comply with Community animal health provisions;

Whereas there is no reason to allow Member States to prohibit the introduction of bovine animals and swine into their territory for reasons other than those of animal health and whereas, therefore, the consignor should at his own request or upon request of his representative be allowed to return the animals to the country of export unless there are reasons to the contrary;

Whereas, in case of prohibition or restriction, the reasons therefor should be made known to the consignor of the animals or his representative and to the competent central authority of the country of export so that they be aware of the reasons why such measures were imposed;

Whereas in the event of dispute between himself and the authority of the Member State of destination as to the justification for prohibition or restriction, the consignor should be enabled to obtain the opinion of a veterinary expert whom he may select from a panel drawn up by the Commission;

Whereas in some cases and for certain categories of animals it appears that the general provisions of this Directive may be relaxed without involving any health risk, by allowing consignee Member States to grant general or special derogations;

Whereas, in certain fields presenting special problems, the provisions in Member States cannot be approximated until a more thorough study has been made;

Whereas a simplified amendement procedure may be provided for Annexes B to D since the rules contained in those Annexes are of a technical nature and liable to change; whereas the Commission should therefore be entrusted with making such amendments after consulting the Member States;

HAS ADOPTED THIS DIRECTIVE: