Council Directive 2003/43/EC

of 26 May 2003

amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the European Parliament(2),

Having regard to the opinion of the European Economic and Social Committee(3),

After consulting the Committee of the Regions,

Whereas:

(1) Directive 88/407/EEC(4) lays down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species.

(2) In the light of the new scientific data available, it is necessary to amend the animal health conditions applying to entry of bulls into artificial insemination centres, in particular concerning infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) and bovine viral diarrhoea/mucosal diarrhoea (BVD/MD).

(3) The same requirements for storage should apply to all establishments whether or not they are associated with a production unit.

(4) The procedure for updating the list of semen collection or storage centres in third countries from which the importation of semen is authorised should be simplified.

(5) Necessary measures should be adopted for the implementation of Directive 88/407/EEC in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5),

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 88/407/EEC is hereby amended as follows:

1. the following subparagraph shall be added to Article 1:"This Directive shall not affect Community and/or national zootechnical provisions governing the organisation of artificial insemination in general and the distribution of semen in particular.";

2. Article 2(b) is replaced by the following:

"(b) - 'Semen collection centre' means an officially approved and officially supervised establishment situated in the territory of a Member State or third country, in which semen is produced for use in artificial insemination;

- 'Semen storage centre' means an officially approved and officially supervised establishment situated in the territory of a Member State or third country in which semen is stored for use in artificial insemination;"

3. Article 3(a) shall be replaced by the following:

"(a) it must have been collected and processed and/or stored if need be in a collection or storage centre or centres approved for the purpose in accordance with Article 5(1), with a view to artificial insemination and for the purposes of intra-Community trade;"

4. Article 4(1) and (2) shall be deleted;

5. in Articles 5, 9(2) and 9(3), the words "semen collection centre(s)" shall be replaced by the words "semen collection or storage centre(s)";

6. Article 9(1) shall be replaced by the following:

"1. The lists of semen collection and storage centres from which Member States shall authorise the importation of semen originating in third countries shall be prepared and updated in accordance with this Article.

An establishment may be placed on such a list only if the competent authority of the third country of origin guarantees that the conditions referred to in paragraphs 2 and 3(b) to (e) are met.

The competent authorities of the third countries appearing on lists drawn up and updated in accordance with Article 8 shall guarantee that lists of semen collection and storage centres from which the semen may be dispatched to the Community are drawn up, kept up-to-date and communicated to the Commission.

The Commission shall provide the contact points designated by Member States with regular notifications concerning new or updated lists that it has received from the competent authorities of the third countries concerned in accordance with subparagraph 3.

If no Member State objects to the new or updated list within 20 working days of the Commission's notification, imports shall be authorised from establishments appearing on the list 10 working days after the day on which the Commission makes it available to the public.

Where written comments are made by at least one Member State or whenever it considers that amendments to a list are necessary in the light of relevant information such as Community inspection reports or the results of the controls carried out under Article 12, the Commission shall inform all Member States and include the matter on the agenda for the relevant sector at the next meeting of the Standing Committee on the Food Chain and Animal Health for decision in accordance with the procedure referred to in Article 18(2).

The Commission shall arrange for up-to-date versions of all lists to be made available to the public.";

7. Article 17 shall be replaced by:

"Article 17

Annex A shall be amended by the Council, acting by qualified majority on a proposal from the Commission, in particular to adapt it to advances in technology.

Annexes B, C and D shall be amended in accordance with the procedure laid down in Article 18(2).";

8. Article 18 shall be replaced by:

"Article 18

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Regulation (EC) No 178/2002(6).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC(7) shall apply.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.";

9. Article 19 shall be deleted;

10. in Articles 5, 8, and 10, the words "the procedure laid down in Article 18" shall be replaced by the words "the procedure referred to in Article 18(2)";

11. in Articles 8, 11 and 16, the words "the procedure laid down in Article 19" shall be replaced by the words "the procedure referred to in Article 18(2)";

12. Annexes A, B, C and D to Directive 88/407/EEC shall be replaced by the text in the Annex to this Directive.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 July 2004. They shall forthwith inform the Commission thereof.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

2. However, up until 31 December 2004, Member States shall authorise intracommunity trade in and imports of semen that have been collected, processed and stored according to the former provisions of Directive 88/407/EEC and that are accompanied by the former specimen certificate.

After that date, Member States shall not authorise intra-Community trade in and imports of semen in accordance with the provisions formerly in force unless it was collected, processed and stored before 31 December 2004.

3. Member States shall inform the Commission of the text of the main provisions of national law which they adopt in the area governed by this Directive.

Article 3

This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 26 May 2003.

For the Council

The President

G. Drys

(1) OJ C 20 E, 28.1.2003, p. 46.

(2) Opinion delivered on 8 April 2003 (not yet published in the Official Journal).

(3) Opinion delivered on 11 December 2002 (not yet published in the Official Journal).

(4) OJ L 194, 22.7.1988, p. 10. Directive as last amended by the 1994 Act of Accession.

(5) OJ L 184, 17.7.1999, p. 23.

(6) OJ L 31, 1.2.2002, p. 1.

(7) OJ L 184, 17.7.1999, p. 23.

ANNEX

'ANNEX A

CHAPTER I CONDITIONS FOR THE OFFICIAL APPROVAL OF CENTRES

1. Semen collection centres must:

(a) be placed under the permanent supervision of a centre veterinarian authorised by the competent authority;

(b) have at least:

(i) animal housing, including isolation facilities;

(ii) semen collection facilities, including a separate room for the cleaning and disinfection or sterilisation of equipment;

(iii) a semen processing room which need not necessarily be on the same site;

(iv) a semen storage room which need not necessarily be on the same site;

(c) be so constructed or isolated that contact with livestock outside is prevented;

(d) be so constructed that the animal housing and the semen collecting, processing and storage facilities can be readily cleaned and disinfected;

(e) have isolation accommodation which has no direct communication with the normal animal accommodation;

(f) be so designed that the animal accommodation is physically separated from the semen processing room and both are separated from the semen storage room.

2. Semen storage centres must:

(a) be placed under the permanent supervision of a centre veterinarian authorised by the competent authority;

(b) be so constructed or isolated that contact with livestock outside is prevented;

(c) be so constructed that the storage facilities can be readily cleaned and disinfected.

CHAPTER II CONDITIONS RELATING TO THE OFFICIAL SUPERVISION OF CENTRES

1. Collection centres must:

(a) be so supervised that they contain only animals of the species whose semen is to be collected. Other domestic animals which are strictly necessary for the normal operation of the collection centre may nonetheless also be admitted, provided that they present no risk of infection to those species whose semen is to be collected, and that they fulfil the conditions laid down by the centre veterinarian;

(b) be so supervised that a record is kept of all bovine animals at the centre, giving details of the breed, date of birth and identification of each of the animals, and also a record of all checks for diseases and all vaccinations carried out for each animal;

(c) be regularly inspected by an official veterinarian, at least twice a year, in the context of standing checks on the conditions of approval and supervision;

(d) be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors must be required to comply with the conditions laid down by the centre veterinarian;

(e) employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread of disease;

(f) be so supervised that:

(i) only semen collected at an approved centre is processed and stored in approved centres, without coming into contact with any other consignment of semen. However, semen not collected in an approved centre may be processed in approved collection centres provided that:

- such semen is produced from bovine animals which fulfil the conditions laid down in Chapter I.1(d) of Annex B,

- processing is carried out with separate equipment or at a different time from semen intended for intra-Community trade, the equipment in the latter case being cleaned and sterilised after use,

- such semen may not be the subject of intra-Community trade and cannot at any time come into contact with, or be stored with, semen intended for intra-Community trade,

- such semen is identifiable by a marking different from that provided for in point (vii);

Deep-frozen embryos may also be stored in approved centres provided that:

- such storage is authorised by the competent authority,

- the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species(1),

- the embryos are stored in separate storage containers in the premises for storing approved semen;

(ii) collection, processing and storage of semen takes place only on the premises set aside for the purpose and under the strictest conditions of hygiene;

(iii) all instruments which come into contact with the semen or the donor animal during collection and processing are properly disinfected or sterilised prior to use, except for single-use instruments;

(iv) products of animal origin used in the processing of semen - including additives or a diluent - are obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented;

(v) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers;

(vi) the cryogenic agent used has not been previously used for other products of animal origin;

(vii) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal and the approval number of the centre can be readily established; each Member State shall communicate to the Commission and other Member States the characteristics and form of the marking used in its territory;

(viii) the storage unit must comply with specific conditions relating to the supervision of semen storage centres provided for in point 2.

2. Storage centres must:

(a) be so supervised that a record is kept of all movement of semen (in and out the centre) and of the status of the donor bulls whose semen is stored there, and which must comply with the requirements of this Directive;

(b) be regularly inspected by an official veterinarian, at least twice a year, in the context of the standing checks on the conditions of approval and supervision;

(c) be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors must be required to comply with the conditions laid down by the centre veterinarian;

(d) employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread of disease;

(e) be so supervised that:

(i) only semen collected at collection centres approved in accordance with this Directive is stored in approved storage centres, without coming into contact with any other semen.

In addition, only semen coming from an approved collection or storage centre and transported in conditions offering every possible health guarantee, having had no contact with any other semen, may be brought into an approved storage centre.

Deep-frozen embryos may also be stored in approved centres provided that:

- such storage is authorised by the competent authority,

- the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species,

- the embryos are stored in separate storage containers in the premises for storing approved semen;

(ii) storage of semen takes place only on the premises set aside for the purpose and under the strictest conditions of hygiene;

(iii) all instruments which come into contact with the semen are properly disinfected or sterilised prior to use, except for single-use instruments;

(iv) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers;

(v) the cryogenic agent used has not been previously used for other products of animal origin;

(vi) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal and the approval number of the collection centre can be readily established; each Member State shall communicate to the Commission and other Member States the characteristics and form of the marking used in its territory.

(1) OJ L 302, 19.10.1989, p. 1. Directive as last amended by Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23).

ANNEX B

CHAPTER I CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO APPROVED SEMEN COLLECTION CENTRES

1. For all bovine animals admitted to a semen collection centre the following requirements shall apply:

(a) they must have been subjected to a period of quarantine of at least 28 days in accommodation specifically approved for the purpose by the competent authority of the Member State, and where only other cloven-hoofed animals having at least the same health status are present;

(b) prior to their stay in the quarantine accommodation described in (a), they must have belonged to a herd which is officially tuberculosis free and officially brucellosis free in accordance with Directive 64/432/EEC. The animals shall not previously have been kept in a herd of a lower status;

(c) they must come from a herd officially free of enzootic bovine leukosis as defined in Directive 64/432/EEC, or have been produced by dams which have been subjected, with negative results, to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC, after removal of the animals from their dam. In the case of animals derived by embryo transfer, "dam" means the recipient of the embryo;

If this requirement cannot be fulfilled, the semen shall not be the subject of trade until the donor has reached the age of two years and has been tested in accordance with Chapter II.1(c) with a negative result;

(d) within the 28 days preceding the period of quarantine specified in (a), they have been subjected to the following tests with negative results in each case, except for the BVD/MD antibody test mentioned in (v):

(i) for bovine tuberculosis, an intradermal tuberculin test carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC;

(ii) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;

(iii) for enzootic bovine leukosis, a serological test carried out in accordance with the procedure laid down in Annex D (Chapter II) to Directive 64/432/EEC;

(iv) for IBR/IPV, a serological test (whole virus) on a blood sample if the animals do not come from an IBR/IPV free herd as defined in Article 2.3.5.3. of the International Animal Health Code;

(v) for BVD/MD,

- a virus isolation test or a test for virus antigen, and

- a serological test to determine the presence or absence of antibodies.

The competent authority may give authorisation for the tests referred to in (d) to be carried out on samples collected in the quarantine station. In this case, the period of quarantine referred to in (a) may not commence before the date of sampling. However, should any of the tests listed in (a) prove positive, the animal concerned shall be immediately removed from the isolation unit. In the event of group isolation, the quarantine period referred to in (a) may not commence for the remaining animals until the animal which tested positive has been removed.

(e) within the period of quarantine specified in (a), and at least 21 days after being admitted to quarantine (at least seven days after being admitted to quarantine to search for Campylobacter fetus ssp. venerealis and Trichomonas foetus), they have been subjected to the following tests with negative results in each case, except for the BVD/MD antibody test (see point (iii) below):

(i) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;

(ii) for IBR/IPV, a serological test (whole virus) on a blood sample;

If any animals test positive, these animals shall be removed immediately from the quarantine station and the other animals of the same group shall remain in quarantine and be retested, with negative results, not less than 21 days after removal of the positive animal(s).

(iii) for BVD/MD,

- a virus isolation test or a test for virus antigen, and

- a serological test to determine the presence or absence of antibodies.

Any animal (seronegative or seropositive) may only be allowed entry to the semen collection facilities if no sero-conversion occurs in animals which tested seronegative before entry into the quarantine station.

If sero-conversion occurs, all animals that remain seronegative shall be kept in quarantine over a prolonged time, until there is no more sero-conversion in the group for a period of three weeks. Serologically positive animals may be allowed entry into the semen collection facilities;

(iv) for Campylobacter fetus ssp. venerealis:

- in the case of animals less than six months old or kept since that age in a single sex group prior to quarantine, a single test on a sample of artificial vagina washings or preputial specimen;

- in the case of animals aged six months or older that could have had contact with females prior to quarantine, a test three times at weekly intervals on a sample of artificial vagina washings or preputial specimen;

(v) for Trichomonas foetus:

- in the case of animals less than six months old or kept since that age in a single sex group prior to quarantine, a single test on a sample of preputial specimen;

- in the case of animals aged six months or older that could have had contact with females prior to quarantine, a test three times at weekly intervals on a sample of preputial specimen.

If any of the above tests is positive, the animal must be removed forthwith from the isolation accommodation. In the case of group isolation, the competent authority must take all necessary measures to re-establish the eligibility of the remaining animals for entry into the collection centre in accordance with the Annex.

(f) prior to the initial dispatch of semen from BVD/MD serologically positive bulls, a semen sample from each animal shall be subjected to a virus isolation or virus antigen ELISA test for BVD/MD. In the event of a positive result, the bull shall be removed from the centre and all of its semen destroyed.

2. All tests must be carried out in a laboratory approved by the Member State.

3. Animals may only be admitted to the semen collection centre with the express permission of the centre veterinarian. All movements, both in and out, must be recorded.

4. No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission. All animals must, without prejudice to paragraph 5, have come from isolation accommodation, as referred to in paragraph 1(a), which on the day of consignment officially fulfils the following conditions:

(a) is situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days;

(b) has for at least three months been free from foot-and-mouth disease and brucellosis;

(c) has for at least 30 days been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E to Directive 64/432/EEC.

5. Provided that the conditions laid down in paragraph 4 are satisfied and the routine tests referred to in Chapter II have been carried out during the previous 12 months, animals may be transferred from one approved semen collection centre to another of equal health status, without isolation or testing if transfer is direct. The animal in question must not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the means of transport used must have been disinfected before use. If the movement from one semen collection centre to another takes place between Member States it must take place in accordance with Directive 64/432/EEC.

CHAPTER II ROUTINE TESTS WHICH MUST BE APPLIED TO ALL BOVINE ANIMALS IN AN APPROVED SEMEN COLLECTION CENTRE

1. All bovine animals kept at an approved semen collection centre must be subjected at least once a year to the following tests, with negative results:

(a) for bovine tuberculosis, an intradermal tuberculin test, carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC;

(b) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;

(c) for enzootic bovine leukosis, a serological test carried out in accordance with the procedure described in Annex D (Chapter II) to Directive 64/432/EEC;

(d) for IBR/IPV, a serological test (whole virus) on a blood sample;

(e) for BVD/MD, a serological antibody which is applied only to seronegative animals;

Should an animal become serologically positive, every ejaculate of that animal collected since the last negative test shall be either discarded or tested for virus with negative results.

(f) for Campylobacter fetus ssp. venerealis, a test on a sample of preputial specimen. Only bulls on semen production or having contact with bulls on semen production need to be tested. Bulls returning to collection after a lay-off of more than six months shall be tested not more than 30 days prior to resuming production;

(g) for Trichomonas foetus, a test on a sample of preputial specimen. Only bulls on semen production or having contact with bulls on semen production need to be tested. Bulls returning to collection after a lay-off of more than six months shall be tested not more than 30 days prior to resuming production.

2. All tests must be carried out in a laboratory approved by the Member State.

3. If any of the above tests is positive, the animal must be isolated and the semen collected from it since the last negative test may not be the subject of intra-Community trade with the exception, for BVD/MD, of semen from every ejaculate which has been tested BVD/MD virus negative.

Semen collected from all other animals at the centre since the date when the positive test was carried out shall be held in separate storage and may not be the subject of intra-Community trade until the health status of the centre has been restored.

ANNEX C

CONDITIONS WHICH SEMEN FOR INTRA-COMMUNITY TRADE OR IMPORTED INTO THE COMMUNITY MUST SATISFY

1. Semen must be obtained from animals which:

(a) show no clinical signs of disease on the day the semen is collected;

(b) (i) have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection, or

(ii) have been vaccinated against foot-and-mouth disease during the 12 months prior to collection, in which case 5 % (with a minimum of five straws) of each collection shall be submitted to a virus isolation test for foot-and-mouth disease with negative results;

(c) have not been vaccinated against foot-and-mouth disease within 30 days immediately prior to collection;

(d) have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to the collection of the semen in the case of collections of fresh semen;

(e) are not allowed to serve naturally;

(f) are kept in semen collection centres which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of dispatch, and which are situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days;

(g) have been kept in semen collection centres which, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, have been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E(I) to Directive 64/432/EEC.

2. Antibiotics as listed below must be added to produce these concentrations in the final diluted semen:

not less than:

- 500 μg streptomycin per ml final dilution,

- 500 IU penicillin per ml final dilution,

- 150 μg lincomycin per ml final dilution,

- 300 μg spectinomycin per ml final dilution.

An alternative combination of antibiotics with an equivalent effect against campylobacters, leptospires and mycoplasmas may be used.

Immediately after their addition the diluted semen must be kept at a temperature of at least 5 °C for a period of not less than 45 minutes.

3. Semen for intra-Community trade must:

(a) be stored in approved conditions for a minimum period of 30 days prior to dispatch. This requirement shall not apply to fresh semen.

(b) be transported to the Member State of destination in containers which have been cleaned and disinfected or sterilised before use and which have been sealed and numbered prior to dispatch from the approved storage facilities.

ANNEX D

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