Directive 88 /407/EEC of the Council of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of frozen semen of animals of the has been incorporated into Spanish legislation through Royal Decree 877/1990 of 6 July 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen frozen animals of the bovine species.

Article 4 of Royal Decree 877/1990 provided for provisional measures for trade in semen from seropositive bulls with regard to infectious bovine rhinotracheitis (IBR) and that these requirements should be reviewed. on the basis of a report presented by the Commission of the European Community. This report indicates that it is necessary to progressively remove bulls which are seropositive or whose situation is unknown before vaccination at the centre until 1998, and to maintain the possibility of vaccinating in the centre itself, necessary to repeal the mentioned Royal Decree in that aspect

On the other hand, bearing in mind that routine vaccination against foot-and-mouth disease has not been practised in the Community since August 1990, and that it is appropriate to clarify certain points and to take account of the progress made. In particular with regard to the treatment of bulls against leptospirosis, it is necessary to repeal the provisions of Royal Decree 877/1990 of 6 July on this issue.

addition, the completion of the internal market provided for in Article 7a of the Treaty establishing the European Community implies the removal of all obstacles to intra-Community trade with a view to the merger of national markets in a single market. In view of the fact that this leads to the abolition of border controls for intra-Community trade and the strengthening of guarantees of origin, no differences can be made between products destined for the domestic market and those intended for the market of another Member State, and the Community rules were therefore enacted.

It is also appropriate to regulate the possibility of amendments to the Annexes by establishing a procedure for close cooperation between the Member States and the European Commission within the Standing Veterinary Committee.

By this Royal Decree, Council Directive 93 /60/EEC of 30 November amending Council Directive 88 /407/EEC laying down the requirements of the health and safety requirements for health and safety at work is transposed into national law. applicable to intra-Community trade in and imports of frozen semen of bovine animals and is extended to the fresh semen of such animals. It is also collected, as Royal Decree 877/1990 of 6 July 1990 repealed, the unchanged provisions of that Directive 88 /407/EEC.

All in accordance with the State competence in the field of foreign trade and the general basis and coordination of the health contained in Article 149.1.10. and 16. of the Constitution, and once the sectors concerned have been heard.

By virtue of the proposal of the Minister for Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 25 November 1994,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This provision lays down the animal health conditions applicable to intra-Community trade and to imports from third countries of semen of bovine animals.

Article 2. Definitions.

For the purposes of this provision, the definitions set out in Article 2 of Royal Decree 434/1990 of 30 March 1990 laying down the health conditions applicable to trade shall be construed as intra-Community trade in bovine animals and swine and in Article 2 of Royal Decree 495/1990 of 20 April 1990 laying down the health conditions to be met by live animals of the bovine and porcine species imported from third countries.

In addition, it is understood by:

a) "Wait": the ejaculation product of a domestic animal of the bovine species, prepared or diluted.

(b) "semen collection centre" means any officially recognised and controlled establishment situated on the territory of a Member State or a third country in which semen is produced for artificial insemination.

(c) For intra-Community trade the "official veterinarian" shall be the one designated by the competent authority of the respective Autonomous Community. For imports from third countries, the 'official veterinarian' shall be designated by the Ministry of Agriculture, Fisheries and Food.

(d) "centre veterinarian" means the veterinarian responsible for daily compliance at the centre of the requirements of this provision.

e) "Lot": a batch of sperm covered by a single certificate.

(f) "Country of collection" means the Member State or third country in which the semen is collected and from which it is dispatched to a Member State.

(g) "recognised laboratory" means any laboratory located on the territory of one of the Member States or of a third country and designated by the competent veterinary authority to carry out the examinations prescribed by the present.

h) "Collection": a quantity of sperm obtained from a donor at any time.

(i) "Competent Authority" means the Ministry of Agriculture, Fisheries and Food for imports from third countries and the corresponding bodies of the Autonomous Communities in respect of trade

intra-Community

CHAPTER II

intra-Community trade

Article 3. Requirements for dispatch and reception.

1. Only semen meeting the following requirements may be issued to other Member States:

(a) That it has been collected and treated with a view to artificial insemination, in a collection centre recognised from the point of view of health for the purposes of intra-Community trade, in accordance with paragraph 1 of the Article 5.

(b) which has been obtained from bovine animals, the health status of which complies with the provisions of Annex B.

(c) which has been collected, processed, stored and transported in accordance with the provisions of Annexes A and C.

(d) That during transport to the country of destination it is accompanied by a health certificate as provided for in Article 6 (1).

2. Shipments to Spain from other Member States shall comply with the requirements set out in the previous paragraph.

Article 4. Admission and issue in particular cases.

1. Without prejudice to paragraph 2, the admission of semen from bulls having submitted a negative result in the seroneutralisation test or in the ELISA test for the detection of bovine rhinotracheitis shall be authorised. infectious or infectious vulvovaginitis, or who have a positive result after vaccination under this Royal Decree.

Until 31 December 1998, the admission of semen of those bulls which react in a positive manner to the test for seroneutralisation or to the ELISA test for the detection of infectious bovine rhinotracheitis shall be authorised. vulvovaginitis purulenta infectious and which have not been vaccinated according to this Royal Decree.

In this case, each batch must be examined by inoculation in a live animal or the virus isolation test, or both.

Such a requirement shall not apply to semen of animals which, before a first routine vaccination at the insemination centre, have given a negative reaction to the tests referred to in the first subparagraph. However, the semen of animals vaccinated as a matter of urgency following the occurrence of an IBR outbreak shall be subjected to the virus isolation test.

These examinations may be carried out, by bilateral agreement, either in the country of collection or in the country of destination.

In this case, the 10 per 100 minimum of each semen collection (with a minimum of five pipettes) must be examined.

2. As long as the health conditions do not vary, the dispatch from Spanish centres to the other Member States in which all the centres only include animals presenting a negative result to the seroneutralisation test may not be carried out. to the ELISA test, which have received the Community benefit of refusing entry into their territory of semen from centres which do not have the same sanitary level.

Identical measure shall be adopted in the event that such a Community benefit has been granted to a part of the territory of a Member State, in so far as all the centres in that part of the territory do not include more animals that have negative results for the seroneutralisation test or the ELISA test.

Until both the Spanish territory or a part of it does not reach a sanitary level similar to that mentioned in the preceding paragraphs, the semen from other Member States cannot be rejected for the reasons stated.

When in an Autonomous Community all the centers of its territory can guarantee that the favorable health circumstances mentioned above are given, and they intend to benefit from the repeated benefit, they will put it in knowledge of the Ministry of Agriculture, Fisheries and Food, in order to initiate, through the established channels, the procedures for the timely recognition by the Commission.

3. The competent authority shall not refuse to accept semen produced by bulls vaccinated against foot-and-mouth disease. However, if the semen comes from a bull vaccinated against foot-and-mouth disease within 12 months of the date of collection, 5 per 100 of each collection (with a minimum of five pipettes) to be sent to another Member State shall be submitted in a laboratory of the Member State of destination or in a laboratory designated by that Member State, a virus isolation test for foot-and-mouth disease, which should provide negative results.

Article 5. Recognition of collection centers.

1. The competent bodies of the respective Autonomous Communities shall carry out the recognition referred to in Article 3.1 (a) if the semen collection centre complies with the conditions laid down in this provision and in the Annex A, in particular

The official veterinarian shall monitor compliance with these provisions, and shall inform the competent authority of the respective Autonomous Community of any non-compliance with these provisions.

The competent body of the respective Autonomous Community shall, in the event of non-compliance with the conditions laid down in this provision, declare the recognition referred to in the preceding paragraph to be extinguished.

2. The Autonomous Communities shall communicate to the Ministry of Agriculture, Fisheries and Food the semen collection centres recognised in their respective territorial areas, in order to be recorded in the veterinary register of collection centres. semen of that Department, each receiving a veterinary registration number. The Ministry of Agriculture, Fisheries and Food shall communicate the list of Spanish semen collection centres, with their veterinary registration number, to the Autonomous Communities and, through the established channels, to the other Member States and the Commission, to which it shall also notify, where appropriate, any withdrawal of recognition.

3. Where the Ministry of Agriculture, Fisheries and Food considers that a semen collection centre situated in another Member State does not comply or no longer complies with the provisions governing recognition, it shall inform the the competent authority of the State concerned, while collecting the decisions taken, as well as the reasons therefor.

If the Ministry of Agriculture, Fisheries and Food had reasonable grounds for believing that the necessary measures would not have been taken or that they were inadequate, it would inform the Commission of the effects of the a provisional ban on the admission of semen from the centre concerned or, where appropriate, to withdraw the authorisation.

Article 6. Health certificate and performance of official veterinarians.

1. Both the dispatch from Spain to other Member States and the reception from these semen shall be subject to presentation to the competent veterinary authority of a health certificate established in accordance with Annex D by a veterinarian. official of the Member State of collection.

This certificate must:

(a) Be drawn up at least in one of the official languages of the Member State of collection and in one of the languages of the Member State of destination; where Spain is a country of collection or destination, it must be drawn up at least in the official Spanish language of the State.

b) accompany the batch to its destination an original copy.

c) Constar of a single sheet or sheet.

d) Be intended for a single recipient.

2. The extension of the health certificates for the dispatch of semen to other Member States shall be the responsibility of the official veterinarian. The same requirements as those laid down in Royal Decree 434/1990 of 30 March 1990 laying down the health conditions for intra-Community trade in live bovine animals and swine shall be met.

3. The official veterinary services of the respective Autonomous Communities shall, within their territorial scope, to:

(a) Carry out checks on the documents accompanying the lots in order to verify that the provisions of Article 3 have been complied with. Where such checks reveal that the above provisions have not been complied with, they shall inform the competent authorities of this fact in order to prohibit the importation or movement into the national territory of those lots.

b) Take the necessary measures, including quarantine, to achieve safe checks when there is a suspicion that the sperm is infected or contaminated by pathogenic germs.

(c) Authorise the reissue of the semen, provided that it does not object to it, health police considerations, following the decisions taken pursuant to paragraphs (a) or (b).

4. Where the entry of semen has been prohibited by any of the grounds referred to in paragraphs (a) or (b) of paragraph 3, the Member State of collection shall, within 30 days, authorise the reissue of the semen, the competent authority of the the respective Autonomous Community may order its destruction.

5. The decisions taken by the competent authority of the Autonomous Community, pursuant to paragraphs 3 and 4, shall be communicated to the sender or his agent, indicating the reasons.

Article 7. Communications and opinions of veterinary experts.

1. Decisions taken by the competent authority of the Autonomous Community, in accordance with the provisions of this provision, shall be notified in writing, to the sender or to his authorised representative, in writing, stating the the resources that come from the legislation in force, as well as the body before which they can be brought, the forms and the time limits for this. Those decisions shall also be communicated to the Ministry of Agriculture, Fisheries and Food for the transfer, through the appropriate course, to the competent veterinary authority of the Member State of collection or provenance.

2. The senders in whose consignments of semen the right to obtain, before the competent authority of the Autonomous Community of the Member States concerned takes other measures, shall be granted to the senders in whose consignments of semen the opinion is to be taken. of a veterinary expert to determine the provisions of Article 6.

The veterinary expert must possess the nationality of a Member State other than the Member State of collection, nor Spanish, and must be included in the list at the time of its proposal by the Member States. drawing up such opinions.

CHAPTER III

Importing third countries

Article 8. List of authorized countries.

Only the importation of semen of bovine animals from third countries listed in the list set out in Annex E. shall be authorised only. This list may be supplemented or amended by the Ministry of Agriculture, Fisheries and Food, in accordance with the decisions taken by the Community authorities.

Article 9. Requirements for authorization.

1. The semen must come from animals which, immediately before obtaining the semen, have been kept for at least six months in the territory of some of the third countries listed in the list referred to in Article 8 (1

.

2. Without prejudice to the provisions of Article 8 and paragraph 1 of this Article, the Ministry of Agriculture, Fisheries and Food shall only authorise imports of semen from any of the third countries included in the list, where the semen complies with the animal health requirements laid down by the Community authorities for the importation of semen from that country.

3. As regards the establishment of the animal health conditions, in accordance with paragraph 2, for tuberculosis as well as brucellosis, the rules laid down by the provisions of the Annex shall apply as a reference basis. I of Royal Decree No 379/1987 of 30 January 1987 on the health status of bovine animals, taking into account the derogations which the Community authorities may lay down after examining whether the third country concerned provides similar health guarantees. In that case, health conditions equivalent to at least those in Annex A shall be established in order to allow the animals concerned to enter the collection centres.

4. The provisions of Article 4 of this provision shall apply to imports from third countries.

Article 10. Health certificate.

1. The Ministry of Agriculture, Fisheries and Food shall only authorise the importation of semen if a health certificate issued and signed by an official veterinarian of the third country of collection is presented.

This certificate must:

(a) Be drawn up at least in the official Spanish language of the State and in one of the official languages of the Member State of destination, if this is not Spain.

b) To accompany the sperm with an original specimen.

c) Constar of a single sheet or sheet.

d) Be written for a single recipient.

2. The health certificate shall conform to the model established by the Community authorities.

Article 11. Controls.

The rules laid down in Royal Decree 2022/1993 of 19 November 1993 laying down the principles governing the organisation of veterinary checks on products entering the Community from countries third parties, shall be applicable to the organisation and monitoring of the checks carried out by the competent authority and the safeguard measures to be applied.

CHAPTER IV

Safeguarding and control measures

Article 12. Prohibitions.

1. Where there is a danger of the spread of any disease among animals, the following measures shall be adopted by the Ministry of Agriculture, Fisheries and Food by the entry into the Spanish territory of semen from another Member State:

(a) prohibit or temporarily restrict the entry of semen from the parts of the territory of the Member State where an epizootic disease has been declared.

(b) to prohibit or temporarily restrict the entry of semen from the whole of the territory of the other Member State in the event that an epizootic disease shows signs of extension or if another disease of animals, severe and contagious.

The Ministry of Agriculture, Fisheries and Food shall without delay inform the other Member States and the Commission of the demonstration in our territory of any disease, through the appropriate channel. epizootic and the measures taken to combat the disease. It will also give you, without delay, the disappearance of the disease.

2. Without prejudice to Articles 8 and 9, and where a contagious disease of animals which may be spread by semen and which may affect the animal health status of any animal shall be expressed or extended in a third country, Member State, or where any other animal health reason justifies it, the Ministry of Agriculture, Fisheries and Food, if Spain is the country of entry, shall prohibit the importation of the semen, whether or not it is a direct import it is a question of indirect importation effected through another Member State being indifferent to such the effect of the semen from the third country as a whole or only from a part of the territory of the country.

3. The measures taken by the Ministry of Agriculture, Fisheries and Food on the basis of paragraphs 1 and 2, as well as their abolition, shall without delay inform the other Member States and the Commission of the reasons for such measures. justify.

4. Consignments of semen from Spain to other Member States either directly or indirectly may be the subject of the measures provided for in paragraphs 1 and 2 by the competent bodies of the Autonomous Communities concerned. they give identical circumstances to which they are listed.

5. The resumption of imports from third countries shall, where appropriate, be authorised after the relevant Community decision.

Article 13. On-the-spot checks.

In the event that experts from the European Commission carry out on-the-spot checks to verify compliance with this Royal Decree, by the competent bodies of the Autonomous Communities and the Ministry of Agriculture, Fisheries and Food, in their respective fields of competence, shall be provided with the assistance necessary for the performance of their tasks, the effects of which may be accompanied by such experts.

Additional disposition first. Basic character.

This Royal Decree is dictated in accordance with the State competence in the field of foreign trade and the general principles and coordination of health contained in Article 149.1.10. and 16. of the Constitution.

Additional provision second. Functions of the Ministry of Agriculture, Fisheries and Food.

By the Ministry of Agriculture, Fisheries and Food will proceed to:

1. To communicate to the Commission, through the established channels, the Spanish laboratories recognised for the conduct of the examinations.

2. To propose to the Commission the names of the veterinary experts to be involved in the opinions.

First transient disposition. Non-applicability.

This Royal Decree shall not apply to semen collected and treated in the Member States before 1 January 1990.

Second transient disposition. Conditions applicable to semen from third countries.

Until the date of the effectiveness of the decisions taken in the application of Articles 8 and 9, no more favourable conditions than those resulting from the application shall apply to imports of semen from third countries. Chapter II concerning intra-Community trade.

Unique repeal Diposition. Unique regulatory repeal.

Royal Decree 877/1990 of 6 July 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of frozen semen of animals of the species is hereby repealed. bovine.

Final disposition first. Faculty of development.

The Minister of Agriculture, Fisheries and Food is empowered to lay down the provisions necessary for the implementation and application of the provisions of this Royal Decree.

In particular, the Minister of Agriculture, Fisheries and Food is empowered, in the field of their competence and in coordination with the Autonomous Communities, to schedule actions leading to the consolidation of the the Spanish centres until the health status is reflected in the first subparagraph of Article 4 (2).

The Minister of Agriculture, Fisheries and Food is empowered to amend the Annexes to this Royal Decree in order to adapt them to the Community provisions.

Final disposition second. Entry into force.

This Royal Decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid on November 25, 1994.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries and Food,

LUIS MARIA ATIENZA SERNA

ANNEX A

CHAPTER I

Recognition requirements for semen collection centers

Sperm Collection Centers should:

a) Be on a permanent basis, under the supervision of a center veterinarian.

b) Dispose at least:

1. Of facilities to ensure the housing and isolation of animals.

2. Of facilities for the collection of the semen, with its own premises for cleaning and disinfection or sterilisation of the equipment.

3. A local for the treatment of sperm that will not necessarily have to be found on the same site.

4. From a sperm storage facility, which will not necessarily have to be found on the same site.

c) Being constructed or isolated in a way that allows to rule out any contact with animals outside.

(d) Be constructed in such a way that the facilities used to house the animals and for the collection, treatment and storage of the semen can be easily cleaned and disinfected.

e) To provide, for the accommodation of the animals to be isolated, of facilities that do not have direct communication with the ordinary facilities.

(f) Being designed in such a way that the housing area of the animals is materially separated from the semen treatment site and that both the first and the second are separated from the storage area of the semen. sperm.

CHAPTER II

Control requirements for semen collection centers

Collection centers must:

(a) Be under surveillance so that they can only remain animals of the species from which the semen is to be obtained. However, other domestic animals which are absolutely necessary for the normal operation of the collection centre may also be permitted provided that it does not present any risk of infection to the animals of the species from which it is go to get the semen and meet the requirements set by the centre veterinarian.

(b) to be under surveillance to ensure that a register is kept for all bovine animals present in the establishment, in which data relating to the breed, date of birth and identification of each of those animals are collected, as well as a register relating to all the controls related to the diseases and to all the vaccinations carried out, in which data is collected from the file on the disease or health status of each animal.

(c) To be subject to regular inspections carried out at least twice a year by an official veterinarian during which the permanent monitoring of the conditions of recognition and surveillance is carried out.

d) Dispose of surveillance that prevents the entry of any unauthorized person. In addition, authorised visitors must be admitted in accordance with the conditions laid down by the centre veterinarian.

e) To employ technically competent personnel, who have received adequate training on disinfection procedures and hygiene techniques to prevent the spread of diseases.

f) Be under surveillance to ensure compliance with the following requirements is ensured:

1. º That only semen collected and stored in recognized centers is treated, without coming into contact with any other batch of sperm. However, it may be possible to treat in the collection centres recognised semen not collected in such centres, provided that:

This semen is obtained from bovine animals meeting the requirements set out in Annex B, Chapter I, paragraph 1, paragraph d), 1. º, 2. º, 3. and

.

The treatment shall be carried out with differentiated equipment and at a time other than that in which the semen is processed for intra-Community trade, in such a case that the semen must be cleaned and sterilised. instruments after use.

This semen is not intended for intra-Community trade and may not, at any time, come into contact or be stored with semen intended for intra-Community trade.

This semen is identified by a mark other than that provided for in paragraph

.

In addition, frozen embryos may be stored in recognised centres provided that such storage is subject to the authorisation of the competent authority; the embryos comply with the requirements of Royal Decree 855/1992, 10 July on animal health conditions applicable to intra-Community trade in and imports from third countries of embryos of domestic animals of the bovine species, and the storage of embryos in the Bottles intended for storage that will be separated from the recognised spermas on the recognized storage premises.

2. That the collection, treatment and storage of the semen are carried out exclusively in the premises reserved for the purpose and in the most rigorous hygiene conditions.

3. º That all utensils that during collection and treatment come into contact with the sperm or the donor animal are properly disinfected or sterilized before each use.

4. ° The products of animal origin used in the treatment of semen-including additives or diluents-come from sources that do not present any health risk or have been subject to appropriate prior treatment to remove that risk.

5. º That containers used for storage and transport are properly disinfected or sterilized before any filling operation begins.

6. º That the cryogenic agent used has not previously been used for other products of animal origin.

7. ° Each individual dose of semen shall be provided with a visible mark which allows the date of obtaining the semen, the breed and the identification of the donor animal, the name of the centre and the status to be easily established serological of the donor animal with respect to the IBR and the IPV, where appropriate by means of a code.

ANNEX B

CHAPTER I

Requirements for the admission of animals to recognised semen collection centres

1. All bovine animals which are admitted to a semen collection centre shall:

(a) Haber has been subjected to a period of isolation of at least 30 days in facilities specially recognised for this purpose, in which other artiodactyl animals at a lower level of health are not found.

(b) Haber belonged, before entering the isolation facilities described in subparagraph (a), to officially tuberculosis-free and officially brucellosis-free cattle, in accordance with Royal Decree 434/1990 of 30 June 1990. March, laying down the health conditions for intra-Community trade in live animals of the bovine and porcine species. The animals may not have been previously kept in any lower-status animal husbandry.

(c) Proceed from an enzootic bovine-leukosis-free cattle, in accordance with the definition of Royal Decree 1114/1992 of 18 September 1992 laying down the rules on enzootic leucosis to be complied with by the breeding or production bovine animals intended for intra-Community trade; or having been born to mothers who have been subjected, with negative results to the agar gel immunodiffusion test, carried out in accordance with Annex C to the Order of 1 The Court of State held that the Court of State held that the Court of State held that the Court of the development of livestock sanitation campaigns in respect of the diagnosis of bovine brucellosis and enzootic bovine leucosis, having been separated from their mothers. In the case of animals born by artificial insemination, 'mother' shall mean the recipient of the embryo.

(d) Have been subjected, before the isolation period referred to in paragraph (a) and during the preceding thirty days, to the following tests, with negative results:

1. An intradermal tuberculinisation carried out in accordance with the procedure laid down in Annex A to the Order of 28 February 1986 laying down rules for the development of livestock sanitation campaigns.

2. A sero-agglutination test according to the procedure described in Annex B to the Order of 28 February 1986 and which would have produced a brucellar index of less than 30 IU of binders per milliliter or a reaction of Complement fixation which has produced a brucellar index of less than 20 EEC units per millilitre (20 ECFT units).

3. A serological test for the detection of enzootic bovine leukosis, carried out in accordance with the procedure laid down in Annex C to the Order of 1 December 1992.

4. º A seroneutralization test or an ELISA test for the detection of infectious bovine rhinotracheitis or infectious purulent vulvovaginitis.

5. A virus isolation test (fluorescence antigen detection test or immuno-peroxidase test) for the detection of viral diarrhea of bovines. For animals less than six months old, the test shall be deferred until they reach that age.

The competent authority may authorise the checks referred to in paragraph (d) to be carried out at the isolation station, provided that the results are known before the start of the isolation period 30 days provided for in paragraph e).

(e) Having been subjected, during the period of isolation of at least thirty days referred to in paragraph (a), to the following tests, with negative results:

1. A sero-agglutination test in accordance with the procedure described in Annex B to the Order of 28 February 1986, of which a brucellar index of less than 30 IU of binders per millilitre was cast, or a reaction which has a brucellar index of less than 20 EEC units per millilitre (20 ICFT units).

2. A test for antibody antigen detection by immunofluorescence and a culture for the infection "campylobacter foetus" on a sample of prepuce material or artificial vaginal washing; in the case of female A vaginal mucus agglutination test should be performed.

3. A microscopic examination and a culture for the detection of "trichomonas foetus" on a vaginal or prepucial wash sample; in the case of females, a vaginal mucus agglutination test must be performed.

4. º A seroneutralization test or an ELISA test, for infectious bovine rhinotracheitis or infectious purulent vulvovaginitis.

If any of the listed tests are positive, the animal must immediately be removed from the isolation facility. If the isolation is group isolation, the official veterinarian shall take all necessary steps to enable the other animals to be subjected to the collection centre in accordance with the provisions of this Annex.

2. All examinations shall be carried out in the officially recognised laboratory.

3. Animals shall only be admitted to the semen collection centre where the centre veterinarian expressly authorises it. All movements of animals shall be recorded, in the case of entry or exit.

4. All animals admitted to the semen collection centre shall be free from clinical signs of disease on the day of their admission and must, without prejudice to paragraph 5, proceed from an isolation facility. referred to in subparagraph (a) of paragraph 1, and which officially meets on the day of issue the following requirements:

(a) Be located in the centre of a zone of a radius of 10 kilometres in which there has been no case of foot-and-mouth disease since at least 30 days before.

(b) Hallse free from foot-and-mouth disease and brucellosis for at least three months before.

(c) Halting free, for at least 30 days before, of the bovine diseases of compulsory declaration, in accordance with Annex A to Royal Decree 434/1990 laying down the health conditions applicable to trade Intra-Community trade in live animals of the bovine and porcine species.

5. Provided that the requirements laid down in paragraph 4 are fulfilled and during the preceding 12 months the regular examinations referred to in Chapter II have been carried out, the animals may be transferred from a recognised collection centre. semen to another, of an equivalent health level, with no period of isolation and no examination, provided that the movement is carried out directly. The animal concerned must not come into direct or indirect contact with artiodactide animals at a lower level of health, and the means of transport used must have been disinfected in advance. The movement of animals from one semen collection centre to another situated in another Member State shall be carried out in accordance with the animal health rules governing intra-Community trade in live bovine animals.

6. However, animals of the bovine species originating in herds free of brucellosis may be admitted to the approved semen collection centres until 1 July 1995. In this case, the animals must be subjected, during the said period, to a complement fixing reaction which results in a brucellar index of less than 20 EEC units per millilitre (20 ECFT units), as set out in the (d) in paragraph 2 (d) and in paragraph 1 (e) of this paragraph.

CHAPTER II

Compulsory routine examinations and treatment for bovines found in the recognised semen collection centre

1. All bovine animals remaining in a semen collection centre shall be subject to the following examinations or treatments at least once a year:

(a) An intradermal tuberculinisation for tuberculosis carried out in accordance with the procedure laid down in Annex A to the Order of 28 February 1986 laying down rules for the development of the livestock sanitation, with negative result.

(b) A seroagglutination test for brucellosis carried out in accordance with the procedure described in Annex B to the Order of 28 February 1986, resulting in an index of less than 30 IU of binders per millilitre, or a complement fixation reaction of less than 20 CEE units per millilitre (20 ECFT units).

(c) A serological examination to detect enzootic bovine leukosis, carried out in accordance with the procedure set out in Annex C to the Order of 1 December 1992, which shall have a negative result.

d) For infectious bovine rhinotracheitis or infectious purulent vulvovaginitis, a seroneutralization test or an ELISA test that deliver negative results.

It shall not be necessary to practice such tests on bulls that have been tested positive for serological testing carried out in accordance with this Royal Decree.

Vaccination against the above mentioned diseases may be performed in seronegative bulls, either by a dose of live temperature-sensitive vaccine and administered by the nasal route or by two doses of inactive vaccine. administered at least three weeks and four weeks at the latest; in both cases, recall vaccinations should be carried out at intervals of not more than six months.

e) A test for the detection of antibodies by antibodies to immunofluorescence or a culture for the infection "campylobacter foetus" on a sample of prepuce or vaginal washing material; if it is female, it must perform a vaginal mucus agglutination test.

However, bulls which are not used for the production of semen may be exempted from the antigen test by antibodies or from the 'campylobacter foetus' infection and may only be readmitted to production. of semen after having been subjected to such test or to such a crop with a negative result.

2. All examinations shall be carried out in an officially recognised laboratory.

3. If any of the above tests results in a positive result, the animal must be isolated and the semen of the animal which has been collected since the date of the last negative test shall not be subject to intra-Community trade.

The semen which has been collected from all other animals which are in the centre from the date on which the positive test was carried out shall be stored separately and shall not be subject to trade intra-community until the health status of the centre is restored.

These provisions will not apply to seropositive bulls which, before being vaccinated for the first time in the insemination centre, in accordance with this Royal Decree, have submitted a negative reaction to the test. for the diagnosis of infectious bovine rhinotracheitis or infectious purulent vulvovaginitis, or to the ELISA test.

The seropositive bulls referred to in the second subparagraph of Article 4 (1) shall be isolated and their semen may be the subject of intra-Community trade in accordance with the rules governing trade in semen from such bulls.

ANNEX C

Requirements to be collected by semen collected at recognised semen collection centres for intra-Community trade

1. The semen must come from animals which:

a) Do not present any clinical manifestations of disease at the time of collection.

b) FMD:

1. No have been vaccinated against foot-and-mouth disease during the 12 months prior to collection, or

2. Hayan was vaccinated against foot-and-mouth disease during the 12 months prior to collection, in which case a 5 per 100 (with a minimum of five pipettes) of each collection shall be submitted to a virus isolation test or to a animal inoculation test for foot-and-mouth disease, which shall be negative results.

(c) Have not been vaccinated against foot-and-mouth disease in the 30 days immediately preceding collection.

(d) have been kept in a recognised semen collection centre for an uninterrupted period of at least 30 days prior to the collection of semen, in the case of fresh semen.

e) Do not be allowed to practice natural covering.

(f) are found in semen collection centres which have been free of foot-and-mouth disease for at least the preceding three months and the 30 days following collection or, in the case of fresh semen, up to the the date of issue, and which are located in the centre of a zone within a radius of 10 kilometres where there has been no case of foot-and-mouth disease at least in the last 30 days.

g) Hayan remained in semen collection centres which, during the period from the 30th day preceding the collection and the 30th day following the collection or, in the case of fresh semen, up to the date of they have been free of bovine diseases subject to compulsory declaration, in accordance with the provisions of Annex A to Royal Decree 434/1990.

2. The antibiotics listed below must be added to obtain the following concentrations in the semen after final dissolution:

Minimum: 500 IU streptomycin per ml; 500 IU penicillin per ml; 150 micrograms lincomycin per ml; 300 micrograms of spectinomycin per ml.

A different concentration of antibiotics may be used that has an equivalent effect against campylobacter, leptospiras, and mycoplasms.

Immediately after the addition of the antibiotics, the diluted semen must be kept at a temperature of at least 5 ° C for at least 45 minutes.

3. Semen intended for intra-Community trade shall:

1. º Store under authorized conditions for a minimum period of thirty days prior to dispatch. This requirement shall not apply to fresh semen.

2. To be transported to the Member State of destination in bottles which have been cleaned, disinfected or sterilised before use and have been sealed and numbered before leaving the recognised storage premises.

ANNEX D

KINGDOM OF SPAIN

Healthcare certificate

Relative to frozen bovine semen intended for a Member State of the European Union.

Number ................................

Collection country ............................................................................................................

Competent Authority ....................................................................................................

Sperm identification:

........................................................................................................................................

Number of doses

Collection date (s)	Identification of the donor animal	Race	Date of birth

II. Origin of the semen:

Address of recognized semen collection center (s):

........................................................................................................................................

........................................................................................................................................

Recognition number (veterinary register) of the semen collection centre (s)

III. Destination of semen:

Sperm is sent from .................................................................................................

(place of loading)

a .....................................................................................................................................

(country and place of destination)

by ..................................................................................................................................

(means of transport)

Sender Name and Address .................................................................................................................................................................................................................................

Name and address of recipient .................................................................................................................................................................................................................................

IV. I, the undersigned official veterinarian, certify:

1. That the semen described above has been obtained, treated and stored under conditions which comply with the provisions of Directive 88 /407/EEC.

2. That the semen described above has been transported to the place of loading in a sealed container in accordance with the provisions of Directive 88 /407/EEC and with the number ..................................................

3. That the semen described above has been obtained in a centre where all the bulls have tested negative in a seroneutralisation test or an ELISA test for the detection of infectious bovine rhinotracheitis or purulent vulvovaginitis infectious, carried out in accordance with the provisions of Directive 88 /407/EEC.

4. That the sperm described above has been obtained from bulls:

1. No, which have been negative in a seroneutralisation test or in an ELISA test for infectious bovine rhinotracheitis or infectious purulent vulvovaginitis, carried out in accordance with the provisions of the Directive 88 /407/EEC (1).

2. That they tested positive in the tests referred to in paragraph 1 but that before receiving a first dose of vaccine in the insemination centre, in accordance with the aforementioned Directive, they had already produced results. negative in such tests (1).

3. ° That they reacted positively to the seroneutralization test or to the ELISA test for infectious bovine rhinotracheitis or infectious purulent vulvovaginitis, and has not been vaccinated according to the provisions of the Directive 88 /407/EEC (1); in which case, the semen comes from a consignment which has been subjected, with negative results, to an examination by inoculation or to a virus isolation test (1) in accordance with the third subparagraph of the Article 4 (1) of Directive 88 /407/EEC in the laboratory ..................... (2).

5. That the above described sperm has been collected from bulls:

1. º That have not been vaccinated against foot-and-mouth disease during the twelve months prior to collection (1).

2. º which have been vaccinated against foot-and-mouth disease within the 12 months prior to collection, in which case the semen comes from a collection in which 5 per 100 of each collection intended for trade (with a minimum of five pipettes) has been subjected, with negative results, to an isolation test for foot-and-mouth disease virus in the laboratory of ...................... (2).

6. That the semen was stored under approved conditions for a minimum period of 30 days prior to dispatch (3).

Made in ............................................................. the ......................................................

........................................................................................................

(Signature)

........................................................................................................

(Surname in uppercase)

Seal

(1) Strike out what does not apply.

(2) Name of the laboratory designated in accordance with Article 4 of Directive 88 /407/EEC.

(3) Can be removed in the case of fresh sperm.

ANNEX E

The list of third countries in respect of which the importation of semen of bovine animals is authorised pursuant to the article of this Royal Decree are as follows:

Australia, Austria, Canada, Czech Republic, Slovakia, United States, Finland, Hungary, successor states to Yugoslavia, Norway, New Zealand, Poland, Romania, Sweden, Switzerland and Israel.