The implementation of the Community provisions dealing with animal health problems affecting intra-Community trade in bovine animals and swine and those relating to the importation of bovine animals animals from third countries have made it possible to ensure that the country of origin ensures compliance with animal health criteria, which makes it possible to avoid the risks of spreading animal diseases.

There was, however, a certain risk of the spread of these diseases in the case of intra-Community trade and imports into the Community of porcine semen.

This aspect has been considered by Council Directive 90 /429/EEC of 26 June laying down the requirements for animal health applicable to intra-Community trade in and imports of animal spermade of the porcine species, which serves as a basis for this provision, the guidelines of which are intended to ensure that the country in which the semen is obtained must ensure that it is carried out and treated in approved and controlled collection centres, in accordance with rules to preserve their correct health status and to be accompanied by a health certificate while driving to the country of destination in order to ensure compliance with those rules.

In the case where the semen of third countries is carried out, in order to prevent the transmission of certain contagious diseases, import controls must be carried out on arrival in the territory of the Community of a lot of semen, except in the case of an external transit.

And finally, as an additional guarantee, it is expected that urgent measures will be taken when communicable diseases arise in another Member State or in your third country, although taking into account that the protective measures to be taken are appreciated in the same way throughout the Community.

Consequently, it is necessary to incorporate into Spanish legislation the animal health requirements set out in that Directive, and in accordance with the state competence contained in Article 149.1.10 and 16 of the Constitution.

In its virtue, on the proposal of the Minister of Agriculture, Fisheries and Food and after deliberation of the Council of Ministers at its meeting on 25 September 1992,

DISPONGO:

Chapter I

General provisions

Article 1.

This provision lays down animal health conditions for intra-Community trade and imports from third countries of semen of animals of the porcine species.

Article 2.

For the purposes of this provision, the definitions set out in Article 2 of Royal Decree 434/1990 of 30 March 1990 laying down health conditions for intra-Community trade shall apply. for live bovine animals and swine, in Article 2 of Royal Decree 495/1990 of 20 April 1990 laying down the health conditions to be met by live bovine animals and swine imported from third countries Article 2 of Royal Decree 877/1990 of 6 July 1990 laying down the requirements of the animal health requirements for intra-Community trade and imports of frozen semen of bovine animals of the bovine species.

The product the ejaculation of a domestic animal of the porcine species, as presented, prepared or diluted, shall also be understood.

Chapter II

intra-Community trade

Article 3.

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

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

(b) which has been obtained from animals of the porcine species, 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) of this Royal Decree.

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

Article 4.

1. Without prejudice to paragraph 2, until 31 December 1992, the reception from other Member States and the dispatch to them of semen originating from verracos who have been vaccinated in the centre of the collected by the attenuated G1 vaccine, provided that such vaccination has only been carried out on a seronegative version of the Aujeszky's disease virus and that the serological tests are carried out three weeks after the vaccination. vaccination, do not indicate the presence of antibodies induced by the disease virus.

In this case, a sample of semen of each daily collection intended for exchange may be subjected to a virus isolation test in an official laboratory of the country of the semen.

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 unvaccinated animals against Aujeszky's disease and present a result shall not be possible. negative to the seroneutralization test or to the Elisa test for the detection of Aujeszky's disease.

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 which animals present negative results to the seroneutralisation test or to 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 sperm from other countries 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 be able to know Ministry of Agriculture, Fisheries and Food to initiate proceedings before the Commission of the European Communities for the appropriate recognition.

3. Without prejudice to Community provisions, while in Spain vaccination against Aujeszky's disease is carried out, consignments of semen to other Member States which do not practise the same, are subject to the condition that such vaccination be carried out. in accordance with this provision, as well as the potential requirement of such countries to be negative for the testing of the presence of antibodies induced by the disease virus to be carried out in accordance with paragraph 1.

If in Spain the vaccination against Aujeszky's disease is stopped, the Ministry of Agriculture, Fisheries and Food shall take appropriate measures to require identical guarantees, to the supply of semen from the Member States which continue to vaccinate.

Article 5.

1. The competent bodies of the Autonomous Communities shall carry out the authorization referred to in Article 3.1 (a) of this Royal Decree if the semen collection centres comply with the conditions laid down in this Regulation. Provision and, in particular, those of Annex

The official veterinarian shall monitor compliance with these provisions and shall inform the relevant organ of the Autonomous Community of any non-compliance with these provisions, proposing, where appropriate, the withdrawal of authorization to the centres.

2. Approved semen collection centres shall be entered in the Veterinary Register of semen collection centres of the relevant organ of the Autonomous Community, each receiving a veterinary registration number.

The Autonomous Communities shall draw up the list of approved semen collection centres, with their veterinary registration numbers, as well as, where appropriate, any withdrawal of approval, and shall notify the Ministry of Agriculture, Fisheries and Food to be sent to the Commission of the European Communities and the other Member States.

3. Where the Autonomous Communities consider that in a semen collection centre situated in another Member State the provisions governing recognition are not fulfilled or no longer complied with, they shall notify the Ministry of Agriculture, Fisheries and Food for the purpose of informing the competent authority of the State concerned, as well as obtaining the decisions taken, as well as the reasons for them.

Also, if the Autonomous Communities estimate that the necessary measures have not been taken or that they are inadequate, they will notify the Ministry of Agriculture, Fisheries and Food for their report to the Commission of the European Communities, for the purposes of the temporary ban on the admission of semen from the centre concerned or, where appropriate, for the withdrawal of the authorisation.

Article 6.

1. Both the dispatch from Spain to other Member States and the reception from those of each consignment of semen must be accompanied by a health certificate established in accordance with Annex D by an official veterinarian 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 language State official Spanish.

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. In addition to the measures provided for in Community legislation concerning veterinary and zootechnical checks applicable in intra-Community trade, where Spain is a country of destination, the necessary measures may be taken including: quarantine provided that it does not alter the validity of the semen, in order to achieve safe checks where there is a suspicion that the semen is infected or contaminated by pathogenic germs.

Chapter III

Third country imports

Article 7.

1. Only the importation of semen of animals from third countries listed in a list drawn up by the Commission of the European Communities shall be authorised and published in the Official Journal of the European Communities. Official > of the European Communities.

2. Without prejudice to the above paragraph, the list referred to therein, and subsequent amendments thereto, shall be published in the Official Journal of the State, at the initiative of the Ministry of Agriculture, Fisheries and Food, for a better understanding of stakeholders.

Article 8.

Only the entry of semen from the collection centres, from third countries, shall be authorised, as referred to in the list approved by the Commission of the European Communities.

Article 9.

1. The semen must come from animals which, immediately before they are obtained, have been kept for at least three months in the territory of one of the third countries listed in the list referred to in Article 7 (1) of this Regulation. Royal Decree.

2. Without prejudice to the provisions of Article 7 of this Royal Decree and the previous paragraph, the Ministry of Agriculture, Fisheries and Food shall only authorise the importation of semen from one of the third countries included in the list if the semen complies with the animal health rules laid down by the Community authorities for the importation of semen from that country.

3. Where appropriate, it shall apply as set out in Article 4 of this Royal Decree.

Article 10.

1. Only the importation of semen shall be authorised if a health certificate issued and signed by an official veterinarian of the third country of collection is presented.

This certificate must:

(a) Be drafted, at least, in the official Spanish language of the State.

b) accompany the sperm in its original specimen to its destination.

c) Single-sheet Constar.

d) Be intended for a single recipient.

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

Article 11.

1. Each consignment of semen arriving in the customs territory of Spain shall be subject to a check by the official veterinary services of the Customs Office under the Ministry of Agriculture, Fisheries and Food, before being released for free circulation or if they are admitted under a customs procedure, the entry of the semen is prohibited:

(a) Not from the territory of a third country listed in the list established in accordance with Article 7 (1) of this Royal Decree.

(b) Do not proceed from a semen collection centre of those listed in the list referred to in Article 8 of this Royal Decree.

(c) Proceed from the territory of any third country from which the import is prohibited in accordance with Article 15 (2) of this Royal Decree.

(d) Not accompanied by the health certificate in accordance with the requirements laid down in Article 10 of this Royal Decree and fixed in application thereof.

This paragraph shall not apply to consignments of semen arriving in the national customs territory and subject to a customs transit procedure in order to be taken to a place of destination situated outside the territory of the territory of national.

However, it shall be applicable in case of waiver of customs transit in the course of transport through the national territory.

2. The Ministry of Agriculture, Fisheries and Food may take the necessary measures, including quarantine, provided that this does not alter the validity of the semen, to arrive at safe checks if the semen is suspected of being contaminated by the semen. pathogenic germs.

3. If the entry of the semen has been prohibited for any of the reasons referred to in paragraphs 1 and 2 and the exporting third country does not authorise the reissue of the semen within 30 days in the case of frozen semen or immediately in the case of fresh semen, the Ministry of Agriculture, Fisheries and Food may order the destruction of the semen.

Article 12.

Each batch of semen whose introduction into the Community has been authorised by Spain, on the basis of the control referred to in Article 11 (1) of this Royal Decree, shall be accompanied by the consignment to the territory of another Member State, by the original of the certificate or by an authenticated copy of the certificate, original or copy, to be duly endorsed by the Ministry of Agriculture, Fisheries and Food as the authority responsible for the examination, is carried out in accordance with Article 11 of this Royal Decree.

Article 13.

If, pursuant to Article 11 (3) of this Royal Decree, measures of destruction are taken, the inherent costs shall be borne by the sender, the consignee or the respective representative of one or the other, without the right to compensation by the State.

Chapter IV

Safeguarding and control measures

Article 14.

Community rules shall apply in particular as regards the control at source, the organisation and the course to be carried out for the checks carried out by the Member State of destination.

Article 15.

1. For intra-Community trade, the safeguard measures provided for in Community legislation concerning veterinary and zootechnical checks on the exchange of animals, meat and products shall apply.

2. Without prejudice to Articles 8, 9 and 10 of this Royal Decree, a contagious disease of animals which may be spread through the semen and which may affect the disease in a third country shall be expressed or extended in a third country. health status of livestock in the national territory, or where any other animal health reason justifies it, the Ministry of Agriculture, Fisheries and Food shall prohibit the importation of the semen, whether or not it is a direct import as in the case of indirect imports 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.

The Ministry of Agriculture, Fisheries and Food shall, through the competent authority, inform the other Member States and the Commission without delay of the measures taken on the basis of the above paragraph, with the expression of the reasons to justify them.

Additional disposition first.

This provision is made under Article 149.1.10 and 16 of the Constitution.

Additional provision second.

This provision shall not apply to semen collected and treated in the Member States before 31 December 1991.

Additional provision third.

Until the date of entry into force of the decisions taken pursuant to Articles 8, 9 and 10 of this Royal Decree, no more favourable conditions shall apply to imports of semen from third countries. those resulting from Chapter II relating to intra-Community trade.

First disposition first.

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 and, in particular, to amend the Annexes to the This provision, in order to adapt them to Community provisions.

Final disposition second.

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

Given in Seville on September 25, 1992.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries and Food,

PEDRO SOLBES MIRA

ANNEX A

Chapter I

Authorization requirements for semen collection centers

Sperm collection centers must:

1. Be permanently under the supervision of a center veterinarian.

2. Have at least:

(a) facilities to ensure the accommodation and isolation of animals;

(b) facilities for the collection of the semen, with a premises of their own for the cleaning and disinfection or sterilisation of the equipment;

(c) of facilities for the treatment of semen, which shall not necessarily be in the same place;

d) of semen storage facilities, which shall not necessarily be located in the same place.

3. Be constructed or isolated in a way that prevents any contact with animals that are outside.

4. 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.

5. Have facilities that do not have direct communication with the ordinary facilities, for the accommodation of the animals to be isolated.

6. Be designed in such a way that the accommodation area of the animals is materially separated from the semen treatment site and that both the first and the second are separate from the semen storage facility.

Chapter II

Monitoring requirements for semen collection centres

Collection centers must:

1. To be under surveillance so that only male animals of the species from which the semen is to be obtained can remain in them.

2. To be under surveillance to keep a record, file or computer support concerning all the details present in the establishment, in which data relating to the breed, the date of birth and the identification of each of the those animals, as well as a record, file or computer support concerning all the controls related to the diseases and with all the vaccinations carried out in which data is collected from the file on the health status of each animal.

3. Be the subject of regular inspections carried out at least twice a year by an official veterinarian during which control is carried out under the conditions of authorisation and surveillance.

4. To be subject to surveillance preventing the entry of any unauthorised person. In addition, authorised visitors must be admitted in accordance with the conditions laid down by the centre veterinarian.

5. Employ technically competent personnel who have received adequate training on disinfection procedures and hygiene techniques to prevent the spread of diseases.

6. Be under surveillance to ensure compliance with the following requirements is ensured:

(a) that only semen collected in approved centres is treated and stored in the approved centres, without coming into contact with any other batch of semen;

(b) that the collection, processing and storage of the semen are carried out exclusively on the premises reserved, without effect and in the same rigorous hygiene conditions;

c) that all utensils that during collection and treatment come into contact with the sperm or donor are properly disinfected or sterilized before each use.

(d) that products of animal origin used in the treatment of semen-including additives or diluents-come from sources which do not present a health risk or have undergone appropriate prior treatment to remove that risk;

e) that the containers used for storage and transport are properly disinfected or sterilised before any filling operation begins;

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

g) that each collection of semen divided or not in individual doses is provided with a visible mark which allows the date of collection of the semen to be easily established, as well as the breed and identification of the donor animal and the the name and registration number of the centre preceded by the name of the country of origin, possibly by means of a code; the characteristics and the model of that mark shall be established in accordance with the intended Community procedure.

ANNEX B

Chapter I

Requirements applicable to the admission of animals to approved semen collection centres

A. All the verraques that are admitted to a semen collection centre shall:

1. Having undergone a period of isolation of at least 30 days in facilities specially approved for that purpose by the competent authority, in which only verraques having the same health status are found.

2. Having been collected, before entering the isolation facilities described in paragraph 1, among the flocks of holdings:

(a) officially free of classical swine fever;

b) brucellosis-free;

(c) where during the preceding 12 months there has not been any animal vaccinated against foot-and-mouth disease;

(d) where no serological or virological clinical manifestation of Aujeszky's disease has been detected during the preceding 12 months;

(e) which are not subject to any prohibition, in accordance with the requirements of Royal Decree 434/1990 of 30 March 1990, as regards African swine fever, swine vesicular disease and as well as disease of Teschen and foot-and-mouth disease.

Animals may not have previously remained in other herds of lower status.

3. Having been subjected, before the isolation period referred to in paragraph 1 and during the preceding 30 days, to the following tests with negative results:

(a) a supplement-fixing test carried out in accordance with the provisions of Annex B to the Order of 28 February 1986 for the development of the livestock sanitation campaigns, as regards brucellosis; cases of pigs not vaccinated against Aujeszky's disease, a seroneutralisation or an Elisa test using all the viral antigens;

(c) in the case of pigs vaccinated with a attenuated G1 vaccine, an Elisa test for G1 antigens;

(d) until the date on which a Community policy on the fight against foot-and-mouth disease is applied, an Elisa test for the detection of foot-and-mouth disease;

e) an Elisa test or a seroneutralization test for the detection of classical swine fever.

The competent authority may grant authorisation for the checks referred to in paragraph 3 to be carried out at the isolation station provided that the results are known before the start of the Thirty-day isolation provided for in paragraph 4.

4. Have been subjected, during the last 15 days of the isolation period, provided that the results are known before starting the isolation period of at least 30 days referred to in paragraph 1, to the following tests with negative results:

(a) a sero-agglutination test in accordance with the procedure laid down in Annex B to the Order of 28 February 1986 for the development of livestock sanitation campaigns, which has produced a brucellar index lower than 30ui of binders per millimeter, as well as a complement-fixing reaction which has yielded a brucellar index of less than 20 EEC units per millilitre (20 ICFT units);

(b) in the case of pigs not vaccinated against Aujeszky, a seroneutralisation or an Elisa test using all viral antigens;

c) in cases of pigs vaccinated with G1 negative vaccine, an Elisa test for G1 antigens;

(d) until the date on which a Community policy on the fight against foot-and-mouth disease is applied, an Elisa test for the detection of foot-and-mouth disease;

e) a microscopic agglutination test for the detection of leptospirosis (serovars, pomona, grippotyphose, tarassovi, hardjo, bratislava and ballum) or been the subject of a treatment against leptospirosis consisting of two Streptomycin injections with fourteen days of interval (25 mg per kg of live weight).

Without prejudice to the applicable provisions, where there are cases of foot-and-mouth disease or swine fever, if any of the tests listed are positive, the animal shall immediately be removed from the facility. (i) If the isolation is group isolation, the competent authority shall take all necessary measures to enable the other animals to be admitted to the collection centre in accordance with the provisions of this Annex.

B. All examinations shall be carried out in a laboratory approved by the competent authorities of the Autonomous Communities.

C. 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.

D. All animals admitted to the semen collection centre shall be exempt from clinical signs of disease on the day of their admission, and must, without prejudice to the provisions of paragraph E, proceed from an installation of the referred to in paragraph 1 of paragraph A, which officially meets, on the day of issue, the following requirements:

1. Be located in the centre of an area of a radius of ten kilometres in which there has been no case of foot-and-mouth disease or swine fever for at least 30 days before.

2. It is free from foot-and-mouth disease and brucellosis from at least three months before.

3. It shall be free, from at least 30 days prior to Aujeszky's disease, as well as from the compulsory declaration of disease, in accordance with Annex A to Royal Decree 434/1990 of 30 March.

E. Provided that the routine examinations referred to in Chapter II have been carried out during the preceding 12 months, the animals of a recognised centre may be moved from a recognised centre of collection of semen to another, of an equivalent health level, with no isolation period and no examination, provided that the movement is carried out directly. The animal in question must not come into direct or indirect contact with the biungulate animals of the lower health level, and the means of transport used must have been disinfected in advance. If the transfer of a semen collection centre to another one has place between Member States, it shall be carried out in accordance with the provisions of Royal Decree 434/1990 of 30 March 1990.

Chapter II

Mandatory routine tests for the verraques found in the semen collection center

1. All verraques who remain in a semen collection centre must undergo the following tests before leaving the centre, with a negative result:

(a) in the case of pigs not vaccinated against Aujeszky, a seroneutralisation or an Elisa test using all viral antigens;

(b) in the case of pigs vaccinated with a G1 negative vaccine, an Elisa test for G1 antigens;

(c) until the date on which a Community policy to combat foot-and-mouth disease is applied, an Elisa test for the detection of foot-and-mouth disease;

(d) a brucellosis complement fixation test carried out in accordance with the provisions of Annex B to the Order of 28 February 1986 for the development of livestock sanitation campaigns as regards brucellosis;

e) an Elisa test or a seroneutralization test for the detection of classical swine fever.

In addition, the verraques who remain in the collection centre for more than 12 months must be subjected to the tests referred to in paragraphs (a), (b) and (d) at the latest, eighteen months after their admission.

2. All examinations shall be carried out in a laboratory approved by the Member State.

3. Without prejudice to the provisions applicable in the case of foot-and-mouth disease or swine fever, if any of the tests referred to above are positive, the animal must be isolated and the semen of the animal which has been collected from the date of the last negative examination shall not be subject to intra-Community trade.

The semen which, collected from all other animals found at the centre from the date of completion of the positive test, shall be stored separately and shall not be subject to intra-Community trade until such time as restore the health status of the centre.

ANNEX C

Requirements to be collected by semen collected at approved 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) have not been vaccinated against foot-and-mouth disease;

(c) comply with the requirements of Chapter I of Annex B;

d) are not allowed to practice natural covering;

(e) are located in semen collection centres which have been free from foot-and-mouth disease for at least the three months preceding the distribution and which are situated in the centre of a zone of 10 radius kilometres in which no case of foot-and-mouth disease has been given, at least in the last 30 days, and in addition not to be situated in a restricted zone defined in accordance with the provisions relating to communicable diseases of the Porcine species;

(f) have been kept in semen collection centres which, during the period of 30 days prior to collection, have been free from porcine diseases subject to compulsory declaration, in accordance with the provisions of the Annex A to Royal Decree 434/1990 and Aujeszky's disease.

2. A combination of antibiotics, particularly effective against leptospiras and mycoplasms, should be added to the semen, after final dissolution. This concentration must have at least an effect equivalent to the following dilutions:

Minimum: 500 iu streptomycin per milliliter,

500 iu penicillin per milliliter,

150 ug of lincomycin per milliliter,

300 ug of spectinomycin per millilitre.

Immediately after the addition of the antibiotics the diluted semen must be kept at a temperature of at least 15 C for at least 45 minutes.

3. Semen intended for intra-Community trade shall:

(a) to be stored prior to dispatch in accordance with Chapters I and II of Annex A;

(b) be transported to the Member State of destination in bottles which have been cleaned, disinfected or sterilised before use and have been sealed before leaving the approved storage premises.

ANNEX D