Royal Decree 1148 / 1992 Of 25 September, That Laying Down The Animal Health Requirements Applicable To Intra-Community Trade And Imports Of Semen Of Domestic Animals Of The Porcine Species.

Original Language Title: Real Decreto 1148/1992, de 25 de septiembre, por el que se fijan las exigencias de sanidad animal aplicables a los intercambios intracomunitarios y a las importaciones de esperma de animales de la especie porcina.

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The implementation of the Community provisions which address the problems of animal health in respect of intra-Community of animals bovine and porcine and those relating to the importation of such animals from third countries, have made sure the country of origin to ensure the observance of the criteria of animal health, allowing you to avoid the risk of spread of animal diseases.

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

This aspect has been considered by the directive 90/429/EEC of the Council of 26 June, laying down the animal health requirements applicable to intra-Community trade and imports of espermade animals of the porcine species, which serves as a basis for this provision, whose guidelines are routed to the country in which the sperm is obtained must ensure that appropriate and be treated in collection centres authorised and controlled in accordance with rules that allow preserving its correct health status and which is accompanied by a health certificate during its ride to the country of destination to ensure the observance of these standards.

Similarly, in the case that appropriate semen from third countries in order to prevent the transmission of certain contagious diseases, is shall be carried out import controls, on arrival at the territory of the community of a consignment of semen, unless in the case of an external transit.

And, finally, as additional guarantee expected that urgent steps be taken when emerging infectious diseases in another Member State or the third country, while taking into account that protection measures that give rise are appreciated in the same way throughout the community.

As a result, it is necessary to incorporate into Spanish legislation concerning animal health requirements contained in the directive, and this according to State competition contained in article 16 of the Constitution and 149.1.10.

By virtue, on the proposal of the Minister of agriculture, fisheries and food, and after deliberation by the Council of Ministers at its meeting of September 25, 1992, available: chapter I General provisions article 1.

This provision establishes the animal health conditions governing intra-Community trade and imports from third countries of semen of domestic animals of the porcine species.

Article 2.

For the purposes of this provision shall apply the definitions contained in article 2 of Royal Decree 434/1990, of March 30, which lays down the health conditions applicable to intra-Community trade in live animals of the bovine and porcine species, in article 2 of the Royal Decree 495/1990, of 20 April, which lays down the sanitary conditions that must meet live animals of the bovine and porcine species imported from third countries, and in article 2 of the Royal Decree 877/1990, of 6 July, laying down the animal health requirements applicable to intra-Community trade and imports of frozen semen of domestic animals of the bovine species.

Also it means the product of the ejaculate of a domestic animal of the porcine species, as presented, prepared or diluted.

Chapter II intra-Community trade article 3.

1 only may be issued with destination to other States members, the semen which meets the following requirements: to) that has been collected and treated with a view to artificial insemination, in a collection centre approved from the point of view of health for Exchange purposes use-in accordance with paragraph 1 of article 5 of the present Royal Decree.

(b) that it has been obtained from animals of the porcine species whose health status complies with the provisions of Annex B.

(c) that have been collected, processed, stored and transported in accordance with the provisions of annexes A and C.

(d) that, during transportation to the country of destination, it will accompanied by a health certificate as provided for in paragraph 1 of article 6 of the present Royal Decree.

2 shipments to Spain from other Member States shall meet the requirements set forth in the preceding paragraph.

Article 4.

1. without prejudice to the provisions of paragraph 2, until 31 December 1992, will be allowed both the reception from other Member States and the shipping to them, of semen from boars which have been vaccinated in the collection through the G1-attenuated vaccine Centre, provided that such vaccination has only been carried out at boars seronegative with regard to Aujeszky's disease virus and to serologic tests which will take place three weeks after vaccination, not to mark the presence of antibodies induced by the disease virus.

In this case, a sperm sample from each daily collection intended to Exchange, may be subject to a test of isolation of the virus in an official laboratory of the country of destination of the semen.

2. While health conditions do not vary shall be send from Spanish centres to the other Member States in which all centres only included animals not vaccinated against Aujeszky's disease and present a negative result to a serum neutralization test or to the Elisa test for Aujeszky's disease detection.

Identical measure will be adopted in the event that such community benefit is granted to a part of the territory of a Member State, in so far as all of the centers of that part of the territory does not include more than animals that presented negative results to the serum neutralization test or to the test Elisa.

Until the Spanish territory or part of the same do not reach a health status similar to the mentioned in the preceding paragraphs, can't is refuse the semen from other countries, for the reasons mentioned.

When in an autonomous region all the centers of its territory to ensure the above mentioned favorable health circumstances arise, and intend to benefit from the repeated profit, you can it to the attention of the Ministry of agriculture, fisheries and food this initiate procedures for the timely recognition before the Commission of the European communities.

3. without prejudice to the Community provisions, while in Spain is carried out vaccination against Aujeszky's disease, the consignments of semen to other Member States which do not practice it, are conditioned that such vaccination is carried out in accordance with this provision, as well as the possible demand from such countries that is negative to tests for the presence of antibodies induced by the virus of the disease to be as expressed in the (1).

If in Spain he would practise vaccination against Aujeszky, the Ministry of agriculture, fisheries and food shall take measures to require identical guarantees, the supply of semen from Member States that keep using vaccines.

Article 5.

1 the competent bodies of the autonomous communities shall proceed to the authorisation referred to in paragraph a) of article 3.1 of the present Royal Decree, if the semen collection centres met the conditions established in this provision, and in particular those of Annex A.

The official veterinarian will monitor compliance with those provisions, and must communicate to the corresponding body of the autonomous community any breach of them, proposing, where appropriate, the withdrawal of authorization to the centers.

2 approved semen collection centres shall be registered in the veterinary register of centres of semen collection of the corresponding body of the autonomous community, each of them receiving a veterinary registration number.

The autonomous communities shall draw up the list of centers of semen collection authorized, with their veterinary registration numbers and, where appropriate, any withdrawal of authorisation and shall notify it to the Ministry of agriculture, fisheries and food to process your submission to the Commission of the European communities and to the other Member States.

3. when the autonomous communities consider that at a semen collection centre, situated in another Member State, be they fail or are no longer complied with the provisions which govern the recognition, they shall notify it to the Ministry of agriculture, fisheries and food in order to inform the competent authority of the State concerned at the same time that it shall seek the decisions adopted, as well as the reasons for them.

Also, if the autonomous communities estimated that necessary measures were not taken or that these were inadequate they shall notify the Ministry of agriculture, fisheries and food, for his report to the Commission of the European communities, for the purposes of eventual provisional ban on the admission of semen from the Centre in question or, where appropriate, the withdrawal of the authorisation of the same.

Article 6.

1. both the shipment from Spain to other Member States such as the reception from these of each consignment of semen, must be accompanied by a health certificate drawn up pursuant to Annex D by an official veterinarian of the Member State of collection.

This certificate must:


(a) be drafted, at least in one of the official languages of the Member State of collection and one of the of the Member State of destination; When Spain is pickup or destination country, it shall be written, at least in the official Spanish language of the State.

(b) accompany the consignment to its destination an original copy.

(c) consist 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 the veterinary and zootechnical checks applicable in intra-Community trade, where Spain is country of destination, the necessary measures may take including storage in quarantine provided that this does not alter the viability of the semen, in order to achieve safe checks when there is suspicion that the sperm is infected or contaminated by pathogens.

Chapter III imports from third countries article 7.

1 only the importation of semen of animals coming from third countries listed in a list drawn up by the Commission of the European Communities shall be permitted and that is published, as well as their subsequent amendments, the European communities.

2. without prejudice to the provisions of the preceding paragraph, the list referred to in it, and its subsequent amendments, will be published in the, on the initiative of the Ministry of agriculture, fisheries and food, to a greater knowledge of stakeholders.

Article 8.

It will be only authorized the introduction of semen from collection centres, from third countries referred to in the list approved by the Commission of the European communities.

Article 9.

1. semen must come from animals which, immediately prior to collection, have been at least three months in the territory of a third country appearing on the list referred to in paragraph 1 of article 7 of the present Royal Decree.

2. without prejudice to the provisions of article 7 of the present Royal Decree and the preceding paragraph, the Ministry of agriculture, fisheries and food only shall authorise the importation of semen from any of the third countries included in the list if cited semen complies with the animal health rules laid down by Community authorities for imports of semen from that country.

3. where appropriate, shall apply the provisions of article 4 of the present Royal Decree.

Article 10.

1. only be authorized the importation of semen if you have a health certificate issued and signed by an official veterinarian of the third country of collection.

This certificate must be: to) be written, at least in the official Spanish language of the State.

(b) accompany the sperm in your original copy to your destination.

(c) consist of a single sheet.

d) be intended for a single recipient.

2. the health certificate shall conform to the model that the EU veterinary authorities established.

Article 11.

1 each consignment of semen entering the customs territory of Spain will be subjected to control by the services official veterinarians of the customs dependent of the Ministry of agriculture, fisheries and food, before being released for free circulation or be admitted under any customs procedure, prohibiting the entry of semen that: to) does not come from the territory of a third country appearing on the list established pursuant to paragraph 1 of article 7 of the Royal present Decree.

(b) not proceed as a Center for semen collection from those contained in the list referred to in article 8 of this Royal Decree.

(c) proceed in the territory of a third country from which the importation is prohibited pursuant to paragraph 2 of article 15 of the present Royal Decree.

(d) not accompanied by the health certificate in accordance with the requirements referred to in article 10 of the present Royal Decree and set in the same application.

This paragraph shall not apply to consignments of semen which arrive to the national customs territory and are subject to a Customs transit procedure in order to be driven to a place of destination situated outside the national territory.

However, it shall apply in the case of the waiver of Customs transit in the course of transport through the national territory.

2. the Ministry of agriculture, fisheries and food will take necessary measures, including storage in quarantine, provided that this does not alter the viability of the semen, to checks safe if it is suspected that the semen is contaminated by pathogens.

3. If the entry of semen has been prohibited on any of the reasons given in paragraphs 1 and 2 and the exporting third country does not authorise the return within the period of thirty days when the case of deep-frozen semen, or immediately in the case of fresh semen, the Ministry of agriculture, fisheries and food may order the destruction of the sperm.

Article 12.

Each consignment of semen authorized whose introduction into the community by Spain, on the basis of the control to that referred to in paragraph 1 of article 11 of the present Royal Decree, it must be accompanied, to be driven to the territory of another Member State, by the original certificate or an authenticated copy of the same, original or copy which must be duly countersigned by the Ministry of agriculture Fisheries and food as the authority responsible for the examination which is carried out in accordance with article 11 of the present Royal Decree.

Article 13.

If, in application of paragraph 3 of article 11 of the present Royal Decree, of destruction measures, costs shall be borne by the sender, the recipient or the respective representative of one or another, without right to compensation by the State.

Chapter IV safeguard and control article 14 measures.

The Community rules laid down in particular as regards the control in origin, the Organization and the action to be taken to the checks carried out by the Member State shall apply recipient.

Article 15.

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

2. without prejudice to the provisions of articles 8, 9 and 10 of the present Royal Decree, if it manifested or extendiere in a third country a contagious disease of animals that can spread through semen and that may affect the health status of the livestock of the national territory, or when any other animal health reason so justifies the Ministry of agriculture, fisheries and food prohibited the importation of semen, so if it's direct import as if it is indirect import through another Member State being indifferent to that effect that the sperm comes from the third country as a whole or only a part of the territory of the same.

The Ministry of agriculture, fisheries and food, through the competent organ, shall inform without delay the other Member States and the Commission about the measures taken on the basis of the previous section, with the expression of the reasons justifying them.

First additional provision.

This provision is run under the protection of article 149.1.10 and 16 of the Constitution.

Second additional provision.

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

Third additional provision.

Until the date of entry into force of the decisions adopted pursuant to articles 8, 9 and 10 of the present Royal Decree, shall not apply to imports of semen from third countries more favourable conditions than those resulting from the chapter II concerning intra-Community.

First final provision.

It empowers the Minister of agriculture, fisheries and food to enact the provisions necessary for compliance with and implementation of provisions of this Royal Decree and, in particular, to amend the annexes to this provision, to adapt them to the Community provisions.

Second final provision.

This Royal Decree shall enter into force the day following its publication in the.

Given in Seville on September 25, 1992.

JUAN CARLOS R.

The Minister of agriculture, fisheries and food, PEDRO SOLBES MIRA annex to chapter I requirements for the approval of semen collection centres semen collection centres must: 1. be, permanently, under the supervision of a centre veterinarian.

2 provide as a minimum: a) facilities that ensure the accommodation and the isolation of the animals;

(b) of installations for the collection of the semen, with a room for the cleaning and disinfection or sterilization of equipment;

(c) of installations for the treatment of the sperm, which must not necessarily be in the same place;

(d) of the storage facilities of the sperm, which must not necessarily be in the same place.

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

4. be constructed so that facilities housing animals and for the collection, treatment and storage of semen can be cleaned and disinfected easily.

5 have facilities that have no direct communication with the ordinary facilities for the accommodation of the animals that need to be isolated.


6 be designed in such a way that the animal accommodation is physically separated from the semen processing room and both the first and the second are separated from the semen storage facility.

Chapter II requirements for supervision of collection centres semen collection centres must: 1. be monitored so that they can only remain male animals of the species that go to obtain the sperm.

2 be under surveillance to take a record, file or computer support to all pigs present on site, which collected data on the race, date of birth and identification of each of these animals, as well as a record, file or computer support relative to all controls related diseases and all vaccinations that they carried out on that record data collected on the State of health of each animal.

3 be carried out regular inspections at least twice a year by an official veterinarian, during which carry out the control conditions of approval and supervision.

4 be monitored that prevents the entry of any unauthorised person. In addition, authorized visitors must be admitted in accordance with the conditions laid down by the Centre veterinarian.

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

6 be monitored to guarantee is the fulfillment of the following requirements: to) that only semen collected at an approved Centre is processed and which is stored in approved centres, without coming into contact with any other consignment of semen;

(b) the collection, treatment and storage of semen takes place only on reserved premises, without effect, and in the same rigorous hygiene conditions;

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

(d) products of animal origin used in the treatment of sperm - including additives or solvents - come from sources that do not present health risk any or which have been subjected to prior treatment appropriate to eliminate that risk;

(e) vessels used for storage and transportation are disinfected or sterilized properly until any filling operation; give start

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

(g) that every collection of sperm split or no dose is provided with a visible mark that easily establish the date of collection of the semen, as well as race and the identification of the donor animal and the name and the registration number preceded Center the name of the country of origin, possibly by means of a code; the characteristics and model of the trade mark shall be established pursuant to the procedure provided for community.

Annex B chapter I requirements applicable to the admission of animals in approved A semen collection centres. All boars that support at a semen collection centre must: 1. have been subjected to a period of isolation of thirty days, at a minimum, in facilities specially authorized for the purpose by the competent authority, where only boars having the same health status are present.

2 have been collected, before entering the isolation accommodation described in paragraph 1, between herds of holdings: to) officially free of classical swine fever;

(b) brucellosis-free;

(c) in which during the preceding twelve months there has been no animal vaccinated against foot and mouth disease;

(d) that has not detected any clinical manifestation serological or virological of Aujeszky's disease in the twelve months preceding;

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

The animals may not have remained previously in other herds of a lower status.

3 having been submitted, before the period of isolation referred to in paragraph 1 and during the 30 days prior to the following tests with negative results: a) a test of complement-fixation conducted pursuant to the provisions of Annex B to the order of February 28, 1986, for the development of livestock sanitation campaigns , in relation to brucellosis; (b) in the case of pigs not vaccinated against Aujeszky, a serum neutralization or an Elisa test using all the viral; antigens

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

(d) up to the date that applies a Community policy on combating foot and mouth disease, an Elisa test for the detection of FMD;

(e) an Elisa test or a serum neutralisation test for the detection of classical swine fever.

The competent authority may grant authorisation so that the controls referred to in paragraph 3 can be carried out in isolation station provided that the results are known before the period of isolation of thirty days referred to in paragraph 4.

4 have been subjected, during the last fortnight of the isolation period provided that the results are known before the isolation period of least 30 days referred to in paragraph 1, to the following tests with negative results: a) a serum agglutination test in accordance with the procedure set out in Annex B to the order of 28 February 1986 the development of campaigns of livestock sanitation, showing a brucella count lower than 30ui of binders by mm, as well as a reaction of complement fixation showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units);

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

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

(d) up to the date that applies a Community policy on combating foot and mouth disease, an Elisa test for the detection of FMD;

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

Without prejudice to the applicable provisions, when occurring cases of foot and mouth disease or swine fever, if either of the listed tests positive, the animal shall immediately be away from insulation installation. If the isolation group, the competent authority must take all measures necessary to enable that other animals may be admitted to the collection centre pursuant to the provisions of this annex.

B. all the tests will be conducted in a laboratory approved by the competent services of the autonomous communities.

C. may be accepted only in the semen collection centre the animals where expressly authorized by the Centre veterinarian. All movements of animals recorded whether they are inputs or outputs.

D. all animals admitted to take-up of sperm should be exempt from clinical manifestations of disease the day of admission, and shall, without prejudice to the provisions of paragraph E, proceed from a facility referred to in paragraph 1 of point A, which meets officially, the day of the expedition, 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 from at least thirty days before.

2 found free from foot and mouth disease and brucellosis from at least three months before.

3 found undamaged, since, at least, thirty days before, disease Aujeszky, as well as pig diseases of obligatory declaration, pursuant to Annex A of Royal Decree 434/1990 of 30 March.

E provided that the requirements referred to in paragraph D and during the previous twelve months made the routine tests referred to in chapter II, animals of semen collection facility may be moving to another, equivalent, without period of isolation and examination of any sanitary level, with the condition that the movement is carried out directly. 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 of a semen collection centre to another any place between Member States, will carry out as laid down in the Royal Decree 434/1990, of 30 March.

Chapter II routine tests mandatory for the boars that are staying in the semen collection centre


1 all boars which are kept at a semen collection centre must be subject, before leaving the Centre to the following tests with negative results: a) in the case of pigs not vaccinated against Aujeszky, a serum neutralization or an Elisa test using all the viral; antigens

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

(c) up to the date that applies a Community policy in the fight against foot and mouth disease, an Elisa test for the detection of FMD;

(d) proof of complement fixation brucellosis carried out pursuant to the provisions of Annex B to the order of February 28, 1986, for the development of campaigns of livestock sanitation in relation to brucellosis;

(e) an Elisa test or a serum neutralisation test for the detection of classical swine fever.

In addition, boars that remain more than twelve months in the collection centre, must be subjected to the tests referred to in paragraphs a), b) and (d)), at the latest, 18 months after his admission.

2. the whole of the examinations is practiced in a laboratory approved by the Member State.

3. without prejudice to the provisions applicable when cases of foot and mouth disease or swine fever, occur if either of the above mentioned tests positive, you must isolate the animal, and the sperm that has been collected from the date of the last negative test may not be the subject of intra.

Which semen collected from all other animals who are staying in the Centre from the date of the positive test, will be stored separately and may not be subject of intra-Community trade until the health status of the Centre has been restored.

Annex C requirements that must collect semen collected at approved centres for collecting semen intended for intra-Community trade 1. Semen must come from animals which: to) do not present any clinical manifestation of disease at the time of collection;

(b) not have been vaccinated against FMD;

(c) meet the requirements of chapter I of Annex B;

(d) not authorized to practise natural mating;

(e) are in collection centres semen that have been free of FMD, at least, during the three months preceding the distribution and that are located in the Centre of an area of a radius of ten kilometres in which no case of foot and mouth disease, at least in the last thirty days has not given and In addition, are not located in a zone defined in accordance with the provisions relating to communicable diseases of swine;

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

2. a combination of antibiotics, in particular against the leptospires and mycoplasmas effective, should be added to the sperm, previous final dissolution. That concentration should at least have an effect equivalent to the following dilutions: minimum: 500 IU streptomycin per ml, 500 IU penicillin per ml, 150 ug of lincomycin per ml, 300 ug per ml spectinomycin.

Immediately after the addition of the antibiotics is must be retained sperm diluted at a temperature of at least 15 C, for forty five minutes, minimum.

3 the semen intended for intra-Community trade must: to) be stored before dispatch pursuant to the provisions of chapters I and II of Annex A;

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

ANNEX D

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