Royal Decree 1550 / 2004, Of June 25, Amending Royal Decree 2256 / 1994, Of 25 November, That Laying Down The Animal Health Requirements Applicable To Intra-Community Trade And Imports Of Semen Of...

Original Language Title: Real Decreto 1550/2004, de 25 de junio, por el que se modifica el Real Decreto 2256/1994, de 25 de noviembre, por el que se fijan las exigencias de policía sanitaria aplicables a los intercambios intracomunitarios y a las importaciones de esperma de ...

Read the untranslated law here: https://www.global-regulation.com/law/spain/1449105/real-decreto-1550-2004%252c-de-25-de-junio%252c-por-el-que-se-modifica-el-real-decreto-2256-1994%252c-de-25-de-noviembre%252c-por-el-que-se-fijan-las-exigenci.html

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By Royal Decree number 2256 / 1994, of 25 November, that laying down the animal health requirements applicable to intra-Community trade and imports of semen of domestic animals of the bovine species, joined domestic Directive 93/60/EEC of the Council of 30 November 1993, amending Directive 88/407/EEC of the Council laying down the animal health requirements applicable to intra-Community trade and imports of frozen semen of domestic animals of the bovine species and expands to fresh semen from these animals, at the time it is collected, to repeal the Royal Decree 877/1990, of 6 July, the unchanged provisions of the abovementioned Directive 88/407/EEC.

Directive 88/407/EEC has been amended by Directive 2003/43/EC of the Council of 26 May 2003, in the light of the new scientific data available, to change the health conditions applicable to the entry of bulls in the centers of artificial insemination, particularly in relation to infectious rhinotracheitis bovine/vulvovaginitis infectious pustular (IBR/IPV) and bovine viral diarrhoea / mucosal disease (DVD/MD).

Appropriate, in consequence, the corresponding part of the Royal Decree 2256 modification / 1994, of 25 November, to incorporate the above-mentioned Directive 2003/43/EC, at the time included reference to the applicable penalties, which is provided for in law 8/2003, of 24 April, animal health, since regulating animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species whose violation could be considered offence punishable pursuant to the Act.

It joins our legal system Directive 2003/43/EC by this Royal Decree.

This Royal Decree has been subjected to consultation of the autonomous communities and the sectors concerned.

By virtue, on the proposal of the Minister of agriculture, fisheries and food, according to the Council of State and after deliberation by the Council of Ministers at its meeting of June 25, 2004, D I S P O N G O: only article. Modification of the Royal Decree 2256 / 1994, of 25 November, that laying down the animal health requirements applicable to intra-Community trade and imports of semen of domestic animals of the bovine species.

The Royal Decree 2256 / 1994, of 25 November, that laying down the animal health requirements applicable to intra-Community trade and imports of semen of domestic animals of the bovine species, is modified in the following terms: one. Article 1 is replaced by the following: 'article 1. Object.

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

This Royal Decree shall not affect community or national rules on zootechnical matters governing the organisation of artificial insemination in general and the distribution of semen in particular."

Two. Paragraph b) of article 2 is drawn up in the following way: «b) will be considered 'semen collection centre' to all officially authorized and officially controlled establishment situated in the territory of a Member State or a third country, in which semen intended for artificial insemination occurs.

Shall be deemed 'semen storage centre' to all officially authorized and officially controlled establishment situated in the territory of a Member State or a third country, in which is stored sperm for artificial insemination."

3. Paragraph to) paragraph 1 of article 3 is replaced by the following: «a) that has been collected and transformed or stored, as appropriate, in a center or collection or storage centres approved for this purpose in accordance with the provisions of paragraph 1 of article 5 with a view to artificial insemination and to be the subject of intra-Community trade.'

Four. Paragraphs 1 and 2 of article 4 shall be deleted.

5. In article 5, the term "semen collection centres" is replaced by "centres of collection or storage of sperm".

6. Article 8 is replaced by the following: 'article 8. List of authorized countries.

«Will be only authorized the importation of semen of domestic animals of the bovine species which fulfils the conditions laid down in Annex C thereto and comes from third countries listed in the list provided in annex E. this list may be supplemented or amended by the Ministry of agriculture, fisheries and food, in accordance with the decisions taken in this regard by the Community authorities.»

7. Added a chapter V, with the following content: "chapter V penalties «article 14. Offences and penalties.

In the case of breach of the provisions of this Royal Decree, shall apply the regime of offences and penalties established in law 8/2003, of 24 April, Animal health, without prejudice to potential liabilities civil, criminal or other order which could go."

8. Annexes A, B, C and D shall be replaced by the contents of the annex of this Royal Decree.

Sole transitional provision. Trade in and imports of semen.

1. up to December 31, 2004, will be authorized for intra-Community trade in and imports of semen collected, processed and stored in accordance with the Royal Decree 2256 / 1994, of 25 November, editorially in force until the entry into force of this Royal Decree and accompanied by the old model of certificate.

2. with subsequent to December 31, 2004, will be cleared intra-Community trade in and imports of semen conforming to the regulations referred to in the preceding paragraph only if the semen was collected, processed and stored before that date.

First final provision. Basic character and competence title.

This Royal Decree is issued under cover of the provisions of article 149.1.16. ª of the Constitution, which attributes to the State exclusive jurisdiction on bases and general coordination of the health. He is excepted from the above the rules on trade with third countries, which is run under the protection of article 149.1.16., first paragraph, of the Constitution, which attributes to the State exclusive competence in the field of foreign health.

Second final provision. Entry into force.

This Royal Decree shall enter into force on 1 July 2004.

Given in Madrid, 25 June 2004.

JUAN CARLOS R.

The Minister of agriculture, fisheries and food, ELENA ESPINOSA MANGANA annex 'Annex A chapter I conditions for the official approval of centres 1. Semen collection centres must: to) be, permanently, under the supervision of a veterinarian Center, authorized by the competent authority.

b) have, as a minimum: 1 facilities that ensure the accommodation and isolation of the animals.

2 of installations for the collection of the semen, with a room for the cleaning and disinfection or sterilization of equipment.

3rd of a facility for the treatment of the sperm, which need not necessarily be on the same site.

4th of a facility for the storage of semen, which need not necessarily be on the same site.

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

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

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

(f) 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.

2 semen storage centres must: to) be, permanently, under the supervision of a veterinarian of the Centre approved by the competent authority.

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

(c) be constructed in a way that allows that the storage facilities can be quickly cleaned and disinfected.

Chapter II requirements of the official surveillance of the centers 1. Semen collection centres must: to) be monitored so that they can only remain animals that go to obtain the sperm. This however may be admitted also other domestic animals that are absolutely necessary for the normal functioning of the collection centre, provided that they do not present any risk of infection for animals of the species that are going to get the sperm and who satisfy the conditions laid down by the Centre veterinarian.

(b) be under surveillance to take a record of all bovine animals present in the establishment, where collected data relating to race, date of birth and identification of each of them, as well as a record of all controls related diseases and all vaccinations carried out for each animal.

(c) be subject to inspections, regular, carried out, as a minimum, twice a year, by an official veterinarian, in the field of permanent of the conditions of approval and supervision controls.


(d) be subject to a surveillance that would prevent the entry of any unauthorised person. In addition, authorized visitors must be admitted in accordance with the conditions laid down by the Centre veterinarian.

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

f) be monitored to guarantee is the fulfillment of the following requirements: 1 only semen collected at an approved Centre will be handled and stored in approved centres, without coming into contact with any other consignment of semen. This however may be, the authorized collection centres, semen not collected at authorized centers, provided that: 1st such semen is obtained from bovine animals which fulfil the requirements laid down in paragraph d) of paragraph 1 of chapter I of Annex B.

2nd the said processing is carried out with different teams at a time other than that are relevant to the processing of the semen intended for intra-Community trade, should be, in this case, clean and sterilize instruments after use.

3.a such semen may be the subject of intra-Community and not to enter, at any time, contact, not be stored with semen intended for intra-Community.

4.a such semen is identifiable by a mark other than that set out in subsection 7th of this paragraph (f)).

Frozen embryos may also be stored in authorized provided that: 1 the storage is authorized by the competent authority.

2nd the embryos meet the requirements of the Real Decree 855/1992 of July 10, that laying down the animal health requirements applicable to intra-Community trade and imports from third countries of embryos of domestic animals of the bovine species.

3rd the embryos are stored in storage container separated into approved semen storage facilities.

2nd collection, treatment and storage of sperm should be done only on the premises set aside for the purpose and under the strictest conditions of hygiene.

3rd utensils that come into contact with the semen or the donor animal during collection and treatment should be disinfected or sterilized prior to each use, except for single-use utensils properly.

4th the products of animal origin used in the processing of semen, including additives or solvents, must come from sources that do not present health risk any or which have been subjected to prior treatment appropriate to eliminate that risk.

5 vessels used for storage and transportation should be disinfected or sterilized is properly until any filling operation, give start except in the case of using single-use containers.

6 the cryogen used agent must not have served previously for other products of animal origin.

7th each individual dose of semen shall be fitted with a visible mark that establish the date of collection of the semen, as well as the breed and identification of the donor animal and the approval number of the Centre easily. Each autonomous community must report to the Ministry of agriculture, fisheries and food, for subsequent transfer by the European Commission and to the other States members, the characteristics and form of the marking applied in its territory.

8th the storage unit must meet specific conditions relating to monitoring of storage centers of sperm set out in the following section.

2 semen storage centres must: to) be monitored, so that you keep a record of all movement of semen (in and out of the Centre) and the status of the donor animals whose semen is stored, which shall comply with the requirements of this Royal Decree.

(b) be subject to inspections, regular, carried out, as a minimum, twice a year by an official veterinarian, in the field of permanent of the conditions of approval and supervision controls.

(c) be subject to a surveillance that would prevent the entry of any unauthorised person. In addition, authorized visitors must be admitted in accordance with the conditions laid down by the Centre veterinarian.

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

(e) be monitored to guarantee is the fulfillment of the following requirements: 1 only sperm obtained at collection centres approved in accordance with this Royal Decree will be stored in approved storage centres, without coming in contact with any other consignment of semen.

Additionally, in authorised storage only possible to introduce semen from collection centres authorised, transported in conditions that provide all the health guarantees and which have not come into contact with any other consignment of semen.

Frozen embryos may also be stored in authorized provided that: 1 the storage is authorized by the competent authority.

2nd the embryos meet the requirements of the Royal Decree 855/1992 of July 10.

3rd the embryos are stored in storage container separated into approved semen storage facilities.

2nd the storage of semen shall be done only on the premises set aside for the purpose and under the strictest conditions of hygiene.

3rd utensils that come into contact with the semen must be disinfected or sterilized properly prior to use, except for single-use utensils.

4th vessels used for storage and transportation should be disinfected or sterilized is properly until any filling operation, give start except in the case of using single-use containers.

5 the cryogen used agent must not have served previously for other products of animal origin.

6 each individual dose of semen shall be fitted with a visible mark that establish the date of collection of the semen, as well as the breed and identification of the donor animal and the approval number of the collection centre with ease. Each autonomous community must report to the Ministry of agriculture, fisheries and food, for subsequent transfer by the European Commission and to the other States members, the characteristics and form of the marking applied in its territory.

Annex B chapter I requirements applicable to the admission of animals into approved semen 1 collection centres. All bovine animals that support at a semen collection centre shall comply with the following requirements: a) have been subjected to a period of quarantine of 28 days in accommodation specially authorized for the purpose by the competent authority, in which other cloven-hoofed animals that have, at least, only present at least the same health status.

((b) prior to its entry into the quarantine accommodation described in paragraph a), have belonged to a herd officially free of tuberculosis and brucellosis in accordance with the Royal Decree 1716 / 2000 of 13 October, on sanitary standards for intra-Community Exchange of animals of the bovine and porcine species. The animals may not have remained previously in a herd of a lower status.

(c) come from a herd officially free of enzootic bovine leukosis, as defined in the Royal Decree 1716 / 2000, 13 October, or having been begotten by mothers who have been subjected, with negative results, to a test carried out in accordance with annex III of the Royal Decree 2611 / 1996, of 20 December, which regulates the national programmes for the eradication of animal diseases , after the separation of the animals of his mother.

In the case of animals originating from embryo transfer, «mother» means the recipient of the embryo.

If you can not meet this requirement, the sperm may not be admitted for trade until the donor has not reached the age of two years and it has been subjected, with negative results to the tests referred to in paragraph (c)) (1) of chapter II.

((d) have been subjected, within the 28 days preceding the period of quarantine referred to in paragraph a), to the following tests with negative results in each case, except for the antibody test DVD/MD mentioned in subsection 5th of this paragraph: 1 for bovine tuberculosis, an intradermotuberculinacion carried out in accordance with the procedure set out in annex 1 of the Royal Decree 2611 / 1996 , of 20 December.

2nd for bovine brucellosis, a test carried out in accordance with the procedure set out in annex 2 of the Royal Decree 2611 / 1996, of 20 December.

3rd for enzootic bovine leukosis, a test carried out in accordance with the procedure set out in annex 3 of the Royal Decree 2611 / 1996, of 20 December.

4th for IBR/IPV, a test serological, full virus in a blood sample if the animals do not come from an IBR/IPV free herd as defined in article 2.3.5.3 of the code animal health international of the International Office of epizootics.

5 for the DVD/MD:


1st a virus isolation test or a test for virus Antigen.

2nd and a serological test to determine the presence or absence of antibodies.

The competent authority may grant authorisation to tests referred to in this subparagraph d) can be carried out with samples collected in the quarantine centre. In such a case, the period of quarantine referred to in paragraph to) may not start before the date of sample collection. However, if any of the test gives a positive result, the animal concerned shall be away immediately insulation installation. If the isolation group, the quarantine period referred to in paragraph to) does not start, for other animals in the group, before the removal of the animal that has given positive result.

((e) during the quarantine period referred to in paragraph a), have been subjected at least 21 days after the quarantine, at least seven days after the quarantine to search for Campylobacter fetus SSP.. bacterin and Trichomonas foetus, to the following tests with negative results, except in the case of the antibody serological tests for the DVD/MD, as shown in the 3rd paragraph: 1 for bovine brucellosis, a test carried out in accordance with the procedure set out in annex 2 of the Royal Decree 2611 / 1996, of 20 December.

2nd for IBR/IPV, a serological, test full virus in a blood sample. When an animal give positive results to the test, you should be transferred immediately quarantine Center and other animals of the same group shall remain in quarantine and be subjected again to the test, with negative results, not less than twenty-one days after the removal of the positive animal.

3rd for the DVD/MD: 1st a virus isolation test or a test for virus Antigen.

2nd and a serological test to determine the presence or absence of antibodies.

Only if there is seroconversion in animals, which gave results seronegative before entering the quarantine centre, can any animal, seronegative or seropositive, entering the semen collection facilities.

If the seroconversion occurs, all animals that remain seronegative must be quarantined for a prolonged period until there are no more seroconversion in the group for a period of three weeks; serologically positive animals may enter the semen collection facilities.

4th for Campylobacter fetus SSP.. bacterin: 1 in the case of animals less than six months or kept since that age in a group of same-sex unions before the quarantine, a single test on a sample of artificial vagina or foreskin washing.

2nd in the case of animals from six months of age who may have had contact with females prior to quarantine, a test three times at weekly intervals on a sample of artificial vagina or foreskin washing.

5 for Trichomonas foetus: 1 in the case of animals less than six months or kept since that age in a group of same-sex prior to quarantine, a test performed once in a sample of foreskin.

2nd in the case of animals from six months of age who may have had contact with females prior to quarantine, a test three times at weekly intervals on a sample of foreskin.

If any of the listed test gives a positive result, the animal must be immediately away from the installation of insulation. If the isolation group, the competent authority shall take all necessary measures so that other animals may be admitted to the collection centre pursuant to the provisions of this annex.

(f) prior to the initial dispatch of semen from bulls serologically positive to the DVD/MD, a sample of sperm from each animal shall be submitted to a virus isolation test or an ELISA test for the detection of antigens of the DVB/MD.

In case of a positive result, del toro should be moved from the Center and destroy all their sperm.

2. all tests will be held in an officially recognized laboratory.

3 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.

4. no animal admitted to the semen collection centre will show clinical manifestations of disease the day of your admission. Without prejudice to the provisions of paragraph 5, all animals must come from isolation accommodation as contemplated in paragraph a) (1) that the day of the shipment, officially meeting the following conditions: to) being located in the Centre of an area within a radius of 10 kilometers in which has been no case of foot and mouth disease from at least 30 days before.

(b) be free from foot and mouth disease and brucellosis since, at least, three months before.

(c) found undamaged, since, at least 30 days before, following required statement bovine diseases: foot and mouth disease, rabies, tuberculosis, brucellosis, contagious bovine pleuropneumonia, enzootic bovine leukosis and anthrax.

5 provided they meet the requirements laid down in paragraph 4 and routine tests referred to in chapter II have been carried out during the previous 12 months, animals from an authorized Center semen collection to another of equal health status, without isolation period and without any examination, may move to 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 transfer of a semen collection centre to another will take place between Member States, will take place pursuant to the Royal Decree 1716 / 2000 of 13 October.

Chapter II routine tests which must be carried out in all the cattle that are in an authorized collection of semen 1. All bovine animals which are kept at a semen collection centre must submit, at least once a year to the following tests with negative results: a) for bovine tuberculosis, an intradermotuberculinacion carried out in accordance with the procedure set out in annex 1 of the Royal Decree 2611 / 1996, of 20 December.

(b) for bovine brucellosis, a test serological carried out in accordance with the procedure set out in annex 2 of the Royal Decree 2611 / 1996, of 20 December.

(c) for enzootic bovine leukosis, serologic effected pursuant to the procedure laid down in annex 3 of the Royal Decree 2611 proof / 1996, of 20 December.

(d) for IBR/IPV, serologic, proof full virus in a blood sample.

(e) for the DVB/MD, serologic proof of antibodies applicable only to seronegative animals.

It should an animal become serologically positive, every ejaculate of that animal collected since the last test with negative results should be discarded or subjected to a test for the detection of the virus with negative results.

f) for Campylobacter fetus SSP.. bacterin, a test on a sample of foreskin. Only must undergo tests the bulls engaged in the production of sperm or the bulls that come into contact with them. The bulls that return to be delivered to the collection after a period of more than six months must be subject to the tests within a maximum period of 30 days before restarting production.

(g) for Trichomonas foetus, a test on a sample of foreskin. Only must undergo tests the bulls engaged in the production of sperm or the bulls that come into contact with them.

The bulls that return to be delivered to the collection after a period of more than six months must be subject to the tests within a maximum period of 30 days before restarting production.

2. all tests will be held in an officially recognized laboratory.

3. If either of the above mentioned tests gives a positive result, you must isolate the animal, and his semen collected from the date of the last negative test may not be the subject of intra-Community trade, with the exception, with regard to the DVB/MD, of semen from every ejaculate which has been subjected to the test for the virus of the DVB/MD with negative results.

Semen collected from all other animals that are in the Center the date in which the positive test was made 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 conditions which must comply with the sperm for the purpose of intra-Community trade or for the purpose of import into the community 1. Semen must come from animals which: to) do not present any clinical manifestation of disease at the time of the collection of the semen.

(b) not have been vaccinated against FMD in the 12 months immediately preceding collection. Or, Alternatively, if they have been vaccinated against FMD in the 12 months immediately preceding the collection, 5%, with a minimum of five straws, each collection shall undergo the test virus isolation for the detection of the foot and mouth disease with negative results.

(c) not have been vaccinated against FMD in the thirty days immediately prior to collection.


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

(e) not authorized to practise natural mating.

(f) are in semen collection centres that have remained free of FMD, at least during the three preceding months and thirty days of collection or, in the case of fresh semen, until the date of shipment, and are located at the Centre of an area within a radius of 10 kilometers in which no case of foot and mouth disease has not been given in at least, the past thirty days.

g) been kept in semen collection centres which, during the period between the thirtieth day preceding collection and the thirtieth day after collection or, in the case of fresh semen, until the date of dispatch, have remained free of obligatory declaration following bovine diseases: foot and mouth disease, rabies, tuberculosis, brucellosis, contagious bovine pleuropneumonia enzootic bovine leukosis and anthrax.

2 antibiotics listed below must be added to obtain sperm, after final dilution, the following concentrations: minimum: l a) 500 g streptomycin per ml final dilution.

(b) 500 IU penicillin per ml final dilution.

(c) l 150 g lincomycin per ml final dilution.

(d) 300 l g spectinomycin per ml final dilution.

You can use a different antibiotic concentration having an equivalent effect against the Campylobacter, the leptospires and mycoplasmas.

Immediately after the addition of the antibiotics is must be retained sperm diluted at a temperature of at least 5 ° C for 45 minutes, minimum.

3 the semen intended for intra-Community trade must: to) stored in conditions allowed for a minimum period of 30 days prior to dispatch; This condition shall not apply to fresh semen.

b) be transported to the Member State recipient containers that have been cleaned, disinfected or sterilized prior to use, and have been sealed and numbered prior to leaving the premises of authorized storage.

ANNEX D

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