By Royal Decree 2256/1994 of 25 November 1994 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species, incorporated into national law Council Directive 93 /60/EEC of 30 November 1993 amending Council Directive 88 /407/EEC laying down the animal health requirements applicable to intra-Community trade and to the imports of frozen semen of animals of the bovine species and is extended to fresh semen of those animals, while collecting, on the repeal of Royal Decree 877/1990 of 6 July 1990, the non-amended provisions of that Directive 88 /407/EEC.

Directive 88 /407/EEC has been amended by Council Directive 2003 /43/EC 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 artificial insemination centres, in particular as regards infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) and bovine viral diarrhoea/mucosal disease (DVD/MD).

It is therefore appropriate to make the corresponding partial amendment of Royal Decree 2256/1994 of 25 November 1994 to incorporate the aforementioned Directive 2003 /43/EC, while the reference to the sanctioning regime is included Applicable, which is that provided for in Law 8/2003 of 24 April of Animal Health, as it lays down animal health requirements for intra-Community trade in and imports of semen of bovine animals of which infringement could be considered as a punishable offence under that law.

By this royal decree the aforementioned Directive 2003 /43/EC is incorporated in our order.

This royal decree has been submitted to the autonomous communities and affected sectors.

In its virtue, on the proposal of the Minister of Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 25 June 2004,

D I S P O N G O:

Single item. Amendment of Royal Decree 2256/1994 of 25 November 1994 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species.

Royal Decree 2256/1994 of 25 November 1994 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species is hereby amended as amended in accordance with the the following terms:

One. Article 1 is replaced by the following:

" Article 1. Object.

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

This royal decree shall not affect the Community or national zootechnical provisions governing the organisation of artificial insemination in general and the distribution of semen in particular. "

Two. Article 2 (b) is worded as follows:

"(b)" semen collection centre " shall be deemed to have been officially approved and officially controlled, situated on the territory of a Member State or a third country, in which semen is produced for the purpose of artificial insemination.

"semen storage centre" shall be considered as an officially approved and officially controlled establishment situated on the territory of a Member State or a third country where semen is stored for the purpose of artificial insemination. "

Three. Article 3 (1) (a) is replaced by the following:

" (a) which has been collected and processed or stored, as the case may be, in a collection or storage centre or centres approved for such purposes in accordance with the provisions of Article 5 (1), with a view to artificial insemination and to be the subject of Community trade. "

Four. Article 4 (1) and (2) are deleted.

Five. In Article 5, the term 'semen collection centres' is replaced by 'semen collection or storage centres'.

Six. Article 8 is replaced by the following:

" Article 8. List of authorized countries.

Only imports of semen of bovine animals of the bovine species which comply with the conditions laid down for that purpose in Annex C shall be authorised and the third countries listed in Annex E. the list may be completed or amended by the Ministry of Agriculture, Fisheries and Food in accordance with the decisions taken by the Community authorities. "

Seven. A Chapter V is added, with the following content:

" CHAPTER V

Sanctioning Regime

" Article 14. Infringements and penalties.

In the event of non-compliance with the provisions of this royal decree, the regime of infringements and penalties laid down in Law 8/2003 of 24 April of Animal Health shall apply, without prejudice to any possible civil, criminal or other order responsibilities that may be present. "

Eight. Annexes A, B, C and D are replaced by the contents in the Annex to this royal decree.

Single transient arrangement. Sperm exchanges and imports.

1. Until 31 December 2004, intra-Community trade and imports of semen collected, processed and stored in accordance with Royal Decree No 2256/1994 of 25 November 1994, in the form in force until entry into force, shall be authorised. in force of this royal decree and accompanied by the old model of certificate.

2. After 31 December 2004, intra-Community trade and imports of semen in accordance with the rules referred to in the preceding paragraph shall be authorised only if the semen was collected, processed and stored before the date of the first that date.

Final disposition first. Basic character and competence title.

This royal decree is issued in accordance with the provisions of Article 149.1.16 of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health. The exception is the regulation on trade with third countries, which is issued under Article 149.1.16.a, first indent, of the Constitution, which gives the State exclusive competence in the field of external health.

Final disposition second. Entry into force.

This royal decree will enter into force on July 1, 2004.

Given in Madrid, 25 June 2004.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries and Food,

ELENA ESPINOSA MANGANA

ANNEX

" ANNEX A

CHAPTER I

Conditions for official authority of centers

1. The semen collection centres shall:

(a) Be permanently under the supervision of a centre veterinarian, approved by the competent authority.

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 facility for the treatment of sperm, which should not necessarily be found on the same site.

4. Of a sperm storage facility, which should not necessarily be located on the same site.

c) Being constructed or isolated in a way that prevents any contact with animals that are 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) Dispose of facilities that do not have direct communication with the ordinary facilities, for the accommodation of the animals to be isolated.

f) Be 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 facility of the sperm.

2. The semen storage centres shall:

(a) Be permanently under the supervision of a veterinarian of the approved centre by the competent authority.

b) Being constructed or isolated in a way that prevents any contact with animals that are outside.

c) Be built in a way that allows storage facilities to be quickly cleaned and disinfected.

CHAPTER II

Requirements for official monitoring of centers

1. The semen collection centres shall:

(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 they do not present any risk of infection to the animals of the species of which the semen is to be obtained and that they meet the requirements laid down by the centre veterinarian.

(b) Be under surveillance to keep track of all bovine animals present in the establishment, where data relating to the breed, date of birth and identification of each of them are collected, as well as a the registration of all disease-related controls and with all vaccinations carried out for each animal.

(c) To be subject to regular inspections, carried out at least twice a year by an official veterinarian, in the field of the permanent controls of the conditions of authorisation and surveillance.

d) To be subject to 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. Only semen collected in an approved centre shall be treated and stored in approved centres, without contact with any other batch of semen. However, in the approved collection centres, semen may be treated not collected in approved centres, provided that:

1. This semen is obtained from bovine animals which meet the requirements of paragraph 1 (d) of Chapter I of Annex B.

2. The said treatment is 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 it should be cleaned and sterilised. the instruments after use.

3. Such semen may not be subject to intra-Community trade and may not, at any time, be in contact with or be stored with semen intended for intra-Community trade.

4.a Such semen is identifiable by means of a mark other than that provided for in paragraph 7. of this paragraph f).

Frozen embryos may also be stored in approved centres provided that:

1. The storage is authorized by the competent authority.

2. The embryos comply with the requirements of Royal Decree 855/1992 of 10 July 1992 laying down the animal health conditions applicable to intra-Community trade and imports from third countries countries of embryos of domestic animals of the bovine species.

3. Th Embryos are stored in separate storage vessels in authorized sperm storage facilities.

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

3. All utensils that during collection and treatment come into contact with the sperm or the donor animal must be properly disinfected or sterilized prior to each use, except in the case of a only use.

4. Products of animal origin used in the treatment of semen, including additives or diluents, must come from sources which do not present a health risk or have undergone prior treatment. appropriate to remove that risk.

5. The canisters used for the

storage and transport must be properly disinfected or sterilised before any filling operation starts, except in the case of use of single-use containers.

6. The cryogenic agent used must not have previously been used for other products of animal origin.

7. ° Each individual dose of semen must be provided with a visible mark allowing the date of collection of the semen to be easily established, as well as the breed and identification of the donor animal and the approval number of the semen. center. Each Autonomous Community shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the European Commission and to the other Member States the characteristics and form of the marking applied in its territory.

8. The storage unit shall comply with the specific conditions relating to the monitoring of the semen storage centres set out in

following paragraph.

2. The semen storage centres shall:

(a) Be under surveillance, so that a record of all movements of sperm (between and out of the centre) and the state of the donor animals whose semen is stored, which must comply with the requirements of the this royal decree.

(b) To be subject to regular inspections, carried out at least twice a year by an official veterinarian, in the field of permanent controls of the conditions of authorisation and surveillance.

c) To be subject to 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.

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

e) Being under surveillance to ensure compliance with the following requirements is ensured:

1.o Only the sperm obtained in the collection centres approved in accordance with this royal decree will be stored in the centres of

authorized storage, without contacting any other batch of sperm.

In addition, only semen from approved collection centres, transported under conditions which offer all the health guarantees and which has not been authorised, may be entered in the approved storage centres. come into contact with no other batch of semen.

Frozen embryos may also be stored in approved centres provided that:

1. The storage is authorized by the competent authority.

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

3. Th Embryos are stored in separate storage vessels in authorized sperm storage facilities.

2. The storage of the semen must be carried out exclusively in the premises reserved for the purpose and in the most rigorous hygiene conditions.

3. All utensils that come into contact with the sperm must be properly disinfected or sterilized prior to use, except in the case of single-use utensils.

4. The canisters used for the

storage and transport must be properly disinfected or sterilised before any filling operation starts, except in the case of use of single-use containers.

5. The cryogenic agent used must not have previously been used for other products of animal origin.

6. ° Each individual dose of semen must be 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 approval number of the semen. collection centre. Each Autonomous Community shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the European Commission and to the other Member States the characteristics and form of the marking applied in its territory.

ANNEX B

CHAPTER I

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

1. All bovine animals that are admitted to a semen collection centre shall comply with the following requirements:

(a) Haber has been subjected to a quarantine period of at least 28 days, in facilities specially approved for that purpose by the competent authority, in which only other biungulate animals having at least the same Same sanitary status.

(b) Prior to their entry into the quarantine facilities described in subparagraph (a), they have belonged to a herd officially free of tuberculosis and brucellosis in accordance with Royal Decree 1716/2000 of 13 September 2000. October, on sanitary rules for the intra-Community trade in bovine animals and swine. Animals may not have been previously kept in a herd of lower status.

(c) Proceed from an officially enzootic-bovine-leukosis-free herd as defined in Royal Decree 1716/2000 of 13 October, or have been engendered by mothers who have been subjected, with negative results, to a test carried out in accordance with Annex III to Royal Decree 2611/1996 of 20 December 1996 governing the national programmes for the eradication of animal diseases following the separation of the animals from their mother.

In the case of animals from embryo transfer, the "mother" shall mean the recipient of the embryo.

If this requirement cannot be met, the semen may not be admitted for trade until the donor has reached the age of two years and has been subjected, with a negative result, to the examinations referred to in the

c) in Chapter II (1) (c).

(d) Having undergone, within the 28 days preceding the quarantine period referred to in subparagraph (a), the following tests, with negative results in each case, except for the DVD/MD antibody test referred to in paragraph 5.o of this paragraph:

1. For bovine tuberculosis, one

intradermal tuberculination performed in accordance with the procedure set out in Annex 1 to Royal Decree 2611/1996 of 20 December 1996.

2. For bovine brucellosis, a serological test carried out in accordance with the procedure laid down in Annex 2 to Royal Decree 2611/1996 of 20 December 1996.

3. For enzootic bovine leukosis, a serological test carried out in accordance with the procedure laid down in Annex 3 to Royal Decree 2611/1996 of 20 December 1996.

4. º For IBR/IPV, a serological test, complete virus, in a blood sample if animals

do not come from an IBR/IPV-free herd as defined in Article 2.3.5.3 of the International Animal Health Code of the International Office of Epizootics.

5. º For DVD/MD:

1. A virus isolation test or virus antigen test.

2. A serological test to determine the presence or absence of antibodies.

The competent authority may grant authorisation for the tests referred to in this paragraph (d) to be carried out on samples collected from the quarantine centre. In such a case, the quarantine period provided for in subparagraph (a) may not commence before the date of collection of the samples. However, if any of the tests are positive, the animal concerned must be removed immediately from the isolation facility. If the isolation is group, the quarantine period provided for in subparagraph (a) shall not begin for the other animals of the group prior to the removal of the animal which has resulted in the positive result.

e) During the quarantine period referred to in subparagraph (a), at least 21 days after the quarantine, at least seven days after the quarantine for the search for Campylobacter fetus ssp. venerealis and Trichomonas foetus, the following tests with negative results, except in the case of serological testing of antibodies to DVD/MD, as indicated in paragraph 3.o:

1. For bovine brucellosis, a serological test carried out in accordance with the procedure laid down in Annex 2 to Royal Decree 2611/1996 of 20 December 1996.

2. º For IBR/IPV, a serological test, complete virus, in a blood sample. If an animal tests positive results, it must be immediately transferred from the quarantine centre and the other animals in the same group must remain in quarantine and be tested again, with results negative, not less than 21 days after the transfer of the positive animal.

3.o For DVD/MD:

1. A virus isolation test or virus antigen test.

2. A serological test to determine the presence or absence of antibodies.

Only if there is no seroconversion in the animals, which yielded seronegative results before entering the quarantine centre, any animal, seronegative or seropositive, may enter the collection facilities. of sperm.

If seroconversion occurs, all animals that continue to be seronegative should be kept in quarantine for an extended period until there is no more seroconversion in the group for a period of three weeks; the positive animals shall be able to enter the semen collection facility.

4. º For Campylobacter fetus ssp. venerealis:

1. In the case of animals under six months of age or kept from that age in a group of the same sex before quarantine, to a single test performed on a sample of artificial or prepuce vagina washing.

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

5. º For Trichomonas foetus:

1. In the case of animals less than six months old or kept from that age in a group of the same sex before quarantine, a test performed once in a prepuce sample.

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

If any of the listed tests are positive, the animal must be immediately removed from the isolation facility. If the isolation is group, 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.

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

If a positive result is obtained, the bull must be moved from the center and all its sperm destroyed.

2. All examinations shall be carried out in an 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. None of the animals admitted to the semen collection centre shall show clinical signs of disease on the day of their admission. Without prejudice to paragraph 5, all animals must come from isolation facilities as referred to in paragraph 1 (a) which, on the day of dispatch, officially fulfil the following conditions:

(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) Free from foot-and-mouth disease and brucellosis from at least three months before.

(c) Free from, at least 30 days before, the following bovine diseases: foot-and-mouth disease, rabies, tuberculosis, brucellosis, contagious bovine pleuropneumonia, enzootic bovine leucosis and Bacterial anthrax.

5. As long as the requirements of paragraph 4 have been met and the routine examinations referred to in Chapter II have been carried out during the preceding 12 months, the animals may be moved from an approved semen collection centre to the other, equivalent sanitary level, without isolation period and without any examination, provided that the movement is carried out directly. The animal in question must not come into direct or indirect contact with biungulate animals of a lower health level and the means of transport used must have been disinfected in advance. If the transfer of a semen collection centre to the other centre is carried out between Member States, it shall be carried out in accordance with Royal Decree 1716/2000 of 13 October.

CHAPTER II

Routine tests to be performed on all bovine animals found in an approved semen collection centre

1. All bovine animals remaining in a semen collection centre shall be subject to the following tests at least once a year, with negative results:

a) For bovine tuberculosis, one

intradermal tuberculination performed in accordance with the procedure set out in Annex 1 to Royal Decree 2611/1996 of 20 December 1996.

(b) For bovine brucellosis, a serological test carried out in accordance with the procedure laid down in Annex 2 to Royal Decree 2611/1996 of 20 December 1996.

(c) For enzootic bovine leukosis, a serological test carried out in accordance with the procedure laid down in Annex 3 to Royal Decree 2611/1996 of 20 December 1996.

d) For IBR/IPV, a serological test, complete virus, in a blood sample.

e) For DVB/MD, a serological test for antibodies applicable only to seronegative animals.

In case an animal becomes serologically positive, each ejaculation of said animal collected since the last test with negative results shall be discarded or tested for the virus with negative results.

f) For Campylobacter fetus ssp. venerealis, a test in a prepuce sample. Only bulls engaged in the production of semen or bulls coming into contact with them shall be subjected to tests. Bulls which are returned to the collection after a period of more than six months must be tested within a maximum of 30 days before the start of production.

g) For Trichomonas foetus, a test in a prepuce sample. Only bulls engaged in the production of semen or bulls coming into contact with them shall be subjected to the tests.

Bulls to be returned for collection after a period of more than six months must be tested within a maximum of 30 days before production is restarted.

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 its semen collected from the date of the last negative test shall not be subject to intra-Community trade, with the exception of: for DVB/MD of the semen from each ejaculation that has been tested for the DVB/MD virus with negative results.

The semen collected from all other animals found in the centre from the date on which the positive test was carried out shall be stored separately, and shall not be subject to intra-Community trade until such time as the health status of the centre is restored.

ANNEX C

Conditions to be met by the semen for the purposes of intra-Community trade or for the purpose of importation into the community

1. The semen must come from animals which:

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

(b) Have not been vaccinated against foot-and-mouth disease in the 12 months immediately preceding the collection. Or, alternatively, if they have been vaccinated against foot-and-mouth disease in the 12 months immediately preceding the collection, five per cent, with a minimum of five straws, of each collection shall be subjected to the virus isolation test for the detection of foot-and-mouth disease with negative results.

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

(d) Hayan remained in an approved semen collection centre for an uninterrupted period of at least 30 days preceding the collection of semen in the case of collection 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 the collection or, in the case of fresh semen, up to the the date of dispatch, and which are located in the centre of an area of a radius of 10 kilometres in which no case of foot-and-mouth disease has been given in at least 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 consignment, have been free of the following bovine diseases of compulsory declaration: foot-and-mouth disease, rabies, tuberculosis, brucellosis, contagious bovine pleuropneumonia, enzootic bovine leukosis and bacterial anthrax.

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

At least:

a) 500 l of streptomycin per milliliter of final dissolution.

b) 500 IU penicillin per milliliter of final dissolution.

c) 150 l g of lincomycin per milliliter of final dissolution.

d) 300 l g of spectinomycin per milliliter of final dissolution.

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:

(a) Be stored under approved conditions for a minimum period of 30 days prior to dispatch; this condition shall not apply to fresh semen.

(b) Transporting to the target Member State in containers that have been cleaned, disinfected or sterilised before use, and have been sealed and numbered before leaving the approved storage facility.

ANNEX D