Council Directive 2008 /73/EC of 15 July 2008 simplifying the procedures for drawing up lists and publishing information in the veterinary and zootechnical fields and amending the Directives 64 /432/EEC, 77 /504/EEC, 88 /407/EEC, 88 /661/EEC, 89 /361/EEC, 89 /556/EEC, 90 /426/EEC, 90 /427/EEC, 90 /428/EEC, 90 /429/EEC, 90 /539/EEC, 91 /68/EEC, 91 /496/EEC, 92 /35/EEC, 92 /65/EEC, 92 /66/EEC, 92 /119/EEC, 94 /28/EC, 2000 /75/EC, Decision 2000 /258/EC and Directives 2001 /89/EC, 2002 /60/EC and 2005 /94/EC, as corrected by the Decision 2009 /436/EC of the Council of 5 May 2009 harmonises the procedures for the registration, listing and updating, transmission and publication of lists, in respect of animal health establishments and in the zootechnical field, and introduces a number of amendments to imports of semen, ova and embryos in order to minimise animal health risks.

This requires the amendment of a number of real animal health and animal health decrees for the proper incorporation of the aforementioned Council Directive 2008 /73/EC of 15 July 2008, which is carried out in a single standard by reasons for clarity and to facilitate its implementation.

By this standard, the procedures for registration, listing and updating, transmission and publication of the procedures are harmonised, as regards animal health establishments and in the zootechnical field, how various modifications are made to imports of semen, ova and embryos in order to minimise animal health risks and, as a result, the corresponding procedures for drawing up lists and publishing are simplified veterinary and zootechnical information.

This royal decree is dictated by the habilitation contained in the fifth final provision of Law 8/2003, of 24 April, of Animal Health.

In the elaboration of this royal decree, the autonomous communities and representative entities of the sectors affected have been consulted.

In its virtue, on the proposal of the Minister of the Environment, and the Rural and Marine Environment, of the Minister of Public Works, and of the Minister of Health and Social Policy, in agreement with the Council of State and after deliberation of the Council of Ministers at their meeting on 5 February 2010,

DISPONGO:

Article first. Amendment of Royal Decree 1716/2000 of 13 October on sanitary rules for the intra-Community trade in bovine animals and swine.

A final paragraph is added to Article 6 (1) (c) of Royal Decree 1716/2000 of 13 October on health rules for the intra-Community trade in bovine animals and swine, with the next content:

" Without prejudice to the foregoing paragraphs, the tuberculosis test may also be carried out in a place other than the herd of origin where it so provides and under the conditions laid down by the Commission. European. "

Article 2. Amendment of Royal Decree 2129/2008 of 26 December establishing the National Programme for the Conservation, Improvement and Promotion of Livestock breeds.

Article 26 (2) of Royal Decree 2129/2008 of 26 December 2008 establishing the National Programme for the Conservation, Improvement and Promotion of Livestock breeds is replaced by the following:

" 2. The competent authorities shall allow access to this information, by electronic means, to other users by establishing different levels of access, without prejudice to the limits that are legally appropriate for the protection of data personal character, if any, and of the provisions of Chapter IV. Specifically, the list and data of entities officially recognised for the management of genealogical books shall be available to the public and to the other Member States. '

Article 3. 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 bovine animals of the bovine species is hereby amended. as follows:

One. Article 5 (2) is worded as follows:

" 2. The autonomous communities shall register in a register all the approved semen collection or storage centres or their modifications by assigning to each of them a veterinary registration number, and shall communicate the data to the Ministry of Environment, and Rural and Marine Environment. The Ministry of the Environment and the Rural and Marine Environment shall keep a list of semen collection or storage centres with their corresponding veterinary registration numbers and shall make that list available to the other Member States. members and the public, enabling access to such information by electronic means. "

Two. The content of Article 8 is replaced by the following:

" Only the importation of semen of bovine animals of the bovine species which satisfies the conditions laid down for the purpose in Annex C shall be authorised and appropriate from the third countries listed in the list to be approved for that purpose. the European Commission. "

Three. The content of Article 11 is replaced by the following:

" The provisions of Royal Decree 1977/1999 of 23 December 1999 laying down the principles governing the organisation of veterinary checks on products from third countries shall apply. in particular with regard to the organisation and monitoring to be carried out of the checks to be carried out and the safeguard measures to be applied. '

Four. Annex E. is repealed

Article 4. Amendment of Royal Decree 855/1992 of 10 July 1992 laying down the animal health conditions applicable to intra-Community trade in and imports from third countries of embryos of domestic animals of the the bovine species.

Royal Decree 855/1992 of 10 July 1992 laying down the animal health conditions applicable to intra-Community trade in and imports from third countries of embryos of domestic animals of the bovine species, is amended as follows.

One. Article 5 (2) is replaced by the following:

" 2. The autonomous communities shall register all the approved embryo collection teams or their modifications, each of them assigning a veterinary registration number to each of them, and shall communicate the data to the Ministry of the Environment, and Rural and Marine Environment, which shall keep up to date a list of embryo collection teams with their corresponding veterinary registration numbers, and shall make such a list available to the other Member States and to the public, enabling the access to such information by electronic means. "

Two. The content of Article 11 is replaced by the following:

" The provisions of Royal Decree 1977/1999 of 23 December 1999 laying down the principles governing the organisation of veterinary checks on products from third countries shall apply. in particular with regard to the organisation and monitoring to be carried out of the checks to be carried out and the safeguard measures to be applied. '

Article 5. Amendment of Royal Decree 596/1994 of 8 April concerning the trade in equidae intended for competitions and the conditions for participation in competitions.

Royal Decree 596/1994 of 8 April 1994 concerning the trade in equidae intended for competitions and the conditions for participation in competitions is amended as follows:

One. Article 4 (2) is replaced by the following:

" 2. However, what is set in the previous article will not be obice for the organization of:

(a) Concourses reserved for equidae registered in a given genealogical book, in order to improve the breed.

b) Regional concourses to select equidae.

c) Historical or traditional character manifestations.

The autonomous communities that intend to make use of these possibilities should inform the Ministry of the Environment and the Rural and Marine Environment, in advance, of this and of the corresponding justifications. move to the other Member States and to the public. "

Two. Article 5 (1) is worded as follows:

" 1. The autonomous communities may reserve, for each contest or type of contest, by means of the bodies officially approved or recognised for that purpose, up to a maximum of 20% of the total amount of the profits or profits which be able to result from it, to the protection, promotion and improvement of the caballar breeding, and to inform the Ministry of the Environment, and the Rural and Marine Environment, on the criteria applied for the distribution of the funds for the purpose of Ministry shall make such criteria available to other Member States and to the public, enabling access to such information by electronic means. '

Article 6. Amendment of Royal Decree 1148/1992 of 25 September 1992 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of animals of the porcine species.

Royal Decree 1148/1992 of 25 September 1992 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of animals of the porcine species is hereby amended. as follows:

One. Article 5 (2) is worded as follows:

" 2. The autonomous communities shall register in a register all approved semen collection centres or their modifications by assigning to each of them a veterinary registration number, and shall communicate such data to the Ministry of the Environment, and Rural and Marine Environment, which shall keep up to date a list of semen collection centres with their corresponding veterinary registration numbers, and shall make such a list available to the other Member States and to the public. '

Two. The content of Article 14 is replaced by the following:

" The provisions of Royal Decree 1977/1999 of 23 December 1999 laying down the principles governing the organisation of veterinary checks on products from third countries shall apply. in particular with regard to the organisation and monitoring to be carried out of the checks to be carried out and the safeguard measures to be applied. '

Item seventh. Amendment of Royal Decree 1888/2000 of 22 November laying down animal health conditions for intra-Community trade in and imports of poultry and hatching eggs from countries third parties.

A new paragraph is added to Article 4 of Royal Decree 1888/2000 of 22 November 2000 laying down animal health conditions for intra-Community trade in and imports of birds of the Poultry and hatching eggs from third countries with the following content:

" 3. The autonomous communities shall draw up and keep up to date a list of establishments approved in accordance with paragraph 1 (a), with their corresponding distinguishing numbers, and shall notify the Ministry of the Environment, and the Rural and Marine Environment, of the which shall make it available to the other Member States and to the public, enabling access to such information by electronic means. "

Article 8. Amendment of Royal Decree 1941/2004 of 27 September 2004 laying down the animal health rules governing intra-Community trade in and imports from third countries of ovine and caprine animals.

Article 12 (3) of Royal Decree 1941/2004 of 27 September 2004 laying down the animal health rules governing intra-Community trade in and imports from third countries of animals of the ovine and caprine species is replaced by the following:

" 3. The competent authority shall assign an authorisation number to each approved concentration centre.

Such authorisation may be limited to one or another species included in this royal decree, or to breeding or fattening animals or to slaughter animals.

The competent authority shall keep these updated data through the Livestock Registry, managed by the Ministry of the Environment, and Rural and Marine Environment, which shall make it available to the other States. members and the public, enabling access to such information by electronic means. "

Article ninth. Amendment of Royal Decree 1430/1992 of 27 November 1992 laying down the principles governing the organisation of veterinary checks and the identity of animals entering the Community from countries third parties.

Article 10 (4) of Royal Decree 1430/1992 of 27 November 1992 laying down the principles governing the organisation of veterinary checks and the identity of animals entering the Community Community from third countries is replaced by the following:

" 4. The authorisation and subsequent update of the list of quarantine stations referred to in point 1.a shall be the responsibility of the European Commission.

The quarantine stations referred to in paragraph 1 (b) or the places referred to in paragraph 2 which comply with the conditions laid down in Annex B shall be authorised by the Ministry of the Environment and the Rural and Seaman, awarded to each station an authorisation number. That Ministry shall draw up and keep up to date a list of quarantine stations authorised together with their approval numbers, and shall make it available to the other Member States and to the public, enabling the access to such information by electronic means. Quarantine stations shall be subject to the inspection provided for in Article 18. '

Article 10. Amendment of Royal Decree 680/1993 of 7 May laying down the control rules and measures for the control of African horse

Royal Decree 680/1993 of 7 May laying down the control rules and measures for the control of African horse sickness is hereby amended as follows:

One. Article 2 (e) is worded as follows:

" (e) Competent authority: the competent authority of the autonomous community to carry out the veterinary checks and the competent bodies of the Ministries of Defence and the Interior in respect of equidae attached to these departments. "

Two. The content of Article 13 is replaced by the following:

" Is designated as the national reference laboratory for African horse sickness to the Central Laboratory of Animal Health of the Ministry of the Environment, and the Rural and Marine Environment in Algette, whose functions are set out in the Annex. VI. This Laboratory shall be kept in contact with the Community reference laboratory. '

Item 11th. Amendment of Royal Decree 1881/1994 of 16 September 1994 laying down animal health conditions governing intra-Community trade in and imports from third countries of animals, semen, ova and embryos not subject to these conditions to the provisions contained in Section I of Annex A to Royal Decree 1316/1992 of 30 October 1992.

Royal Decree 1881/1994 of 16 September 1994 laying down the animal health conditions applicable to intra-Community trade in and imports from third countries of animals, semen, ova and embryos not subject to these conditions, to the provisions contained in Section I of Annex A to Royal Decree 1316/1992 of 30 October 1992, is amended as follows:

One. Article 2 (e) is worded as follows:

" (e) Competent Authority: with regard to intra-Community trade, the competent bodies of the autonomous communities and the competent bodies of the Ministries of Defence and the Interior in respect of equidae (a) attached to the abovementioned departments and the Ministry of the Environment, and the Rural and Marine Environment, in respect of imports from third countries. '

Two. Article 11 is replaced by the following:

" Article 11. Animal health conditions for the exchange of semen, ova and embryos.

1. The competent authority shall take the necessary measures to ensure that, without prejudice to the animal health conditions to be met in the trade in animals, semen, ova and embryos other than those referred to in Articles 5 to 11, only semen, ova and embryos which meet the requirements of paragraphs 2, 3, 4 and 5 are subject to trade.

2. The semen of the ovine, caprine and equine species shall, without prejudice to the possible criteria to be respected for the inclusion of equidae in the breeding books for certain specific breeds:

(a) Having been collected, processed and stored for artificial insemination at an approved station or centre, from a health point of view, in accordance with Chapter I of Annex D. However, in the case of ovine and caprine animals may also have been collected and treated for artificial insemination on a holding which complies with the requirements of Royal Decree 1941/2004 of 27 September 2004 laying down animal health rules which regulate intra-Community trade in and imports from third countries of animals of the ovine and caprine species.

(b) Have been collected in animals that meet the conditions laid down in Chapter II of Annex D (admission and routine control of animals).

(c) Have been collected, treated, preserved, stored and transported in accordance with the provisions of Chapter III of Annex D.

(d) To be accompanied, in their transfer to another Member State, by a health certificate in accordance with the model to be determined by the European Commission.

3. Ova and embryos of the ovine, caprine, equine and porcine species shall:

(a) To have been taken or produced by a collection team authorised by the competent authority, which complies with the conditions laid down by the European Commission.

(b) Have been collected, processed and preserved in an appropriate laboratory, stored and transported in accordance with the provisions of Chapter III of Annex D.

(c) To be accompanied, on dispatch to another Member State, of a health certificate in accordance with the model to be determined by the European Commission.

The semen for the insemination of donor females must be in accordance with the provisions of paragraph 2 for sheep, goats and equidae, and for the provisions laid down in Royal Decree 1148/1992 of 25 June 1992. September, laying down the animal health requirements applicable to intra-Community trade in and imports of semen of animals of the porcine species.

The provisions of this paragraph shall be without prejudice to any additional guarantees that may be provided by the European Commission.

4. The competent authority shall register in a register the approved stations or centres referred to in paragraph 2 (a) and the approved collection teams referred to in paragraph 3 (a), or their modifications, and shall give each of them a number of of veterinary registration.

This data will be submitted to the Ministry of Environment, and Rural and Marine Environment, which will draft and keep up to date a list of those centers and stations and authorized teams with their corresponding registration numbers. It shall make such a list available to the other Member States and to the public, enabling access to such information by electronic means.

5. The animal health requirements and models of health certificates applicable to semen, ova and embryos of species not mentioned in paragraphs 2 and 3 shall be established by the European Commission.

Pending the establishment of the animal health requirements and the models of health certificates for trade in semen, ova and embryos mentioned above, national rules shall continue to apply. "

Three. A new paragraph is added to Article 14, with the following content:

" 4. The competent authority shall register in a register all the approved bodies, institutes and centres to which it issues an authorisation number, and shall draw up and keep up to date a list of approved bodies, institutes and centres with their corresponding authorization numbers. Such data shall be forwarded to the Ministry of the Environment, and the Rural and Marine Environment, which shall draw up and keep up to date a list of those bodies, institutes and centres approved with their veterinary registration numbers and shall make such a list. list available to the other Member States and to the public, enabling access to such information by electronic means. '

Four. Article 16 is replaced by the following:

" Article 16. Conditions applicable to third countries.

1. For the purposes of uniform application of Article 15, the provisions of the following paragraphs shall apply.

2. Only the animals and the semen, ova and embryos referred to in Article 1 may be imported which meet the following requirements:

(a) Proceed from a third country listed in the list referred to in paragraph 3 (a).

(b) Be accompanied by a health certificate, in accordance with the model established by the European Commission, which shall be signed by the competent authority of the exporting country and shall certify that:

1. The animals comply with the additional conditions, or offer the guarantees at least equivalent so recognized by the European Commission, and come from approved centres, agencies or institutes offering guarantees at least equivalent to those set out in Annex C.

2. The semen, ova and embryos come from approved collection and storage centres or approved collection and production equipment offering guarantees at least equivalent to those laid down in the Chapter I of Annex D by the European Commission.

Pending the establishment of the lists of third countries, the approved establishment referred to in point (b), the animal health requirements and the model health certificates referred to in points (a) and (b), national rules shall continue to apply, provided that they are not more favourable than those laid down in Chapter II of Annex D.

3. For these purposes, it shall apply:

(a) The list of third countries or parts of third countries established by the European Commission.

(b) The list of approved centres or equipment, referred to in Article 11.2.a and 11.3.a, located in one of the third countries listed in that list, provided by the European Commission.

(c) Specific animal health requirements approved by the European Commission, in particular those aimed at protecting the Community from certain exotic diseases, or guarantees equivalent to those provided for in this standard. "

Five. The content of the third additional provision is replaced by the following:

" In relation to the organization and the course to be given to the controls that the competent authorities must carry out, as well as to safeguard measures to be applied, it will be of application the previewed in the Royal Decree 1977/1999 of 23 December 1999 laying down the principles governing the organisation of veterinary checks on products from third countries. '

Article twelfth. Amendment of Royal Decree 1988/1993 of 12 November establishing measures for the fight against Newcastle disease.

The content of Article 12 of Royal Decree 1988/1993 of 12 November 1993 laying down measures for the fight against Newcastle disease is replaced by the following:

" 1. The national reference laboratory for Newcastle disease shall be as set out in Annex IV and shall have the following functions:

(a) Make complete typing of the antigenic and biological characteristics of the Newcastle disease virus and confirm the results obtained by the diagnostic laboratories of the Autonomous Communities.

b) Control the reagents used by the diagnostic laboratories of the Autonomous Communities.

c) Control the efficacy, potency and purity of vaccines used as a preventive measure in the national territory or stored for emergency intervention.

2. The laboratory shall be responsible for the coordination of the rules and methods of diagnosis of Newcastle disease established, where appropriate, in each diagnostic laboratory of the Autonomous Communities, as well as the use of reagents and the testing of vaccines. To do this:

a) You will be able to provide these laboratories with the reactive autonomous communities for diagnosis.

b) Control the quality of all diagnostic reagents used in the national territory.

c) You will periodically organize comparative tests.

d) Keep isolated Newcastle disease viruses collected from confirmed cases in the national territory.

e) Will confirm the positive results obtained in the diagnostic laboratories of the Autonomous Communities.

3. The national reference laboratory shall be kept in contact with the Community reference laboratory.

4. The competent authorities shall keep up-to-date lists of regional laboratories and communicate them to the Ministry of the Environment, and the Rural and Marine Environment, which shall make them available to the other Member States and to the public, enabling the access to such information by electronic means. "

Article 13th. Amendment of Royal Decree 650/1994 of 15 April laying down general measures for the control of certain animal diseases and specific measures against swine vesicular disease.

The content of Article 17 of Royal Decree 650/1994 of 15 April 1994 laying down general measures for the control of certain animal diseases and specific measures against swine vesicular disease, is replaced by the following:

" 1. The Central Laboratory of Animal Health of the Ministry of the Environment, and the Rural and Marine Environment, located in Algete, is designated as the National Reference Laboratory to detect at any time and, above all, in the first manifestations of the the disease in question, the type, subtype and variant of the virus and confirm the results obtained by the diagnostic laboratories authorised by the competent authority. This laboratory shall also be responsible for monitoring the reagents used by these diagnostic laboratories.

2. The designated national laboratory shall be responsible for coordinating the standards and diagnostic methods established in each diagnostic laboratory approved by the competent authority of the disease concerned, as well as the use of reagents. To this end:

a) You will be able to provide diagnostic diagnostic laboratories for diagnosis.

b) Control the quality of all diagnostic reagents used.

c) You will periodically organize comparative tests.

d) Keep isolated disease viruses in question collected from confirmed cases.

e) Will confirm the positive results obtained in the diagnostic laboratories.

3. The competent authorities shall keep up-to-date lists of the diagnostic laboratories which they have authorised and communicate them to the Ministry of the Environment, and the Rural and Marine Environment, which shall make them available to the other Member States and to the public, enabling access to such information by electronic means. "

Article 14. Amendment of Royal Decree 1228/2001 of 8 November establishing specific measures for the control and eradication of bluetongue or bluetongue.

The content of Article 3 of Royal Decree 1228/2001 of 8 November establishing specific measures for the control and eradication of bluetongue or bluetongue is replaced by the following:

" 1. The Central Laboratory of Animal Health of the Ministry of the Environment, and the Rural and Marine Environment, located in Algete, is designated as the national reference laboratory.

2. The Autonomous Communities may authorise, at their territorial level, diagnostic laboratories for bluetongue or bluetongue, the positive diagnoses of which shall be confirmed by the national reference laboratory.

3. The national reference laboratory shall be responsible for the coordination of the standards and diagnostic methods laid down in each diagnostic laboratory approved by the competent authority for this disease, as well as for the use of of the reagents and tests of the vaccines and shall have the following functions:

a) Supply diagnostic reagents to the diagnostic laboratories that request it.

b) Control the quality of all diagnostic reagents used.

c) Periodic Organization of Comparative Tests.

d) Conservation of disease-causing agents or tissues containing them that have been isolated from confirmed cases.

e) Confirmation of the positive results obtained in the diagnostic laboratories.

4. The national reference laboratory shall be kept in contact with the Community reference laboratory. '

Item 15th. Amendment of Royal Decree 1071/2002 of 18 October 2002 laying down minimum measures for the control of classical swine fever.

Paragraph 1 of Annex III to Royal Decree 1071/2002 of 18 October 2002 laying down minimum measures for the control of classical swine fever is replaced by

following:

" 1. The Central Laboratory of Animal Health of the Ministry of the Environment, and the Rural and Marine Environment, located in Algete, is designated as the national reference laboratory. "

Article sixteenth. Amendment of Royal Decree 546/2003 of 9 May laying down specific provisions for the control of African swine fever.

Paragraph 1 of Annex IV to Royal Decree 546/2003 of 9 May 2003 laying down specific provisions for the control of African swine fever is replaced by the following:

" 1. The Central Laboratory of Animal Health of the Ministry of the Environment, and the Rural and Marine Environment, located in Algete, is designated as the national reference laboratory. "

Final disposition first. Competence title.

This royal decree is of a basic character, except for the second article, and is dictated by the provisions of Article 149.1.16. of the Constitution, which attributes exclusive competence to the State in the field of bases and coordination. general of health.

The regulation contained in paragraphs 2, 3 and 4 of the third paragraph of Article 4 (2), in Article 6 (2), in Article 9 (2) and Article 6 (2) of Regulation (EC) No 4136/ in paragraphs 3 and 4 of Article 11, which is issued under the provisions of Article 149.1.16, first indent, of the Constitution, which confers exclusive competence on the State in matters of external health.

Final disposition second. Incorporation of European Union law.

By this royal decree, the Council Directive 2008 /73/EC of 15 July 2008 is incorporated into our internal order, which simplifies the procedures for drawing up lists and publishing information in the veterinary and zootechnical matters and amending Directives 64 /432/EEC, 77 /504/EEC, 88 /407/EEC, 88 /661/EEC, 89 /361/EEC, 89 /556/EEC, 90 /426/EEC, 90 /427/EEC, 90 /428/EEC, 90 /429/EEC, 90 /539/EEC, 91 /68/EEC, 91 /496/EEC, 92 /35/EEC, 92 /65/EEC, 92 /66/EEC, 92 /119/EEC, 94 /28/EC, 2000 /75/EC, Decision 2000 /258/EC and the Directives 2001 /89/EC, 2002 /60/EC and 2005 /94/EC.

Final disposition third. Entry into force.

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

Given in Madrid, on February 5, 2010.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ