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Royal Decree 676/2016, Of December 16, Which Regulates The System Of Identification And Registration Of Animals Of The Equine Species.

Original Language Title: Real Decreto 676/2016, de 16 de diciembre, por el que se regula el sistema de identificación y registro de los animales de la especie equina.

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TEXT

Commission Regulation (EC) No 504/2008 of 6 June 2008 implementing Directives 90 /426/EEC and 90 /427/EEC as regards the methods for the identification of equidae has been repealed by the Commission. Commission Implementing Regulation (EU) No 2015/262 of 17 February 2015 laying down rules in accordance with Council Directives 90 /427/EEC and 2009 /156/EC as regards the methods of identification of equidae (Regulation of the European Parliament and of the Council) Equine passport).

The Kingdom of Spain approved, in order to implement Commission Regulation (EC) No 504/2008 of 6 June 2008, Royal Decree 1515/2009 of 2 October 2008 establishing a system for the identification and registration of the animals of the equine species. Without prejudice to the direct applicability and effectiveness of Commission Implementing Regulation (EU) No 2015/262 of 17 February 2015, in order to adapt our rules to the amendments to the new Regulation, and to remove provisions of Royal Decree 1515/2009 of 2 October, which have become obsolete, in the interests of greater rationality and clarity, it is necessary to proceed to the approval of a new royal decree to regulate the system of identification and registration of the animals of the equine species, which replace the aforementioned Royal Decree 1515/2009 of 2 October.

For the rest, it should be noted in this regard that when in this royal decree the holder is quoted, it refers to the person who holds the equid, which, although it may coincide with the owner of the holding in which the animal is located, does not will be in all cases.

Also, with this royal decree is amended Royal Decree 804/2011 of 10 June, which regulates the zootechnical, sanitary and animal welfare management of equine farms and establishes the equine health plan, in such a way that the concept of the owner of the animal is suppressed, in all cases being the concept of the holder of the animal, since it is a rule of administrative law and not of private law, and an easy way to change is opened (i) the right to be entitled to abandoned animals, without prejudice to the provisions laid down in the with respect to the Autonomous Communities.

Without interfering with the above, the General Register of individual identification of the equidae created by the aforementioned Royal Decree 1515/2009 of 2 October, attached to the Directorate General of Health of the Agricultural production of the Ministry of Agriculture and Fisheries, Food and Environment, which includes the data in the records of the competent authorities, which are established for equine animals in Annex IV of this royal decree. This Register continues to be integrated into the General Register of Individual Animal Identification (RIIA) referred to in Royal Decree 728/2007 of 13 June establishing and regulating the General Register of Livestock Movements and the Register Individual identification of animals.

Given the change in the management of electronic identification due to the progress it has made, the competences of the Spanish Committee for Electronic Identification of Animals have become obsolete, Therefore, it is necessary to do so.

In the preparation of this provision, the autonomous communities and cities of Ceuta and Melilla, and the representative entities of the sector, have been consulted.

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

In its virtue, on the proposal of the Minister of Agriculture and Fisheries, Food and Environment, with the prior approval of the Minister of Finance and Public Administrations, according to the State Council and after deliberation of the Council of Ministers at its meeting on 16 December 2016,

DISPONGO:

Article 1. Object.

This royal decree aims to establish the basic characteristics of the system for the identification and registration of equine animals in Spain, in accordance with the provisions of Implementing Regulation (EU) No 2015/262. Commission of 17 February 2015 laying down rules in accordance with Council Directives 90 /427/EEC and 2009 /156/EC as regards the methods of identification of equidae (Equine passport Regulation).

Article 2. Definitions.

1. For the purposes of this royal decree, the definitions provided for in Article 2 of Commission Implementing Regulation (EU) No 2015/262 of 17 February 2015, being understood as 'the holder' of the 'holder' and as 'trait', shall apply. 'trade mark', in Article 3 of Law 8/2003 of 24 April of animal health and in Article 2.1 of Royal Decree 804/2011 of 10 June 2011 governing the zootechnical, health and animal welfare organisation of equine holdings establishes the equine health plan.

2. In addition, and without prejudice to Article 2 (b) of Royal Decree 2129/2008 of 26 December 2008 establishing the National Programme for the Conservation, Improvement and Promotion of Livestock Breeds, the functions of the 'zootechnical authority' for the purposes of the application of this royal decree shall be exercised by the competent authority for the identification of the animals.

Article 3. General principles and obligations for the identification of equidae.

1. They must be identified as stipulated in this royal decree.

(a) equidae born in Spain.

(b) equidae released for free circulation in the Union in accordance with the customs procedure of the Union.

2. The holder will be responsible for the compliance with the provisions of this royal decree. When the owner is not the owner, he/she will act on behalf of the owner.

3. It shall be for the issuing body to submit the application for the identification document, or to amend the data in that document, and the document to be shown in Section IV of the identification document, without prejudice to the laying down the statutes of the issuing body for the identification document for registered equidae.

Article 4. System for the identification of equidae.

The system for the identification and registration of equine animals in the Kingdom of Spain shall consist of:

1. The equine identification document (EID) or passport, which shall be permanent and unique in accordance with:

(a) The model of DIE set out in Annex I to Commission Implementing Regulation (EU) No 2015/262 of 17 February 2015.

b) And the additional requirements set out in Annex I to this Royal Decree.

2. The injectable transponder or an alternative mark authorised in accordance with Article 15.

3. The Database set up in Article 26.3, which records the information set out in Annex IV to this Royal Decree.

Article 5. Issuing bodies of the equine identification documents.

1. For registered equidae, the bodies designated for the issuance of identification documents for equidae shall be:

(a) The organizations or associations officially recognized for the creation or taking of the herd book of the breed of that animal, in accordance with Royal Decree 2129/2008 of 26 December, or

(b) a branch, based in Spain, of an international association or organisation in charge of the control of equidae for competitions or races.

2. For equidae for breeding and for income, the issuing of the identification document for equidae shall be the responsibility of the competent authority of the autonomous community or cities of Ceuta and Melilla where the holding in which the animal is located is located. the time of identification or body designated by that authority.

3. The competent authority shall only designate issuing bodies in accordance with paragraph 2, which meet the following conditions:

(a) The tasks and responsibilities that the issuing body must carry out and assume, as well as the conditions under which it may do so, should be accurately described; and once the competent authority has verified that the issuer:

1. Possesses The Expertise, Equipment, and Infrastructure required to perform the tasks delegated to you,

2. Account with sufficient suitably qualified and experienced staff

3. º Is impartial and has no conflict of interest with regard to the exercise of the tasks delegated to you,

4. º You have an identification document model that conforms to the requirements set forth in this royal decree.

(b) The issuing body must cooperate closely with the competent authority to prevent cases of non-compliance with the requirements of this royal decree and remedy them;

(c) There must be efficient and effective coordination between the competent authority and the designated issuing body.

4. However, in accordance with Article 1 of Commission Decision 96 /78/EC of 10 January 1996 laying down the criteria for the entry and registration of equidae in breeding books for breeding purposes, the holder of the may submit the application to the appropriate issuing body, in accordance with paragraph 1 of this Article, which is based outside the Kingdom of Spain, while the equine animal is located on a Spanish holding.

5. The issuing bodies for equine identification documents for registered equidae and for equidae for breeding and income, in accordance with the powers laid down in paragraphs 1 and 2 of this Article, shall notify their data to the Directorate-General for Agricultural Production of the Ministry of Agriculture and Fisheries, Food and the Environment.

The Directorate-General for Health of Agricultural Production will keep a list of the issuing agencies in Spain, where the contact details will be included, and the identification code compatible with the EU. (Universal Equine Life Number) of six digits of the databases of the issuing agencies. This information will also be communicated to the European Commission and to the other Member States via a link on the website of the Ministry of Agriculture and Fisheries, Food and the Environment.

6. The Subdirectorate-General for Animal Health and Hygiene and Traceability of the Directorate-General for the Health of Agricultural Production is the point of contact for the purposes of Article 14 of this royal decree.

7. Where the competent authority has reasonable grounds to conclude that an issuing body is involved in acts which do not comply with the requirements laid down in this Royal Decree, it shall initiate a procedure of investigation. The opening of such proceedings shall determine the precautionary suspension until the end of the investigation or, if any non-compliance has been found, until they have been remedied.

8. Failure to comply with the requirements set out in this royal decree shall determine the withdrawal of the authorisation, without prejudice to the infringement procedure which, where appropriate, applies.

Following the withdrawal of the authorisation to issue identification documents, the competent authority shall ensure that the equidae are correctly identified and that the identification documents returned or which are return are guarded by itself or by an issuing body in which you have delegated this task.

Article 6. Obligations of the issuing bodies in respect of identification documents.

1. Issuing bodies shall ensure that the identification document contains a sufficient number of pages with type fields, to insert in them the information required according to the following sections specified in the model of document of identification of Part 1 of Annex I to Commission Implementing Regulation (EU) No 2015/262 of 17 February 2015:

(a) In the case of registered equidae, at least Sections I to IX;

(b) In the case of equidae for breeding and income, at least Sections I to IV.

2. The issuing bodies shall ensure that the order and numbering of the sections of the identification documents set out in Part 1 of Annex I to Commission Implementing Regulation (EU) No 2015/262 of 17 December 2016 are not altered. February 2015, and in the case of sections offering space for multiple entries, a sufficient number of pages are included.

3. Issuing bodies shall only issue identification documents which:

a) Cumplan the requirements set forth in this royal decree.

(b) duly completed Section I with information verified by or on behalf of the issuing body referred to in point 11 of Part A of Section I.

c) Have duly updated Section IV.

(d) In the case of registered equidae, Section V shall be completed by the issuing body set out in Article 5.1 in accordance with the rules of the herd book, the information being inserted in this section. is contained in the certificate of origin referred to in the second paragraph of Article 8.1 of Directive 90 /427/EEC and the Annex to that Directive.

4. The issuing entities are responsible for the safe management of the blank and completed identification documents that are in their possession.

Article 7. Obligations of the competent authority as regards identification documents.

The zootechnical authority and the competent authority shall ensure that the identification document issuing entities:

1. Issue identification documents that meet the requirements set out in this royal decree.

2. They have the necessary systems to verify, when required by the competent authority, whether an identification document allegedly issued by them:

a) It is unique, genuine and authentic,

b) Includes, in the case of stock of blank printed identification documents, a serial number printed at least on the pages containing sections I, II and III of the identification document.

Article 8. Derogation from the completion of certain information in Sections I and IV of the identification document.

1. The competent authority may authorise issuing bodies not to draw up by drawing the information in points 12 to 18 of the graphic review of the identification document set out in the Annex to the Implementing Regulation (EU) No Commission Implementing Regulation (EU) 2015/262 of 17 February 2015, set out in Part B of Section I of Annex I, provided that the following two conditions are met:

a) Have an injectable transponder implanted in accordance with this royal decree, or an alternative mark authorized in accordance with Article 16.

(b) Be replaced by a photograph or a sufficiently detailed photographic copy to describe the equine animal, without prejudice to the rules for the identification of equidae established by the issuing entities.

2. The ownership information in Section IV of the passports issued by the issuing bodies referred to in Article 5.1 of this royal decree may be provided in the format of a letter of ownership in which it shall include:

a) The UELN.

b) The identification document number where applicable and the transponder code.

The destination of the title card will be the same as that of the passport when the animal dies, is sold or lost, stolen or sacrificed.

Article 9. Time limit for identification of equidae.

1. Equidae must be identified no later than one year after the date of birth and, in any case, before leaving the holding of birth, except where this transfer is carried out as a breastfed foal, accompanied by his mother, such and as provided for in Article 17.2.c) and in the case of equidae for slaughter referred to in Article 18.2.

2. However, at any time, the issuing body may issue a new identification document:

(a) On its own initiative or at the request of the competent authority, where the existing identification document does not comply with the format and content requirements set out in this royal decree for the identification document, or

(b) where an equine animal for breeding and income becomes an equine animal registered in accordance with the rules of the issuing body referred to in Article 5.1 (a) and (b), and the existing identification document cannot be adapt accordingly, or

(c) where the identification document has been issued under the various exceptions which, in terms of format and content, authorise this royal decree, and cannot be adapted.

The identification document prior to the issuance of the new one must be delivered to the issuing body to destroy it.

Article 10. Derogations concerning the identification of certain equidae living in wild or semi-wild conditions.

1. The competent authority may decide that equidae constituting defined populations living in wild or semi-wild conditions in certain areas shall be identified by means of an identification document only when:

(a) Be withdrawn from those stocks, excluding the transfer under official supervision of a defined population to another, or

b) become domestic production or company.

2. The competent authorities shall notify the Ministry of Agriculture and Fisheries, Food and the Environment of the stocks and areas in question before applying this derogation, without prejudice to the provisions of the Article 52 of Law 42/2007, of 13 December, of Natural Heritage and Biodiversity.

Article 11. Identification of equidae from other Member States of the European Union.

All equidae from another Member State of the European Union shall keep their equine identification document or equine passport in accordance with the provisions of Commission Implementing Regulation (EU) No 2015/262 of 17 December 2013. February 2015.

Article 12. Identification of equidae from third countries.

1. Identification documents issued in third countries shall be considered valid if:

a) They have been issued:

1. In the case of registered equidae, by a body of a third country, included in the list set out in Article 5 (a) of Royal Decree 52/1995 of 20 January establishing the principles relating to the zootechnical and genealogical conditions applicable to the importation of animals, semen, ova and embryos from third countries, issuing family certificates,

2. in the case of registered horses, by a national branch of an international organisation or association which manages horses for competitions or races and whose headquarters are in the third country of the international organisation or association within the meaning of Article 5 (1) (b)

or

3. in other cases, by the competent authority of the third country of origin of the equine animal.

b) Meet all the requirements set out in this royal decree; otherwise, the holder must ask the issuing body to complete the same and, if this is not possible, to issue a new one.

2. The holder of an equine from a third country which is not identified shall submit the application for the equine identification document within 30 days after the end of the definitive customs procedure before the end of the the issuing body corresponding to the status of the equine.

3. Animal data from third countries shall be recorded in RIIA by the issuing body corresponding to its status or, where appropriate, by the competent authority of the autonomous community where the holding is located. the animal.

Article 13. Measures to detect a previous identification of equidae.

1. Before issuing an identification document, the issuing body shall take all appropriate measures to:

(a) Verify that an identification document for the equine animal in question has not already been issued.

b) Avoid fraudulent issuance of several identification documents for the same equine animal.

2. The measures referred to in paragraph 1 shall

:

(a) The consultation of the database and any additional documentation accompanying the animal concerned.

b) The estimate of the age of the equine animal.

(c) The examination of the equine animal for signs or marks indicating a previous identification:

1. The existence of a previously implanted transponder, acting and using the technologies provided for in Article 171.a of Commission Implementing Regulation (EU) 2015/262 of 17 February 2015.

2. º Any clinical sign indicative of the prior surgical removal of a transponder.

3. º Any alternative mark on the animal applied in accordance with this royal decree.

3. Where an equine has been identified as previously identified, the issuing body shall:

a) Issue a duplicate or substitute identification document as appropriate in accordance with this royal decree.

b) You will enter this information appropriately in section I of the equine identification document, both in Part A and in the graphic review of Part B.

c) You will update the information in the database.

4. Where the undocumented extraction of a transponder or an alternative mark is confirmed in an equine animal, the issuing body of the autonomous community in which it radiates the animal, shall issue a replacement equine identification document in accordance with Article 22 of this royal decree.

5. The competent authority may authorise the issue of an identification document for equidae living in wild or semi-wild conditions and carrying a transponder but for which no document has been issued identification, provided that the code of the transponder has been recorded, at the time of its implementation, in the data base of the issuing body competent for that stock of equidae.

Article 14. Identification procedure.

1. The issuing body shall ensure that, at the time of the first issue of the equine identification document, any equine animal identified in Spain is actively marked with the introduction of an electronic transponder for injection which complies with the requirements set out in Annex II and III of this Royal Decree.

2. The transponder will be implanted by parenteral route in aseptic conditions in the upper third of the left side of the neck, between the neck and the cross in the area of the nucal ligament, with the required qualification for the application of the Graduate or graduate in veterinary medicine.

3. The codes of the transponders of equidae identified in Spain shall contain the information of species, country and autonomous community or cities of Ceuta or Melilla in which the holding in which the animal is identified is based, according to the provisions of Annexes II and III to Royal Decree 685/2013 of 16 September establishing a system for the identification and registration of ovine and caprine animals. These Annexes shall be fully applicable to the identification of equine animals, except as regards the coding of species, which for horses, donkeys, mules, burdeans, onagros and zebras shall be 01.

4. The guarantee of the unique codes of equine animals identified in Spain shall be made by the inclusion of all the codes of transponders used in the national database of animal electronic identification codes. established in Article 14 of Royal Decree 685/2013 of 16 September. Article 15 of that royal decree shall be fully applicable to the identification of equine animals, with the exception of the time limit laid down in paragraph 6 for the maintenance of the information in the database, which shall be 35 years for the codes allocated for the identification of equidae.

5. The competent authorities of the autonomous communities or cities of Ceuta and Melilla shall assign the codes for the identification of equidae to be carried out on holdings located on their territory.

Social-based issuing bodies in another country identifying animals born in the Kingdom of Spain shall, where appropriate, request the allocation of codes through the point of contact established in Article 5 of this Regulation. decree.

6. The issuing body shall enter the following information in the identification document:

(a) In Section I, Part A, point 5, the complete sequence of the twenty-three digits of the code transmitted by the transponder shall be shown. If an adhesive label is used with a barcode the page must be sealed by means of a transparent adhesive sheet.

(b) In point 13 of the scheme set out in Section I, Part B, the place of implantation of the transponder in the equine animal.

Article 15. Alternative marking for animals born in Spain.

1. By way of derogation from Article 14 of this royal decree, and in accordance with Article 21 of Commission Implementing Regulation (EU) No 2015/262 of 17 February 2015, an alternative mark, consisting of a trade mark, may be applied. electronic auricular, exclusively for animals born on holdings of type production and reproduction, pasture and holdings of wild or semi-wild horses in accordance with the classification referred to in Annex III to the Royal Decree 479/2004 of 26 March 2004 laying down and regulating the general register of holdings livestock, the aim of which is the production of equidae for slaughter.

2. The electronic ear tag shall comply with the specific technical characteristics set out in Annex III and with the general technical characteristics of the electronic transponders of Annex II.

Article 16. Alternative marking for non-Spanish-born animals.

1. Equidae identified by alternative marks, authorised in the countries of provenance, may be introduced into the Kingdom of Spain.

2. The issuing body shall ensure that no identification document is issued for an equine animal, unless the alternative method referred to in paragraph 1 is inserted in points 6 or 7 of Part A of Section I of the Equine identification and is recorded in the database of individually identified equine animals.

3. Where an alternative marking is used, the holder shall provide the means of access to such identification information or, where appropriate, shall bear the costs of verifying the identity of the animal.

Article 17. Movement and transport of equidae.

1. The equine identification document shall at all times accompany registered equidae and equidae for breeding and income except where:

a) State or grazing, and the holder may present the equine identification document as soon as possible.

(b) are temporarily moved, either in the vicinity of the livestock holding in a movement on national territory in such a way as to enable the equine identification document to be submitted within three hours; or the transhumance of the equidae to or from the summer pasture and the equine identification documents may be submitted on the livestock holding of exit.

(c) Equidae are not weaned and permanently accompany their mother or nurse.

d) Participate in a training, in a trial or event of an equestrian competition that forces them to temporarily abandon the place where the competition takes place.

e) be moved or transported in an emergency situation relating to themselves or, without prejudice to the provisions of Article 14.1, second paragraph, of Royal Decree 2179/2004 of 12 November 2004 laying down measures to combat foot-and-mouth disease, with the livestock holding to which they belong.

Article 18. Movement and transport of equidae for slaughter.

The equidae for slaughter must be accompanied by the identification document issued in accordance with this royal decree to the slaughterhouse. However, the competent authority may authorise equidae for slaughter for which an identification document has not been issued to be transported directly from the holding of birth to the slaughterhouse, provided that:

a) Have less than twelve months and their side incisors of milk have visible dental stars.

(b) Exist an uninterrupted traceability from the holding of birth to the slaughterhouse.

c) During transport to the slaughterhouse, be individually marked in accordance with this royal decree.

(d) The consignment is accompanied by information on the food chain in accordance with Royal Decree 361/2009 of 20 March 2009 regulating information on the food chain to accompany animals. intended for slaughter, which should include a reference to the individual marking referred to in point (c) of this paragraph.

Article 19. Obligation of the holders in relation to the management of the identification documents.

1. The holder of an equine animal shall ensure that the following identifying data contained in the identification document are up to date, and are correct at all times:

(a) The status of the equine animal as to its eligibility for slaughter for human consumption.

b) The readable code of the transponder or the alternative mark.

c) The status of "registered equid" or "parenting and income equid".

(d) Information on the ownership of the animal, except for the exceptions provided by Royal Decree 577/2014 of 4 July, governing the equine movement card, for those equine animals to which they are entitled issued an equine movement card.

2. Irrespective of the issuing body issuing the identification document, the holder of an equine animal shall ensure that the identification document is deposited with the issuing body within the meaning of Article 5 (1) and (2), which corresponds to the category of the equine animal, in order to provide the identifying data which must be recorded in the database of the equine animal within 30 days of:

(a) The issuance of the identification document by the issuing body that is based outside Spain, in accordance with Article 5 (4) of this royal decree.

b) The introduction of the equine animal into Spain with the exception of:

1. º Equidae participating in competitions, races, shows, training or shooting competitions and drag for a period not exceeding ninety days.

2. º The stallions that remain in Spain during the time of reproduction.

3. The mares that remain in Spain for reproduction for a period not exceeding ninety days.

4. º Equidae housed in a veterinary facility for medical reasons.

5. The equidae intended for slaughter within 10 days of their introduction.

3. If it is necessary to update the identifying data contained in the identification document referred to in Article 26 of this royal decree, the holder shall deposit the identification document within thirty days of the date of the fact that has affected that data:

(a) In the case of registered equidae, in the issuing body within the meaning of Article 5.1 (a), which:

1. º Exorder the identification document of the registered equine animal in question, or

2. is authorised in accordance with Commission Decision 92/353/EEC of 11 June 1992 laying down the criteria for the authorisation or recognition of organisations and associations which carry or create breeding books for registered equidae in Spain, and have set up a herd-book in which that animal can be registered or registered in accordance with Commission Decision 96 /78/EC of 10 January 1996.

(b) In the case of registered equidae, in the issuing body within the meaning of Article 5.1 (b), in accordance with the rules of the issuing body which issued the identification document for the registered equidae in question, or

(c) in the competent authority of the autonomous community or cities of Ceuta and Melilla where the holding of the equine animal is located. In the case of registered equidae, the autonomous community shall communicate the changes to the issuing body.

4. In any case, and at the request of the holder of the animal, the competent authority of the autonomous community or cities of Ceuta and Melilla where the holding of the equine animal is located may update the data of the ownership of the animal.

Article 20. Obligation on the issuing bodies for identification documents in relation to their management.

The issuing bodies of identification documents shall:

a) Carry out the necessary updates of the identifying data contained in the identification document.

(b) Consignate in Part C of Section I of the identification document the information required on the issuing body, which should consist of at least the number of the UELN-compliant database, if it did not issue initially the identification document.

c) Meet the entries in section IV of the identification document.

d) Introduce or complete in the database the identifying data contained in the identification document, in accordance with the provisions of Article 26 of this royal decree.

Article 21. Duplicate identification documents.

1. The issuing body of the identification document shall issue a duplicate of the identification document when:

(a) The original identification document has been lost, and the identity of the animal can be determined, in particular by the code transmitted by the transponder, or

(b) the animal has not been identified within the time limits referred to in Article 9.1, provided that the certificate of cover and the biological mother is available or, in the case of transfer of embryos, the suckler is identified in accordance with this royal decree, or

(c) the competent authority has evidence that certain identifying data contained in the existing identification document do not correspond to the equine animal in question and cannot be issued with a new document identification as set out in Article 9.2 (a).

2. In the cases described in paragraph 1, the issuing body of the document shall, at the request of the holder or at the request of the competent authority:

a) Apply to the animal, if necessary, a transponder or an alternative mark.

b) Exorder a duplicate of the clearly marked identification document as such ("duplicate of the identification document") with the unique permanent number recorded in the database.

(c) Classify the equine animal in Part II of Section II of the duplicate identification document as an animal not intended for slaughter for human consumption.

3. The issuing body of the duplicate identification document shall update the data of this animal in the database.

4. Where the missing identification document has been issued by an identification document issuing entity that no longer exists, the duplicate of the identification document shall be issued by an issuing body in the autonomous community. where the holding of the equine animal is located, or by a registered equidae issuing body which has acquired such responsibility.

5. Where the missing identification document has been issued by a document issuing authority of a third country authorised in accordance with this royal decree, that entity shall issue a duplicate of the identification document, which shall comply with this royal decree and shall be sent to the holder of the animal.

6. By way of derogation from paragraph 2 (c), the competent authority may decide to suspend the status of 'animal intended for slaughter for human consumption' of an equine animal for only a period of six months, by introducing the date of start of the suspension period in the first column of Part III of section II of the duplicate identification document and fill in the third column of the identification document where:

(a) The holder can demonstrate satisfactorily within 30 days of the declared date of loss of the identification document that the status of "animal intended for slaughter for human consumption" of the animal Equine has not been compromised by any medical-veterinary treatment.

(b) The application for identification has been made in accordance with the second indent of Article 1.1 of Commission Decision 96 /78/EC of 10 January 1996 during the first year of life, but after the expiry of the maximum period authorized for identification in accordance with this royal decree.

Article 22. Substitute identification documents.

1. The issuing body for identification documents for equidae for breeding and income of the autonomous community or cities of Ceuta or Melilla where the equine animal is located shall issue a replacement identification document to an equine animal. when:

a) The original identification document has been lost and:

1. The identity of the animal cannot be determined.

2. No indications or evidence that an identification document has been issued by an issuing body for the animal in question in advance.

b) Or, the animal has not been identified within the deadlines set by this royal decree.

2. In the cases described in paragraph 1, the issuing body for identification documents for equidae for breeding and for the income of the autonomous community where equine animal is found shall, at the request of the holder or at the request of the authority competent:

a) If this is the case, implant in the animal a transponder or alternative mark according to this royal decree.

(b) Exorder a clearly marked replacement identification document as such ("replacement identification document") with a single permanent number corresponding to that of the issuing body of the document Substitution identification.

(c) Classify the equine animal in Part II of Section II of the substitute identification document as an animal not intended for slaughter for human consumption.

3. The body issuing the replacement document shall enter the data in the database, as set out in Article 26 of this Royal Decree.

Article 23. Suspension of equine identification documents for movements of equidae.

The competent authority shall suspend the validity of the equine identification document for movements of equidae by indicating it in an appropriate manner in Section III of that document when an equine animal is in a holding, or proceeding from a holding, which is:

(a) Subject to a prohibition measure, in the terms of Article 4 of Royal Decree 1347/1992 of 6 November 1992 amending the rules for the control of African horse sickness and laying down animal health conditions which regulate intra-Community movements of equidae and imports of such animals from third countries, or

(b) located in or in part of a Member State or third country not free from African horse sickness.

Article 24. Death and slaughter of equidae.

1. Before admission for slaughter, and without prejudice to animal welfare considerations referred to in Annex I, Section II, Chapter III.2 of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption, the operator of the slaughterhouse, as provided for in Article 5 of the Royal Treaty Decree 361/2009, of 20 March, will perform the following actions:

a) You will check the identity of each animal, using the appropriate reading means, and adopt the appropriate decision.

(b) Check the information contained in section II of the DIE with regard to the suitability of each animal for human consumption.

These actions shall be verified by the official veterinarian in accordance with the functions assigned to it in Article 7 of the Royal Decree 361/2009 of 20 March 2009.

2. Where the equine animal is slaughtered or killed, the following measures shall be taken:

a) The identification document must be destroyed:

1. Under official supervision in the slaughterhouse where the animal has been slaughtered. The date of slaughter of the animal and the date of destruction of the identification document shall be communicated to the issuing body so that the issuing body of the passport reflects that information in the database.

The communication of the death data of the equine animal to the RIIA database by the slaughterhouse shall be understood as certifying, in accordance with Article 10a of Royal Decree 728/2007 of 13 June on the the general register of livestock movements and the general registration of individual identification of animals.

2. Under the supervision of the official veterinarian in case of slaughter or death as a result of disease control, or after the slaughter of the animal in accordance with Articles 4 and 6.3 of Royal Decree 1347/1992, 6 of November.

3. º By the competent authority defined in Royal Decree 1528/2012 of 8 November laying down the rules applicable to animal by-products and derived products not intended for human consumption, in the case of removal or transformation of the equine animal's carcass if it is accompanied by a passport.

b) A subsequent fraudulent use of the transponder will be avoided, in particular by retrieving it, destroying it, or removing it "in situ".

However, where the transponder cannot recover from an equine animal slaughtered for human consumption, the official veterinarian shall declare the meat or part of the meat or part containing the transponder as not suitable for human consumption, in accordance with Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004.

3. In all cases of death or loss of the equine animal, including theft, not mentioned in this article, except if the passport accompanies the channel to a SANDACH establishment, the holder shall return the identification document for his/her destruction to the body that issued it within 30 days after the death or loss of the equine animal.

4. Except in the case of slaughter in slaughter within 15 days, the holder shall be responsible for the communication of the death of the animal to the issuing body which corresponds in accordance with Article 5 (1) and (2), which shall reflect it in the database immediately.

Article 25. Fitness for human consumption and registration of medicines.

1. An equine animal shall be deemed to be intended for slaughter for human consumption except where, in accordance with this royal decree, the contrary in Part II of Section II of the document has been declared irreversibly. identification by:

a) The owner's signature, at its own discretion, endorsed by the issuing body, or

(b) the signature of the holder and of the responsible veterinarian acting in accordance with Article 82 of Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products

or

(c) the entry made by the issuing body when issuing a duplicate of the identification document or a replacement identification document.

2. Before proceeding to any treatment of exceptional prescription to equidae, of veterinary medicinal products authorised for non-food-producing species, or any other treatment involving the administration of an authorised medicinal product in accordance with the last paragraph of Article 6.5 of Royal Decree 1246/2008 of 18 July 2008 governing the procedure for the authorisation, registration and pharmacovigilance of veterinary medicinal products manufactured industrially, responsible veterinarian shall determine the status of the equine animal, either as an animal intended for slaughter for human consumption, or as an animal not intended for slaughter for human consumption, as set out in Part II of Section II of the identification document.

3. If the treatment referred to in paragraph 2 of this Article is not permitted in an equine animal intended for slaughter for human consumption, the responsible veterinarian shall ensure that the equine animal in question is irreversibly declared, prior to treatment, animal not intended for slaughter for human consumption:

a) Meeting and signing Part II of Section II of the identification document, and

b) by invalidating Part III of section II of the identification document in accordance with the instructions set out in that part.

4. After the measures provided for in paragraph 3 have been taken, the holder of the equine animal shall within a maximum period of 14 days from the date on which Part II of Section II of the identification document is signed:

(a) Depositary the identification document in the issuing body for identification documents of the equidae for breeding and income of the autonomous community or cities of Ceuta and Melilla where the holding of the animal is located equine, or

b) to provide the information "on line", if the corresponding access to the database is established.

5. By way of derogation from paragraph 4, the responsible veterinarian shall notify the database of the measures carried out in accordance with paragraph 3 within 14 days of the date on which Part II of Section II of the Annex is signed. identification document, either:

a) Through the equine movement card (TME) or

b) Directly to the competent authority of the autonomous community or cities of Ceuta and Melilla where the holding is located where the animal is located.

6. Where an equine animal is required to undergo treatment with one of the active substances included in Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing a list of substances essential for the treatment of the equidae, and for which the waiting time is at least six months, the responsible veterinarian shall enter in Section II, Part III of the equine identification document, the information required on the medicinal product, including the substances essential for the treatment of equidae listed in that Regulation.

The responsible veterinarian will record the date of the last administration of the medicinal product, as prescribed, and, pursuant to Royal Decree 109/1995 of 27 January, will inform the holder about the date of completion of the time-out that you have set and will notify the above information to the database:

a) Directly through the equine movement card (TME), or

b) Through the competent authority of the autonomous community or cities of Ceuta and Melilla where the holding is located where the animal is located.

Article 26. Database.

1. When issuing the equine identification document or recording the identification documents issued above, the issuing body shall record in a database its own information on the equine animal listed in Annex IV.

2. The issuing body shall keep in its registered and up-to-date database the information referred to in paragraph 1 for a minimum of thirty-five years or, at least, up to two years after the date of death of the equine animal, compliance with this royal decree.

3. The General Register for the individual identification of equidae attached to the Directorate-General for Health of Agricultural Production, of the Ministry of Agriculture and Fisheries, Food and the Environment, which includes the data in the registers, is hereby established. of the competent authorities, which are established for equine animals in Annex IV to this royal decree. This Register is integrated into the General Register of Individual Animal Identification (RIIA) as referred to in Royal Decree 728/2007 of 13 June.

The information in this Register will be transferred, preferably by electronic means, to those bodies and bodies that need to access their data in the exercise of their competences. The Directorate-General for Health of Agrarian Production will respond to the requests for more frequent information made by the different public bodies and bodies through the Platform for the Intermediation of the Data of the Administrations. Public.

4. Immediately after recording the information referred to in paragraph 1, the issuing entities shall communicate to the records of the competent authorities, in the manner in which they are determined, the data of the equidae which they have identified in their respective territories. In the case of entities issuing identification documents for registered equidae of a national nature, the competent authorities may determine that such communication is carried out through the General Register of Individual Identification created referred to in paragraph 3.

5. For the purposes of coordination, the records of the competent authorities shall be computerised and their management system shall allow the records of animals to be carried out to be immediately reflected in the RIIA.

6. In the case of an issuing body with a social reason in another Member State of the European Union or in a third country identifying animals born in the Kingdom of Spain, it shall be the holder of the equine animal which, within 30 days, must communicate the information referred to in paragraph 1 of this Article to the database of the autonomous community where the holding is located where the animal is located.

7. The issuing bodies with a social reason in the Kingdom of Spain identifying animals born in another Member State of the European Union shall communicate no more than 15 days after the date of registration of the information referred to in the paragraph 1 to the central database of the country where the animal was born.

Article 27. Controls.

In the framework of the National Plan of Official Control of the Food Chain, the Ministry of Agriculture and Fisheries, Food and the Environment, and the competent authorities of the Autonomous Communities, in the working groups carry out regularly between the General Administration of the State and the Autonomous Communities, establish and approve an annual control programme to ensure the proper functioning of this identification system. This control shall comply with the conditions imposed by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls carried out to ensure the verification of compliance with the legislation on feed and food and animal health and animal welfare legislation.

Article 28. Penalties.

For the purposes of Article 29 of Commission Implementing Regulation (EU) 2015/262 of 17 February 2015, the regime of infringements and penalties laid down in Law 8/2003 of 24 April 2015 shall apply. of animal health, without prejudice to the civil, criminal or other responsibilities that may be held.

Additional disposition first. Regulatory references.

References to Royal Decree 1515/2009 of 2 October will be construed as references to this royal decree.

Additional provision second. Animal movements.

The provisions of this royal decree shall be without prejudice to the movements within the national territory of Royal Decree 577/2014 of 4 July 2014 governing the equine movement card.

Additional provision third. No increase in staff costs.

The measures included in this rule may not result in an increase in appropriations or remuneration or other personnel costs.

Additional provision fourth. Obligation of identification.

The obligation of identification of all equidae, regulated in this royal decree, in application of the rules of the European Union, will compete in all cases, included in those in which the regulation is applicable the administration and the scheme of the animals shown, approved by Royal Decree of 24 April 1905. If the animal is not identified, the replacement identification document provided for in Article 22 shall apply and agree to this royal decree, and shall not be intended for human consumption.

First transient disposition. Existing data.

The individual identification data of the equidae existing at the time of the entry into force of this royal decree, in accordance with Article 17.3 of Royal Decree 1515/2009 of 2 October, will be entered directly by the competent authorities in the Register provided for in Article 26.3 of this Royal Decree.

Second transient disposition. Issuing entities.

For the purposes set out in Article 5.5, it will not be necessary to re-notify those issuing entities which have already been notified by the competent authorities in accordance with Royal Decree 1515/2009 of 2 October 2009. of the entry into force of this royal decree.

Transitional provision third. Wild or semi-wild areas.

For the purposes referred to in Article 10.2, it shall not be necessary to re-notify those wild or semi-wild areas which have already been notified by the competent authorities in accordance with Royal Decree 1515/2009, 2 of October, the day of the entry into force of this royal decree.

Transitional disposition fourth. Animals identified.

The following equidae shall be considered to be identified in accordance with this royal decree:

(a) Equidae born at the latest on 30 June 2009 and identified up to that date in accordance with Decisions 93 /623/EEC or 2000 /68/EC, provided that their identification documents:

1. º Have been registered in the database in accordance with the provisions of Royal Decree 1515/2009 of 2 October 2009, no later than 31 December 2009, and

2. contain a section corresponding to section IX of the model document identifying the Annex to Commission Decision 93 /623/EEC of 20 October 1993 laying down the identification document (passport) to accompany registered equidae, and Part III-A of the identification document is completed if information has been entered in Part III-B;

(b) equidae born at the latest on 30 June 2009 and not identified until that date in accordance with Commission Decision 93 /623/EEC of 20 October 1993 or Commission Decision 2000 /68/EC, 2000 /68/EC, of 22 December 1999 amending Commission Decision 93 /623/EEC and regulating the identification of equidae for breeding and production, provided that they have been identified in accordance with Royal Decree 1515/2009 of 2 December 1999. by 31 December 2009 at the latest;

(c) equidae identified in accordance with Royal Decree 1515/2009 of 2 October 2015 at the latest by 31 December 2015.

2. Equidae born in the Union or imported into the Union from a third country after 30 June 2009 and which have not been identified in accordance with Royal Decree 1515/2009 of 2 October 2015, by 31 December 2015 at the latest, shall identify according to this royal decree, depending on the information available on your identity.

Single repeal provision. Regulatory repeal.

Repealed:

(a) Royal Decree 1515/2009 of 2 October establishing a system for the identification and registration of animals of the equine species.

(b) Order APA/2405/2002 of 27 September establishing the Spanish Committee for the Electronic Identification of Animals.

Final disposition first. Amendment of Royal Decree 685/2013 of 16 September establishing a system for the identification and registration of ovine and caprine animals.

Article 8 (1) is worded as follows:

" 1. Any animal intended for intra-Community trade shall be identified in accordance with Article 4.

However, those animals identified in accordance with Article 5.1 which are intended for intra-Community trade before the age of 12 months may be identified by an eartag which meets the expected characteristics. in Annex I, paragraph A or B and an electronic ear tag which meets the characteristics laid down in Annex I, paragraph H, '

Final disposition second. Amendment of Royal Decree 804/2011 of 10 June 2011 governing the zootechnical, health and animal welfare management of equine holdings and establishing the equine health plan.

Royal Decree 804/2011 of 10 June, governing the zootechnical, health and animal welfare management of equine holdings and establishing the equine health plan, is amended as follows:

One. The content of Article 2.3 is replaced by the following:

" 3. In addition,

following definitions shall apply:

(a) Small-capacity equine holding: that holding equidae up to a maximum of 5 units of livestock (UGM) or 10 UGM in the case of slaughter animals. For these purposes,

following definitions shall apply:

1. 1 UGM: Every animal over twelve months of age.

2. º 0.5 UGM: Every animal over six months and up to twelve months of age.

3. 0.2 UGM: Every animal up to six months of age.

(b) Holder: The provision as such in the basic regulation of the system for the identification and registration of animals of the equine species. "

Two. The content of Article 6.3 is replaced by the following:

" 3. The competent authorities may exempt non-commercial holdings of small capacity and pasture from the need for the book of exploitation, although in such case holdings must bear a simplified book in the which contain at least the data relating to the holder, the identification of the animals, and the births and deaths of the animals. '

Three. The content of Article 7.2 is replaced by the following:

" The holder of the equine must allow the health checks provided for in this royal decree to be carried out, as well as the actions resulting from the application, where appropriate, of the basic sanitary hygiene programme provided for in the Article 4 and the health programmes provided for in Article 8 and to bear the costs arising therefrom. It shall also provide the holder of the holding with the information necessary for the fulfilment of his obligations and shall comply with the hygiene-health measures laid down for holdings where his animals are housed. '

Four. The content of the single additional provision 'Abandoned animals' is replaced by the following:

" Single additional disposition. Abandoned animals.

In the case of abandoned animals of the equine species in the reception or collection centre, the holder of the centre shall be understood to be the holder of the centre, who shall be responsible for the damage to which the animal may cause to third parties.

Those assumptions in which equine species found in the host or collection centre come from an interim or final seizure, ordered by the judicial authority or the competent authority, are exempted from the previous rule. competent administrative authority, and the identity of the previous holder, to which the damage the animal has caused to third parties may be claimed and until such time as its health status is considered to be standardised and restored, until a period of time has elapsed maximum one year of the effectiveness of the seizure.

The same liability of the previous paragraph may be required for cases where the animals of the equine species are in the reception or collection centre on the basis of a voluntary transfer by the holder, provided that the that the same originates in a recommendation made by a judicial or administrative authority competent for the failure to comply with the duty to care for the animals or the infringement of the rules of protection laid down in the law legal. "

Final disposition third. Competence title.

This royal decree is issued under the terms of Article 149.1.13. and 16. of the Constitution, which attributes to the State exclusive competence in the field of bases and coordination of the general planning of economic activity, and of General principles and coordination of health, respectively.

Except for the regulation contained in Articles 12, 16 and 21.5, which is issued under the terms of Article 149.1.10. and 16. first indent of the Spanish Constitution, which attribute exclusive competence to the State external trade and external health.

Final disposition fourth. Ability to modify.

The Minister of Agriculture and Fisheries, Food and the Environment is empowered to adopt, in the field of their competences, the necessary measures for the adaptation of the annexes of this royal decree to the rules of the Union European or international.

Final disposition fifth. Entry into force.

This royal decree shall enter into force on the day following that of its publication in the "Official Gazette of the State" with effect from 1 January 2016 on the application.

Given in Madrid, on December 16, 2016.

FELIPE R.

The Minister of Agriculture and Fisheries, Food and Environment,

ISABEL GARCÍA TEJERINA

ANNEX I

Identification document requirements for equidae

a) Size: Each of the pages that make up the DIE will correspond to a size DIN A5.

b) You will have a sufficiently protective, differentiated cover (front and back). The obverse shall include the official shield of the Kingdom of Spain and may include the logo of the issuing body, as well as a pocket on the inside of the cover to insert the pages containing the sections. IV to XI, as appropriate.

(c) It shall have at least Sections I to III remacfairies indivisibly machine to prevent the removal or fraudulent substitution of pages.

(d) In the case of serial number, this shall be printed at least in Sections I, II and III.

e) Each page must be numbered in the form "X of the total and pages".

(f) At least, in Sections I, II and III, the EULN shall be included.

g) shall have part A of section I sealed by means of a transparent adhesive sheet applied after the required information has been entered, unless the issuing body prints out section I of the identification document a way to prevent modification once the required information has been entered.

h) Carry out the general instructions set out in Part I of Annex I to Commission Implementing Regulation (EU) 2015/262 of 17 February 2015.

ANNEX II

Electronic transponder features

1. The electronic identifiers used shall comply with the UNE-EN-ISO standards: 11784 and UNE-EN-ISO: 11785 and subsequent modifications.

2. The structure of the electronic identification code will consist of 23 digits, which read from left to right will correspond to:

a) First digit: Use of the identifier, which will be a 1 when the target is an animal.

b) Second digit: Reidentification Counter.

c) Third and fourth digits: Animal species code, which will be 01 for the whole group of horses (horses, donkeys, mules, burdeans ...).

d) Fifth and sixth digits: Digits reserved for future uses.

e) Seventh digit: Presence of additional information, which shall be a 0 for identification devices without additional information compatible with ISO 11784 and 1 for advanced compatible transponders only with the ISO 14223 standard that may possess such information.

f) Eighth, ninth, tenth, and eleventh digits: Country code, which according to the UNE-EN-ISO standard: 3166 for Spain is 0724.

g) 12th and 13th digits: Autonomous Community Code, as per Annex II to Royal Decree 685/2013, dated September 16.

h) 14th to 20th digit: Animal identification serial code.

3. The structure of the visual identification code, if applicable, shall not display the first seven digits of the electronic identification code, and replace the four digits corresponding to the country code with its equivalent in letters, also according to the UNE-EN-ISO standard: 3166, and for the Kingdom of Spain it is 'ES'. This way it will:

a) First two characters: Country code in letters (ES: Spain).

b) Third and fourth digits: Autonomous Community code according to Annex II to Royal Decree 685/2013 of 16 September.

c) From fifth to tenth digit: Animal identification serial code.

4. The employee transponders will be passive, read only, and will use HDX or FDX-B. technology

5. Transponders must be readable by means of reading equipment, whether fixed or mobile, complying with the standard UNE-EN-ISO: 11785. Such reading equipment shall be capable of reading at least HDX and FDX-B transponders. The minimum reading distance shall be 12 centimetres as laid down in Commission Implementing Regulation (EU) 2015/262 of 17 February 2015.

ANNEX III

Specific technical characteristics of the electronic ear tag and the injectable transponder

A. Electronic ear tag.

1. The eartag shall consist of a yellow button-button type of yellow, made of unalterable, counterfeit, non-reusable material, with a design that allows it to remain subject to the animal without damaging the animal for the entire life of the animal. animal, and easily visible at a distance.

2. The crotal will consist of two pieces printed, male and female. The female's head will be closed. The tip of the stem shall be inserted into the existing cavity in the female and shall be coupled in such a way that it does not protrude from the neck thereof. The application shall be carried out on the animal by means of a semi-automatic application tenaza, so that the two parts are joined together, their separation being impossible without permanently using the two parts.

3. In any case, both the male and female parts will have a system that avoids the reuse of either piece.

Materials in contact with the animal must be biocompatible.

4. Description of the elements:

a) Female pieces: The piece must be of type "button" and be made of thermoplastic material (polyurethane), inviolable and of closed head. It will allow rotation and aeration. The colour will be yellow RAL 1016, allowing for the exception of another colour for the head of safety, and being stable both colours to the ultraviolet rays. It will present a constitutional shield by injection with a maximum dimensions of 7 x 7 mm and an indication of the date of manufacture through a date of the registration. This part will contain the inviolable electronic transponder that will carry the code of the animal electronic identification. The technical characteristics of the transponder are specified in Annex II.

The compartment for the transponder will be 100% watertight

Part measures:

i. External diameter of the piece: 20-34 mm.

ii. Thickness: 4-7 mm.

iii. External diameter of the head: 8-13 mm.

b) Male pieces: The piece must be "button" and made of plastic material, inviolable. The color will be yellow RAL 1016 and stable to the ultraviolet rays. It will present a constitutional shield by injection with a maximum dimensions of 7 x 7 mm and an indication of the date of manufacture through a date of registration.

Part measures:

i. Outer diameter of the piece: 20-34 mm.

ii. Thickness: 1 ± 0,25 mm.

iii. Stem diameter: 4,5-7.4 mm.

The distance between the female part and the male part shall be at least 9,5 mm.

Maximum weight of the assembly (female piece + male part): 8.5 gr.

The images are indicative, their representation does not involve any design or manufacturing obligation.

1

5. The crotal (both the female and the male part) shall be printed on both pieces, indelibly, the same visual identification code of the animal, the structure of which is specified in Annex II, paragraph 3 of this royal decree.

6. The code shall be printed on a single line adapted to the shape of the crotal, parallel to the outer edge and occupying at most half of the total circumference. Printing will be by laser, with no addiction or no pigment subtraction. The minimum separation between characters shall be 1 mm and the minimum font size shall be 4 mm in height.

7. Additionally, the front of the male part may contain any other additional information, provided that this does not affect the readability of the identification code.

Technical characteristics of semi-automatic crotal applicators (tongs).

1. Semi-automatic applicators (tongs) shall be used to place crotals with anti-slip properties on the gripping points to facilitate their use and with an interchangeable, broken-point needle. The manufacturer must supply a replacement needle with each applicator.

2. The tongs shall be preferably universal, and may be used for other animal species, where it is recommended that the tongs bear the manufacturer's indications, in order to ensure the effectiveness of the crotal-tenaza ratio; and optimize the application of the crotals.

B. Injectable transponder.

1. The transponder must be encapsulated in a biocompatible material.

2. The injectable transponder shall be implanted by parenteral route by a single-use specific trocar needle that ensures proper application in violation of the least possible suffering and damage to the animal, at all times being observed hygiene-sanitary measures.

C. Considerations of devices and readers in the identification of animals of the equine species. In the case of both the electronic ear tags and the injectable tansponers:

1. If it is necessary to verify compliance with the characteristics, the manufacturer must present:

(a) A declaration of conformity of their product with the standards set out in Annex II and the requirements specified in this Annex III.

(b) A technical file issued by one or more independent accredited test laboratories relevant to this type of test according to standard UNE-EN ISO/IEC 17025.

However, the manufacturer may demonstrate compliance with the above requirements by certification by an appropriately accredited body.

2. Waste and residues resulting from the process of application of the devices must be collected and processed in accordance with the current environmental legislation.

ANNEX IV

Minimum animal database data

1. Single permanent number (UELN).

2. Species.

3. Sex.

4. Race.

5. Layer.

6. Country of birth.

7. Code of the identification holding.

8. Date of birth.

9. Type of identification of the animal.

10. Electronic identification code or, if applicable, alternative method code.

11. Means of identification of the means of identification.

12. Orientation of the animal.

13. Birth name of the animal and, if applicable, trade name.

14. Fitness for human consumption.

15. Duplicate document/replacement document.

16. Date of death.

17. Date of issue of the identification document.

18. Name and address of the holder and, in the case of change, of the new holder or later in accordance with the provisions of this royal decree.

19. Serial number of the passport, if applicable.

20. TME.