S.I. No. 112/1996 — European Communities (Trade in Bovine Breeding Animlas, Their Semen,Ova and Embryos) Regulations, 1996.

S.I. No. 112/1996 — European Communities (Trade in Bovine Breeding Animlas, Their Semen,Ova and Embryos) Regulations, 1996. 1996 112

S.I. No. 112/1996:

EUROPEAN COMMUNITIES (TRADE IN BOVINE BREEDING ANIMLAS, THEIR SEMEN,OVA AND EMBRYOS) REGULATIONS, 1996.

I, IVAN YATES, Minister for Agriculture, Food and Forestry, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Directive No. 77/504/EEC of 25 July 1977⁽¹⁾ (as amended by Council Directive 91/174/EEC of 25 March 1991⁽²⁾ and Council Directive 94/28/EC of 23 June 1994⁽³⁾), Commission Decision 84/247/EEC of 27 April 1984⁽⁴⁾, Commission Decision 84/419/EEC of 19 July 1984⁽⁵⁾ Commission Decision 86/130/EEC of 11 March 1986⁽⁶⁾ (as amended by Commission Decision 94/515/EC of 27 July 1994⁽⁷⁾), Commission Decision 86/404/EEC of 29 July 1986⁽⁸⁾ Council Directive 87/328/EEC of 18 June 1987⁽⁹⁾ Commission Decision 88/124/EEC of 21 January 1988⁽¹⁰⁾ Council Directive 88/407/EEC of 14 June 1988⁽¹¹⁾ (as amended by Council Directive 90/120/EEC of 5 March 1990⁽¹²⁾), Council Directive 89/556/EEC of 25 September 1989⁽¹³⁾ Council Directive 93/52/EEC of 24 June 1993⁽¹⁴⁾ Council Directive 93/60/EEC of 30 June 1993⁽¹⁵⁾ and Commission Decision 94/113/EC of 8 February 1994, hereby make the following regulations:

(1)O.J No. L206, 12.8.77,	p. 8
(2) O.J No. L85, 5.4.91,	p.37
(3) O.J No. L178, 12.7.94,	p.66
(4) O.J No. L124, 12.5.84,	p.58
(5) O.J No. L206, 5.9.84,	p. 12
(6) O.J No. L 101, 17.4.86,	p.37
(7) O.J No. L207, 10.8.94,	p.30
(8) O.J No. L233,20.8.86,	p. 19
(9) O.J No. L167,26.6.87,	p.54
(10) O.J No. L62, 8.3.88,	p.32
(11) O.J No. L194 22.7.88,	p.10
(12) O.J. No. L71, 17.3.90,	p.37
(13) O.J. No. L302, 19.10.89,	p.1
(14) O.J. No. L175, 19.77.93,	p.21
(15) O.J. No. L186, 28.7.93,	p.28
(16) O.J No. L53, 24.2.94,	p.23

Part I Preliminary

Citation

1. These Regulations may be cited as the European Communities (Trade in Bovine Breeding Animals, their Semen, Ova and Embryos) Regulations, 1996.

Interpretation

2. (1) In these Regulations, save where the context otherwise requires—

"animal health certificate" means a certificate in which the health status of animals, semen, ova or embryos is certified for the purposes of these Regulations by an official veterinarian issuing the certificate;

"approval" means an approval granted under Regulation 6 by the Minister or a competent authority designated under Regulation 5 for the purposes of these Regulations and the Directives and Decisions;

approved" means approved by the Minister or a competent authority designated under Regulation 5 for the purposes of these Regulations and the Directives and Decisions;

"approved for breeding" means breeding animals or the semen, ova and embryos of such animals approved for breeding;

"approved laboratory" means a laboratory approved to carry out the analytical or diagnostic tests required under these Regulations;

"application for approval" means an application to the Minister or a competent authority designated under Regulation 5 in respect of an approval in relation to any of the matters specified in Regulation 6(2) for the purposes of these Regulations and the Directives and Decisions;

"authorised officer" means a person appointed by the Minister to be an authorised officer under Regulation 24 or an officer of Customs and Excise;

"breeding animal" means a bovine animal including buffalo used for breeding;

"breeders' organisation or association" means a breeders' organisation or association which establishes and maintains a herd book for pure-bred breeding animals;

"centre veterinarian" means a veterinarian responsible for the day-to-day supervision of a semen collection centre;

"collection of semen" means a quantity of semen taken from a donor animal at any one time;

"consignment of embryos" means a quantity of embryos removed in one operation from a single donor animal, and covered by the appropriate animal health and zootechnical certificates;

"consignment of semen" means a quantity of semen from a donor animal, which is accompanied by the appropriate animal health and zootechnical certificate.

"Council Directive 64/432/EEC" means Council Directive 64/432/EEC of 26 June 1964 (17);

(17) O.J No. L121 of 29.7.64 p. 1.

"Council Directive 88/407/EEC" means Council Directive 88/407/EEC of 14 June 1988(11);

"Council Directive 94/28/EC" means Council Directive 94/28/EC of 23 June, 1994(3)^;

"the Directives and Decisions" means Council Directive No. 77/504/EEC of 25 July 1977(1) (as amended by Council Directive 91/174/EEC of 25 March 1991(2) and Council Directive 94/28/EC of 23 June 1994⁽³⁾) Commission Decision 84/247/EEC of 27 April 1984(4), Commission Decision 84/419/EEC of 19 July 1984⁽⁵⁾, Commission Decision 86/130/EEC of 11 March 1986(6) (as amended by Commission Decision 94/515/EC of 27 July 1994(7)), Commission Decision 86/404/EEC of 29 July 1986(8), Council Directive 87/328/EEC of 18 June 1987(9), Commission Decision 88/124/EEC of 21 January 1988(10), Council Directive 88/407/EEC of 14 June 1988(11) (as amended by Council Directive 90/120/EEC of 5 March 1990(12)), and Council Directive 89/556/EEC of 25 September 1989(13) Council Directive 93/52/EEC of 24 June 1993(14), Council Directive 93/60/EEC of 30 June 1993(15) and Commission Decision 94/113/EC of 8 February 1994(16), or any one or more of those Directives and Decisions, as the case may be;

"embryo" means an ovum that has been fertilised and is in the initial stage of development while it is suitable for being transferred to a recipient bovine dam;

"herd book" means any book, register, file or data medium –

(a) which is maintained by a breeders' organisation or association, and

(b) in which pure-bred breeding animals are entered or registered with mention of their ancestors;

"the Commission" means the Commission of the European Communities;

"intra-Community trade" means trade between Member States;

"Member State" means a Member State of the European Union;

"the Minister" means the Minister for Agriculture, Food and Forestry;

"official veterinarian" means a registered veterinary surgeon, within the meaning of section 1 of the Veterinary surgeons Act, 1931 (No. 36 of 1931), appointed by the Minister for the purposes of these Regulations;

"officer of Customs and Excise" has the same meaning as in the Customs Act, 1956 (No. 7 of 1956);

"ova/embryo collection centre" means an establishment in which ova or embryos (or both) from breeding animals are collected for use in artificial insemination;

"ova/embryo collection or production team" means a group of technicians supervised by a team veterinarian, approved to perform in vitro fertilization, the collection, processing and storage of ova or embryos of breeding animals;

"premises" includes any house or land or water and fixed or moveable structure therein and also includes vessels, vehicles, trains, aircraft and other means of transport;

"pure-bred breeding animal" means a pure-bred breeding animal entered in the main section of a herd book whose parents and grandparents are entered in a herd book of the same breed;

"semen" means the prepared or diluted ejaculate of a breeding animal;

"semen collection centre" means an establishment in which semen from breeding animals is collected from bulls for use in artificial insemination;

"team veterinarian" means the veterinarian responsible for the supervision of an ova/embryo collection team;

"testing or genetic evaluation" means the testing or genetic evaluation of breeding animals for the purpose of assessing their genetic merit for the purposes of these Regulations and the Directives and Decisions;

"third country" means a country or territory which is not a Member State;

"trade" includes domestic trade and imports and exports and where relevant applies equally to the purchaser as well as vendor;

"working day" means any day other than –

(a) Saturday or Sunday, or

(b) a public holiday within the meaning of the Holidays (Employees) Act, 1973 (No. 25 of 1973);

"zootechnical certificate" means a certificate giving the identity, ancestry, blood type, and performance or progeny test results as required by these Regulations issued by a person designated by the Minister.

(2) A word or expression that is used in these Regulations and is also used in the Directives and Decisions has, unless the contrary intention appears, the meaning in these Regulations that it has in the Directives and Decisions.

(3) In these Regulations, unless otherwise indicated –

(a) a reference to a Regulation or a Schedule is to a Regulation of, or a Schedule to, these Regulations,

(b) a reference to a paragraph or a subparagraph is a reference to a paragraph or subparagraph of the Regulation or Schedule in which the reference occurs.

Scope of Regulations

3. (1) These Regulations apply to trade in, and approval for breeding of, breeding animals, their semen, ova and embryos, excluding embryos derived by transfer of nuclei.

(2) These Regulations are in addition to and not in substitution for the Disease of Animals Act, 1966 (No. 6 of 1966), or any order made under or continued in force by that Act.

Competent Authority

4. For the purposes of these Regulations and the Directives and Decisions the Minister shall be the competent authority in the State.

Designation of other competent authorities

5. (1) Notwithstanding Regulation 4, the Minister may designate any other person, for such period as the minister sees fit and specifies in the designation, also to be a competent authority, subject to any limitations or conditions as he decides, to grant approvals in relation to any or all of the matters referred to in these regulations.

(2) The Minister may at any time revoke or alter a designation made under this Regulation.

(3) Where the Minister makes or revokes a designation made under this Regulation the designation or revocation shall be published in Iris Oifigiúil and in at least 2 daily newspapers published and circulating in the State.

Part II Approvals'

6. (1) Subject to these Regulations, the Minister may grant an approval to a person for the purposes of these Regulations and the Directives and Decisions in relation to any of the matters specified in paragraph (2) the Minister is satisfied that the requirements of these Regulations and the Directives and Decisions will be complied with.

(2) An approval may be granted by the Minister in respect of—

(a) a breeders' organisation or association in accordance with Regulation 7,

(b) a laboratory to carry out the blood typing, analytical or diagnostic tests in accordance with Regulation 8,

(d) a centre veterinarian in accordance with Regulation 10,

(e) a semen collection centre in accordance with Regulation 11,

(f) an ova/embryo collection or production centre or an ova/embryo collection or production team in accordance with Regulation 12,

(g) breeding animals, semen, ova and embryos for breeding purposes in accordance with Regulation 13,

(h) a scientific and educational research programme involving trade in semen, ova or embryos in accordance with Regulation 14.

(3) An application for approval shall—

(a) be submitted in writing by the applicant to the Minister,

(b) be in such form as the Minister may specify

(c) be legible and state the name and address of the applicant and where the applicant is a body corporate its principal place of business,

(d) be accompanied by such fee as may be determined in accordance with Regulation 25, and

(e) be addressed to –

The Officer in Charge,

Livestock Breeding Division (Cattle)

Department of Agriculture, Food and Forestry,

Farnham Street,

Cavan,

or to such other person or address as the Minister may direct and as published in at least 2 daily newspapers published and circulating in the State.

(4) A person applying for approval shall furnish the Minister with such information as the Minister may reasonably require to ensure that the Directives and Decisions will be complied with and to decide whether or not to grant the approval.

(5) A person who in making an application for approval wilfully makes a false or misleading statement shall be guilty of an offence.

(6) An approval with any conditions attached thereto, shall be in writing and in such form as the Minister may decide and signed by an officer of the Minister.

(7) An approval shall be valid for such period as the Minister may determine.

(8) The Minister may attach any condition (including a condition as to the keeping of appropriate records) to an approval at the time it is granted or at any time subsequently and the Minister may amend or revoke a condition attached to the approval and shall notify the person who has applied for or holds an approval in writing of the conditions, amendment or revocation, as the case may be, in relation to that approval; and in relation to any approval, compliance with the relevant provisions of the Directives and Decisions and of these Regulations shall be a condition of such approval.

(9) The Minister may, if he is not satisfied that the relevant provisions of the Directives and Decisions and of these Regulations are being or will be complied with, refuse an application for approval or revoke an approval and shall notify the owner or person in charge of the establishment concerned in writing of the refusal or revocation.

(10) The Minister shall not—–

(a) revoke an approval, or

(b) refuse an application for approval, or

without —

(d) notifying the holder of, or applicant for, the approval of his intention to revoke the approval or refuse the application, or amend the condition, as the case may be,

(e) specifying his reasons for the intended revocation or refusal of the approval, or amendment of the condition, and

(f) affording the holder of, or applicant for, the approval the opportunity of making representations or having representations made on his behalf to the Minister in relation to the proposed revocation or refusal or amendment of the condition, as the case may be, within 14 days of the receipt by that person of the notification referred to in subparagraph (d) and having had regard to any such representations.

(11) The holder of an approval shall inform the Minister if significant changes are made in the operation or organisation of the activities to which the approval relates.

(12) A person who contravenes an approval or a condition of an approval or fails to comply with paragraph (11) shall be guilty of an offence.

(13) In this Part (other than Regulation 14) a reference to the Minister shall be construed as including a reference to any competent authority designated under Regulation 5.

Breeders' Organisations and Association

7. (1) A person shall not carry on the activities or any of the activities of a breeders' organisation or association or hold himself out as carrying on such activities unless he is the holder of an approval in respect of such breeders' organisation or association.

(2) An approval in respect of a breeders' organisation or association shall only be granted provided that:

(a) the applicant for the approval has met the conditions specified in Schedule A, and

(b) the approval does not endanger the preservation of the breed or jeopardise the zootechnical programme of existing breeders' organisations or associations for the same breed.

(3) The entry of animals in herd books maintained by breeders' organisations or associations shall been accordance with the conditions specified in Schedule B.

(4) Breeders' organisations or associations shall not refuse the entry into their herd books of pure-bred breeding animals from herd books approved by the competent authorities in other Member States provided such animals comply with the veterinary and zootechnical requirements specified in Regulation 20.

(5) Breeders' organisations or associations shall not have entry standards higher than those applicable) pure-bred animals produced by natural service for entry into their herd books of pure bred breeding animals which are the result of using semen or embryos which comply with the veterinary and zootechnical requirements specified in Regulation 20 and have been approved for breeding in accordance with Regulation 13.

(6) Breeders' organisations or associations approved by the competent authorities in other Member States or in third countries which meet the conditions specified in Schedules A and B and which maintain herd looks for pure bred breeding animals shall be deemed to be approved.

Approved Laboratory

8. A person shall not carry out or cause to be carried out blood typing, analytical or diagnostic tests for the purposes of these Regulations and the Directives and Decisions save in an approved laboratory.

Testing, Genetic Evaluation or publication of evaluation results

9. (1) A person who is not the holder of an approval in respect of testing, genetic evaluation or publication of evaluation results shall not purport to be the holder of such an approval or carry out testing or evaluation for the purposes of these Regulations or the Directives and Decisions.

(2) The holder of an approval to carry out testing, genetic evaluation or publication of evaluation results of breeding animals for the purpose of these Regulations and the Directives and Decisions shall comply with the conditions specified in Part I of Schedule C, and shall comply with the performance monitoring methods and the methods used for assessing the genetic merit of breeding animals for the traits concerned which are specified in Part II of Schedule C.

Centre Veterinarian

10. (1) A person shall not be employed or engaged as, or operate or represent himself to be, a centre veterinarian unless he is the holder of an approval relating to the centre at which he is so employed or engaged, or so operates, or so represents himself, as the case may be.

(2) An approval in respect of a centre veterinarian may only be granted to a person who in the opinion of the Minister is suitably qualified and has the appropriate expertise.

(3) An approval in respect of a centre veterinarian shall be limited to the centre named in the application.

Semen Collection Centres

11. (1) A person shall not engage in the activities or any of the activities of a semen collection centre unless he is the holder of an approval in respect of that centre.

(2) The holder of an approval in respect of a semen collection centre shall comply with the following:

(a) the conditions for the approval of semen collection centres as specified in Schedule D,

(b) the conditions relating to the supervision of approved semen collection centres as specified in Schedule E,

(c) the conditions applying to the movement of animals into approved semen collection centres as specified in Schedule F,

(d) the routine tests and treatment which shall be applied to all bovine animals in an approved semen collection centre as specified in Schedule G, and

(e) any analysis required under Schedules D to G to be carried out in approved laboratories.

(3) An approved semen collection centre shall be assigned a veterinary registration number and be recorded in a register maintained by the Minister.

(4) The holder of an approval in respect of a semen collection centre shall cause to be kept at the centre such records as the Minister may reasonably require in relation to animal health

(a) as respects an animal which is in the centre, during the period the animal is in the centre, and

(b) as respects semen, ova and embryos, while stocks of semen, ova or embryos are stored in the centre,

and for the period of 2 years thereafter.

Ova/Embryo Collection or Production Team

12. (1) A person shall not carry on the activities or any of the activities of an ova/embryo collection or production team except under and in accordance with an approval.

(2) The holder of an approval in respect of an ova/embryo collection or production team and every member of his ova/embryo collection or production team the subject of such approval shall comply with the following conditions:

(a) the conditions for the approval of an embryo collection or production team as specified in Schedule H,

(b) the conditions relating to the collection, processing, storage and transport of embryos as specified in Schedule I, and

(3) Each approved ova/embryo collection or production team shall be registered with the Minister and shall be given a veterinary registration number.

Breeding animals, semen, ova and embryos for breeding purposes

13. A person shall not use —

(a) a breeding animal for breeding purposes unless the animal complies with the conditions specified in Part I of Schedule Q,

(b) semen for artificial insemination or fertilisation unless such semen has been approved pursuant to an application for such approval made in accordance with Part II (1) of Schedule Q and complies with the applicable conditions specified in Part II(2) of Schedule Q, or

(c) ova or embryos of breeding animals for breeding purposes unless such ova or embryos (as the case may be) comply with the conditions specified in Part III of Schedule Q.

Scientific and Educational Research Programme

14. (1) Subject to this Regulation, a person shall not carry out a scientific and educational research programme involving trade in semen, ova or embryos except in accordance with an approval.

(2) These Regulations shall not apply to Teagasc or an approved scientific and educational institution or a university in the State carrying out a research programme involving semen, ova or embryos of breeding animals which, in the opinion of the Minister, does not involve trade in these products.

(3) An approval in respect of a scientific and research programme involving trade shall be limited to the duration of the programme.

Offence

15. A person who contravenes Regulation 7, 8,9, 10, 11,12, 13, or 14 shall be guilty of an offence.

PART III Trade

16. (1) A person shall not trade or attempt to trade in pure-bred breeding animals or in semen, ova or embryos of breeding animals except under and in accordance with these Regulations.

(2) A person shall not have in his possession or control or offer for sale any pure-bred breeding animal or any semen, ova or embryos except under and in accordance with these Regulations.

17. The consignee in the State of pure-bred breeding animals, semen, ova or embryos which are to be imported into the State shall report at least one working day in advance of such importation to an officer of the Minister at—

Livestock Breeding Division (Cattle),

Department of Agriculture, Food and Forestry,

Farnham Street,

Cavan,

or to such other person or address as the Minister may direct and as published in at least 2 daily newspapers published and circulating in the State stating

(a) the nature of the consignment and giving any details required by an officer of the Minister,

(b) the name and address of the establishment to which it is being consigned,

(d) in the case of third country imports, their point of entry into the State

18. A person shall not import into the State breeding animals, semen, ova or embryos from a third country other than through an entry point approved for that purpose.

19. A person who has imported into the State any semen, ova or embryos shall consign such semen, ova or embryos to an approved semen or ova/embryo collection centre, as may be appropriate.

20. A person shall not trade in pure-bred breeding animals, semen, ova or embryos unless, such animals, semen, ova or embryos are approved for breeding and the following veterinary and zootechnical requirements n relation to trade in the State or with another Member State or with a third country (as the case may be) are complied with:

(1) Animals

Pure-bred breeding animals shall:—

(a) meet the veterinary requirements specified in the European Communities (Diseases of Animals Acts, 1966 and 1979, Orders) (General Authorisations for Imports) Regulations, 1985 ( S.I. No. 365 of 1985 ),

(b) in relation to exports to other Member States, meet the animal health conditions specified in Council Directive 64/432/EEC, as amended,

(c) in relation to imports from and exports to another Member State or third country be accompanied by a zootechnical certificate conforming with the model or the alternative specified in Schedule K,

(d) in the case of imports from third countries, be

(i) (I) entered or registered in a herd book or register kept by an authority mentioned on a list referred to in Article 3(1) of Council Directive 94/28/EC, and

(II) accompanied by a pedigree and zootechnical certificate drawn up in accordance with Article 12 of the said Directive, or

(ii) accompanied by evidence that they are going to be entered or registered in a herd book or register of a Member State in accordance with Article 12 of the said Directive.

(2) Semen

(a) Semen of breeding animals shall—

(i) be collected, processed and stored in an approved semen collection centre as specified in Schedules D, E, F and G. However, in relation to the storage of semen, this requirement shall not apply to the holder of a licence which is in force issued under section 7 of the Live Stock (Artificial Insemination) Act, 1947 (No. 32 of 1947), to a farmer to carry out artificial insemination of bovines in his own herd only,

(ii) meet the conditions specified in Schedule N,

(iii) be accompanied by an animal health certificate as specified in Schedule O,

(iv) be accompanied by a zootechnical certificate conforming with the model or the alternative specified in Schedule L,

(v) in the case of importation into the State of bovine semen giving a negative reaction to a test specified in paragraph 1(e)(iv) of Schedule F or showing a positive result after vaccination in accordance with Council Directive 88/407/EEC, be permitted entry into the State, until 31 December, 1998,

(vi) in the case of the importation into the State of bovine semen before such date giving a positive reaction to a test specified in paragraph 1(e)(iv) of Schedule F and not having been vaccinated in accordance to the Council Directive 88/407/EEC, be prohibited entry into the State unless each collection passes an examination by inoculation into a live animal or a virus isolation test (or both), and

(b) The requirements set down in subparagraph (a)(v) and (vi) shall not apply in respect of semen of breeding animals which, prior to their first routine vaccination at the insemination centre, reacted negatively to the tests referred to in paragraph 1(e)(IV) of Schedule F. However, the semen of animals given emergency vaccinations following an outbreak of IBR must pass a virus isolation test in which case at least 10 per cent. of each collection of semen (with a minimum of five straws) must be examined. These examinations may by bilateral agreement, be carried out either in the country of collection or in the country of destination.

(c) The Minister shall not oppose the admission from another Member State of semen from bulls vaccinated against foot-and-mouth disease. However, where the semen was obtained from a bull which was vaccinated against foot-and-mouth disease during the 12 month period prior to collection up to 5 per cent. of the semen from each collection (with a minimum of five straws) intended for import into the State shall be subjected in an approved laboratory in a Member State or a laboratory designated by the Minister to a new isolation test for foot and mouth disease, with negative results.

(d) Semen of breeding animals for importation into the State from a third country shall:—

(i) originate in a country which appears on an list drawn up by the Commission,

(ii) in accordance with Article 9 of Council Directive 88/407/EEC, have been collected at a semen collection centre in that third country which appears on an approved list of collection centres from which Member States may authorise the importation of semen originating in third countries,

(iii) be accompanied by an animal health certificate drawn up and signed by an official veterinarian of the third country of collection as required in Article 11 of Council Directive 88/407/EEC,

(iv) be accompanied by a zootechnical certificate conforming with the model or the alternative specified in Schedule L, or as may be specified by the Commission,

(v) In the case of semen imported from Third Countries—

(I) come from an animal which is entered or registered in a herd book or register kept by an authority mentioned on a list referred to in Article 3(1) of Council Directive 94/28/EC,

(II) come from an animal which has undergone the performance checks and genetic value assessment determined in accordance with Article 12 of the said Directive, and

(III) be accompanied by a pedigree and zootechnical certificate drawn up in accordance with the said Article 12.

(3) Ova and Embryos

(a) Ova and embryos of breeding animals shall—

(i) comply with the conditions relating to collection, processing, storage and transport specified in Schedule I,

(ii) have been conceived as a result of artificial insemination or in vitro fertilization with semen from a donor sire standing at an approved semen collection centre or by semen imported in accordance with Council Directive 88/407/EEC,

(iii) meet the requirements specified in Schedule J relating to conditions applying to donor animals,

(iv) be accompanied by an animal health certificate as specified in Schedule P,

(v) be accompanied by a zootechnical certificate conforming to the model or alternative specified in Schedule M,

(vi) if there is more than one ova or embryo in a single straw, be accompanied by a certificate to this effect and such ova or embryos shall all have the same parentage,

(b) Ova or embryos of breeding animals for importation into the State from third countries shall—

(i) originate in a country which appears on an approved list drawn up by the Commission and in accordance with Commission Decision 92/471/EEC,

(ii) in accordance with Article 8 of Council Directive 89/556/EEC, have been collected by an ova/embryo collection team which appears on an approved list from which Member States may authorise the importation of ova/embryos originating in third countries,

(iii) be accompanied by a zootechnical certificate conforming to the model or alternative specified in Schedule M, or as may be specified by the Commission,

(iv) (I) come from an animal which is entered or registered in a herd book or register kept by an authority mentioned on a list referred to in Article 3(1) of Council Directive 94/28/EC, and

(II) be accompanied by a pedigree and zootechnical certificate drawn up in accordance with Article 12 of the said Directive.

(c) Only frozen embryos may be imported from third countries where vaccination against foot-and-mouth disease is practised. The embryos shall be stored under approved conditions for a minimum of 30 days before consignment. Donor animals shall come from a holding in which no animal has been vaccinated against foot-and-mouth disease during the period of 30 days prior to collection, and which is not subject to any prohibition or quarantine measures.

(d) The provisions of Commission Decision 94/113/EEC shall not apply to embryos collected, processed and stored before 1 March, 1994.

(4) If a documentary check reveals that any requirement of this Regulation has not been met, or if for any other reason an authorised officer suspects that the animals, semen, ova or embryos may be infected or contaminated by pathogenic organisms, that officer may take the necessary measures, including the storage of which animals, semen, ova or embryos in quarantine, to satisfy himself regarding their actual status.

21. The veterinary and zootechnical requirements specified in Regulation 20 shall not apply to consignments of breeding animals or products to which these Regulations apply which arrive in the customs territory of the late and are placed under a customs transit procedure for consignment to a destination situated outside the territory of the European Union.

22. In the case of trade in semen in the State a declaration as specified in Schedule R may be substituted for the zootechnical and veterinary certificates referred to in Regulation 20(2) above required to accompany semen.

23. (1) A person who contravenes any provision of this Part shall be guilty of an offence.

(2) Where in any proceedings for an offence under this section for contravening the provisions of Regulation 18 or 20 it is shown to the satisfaction of the court that the accused was trading in or had in his session or control or had offered for sale any pure-bred breeding animal or any semen, ova or embryos it shall be presumed until the contrary is shown that the accused traded in or had in his possession or control or had offered for sale, as the case may be, such pure-bred breeding animal, or such semen, ova or embryos, as the case may be, contrary to the relevant provisions.

PART IV Miscellaneous Provisions

Powers of Authorised Officers

24. (1) The Minister may appoint in writing such and so many persons as the Minister thinks fit to be authorised officers for the purposes of all or any of the provisions of these Regulations.

(2) Every authorised officer shall be furnished with a warrant of his appointment as an authorised officer stating that he is acting under these Regulations.

(3) An authorised officer, on production of the officer's authorisation, if so required by any person effected, may, for the purposes of these Regulations—

(a) subject to paragraph (4) at all reasonable times enter and search any premises where the officer reasonably suspects that any breeding animals or their products or any thing the subject of these Regulations is being used, collected, stored, sold, packaged, transported, imported or exported or any establishment in respect of which an application for an approval under these Regulations has been made to the Minister,

(b) there or at any other place, carry out such examinations, tests, checks and inspections of the premises or place and any equipment, machinery or plant thereat and any animal, product or thing found thereat as the officer reasonably considers necessary or expedient for the purposes of his functions under these Regulations,

(c) take, without payment, such samples of any substance or, if the authorised officer is an official veterinarian, take from any animal a sample, at the premises or place as he may reasonably require for the purposes of such functions and carry out or have carried out on the samples such examination checks and inspections according with any relevant provisions of these Regulations as he considers necessary or expedient for the purposes of such functions,

(d) require any person at the premises or place or the owner or person in charge thereof and any person employed in connection therewith to give him such information and to produce to him such books, documents and other records within the power or procurement of the person as he may reasonably require for the purposes of such functions,

(e) examine and take copies of, or extracts from, any such records (including in the case of information in non-legible form a copy of or extract from such information in permanent legible form),

(f) seize or detain any breeding animals, semen, ova or embryos including any container in which semen, ova or embryos are kept which he reasonably believes have been produced or imported or to be intended for export in contravention of these Regulations,

(g) if accompanied by a member of the Garda Síochána, stop any vehicle which the officer reasonably suspects to contain any breeding animals their semen, ova or embryos the subject of these Regulations.

(4) An authorised officer shall not, other than with the consent of the occupier, enter a premises unless officer has obtained a warrant from the District Court under paragraph (5) authorising such entry.

(5) If a judge of the District Court is satisfied by information on oath by an authorised officer that :re is reasonable cause for suspecting that—

(a) evidence of or relating to the commission or intended commission of an offence under these Regulations is to be found in any premises,

(b) there is or was any product or thing the subject of these Regulations in any premises, or

(c) a document directly or indirectly connected with any product or thing the subject of these Regulations is in the possession or control of a person in any premises,

such judge may issue a search warrant.

(6) A search warrant issued under paragraph (5) shall be expressed and operate to authorise a named authorised officer, accompanied by such authorised officers, members of the Garda Síochána or officers of and Excise as the named officer thinks necessary, at any time or times within one month from the 2nd of issue of the warrant, on production if so requested of the warrant, to enter (if necessary by force) the named in the warrant.

(7) Where a premises is entered under a search warrant issued under paragraph (5) all or any of the set out in paragraph (3) (b) to (g) may be exercised by the authorised officer who so enters.

(8) A person who obstructs or otherwise interferes with an authorised officer in the performance of the officers functions under these Regulations or who, in purported compliance with a requirement under subparagraph (3)(d), gives information to an authorised officer that he or she knows to be false or misleading in a material respect shall be guilty of an offence.

(9) A person who, with intent to deceive—

(a) tampers with any breeding animal, product or thing the subject of these Regulations so that a sample of it taken under these Regulations does not accurately represent the aforementioned breeding animal, product, or thing, or

(b) tampers or interferes with any sample taken under these Regulations, shall be guilty of an offence.

(10) Where an authorised officer finds or comes into possession of any breeding animal, product or thing the subject of these Regulations or any breeding animal, product or thing which the officer reasonably believes to be evidence of the commission of an offence under these Regulations, the officer may seize it and detain it for use in evidence in a prosecution for an offence under these Regulations for such period from the date of the seizure as may be reasonable or, if proceedings are commenced in which the breeding animal, product or thing the subject of these Regulations is required for use in evidence, until the conclusion of the proceedings.

(11) An authorised officer may by notice in writing given to the owner or the person who appears to be in charge or control of any breeding animal, product or thing the subject of these Regulations which has been seized and detained in accordance with these Regulations—

(a) require anything specified in the notice to be done by the person to whom the notice is directed before the breeding animal, product or thing the subject of these Regulations is released by an authorised officer, or

(b) either—

(i) require the disposal of the breeding animal, product or thing the subject of these Regulations by the person to whom the notice is directed, upon its release by the authorized officer, in the manner specified in the notice and at the expense of the owner, or

(ii) indicate the authorised officer's intention to dispose of the breeding animal, product or thing the subject of these Regulations in a specified manner and at the expense of the owner,

the manner of disposal in either case being such as to prevent the breeding animal, product or thing the subject of these Regulations, being exported, imported or used in contravention of these Regulations, and where a notice under this paragraph requires a specified thing to be done, an authorised officer may retain control of the breeding animal, product or thing the subject of these Regulations to which the notice relates until the requirements of the notice have been complied with.

(12) Where a notice is given under paragraph (11) a person shall not, without the consent of the authorised officer by whom the notice was directed, move, dispose of, interfere with or otherwise deal with the breeding animal, product or thing the subject of these Regulations other than in compliance with the requirements of the notice.

(13) Any person who is aggrieved by a notice under this Regulation may, not later than 21 days after the date of the notice, or such further period (if any) as the District Court may allow, appeal against the notice to the District Court.

(14) Notice of an appeal under paragraph (13) shall be given to the Minister by the person bringing the appeal at least 7 days prior to the hearing of the appeal.

(15) (a) Where an appeal is brought under paragraph (13), the District Court shall make such order as it considers just (including an order directing that the breeding animal, product or thing the subject of these Regulations be disposed of, at the expense of the owner, in such manner as it may specify).

( b ) The cost of disposal by an authorised officer under this Regulation or pursuant to an order of the District Court under this Regulation shall be recoverable by the Minister by whom it is incurred as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the breeding animal, product or thing the subject of these Regulations at the time of its seizure and detention under these Regulations.

(16) A notice under this Regulation shall not come into force until—

( a ) in the case where there is an appeal to the District Court against the notice, the appeal and any appeal therefrom has been determined, or

( b ) in any other case, the period during which such an appeal may be brought has expired.

(17) (a) The jurisdiction conferred on the District Court by this Regulation shall be exercised by the judge of that court for the time being assigned to the District Court district in which the breeding animal, product or thing the subject of these Regulations was seized or in which the owner or person then in charge or control thereof ordinarily resides or carries on any profession, business or occupation.

( b ) For the purposes of subparagraph (a) the breeding animal, product or thing the subject of these Regulations shall be deemed to be situated in a district court district as if it is situated on a premises which is situated wholly or partly in such district.

(18) An officer of customs and excise may seize and detain any breeding animal, semen, ova or embryos the subject of these Regulations being exported or imported as respects which he reasonably believes that there is a failure to comply with a provision of these Regulations and may for that purpose open any package containing or suspected by the officer to contain any product or thing the subject of these Regulations.

(19) In this Regulation "thing" includes a substance or a liquid.

Fees

25. (1) There may be charged by the Minister or other competent authority such fees in respect of any or all of the applications for approvals, blood typing, analytical or diagnostic tests and testing or genetic evaluations processed or carried out in connection with these Regulations as the Minister, or other competent "authority, from time to time, may determine.

(2) A fee charged under this Regulation shall be payable by the owner or person in charge of the establishment to which the approval relates and the Minister or other competent authority, as the case may be, may refuse to grant or may revoke an approval until such fee has been paid,

(3) Fees under this Regulation payable to the Minister shall be collected and taken in such manner as the Minister for Finance directs and shall be paid into or disposed of for the benefit of the Exchequer in accordance with the direction of that Minister.

(4) A fee payable under this Regulation may be recovered by the Minister or other competent authority, as the case may be, as a simple contract debt in any court of competent jurisdiction.

(5) In this Regulation "other competent authority" means a competent authority designated by the Minister under Regulation 5.

(6) A fee charged under this Regulation shall not exceed an amount equal to the costs, estimated by the Minister, incurred in respect of any or all of the applications for approvals, blood typing, analytical or diagnostic tests and testing or genetic evaluations processed or carried out in connection with these Regulations.

Proceedings for Offences and Penalties

26. (1) An offence under these Regulations may be prosecuted by the Minister.

(2) A person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding £1,500.

(3) Where a person is convicted of contravening these Regulations and after such conviction continues to contravene the provision concerned, he shall be guilty of a further offence on every day on which the contravention continues and for each such offence he shall be liable on summary conviction to a fine not exceeding £250.

(4) Where an offence is committed under these Regulations by a body corporate and is proved to have been so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first mentioned offence.

Revocation and continuance of approvals and authorised officers

27. (1) The Regulations of 1994 are hereby revoked.

(2) All authorised officers appointed under the Regulations of 1993 and 1994 and holding office immediately before the commencement of these Regulations shall continue in office after such commencement as if appointed under these Regulations.

(3) All approvals granted under the Regulations of 1993 and 1994 and in force immediately before the commencement of these Regulations shall continue in force after such commencement as if granted under these Regulations.

(4) Anything seized or detained by an authorised officer under the Regulations of 1994 and which is in the officer's custody immediately before the commencement of these Regulations shall be deemed to have been seized or detained under these Regulations.

(5) In this Regulation "the Regulations of 1994" means the European Communities (Trade in Bovine Breeding Animals, their Semen, Ova and Embryos) Regulations, 1994 ( S.I. No. 297 of 1994 ).

Regulation 7

SCHEDULE A

CONDITIONS FOR APPROVAL OF BREEDERS ORGANISATIONS AND ASSOCIATIONS

In order to be approved, a breeders' organisation or association shall:

1. have legal personality;

2. prove to the Minister or another competent authority designated under Regulation 5:

( a ) that it operates efficiently;

( b ) that it can carry out the checks necessary for recording pedigrees;

( c ) that it has a sufficiently large herd to carry out a breed improvement programme or that it has a sufficiently large herd to preserve the breed where this is considered necessary;

and

( d ) that it can make use of the livestock performance data necessary for carrying out its breed improvement or preservation programme;

3. have a set of rules covering:

( a ) the definition of the breed's characteristics;,

( b ) the system for identifying animals;

( c ) the system for recording pedigrees;

( d ) the definition of its breeding objectives;

( e ) the systems for making use of livestock performance data;

( f ) the division of the herd-book, if there are different conditions for entering animals or if there are different procedures for classifying the animals entered in the book; and

4 have rules of procedure, adopted in accordance with its articles of association, laying down, in particular, principle of non-discrimination between the members of the breeders' organisation or association concerned.

Regulation 7

SCHEDULE B

CONDITIONS FOR ENTERING CATTLE IN HERD-BOOKS

1. To qualify for entry in the main section of the herd-book of its breed an animal shall:

( a ) be descended from parents and grandparents entered in a herd-book of that same breed,

( b ) be identified at birth according to the rules of that herd book, and

( c ) have a pedigree established in accordance with the rules of that herd-book.

2. The main section of a herd-book may be divided into several classes according to the animals' merits. Only cattle meeting the criteria laid down in paragraph 1 may be entered in one of those classes. Where a herd-book contains several classes in the main section, an animal from another Member State shall be entered in the class of the book whose criteria it meets.

3. A Breeders' organisation or association may decide that a female, which does not meet the criteria laid own in paragraph I may be entered in a supplementary section of that herd-book. In such case the female shall—

( a ) be identified in accordance with the herd-book rules,

( b ) be judged to conform to the breed standard, and

( c ) have a minimum performance criteria as laid down by the herd-book rules.

The requirements mentioned in subparagraphs (b) and (c) may be differentiated according to whether the female belongs to the breed although it has no known origin or was obtained from a crossing programme approved by the breeders' organisation or association managing the herd-book.

4. A bovine female whose mother and maternal grandmother are entered in a supplementary section of the herd-book as provided for in paragraph 3 and whose father and two grandfathers are entered in the main section of the herd book in accordance with the criteria laid down in paragraph 1 above, shall be regarded as a pure-bred female and entered in the main section of the herd book, provided for in paragraph 1.

Regulation 9

SCHEDULE C

CONDITIONS FOR GRANTING APPROVAL TO CARRY OUT TESTING, GENETIC EVALUATION OR PUBLICATION OF EVALUATION RESULTS

PART I

A person carrying out testing, genetic evaluation or publication of evaluation results

( a ) shall have adequate resources, facilities and staff, and where necessary commercial industry support, co-operation and involvement to ensure complete, unbiased and accurate evaluations of animals,

( b ) shall ensure that all animals involved in testing or genetic evaluation are properly identified and that complete and accurate records (being open to inspection at all reasonable times by an authorised officer) are kept as required by the Minister or another competent authority designated under Regulation 5,

( c ) shall give an account of the recording methods, the model of performance description, the statistical method of analysis and the genetic parameters used for each evaluated trait.

( d ) shall enable all aspects of the testing or evaluation to be under the effective supervision of the Minister or another designated competent authority.

PART II

In accordance with Commission Decision 86/130/EEC of 11 March 1986, as amended by Commission Decision 94/515/EC of 27 July 1994 an account of the recording methods, the model of performance description, the statistical method of analysis and the genetic parameters used for each evaluated trait shall be given and shall also comply with the following:

I. PERFORMANCE RECORDING

All data must be recorded under the responsibility of the approved body.

1. Beef production traits

( a ) Individual performance and/or progeny testing at a station

(i) The test method and the number of animals tested are to be indicated

(ii) The following are to be indicated in the test protocol:

— conditions for acceptance into the station,

— if applicable, the on-farm performance of the test animals

— prior to entry into the station,

— identity of the owner of the test animals for individual performance testing,

— maximum age for the test animals entering the station and the age of range of contemporary animals on the station,

— length of adaptation and test periods at the station,

— type of diet and system of feeding.

(iii) Traits recorded: the minimum traits to be recorded include live weight gain and muscular development (beef conformation) and, if available, other traits such as feed conversion and carcass trait.

Specialised units can operate as stations under the responsibility of the approved body.

( b ) Testing in the field (on-farm)

The test method and the method to validate test results must be provided by the approved body. The minimum traits to be recorded include live weight and age and, if available, other traits such as beef conformation.

( c ) Testing through survey data from farms and points of sale and slaughter

If available and appropriate the live and slaughter weights, sales prices, carcass grade according to the Community carcass classification scheme, meat quality and other beef traits must be recorded.

2. Milk Recording

Recording milk production data must comply with the principles agreed by competent international bodies (e.g. International Committee for Animal Recording (ICAR)).

3. Reproduction (secondary traits)

When fertility, calving aptitude and longevity are being evaluated, they must be assessed on the basis of data on fertilization (e.g. non-return rate), calving score and on functional age (e.g. stayability, culling age, length of productive life), respectively.

4. Morphological (type) assessment

When Morphological rating is carried out, it must be done using an approved recording system.

II. GENETIC EVALUATION

1. Principles

The genetic evaluation of breeding animals must be carried out under the responsibility of the approved body and must include the following performance traits according to the selection objectives:

— milk production traits for animals of dairy breeds

— beef production traits for animals of beef breeds

— milk and beef production traits for dual purpose breeds

Furthermore, it is recommended that the genetic evaluation should also include the traits of reproductive performance and of morphology for breeds in which recording of these traits is being practised. The breeding value of an animal is calculated on the basis of the results of the performance of the individual and/or of its relatives.

The statistical methods applied in genetic evaluation must comply with the principles agreed by competent international bodies (e.g. ICAR) and should guarantee a genetic evaluation unbiased from the influences of the main environmental factors and data structure.

The reliability of the genetic evaluation must be measured as the coefficient of determination in accordance with principles agreed by competent international bodies (e.g. ICAR). When publishing the evaluation results, the reliability as well as the date of evaluation must be given.

Genetic peculiarities and genetic defects of an animal defined by the bodies officially appointed for the determination of these characters, in agreement with the breeders organizations or associations, recognized in conformity with Commission Decision 84/247/EEC of 27 April 1984 laying down the criteria for the recognition of breeders organizations and associations which maintain or establish herd-books for pure-bred breeding animals of the bovine species (¹), have to be published.

⁽¹⁾ OJ No. L 125 12.5. 1984. p.58

(2) Genetic evaluation of bulls for artificial insemination

The bulls must be subjected to a genetic evaluation on compulsory traits and breeding values on them must be published. Other available breeding values also must be published.

These provisions do not apply to breeds threatened with extinction.

( a ) Genetic evaluation of artificial insemination bulls for milk production traits

In the genetic evaluation of dairy traits, the milk yield and content (butterfat and protein percentage) as well as other available and relevant data for the genetic aptitude for dairy traits must be included.

The minimum reliability of the genetic evaluation of AI bulls of the dairy breeds must be at least 0.5 for the main production traits according to ICAR principles taking into account all information from relatives.

( b ) Genetic evaluation of artificial insemination bulls for beef production traits

The genetic evaluation of these bulls is carried out on the basis of one of the following performance testing methods:

(i) individual performance testing on station;

(ii) progeny and/or sib test on station or in specialized units

(iii) progeny and/or sib test on farm; in such a way that the offsprings are distributed among the recorded herds to allow a valid comparison of bulls to be made;

(iv) progeny and/or sib test by means of collecting data on farms, in auction sales or in slaughter houses in such a way that a valid comparison of bulls can be made.

If carcass weight and, where appropriate, traits of meat quality, growth performance and calving aptitude are being recorded, these traits as well as any other relevant trait must be included in the genetic evaluation of the bull.

REGULATION 11

SCHEDULE D

CONDITIONS FOR THE APPROVAL OF SEMEN COLLECTION CENTRES

1. Semen collection centres shall:

(a) be placed under the permanent supervision of a centre veterinarian;

(b) have at least—

(i) animal housing including isolation facilities;

(ii) semen collection facilities including a separate room for the cleaning and disinfection or sterilisation of equipment;

(iii) a semen processing room which need not necessarily be on the same site; and

(iv) a semen storage room which need not necessarily be on the same site;

(d) be so constructed that the animal housing and the semen collecting, processing and storage facilities can be readily cleaned and disinfected;

(e) have isolation accommodation which shall have no direct communication with the normal animal accommodation;

(f) be so designed that the animal accommodation is physically separated from the semen processing room and both are separated from the semen storage room.

Regulation 11

SCHEDULE E

CONDITIONS RELATING TO THE SUPERVISION OF SEMEN COLLECTION CENTRES

1. Semen collection centres shall:

(a) be so supervised that they contain only animals of the species whose semen is to be collected. Other domestic animals which are strictly necessary for the normal operation of the collection centre may nonetheless also be admitted, provided that they present no risk of infection to those species whose semen is to be collected and they fulfil the conditions laid down by the centre veterinarian;

(b) be so supervised that a record is kept of all bovine animals at the centre, giving details of the breed, date of birth and identification of each of the animals, and also a record of all checks for diseases and all vaccinations carried out, giving also information from the disease/health file of each animal;

(c) be regularly inspected by an official veterinarian, at least twice a year, at which time standing checks on the conditions of approval and supervision shall be carried out;

(d) be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors shall be required to comply with the conditions laid down by the centre veterinarian;

(e) employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread of disease; and

(f) be so supervised that only semen collected at an approved semen collection centre is processed and stored in approved semen collection centres, without coming into contact with any other consignment of semen. However, semen not collected in an approved collection centre may be processed in approved semen collection centres provided that:

(i) such semen is produced from bovine animals which fulfil the conditions laid down in paragraph 1(d) (i), (ii), (iii) and (v) of Schedule F,

(ii) processing of such semen is carried out with separate equipment or at a different time from semen intended for intra-Community trade, the equipment in the latter case being cleaned and sterilised after such processing,

(iii) such semen may not be the subject of intra-Community trade and cannot at any time come into contact with or be stored with semen intended for intra-Community trade,

(iv) such semen is identifiable by a marking different from that provided for in paragraph 7.

(2) Deep-frozen embryos may also be stored in approved semen collection centres provided that—

(i) such storage is authorised by the Minister,

(ii) the embryos meet the requirements on animal health grounds of Council Directive 89/556/EEC, and

(iii) the embryos are stored in separate storage flasks in the premises for storing approved semen.

(3) Collection, processing and storage of semen shall take place only on the premises set aside for the purpose and under conditions of the strictest hygiene.

(4) All implements which come into contact with semen or the donor animal during collection and processing shall be properly disinfected or sterilised prior to use.

(5) Products of animal origin used in the processing of semen, including additives or a diluent, shall be obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented.

(6) Storage flasks and transport flasks shall be properly disinfected or sterilised before the commencement of each filling operation.

(7) The cryogenic agent used shall not have been previously used for other products of animal origin.

(8) Each individual dose of semen shall be clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal, the name of the semen collection centre and the serological status of the donor animal in respect of infectious bovine rhinotracheitis and infectious pustular vulvo-vaginitis, possibly in code, can be readily established; the characteristics and form of this marking shall be established in accordance with the procedure laid down in Article 19 of Council Directive 88/407/EEC.

Regulation 11

SCHEDULE F

CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO APPROVED

SEMEN COLLECTION CENTRES

1. All bovine animals admitted to a semen collection centre shall:

(a) have been subjected to a period of isolation of at least 30 days in accommodation specifically approved for the purpose by the Minister and where only other cloven-hoofed animals having at least the same health status are present;

(b) prior to their stay in the isolation accommodation described in subparagraph (a), have belonged to a herd which is officially tuberculosis free and officially brucellosis free in accordance with Council Directive 64/432/EEC. The animals may not previously have been kept in one or more herds of a lower status;

(c) have come from a herd free of enzootic bovine leukosis as defined in Council Directive 64/432/EEC, or have been produced by dams which have been subjected with negative results, to an Agar Gel immunodiffusion test carried out in accordance with Annex G of Council Directive 64/432/EEC, after removal of the animals from their dam. In the case of animals derived by embryo transfer, "dam" means the recipient of the embryo. If this requirement cannot be fulfilled, the semen may not be the subject of trade until the donor has reached the age of two years and has been tested in accordance with schedule G 1 (c) with a negative result;

(d) before the period of isolation specified in (a), and within the previous 30 days, have been subjected to the following tests with negative results:

(i) an intradermal tuberculin test carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC;

(ii) a serum agglutination test carried out in accordance with the procedure described in Annex C to Council Directive 64/432/EEC and showing a brucella count lower than 30 IU of agglutination per mililitre, or a complement fixation test showing a brucella count lower than 20 EEC units per mililitre (20 ICFT units);

(iii) a serological test for enzootic bovine leukosis carried out in accordance with the procedure laid down in Annex G to Directive 64/432/EEC;

(iv) a serum neutralization test or an Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis;

(v) a virus isolation test (fluorescent antibody test or immunoperoxidase test) for bovine viral diarrhoea which in the case of an animal less than 6 months of age must be deferred until the animal has reached that age.

However the Minister may give authorization for the tests referred to in sub paragraph (d) to be carried out in the isolation accommodation, provided that the results are known before the commencement of the 30-day isolation period laid down in sub paragraph (a);

(e) during the period of isolation of at least 30 days specified in sub paragraph (a), have been subjected to the following tests with negative results:

(i) a serum agglutination test complying with the procedure described in Annex C to Council Directive 64/432/EEC and showing a brucella count lower than 30 IU of agglutination per mililitre or a complement fixation test showing a brucella count lower than 20 EEC units per mililitre (20 ICFT units)

(ii) either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings; in the case of female animals a vaginal mucus agglutination test shall be carried out;

(iii) a microscopic examination and culture test for trichomonas foetus on a sample of vaginal washings or preputial washings; in the case of female animals a vaginal mucus agglutination test shall be carried out;

(iv) a serum neutralization test or an Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis.

If any of the above tests should prove positive, the animal shall be removed forthwith from the isolation accommodation. In the case of group isolation, it will be necessary to re-establish the eligibility of the remaining animals for entry into the collection centre in accordance with this Schedule.

2. All tests must be carried out in an approved laboratory.

3. Animals may only be admitted to the semen collection centre with the express permission of the centre veterinarian. All movements, both in and out, must be recorded.

4. No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission. All animals shall, without prejudice to paragraph 5, have come from isolation accommodation as referred to in paragraph 1(a) which, on the day of consignment, officially fulfils the following conditions:

(a) is situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days;

(b) has for at least three months been free from foot-and-mouth disease and brucellosis;

(c) has for at least 30 days been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E to Directive 64/432/EEC.

5. Provided that the conditions laid down in paragraph 4 are satisfied and the routine tests referred to in Schedule G have been carried out during the previous 12 months, animals may be transferred from one approved semen collection centre to another of equal health status without isolation or testing if transfer is direct. The animal in question shall not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the means of transport used shall have been disinfected before use. If the movement from one semen collection centre to another takes place between Member States it must take place in accordance with Directive 64/432/EEC.

Regulation 11

SCHEDULE G

ROUTINE TESTS AND TREATMENT WHICH MUST BE APPLIED TO ALL BOVINE ANIMALS IN AN APPROVED SEMEN COLLECTION CENTRE

1. All bovine animals kept at an approved semen collection centre shall be subjected at least once a year to the following tests and treatment:

(a) an intradermal tuberculin test for tuberculosis, carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC, with a negative result;

(b) a serum agglutination test for brucellosis, carried out in accordance with the procedure laid down in Annex C to Council Directive 64/432/EEC, giving a count lower than 30 IU of agglutination per mililitre, or a complement fixation test showing a brucella count lower than 20 EEC units per mililitre (20 ICFT units)

(c) a screening test for enzootic bovine leucosis, carried out in accordance with the procedure described in Annex G to Council Directive 64/432/EEC, with a negative result;

(d) for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis, a serum neutralization test or an Elisa test with a negative result. However,

— it is not necessary to carry out these tests on bulls which have already been subjected to such tests and have given a positive result to the serological test carried out in accordance with Directive 88/407/EEC as amended,

— vaccination against these diseases may be practised on sero-negative bulls, either with one dose of a temperature-sensitive live vaccine administered intranasally or two doses of an inactivated vaccine separated by an interval of not less than three weeks and not more than 4 weeks; the vaccination must be repeated subsequently at intervals of not more than 6 months.

(e) either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings; in the case of female animals a vaginal mucus agglutination test shall be earned out.

However, bulls which are not used for the production of semen may be exempt from the antibody test or a culture test for campylobacter foetus infection, with the proviso that such bulls may not be re-admitted to semen production until they have been subjected to such a test or culture and given a negative result.

2. All tests must be carried out in an approved laboratory.

3. If any of the above tests should prove positive, the animal shall be isolated and the semen collected from it since the last negative test may not be the subject of intra-Community trade.

Semen collected from all other animals at the centre since the date when the positive test was carried out shall be held in separate storage and may not be the subject of intra-Community trade until the health status of the centre has been re-established.

These provisions shall not apply to sero-positive bulls which, prior to their first vaccination in accordance with Council Directive 88/407/EEC (as amended), at the insemination centre, gave a negative reaction to the serum neutralization test or the ELISA test for infectious bovine rhinotracheitis or infectious pustular vulvo-vaginitis;

Sero-positive bulls referred to in the second subparagraph of Article 4(1) of Council Directive 88/407/EEC must be isolated, since their semen may be the subject of intra-Community trade in accordance with the provisions for trade in semen from such bulls.

Regulation 12

SCHEDULE H

CONDITIONS FOR THE APPROVAL OF AN OVA/EMBRYO COLLECTION AND OVA/EMBRYO PRODUCTION TEAMS

In order to be granted approval each embryo collection team shall fulfil the following conditions:

(a) The collection, processing and storage of embryos shall be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene.

(b) The embryo collection team shall be placed under the general supervision and authority of an official veterinarian.

(c) The embryo collection team shall have at its disposal permanent or mobile laboratory facilities where embryos can be examined, processed and packed, consisting of at least a work surface, a microscope and cryogenic equipment.

(d) In the case of a permanently sited laboratory, the embryo collection team shall have at its disposal—–

(i) a room where embryos can be manipulated which is adjacent to but physically separate from the area used to handle the donor animals during collection, and

(ii) a room or area equipped for cleansing and sterilizing instruments and equipment used in embryo collection and manipulation.

(iii) Where micromanipulation of the embryo which involves penetration of the zona pellucida is to be carried out, this shall be done in suitable laminar-flow facilities which shall be properly cleaned and disinfected between batches.

(e) The embryo collection team shall have at its disposal in the case of a mobile laboratory a specially equipped part of the vehicle consisting of two separate sections–

(i) one for the examination and manipulation of embryos which shall be a clean section, and

(ii) the other for accommodating equipment and materials used in contact with the donor animals.

A mobile laboratory shall always have contact with a permanently sited laboratory to ensure the sterilization of its equipment and the provision of fluids and other products necessary for the collection and manipulation of embryos.

(f) To be approved as a team for the production and processing of embryos derived by in vitro fertilization and/or in-vitro culture, an embryo production team must fulfil the following additional requirements:

(i) the personal shall be trained in appropriate disease control and laboratory techniques, particularly in procedures for working in sterile conditions;

(ii) it shall have at its disposal a permanently-sited processing laboratory which must:

— have adequate equipment and facilities, including a separate room for recovering oocytes from ovaries and separate rooms or areas for processing oocytes and embryos, and storing embryos and

— have laminar-flow facilities under which all oocytes, semen and embryos must be processed; however, the centrifugation of semen may be carried out outside the laminar-flow facility, as long as full hygienic precautions are taken;

(iii) where oocytes and other tissues are to be collected in an abattoir, it must have at its disposal suitable equipment for the collection and transport of the ovaries and other tissues to the processing laboratory in a hygienic and safe manner.

(g) It is the responsibility of the team veterinarian to ensure the welfare of the breeding female animals concerned. In particular embryos shall only be collected from breeding females to which suitable epidural anaesthesia have been administered which will have effect during the entire process of embryo collection.

Regulation 12

SCHEDULE I

CONDITIONS RELATING TO THE COLLECTION OR PRODUCTION, PROCESSING, STORAGE AND TRANSPORT OF OVA/EMBRYOS BY AN APPROVED EMBRYO

COLLECTION OR PRODUCTION TEAM

1. Collection and processing

(a) Embryos shall be collected and processed by an approved collection team without coming into contact with any other consignment of embryos not meeting the requirements of these Regulations.

(b) Embryos shall be collected in a place which is isolated from other parts of the premises or holding and which shall be in good repair and easy to cleanse and disinfect.

(c) Embryos shall be processed (examined, washed, treated and placed in identified and sterile containers) in either a permanent laboratory facility or a mobile laboratory facility, which is not situated in a zone subject to prohibition or quarantine measures.

(d) All implements which come into contact with the embryos or the donor animal during collection and processing shall be disposable or shall be properly disinfected or sterilised prior to use.

(e) Products of animal origin used during collection of the embryos and in the transport medium shall be obtained from sources which present no animal health risk or are to be so treated prior to use so that such risk is prevented. All media and solutions shall be sterilised by approved methods according to the recommendations of the manual of the International Embryo Transfer Society (IETS). Antibiotics may be added to the media in accordance with the IETS manual.

(f) Storage flasks and transport flasks shall be properly disinfected or sterilized before the commencement of each filling operation.

(g) The cryogenic agent used shall not have been previously used for other products of animal origin.

(h) Each embryo container and the containers in which they are stored and transported shall be clearly code-marked in such a way that the date of collection of the embryos and the breed and identification of the donor sire and donor dam, as well as the registration number of the team can be readily established. The characteristics and form of this marking shall be in accordance with that specified by the Minister.

(i) Each embryo shall be washed at least 10 times in a special fluid for embryos which shall be changed each time and which, unless decided otherwise, shall contain trypsin, in accordance with internationally recognized procedures. Each wash shall be a 100 -fold dilution of the previous wash and a sterile micropipette shall be used to transfer the embryo on each occasion.

(j) After the last wash each embryo shall be subjected to microscopic examination at a magnification of at least x 50 over its entire surface to determine that the 'zona pellucida' is intact and is free from any adherent material. Any micro-manipulation which involves penetration of the zona pellucida shall be carried out in the facilities approved for the purpose, and after the last wash and examination. Such micromanipulation may only be carried out on an embryo having an intact zona pellucida.

(k) Each consignment of embryos that has successfully undergone the examination provided for in subparagraph (j) shall be placed in a sterile container marked in accordance with sub paragraph (h) and which shall be sealed immediately.

(l) Each embryo shall, where appropriate, be frozen as soon as possible and stored in a place which is under the control of the team veterinarian and which is subject to regular inspection by an official veterinarian.

(m) All products in the processing, washing, transportation media must be obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented.

(n) Each collection team shall submit to an approved laboratory specified by the Minister routine samples of flushing fluids, washing fluids, disintegrated embryos, non-fertilized ova etc, resulting from its activities for official examination for bacterial and viral contamination. The procedure for collecting of samples, conducting such examinations, together with the standards to be achieved shall be in accordance with that specified by the Minister. If the standards laid down are now achieved the Minister shall withdraw approval.

(o) Each collection team shall keep a record of its activities in respect of embryo collection during the 12 months before and 12 months after storage including:

(i) the breed, age and identification of the donor animals concerned,

(ii) the place of collection, processing and storage of embryos collected by the team,

(iii) the identification of the embryos together with details of their destination if known, and

(iv) details of micromanipulation techniques which involve penetration of the zona pellucida or other techniques such as in vitro fertilization and/or in vitro culture which have been performed on the embryos. In the case of embryos derived by an in-vitro fertilization, the identification may be done on the basis of a batch, but must contain details of the date and place of collection of ovaries and/or oocytes. It must also be possible to identify the herd of origin of the donor animals.

(p) The conditions laid down in paragraphs (a) to (o) shall apply as appropriate to the collection, processing, storage and transport of ovaries, oocytes and other tissues for use in in vitro fertilization and/or in vitro culture. Furthermore, the following additional conditions shall apply:

(i) when ovaries and other tissues are to be collected at an abattoir, the abattoir should be officially approved and under the control of an official veterinarian whose responsibility it is to carry out ante and post mortem inspection of donors;

(ii) materials and equipment coming into direct contact with ovaries and other tissues shall be sterilized before use and after sterilization, used exclusively for those purposes. Separate equipment shall be used to handle oocytes and embryos from different batches of donor animals;

(iii) ovaries and other tissues shall not be allowed to enter the processing laboratory until completion of the post mortem inspection of the batch. If relevant disease is found in the batch of donors, or in any animals slaughtered in that abattoir on that day, all tissues from that batch must be traced and discarded;

(iv) the washing and examination procedure laid down in subparagraphs (i) and (j) shall be carried out after the culture procedure has been completed;

(v) any micromanipulation which involves penetration of the zona pellucida shall be carried out in accordance with the provisions of subparagraph (i), after the procedures laid down in subparagraph (s) have been completed;

(vi) only embryos from the same batch of donors should be stored in the same ampoule/straw.

2. Storage

Each embryo collection or production team shall ensure that the embryos are stored at suitable temperatures in premises approved for the purpose by the Minister.

In order to be approved these premises shall:

(i) comprise at least one lockable room intended exclusively for embryo storage;

(ii) be easy to cleanse and disinfect;

(iii) have permanent records of all incoming and outgoing movements of embryos and the final destination of the embryos in particular shall be specified in such records;

(iv) be subject to inspection by the official veterinarian.

The competent authority may authorise the storage of semen that fulfils the requirements of Directive 88/407/EEC in the approved storage premises.

3. Transport

Embryos for trade shall be transported in hygienic conditions in sealed containers from the approved storage premises until their arrival at their destination.

The containers shall be marked in such a way that the number coincides with the number on the animal health certificate.

Regulation 12

SCHEDULE J

CONDITIONS APPLYING TO DONOR ANIMALS

1. For the purposes of embryo collection, donor animals shall meet the following requirements:

(a) they shall have spent at least the previous 6 months within the territory of the European Union or in the third country of collection;

(b) they shall have been present in the herd of origin for at least 30 days prior to collection;

— officially tuberculosis free

— officially brucellosis free or brucellosis free

— enzootic bovine leucosis free

in derogation from the third indent, they may come from a herd which is not leucosis free but for which certification has been obtained that there has not been any clinical case of enzootic bovine leucosis during the past 3 years;

(d) during the previous year, they shall not have been present in a herd which has shown any clinical sign of infectious bovine rhinotracheitis/infectious pustular vulvovaginitis.

2. On the day of embryo collection the donor cow:

(a) shall be kept in a holding which is not subject to veterinary prohibition or quarantine measures;

(b) shall show no clinical signs of disease.

3. Furthermore, the above conditions shall apply to live animals intended as donors of oocytes by ovum pickup or ovariectomy.

4. In the case of donors of ovaries and other tissues to be collected after slaughter in an abattoir, they should not have been designated for slaughter as part of a national disease eradication programme, nor should they have come from a holding subject to restrictions because of animal disease.

5. The abattoir where the ovaries and other tissues are collected shall not be situated in a zone subject to prohibition or quarantine measures.

Regulation 20

SCHEDULE K

ZOOTECHNICAL CERTIFICATE

For trade in pure-bred breeding animals of the bovine species

1. Model Certificate:—–

Issuing body:	............................................................ .........................................................
Name of herd book:			............................................................ .................................................
Entry No in herd book:				............................................................ .............................................
System of identification (tag, tattoo, brand, earmark, sketch card):									..........................................
Identification:	............................................................ .........................................................
Name of animal:		............................................................ .....................................................
Date of birth:.......................................								Breed:.................................			Sex:...................
Name and address of breeder:						............................................................ ...............................
Name and address of owner:					............................................................ ...................................
					............................................................ ...................................
Father							Grandfather			Grandmother
Herd Book No....................							Herd Book No ......................			Herd Book No................
Pedigree:
Mother							Grandfather			Grandmother
Herd Book No....................							Herd Book No......................			Herd Book No................

The results of performance tests and results with origin of the assessment of the genetic value, on the animal itself and its parents and grandparents.

Known hereditary defects in the donor animal or its ancestors shall be indicated. (State none if applicable).

___________________________________

Done at .......................	on ............................................................
				............................................................ .
(Signature)
		NAME IN CAPITAL LETTERS AND TITLE OF SIGNATORY
			............................................................ ........

SCHEDULE K (contd)

2. Alternative Certification

An alternative may be provided in documentation accompanying the pure-bred breeding animal. In this event the competent authorities of the exporting country shall certify that the particulars required under paragraph 1 above are indicated in those documents, by the following formula:

"The undersigned certifies that these documents contain the particulars mentioned in Article 1 of Commission Decision 86/404/EEC."

Regulation 20

SCHEDULE L

ZOOTECHNICAL CERTIFICATE

For trade in the semen of pure bred breeding animals

1. Model Certificate

Issuing body:

............................................................ ........................................................

Name of herd book:

............................................................ ................................................

Entry no in herd book:

............................................................ ............................................

System of identification (tag, tattoo, brand, earmark, sketch card):

.........................................

............................................................ ........................................................

Name of animal

............................................................ ....................................................

Date of birth: .............................................

Breed: .................................

Sex: ...............

Name and address of breeder:

............................................................ ...............................

Name and address of owner:

............................................................ ...................................

Father

Grandfather

Grandmother

Herd Book No ..................

Herd Book No ........................

Herd Book No..............

Pedigree:

Mother

Grandfather

Grandmother

Herd Book No ...................

Herd Book No ........................

Herd Book No..............

Blood group .................................

The updated results of performance tests and updated results with origin of the assessment of the genetic value, on the animal itself and its parents and grandparents.

Known hereditary defects in the donor animal or its ancestors shall be indicated. (State none if applicable).

____________________________________

Done at: ..............................	on ............................................................
				............................................................
(Signature)
		NAME IN CAPITAL LETTERS AND TITLE OF SIGNATORY
			............................................................ .......

2. DOCUMENT RELATING TO SEMEN

Semen identification system (colour, number):		............................................................ ...
Identification:	............................................................ ..............................................

Number of doses	Date(s) of collection	Identification donor animal (Name/Herd Book No.)	Breed

Origin of semen:

Address of semen collection centre(s):			............................................................ ..................
............................................................ ............................................................ ......................
Destination of semen:
Name and address of consignee:		............................................................ .........................
............................................................ ............................................................ ......................
Done at: ............................	on ............................................................
						............................................................ ...
(Signature)
				NAME IN CAPITAL LETTERS AND TITLE OF SIGNATORY
					............................................................ ........

SCHEDULE L (contd)

3. Alternative Certificate

An alternative certificate may be provided in documentation accompanying the semen. In this event the competent authorities of the exporting country shall certify that the particulars required under Paragraph 1 are indicated in those documents, by the following formula:

"The undersigned certifies that these documents contain the particulars mentioned in Article 1 of Commission Decision 88/124/EEC".

Regulation 20

SCHEDULE M

ZOOTECHNICAL CERTIFICATE

For trade in embryos of pure bred breeding animals

1. Model Certificate

A. Particulars on donor bull:

Issuing body:

............................................................ ........................................................

Name of herd book:

............................................................ ................................................

Entry No. in herd book:

............................................................ ...........................................

System of identification (tag, tattoo, brand, earmark, sketch card):

.........................................

Name of animal:

............................................................ ....................................................

Date of birth: .........................................

Breed: .................................

........................

Name and address of breeder:

............................................................ ...............................

Name and address of owner:

............................................................ ...................................

Father

Grandfather

Grandmother

Herd Book No ...................

Herd Book No ......................

Herd Book No ..............

Pedigree:

Mother

Grandfather

Grandmother

Herd Book No ...................

Herd Book No .....................

Herd Book No .............

Blood group .....................................................

The updated results of performance tests and updated results with origin of the assessment of the genetic value, on the donor bull itself and its parents and grandparents.

Known hereditary defects in the donor animal or its ancestors should be indicated. (State none if applicable).
...........................................

SCHEDULE M (contd)

B. Particulars on donor cow:

Issuing body:

............................................................ .......................................................

Name of herd book:

............................................................ ...............................................

Entry no in herd book:

............................................................ ...........................................

System of identification (tag, tattoo, brand, earmark, sketch card):

.........................................

Identification:

............................................................ ........................................................

Name of animal:

............................................................ .....................................................

Date of birth: ........................................

Breed: .................................

Sex: ...................

Name and address of breeder:

............................................................ ................................

Name and address of owner:

............................................................ ...................................

Father

Grandfather

Grandmother

Herd Book No .................

Herd Book No ......................

Herd Book No ...............

Pedigree:

Mother

Grandfather

Grandmother

Herd Book No ...................

Herd Book No ......................

Herd Book No ...............

Blood group .....................................................

The updated results of performance tests and updated results with origin of the assessment of genetic value, on the donor cow itself and its parents and grandparents.

Known hereditary defects in the donor animal or its ancestors should be indicated. (State none if
applicable)

Done at ...............................	on ............................................................
				............................................................ ..
(Signature)
		NAME IN CAPITAL LETTERS AND TITLE OF SIGNATORY
			............................................................ .

SCHEDULE M (contd)

2. DOCUMENT ON EMBRYO(S)

Embryo identification system (number, colour):			............................................................ .......
Identification:	............................................................ ........................................................
Number of embryos per straw:		............................................................ .............................

Number of Embryos	Date(s) of insemination	Date of Collection	Identification of donor cow and donor bull (Herd Book No.)	Breed

Origin of the embryo(s):
Address of embryo collection centre(s):			............................................................ ....................
............................................................ ............................................................ ........................
Destination of embryo(s):
Name and address of consignee:		............................................................ .............................
............................................................ ............................................................ ............................................................ ...........
Done at ................................	on ............................................................
					............................................................ ...
(Signature)
			NAME IN CAPITAL LETTERS AND TITLE OF SIGNATORY
				............................................................ .....

SCHEDULE M (contd)

3. Alternative Certification

An alternative certificate may be provided in documentation accompanying the embryos. In this event the competent authorities of the exporting country shall certify that the particulars required under paragraph 1 are indicated in those documents, by the following formula:

"The undersigned certifies that these documents contain the particulars mentioned in Article 2 of Commission Decision 88/124/EEC".

Regulation 20

SCHEDULE N

CONDITIONS WHICH SEMEN COLLECTED AT APPROVED CENTRES MUST SATISFY FOR THE PURPOSES OF TRADE

1. Semen must be obtained from animals which:

(a) show no clinical signs of disease on the day the semen is collected;

(b) in the case of semen to be imported —

(i) have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection or

(ii) have been vaccinated against foot-and-mouth disease during the 12 months prior to collection, in which case 5% (with a minimum of five straws) of each collection shall be submitted to virus isolation test for foot-and-mouth disease with negative results;

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

(e) are not allowed to serve naturally;

(f) are kept in semen collection centres which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection, or, in the case of fresh semen, until the date of dispatch and are situated in the centre of an area of 10 kilometres radius in which for at least 30 days there has been no case of foot-and-mouth disease

(g) have been kept in semen collection centres which, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, have been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E to Council Directive 64/432/EEC.

2. Antibiotics as listed below shall be added to produce these concentrations in the final diluted semen:

not less than:	500 IU per ml streptomycin,
	500 IU per ml penicillin,
	150 Ug per ml lincomycin,
	300 Ug per ml spectinomycin.

An alternative combination of antibiotics with an equivalent effect against campylobacters, leptospires and mycoplasmas may be used.

Immediately after their addition the diluted semen shall be kept at a temperature of at least 5°C for a period of not less than 45 minutes.

3. Semen shall:

(i) be stored in approved conditions for a minimum period of 30 days prior to dispatch. This requirement shall not apply to fresh semen.

(ii) be transported in flasks which have been cleaned and disinfected or sterilised before use and which have been sealed prior to dispatch from the approved storage facilities.

Regulation 20

SCHEDULE O

ANIMAL HEALTH CERTIFICATION FOR TRADE IN SEMEN

				No: ......................	Original
Country of collection:		............................................................ .......................................
Competent authority:	............................................................ ............................................
Competent local authority:			............................................................ ..................................

I. Identification of semen:
............................................................ ...

Number of Straws	Date(s) of collection	Identification of donor animal Name/Herd Book No.	Breed	Date of Birth

II. Origin of semen:

Address of semen collection centre(s):	............................................................ ..........
............................................................ ............................................................ .............
Approval number of semen collection centre(s):		...........................................................
............................................................ ............................................................ ...............

III. Destination of semen:

The semen will be sent from:	............................................................ .................
		(place of loading)
		to: ............................................................ ...
		(country and place of destination)
		by: ............................................................ ...
		(means of transport)

Name and address of consignor:	............................................................ ......
............................................................ ............................................................ ....
Name and address of consignee:	............................................................ .....

IV. I, the undersigned official veterinarian, certify that:

1. The semen described above was collected, processed and stored under conditions which comply with the standards laid down in Directive 88/407/EEC.

2 The semen described above was sent to the place of loading in a sealed container under conditions which comply with Directive 88/407/EEC.

3. The semen described above was collected in a centre where all bulls gave a negative result to a serum neutralization test or an ELISA test for infectious bovine rhinotracheitis or infectious pustular vulvo-vaginitis carried out in accordance Directive 88/407/EEC(¹);

⁽¹⁾ Delete as necessary

4. The semen described above was collected from bulls:

(i) which gave negative result to a serum neutralization test or an ELISA test for infectious rhinotracheitis or infectious pustular vulvo-vaginitis carried out in accordance with Directive 88/407/EEC(¹); or

(ii) which gave a positive result to the tests referred to at (i) but which had already given a negative reaction to these tests prior to a first vaccination in accordance with the Directive 88/407/EEC at the semen collection centre (¹); or

(iii) which gave a positive result to a serum neutralization test or an ELISA test for infectious bovine rhinotracheitis or infectious pustular vulvo-vaginitis and have not been vaccinated in accordance with Directive 88/407/EEC(¹): and in which case the semen comes from a collection which has been subjected, with a negative result, to an examination by inoculation or a virus isolation test(¹) as referred to in the third subparagraph or Article 4 (1) of Directive 88/407/EEC in...... laboratory (²);

⁽²⁾ Name of approved laboratory

5. The semen described above was collected from bulls:

(i) which have not been vaccinated against foot-and-mouth disease within 12 months prior to collection (¹); or

(ii) which have been vaccinated against foot-and-mouth disease within 12 months prior to collection, in which case the semen comes from a collection in which 5% of each collection intended for trade (with a minimum of 5 straws) has been subjected, with negative results, to a virus isolation test for foot-and-mouth disease in.... laboratory (²).

6. The semen was stored in approved conditions for a minimum period of 30 days prior to dispatch (³).

Done at .................................	on .......................
		...........................................
		(Signature)
		.............................................
		(Name in block letters)

(3) May be deleted for fresh semen.

Regulation 20

SCHEDULE P

Animal Health Certification for trade in embryos

1. Consignor (Name and full address)	ANIMAL HEALTH CERTIFICATE
	No		ORIGINAL
	2. Member State of collection
3. Consignee (name and full address)	4. COMPETENT AUTHORITY
NOTES (a) A separate certificate shall be issued for each consignment of embryos (b) The original of this certificate shall accompany the consignment to the place of destination	5. COMPETENT LOCAL AUTHORITY
6. Place of loading	7. Name and address of embryo collection team
8. Means of transport
9. Place and Member State of destination
	10. Registration number of embryo collection team
11. Number and code-mark of embryo containers
12. Identification of consignment
(a) Number of embryos	(b) Date(s) of Collection	(c) Breed

(¹) (d) Embryos derived by natural/in vitro(²) fertilization and subjected to/not (²) subjected to penetration of the zona pellucida.

(¹) This need not be completed for embryos collected, processed and stored before 1 March, 1994.

(²) Delete as appropriate.

13. I, the undersigned official veterinarian, certify that:

(a) the embryos described above were collected, processed and stored under conditions which comply with the standards laid down in Directive No 89/556/EEC.

(b) the embryos described above were sent to the place of loading in sealed containers under conditions which comply with the provision of Directive No 89/556/EEC.

Done at .................................	...................................
		Signature ......................................
		Name and qualification (in block letters):
		.......................................................

Regulation 13

SCHEDULE Q

Approval for Breeding

Part I

Breeding Animals:

Breeding animals which comply with the following conditions are approved for breeding:

(1) female breeding animals,

(2) purebred male breeding animals entered in the main section of an approved herd book for natural service,

(3) other male breeding animals for natural service which comply with the Control of Bulls for Breeding Act, 1985 and any Regulations made thereunder.

Part II

Semen of Breeding Animals for use in artificial insemination/fertilisation:

(1) Applications for approval for breeding of semen of breeding animals shall be accompanied by:—

(a) a zootechnical certificate in accordance with Schedule L in the case of semen of pure bred breeding animals,

(b) in the case of semen from other breeding animals the ancestry and zootechnical information similar to that referred to in Schedule L shall be provided; the origin of this information shall be stated and be acceptable to the Minister,

(c) a declaration that the donor animal is or will be blood typed and that a blood typing certificate will be available from an approved laboratory on request, and

(d) a declaration of known genetic defects in the animal itself or its ancestry, and also

(e) in the case of semen for testing and genetic evaluation purposes, the name of the holder of an approval in accordance with Regulation 9.

(2) Semen of breeding animals shall comply with the following conditions :—

(a) Semen for unrestricted use:

The genetic merit of the semen for required traits as specified by the Minister must have been established in accordance with Part II of Schedule C.

(b) Semen for the testing and genetic evaluation of untested bulls:

Semen from untested breeding animals may only be used for the purpose of testing and genetic evaluation of such breeding animals. The number of inseminations and if necessary the time period for the use of such semen may be specified by the Minister.

( c ) Semen for special breeding purposes

Notwithstanding paragraph (2) (b) semen from untested breeding animals may be approved for special breeding purposes for use in individual herds at the discretion of the Minister.

In such cases the Minister may attach conditions as he thinks fit to such approvals.

Part III

(1) Ova and embryos of breeding animals which comply with the following are approved for breeding—

(a) Ova and embryos of pure bred breeding animals

(b) Embryos of other breeding animals the result of fertilization by semen approved for unrestricted use under Part II (2)(a).

Regulation 22

SCHEDULE R

Exemption from accompanying Zootechnical and Veterinary Certification-required under Regulation 20(2)

Name and Address of approved
semen collection centre

Name and Address of Consignee

Details of semen:

Name of Bull	HB Number	Breed	A.I. Code	No. Straws
1.
2.
3.
4.
5.

— the following declaration signed by a designated employee of the centre

"The semen referred to above was stored at the above named centre and has been released for supply to the above named consignee"

	Signed:
	on behalf of approved centre

The above schedule shall accompany delivery of semen to the consignee and shall be retained by the consignee for a period of 2 years.

Given under my Official Seal,

this 23rd day of April, 1996

IVAN YATES

Minister for Agriculture, Food and Forestry

EXPLANATORY NOTE

These Regulations (a) implement into National law insofar as bovine breeding animals are concerned the provisions of Council Directives 94/28/EC which lays down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species, (b) make the possession of illegally imported semen, ova or embryos of the bovine species an offence, (c) reduces to one working day the advance notification required in respect of imports of bovine semen, ova or embryos and (d) integrate these provisions with the provisions of S.I. No. 297 of 1994 , the European Communities (Trade in Bovine Breeding Animals, their Semen, Ova and Embryos) Regulations. S.I. No. 297 of 1994 is thereby revoked by these Regulations.

Copies of the relevant Council Directives and Commission Decisions may be obtained from the Government Publications Sale Office, Molesworth Street, Dublin 2.