(3)Ova and embryos of the ovine, caprine, equine and porcine species must: (a) have been removed from donor females meeting the conditions laid down in Schedule D (CHAPTER I) by a collection team or have been produced by a production team approved by the competent authority of the Member State and satisfying the conditions to be established in Schedule D (CHAPTER I) in accordance

(2)in the case of sheep, goats and equids and with the provisions of the Animal Health Conditions (Intra-Community Trade and Imports from Third Countries of DeepFrozen Semen of Domestic Animals of the Porcine Species) Rules S.L. 437.102 14 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS for swine. Any additional guarantees may be determined in accordance with the procedures referred to in Article 26 of Directive 92/65/EEC.

(4)The approved centres referred to in sub-rule

(2)(a) and the approved teams referred to in sub-rule

(3)(a) shall be registered by the competent authority of the Member State concerned, each centre and team being given a veterinary registration number. The competent authority shall draw up and keep up to date a list of the approved centres and teams and their veterinary registration numbers within the territory of Malta and shall make this list available to the other Member States and to the public. Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedures referred to in Article 26 of Directive 92/65/EEC.

(5)The animal health requirements and the specimen health certificates applicable to semen, ova and embryos of species not mentioned in sub-rules

(2)and

(3)shall be established in accordance

(1)The rules on checks established by the Veterinary and Zootechnical Checks applicable in Trade with Member States in certain Live Animals and Products Regulations shall apply, in particular as regards the organization of, and follow-up to, the checks to be carried out, to the animals, semen, ova and embryos covered by these rules which are accompanied by a health certificate. Other animals must come from holdings subject to the principles of the Veterinary and Zootechnical Checks applicable in Trade with Member States in certain Live Animals and Products Regulations as regards checks on origin and destination.

(2)Regulation 10 of the Veterinary and Zootechnical Checks applicable in Trade with Member States in certain Live Animals and Products Regulations shall apply to animals, semen, ova and embryos covered by these rules.

(3)For the purpose of trade, regulation 13 of the Veterinary and Zootechnical Checks applicable in Trade with Member States in certain Live Animals and Products Regulations shall extend to dealers who keep, on a permanent or occasional basis, animals referred to in rules 7, 9 and 10.

(4)The communication of the place of destination as provided for in regulation 4

(2)of the Veterinary and Zootechnical Checks applicable in Trade with Member States in certain Live Animals and Products Regulations shall, in respect of animals, semen, ova or embryos accompanied by a health certificate in accordance with these rules, take place using the TRACES system.

(5)Without prejudice to the specific provisions of these rules, the competent authority shall, where it is suspected that these rules have not been complied with or there is doubt as to the health of the animals or the quality of the semen, ova and embryos referred to in these rules, carry out any checks it deems appropriate. ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 13.

(1)Trade in animals of species susceptible to the diseases listed in Schedule A or to the diseases listed in Schedule B, and trade in semen, ova or embryos of such animals consigned to and from bodies, institutes or centres approved in accordance with Schedule C shall be subject t o the production of a transport document corresponding to the specimen in Schedule E. This document, which must be completed by the veterinarian responsible for the body, institute or centre of origin, must specify that the animals, semen, ova or embryos come from a body, institute or centre approved in accordance with Schedule C and must accompany them during transport.

(2)Animals of species susceptible to diseases. (

1. a)To be approved, bodies, institutes or centres shall, as regards notifiable diseases, submit to the competent authority of the Member State where they are established all relevant supporting documents relating to the requirements contained in Schedule C. (
2. b)After receiving the file relating to the request for approval or for renewal of approval, the competent authority shall examine it in the light of the information it contains and, where appropriate, of the results of the tests conducted on the spot. (
3. c)The competent authority shall withdraw an approval in accordance with point 3 of Schedule C. (
4. d)All approved bodies, institutes and centres shall be registered and issued with an approval number established by the competent authority.

(3)The competent authority shall draw up and keep up to date a list of approved bodies, institutes and centres and their approval numbers and shall make it available to the other Member States and to the public. 14.

(1)The competent authority may establish either directly or through the breeders, a voluntary or compulsory control or monitoring programme for one of the diseases referred to in Schedule B. It may present the programme to the Commission outlining in particular: (

1. a)the distribution of the disease in its territory, (
2. b)whether the disease is notifiable, (
3. c)the reasons for undertaking the programme, taking account of its cost-effectiveness and the significance of the disease, (
4. d)the geographical area in which the programme is to be implemented, (
5. e)the status categories to be applied to establishments, the requirements for each species when being introduced into a holding and the test procedures to be used, (
6. f)the programme monitoring procedures, including the extent of the breeders’ involvement in implementing the control or monitoring programme, (
7. g)the action to be taken if, for any reason, a holding loses 15 Voluntary or compulsory control or monitoring programme. 16 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS its status, (
8. h)the measures to be taken if the results of the tests carried out under the programme are positive, (
9. i)the non-discriminatory nature of trade within the territory of Malta with respect to intra-Community trade.

(2)Programmes referred to in sub-rule

(1)shall be examined by the Commission, and may be approved under the procedure provided for in Article 26 of Directive 92/65/EEC. Under the same procedure, the additional guarantees, general or limited, which may be required in trade, and which shall not exceed the guarantees implemented nationally, shall be defined at the same time or at the latest three months after presentation of the programmes.

(3)The programmes submitted to the Commission may be amended or supplemented under the procedure laid down in Article 26 of Directive 92/65/EEC. Under the same procedure, amendments may be made to the guarantees referred to in sub-rule

(2). Where territory of Malta or part thereof is free from one of the diseases listed in Schedule B. 15.

(1)Where the competent authority considers that the territory of Malta or part thereof is free from one of the diseases listed in Schedule B to which the animals covered by these rules are susceptible, it shall present to the Commission appropriate supporting documentation, setting out in particular: (

1. a)the nature of the disease and the history of its occurrence in its territory, (
2. b)the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation, (
3. c)the period during which this disease was notifiable to the competent authorities, (
4. d)the period over which the surveillance was carried out, (
5. e)where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition, (
6. f)the arrangements for verifying the absence of the disease.

(2)The documentation referred to in sub-rule

(1)shall be examined by the Commission which shall submit to the Standing Veterinary Committee a decision approving or rejecting the plan. If the plan is accepted, the additional guarantees, general or specific, which may be required in trade and which shall not exceed the guarantees implemented nationally, shall be defined under the procedure laid down in Article 26 of Directive 92/65/EEC. Pending a decision, the relevant requirements needed in order to maintain the then current status may be maintained in trade dealings.

(3)The Commission shall be notified of any change in the particulars specified in sub-rule

(1). The guarantees defined in subrule

(2)may, in the light of such notification, be amended or ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 17 withdrawn under the procedure laid down in Article 26 of Directive 92/65/EEC. CHAPTER III Provisions applicable to imports into the Community 16.

(1)The conditions applicable to imports of animals, semen, ova and embryos covered by rules 17, 18, 19 and 20 must be at least equivalent to those laid down in Chapter II.

(2)With respect to cats, dogs and ferrets, import conditions must be at least equivalent to those provided for in points (a) to (d) of Article 10

(1)and point (a) of Article 12 of Regulation (EU) No 576/ 2013. Imports of animals, semen, ova and embryos covered by rules 17, 18, 19 and 20.

(3)In addition to the conditions referred to in sub-rule

(2), dogs, cats and ferrets shall, during transport to the place of destination, be accompanied by a health certificate, which is completed and signed by an official veterinarian who shall attest that a clinical examination was carried out within forty-eight hours prior to the time of dispatch of the animals by a veterinarian authorised by the competent authority who has verified that at the time of the clinical examination, the animals were fit to be transported for the intended journey. 17.

(1)The following paragraphs shall apply for the purposes of the uniform application of rule 16.

(2)Only animals and semen, ova and embryos referred to in rule 11 which satisfy the following requirements may be imported into the Community: (a) they must come from a third country on a list to be drawn up in accordance with sub-rule

(3)(a); (b) they must be accompanied by the health certificate corresponding to a specimen to be drawn up in accordance

(4), and come from approved centres, bodies, institutes offering guarantees at least equivalent to those in Schedule C; semen, ova and embryos come from approved collection and storage centres or collection and production teams offering guarantees at least equivalent to those to be established in Schedule D(I) in accordance

(3)In accordance with the information received, there shall be established: (a) in accordance

(2)(a) and

(3)(

1. a)situated in one of the third countries appearing on the list referred to in paragraph (
2. a)above, and for which the competent authority is able to give the guarantees provided for in rule 11

(2)and

(3). The list of approved centres and teams referred to in this paragraph and their veterinary registration numbers shall be communicated to the Commission. The approval of centres or teams must be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions referred to in rule 11

(2)and

(3)and the Commission must be immediately informed thereof; (c) in accordance

(4)The list provided for in sub-rule

(3)may include only third countries or parts of third countries: (

1. a)from which imports are not prohibited: (
2. i)(
3. ii)as a result of the existence of one of the diseases referred to in Schedule A or of any other disease exotic to the Community, pursuant to Articles 6, 7 and 14 of Directive 72/ 462/EEC and Article 17 of Directive 91/495/EEC and of Directive 71/118/EEC as defined in Schedule H or, in the case of the other animals covered by these rules, under a decision taken in accordance with the procedure laid down in Article 26 of Directive 92/65/EEC, account being taken of their state of health; (
4. b)which, in view of their legislation and the organization of their veterinary services and inspection services, the ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 19 powers of such services and the supervision to which they are subject, have been recognized, in accordance with Article 3

(2)of Directive 72/462/EEC, as capable of guaranteeing the implementation of their legislation in force; (c) the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Chapter II are being complied with.

(5)The competent authority of the third country shall allow experts from the Commission and the Member States to carry out onthe-spot inspections to verify whether the guarantees given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community. The experts from the Member States responsible for these inspections shall be appointed by the Commission acting on a proposal from the Member States. These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection.

(6)Pending the organization of the inspections referred to in sub-rule

(5), national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with the guarantees offered in accordance with sub-rule

(3), found during these inspections. 18.

(1)The competent authority shall ensure that the animals, semen, ova and embryos covered by these rules are imported into the Community only if they: (

1. a)are accompanied by a certificate to be drawn up by the official veterinarian, the specimen certificate shall, depending on the species, be drawn up under the procedure laid down in Article 26 of Directive 92/65/ EEC; (
2. b)have satisfied the checks required by Directive 90/675/ EEC and the Principles Governing the Organisation of Veterinary Checks on Animals Entering the Community from Third Countries via Border Inspection Posts of the Territory of Malta Regulations, (
3. c)have undergone, prior to shipment to Community territory, a check by an official veterinarian to ensure that the transport conditions specified in the Staging Posts Regulations have been complied with, in particular as regards watering and feeding, (
4. d)have, in the case of the animals referred to in rules 5 to 10, been quarantined before being placed on the market, in accordance with detailed rules to be established under the procedure laid down in Article 26 of Directive 92/65/ EEC.

(2)Pending the establishment of specific rules for this rule, the national rules currently applicable to imports from third countries for Importation of animals, semen, ova and embryos into the Community. S.L. 437.40 S.L. 439.04 20 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS which such requirements have not been adopted at Community level shall continue to apply, provided they are not more favourable than those laid down in Chapter II. Applicability of procedure laid down in Article 26 of Directive 92/65/ EEC. 19. The following shall be decided under the procedure laid down in Article 26 of Directive 92/65/EEC: (

1. a)specific animal health requirements, for imports into the Community, and the nature and content of accompanying documents for animals intended for zoos, circuses, amusement parks or experimental laboratories, according to the species; (
2. b)additional guarantees to those provided for in respect of the various animal species covered by these rules, to protect the Community species concerned. Applicability of the Principles Governing the Organisation of Veterinary Checks on Products Entering the Territory of Malta from Third Countries Regulations. S.L. 437.41 S.L. 437.40 20.

(1)The rules laid down in the Principles Governing the Organisation of Veterinary Checks on Products Entering the Territory of Malta from Third Countries Regulations shall apply in particular to the organisation of, and follow-up to the checks to be carried out by the Member States and the safeguard measures to be applied in accordance

(2)Pending implementation of the decisions provided for in regulation 8

(6)of the Principles Governing the Organisation of Veterinary Checks on Animals Entering the Community from Third Countries via Border Inspection Posts of the Territory of Malta Regulations, the relevant provisions of sub-regulations

(1)and

(2)of the said regulation shall continue to apply, without prejudice to compliance with the principles and rules referred to in sub-rule

(1). CHAPTER IV Specimens of certificates applicable to trade. Schedules. Derogation from Chapter II. Cap.

1. Health certificate. Common final provisions
2. All specimens of certificates applicable to trade and the animal health conditions to be met in order for it to be possible to trade in animals, semen, ova and embryos other than those covered by rules 5 to 11 shall, where the need arises, be determined under the procedure laid down in Article 26 of Directive 92/65/EEC. When such modifications and amendments take place to the specimen certificates, these amended versions shall be deemed to apply under these rules in replacement of the present specimen certificates.
3. The Schedules to these rules are to be amended whenever the relative annexes to Directive 92/65/EEC are amended under the procedure laid down in Article 26 of the said Directive.
4. Under the procedure laid down in Article 26 of Directive 92/65/EEC, special requirements may be laid down, if appropriate, by way of derogation from Chapter II, for the movement of circus and fairground animals and for trade in animals, semen, ova and embryos intended for zoos, without prejudice to the provisions relating to circuses in the Animal Welfare Act.
5. The competent authority shall allow the entry into Malta of ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 the animals (including cage birds), semen, ova and embryos referred to in these rules which have passed through the territory of a third country subject to the production of a health certificate certifying compliance with the requirements of these rules, and the Commission and the other Member States shall be informed accordingly.
6. The derogation to rule 10

(2)(b) in terms of the powers delegated to Member States by article 7 of Council Regulation 576/ 2013 to authorise the non-commercial movement into their territory from another Member State of pet animals of the species listed in Part A of Annex I of the same Council Regulation relating to dogs, cats and ferrets shall not be applied. The said rule 10

(2)(b) shall be applicable to the dogs, cats and ferrets originating in third countries, and animals of these species younger than fifteen weeks shall not be accepted on importation. The same rule shall also apply to all animals listed in Part A of schedule H that are younger than fifteen weeks and such animals shall not be allowed to travel. 26. The competent authority may grant another Member State a derogation from the provisions of Articles 6(A)

(1)(f), 8(b) and 11

(1)(d) of Directive 92/65/EEC on a reciprocal basis if the recipient Member State has implemented an alternative control system providing guarantees equivalent to those laid down in these rules as regards movements within their territory of the animals, semen, ova and embryos. 27. Under the procedure laid down in Article 26 of Directive 92/65/EEC, transitional measures may be adopted for a period of three years to facilitate the transition to the new arrangements established by these rules. 28.

(1)Any person who acts in contravention of these rules and in contravention of Council Regulations 576/2013 and 577/2013 shall be guilty of an offence and shall, on conviction, be liable to a fine (multa) of not more than twenty-three thousand and three hundred (€23,300) or to imprisonment for not more than six months, or to both such fine and imprisonment.

(2)Any person who acts in contravention of these rules and in contravention of Council Regulations 576/2013 and 577/2013, which infringement relates only to the drawing up of certificates or documents which do not conform or are not compliant with the requirements referred to rule 12

(1), and with the requirements of Council Regulations 576/2013 and 577/2013 shall, on conviction, be liable to a fine (multa) of not more than three hundred euro (€300).

(3)Any person who commits an infringement of these rules which involves the identification of the animals or the marking of the semen, ova and embryos which do not conform or are not compliant with the rules laid down in European Community law and national legislation on the subject-matter shall, on conviction, be liable to a fine (multa) of not more than twenty-three thousand and three hundred (€23,300), or to imprisonment for not more than six months, or to both such fine and imprisonment.

(4)Any person who commits any infringement of these rules which involves the lack of checks of the animals or products in 21 Non-applicability of derogation. Reciprocal derogation from the provisions of Articles 6(A)

(1)(f), 8(b) and 11

(1)(d) of Directive 92/65/ EEC. Transitional measures. Offences and penalties. 22 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS question as required in rule 12, or Council Regulations 576/2013 and 577/2013, or by other relevant European Community law and national legislation shall be liable to the same penalties laid down in sub-rule

(1).

(5)Any person who commits any infringement of the requirements of Commission Regulation 1152/2011, as required by Article 19 of Council Regulation 576/2013, which involves only the lack of administration of antip arasitic agents as required by legislation regulating the movement and importation of dogs shall be liable on conviction to a fine (multa) of ninety euro (€90), together with the charges for a period of twenty-four hours in quarantine, the cost of the medication and any other cost incurred during the quarantine period for every animal. Applicability of certain provisions of the Act. 29. The provisions of articles 57

(2), 58, 60 and 61 of the Act shall apply to the infringements against these rules which are punishable in accordance with rule

1. ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 23 SCHEDULE A Notifiable diseases in the context of Directive 92/65/EEC Disease Order/family/species primarily concerned African horse sickness Equidae African swine fever Suidae and Tayassuidae Avian influenza Aves American foulbrood Apis Anthrax Bovidae, Camelidae, Cervidae, Elephantidae, Equidae and Hippopotamidae Antilocapridae, Bovidae, Cervidae, Giraffidae, and Rhinocerotidae Antilocapri dae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae Antilocapridae, B ovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae Camelidae, Tragulidae, Cervidae, Giraffidae, Bovidae and Antilocapridae Cervidae, Leporidae, Ovi bos moschatus, Suidae and Tayassuidae Suidae and Tayassuidae Bluetongue Brucella abortus Brucella melitensis Brucella ovis Brucella suis Classical swine fever Contagious bovine pleuropneumonia Ebola Bovines (including zebu, buffalo, bison and yak) Foot-and-mouth disease Artiodactyla and Asian elephants Non-human primates Infectious haematopoeiticSalmonidae necrosis Lumpy skin disease Bovidae and Giraffidae Monkey pox Rodentia and non-human primates Mycobacterium bovis Newcastle disease Mammalia, in particular Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, and Tragulidae Aves Peste des petits ruminants Bovidae and Suidae 24 [ S.L.437.98 Porcine enterovirus encephalomyelitis Psitacosis ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS Suidae Psittaciformes Rabies Carnivora and Chiroptera Rift valley fever Bovidae, Camelus species and Rhinocerotidae Rinderpest Artiodactyla Small hive beetle (Aethina tumida) Sheep and goat pox Apis and Bombus Bovidae Swine vesicular disease Suidae and Tayassuidae Tropilaelaps mite (Tropilaelaps spp.) Vesicular stomatitis Apis TSE Bovidae, Cervidae, Felidae and Mustelidae Artiodactyla and Equidae SCHEDULE B List of diseases for which national programmes may be recognized under Directive 92/65/EEC Mink Viral enteritis Aleutian disease Bees European foulbrood varroasis and acariasis Apes and felids Tuberculosis Ruminants Tuberculosis Lagomorphs Myxomatosis Viral haemorrhagic disease Tularaemia ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 25 SCHEDULE C Conditions governing approval of bodies, institutes or centres
2. In order to be granted official approval under Article 13

(2)of Directive 92/65/ EEC, a body, institute or centre as defined in Article 2

(1)(

1. c)must: (
2. a)be clearly demarcated and separated from its surroundings or the animals confined and located so as not to pose a health risk to agricultural holdings whose health status might be jeopardised; (
3. b)have adequate means for catching, confining and isolating animals and, have available adequate quarantine facilities and approved procedures for animals coming from non-approved sources; (
4. c)be free of the diseases listed in Annex A and the diseases listed in Annex B where the country concerned has a programme pursuant to Article 14. In order that a body, institute or centre is declared free from these diseases, the competent authority shall assess the records on the animal health status kept for at least the previous three years and the results of the clinical and laboratory tests carried out on the animals in the body, institute or centre. However, by way of derogation from this requirement new establishments shall be approved if the animals forming the collection are derived from approved establishments; (
5. d)keep up to date records indicating: (
6. i)(
7. ii)(iii) (
8. iv)(
9. v)(
10. vi)the number and identity (age, sex, species and individual identification where practical) of the animals of each species present in the establishment; the number and identity (age, sex, species and individual identification where practical) of animals arriving in the establishment or leaving it, together with information on their origin or destination, the transport from or to the establishment and the animals health status; the results of blood tests or any other diagnostic procedures; cases of disease and, where appropriate, the treatment administered; the results of the post-mortem examinations on animals that have died in the establishment, including still-born animals; observations made during any isolation or quarantine period; (
11. e)either have an arrangement with a competent laboratory to perform postmortem examinations, or have one or more appropriate premises where these examinations may be performed by a competent person under the authority of the approved veterinarian; (
12. f)either have suitable arrangements or on-site facilities for the appropriate disposal of the bodies of animals which die of a disease or are euthanised; (
13. g)secure, by contract or legal instrument, the services of a veterinarian approved by and under the control of the competent authority, who: (
14. i)(
15. ii)shall comply mutatis mutandis with the requirements referred to in Article 14

(3)(B) of Directive 64/432/EEC, shall ensure that appropriate disease surveillance and control measures in relation to the disease situation of the country concerned are approved by the competent authority and applied in the body, institute or centre. Such measures shall include: 26 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS - (iii) (

1. iv)(
2. v)an annual disease surveillance plan including appropriate zoonoses control of the animals, clinical, laboratory and post-mortem testing of animals suspected to be affected by transmissible diseases, vaccination of susceptible animals against infectious diseases as appropriate, only in conformity with Community legislation; shall ensure that any suspect deaths or the presence of any other symptom suggesting that animals have contracted one or more of the diseases referred to in Annexes A and B is notified without delay to the competent authority, if that particular disease is notifiable in the Member State concerned; shall ensure that incoming animals have been isolated as necessary, and in accordance with the requirements of Directive 92/65/EEC and the instructions, if any, given by the competent authority; shall be responsible for the day to day compliance with the animal health requirements of Directive 92/65/EEC and of Community legislation on welfare of animals during transport and disposal of animal waste; (
3. h)if it keeps animals intended for laboratories carrying out experiments, in conformity with the provisions of Article 5 of Directive 86/609/EEC. 2. Approval shall be maintained where the following requirements are met: (
4. a)the premises are under the control of an official veterinarian from the competent authority, who: (
5. i)(
6. ii)(iii) shall visit the premises of the body, institute or centre at least once per year; shall audit the activity of the approved veterinarian and the implementation of the annual disease surveillance plan; shall ensure that the provisions of Directive 92/65/EEC are met; (
7. b)only animals coming from another approved body, institute or centre, are introduced into the establishment, in accordance with the provisions of Directive 92/65/EEC; (
8. c)the official veterinarian verifies that: - other provisions of Directive 92/65/EEC are fulfilled, the results of the clinical, post-mortem and laboratory tests on the animals have revealed no occurrence of the diseases referred to in Annexes A and B; (
9. d)the body, institute or centre keeps the records referred to in point 1(
10. d)after approval, for a period of at least ten years. 3. By way of derogation from Article 5

(1)of Directive 92/65/EEC and point 2(

1. b)of this Annex, animals including apes (simiae and prosimiae) having an origin other than an approved body, institute or centre may be introduced in an approved body, institute or centre, provided that these animals undergo a quarantine under official control and in accordance with the instructions given by the competent authority before being added to the collection. For apes (simiae and prosimiae) the quarantine requirements laid down in the OIE International Health Code (Chapter 2.10.1 and Appendix 3.5.1) shall be respected. ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 27 For other animals undergoing quarantine in accordance with point 2(
2. b)of this Annex, the quarantine period must be at least 30 days with respect to the diseases listed in Annex A. 4. Animals held in an approved body, institute or centre, shall only leave this establishment if destined to another approved body, institute or centre, in that Member State or another Member State; however, if not destined to an approved body, institute or centre, shall only leave in accordance with the requirements of the competent authority to ensure no risk of possible spread of disease. 5. Where a Member State benefits from additional guarantees under Community legislation it may request appropriate additional requirements and certification for the susceptible species to be added to the approved body, institute or centre. 6. The procedures for partly or completely suspending, withdrawing or restoring approval are the following: (
3. a)where the competent authority finds that the requirements of point 2 have not been fulfilled or there has been a change of usage which is no longer covered by Article 2 of Directive 92/65/EEC the approval shall be suspended or withdrawn; (
4. b)where notification is given of the suspicion of one of the diseases listed in Annex A or B, the competent authority shall suspend approval of the body, institute or centre, until the suspicion has been officially ruled out. Depending on the disease involved and the risk of disease transmission, the suspension may relate to the establishment as a whole or only to certain categories of animals susceptible to the disease in question. The competent authority shall ensure that the measures necessary to confirm or rule out the suspicion and to avoid any spread of disease are taken, in accordance with Community legislation governing measures to be taken against the disease in question and on trade in animals; (
5. c)where the suspected disease is confirmed, the body, institute or centre shall again be approved only when, after eradication of the disease and source of infection in the premises, including suitable cleaning and disinfection, the conditions laid down in point 1 of this Annex, with the exception of point 1(c), are again fulfilled; (
6. d)the competent authority shall inform the Commission of the suspension, withdrawal or restoration of approval of a body, institute or centre. [ S.L.437.98 28 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS SCHEDULE D CHAPTER I Conditions applicable to semen collection centres, semen storage centres, embryo collection teams and embryo production teams I. Conditions for the approval of semen collection and storage centres 1. In order to be given approval and the veterinary registration number referred to in Article 11

(4)each semen collection centre shall: 1.1. be placed under the supervision of a centre veterinarian authorised by the competent authority; 1.2. have at least: (

1. a)lockable animal accommodation and if required for equidae an exercise area which is physically separated from the collection facilities, the processing and storage rooms; (
2. b)isolation facilities which have no direct communication with the normal animal accommodation; (
3. c)semen collection facilities, that may be open air protected from adverse weather effects, with slip-proof flooring which protects from dramatic injury in case of fall, at and around the place of semen collection, without prejudice to the requirements in point 1.4; (
4. d)a separate room for the cleansing and disinfection or sterilisation of equipment; (
5. e)a semen processing room separated from the collection facilities and the room for cleansing equipment referred to in point (
6. d)which need not necessarily be on the same site; (
7. f)1.3. a semen storage room which need not necessarily be on the same site; be so constructed or isolated that contact with outside livestock is prevented; 1.4. be so constructed that the entire semen collection centre except the office rooms and, in the case of equidae the exercise area, can be readily cleansed and disinfected. 2. In order to be given approval each semen storage centre shall: (
8. a)in the case the storage is not limited to semen of a single species collected at semen collection centres approved in accordance with Directive 92/65/ EEC, or embryos are stored at the centre in compliance with Directive 92/ 65/EEC, be given distinct veterinary registration numbers referred to in Article 11

(4)for each of the species the semen of which is stored at the centre; (

1. b)be placed under the permanent supervision of a centre veterinarian authorised by the competent authority; (
2. c)have a semen storage room furnished with the necessary installation to store the semen and/or the embryos, which is so constructed that it protects those products and the installation from adverse weather and environment effects; (
3. d)be so constructed that contact with outside livestock or other animals is prevented; (
4. e)be so constructed that the entire centre except the office rooms and, in ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 29 the case of equidae the exercise area, can be readily cleansed and disinfected; (
5. f)be so constructed that unauthorised access of people is effectively prevented. II. Conditions for the supervision of semen collection and storage centres 1. Semen collection centres shall: 1.1. be supervised to ensure that: (
6. a)they contain only animals of the species whose semen is to be collected; Other domestic animals may none the less also be admitted, provided that they present no risk of infection to those species whose semen is to be collected, and that they comply with the conditions laid down by the centre veterinarian. If in the case of equidae the semen collection centre shares a site with an artificial insemination or service centre, then female equidae (mares) and uncastrated male equidae (stallions) for teasing or natural service shall be admitted provided that they meet the requirements of points 1.1, 1.2, 1.3 and 1.4 of Section I of Chapter II; (
7. b)the entry of unauthorised persons is prevented and that authorised visitors are required to comply with the conditions laid down by the centre veterinarian; (
8. c)only competent staff is employed who have received adequate training on disinfection and hygiene techniques to prevent the spread of disease; 1.2. be monitored to ensure that: (
9. a)records are kept which show: (
10. i)(
11. ii)(iii) (
12. iv)(
13. v)(
14. vi)the species, breed, date of birth and identification of each animal present in the centre; any movement of animals entering or leaving the centre; the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on animals kept; the date of collecting and processing semen; the destination of semen; the storage of semen; (
15. b)none of the animals kept in the centre is used for natural breeding at least 30 days prior to the date of the first semen collection and during the collection period; (
16. c)the collection, processing and storage of semen is carried out only in premises set aside for these purposes; (
17. d)all instruments which come into contact with the semen or the donor animal during collection and processing are properly disinfected or sterilised prior to use, except for instruments which are new, disposable and discarded after use (single-use instruments); Where, in the case of equidae, the collection centre shares a site with an artificial insemination centre or a service centre, there shall be a strict separation between the semen and instruments and equipment for artificial insemination or natural service and instruments and equipment coming into contact with donor animals or other animals kept in the collection centre; [ S.L.437.98 30 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS (
18. e)products of animal origin used in the processing of semen, including diluents, additives or extenders, are obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented; (
19. f)cryogenic agents used for the preservation or storage of semen have not been previously used for other products of animal origin; (
20. g)storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for containers which are new, disposable and discarded after use (single-use containers); (
21. h)each individual dose of semen or each ejaculate of fresh semen intended for further processing is clearly marked in such a way that the date of collection of the semen, the species, the breed and identification of the donor animal and the approval number of the semen collection centre can be readily established; 1.3. be inspected by an official veterinarian during the breeding season at least once every calendar year in the case of animals with seasonal breeding and twice every calendar year in the case of a non-seasonal reproduction in order to consider and verify, where necessary on the base of records, standard operating procedures and internal audits, all matters relating to the conditions of approval, supervision and monitoring. 2. Semen storage centres shall: 2.1. be supervised to ensure that: (
22. a)the status of the donor animals whose semen is stored at the centre complies with the requirements of Directive 92/65/EEC; (
23. b)the requirements laid down in points 1.1(
24. b)and (
25. c)are complied with; (
26. c)records are kept of all movement of semen entering and leaving the storage centre; 2.2. be monitored that: (
27. a)only semen collected in and coming from approved semen collection or storage centres and transported in conditions offering every possible health guarantee, having had no contact with semen not complying with Directive 92/65/EEC, is brought into an approved semen storage centre; (
28. b)storage of semen takes place only on the premises set aside for the purpose and under strict conditions of hygiene; (
29. c)all instruments which come into contact with the semen are properly disinfected or sterilised prior to use, except for single-use instruments; (
30. d)storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers; (
31. e)cryogenic agents used for preservation or storage of semen have not been previously used for other products of animal origin; (
32. f)each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the species, the breed and identification of the donor animal, the approval number of the semen collection centre can be readily established; each Member State shall communicate to the Commission and other Member States the characteristics and form of the ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 31 marking used in its territory; 2.3. by way of derogation from point 2.2(a), the storage of embryos in the approved semen storage centre is authorised provided they meet the requirements of Directive 92/65/EEC and are stored in separate storage containers; 2.4. be inspected by an official veterinarian at least twice every calendar year in order to consider and verify, where necessary based on records, standard operating procedures and internal audits, all matters relating to the conditions of approval, supervision and monitoring. III. Conditions for the approval and the supervision of embryo collection teams and embryo production teams 1. In order to be given approval each embryo collection team shall comply with the following requirements: 1.1. 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 and in techniques and principles of disease control; 1.2. the team veterinarian shall be responsible for all team operations, including amongst others: (
33. a)verification of the identity and health status of the donor animal; (
34. b)sanitary handling and surgery of donor animals; (
35. c)disinfection and hygienic procedures; (
36. d)keeping records which show: (
37. i)the species, breed, date of birth and identification of each donor animal; (
38. ii)the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on donor animals; (iii) the place and date of collecting, processing and storing of oocytes, ova and embryos; (
39. iv)the identification of embryos and details of their destination if known; 1.3. the team shall be placed under the general supervision of the official veterinarian, who shall inspect it at least once every calendar year to ensure, where necessary based on records, standard operating procedures and internal audits, compliance with the sanitary conditions regarding collection, processing and storage of embryos and to verify all matters relating to the conditions of approval and supervision; 1.4. the team shall have at its disposal a permanently sited laboratory or a mobile laboratory where embryos can be examined, processed and packed, consisting of at least a work surface, an optical or stereo microscope and cryogenic equipment where necessary; 1.5. in the case of a permanently sited laboratory, it shall have: (
40. a)a room where embryos can be processed which is physically separate from the area used to handle the donor animals during collection; (
41. b)a room or area for cleansing and sterilising instruments, except when using only single-use equipment; (
42. c)a room for storing embryos; 32 1.6. [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS in the case of a mobile laboratory, it shall: (
43. a)have a specially equipped part of the vehicle consisting of two separate sections: (
44. i)(
45. ii)one for the examination and processing of embryos which shall be a clean section; and the other for accommodating equipment and materials used in contact with the donor animals; (
46. b)use only single-use equipment, unless the sterilisation of its equipment and the provision of fluids and other products necessary for the collection and processing of embryos can be ensured by the contact with a permanently sited laboratory; 1.7. the design and layout of buildings and laboratories shall be laid out and team operations carried out so as to ensure that cross-contaminations of embryos are prevented; 1.8. the team shall have at its disposal storage premises which shall: (
47. a)comprise at least one lockable room for the storage of ova and embryos; (
48. b)be easy to cleanse and disinfect; (
49. c)have permanent records of all incoming and outgoing ova or embryos; (
50. d)have storage containers for ova and embryos which are stored in a place which is under the control of the team veterinarian and which is subject to regular inspections by an official veterinarian; 1.9. the competent authority may authorise storage of semen in storage premises referred to in point 1.8 provided that the semen: (
51. a)meets the requirements of Directive 92/65/ EEC for either ovine and caprine species or equine species, or of Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species for porcine species; (
52. b)is stored for the operation of the team in separate storage containers in the premises for storing approved embryos. 2. In order to be given approval each embryo production team shall also comply with the following additional requirements: 2.1. the team members have received adequate training on disease control and laboratory techniques, particularly in procedures for working in sterile conditions; 2.2. the team shall have at its disposal a permanently sited laboratory which shall: (
53. a)have adequate equipment and facilities, including separate rooms for: - recovering oocytes from ovaries, processing oocytes, ova and embryos, storing embryos; (
54. b)have a laminar-flow or other suitable facilities where all technical operations associated with specific sterile conditions (processing of ova, embryos and semen) are conducted. However, the centrifugation of semen may be carried out outside the laminar-flow facility or other facility, as long as full hygienic precautions ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 33 are taken; 2.3. where ova and other tissues are to be collected in a slaughterhouse, it shall 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. CHAPTER II Conditions applicable to donor animals I. Conditions applicable to donor stallions 1. In order to be used for the collection of semen, the donor stallion shall, to the satisfaction of the centre veterinarian, meet the following requirements: 1.1. it shall not show any clinical sign of an infectious or contagious disease at the time of admission and on the day the semen is collected; 1.2. it shall come from the territory or, in the case of regionalisation, from the part of the territory of a Member State or a third country and from a holding under veterinary supervision each of which satisfy the requirements of Directive 90/426/EEC; 1.3. it shall be kept for 30 days prior to the date of semen collection in holdings where no equine has shown any clinical sign of equine viral arteritis or contagious equine metritis during that period; 1.4. it shall not be used for natural mating during the 30 days prior to the first semen collection and during the collection period; 1.5. it shall be subjected to the following tests, carried out and certified in a laboratory which is recognised by the competent authority and has the tests referred to hereinafter included in its accreditation in accordance with Article 12 of Regulation (EC) No 882/2004 of the European Parliament and of the Council, according to the programme provided for in point 1.6: (
55. a)an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia with negative result; (
56. b)a test for the isolation of the equine arteritis virus or the detection of its genome by polymerase chain reaction (PCR) or real-time PCR carried out with negative result on an aliquot of the entire semen of the donor stallion, unless the donor stallion has reacted with negative result at a serum dilution of one in four in a serum neutralisation test for equine viral arteritis; (
57. c)an agent identification test for contagious equine metritis, carried out with negative result in each case on three specimens (swabs) taken from the donor stallion on two occasions with an interval of not less than seven days, and in no case earlier than seven days (systemic treatment) or 21 days (local treatment) after possible antimicrobial treatment of the donor stallion, from at least the following sites: - the penile sheath (prepuce), the urethra, the fossa glandis. The specimens shall be placed in transport medium with activated charcoal, such as Amies medium, before dispatch to the laboratory. The specimens shall be subjected to at least one of the following tests: (
58. i)culture under microaerophilic conditions for at least 7 days for the 34 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS isolation of Taylorella equigenitalis, set up within 24 hours after taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport; or (
59. ii)polymerase chain reaction (PCR) or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within 48 hours after taking the specimens from the donor animal. 1.6. it shall be subjected to one of the following testing programmes: (
60. a)if the donor stallion is continuously resident on the semen collection centre for at least 30 days prior to the date of the first semen collection and during the collection period, and no equidae on the semen collection centre come into direct contact with equidae of lower health status than the donor stallion, the tests required in point 1.5 shall be carried out on samples taken from the donor stallion at least once a year at the beginning of the breeding season or prior to the first collection of semen intended for trade in fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection; (
61. b)if the donor stallion is resident on the semen collection centre for at least 30 days prior to the date of the first semen collection and during the collection period, but may leave the centre occasionally under the responsibility of the centre veterinarian for a continuous period of less than 14 days, and/or other equidae on the collection centre come into direct contact with equidae of lower health status, the tests required in point 1.5 shall be carried out as follows: (
62. i)(
63. ii)at least once a year on samples taken from the donor stallion at the beginning of the breeding season or prior to the first collection of semen intended for trade in fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection; and during the period of collection of semen intended for trade in fresh, chilled or frozen semen as follows: the test required in point 1.5(
64. a)on samples taken not more than 90 days prior to the collection of semen for trade, the test required in point 1.5(
65. b)on samples taken not more than 30 days prior to the collection of semen for trade, unless the non-shedder state of a donor stallion is confirmed by virus isolation test, PCR or real-time PCR carried out on samples of an aliquot of the entire semen taken not more than 6 months prior to the collection of semen for trade and the donor stallion has reacted with positive result at a serum dilution of at least one in four in a serum neutralisation test for equine viral arteritis, the test required in point 1.5(
66. c)on samples taken not more than 60 days prior to the collection of semen for trade, which in the case of PCR or real-time PCR may be carried out on three specimens (swabs) taken on a single occasion; (
67. c)if the donor stallion does not meet the conditions in points (
68. a)and (
69. b)and the semen is collected for trade in frozen semen, the tests required in point ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 35 1.5 shall be carried out on samples collected from the donor stallion as follows: (
70. i)(
71. ii)at least once a year at the beginning of the breeding season; during the storage period provided for in point 1.3(
72. b)of Section I of Chapter III and before the semen is removed from the centre or used, on samples taken not earlier than 14 days and not later than 90 days following the date of collection of the semen. By way of derogation from point (
73. ii)of the first sub-paragraph, postcollection sampling and testing for equine viral arteritis as described in 1.5(
74. b)is not required in case the non-shedder state of a seropositive donor stallion is confirmed by virus isolation test, PCR or real-time PCR carried out with negative result on samples of an aliquot of the entire semen of the donor stallion taken twice a year at an interval of at least four months and the donor stallion has reacted with positive result at a serum dilution of at least one in four in a serum neutralisation test for equine viral arteritis. 1.7. if any of the tests provided for in point 1.5 is positive, the donor stallion shall be isolated, and the semen collected from it since the date of the last negative test shall not be subject for trade with the exception, for equine viral arteritis, of semen from every ejaculate which has undergone the equine arteritis virus isolation test with negative result. Semen collected from all other stallions at the semen collection centre since the date when the last sample was collected that gave a negative result in one of the tests provided for in point 1.5. shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases mentioned in point 1.5; 1.8. semen collected from stallions at a semen collection centre subject to a prohibition order in accordance with Article 4 or 5 of Directive 90/426/EEC shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored by the official veterinarian in accordance with Directive 90/426/ EEC and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases listed in Annex A to Directive 90/426/EEC. II. Conditions applicable to male ovine and caprine donor animals 1. For all ovine and caprine animals admitted to a semen collection centre the following requirements shall apply: 1.1. they have been kept in quarantine for a period of at least 28 days in accommodation specifically approved for the purpose by the competent authority, and where only animals having at least the same health status are present (quarantine accommodation); 1.2. prior to their stay in the quarantine accommodation, they have belonged to an officially brucellosis-free ovine or caprine holding pursuant to Article 2 of Directive 91/68/EEC and they shall not be previously kept in a holding of a lower health status as regards brucellosis; 1.3. they come from a holding where during the 60 days prior to their stay in the quarantine accommodation they have undergone a serological test for contagious epidydimitis (B. ovis) carried out in accordance with Annex D to Directive 91/ 68/ EEC or any other test with an equivalent documented sensitivity and specificity; ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS 36 [ S.L.437.98 1.4. they have undergone the following tests carried out on a blood sample collected within the 28 days preceding the commencement of the period of quarantine specified in point 1.1, with negative results in each case, except for the test for Border disease referred to in point (c)(ii): (
75. a)for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/EEC; (
76. b)for contagious epidydimitis (B. ovis), a serological test carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity; (
77. c)for Border disease: (
78. i)(
79. ii)a virus isolation test or a test for virus antigen; and a serological test to determine the presence or absence of antibodies (antibody test). The competent authority may authorise that the tests referred to in this point are carried out on samples collected in the quarantine accommodation. If such authorisation is granted, the period of quarantine referred to in point 1.1 shall not commence before the date of sampling. However, if any of the tests referred to in this point prove positive, the animal concerned shall be immediately removed from the quarantine accommodation. In the event of group isolation, the quarantine period referred to in point 1.1 shall not commence for the remaining animals until the animal which tested positive has been removed; 1.5. they have undergone the following tests carried out on samples taken during the period of quarantine specified in point 1.1, and at least 21 days after being admitted to the quarantine accommodation, with negative results: (
80. a)for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/EEC; (
81. b)for contagious epidydimitis (B. ovis), a serological test carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity; 1.6. they have undergone the tests for Border disease referred in points 1.4(c)(
82. i)and (
83. ii)carried out on the blood samples taken during the period of quarantine specified in point 1.1, and at least 21 days after being admitted to the quarantine accommodation. Any animal (seronegative or seropositive) shall only be allowed entry to the semen collection centre if no sero-conversion occurs in animals which tested seronegative before the day of entry into the quarantine accommodation. If sero-conversion occurs, all animals that remain seronegative shall be kept in quarantine over a prolonged time, until there is no more sero-conversion in the group for a period of three weeks from the day the sero-conversion occurred. Serologically positive animals shall be allowed entry into the semen collection centre subject to a negative result in a test referred in point 1.4(c)(i). 2. Animals shall only be admitted to the semen collection centre with the express permission of the centre veterinarian. All movements into and out of the semen collection centre shall be recorded. 3. No animals admitted to the semen collection centre shall show any clinical sign of disease on the date of admission. ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 37 All animals shall, without prejudice to point 4, have come from quarantine accommodation, which on the day of dispatch of the animals to the semen collection centre complies with the following conditions: (
84. a)it is situated in an area in which there has been no outbreak of foot-andmouth disease for the past 30 days within a 10 kilometre radius; (
85. b)it has for the past three months been free from foot-and-mouth disease and brucellosis; (
86. c)it has for the past 30 days been free from compulsory notifiable diseases as defined in Article 2(b)

(6)of Directive 91/68/EEC. 4. Provided, that the conditions set out in point 3 are complied with and the routine tests referred to in point 5 have been carried out during 12 months prior to the movement of the animals, animals may be moved from one approved semen collection centre to another of equal health status, without isolation or testing if the transfer is direct. The animal in question must not come into direct or indirect contact with clovenhoofed animals of a lower health status and the means of transport used shall be disinfected before use. If an animal is moved from one semen collection centre to a semen collection centre in another Member State that movement shall be carried out in accordance with Directive 91/68/EEC. 5. All ovine and caprine animals kept at an approved semen collection centre shall be subjected at least once every calendar year to the following tests, with negative results: (

1. a)for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/ EEC; (
2. b)for contagious epidydimitis (B. ovis) a serological test carried out in accordance with Annex D to Directive 91/68/ EEC, or any other test with an equivalent documented sensitivity and specificity; (
3. c)for Border disease, the antibody test referred to in point 1.4(c)(
4. ii)which is applied only to seronegative animals. 6. All tests referred to in this section shall be carried out by an approved laboratory. 7. If any of the tests described in point 5 is positive, the animal shall be isolated and the semen collected from it since the date of the last negative test shall not be subject for trade. The animal referred to in the first paragraph shall be removed from the centre, except in the case of Border disease, in which case the animal shall be subjected with negative result to a test referred in point 1.4(c)(i). Semen collected from all other animals at the semen collection centre since the date when the last sample was collected that gave a negative result in one of the tests described in point 5 shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases mentioned in point 5. 8. Semen shall be obtained from animals which: (
5. a)show no clinical signs of disease on the date the semen was collected; (
6. b)during the 12 months prior to the date of the collection of the semen: (
7. i)either have not been vaccinated against foot-and-mouth disease; or [ S.L.437.98 38 (
8. ii)ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS have been vaccinated against foot-and-mouth disease at least 30 days prior to the collection, in which case 5% (with a minimum of five straws) of each semen collection shall be submitted to a virus isolation test for foot-and-mouth disease with negative results; (
9. c)have been kept at an approved semen collection centre for a continuous period of at least 30 days prior to the date of collection of the semen, in the case of collection of fresh semen; (
10. d)meet the requirements laid down in Articles 4, 5 and 6 of Directive 91/ 68/EEC; (
11. e)if kept on holdings referred to in the first indent of Article 11

(2), had undergone with negative results during the 30 days prior to the date of collection of the semen: (

1. i)(
2. ii)(iii) (
3. f)a serological test for brucellosis (B. melitensis) carried out in accordance with Annex C to Directive 91/68/EEC; a serological test for contagious epididymitis (B. ovis) carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity; a test for the Border disease virus; shall not be used for natural breeding during at least 30 days prior to the date of first semen collection and between the date of the first sample referred to in points 1.5 and between the date of the first sample referred to in points 1.5 and 1.6 or in point (
4. e)and until the end of the collection period. 9. Semen collected from male ovine and caprine donor animals at a semen collection centre or holding referred to in first indent of Article 11

(2)subject to a prohibition on animal health grounds in accordance with Article 4 of Directive 91/68/ EEC shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre or the holding has been restored by the official veterinarian in accordance with Directive 91/ 68/EEC and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases listed in Annex B(I) to Directive 91/68/EEC. CHAPTER III Requirements applicable to semen, ova and embryos I. Conditions for the collection, processing, preservation, storage and transport of semen 1.1. Where, without prejudice to Directive 2001/82/EC of the European Parliament and of the Council, antibiotics or a mixture of antibiotics are added with a bactericidal activity at least equivalent to that of the following mixtures in each ml of semen: gentamicin (250 icin tylosin (50 in (5lincomycin-spectinomycin (150/300 spectinomycin (150/300 ibiotics are added with alincomycin-spectinomycin (150/300spectinamikacin (75 cin (divekacin (25 acin (25 ctinomycin (150/300 ibiotics are added with a bacteion shall be stated in the health certificate referred to in the fourth indent of Article 11

(2). 1.2. All instruments used for the collection, processing, preservation or freezing of semen shall be either disinfected or sterilised as appropriate before use, except for single-use instruments. 1.3. Frozen semen shall: ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 39 (

1. a)be placed and stored in storage containers: (
2. i)(
3. ii)(
4. b)1.4. which have been cleansed and disinfected or sterilised before use, or are single-use containers; with a cryogenic agent; which shall not be previously used for other products of animal origin; prior to dispatch or use, be stored in approved conditions for a minimum period of 30 days from the date of collection. Semen to be subject for trade shall: (
5. a)be transported to the Member State of destination in transport containers which have been cleansed and disinfected or sterilised before use, or are single-use containers, and which have been sealed and numbered prior to dispatch from the approved semen collection or storage centres; (
6. b)be marked in such a way that the number on the straws or other packages coincides with the number on the health certificate referred to in the fourth indent of Article 11

(2)and with the container in which they are stored and transported. II. Conditions for ova and embryos 1. Collection and processing of in vivo derived embryos In vivo derived embryos shall be conceived as a result of artificial insemination with semen meeting the requirements of this Directive and shall be collected, processed and preserved in accordance with the following: 1.1. Embryos shall be collected and processed by an approved embryo collection team, without coming into contact with any other batch of embryos not complying with the requirements of Directive 92/65/EEC. 1.2. Embryos shall be collected in a place, which is separated from other parts of the premises or holding where the embryo is collected and which shall be in good repair and constructed with materials which permit its effective and easy cleansing and disinfection. 1.3. Embryos shall be processed (examined, washed, treated and placed in identified and sterile straws, ampoules or other packages) in either a permanently sited laboratory or a mobile laboratory, which, as regards susceptible species, is situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius. 1.4. All equipment used to collect, handle, wash, freeze and store embryos shall either be sterilised or properly cleansed and disinfected prior to use according to the IETS Manual, or be single-use equipment. 1.5. Any biological product of animal origin used in the media and solutions for collection, processing, washing or storage of embryos shall be free of pathogenic microorganisms. Media and solutions used in the collection, freezing and storage of embryos shall be sterilised by approved methods according to the IETS Manual and handled in such a manner as to ensure that sterility is maintained. Antibiotics might be added, when appropriate, to collection, processing, washing and storage media according to the IETS Manual. 1.6. The cryogenic agents used for preservation or storage of embryos shall not be previously used for other products of animal origin. 1.7. Each embryo straw, ampoule or other package shall be clearly identified by ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS 40 [ S.L.437.98 labels according to the standardised system according to the IETS Manual. 1.8. The embryos shall be washed and have an intact zona pellucida, or the embryonic capsule in case of equine embryos, before and immediately after washing. In accordance with the IETS Manual, the standard washing procedure shall be modified to include additional washes with the enzyme trypsin where recommended for the inactivation or removal of certain pathogens. 1.9. Embryos from different donor animals shall not be washed together. 1.10. The zona pellucida of each embryo, or the embryonic capsule in case of equine embryos, shall be examined over its entire surface area at not less than 50 × magnification and certified to be intact and free of adherent material. 1.11. Embryos of a batch that has successfully undergone the examination set out in point 1.10 shall be placed in a sterile straw, ampoule or other package marked in accordance with point 1.7 which shall be sealed immediately. 1.12. 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. 1.13. Each embryo collection team shall submit for official examination for bacterial and viral contamination routine samples of non-viable embryos or ova, flushing fluids or washing fluids resulting from its activities according to the IETS Manual. 1.14. Each embryo collection team shall keep a record of its activities in respect of embryo collection for a period of two years after the embryos have been the subject of trade or import, including: (

1. a)the breed, age and individual identification of the donor animals concerned; (
2. b)the place of collection, processing and storage of embryos collected by the team; (
3. c)the identification of the embryos together with details of the consignee of the shipment. 2. Collection and processing of ova, ovaries and other tissues, with the aim of producing in vitro derived embryos The conditions set out in points 1.1 to 1.14 shall apply mutatis mutandis to the collection and processing of ova, ovaries and other tissues for use in in vitro fertilisation and/or in vitro culture. In addition, the following shall apply: 2.1. The competent authority shall have knowledge of, and authority over, the holding(
4. s)of origin of the donor animals. 2.2. When ovaries and other tissues are collected at a slaughterhouse, either from individual animals or from batches of donors (batch collection), the slaughterhouse shall be officially approved in accordance with Regulation (EC) No 854/ 2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption and under the supervision of a veterinarian whose responsibility it is to ensure that ante-mortem and post-mortem inspections of potential donor animals are carried out and to certify them to be free of signs of the relevant contagious diseases transmissible to animals. The slaughterhouse shall, as regards susceptible species, be situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius. 2.3. Batches of ovaries shall not be brought into the processing laboratory until post- ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 41 mortem inspection of donor animals is completed. 2.4. Equipment for removal and transport of ovaries and other tissues shall be cleansed and disinfected or sterilised before use and exclusively used for these purposes. 3. Processing of in vitro derived embryos The conditions laid down in points 1.1 to 1.14 shall apply mutatis mutandis to the processing of in vitro derived embryos. In addition, the following shall apply: 3.1. In vitro derived embryos shall be conceived as a result of in vitro fertilisation with semen meeting the requirements of Directive 92/65/EEC. 3.2. After the in vitro culture period is completed but prior to freezing, storage and transport of the embryos, they shall be washed and undergo the treatments referred to in points 1.8, 1.10 and 1.11. 3.3. Embryos from different donor animals, in the case of individual animal recovery, or from different batch collections shall not be washed together. 3.4. Embryos from different donor animals, in the case of individual animal recovery, or from different batch collections shall not be stored in the same straw, ampoule or other package. 4. Processing of micromanipulated embryos Prior to any micromanipulation which compromises the integrity of the zona pellucida, all embryos or ova shall be collected and processed according to the sanitary conditions set out in points 1, 2 and 3. In addition, the following conditions shall apply: 4.1. Where micromanipulation of the embryo which involves penetration of the zona pellucida is carried out, this shall be done in suitable laboratory facilities under supervision of an approved team veterinarian. 4.2. Each embryo collection team shall keep records of its activities according to point 1.14, including details of micromanipulation techniques which involve penetration of the zona pellucida and which have been performed on the embryos. In the case of embryos derived by in vitro fertilisation, the identification of the embryos may be done on the basis of a batch, but shall contain details of the date and place of collection of ovaries and/or ova. It shall also be possible to identify the holding of origin of the donor animals. 5. Storage of embryos 5.1. Each embryo collection and production teams shall ensure that the embryos are stored at suitable temperatures in storage premises referred to in point 1.8 of Section III of Chapter I. 5.2. Frozen embryos shall, prior to dispatch, be stored in approved conditions for a minimum period of 30 days from the date of their collection or production. 6. Transport of embryos 6.1. Embryos to be subject for trade shall be transported to the Member State of destination in containers which have been cleansed and disinfected or sterilised before use, or are single-use containers, and which have been sealed and numbered prior to dispatch from the approved storage premises. 6.2. The straws, ampoules or other packages shall be marked in such a way that the number on the straws, ampoules or other packages coincides with the number on the health certificate referred to in the third indent of Article 11

(3)and with the container in ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS 42 [ S.L.437.98 which they are stored and transported. CHAPTER IV Requirements applicable to donor females

1. Donor females shall only be used for the collection of embryos or ova if they and the holdings from which they originate meet, to the satisfaction of the official veterinarian, the requirements of the relevant Directives on intra-Union trade in live animals for breeding and production for the species concerned.
2. In addition to the requirements laid down in Directive 64/ 432/EEC, donor females of porcine species shall, except in vivo derived embryos subject to a trypsin treatment, comply with the requirements for Aujeszky’s disease laid down in accordance with Article 9 or 10 of that Directive.
3. The provisions of Directive 91/68/EEC shall apply to donor females of ovine and caprine species.
4. In addition to the requirements laid down in Directive 90/ 426/EEC, donor mares shall: 4.
5. not be used for natural breeding during at least 30 days prior to the date of collection of ova or embryos and between the date of the first sample referred to in points 4.2 and 4.3 and the date of the collection of ova and embryos; 4.
6. be subjected with negative result to an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia carried out on a blood sample taken not less than 14 days following the date of the commencement of the period of at least 30 days referred to in point 4.1 and not more than 90 days prior to the collection of ova or embryos for trade; 4.
7. be subjected to an agent identification test for contagious equine metritis, carried out with negative result in each case in a laboratory referred to in point 1.5 of Chapter (II)(I) on at least two specimens (swabs) taken from the donor mare in no case earlier than seven days (systemic treatment) or 21 days (local treatment) after possible antimicrobial treatment of the donor mare, from at least the following sites: - the mucosal surfaces of the clitoral fossa, - the clitoral sinuses. The specimens shall be taken during the period referred to in point 4.1 on two occasions with an interval of not less than seven days in the case of the test referred to in point (i), or on one occasion in the case of the test referred to in point (ii). The specimens shall be placed in transport medium with activated charcoal, such as Amies medium, before dispatch to the laboratory. The specimens shall be subjected to at least one of the following tests: (i) culture under microaerophilic conditions for at least seven days for the isolation of Taylorella equigenitalis, set up within 24 hours after taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport; or (ii) polymerase chain reaction (PCR) or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within 48 hours after taking the specimens from the donor animal. ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 43 SCHEDULE E Part 1 - Health Certificate for trade in animals from holdings (ungulates, birds vaccinated against avian influenza, lagomorphs, dogs, cats and ferrets) 92/65 EI 44 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 45 46 [ S.L.437.98 ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT SUBJECT TO ANIMAL HEALTH REQUIREMENTS LAID DOWN IN SPECIFIC COMMUNITY ACTS [ S.L.437.98 Part 2 - Health certificate for trade in bees and bumble bees 92/65 EII 47 48 [ S.L.43