Animal Health Requirements governing Trade in and Imports into the Community of Animals, Semen, Ova and Embryos not subject to Animal Health Requirements laid down in Specific Community Acts Rules, 2015 (L.N. 192 of 2015)

B 1644 L.N. 192 of 2015 VETERINARY SERVICES ACT (CAP. 437) Animal Health Requirements governing Trade in and Imports into the Community of Animals, Semen, Ova and Embryos not subject to Animal Health Requirements laid down in Specific Community Acts Rules, 2015 IN exercise of the powers conferred by article 37(2) of the Veterinary Services Act, the Minister for Sustainable Development, the Environment and Climate Change has made the following rules: CHAPTER I General provisions Citation and scope. 1. (1) The title of these rules is the Animal Health Requirements governing Trade in and Imports into the Community of Animals, Semen, Ova and Embryos not subject to Animal Health Requirements laid down in Specific Community Acts Rules, 2015. (2) These rules lay down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to in Schedule F which shall apply without prejudice to the provisions adopted pursuant to other national rules and community rules which may apply in this regard. These rules shall apply without prejudice to the provisions adopted pursuant to Commission Regulation (EEC) No 3626/82 These rules shall not affect national rules applicable to pet animals, although their retention may not jeopardize the abolition of veterinary checks at the frontiers between Member States. These rules shall be read together with Council Regulation (EU) No. 576/2013 on the non commercial movement of pet animals and repealing Regulation (EC) No.998/2003 and Council Regulation (EU) No. 577/ 2013 on the model identification documents for the non-commercial movement of dogs, cats and ferrets, the establishment of lists of territories and third countries and the format, layout and language requirements of the declarations attesting compliance with certain conditions provided for in Regulation (EU) No 576/2013 of the European Parliament and of the Council. (3) The scope of these rules is to transpose Directive 92/65/ EEC with all amendments, including Directive 2013/31/EU, thereto VERŻJONI ELETTRONIKA B 1645 and related Decisions. Interpretation. 2. Unless otherwise provided in these Rules, the following definitions shall apply and the definitions, other than those of approved centres and bodies, contained in any other law or rule governing trade shall mutatis mutandis apply, unless they are inconsistent with these rules: Cap. 437."Act" means the Veterinary Services Act; "animals" means specimens of animal species other than those animals referred to in other Community law, in Directives 64/432/ EEC, 90/426/EEC, 90/539/EEC, 91/67/EEC, 91/68/ EEC, 91/492/ EEC and 91/493/EEC, which mean (a) Ungulates: (i) bovine animals including specimens of the species Bubalis bubalis; (ii) swine (with the exception of feral pigs); (iii) equidae including all wild or domesticated animals of the equine (including zebras) or asinine species or the offspring of crossings of those species; (iv) ovine or caprine animals; (b) poultry including: (i) fowl, turkeys, guinea fowl, ducks, geese, quails, pigeons, pheasants, partridges and ratites (Ratitae) reared or kept in captivity for breeding, the production of meat or eggs for consumption, or for re-stocking supplies of game; (ii) hatching eggs meaning eggs for incubation, laid by poultry; and (iii) ‘day-old chicks’ of all poultry which are less than 72 hours old, not yet fed; however, muscovy ducks (Cairina moschata) or their crosses may be fed; (c) imported aquaculture animals and products thereof including consignments in transit; (d) ‘bivalve molluscs’ which means filter-feeding lamellibranch molluscs; VERŻJONI ELETTRONIKA B 1646 (e) animals as defined in Regulation (EU) No 576/2013 of the European Parliament and of the Council. The term ‘animals’, shall not apply to: (a) ornamental aquatic animals reared in non commercial aquaria; (b) wild aquatic animals harvested or caught for direct entry into the food chain; (c) aquatic animals caught for the purpose of production of fishmeal, fish feed, fish oil and similar products. The term ‘animals’ applies to all animals listed in Schedule H, Parts A and B, as well as all other animals not excluded by the previous paragraphs; "approved body, institute or centre" means any permanent, geographically limited establishment, approved in accordance with rule 13, where one or more species of animal are habitually kept or bred, whether or not for commercial ends, and exclusively for one or more of the following purposes: S.L. 439.08 display of the animals and education of the public holding a zoo licence in terms of the Keeping of Wild Animals in Zoos Regulations; conservation of the species; S.L. 439.13 basic or applied scientific research or breeding of animals for the purposes of such research holding an authorisation or licence in terms of the Protection of Animals for Scientific Purposes Regulations; "aquaculture products" means all fishery products born and raised in controlled conditions until placed on the market as a foodstuff: However seawater or freshwater fish or crustaceans caught in their natural environment when juvenile and kept until they reach the desired commercial size for human consumption are also considered to be aquaculture products. Fish and crustaceans of commercial size caught in their natural environment and kept alive to be sold at a later date are not considered to be aquaculture products if they are merely kept alive without any attempt being made to increase their size or weight; VERŻJONI ELETTRONIKA B 1647 "authorisation" means any authorisation granted under these rules and in relation to authorised providers and services means a permit, licence, warrant, appointment, concession or any decision concerning access to a service activity or the exercise thereof; "authorised provider" means and includes any person who is a trader or importer in terms of these rules and who is in possession of an authorisation issued in his favour by the Department of Trade to import and trade in animals and products of animal origin subject to trade from a Member State or third country to Malta; "commercial document" means a document that may or may not have tax value, which contains specific reference to the consignment together with means of identification of the consignment, which may accompany the consignment and it shall be used by the competent authorities together or not with the veterinary documentation, in order to carry out either a documentary or an identity check of the consignment, or both; "the Community" means the Community of the European Union; "competent authority" means the Veterinary Services in Malta, as referred to in the Act; "final consumer" means any natural or legal person purchasing animals and animal products subject to trade for his own use and not for resale or transfer purposes; "fishery products" means all seawater or freshwater animals or parts thereof, including their roes, excluding aquatic mammals, frogs and aquatic animals covered by Community acts, other than Directive 92/65/EEC; "health certificate" means a certificate issued by the competent authority of the country of origin or despatch as an appropriate means of guaranteeing and monitoring compliance as regards animals and products of animal origin subject to trade with animal health requirements and any other requirements contained in these rules; "importer" means a person who, in terms of an authorisation issued in his favour by the Department of Trade, is authorised to import in Malta animals and products of animal origin transported from any third country or other Member State VERŻJONI ELETTRONIKA B 1648 in terms of these rules; "Member State" means a State which is a member of the European Union; "monitoring programme" means a control or monitoring programme drawn up by the competent authority for the purpose of keeping of records of animals and products of animal of origin subject to trade with regard to the outbreak of notifiable diseases and of diseases referred to in Schedule B; "notifiable diseases" means the diseases listed in Schedule A; "official veterinarian" means a veterinarian of the approved body, institute or centre of origin appointed and approved by the competent authority who, for the purpose of these rules, shall be responsible to guarantee the animals’ health; "overriding reasons relating to public interest" means reasons recognised as such in case law of the European Courts of Justice and which reasons present a justification for the issue of an authorisation and, or the issue of a condition thereto and, or to any other policy decision taken in terms of such authorisation, when such authorisation, and, or condition and, or policy decision thereto could not have been issued or taken under normal circumstances but for such overriding reasons relating to public interest which include the following grounds: (a) public policy, public security, public safety and public health, provided that these grounds shall be interpreted within the meaning of Article 46 and Article 55 of the Treaty; (b) the maintenance of order in society; (c) social policy objectives; (d) the protection of the recipients of services; (e) consumer protection; (f) the prevention of fraud; (g) the protection of the environment; "placing on the market" shall have the same meaning provided for in the Act and the same meaning given to trade in these rules; "recipient" means any natural person who is a national of a VERŻJONI ELETTRONIKA B 1649 Member State, who benefits from rights conferred upon him by community acts or any legal person established in a Member State, who for professional or non-professional purposes, uses, or wishes to use, a service against non-economic considerations; "registered dealer" means an importer, exporter, person responsible for the load, brokers, middlemen and any legal person or entity involved in trade; "service activity" means any self-employed activity performed for economic considerations; "third country" means a country which is not a member of the European Community; "trade" shall have the meaning as defined by Article 9(2) of the Treaty as well as any transfer, movement or exchange between holdings or sites and, or all classes of natural and legal persons whether profitable or not; "the Treaty" means the treaty as established by the European Community; Cap. 379. "undertaking" shall have the same meaning as provided for under the Competition Act; and "veterinary checks" means any physical check and, or administrative formality, verification, control, monitoring, organisation of checks and any follow-up thereto with regard to animals and products of animal origin made by official veterinarians, and which shall apply in particular, to checks at the point of origin and checks carried out on arrival by the Member State of destination to guarantee animals’ health and to safeguard measures to be implemented in this regard, in order to ensure conformity with animal health requirements governing trade and which are intended for the protection, direct or otherwise, of public and, or animal health. CHAPTER II Provisions applicable to trade Prohibitions of, or restrictions on, trade for animal health reasons. 3. Trade, as referred to in rule 1(2), is not prohibited or restricted for animal health reasons other than those arising from the application of these rules or from other local and Community legislation, and in particular any safeguard measures taken. VERŻJONI ELETTRONIKA B 1650 Trading or placing on the market of animals. 4. (1) Animals cannot be traded or placed on the market unless they are identified and registered in accordance with Community rules and Maltese legislation. All animals and products of animal origin originating therefrom intended for trade or placed on the market shall have to be compliant with the national and Community health and zootechnical requirements at all stages of production and trade. (2) The competent authority shall implement the following inspection measures on arrival of animals also in transit in the territory of Malta: (a) the competent authority may, at entry points, control posts and, or at the places of destination of animals and products thereof, establish by means of non-discriminatory veterinary spot checks that animals and products being traded are compliant with all the relevant national and Community health and zootechnical requirements; it may take samples at the same time. Furthermore, checks may also be carried out during the transport of animals and products thereof in its territory where the competent authority has information leading it to suspect an infringement of the rules; (b) furthermore, where the animals originating in another State are intended (i) for an approved market or assembly centre as defined by Community rules, the operator thereof shall be responsible for the admission of animals not meeting the requirements of these rules. The competent authority must check, by means of non-discriminatory inspections of the certificates or documents accompanying the animals, that the animals meet the said requirements; (ii) for a slaughterhouse placed under the supervision of an official veterinarian, the latter must ensure, in particular on the basis of the certificate that only animals that meet the requirements of this rule are slaughtered. The operator of the slaughterhouse shall be responsible for slaughtering animals which do not meet the requirements of this rule; (iii) for a registered dealer who divides up the consignments or for any establishment not subject to permanent supervision, such dealer or establishment shall be regarded by the competent authority as the consignee of the animals and shall be responsible for the movement and, VERŻJONI ELETTRONIKA B 1651 or trade of animals which do not meet the requirements of this rule; (iv) for holdings, centres or organizations including, where the consignment is partly unloaded during transport, each animal or group of animals must be accompanied by the original health certificate or accompanying document until it reaches the consignee mentioned therein. (3) The consignees referred to in sub-rule (2)(b)(iii) and (iv) must: (a) be registered in an official register before starting to trade; (b) keep a record of all consignments and deliveries. before any consignment is divided up or subsequently marketed, and check that the identification marks, certificates or documents are present; (c) notify the competent authority of any irregularity or anomaly and, in the latter case, isolate the animals in question until the competent authority has taken a decision regarding them; (d) keep records of the subsequent destination of the animals and products of the divided consignments. (4) The records referred to in sub-rule (3) shall be preserved for a period of three years and the consignee shall make them available on request by the competent authority. The competent authority shall carry out random checks to verify compliance with these rules. (5) All the consignees appearing on the certificates or accompanying document S.L. 449.43 (a) shall, at the request of the competent authority and to the extent necessary to carry out the checks referred to in the this rule, report in advance the arrival of animals and products thereof from another Member State and, in particular, the nature of the consignment and the anticipated arrival date. This limit is established as not less than forty-eight hours in accordance with the provisions of the Trading Regulations; (b) shall keep, for a period of six months, the copies of the original health certificates or accompanying documents for VERŻJONI ELETTRONIKA B 1652 presentation to the competent authority, on request, of the animals or products thereof. (6) Animals referred to in rules 5 to 10 may, without prejudice to rule 13 and to the particular provisions to be adopted in implementation of rule 24, be the subject of trade only if they satisfy the conditions laid down in rules 5 to 10 and come from the holdings or businesses, referred to in rule 12(1) and (3), which are registered by the competent authority and which undertake to: (a) have the animals held examined regularly in accordance with Community and Maltese legislation and animal health programmes that are decided by the Director; (b) notify the competent authority, aside from the outbreak of notifiable diseases, of the outbreak of the diseases referred to in Schedule B for which the competent authority has drawn up a control or monitoring programme; (c) comply with the specific measures to control a disease which is of particular importance to Malta and is covered by a programme drawn up in accordance with rule 14 or a decision under rule 15(2); (d) place on the market for the purposes of trade only animals which show no signs of disease and which come from holdings or areas not subject to any ban on animal health grounds and with respect to animals not accompanied by a health certificate or a commercial document provided for in rules 5 to 11, only animals accompanied by self-certification by the operator stating that the animals in question do not at the time of dispatch show any obvious signs of disease and that his holding is not subject to any animal-health restrictions; and (e) comply with the requirements ensuring the welfare of the animals held in accordance with Community and Maltese legislation, or in line with national guidelines where such legislation is not available. Trade in apes. 5. (1) The competent authority shall ensure that trade in apes (simiae and prosimiae) is restricted solely to animals consigned from and to a body, institute or centre approved by the competent authority in accordance with rule 13 and that such animals are accompanied by a veterinary certificate corresponding to the specimen in Schedule E, the declaration in which must be completed by the official veterinarian of the body, institute or centre of origin to guarantee the animals’ health. VERŻJONI ELETTRONIKA B 1653 (2) The competent authority may, by way of derogation from sub-rule (1), authorize the acquisition by an approved body, institute or centre of apes belonging to an individual. Trade in ungulates. 6. Without prejudice to the provisions of rules 14 and 15, the competent authority shall ensure that ungulates of species other than those referred to in paragraph (a) of the definition ‘animals’ in rule 2, may be the subject of trade only if they meet the following requirements: (a) in general they (i) must be identified in accordance with Community rules and Maltese legislation to ensure traceability; (ii) must not be intended for slaughter under a programme for the eradication of an infectious disease; S.L. 437.50 S.L. 437.81 S.L. 437.48 S.L. 437.48 S.L. 437.50 S.L. 437.81 S.L. 437.79 (iii) must not have been vaccinated against foot and-mouth disease and must satisfy the relevant requirements of the Foot-and-Mouth Disease (Control Measures) Rules and the Foot-and-Mouth Disease (Control Measures) Rules as well as regulation 4 of the Animal Health Problems affecting Intra-Community Trade in Bovine Animals and Swine Regulations; (iv) must come from a holding, referred to in regulation 3(2)(b) and (c) of the Animal Health Problems affecting Intra-Community Trade in Bovine Animals and Swine Regulations, which is not the subject of animal health measures, particularly those taken under the Foot and-Mouth Disease (Control Measures) Rules, the Foot and-Mouth Disease (Control Measures) Rules and the Health Conditions governing Intra-Community Trade in Ovine and Caprine Animals Rules, as well as Directive 80/ 217/EEC, and have been kept therein permanently since birth or for the last thirty days before dispatch; (v) must be accompanied by a certificate corresponding to the specimen in Part I of Schedule E, bearing the declaration in Schedule; (b) in the case of ruminants: VERŻJONI ELETTRONIKA B 1654 S.L. 437.48 S.L. 437.79 (i) they must come from an officially tuberculosis-free and officially brucellosis-free herd in accordance with the Animal Health Problems affecting Intra-Community Trade in Bovine Animals and Swine Regulations or the Health Conditions governing Intra Community Trade in Ovine and Caprine Animals Rules and satisfy, as regards animal health rules, the relevant requirements laid down for the bovine species in regulation 3(2)(c), (d), (f), (g) and (h) of Directive 64/42/ EEC or rule 3 of Health Conditions governing Intra-Community Trade in Ovine and Caprine Animals Rules; (ii) where they do not come from a herd meeting the conditions laid down in paragraph (i), they must come from a holding in which no case of brucellosis or tuberculosis has been recorded in the forty-two days preceding loading of the animals and in which the ruminants have in the thirty days prior to dispatch undergone with negative results a test for brucellosis and tuberculosis; (iii) in accordance with the procedure laid down in Article 26 of Directive 92/65/EEC, provisions may be adopted regarding leucosis; (c) in the case of suidae: S.L. 437.48 (i) they must not have come from an area which is the subject of prohibition measures associated with the presence of African swine fever in accordance with regulation 9 of the Animal Health Problems affecting Intra Community Trade in Bovine Animals and Swine Regulations; (ii) they must come from a holding which is not subject to any of the restrictions laid down in Directive 80/ 217/EEC as a result of classical swine fever; S.L. 437.48 (iii) they must come from a brucellosis-free holding in accordance with the Animal Health Problems affecting Intra-Community Trade in Bovine Animals and Swine Regulations and satisfy the relevant animal health requirements laid down for swine in the said regulations; (iv) where they do not come from a herd meeting the conditions set out in the previous sub-paragraph, they must, in the thirty days prior to their dispatch, have undergone with negative results a test designed to show the VERŻJONI ELETTRONIKA B 1655 absence of antibodies to brucellosis; (d) the testing requirements referred to in this rule and their criteria shall be established in accordance with the procedure laid down in Article 26 of Directive 92/65/EEC; (e) under the procedure laid down in rule 12, the health certificates, specimens of which are reproduced in Schedule F, may be amended or supplemented, in particular in order to take account of the requirements of this rule; (f) the trader, owner, the keeper, the dealer, the importer, the consignee, the carrier, the retailer or any other person authorised under the Act to dispose of live animals shall be responsible for the animals being traded and shall abide by all the provisions of these rules and of article 37(1) of the Act at all times. Requirements in the case of birds subject to trade. S.L. 437.103 7. The competent authority shall ensure that birds, other than those referred to in the Animal Health Conditions (Intra-Community Trade and Imports from Third Countries of Poultry and Hatching Eggs) Rules, may be the subject of trade only if they meet the following requirements: (a) in general they must: (i) come from a holding in which avian influenza has not been diagnosed in the thirty days preceding the dispatch; (ii) come from a holding or an area not subject to restrictions under measures to be applied to combat Newcastle disease. S.L. 437.103Pending the implementation of the Community measures referred to in the Animal Health Conditions (Intra-Community Trade and Imports from Third Countries of Poultry and Hatching Eggs) Rules, national requirements for combating Newcastle disease shall continue to apply, in compliance with the general provisions of the Treaty; S.L. 437.40 (iii) have, in accordance with rule 10(1) 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, been quarantined, if they have been imported from a third country, in the quarantine of the VERŻJONI ELETTRONIKA B 1656 competent authority or approved quarantine or in the holding to which they were taken after they entered the territory of the Community; (b) in addition, psittacidae must: (i) not come from a holding nor have been in contact with animals from a holding on which psittacosis (Chlamydia psittaci) has been diagnosed. The period of prohibition since the last recorded case and the period of treatment under veterinary supervision recognized under the procedure provided for in Article 26 of Directive 92/65/EEC must be at least two months; S.L. 437.38 (ii) be identified in accordance with rule 3(1)(c) of the Veterinary and Zootechnical Checks applicable in Trade with Member States in certain Live Animals and Products Regulations. The methods for identifying psittacidae, and in particular sick psittacidae, shall be established under the procedure provided for in Article 26 of Directive 92/65/ EEC; (iii) be accompanied by a commercial document signed by the official veterinarian or by the veterinarian responsible for the holding or business of origin and empowered for this purpose by the competent authority. Requirements in the case of bees subject to trade. 8. The competent authority shall ensure that bees (Apis melifera) may be the subject of trade only if they meet the following requirements: (a) they come from an area which is not the subject of a prohibition order associated with an occurrence of American foulbrood. The period of prohibition must continue for at least thirty days following the last recorded case and the date on which all hives within a radius of three kilometres have been checked by the competent authority and all infected hives burned or treated and inspected to the satisfaction of the said competent authority. In accordance with the procedure laid down in Article 26 of Directive 92/65/EEC, and after consulting the Scientific Veterinary Committee, the requirements applied to bees (Apis VERŻJONI ELETTRONIKA B 1657 melifera) or equivalent requirements may be applied to bumble bees; (b) they are accompanied by a health certificate corresponding to the specimen in Schedule E, the declaration in which is completed by the competent authority to certify that the requirements laid down in paragraph (a) are met. Requirements in the case of lagomorphs subject to trade. 9. (1) The competent authority shall ensure that lagomorphs may be the subject of trade only if they meet the following requirements: (a) they must not come from or have been in contact with animals from a holding on which rabies is present or is suspected of having been present within the last month; (b) they must come from a holding in which no animal shows clinical signs of myxomatosis. (2) Rabbits travelling to Malta shall be accompanied by a health certificate corresponding to the specimen in Schedule E, supplemented by the following declaration: ‘I the undersigned, ............................ certify that the above consignment satisfies the requirements of Article 9 of Directive 92/ 65/EEC and that the animals showed no clinical sign of disease on examination.’. This certificate must be issued by the official veterinarian or by the veterinarian responsible for the holding of origin and empowered for this purpose by the competent authority and for industrial breeding, by the official veterinarian. Trade in mink and foxes. 10. (1) All trade in mink and foxes which come from or have been in contact with animals from a holding on which rabies is present or is suspected of having been present within the previous six months, inasmuch as no systematic vaccination programme is applied, is prohibited. (2) To be the subject of trade, dogs, cats and ferrets shall: (a) satisfy the conditions set out in Article 6 and, where applicable, in Article 7 of Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals; (b) undergo a clinical examination carried out within forty-eight hours prior to the time of dispatch of the animals by VERŻJONI ELETTRONIKA B 1658 a veterinarian authorised by the competent authority; and (c) be accompanied during transport to the place of destination by a health certificate which: (i) corresponds to the specimen in Part 1 of Schedule E; and (ii) is signed by an official veterinarian who shall attest that the veterinarian authorised by the relative competent authority of the Member State or country of despatch, has documented in the relevant section of the identification document in the format provided for in Article 21(1) of Regulation (EU) No 576/2013 the clinical examination carried out in accordance with paragraph (b) showing, at the time of the clinical examination, that the animals are fit to be transported for the intended journey in accordance with Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations. (3) Without prejudice to sub-rules (1) and (2), the regulations on quarantine for all carnivores, with the exception of the species referred to in sub-rule (2), as well as quarantine primates, bats and other animals susceptible to rabies covered by these rules which cannot be shown to have been born on the holding of origin and kept in captivity since birth, although the retention of those regulations may not jeopardize the abolition of veterinary checks at the frontiers between Member States. (4) The competent authority shall ensure that the costs of applying the serological test are borne by the owner or the importer, trader or person responsible for the load. Semen, ova and embryos which are the subject of trade. 11. (1) The competent authority shall ensure that, without prejudice to the decisions to be taken in implementation of rules 21 and 23, only semen, ova and embryos meeting the conditions laid down in sub-rules (2), (3), (4) and (5) are the subject of trade. (2) Semen of the ovine, caprine and equine species must, without prejudice to any criteria to be complied with for the entry of equids in stud books for certain specific breeds: VERŻJONI ELETTRONIKA B 1659 ‘ S.L. 437.79 (a) have been collected, processed and stored with a view to artificial insemination in a centre approved from the health point of view in accordance with Schedule D (CHAPTER I), or, in the case of ovine and caprine animals by way of derogation from the above, in a holding satisfying the requirements of the Health Conditions governing Intra Community Trade in Ovine and Caprine Animals Rules; (b) have been collected from animals meeting the conditions laid down in Schedule D (CHAPTER II); (c) have been collected, processed, preserved, stored and transported in accordance with Schedule D (CHAPTER III); (d) have been accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26 of Directive 92/65/EEC. (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 with the procedure referred to in Article 26 of Directive 92/65/EEC; (b) have been collected, processed and preserved in an appropriate laboratory, stored and transported in accordance with Schedule D (CHAPTER III); (c) be accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26 of Directive 92/65/EEC. S.L. 437.102 Semen used for the insemination of donor females must comply with the provisions of sub-rule (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 Deep Frozen Semen of Domestic Animals of the Porcine Species) Rules for swine. Any additional guarantees may be determined in accordance with the procedures referred to in Article 26 of Directive 92/65/EEC. VERŻJONI ELETTRONIKA B 1660 (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 with the procedure referred to in Article 26 of Directive 92/65/EEC. Organization of, and follow-up to, the checks to be carried out. S.L. 437.38 12. (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. S.L. 437.38 (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. S.L. 437.38 (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. VERŻJONI ELETTRONIKA B 1661 (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. Animals of species susceptible to diseases. 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 to 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) (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. (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. (c) The competent authority shall withdraw an approval in accordance with point 3 of Schedule C. (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. Voluntary or compulsory control or monitoring programme. 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: (a) the distribution of the disease in its territory, VERŻJONI ELETTRONIKA B 1662 (b) whether the disease is notifiable, (c) the reasons for undertaking the programme, taking account of its cost-effectiveness and the significance of the disease, (d) the geographical area in which the programme is to be implemented, (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, (f) the programme monitoring procedures, including the extent of the breeders’ involvement in implementing the control or monitoring programme, (g) the action to be taken if, for any reason, a holding loses its status, (h) the measures to be taken if the results of the tests carried out under the programme are positive, (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: (a) the nature of the disease and the history of its occurrence in its territory, VERŻJONI ELETTRONIKA B 1663 (b) the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation, (c) the period during which this disease was notifiable to the competent authorities, out, (d) the period over which the surveillance was carried (e) where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition, (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 sub rule (2) may, in the light of such notification, be amended or withdrawn under the procedure laid down in Article 26 of Directive 92/65/EEC. CHAPTER III Provisions applicable to imports into the Community Imports of animals, semen, ova and embryos covered by rules 17, 18, 19 and 20. 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. (3) In addition to the conditions referred to in sub-rule (2), VERŻJONI ELETTRONIKA B 1664 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. Uniform application of rule 16. 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 with the procedure referred to in Article 26 of Directive 92/65/EEC, signed by the competent authority of the exporting country and certifying that (i) the animals meet the additional conditions or offer the equivalent guarantees referred to in sub-rule (4), and come from approved centres, bodies, institutes offering guarantees at least equivalent to those in Schedule C; (ii) 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 with the procedure referred to in Article 26 of Directive 92/65/EEC. Pending the establishment of lists of third countries, approved establishments listed in paragraph (b), animal health requirements and specimen health certificates as referred to in paragraphs (a) and (b), the then current national rules shall continue to apply provided they are not more favourable than those laid down in Chapter II. VERŻJONI ELETTRONIKA B 1665 (3) In accordance with the information received, there shall be established: (a) in accordance with the procedure referred to in Article 26 of Directive 92/65/EEC, a list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II in relation to animals, semen, ova and embryos; and (b) a list of approved centres or teams as referred to in the rule 11(2)(a) and (3)(a) situated in one of the third countries appearing on the list referred to in paragraph (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 with the procedure referred to in Article 26 of Directive 92/65/EEC, the specific animal health requirements, in particular for the protection of the Community from certain exotic diseases, or guarantees equivalent to those provided for in these rules. The specific requirements and equivalent guarantees established for third countries may not be more favourable than those provided for in Chapter II. (4) The list provided for in sub-rule (3) may include only third countries or parts of third countries: (a) from which imports are not prohibited: (i) 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, (ii) 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 VERŻJONI ELETTRONIKA B 1666 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; (b) which, in view of their legislation and the organization of their veterinary services and inspection services, the 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 on the-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. Importation of animals, semen, ova and embryos into the Community. 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: (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; S.L. 437.40 (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, VERŻJONI ELETTRONIKA B 1667 S.L. 439.04 (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, (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 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: (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; (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 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 with the procedure referred to in regulation 19 of the said regulations. S.L. 437.40 (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). VERŻJONI ELETTRONIKA B 1668 CHAPTER IV Common final provisions Specimens of certificates applicable to trade. 21. 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. Schedules. 22. 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. Derogation from Chapter II. Cap. 439. 23. 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. Health certificate. 24. The competent authority shall allow the entry into Malta of 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. Non applicability of derogation. 25. 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. Reciprocal derogation from the provisions of Articles 6(A)(1)(f), 8(b) and 11(1)(d) of Directive 92/65/ EEC. 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 VERŻJONI ELETTRONIKA B 1669 and embryos. Transitional measures. 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. Offences and penalties. 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 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 antiparasitic 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. VERŻJONI ELETTRONIKA B 1670 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 28. Revocation of Legal Notice 351 of 2009. 30. 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, Rules, 2009, are hereby revoked. 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 Bluetongue Antilocapridae, Bovidae, Cervidae, Giraffidae, and Rhinocerotidae Brucella abortus Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae Brucella melitensis Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae Brucella ovis Camelidae, Tragulidae, Cervidae, Giraffidae, Bovidae and Antilocapridae Brucella suis Cervidae, Leporidae, Ovibos moschatus, Suidae and Tayassuidae Classical swine fever Suidae and Tayassuidae Contagious bovine pleuropneumonia Bovines (including zebu, buffalo, bison and yak) Ebola Non-human primates Foot-and-mouth disease Artiodactyla and Asian elephants VERŻJONI ELETTRONIKA B 1671 Infectious haematopoeitic necrosis Salmonidae Lumpy skin disease Bovidae and Giraffidae Monkey pox Rodentia and non-human primates Mycobacterium bovis Mammalia, in particular Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, and Tragulidae Newcastle disease Aves Peste des petits ruminants Bovidae and Suidae Porcine enterovirus encephalomyelitis Suidae Psitacosis Psittaciformes Rabies Carnivora and Chiroptera Rift valley fever Bovidae, Camelus species and Rhinocerotidae Rinderpest Artiodactyla Small hive beetle (Aethina tumida) Apis and Bombus Sheep and goat pox Bovidae Swine vesicular disease Suidae and Tayassuidae Tropilaelaps mite (Tropilaelaps spp.) Apis Vesicular stomatitis Artiodactyla and Equidae TSE Bovidae, Cervidae, Felidae and Mustelidae VERŻJONI ELETTRONIKA B 1672 SCHEDULE B List of diseases for which national programmes may be recognized under Directive 92/65/EEC SCHEDULE C Conditions governing approval of bodies, institutes or centres 1. 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)(c) must: (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; (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; (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; Mink Viral enteritis Aleutian disease Bees European foulbrood varroasis and acariasis Apes and felids Tuberculosis Ruminants Tuberculosis Lagomorphs Myxomatosis Viral haemorrhagic disease Tularaemia VERŻJONI ELETTRONIKA B 1673 (d) keep up to date records indicating: (i) the number and identity (age, sex, species and individual identification where practical) of the animals of each species present in the establishment; (ii) 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; (iii) the results of blood tests or any other diagnostic procedures; (iv) cases of disease and, where appropriate, the treatment administered; (v) the results of the post-mortem examinations on animals that have died in the establishment, including still-born animals; (vi) observations made during any isolation or quarantine period; (e) either have an arrangement with a competent laboratory to perform post-mortem 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; (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; (g) secure, by contract or legal instrument, the services of a veterinarian approved by and under the control of the competent authority, who: (i) shall comply mutatis mutandis with the requirements referred to in Article 14(3)(B) of Directive 64/432/EEC, (ii) 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: VERŻJONI ELETTRONIKA B 1674 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; (iii) 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; (iv) 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; (v) 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; (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: (a) the premises are under the control of an official veterinarian from the competent authority, who: (i) shall visit the premises of the body, institute or centre at least once per year; (ii) shall audit the activity of the approved veterinarian and the implementation of the annual disease surveillance plan; (iii) shall ensure that the provisions of Directive VERŻJONI ELETTRONIKA B 1675 92/65/EEC are met; (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; (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; (d) the body, institute or centre keeps the records referred to in point 1(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(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. For other animals undergoing quarantine in accordance with point 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. VERŻJONI ELETTRONIKA B 1676 6. The procedures for partly or completely suspending, withdrawing or restoring approval are the following: (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; (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; (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; (d) the competent authority shall inform the Commission of the suspension, withdrawal or restoration of approval of a body, institute or centre. VERŻJONI ELETTRONIKA B 1677 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: (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; (b) isolation facilities which have no direct communication with the normal animal accommodation; (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 (d) a separate room for the cleansing and disinfection or sterilisation of equipment; (e) a semen processing room separated from the collection facilities and the room for cleansing equipment referred to in point (d) which need not necessarily be on the same site; (f) a semen storage room which need not necessarily be on the same site; 1.3. 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. VERŻJONI ELETTRONIKA B 1678 2. In order to be given approval each semen storage centre shall: 2. In order to be given approval each semen storage centre (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; (b) be placed under the permanent supervision of a centre veterinarian authorised by the competent authority; (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; (d) be so constructed that contact with outside livestock or other animals is prevented; (e) be so constructed that the entire centre except the office rooms and, in the case of equidae the exercise area, can be readily cleansed and disinfected; (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: (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 VERŻJONI ELETTRONIKA B 1679 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; (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; (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: (a) records are kept which show: (i) the species, breed, date of birth and identification of each animal present in the centre; (ii) any movement of animals entering or leaving the centre; (iii) the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on animals kept; (iv) the date of collecting and processing semen; (v) the destination of semen; (vi) the storage of semen; (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; (c) the collection, processing and storage of semen is carried out only in premises set aside for these purposes; (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, VERŻJONI ELETTRONIKA B 1680 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; (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; (f) cryogenic agents used for the preservation or storage of semen have not been previously used for other products of animal origin; (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); (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: (a) the status of the donor animals whose semen is stored at the centre complies with the requirements of Directive 92/65/EEC; (b) the requirements laid down in points 1.1(b) and (c) are complied with; (c) records are kept of all movement of semen entering and leaving the storage centre; VERŻJONI ELETTRONIKA B 1681 2.2. be monitored that: (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; (b) storage of semen takes place only on the premises set aside for the purpose and under strict conditions of hygiene; (c) all instruments which come into contact with the semen are properly disinfected or sterilised prior to use, except for single-use instruments; (d) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers; (e) cryogenic agents used for preservation or storage of semen have not been previously used for other products of animal origin; (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 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: VERŻJONI ELETTRONIKA B 1682 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: (a) verification of the identity and health status of the donor animal; (b) sanitary handling and surgery of donor animals; (c) disinfection and hygienic procedures; (d) keeping records which show: (i) the species, breed, date of birth and identification of each donor animal; (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; (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: (a) a room where embryos can be processed which is VERŻJONI ELETTRONIKA B 1683 physically separate from the area used to handle the donor animals during collection; (b) a room or area for cleansing and sterilising instruments, except when using only single-use equipment; (c) a room for storing embryos; 1.6. in the case of a mobile laboratory, it shall: (a) have a specially equipped part of the vehicle consisting of two separate sections: (i) one for the examination and processing of embryos which shall be a clean section; and (ii) the other for accommodating equipment and materials used in contact with the donor animals; (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: (a) comprise at least one lockable room for the storage of ova and embryos; (b) be easy to cleanse and disinfect; (c) have permanent records of all incoming and outgoing ova or embryos; (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: VERŻJONI ELETTRONIKA B 1684 (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; (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: (a) have adequate equipment and facilities, including separate rooms for: recovering oocytes from ovaries, processing oocytes, ova and embryos, storing embryos; (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 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 VERŻJONI ELETTRONIKA B 1685 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: (a) an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia with negative result; (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; (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), VERŻJONI ELETTRONIKA B 1686 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: (i) culture under microaerophilic conditions for at least 7 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. 1.6. it shall be subjected to one of the following testing programmes: (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; (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: VERŻJONI ELETTRONIKA B 1687 (i) 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 (ii) 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(a) on samples taken not more than 90 days prior to the collection of semen for trade, the test required in point 1.5(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(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; (c) if the donor stallion does not meet the conditions in points (a) and (b) and the semen is collected for trade in frozen semen, the tests required in point 1.5 shall be carried out on samples collected from the donor stallion as follows: (i) at least once a year at the beginning of the breeding season; (ii) during the storage period provided for in point 1.3(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. VERŻJONI ELETTRONIKA B 1688 By way of derogation from point (ii) of the first sub-paragraph, post-collection sampling and testing for equine viral arteritis as described in 1.5(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 VERŻJONI ELETTRONIKA B 1689 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; 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): (a) for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/ EEC; (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; (c) for Border disease: (i) a virus isolation test or a test for virus antigen; and (ii) 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 VERŻJONI ELETTRONIKA B 1690 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: (a) for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/ EEC; (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)(i) and (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. 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: VERŻJONI ELETTRONIKA B 1691 (a) it 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; (b) it has for the past three months been free from foot and-mouth disease and brucellosis; (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 cloven-hoofed 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: (a) for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/ EEC; (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; (c) for Border disease, the antibody test referred to in point 1.4(c)(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 VERŻJONI ELETTRONIKA B 1692 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: (a) show no clinical signs of disease on the date the semen was collected; (b) during the 12 months prior to the date of the collection of the semen: (i) either have not been vaccinated against foot and-mouth disease; or (ii) 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; (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; (d) meet the requirements laid down in Articles 4, 5 and 6 of Directive 91/68/EEC; (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: (i) a serological test for brucellosis (B. melitensis) carried out in accordance with Annex C to Directive 91/68/EEC; (ii) 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 VERŻJONI ELETTRONIKA B 1693 documented sensitivity and specificity; (iii) a test for the Border disease virus; (f) 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 (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 (150/300-spectinamikacin (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: (a) be placed and stored in storage containers: (i) which have been cleansed and disinfected or VERŻJONI ELETTRONIKA B 1694 sterilised before use, or are single-use containers; (ii) with a cryogenic agent; which shall not be previously used for other products of animal origin; (b) prior to dispatch or use, be stored in approved conditions for a minimum period of 30 days from the date of collection. 1.4. Semen to be subject for trade shall: (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; (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. VERŻJONI ELETTRONIKA B 1695 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 micro-organisms. 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 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. VERŻJONI ELETTRONIKA B 1696 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: (a) the breed, age and individual identification of the donor animals concerned; (b) the place of collection, processing and storage of embryos collected by the team; (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(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-mortem inspection of donor animals is completed. VERŻJONI ELETTRONIKA B 1697 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. VERŻJONI ELETTRONIKA B 1698 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 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: 4.1. 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 VERŻJONI ELETTRONIKA B 1699 collection of ova and embryos; 4.2. 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; 4.3. 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. VERŻJONI ELETTRONIKA B 1700 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 VERŻJONI ELETTRONIKA B 1701 VERŻJONI ELETTRONIKA B 1702 VERŻJONI ELETTRONIKA B 1703 VERŻJONI ELETTRONIKA B 1704 Part 2 - Health certificate for trade in bees and bumble bees 92/65 EII VERŻJONI ELETTRONIKA B 1705 VERŻJONI ELETTRONIKA B 1706 Part 3 - Health certificate for trade in animals, semen, ova and embryos from approved bodies, institutes or centres - 92/65 EIII VERŻJONI ELETTRONIKA B 1707 SCHEDULE F CD64/432 as transposed into SL437.48, Council Directive 64/432/ EEC of 26 June 1964 on animal health problems affecting intra Community trade in bovine animals and swine S.L. 437.48 Animal Health Problems affecting Intra-Community Trade in Bovine Animals and Swine Regulations VERŻJONI ELETTRONIKA B 1708 CD88/407 as transposed into SL437.99, Council Directive 88/407/ EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species S.L. 437.99 Animal Health Conditions Applicable to Intra-Community Trade and Imports from Third Countries of Deep-Frozen Semen of Domestic Animals of the Bovine Species Rules CD89/556 as transposed into SL437.100, Council Directive 89/556/ EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species S.L. 437.100 Animal Health Conditions Governing Intra-Community Trade and Importation from Third Countries of Embryos of Domestic Animals of the Bovine Species Rules CD90/426 as transposed into SL.437.60, Council Directive 90/426/ EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of Equidae S.L. 437.60 Animal Health Conditions governing the Movement and Import from Third Countries of Equidae Rules CD90/429 as transposed into SL437.102, 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 S.L. 437.102 Animal Health Conditions (Intra-Community Trade and Imports from Third Countries of Deep-Frozen Semen of Domestic Animals of the Porcine Species) Rules VERŻJONI ELETTRONIKA B 1709 SCHEDULE G Declaration I, the undersigned (official veterinarian), certify that the ruminant(s)(1)/suida(e)(1) other than that (1)/those(1) covered by Directive 64/432/EEC: ............................................... belong/belongs(1) to the (species) At the time of examination, do(1)/does not(1) show any clinical sign of any disease to which it(1)/they(1) is(1)/are(1) susceptible; Come(s) from an officially tubercolosis-free(1)/officially brucellosis free(1) or brucellosis-free herd(1)/ holding(1) not subject to swine fever restrictions or from a holding where it(1)/ they(1) was(1)/ were(1) subjected with negative results to the test(s) laid down in Article 6(2)(b) of Directive 92/65/EEC. (1) Delete where inapplicable; Signature of Official veterinarian. Competent authority Date VERŻJONI ELETTRONIKA B 1710 SCHEDULE H (Part A) • All species of the order Scorpiones (scorpions) except those belonging to the species Euscorpius sicanus. • Spiders belonging to the order Solifugae (camel spider), the species Atrax robustus (funnel web spider) and others that may be poisonous to the extent of killing a human being with their poison. • All species of the orders Scutigeromorpha, Lithobiomorpha, Craterostigmomorpha, Scolopen-romorpha and Geophilomorpha (centipedes) that may be poisonous to the extent of killing a human being with their poison except those belonging to the native species occurring in the Maltese natural habitat. • All species of poisonous reptiles with specific reference to the Crotalids, Cobras, Mambas and Aspids. • All species of the order Crocodilia (crocodiles and alligators) and Varanus komodensis (komodo dragon). • All species of poisonous amphibians. • All species of the order Dasyuro morphia (marsupial carnivores as the dasyurids, the tasmanian devil, thylacine, numbat, et. al.). • All species of the order Pera mele morphia (bandicoots et. al.). • All species of the family Nandiniidae (the African palm civet et. al.). • All species of the family Felidae (felines) except those belonging to Felis catus domesticus. • All species of the family Viverridae (civets et. al.) including all subspecies of the subfamily Prinonodontidae (the Asiatic linsangs et. al.). • All species of the family Hyaenidae (hyenas et. al.). • All species of the family Eupleridae (Malagasy carnivores et. al.). • All species of the family Herpestidae (mongooses et. al.). VERŻJONI ELETTRONIKA B 1711 • All species of the family Canidae (dogs and wolves) except those belonging to Canis lupus familiaris but not the Dingo. • All species of the family Ursidae (bears et. al.). • All species of the family Ailuridae (red panda et. al.). • All species of the family Odobenidae (walruses et. al.). • All species of the family Otariidae (sea lions et. al.). • All species of the family Phocidae (seals et. al.). • All species of the family Rhinocerotidae (rhinos). • All species of the family Hippopotamidae (hippos). • All species of the family Proboscinae (elephants). • All species of the order Cetacea (cetaceans). • All species of the family Hylobatidae (gibbons et. al.). • All species of the family Hominidae or Ponginae, (great apes including gorillas, chimpanzees and orangutangs et. al.) except those belonging to Homo sapiens. • All species of the genus Popio (baboons et. al.). • All species of the genus Mandrillus (mandrills et. al.). (Part B) • All members of the Order Squamata not included in Schedule A and not part of the local fauna. • All members of the Order Testudines. • All the members of Amphibians not included in Schedule A and not part of the local fauna. • Members of the class Aves, of the Orders Accipitriformes, Falconiformesand the Order Psittaciformes except budgerigars, cockatiels and lovebirds. • Members of the Order Artiodactyla not mentioned in Schedule A and not normally domesticated. This excludes bovines, ovines, caprines and pigs normally kept in farming practice. Dwarf and exotic breeds of these farming animals accepted by VERŻJONI ELETTRONIKA B 1574 Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper Prezz/Price €6.30 B 1712 the Director will be registered under these rules. The carcasses of these animals will not enter the food chain. • The members of the Order Perissodactyla except domestic equines. • All the members of the Order Primates not included in Schedule A and not including Homo sapiens. • All the members of the Orders Chiroptera, Dermoptera, Didelphimorphia, Diprotodontia, Hyracoidea, Insectivora, Macroscelidea,Microbiotheria, Monotremata, Notoryctemorphia,Puacituberculata, Pholidota, Scandentia, Sirenia, Tubulidentata, Xenarthra and not part of the local fauna. • All members of the Families Mephitidae, Procyonidae, Erethinzontidae, Hystricidae, Aplodontiidae and Hydrochoeridae. VERŻJONI ELETTRONIKA