L.S. 437.100(R) Regoli dwar il-Kondizzjonijiet ta’ Saħħa tal-Annimali li jirregolaw il-Kummerċ intra-Komunitarju u l-Importazzjoni minn Pajjiżi Terzi

(1)The title of these rules is the Animal Health Conditions Governing Intra-Community Trade and Importation from Third Countries of Embryos of Domestic Animals of the Bovine Species Rules. Citation and scope.

(2)The scope of these rules is to transpose Directive 89/556/ EEC laying down animal health conditions governing intraCommunity trade and importation from third countries of embryos of domestic animals of the bovine species, and shall apply without prejudice to the provisions adopted pursuant to other regulations and community rules and other national legislation regarding domestic or pet animals which may apply in this regard.

(3)These rules are being made for the safeguarding of the public interest and public safety. Any requirements and safeguard measures contained therein including those relating to authorisations are made for overriding reasons relating to public interest. 2.

(1)Unless stated otherwise in these rules, the definitions in the Act, those contained under 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 and those contained under the Animal Health Problems Affecting IntraCommunity Trade in Bovine Animals and Swine Regulations shall continue to apply. Interpretation. S.L. 437.98 S.L. 437.48

(2)For the purpose of these rules and unless the context otherwise requires the following definitions shall apply: "the Act" means the Veterinary Services Act; "animals of the bovine species" means bovine animals whose embryos are subject to intra-Community trade and imports from third countries, after being removed from a female donor for the purpose of being transmitted, transplanted or injected to the female recipient; *These rules have been repealed by Legal Notice 77 of 2025. †see rule 1

(4)as originally promulgated. Cap. 437. 2 ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES "approved diagnostic laboratory" means a laboratory situated in a Member State or third country approved by the competent veterinary authority to carry out the diagnostic tests laid down in these rules; "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; S.L. 437.98 "authorised provider" shall have the same meaning as that provided under 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; "the Commission" means the European Commission; "the Community" means the European Community as established by the Treaty of the European Union; "the competent authority" means the Department responsible for veterinary services in Malta as established by the Act; "consignment of embryos" means a quantity of embryos removed in one operation from a single female donor and covered by a single certificate; "country of collection" means the Member State or third country in which embryos are produced, collected, processed and, where necessary, stored, and from which they are sent to a Member State; "the Director" means the Director responsible for veterinary services or any veterinarian officer nominated by him; "embryo" means the initial stage of development of a domestic animal of the bovine species while it is capable of being transferred to a recipient dam or a female parent of such species; "embryo collection team" means an officially approved group of t e c h ni c i a n s o r st r u c t u r e su p e r v i s e d b y a t e a m v e t e r i n a r ia n competent to perform the collection, processing and storage of embryos according to the conditions set out in Schedule A; "embryo transfer (ET)" means the transfer of embryos from the female donor to the female recipient, being a practiced method of multiplying the genetic of animals of the bovine species for the purpose of these rules. It is the process by which an embryo is collected (flushed) from one female donor and transferred to another female recipient to complete the gestation period; S.L. 437.98 "final consumer" shall have the same meaning as that provided for under 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; "gestation period" means the time in which a fetus develops, beginning with fertilization and ending at birth; ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.100 "health certificate" means a certificate properly issued by the competent authority in accordance with Schedule C, as a means of guaranteeing and monitoring compliance with animal health requirements as regards animals and products of animal origin subject to trade for the purpose of these rules; "Member St ate" m eans a St ate which is a m ember to the European Union; "Member State of destination" means such Member State to which embryos are transported from the embryo collection centre or estab lish men t o f origi n si tuat ed in the Mem ber State of collection or in a third country; "official veterinarian" shall have the same meaning as that provided for under 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; "the product" means any product of animal origin subject to trade and trading purposes; "Standing Committee on the Food Chain and Animal Health" or "the Committee" means a Committee made up of Member States’ representatives named committee members, who assist and consult the Com mission by delivering an Opinion regarding safety measures with respect to animal health issues to be then formally adopted by the Commission in accordance with the appropriate procedure. Such committee procedure covers the entire food supply chain, ranging from animal health issues on the farm to the product which arrives to the final consumer, therefore significantly enhancing its ability to target risks to health wherever they arise in the production of food; "team veterinarian" means the veterinarian responsible for the supervision of an embryo collection team in accordance with the conditions laid down in Schedule A; "third country" means a country which is not a member of the European Community; "trade" means for the purpose of these rules, trade between Member States or between Member States and a third country in animals and their products, a business or occupation to make profit or gain, particularly in wholesale or retail and includes dealings in a particular business activity; "the Treaty" means the treaty as established by the European Community; S.L. 437.98 3 4 S.L. 437.98 S.L. 437.41 Applicability. ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES "veterinary checks" means checks or import controls carried out on embryos of domestic animals of the bovine species, either upon importation from the Community or from a third country subject to their respective procedures, as provided under 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 for veterinary checks carried out on imports into the Community, and under the Principles Governing the Organisation of Veterinary Checks on Products Entering the Territory of Malta from Third Countries Regulations, for veterinary checks carried out via border inspection posts on imports from third countries. 3.

(1)These rules shall apply to: (

1. a)the use of embryos of domestic animals of the bovine species as part of an efficient breeding policy which leads to better productivity and increased margins in this sector; (
2. b)the free movement of such embryos which encourage a rational development, taking into account the use of optimum production factors; (
3. c)the fulfilling of guarantees regarding animal health criteria with regard to intra-Community trade and imports into the Community of bovine animals from third countries, so that the risk of animal disease spreading is eliminated in the case of trade in embryos; (
4. d)the harmonization of national animal health provisions governing intra-Community trade in animals and animal products, and the necessity to create a harmonized system for intra-Community trade and imports into the Community of embryos of domestic animals of the bovine species; (
5. e)the obligations of the Member State of collection to ensure that: (
6. i)such embryos have been collected and processed by approved and supervised embryo collection teams; (
7. ii)they have been obtained from animals whose health status is such as to ensure that the risk of spread of animal disease is eliminated; (iii) they have been collected, processed, stored and transported in accordance with the rules which preserve their health status and are accompanied during transport to the Member State of destination by an animal health certificate in order to ensure that such obligation has been fulfilled; (
8. f)vaccination against foot-and-mouth disease justifying the maintenance, for fresh embryos, of derogations, ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.100 5 limited in time, authorizing additional protection by Member States against that disease; (
9. g)a list of third countries which should be drawn up, taking into account animal health criteria, from which embryos may be imported into the Community, provided that without prejudice to such a list, approval or authorisation of imports of embryos may also be suspended or withdrawn, if it is deemed appropriate to Member States that animal health criteria and standards have not been satisfied or fulfilled; (
10. h)on-the-spot checks which may be carried out in order to verify compliance with animal health standards and criteria; (
11. i)the prevention against transmission of certain contagious diseases, whereby import controls should be carried out when a consignment of embryos arrives and is placed on the market of the Community, and the measures to be taken by Member States after such controls have been defined, in case of internal transit.

(2)These rules shall not apply to embryos resulting from in vitro fertilization nor to embryos subjected to sexing, splitting (twinning), cloning or any manipulation which interferes with the integrity of the zona pellucida.

(3)The Director shall apply all such necessary administrative measures conforming to the requirements of the Food Chain and Animal Health according to the requirements of these rules, to ensure that there is no breach of these rules and also to reduce the risk for final consumers and any additional risk to animals and to the environment.

(4)These measures shall include the direct confiscation of the product, the suspension of the activities carried out by the auth orised provi der wh en t hese are c reating a risk to final consumers and to the environment, and the forfeiture of any authorisation, licence or permit in addition to the application of any other administrative penalty in terms of article 61 of the Act. 4. The competent authority shall ensure that embryos shall not be sent from Malta to another Member State unless they meet the following conditions: (a) they shall have been conceived as a result of artificial insemination with semen from a donor sire or male parent of the bovine species standing at a semen collection centre as defined in rule 2

(2)of the Animal Health Conditions Applicable to Intra-Community Trade and Imports from Third Countries of DeepFrozen Semen of Domestic Animals of the Bovine Species Rules; (

1. b)they shall have been collected from domestic animals of the bovine species whose health status complies with Schedule B; Intra-Community trade. S.L. 437.99 6 ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES (
2. c)they shall have been collected, processed and stored by an embryo collection team approved in accordance with rule 6

(1); (

1. d)they shall have been collected, processed and stored by the embryo collection team in accordance with Schedule A; and (
2. e)they shall be accompanied, during transport to the Member State of destination, by an animal health certificate complying with rule 7

(1). Approval of an embryo collection team. 5.

(1)Approval of an embryo collection team as provided for in rule 4(c) shall be granted only where the provisions of Chapter I of Schedule A are observed and where the embryo collection team is able to satisfy the other provisions of these rules. Any major change in the organisation of the team shall be notified to the competent authority.

(2)The approval of the team shall be renewed whenever the team veterinarian is replaced or whenever any major changes are made in its organization or the laboratories or equipment at its disposal.

(3)The official veterinarian shall supervise observance of the provisions outlined above. Approval shall be withdrawn where one or more of the provisions is no longer observed.

(4)The competent authority shall register embryo collection teams and give a veterinary registration number to each team. The competent authority shall draw up and keep up to date a list of embryo collection teams and their veterinary registration numbers and make it available to the other Member States and to the public. Consignment of embryos subject to an animal health certificate. 6.

(1)An animal health certificate drawn up by an official v e t e r i n a r i a n o f t h e M e m b e r St a t e o f c o l l e c t i o n o n a f o r m conforming to the specimen in Schedule C shall accompany each consignment of embryos. A separate certificate shall be issued for each consignment.

(2)The animal health certificate shall: (

1. a)consist of a single form and be drawn up in at least the official language(
2. s)of the Member State of destination; (
3. b)be made out to a single consignee; and (
4. c)accompany the consignment of embryos to its destination in its original form. Importation of embryos from third countries 7.

(1)Embryos shall be imported only from those third countries or parts thereof which appear on a list drawn up in a c c o r d a n c e wi t h th e p r o c e d u r e l a id d o w n i n t h e d e f i n i t i o n "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2). Such list may be supplemented or amended in accordance with the same procedure.

(2)In deciding whether a third country or parts thereof may ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.100 7 appear on the list referred to in sub-rule

(1), particular account shall be taken of: (

1. a)the state of health of the livestock, other domestic animals and wildlife in the third country, with particular reference to exotic animal diseases, and of the environmental health situation in that country, which might endanger animal health in Malta; (
2. b)the regularity and rapidity of the information supplied by the third country concerning the existence of contagious animal diseases in its territory, in particular those diseases mentioned in lists A and B of the International Office of Epizootic Diseases; (
3. c)the rules of the third country on animal disease prevention and control; (
4. d)the structure of the veterinary services in the third country and their powers; (
5. e)the organization and implementation of measures to prevent and control contagious animal diseases; and (
6. f)the guarantees which the third country can give with regard to compliance with these rules. 8.

(1)The competent authority shall only authorise imports of embryos dispatched from an embryo collection or production team situated in one of the third countries appearing on the list referred to in rule 7

(1), and for which the competent authority of the third country concerned is able to give the guarantees that the following conditions relating to embryo collection and production team are met: (

1. a)it meets the conditions: (
2. i)for the approval of embryo collection and embryo production teams set out in Chapter I of Schedule A; (
3. ii)relating to the collection, processing, storage and transport of embryos by such teams set out in Chapter II of that Schedule; (
4. b)it has been officially approved by the competent authority of the third country for exports to the Community; and (
5. c)it is subject to inspections by an official veterinarian of the third country at least twice a year.

(2)The list of embryo collection or production teams that the competent authority of the third country appearing on the list referred to in rule 7

(1)has approved in accordance with the conditions set out in sub-rule

(1), and from which embryos may be dispatched to the Community shall be communicated to the Commission.

(3)The approval of an embryo collection or production team shall be immediately suspended or withdrawn by the competent Conditions relating to embryo collection or production teams. 8 ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES authority of the third country where it no longer complies with the conditions set out in sub-rule

(1), and the Commission shall be immediately informed thereof. Detailed rules for the uniform application of this rule may be adopted in accordance with the procedure referred to in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2). Conditions relating to importation of embryos from third countries. 9.

(1)Importation of embryos from a third country or part thereof on the list drawn up in accordance with rule 7

(1)shall take place only if the embryos: (a) come from donor animals which, immediately prior to the collection of their embryos, have remained for at least six months in the third country concerned, and in a maximum of two herds complying with at least the requirements set out in sub-rule

(2); and (b) comply with the animal health requirements adopted in accordance with the procedure laid down in the defintion "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2)for imports of embryos from that country.

(2)In adopting the requirements referred to in sub-rule

(1), particular account shall be given to: (

1. a)the health situation in the area surrounding the place of embryo collection, with particular reference to the diseases appearing on list A of the International Office of Epizootic Diseases; (
2. b)the state of health of the herd concerned in the embryo collection, including testing requirements; (
3. c)the state of health of the donor animal and testing requirements; and (
4. d)collecting, processing and storing requirements in relation to embryos. S.L. 437.48

(3)The reference basis for fixing animal health conditions in accordance with sub-rules

(1)and

(2)for tuberculosis, bovine brucellosis and enzootic bovine leucosis, shall be the standards laid down in Schedules A and D to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations.

(4)Under the procedure laid down in "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2), and on a case-by-case basis, derogations from such provisions contained in sub-rules

(1)and

(2), may be decided upon where an interested third country provides similar and at least equivalent guarantees with reference to animal health. Rule 4 shall mutatis mutandis apply. ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.100 10.

(1)Importation of embryos shall only be authorised on submission of an animal health certificate drawn up and signed by an official veterinarian of the third country of collection. The certificate shall: (

1. a)be drawn up in at least the official language or languages of the Member State of destination and the official language or languages of the Member State of collection where the import control provided for in rule 12 has been carried out; 9 Submission of animal health certificates regarding importation of embryos from third countries. (
2. b)be made out to a single consignee; and (
3. c)accompany the embryos in the original.

(2)The animal health certificate shall be on a form conforming to a specimen drawn up in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2).

1. The provisions 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 competent authority, when Malta is the Member State of destination, and the safeguard measures to be applied in accordance with the procedure referred to in regulation 19 of the said regulations, regarding a disease or any other phenomenon or circumstance liable to present a serious threat to animal or public health which manifests itself or spreads. Veterinary checks by the competent authority. S.L. 437.41
2. Each consignment of embryos authorised for importation into the Community by a Member State of destination on the basis of the control referred to in rule 11 shall, when sent to another Member State, be accompanied by the original animal health certificate or an authenticated copy thereof, suitably endorsed, in either case, by the competent authority responsible for the control carried out in accordance with rule
3. Consignment of embryos subject to an animal health certificate.
4. Any costs arising from implementation of measures pursuant to rule 11 shall be chargeable to the consignor or its agent or representitive, without compensation thereto by the competent authority. Costs relating to veterinary checks. 14.

(1)If a contagious animal disease which may be carried by embryos breaks out or spreads, or if any other reason connected with animal health which might endanger the health of the livestock in Malta so justify: Rules on safeguard and control measures. (

1. a)the safeguard measures laid down in regulation 9 of the Animal Health Problems Affecting IntraCommunity Trade in Bovine Animals and Swine Regulations, regarding a compulsory national control programme for contagious diseases may be applied; and (
2. b)where all or part of a third country is concerned, the Member State of destination shall prohibit the importation of those embryos whether imported S.L. 437.48 10 ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES directly or indirectly through another Member State, either from the whole of the third country or from only part only thereof.

(2)Measures taken by the competent authority pursuant to subrule

(1)and the repeal of such measures shall be communicated immediately to the other Member States and the Commission together with the reasons for taking or repealing such measures.

(3)In accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2), it may be decided that such measures shall be amended, in particular in order to coordinate them with measures adopted by other Member States, or that they shall be repealed.

(4)If the situation envisaged in sub-rule

(1)arises, and it is necessary that other Member States also apply the measures taken under such sub-rule as amended where necessary in accordance with sub-rule

(3), appropriate steps shall be taken in accordance w i t h t h e p r o c e d u r e l a i d d o w n i n t h e d e f i n i t i o n " St a n d i n g C o m m i t t e e on t h e F oo d C h a i n a n d A n i m a l H e a l t h " o r "t h e Committee" in rule 2

(2). Resumption of importation from the third country concerned shall be authorised in accordance with the same procedure. Veterinary experts. 15.

(1)Veterinary experts from the Commission may, in cooperation with the com petent authority or the com petent authorities of third countries, make on-the-spot checks in so far as that is indispensable for ensuring uniform application of these rules.

(2)The country of collection within which a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The country of collection concerned shall take any measures which may prove necessary to take account of the results of the investigation.

(3)If the country of collection does not take such measures referred to in sub-rule

(2), the competent authority may refuse importation of embryos collected, processed or stored by the collection team in question or withdraw approval in the case of third countries, provided it shall be authorised to do so by the Commission acting in consultation with the Committee.

(4)The general provisions for implementing this rule, especially as regards the frequency and method of carrying out the checks referred to in sub-rule

(1), shall be laid down in accordance with the procedure set out in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2). Amendments to Schedules. 16. Amendments made to the Schedules, in particular to adapt them to advances in technology, shall be decided in accordance with the procedure set out in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.100 11 2

(2). 17.

(1)Any person who fails to abide by these rules shall be guilty of an offence in terms of the Act and the provisions and measures rule 3

(3)and

(4)shall apply to it.

(2)Any right given to the competent authority under these rules to apply all such necessary measures prescribed in rule 3

(3)and

(4)shall be given to the Authority without prejudice to other criminal procedures which may be taken under the Act or any other law when a person commits an offence by failing to abide by these rules. Offences and penalties. 12 ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES SCHEDULE A CHAPTER I Conditions for the approval of an embryo collection team In order to be given approval each embryo collection team shall fulfill the following requirements: (

1. a)the collection, processing and storage of embryos shall be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene; (
2. b)it shall be placed under the general supervision and authority of the official veterinarian; (
3. c)it shall have at its disposal permanent or mobile laboratory facilities where embryos can be examined, processed and packed, consisting of at least a work surface, a microscope and cryogenic equipment; (
4. d)in the case of a permanently sited laboratory, it shall have at its disposal: (
5. i)a room where embryos can be manipulated which is adjacent to but physically separate from the area used to handle the donor animals during collection, (
6. ii)a room or area equipped for cleansing and sterilizing instruments and equipment used in embryo collection and manipulation; (
7. e)it shall have at its disposal, in the case of a mobile laboratory, a specially equipped part of the vehicle consisting of two separate sections: (
8. i)one for the examination and manipulation of embryos which shall be a clean section; and (
9. ii)the other for accommodating equipment and materials used in contact with the donor animals. A mobile laboratory shall always have contact with a permanently sited laboratory to ensure the sterilization of its equipment and the provision of fluids and other products necessary for the collection and manipulation of embryos. CHAPTER II Conditions relating to the collection, processing, storage and transport of embryos by the approved embryo collection team 1. Collection and processing (
10. a)Embryos shall be collected and processed by an approved collection team, without coming into contact with any other consignment of embryos not meeting the requirements of these rules. (
11. b)Embryos shall be collected in a place which is isolated from other parts of the premises or holding and which shall be in good repair and easy to cleanse and disinfect. (
12. c)Embryos shall be processed (examined, washed, treated and placed in identified and sterile containers) in either a permanent laboratory facility or a mobile laboratory facility, which is not situated in a zone subject to prohibition or quarantine measures. ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.100 13 (
13. d)All implements which come into contact with the embryos or the donor animal during collection and processing shall be disposable or shall be properly disinfected or sterilized prior to use. (
14. e)Products of animal origin used during collection of the embryos and in the transport medium shall be obtained from sources which present no animal health risk or are to be so treated prior to use so that such risk is prevented. (
15. f)Storage flasks and transport flasks shall be properly disinfected or sterilized before the commencement of each filling operation. (
16. g)The cryogenic agent used shall not have been previously used for other products of animal origin. (
17. h)Each embryo container and the containers in which they are stored and transported shall be clearly code-marked in such a way that the date of collection of the embryos and the breed and identification of the donor sire and donor dam, as well as the registration number of the team can be readily established. The characteristics and form of this codemarking shall be established in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health or the Committee" in rule 2

(2). (

1. i)Each embryo shall be washed at least ten times in a special fluid for embryos which shall be changed each time and which, unless decided otherwise under paragraph (m), shall contain trypsin, in accordance with internationally recognized procedures. Each wash shall be a 100fold dilution of the previous wash and a sterile micropipette shall be used to transfer the embryo on each occasion. (
2. j)After the last wash each embryo shall be subjected to microscopic examination over its entire surface to determine that the zona pellucida is intact and is free from any adherent material. (
3. k)Each consignment of embryos that has successfully undergone the examination provided for in paragraph (
4. j)shall be placed in a sterile container marked in accordance with paragraph (
5. h)and which shall be sealed immediately. (
6. l)Each embryo shall, where appropriate, be frozen as soon as possible and stored in a place which is under the control of the team veterinarian and which is subject to regular inspection by an official veterinarian. (
7. m)In accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" in rule 2

(2)concerning authorised flushing and washing fluids, washing techniques and, where necessary, enzymatic treatments together with authorized transportation media. Pending the adoption of a protocol on enzymatic treatments, the national rules on the use of trypsin shall continue to apply, in compliance with the general provisions of the Treaty. (n) Each collection team shall submit routine samples of flushing fluids, washing fluids, disintegrated embryos, non-fertilized ova etc., resulting from its activities for official examination for bacterial and viral contamination. The procedure for collecting of samples, conducting such examinations, together with the standards to be achieved shall be decided in accordance with the procedure laid down in in the definition "Standing Committee on the Food Chain and Animal Health" or "the ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES 14 Committee" in rule 2

(2). If the standards laid down are not achieved the competent authority which granted the official approval to the team shall withdraw that approval. (

1. o)Each collection team shall keep a record of its activities in respect of embryo collection during the twelve months before and twelve months after storage including: (
2. i)the breed, age and identification of the donor animals concerned, (
3. ii)the place of collection, processing and storage of embryos collected by the team, (iii) the identification of the embryos together with details of their destination if known. 2. Storage Each embryo collection team shall ensure that the embryos are stored at suitable temperatures in premises approved for the purpose by the competent authority. In order to be approved these premises shall: (
4. i)comprise at least one lockable room intended exclusively for embryo storage; (
5. ii)be easy to cleanse and disinfect; (iii) have permanent records of all incoming and outgoing movements of embryos. The final destination of the embryos in particular shall be specified in such records; (
6. iv)be subject to inspection by the official veterinarian. The competent authority may authorize the storage of semen that fulfils the requirements of the 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 2010 in the approved storage premises. 3. Transport Embryos for trade shall be transported in satisfactory hygienic conditions in sealed containers from the approved storage premises until their arrival at their destination. The containers shall be marked in such a way that the number coincides with the number on the animal health certificate. SCHEDULE B Conditions applying to donor animals 1. For the purposes of embryo collection donor animals shall meet the following requirements: (
7. a)they shall have spent the previous six months within the Community or in the third country of collection in at least one herd: (
8. i)which is officially tuberculosis free; and (
9. ii)which is officially brucellosis free or brucellosis free; (iii) which is enzootic bovine leucosis free or which, during the three previous years, has shown no clinical signs of enzootic bovine leucosis; ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES (
10. iv)[ S.L.437.100 15 which, during the previous year, has shown no clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvovaginitis; (
11. b)during the six months preceding embryo collection, donor cows may have spent successive periods in a maximum of two different herds meeting the requirements set out above. 2. On the day of embryo collection the donor cow: (
12. a)shall be resident in a holding which is not subject to veterinary prohibition or quarantine measures; (
13. b)shall show no clinical signs of disease. SCHEDULE C ANIMAL HEALTH CERTIFICATE NO. 1. Consignor (name and full address) 2. Member State of collection 3. Consignee (name and full address) ORIGINAL NOTES (
14. a)A separate certificate shall be issued for each consignment of embryos. (
15. b)The original of this certificate shall accompany the consignment to the place of destination. 4. Competent authority 5. Place of loading 6. Name and address of embryo collection team 7. Means of transport 8. Place and Member State of destination 9. Registration number of embryo collection team 10. Number and code-mark of embryo containers 11. Identification of consignment (
16. a)Number of embryos (
17. b)Date(
18. s)of collection (
19. c)Breed 12. I, the undersigned official veterinarian, certify that: (
20. a)the embryos described above were collected, processed and stored and where consigned to Malta under conditions which comply with the standards laid down in the Animal Health Conditions Governing IntraCommunity Trade and Importation from Third Countries of Embryos of Domestic Animals of the Bovine Species Rules; and (
21. b)the embryos described above were sent to the place of loading in sealed containers under conditions which comply with the provisions of the 16 ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF [ S.L.437.100 EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES Animal Health Conditions Applicable to Intra-Community Trade and Importation from Third Countries of Embryos of Domestic Animals of the Bovine Species Rules. Done at: Signature: Name and qualification (in block letters): Stamp