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Rules for movements to other Member States of germinal products of bovine, porcine, ovine, caprine and equine animals from approved germinal product establishments
Operators shall only move to another Member State semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals, which were collected, produced, processed and stored in approved germinal product establishments.
Derogation for the movements to other Member States of semen of ovine and caprine animals from the establishments where those animals are kept
By way of derogation from Article 12, operators may move to other Member States consignments of semen of ovine and caprine animals which were collected, processed and stored at the establishment where those donor animals are kept, provided that those operators: (a) obtain the prior consent of the competent authority of the Member State of destination to accept the consignment; (b) ensure that the donor animals have been clinically examined by a veterinarian prior to semen collection and showed no symptoms suggesting the presence of any of the category D diseases or of the emerging diseases relevant for the ovine and caprine animals or clinical signs of such category D or emerging diseases, on the day the semen was collected; (c) ensure that the donor animals come from establishments which fulfil the animal health requirements laid down in Article 15(1), (2), (3) and (4) of Delegated Regulation (EU) 2020/688; (d) ensure that the donor animals have undergone the following tests with negative results carried out on samples taken during the period of isolation which must commence at least 30 days prior to the date of collection of the semen: (i) a serological test referred to in point 1 of Part 1 of Annex I to Delegated Regulation (EU) 2020/688 for infection with Brucella abortus, Brucella melitensis and Brucella suis ; (ii) in the case of ovine animals, a serological test for ovine epididymitis ( Brucella ovis ); (iii) in the case of caprine animals kept together with ovine animals, a serological test for ovine epididymitis ( Brucella ovis ); (e) ensure that the donor animals are identified in accordance with Article 45(2) or (4), or Article 46(1), (2) or (3) of Regulation (EU) 2019/2035; (f) ensure that the semen has been marked in accordance with the requirements provided for in Article 10; (g) keep records at the establishment which must include at least the information provided for in Article 8(1)(a); (h) ensure that the consignment of semen is transported in accordance with Articles 28 and 29.
Derogation for movements to other Member States of germinal products of bovine, porcine, ovine, caprine and equine animals kept at confined establishments
By way of derogation from Article 12, operators of confined establishments may move to other Member States consignments of semen, oocytes and embryos collected at those establishments from bovine, porcine, ovine, caprine and equine animals, provided that those operators: (a) only move consignments of those germinal products to another confined establishment; (b) ensure that the donor animals: (i) do not come from an establishment, nor have been in contact with animals from an establishment, situated in a restricted zone established due to the occurrence of a category A disease or of an emerging disease relevant for bovine, porcine, ovine, caprine or equine animals; (ii) come from an establishment where none of the category D diseases relevant for bovine, porcine, ovine, caprine or equine animals have been reported for a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos; (iii) have remained in a single confined establishment of origin for a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos; (iv) have been clinically examined by the establishment veterinarian responsible for the activities carried out at confined establishment, and showed no symptoms suggesting the presence of any of the category D diseases referred to in point (ii) or of the emerging diseases or clinical signs of such diseases, on the day of collection of the semen, oocytes or embryos; (v) as much as possible, were not used for natural breeding during a period of at least 30 days prior to the date of first collection and during the period of collection of the semen, oocytes or embryos intended for movement to another Member State; (vi) are identified in accordance with requirements laid down in Regulation (EU) 2019/2035; — for bovine animals in Article 38, — for porcine animals in Article 52(1) or 54(2), — for ovine and caprine animals in Article 45(2) or (4), or Article 46(1), (2) or (3), — for equine animals in Article 58(1) or 59(1) or 62(1); (c) ensure that the germinal products have been marked in accordance with the requirements provided for in Article 10; (d) ensure that the germinal products are transported in accordance with Articles 28 and 29.
Responsibilities of operators for compliance with the animal health requirements for donor bovine, porcine, ovine, caprine and equine animals from which germinal products were collected
Operators shall only move to another Member State consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals which comply with the following requirements: (a) the germinal products were collected from animals which did not show symptoms or clinical signs of transmissible animal diseases on the day of collection; (b) the movement was authorised respectively by the centre or team veterinarian.
Responsibilities of centre veterinarians and team veterinarians for compliance with the animal health requirements for donor bovine, porcine, ovine, caprine and equine animals from which germinal products were collected
Centre veterinarians, as regards donor animals of semen, or team veterinarians, as regards donor animals of oocytes and embryos, shall ensure that the donor bovine, porcine, ovine, caprine and equine animals comply with the following requirements: (a) they were born and have remained since birth in the Union, or have entered the Union in accordance with the requirements for entry into the Union; (b) they come from establishments in a Member State or zone thereof, or from establishments under official control by the competent authority in a third country or territory, or a zone thereof, each of which fulfils the animal health requirements laid down in Delegated Regulation (EU) 2020/688: (i) for bovine animals in Article 10(1), Article 11(1), (2) and (3) and Article 12(1), (2) and (3); (ii) for porcine animals in Article 19(1) and Article 20(1) and (2); (iii) for ovine and caprine animals in Article 15(1), (2), (3) and (4); (iv) for equine animals in Article 22(1) and (2); (c) they have been identified in accordance with requirements laid down in Regulation (EU) 2019/2035: (i) for bovine animals in Article 38; (ii) for porcine animals in Article 52(1) or 54(2); (iii) for ovine and caprine animals in Article 45(2) or (4), or Article 46(1), (2) or (3); (iv) for equine animals in Article 58(1) or 59(1) or 62(1); (d) for a period of at least 30 days prior to the date of the first collection of the germinal products and during the collection period: (i) they have been kept in establishments which are not situated in a restricted zone established due to the occurrence in bovine, porcine, ovine, caprine or equine animals of a category A disease or of an emerging disease relevant for those animals; (ii) they have been kept in establishments where no category D diseases relevant for those animals have been reported; (iii) they have not been in contact with animals from establishments situated in a restricted zone referred to in point (i) or from establishments which do not meet the conditions referred to in point (ii); (iv) they have not been used for natural breeding; (e) they showed neither symptoms nor clinical signs of any of the category D diseases referred to in point (d)(ii) or of the emerging diseases on the day of collection of the semen, oocytes or embryos; (f) they comply with the additional animal health requirements set out: (i) for bovine animals in Article 20, and in Part 1 and Chapters I, II and III of Part 5 of Annex II; (ii) for porcine animals in Article 21, and in Part 2 and Chapters I and IV of Part 5 of Annex II; (iii) for ovine and caprine animals in Article 22, and in Part 3 and Chapters I, II and III of Part 5 of Annex II; (iv) for equine animals in Article 23, and in Part 4 of Annex II.
Responsibilities of centre veterinarians and team veterinarians for compliance with the animal health requirements for donor bovine, porcine, ovine, caprine and equine animals from which germinal products were collected from establishments subject to movement restrictions on animal health grounds
Centre veterinarians, as regards donor animals of semen, or team veterinarians, as regards donor animals of oocytes and embryos, shall ensure that semen, oocytes and embryos, collected at either a semen collection centre or an establishment which is subjected to movement restrictions on animal health grounds concerning the diseases referred to in Article 16(b), 20, 21, 22 or 23, comply with the following requirements: (a) they must be kept in separate storage; (b) they must not be moved between Member States until the movement restrictions applied to either the semen collection centre or the establishment where the semen was collected has been removed by the competent authorities; and (c) the semen, oocytes and embryos stored must have undergone the appropriate official investigations to rule out the presence in the semen, oocytes and embryos of animal pathogens causing the diseases for which the movement restrictions were established.
Additional responsibilities of centre veterinarians for compliance with the animal health requirements for donor bovine, porcine, ovine, caprine and equine animals from which semen was collected
Centre veterinarians shall ensure that donor bovine, porcine, ovine, caprine and equine animals comply with the following requirements: (a) they showed neither symptoms nor clinical signs of any of the category D diseases referred to in Article 16(d)(ii) on the day of their admission to a semen collection centre; (b) in the case of donor bovine, porcine, ovine and caprine animals, prior to the day of their admission to a semen collection centre, they were kept in a quarantine accommodation which on that day complied with the following conditions: (i) none of the category D diseases relevant for the bovine, porcine, ovine or caprine animals has been reported for a period of at least the preceeding 30 days; (ii) it was not situated in a restricted zone established due to the occurrence in bovine, porcine, ovine or caprine animals of a category A disease or of an emerging disease relevant for those animals; (c) they are kept at the semen collection centre which: (i) during a period which comprises at least 30 days prior to date of collection and at least 30 days following the date of collection of the semen or, in the case of fresh semen, until the date of dispatch of the consignment of semen, none of the category D diseases relevant for bovine, porcine, ovine, caprine or equine animals have been reported; (ii) it is not situated in a restricted zone established due to the occurrence in bovine, porcine, ovine, caprine or equine animals of a category A disease or of an emerging disease relevant for those animals.
Derogation from the animal health requirements for donor bovine, porcine, ovine, caprine and equine animals moved between semen collection centres
1. By way of derogation from point (b) of Article 18, operators may move donor bovine, porcine, ovine and caprine animals, and donor equine animals subjected to the testing programme for certain diseases as referred to in point 1(b)(i) of Chapter I of Part 4 of Annex II, directly from one semen collection centre to another semen collection centre: (a) without quarantine or testing, before and after the movement, as referred to in Annex II for the following animals: (i) for bovine animals, in Part 1 and Chapters I, II and III of Part 5 thereof; (ii) for porcine animals, in Part 2 and Chapters I and IV of Part 5 thereof; (iii) for ovine and caprine animals, in Part 3 and Chapters I, II and III of Part 5 thereof; (iv) for equine animals, in point 1(a) of Chapter I of Part 4 thereof; and (b) provided that the donor animals: (i) show no disease symptoms or signs of any of the category D diseases relevant for the bovine, porcine, ovine, caprine or equine animals on the day of that movement; (ii) before that movement, they were permanently present since the date of their admission at the semen collection centre and were subjected to the following tests relevant for the bovine, porcine, ovine, caprine or equine animals referred to in paragraph 1(a), with negative results: — all compulsory routine tests referred to in Annex II in the period of the preceding 12 months prior to date of that movement, or — where the compulsory routine tests have not yet been carried out at the semen collection centre, all tests required before admission to a semen collection centre carried out during the period immediately preceding quarantine and during the quarantine period. 2. Operators shall only move donor animals, as referred to in the introductory phrase of paragraph 1, where the movement is authorised by the competent authority of the semen collection centre of origin and with the prior consent of the centre veterinarian of the semen collection centre of destination. 3. Operators shall ensure that donor animals referred to in the introductory phrase of paragraph 1 do not come into direct or indirect contact with animals of a lower health status during the movement and the means of transport used have been cleansed and disinfected before use. 4. Operators of semen collection centres of destination shall subject donor animals referred to in the introductory phrase of paragraph 1 to all compulsory routine tests referred to in paragraph 1(a) not later than 12 months following the date the last compulsory routine tests were carried out on those animals.
Additional animal health requirements for donor bovine animals from which semen, oocytes and embryos were collected
1. The centre veterinarian, as regards donor animals of semen, or the team veterinarian, as regards donor animals of oocytes and embryos, shall ensure that donor bovine animals comply with the following requirements: (a) they came from an establishment, in the case of donor animals of semen prior to their admission to a quarantine accommodation, that was free from the following diseases and have never been kept previously in any establishment of a lower health status: (i) infection with Mycobacterium tuberculosis complex ( M. bovis, M. caprae and M. tuberculosis ); (ii) infection with Brucella abortus, Brucella melitensis and Brucella suis ; (iii) enzootic bovine leukosis; (iv) infectious bovine rhinotracheitis/infectious pustular vulvovaginitis; (b) they fulfil the additional animal health requirements laid down in Part 1 and Chapters I, II and III of Part 5 of Annex II. 2. By way of derogation from paragraph 1(a)(iii), the centre veterinarian may accept that a donor animal of semen came from an establishment which was not free from enzootic bovine leukosis provided that the animal either: (a) is less than 2 years of age and has been produced by a dam which was subjected, with negative results, to a serological test for enzootic bovine leukosis after removal of that animal from its dam; or (b) has reached the age of 2 years and was subjected, with negative results, to a serological test for enzootic bovine leukosis. 3. By way of derogation from paragraph 1(a)(iii), the team veterinarian may accept a donor animal of oocytes and embryos that was less than 2 years of age which came from an establishment which was not free from enzootic bovine leukosis provided that the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of enzootic bovine leukosis during a period of at least the preceding 3 years. 4. By way of derogation from paragraph 1(a)(iv), (a) the centre veterinarian, as regards donor animals of semen, may accept a donor animal which came from an establishment which was not free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis provided that the animal has undergone the test required in accordance with point 1(b)(iv) of Chapter I of Part 1 of Annex II, or (b) the team veterinarian, as regards donor animals of oocytes and embryos, may accept a donor animal which came from an establishment which was not free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis provided that the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of infectious bovine rhinotracheitis/infectious pustular vulvovaginitis during a period of at least the preceding 12 months.
Additional animal health requirements for donor porcine animals from which semen, oocytes and embryos were collected
1. The centre veterinarian, as regards donor animals of semen, or the team veterinarian, as regards donor animals of oocytes and embryos, shall ensure that donor porcine animals comply with the following requirements: (a) they came from an establishment, in the case of donor animals of semen prior their admission to a quarantine accommodation, where no clinical, serological, virological or pathological evidence of infection with Aujeszky’s disease virus had been detected during a period of at least the preceding 12 months; (b) they fulfil additional animal health requirements laid down in Part 2 and Chapters I and IV of Part 5 of Annex II. 2. The centre veterinarian shall ensure that donor porcine animals of semen comply with the following requirements: (a) prior to their admission to a quarantine accommodation, they came from an establishment which was free from infection with Brucella abortus, Brucella melitensis and Brucella suis in accordance with the requirements laid down in Chapter IV of Part 5 of Annex II; (b) they were kept at the quarantine accommodation which on the day of admission was free from infection with Brucella abortus, Brucella melitensis and Brucella suis for the period of at least the preceding 3 months; (c) they are kept in a semen collection centre where no clinical, serological, virological or pathological evidence of infection with Aujeszky’s disease virus has been reported for a period comprising at least 30 days prior to the date of admission and at least 30 days immediately prior to the date of collection; (d) they have not been vaccinated against infection with porcine reproductive and respiratory syndrome virus and were kept, since birth or for a period comprising at least 3 months prior to the date of entry into the quarantine accommodation, in an establishment where no animals have been vaccinated against infection with porcine reproductive and respiratory syndrome virus and no infection with porcine reproductive and respiratory syndrome virus was detected during that period.
Additional animal health requirements for donor ovine and caprine animals from which semen, oocytes and embryos were collected
The centre veterinarian, as regards donor animals of semen, or the team veterinarian, as regards donor animals of oocytes and embryos, shall ensure that donor ovine and caprine animals comply with the following requirements: (a) they did not come from an establishment, nor have been in contact with animals from an establishment, in the case of donor animals of semen prior to their admission to a quarantine accommodation, which has been the subject to movement restrictions as regards infection with Brucella abortus, Brucella melitensis and Brucella suis. The movement restrictions concerning the establishment are lifted after the period comprising of at least 42 days from the date of slaughter or killing and the disposal of the last animal infected or susceptible to that disease; (b) they came from an establishment, in the case of donor animals of semen prior to their admission to a quarantine accommodation, which was free from infection with Brucella abortus, Brucella melitensis and Brucella suis and have never been kept previously in any establishment of a lower health status; (c) they fulfil additional animal health requirements laid down in Part 3 and Chapters I, II and III of Part 5 of Annex II.
Additional animal health requirements for donor equine animals from which semen, oocytes and embryos were collected
1. The centre veterinarian shall ensure that equine animals admitted to a semen collection centre and the team veterinarian shall ensure that equine animals used for the collection of oocytes and embryos or the production of embryos comply with the following requirements prior to the collection of the germinal products: (a) they come from an establishment: (i) where surra ( Trypanosoma evansi ) has not been reported during the period of the preceding 30 days, or where surra ( Trypanosoma evansi ) has been reported during the period of the preceding 2 years and following the last outbreak the affected establishment remained under movement restrictions until: — the infected animals have been removed from the establishment, and — the remaining animals in the establishment have been subjected to a test for surra ( Trypanosoma evansi ) with one of the diagnostic methods provided for in Part 3 of Annex I to Delegated Regulation (EU) 2020/688, with negative results carried out on samples taken at least 6 months after the last infected animal has been removed from the establishment; (ii) where dourine has not been reported during the period of the preceding 6 months, or where dourine has been reported during the period of the preceding 2 years and following the last outbreak the affected establishment remained under movement restrictions until: — the infected animals have been killed and destroyed or slaughtered, or the infected entire male equine animals have been castrated, and — the remaining equine animals in the establishment, with the exception of the castrated male equine animals referred to in the first indent kept apart from female equine animals, have been subjected to a test for dourine with one of the diagnostic methods provided for in Part 8 of Annex I to Delegated Regulation (EU) 2020/688, with negative results, carried out on samples taken at least 6 months after the measures described in the first indent have been completed; (iii) where equine infectious anaemia has not been reported during the period of the preceding 90 days, or where equine infectious anaemia has been reported during the period of the preceding 12 months and following the last outbreak the affected establishment remained under movement restrictions until: — the infected animals have been killed and destroyed or slaughtered, and — the remaining equine animals in the establishment have been subjected to a test for equine infectious anaemia with one of the diagnostic methods provided for in Part 9 of Annex I to Delegated Regulation (EU) 2020/688, with negative results, carried out on samples taken on two occasions at least 3 months apart after the measures described in the first indent have been completed and the establishment was cleaned and disinfected; (b) in the case of semen donors, they were kept for a period of 30 days prior to the date of semen collection in establishments where no equine animal has shown any clinical sign of infection with equine arteritis virus or of contagious equine metritis during that period; (c) they fulfil the additional animal health requirements laid down in Part 4 of Annex II. 2. By way of derogation from paragraph 1(a), the movement restrictions referred to in paragraph 1(a)(i) to (iii) must remain in place for a period of at least 30 days, beginning on the day on which all the animals on the establishment of species listed for the respective disease referred to in paragraph 1(a)(i) to (iii) were either killed and destroyed or slaughtered, where allowed in accordance with paragraph 1(b), and the establishment was cleaned and disinfected.
Laboratory and other tests to be carried out on donor bovine, porcine, ovine, caprine and equine animals and germinal products thereof
Operators shall ensure that: (a) donor animals whose germinal products are to be moved to other Member States have undergone the following tests: (i) for bovine animals, in Part 1 and as applicable in Chapters I, II and III of Part 5 of Annex II; (ii) for porcine animals, in Part 2 and as applicable Chapters I and IV of Part 5 of Annex II; (iii) for ovine and caprine animals, in Part 3 and as applicable in Chapters I, II and III of Part 5 of Annex II; (iv) for equine animals, in Part 4 of Annex II; (b) all the tests referred to in point (a) are carried out in official laboratories.
Authorisation for laboratory tests to be carried out on donor animals of the bovine, porcine, ovine and caprine species in quarantine accommodation
1. The competent authority may authorise the following tests referred to in Annex II to be carried out on samples taken in the quarantine accommodation: (a) for bovine animals, the tests referred to in point 1(b) of Chapter I of Part 1 thereof; (b) for porcine animals, the tests referred to in point 1(b) of Chapter I of Part 2 thereof; (c) for ovine and caprine animals, the tests referred to in point 1(c) of Chapter I of Part 3 thereof. 2. Where the competent authority has granted the authorisations referred to in paragraph 1, the following conditions shall be met: (a) the period of quarantine in the quarantine accommodation must not commence before the date of sampling for the purpose of testing referred to in paragraph 1(a), (b) and (c); (b) where results of any of the tests referred to in paragraph 1 are positive, the animal concerned must be immediately removed from the quarantine accommodation; (c) in the case of quarantine of a group of animals, if any of the animals prove positive for a test referred to in paragraph 1, the quarantine in the quarantine accommodation must not commence for the remaining animals until the animal which proved positive has been removed from the quarantine accommodation.
Obligations on operators as regards the animal health requirements for the collection, production, processing and storage of germinal products of bovine, porcine, ovine, caprine and equine animals
Operators shall ensure that consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals are only moved to other Member States if those consignments fulfil the animal health requirements for the collection, production, processing and storage of germinal products set out in Annex III.
Responsibilities of centre veterinarians and team veterinarians for compliance with the animal health requirements for the transport of germinal products of bovine, porcine, ovine, caprine and equine animals
1. Where germinal products of bovine, porcine, ovine, caprine and equine animals are moved to another Member State or to a germinal product processing establishment or a germinal product storage centre within the same Member State, the centre veterinarian or the team veterinarian shall ensure that: (a) the transport containers are sealed and numbered prior to their dispatch from the approved germinal product establishment; (b) the mark on the straws or other packages, applied in accordance with Article 10, corresponds with the number provided either in the animal health certificate or in the self-declaration document and on the container in which they are transported. 2. The seal referred to in paragraph 1(a) applied under the responsibility of the centre veterinarian or the team veterinarian may be replaced by the official veterinarian.
Responsibilities of operators for compliance with the animal health requirements for the transport of germinal products of bovine, porcine, ovine, caprine and equine animals
1. Operators shall only move semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals to other Member States subject to compliance with the following conditions: (a) only one type of germinal product of one species has been placed in the transport container; (b) the transport container, referred to in point (a): (i) has been cleaned and either disinfected or sterilised before use, or is a new single-use container; (ii) has been filled in with the cryogenic agent which has not been previously used for other products. 2. By way of derogation from paragraph 1, operators may place in one transport container semen, oocytes and embryos of the same species provided that: (a) straws or other packages in which germinal products are placed are securely and hermetically sealed; (b) the germinal products of different types are separated from each other by physical compartments or by being placed in secondary protective bags. 3. By way of derogation from paragraphs 1 and 2, operators may place in one transport container semen, oocytes and embryos of ovine and caprine animals.
Additional responsibilities on operators for the transport of semen of bovine, porcine, ovine and caprine animals
Where operators move to another Member State consignments of semen of bovine, porcine, ovine or caprine animals which has been collected from more than one donor animal and placed in a single straw or another package, the operators shall: (a) ensure that the semen is collected and dispatched from a single semen collection centre or, in the case of the derogations provided for in Articles 13 and 14, a single establishment where it was collected; (b) have procedures in place as regards the processing of that semen in order to ensure its traceability in accordance with Articles 10 and 19.
Rules on animal health certification
1. Before issuing an animal health certificate for movements between Member States of consignments of germinal products of bovine, porcine, ovine, caprine and equine animals, the official veterinarian shall carry out: (a) a visual examination of the transport container in order to verify if the requirements referred to in Article 28 have been fulfiled and to check: (i) the seal and number applied by the centre or team veterinarian on the transport container as referred to in Article 27(1)(a); or (ii) if necessary, the germinal products placed in the transport container and to seal and number the transport container after that check; (b) a documentary check of the data submitted by the centre or team veterinarian to ensure that: (i) the information to be certified is supported by the records kept in accordance with Article 8; (ii) the mark on the straws or other packages, applied in accordance with Article 10, corresponds with the number provided in the animal health certificate and on the container in which they are transported; (iii) the requirements referred to in Chapter 1 of Part III have been fullfiled. 2. The official veterinarian shall carry out the checks and examinations as provided for in paragraph 1 and issue the animal health certificate within the period of 72 hours preceding the time of dispatch of the consignment of germinal products. 3. The animal health certificate shall be valid for a period of 10 days from the date of issuing.
Information to be contained in the animal health certificate for germinal products of bovine, porcine, ovine, caprine and equine moved between Member States
The animal health certificates for movements between Member States of consignments of germinal products of bovine, porcine, ovine, caprine and equine animals, shall contain at least the information set out in point 1 of Annex IV.
Requirements concerning the self-declaration document for movements to and from germinal product processing establishments of consignments of germinal products of bovine, porcine, ovine, caprine and equine animals
1. Where an operator of an approved germinal product establishment of bovine, porcine, ovine, caprine and equine animals arranges for germinal products to be processed by a germinal product processing establishment, that operator shall ensure that a self-declaration document accompanies the consignment of the germinal products during the transport to and from that germinal product processing establishment. 2. An operator of an approved germinal product establishment shall ensure that the self-declaration document referred to in paragraph 1 includes at least the following information: (a) the name and address of the approved germinal product establishment of the collection or production of the germinal products; (b) the name and address of the germinal product processing establishment to which the germinal products are moved for processing; (c) the dates of movement of the consignment of the germinal products to and from a germinal product processing establishment; (d) the type and the quantity of the germinal products; (e) the marking of the germinal products, as required by Article 10.
Requirement for advance notification by operators of movements of consignments of germinal products of bovine, porcine, ovine, caprine and equine animals between Member States
Where consignments of germinal products of bovine, porcine, ovine, caprine and equine animals are moved to another Member State, operators of approved germinal product establishments, establishments where ovine and caprine animals are kept as referred to in Article 13 or confined establishments as referred to in Article 14 shall notify the competent authority in their Member State of origin in advance of the intended movement of those consignments of germinal products.
Information necessary to notify movements of consignments of germinal products of bovine, porcine, ovine, caprine and equine animals between Member States
Operators notifying the competent authority in their Member State of origin in accordance with Article 33, shall provide that competent authority with the information concerning each consignment of germinal products to be moved to another Member State provided for in: (a) points 1(a) to (f) of Annex IV, where the germinal products are accompanied by an animal health certificate; or (b) Article 32(2), where the germinal products are accompanied by a self-declaration document.
Emergency procedures for the notification of movements of consignments of germinal products of bovine, porcine, ovine, caprine and equine animals between Member States in the event of power cuts and other disturbances of IMSOC
1. In the event of power cuts and other disturbances of IMSOC, the competent authority of the place of origin of the consignment of germinal products of bovine, porcine, ovine, caprine and equine animals to be moved to another Member State shall notify the Commission and the competent authority of the place of destination of the movement of that consignment by fax or email. 2. The notification, referred to in paragraph 1, shall be done by the competent authority of the place of origin of the consignment of germinal products in accordance with the contingency arrangements to be applied in the event of unavailability of any of the functionalities IMSOC.
Animal health requirements for movements to other Member States of germinal products of dogs and cats
Operators shall only move to other Member States semen, oocytes and embryos collected from dogs ( Canis lupus familiaris ) and cats ( Felis silvestris catus ) which: (a) have been born and remained since birth in the Union, or have entered the Union in accordance with the requirements for entry into the Union; (b) come from an establishment where infection with rabies virus has not been confirmed for a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos; (c) showed no disease symptoms on the day of collection of the semen, oocytes or embryos; (d) are marked by the implantation of a transponder or by a clearly readable tattoo in accordance with Article 17(1) of Regulation (EU) No 576/2013 of the European Parliament and of the Council ( 17 ) or identified in accordance with Article 70 of Regulation (EU) 2019/2035; (e) have received an anti-rabies vaccination that complies with the validity requirements set out in Part 1 of Annex VII to Delegated Regulation (EU) 2020/688; (f) comply with any preventive health measure for diseases or infections other than rabies set out in Part 2 of Annex VII to Delegated Regulation (EU) 2020/688; (g) were not used for natural breeding during a period of at least 30 days prior to the date of collection of semen, oocytes or embryos and during the collection period.
Animal health requirements for movements to other Member States between confined establishments of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine and equine animals
Operators of confined establishments shall only move germinal products of terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at those establishments to confined establishments in other Member States when the donor animals: (a) have been born and remained since birth in the Union, or have entered the Union in accordance with the requirements for entry into the Union; (b) have remained in a single confined establishment of origin for a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos; (c) do not come from an establishment, nor have been in contact with animals from an establishment, situated in a restricted zone established due to the occurrence of a category A disease or of an emerging disease relevant for the species in those kept terrestrial animals; (d) come from an establishment where no category D disease relevant for that species has been reported for a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos; (e) are identified and registered in accordance with the rules of that confined establishment; (f) as much as possible, were not used for natural breeding during a period of at least 30 days prior to the date of first collection and during the period of collection of the semen, oocytes or embryos intended for movement to another Member State; (g) have been clinically examined by the establishment veterinarian responsible for the activities carried out at confined establishment, and show no disease symptoms on the day the semen, oocytes or embryos are collected.
Animal health requirements for movements to other Member States of germinal products of animals of the families Camelidae and Cervidae
Operators shall only move to another Member State germinal products collected from animals of the family Camelidae or Cervidae which: (a) have been born and remained since birth in the Union, or have entered the Union in accordance with the requirements for entry into the Union; (b) have remained in a single establishment of origin for a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos; (c) do not come from an establishment, nor have been in contact with animals from an establishment, situated in a restricted zone established due to the occurrence of a category A disease or of an emerging disease relevant for the species in those kept terrestrial animals; (d) come from an establishment where during a period of at least the preceding 12 months prior to the date of collection of the semen, oocytes or embryos: (i) a surveillance programme to detect infection with Mycobacterium tuberculosis complex ( M. bovis, M. caprae and M. tuberculosis ) has been carried out in accordance with Part 2 or 3 of Annex II to Delegated Regulation (EU) 2020/688; (ii) no animals of the family Camelidae or Cervidae which do not fulfil the requirements referred to in point (i) has been introduced; (iii) in case of suspicion of infection with Mycobacterium tuberculosis complex ( M. bovis, M. caprae and M. tuberculosis ), investigations were carried out and the disease was ruled out; (e) come from an establishment: (i) where infection with Brucella abortus, Brucella melitensis and Brucella suis has not been reported during the period of at least the preceding 42 days prior to the date of collection of the semen, oocytes or embryos; (ii) in case of animals of the family Camelidae, where all animals present have been subjected to a test for infection with Brucella abortus, Brucella melitensis and Brucella suis as referred to in Part 1 of Annex I to Delegated Regulation (EU) 2020/688 with negative results carried out on samples taken during the period of the preceding 30 days prior to the date of collection of the semen, oocytes or embryos; (f) come from an establishment where infectious bovine rhinotracheitis/infectious pustular vulvovaginitis has not been reported during the period of at least the preceding 30 days prior to the date of collection of the semen, oocytes or embryos; (g) come from an establishment where infection with epizootic haemorrhagic disease virus has not been reported during a period of at least the preceding 2 years prior to the date of collection of the semen, oocytes or embryos within a radius of 150 km around the establishment; (h) come from an establishment where infection with rabies virus has not been confirmed during the period of at least the preceding 30 days prior to the date of collection of the germinal products; (i) come from an establishment where anthrax has not been reported during the period of at least the preceding 15 days prior to the date of collection of the semen, oocytes or embryos collection; (j) come from an establishment where surra ( Trypanosoma evansi ): (i) has not been reported during a period of at least the preceding 30 days prior to the date of collection of the semen, oocytes or embryos; or (ii) has been confirmed during the preceeding 2 years, but following the last outbreak of that disease the establishment has remained under movement restrictions until: — the infected animals were removed from the establishment, and — the remaining animals on the establishment were subjected to a test for surra ( Trypanosoma evansi ) referred to in Part 3 of Annex I to Delegated Regulation (EU) 2020/688, with negative result, carried out on samples taken at least 6 months after the infected animals were removed from the establishment; (k) fulfil animal health requirements as regards infection with bluetongue virus (serotypes 1-24) laid down in Chapter II of Part 5 of Annex II; (l) have not been in contact with animals which did not comply with the requirements set out in point (a) and in points (c) to (k) during the residency period of at least 30 days set out in point (b); (m) have been clinically examined by a veterinarian and showed no disease symptoms on the day of collection of the semen, oocytes or embryos; (n) are identified in accordance with Article 73(1) or (2) or Article 74 of Regulation (EU) 2019/2035; (o) were not used for natural breeding during a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos and during the collection period.
Rules concerning animal health certification
1. Before signing an animal health certificate for movements between Member States of consignments of germinal products of dogs or cats, the official veterinarian shall carry out: (a) a visual examination of the transport container in order to check: (i) the seal and number applied by the operator on the transport container; or (ii) if necessary, the germinal products placed in the transport container and to seal and number the transport container after that check; (b) a documentary check of the data submitted by the operator to ensure that: (i) the information to be certified is supported by the records kept at the establishment; (ii) the mark on the straws or other packages, applied in accordance with Article 11, corresponds with the number provided in the animal health certificate and on the container in which they are transported; (iii) the requirements referred to in Article 36 have been fullfiled. 2. Before signing an animal health certificate for movements between Member States of consignments of germinal products of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals kept at confined establishments, the official veterinarian shall carry out: (a) a visual examination of the transport container in order to check: (i) the seal and number applied by the establishment veterinarian responsible for the activities carried out at confined establishment on the transport container; or (ii) if necessary, germinal products placed in the transport container and to seal and number the transport container after that check; (b) a documentary check of the data submitted by the establishment veterinarian responsible for the activities carried out at confined establishment to ensure that: (i) the information to be certified is supported by the records kept at the confined establishment; (ii) the mark on the straws or other packages, applied in accordance with Article 11, corresponds with the number provided in the animal health certificate and on the container in which they are transported; (iii) the requirements referred to in Article 37 have been fullfiled. 3. Before signing an animal health certificate for movements between Member States of consignments of germinal products of animals of the family Camelidae or Cervidae , the official veterinarian shall carry out: (a) a visual examination of the transport container in order to check: (i) the seal and number applied by the operator on the transport container; or (ii) if necessary, the germinal products placed in the transport container and to seal and number the transport container after that check; (b) a documentary check of the data submitted by the operator to ensure that: (i) the information to be certified is supported by the records kept at the establishment; (ii) the mark on the straws or other packages, applied in accordance with Article 11, corresponds with the number provided in the animal health certificate and on the container in which they are transported; (iii) the requirements referred to in Article 38 have been fullfiled. 4. The official veterinarian shall carry out the checks and examinations as provided for in paragraphs 1, 2 and 3 and issue the animal health certificate within the period of 72 hours preceding the time of dispatch of the consignment of germinal products. 5. The animal health certificate provided for in paragraphs 1, 2 and 3 shall be valid for 10 days from the date of issuing.
Animal health certification requirements for movements of consignments of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine and equine animals between Member States
The animal health certificates for movements between Member States of consignments of germinal products of dogs and cats, and of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals kept at confined establishments or of animals of the family Camelidae or Cervidae , shall contain at least the information set out in point 2 of Annex IV.
Requirement for advance notification by operators of movements of consignments of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine and equine animals between Member States
Where consignments of germinal products of dogs or cats, of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals kept at confined establishments or of animals of the family Camelidae or Cervidae are moved to another Member State, the operator shall notify the competent authority in the Member State of origin of the consignments in advance of the intended movement of those consignments of germinal products.
Information necessary to notify movements of consignments of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine and equine animals between Member States
Operators required to notify the competent authority in the Member State of origin of the consignments in accordance with Article 41, shall provide that competent authority with the information concerning each consignment of germinal products to be moved to another Member State provided for in point 2(a) to (f) of Annex IV.
Emergency procedures for the notification of movements of consignments of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine and equine animals between Member States in the event of power cuts and other disturbances of IMSOC
1. In the event of power cuts and other disturbances of IMSOC, the competent authority of the place of origin of the consignment of germinal products of dogs or cats, of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals kept at confined establishments or of animals of the family Camelidae or Cervidae , to be moved to another Member State, shall notify the Commission and the competent authority of the place of destination of the movement of that consignment by fax or email. 2. The notification, referred to in paragraph 1, shall be carried out by the competent authority of the place of origin of the consignment of the germinal products in accordance with the contingency arrangements to be applied in the event of unavailability of any of the functionalities of IMSOC.
Additional rules for the granting of derogations by competent authorities for germinal products intended for scientific purposes
1. The competent authorities of the Member States of origin may grant derogation for the movement to another Member State of germinal products intended for scientific purposes which do not fulfil the animal health requirements provided for in Chapter 1 or 3, provided the operator of the establishment of dispatch has obtained the prior written consent of the competent authority of the Member State of destination to accept the consignment of germinal products. 2. The competent authority of the Member State of destination shall only consent to accept the consignment of germinal products referred to in paragraph 1, where the operator of the establishment of destination intended to receive those germinal products ensures that the germinal products are only used for scientific purposes under conditions that prevent the spread of category D diseases.
Additional rules for the granting of derogations by competent authorities for germinal products moved to gene banks in another Member State
1. The competent authorities of the Member States of origin may grant derogations for movements to gene banks in another Member State of germinal products, provided that the operator of the establishment of dispatch has obtained the prior written consent of the competent authority of the Member State of destination to accept the consignment of germinal products, of: (a) endangered breeds which do not fulfil the animal health requirements provided for in Chapter 1; or (b) terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at confined establishments which do not fulfil the animal health requirements provided for in Article 37. 2. The competent authority of the Member State of destination shall only consent to accept the consignment of germinal products referred to in paragraph 1, provided that: (a) the operator of the gene bank intended to receive those germinal products ensures that the germinal products are only used for the ex situ conservation and sustainable use of genetic resources of kept terrestrial animals for which the receiving gene bank was established; (b) it has sufficient information, including information provided by the competent authority of the Member State of origin or results of testing, or carries out treatment of the germinal products enabling it to prevent the spread of foot-and-mouth disease, infection with rinderpest virus and other listed diseases.
Rules on and information to be contained in the self-declaration document for germinal products intended for scientific purposes or to be moved to gene banks in another Member State
1. Where germinal products intended for scientific purposes or for storage at gene banks are to be moved to another Member State, the operator of the establishment of dispatch shall ensure that a self-declaration document accompanies the germinal products during the transport to the place of destination. 2. The operator of the establishment of dispatch shall ensure that the self-declaration document provided for in paragraph 1 includes at least the following information: (a) the name and address of the consignor and the consignee; (b) the name and address of the place of dispatch and the place of destination; (c) where the germinal products were moved to and from a germinal product processing establishment, the dates of those movements; (d) the type of the germinal products and the species of donor animals; (e) the number of straws or other packages in the consignment to be dispatched; (f) the following information allowing the identification of germinal products: (i) the marking applied on the straws or other packages; (ii) the place and date of their collection or production; (g) available results of the tests referred to in Article 45(2)(b).
Advance notification by operators of movements of germinal products intended for scientific purposes or to gene banks between Member States
Where germinal products intended for scientific purposes or for storage at gene banks are moved to another Member State, the operator of the establishment of dispatch shall notify the competent authority in the Member State of origin of the consignment in advance of the intended movement of those germinal products and provide the information listed in Article 46(2)(a) to (g).
Emergency procedures for the notification of movements between Member States of germinal products intended for scientific purposes or to gene banks in the event of power cuts and other disturbances of IMSOC
1. In the event of power cuts and other disturbances of IMSOC, the competent authority of the place of origin of the consignment of germinal products intended for scientific purposes or for storage at gene banks, to be moved to another Member State, shall notify the Commission and the competent authority of the place of destination of the movement of that consignment by fax or email. 2. The notification, referred to in paragraph 1, shall be done by the competent authority of the place of origin of the consignment of the germinal products in accordance with the contingency arrangements to be applied in the event of unavailability of any of the functionalities of IMSOC.
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