Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (Text with EEA relevance) (Text with EEA relevance)

• (a) the animal shall be subjected to the following tests, in accordance with one of the testing programmes provided for in point (b):
• (i) an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia with a negative result;
• (ii) a test for the isolation of the equine arteritis virus or the detection of its genome by polymerase chain reaction (PCR) or real-time PCR carried out with a negative result on an aliquot of the entire semen of the donor stallion, unless the donor stallion has been subjected to a serum neutralisation test for equine viral arteritis where a negative result was obtained at a serum dilution of one in four;
• (iii) an agent identification test for contagious equine metritis (Taylorella equigenitalis), carried out with a negative result in each case on three specimens (swabs) taken from the donor stallion on two occasions with an interval of not less than 7 days, and in any case no earlier than 7 days (systemic treatment) or 21 days (local treatment) after the possible antimicrobial treatment of the donor stallion, from at least the following sites:
• — the penile sheath (prepuce),
• — the urethra,
• — the fossa glandis. The specimens subject to culture shall be placed in a transport medium with activated charcoal, such as Amies medium, before being dispatched to the laboratory. The specimens shall be subjected to at least one of the following tests:
• — culture under microaerophilic conditions for a period of at least 7 days for the isolation of Taylorella equigenitalis, set up within 24 hours from the time of taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport, or
• — PCR or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within a period of 7 days from the time of taking the specimens from the donor animal;

• (b) the animal shall be subjected to one of the following testing programmes:
• (i) if the donor stallion is continuously resident at the semen collection centre for a period of at least 30 days prior to the date of the first semen collection and during the collection period, and no equine animals in the semen collection centre come into direct contact with equine animals of a lower health status than the donor stallion, the tests required in accordance with point (a) shall be carried out on samples taken from the donor stallion at least once a year (compulsory routine tests) at the beginning of the breeding season or prior to the first collection of semen intended for movement to another Member State as fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection;
• (ii) if the donor stallion is resident at the semen collection centre for a period of at least 30 days prior to the date of the first semen collection and during the collection period, but it may leave the semen collection centre occasionally, under the responsibility of the centre veterinarian, for a total period of less than 14 days during the collection period, or other equine animals in the semen collection centre come into direct contact with equine animals of a lower health status, the tests required in accordance with point (a) shall be carried out as follows:
• — at least once a year on samples taken from the donor stallion at the beginning of the breeding season or prior to the first collection of semen intended for movement to another Member State as fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection, and
• — during the period of collection of semen intended for movement to another Member State as fresh, chilled or frozen semen as follows: — the test required in point (a)(i) on samples taken not more than 90 days prior to the date of the collection of semen intended for movement to another Member State, — the test required in point (a)(ii) on samples taken not more than 30 days prior to the date of the collection of semen intended for movement to another Member State, unless the non-shedder state of the donor stallion is confirmed by a virus isolation test, PCR or real-time PCR carried out on samples of an aliquot of the entire semen taken not more than 6 months prior to the date of the collection of semen intended for movement to another Member State and the donor stallion has been subjected to a serum neutralisation test for equine viral arteritis with a positive result at a serum dilution of at least one in four, — the test required in point (a)(iii) on samples taken not more than 60 days prior to the date of the collection of semen intended for movement to another Member State, which in the case of PCR or real-time PCR may be carried out on three specimens (swabs) taken on a single occasion;
• (iii) if the donor stallion does not meet the conditions set out in points (i) and (ii) and the semen is collected for movement to another Member State as frozen semen, the tests required in accordance with point (a) shall be carried out on samples taken from the donor stallion as follows:
• — at least once a year at the beginning of the breeding season,
• — during the storage period provided for in point 2(b) of Part 1 of Annex III and before the semen is removed from the semen collection centre or used, on samples taken not earlier than 14 days and not later than 90 days following the date of collection of the semen. By way of derogation from the second indent of point (iii), post-collection sampling and testing for equine viral arteritis as described in point (a)(ii) shall not be required where the non-shedder state of a seropositive donor stallion is confirmed by a virus isolation test, PCR or real-time PCR carried out with a negative result on samples of an aliquot of the entire semen of the donor stallion taken twice a year at an interval of at least 4 months and the donor stallion has been subjected to a serum neutralisation test for equine viral arteritis with a positive result at a serum dilution of at least one in four;

• (c) if any of the tests provided for in point (b) prove positive, the donor stallion shall be isolated and the semen collected from it since the date of the last negative test shall not be moved between Member States with the exception, for equine viral arteritis, of semen from every ejaculate which has undergone the equine arteritis virus isolation test with a negative result. Semen collected from all other stallions at the semen collection centre since the date when the last sample was taken that gave a negative result in one of the tests provided for in point (b) shall be kept in separate storage and shall not be moved between Member States until the health status of the semen collection centre has been restored and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens that cause diseases referred to in point (b).

Chapter II

Additional animal health requirements for equine animals from which oocytes and embryos are collected, and concerning the quarantine and laboratory or other tests of those animals

• 1.Donor equine animals must have been clinically examined by the team veterinarian or a team member and certified to be free of symptoms or signs of any of the category D diseases relevant for the animals of the equine species on the day of oocyte or embryo collection.

• 2.In addition to the requirements referred to in point 1, donor equine animals shall:

• (a) not be used for natural breeding during a period of at least 30 days prior to the date of collection of oocytes or embryos and between the date of the first sample referred to in points (b) and (c) and the date of the collection of oocytes and embryos;

• (b) be subjected with a negative result to an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia carried out on a blood sample taken not less than 14 days following the date of the commencement of the period of at least 30 days referred to in point (a) and not more than 90 days prior to the date of the collection of oocytes or embryos for movement between Member States;

• (c) be subjected to an agent identification test for contagious equine metritis (Taylorella equigenitalis), carried out with a negative result in each case on at least two specimens (swabs) taken from the donor animal, which must in any case not be earlier than 7 days (systemic treatment) or 21 days (local treatment) after the possible antimicrobial treatment of the donor animal, from at least the following sites:
• — the mucosal surfaces of the clitoral fossa,
• — the clitoral sinuses.

• The specimens shall be taken during the period of at least 30 days referred to in point (a) on two occasions with an interval of not less than 7 days in the case of the test referred to in point (i), or on one occasion in the case of the test referred to in point (ii).

• The specimens referred to in point (i) shall be placed in a transport medium with activated charcoal, such as Amies medium, before being dispatched to the laboratory.

• The specimens shall be subjected to at least one of the following tests:

• (i) culture under microaerophilic conditions for a period of at least 7 days for the isolation of Taylorella equigenitalis, set up within 24 hours from the time of taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport; or

• (ii) PCR or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within a period of 7 days from the time of taking the specimens from the donor animal.

• 3.Semen used to inseminate donor animals artificially must have been collected, processed and stored in accordance with the requirements of Chapter I of Part 4 of Annex II, and of Part 1 of Annex III.

PART 5

OTHER ANIMAL HEALTH REQUIREMENTS FOR BOVINE, PORCINE, OVINE AND CAPRINE ANIMALS AND ANIMALS OF THE FAMILIES CAMELIDAE AND CERVIDAE FROM WHICH GERMINAL PRODUCTS ARE COLLECTED, AND CONCERNING THE QUARANTINE AND LABORATORY OR OTHER TESTS OF THOSE ANIMALS, AS REFERRED TO IN ARTICLES 20, 21, 22 AND 38

Chapter I

Requirements for bovine, porcine, ovine and caprine animals as regards foot-and-mouth disease

• 1.The bovine, porcine, ovine and caprine animals which are semen, oocyte or embryo donors must:

• (a) come from establishments:
• (i) situated in an area where foot-and-mouth disease has not been reported within a 10-km radius centred on the establishment for a period of at least 30 days immediately prior to the date of collection;
• (ii) in which foot-and-mouth disease has not been reported during a period of at least 3 months immediately prior to the date of collection;

• (b) have not been vaccinated against foot-and-mouth disease during the period of 12 months immediately prior to the date of collection.

• 2.The centre veterinarian shall ensure that:

• (a) the bovine, porcine, ovine and caprine animals which are semen donors are only admitted to the semen collection centre after they have undergone isolation in the quarantine accommodation, which on the day of admission of the animals to the semen collection centre must:
• (i) be situated in an area where foot-and-mouth disease has not been reported within a 10-km radius centred on the quarantine accommodation for a period of at least 30 days;
• (ii) have had no outbreak of foot-and-mouth disease reported during the period of 3 months preceding the date of admission of the animals into the semen collection centre;

• (b) semen is only moved to another Member State subject to compliance with the following conditions:
• (i) the semen collection centre is situated in an area where foot-and-mouth disease has not been reported within a 10-km radius centred on the semen collection centre for a period of at least 30 days;
• (ii) the semen collection centre has been free from foot-and-mouth disease for a period of at least 3 months prior to the date of collection of the semen and 30 days from the date of collection or, in the case of fresh semen, until the date of dispatch of the consignment of semen to another Member State;
• (iii) in the case of fresh semen, the donor animal has been kept at the semen collection centre referred to in point (i) for a continuous period of at least 30 days immediately prior to the date of collection of the semen.

• 3.By way of derogation from point 1(b), the centre veterinarian may authorise the dispatch of semen collected from a kept donor animal which has been vaccinated against foot-and-mouth disease during the period of 12 months immediately prior to the date of collection, provided that:

• (a) the donor animal has not been vaccinated against foot-and-mouth disease within the period of at least 30 days immediately prior to the date of collection;

• (b) 5 % (with a minimum of five straws) of each quantity of semen taken from a donor animal at any time is submitted to a virus isolation test for foot and mouth disease with negative results.

• 4.By way of derogation from point 1(b), the team veterinarian may authorise the dispatch, to another Member State, of in vivo derived embryos collected from a donor animal which has been vaccinated against foot-and-mouth disease during the 12-month period immediately prior to the date of collection, provided that:

• (a) the female donor animal has not been vaccinated against foot-and-mouth disease within the period of at least 30 days immediately prior to the date of collection;

• (b) the semen used for fertilisation was collected from a male donor that complies with the conditions set out in point 1(b) or the semen complies with the conditions set out in point 2;

• (c) prior to freezing, the embryos have been subjected to trypsin washing carried out in accordance with the recommendations of the IETS Manual ([^E0003]);

• (d) the embryos are stored deep frozen for a period of at least 30 days from the date of collection, and during this period the donor animal has not shown clinical signs of foot-and-mouth disease.

Chapter II

Requirements for bovine, ovine and caprine animals and for animals of the families Camelidae and Cervidae as regards infection with bluetongue virus (serotypes 1-24)

• 1.The bovine, ovine and caprine animals and animals of the families Camelidae and Cervidae which are semen donors must fulfil at least one of the following conditions:

• (a) they have been kept for a period of at least 60 days prior to and during collection of the semen in a Member State or zone thereof where infection with bluetongue virus (serotypes 1-24) has not been reported for a period of at least the preceding 2 years within a radius of 150 km of the establishment;

• (b) they have been kept for a period of at least 60 days prior to and during collection of semen in an area seasonally vector-free in relation to infection with bluetongue virus (serotypes 1-24);

• (c) they have been kept in a vector-protected establishment for a period of at least 60 days prior to and during collection of the semen;

• (d) they have been subjected to a serological test to detect antibodies to the bluetongue virus serogroup 1-24, with negative results, between 28 and 60 days from the date of each collection of the semen;

• (e) they have been subjected to an agent identification test for bluetongue virus (serotypes 1-24), with negative results, on blood samples taken at commencement and final collection of the semen and during collection of the semen at intervals of:
• (i) at least every 7 days, in the case of the virus isolation test; or
• (ii) at least every 28 days, in the case of PCR.

• 2.The ovine and caprine animals and animals of the families Camelidae and Cervidae which are in vivo derived embryo donors and bovine, ovine and caprine animals and animals of the families Camelidae and Cervidae which are oocyte donors for the in vitro production of embryos must fulfil at least one of the following conditions:

• (a) they have been kept for a period of at least 60 days prior to and during collection of the oocytes or embryos in a Member State or zone thereof where infection with bluetongue virus (serotypes 1-24) has not been reported for a period of at least the preceding 2 years within a radius of 150 km of the establishment;

• (b) they have been kept for a period of 60 days prior to and during collection of the oocytes or embryos, in an area seasonally vector-free in relation to infection with bluetongue virus (serotypes 1-24);

• (c) they have been kept in a vector-protected establishment for a period of at least 60 days prior to and during collection of the oocytes or embryos;

• (d) they have been subjected to a serological test to detect antibodies to the bluetongue virus serogroup 1-24, with negative results, on a blood sample taken between 28 and 60 days from the date of collection of the oocytes or embryos;

• (e) they have been subjected to an agent identification test for bluetongue virus (serotypes 1-24), with negative results, on a blood sample taken on the date of collection of the oocytes or embryos.

• 3.The semen used to fertilise the oocytes must be collected from animals which comply with the requirements set out in point 1.

Chapter III

Requirements for bovine, ovine and caprine animals and for animals of the families Camelidae and Cervidae as regards infection with the epizootic haemorrhagic disease virus

• 1. The bovine, ovine and caprine animals and animals of the families Camelidae and Cervidae which are semen donors must fulfil at least one of the following conditions:
• (a) they have been kept for a period of at least 60 days prior to and during collection of the semen in a Member State or zone thereof where infection with epizootic haemorrhagic disease virus has not been reported for a period of at least the preceding 2 years within a radius of 150 km of the establishment;
• (b) they have been kept for a period of at least 60 days prior to and during collection of the semen in an area seasonally vector-free in relation to infection with epizootic haemorrhagic disease virus;
• (c) they have been kept in a vector-protected establishment for a period of at least 60 days prior to and during collection of the semen;
• (d) they have been subjected to a serological test to detect antibodies to infection with epizootic haemorrhagic disease virus, with negative results, at least every 60 days throughout the collection period and between 28 and 60 days from the date of the final collection of the semen;
• (e) they have been subjected to an agent identification test for infection with epizootic haemorrhagic disease virus, with negative results, on blood samples taken at commencement and final collection of the semen and during collection of the semen at intervals of:
• (i) at least every 7 days, in the case of virus isolation test; or
• (ii) at least every 28 days, in the case of PCR.

• 1. The bovine, ovine and caprine animals and animals of the families Camelidae and Cervidae which are oocyte donors for the in vitro production of embryos and in vivo derived embryo donors must fulfil at least one of the following conditions:
• (a) they have been kept for a period of at least 60 days prior to and during collection of the oocytes or embryos in a Member State or zone thereof where infection with epizootic haemorrhagic disease virus has not been reported for a period of at least the preceding 2 years within a radius of 150 km of the establishment;
• (b) they have been kept for a period of at least 60 days prior to and during collection of the oocytes or embryos in an area seasonally vector-free in relation to infection with epizootic haemorrhagic disease virus;
• (c) they have been kept in a vector-protected establishment for a period of at least 60 days prior to and during collection of the oocytes or embryos;
• (d) they have been subjected to a serological test to detect antibodies to infection with epizootic haemorrhagic disease virus, with negative results, on a blood sample taken between 28 and 60 days from the date of collection of the oocytes or embryos;
• (e) they have been subjected to an agent identification test for infection with epizootic haemorrhagic disease virus, with negative results, on a blood sample taken on the date of collection of the oocytes or embryos.

• 1. The semen used to fertilise the oocytes must be collected from animals which comply with the requirements set out in point 1.

Chapter IV

Requirements for an establishment to be considered free from infection with Brucella abortus, Brucella melitensis and Brucella suis in porcine animals

To qualify as free from infection with Brucella abortus, Brucella melitensis and Brucella suis, an establishment of porcine animals must satisfy the following requirements:

• (a) infection with Brucella abortus, Brucella melitensis and Brucella suis must be a notifiabledisease in porcine animals in the Member State;

• (b) infection with Brucella abortus, Brucella melitensis and Brucella suis has not been confirmed in the establishment for a period of at least the preceding 3 years;

• (c) animals showing clinical signs consistent with infection with Brucella abortus, Brucella melitensis and Brucella suis such as abortions or orchitis are subjected to the necessary diagnostic tests with negative results;

• (d) no porcine animals belonging to the establishment have been vaccinated against infection with Brucella abortus, Brucella melitensis and Brucella suis for at least the preceding 3 years;

• (e) porcine animals which have been introduced to the establishment:
• (i) either come from establishments free from infection with Brucella abortus, Brucella melitensis and Brucella suis for a period of at least the preceding 3 years, or were tested on a sample taken within a period of 30 days prior to the date of dispatch with negative results; and
• (ii) have not been vaccinated against infection with Brucella abortus, Brucella melitensis and Brucella suis for a period of at least the preceding 3 years;

• (f) for a period of at least the preceding 3 years, there has been no evidence of infection with Brucella abortus, Brucella melitensis and Brucella suis in other epidemiological units of the same establishment, or measures have been implemented to prevent any transmission of infection with Brucella abortus, Brucella melitensis and Brucella suis from those other epidemiological units.

ANNEX III

ANIMAL HEALTH REQUIREMENTS FOR THE COLLECTION, PRODUCTION, PROCESSING AND STORAGE OF GERMINAL PRODUCTS OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS AS REFERRED TO IN ARTICLE 26

PART 1

ANIMAL HEALTH REQUIREMENTS FOR THE COLLECTION, PROCESSING AND STORAGE OF FRESH, CHILLED OR FROZEN SEMEN OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS, AND FOR THE TRANSPORT OF THAT SEMEN

• 1.All instruments used for the collection, processing, preservation or freezing of semen shall be cleansed and either disinfected or sterilised before use, except for new single-use instruments.

• 2.Frozen semen shall:

• (a) be placed and stored in storage containers:
• (i) which have been cleansed and either disinfected or sterilised before use, or which are new single-use containers;
• (ii) with a cryogenic agent, which must not have previously been used for other biological products originating from animals;

• (b) prior to dispatch or use, be stored in approved conditions for a minimum period of 30 days from the date of collection.

• 3.Where necessary, antibiotics or mixtures of antibiotics may be added to semen or contained in semen diluents.

• 6.Where an antibiotic or a mixture of antibiotics is(are) added to semen:

• (a) the name(s) of the antibiotic(s) added and its(their) concentration or the commercial name of the semen diluent containing antibiotics shall be stated in the animal health certificate accompanying the consignment;

• (b) it(they) shall be added to the semen after final dilution or to the diluent;

• (c) in the case of frozen semen, it(they) shall be added before the semen is frozen.

• 7.For frozen or chilled semen, immediately after the addition of the antibiotics, the diluted semen shall be kept at:

• (a) a temperature of at least 5 °C, except in the case of semen of porcine animals, which may be kept at a temperature of at least 15 °C for a period of not less than 45 minutes; or

• (b) a time-temperature regime with a documented equivalent bactericidal activity.

PART 2

ANIMAL HEALTH REQUIREMENTS FOR THE COLLECTION AND PROCESSING OF IN VIVO DERIVED EMBRYOS OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS

In vivo derived embryos shall be collected, processed and preserved in accordance with the following requirements:

• 1. Embryos shall be collected and processed by an embryo collection team, without coming into contact with any other consignment of embryos not complying with the requirements of this Regulation.

• 1. Embryos shall be collected in a place which is separated from other parts of the premises or establishment and which shall be kept in good repair and constructed with materials which permit its effective and easy cleansing and disinfection.

• 1. Embryos shall be processed (examined, washed, treated and placed in straws or other packages) in either a permanently located laboratory or a mobile laboratory.

• 1. All equipment used to collect, handle, wash, freeze and store embryos shall be cleansed and either disinfected or sterilised before use, according to the IETS Manual, or be a new single-use equipment.

• 1. Any biological product originating from animals used in the media and solutions for the collection, processing, washing or storage of embryos shall be free from pathogenic microorganisms. Media and solutions used in the collection, freezing and storage of embryos shall be sterilised by methods approved in accordance with the IETS Manual and handled in such a manner as to ensure sterility.

• 1. Where, according to the IETS Manual, antibiotics or a mixture of antibiotics are added to the collection, processing, washing and storage media, the names of the antibiotics added and their concentration shall be stated in the animal health certificate accompanying the consignment.

• 1. The cryogenic agents used for the preservation or storage of embryos shall not have previously been used for other biological products originating from animals.

• 1. The embryos shall be washed according to the IETS Manual and have an intact zona pellucida or, in the case of equine embryos, the embryonic capsule, before and immediately after washing. Each embryo shall be washed at least 10 times in a special fluid for embryos, which shall be changed each time. Each wash shall be a 100-fold dilution of the previous wash and a sterile micropipette shall be used to transfer the embryo on each occasion. The standard washing procedure shall be modified to include additional washes with the enzyme trypsin, according to the IETS Manual, when inactivation or removal of certain pathogens is required.

• 1. Embryos from different donor animals shall not be washed together.

• 1. The zona pellucida or, in the case of equine embryos, the embryonic capsule of each embryo shall be examined over its entire surface area at not less than 50× magnification and certified to be intact and free of adherent material.

• 1. Embryos that have successfully undergone the examination set out in point 10 shall be placed in a cleansed and either disinfected or sterile, except for a new single-use, straw or another package which is marked in accordance with Article 10(1) and (5) and which shall be sealed immediately.

• 1. Each embryo shall, where appropriate, be frozen as soon as possible and stored in a storage premises, referred to in point 2(b) of Part 2 of Annex I, which is under the responsibility of the team veterinarian.

• 1. Where there is no other procedure to verify the health status of the donor animals, or in order to verify compliance with the animal health and biosecurity requirements laid down by the team veterinarian, including in the framework of the quality control scheme referred to in point 1(b) of Part 2 of Annex I, the embryo collection team shall, in accordance with the IETS Manual, submit to an official or authorised by the competent authority laboratory routine samples of non-viable embryos or oocytes, flushing fluids or washing fluids resulting from its activities for the detection of bacterial and viral contamination at a frequency to be established by the team veterinarian.

PART 3

ANIMAL HEALTH REQUIREMENTS FOR THE COLLECTION AND PROCESSING OF OOCYTES, OVARIES AND OTHER TISSUES FOR IN VITRO PRODUCTION OF EMBRYOS OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS

In addition to the requirements set out in Part 2, the following additional requirements shall apply to the collection, processing and transport of oocytes, ovaries and other tissues for use in in vitro fertilisation and in vitro culture:

• 1. The ovaries and other tissues collected at a slaughterhouse, either from an individual donor animal or from a batch of donor animals, shall be collected in a slaughterhouse approved in accordance with Article 148 of Regulation (EU) 2017/625. Those potential donor animals must have undergone ante-mortem and post-mortem inspections carried out by a veterinarian at the slaughterhouse who must have certified them to be free of symptoms and signs of any of the category A, B, C and D diseases relevant for the bovine, porcine, ovine, caprine or equine animals. The slaughterhouse must be situated in an area where foot-and-mouth disease has not been reported within a 10-km radius for a period of at least the preceding 30 days before the date of collection of the ovaries and other tissues.

• 1. Ovaries shall not be brought into the laboratory of an embryo production team for processing until a post-mortem inspection of donor animals is completed with satisfactory results. If a disease referred to in point 1 is found in the individual donor animal, the batch of donor animals or in any animals slaughtered in that slaughterhouse on that day, all ovaries and other tissues from those donor animals shall be traced and discarded.

• 1. Equipment for the removal and transport of ovaries and other tissues shall be cleansed and either disinfected or sterilised before use, except for new single-use equipment, and exclusively used for those purposes.

Separate equipment shall be used to handle oocytes and embryos from different individual donor animals and from different batches of donor animals.

PART 4

ANIMAL HEALTH REQUIREMENTS FOR THE PROCESSING OF IN VITRO PRODUCED EMBRYOS OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS

In addition to the requirements set out in Part 2, the following additional requirements shall apply to the processing of in vitro produced embryos:

• 1. After the in vitro culture period is completed, but prior to the freezing, storage and transport of the embryos, they shall be washed and undergo the treatments referred to in points 7, 10 and 11 of Part 2.

• 1. Embryos from different individual donor animals or from different batches of donor animals, referred to in point 1 of Part 3, shall not be washed together.

• 1. Embryos from different individual donor animals or from different batches of donor animals shall not be placed in the same straw or other package.

PART 5

ANIMAL HEALTH REQUIREMENTS FOR THE PROCESSING OF MICROMANIPULATED EMBRYOS OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS

Prior to any micromanipulation which compromises the integrity of the zona pellucida or, in the case of equine embryos, the embryonic capsule, all embryos or oocytes shall be collected and processed in accordance with the animal health requirements set out in Parts 2, 3 and 4.

In addition, the following requirements shall apply:

• 1. Where micromanipulation of the embryo which involves penetration of the zona pellucida or, in the case of equine embryos, the embryonic capsule, this shall be carried out in a laboratory referred to in point 2(a) of Part 3 of Annex I, which is under the responsibility of the team veterinarian.

• 1. Each embryo production team shall keep records of its activities in accordance with Article 8(1)(b). In the case of embryos produced by in vitro fertilisation, the identification of the embryos may be done on the basis of a batch of donor animals, but shall contain details of the date and place of collection of ovaries and oocytes. It shall also allow the establishment of origin of the donor animals to be traced.

• 1. Any micromanipulation which involves penetration of the zona pellucida or, in the case of equine embryos, the embryonic capsule, shall be carried out in the facilities approved for that purpose, and after the last wash and examination. Such micromanipulation may only be carried out on an embryo with an intact zona pellucida or, in the case of equine embryos, an intact embryonic capsule.

PART 6

ANIMAL HEALTH REQUIREMENTS FOR THE STORAGE OF IN VIVO DERIVED AND IN VITRO PRODUCED EMBRYOS, AND OF OOCYTES OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS

• 1.Each embryo collection team and embryo production team shall ensure that the embryos and oocytes are stored at suitable temperatures in storage premises referred to in point 2(b) of Part 2 of Annex I.

• 2.Only embryos collected by an embryo collection team, or oocytes collected by and embryos produced by an embryo production team, and transported in conditions ensuring that cross-contamination of embryos and oocytes is prevented, as they have had no contact with embryos and oocytes which do not comply with the requirements laid down in this Regulation, may be brought into the storage premises referred to in point 2(b) of Part 2 of Annex I.

• In vivo derived embryos, in vitro produced embryos and oocytes shall be stored in distinct storage containers assigned for each type of germinal product and the handling of stored germinal products of different types and species must be carried out by separate staff or at a different time.

• 3.The team veterinarian may decide that embryos not collected by an embryo collection team, or oocytes not collected and embryos not produced by an embryo production team, may be processed by the embryo collection team or the embryo production team provided that:

• (a) such oocytes and embryos are collected from animals which fulfil the conditions laid down:
• (i) in respect of bovine animals, in point 1 of Chapter II of Part 1 of Annex II and as applicable in Chapters I, II and III of Part 5 of Annex II;
• (ii) in respect of porcine animals, in points 1, 2 and 3 of Chapter II of Part 2 of Annex II and as applicable in Chapters I and IV of Part 5 of Annex II;
• (iii) in respect of ovine and caprine animals, in point 1 of Chapter II of Part 3 of Annex II and as applicable in Chapters I to III of Part 5 of Annex II;
• (iv) in respect of equine animals, in points 1 and 2 of Chapter II of Part 4 of Annex II;

• (b) processing is carried out with separate equipment or at a different time from oocytes and embryos intended to be moved to another Member State, the equipment in the latter case being cleaned and sterilised after use;

• (c) such oocytes and embryos shall not be moved to another Member State and shall not at any time come into contact with, or be stored with, oocytes and embryos intended to be moved to another Member State;

• (d) such oocytes and embryos must be identifiable by a marking which is different from that referred to in point 1(a)(v) of Part 1 of Annex I.

• 4.Frozen embryos or oocytes shall, prior to dispatch to another Member State, be stored in storage premises referred to in point 2(b) of Part 2 of Annex I for a period of at least 30 days from the date of their collection or production.

• 5.Only embryos or oocytes from an individual donor animal or from one batch of donor animals, referred to in point 1 of Part 3, shall be placed in the same straw or another package.

ANNEX IV

INFORMATION TO BE CONTAINED IN THE ANIMAL HEALTH CERTIFICATE FOR GERMINAL PRODUCTS MOVED BETWEEN MEMBER STATES AS REFERRED TO IN ARTICLES 31 AND 40

• 1.The animal health certificate for germinal products of bovine, porcine, ovine, caprine and equine animals moved between Member States, referred to in Article 31, shall contain at least the following information:

• (a) the name and address of the consignor and the consignee;

• (b) the name and address of the establishment of dispatch, and
• (i) the unique approval number of that establishment, where the establishment of dispatch is an approved germinal product establishment or a confined establishment, referred to in Article 14; or
• (ii) the unique registration number of that establishment, where the establishment of dispatch is an establishment where ovine and caprine animals are kept, referred to in Article 13;

• (c) the name and address of the establishment of destination, and
• (i) the unique approval number of that establishment, where the establishment of destination is an approved germinal product establishment or a confined establishment; or
• (ii) the unique registration number of that establishment, where the establishment of destination is a registered germinal product establishment or any other registered establishment;

• (d) the type of germinal products and the species of donor animals;

• (e) the number of straws or other packages to be dispatched;

• (f) the information allowing identification of germinal products:
• (i) the species and identification of the donor animals in accordance with the requirements laid down in Title I, II, III or IV of Part III of Delegated Regulation (EU) 2019/2035 from which germinal products were collected;
• (ii) the marking applied to the straws or other packages in accordance with the requirements provided for in Article 10;
• (iii) the place and date of their collection or production;

• (g) the number on the seal applied to the transport container;

• (h) the information on the animal health situation, additional guarantees and, where necessary, test results in relation to:
• (i) the Member State or zone thereof;
• (ii) the establishment of origin of the donor animals;
• (iii) the germinal product establishment or, in the case provided for in Article 14, the confined establishment of germinal products collection or production, processing and storage;
• (iv) the donor animals from which germinal products were collected;
• (v) the germinal products to be dispatched;

• (i) the date and place of issue of the animal health certificate, the name, capacity and signature of the official veterinarian, and the stamp of the competent authority of the place of origin of the consignment;

• (j) the date of dispatch of the consignment.

• 1. The animal health certificate for the germinal products of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals kept at confined establishments and of animals of the family Camelidae or Cervidae moved between Member States, referred to in Article 40, shall contain at least the following information:

• (a) the name and address of the consignor and the consignee;

• (b) the name and address of the establishment of dispatch, and
• (i) the unique registration number, where the establishment of dispatch was assigned with such registration number; or
• (ii) the unique approval number of that confined establishment, where the establishment of dispatch is a confined establishment;

• (c) the name and address of the establishment of destination and, where the establishment of destination is a confined establishment, the unique approval number of that confined establishment;

• (d) the type of germinal products and the species of donor animals;

• (e) the number of straws or other packages to be dispatched;

• (f) the information allowing identification of germinal products:
• (i) the species, where necessary the subspecies, and identification of the donor animals from which germinal products were collected,
• — in the case of dogs and cats, in accordance with Article 17(1) of Regulation (EU) No 576/2013 or Article 70 of Regulation (EU) 2019/2035, or
• — in the case of terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at confined establishments, in accordance with the rules of that confined establishment, or
• — in the case of animals of the families Camelidae and Cervidae, in accordance with Article 73(1) or (2) or Article 74 of Regulation (EU) 2019/2035;
• (ii) the marking applied to the straws or other packages in accordance with Article 11;
• (iii) the place and date of their collection or production;

• (g) the number on the seal applied to the transport container;

• (h) the information on the animal health situation, additional guarantees and, where necessary, test results in relation to:
• (i) the Member State or zone thereof;
• (ii) the establishment of origin of the donor animals;
• (iii) the donor animals from which germinal products were collected;
• (iv) the germinal products to be dispatched;

• (i) the date and place of issue of the animal health certificate, the name, capacity and signature of the official veterinarian, and the stamp of the competent authority of the place of origin of the consignment;

• (j) the date of dispatch of the consignment.

[^E0001]: Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (‘the IMSOC Regulation’) (OJ L 261, 14.10.2019, p. 37).

[^E0003]: Manual of the International Embryo Transfer Society – A procedural guide and general information for the use of embryo transfer technology emphasising sanitary procedures, published by the International Embryo Transfer Society 1 111 North Dunlap Avenue, Savoy, Illinois 61 874 USA (http://www.iets.org/).