1.1.

be placed under the permanent supervision of a centre veterinarian authorised by the competent authority;

1.2.

have at least:

1.3.

be so constructed or isolated that contact with outside livestock is prevented;

1.4.

be so constructed that the entire semen collection centre except the office rooms and, in the case of equidae the exercise area, can be readily cleansed and disinfected.

(a)

in the case the storage is not limited to semen of a single species collected at semen collection centres approved in accordance with this Directive, or embryos are stored at the centre in compliance with this Directive, be given distinct veterinary registration numbers referred to in Article 11(4) for each of the species the semen of which is stored at the centre;

(b)

be placed under the permanent supervision of a centre veterinarian authorised by the competent authority;

(c)

have a semen storage room furnished with the necessary installation to store the semen and/or the embryos, which is so constructed that it protects those products and the installation from adverse weather and environment effects;

(d)

be so constructed that contact with outside livestock or other animals is prevented;

(e)

be so constructed that the entire centre except the office rooms and, in the case of equidae the exercise area, can be readily cleansed and disinfected;

(f)

be so constructed that unauthorised access of people is effectively prevented.

1.1.

be supervised to ensure that:

1.2.

be monitored to ensure that:

1.3.

be inspected by an official veterinarian during the breeding season at least once every calendar year in the case of animals with seasonal breeding and twice every calendar year in the case of a non-seasonal reproduction in order to consider and verify, where necessary on the base of records, standard operating procedures and internal audits, all matters relating to the conditions of approval, supervision and monitoring.

2.1.

be supervised to ensure that:

2.2.

be monitored that:

2.3.

by way of derogation from point 2.2(a), the storage of embryos in the approved semen storage centre is authorised provided they meet the requirements of this Directive and are stored in separate storage containers;

2.4.

be inspected by an official veterinarian at least twice every calendar year in order to consider and verify, where necessary based on records, standard operating procedures and internal audits, all matters relating to the conditions of approval, supervision and monitoring.

1.1.

the collection, processing and storage of embryos shall be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene and in techniques and principles of disease control;

1.2.

the team veterinarian shall be responsible for all team operations, including amongst others:

1.3.

the team shall be placed under the general supervision of the official veterinarian, who shall inspect it at least once every calendar year to ensure, where necessary based on records, standard operating procedures and internal audits, compliance with the sanitary conditions regarding collection, processing and storage of embryos and to verify all matters relating to the conditions of approval and supervision;

1.4.

the team shall have at its disposal a permanently sited laboratory or a mobile laboratory where embryos can be examined, processed and packed, consisting of at least a work surface, an optical or stereo microscope and cryogenic equipment where necessary;

1.5.

in the case of a permanently sited laboratory, it shall have:

1.6.

in the case of a mobile laboratory, it shall:

1.7.

the design and layout of buildings and laboratories shall be laid out and team operations carried out so as to ensure that cross-contaminations of embryos are prevented;

1.8.

the team shall have at its disposal storage premises which shall:

1.9.

the competent authority may authorise storage of semen in storage premises referred to in point 1.8 provided that the semen:

2.1.

the team members have received adequate training on disease control and laboratory techniques, particularly in procedures for working in sterile conditions;

2.2.

the team shall have at its disposal a permanently sited laboratory which shall:

2.3.

where ova and other tissues are to be collected in a slaughterhouse, it shall have at its disposal suitable equipment for the collection and transport of the ovaries and other tissues to the processing laboratory in a hygienic and safe manner.

1.1.

it shall not show any clinical sign of an infectious or contagious disease at the time of admission and on the day the semen is collected;

1.2.

it shall come from the territory or, in the case of regionalisation, from the part of the territory of a Member State or a third country and from a holding under veterinary supervision each of which satisfy the requirements of Directive 90/426/EEC;

1.3.

it shall be kept for 30 days prior to the date of semen collection in holdings where no equine has shown any clinical sign of equine viral arteritis or contagious equine metritis during that period;

1.4.

it shall not be used for natural mating during the 30 days prior to the first semen collection and during the collection period;

1.5.

it shall be subjected to the following tests, carried out and certified in a laboratory recognised by the competent authority, according to the program provided for in point 1.6:

1.6.

it shall be subjected to one of the following testing programmes:

1.7.

if any of the tests provided for in point 1.5 is positive, the donor stallion shall be isolated, and the semen collected from it since the date of the last negative test shall not be subject for trade with the exception, for equine viral arteritis, of semen from every ejaculate which has undergone the equine arteritis virus isolation test with negative result.

Semen collected from all other stallions at the semen collection centre since the date when the last sample was collected that gave a negative result in one of the tests provided for in point 1.5. shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases mentioned in point 1.5;

1.8.

semen collected from stallions at a semen collection centre subject to a prohibition order in accordance with Article 4 or 5 of Directive 90/426/EEC shall be kept in separate storage and shall not be subject for trade until the health status of the semen collection centre has been restored by the official veterinarian in accordance with Directive 90/426/EEC and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens causing diseases listed in Annex A to Directive 90/426/EEC.

1.1.

they have been kept in quarantine for a period of at least 28 days in accommodation specifically approved for the purpose by the competent authority, and where only animals having at least the same health status are present (quarantine accommodation);

1.2.

prior to their stay in the quarantine accommodation, they have belonged to an officially brucellosis-free ovine or caprine holding pursuant to Article 2 of Directive 91/68/EEC and they shall not be previously kept in a holding of a lower health status as regards brucellosis;

1.3.

they come from a holding where during the 60 days prior to their stay in the quarantine accommodation they have undergone a serological test for contagious epidydimitis (B. ovis) carried out in accordance with Annex D to Directive 91/68/EEC or any other test with an equivalent documented sensitivity and specificity;

1.4.

they have undergone the following tests carried out on a blood sample collected within the 28 days preceding the commencement of the period of quarantine specified in point 1.1, with negative results in each case, except for the test for Border disease referred to in point (c)(ii):

The competent authority may authorise that the tests referred to in this point are carried out on samples collected in the quarantine accommodation. If such authorisation is granted, the period of quarantine referred to in point 1.1 shall not commence before the date of sampling. However, if any of the tests referred to in this point prove positive, the animal concerned shall be immediately removed from the quarantine accommodation. In the event of group isolation, the quarantine period referred to in point 1.1 shall not commence for the remaining animals until the animal which tested positive has been removed;

1.5.

they have undergone the following tests carried out on samples taken during the period of quarantine specified in point 1.1, and at least 21 days after being admitted to the quarantine accommodation, with negative results:

1.6.

they have undergone the tests for Border disease referred in points 1.4(c)(i) and (ii) carried out on the blood samples taken during the period of quarantine specified in point 1.1, and at least 21 days after being admitted to the quarantine accommodation.

Any animal (seronegative or seropositive) shall only be allowed entry to the semen collection centre if no sero-conversion occurs in animals which tested seronegative before the day of entry into the quarantine accommodation.

If sero-conversion occurs, all animals that remain seronegative shall be kept in quarantine over a prolonged time, until there is no more sero-conversion in the group for a period of three weeks from the day the sero-conversion occurred.

Serologically positive animals shall be allowed entry into the semen collection centre subject to a negative result in a test referred in point 1.4(c)(i).

(a)

it is situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius;

(b)

it has for the past three months been free from foot-and-mouth disease and brucellosis;

(c)

it has for the past 30 days been free from compulsory notifiable diseases as defined in Article 2(b)(6) of Directive 91/68/EEC.

(a)

for brucellosis (B. melitensis), a serological test carried out in accordance with Annex C to Directive 91/68/EEC;

(b)

for contagious epidydimitis (B. ovis) a serological test carried out in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;

(c)

for Border disease, the antibody test referred to in point 1.4(c)(ii) which is applied only to seronegative animals.

(a)

show no clinical signs of disease on the date the semen was collected;

(b)

during the 12 months prior to the date of the collection of the semen:

(c)

have been kept at an approved semen collection centre for a continuous period of at least 30 days prior to the date of collection of the semen, in the case of collection of fresh semen;

(d)

meet the requirements laid down in Articles 4, 5 and 6 of Directive 91/68/EEC;

(e)

if kept on holdings referred to in the first indent of Article 11(2), had undergone with negative results during the 30 days prior to the date of collection of the semen:

(f)

shall not be used for natural breeding during at least 30 days prior to the date of first semen collection and between the date of the first sample referred to in points 1.5 and 1.6 or in point (e) and until the end of the collection period.

1.1.

1.2.

1.3.

1.4.

1.1.

Embryos shall be collected and processed by an approved embryo collection team, without coming into contact with any other batch of embryos not complying with the requirements of this Directive.

1.2.

Embryos shall be collected in a place, which is separated from other parts of the premises or holding where the embryo is collected and which shall be in good repair and constructed with materials which permit its effective and easy cleansing and disinfection.

1.3.

Embryos shall be processed (examined, washed, treated and placed in identified and sterile straws, ampoules or other packages) in either a permanently sited laboratory or a mobile laboratory, which, as regards susceptible species, is situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius.

1.4.

All equipment used to collect, handle, wash, freeze and store embryos shall either be sterilised or properly cleansed and disinfected prior to use according to the IETS Manual (3), or be single-use equipment.

1.5.

Any biological product of animal origin used in the media and solutions for collection, processing, washing or storage of embryos shall be free of pathogenic micro-organisms. Media and solutions used in the collection, freezing and storage of embryos shall be sterilised by approved methods according to the IETS Manual and handled in such a manner as to ensure that sterility is maintained. Antibiotics might be added, when appropriate, to collection, processing, washing and storage media according to the IETS Manual.

1.6.

The cryogenic agents used for preservation or storage of embryos shall not be previously used for other products of animal origin.

1.7.

Each embryo straw, ampoule or other package shall be clearly identified by labels according to the standardised system according to the IETS Manual.

1.8.

The embryos shall be washed according to the IETS Manual and have an intact zona pellucida before and immediately after washing. 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 viruses is required.

1.9.

Embryos from different donor animals shall not be washed together.

1.10.

The zona pellucida of each embryo shall be examined over its entire surface area at not less than 40 × magnification and certified to be intact and free of adherent material.

1.11.

Embryos of a batch that has successfully undergone the examination set out in point 1.10 shall be placed in a sterile straw, ampoule or other package marked in accordance with point 1.7 which shall be sealed immediately.

1.12.

Each embryo shall, where appropriate, be frozen as soon as possible and stored in a place which is under the control of the team veterinarian.

1.13.

Each embryo collection team shall submit for official examination for bacterial and viral contamination routine samples of non-viable embryos or ova, flushing fluids or washing fluids resulting from its activities according to the IETS Manual.

1.14.

Each embryo collection team shall keep a record of its activities in respect of embryo collection for a period of two years after the embryos have been the subject of trade or import, including:

2.1.

The competent authority shall have knowledge of, and authority over, the holding(s) of origin of the donor animals.

2.2.

When ovaries and other tissues are collected at a slaughterhouse, either from individual animals or from batches of donors (batch collection), the slaughterhouse shall be officially approved in accordance with Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (4) and under the supervision of a veterinarian whose responsibility it is to ensure that ante-mortem and post-mortem inspections of potential donor animals are carried out and to certify them to be free of signs of the relevant contagious diseases transmissible to animals. The slaughterhouse shall, as regards susceptible species, be situated in an area in which there has been no outbreak of foot-and-mouth disease for the past 30 days within a 10 kilometre radius.

2.3.

Batches of ovaries shall not be brought into the processing laboratory until post-mortem inspection of donor animals is completed.

2.4.

Equipment for removal and transport of ovaries and other tissues shall be cleansed and disinfected or sterilised before use and exclusively used for these purposes.

3.1.

In vitro derived embryos shall be conceived as a result of in vitro fertilisation with semen meeting the requirements of this Directive.

3.2.

After the in vitro culture period is completed but prior to freezing, storage and transport of the embryos, they shall be washed and undergo the treatments referred to in points 1.8, 1.10 and 1.11.

3.3.

Embryos from different donor animals, in the case of individual animal recovery, or from different batch collections shall not be washed together.

3.4.

Embryos from different donor animals, in the case of individual animal recovery, or from different batch collections shall not be stored in the same straw, ampoule or other package.

4.1.

Where micromanipulation of the embryo which involves penetration of the zona pellucida is carried out, this shall be done in suitable laboratory facilities under supervision of an approved team veterinarian.

4.2.

Each embryo collection team shall keep records of its activities according to point 1.14, including details of micromanipulation techniques which involve penetration of the zona pellucida and which have been performed on the embryos. In the case of embryos derived by in vitro fertilisation, the identification of the embryos may be done on the basis of a batch, but shall contain details of the date and place of collection of ovaries and/or ova. It shall also be possible to identify the holding of origin of the donor animals.

5.1.

5.2.

6.1.

6.2.

4.1.

not be used for natural breeding during at least 30 days prior to the date of collection of ova or embryos and between date of the first sample referred to in 4.2 and 4.3 and the date of the collection of ova and embryos;

4.2.

be subjected with negative result to an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia carried out on a blood samples taken initially during the past 30 days prior to the date of the first collection of ova or embryos and then every 90 days during the collection period;

4.3.

be subjected to a test for contagious equine metritis by isolation of Taylorella equigenitalis carried out on samples collected from mucosal surfaces of the clitoral fossa and clitoral sinuses on two consecutives oestrus periods, and during one of oestrus periods an additional culture specimen taken from the endometrial cervix, all with negative results after a cultivation of 7 to 14 days.’