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) 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.

Article 38

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;

• (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 the animal health requirements as regards infection with bluetongue virus (serotypes 1-24) and infection with epizootic haemorrhagic disease virus laid down in Chapters II and III 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.

Article 39

Rules concerning animal health certification

• (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, and the number of the seal applied on the container in which the straws or other packages are transported, correspond with the mark and the number provided in the animal health certificate;
• (iii) the requirements referred to in Article 37 have been fullfiled.

• (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, and the number of the seal applied on the container in which the straws or other packages are transported, correspond with the mark and the number provided in the animal health certificate;
• (iii) the requirements referred to in Article 38 have been fullfiled.

Article 40

Animal health certification requirements for movements of consignments of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine or equine animals between Member States

The animal health certificates 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 and of animals of the family Camelidae or Cervidae, shall contain at least the information set out in point 2 of Annex IV.

Article 41

Requirement for advance notification by operators of movements of consignments of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine or equine animals between Member States

Where consignments of germinal products 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.

Article 42

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.

Article 43

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 the IMSOC

In the event of power cuts and other disturbances of the IMSOC, the competent authority of the place of origin of the consignment of germinal products of kept terrestrial animals other than bovine, porcine, ovine, caprine and equine animals to be moved between Member State shall comply with the contingency arrangements set out in Article 46 of Implementing Regulation (EU) 2019/1715.

CHAPTER 4 Additional rules for the granting of derogations by competent authorities for germinal products

Article 44

Additional rules for the granting of derogations by competent authorities for germinal products intended for scientific purposes

Article 45

Additional rules for the granting of derogations by competent authorities for germinal products moved to gene banks in another Member State

• (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.

• (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.

Article 46

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

• (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) the date of dispatch of the consignment;

• (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);

• (h) the number of the seal applied on the transport container;

• (i) the declaration that the consignment fulfils requirements laid down in Article 44 or 45, including that the prior written consent of the competent authority of the Member State of destination to accept the consignment of germinal products has been obtained.

Article 47

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).

Article 48

Emergency procedures for the notification of movements between Member States of germinal products intended for scientific purposes or for storage in gene banks in the event of power cuts and other disturbances of the IMSOC

In the event of power cuts and other disturbances of the IMSOC, the competent authority of the place of origin of the consignment of germinal products intended for scientific purposes or for storage in gene banks to be moved between Member State shall comply with the contingency arrangements set out in Article 46 of Implementing Regulation (EU) 2019/1715.

PART IV

FINAL PROVISIONS

Article 49

Transitional measures

In all other respects, they shall be subject to the rules provided for in Regulation (EU) 2016/429, and in this Regulation.

Article 50

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 21 April 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

RULES FOR THE COLLECTION, PRODUCTION, PROCESSING AND STORAGE OF GERMINAL PRODUCTS OF BOVINE, PORCINE, OVINE, CAPRINE AND EQUINE ANIMALS AS REFERRED TO IN CHAPTER 1 OF PART II

PART 1

REQUIREMENTS FOR SEMEN COLLECTION CENTRES REFERRED TO IN ARTICLE 4

• 1.The responsibilities of the centre veterinarian, as referred to in Article 4(1)(a)(i), shall be the following:

• (a) the centre veterinarian shall ensure that:
• (i) at the semen collection centre, only animals which have not been used for natural breeding for a period of at least 30 days prior to the date of the first semen collection and during the collection period are kept;
• (ii) at the semen collection centre, records are kept in accordance with the requirements laid down in Article 8(1)(a);
• (iii) the entry of unauthorised persons is effectively prevented;
• (iv) authorised visitors comply with the animal health and biosecurity requirements referred to in point (c)(i);
• (v) each straw or other package in which semen is placed is clearly marked in accordance with the requirements laid down in Article 10;
• (vi) the collection, processing and storage of semen takes place only on the premises set aside for that purpose and under strict hygiene conditions;
• (vii) only semen collected at a semen collection centre is processed and stored at that semen collection centre, and it must not come into contact with any other consignment of germinal products of lesser health status;
• (viii) all instruments which come into contact with the semen or the donor animal during the collection and processing of semen are cleaned and either disinfected or sterilised prior to use, except for new single-use instruments;
• (ix) where, in the case of equine animals, the semen collection centre is located within the perimeters of a registered establishment which also hosts an artificial insemination or service centre, there is a strict separation between the instruments and equipment coming into contact with donor animals, their semen and other animals kept in the semen collection centre and the semen, instruments and equipment used for artificial insemination or natural service;
• (x) any biological product originating from animals used in the processing of semen, including diluents, additives or extenders, is obtained from sources which present no animal health risk or which are treated prior to use so that such risk is prevented;
• (xi) before the commencement of each filling operation, the storage containers and transport containers are cleaned and either disinfected or sterilised, except for new single-use containers;
• (xii) the cryogenic agents used for the preservation or storage of semen have not previously been used for other products;
• (xiii) the staff employed at the semen collection centre have received adequate training on disinfection and hygiene techniques to prevent the spread of diseases;

• (b) by way of derogation from point (a)(vii), the centre veterinarian may authorise semen that was not collected at a semen collection centre to be processed at the semen collection centre provided that the following conditions are met:
• (i) such semen is collected from animals which fulfil the following requirements set out in Annex II
• — in respect of bovine animals, the requirements set out in point 1(b) of Chapter I of Part 1, and as applicable in Chapters I, II and III of Part 5 thereof,
• — in respect of porcine animals, the requirements set out in point 1(b) of Chapter I of Part 2, and as applicable in Chapters I and IV of Part 5 thereof,
• — in respect of ovine and caprine animals, the requirements set out in point 1(c) of Chapter I of Part 3, and as applicable in Chapters I, II and III of Part 5 thereof,
• — in respect of equine animals, in point 1(a) of Chapter I of Part 4 thereof;
• (ii) processing is carried out with separate equipment or at a different time from semen intended to be moved to another Member State, and the equipment in the latter case must be cleaned and sterilised after use;
• (iii) such semen is not moved to another Member State and does not at any time come into contact with, or is stored with, semen intended to be moved to another Member State;
• (iv) such semen is identifiable by a marking which must be different from that referred to in point (a)(v);

• (c) the centre veterinarian shall:
• (i) lay down the animal health and biosecurity requirements for the operation of the semen collection centre and the measures to ensure compliance with those requirements;
• (ii) only accept into the semen collection centre animals of species whose semen is to be collected;

• (d) by way of derogation from point (c)(ii), the centre veterinarian may authorise kept animals other than bovine, porcine, ovine, caprine or equine animals to be admitted to the semen collection centre, provided that they present no risk of infection to those species whose semen is to be collected, and they comply with the animal health and biosecurity requirements referred to in point (c)(i);

• (e) the centre veterinarian of a semen collection centre for equine animals, located within the perimeters of a registered establishment which also hosts an artificial insemination or service centre, shall ensure that equine animals entering the establishment meet the requirements of Article 23(1), point (a), and may decide that where direct contact of donor male equine animals with female equine animals or castrated male equine animals for teasing or with uncastrated male equine animals used on the establishment outside the semen collection centre for natural service cannot be excluded, those female and male equine animals must meet all the requirements of Article 23(1).

• 2.The requirements for the facilities, equipment and operational procedures of the semen collection centre, as referred to in Article 4(1)(b)(i), shall be the following:

• (a) the semen collection centre must have at least:
• (i) lockable animal accommodation and, if required, an exercise area for equine animals which is physically separated from the semen collection facilities, the semen processing room and the storage room;
• (ii) isolation facilities for animals which have failed tests referred to in Annex II of this Regulation or which show symptoms or signs of any of the category D diseases relevant for the bovine, porcine, ovine, caprine or equine animals, and which have no direct connection with the regular animal accommodation referred to in point (i);
• (iii) semen collection facilities that may be open air provided that they are protected from adverse weather effects and are equipped with slip-proof flooring at and around the place of semen collection;
• (iv) a separate room for the cleansing and disinfection or sterilisation of equipment;
• (v) a semen processing room, separated from the semen collection facilities and the room for cleansing equipment referred to in point (iv), which need not necessarily be on the same site;
• (vi) a semen storage room, which need not necessarily be on the same site; the semen storage room must be furnished with the necessary installation to store germinal products, which must be so constructed that it protects those germinal products and the installation from adverse weather and environment effects;

• (b) the semen collection centre must be so constructed or isolated that contact with outside livestock is prevented;

• (c) the semen collection centre must be so constructed that, except for the office rooms and, in the case of equine animals, the exercise area, it can be readily cleansed and disinfected;

• (d) the semen collection centre must be so constructed that unauthorised access of people is effectively prevented.

PART 2

REQUIREMENTS FOR THE APPROVAL OF AN EMBRYO COLLECTION TEAM REFERRED TO IN ARTICLE 4

• 1.The responsibilities of the team veterinarian of an embryo collection team, as referred to in Article 4(1)(a)(ii), shall be the following:

• (a) the team veterinarian shall be responsible for all embryo collection team operations, including, amongst others, the following:
• (i) the verification of the identity and health status of donor animals;
• (ii) the clinical examination and surgery of donor animals;
• (iii) the disinfection and hygiene procedures, including procedures ensuring the transport of embryos to the laboratory in a hygienic and safe manner;
• (iv) record-keeping in accordance with the requirements laid down in Article 8(1)(b);
• (v) the marking of straws and other packages where oocytes or in vivo derived embryos are placed in accordance with the requirements set out in Article 10(1) and (5);
• (vi) the training of members of the embryo collection team on disinfection and hygiene techniques to prevent the spread of diseases;

• (b) the team veterinarian shall lay down the animal health and biosecurity requirements for the operation of the embryo collection team and the measures to ensure compliance with those requirements, including the testing of samples within a quality control scheme.

• 2.The facilities, equipment and operational procedures of the embryo collection team, as referred to in Article 4(1), point (b)(ii), shall comply with the following points (a) and (b):

• (a) the embryo collection team must have at its disposal a laboratory where oocytes or in vivo derived embryos can be examined, processed and packaged with adequate equipment, and that laboratory must be either:
• (i) a permanently located laboratory, which must have the following:
• — a room where oocytes or in vivo derived embryos can be processed which is physically separated from the area used to handle the donor animals during collection,
• — a room or area for cleansing and sterilising instruments used for oocytes or in vivo derived embryo collection and processing, except when using only new single-use equipment,
• — a room for the storing of oocytes or in vivo derived embryos; or
• (ii) a mobile laboratory, which must:
• — have a specially equipped part of the vehicle consisting of two separate sections: one section for the examination and processing of oocytes or in vivo derived embryos, which must be the clean section; and another section for accommodating equipment and materials used in contact with the donor animals,
• — use only new single-use equipment, unless the sterilisation of its equipment and the provision of fluids and other products necessary for the collection and processing of oocytes or in vivo derived embryos is carried out at a permanently located laboratory. The laboratories referred to in points (i) and (ii) must be designed and have a layout so as to prevent the cross-contamination of oocytes or in vivo derived embryos, and team operations shall be carried out in a manner that prevents such cross-contamination;

• (b) the embryo collection team must have at its disposal storage premises which comply with the following conditions:
• (i) they comprise at least one lockable room for the storage of oocytes or in vivo derived embryos;
• (ii) they must be easy to cleanse and disinfect;
• (iii) they must have permanent records of all incoming and outgoing oocytes or in vivo derived embryos;
• (iv) they must have storage containers for oocytes or in vivo derived embryos.

PART 3

REQUIREMENTS FOR THE APPROVAL OF AN EMBRYO PRODUCTION TEAM REFERRED TO IN ARTICLE 4

• 1.In addition to the responsibilities listed in point 1 of Part 2 of this Annex, the team veterinarian of an embryo production team, referred to in Article 4(1)(a)(ii), shall ensure that the embryo production team members have received adequate training on disease control and laboratory techniques, particularly on procedures for working in sterile conditions.

• 2.In addition to the requirements listed in point 2 of Part 2 of this Annex, the facilities, equipment and operational procedures of an embryo production team, referred to in Article 4(1)(b)(iii), shall comply with the following requirements:

• (a) the embryo production team must have at its disposal a permanently located laboratory which must have:
• (i) adequate equipment and facilities, including separate rooms or areas for:
• — the recovery of oocytes from ovaries,
• — the processing of oocytes and embryos, and
• — the storing of embryos and semen;
• (ii) a laminar flow facility or other suitable facilities where all technical operations associated with specific sterile conditions (namely, the processing of oocytes, embryos and semen) are conducted; however, the centrifugation of semen may be carried out outside the laminar flow facility or other facility as long as full hygiene precautions are taken;

• (b) where oocytes and other tissues are to be collected in a slaughterhouse, the embryo production team must 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;

• (c) the embryo production team may outsource the collection of oocytes to a group of specialised professionals provided that their activity is included in the approval by the competent authority of the embryo production team and the responsibilities of the team veterinarian referred to in point 1 are extended to their activities;

• (d) the embryo production team shall use semen which:
• (i) meets the requirements of this Regulation;
• (ii) is stored for the operation of the embryo production team in separate storage containers in the premises referred to in point 2(b) of Part 2 for the storing of produced embryos.

PART 4

REQUIREMENTS FOR THE APPROVAL OF A GERMINAL PRODUCT PROCESSING ESTABLISHMENT REFERRED TO IN ARTICLE 4

• 1.The responsibilities of the centre veterinarian, referred to in Article 4(1)(a)(i), shall be the following:

• (a) the centre veterinarian shall ensure that:
• (i) at the germinal product processing establishment records are kept in accordance with the requirements laid down in Article 8(1)(c);
• (ii) the entry of unauthorised persons is effectively prevented;
• (iii) authorised visitors comply with the animal health and biosecurity requirements referred to in point (b)(i);
• (iv) each straw or other package in which semen, oocytes or embryos are placed is clearly marked in accordance with the requirements laid down in Article 10;
• (v) the processing and storage of germinal products takes place only on the premises set aside for that purpose and under strict hygiene conditions;
• (vi) all instruments which come into contact with the germinal products are cleansed and either disinfected or sterilised prior to use, except for new single-use instruments;
• (vii) before the commencement of each filling operation, the storage containers and transport containers are cleansed and either disinfected or sterilised, except for new single-use containers;
• (viii) cryogenic agents used for the preservation or storage of germinal products have not previously been used for other products;
• (ix) the staff of the germinal product processing establishment have received adequate training:
• — on disinfection and hygiene techniques to prevent the spread of diseases,
• — for the purpose of processing germinal products, on laboratory techniques and particularly on procedures for working in sterile conditions;

• (b) the centre veterinarian shall:
• (i) lay down the animal health and biosecurity requirements for the operation of the germinal product processing establishment and the measures to ensure compliance with those requirements;
• (ii) only accept into a germinal product processing establishment semen, oocytes or embryos collected, produced, processed and stored in an approved germinal product establishment, and transported under conditions that ensure that cross-contamination of semen, oocytes or embryos is prevented, as they have had no contact with germinal products which do not comply with the rules laid down in this Regulation.

• 2.The requirements for the facilities, equipment and operational procedures of a germinal product processing establishment, referred to in Article 4(1)(b)(iv), shall be the following:

• (a) the germinal product processing establishment must have at least:
• (i) a germinal products processing room, separated from the germinal products storage room referred to in point (ii) and the room used for cleansing equipment referred to in point (iii);
• (ii) a germinal products storage room, which need not necessarily be on the same site, furnished with the necessary installation to store germinal products, and which is so constructed that it protects those germinal products and the installation from adverse weather and environment effects;
• (iii) a separate room for the cleansing and disinfection or sterilisation of equipment;

• (b) where processing is not limited to germinal products delivered from one approved germinal product establishment or is not limited to a germinal product of one type or of a single species, the germinal product processing establishment must have procedures in place to ensure that:
• (i) the processing of each consignment of germinal products is separated in time; and
• (ii) the equipment is cleansed and disinfected between the processing of different consignments;

• (c) where storage is not limited to a germinal product of one type or of a single species,
• (i) the germinal product processing establishment must have distinct storage containers assigned for each type and species of germinal product that is stored in the germinal products storage room referred to in point (a)(ii), and
• (ii) the handling of stored germinal products of different types and species must be carried out by separate staff or at a different time;

• (d) the germinal product processing establishment must be so constructed that, except the office rooms, it can be readily cleansed and disinfected;

• (e) the germinal product processing establishment must be so constructed that unauthorised access of people is effectively prevented.

PART 5

REQUIREMENTS FOR THE APPROVAL OF A GERMINAL PRODUCT STORAGE CENTRE REFERRED TO IN ARTICLE 4

• 1.The responsibilities of the centre veterinarian, referred to in Article 4(1)(a)(i), shall be the following:

• (a) the centre veterinarian shall ensure that:
• (i) at the germinal product storage centre records are kept in accordance with the requirements laid down in Article 8(1)(c);
• (ii) the entry of unauthorised persons is effectively prevented;
• (iii) authorised visitors comply with the animal health and biosecurity requirements referred to in point (b)(i);
• (iv) each straw or other package in which semen, oocytes or embryos are placed is clearly marked in accordance with the requirements laid down in Article 10;
• (v) storage of germinal products takes place only on the premises set aside for that purpose and under strict hygiene conditions;
• (vi) all instruments which come into contact with the germinal products are cleansed and either disinfected or sterilised prior to use, except for new single-use instruments;
• (vii) before the commencement of each filling operation, the storage containers and transport containers are cleansed and either disinfected or sterilised, except for new single-use containers;
• (viii) cryogenic agents used for preservation or storage of germinal products have not previously been used for other products;
• (ix) the staff employed at the germinal product storage centre have received adequate training on disinfection and hygiene techniques to prevent the spread of diseases;

• (b) the centre veterinarian shall:
• (i) lay down the animal health and biosecurity requirements for the operation of the germinal product storage centre and the measures to ensure compliance with those requirements;
• (ii) only accept into a germinal product storage centre semen, oocytes or embryos collected, produced, processed and stored in an approved germinal product establishment, and transported in conditions which ensure that cross-contamination of semen, oocytes or embryos is prevented, as they have had no contact with germinal products which do not comply with the rules laid down in this Regulation.

• 2.The requirements for the facilities, equipment and operational procedures of a germinal product storage centre, referred to in Article 4(1)(b)(v), shall be the following:

• (a) the germinal product storage centre must have a storage room furnished with necessary installation to store germinal products, which is so constructed that it protects those germinal products and the installation from adverse weather and environment effects;

• (b) where storage is not limited to a germinal product of one type or of a single species,
• (i) the germinal product storage centre must have distinct storage containers assigned for each type and species of germinal product that is stored at the centre, and
• (ii) the handling of stored germinal products of different types and species must be carried out by separate staff or at a different time;

• (c) the germinal product storage centre must be so constructed that, except the office rooms, it can be readily cleansed and disinfected;

• (e) the germinal product storage centre must be so constructed that unauthorised access of people is effectively prevented.

ANNEX II

ADDITIONAL ANIMAL HEALTH REQUIREMENTS FOR BOVINE, OVINE, CAPRINE, PORCINE AND EQUINE ANIMALS FROM WHICH GERMINAL PRODUCTS ARE COLLECTED, AND CONCERNING QUARANTINE AND LABORATORY OR OTHER TESTS OF THOSE ANIMALS AS REFERRED TO IN SECTION 2 OF CHAPTER 1 OF PART III

PART 1

ADDITIONAL ANIMAL HEALTH REQUIREMENTS FOR BOVINE ANIMALS FROM WHICH GERMINAL PRODUCTS ARE COLLECTED, AND CONCERNING QUARANTINE AND LABORATORY OR OTHER TESTS OF THOSE ANIMALS, AS REFERRED TO IN ARTICLE 20

Chapter I

Additional animal health requirements for bovine animals from which semen is collected, and concerning quarantine and laboratory or other tests for those animals

• 1.For all bovine animals admitted to a semen collection centre, the following requirements shall apply:

• (a) the animals must have been subjected to quarantine in quarantine accommodation where only other cloven-hoofed animals with at least the same health status were present;

• (b) within the period of 30 days prior to the commencement of the quarantine referred to in point (a), the animals must have been subjected to the following tests with a negative result in each case, except for the bovine viral diarrhoea antibody test referred to in point (v):
• (i) for infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), a test referred to in Part 2 of Annex I to Delegated Regulation (EU) 2020/688;
• (ii) for infection with Brucella abortus, Brucella melitensis and Brucella suis, a serological test referred to in point 1 of Part 1 of Annex I to Delegated Regulation (EU) 2020/688;
• (iii) for enzootic bovine leukosis, a serological test referred to in point (a) of Part 4 of Annex I to Delegated Regulation (EU) 2020/688, unless the derogation provided for in Article 20(2)(a) of this Regulation applies;
• (iv) for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, a serological test (whole virus) on a blood sample if the animals do not come from an establishment free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis;
• (v) for bovine viral diarrhoea:
• — a virus isolation test, a test for virus genome or a test for virus antigen, and
• — a serological test to determine the presence or absence of antibodies;

• (c) during the quarantine referred to in point (a), and for a period of at least 21 days, or 7 days in the case of the tests required in accordance with points (iv) and (v), after being admitted to the quarantine accommodation, the animals must have been subjected to the following tests with a negative result in each case, except for the bovine viral diarrhoea antibody test referred to in point (iii):
• (i) for infection with Brucella abortus, Brucella melitensis and Brucella suis, a serological test referred to in point 1 of Part 1 of Annex I to Delegated Regulation (EU) 2020/688;
• (ii) for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, a serological test (whole virus) on a blood sample.
• (iii) for bovine viral diarrhoea:
• — a virus isolation test, a test for virus genome or a test for virus antigen, and
• — a serological test to determine the presence or absence of antibodies. Any seronegative or seropositive animal shall only be allowed to enter the semen collection centre if no seroconversion occurs in animals which tested seronegative before entry into the quarantine accommodation. If seroconversion occurs, all animals that remain seronegative shall be kept in quarantine accommodation over a prolonged period until there is no longer seroconversion in the group of animals for a period of 3 weeks. Serologically positive animals may be allowed to enter the semen collection centre;
• (iv) for bovine genital campylobacteriosis (Campylobacter fetus ssp. venerealis):
• — in the case of animals less than 6 months old or kept since that age in a single sex group without contact with females prior to the quarantine referred to in point (a), a single test carried out on a sample of artificial vagina washings or preputial specimen, or
• — tests carried out on samples of artificial vagina washings or preputial specimens taken on three occasions at intervals of at least 7 days;
• (v) for trichomonosis (Trichomonas foetus):
• — in the case of animals less than 6 months old or kept since that age in a single sex group without contact with females prior to the quarantine referred to in point (a), a single test carried out on a sample of preputial specimen, or
• — tests carried out on preputial specimens taken on three occasions at intervals of at least 7 days. If any of the tests referred to in point (c) prove positive, the animal concerned shall be removed immediately from the quarantine accommodation. In the event of the quarantine of a group of animals, the competent authority shall take all necessary measures to re-establish the eligibility of the remaining animals for entry into the semen collection centre in accordance with Chapter I of Part 1 of this Annex;

• (d) prior to the initial dispatch of semen from bovine viral diarrhoea serologically positive bulls, a semen sample from each animal shall be subjected to a virus isolation or virus antigen enzyme-linked immunosorbent assay (ELISA) for bovine viral diarrhoea. In the event of a positive result, the bull shall be removed from the semen collection centre and all of its semen shall be destroyed.

• 2.All bovine animals kept at a semen collection centre shall be subjected at least once a year to the following tests (compulsory routine tests), with negative results:

• (a) for infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), a test referred to in Part 2 of Annex I to Delegated Regulation (EU) 2020/688;

• (b) for infection with Brucella abortus, Brucella melitensis and Brucella suis, a serological test referred to in point 1 of Part 1 of Annex I to Delegated Regulation (EU) 2020/688;

• (c) for enzootic bovine leukosis, a serological test referred to in point (a) of Part 4 of Annex I to Delegated Regulation (EU) 2020/688;

• (d) for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, a serological test (whole virus) on a blood sample;

• (e) for bovine viral diarrhoea, a serological test for the detection of an antibody which is applied only to seronegative animals. In the event that an animal becomes serologically positive, every ejaculate of that animal collected since the last negative test shall be either discarded or tested for virus or virus genome with negative results;

• (f) for bovine genital campylobacteriosis, a test on a sample of preputial specimen. Only bulls in semen production or having contact with bulls in semen production shall be required to be tested. Bulls returning to collection after a lay-off period of more than 6 months shall be tested during a period of 30 days prior to resuming production;

• (g) for trichomonosis, a test on a sample of preputial specimen. Only bulls in semen production or having contact with bulls in semen production shall be required to be tested. Bulls returning to collection after a lay-off period of more than 6 months shall be tested during a period of 30 days prior to resuming production.

• 3.If any of the tests referred to in point 2 prove positive, the animal shall be isolated and the semen collected from it since the last negative test shall not be moved to another Member State, with the exception, for bovine viral diarrhoea, of semen from every ejaculate which has been tested negative for either bovine viral diarrhoea virus or virus genome.

• The animal referred to in the first subparagraph shall be removed from the semen collection centre.

• Semen collected from all other animals at the semen collection centre since the date when the last sample was taken that gave a negative result in one of the tests described in point 2 shall be kept in separate storage and shall not be subject to movement 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 2.

Chapter II

Additional animal health requirements for bovine animals which are in vivo derived embryos donors, and concerning the quarantine of those animals

• 1.Donor bovine 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 bovine species on the day of embryo collection.

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

Chapter III

Additional animal health requirements for bovine animals from which oocytes for in vitro production of embryos are collected, and concerning quarantine of those animals

• 1.When oocytes are recovered from individual live bovine animals (either by aspiration from surgically excised ovaries (‘ovariectomy’) or by ultrasonographically guided transvaginal aspiration (‘ovum pick-up’), the requirements laid down in Chapter II shall apply to the donor animals of such oocytes.

• 2.In the case of donor bovine animals of ovaries and other tissues to be collected after slaughter in a slaughterhouse, those animals must not have been designated for slaughter as part of an approved eradication programme, nor have come from an establishment situated in a restricted zone established due to an outbreak of a category A disease or of an emerging disease in accordance with Article 6 of Regulation (EU) 2016/429 in donor bovine animals.

• 3.The slaughterhouse where the ovaries and other tissues are collected must not be situated in a restricted zone established due to an outbreak of a category A disease or of an emerging disease in accordance with Article 6 of Regulation (EU) 2016/429 in donor bovine animals.

• 4.Semen used to fertilise oocytes of bovine animals for in vitro production of embryos must have been collected, processed and stored in accordance with the requirements of Chapter I of Part 1 of Annex II, and of Part 1 of Annex III.

PART 2

ADDITIONAL ANIMAL HEALTH REQUIREMENTS FOR PORCINE ANIMALS FROM WHICH GERMINAL PRODUCTS ARE COLLECTED, AND CONCERNING QUARANTINE AND LABORATORY OR OTHER TESTS OF THOSE ANIMALS, AS REFERRED TO IN ARTICLE 21

Chapter I

Additional animal health requirements for porcine animals from which semen is collected, and concerning quarantine and laboratory or other tests of those animals

• 1.For all porcine animals admitted to a semen collection centre, the following requirements shall apply:

• (a) the animals must have been subjected to quarantine in quarantine accommodation where only other cloven-hoofed animals with at least the same health status were present;

• (b) within a period of 30 days prior to entering the quarantine accommodation referred to in point (a), the animals must have been subjected to the following tests, with negative results:
• (i) as regards infection with Brucella abortus, Brucella melitensis and Brucella suis, a buffered Brucella antigen test (rose Bengal test), a competitive ELISA or an indirect ELISA for the detection of antibodies to smooth Brucella species. If any of the animals prove positive in the serological tests detecting antibodies to smooth Brucella species (including Brucella abortus, Brucella melitensis and Brucella suis), animals with negative results in the same establishment shall not be admitted into the quarantine accommodation until a disease-free status of the infection with Brucella abortus, Brucella melitensis and Brucella suis of the establishments of origin of the animals that proved positive has been confirmed;
• (ii) as regards infection with Aujeszky’s disease virus:
• — in the case of non-vaccinated animals, an ELISA to detect antibodies to the whole Aujeszky’s disease virus or to glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) of the virus or a serum neutralisation test,
• — in the case of animals vaccinated with a gE deleted vaccine, an ELISA to detect antibodies to glycoprotein E (ADV-gE) of Aujeszky’s disease virus. The serological tests for infection with Aujeszky’s disease virus must meet the standards set out in Part 7 of Annex I to Delegated Regulation (EU) 2020/688;
• (iii) as regards classical swine fever, an antibody ELISA or serum neutralisation test, in case of animals coming from a Member State or zone thereof where classical swine fever has been reported or vaccination against this disease has been practiced for the period of the preceding 12 months;
• (iv) as regards infection with porcine reproductive and respiratory syndrome virus, a serological test (the immunoperoxidase monolayer assay (IPMA), immunofluorescence assay (IFA), or ELISA);

• (c) the animals have been subjected to the following tests carried out on samples taken during a period of at least 21 days after being admitted to the quarantine accommodation referred to in point (a):
• (i) as regards infection with Brucella abortus, Brucella melitensis and Brucella suis, a buffered Brucella antigen test (rose Bengal test), a competitive ELISA or an indirect ELISA for the detection of antibodies to smooth Brucella species. Animals which proved positive in a test referred to in the first subparagraph are to be removed from the quarantine accommodation, unless the suspicion of infection with Brucella abortus, Brucella melitensis and Brucella suis has been ruled out in accordance with point (d);
• (ii) as regards infection with Aujeszky’s disease virus:
• — in the case of non-vaccinated animals, an ELISA to detect antibodies to the whole Aujeszky’s disease virus or to glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) of the virus or a serum neutralisation test,
• — in the case of animals vaccinated with a gE deleted vaccine, an ELISA to detect antibodies to glycoprotein E (ADV-gE) of Aujeszky’s disease virus. If any of the animals prove positive in the tests for infection with Aujeszky’s disease virus, those animals shall be removed immediately from the quarantine accommodation; —————
• (iv) as regards infection with porcine reproductive and respiratory syndrome virus, a serological test (IPMA, IFA, or ELISA) or a test for virus genome (reverse-transcription polymerase chain reaction (RT-PCR), nested set RT-PCR, real-time RT-PCR). If any of the animals prove positive in the serological tests for infection with porcine reproductive and respiratory syndrome virus, the competent authority shall classify all animals in the quarantine accommodation as a suspected case in accordance with Article 9(1), point (b), of Delegated Regulation (EU) 2020/689. The operator shall isolate the positive animals immediately from other animals within the quarantine accommodation. The competent authority shall conduct an investigation to confirm or to rule out infection with porcine reproductive and respiratory syndrome virus in accordance with Article 8 of Delegated Regulation (EU) 2020/689. If any of the animals prove positive in the tests for virus genome for porcine reproductive and respiratory syndrome virus, the competent authority shall classify all animals in the quarantine accommodation as a confirmed case in accordance with Article 9(2), point (b), of Delegated Regulation (EU) 2020/689. The operator shall remove those animals immediately from the quarantine accommodation and follow the instructions of the competent authority. Where a group of animals is quarantined, the competent authority shall take all necessary measures to ensure that the remaining animals which have proved negative in the tests referred to in points (i), (ii), (iii) and (iv) have a satisfactory health status before they are admitted to the semen collection centre in accordance with this Chapter;

• (d) the following measures shall be taken in the case of a suspicion of infection with Brucella abortus, Brucella melitensis and Brucella suis:
• (i) the following protocol shall be implemented with regard to animals which have proved positive for infection with Brucella abortus, Brucella melitensis and Brucella suis in a test referred to in point (c)(i):
• — the positive sera are subjected to at least one of the alternative tests set out in point (c)(i) which has not been carried out on the samples referred to in point (c),
• — an epidemiological enquiry is carried out on the establishment(s) of origin of the animals which have proved positive in the test for infection with Brucella abortus, Brucella melitensis and Brucella suis,
• — not earlier than 7 days following the date of the collection of the samples referred to in point (c), samples are taken from all the animals which have proved positive in the tests referred to in point (c)(i) and in the first indent of point (d)(i) and subjected to a serological test provided for in point (c)(i), or all animals referred to in point (c) are subjected to a brucelin skin test;
• (ii) the suspicion of infection with Brucella abortus, Brucella melitensis and Brucella suis shall be ruled out provided that the epidemiological enquiry on the establishment(s) of origin did not reveal the presence of infection with Brucella abortus, Brucella melitensis and Brucella suis and either:
• — the repeat testing referred to in the first indent of point (d)(i) or the test referred to in the third indent of point (d)(i) were carried out with a negative result, or
• — all animals which proved positive in the tests referred to in the first or third indent of point (d)(i) have been subjected to a post-mortem inspection and agent detection test (PCR or bacteriological culture) for smooth Brucella species (including Brucella abortus, Brucella melitensis and Brucella suis), with a negative result in each case;
• (iii) after the suspicion of infection with Brucella abortus, Brucella melitensis and Brucella suis is ruled out, all of the animals from the quarantine accommodation referred to in the second paragraph of point (c) may be admitted to the semen collection centre.

• 2.Compulsory routine testing of porcine animals kept at semen collection centres shall be carried out as follows:

• (a) all porcine animals kept at the semen collection centre shall be subjected to the following tests with negative results:
• (i) as regards infection with Brucella abortus, Brucella melitensis and Brucella suis, a buffered Brucella antigen test (rose Bengal test), or a competitive ELISA or an indirect ELISA;
• (ii) as regards infection with Aujeszky’s disease virus:
• — in the case of non-vaccinated animals, an ELISA to detect antibodies to the whole Aujeszky’s disease virus or to glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) of the virus or a serum neutralisation test,
• — in the case of animals vaccinated with a gE deleted vaccine, an ELISA to detect antibodies to glycoprotein E (ADV-gE) of Aujeszky’s disease virus;
• (iii) as regards classical swine fever, an antibody ELISA or serum neutralisation test, in case of animals in a Member State or zone thereof where classical swine fever has been reported or vaccination against this disease has been practiced for the period of the preceding 12 months;
• (iv) as regards infection with porcine reproductive and respiratory syndrome virus, a serological test (IPMA, IFA, or ELISA);

• (b) the tests set out in point (a) shall be carried out on samples taken from:
• (i) all animals immediately prior to leaving the semen collection centre, or upon arrival at the slaughterhouse, and in no case later than 12 months from the date of admission to the semen collection centre; or
• (ii) at least:
• — 25 % of the animals in the semen collection centre every 3 months to test for infection with Brucella abortus, Brucella melitensis and Brucella suis, infection with Aujeszky’s disease virus and classical swine fever and from at least 10 % of the animals in the semen collection centre every month to test for infection with porcine reproductive and respiratory syndrome virus, or
• — 10 % of the animals in the semen collection centre every month to test for infection with Brucella abortus, Brucella melitensis and Brucella suis, infection with Aujeszky’s disease virus, classical swine fever and infection with porcine reproductive and respiratory syndrome virus. In the case of sampling carried out in accordance with the two options listed in point (ii), the centre veterinarian shall ensure that the sampled animals are representative of the total population of that centre, in particular with respect to age groups and housing;

• (c) where the testing is carried out in accordance with point 2(b)(ii), the centre veterinarian shall ensure that all animals are tested for the diseases referred to in point 2(a) at least every 12 months from the date of admission to the semen collection centre.

• 3.If any of the tests set out in point 2(a) prove positive, the animal shall be isolated and the semen collected from them since the last negative test shall not be the subject of movement between Member States.

• The animal referred to in the first subparagraph shall be removed immediately from the semen collection centre.

• Semen collected from all other animals present at the semen collection centre since the date when the last sample was taken that gave a negative result in one of the tests described in point 2(a) shall be kept in separate storage and shall not be the subject of movement 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 2(a).

Chapter II

Additional animal health requirements for porcine animals from which oocytes and embryos are collected, and concerning the quarantine of those animals

• 1.Donor porcine 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 porcine animals on the day of oocyte or embryo collection.

• 2.In addition to the requirements referred to in point 1, donor porcine females shall, except donors of in vivo derived embryos subject to trypsin treatment, come from a Member State or zone thereof which is free from infection with Aujeszky’s disease virus or where an approved eradication programme for infection with Aujeszky’s disease virus is carried out.

• 3.As regards infection with porcine reproductive and respiratory syndrome virus, the donor porcine females of in vivo derived embryos shall be subjected to a serological test for infection with porcine reproductive and respiratory syndrome virus, with negative results, on two occasions, at an interval of not less than 21 days, the second test being performed within a period of 15 days prior to embryo collection.

• 4.Semen used to inseminate donor porcine animals artificially must have been collected, processed and stored in accordance with the requirements of Chapter I of Part 2 of Annex II, and of Part 1 of Annex III.

PART 3

ADDITIONAL ANIMAL HEALTH REQUIREMENTS FOR OVINE AND CAPRINE ANIMALS FROM WHICH GERMINAL PRODUCTS ARE COLLECTED, AND CONCERNING THE QUARANTINE AND LABORATORY OR OTHER TESTS OF THOSE ANIMALS, AS REFERRED TO IN ARTICLE 22

Chapter I

Additional animal health requirements for ovine and caprine animals from which semen is collected, and concerning the quarantine and laboratory or other tests of those animals

• 1.For all ovine and caprine animals admitted to a semen collection centre, the following requirements shall apply:

• (a) the animals must have been subjected to quarantine in quarantine accommodation where only other cloven-hoofed animals with at least the same health status were present;

• (b) in the case of ovine animals, they must come from an establishment where, during the period of 60 days prior to their stay in the quarantine accommodation referred to in point (a), they, and any male caprine animal kept with them together, have been subjected with negative results to a serological test for ovine epididymitis (Brucella ovis), or any other test for ovine epididymitis (Brucella ovis) of an equivalent documented sensitivity and specificity;

• (c) the animals have been subjected to the following tests carried out on samples taken within a period of 30 days preceding the commencement of the period of quarantine referred to in point (a), with negative results:
• (i) for infection with Brucella abortus, Brucella melitensis and Brucella suis, a serological test referred to in point 1 of Part 1 of Annex I to Delegated Regulation (EU) 2020/688;
• (ii) in the case of ovine animals, and any male caprine animals kept with them together, a serological test for ovine epididymitis (Brucella ovis), or any other test for ovine epididymitis (Brucella ovis) of an equivalent documented sensitivity and specificity;

• (d) the animals have been subjected to the following tests carried out on samples taken during the period of quarantine referred to in point (a), and within a period of at least 21 days from the date of being admitted to the quarantine accommodation, with negative results:
• (i) for infection with Brucella abortus, Brucella melitensis and Brucella suis, a serological test referred to in point 1 of Part 1 of Annex I to Delegated Regulation (EU) 2020/688;
• (ii) in the case of ovine animals, and any male caprine animals kept with them together, a serological test for ovine epididymitis (Brucella ovis), or any other test for ovine epididymitis (Brucella ovis) of an equivalent documented sensitivity and specificity.

• 2.All ovine and caprine animals kept at a semen collection centre shall be subjected at least once a year to the following tests (compulsory routine tests), with negative results:

• (a) for infection with Brucella abortus, Brucella melitensis and Brucella suis, a serological test referred to in point 1 of Part 1 of Annex I to Delegated Regulation (EU) 2020/688;

• (b) in the case of ovine animals, for ovine epidydimitis (Brucella ovis) a serological test or any other test with an equivalent documented sensitivity and specificity. In the case where ovine animals are kept together with caprine animals, those caprine animals shall also be subjected to a serological test for ovine epididymitis (Brucella ovis) with negative results.

• 3.If any of the tests described in point 2 prove positive, the animal shall be isolated and the semen collected from it since the date of the last negative test shall not be moved between Member States.

• The animal referred to in the first subparagraph shall be removed from the semen collection centre.

• Semen collected from all other animals present at the semen collection centre since the date when the last sample was taken that gave a negative result in one of the tests described in point 2 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 2.

Chapter II

Additional animal health requirements for ovine and caprine animals from which oocytes and embryos are collected, and concerning the quarantine of those animals

• 1.Donor ovine and caprine 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 ovine and caprine species on the day of collection of the oocytes or embryos.

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

PART 4

ADDITIONAL ANIMAL HEALTH REQUIREMENTS FOR EQUINE ANIMALS FROM WHICH GERMINAL PRODUCTS ARE COLLECTED, AND CONCERNING THE QUARANTINE AND LABORATORY OR OTHER TESTS OF THOSE ANIMALS, AS REFERRED TO IN ARTICLE 23

Chapter I

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

• 1.In order to be used for the collection of semen, the donor equine animal shall, to the satisfaction of the centre veterinarian, meet the following requirements: