CELEX: 
Language: en
Date: 2019-12-17 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... 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

EUROPEAN
                            COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 4055 final
                 COMMISSION DELEGATED REGULATION (EU) …/...
                                        of 17.12.2019
      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)
EN                                                                                         EN
 ---pagebreak---                                    EXPLANATORY MEMORANDUM
   1.        CONTEXT OF THE DELEGATED ACT
   Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on
   transmissible animal diseases and amending and repealing certain acts in the area of animal
   health (‘Animal Health Law’)1 was published in the Official Journal of European Union on
   31 March 2016. It came into force on 20 April 2016 and applies from 21 April 2021.
   The Animal Health Law lays down rules on transmissible animal diseases, and inter alia,
   rules for the registration and approval of germinal product establishments and for traceability
   of consignments and the animal health requirements for germinal products moved within the
   Union.
   The Animal Health Law, once applicable, will replace, inter alia, four Council Directives
   (namely, Council Directives 88/407/EEC2, 89/556/EEC3, 90/429/EEC4 and 92/65/EEC5), as
   well as a number of Commission Decisions, adopted pursuant to those Directives, laying
   down animal health requirements for trade within the Union in germinal products.
   The Animal Health Law aims at providing a simpler and more flexible regulatory framework,
   while at the same time ensuring a more risk-based approach to animal health requirements,
   enhanced disease preparedness, prevention and control for listed diseases 6. These elements,
   however, can only become operational once more detailed requirements are laid down in
   delegated and implementing acts complementing the Animal Health Law.
   The Animal Health Law provides for the Commission to adopt delegated acts, including
   delegated acts for the movement within the Union of consignments of germinal products of
   certain kept terrestrial animals.
   This Commission Delegated Regulation lays down rules concerning the approval of germinal
   product establishments, and the traceability, animal health, certification and notification
   requirements for the movements within the Union of consignments of germinal products of
   certain kept terrestrial animals, that are required to be adopted pursuant to the Animal Health
   Law, and more particularly under Chapters 1, 2 and 5 of Title I of Part IV of that act.
   The Animal Health Law was one of the first main legislative acts adopted following the
   adoption of the Treaty on the Functioning of the European Union. At that time, all the
   implications and practicalities related to the adoption of the delegated acts in accordance with
   Article 290 of the Treaty were not yet known nor discussed, and accordingly were not taken
   into consideration at the time of drafting. Hence, the various 'empowerment' articles in the
   1
           OJ L 84, 31.3.2016, p. 1.
   2
           Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable
           to intra-Community trade in and imports of semen of domestic animals of the bovine species (OJ L 194,
           22.7.1988, p. 10).
   3
           Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-
           Community trade in and importation from third countries of embryos of domestic animals of the bovine
           species (OJ L 302, 19.10.1989, p. 1).
   4
           Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable
           to intra-Community trade in and imports of semen of domestic animals of the porcine species
           (OJ L 224, 18.8.1990, p. 62).
   5
           Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade
           in and imports into the Community of animals, semen, ova and embryos not subject to animal health
           requirements laid down in specific Community rules referred to in Annex A (I) to Directive
           90/425/EEC (OJ L 268, 14.9.1992, p. 54).
   6
           'Listed disease' means a disease listed in accordance with Article 5(1) of the Animal Health Law. See
           also Annex II to that Regulation.
EN                                                        1                                                      EN
 ---pagebreak---    Animal Health Law providing for the adoption of delegated acts are not grouped together at
   the end of a Chapter, Title or Part dealing with a particular subject, but instead are mostly
   spread across different articles of those divisions of the act, even though, content-wise, they
   are closely linked with each other. Therefore, this draft delegated act 'bundles' a number of the
   empowerment provisions provided for in the Animal Health Law and cites them all as legal
   bases. In addition, in the interests of coherency, transparency and to avoid duplication, it is
   important that these rules are laid down in the same delegated act, as they are all interrelated.
   The rules laid down in this Delegated Regulation are largely 'taking over' rules currently laid
   down in existing Union acts establishing the animal health requirements for the movement
   within the Union of consignments of germinal products, as they have proven to be effective in
   preventing the spread of listed diseases within the Union.
   2.       CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
   The expert group meetings for the purpose of this Delegated Regulation took place on
   24 April 2017, 24 November 2017, 16 April 2018, 18 May 2018 and 18 June 2018. The
   Member States' representatives from the national competent authorities participated in those
   meetings. At the first meeting of the expert group, representatives of the RepVet Group
   (veterinarians from European Artificial Insemination companies in the cattle and pig sectors),
   were also present due to the need for specific expertise.
   The purpose of the expert group meetings which took place on 24 April and 24 November
   2017 was to exchange views, experiences and good practices among representatives of the
   competent authorities of the Member States responsible for the development and
   implementation of animal health policy in the area of germinal products, and with the
   stakeholders in that sector. The aim of those meetings was to identify provisions of the
   existing European Union legislation on germinal products which should either be kept or
   improved in the upcoming acts to be adopted within the framework of the Animal Health
   Law, as well as to point out new obligations arising under the Animal Health Law.
   The conclusions of the expert group meetings, as regards the rules to be laid down in the
   future delegated acts on germinal products, to be adopted within the framework of the Animal
   Health Law, were the following:
   (a)      a derogation for collection of semen of ovine and caprine animals at establishments
            where those animals are kept and which is then dispatched to another Member State,
            as currently provided for in Directive 92/65/EEC, should be maintained; however,
            special conditions for such dispatch (including the purpose of such movements and
            the consent of the Member State of destination) should be established;
   (b)      all three types of residency of stallions at semen collection centres, as currently
            provided for in Directive 92/65/EEC should be maintained; however, the conditions
            for the testing programme as specified in point 1.6(b) of Chapter II(I) of Annex D to
            Directive 92/65/EEC - donors which may leave the semen collection centre
            occasionally - and the testing programme as specified in point 1.6(c) of Chapter II(I)
            of Annex D to Council Directive 92/65/EEC - "walk-in stallions" - should be
            improved and strengthened;
   (c)      rules for dispatch of consignments of germinal products between confined
            establishments should be laid down;
   (d)      rules for the storage and dispatch of consignments of germinal products collected by
            a germinal product establishment which ceases its activity should be laid down, also
            rules covering a situation when such a germinal product establishment should remain
EN                                                 2                                                 EN
 ---pagebreak---        in the list of approved germinal product establishments of a particular Member State,
       and the date when the activity was ceased should be indicated in that list;
   (e) rules should be laid down concerning the dispatch of consignments of bovine oocytes
       and ovaries within the Union;
   (f) it is necessary to lay down rules concerning mixed/pooled semen of bovine, porcine,
       ovine and caprine animals; however, the mixing of semen should be restricted to the
       semen collection centre where it was collected;
   (g) the current system for the marking of straws and other packages of germinal products
       has been working well to date; however, further discussions on the possible
       standardisation of the code placed on the straws will continue;
   (h) rules should be laid down covering the traceability and animal health requirements
       for the dispatch of consignments of germinal products of dogs and cats, of terrestrial
       animals of species other than those of the bovine, porcine, ovine, caprine and equine
       species kept at confined establishments and of animals of the families Camelidae and
       Cervidae;
   (i) there was support for laying down rules for germinal product storage centres where
       semen, oocytes or embryos of one or more species (namely of the bovine, porcine,
       ovine, caprine and equine species), or any combination of those germinal products of
       those species, are stored under additional special conditions;
   (j) there is a need for the specific rules permitting the dispatch to other Member States
       of consignments of germinal products for scientific purposes and those stored at gene
       banks, which do not necessary fulfil the requirements laid down in the existing acts.
       The germinal products stored at the gene banks have a particular value being a
       genetic material of rare, endangered or even extinct breeds, therefore derogation
       from standard requirements for the dispatch of such germinal products should be laid
       down in this Delegated Regulation;
   (k) specialised units for the sex-sorting of semen should be considered to be germinal
       product establishments where processing and storage of germinal products takes
       place; they do not only process germinal products, including sex-sorting of semen,
       but also prepare the final product ready to be used or for storage; however, the option
       for processing, mainly sex-sorting, of semen outside the semen collection centre and
       the subsequent return of that processed semen to the semen collection centre of
       semen origin should also be provided for;
   (l) containers transporting germinal products from approved germinal products
       establishments to other Member States or nationally from approved germinal product
       establishments to germinal product processing establishments and germinal product
       storage centres should be sealed. A centre or team veterinarian should ensure that
       such seal is applied on the transport container, whereas an official veterinarian
       should have a possibility of breaking that seal for the purpose of verifying the
       content of the transport container and later on re-sealing the transport container,
       before issuing of a health certificate;
   (m) the transport in one container of different types of germinal products of a single
       species, under additional special conditions, should be allowed. Also, the transport
       within a single container of germinal products of ovine and caprine animals should
       be allowed;
EN                                             3                                               EN
 ---pagebreak---    (n)       animal health requirements related to ovine epididymitis (Brucella ovis) are only
             relevant for ovine animals and those caprine animals which are kept together with
             ovine animals;
   (o)       the experts acknowledged the prudent use of antibiotics; however, they preferred
             that, in particular with the view to possible exports, the use of antibiotics in semen
             diluents should be in line with the recommendations of the World Organisation for
             Animal Health (OIE).
   During the expert group meetings which took place on 16 April 2018, 18 May 2018 and 18
   June 2018 a working document of a draft Commission Delegated Regulation supplementing
   Regulation (EU) 2016/429 of the European Parliament and of the Council as regards approval
   of germinal product establishments, traceability and animal health requirements for the
   movements within the Union of germinal products of certain kept terrestrial animals was
   presented and discussed. This working document was prepared based on current Union
   legislation establishing the animal health requirements for the movement within the Union of
   germinal products and taking into account views, opinions and comments received from the
   experts participating in the expert group meetings which had taken place on 24 April and 24
   November 2017.
   This draft Delegated Regulation was also made available to the European Parliament and the
   Council.
   There were no comments received from the Council.
   There were no comments received from the European Parliament.
   In addition, stakeholders' comments on the draft Delegated Regulation were collected in the
   context of the Better Regulation feedback mechanism during the period between 9 January
   and 6 February 2019. 34 feedbacks were received in total, including opinions of the following
   stakeholders: ETS-Holland, European Association of Zoos and Aquaria (EAZA ), European
   Association of Zoo and Wildlife Veterinarians, European Forum of Farm Animal Breeders
   (EFFAB), Association of Embryo Technologies in Europe, British and Irish Association of
   Zoos and Aquariums, the following public authorities: Canadian Food Inspection Agency,
   Animal and Plant Health Agency of the United Kingdom and U.S. Department of Agriculture,
   Animal and Plant Health Inspection Service (USDA-APHIS-IS), and some anonymous
   opinions.
   In addition, there were several opinions submitted to the Commission by e-mail.
   The main following requests were submitted and points made:
   (a)       to adjust the list of antibiotics and mixtures of antibiotics used in ovine and caprine
             semen diluents in accordance with existing practices. Having regard that use of
             antibiotics in ovine and caprine semen is voluntary and in order to make the
             provisions of this Delegated Regulation clearer, the text of the Delegated Regulation
             was amended;
   (b)       the ovine semen sector welcomed provisions of this Delegated Regulation which
             supports the existing practice that most of the ovine semen is dispatched and used as
             fresh semen;
   (c)       the operators of confined establishments disagree with the requirement of no natural
             breeding to have taken place for at least 30 days prior to the collection of germinal
             products. Many non-domestic animals of the bovine, ovine, equine and caprine
             species, complex and highly social, are kept at confined establishments. To maximise
             the welfare of these animals, they are kept in social groups to replicate that of their
EN                                                  4                                                EN
 ---pagebreak---         free-living counterparts. Therefore, it is not possible to keep donor animals in
        isolation for 30 days. The text of the Delegated Regulation was therefore amended;
   (d)  some operators disagree with a derogation provided for in this Regulation allowing
        collection of semen of ovine and caprine animals, which is to be moved to another
        Member State, at the establishment of origin of those animals instead of at a semen
        collection centre. They claim that it is a disadvantage for those operators which are
        approved as semen collection centre. This Delegated Regulation, based on the
        possible risk posed by the movement of such semen, allows for such derogation,
        which was already established by Directive 92/65/EEC;
   (e)  the acknowledgements for the conditions laid down in this Delegated Regulation for
        the movement of germinal products stored at national gene banks to other Member
        States, including definition of a gene bank;
   (f)  the request to take into account germinal products donors vaccinated against
        infection with bluetongue virus. This Delegated Regulation is in line with
        recommendations of the Terrestrial Animal Health Code of the World Organisation
        for Animal Health (OIE).
   3.   LEGAL ELEMENTS OF THE DELEGATED ACT
   3.1. Summary of the proposed rules
        This Delegated Regulation will supplement the rules laid down in Chapters 1, 2 and
        5 of Title I of Part IV of the Animal Health Law.
        While the Animal Health Law did not substantially alter the pre-existing legal
        framework applicable to germinal products, it provides for the Commission to adopt
        rules updating those that had been previously laid down in pre-existing acts, and
        supplementing those laid in the basic act.
        Accordingly, this Delegated Regulation will include the following additional rules
        supplementing those already laid down in the basic act as regards:
        (a)    requirements for the approval and for the cessation of activities of germinal
               products establishments for bovine, porcine, ovine, caprine and equine animals;
        (b)    the information to be included in the registers of registered and approved
               germinal products establishments to be kept by the competent authority;
        (c)    record keeping obligations for operators, including additional record-keeping
               requirements for germinal product establishments that have ceased their
               activities;
        (d)    traceability requirements for germinal products of bovine, porcine, ovine,
               caprine and equine animals;
        (e)    traceability requirements for germinal products of dogs, cats, and terrestrial
               animals of species other than those of the bovine, porcine, ovine, caprine and
               equine species kept at confined establishments and animals of the families
               Camelidae and Cervidae;
        (f)    animal health requirements for the dispatch of consignments of germinal
               products between Member States;
        (g)    animal health certification and notification requirements for the dispatch of
               consignments of germinal products between Member States;
EN                                             5                                               EN
 ---pagebreak---         (h)   rules for the granting of derogations by the competent authorities for the
              dispatch of consignments of germinal products between Member States for
              scientific purposes and germinal products stored at gene banks;
        (i)   transitional measures to protect the acquired rights and legitimate expectations
              of stakeholders resulting from pre-existing Union acts.
   3.2. Legal basis
        The draft Delegated Regulation is to be adopted within the framework of Regulation
        (EU) 2016/429, and in particular pursuant to Article 94(3), Article 97(2), Article
        101(3), Article 106(1), Article 122(1) and (2), Article 131(1), Article 160(1) and (2),
        Article 161(6), Article 162(3) and (4), Article 163(5), Article 164(2), Article 165(3)
        and Article 279(2) thereof.
EN                                            6                                                 EN
 ---pagebreak---                      COMMISSION DELEGATED REGULATION (EU) …/...
                                                of 17.12.2019
        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)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of
   9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the
   area of animal health ('Animal Health Law')7, and in particular Article 94(3), Article 97(2),
   Article 101(3), Article 106(1), Article 122(1) and (2), Article 131(1), Article 160(1) and (2),
   Article 161(6), Article 162(3) and (4), Article 163(5), Article 164(2), Article 165(3) and
   Article 279(2) thereof,
   Whereas:
   (1)     Regulation (EU) 2016/429 lays down rules for the prevention and control of animal
           diseases which are transmissible to animals or to humans. Those rules provide, inter
           alia, for the registration and approval of germinal product establishments, and for the
           traceability and animal health requirements for movements of consignments of
           germinal products within the Union. Regulation (EU) 2016/429 also empowers the
           Commission to adopt rules to supplement certain non-essential elements of that
           Regulation by means of delegated acts. It is therefore appropriate to adopt such rules
           in order to ensure the smooth functioning of the system in the new legal framework
           established by Regulation (EU) 2016/429.
   (2)     The rules laid down in this Regulation are required to supplement those laid down in
           Chapters 1, 2 and 5 of Title I of Part IV of Regulation (EU) 2016/429, as regards the
           approval of germinal product establishments, the registers of germinal product
           establishments to be kept by the competent authorities, the record-keeping obligations
           of operators, the traceability and animal health requirements, and animal health
           certification and notification requirements for movements within the Union of
           consignments of germinal products of certain kept terrestrial animals in order to
           prevent the spread of transmissible animal diseases within the Union by those
           products.
   (3)     These rules are substantively linked and many are intended to be applied in tandem. In
           the interests of simplicity and transparency, as well as to facilitate their application and
           to avoid a multiplication of rules, they therefore should be laid down in a single act
           rather than in a number of separate acts with many cross-references and the risk of
           duplication.
   7
           OJ L 84, 31.3.2016, p. 1.
EN                                                    7                                                 EN
 ---pagebreak---    (4) Indeed, Regulation (EU) 2016/429 aims at providing a simpler and more flexible
       regulatory framework than previously existed, while at the same time ensuring a more
       risk-based approach to animal health requirements, enhanced disease preparedness,
       prevention and control of animal diseases. It was also adopted in order to ensure that
       the rules concerning animal diseases were laid down mainly in a single act, as opposed
       to being scattered in a number of different acts. The rules laid down in this Regulation
       concerning germinal products also follow the same approach.
   (5) Prior to the adoption of Regulation (EU) 2016/429, Union rules on germinal products
       were laid down in Council Directives 88/407/EEC8, 89/556/EEC9, 90/429/EEC10 and
       92/65/EEC11. Regulation (EU) 2016/429 repeals and replaces those four Directives
       with effect from 21 April 2021. Those Directives laid down the animal health
       conditions for trade within the Union and for the entry into the Union of consignments
       of semen, ova and embryos of bovine, ovine, caprine, porcine and equine animals and
       in principle of certain other animal species. The rules laid down in those Directives
       have proven to be effective in preventing the spread of transmissible animal diseases
       within the Union. Accordingly, the main substance of those rules should be
       maintained, but updated to take account of the experience gained in their application
       and current scientific knowledge.
   (6) Germinal products, and in particular semen, but also to a lesser extent oocytes and
       embryos may represent an important risk for the spread of animal diseases. They are
       collected or produced from a limited number of donors, but are used widely in the
       general animal population so they can, if not handled properly or not classified with
       the correct health status, be a source of disease for a large number of animals. Such
       cases have occurred in the past and have caused substantial economic losses.
   (7) To prevent the risk of the spread of disease, Regulation (EU) 2016/429 provides that
       germinal products should be collected, produced, processed and stored at specialised
       germinal product establishments and be subject to special animal health and hygiene
       regimes. At the same time, in order for animals to be admitted into those germinal
       product establishments and be classified as donors of germinal products which may be
       moved between Member States, they are required to comply with higher animal health
       standards than those applicable to the general animal population. Regulation (EU)
       2016/429 also lays down specific procedures to ensure the traceability of those
       germinal products and a special set of animal health requirements apply to their
       movements within the Union. Within this framework, it is appropriate to lay down in
       this Regulation rules with regard to the movements of consignments of germinal
       products on the basis of several empowering provisions laid down in Regulation (EU)
   8
       Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable
       to intra-Community trade in and imports of semen of domestic animals of the bovine species (OJ L 194,
       22.7.1988, p. 10).
   9
       Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-
       Community trade in and importation from third countries of embryos of domestic animals of the bovine
       species (OJ L 302, 19.10.1989, p. 1).
   10
       Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable
       to intra-Community trade in and imports of semen of domestic animals of the porcine species
       (OJ L 224, 18.8.1990, p. 62).
   11
       Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade
       in and imports into the Community of animals, semen, ova and embryos not subject to animal health
       requirements laid down in specific Community rules referred to in Annex A (I) to Directive
       90/425/EEC (OJ L 268, 14.9.1992, p. 54).
EN                                                  8                                                        EN
 ---pagebreak---         2016/429 which provide for the Commission to adopt delegated acts, and in particular
        those laid down in Part IV thereof.
   (8)  Article 160(1) of Regulation (EU) 2016/429 provides for the Commission to adopt
        delegated acts laying down animal health requirements for movements to other
        Member States of germinal products of bovine, porcine, ovine, caprine and equine
        animals. One of the conditions for such movements is that those germinal products
        must come from a germinal product establishment approved for that purpose in
        accordance with conditions to be laid down in a delegated act. Furthermore, Article
        94(3)(c) of Regulation (EU) 2016/429 provides for the Commission to adopt delegated
        acts concerning the special rules for the cessation of activities of germinal product
        establishments previously approved in accordance with the conditions laid down in a
        delegated act. At the same time, Article 101(3) of that Regulation provides for the
        Commission to adopt delegated acts on the detailed information to be included in the
        registers of registered and approved germinal product establishments kept by the
        competent authority, which will also include germinal product establishments which
        have ceased their activity.
   (9)  As the animal health requirements and derogations to be adopted pursuant to those
        provisions of Regulation (EU) 2016/429 all relate to movements of germinal products
        of kept terrestrial animals within the Union, albeit pertaining to a number of different
        species, in the interests of simplication of Union rules, they should be laid down in a
        single delegated act, rather than scattered in a number of different delegated acts.
   (10) Article 162(1) of Regulation (EU) 2016/429 lays down requirements concerning the
        minimum information to be included in animal health certificates for movements
        between Member States of germinal products of bovine, porcine, ovine, caprine and
        equine animals. They must include information on the marking of the germinal
        products, when so required by Article 121(1) of that Regulation or by any rules laid
        down in delegated acts adopted pursuant to Article 122(1) thereof, and the information
        needed to demonstrate that the germinal products fulfil the movement requirements as
        provided for in Articles 157 and 159 of that Regulation or by rules set out in delegated
        acts adopted pursuant to Article 160 thereof. Article 162(3) of that Regulation
        provides for delegated acts to be adopted concerning the information to be contained
        in the animal health certificates. At the same time, Article 163(5) thereof provides for
        delegated acts to be adopted on the notification requirements for movements between
        Member States of germinal products of certain kept terrestrial animals, accompanied
        by an animal health certificate whose content is to be established in accordance with
        Article 162(3) and (4) of that Regulation.
   (11) Article 94(1) of Regulation (EU) 2016/429 provides that germinal products of bovine,
        porcine, ovine, caprine and equine animals may be moved to another Member State if
        those germinal products were collected at germinal product establishments which have
        been approved by the competent authorities in accordance with Article 97(1) thereof.
        Such approval may only be granted if those germinal product establishments comply
        with particular requirements relating to quarantine, isolation and other biosecurity
        measures, surveillance, facilities and equipment, as well as responsibilities,
        competence and specialised training of personnel and veterinarians. Therefore, based
        on those requirements, it is necessary to set out in this Regulation the detailed rules
        and conditions for the approval of germinal product establishments for bovine,
        porcine, ovine, caprine and equine animals from which germinal products of those
        animals may be moved to another Member State.
EN                                               9                                               EN
 ---pagebreak---    (12) Directive 92/65/EEC provides that semen of ovine and caprine animals, which is to be
        moved to another Member State, may be collected at the establishment of origin of
        those animals instead of at a semen collection centre. This Regulation should provide
        for a similar derogation. However, special conditions for movements of consignments
        of such semen, including the purpose of such movements and the consent of the
        Member State of destination, should be established. Therefore, based on the possible
        risk posed by the movement of such semen, the rules and conditions authorising such
        derogations should be laid down in this Regulation.
   (13) The collection of equine semen has its own particular characteristics due to the special
        breeding system of equine animals which takes account of the participation of such
        animals in dedicated equine competitions, shows and other equestrian events.
        Currently, Directive 92/65/EEC provides for three types of residency of stallions at
        semen collection centres. The main rules laid down in the current system provided for
        in that Directive should be maintained in this Regulation. However, the conditions for
        the testing programme as specified in point 1.6(b) of Chapter II(I) of Annex D to
        Directive 92/65/EEC for donors which may leave the semen collection centre
        occasionally and for the testing programme as specified in point 1.6(c) of Chapter II(I)
        of Annex D to Directive 92/65/EEC for "walk-in stallions", should be improved and
        strengthened in this Regulation.
   (14) This Regulation should also provide for germinal product storage centres storing
        germinal products of any type and originating from more than one species, under one
        unique approval number and subject to rules that ensure traceability, as there are no
        animal health reasons requiring separate storage centres per type of germinal product
        or per species. Information on the types and species of stored germinal products
        should be specified in the approval of such establishments and in the publicly
        available register of approved germinal product establishments kept by the competent
        authorities. This Regulation should also lay down specific provisions on the storage of
        fresh, chilled and frozen semen.
   (15) The continual progress in germinal products processing techniques has lead to the
        establishment of specialised units for that purpose. Those units not only process
        germinal products, including sex-sorting of semen, but they also prepare the final
        product ready for use or for storage. Therefore, such units should be considered to be
        germinal product establishments where the processing and storage of germinal
        products takes place. However, as equipment for sex-sorting of semen is costly, semen
        collection centres may use services of other operators for processing, including sex-
        sorting, of semen. In that case, semen is sent out for processing and is then returned to
        the semen collection centre of origin. Therefore, it is appropriate to lay down in this
        Regulation rules for the processing of germinal products, including the possibility for
        their processing at germinal product processing establishments, as well as detailed
        rules for the transport and the marking of semen and other germinal products to and
        from such germinal product processing establishments. Where semen is processed at a
        germinal product processing establishment, a marking on the straw or another package
        should include the approval or registration number of both the semen collection centre
        and the germinal product processing establishment in order to ensure traceability of
        the semen.
   (16) While antibiotics should be used prudently, at the same time, in particular with a view
        to possible international trade, the inclusion of antibiotics in semen diluents should be
        in line with the provisions of Article 4.6.7 of the Terrestrial Animal Health Code (‘the
EN                                               10                                               EN
 ---pagebreak---         Code’) of the World Organisation for Animal Health (OIE), Edition 201712. In
        accordance with Directive 88/407/EEC, there is an obligation to add to bovine semen
        antibiotics that are effective against campylobacters, leptospires and mycoplasmas,
        and in accordance with Directive 90/429/EEC there is an obligation to add to porcine
        semen antibotics which are effective against leptospires, while Directive 92/65/EEC
        provides for the voluntary use of antibiotics. This Regulation should maintain the rules
        for the usage of antibiotics laid down in Directives 88/407/EEC, 90/429/EEC and
        92/65/EEC, as well as those recommended by the OIE. Where antibiotics are are
        added to semen, information about the active substance(s) and their concentration
        should be indicated in the accompanying health certificate.
   (17) Article 101(1) of Regulation (EU) 2016/429 provides that each competent authority
        should establish and keep up-to-date registers of registered germinal product
        establishments and of approved germinal product establishments which should be
        made available to the Commission and the competent authorities of the Member
        States. In addition, the register of approved germinal product establishments should be
        made available to the public. Therefore, it is appropriate to lay down in this Regulation
        the detailed information which should be included in those registers and the public
        availability of the register of the approved germinal product establishments.
   (18) Due to the lengthy stocking capabilities for semen, oocytes and embryos, it is
        necessary to lay down in this Regulation special rules for the storage and movement of
        germinal products collected by approved germinal product establishments which cease
        their activity. Information concerning such germinal product establishments should be
        retained in the register of approved germinal product establishments of the Member
        State concerned and dates when the activity was stopped should be included. In
        addition, the date of withdrawal of the approval should be indicated in that register.
        The period for retaining information concerning such germinal product establishments
        in that register should also be established.
   (19) In addition, this Regulation should also lay down rules to ensure that operators of
        approved germinal product establishments who cease their activity, prior to the date of
        withdrawal of the approval of their germinal product establishment, move the semen,
        oocytes or embryos collected or produced and stored in those germinal product
        establishments for further storage to a germinal product storage centre, or for
        reproduction purposes to an establishment where bovine, porcine, ovine, caprine or
        equine animals are kept, or for safe disposal or use as animal by-products in
        accordance with Article 13 of Regulation (EC) No 1069/2009 of the European
        Parliament and of the Council13.
   (20) Article 121 of Regulation (EU) 2016/429 lays down traceability requirements for
        germinal products of bovine, ovine, caprine, porcine and equine animals and detailed
        rules in relation to the marking of those germinal products should be laid down in this
        Regulation. The current system for the marking of straws and other packages with
        germinal products is well established. Account should also be taken of the
   12
        http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_coll_semen.htm.
   13
        Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009
        laying down health rules as regards animal by-products and derived products not intended for human
        consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)
        (OJ L 300, 14.11.2009, p. 1).
EN                                                  11                                                     EN
 ---pagebreak---         recommendations of the International Committee for Animal Recording (ICAR)14 in
        this respect.
   (21) The collection and processing of semen of ovine and caprine animals also have
        particular characteristics. Some semen collection centres freeze semen in pellets, while
        others place fresh or chilled semen for a short time in receptacles, such as tubes. The
        individual marking of such pellets and tubes is time consuming and onerous. In order
        to allow the movement to other Member States of semen of ovine and caprine animals,
        while at the same time ensuring its traceability, group identification of pellets of
        frozen semen or tubes or straws with fresh or chilled semen should be available.
        Therefore, it is necessary to lay down in this Regulation rules for the marking of
        collective packages, such as goblets, where pellets of frozen semen, or tubes or straws
        with fresh or chilled semen of ovine and caprine animals are placed.
   (22) Traceability requirements for germinal products of bovine, ovine, caprine, porcine and
        equine animals laid down in this Regulation are to be supplemented by the rules
        concerning technical requirements and specifications for marking of straws and other
        packages which will be laid down in Commission Implementing Regulation adopted
        in accordance with Article 123 of Regulation (EU) 2016/429.
   (23) An increasing number of germinal products of dogs and cats, of terrestrial animals
        other than bovine, porcine, ovine, caprine and equine animals kept at confined
        establishments and of animals of the families Camelidae and Cervidae are moved
        between Member States. Therefore, it is appropriate to establish harmonised rules on
        the marking of straws and other packages containing such germinal products.
        Additional rules on the traceability of germinal products of kept terrestrial animals of
        species other than those of the bovine, porcine, ovine, caprine and equine species
        should be laid down in this Regulation.
   (24) Article 159 of Regulation (EU) 2016/429 lays down rules concerning the authorisation
        of movements to other Member States of germinal products of kept animals of the
        bovine, ovine, caprine, porcine and equine species. In order to make those rules
        operational, it is necessary to lay down in this Regulation detailed rules for the
        collection, production, processing, storage and transport of germinal products, and
        animal health requirements for kept donor animals from which germinal products are
        collected and concerning isolation and quarantine for such animals, and requirements
        for the laboratory and other tests to be carried out on kept donor animals and germinal
        products, as well as animal health requirements for the collection, production,
        processing, storage or other procedures and transport of those germinal products.
   (25) In addition, Directives 88/407/EEC, 90/429/EEC and 92/65/EEC provided for
        derogations, under certain conditions, from testing obligations for donor animals of the
        bovine, porcine, ovine and caprine species when those animals are moved between
        semen collection centres. As such derogations decrease the procedural and economic
        burdens for operators of semen collection centres and are justified from an animal
        health point of view, it is appropriate to maintain in this Regulation such derogations
        from certain animal health requirements for donor animals of the bovine, ovine,
        caprine and porcine species moved between approved semen collection centres.
   (26) Based on current scientific knowledge, the transport of different types of germinal
        products of a single species in one container does not pose a risk for the contamination
        of germinal products if they are transported under certain conditions. These conditions
   14
        https://www.icar.org/
EN                                              12                                               EN
 ---pagebreak---         include being transported in physically separated compartments of the transport
        container or with the use of double-bag system protecting the commodity of one type
        from the other. Therefore, it is appropriate to lay down rules in this Regulation
        permitting the transport of germinal products of different types of a single species in
        one container under certain conditions.
   (27) The sealing of containers in which germinal products are transported from approved
        germinal product establishments to other Member States or nationally from approved
        germinal product establishments to germinal product processing establishments and
        germinal product storage centres ensures that the animal health conditions for the
        transport of germinal products are not compromised. The centre veterinarian or team
        veterinarian responsible for the germinal product establishment, whose name is
        specified in the approval of that establishment, should ensure that such seal is applied
        on the transport container. An official veterinarian certifying a consignment of
        germinal products should have the possibility of breaking that seal for the purpose of
        verifying the content of the transport container and later on re-sealing the transport
        container. Those arrangements should be taken into account in the rules laid down in
        this Regulation.
   (28) Directive 89/556/EEC lays down conditions for intra-Union trade in and imports into
        the Union of embryos of animals of the bovine species. However, it is also necessary
        to lay down in this Regulation rules on movements within the Union of bovine oocytes
        as well as ovaries.
   (29) Union legislation in force prior to the adoption of Regulation (EU) 2016/429 and this
        Regulation laid down the rules on trade in semen covering situations where each dose
        of the consignment consists of ejaculates of one particular donor. However, due to the
        fact that mixed or pooled semen from several donors may increase fertility and such
        semen is commonly used, this Regulation should lay down rules on movements of
        mixed or pooled semen of bovine, porcine, ovine and caprine animals, provided that
        mixing of semen is restricted only to one semen collection centre where the semen was
        collected and a mark on each straw or other package in which mixed semen is placed
        allows tracing the individual identification numbers of all donor animals. In addition,
        the operator should have procedures in place as regards the processing of mixed semen
        and should include, in its records, details of movements of such semen from semen
        collection centre.
   (30) Article 13 of Directive 92/65/EEC lays down rules for trade in semen, ova and
        embryos of animals of species susceptible to the diseases listed in Annex A or B
        thereto which are consigned to and from bodies, institutes or centres approved in
        accordance with Annex C thereto. Annex E to that Directive sets out the model animal
        health certificate for trade which should accompany the consignments of such semen,
        ova or embryos. Articles 95 and 137 of Regulation (EU) 2016/429 establish the
        concept of 'a confined establishment' which is equivalent to 'approved body, institute
        or centre' defined in Article 2(1)(c) of Directive 92/65/EEC. Given that genetic
        material of animals is currently exchanged between approved bodies, institutes and
        centres, it is necessary to maintain the possibility for such intra-Union movements in
        this Regulation. It is therefore appropriate to lay down in this Regulation the animal
        health requirements for movements to other Member States of germinal products of
        terrestrial animals kept at confined establishments. This Regulation should thus
        provide for a possibility for operators of confined establishments to move to other
        Member States consignments of germinal products collected from animals kept at
        those establishments without a need for additional approval as germinal product
EN                                              13                                               EN
 ---pagebreak---         establishment. High animal health requirements for the approval as a confined
        establishment, controlled management of animals at those establishments, specific
        surveillance requirements and targeted movement of consignments of germinal
        products to another confined establishment should provide for sufficient guarantees to
        prevent the spread of animal diseases.
   (31) Article 162 of Regulation (EU) 2016/429 lays down rules concerning the minimum
        information which must be included in animal health certificates for movements
        between Member States of germinal products of kept terrestrial animals of the bovine,
        porcine, ovine, caprine and equine species. Therefore, this Regulation should specify
        the detailed information that should be contained in such certificates.
   (32) Article 163 of Regulation (EU) 2016/429 provides that operators should inform the
        competent authority in their Member State of origin in advance of the intended
        movement to another Member State of germinal products of kept terrestrial animals of
        the bovine, porcine, ovine, caprine and equine species and should provide all the
        necessary information to enable that competent authority to notify the movement of
        germinal products to the competent authority of the Member State of destination.
        Therefore, it is necessary to lay down in this Regulation detailed rules concerning the
        requirements for the advance notification by operators, the information necessary to
        notify such movements and the emergency procedures for such notifications.
   (33) Article 163(2) of Regulation (EU) 2016/429 provides that Traces should be used for
        the notification purposes when consignments of germinal products are intended to be
        moved to other Member States. Traces is the integrated computerised veterinary
        system as provided for in Commission Decisions 2003/24/EC15 and 2004/292/EC16.
        Article 131 of Regulation (EU) 2017/625 of the European Parliament and of the
        Council17 provides for the establishment of an information management system for
        official controls (IMSOC) which will incorporate functionalities of Traces. IMSOC
        should therefore be referred to in this Regulation instead of Traces.
   (34) Article 165 of Regulation (EU) 2016/429 provides that the competent authority of the
        place of destination may, subject to agreement of the competent authority of the place
        of origin, authorise for scientific purposes movements of germinal products into its
        territory where those movements do not fulfil the standard requirements for
        movements of germinal products. In order to allow such movements, it is appropriate
        to lay down in this Regulation the rules for the granting of derogations by the
        competent authorities for movements between Member States of germinal products for
        scientific purposes.
   15
        Commission Decision 2003/24/EC of 30 December 2002 concerning the development of an integrated
        computerised veterinary system (OJ L 8, 14.1.2003, p. 44).
   16
        Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and
        amending Decision 92/486/EEC (OJ L 94, 31.3.2004, p. 63).
   17
        Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official
        controls and other official activities performed to ensure the application of food and feed law, rules on
        animal health and welfare, plant health and plant protection products, amending Regulations (EC)
        No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU)
        No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council,
        Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC,
        1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC)
        No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives
        89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council
        Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
EN                                                     14                                                         EN
 ---pagebreak---    (35) A national gene bank plays an important role in storing the genetic material of animal
        populations that are particular to that Member State. The objective of such national
        gene banks is ex situ conservation and sustainable use of animal genetic resources.
        Germinal products stored at the national gene banks are often of unknown animal
        health status or were collected, produced, processed and stored in accordance with a
        different animal health regime than it is currently applicable in accordance with Union
        and national legislation. As such germinal products have a particular value, as they are
        often genetic material of endangered breeds as defined in point (24) of Article 2 of
        Regulation (EU) 2016/1012 of the European Parliament and of the Council18, or
        breeds that are extinct since collection of the germinal products, and Member States
        have expressed their interest in exchanging such germinal products amongst
        themselves, special conditions for granting derogations by the competent authorities
        for the movement of germinal products stored in national gene banks to other Member
        States should be laid down in this Regulation. As a general rule, this Regulation
        should lay down the conditions for movements of those germinal products between
        national gene banks of different Member States, while rules for national distribution of
        germinal products from national gene banks to operators should be left to the
        competent authorities of Member States. Special attention should also be paid to the
        animal health conditions for such movements, where testing for particular diseases
        may be required.
   (36) This Regulation refers to Commission Implementing Regulation (EU) 2018/188219
        and Commission Delegated Regulations 2019/203520, 2019/…21 and 2019/…22 which
        were also adopted under Regulation (EU) 2016/429. The references to those
        Regulations are necessary as they lay down requirements on surveillance, eradication
        programmes and disease free statuses, identification and registration, traceability and
        movements within the Union and entry into the Union of animals, which are also
        applicable to germinal product donor animals.
   (37) In order to ensure a smooth transition to the new legal framework for semen collection
        or storage centres or embryo collection or production teams approved under acts
        adopted pursuant to Directives 88/407/EEC, 89/556/EEC, 90/429/EEC and
        92/65/EEC, which are repealed by Regulation (EU) 2016/429 with effect from 21
        April 2021, carrying out activities related to the collection, production, processing,
   18
        Regulation (EU) 2016/1012 of the European Parliament and of the Council of 8 June 2016 on
        zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of purebred
        breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation
        (EU) No 652/2014, Council Directives 89/608/EEC and 90/425/EEC and repealing certain acts in the
        area of animal breeding (‘Animal Breeding Regulation’) (OJ L 171, 29.6.2016, p. 66).
   19
        Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of
        certain disease prevention and control rules to categories of listed diseases and establishing a list of
        species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L
        308, 4.12.2018, p. 21).
   20
        Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU)
        2016/429 of the European Parliament and of the Council as regards rules for establishments keeping
        terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching
        eggs (OJ L 314, 5.12.2019, p. 115).
   21
        [Commission Delegated Regulation (EU) 2019/… of … supplementing Regulation (EU) 2016/429 of
        the European Parliament and of the Council as regards rules for surveillance, eradication programmes,
        and disease-free status for certain listed and emerging diseases (document SANTE/7066/2019),
        C(2019)4056].
   22
        [Commission Delegated Regulation (EU) 2019/… of … supplementing Regulation (EU) 2016/429 of
        the European Parliament and the Council, as regards animal health requirements for movements within
        the Union of terrestrial animals and hatching eggs (SANTE/7072/2019), C(2019)4058].
EN                                                     15                                                         EN
 ---pagebreak---          storing and transport of germinal products, they should be deemed to be approved in
         accordance with this Regulation. Member States should ensure that those operators
         comply with all the rules provided for in this Regulation, in particular by submitting
         them to regular and risk-based official controls. In the event of non-compliance, the
         competent authorities should ensure that those operators take the necessary measures
         to remedy that non-compliance and, where necessary, suspend or withdraw their
         approval.
   (38)  In order to ensure a smooth transition for germinal products collected and produced
         before the date of application of this Regulation, straws and other packages in which
         such semen, oocytes or embryos, whether or not separated into individual doses, are
         placed, stored and transported, and which are marked before 21 April 2021 in
         accordance with the legislation adopted pursuant to Directives 88/407/EEC,
         89/556/EEC, 90/429/EEC and 92/65/EEC, should be considered to have been marked
         in accordance with this Regulation and eligible for movement between Member States.
   (39)  This Regulation should be applicable from 21 April 2021 in accordance with the date
         of application of Regulation (EU) 2016/429,
   HAS ADOPTED THIS REGULATION:
                                             PART I
        SUBJECT MATTER, SCOPE AND DEFINITIONS
                                               Article 1
                                      Subject matter and scope
   1.      This Regulation supplements the rules laid down in Regulation (EU) 2016/429 as
           regards registered and approved germinal product establishments and the traceability
           and animal health requirements for movements within the Union of germinal
           products of certain kept terrestrial animals.
   2.      Chapter 1 of Part II lays down the requirements for the approval of germinal product
           establishments for bovine, porcine, ovine, caprine and equine animals from which
           germinal products of those animals are moved to another Member State in relation
           to:
           (a)   quarantine, isolation and other biosecurity measures;
           (b)   surveillance requirements;
           (c)   facilities and equipment;
           (d)   responsibilities, competence and specialised training of personnel and
                 veterinarians for the activity of germinal product establishments;
           (e)   responsibilities of the competent authority approving germinal product
                 establishments;
           (f)   special rules for the cessation of activities of those germinal product
                 establishments.
   3.      Chapter 2 of Part II lays down the requirements on:
           (a)   the information to be included by the competent authority in the register of
                 registered germinal product establishments;
EN                                                16                                            EN
 ---pagebreak---       (b)   the information to be included by the competent authority in the register of the
            of approved germinal product establishments for bovine, porcine, ovine,
            caprine and equine animals; and the rules for the availability to the public of
            that register when germinal products of those animals are to be moved between
            Member States.
   4. Chapter 3 of Part II lays down:
      (a)   the rules for the record-keeping obligations on operators of approved germinal
            product establishments for bovine, porcine, ovine, caprine and equine animals,
            and the requirements for record-keeping in respect of the germinal products
            collected, produced or processed in such an establishment after it has ceased its
            activities;
      (b)   the traceability requirements for germinal products of:
            (i)    bovine, porcine, ovine, caprine and equine animals;
            (ii)   dogs (Canis lupus familiaris) and cats (Felis silvestris catus);
            (iii) terrestrial animals other than bovine, porcine, ovine, caprine and equine
                   animals kept at confined establishments;
            (iv) animals of the families Camelidae and Cervidae.
   5. Chapter 1 of Part III lays down the animal health requirements, including
      derogations, for movements between Member States of germinal products of bovine,
      porcine, ovine, caprine and equine animals, specifying:
      (a)   the rules for the collection, production, processing and storage of germinal
            products in the approved germinal product establishments;
      (b)   the animal health requirements for donor animals from which germinal
            products were collected, and concerning isolation or quarantine for those
            animals;
      (c)   the laboratory and other tests to be carried out on donor animals and germinal
            products;
      (d)   the animal health requirements for the collection, production, processing,
            storage and other procedures, and for the transport of germinal products.
   6. Chapter 2 of Part III, for movements between Member States of germinal products of
      bovine, porcine, ovine, caprine and equine animals, lays down:
      (a)   the rules on animal health certification;
      (b)   the information to be contained in the animal health certificate;
      (c)   the requirements concerning self-declaration document;
      (d)   the notification requirements.
   7. Chapter 3 of Part III lays down the animal health, certification and notification
      requirements for movements between Member States of germinal products of:
      (a)   dogs and cats;
      (b)   terrestrial animals other than bovine, porcine, ovine, caprine and equine
            animals kept at confined establishments;
      (c)   animals of the families Camelidae and Cervidae.
EN                                           17                                               EN
 ---pagebreak---    8.      Chapter 4 of Part III lays down rules for the granting of derogations by competent
           authorities for movements between Member States of germinal products for
           scientific purposes and germinal products stored at gene banks.
   9.      Part IV lays down certain transitional measures regarding Directives 88/407/EEC,
           89/556/EEC, 90/429/EEC and 92/65/EEC in relation to:
           (a)    the approval of semen collection centres, semen storage centres, embryo
                  collection teams and embryo production teams;
           (b)    the marking of straws and other packages in which semen, oocytes or embryos
                  are placed, stored and transported.
   10.     This Regulation shall not apply to germinal products of wild animals.
                                               Article 2
                                              Definitions
   For the purposes of this Regulation, in addition to the definitions laid down in Article 1 of
   Regulation (EU) 2018/1882, the following definitions shall apply:
   (1)     'registered germinal product establishment' means a germinal product establishment,
           other than an approved germinal product establishment, registered with the
           competent authority in accordance with point (a) of the first subparagraph of Article
           93 of Regulation (EU) 2016/429;
   (2)     ‘approved germinal product establishment’ means a semen collection centre, an
           embryo collection team, an embryo production team, a germinal product processing
           establishment or a germinal product storage centre, approved in accordance with
           Article 97 of Regulation (EU) 2016/429;
   (3)     ‘bovine animal' or 'animal of the bovine species' means an animal of the species of
           ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos,
           Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring
           of crossings of those species;
   (4)     ‘porcine animal' or 'animal of the porcine species' means an animal of the ungulate
           species of Sus scrofa;
   (5)     ‘ovine animal' or 'animal of the ovine species' means an animal of the species of
           ungulates belonging to the genus Ovis and the offspring of crossings of those species;
   (6)     ‘caprine animal' or 'animal of the caprine species' means an animal of the species of
           ungulates belonging to the genus Capra and the offspring of crossings of those
           species;
   (7)     ‘equine animal' or 'animal of the equine species' means an animal of the species of
           solipeds belonging to genus Equus (including horses, asses, and zebras) and the
           offspring of crossings of those species;
   (8)     'animal health certificate' means a document issued by the competent authority of the
           Member State of origin to accompany a consignment of germinal products to their
           place of destination as referred to in Article 161(4) of Regulation (EU) 2016/429;
   (9)     'self-declaration document' means a document issued by the operator to accompany a
           consignment of germinal products to their place of destination as referred to in
           Articles 32 and 46;
EN                                                18                                              EN
 ---pagebreak---    (10) ‘gene bank’ means a repository of animal genetic material for ex situ conservation
        and sustainable use of genetic resources of kept terrestrial animals, held by a host
        institution authorised or recognised by the competent authority to fulfil these tasks;
   (11) ‘semen collection centre’ means a germinal product establishment approved by the
        competent authority for the collection, processing, storage and transport of semen of
        bovine, porcine, ovine, caprine or equine animals intended for movement to another
        Member State, as referred to in Article 4;
   (12) ‘embryo collection team’ means a germinal product establishment comprised of a
        group of professionals or a structure approved by the competent authority for the
        collection, processing, storage and transport of in vivo derived embryos of bovine,
        porcine, ovine, caprine or equine animals intended for movement to another Member
        State, as referred to in Article 4;
   (13) ‘embryo production team’ means a germinal product establishment comprised of a
        group of professionals or a structure approved by the competent authority for the
        collection, processing, storage and transport of oocytes, and the in vitro production,
        where applicable with stored semen, processing, storage and transport of embryos, of
        bovine, porcine, ovine, caprine or equine animals both intended for movement to
        another Member State, as referred to in Article 4;
   (14) ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or
        prepared or diluted;
   (15) ‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes
        and ova;
   (16) ‘embryo’ means the initial stage of development of an animal while it is capable of
        being transferred to a recipient dam;
   (17) ‘consignment of germinal products’ means a quantity of semen, oocytes, in vivo
        derived embryos or in vitro produced embryos dispatched from a single approved
        germinal product establishment covered by a single animal health certificate;
   (18) ‘germinal product processing establishment’ means a germinal product establishment
        approved by the competent authority for the processing, including semen sex-sorting
        where appropriate, and the storage of semen, oocytes or embryos of bovine, porcine,
        ovine, caprine or equine animals of one or more species, or any combination of types
        of germinal products or species, intended for movement to another Member State, as
        referred to in Article 4;
   (19) ‘germinal product storage centre’ means a germinal product establishment approved
        by the competent authority for the storage of semen, oocytes or embryos of bovine,
        porcine, ovine, caprine or equine animals of one or more species, or any combination
        of types of germinal products or species, intended for movement to another Member
        State , as referred to in Article 4;
   (20) ‘centre veterinarian’ means the veterinarian responsible for the activities carried out
        at the semen collection centre, at the germinal product processing establishment or at
        the germinal product storage centre as laid down in this Regulation;
   (21) ‘team veterinarian’ means the veterinarian responsible for the activities carried out
        by an embryo collection team or by an embryo production team as laid down in this
        Regulation;
   (22) 'unique approval number' means a number assigned by the competent authority;
EN                                             19                                               EN
 ---pagebreak---    (23) 'withdrawal date of the approval' means the date on which the competent authority
        has suspended or withdrawn the approval of an approved germinal product
        establishment in accordance with Article 100 of Regulation (EU) 2016/429;
   (24) 'unique registration number' means a number assigned to a registered germinal
        product establishment;
   (25) ‘quarantine accommodation’ means a facility authorised by the competent authority
        for the purpose of the isolation of bovine, porcine, ovine or caprine animals for a
        period of at least 28 days before they are admitted to a semen collection centre;
   (26) ‘establishment free from (disease)’ means an establishment granted the status in
        accordance with the requirements set out in Article 20 of Regulation (EU) 2019/…
        [document SANTE/7066/2019, C(2019)4056];
   (27) ‘official laboratory’ means a laboratory, situated in a Member State or third country
        or territory, designated in accordance with Article 37 of Regulation (EU) 2017/625
        by the competent authority to carry out the tests provided for in Articles 24 and 25 of
        this Regulation;
   (28) 'IMSOC' means an information management system for official controls for the
        integrated operation of the mechanisms and tools through which data, information
        and documents concerning official controls and other official activities are managed,
        handled, and automatically exchanged as referred to in Article 131 of Regulation
        (EU) 2017/625 and is the system now used instead of Traces;
   (29) ‘endangered breed’ means a local breed, recognised by a Member State to be
        endangered, genetically adapted to one or more traditional production systems or
        environments in that Member State and where the endangered status is scientifically
        established by a body possessing the necessary skills and knowledge in the area of
        endangered breeds as referred to in Article 2(24) of Regulation (EU) 2016/1012;
   (30) ‘approved eradication programme’ means a disease eradication programme
        implemented in a Member State or zone thereof as approved by the Commission in
        accordance with Article 31(3) of Regulation (EU) 2016/429;
   (31) ‘batch of donor animals’ means a group of animals of the same health status from
        which germinal products are collected and processed at the same time, and
        transported together.
EN                                            20                                                EN
 ---pagebreak---                                              PART II
                APPROVAL OF GERMINAL PRODUCT
           ESTABLISHMENTS, REGISTERS, RECORD-
                       KEEPING AND TRACEABILITY
                                           CHAPTER 1
                    Approval of germinal product establishments
                                                Article 3
    Requirements for the approval of germinal product establishments for bovine, porcine, ovine,
                                     caprine and equine animals
   Operators of the following germinal product establishments for bovine, porcine, ovine,
   caprine and equine animals shall apply in accordance with Article 94(1)(b) of Regulation
   (EU) 2016/429 to the competent authority for approval for the purpose of moving
   consignments of germinal products of those animals to other Member States:
   (a)     the establishment where semen of bovine, porcine, ovine, caprine or equine animals
           is collected, processed and stored for approval as a semen collection centre;
   (b)     the group of professionals or the structure supervised by a team veterinarian
           competent to perform the collection, processing and storage of embryos of bovine,
           porcine, ovine, caprine or equine animals for approval as a embryo collection team;
   (c)     the group of professionals or the structure supervised by a team veterinarian
           competent to perform the collection, processing and storage of oocytes and
           production, processing and storage of embryos of bovine, porcine, ovine, caprine or
           equine animals for approval as an embryo production team;
   (d)     the establishment where fresh, chilled or frozen semen, oocytes or embryos of
           bovine, porcine, ovine, caprine or equine animals are processed and stored for
           approval as a germinal product processing establishment;
   (e)     the establishment where fresh, chilled or frozen semen, oocytes or embryos of
           bovine, porcine, ovine, caprine or equine animals are stored for approval as a
           germinal product storage centre.
                                                Article 4
    Approval by the competent authority of germinal product establishments for bovine, porcine,
                                  ovine, caprine and equine animals
   1.      The competent authority shall only grant approval of a germinal product
           establishment for bovine, porcine, ovine, caprine or equine animals as referred to in
           Article 97 of Regulation (EU) 2016/429 after it has ensured that it complies with the
           following requirements:
           (a)    the operator has appointed:
                  (i)   a centre veterinarian responsible for the activities set out in:
                        –     point 1 of Part 1 of Annex I, in the case of an application for
                              approval of a germinal product establishment referred to in point
                              (a) of Article 3 as a semen collection centre;
EN                                                 21                                            EN
 ---pagebreak---                   –      point 1 of Part 4 of Annex I, in the case of an application for
                         approval of a germinal product establishment referred to in point
                         (d) of Article 3 as a germinal product processing establishment;
                  –      point 1 of Part 5 of Annex I, in the case of an application for
                         approval of a germinal product establishment referred to in point
                         (e) of Article 3 as a germinal product storage centre; or
            (ii)  a team veterinarian responsible for the activities set out in:
                  –      point 1 of Part 2 of Annex I, in the case of an application for
                         approval of a germinal product establishment referred to in point
                         (b) of Article 3 as a embryo collection team;
                  –      point 1 of Part 3 of Annex I, in the case of an application for
                         approval of a germinal product establishment referred to in point
                         (c) of Article 3 as a embryo production team;
      (b)   the facilities, equipment and operational procedures for the activity in question
            comply with the requirements set out in:
            (i)   point 2 of Part 1 of Annex I, in respect of the collection, processing,
                  storage and transport of semen of bovine, porcine, ovine, caprine or
                  equine animals;
            (ii)  point 2 of Part 2 of Annex I, in respect of the collection, processing,
                  storage and transport of embryos of bovine, porcine, ovine, caprine or
                  equine animals;
            (iii) point 2 of Part 3 of Annex I, in respect of the collection of oocytes and of
                  the production, processing, storage and transport of embryos of bovine,
                  porcine, ovine, caprine or equine animals, including the processing and
                  storage of semen and oocytes used for the embryo production;
            (iv) point 2 of Part 4 of Annex I, in respect of the processing, storage and
                  transport of fresh, chilled or frozen semen, oocytes or embryos of bovine,
                  porcine, ovine, caprine or equine animals;
            (v)   point 2 of Part 5 of Annex I, in respect of the storage and transport of
                  fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine,
                  ovine, caprine or equine animals.
   2. When granting approval of a germinal product establishment for bovine, porcine,
      ovine, caprine and equine animals, as referred to in Articles 97 and 99 of Regulation
      (EU) 2016/429, the competent authority shall assign it with a unique approval
      number, which shall include the ISO 3166-1 alpha-2 code of the country in which the
      approval is granted.
EN                                            22                                               EN
 ---pagebreak---                                                  Article 5
    Special rules for the cessation of activities of approved germinal product establishments for
                           bovine, porcine, ovine, caprine and equine animals
   1.       Where the operator of an approved germinal product establishment for bovine,
            porcine, ovine, caprine and equine animals ceases its activity, that operator shall
            ensure that prior to the withdrawal date of the approval all consignments of semen,
            oocytes or embryos collected or produced and stored in that germinal product
            establishment have been moved:
            (a)    to a germinal product storage centre for further storage; or
            (b)    for reproduction purposes to an establishment where bovine, porcine, ovine,
                   caprine or equine animals are kept; or
            (c)    for safe disposal or use as animal by-products in accordance with Article 13 of
                   Regulation (EC) No 1069/2009.
   2.       Where consignments of semen, oocytes or embryos are not moved from the approved
            germinal product establishment prior the withdrawal date of the approval as referred
            to in paragraph 1, such consignments shall not be moved to another Member State.
                                             CHAPTER 2
      Registers to be kept by the competent authority of registered and
                       approved germinal product establishments
                                                 Article 6
    Register to be kept by the competent authority of registered germinal product establishments
   1.       The competent authority shall draw up and keep up-to-date a register of registered
            germinal product establishments.
   2.       The competent authority shall include at least the following information in the
            register referred to in paragraph 1, for each registered germinal product
            establishment:
            (a)    the name, contact details and, where available, the Uniform Resource Locator
                   (URL) of the website of the registered germinal product establishment;
            (b)    the address of the registered germinal product establishment;
            (c)    the type of germinal products and animal species for which it was registered;
            (d)    the unique registration number assigned by the competent authority and the
                   date of the registration;
            (e)    if activities of the registered germinal product establishment have ceased, the
                   date of cessation of those activities.
                                                 Article 7
    Register to be kept by the competent authority of approved germinal product establishments
                         for bovine, porcine, ovine, caprine and equine animals
   1.       The competent authority shall draw up and keep up to date a register of approved
            germinal product establishments for bovine, porcine, ovine, caprine and equine
            animals.
EN                                                  23                                             EN
 ---pagebreak---    2. The competent authority shall include at least the following information in the
      register referred to in paragraph 1 for each approved germinal product establishment:
      (a)    the name, contact details and, where available, the URL of the website of the
             germinal product establishment;
      (b)    the address of the germinal product establishment;
      (c)    the name of the centre veterinarian or the team veterinarian;
      (d)    the type of germinal products, the type of the germinal product establishment
             and animal species for which the approval has been granted;
      (e)    the unique approval number assigned by the competent authority and the date
             of the approval.
   3. Where, based on requirements provided for in Article 4, a germinal product
      processing establishment or a germinal product storage centre is approved by the
      competent authority for the storage and, in respect of the germinal product
      processing establishment, the processing, of germinal products of more than one type
      or of more than one animal species, the competent authority shall include
      information on the type of the germinal products and on the animal species thereof
      stored and, if applicable, processed at the approved germinal product establishment
      in its register of approved germinal product establishments.
   4. Where the competent authority has suspended or withdrawn the approval of an
      approved germinal product establishment in accordance with Article 100(2) of
      Regulation (EU) 2016/429, it shall, without undue delay:
      (a)    indicate that suspension or withdrawal in its register of approved germinal
             product establishments;
      (b)    specify in the case of the suspension of the approval, the commencement and
             end date, and in the case of withdrawal, the withdrawal date of the approval.
   5. Where an approved germinal product establishment has ceased its activity as referred
      to in Article 5, the competent authority shall, without undue delay, indicate the date
      of cessation of those activities in its register of approved germinal product
      establishments.
   6. The competent authority shall make the register referred to in paragraph 1 available
      to the public on its website, where germinal products are to be moved between
      Member States and notify the URL of that website to the Commission.
      Where the URL of the website of a competent authority has been changed it shall
      notify, without undue delay, the new URL of that website to the Commission.
EN                                           24                                              EN
 ---pagebreak---                                             CHAPTER 3
                              Record-keeping and traceability
                                              SECTION 1
                                         RECORD KEEPING
                                                Article 8
      Record-keeping obligations of operators of approved germinal product establishments for
                         bovine, porcine, ovine, caprine and equine animals
   1.       Operators of approved germinal product establishments for bovine, porcine, ovine,
            caprine and equine animals shall keep and maintain records containing at least the
            following information:
            (a)   in respect of a semen collection centre:
                  (i)   the species, breed, date of birth and identification of each donor animal
                        present at the semen collection centre;
                  (ii)  the dates of any movement of donor animals to and from the semen
                        collection centre and, where those animals are accompanied by any
                        document, the reference to those documents;
                  (iii) the health status, the results of clinical and diagnostic tests and the
                        laboratory techniques used, treatments and vaccinations carried out on
                        the donor animals;
                  (iv) the date of semen collection and, where relevant, the date and the place
                        of processing of semen;
                  (v)   the identification of semen and details of its destination;
            (b)   in respect of an embryo collection team, an embryo production team or an
                  embryo collection and production team:
                  (i)   the species, breed, date of birth and identification of each donor animal
                        from which oocytes or embryos were collected;
                  (ii)  the health status, the results of clinical and diagnostic tests and the
                        laboratory techniques used, treatments and vaccinations carried out on
                        donor animals of oocytes or embryos;
                  (iii) the date and place of oocytes or embryos collection, examination, and
                        processing;
                  (iv) the identification of oocytes or embryos and details of their destination;
                  (v)   where micromanipulation is being performed on the embryos, the details
                        of micromanipulation techniques used which involve penetration of the
                        zona pellucida or, in case of equine embryos, the embryonic capsule;
                  (vi) the origin of semen used for artificial insemination of donor animals or to
                        fertilise oocytes for in vitro production of embryos;
EN                                                  25                                             EN
 ---pagebreak---             (c)   in respect of a germinal product processing establishment or a germinal
                  product storage centre:
                  (i)    the type of germinal products either processed and stored or stored at the
                         approved germinal product establishment with reference to the species of
                         the donor animal;
                  (ii)   the dates of movement of germinal products to and from the approved
                         germinal product establishment with the reference to the documents
                         which accompanied those germinal products;
                  (iii) the documents, including an animal health certificate and a self-
                         declaration document, confirming that the health status of the donor
                         animals whose germinal products are either processed and stored or
                         stored at the approved germinal product establishment complies with the
                         requirements of this Regulation;
                  (iv) the identification of germinal products that are either processed and
                         stored or stored at the approved germinal product establishment.
   2.       Where a germinal product establishment, referred to in paragraph 1(c), is approved
            by the competent authority for either processing and storage or storage of germinal
            products of more than one type or of more than one animal species, the operator shall
            keep and maintain records separately for each type of germinal product and germinal
            products of each animal species either processed and stored or stored.
                                                 Article 9
      Record-keeping obligations of operators of approved germinal product establishments for
             bovine, porcine, ovine, caprine and equine animals that cease their activity
   1.       Where an approved germinal product establishment for bovine, porcine, ovine,
            caprine and equine animals ceases its activity as referred to in Article 5, the operator
            of that establishment shall only move consignments of stored germinal products to a
            germinal product storage centre if such consignments are accompanied by originals
            or copies of the records required in accordance with Article 8(1).
   2.       The operator of the germinal product storage centre receiving the consignment of
            germinal products from the establishment that has ceased its activity as referred to in
            paragraph 1 shall record the entry and details of the germinal products based on the
            accompanying records required in accordance with Article 8(1)(c).
EN                                                  26                                               EN
 ---pagebreak---                                              SECTION 2
                                          TRACEABILITY
                                              Article 10
      Traceability requirements for germinal products of bovine, porcine, ovine, caprine and
                                           equine animals
   1.     Operators collecting, producing, processing or storing germinal products of bovine,
          porcine, ovine, caprine or equine animals shall mark each straw or other package in
          which semen, oocytes or embryos, whether or not separated into individual doses, are
          placed, stored and transported, in such a way that the following information can be
          readily established:
          (a)    the date of collection or production of those germinal products;
          (b)    the species and identification of the donor animal(s);
          (c)    the unique approval number of the germinal product establishment of
                 collection or production, processing and storage of those germinal products;
          (d)    any other relevant information.
   2.     In case of sex-sorting of semen at a germinal product processing establishment, the
          operator of the semen collection centre shall supplement the information referred to
          in paragraph 1 with information which permits the identification of the unique
          approval number of the germinal product processing establishment where that semen
          was sex-sorted.
   3.     Where a single straw or another package contains semen of bovine, porcine, ovine or
          caprine animals collected from more than one donor animal, the operator shall ensure
          that the information referred to in paragraph 1 permits the identification of all donor
          animals that have contributed to the dose of semen used for insemination.
   4.     By way of derogation from paragraph 1, where the semen of ovine or caprine
          animals is
          (a)    frozen in pellets, the operator may mark the goblet containing the semen pellets
                 of a single donor instead of marking each individual pellet in that goblet;
          (b)    fresh or chilled semen, the operator may mark the goblet containing the semen
                 tubes or straws of a single donor instead of marking each individual tube or
                 straw in that goblet.
   5.     By way of derogation from paragraph 1(c), the operator shall ensure that the marking
          of each straw or other package in which semen, oocytes or embryos are placed,
          stored and transported, is carried out in such a way that it permits the identification
          of:
          (a)    in the case of semen of ovine and caprine animals which has been collected at
                 the establishment where the donor animals are kept as referred to in Article 13,
                 the unique registration number of that establishment; or
          (b)    in the case of germinal products of bovine, porcine, ovine, caprine or equine
                 animals which have been collected or produced at a confined establishment
                 referred to in Article 14, the unique approval number of that confined
                 establishment.
EN                                                27                                              EN
 ---pagebreak---                                               Article 11
    Traceability requirements for germinal products of dogs and cats, terrestrial animals other
   than bovine, porcine, ovine, caprine and equine animals kept at confined establishments, and
                          animals of the families Camelidae and Cervidae
   1.      Operators collecting, producing, processing or storing germinal products of dogs or
           cats, of terrestrial animals other than bovine, porcine, ovine, caprine or equine
           animals kept at confined establishments or of animals of the family Camelidae or
           Cervidae shall mark each straw or other package in which semen, oocytes or
           embryos, whether or not separated into individual doses, are placed, stored and
           transported in such a way that the following information can be readily established:
           (a)   the date of collection or production of those germinal products;
           (b)   the species, where necessary subspecies, and identification of the donor
                 animal(s);
           (c)   one of the following:
                 (i)   the address of the establishment of collection or production, processing
                       and storage of those germinal products;
                 (ii)  where the establishment of collection or production, processing and
                       storage of those germinal products was assigned with a unique
                       registration number, the unique registration number which shall include
                       the ISO 3166-1 alpha-2 code of the country in which the establishment is
                       registered;
                 (iii) where the establishment of collection or production, processing and
                       storage of those germinal products is a confined establishment, the
                       unique approval number which shall include the ISO 3166-1 alpha-2
                       code of the country in which the approval is granted;
           (d)   any other information.
   2.      In case of sex-sorting of semen at an establishment other than the establishment of its
           collection or production, the operator of the establishment of collection or production
           of that semen shall supplement the information referred to in paragraph 1 with
           information which permits the identification of the establishment where that semen
           was sex-sorted.
   3.      By way of derogation from paragraph 1, where the semen of the animals referred to
           in paragraph 1 is frozen in pellets, the operator may mark the goblet containing
           semen pellets of a single donor instead of marking each individual pellet in that
           goblet.
   4.      Where a single straw or another package contains semen collected from more than
           one donor animal, the operator shall ensure that the information, referred to in
           paragraph 1, includes the identification of all donor animals.
EN                                                28                                               EN
 ---pagebreak---                                               PART III
              MOVEMENTS OF GERMINAL PRODUCTS
                          BETWEEN MEMBER STATES
                                             CHAPTER 1
    Animal health requirements for movements of germinal products of
                 bovine, porcine, ovine, caprine and equine animals
                                                Section 1
       Rules for the collection, production, processing and storage of germinal
    products of bovine, porcine, ovine, caprine and equine animals in approved
                               germinal product establishments
                                                Article 12
    Rules for movements to other Member States of germinal products of bovine, porcine, ovine,
             caprine and equine animals from approved germinal product establishments
   Operators shall only move to another Member State semen, oocytes and embryos of bovine,
   porcine, ovine, caprine and equine animals, which were collected, produced, processed and
   stored in approved germinal product establishments.
                                                Article 13
   Derogation for the movements to other Member States of semen of ovine and caprine animals
                         from the establishments where those animals are kept
   By way of derogation from Article 12, operators may move to other Member States
   consignments of semen of ovine and caprine animals which were collected, processed and
   stored at the establishment where those donor animals are kept, provided that those operators:
   (a)       obtain the prior consent of the competent authority of the Member State of
             destination to accept the consignment;
   (b)       ensure that the donor animals have been clinically examined by a veterinarian prior
             to semen collection and showed no symptoms suggesting the presence of any of the
             category D diseases or of the emerging diseases relevant for the ovine and caprine
             animals or clinical signs of such category D or emerging diseases, on the day the
             semen was collected;
   (c)       ensure that the donor animals come from establishments which fulfil the animal
             health requirements laid down in Article 15(1), (2), (3) and (4) of Regulation (EU)
             2019/… [document SANTE/7072/2019, C(2019)4058];
   (d)       ensure that the donor animals have undergone the following tests with negative
             results carried out on samples taken during the period of isolation which must
             commence at least 30 days prior to the date of collection of the semen:
             (i)   a serological test referred to in point 1 of Part 1 of Annex I to Regulation (EU)
                   2019/… [document SANTE/7072/2019, C(2019)4058] for infection with
                   Brucella abortus, Brucella melitensis and Brucella suis;
EN                                                   29                                              EN
 ---pagebreak---             (ii)   in the case of ovine animals, a serological test for ovine epididymitis (Brucella
                   ovis);
            (iii) in the case of caprine animals kept together with ovine animals, a serological
                   test for ovine epididymitis (Brucella ovis);
   (e)      ensure that the donor animals are identified in accordance with Article 45(2) or (4),
            or Article 46(1), (2) or (3) of Regulation (EU) 2019/2035;
   (f)      ensure that the semen has been marked in accordance with the requirements provided
            for in Article 10;
   (g)      keep records at the establishment which must include at least the information
            provided for in Article 8(1)(a);
   (h)      ensure that the consignment of semen is transported in accordance with Articles 28
            and 29.
                                                Article 14
     Derogation for movements to other Member States of germinal products of bovine, porcine,
                  ovine, caprine and equine animals kept at confined establishments
   By way of derogation from Article 12, operators of confined establishments may move to
   other Member States consignments of semen, oocytes and embryos collected at those
   establishments from bovine, porcine, ovine, caprine and equine animals, provided that those
   operators:
   (a)      only move consignments of those germinal products to another confined
            establishment;
   (b)      ensure that the donor animals:
            (i)    do not come from an establishment, nor have been in contact with animals
                   from an establishment, situated in a restricted zone established due to the
                   occurrence of a category A disease or of an emerging disease relevant for
                   bovine, porcine, ovine, caprine or equine animals;
            (ii)   come from an establishment where none of the category D diseases relevant for
                   bovine, porcine, ovine, caprine or equine animals have been reported for a
                   period of at least 30 days prior to the date of collection of the semen, oocytes
                   or embryos;
            (iii) have remained in a single confined establishment of origin for a period of at
                   least 30 days prior to the date of collection of the semen, oocytes or embryos;
            (iv) have been clinically examined by the establishment veterinarian responsible for
                   the activities carried out at confined establishment, and showed no symptoms
                   suggesting the presence of any of the category D diseases referred to in point
                   (ii) or of the emerging diseases or clinical signs of such diseases, on the day of
                   collection of the semen, oocytes or embryos;
            (v)    as much as possible, were not used for natural breeding during a period of at
                   least 30 days prior to the date of first collection and during the period of
                   collection of the semen, oocytes or embryos intended for movement to another
                   Member State;
            (vi) are identified in accordance with requirements laid down in Regulation (EU)
                   2019/2035;
EN                                                  30                                                EN
 ---pagebreak---                    –     for bovine animals in Article 38;
                   –     for porcine animals in Article 52(1) or 54(2);
                   –     for ovine and caprine animals in Article 45(2) or (4), or Article 46(1), (2)
                         or (3);
                   –     for equine animals in Article 58(1) or 59(1) or 62(1);
   (c)      ensure that the germinal products have been marked in accordance with the
            requirements provided for in Article 10;
   (d)      ensure that the germinal products are transported in accordance with Articles 28 and
            29.
                                              Section 2
        Animal health requirements for donor animals from which germinal
       products were collected, and isolation and quarantine requirements for
                                            those animals
                                             Sub-Section I
      General animal health requirements for donor bovine, porcine, ovine, caprine and equine
                                                animals
                                               Article 15
     Responsibilities of operators for compliance with the animal health requirements for donor
       bovine, porcine, ovine, caprine and equine animals from which germinal products were
                                               collected
   Operators shall only move to another Member State consignments of semen, oocytes and
   embryos of bovine, porcine, ovine, caprine and equine animals which comply with the
   following requirements:
   (a)      the germinal products were collected from animals which did not show symptoms or
            clinical signs of transmissible animal diseases on the day of collection;
   (b)      the movement was authorised respectively by the centre or team veterinarian.
                                               Article 16
       Responsibilities of centre veterinarians and team veterinarians for compliance with the
      animal health requirements for donor bovine, porcine, ovine, caprine and equine animals
                             from which germinal products were collected
   Centre veterinarians, as regards donor animals of semen, or team veterinarians, as regards
   donor animals of oocytes and embryos, shall ensure that the donor bovine, porcine, ovine,
   caprine and equine animals comply with the following requirements:
   (a)      they were born and have remained since birth in the Union, or have entered the
            Union in accordance with the requirements for entry into the Union;
   (b)      they come from establishments in a Member State or zone thereof, or from
            establishments under official control by the competent authority in a third country or
            territory, or a zone thereof, each of which fulfils the animal health requirements laid
            down in Regulation (EU) 2019/… [document SANTE/7072/2019, C(2019)4058]:
EN                                                 31                                                 EN
 ---pagebreak---        (i)   for bovine animals in Article 10(1), Article 11(1), (2) and (3) and Article 12(1),
             (2) and (3);
       (ii)  for porcine animals in Article 19(1) and Article 20(1) and (2);
       (iii) for ovine and caprine animals in Article 15(1), (2), (3) and (4);
       (iv) for equine animals in Article 22(1) and (2);
   (c) they have been identified in accordance with requirements laid down in Regulation
       (EU) 2019/2035:
       (i)   for bovine animals in Article 38;
       (ii)  for porcine animals in Article 52(1) or 54(2);
       (iii) for ovine and caprine animals in Article 45(2) or (4), or Article 46(1), (2) or
             (3);
       (iv) for equine animals in Article 58(1) or 59(1) or 62(1);
   (d) for a period of at least 30 days prior to the date of the first collection of the germinal
       products and during the collection period:
       (i)   they have been kept in establishments which are not situated in a restricted
             zone established due to the occurrence in bovine, porcine, ovine, caprine or
             equine animals of a category A disease or of an emerging disease relevant for
             those animals;
       (ii)  they have been kept in establishments where no category D diseases relevant
             for those animals have been reported;
       (iii) they have not been in contact with animals from establishments situated in a
             restricted zone referred to in point (i) or from establishments which do not
             meet the conditions referred to in point (ii);
       (iv) they have not been used for natural breeding;
   (e) they showed neither symptoms nor clinical signs of any of the category D diseases
       referred to in point (d)(ii) or of the emerging diseases on the day of collection of the
       semen, oocytes or embryos;
   (f) they comply with the additional animal health requirements set out:
       (i)   for bovine animals in Article 20, and in Part 1 and Chapters I, II and III of Part
             5 of Annex II;
       (ii)  for porcine animals in Article 21, and in Part 2 and Chapters I and IV of Part 5
             of Annex II;
       (iii) for ovine and caprine animals in Article 22, and in Part 3 and Chapters I, II and
             III of Part 5 of Annex II;
       (iv) for equine animals in Article 23, and in Part 4 of Annex II.
EN                                             32                                                 EN
 ---pagebreak---                                                  Article 17
       Responsibilities of centre veterinarians and team veterinarians for compliance with the
      animal health requirements for donor bovine, porcine, ovine, caprine and equine animals
       from which germinal products were collected from establishments subject to movement
                                  restrictions on animal health grounds
   Centre veterinarians, as regards donor animals of semen, or team veterinarians, as regards
   donor animals of oocytes and embryos, shall ensure that semen, oocytes and embryos,
   collected at either a semen collection centre or an establishment which is subjected to
   movement restrictions on animal health grounds concerning the diseases referred to in Article
   16(b), 20, 21, 22 or 23, comply with the following requirements:
   (a)       they must be kept in separate storage;
   (b)       they must not be moved between Member States until the movement restrictions
             applied to either the semen collection centre or the establishment where the semen
             was collected has been removed by the competent authorities; and
   (c)       the semen, oocytes and embryos stored must have undergone the appropriate official
             investigations to rule out the presence in the semen, oocytes and embryos of animal
             pathogens causing the diseases for which the movement restrictions were established.
                                                 Article 18
       Additional responsibilities of centre veterinarians for compliance with the animal health
   requirements for donor bovine, porcine, ovine, caprine and equine animals from which semen
                                               was collected
   Centre veterinarians shall ensure that donor bovine, porcine, ovine, caprine and equine
   animals comply with the following requirements:
   (a)       they showed neither symptoms nor clinical signs of any of the category D diseases
             referred to in Article 16(d)(ii) on the day of their admission to a semen collection
             centre;
   (b)       in the case of donor bovine, porcine, ovine and caprine animals, prior to the day of
             their admission to a semen collection centre, they were kept in a quarantine
             accommodation which on that day complied with the following conditions:
             (i)   none of the category D diseases relevant for the bovine, porcine, ovine or
                   caprine animals has been reported for a period of at least the preceeding 30
                   days;
             (ii)  it was not situated in a restricted zone established due to the occurrence in
                   bovine, porcine, ovine or caprine animals of a category A disease or of an
                   emerging disease relevant for those animals;
   (c)       they are kept at the semen collection centre which:
             (i)   during a period which comprises at least 30 days prior to date of collection and
                   at least 30 days following the date of collection of the semen or, in the case of
                   fresh semen, until the date of dispatch of the consignment of semen, none of
                   the category D diseases relevant for bovine, porcine, ovine, caprine or equine
                   animals have been reported;
             (ii)  it is not situated in a restricted zone established due to the occurrence in
                   bovine, porcine, ovine, caprine or equine animals of a category A disease or of
                   an emerging disease relevant for those animals.
EN                                                   33                                              EN
 ---pagebreak---                                               Article 19
      Derogation from the animal health requirements for donor bovine, porcine, ovine, caprine
                     and equine animals moved between semen collection centres
   1.      By way of derogation from point (b) of Article 18, operators may move donor
           bovine, porcine, ovine and caprine animals, and donor equine animals subjected to
           the testing programme for certain diseases as referred to in point 1(b)(i) of Chapter I
           of Part 4 of Annex II, directly from one semen collection centre to another semen
           collection centre:
           (a)    without quarantine or testing, before and after the movement, as referred to in
                  Annex II for the following animals:
                  (i)   for bovine animals, in Part 1 and Chapters I, II and III of Part 5 thereof;
                  (ii)  for porcine animals, in Part 2 and Chapters I and IV of Part 5 thereof;
                  (iii) for ovine and caprine animals, in Part 3 and Chapters I, II and III of Part
                        5 thereof ;
                  (iv) for equine animals, in point 1(a) of Chapter I of Part 4 thereof ; and
           (b)    provided that the donor animals:
                  (i)   show no disease symptoms or signs of any of the category D diseases
                        relevant for the bovine, porcine, ovine, caprine or equine animals on the
                        day of that movement;
                  (ii)  before that movement, they were permanently present since the date of
                        their admission at the semen collection centre and were subjected to the
                        following tests relevant for the bovine, porcine, ovine, caprine or equine
                        animals referred to in paragraph 1(a), with negative results:
                        –     all compulsory routine tests referred to in Annex II in the period of
                              the preceding 12 months prior to date of that movement; or
                        –     where the compulsory routine tests have not yet been carried out at
                              the semen collection centre, all tests required before admission to a
                              semen collection centre carried out during the period immediately
                              preceding quarantine and during the quarantine period.
   2.      Operators shall only move donor animals, as referred to in the introductory phrase of
           paragraph 1, where the movement is authorised by the competent authority of the
           semen collection centre of origin and with the prior consent of the centre veterinarian
           of the semen collection centre of destination.
   3.      Operators shall ensure that donor animals referred to in the introductory phrase of
           paragraph 1 do not come into direct or indirect contact with animals of a lower health
           status during the movement and the means of transport used have been cleansed and
           disinfected before use.
   4.      Operators of semen collection centres of destination shall subject donor animals
           referred to in the introductory phrase of paragraph 1 to all compulsory routine tests
           referred to in paragraph 1(a) not later than 12 months following the date the last
           compulsory routine tests were carried out on those animals.
EN                                                34                                                EN
 ---pagebreak---                                              Sub-Section II
               Additional animal health requirements for certain species of ungulates
                                               Article 20
    Additional animal health requirements for donor bovine animals from which semen, oocytes
                                      and embryos were collected
   1.      The centre veterinarian, as regards donor animals of semen, or the team veterinarian,
           as regards donor animals of oocytes and embryos, shall ensure that donor bovine
           animals comply with the following requirements:
           (a)    they came from an establishment, in the case of donor animals of semen prior
                  to their admission to a quarantine accommodation, that was free from the
                  following diseases and have never been kept previously in any establishment of
                  a lower health status:
                  (i)   infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae
                        and M. tuberculosis);
                  (ii)  infection with Brucella abortus, Brucella melitensis and Brucella suis;
                  (iii) enzootic bovine leukosis;
                  (iv) infectious bovine rhinotracheitis/infectious pustular vulvovaginitis;
           (b)    they fulfil the additional animal health requirements laid down in Part 1 and
                  Chapters I, II and III of Part 5 of Annex II.
   2.      By way of derogation from paragraph 1(a)(iii), the centre veterinarian may accept
           that a donor animal of semen came from an establishment which was not free from
           enzootic bovine leukosis provided that the animal either:
           (a)    is less than 2 years of age and has been produced by a dam which was
                  subjected, with negative results, to a serological test for enzootic bovine
                  leukosis after removal of that animal from its dam; or
           (b)    has reached the age of 2 years and was subjected, with negative results, to a
                  serological test for enzootic bovine leukosis.
   3.      By way of derogation from paragraph 1(a)(iii), the team veterinarian may accept a
           donor animal of oocytes and embryos that was less than 2 years of age which came
           from an establishment which was not free from enzootic bovine leukosis provided
           that the official veterinarian responsible for the establishment of origin has certified
           that there has been no clinical case of enzootic bovine leukosis during a period of at
           least the preceding 3 years.
   4.      By way of derogation from paragraph 1(a)(iv),
           (a)    the centre veterinarian, as regards donor animals of semen, may accept a donor
                  animal which came from an establishment which was not free from infectious
                  bovine rhinotracheitis/infectious pustular vulvovaginitis provided that the
                  animal has undergone the test required in accordance with point 1(b)(iv) of
                  Chapter I of Part 1 of Annex II, or
           (b)    the team veterinarian, as regards donor animals of oocytes and embryos, may
                  accept a donor animal which came from an establishment which was not free
                  from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis
                  provided that the official veterinarian responsible for the establishment of
EN                                                  35                                              EN
 ---pagebreak---                   origin has certified that there has been no clinical case of infectious bovine
                  rhinotracheitis/infectious pustular vulvovaginitis during a period of at least the
                  preceding 12 months.
                                               Article 21
    Additional animal health requirements for donor porcine animals from which semen, oocytes
                                      and embryos were collected
   1.       The centre veterinarian, as regards donor animals of semen, or the team veterinarian,
            as regards donor animals of oocytes and embryos, shall ensure that donor porcine
            animals comply with the following requirements:
            (a)   they came from an establishment, in the case of donor animals of semen prior
                  their admission to a quarantine accommodation, where no clinical, serological,
                  virological or pathological evidence of infection with Aujeszky’s disease virus
                  had been detected during a period of at least the preceding 12 months;
            (b)   they fulfil additional animal health requirements laid down in Part 2 and
                  Chapters I and IV of Part 5 of Annex II.
   2.       The centre veterinarian shall ensure that donor porcine animals of semen comply
            with the following requirements:
            (a)   prior to their admission to a quarantine accommodation, they came from an
                  establishment which was free from infection with Brucella abortus, Brucella
                  melitensis and Brucella suis in accordance with the requirements laid down in
                  Chapter IV of Part 5 of Annex II;
            (b)   they were kept at the quarantine accommodation which on the day of
                  admission was free from infection with Brucella abortus, Brucella melitensis
                  and Brucella suis for the period of at least the preceding 3 months;
            (c)   they are kept in a semen collection centre where no clinical, serological,
                  virological or pathological evidence of infection with Aujeszky’s disease virus
                  has been reported for a period comprising at least 30 days prior to the date of
                  admission and at least 30 days immediately prior to the date of collection;
            (d)   they have not been vaccinated against infection with porcine reproductive and
                  respiratory syndrome virus and were kept, since birth or for a period
                  comprising at least 3 months prior to the date of entry into the quarantine
                  accommodation, in an establishment where no animals have been vaccinated
                  against infection with porcine reproductive and respiratory syndrome virus and
                  no infection with porcine reproductive and respiratory syndrome virus was
                  detected during that period.
                                               Article 22
       Additional animal health requirements for donor ovine and caprine animals from which
                             semen, oocytes and embryos were collected
   The centre veterinarian, as regards donor animals of semen, or the team veterinarian, as
   regards donor animals of oocytes and embryos, shall ensure that donor ovine and caprine
   animals comply with the following requirements:
   (a)      they did not come from an establishment, nor have been in contact with animals from
            an establishment, in the case of donor animals of semen prior to their admission to a
            quarantine accommodation, which has been the subject to movement restrictions as
EN                                                 36                                                EN
 ---pagebreak---            regards infection with Brucella abortus, Brucella melitensis and Brucella suis. The
           movement restrictions concerning the establishment are lifted after the period
           comprising of at least 42 days from the date of slaughter or killing and the disposal
           of the last animal infected or susceptible to that disease;
   (b)     they came from an establishment, in the case of donor animals of semen prior to their
           admission to a quarantine accommodation, which was free from infection with
           Brucella abortus, Brucella melitensis and Brucella suis and have never been kept
           previously in any establishment of a lower health status;
   (c)     they fulfil additional animal health requirements laid down in Part 3 and Chapters I,
           II and III of Part 5 of Annex II.
                                                Article 23
    Additional animal health requirements for donor equine animals from which semen, oocytes
                                      and embryos were collected
   1.      The centre veterinarian shall ensure that equine animals admitted to a semen
           collection centre and the team veterinarian shall ensure that equine animals used for
           the collection of oocytes and embryos or the production of embryos comply with the
           following requirements prior to the collection of the germinal products:
           (a)   they come from an establishment:
                 (i)    where surra (Trypanosoma evansi) has not been reported during the
                        period of the preceding 30 days, or where surra (Trypanosoma evansi)
                        has been reported during the period of the preceding 2 years and
                        following the last outbreak the affected establishment remained under
                        movement restrictions until:
                        –      the infected animals have been removed from the establishment;
                               and
                        –      the remaining animals in the establishment have been subjected to a
                               test for surra (Trypanosoma evansi) with one of the diagnostic
                               methods provided for in Part 3 of Annex I to Regulation (EU)
                               2019/… [document SANTE/7072/2019, C(2019)4058], with
                               negative results carried out on samples taken at least 6 months after
                               the last infected animal has been removed from the establishment;
                 (ii)   where dourine has not been reported during the period of the preceding 6
                        months, or where dourine has been reported during the period of the
                        preceding 2 years and following the last outbreak the affected
                        establishment remained under movement restrictions until:
                        –      the infected animals have been killed and destroyed or slaughtered,
                               or the infected entire male equine animals have been castrated; and
                        –      the remaining equine animals in the establishment, with the
                               exception of the castrated male equine animals referred to in the
                               first indent kept apart from female equine animals, have been
                               subjected to a test for dourine with one of the diagnostic methods
                               provided for in Part 8 of Annex I to Regulation (EU) 2019/…
                               [document SANTE/7072/2019, C(2019)4058], with negative
                               results, carried out on samples taken at least 6 months after the
                               measures described in the first indent have been completed;
EN                                                  37                                               EN
 ---pagebreak---                  (iii) where equine infectious anaemia has not been reported during the period
                        of the preceding 90 days, or where equine infectious anaemia has been
                        reported during the period of the preceding 12 months and following the
                        last outbreak the affected establishment remained under movement
                        restrictions until:
                        –      the infected animals have been killed and destroyed or slaughtered;
                               and
                        –      the remaining equine animals in the establishment have been
                               subjected to a test for equine infectious anaemia with one of the
                               diagnostic methods provided for in Part 9 of Annex I to Regulation
                               (EU) 2019/… [document SANTE/7072/2019, C(2019)4058], with
                               negative results, carried out on samples taken on two occasions at
                               least 3 months apart after the measures described in the first indent
                               have been completed and the establishment was cleaned and
                               disinfected;
           (b)   in the case of semen donors, they were kept for a period of 30 days prior to the
                 date of semen collection in establishments where no equine animal has shown
                 any clinical sign of infection with equine arteritis virus or of contagious equine
                 metritis during that period;
           (c)   they fulfil the additional animal health requirements laid down in Part 4 of
                 Annex II.
   2.      By way of derogation from paragraph 1(a), the movement restrictions referred to in
           paragraph 1(a)(i) to (iii) must remain in place for a period of at least 30 days,
           beginning on the day on which all the animals on the establishment of species listed
           for the respective disease referred to in paragraph 1(a)(i) to (iii) were either killed
           and destroyed or slaughtered, where allowed in accordance with paragraph 1(b), and
           the establishment was cleaned and disinfected.
                                               Section 3
     Laboratory and other tests to be carried out on kept donor animals of the
     bovine, porcine, ovine, caprine and equine species and germinal products
                                                thereof
                                               Article 24
      Laboratory and other tests to be carried out on donor bovine, porcine, ovine, caprine and
                            equine animals and germinal products thereof
   Operators shall ensure that:
   (a)     donor animals whose germinal products are to be moved to other Member States
           have undergone the following tests:
           (i)   for bovine animals, in Part 1 and as applicable in Chapters I, II and III of Part 5
                 of Annex II;
           (ii)  for porcine animals, in Part 2 and as applicable Chapters I and IV of Part 5 of
                 Annex II;
           (iii) for ovine and caprine animals, in Part 3 and as applicable in Chapters I, II and
                 III of Part 5 of Annex II;
EN                                                 38                                                EN
 ---pagebreak---             (iv) for equine animals, in Part 4 of Annex II;
   (b)      all the tests referred to in point (a) are carried out in official laboratories.
                                                 Article 25
    Authorisation for laboratory tests to be carried out on donor animals of the bovine, porcine,
                        ovine and caprine species in quarantine accommodation
   1.       The competent authority may authorise the following tests referred to in Annex II to
            be carried out on samples taken in the quarantine accommodation:
            (a)    for bovine animals, the tests referred to in point 1(b) of Chapter I of Part 1
                   thereof;
            (b)    for porcine animals, the tests referred to in point 1(b) of Chapter I of Part 2
                   thereof;
            (c)    for ovine and caprine animals, the tests referred to in point 1(c) of Chapter I of
                   Part 3 thereof.
   2.       Where the competent authority has granted the authorisations referred to in
            paragraph 1, the following conditions shall be met:
            (a)    the period of quarantine in the quarantine accommodation must not commence
                   before the date of sampling for the purpose of testing referred to in paragraph
                   1(a), (b) and (c);
            (b)    where results of any of the tests referred to in paragraph 1 are positive, the
                   animal concerned must be immediately removed from the quarantine
                   accommodation;
            (c)    in the case of quarantine of a group of animals, if any of the animals prove
                   positive for a test referred to in paragraph 1, the quarantine in the quarantine
                   accommodation must not commence for the remaining animals until the animal
                   which proved positive has been removed from the quarantine accommodation.
                                                 Section 4
       Animal health requirements for the collection, production, processing,
       storage and other procedures of germinal products of bovine, porcine,
                                ovine, caprine and equine animals
                                                 Article 26
       Obligations on operators as regards the animal health requirements for the collection,
     production, processing and storage of germinal products of bovine, porcine, ovine, caprine
                                            and equine animals
   Operators shall ensure that consignments of semen, oocytes and embryos of bovine, porcine,
   ovine, caprine and equine animals are only moved to other Member States if those
   consignments fulfil the animal health requirements for the collection, production, processing
   and storage of germinal products set out in Annex III.
EN                                                   39                                               EN
 ---pagebreak---                                               Section 5
       Animal health requirements for the transport of germinal products of
                   bovine, porcine, ovine, caprine and equine animals
                                              Article 27
      Responsibilities of centre veterinarians and team veterinarians for compliance with the
    animal health requirements for the transport of germinal products of bovine, porcine, ovine,
                                     caprine and equine animals
   1.      Where germinal products of bovine, porcine, ovine, caprine and equine animals are
           moved to another Member State or to a germinal product processing establishment or
           a germinal product storage centre within the same Member State, the centre
           veterinarian or the team veterinarian shall ensure that:
           (a)   the transport containers are sealed and numbered prior to their dispatch from
                 the approved germinal product establishment;
           (b)   the mark on the straws or other packages, applied in accordance with Article
                 10, corresponds with the number provided either in the animal health certificate
                 or in the self-declaration document and on the container in which they are
                 transported.
   2.      The seal referred to in paragraph 1(a) applied under the responsibility of the centre
           veterinarian or the team veterinarian may be replaced by the official veterinarian.
                                              Article 28
      Responsibilities of operators for compliance with the animal health requirements for the
       transport of germinal products of bovine, porcine, ovine, caprine and equine animals
   1.      Operators shall only move semen, oocytes and embryos of bovine, porcine, ovine,
           caprine and equine animals to other Member States subject to compliance with the
           following conditions:
           (a)   only one type of germinal product of one species has been placed in the
                 transport container;
           (b)   the transport container, referred to in point (a):
                 (i)    has been cleaned and either disinfected or sterilised before use, or is a
                        new single-use container;
                 (ii)   has been filled in with the cryogenic agent which has not been previously
                        used for other products.
   2.      By way of derogation from paragraph 1, operators may place in one transport
           container semen, oocytes and embryos of the same species provided that:
           (a)   straws or other packages in which germinal products are placed are securely
                 and hermetically sealed;
           (b)   the germinal products of different types are separated from each other by
                 physical compartments or by being placed in secondary protective bags.
   3.      By way of derogation from paragraphs 1 and 2, operators may place in one transport
           container semen, oocytes and embryos of ovine and caprine animals.
EN                                                40                                              EN
 ---pagebreak---                                                 Article 29
    Additional responsibilities on operators for the transport of semen of bovine, porcine, ovine
                                          and caprine animals
   Where operators move to another Member State consignments of semen of bovine, porcine,
   ovine or caprine animals which has been collected from more than one donor animal and
   placed in a single straw or another package, the operators shall:
   (a)      ensure that the semen is collected and dispatched from a single semen collection
            centre or, in the case of the derogations provided for in Articles 13 and 14, a single
            establishment where it was collected;
   (b)      have procedures in place as regards the processing of that semen in order to ensure
            its traceability in accordance with Articles 10 and 19.
                                            CHAPTER 2
         Animal health certification, self-declaration and movement
    notification for germinal products of bovine, porcine, ovine, caprine
                                       and equine animals
                                                Article 30
                                   Rules on animal health certification
   1.       Before issuing an animal health certificate for movements between Member States of
            consignments of germinal products of bovine, porcine, ovine, caprine and equine
            animals, the official veterinarian shall carry out:
            (a)    a visual examination of the transport container in order to verify if the
                   requirements referred to in Article 28 have been fulfiled and to check:
                   (i)   the seal and number applied by the centre or team veterinarian on the
                         transport container as referred to in Article 27(1)(a); or
                   (ii)  if necessary, the germinal products placed in the transport container and
                         to seal and number the transport container after that check;
            (b)    a documentary check of the data submitted by the centre or team veterinarian
                   to ensure that:
                   (i)   the information to be certified is supported by the records kept in
                         accordance with Article 8;
                   (ii)  the mark on the straws or other packages, applied in accordance with
                         Article 10, corresponds with the number provided in the animal health
                         certificate and on the container in which they are transported;
                   (iii) the requirements referred to in Chapter 1 of Part III have been fullfiled.
   2.       The official veterinarian shall carry out the checks and examinations as provided for
            in paragraph 1 and issue the animal health certificate within the period of 72 hours
            preceding the time of dispatch of the consignment of germinal products.
   3.       The animal health certificate shall be valid for a period of 10 days from the date of
            issuing.
EN                                                  41                                              EN
 ---pagebreak---                                                Article 31
    Information to be contained in the animal health certificate for germinal products of bovine,
                  porcine, ovine, caprine and equine moved between Member States
   The animal health certificates for movements between Member States of consignments of
   germinal products of bovine, porcine, ovine, caprine and equine animals, shall contain at least
   the information set out in point 1 of Annex IV.
                                               Article 32
    Requirements concerning the self-declaration document for movements to and from germinal
    product processing establishments of consignments of germinal products of bovine, porcine,
                                   ovine, caprine and equine animals
   1.       Where an operator of an approved germinal product establishment of bovine,
            porcine, ovine, caprine and equine animals arranges for germinal products to be
            processed by a germinal product processing establishment, that operator shall ensure
            that a self-declaration document accompanies the consignment of the germinal
            products during the transport to and from that germinal product processing
            establishment.
   2.       An operator of an approved germinal product establishment shall ensure that the self-
            declaration document referred to in paragraph 1 includes at least the following
            information:
            (a)    the name and address of the approved germinal product establishment of the
                   collection or production of the germinal products;
            (b)    the name and address of the germinal product processing establishment to
                   which the germinal products are moved for processing;
            (c)    the dates of movement of the consignment of the germinal products to and
                   from a germinal product processing establishment;
            (d)    the type and the quantity of the germinal products;
            (e)    the marking of the germinal products, as required by Article 10.
                                               Article 33
   Requirement for advance notification by operators of movements of consignments of germinal
       products of bovine, porcine, ovine, caprine and equine animals between Member States
   Where consignments of germinal products of bovine, porcine, ovine, caprine and equine
   animals are moved to another Member State, operators of approved germinal product
   establishments, establishments where ovine and caprine animals are kept as referred to in
   Article 13 or confined establishments as referred to in Article 14 shall notify the competent
   authority in their Member State of origin in advance of the intended movement of those
   consignments of germinal products.
                                               Article 34
    Information necessary to notify movements of consignments of germinal products of bovine,
                 porcine, ovine, caprine and equine animals between Member States
   Operators notifying the competent authority in their Member State of origin in accordance
   with Article 33, shall provide that competent authority with the information concerning each
   consignment of germinal products to be moved to another Member State provided for in:
EN                                                 42                                              EN
 ---pagebreak---    (a)      points 1(a) to (f) of Annex IV, where the germinal products are accompanied by an
            animal health certificate; or
   (b)      Article 32(2), where the germinal products are accompanied by a self-declaration
            document.
                                                 Article 35
        Emergency procedures for the notification of movements of consignments of germinal
   products of bovine, porcine, ovine, caprine and equine animals between Member States in the
                          event of power cuts and other disturbances of IMSOC
   1.       In the event of power cuts and other disturbances of IMSOC, the competent authority
            of the place of origin of the consignment of germinal products of bovine, porcine,
            ovine, caprine and equine animals to be moved to another Member State shall notify
            the Commission and the competent authority of the place of destination of the
            movement of that consignment by fax or e-mail.
   2.       The notification, referred to in paragraph 1, shall be done by the competent authority
            of the place of origin of the consignment of germinal products in accordance with the
            contingency arrangements to be applied in the event of unavailability of any of the
            functionalities IMSOC.
                                             CHAPTER 3
         Animal health requirements, animal health certification and
       notification for germinal products of animals other than bovine,
                       porcine, ovine, caprine and equine animals
                                                 Article 36
      Animal health requirements for movements to other Member States of germinal products of
                                               dogs and cats
   Operators shall only move to other Member States semen, oocytes and embryos collected
   from dogs (Canis lupus familiaris) and cats (Felis silvestris catus) which:
   (a)      have been born and remained since birth in the Union, or have entered the Union in
            accordance with the requirements for entry into the Union;
   (b)      come from an establishment where infection with rabies virus has not been
            confirmed for a period of at least 30 days prior to the date of collection of the semen,
            oocytes or embryos;
   (c)      showed no disease symptoms on the day of collection of the semen, oocytes or
            embryos;
   (d)      are marked by the implantation of a transponder or by a clearly readable tattoo in
            accordance with Article 17(1) of Regulation (EU) No 576/2013 of the European
            Parliament and of the Council23 or identified in accordance with Article 70 of
            Regulation (EU) 2019/2035;
   23
           Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the
           non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178,
           28.6.2013, p. 1).
EN                                                   43                                                     EN
 ---pagebreak---    (e)      have received an anti-rabies vaccination that complies with the validity requirements
            set out in Part 1 of Annex VII to Regulation (EU) 2019/…[document
            SANTE/7072/2018, C(2019)4058];
   (f)      comply with any preventive health measure for diseases or infections other than
            rabies set out in Part 2 of Annex VII to Regulation (EU) 2019/…[document
            SANTE/7072/2018, C(2019)4058];
   (g)      were not used for natural breeding during a period of at least 30 days prior to the date
            of collection of semen, oocytes or embryos and during the collection period.
                                               Article 37
        Animal health requirements for movements to other Member States between confined
     establishments of germinal products of kept terrestrial animals other than bovine, porcine,
                                  ovine, caprine and equine animals
   Operators of confined establishments shall only move germinal products of terrestrial animals
   other than bovine, porcine, ovine, caprine and equine animals kept at those establishments to
   confined establishments in other Member States when the donor animals:
   (a)      have been born and remained since birth in the Union, or have entered the Union in
            accordance with the requirements for entry into the Union;
   (b)      have remained in a single confined establishment of origin for a period of at least 30
            days prior to the date of collection of the semen, oocytes or embryos;
   (c)      do not come from an establishment, nor have been in contact with animals from an
            establishment, situated in a restricted zone established due to the occurrence of a
            category A disease or of an emerging disease relevant for the species in those kept
            terrestrial animals;
   (d)      come from an establishment where no category D disease relevant for that species
            has been reported for a period of at least 30 days prior to the date of collection of the
            semen, oocytes or embryos;
   (e)      are identified and registered in accordance with the rules of that confined
            establishment;
   (f)      as much as possible, were not used for natural breeding during a period of at least 30
            days prior to the date of first collection and during the period of collection of the
            semen, oocytes or embryos intended for movement to another Member State;
   (g)      have been clinically examined by the establishment veterinarian responsible for the
            activities carried out at confined establishment, and show no disease symptoms on
            the day the semen, oocytes or embryos are collected.
                                               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;
EN                                                 44                                                 EN
 ---pagebreak---    (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 Regulation (EU) 2019/… [document
              SANTE/7072/2019, C(2019)4058];
       (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 Regulation (EU)
              2019/… [document SANTE/7072/2019, C(2019)4058] with negative results
              carried out on samples taken during the period of the preceding 30 days prior to
              the date of collection of the semen, oocytes or embryos;
   (f) come from an establishment where infectious bovine rhinotracheitis/ infectious
       pustular vulvovaginitis has not been reported during the period of at least the
       preceding 30 days prior to the date of collection of the semen, oocytes or embryos;
   (g) come from an establishment where infection with epizootic haemorrhagic disease
       virus has not been reported during a period of at least the preceding 2 years prior to
       the date of collection of the semen, oocytes or embryos within a radius of 150 km
       around the establishment;
   (h) come from an establishment where infection with rabies virus has not been
       confirmed during the period of at least the preceding 30 days prior to the date of
       collection of the germinal products;
   (i) come from an establishment where anthrax has not been reported during the period
       of at least the preceding 15 days prior to the date of collection of the semen, oocytes
       or embryos collection;
   (j) come from an establishment where surra (Trypanosoma evansi)
       (i)    has not been reported during a period of at least the preceding 30 days prior to
              the date of collection of the semen, oocytes or embryos; or
EN                                              45                                              EN
 ---pagebreak---        (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
                     Regulation (EU) 2019/… [document SANTE/7072/2019, C(2019)4058],
                     with negative result, carried out on samples taken at least 6 months after
                     the infected animals were removed from the establishment;
   (k) fulfil animal health requirements as regards infection with bluetongue virus
       (serotypes 1-24) laid down in Chapter II of Part 5 of Annex II;
   (l) have not been in contact with animals which did not comply with the requirements
       set out in point (a) and in points (c) to (k) during the residency period of at least 30
       days set out in point (b);
   (m) have been clinically examined by a veterinarian and showed no disease symptoms on
       the day of collection of the semen, oocytes or embryos;
   (n) are identified in accordance with Article 73(1) or (2) or Article 74 of Regulation
       (EU) 2019/2035;
   (o) were not used for natural breeding during a period of at least 30 days prior to the date
       of collection of the semen, oocytes or embryos and during the collection period.
                                            Article 39
                          Rules concerning animal health certification
   1.  Before signing an animal health certificate for movements between Member States of
       consignments of germinal products of dogs or cats, the official veterinarian shall
       carry out:
       (a)    a visual examination of the transport container in order to check:
              (i)    the seal and number applied by the operator on the transport container; or
              (ii)   if necessary, the germinal products placed in the transport container and
                     to seal and number the transport container after that check;
       (b)    a documentary check of the data submitted by the operator to ensure that:
              (i)    the information to be certified is supported by the records kept at the
                     establishment;
              (ii)   the mark on the straws or other packages, applied in accordance with
                     Article 11, corresponds with the number provided in the animal health
                     certificate and on the container in which they are transported;
              (iii) the requirements referred to in Article 36 have been fullfiled.
   2.  Before signing an animal health certificate for movements between Member States of
       consignments of germinal products of terrestrial animals other than bovine, porcine,
       ovine, caprine or equine animals kept at confined establishments, the official
       veterinarian shall carry out:
       (a)    a visual examination of the transport container in order to check:
EN                                              46                                              EN
 ---pagebreak---                    (i)    the seal and number applied by the establishment veterinarian responsible
                          for the activities carried out at confined establishment on the transport
                          container; or
                   (ii)   if necessary, germinal products placed in the transport container and to
                          seal and number the transport container after that check;
            (b)    a documentary check of the data submitted by the establishment veterinarian
                   responsible for the activities carried out at confined establishment to ensure
                   that:
                   (i)    the information to be certified is supported by the records kept at the
                          confined establishment;
                   (ii)   the mark on the straws or other packages, applied in accordance with
                          Article 11, corresponds with the number provided in the animal health
                          certificate and on the container in which they are transported;
                   (iii) the requirements referred to in Article 37 have been fullfiled.
   3.       Before signing an animal health certificate for movements between Member States of
            consignments of germinal products of animals of the family Camelidae or Cervidae,
            the official veterinarian shall carry out:
            (a)    a visual examination of the transport container in order to check:
                   (i)    the seal and number applied by the operator on the transport container; or
                   (ii)   if necessary, the germinal products placed in the transport container and
                          to seal and number the transport container after that check;
            (b)    a documentary check of the data submitted by the operator to ensure that:
                   (i)    the information to be certified is supported by the records kept at the
                          establishment ;
                   (ii)   the mark on the straws or other packages, applied in accordance with
                          Article 11, corresponds with the number provided in the animal health
                          certificate and on the container in which they are transported;
                   (iii) the requirements referred to in Article 38 have been fullfiled.
   4.       The official veterinarian shall carry out the checks and examinations as provided for
            in paragraphs 1, 2 and 3 and issue the animal health certificate within the period of
            72 hours preceding the time of dispatch of the consignment of germinal products.
   5.       The animal health certificate provided for in paragraphs 1, 2 and 3 shall be valid for
            10 days from the date of issuing.
                                                 Article 40
   Animal health certification requirements for movements of consignments of germinal products
      of kept terrestrial animals other than bovine, porcine, ovine, caprine and equine animals
                                          between Member States
   The animal health certificates for movements between Member States of consignments of
   germinal products of dogs and cats, and of terrestrial animals other than bovine, porcine,
   ovine, caprine or equine animals kept at confined establishments or of animals of the family
   Camelidae or Cervidae, shall contain at least the information set out in point 2 of Annex IV.
EN                                                   47                                              EN
 ---pagebreak---                                                 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 and equine
                                    animals between Member States
   Where consignments of germinal products of dogs or cats, of terrestrial animals other than
   bovine, porcine, ovine, caprine or equine animals kept at confined establishments or of
   animals of the family Camelidae or Cervidae are moved to another Member State, the
   operator shall notify the competent authority in the Member State of origin of the
   consignments in advance of the intended movement of those consignments of germinal
   products.
                                                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 IMSOC
   1.        In the event of power cuts and other disturbances of IMSOC, the competent authority
             of the place of origin of the consignment of germinal products of dogs or cats, of
             terrestrial animals other than bovine, porcine, ovine, caprine or equine animals kept
             at confined establishments or of animals of the family Camelidae or Cervidae, to be
             moved to another Member State, shall notify the Commission and the competent
             authority of the place of destination of the movement of that consignment by fax or
             e-mail.
   2.        The notification, referred to in paragraph 1, shall be carried out by the competent
             authority of the place of origin of the consignment of the germinal products in
             accordance with the contingency arrangements to be applied in the event of
             unavailability of any of the functionalities of IMSOC.
EN                                                  48                                             EN
 ---pagebreak---                                          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
   1.     The competent authorities of the Member States of origin may grant derogation for
          the movement to another Member State of germinal products intended for scientific
          purposes which do not fulfil the animal health requirements provided for in Chapter
          1 or 3, provided the operator of the establishment of dispatch has obtained the prior
          written consent of the competent authority of the Member State of destination to
          accept the consignment of germinal products.
   2.     The competent authority of the Member State of destination shall only consent to
          accept the consignment of germinal products referred to in paragraph 1, where the
          operator of the establishment of destination intended to receive those germinal
          products ensures that the germinal products are only used for scientific purposes
          under conditions that prevent the spread of category D diseases.
                                             Article 45
      Additional rules for the granting of derogations by competent authorities for germinal
                     products moved to gene banks in another Member State
   1.     The competent authorities of the Member States of origin may grant derogations for
          movements to gene banks in another Member State of germinal products, provided
          that the operator of the establishment of dispatch has obtained the prior written
          consent of the competent authority of the Member State of destination to accept the
          consignment of germinal products, of:
          (a)   endangered breeds which do not fulfil the animal health requirements provided
                for in Chapter 1; or
          (b)   terrestrial animals other than bovine, porcine, ovine, caprine and equine
                animals kept at confined establishments which do not fulfil the animal health
                requirements provided for in Article 37.
   2.     The competent authority of the Member State of destination shall only consent to
          accept the consignment of germinal products referred to in paragraph 1, provided
          that:
          (a)   the operator of the gene bank intended to receive those germinal products
                ensures that the germinal products are only used for the ex situ conservation
                and sustainable use of genetic resources of kept terrestrial animals for which
                the receiving gene bank was established;
          (b)   it has sufficient information, including information provided by the competent
                authority of the Member State of origin or results of testing, or carries out
                treatment of the germinal products enabling it to prevent the spread of foot-
                and-mouth disease, infection with rinderpest virus and other listed diseases.
EN                                               49                                             EN
 ---pagebreak---                                                  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
   1.       Where germinal products intended for scientific purposes or for storage at gene
            banks are to be moved to another Member State, the operator of the establishment of
            dispatch shall ensure that a self-declaration document accompanies the germinal
            products during the transport to the place of destination.
   2.       The operator of the establishment of dispatch shall ensure that the self-declaration
            document provided for in paragraph 1 includes at least the following information:
            (a)    the name and address of the consignor and the consignee;
            (b)    the name and address of the place of dispatch and the place of destination;
            (c)    where the germinal products were moved to and from a germinal product
                   processing establishment, the dates of those movements;
            (d)    the type of the germinal products and the species of donor animals;
            (e)    the number of straws or other packages in the consignment to be dispatched;
            (f)    the following information allowing the identification of germinal products:
                   (i)   the marking applied on the straws or other packages;
                   (ii)  the place and date of their collection or production;
            (g)    available results of the tests referred to in Article 45(2)(b).
                                                 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 to gene banks in the event of power cuts and
                                      other disturbances of IMSOC
   1.       In the event of power cuts and other disturbances of IMSOC, the competent authority
            of the place of origin of the consignment of germinal products intended for scientific
            purposes or for storage at gene banks, to be moved to another Member State, shall
            notify the Commission and the competent authority of the place of destination of the
            movement of that consignment by fax or e-mail.
   2.       The notification, referred to in paragraph 1, shall be done by the competent authority
            of the place of origin of the consignment of the germinal products in accordance with
            the contingency arrangements to be applied in the event of unavailability of any of
            the functionalities of IMSOC.
EN                                                   50                                            EN
 ---pagebreak---                                                PART IV
                                   FINAL PROVISIONS
                                                 Article 49
                                          Transitional measures
   1.        Semen collection centres, semen storage centres, embryo collection teams and
             embryo production teams which have been approved before 21 April 2021 in
             accordance with Directives 88/407/EEC, 89/556/EEC, 90/429/EEC and 92/65/EEC
             referred to in the 6th, 7th, 8th and 12th indents of Article 270(2) of Regulation (EU)
             2016/429 shall be considered to have been approved in accordance with this
             Regulation.
             In all other respects, they shall be subject to the rules provided for in this Regulation,
             and in Regulation (EU) 2016/429.
   2.        Straws and other packages in which semen, oocytes or embryos, whether or not
             separated into individual doses, are placed, stored and transported, marked before 21
             April 2021 in accordance with Directives 88/407/EEC, 89/556/EEC, 90/429/EEC
             and 92/65/EEC shall be considered to have been marked in accordance with this
             Regulation.
   3.        Animal health certificates issued before 21 April 2021 in accordance with Directives
             88/407/EEC, 89/556/EEC, 90/429/EEC and 92/65/EEC shall be considered to have
             been issued in accordance with 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.
   Done at Brussels, 17.12.2019
                                                   For the Commission
                                                   The President
                                                   Ursula von der LEYEN
EN                                                   51                                                 EN
 ---documentbreak---                            EUROPEAN
                           COMMISSION
                                                    Brussels, 17.12.2019
                                                    C(2019) 4055 final
                                                    ANNEXES 1 to 4
                                        ANNEXES
                                          to the
                 COMMISSION DELEGATED REGULATION (EU) .../...
      supplementing Regulation (EU) 2016/429 of the European Parliament and of the
    Council as regards 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
EN                                                                                      EN
 ---pagebreak---                                               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 prevented;
                (iv) authorised visitors comply with the animal health and biosecurity
                       requirements referred to in point (c)(i);
                (v)    each individual dose of semen 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;
EN                                                 1                                              EN
 ---pagebreak---        (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)(a) to (c) 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
EN                                         2                                                EN
 ---pagebreak---                  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;
EN                                                   3                                              EN
 ---pagebreak---             (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 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)(b)(ii), shall comply with the following points (a) and
      (b):
      (a)   the embryo collection team must have at its disposal a laboratory where
            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 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
                          embryo collection and processing, except when using only new
                          single-use equipment;
                   –      a room for the storing of 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 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 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 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:
EN                                             4                                             EN
 ---pagebreak---                   (i)    they comprise at least one lockable room for the storage of embryos;
                  (ii)   they must be easy to cleanse and disinfect;
                  (iii) they must have permanent records of all incoming and outgoing
                         embryos;
                  (iv) they must have storage containers for 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
EN                                                    5                                               EN
 ---pagebreak---    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 prevented;
            (iii) authorised visitors comply with the animal health and biosecurity
                   requirements referred to in point (b)(i);
            (iv) each individual dose of semen, oocytes or embryos is clearly marked in
                   accordance with the traceability requirements set out 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:
EN                                            6                                                 EN
 ---pagebreak---                 (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 individual dose of semen, oocytes or embryos is clearly marked in
                      accordance with the requirements set out in Article 10;
EN                                               7                                                  EN
 ---pagebreak---             (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;
      (d)   the germinal product storage centre must be so constructed or isolated that
            contact with outside livestock is prevented;
      (e)   the germinal product storage centre must be so constructed that unauthorised
            access of people is effectively prevented.
EN                                            8                                                EN
 ---pagebreak---                                                 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), an intradermal tuberculin test referred to in
                         point 1 of Part 2 of Annex I to Regulation (EU) 2019/… [document
                         SANTE/7072/2019, C(2019)4058];
                   (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
                         Regulation (EU) 2019/… [document SANTE/7072/2019, C(2019)4058];
                   (iii) for enzootic bovine leukosis, a serological test referred to in point (a) of
                         Part 4 of Annex I to Regulation (EU) 2019/… [document
                         SANTE/7072/2019, C(2019)4058], using the derogation provided for in
                         Article 20(2)(a);
                   (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)
EN                                                  9                                                 EN
 ---pagebreak---    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
          Regulation (EU) 2019/… [document SANTE/7072/2019, C(2019)4058];
   (ii)   for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, a
          serological test (whole virus) on a blood sample.
          If any animals prove positive, these animals shall be removed
          immediately from the quarantine accommodation and the other animals
          of the same group shall remain in quarantine and be retested, with
          negative results, not earlier than on the 21st day from the date of the
          removal of the positive animal(s);
   (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;
EN                                     10                                              EN
 ---pagebreak---             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), an intradermal tuberculin test referred to in point 1 of
            Part 2 of Annex I to Regulation (EU) 2019/… [document SANTE/7072/2019,
            C(2019)4058];
      (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 Regulation (EU)
            2019/… [document SANTE/7072/2019, C(2019)4058];
      (c)   for enzootic bovine leukosis, a serological test referred to in point (a) of Part 4
            of Annex I to Regulation (EU) 2019/… [document SANTE/7072/2019,
            C(2019)4058];
      (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.
EN                                           11                                                 EN
 ---pagebreak---             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.
EN                                                 12                                               EN
 ---pagebreak---                                                   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 Regulation (EU)
                         2019/… [document SANTE/7072/2019, C(2019)4058];
                  (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;
EN                                                  13                                              EN
 ---pagebreak---        (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.
       (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 not been reported and
              vaccination against this disease has not 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) and 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 tests for infection with porcine
              reproductive and respiratory syndrome virus, those animals shall be
              removed immediately from the quarantine accommodation.
       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:
EN                                       14                                                EN
 ---pagebreak---             (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;
EN                                            15                                                   EN
 ---pagebreak---                    –      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;
            (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).
EN                                             16                                                 EN
 ---pagebreak---                                                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 have been subjected to a
                   serological test for ovine epidydimitis (Brucella ovis) 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;
            (c)    the animals have been subjected to the following tests carried out on a blood
                   sample taken within a period of 30 days preceding the commencement of the
                   period of quarantine referred to in point (a), with a negative result in each case:
EN                                                 17                                                  EN
 ---pagebreak---             (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
                   Regulation (EU) 2019/… [document SANTE/7072/2019, C(2019)4058];
            (ii)   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;
      (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
                   Regulation (EU) 2019/… [document SANTE/7072/2019, C(2019)4058];
            (ii)   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.
   2. All ovine and caprine animals kept at an approved 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 Regulation (EU)
            2019/… [document SANTE/7072/2019, C(2019)4058];
      (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.
EN                                            18                                                EN
 ---pagebreak---                                                 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:
            (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 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:
EN                                                  19                                                  EN
 ---pagebreak---              –      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 48 hours 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
EN                                       20                                                EN
 ---pagebreak---                             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).
EN                                         21                                                EN
 ---pagebreak---                                                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) below, or on one occasion in the case of the test referred to in
          point (ii) below.
          The specimens 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 48 hours from the time of taking the specimens from the
                donor animal.
EN                                                 22                                               EN
 ---pagebreak---    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;
EN                                                  23                                               EN
 ---pagebreak---                   (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 months 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 Manual1;
           (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 in a Member State or zone thereof free from infection with
                  bluetongue virus (serotypes 1-24) for a period of at least 60 days prior to and
                  during collection of the semen;
           (b)    they have been kept in a seasonally disease-free zone, during the seasonally
                  disease-free period, for a period of at least 60 days prior to and during
                  collection of the semen, in a Member State or zone thereof:
                  (i)    with an approved eradication programme against infection with
                         bluetongue virus (serotype 1-24), or
   1
         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/).
EN                                                  24                                                    EN
 ---pagebreak---             (ii)  where the competent authority of the place of origin of the consignment
                  of semen has obtained the prior written consent of the competent
                  authority of the Member State of destination to the conditions for
                  establishment of that seasonally disease-free zone and to accept the
                  consignment of semen;
      (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 in a Member State or zone thereof free from infection with
            bluetongue virus (serotypes 1-24) for a period of at least 60 days prior to and
            during collection of the oocytes or embryos;
      (b)   they have been kept in a seasonally disease-free zone, during the seasonally
            disease-free period, 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:
            (i)   with an approved eradication programme against infection with
                  bluetongue virus (serotype 1-24), or
            (ii)  where the competent authority of the place of origin of the consignment
                  of oocytes or embryos has obtained the prior written consent of the
                  competent authority of the Member State of destination to the conditions
                  for establishment of that seasonally disease-free zone and to accept the
                  consignment of oocytes or embryos;
      (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.
EN                                           25                                              EN
 ---pagebreak---    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 as regards
            infection with the epizootic haemorrhagic disease virus (serotypes 1-7)
   1.      The bovine, ovine and caprine animals 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 (serotypes 1-7) (EHDV 1-7) 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 in a vector-protected establishment for a period of at least
                 60 days prior to and during collection of the semen;
           (c)   they have been subjected to a serological test to detect antibodies to EHDV 1-
                 7, 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;
           (d)   they have been subjected to an agent identification test for EHDV 1-7, with
                 negative results, on blood samples taken at the commencement and final
                 collection of the semen and during the 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.
   2.      The ovine and caprine animals which are in vivo derived embryo donors and bovine,
           ovine and caprine animals 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 where EHDV
                 1-7 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 in a vector-protected establishment for a period of at least
                 60 days prior to and during collection of the oocytes or embryos;
           (c)   they have been subjected to a serological test to detect antibodies to EHDV 1-
                 7, with negative results, on a blood sample taken between 28 and 60 days from
                 the date of collection of the oocytes or embryos;
           (d)   they have been subjected to an agent identification test for EHDV 1-7, 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 IV
     Requirements for an establishment to be considered free from infection with Brucella
               abortus, Brucella melitensis and Brucella suis in porcine animals
EN                                                26                                               EN
 ---pagebreak---    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
            notifiable disease 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.
EN                                                 27                                               EN
 ---pagebreak---                                               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, the antibiotics or mixtures of antibiotics with a bactericidal activity
           at least equivalent to that of the following antibiotics or their mixtures in each ml of
           semen, may be added to semen or contained in semen diluents:
           (a)    in the case of semen of bovine and porcine animals, a mixture of lincomycin-
                  spectinomycin (150/300 μg), penicillin (500 IU) and streptomycin (500 μg); or
           (b)    in the case of semen of ovine and caprine animals, gentamicin (250 μg) or a
                  mixture of penicillin (500 IU) and streptomycin (500 μg); or
           (c)    a mixture of gentamicin (250 μg), tylosin (50 μg), lincomycin-spectinomycin
                  (150/300 μg), penicillin (500 IU) and streptomycin (500 μg); or
           (d)    a mixture of amikacin (75 μg) and divekacin (25 μg).
   4.      In respect of semen of bovine animals, antibiotics referred to in point 3(a), (c) and
           (d), or semen diluents containing such antibiotics or mixtures of antibiotics, shall be
           added and be effective in particular against campylobacters, leptospires and
           mycoplasmas.
   5.      In respect of semen of porcine animals, antibiotics or mixtures of antibiotics referred
           to in point 3(a), (c) and (d), or semen diluents containing such antibiotics or mixtures
           of antibiotics, shall be added and be effective in particular against leptospires.
   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;
EN                                                 28                                               EN
 ---pagebreak---             (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.
   2.       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.
   3.       Embryos shall be processed (examined, washed, treated and placed in straws or other
            packages) in either a permanently located laboratory or a mobile laboratory.
   4.       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.
   5.       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.
   6.       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.
   7.       The cryogenic agents used for the preservation or storage of embryos shall not have
            previously been used for other biological products originating from animals.
   8.       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.
   9.       Embryos from different donor animals shall not be washed together.
EN                                                  29                                              EN
 ---pagebreak---    10.       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.
   11.       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.
   12.       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.
   13.       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.
   2.        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.
   3.        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.
EN                                                    30                                               EN
 ---pagebreak---             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.
   2.       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.
   3.       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.
   2.       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.
   3.       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.
EN                                                 31                                               EN
 ---pagebreak---    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.
EN                                            32                                               EN
 ---pagebreak---                                            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, breed and identification of the donor animals in accordance
                      with the requirements laid down in Title I, II, III or IV of Part III of
                      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;
EN                                              33                                              EN
 ---pagebreak---              (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.
   2. The animal health certificate for the germinal products of dogs and cats, and of
      terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept
      at confined establishments and of animals of the families Camelidae and 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;
EN                                            34                                               EN
 ---pagebreak---    (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.
EN                                      35                                              EN