Delegated regulation 2020/686 - Supplement to Regulation 2016/429 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 - Main contents

EN

Official Journal of the European Union

L 174/1

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.

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.

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.

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.

Prior to the adoption of Regulation (EU) 2016/429, Union rules on germinal products were laid down in Council Directives 88/407/EEC (2), 89/556/EEC (3), 90/429/EEC (4) and 92/65/EEC (5). 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.

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.

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) 2016/429 which provide for the Commission to adopt delegated acts, and in particular those laid down in Part IV thereof.

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.

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.

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.

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.

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.

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.

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.

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.

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 Code’) of the World Organisation for Animal Health (OIE), Edition 2017 (6). 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.

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.

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.

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 Council (7).

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 recommendations of the International Committee for Animal Recording (ICAR) (8) in this respect.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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 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.

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.

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.

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/EC (9) and 2004/292/EC (10). Article 131 of Regulation (EU) 2017/625 of the European Parliament and of the Council (11) 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.

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.

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 Council (12), 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.

This Regulation refers to Commission Implementing Regulation (EU) 2018/1882 (13) and Commission Delegated Regulations (EU) 2019/2035 (14), (EU) 2020/689 (15) and (EU) 2020/688 (16) 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.

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, 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.

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.

This Regulation should be applicable from 21 April 2021 in accordance with the date of application of Regulation (EU) 2016/429,

quarantine, isolation and other biosecurity measures;

surveillance requirements;

facilities and equipment;

responsibilities, competence and specialised training of personnel and veterinarians for the activity of germinal product establishments;

responsibilities of the competent authority approving germinal product establishments;

special rules for the cessation of activities of those germinal product establishments.

the information to be included by the competent authority in the register of registered germinal product establishments;

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.

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;

the traceability requirements for germinal products of:

the rules for the collection, production, processing and storage of germinal products in the approved germinal product establishments;

the animal health requirements for donor animals from which germinal products were collected, and concerning isolation or quarantine for those animals;

the laboratory and other tests to be carried out on donor animals and germinal products;

the animal health requirements for the collection, production, processing, storage and other procedures, and for the transport of germinal products.

the rules on animal health certification;

the information to be contained in the animal health certificate;

the requirements concerning self-declaration document;

the notification requirements.

dogs and cats;

terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at confined establishments;

animals of the families Camelidae and Cervidae.

the approval of semen collection centres, semen storage centres, embryo collection teams and embryo production teams;

the marking of straws and other packages in which semen, oocytes or embryos are placed, stored and transported.

‘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;

‘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;

‘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;

‘porcine animal’ or ‘animal of the porcine species’ means an animal of the ungulate species of Sus scrofa;

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;

‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova;

‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;

‘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;

‘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;

‘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;

‘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;

‘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;

‘unique approval number’ means a number assigned by the competent authority;

‘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;

‘unique registration number’ means a number assigned to a registered germinal product establishment;

‘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;

‘establishment free from (disease)’ means an establishment granted the status in accordance with the requirements set out in Article 20 of Delegated Regulation (EU) 2020/689;

‘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;

‘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;

‘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;

‘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;

‘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.

the establishment where semen of bovine, porcine, ovine, caprine or equine animals is collected, processed and stored for approval as a semen collection centre;

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;

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;

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;

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.

the operator has appointed:

the facilities, equipment and operational procedures for the activity in question comply with the requirements set out in:

to a germinal product storage centre for further storage; 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.

the name, contact details and, where available, the Uniform Resource Locator (URL) of the website of the registered germinal product establishment;

the address of the registered germinal product establishment;

the type of germinal products and animal species for which it was registered;

the unique registration number assigned by the competent authority and the date of the registration;

if activities of the registered germinal product establishment have ceased, the date of cessation of those activities.

the name, contact details and, where available, the URL of the website of the germinal product establishment;

the address of the germinal product establishment;

the name of the centre veterinarian or the team veterinarian;

the type of germinal products, the type of the germinal product establishment and animal species for which the approval has been granted;

the unique approval number assigned by the competent authority and the date of the approval.

indicate that suspension or withdrawal in its register of approved germinal product establishments;

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.

in respect of a semen collection centre:

in respect of an embryo collection team, an embryo production team or an embryo collection and production team:

in respect of a germinal product processing establishment or a germinal product storage centre:

the date of collection or production of those germinal products;

the species and identification of the donor animal(s);

the unique approval number of the germinal product establishment of collection or production, processing and storage of those germinal products;

any other relevant information.

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;

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.

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

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.

the date of collection or production of those germinal products;

the species, where necessary subspecies, and identification of the donor animal(s);

one of the following:

any other information.

obtain the prior consent of the competent authority of the Member State of destination to accept the consignment;

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;

ensure that the donor animals come from establishments which fulfil the animal health requirements laid down in Article 15(1), (2), (3) and (4) of Delegated Regulation (EU) 2020/688;

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:

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;

ensure that the semen has been marked in accordance with the requirements provided for in Article 10;

keep records at the establishment which must include at least the information provided for in Article 8(1)(a);

ensure that the consignment of semen is transported in accordance with Articles 28 and 29.

only move consignments of those germinal products to another confined establishment;

ensure that the donor animals:

ensure that the germinal products have been marked in accordance with the requirements provided for in Article 10;

ensure that the germinal products are transported in accordance with Articles 28 and 29.

the germinal products were collected from animals which did not show symptoms or clinical signs of transmissible animal diseases on the day of collection;

the movement was authorised respectively by the centre or team veterinarian.

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;

they come from establishments in a Member State or zone thereof, or from establishments under official control by the competent authority in a third country or territory, or a zone thereof, each of which fulfils the animal health requirements laid down in Delegated Regulation (EU) 2020/688:

they have been identified in accordance with requirements laid down in Regulation (EU) 2019/2035:

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:

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;

they comply with the additional animal health requirements set out:

they must be kept in separate storage;

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

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.

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;

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:

they are kept at the semen collection centre which:

without quarantine or testing, before and after the movement, as referred to in Annex II for the following animals:

provided that the donor animals:

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:

they fulfil the additional animal health requirements laid down in Part 1 and Chapters I, II and III of Part 5 of Annex II.

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

has reached the age of 2 years and was subjected, with negative results, to a serological test for enzootic bovine leukosis.

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

the team veterinarian, as regards donor animals of oocytes and embryos, may accept a donor animal which came from an establishment which was not free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis provided that the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of infectious bovine rhinotracheitis/infectious pustular vulvovaginitis during a period of at least the preceding 12 months.

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;

they fulfil additional animal health requirements laid down in Part 2 and Chapters I and IV of Part 5 of Annex II.

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;

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;

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;

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.

they did not come from an establishment, nor have been in contact with animals from an establishment, in the case of donor animals of semen prior to their admission to a quarantine accommodation, which has been the subject to movement restrictions as regards infection with Brucella abortus, Brucella melitensis and Brucella suis. The movement restrictions concerning the establishment are lifted after the period comprising of at least 42 days from the date of slaughter or killing and the disposal of the last animal infected or susceptible to that disease;

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;

they fulfil additional animal health requirements laid down in Part 3 and Chapters I, II and III of Part 5 of Annex II.

they come from an establishment:

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;

they fulfil the additional animal health requirements laid down in Part 4 of Annex II.

donor animals whose germinal products are to be moved to other Member States have undergone the following tests:

all the tests referred to in point (a) are carried out in official laboratories.

for bovine animals, the tests referred to in point 1(b) of Chapter I of Part 1 thereof;

for porcine animals, the tests referred to in point 1(b) of Chapter I of Part 2 thereof;

for ovine and caprine animals, the tests referred to in point 1(c) of Chapter I of Part 3 thereof.

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);

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;

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.

the transport containers are sealed and numbered prior to their dispatch from the approved germinal product establishment;

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.

only one type of germinal product of one species has been placed in the transport container;

the transport container, referred to in point (a):

straws or other packages in which germinal products are placed are securely and hermetically sealed;

the germinal products of different types are separated from each other by physical compartments or by being placed in secondary protective bags.

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;

have procedures in place as regards the processing of that semen in order to ensure its traceability in accordance with Articles 10 and 19.

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:

a documentary check of the data submitted by the centre or team veterinarian to ensure that:

the name and address of the approved germinal product establishment of the collection or production of the germinal products;

the name and address of the germinal product processing establishment to which the germinal products are moved for processing;

the dates of movement of the consignment of the germinal products to and from a germinal product processing establishment;

the type and the quantity of the germinal products;

the marking of the germinal products, as required by Article 10.

points 1(a) to (f) of Annex IV, where the germinal products are accompanied by an animal health certificate; or

Article 32(2), where the germinal products are accompanied by a self-declaration document.

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;

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;

showed no disease symptoms on the day of collection of the semen, oocytes or embryos;

are marked by the implantation of a transponder or by a clearly readable tattoo in accordance with Article 17(1) of Regulation (EU) No 576/2013 of the European Parliament and of the Council (17) or identified in accordance with Article 70 of Regulation (EU) 2019/2035;

have received an anti-rabies vaccination that complies with the validity requirements set out in Part 1 of Annex VII to Delegated Regulation (EU) 2020/688;

comply with any preventive health measure for diseases or infections other than rabies set out in Part 2 of Annex VII to Delegated Regulation (EU) 2020/688;

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.

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;

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;

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;

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;

are identified and registered in accordance with the rules of that confined establishment;

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;

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.

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;

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;

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;

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:

come from an establishment:

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;

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;

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;

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;

come from an establishment where surra (Trypanosoma evansi):

fulfil animal health requirements as regards infection with bluetongue virus (serotypes 1-24) laid down in Chapter II of Part 5 of Annex II;

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);

have been clinically examined by a veterinarian and showed no disease symptoms on the day of collection of the semen, oocytes or embryos;

are identified in accordance with Article 73(1) or (2) or Article 74 of Regulation (EU) 2019/2035;

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.

a visual examination of the transport container in order to check:

a documentary check of the data submitted by the operator to ensure that:

a visual examination of the transport container in order to check:

a documentary check of the data submitted by the establishment veterinarian responsible for the activities carried out at confined establishment to ensure that:

a visual examination of the transport container in order to check:

a documentary check of the data submitted by the operator to ensure that:

endangered breeds which do not fulfil the animal health requirements provided for in Chapter 1; or

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.

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;

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.

the name and address of the consignor and the consignee;

the name and address of the place of dispatch and the place of destination;

where the germinal products were moved to and from a germinal product processing establishment, the dates of those movements;

the type of the germinal products and the species of donor animals;

the number of straws or other packages in the consignment to be dispatched;

the following information allowing the identification of germinal products:

available results of the tests referred to in Article 45(2)(b).

1.

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

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:

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:

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):

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:

1.

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

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:

1.

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

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:

1.

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

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:

3.

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

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

Semen collected from all other animals at the semen collection centre since the date when the last sample was taken that gave a negative result in one of the tests described in point 2 shall be kept in separate storage and shall not be subject to movement between Member States until the health status of the semen collection centre has been restored and the semen stored has undergone the appropriate official investigations to rule out the presence in the semen of pathogens that cause diseases referred to in point 2.

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.

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.

1.

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

2.

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

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).

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.

1.

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

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:

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.

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.

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:

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:

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:

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.

1.

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

2.

The centre veterinarian shall ensure that:

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:

4.

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

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:

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:

3.

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

1.

The bovine, ovine and caprine animals which are semen donors must fulfil at least one of the following conditions:

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:

3.

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

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

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;

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;

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;

porcine animals which have been introduced to the establishment:

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.

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:

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:

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:

7.

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

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.

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.

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

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.

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.

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.

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

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.

Embryos from different donor animals shall not be washed together.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

1.

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

2.

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

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

3.

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

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.

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:

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: