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

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’)^f1, 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:

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^f2, 89/556/EEC^f3, 90/429/EEC^f4 and 92/65/EEC^f5. 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^f6. 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^f7.

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)^f8 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^f9 and 2004/292/EC^f10. Article 131 of Regulation (EU) 2017/625 of the European Parliament and of the Council^f11 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^f12, 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^f13 and Commission Delegated Regulations (EU) 2019/2035^f14, (EU) 2020/689^f15 and (EU) 2020/688^f16 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,

HAS ADOPTED THIS REGULATION: