EN Official Journal of the European Union L 171/66

REGULATION (EU) 2016/1012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 8 June 2016

on zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of purebred breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and 90/425/EEC and repealing certain acts in the area of animal breeding (‘Animal Breeding Regulation’)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 42 and Article 43(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) The breeding of animals of the bovine, porcine, ovine, caprine and equine species occupies, in economic and social terms, a strategic place in Union agriculture and contributes to the Union's cultural heritage. This agricultural activity, which contributes to food security in the Union, is a source of income for the agricultural community. The breeding of animals of those species is best promoted by encouraging the use of purebred breeding animals or hybrid breeding pigs of recorded high genetic quality.

(2) Consequently, as part of their agricultural policy, Member States have consistently endeavoured to promote the production of livestock with particular genetic characteristics by setting standards, sometimes doing so through public investment. Disparities between those standards have the potential to create technical barriers to trade in breeding animals and their germinal products, as well as technical barriers to their entry into the Union.

(3) The legal framework for Union law on the breeding of purebred breeding animals of the bovine, porcine, ovine, caprine and equine species and hybrid breeding pigs is provided by Council Directives 88/661/EEC (3), 89/361/EEC (4), 90/427/EEC (5), 91/174/EEC (6), 94/28/EC (7) and 2009/157/EC (8). The aim of those Directives was to develop livestock breeding in the Union, while at the same time regulating the trade in breeding animals and their germinal products and their entry into the Union, thereby maintaining the competitiveness of the Union animal breeding sector.

(4) Council Directives 87/328/EEC (9), 90/118/EEC (10) and 90/119/EEC (11) were adopted to prevent Member States from maintaining or adopting national rules relating to the acceptance for breeding purposes of breeding animals of the bovine and porcine species and the production and use of their semen, oocytes and embryos which could constitute a prohibition or restriction on trade or an obstacle thereto whether in the case of natural service, artificial insemination or collection of semen, oocytes or embryos.

(5) On the basis of Directives 88/661/EEC, 89/361/EEC, 90/427/EEC, 91/174/EEC, 94/28/EC and 2009/157/EC, the Commission, after consulting Member States through the Standing Committee on Zootechnics established in accordance with Council Decision 77/505/EEC (12), adopted a number of Decisions laying down species-specific criteria for the approval or recognition of breeding organisations and breeders' associations, for the entry of breeding animals in herd-books, flock-books and stud-books, for the acceptance of purebred breeding animals of the ovine and caprine species for breeding and artificial insemination, for performance testing and genetic evaluation of breeding animals of the bovine, porcine, ovine and caprine species, and for the establishment of pedigree or zootechnical certificates for trade in breeding animals and their germinal products.

(6) The Commission also established a list of breeding bodies in third countries and the model pedigree or zootechnical certificates for entry into the Union of breeding animals and their semen, oocytes and embryos.

(7) Directives 88/661/EEC, 89/361/EEC, 90/427/EEC, 91/174/EEC, 94/28/EC and 2009/157/EC are largely similar in structure and content. Several of those Directives have been amended over time. In the interests of the simplicity and consistency of Union law, it is appropriate to streamline the Union rules laid down in those Directives.

(8) Over the last 20 years, the Commission has had to respond to a significant number of complaints, raised by breeders and operators carrying out breeding programmes, in relation to the national transposition and interpretation of Union legal acts on the breeding of animals in different Member States. To ensure the uniform application of Union rules on breeding animals and to avoid obstacles to trade in breeding animals and their germinal products resulting from divergences in the national transposition of those Directives, the zootechnical and genealogical conditions for trade in breeding animals and their germinal products and their entry into the Union should be laid down in a Regulation.

(9) In addition, experience has shown that, in order to facilitate the application of the rules provided for in those Directives, more precise wording needs to be used in a number of their provisions, along with consistent terminology that is standard across all Member States. In the interests of clarity and consistency of Union law, it is also appropriate to provide for more definitions, including a definition of ‘breed’.

(10) Efforts to achieve competitiveness in the animal breeding sector should not lead to the disappearance of breeds with characteristics that are adapted to specific biophysical contexts. If their population size is too small, local breeds could be at risk of losing genetic diversity. As an important part of the agricultural biodiversity, animal genetic resources provide an essential basis for the sustainable development of the livestock sector and offer opportunities to adapt animals to changing environments, production conditions and market and consumer demands. Union legal acts on the breeding of animals should thus contribute to the preservation of animal genetic resources, to the protection of biodiversity and to the production of typical quality regional products that rely on the specific hereditary characteristics of local breeds of domestic animals. Union legal acts should also promote viable breeding programmes for the improvement of breeds, and particularly in the case of endangered breeds or autochtonous breeds which are not commonly found in the Union, for the preservation of breeds and the preservation of the genetic diversity within and between breeds.

(11) Through selection and breeding significant progress has been achieved in the development of traits related to the productivity of farmed animals, leading to reduced production costs at farm level. However, this has, in some cases, led to undesirable side effects, raising concerns in society about animal welfare and environment-related issues. The application of genomics and the use of advanced information technologies such as ‘Precision livestock farming’ — which allows large data sets on alternative traits, directly or indirectly related to animal welfare and sustainability issues, to be recorded — hold considerable potential to address concerns in society and achieve the objectives of sustainable animal breeding in terms of improved resource efficiency and the enhanced resilience and robustness of animals. The collection of data on these alternative traits should gain in importance within the framework of breeding programmes and should be given greater prominence in the definition of selection objectives. In this context, genetic resources of endangered breeds should be considered to be a reservoir of genes that can potentially contribute to achieving these animal welfare and sustainability goals.

(12) This Regulation should apply to breeding animals of the bovine, porcine, ovine, caprine and equine species and their germinal products where it is intended that those animals or the offspring resulting from those germinal products be entered as purebred breeding animals in a breeding book or registered as hybrid breeding pigs in a breeding register, in particular with a view to trading within the Union, including within a Member State, or the entry into the Union of those breeding animals and their germinal products.

(13) The term ‘breeding animal’ or ‘purebred breeding animal’ should not be understood as only covering animals which still possess their reproductive function. Indeed, castrated animals might contribute with their genealogical and zootechnical records to the assessment of the genetic quality of the breeding population and thus to the integrity of the rankings of breeding animals based on those results. Depending on the objectives of the breeding programme, a lack of or loss of data resulting from the explicit exclusion of castrated animals from entry in a breeding book or register would be likely to bias the results of the assessment of the genetic quality of breeding animals that are genetically related to those castrated animals.

(14) The aim of the rules on purebred breeding animals laid down in this Regulation should be to grant access to trade based on agreed principles applicable to the recognition of breed societies managing breeds and the approval of their respective breeding programmes. This Regulation should also lay down rules governing the entry of purebred breeding animals in the main section of the breeding books and, where they exist, in the different merit classes of the main section. It should also lay down rules for performance testing and genetic evaluation and rules for the acceptance of breeding animals for breeding as well as the content of the zootechnical certificates.

(15) Similarly, the aim of the rules on hybrid breeding pigs laid down in this Regulation should be to grant access to trade based on agreed principles applicable to the recognition of breeding operations managing different breeds, lines or crosses of the porcine species and the approval of their breeding programmes. This Regulation should also lay down rules governing the registration of hybrid breeding pigs in breeding registers. It should also lay down rules for performance testing and genetic evaluation and rules for the acceptance of hybrid breeding pigs for breeding as well as the content of the zootechnical certificates.

(16) It is not appropriate for issues relating to cloning to be addressed in this Regulation.

(17) Since the objectives of this Regulation, namely to ensure a harmonised approach to trade in breeding animals and their germinal products and their entry into the Union, as well as to the official controls necessary to be performed on breeding programmes carried out by breed societies and breeding operations, cannot be sufficiently achieved by the Member States but can rather, by reason of its effect, complexity, transborder and international character, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as referred to in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(18) The quality of the services provided by breed societies and breeding operations and the way that they evaluate and classify breeding animals has an impact on the quality and accuracy of zootechnical and genealogical information collected or determined in respect of those animals and their value on the market. Accordingly, rules should be laid down for the recognition of breed societies and breeding operations and the approval of their breeding programmes based on harmonised Union criteria. Those rules should also cover their supervision by the competent authorities of Member States in order to ensure that the rules established by breed societies and breeding operations do not give rise to disparities between breeding programmes, thereby creating technical barriers to trade in the Union.

(19) Similar procedures to those laid down in Directives 88/661/EEC, 89/361/EEC, 90/427/EEC, 91/174/EEC, 94/28/EC and 2009/157/EC for listing recognised breed societies and breeding operations, including the updating, transmission and publication of the lists, should be provided for in this Regulation.

(20) Breeding programmes on purebred breeding animals are carried out with the overall aim of improving, in a sustainable manner, the production and non-production traits of animals of a breed or to preserve a breed. Those breeding programmes should cover a sufficiently large number of purebred breeding animals kept by breeders which, through breeding and selection, promote and develop desirable traits in those animals or guarantee the preservation of the breed, in accordance with the objectives that are commonly accepted by the participating breeders. Likewise, breeding programmes concerning hybrid breeding pigs are carried out with the purpose of developing desirable traits by deliberate crossbreeding between different breeds, lines or crosses of pigs. Breeding animals (purebred or hybrid) participating in a breeding programme are entered in a breeding book or register, including information on their ascendants, and, depending on the breeding objectives set out in the breeding programme, undergo performance testing or any other assessment that results in the recording of data on traits in relation to the objectives of that breeding programme. Where specified in the breeding programme, genetic evaluation is carried out to estimate the breeding value of the animals which may be ranked accordingly. Those breeding values and performance test results, as well as the genealogical information, form the basis for breeding and selection.

(21) The right to be recognised as a breed society or breeding operation which meets the established criteria should be a fundamental principle of the Union law on the breeding of animals and of the internal market. The protection of the economic activity of an existing recognised breed society should not justify the refusal by the competent authority of the recognition of a further breed society for the same breed or violations of the principles governing the internal market. The same applies to the approval of a further breeding programme, or to the approval of the geographical extension of an existing breeding programme, which is carried out on the same breed, or on breeding animals of the same breed that can be recruited from the breeding population of a breed society that is already carrying out a breeding programme on that breed. However, where in a Member State one or more recognised breed societies are already carrying out an approved breeding programme on a given breed, the competent authority of that Member State should, in certain specific cases, be allowed to refuse to approve a further breeding programme for the same breed, even if that breeding programme complies with all the requirements necessary for approval. One reason for refusal could be that the approval of a further breeding programme for the same breed would compromise the preservation of that breed or the genetic diversity within that breed in that Member State. The preservation of that breed might, in particular, be compromised as a result of the fragmentation of the breeding population, possibly leading to higher inbreeding, to increased incidences of observed genetic defects, to a loss in the selection potential or to reduced access of the breeders to purebred breeding animals or the germinal products thereof. Another reason for refusal could be linked to inconsistencies in the defined breed characteristics or in the main objectives of those breeding programmes. Indeed, independently of the aim of the breeding programme, namely the preservation of the breed or the improvement of the breed, the competent authority should be allowed to refuse approval for a further breeding programme in respect of the same breed where differences in the main objectives of the two breeding programmes, or in essential traits of the breed characteristics defined in those breeding programmes, would result in a loss of efficiency in terms of genetic progress in those objectives or in those traits or any correlated traits, or where an exchange of animals between both breeding populations would bear a risk of out selection or out breeding of those essential traits in the initial breeding population. Finally, in the case of an endangered breed or an autochthonous breed not commonly found in one or more of the territories of the Union, a competent authority should also be allowed to refuse the approval of a further breeding programme for the same breed on the grounds that that further breeding programme would impede the effective implementation of the existing breeding programme, in particular due to a lack of coordination, or exchange, of genealogical and zootechnical information resulting in a failure to benefit from the common evaluation of data collected on that breed. In the event of a refusal to approve a breeding programme, the competent authority should always provide a reasoned explanation to the applicants and give them the right to appeal against that refusal.

(22) Breeders should have the right to design and implement a breeding programme for their own use, without that breeding programme having to be approved by the competent authorities. However, each Member State or its competent authorities should retain the possibility of regulating those activities, in particular as soon as such a breeding programme leads to business transactions in respect of breeding animals or the germinal products thereof or jeopardises an already existing approved breeding programme for that same breed.

(23) If the aim of the breeding programme is to preserve the breed, the requirements of the breeding programme could be complemented by ex situ and in situ conservation measures or any other tools for monitoring the status of the breed that would ensure a longterm, sustainable conservation of that breed. It should be possible for those measures to be laid down in the breeding programme.

(24) Breeders' associations, breeding organisations, including breeding organisations which are private undertakings, or public bodies should only be recognised as breed societies when they have breeders participating in their breeding programmes and when they ensure that those breeders have free choice in the selection and breeding of their purebred breeding animals, the right to have the offspring descended from those animals entered in their breeding books and the possibility of owning those animals.

(25) Prior to the implementation of changes in the approved breeding programme, a breed society or breeding operation should submit those changes to the competent authority that has recognised that breed society or breeding operation. In order to avoid an unnecessary administrative burden for the competent authority and the breed society or breeding operation, only those changes which are likely to substantially affect the breeding programme should be communicated by the breed society or breeding operation to the competent authority. Those changes should, in particular, cover the extension of the geographical territory, changes in the aim or in the selection and breeding objectives of the breeding programme, changes in the description of the breed characteristics or in the delegation of tasks to third parties, as well as major changes in the system for recording pedigrees or in the methods used for performance testing and genetic evaluation and any other changes which the competent authority considers to be a substantial modification of the breeding programme. Irrespective of the mandatory submission of significant changes to the competent authority, the breed society or breeding operation should, at the request of the competent authority, provide it with an up-to-date version of the breeding programme.

(26) Where there is a recognised need to maintain or promote the development of a breed on a certain territory, or in the case of an endangered breed, the competent authority should itself have the possibility to carry out, on a temporary basis, a breeding programme for that breed, provided that no breeding programme is already effectively in place for that breed. A competent authority carrying out such a breeding programme should, however, no longer have that possibility if it is possible for the breeding programme to be handed over to an operator fulfilling the requirements necessary for the proper implementation of that breeding programme.

(27) Because the preservation of endangered breeds requires the setting up and recognition of breed societies with a limited number of breeding animals participating in their breeding programmes, the size of the breeding population should not, in general, be considered to be an essential requirement for the recognition of breed societies managing endangered breeds or for the approval of their breeding programmes, particularly since the recognition is carried out nationally.

(28) Specific rules, in particular those on the upgrading from the supplementary section into the main section and on derogations for the performance testing and genetic evaluation, should be laid down in this Regulation to take account of the specific status of endangered breeds.

(29) The Union is a contracting party to the Convention on Biological Diversity, approved by Council Decision 93/626/EEC (13), the objectives of which are in particular the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources. That Convention stipulates that the contracting parties have sovereign rights to their biological resources and are responsible for the conservation of their biological diversity and the sustainable use of their biological resources. The Union is also a party to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, approved by Council Decision 2014/283/EU (14). This Regulation should therefore take into account, where applicable, the Convention on Biological Diversity, as well as the Nagoya Protocol and should apply without prejudice to Regulation (EU) No 511/2014 of the European Parliament and of the Council (15).

(30) Breed societies and breeding operations recognised in one Member State should have the possibility to implement their approved breeding programme in one or more other Member States in order to ensure the best possible use, within the Union, of breeding animals of high genetic value. To this end a simplified notification procedure should ensure that the competent authority in the other Member State is aware of the intention to carrying out of crossborder activities. However, seasonal movements of breeding animals within the borders of a Member State or taking place over several Member States should not mandatorily entail the extension of the geographical territory.

(31) Cross-border cooperation between breed societies and between breeding operations which wish to engage therein should be facilitated, while ensuring free entrepreneurship and the removal of obstacles to the free movement of breeding animals and their germinal products.

(32) Since a competent authority might have to approve several breeding programmes carried out by one breed society or breeding operation it has recognised, and since a competent authority might have to approve the extension on its territories of breeding programmes carried out by a breed society or breeding operation recognised in another Member State, the recognition of the breed society or breeding operation should be separated from the approval of its breeding programmes. However, when evaluating an application for recognition as a breed society or breeding operation, the competent authority should also be provided with an application for the approval of at least one breeding programme.

(33) From various complaints the Commission has had to deal with in previous years, it appears that this Regulation should provide for clear rules governing the relationship between the breed society that establishes a filial breeding book for a particular breed of purebred breeding animals of the equine species and the breed society that claims to have established the breeding book of the origin of that breed.

(34) It is necessary to clarify the relationship between breeders and breed societies, in particular to ensure their right to participate in the breeding programme within the geographical territory for which it is approved and, where membership is provided for, to ensure that those breeders have the right to be members. Breed societies should have rules in place to settle disputes with breeders participating in their breeding programmes and to ensure that those breeders are treated equally. They should also set out their own rights and obligations as well as those of breeders participating in their breeding programmes.

(35) Breeders whose breeding animals are moved seasonally within the border of a Member State or an area straddling national borders should have the right to continue to participate in the breeding programme as long as the headquarters of their holding is located within the geographical territory of that breeding programme.

(36) The specific situation prevailing in the hybrid breeding pig sector should be taken into account in this Regulation. Most private undertakings in the hybrid breeding pig sector have closed production systems and manage their own breeding stock. Provision should therefore be made for a number of derogations for these undertakings, in particular as regards the participation by breeders in the breeding programme and the right to register hybrid breeding pigs in the breeding registers.

(37) The definition of ‘hybrid breeding pig’ covers animals from all levels in the breeding and selection pyramid, that are used for optimising cross-breeding by combining specific assets of their different genotypes and exploiting heterosis effects. Depending on the level of the breeding and selection pyramid, ‘hybrid breeding pig’ covers breeds, lines or crosses. Thus, not all animals are necessarily ‘hybrid’ in the traditional sense.

(38) Experience gained, particularly in the application of Directive 90/427/EEC, and to a lesser extent Directives 89/361/EEC and 2009/157/EC, indicates that more precise rules are required to settle effectively disputes between breeders on the one hand and breed societies on the other hand, based on clearly established rules of procedure and described rights and duties of breeders. This is best achieved if the disputes are settled within the legal system of the Member State where they arise.

(39) Breed societies which establish and maintain breeding books for purebred breeding animals of the bovine, porcine, ovine, caprine and equine species, as well as breeding operations other than private undertakings operating in closed production systems, which establish and maintain breeding registers for hybrid breeding pigs, should enter breeding animals in their breeding books or register them in their breeding registers without discrimination as regards the Member State of origin of the animals or their owners and, where this is provided for in the breeding programme, should classify those animals according to their merits.

(40) Breed societies should also be allowed to establish supplementary sections for the recording of animals which do not meet the parentage criteria but which are judged by the breed societies to comply with the breed characteristics laid down in the breeding programme of the breed concerned, with the aim of subsequently breeding those animals with purebred breeding animals belonging to the breed covered by the breeding programme in order for the progeny to be upgraded into the main section of the breeding book. The specific rules for upgrading the progeny of those animals into the main section of a breeding book should be laid down at Union level.

(41) The upgrading of offspring to the main section of breeding books should only be allowed through the female line, except in the case of equine species. However, for an endangered breed of the bovine, porcine, ovine and caprine species and for ‘hardy’ sheep breeds for which there are not enough purebred male reproductive animals, Member States should have the possibility to authorise the breed societies to apply less stringent rules for upgrading the progeny of those animals recorded in supplementary sections to the main section of the breeding book in order to avoid the further deterioration of the genetic diversity of those breeds. Likewise, special rules should be provided for to allow for the reconstruction of breeds which have disappeared or are in serious danger of disappearing. Member States making use of such derogations should carefully evaluate the risk status of those breeding populations and ensure secure management of genetic resources.

(42) Where there is a need to create a new breed by associating characteristics from purebred breeding animals from different breeds or by assembling animals with a sufficient degree of physical resemblance which already reproduce with sufficient genetic stability for them to be considered as having evolved into a new breed, breed societies should be given the possibility of establishing breeding books and of carrying out breeding programmes on those new breeds.

(43) Nothing in this Regulation should prevent animals recorded in a supplementary section of a breeding book of a certain breed from falling under the scope of the commitments of the agri-environment-climate measure referred to in Article 28 of Regulation (EU) No 1305/2013 of the European Parliament and of the Council (16) and thus being eligible for support by the national or regional authorities under their rural development programmes.

(44) For purebred breeding animals of the equine species, breed societies should be able to lay down rules in their breeding programmes that prohibit or limit the use of certain reproduction techniques and of certain purebred breeding animals, including the use of their germinal products. The breed societies should, for example, be able to request that the offspring result from natural mating only. Breed societies making use of this prohibition or limitation should lay down those rules in their breeding programme in accordance with the rules set out by the breed society which is maintaining the breeding book of origin.

(45) Purebred breeding animals entered in breeding books should be identified in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council (17).

(46) In the case of purebred breeding animals of the equine species, Regulation (EU) 2016/429 provides that the competent authorities in the field of animal health shall issue, for animals of the equine species, a single lifetime identification document which is to be further specified by the Commission through delegated acts. In order for the zootechnical certificate to be streamlined as far as possible with that single lifetime identification document as regards content and administrative procedure, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of the format and content of a single lifetime identification document for animals of the equine species.

(47) The eligibility of purebred breeding animals of the equine species to compete internationally is regulated by international private agreements. Considering the international dimension of the equine sector, the Commission, when preparing and drawing up the relevant delegated and implementing acts, should take into account those agreements, so as to maintain the eligibility of those purebred breeding animals of the equine species to compete at international level.

(48) The acceptance of breeding animals for breeding purposes, and in particular for natural service or assisted reproduction, should be regulated at Union level to prevent obstacles to trade, in particular where such breeding animals have undergone performance testing or genetic evaluation carried out in accordance with the rules laid down in this Regulation and in particular in Annex III.

(49) It is understood that Member States or their competent authorities should not use this Regulation in order to prohibit, restrict or impede the use of purebred breeding animals or germinal products thereof for the production of animals not intended to be entered or registered as breeding animals in a breeding book or breeding register.

(50) While the rules for performance testing and genetic evaluation have been established at Union level for breeding animals of the bovine, porcine, ovine and caprine species which are tested for a certain number of traits, the numerous requirements for different breeds, uses and selections of purebred breeding animals of the equine species have, to date, prevented their harmonisation. Instead, breed specific rules for performance testing and genetic evaluation are currently established by the studbook of the origin of the breed.

(51) In order to take account of technical developments, scientific advances or the need to preserve valuable genetic resources, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex III to this Regulation. In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should also be conferred on the Commission, enabling it to lay down uniform and more detailed rules for performance testing and for the genetic evaluation of purebred breeding animals of the bovine, ovine and caprine species.

(52) It should be possible for performance testing or genetic evaluation to be carried out by a third party designated by the breed society or the breeding operation or a public body including an authority exercising this mission as a sovereign task. That third party could be authorised and evaluated by the competent authority in the context of the approval of the breeding programme. A breed society or breeding operation outsourcing performance testing or genetic evaluation should, unless otherwise decided by the relevant Member State or its competent authorities, remain responsible for ensuring compliance with the requirements applicable to those activities and should specify the designated third party in its breeding programme.

(53) Depending, inter alia, on the species or on the breed, there might be a need for the harmonisation or the improvement of the methods of performance testing and genetic evaluation of purebred breeding animals used by breed societies or by the third parties designated by them. To ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission enabling it to designate European Union reference centres. In order, where necessary, to modify the task of those reference centres, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. Those European Union reference centres should qualify for Union financial support in accordance with Regulation (EU) No 652/2014 of the European Parliament and of the Council (18). In the case of purebred breeding animals of the bovine species, those tasks are carried out by the Interbull Centre, a permanent subcommittee of the International Committee for Animal Recording (ICAR), which is the European Union reference centre designated by Council Decision 96/463/EC (19).

(54) In addition, in order to provide support to breed societies managing endangered breeds, where there is a recognised need, implementing powers should be conferred on the Commission, enabling it to designate European Union reference centres charged with the specific task of promoting the establishment or harmonisation of methods used by those breed societies. In order, where necessary, to modify the task of those reference centres, the power to adopt acts in accordance with Article 290 TFEU should also be delegated to the Commission. When designating those centres and describing their tasks, the Commission should take duly into account the activities of the European Regional Focal Point for Animal Genetic Resources (ERFP) which has been established in the framework of the Global Plan of Action for Animal Genetic Resources in Europe of the Food and Agriculture Organisation (FAO). The methods established by these centres should not be binding.

(55) Breeders who are participating in a breeding programme should have the right to receive zootechnical certificates for their breeding animals covered by that breeding programme and for the germinal products of those animals. Zootechnical certificates should accompany breeding animals or the germinal products thereof where they are traded or entered into the Union in view of an entry or registration of those animals or of the progeny produced from those germinal products in other breeding books or breeding registers. Zootechnical certificates should inform the breeder about the genetic quality and the pedigree of the acquired animal. Such certificates should, for example, be issued, where necessary, to accompany breeding animals for exhibition purposes or when they are placed in test stations or in artificial insemination centres.

(56) It should be understood that this Regulation does not prohibit Member States or competent authorities from requiring that, when traded, the semen of purebred breeding animals of the bovine, porcine, ovine, caprine and equine species intended for artificial insemination in view of the production of animals that are not intended to become purebred breeding animals be accompanied by information on the quality and the pedigree of that animal. In general, by making the germinal products of breeding animals, and in particular their semen, and the related information on the zootechnical certificates also available for operators which reproduce animals without the intention of having their progeny entered in a breeding book, it is hoped that the competitiveness of the Union animal breeding sector could be improved.

(57) The entry into the Union and the export to third countries of breeding animals and their germinal products is important for Union agriculture. The entry into the Union of breeding animals and their germinal products should therefore be carried out under conditions that are closely comparable to the rules applicable to trade in the Union. However, breeding animals and their germinal products should only be entitled to entry in the main section of a breeding book or breeding register in the Union, if the level of controls carried out in the exporting third country ensures the same certainty of pedigree details and results of performance testing and genetic evaluation as in the Union and if the breeding bodies providing those details and results are included in a list maintained by the Commission. In addition, breeding bodies in third countries should, as a matter of reciprocity, accept breeding animals and their germinal products from the respective breed society or breeding operation recognised in the Union.

(58) Council Regulation (EEC) No 2658/87 (20) provides that a goods nomenclature, namely the ‘Combined Nomenclature’, or in abbreviated form ‘CN’, which meets at one and the same time the requirements of the Common Customs Tariff, the external trade statistics of the Community and other Union policies concerning the importation or exportation of goods, is to be established by the Commission. Annex I to that Regulation lists the CN codes for purebred breeding animals of the bovine, porcine, ovine, caprine and equine species and of bovine semen and indicates that they are exempt from the conventional rate of duties. In that case, those animals and their germinal products should be accompanied by the appropriate zootechnical certificate to support their classification as purebred breeding animals or germinal products thereof. In the case of purebred breeding animals, they should also be accompanied by a document indicating that they will be entered in a breeding book maintained by a breed society or registered in a breeding register maintained by a breeding operation.

(59) Upon entry into the Union, breeding animals and their germinal products undergo veterinary checks in accordance with Council Directives 91/496/EEC (21) and 97/78/EC (22). In the case of purebred breeding animals, they should also undergo the necessary checks for the application of the exemption of the conventional rate of duty for purebred breeding animals.

(60) It is necessary to lay down rules on official controls performed for the verification of compliance with the rules provided for in this Regulation and on other official activities carried out by the competent authorities in accordance with this Regulation that are adapted to the animal breeding sector. The competent authorities should have the possibility to carry out official controls on all operators that are subject to this Regulation, and in particular on breed societies, on breeding operations, on third parties carrying out performance testing or genetic evaluation and on breeders, and, if they issue zootechnical certificates, on semen collection and storage centres, embryo storage centres, and on embryo collection or production teams.

(61) Competent authorities should carry out official controls in order to verify compliance with the rules set out in this Regulation and the requirements laid down in the approved breeding programme. Those controls might include the inspection of equipment used for performance testing or the verification of the procedures put in place for recording zootechnical and genealogical data, or the examination of documents or systems used for storing and processing such data collected on breeding animals. That examination could take into account quality checks or control systems for ensuring the accuracy of the recorded data, such as parentage controls carried out in order to verify an animal's pedigree. The competent authorities might carry out official controls on the premises and offices and on the equipment of breeders, breed societies or breeding operations as well as on the breeding animals, or the germinal products collected from those breeding animals covered by the breeding programme.

(62) Where, in this Regulation, reference is made to ‘other official activities’, this should be interpreted as covering the recognition of breed societies and breeding operations, the approval of breeding programmes or the provision of assistance to other Member States and third countries.

(63) For the effective application of Union rules on breeding animals and their germinal products laid down in this Regulation, it is necessary for the competent authorities of the Member States to cooperate with each other and to provide administrative assistance whenever necessary. Accordingly, general rules on administrative assistance and cooperation, similar to those currently set out in Title IV of Regulation (EC) No 882/2004 of the European Parliament and of the Council (23), should be laid down, with the necessary adaptations, in this Regulation.

(64) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt, where there is evidence that widespread serious non-compliance with Union law on the breeding of animals is taking place in a third country, special measures in order to limit the impact of such non-compliance.

(65) The competent authorities of the Member States should also have the necessary powers to enforce zootechnical and genealogical rules on breeding animals laid down in this Regulation, including the suspension of the approval of a breeding programme or the withdrawal of the recognition of a breed society or breeding operation in the event of non-compliance with the rules laid down in this Regulation.

(66) The Commission should carry out controls in Member States as appropriate, inter alia, in the light of the results of the official controls carried out by Member States, to ensure the application of the rules laid down in this Regulation in all Member States.

(67) The Commission should carry out controls in third countries, as appropriate, with a view to establishing the list of third country breeding bodies from which entry into the Union of breeding animals and their semen, oocytes and embryos should be allowed, with a view to drawing up the conditions for their entry into the Union and with a view to obtaining the zootechnical and genealogical information relating to the functioning of equivalence agreements. The Commission should also carry out controls in third countries where any recurring or emerging problem in relation to breeding animals or the germinal products thereof so warrants.

(68) The verification of compliance with the rules provided for in this Regulation through official controls is of fundamental importance to ensuring that, across the Union, the objectives of this Regulation are effectively achieved. Failures in a Member State's control system might in certain cases substantially hinder the achievement of those objectives and lead to situations of serious widespread non-compliance with those rules. The Commission should, therefore, be able to react to serious failures in a Member State's control system by adopting measures applicable until such time as the Member State concerned takes the necessary action to remedy the disruption. Such measures include the prohibition or the enforcement of special conditions on the trade of breeding animals or their germinal products or any other measures which the Commission deems appropriate to address that widespread infringement.

(69) As Directives 88/661/EEC, 89/361/EEC, 90/427/EEC, 94/28/EC and 2009/157/EC are to be repealed and replaced by this Regulation, it is also necessary to repeal the Commission acts adopted pursuant to those Directives and, where necessary, to replace them by either delegated acts or implementing acts adopted pursuant to the respective powers conferred in this Regulation. Accordingly, those Commission acts should be repealed and, where necessary, replaced.

(70) In order to ensure the proper application of this Regulation and to supplement it, or to amend Annexes to it, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of laying down the requirements for performance testing and genetic evaluation, the tasks of and requirements for European Union reference centres and the content and format of zootechnical certificates.

(71) When preparing and drawing up delegated acts, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016 (24). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as the Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(72) In order to ensure uniform conditions for the implementation of the provisions of this Regulation concerning model forms for the information to be provided by Member States to the public on the list of recognised breed societies and breeding operations, the methods for the verification of the identity of purebred breeding animals, the performance testing and genetic evaluation, the designation of European Union reference centres, the model forms of the single lifetime identification document for equidae, the models for zootechnical certificates accompanying breeding animals and their germinal products, the recognition of equivalence of measures applied in third countries, serious disruptions in the control system of a Member State and the establishment of special measures regarding the entry into the Union of breeding animals and their germinal products, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (25). Where the Standing Committee on Zootechnics delivers no opinion, the Commission should not adopt the implementing act.

(73) The rules laid down in Directives 87/328/EEC, 88/661/EEC, 89/361/EEC, 90/118/EEC, 90/119/EEC, 90/427/EEC, 91/174/EEC, 94/28/EC and 2009/157/EC and Decision 96/463/EC are to be replaced by the rules laid down in this Regulation and in delegated and implementing acts of the Commission adopted pursuant to the powers conferred in this Regulation. Accordingly, those legal acts should therefore be repealed.

(74) The following Commission Decisions concerning, inter alia, species-specific criteria for the approval or recognition of breed societies and breeding operations, the entry of breeding animals in breeding books and the acceptance for breeding and artificial insemination, for performance testing and genetic evaluation were adopted pursuant to Directives 88/661/EEC, 89/361/EEC, 90/427/EEC, 94/28/EC and 2009/157/EC: Commission Decisions 84/247/EEC (26), 84/419/EEC (27), 89/501/EEC (28), 89/502/EEC (29), 89/504/EEC (30), 89/505/EEC (31), 89/507/EEC (32), 90/254/EEC (33), 90/255/EEC (34), 90/256/EEC (35), 90/257/EEC (36), 92/353/EEC (37), 96/78/EC (38) and 2006/427/EC (39). This Regulation should provide for rules replacing those laid down in those Commission decisions.

(75) Similar rules to those laid down in Commission Decision 92/354/EEC (40) should be laid down in this Regulation.

(76) The following Commission legal acts were adopted pursuant to Directives 88/661/EEC, 89/361/EEC, 90/427/EEC, 94/28/EC and 2009/157/EC: Commission Decisions 89/503/EEC (41), 89/506/EEC (42), 90/258/EEC (43), 96/79/EC (44), 96/509/EC (45), 96/510/EC (46) and 2005/379/EC (47), and Commission Implementing Regulation (EU) 2015/262 (48). This Regulation should provide for rules replacing those laid down in those Commission legal acts.

(77) To ensure legal clarity and to avoid duplication, the Commission legal acts referred to in Recitals 74, 75 and 76 should be repealed from the date of application of this Regulation. In addition, the Commission should, at least 18 months before the date of application of this Regulation, adopt implementing acts laying down the model forms for the presentation of the information to be included in the list of recognised breed societies and breeding operations that is to be made public by the Member States, as well as the model forms for the zootechnical certificates for breeding animals and their germinal products. Those implementing acts should be applicable by the date of application of this Regulation.

(78) In order to ensure a smooth transition for breeders' organisations, breeding organisations, breeders' associations, private undertakings or other organisations or associations which have been approved or recognised with or without a limitation in time under the acts repealed by this Regulation and for the breeding programmes carried out by those operators, those operators and their breeding programmes should be deemed to be recognised or approved in accordance with this Regulation. Consequently, those operators should not be subject to the procedures for recognition, for approval and for notification of the extension of the geographical territory to other Member States set out in this Regulation, although the other provisions of this Regulation should apply to them. Member States should ensure that those operators comply with all the rules provided for in this Regulation in particular by carrying out risk-based official controls on them. 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 the recognition of those operators or the approval of their breeding programmes.

(79) The Commission recently adopted a proposal for a new Regulation on official controls and other official activities. That new Regulation is intended to repeal Regulation (EC) No 882/2004, Council Directive 89/608/EEC (49), Council Directive 90/425/EEC (50), and Directives 91/496/EEC and 97/78/EC. It is also intended to incorporate, with the necessary adaptations, certain of the rules laid down in Regulation (EC) No 882/2004 and in those Directives. However, the breeding of animals is not intended to fall within the scope of that new Regulation. For legal clarity and certainty and pending the repeal of Directives 89/608/EEC, 90/425/EEC, 91/496/EEC and 97/78/EC by means of that new Regulation, it is necessary to delete the references to ‘zootechnical’ from Directives 89/608/EEC and 90/425/EEC, while Directives 91/496/EEC and 97/78/EC do not require such amendment. Directives 89/608/EEC and 90/425/EEC should therefore be amended accordingly.

(80) Until the date of the application of Article 110 of Regulation (EU) 2016/429, breed societies carrying out approved breeding programmes on purebred breeding animals of the equine species should be able to continue to issue the identification documents for those purebred breeding animals in accordance with Article 8(1) of Directive 90/427/EEC.

(81) This Regulation should be applicable from the first day of the twenty-eighth month after the date it enters into force,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

General Provisions

Article 1

Subject matter and scope

1. This Regulation lays down:

(a) zootechnical and genealogical rules for trade in breeding animals and their germinal products, and for their entry into the Union;

(b) rules for the recognition of breed societies and breeding operations and for the approval of their breeding programmes;

(c) the rights and obligations of breeders, breed societies and breeding operations;

(d) rules for the entry of breeding animals in breeding books and breeding registers and for the acceptance for breeding of breeding animals and their germinal products;

(e) rules for the performance testing and genetic evaluation of breeding animals;

(f) rules for the issuing of zootechnical certificates for breeding animals and their germinal products;

(g) rules for the performance of official controls, and in particular those on breed societies and breeding operations, and rules for the performance of other official activities;

(h) rules for administrative assistance and cooperation and rules for enforcement by Member States;

(i) rules for the performance of controls by the Commission in Member States and third countries.

2. This Regulation applies to breeding animals and their germinal products where those animals or the offspring resulting from those germinal products are intended to be entered as purebred breeding animals in a breeding book or registered as hybrid breeding pigs in a breeding register.

3. This Regulation does not apply to breeding animals and their germinal products where those animals and germinal products are intended for technical or scientific experiments carried out under the supervision of the competent authorities.

4. Article 9(4), Article 13, Article 14(3) and (4), Articles 23 and 24, Article 28(2) and Article 36(1) do not apply to private undertakings, recognised as breeding operations, which operate in closed production systems.

5. This Regulation is without prejudice to Member States' rights to take national measures to regulate the carrying out of breeding programmes that have not been approved in accordance with Article 8(3), and, where applicable, Article 12.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘animal’ means a domestic animal of: (a) the bovine species (Bos taurus, Bos indicus and Bubalus bubalis); (b) the porcine species (Sus scrofa); (c) the ovine species (Ovis aries); (d) the caprine species (Capra hircus); or (e) the equine species (Equus caballus and Equus asinus);

(2) ‘breed’ means a population of animals sufficiently uniform to be considered to be distinct from other animals of the same species by one or more groups of breeders which have agreed to enter those animals in breeding books with details of their known ascendants for the purpose of reproducing their inherited characteristics by way of reproduction, exchange and selection within the framework of a breeding programme;

(3) ‘breeding animal’ means a purebred breeding animal or a hybrid breeding pig;

(4) ‘germinal products’ means semen, oocytes and embryos collected or produced from breeding animals for the purpose of assisted reproduction;

(5) ‘breed society’ means any breeders' association, breeding organisation or public body, other than competent authorities, which is recognised by the competent authority of a Member State in accordance with Article 4(3) for the purpose of carrying out a breeding programme on purebred breeding animals entered in the breeding book(s) it maintains or establishes;

(6) ‘breeding operation’ means any breeders' association, breeding organisation, private undertaking operating in a closed production system or public body, other than competent authorities, which is recognised by the competent authority of a Member State in accordance with Article 4(3) for the purpose of carrying out a breeding programme on hybrid breeding pigs registered in the breeding register(s) it maintains or establishes;

(7) ‘breeding body’ means any breeders' association, breeding organisation, private undertaking, stock-rearing organisation or official service in a third country which, in respect of purebred breeding animals of the bovine, porcine, ovine, caprine or equine species or of hybrid breeding pigs, has been accepted by that third country in connection with the entry into the Union of breeding animals for breeding;

(8) ‘competent authorities’ means the authorities of a Member State which are responsible, pursuant to this Regulation, for: (a) the recognition of breed societies and breeding operations and the approval of the breeding programmes they carry out on breeding animals; (b) official controls on operators; (c) the provision of assistance to other Member States and third countries in case of detected non-compliances; (d) official activities other than those referred to in points (a) and (c);

(9) ‘purebred breeding animal’ means an animal which is entered or registered and eligible for entry in the main section of a breeding book;

(10) ‘hybrid breeding pig’ means an animal of the porcine species registered in a breeding register, which is produced by deliberate cross-breeding or used for deliberate cross-breeding between: (a) purebred breeding pigs of different breeds or lines; (b) breeding pigs which are themselves the outcome of a cross (hybrid) between different breeds or lines; (c) breeding pigs belonging to one or the other of the categories referred to in (a) or (b);

(11) ‘line’ means a genetically stable and uniform subpopulation of purebred breeding animals of a particular breed;

(12) ‘breeding book’ means: (a) any herd-book, flock-book, stud-book, file or data medium which is maintained by a breed society consisting of a main section and, where the breed society so decides, of one or more supplementary sections for animals of the same species that are not eligible for entry in the main section; (b) where appropriate, any corresponding book maintained by a breeding body;

(13) ‘main section’ means the section of a breeding book in which purebred breeding animals are entered or registered and eligible for entry with details of their ascendants and, where applicable, their merits;

(14) ‘class’ means a horizontal division of the main section in which purebred breeding animals are entered according to their merits;

(15) ‘merit’ means a quantifiable heritable characteristic or a genetic peculiarity of a breeding animal;

(16) ‘breeding value’ means an estimate of the expected effect of the genotype of a breeding animal on a given characteristic in its progeny;

(17) ‘breeding register’ means: (a) any file or data medium which is maintained by a breeding operation in which hybrid breeding pigs are registered with details of their ascendants; (b) where appropriate, any corresponding register maintained by a breeding body;

(18) ‘official control’ means any type of control that the competent authorities perform in order to verify compliance with the rules laid down in this Regulation;

(19) ‘other official activities’ means any activity other than an official control which is performed by competent authorities in accordance with this Regulation in order to ensure the application of the rules laid down in this Regulation;

(20) ‘zootechnical certificate’ means breeding certificates, attestations or commercial documentation which are issued on paper or in electronic form for breeding animals and their germinal products and which provide information on pedigree, identification and, where available, results of performance testing or genetic evaluation;

(21) ‘entering the Union’ or ‘entry into the Union’ means the action of bringing breeding animals and their germinal products into one of the territories listed in Annex VI from outside those territories excluding transit;

(22) ‘trade’ means the action of buying, selling, exchanging or otherwise acquiring or releasing animals or their germinal products within the Union, including within a Member State;

(23) ‘operator’ means any natural or legal person subject to the rules provided for in this Regulation, such as breed societies, breeding operations, third parties that have been designated by breed societies or breeding operations in accordance with Article 27(1)(b), semen collection and storage centres, embryo storage centres, embryo collection or production teams, and breeders;

(24) ‘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;

(25) ‘private undertaking operating in a closed production system’ means a private undertaking with a breeding programme in which participate either no breeders or a restricted number of breeders who are bound to that private undertaking to accept from it the supply of hybrid breeding pigs or to supply hybrid breeding pigs to it;

(26) ‘breeding programme’ means a set of systematic actions, including recording, selection, breeding and exchange of breeding animals and their germinal products, designed and implemented to preserve or enhance desired phenotypic and/or genotypic characteristics in the target breeding population.

Article 3

General zootechnical and genealogical rules for trade in breeding animals and their germinal products, and for their entry into the Union

1. Trade in breeding animals and their germinal products and the entry into the Union of breeding animals and their germinal products shall not be prohibited, restricted or impeded on zootechnical or genealogical grounds other than those grounds resulting from the rules provided for in this Regulation.

2. Breeders of breeding animals, breed societies, breeding operations or breeding bodies shall not be discriminated against on the basis of their country of origin or of the country of origin of their breeding animals or the germinal products thereof.

CHAPTER II

Recognition of breed societies and breeding operations in Member States and approval of breeding programmes

Section 1

Recognition of breed societies and breeding operations

Article 4

Recognition of breed societies and breeding operations

1. In respect of purebred breeding animals, breeders' associations, breeding organisations or public bodies may apply to the competent authorities for recognition as a breed society.

In respect of hybrid breeding pigs, breeders' associations, breeding organisations, private undertakings operating in a closed production system or public bodies may apply to the competent authorities for recognition as a breeding operation.

2. The applications referred to in paragraph 1 shall be in writing, either on paper or in electronic form.

3. The competent authorities shall evaluate the applications referred to in paragraph 1. They shall recognise as a breed society any applicant referred to in the first subparagraph of paragraph 1, and as a breeding operation any applicant referred to in the second subparagraph of paragraph 1 that complies with the following requirements:

(a) it has its head office on the territory of the Member State where the competent authority is located;

(b) it demonstrates in its application that it complies with the requirements set out in Part 1 of Annex I for its breeding programmes in respect of which it intends to apply for approval in accordance with Article 8(3), and, where applicable, Article 12;

(c) its application contains, in respect of each of those intended breeding programmes, a draft version of the breeding programme which is to include the information set out in Part 2 of Annex I, and, additionally in the case of purebred breeding animals of the equine species, in Part 3 of Annex I;

(d) when submitting its application referred to in paragraph 1 of this Article, it submits an application for approval of at least one of those intended breeding programmes, in accordance with Article 8(2).

Article 5

Refusal of recognition of breed societies and breeding operations

1. For the purposes of Article 4(1), where the competent authority intends to refuse to recognise an applicant as a breed society or breeding operation, it shall provide that applicant with a reasoned explanation for doing so. That applicant shall have the right to request that the competent authority reconsider that intended refusal within 60 days from the date of receipt of the reasoned explanation, or earlier where national rules provide for shorter time-limits.

2. Where, in the light of the reconsideration referred to in paragraph 1 the competent authority decides to confirm its refusal, it shall provide the applicant with a reasoned explanation of its decision to refuse recognition within 90 days from its receipt of the applicant's request for reconsideration, or earlier where national rules provide for shorter time-limits. At the same time, the competent authority shall inform the Commission of its decision to refuse recognition and of its reasons for doing so.

Article 6

Submission of modified breeding programmes in cases of refusal and withdrawal of the recognition of breed societies or breeding operations in the absence of approved breeding programmes

1. Where the competent authority which has recognised a breed society or breeding operation in accordance with Article 4(3) refuses to approve a breeding programme submitted by that breed society or breeding operation in accordance with Article 8, that breed society or breeding operation shall have the possibility of submitting a modified version of that breeding programme within 6 months after that refusal.

2. The competent authority shall withdraw recognition from that breed society or breeding operation if, by the end of the period referred to in paragraph 1 of this Article, no modified version of the breeding programme has been submitted and where that breed society or breeding operation has no other breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12.

Article 7

Lists of recognised breed societies and breeding operations

1. Member States shall draw up and keep up to date a list of breed societies and breeding operations that their competent authorities have recognised in accordance with Article 4(3) and which have at least one breeding programme that has been approved in accordance with Article 8(3). Member States shall make that list available to the public.

2. The list provided for in paragraph 1 shall include the following information:

(a) the name, contact details and, where available, the website of the breed society or breeding operation;

(b) for each breed society or breeding operation on that list: (i) in the case of purebred breeding animals, the name of the breed, or, in the case of hybrid breeding pigs, the name of the breed, line or cross, covered by each of its breeding programmes approved in accordance with Article 8(3), and, where the breed society makes use of the derogations referred to in Article 19 or point 2 of Chapter III of Part 1 of Annex II, a reference to those derogations; (ii) the geographical territory where each of its breeding programmes is to be carried out; (iii) in the case of purebred breeding animals of the equine species, where applicable, the name and contact details of the breed society which maintains the breeding book of the origin of the breed; (iv) for each of its breeding programmes, where available, a reference to a website where information on those breeding programmes can be accessed.

3. Member States shall also include in the list provided for in paragraph 2 of this Article any competent authority which carries out a breeding programme in accordance with Article 38.

4. Where the recognition of a breed society or a breeding operation is withdrawn in accordance with point (e) of third subparagraph of Article 47(1) or the approval of a breeding programme is suspended or withdrawn in accordance with point (d) of third subparagraph of Article 47(1), Member States shall, without undue delay, indicate that suspension or withdrawal in the list provided for in paragraph 1 of this Article.

Where, for a period of 24 months, that recognition remains withdrawn or that approval remains suspended or withdrawn, Member States shall definitively remove that breed society, breeding operation or breeding programme from the list provided for in paragraph 1.

5. The Commission shall adopt implementing acts, laying down model forms for the presentation of the information to be included in the list of recognised breed societies and breeding operations provided for in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 62(2).

Section 2

Approval of breeding programmes

Article 8

Approval of breeding programmes carried out by breed societies and breeding operations

1. A breed society or a breeding operation shall submit applications for approval of its breeding programmes to the competent authority which has recognised that breed society or breeding operation in accordance with Article 4(3).

2. The applications referred to in paragraph 1 shall be in writing, either on paper or in electronic form.

3. The competent authority referred to in paragraph 1 shall evaluate those breeding programmes and approve them provided that:

(a) they have one or more of the following aims: (i) in the case of purebred breeding animals: — the improvement of the breed, — the preservation of the breed, — the creation of a new breed, — the reconstruction of a breed; (ii) in the case of hybrid breeding pigs: — the improvement of the breed, line or cross, — the creation of a new breed, line or cross;

(b) they describe in detail the selection and breeding objectives;

(c) they comply with the requirements set out in Part 2 of Annex I, and in addition in the case of purebred breeding animals of the equine species, in Part 3 of Annex I.

4. Breed societies or breeding operations may outsource to a third party specific technical activities related to the management of their breeding programmes, including performance testing and genetic evaluation, provided that:

(a) the breed societies and breeding operations remain responsible to the competent authority for ensuring compliance with the requirements provided for in Parts 2 and 3 of Annex I;

(b) there is no conflict of interests between that third party and the economic activities of breeders who participate in the breeding programme;

(c) that third party fulfils all the necessary requirements to carry out those activities;

(d) those breed societies and breeding operations specify the activities which they intend to outsource and the name and contact details of those third parties in their applications referred to in paragraph 2.

5. Where, for at least 24 months, there are no breeders which have their holdings, on which they keep their breeding animals, located on a given part of the geographical territory that are participating in a breeding programme approved in accordance with paragraph 3, the competent authority referred to in paragraph 1 may require the breed society or breeding operation concerned to adjust the geographical territory of its breeding programme so as not to include that given part.

Article 9

Changes to an approved breeding programme

1. Prior to the implementation of any significant changes relating to the requirements referred to in Article 8(3) in its breeding programme approved in accordance with that provision, a breed society or breeding operation shall notify those changes to the competent authority which has recognised that breed society or breeding operation in accordance with Article 4(3).

2. The notification shall be in writing, either on paper or in electronic form.

3. Unless that competent authority indicates otherwise within a period of 90 days from the date of notification, those changes shall be considered to have been approved.

4. Breed societies and breeding operations shall inform in a transparent and timely manner the breeders participating in their breeding programmes of the changes in their breeding programme that have been approved in accordance with paragraph 3.

Article 10

Derogations from Article 8(3) concerning the approval of breeding programmes

1. By way of derogation from Article 8(3), the competent authority which has recognised a breed society in accordance with Article 4(3) may refuse to approve a breeding programme of that breed society that complies with the requirements set out in Part 2 of Annex I, and additionally in the case of purebred breeding animals of the equine species, in Part 3 of Annex I, on the grounds that that breeding programme would compromise the breeding programme carried out by another breed society for the same breed which has already been approved in that Member State as regards at least one of the following:

(a) the essential traits of the breed characteristics or the main objectives of that breeding programme;

(b) the preservation of that breed or of the genetic diversity within that breed; or

(c) where the aim of that breeding programme is the preservation of that breed, the effective implementation of that breeding programme: (i) in the case of an endangered breed; or (ii) in the case of an autochthonous breed which is not commonly found in one or more of the territories of the Union.

2. For the purpose of paragraph 1, the competent authority shall take due account of the following:

(a) the number of breeding programmes already approved for that breed in that Member State;

(b) the size of the breeding populations covered by those breeding programmes;

(c) the possible genetic input from breeding programmes carried out by other breed societies for the same breed in other Member States or by breeding bodies in third countries.

Article 11

Refusal of the approval of breeding programmes

Where the competent authority which has recognised a breed society or breeding operation in accordance with Article 4(3) refuses to approve a breeding programme submitted by such breed society or breeding operation in accordance with Article 8(1) or refuses to approve changes to a breeding programme notified in accordance with Article 9(1), it shall provide that breed society or breeding operation with a reasoned explanation for its refusal.

Article 12

Notification and approval of breeding programmes carried out in Member States other than the Member State in which the breed society or breeding operation is recognised

1. Where a breed society or a breeding operation intends to carry out a breeding programme approved in accordance with Article 8(3) also on breeding animals kept in a Member State other than the Member State where that breed society or breeding operation is recognised in accordance with Article 4(3) (for the purpose of this Article, ‘that other Member State’), that breed society or breeding operation shall notify the intended extension of its geographical territory to the competent authority which has recognised that breed society or breeding operation in accordance with Article 4(3).

2. The competent authority which has recognised that breed society or breeding operation in accordance with Article 4(3) shall:

(a) notify the competent authority of that other Member State at least 90 days before the intended commencement date of the breeding programme in that other Member State, and, at the request of the notified authority, provide a translation of that notification in one of the official languages of that other Member State;

(b) at the request of the notified authority, provide, at least 60 days before the intended commencement date of the breeding programme in that other Member State, a copy of the breeding programme as approved in accordance with Article 8(3) accompanied, if requested by that authority, by a translation into one of the official languages of that other Member State which shall be provided by the applying breed society or breeding operation.

3. The competent authority of that other Member State may, within 90 days from the date of receipt of the notification referred to in point (a) of paragraph 2, refuse to approve the carrying out on its territory of the breeding programme, where:

(a) an approved breeding programme is already being carried out in that other Member State on purebred breeding animals of the same breed; and

(b) the approval of a further breeding programme would compromise the breeding programme carried out by another breed society for the same breed which has already been approved in that other Member State as regards at least one of the following: (i) the essential traits of the breed characteristics or the main objectives of that breeding programme; (ii) the preservation of that breed or of the genetic diversity within that breed; (iii) where the aim of that breeding programme is the preservation of that breed, the effective implementation of that breeding programme: — in the case of an endangered breed, or — in the case of an autochthonous breed which is not commonly found in one or more of the territories of the Union.

4. The competent authority of that other Member State shall inform the competent authority which has recognised the breed society or breeding operation in accordance with Article 4(3) about the result of the notification provided for in paragraph 1 of this Article and, where it refuses the approval for the carrying out on its territory of the breeding programme, shall provide a reasoned explanation for its refusal.

5. Failure by the competent authority of that other Member State to reply to the notification referred to in point (a) of paragraph 2 within 90 days from the date of receipt of that notification shall constitute approval.

6. The competent authority which has recognised the breed society or breeding operation in accordance with Article 4(3) shall inform the breed society or breeding operation of the result of the notification provided for in point (a) of paragraph 2 of this Article without undue delay and, in the case of refusal, shall provide that breed society or breeding operation with the reasoned explanation for that refusal referred to in paragraph 4 of this Article.

7. Where the competent authority of that other Member State refuses the approval in accordance with paragraph 3, it shall inform the Commission of its refusal together with a statement of reasons for that refusal.

8. Where the competent authority of that other Member State refuses the approval in accordance with paragraph 3 of this Article and the breed society or breeding operation which intends to carry out that breeding programme in that other Member State requests reconsideration of that refusal, the competent authority of that other Member State and the competent authority which has recognised the breed society or breeding operation in accordance with Article 4(3) shall cooperate with each other with regard to that request for reconsideration.

9. The competent authority which has recognised the breed society or breeding operation in accordance with Article 4(3) shall inform the competent authority of that other Member State of the changes in breeding programmes approved in accordance with Article 9(3).

10. At the request of the competent authority of that other Member State, the breed society or breeding operation operating in accordance with this Article on the territory of that other Member State shall provide up-to-date information to that competent authority in particular with regard to the number of breeders and breeding animals on which the breeding programme is carried out on that territory. Any such request shall be made in the same manner as requests to the breed societies or breeding operations recognised in that other Member State.

11. The competent authority of that other Member State may withdraw the approval of the breeding programme provided for in this Article, where, for at least 12 months, no breeder on the territory of that other Member State participates in that breeding programme.

CHAPTER III

Rights and obligations of breeders, breed societies and breeding operations

Article 13

Rights of breeders participating in breeding programmes approved in accordance with Article 8(3), and, where applicable, Article 12

1. Breeders shall have the right to participate in a breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12 provided that:

(a) their breeding animals are kept on holdings located within the geographical territory of that breeding programme;

(b) their breeding animals belong, in the case of purebred breeding animals, to the breed, or, in the case of hybrid breeding pigs, to the breed, line or cross, covered by that breeding programme.

2. Breeders participating in a breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12 shall have the right:

(a) to have their purebred breeding animals entered in the main section of the breeding book established for the breed by the breed society in accordance with Articles 18 and 20;

(b) to have their animals recorded in a supplementary section of the breeding book established for the breed by the breed society in accordance with Article 20;

(c) to have their hybrid breeding pigs registered in a breeding register established for the breed, line or cross by a breeding operation in accordance with Article 23;

(d) to participate in performance testing and genetic evaluation in accordance with Article 25;

(e) to be provided with a zootechnical certificate in accordance with Article 30(1) and (4);

(f) on request, to be provided, with up-to-date results of the performance testing and genetic evaluation for their breeding animals, where those results are available;

(g) to have access to all the other services provided in relation to that breeding programme to the participating breeders by the breed society or breeding operation carrying out that breeding programme.

3. In addition to the rights laid down in paragraphs 1 and 2, where the rules of a breed society or breeding operation provide for membership, the breeders referred to in paragraph 1 shall also have the right:

(a) to become a member of that breed society or breeding operation;

(b) to participate in the defining and development of the breeding programme in accordance with the rules of procedure referred to in point B(1)(b) of Part 1 of Annex I.

Article 14

Rights and obligations of breed societies and breeding operations

1. As regards their breeding programmes approved in accordance with Article 8(3), and, where applicable, Article 12, breed societies and breeding operations shall have the right to define and carry out such breeding programmes autonomously, provided that they comply with this Regulation and any conditions of their approval.

2. Breed societies or breeding operations shall have the right to exclude breeders from participating in a breeding programme where those breeders fail to comply with the rules of that breeding programme or with the obligations set out in the rules of procedure referred to in point B(1)(b) of Part 1 of Annex I.

3. In addition to the right referred to in paragraph 2, breed societies and breeding operations which provide for membership shall have the right to exclude breeders from membership where those breeders fail to comply with their obligations set out in the rules of procedure referred to in point B(1)(b) of Part 1 of Annex I.

4. Breed societies and breeding operations shall, without prejudice to the role of the courts, have a responsibility to settle disputes that may arise between breeders, and between breeders and the breed society or breeding operation, in the process of carrying out breeding programmes approved in accordance with Article 8(3), and, where applicable, Article 12, in accordance with the rules of procedure referred to in point B(1)(b) of Part 1 of Annex I.

CHAPTER IV

Entry of breeding animals in breeding books and breeding registers and acceptance for breeding

Section 1

Entry of purebred breeding animals in breeding books and acceptance for breeding

Article 15

Structure of breeding books

Breeding books shall consist of a main section and, where specified in the breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12, one or more supplementary sections.

Article 16

Main section of breeding books

1. Where different criteria or procedures are established by breed societies for entering purebred breeding animals in different classes, those breed societies may divide the main section of breeding books into classes:

(a) according to the merits of those animals and subdivide those classes according to their age or gender; or

(b) according to the age or gender of those animals, provided that those classes are also subdivided according to their merits.

Those criteria and procedures may require that the purebred breeding animal undergo the performance testing or genetic evaluation provided for in Article 25 or any other assessment described in the breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12 prior to it being entered in a specific class of the main section.

2. Where the breeding programme establishes conditions for entry in the main section of the breeding book in addition to those set out in Chapter I of Part 1 of Annex II, the breed society carrying out that breeding programme shall establish, in that main section, at least one class for purebred breeding animals that fulfil only the conditions of Chapter I of Part 1 of Annex II and Article 21 to be entered, on application by the breeder.

Article 17

Supplementary sections of breeding books

Breed societies may establish one or more supplementary sections in the breeding book for animals of the same species that are not eligible for entry in the main section, provided that the rules set out in the breeding programme allow the progeny of those animals to be entered in the main section in accordance with the rules set out:

(a) in the case of female animals of the bovine, porcine, ovine and caprine species, in point 1(a) of Chapter III of Part 1 of Annex II;

(b) in the case of animals of endangered breeds of the bovine, porcine, ovine and caprine species or of ‘hardy’ sheep breeds, in point 2 of Chapter III of Part 1 of Annex II; or

(c) in the case of male and female animals of the equine species, in point 1(b) of Chapter III of Part 1 of Annex II.

Article 18

Entry of purebred breeding animals in the main section of the breeding book

1. Breed societies shall, at the request of breeders, enter or register for entry in the main section of their breeding book any purebred breeding animals of the breed covered by their breeding programme, provided that those animals comply with the requirements set out in Chapter I of Part 1 of Annex II and, where applicable, that those animals are the offspring of breeding animals or result from the germinal products thereof, in accordance with the rules provided for in Article 21.

2. Breed societies shall not refuse the entry in the main section of their breeding books of a purebred breeding animal on the grounds that it has already been entered in the main section of a breeding book of the same breed or, in the case of a cross-breeding programme carried out on purebred breeding animals of the equine species, of a different breed established by another breed society recognised in accordance with Article 4(3) or by a breeding body in a third country included in the list provided for in Article 34.

3. Where the main section of the breeding book is divided into classes, purebred breeding animals meeting the criteria for entry in the main section shall be entered by the breed society in the class that corresponds to the merits of those purebred breeding animals.

Article 19

Derogations from the requirements for the entry of animals in the main section of breeding books in the case of the creation of a new breed or the reconstruction of a breed

1. By way of derogation from Article 18(1), where a breed society carries out a breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12, for a breed for which no breeding book exists in any Member State or third country included in the list provided for in Article 34, that breed society may enter in the main section of that newly established breeding book, purebred breeding animals or descendants from purebred breeding animals of different breeds or any animal which is judged by the breed society to conform to the characteristics of that new breed and, where applicable, fulfils the minimum performance requirements laid down in the breeding programme.

Breed societies making use of this derogation shall:

(a) set in their breeding programme a period for the establishment of the new breeding book that is appropriate for the generation interval of the species or the breed concerned;

(b) make reference to any existing breeding book in which the purebred breeding animals or their parents have been entered for the first time after birth, together with the original registration number in that breeding book;

(c) in their system for recording pedigrees, identify the animals which are considered by them to be the breed's foundation stock.

2. Where a breed society intends to reconstruct a breed that has disappeared or that is in serious danger of disappearing, a Member State, or, if it so decides, the competent authority, may authorise the breed society to enter, in the main section of the breeding book, descendants of purebred breeding animals of the breed to be reconstructed or purebred breeding animals or descendants from purebred breeding animals of other breeds which enter in the reconstruction of that breed or any animal which is judged by the breed society to conform to the characteristics of the breed to be reconstructed and which, where applicable, fulfil the minimum performance requirements laid down in the breeding programme provided that:

(a) a period for the establishment or re-establishment of that breeding book, appropriate for the breed concerned, is set in the breeding programme;

(b) where applicable, reference is made to any breeding book in which those purebred breeding animals or ascendants have been entered together with the original registration number in that breeding book;

(c) the animals which are considered by that breed society to be the breed's reconstruction stock are identified in the system for recording pedigrees.

3. A breed society seeking to avail itself of the derogation referred to in paragraph 1 of this Article or the derogation referred to in paragraph 2 of this Article shall lay down a detailed plan for the creation or reconstruction of the breed in its breeding programme referred to in Article 8(1).

4. By the end of the periods referred to in point (a) of paragraph 1 of this Article and point (a) of paragraph 2 of this Article, the competent authority shall carry out an official control as provided for in Article 43.

5. Where a breed is being created or reconstructed in accordance with this Article, Member States shall make that information publicly available by including an indication to that effect in the list provided for in Article 7.

Article 20

Recording of animals in supplementary sections and upgrading of their offspring to the main section

1. Where supplementary sections are established by a breed society in accordance with Article 17, that breed society shall, on application by breeders, record in the appropriate supplementary sections provided for in Article 17 animals of the species covered by its breeding programme that are not eligible for entry in the main section, provided that those animals meet the conditions set out in Chapter II of Part 1 of Annex II.

2. Breed societies shall, on application by breeders, enter the progeny of the animals referred to in paragraph 1 of this Article in the main section provided for in Article 16 and shall regard that progeny as purebred breeding animals, provided that that progeny meets the conditions set out in Chapter III of Part 1 of Annex II.

Article 21

Acceptance of purebred breeding animals and their germinal products for breeding

1. A breed society carrying out a breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12 for a breed shall accept:

(a) for natural service, any purebred breeding animal of that breed;

(b) for artificial insemination, semen collected from purebred breeding animals of the bovine species which have undergone genetic evaluation in accordance with Article 25;

(c) for artificial insemination, semen collected from purebred breeding animals of the porcine, ovine or caprine species which have undergone performance testing or genetic evaluation in accordance with Article 25;

(d) for artificial insemination, semen collected from purebred breeding animals of the equine species which have undergone, where required by the breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12, performance testing or genetic evaluation in accordance with Article 25;

(e) for embryo transfer, oocytes collected and used for in vitro production of embryos and in vivo derived embryos conceived by use of semen referred to in point (b) or (c) of this paragraph, provided that those oocytes and embryos have been collected from purebred breeding animals of the bovine, porcine, ovine or caprine species which have undergone performance testing or genetic evaluation in accordance with Article 25;

(f) for embryo transfer, oocytes collected and used for in vitro production of embryos and in vivo derived embryos conceived by use of semen referred to in point (d) of this paragraph, provided that those oocytes and embryos have been collected from purebred breeding animals of the equine species which have undergone, where required by the breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12, performance testing or genetic evaluation in accordance with Article 25;

(g) for testing of male purebred breeding animals of the bovine, porcine, ovine and caprine species, semen collected from purebred breeding animals which have not undergone performance testing or genetic evaluation provided that that semen is solely used for the purpose of testing those male purebred breeding animals within the quantity limits necessary to enable that breed society to carry out such tests in accordance with Article 25.

2. In the case of purebred breeding animals of the equine species, by way of derogation from paragraph 1 of this Article, a breed society may prohibit or limit the use of one or more reproduction techniques referred to in that paragraph or the use of purebred breeding animals for one or more of those reproduction techniques, including the use of their germinal products, provided that that prohibition or limitation is specified in its breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12.

Any such prohibition or limitation that is specified in the breeding programme of the breed society which has established the breeding book of the origin of the breed in accordance with point 3(a) of Part 3 of Annex I shall be binding for the breeding programmes of the breed societies that establish filial breeding books for the same breed in accordance with point 3(b) of Part 3 of Annex I.

3. In the case of an endangered breed, a breed society may prohibit or restrict the use of a purebred breeding animal of that breed, including the use of its germinal products, where that use would compromise the preservation or the genetic diversity of that breed.

4. Semen referred to in point (g) of paragraph 1 collected from male purebred breeding animals which are entered in the main section of a breeding book established by a breed society carrying out a breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12, shall be accepted by another breed society carrying out an approved breeding programme on the same breed in the same or another Member State under the same conditions and quantity limits for performance testing and, where applicable, genetic evaluation as those applied to its own male purebred breeding animals.

5. For the purpose of paragraphs 1 and 4, the germinal products of purebred breeding animals referred to in those paragraphs shall be collected, produced, processed and stored at a semen collection or storage centre, or by an embryo collection or production team, approved for intra-Union trade in these commodities in accordance with Union animal health law.

6. By way of derogation from paragraph 5, a Member State may authorise the collection, production, processing and storage for use within the territory of that Member State of germinal products of purebred breeding animals at a semen collection or storage centre, at an embryo storage centre, by an embryo collection or production team or by specifically qualified staff, approved in accord