29.6.2016   

EN

Official Journal of the European Union

L 171/66

(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,

(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.

(1)

‘animal’ means a domestic animal of:

(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:

(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:

(11)

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

(12)

‘breeding book’ means:

(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:

(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.

(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).

(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:

(a)

they have one or more of the following aims:

(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.

(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.

(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:

(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.

(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.

(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:

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(a)

for natural service, any hybrid breeding pig of the same breed, line or cross as defined in that breeding programme;

(b)

for artificial insemination, semen collected from hybrid breeding pigs 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;

(c)

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), provided that those oocytes and embryos have been collected from hybrid breeding pigs 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;

(d)

for the testing of male hybrid breeding pigs, semen collected from those hybrid breeding pigs which have not undergone performance testing or genetic evaluation, provided that that semen is solely used for the purpose of testing of those hybrid breeding pigs within the quantity limits necessary for that breeding operation to carry out such tests in accordance with Article 25.

(a)

in the case of purebred breeding animals of the bovine, porcine, ovine and caprine species and in the case of hybrid breeding pigs, Annex III;

(b)

in the case of purebred breeding animals of the equine species, the breeding programme carried out by that breed society as approved in accordance with Article 8(3), and, where applicable, Article 12.

(a)

scientific advances;

(b)

technical developments; or

(c)

the needs to preserve valuable genetic resources.

(a)

carry out that performance testing or genetic evaluation themselves; or

(b)

designate the third parties to which that performance testing or genetic evaluation is to be outsourced.

(a)

the facilities and equipment necessary to carry out that performance testing or genetic evaluation;

(b)

suitably qualified staff; and

(c)

the capability to carry out that performance testing or genetic evaluation in accordance with Article 25.

(a)

records of all data resulting from performance testing and genetic evaluation in relation to breeding animals from holdings located on the territory where that competent authority operates;

(b)

details of the recording methods for traits;

(c)

details of the model of performance description used for the analysis of the results of performance testing;

(d)

details of the statistical methods used for the analysis of the results of performance testing for each evaluated trait;

(e)

details of the genetic parameters used for each evaluated trait, including, where applicable, details of the genomic evaluation.

(a)

comply with the requirements set out in point 1 of Annex IV; and

(b)

be responsible for the tasks:

if those tasks are included in the reference centres' annual or multiannual work programmes established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014.

(a)

the requirements for European Union reference centres set out in point 1 of Annex IV;

(b)

the tasks of European Union reference centres set out in points 2 and 3 of Annex IV.

(a)

the species of purebred breeding animals for which the methods of performance testing and genetic evaluation are to be harmonised or improved and the scientific and technical advances in the area of performance testing or genetic evaluation; or

(b)

the endangered breeds for which methods for the preservation of those breeds or the preservation of the genetic diversity within those breeds are to be established or harmonised and the scientific and technical advances in those areas.

(a)

they comply with the requirements set out in point 1 of Annex IV;

(b)

they fulfil the tasks:

(a)

breed societies or breeding operations carrying out breeding programmes approved in accordance with Article 8, and, where applicable, Article 12, on those breeding animals;

(b)

the competent authorities referred to in Article 8(3), or, where applicable, Article 12(2)(a), if those authorities so decide; or

(c)

breeding bodies included in the list provided for in Article 34 carrying out breeding programmes on those breeding animals.

(a)

contain the information set out in the relevant Parts and Chapters of Annex V;

(b)

comply with the corresponding model forms of zootechnical certificates provided for in the implementing acts adopted pursuant to paragraph 10.

(a)

results of that performance testing;

(b)

up-to-date results of that genetic evaluation; and

(c)

genetic defects and genetic peculiarities in relation to that breeding programme affecting that breeding animal or the donors of those germinal products.

(a)

results of that performance testing;

(b)

up-to-date results of that genetic evaluation; and

(c)

genetic defects and genetic peculiarities in relation to that breeding programme affecting that breeding animal or the donors of those germinal products.

(a)

scientific advances;

(b)

technical developments;

(c)

the functioning of the internal market; or

(d)

the needs to preserve valuable genetic resources.

(a)

in the case of breeding animals of the bovine, porcine, ovine and caprine species, the information set out in Chapter I of Part 2 of Annex V or Chapter I of Part 3 of Annex V is contained in other documents accompanying those breeding animals, issued by the breed society or breeding operation;

(b)

in the case of germinal products of the bovine, porcine, ovine, caprine and equine species:

(a)

the information set out in the relevant Parts and Chapters of Annex V is contained in other documents accompanying the breeding animal or their germinal products;

(b)

the breeding body carrying out the breeding programme, or another operator referred to in paragraph 1, provides an exhaustive list of those documents, declares that the information set out in the relevant Parts and Chapters of Annex V is contained in those documents and certifies the content of those documents.

(a)

it carries out a breeding programme that is equivalent to breeding programmes approved in accordance with Article 8(3) carried out by breed societies on the same breed, or carried out by breeding operations on the same breed, line or cross, as regards:

(b)

it is supervised or controlled by an official service in that third country;

(c)

it has adopted rules of procedure to ensure that breeding animals entered in breeding books by breed societies or registered in breeding registers by breeding operations, and the offspring produced from germinal products of such breeding animals, are entered or eligible for entry without discrimination on account of their country of origin, in the case of purebred breeding animals, in the breeding book of the same breed, or, in the case of hybrid breeding pigs, in the breeding register of the same breed, line or cross, maintained by that breeding body.

(a)

the recognition of breed societies and breeding operations provided for in Article 4;

(b)

the approval of breeding programmes of breed societies and breeding operations provided for in Article 8;

(c)

the entry of purebred breeding animals in breeding books and the registration of hybrid breeding pigs in breeding registers provided for in Articles 18, 20 and 23;

(d)

the acceptance of breeding animals for breeding provided for in Articles 21, 22 and 24;

(e)

the use of germinal products of breeding animals for testing and breeding provided for in Articles 21 and 24;

(f)

the performance testing and genetic evaluation provided for in Article 25;

(g)

the official controls on operators provided for in Article 43.

(a)

a thorough examination of the information and data provided by the third country which is seeking to have its measures recognised as equivalent to those required by this Regulation;

(b)

where appropriate, the satisfactory outcome of a control performed by the Commission in accordance with Article 57.

(a)

the format and content of the zootechnical certificates accompanying those breeding animals or the germinal products thereof;

(b)

specific requirements applicable to the entry into the Union of those breeding animals or the germinal products thereof and the official controls to be performed on those breeding animals or on the germinal products thereof upon entry into the Union;

(c)

where necessary, procedures for drawing up and amending lists of breeding bodies, located in the third country concerned, from which the entry into the Union of breeding animals and the germinal products thereof is permitted.

(a)

that breeding animal or the donors of those germinal products are entered in a breeding book or registered in a breeding register maintained by a breeding body in the third country of dispatch;

(b)

those germinal products meet the conditions laid down in Article 21(1) or (2), where that is a requirement of the breeding programme carried out by that breed society or that breeding operation;

(c)

that breeding animal meets the characteristics of the breed or, in the case of a hybrid breeding pig, the characteristics of the breed, line or cross set out in the breeding programme carried out by that breed society or breeding operation;

(d)

the breeding body referred to in point (a) is included in the list of breeding bodies provided for in Article 34.

(a)

those animals shall be accompanied by:

(b)

checks shall be carried out on that consignment at the border inspection post in which the documentary, identity and physical checks referred to in Article 4 of Directive 91/496/EEC are carried out.

(a)

the consignment is accompanied by the documents referred to in point (a) of paragraph 1;

(b)

the content and the labelling of the consignment correspond to the information provided in the documents referred to in point (a) of paragraph 1.

(a)

there is a need to maintain that breed or to establish that breed in the Member State or territory where that competent authority operates; or

(b)

that breed is an endangered breed.

(a)

for breeding organisations, breeders' associations or public bodies to be recognised as breed societies in accordance with Article 4(3);

(b)

for breed societies to have their breeding programmes approved in accordance with Article 8(3), and, where applicable, Article 12.

(a)

have sufficient and qualified staff and adequate facilities and equipment to implement efficiently that breeding programme;

(b)

be capable of carrying out the checks necessary for recording pedigrees of the purebred breeding animals covered by that breeding programme;

(c)

have a sufficiently large population of purebred breeding animals and a sufficient number of breeders within the geographical territory covered by that breeding programme;

(d)

be capable of generating, or have had generated for them, and be capable of using data collected on purebred breeding animals necessary for carrying out that breeding programme;

(e)

have adopted rules of procedure:

(a)

information on its aim which is to be the preservation of the breed, the improvement of the breed, the creation of a new breed or the reconstruction of a breed, or any combination thereof;

(b)

the name of the breed covered by that breeding programme to prevent confusion with similar purebred breeding animals of other breeds entered in other existing breeding books;

(c)

the detailed characteristics of the breed, including an indication of the essential traits, covered by that breeding programme;

(d)

information on the geographical territory where it is carried out;

(e)

information on the system for identifying purebred breeding animals which is to ensure that purebred breeding animals are only entered in the breeding book when they are identified individually and in accordance with Union animal health law on the identification and registration of animals of the species concerned;

(f)

information on the system for recording pedigrees of purebred breeding animals entered or registered and eligible for entry in breeding books;

(g)

the selection and breeding objectives of the breeding programme, including an indication of the main objectives of that breeding programme, and, where applicable, the detailed evaluation criteria related to those objectives for the selection of purebred breeding animals;

(h)

where the breeding programme requires performance testing or genetic evaluation:

(i)

where supplementary sections are established, as provided for in Article 17, or where the main section is subdivided into classes, as provided for in Article 16, the rules for the division of the breeding book and the criteria or procedures applied for recording animals in those sections or classifying them in those classes;

(j)

where in the case of purebred breeding animals of the equine species, the breeding programme prohibits or limits the use of one or more reproduction techniques or the use of purebred breeding animals for one or more reproduction techniques as referred to in Article 21(2), information on such prohibitions or limitations;

(k)

where the competent authority outsources specific technical activities related to the management of its breeding programme to third parties, information on those activities and the name and contact details of the designated third parties.

(a)

draw up and keep up to date a list of the competent authorities it has designated in accordance with paragraph 1, including their contact details;

(b)

specify in the list provided for in point (a) the address to which the following is to be sent:

(c)

make the list referred to in point (a) available to the public on a website and notify that website to the Commission.

(a)

have procedures or arrangements, or both, in place to ensure and verify the effectiveness, appropriateness, impartiality, quality and consistency of the official controls and of the other official activities that they perform;

(b)

have procedures or arrangements, or both, in place to ensure that their staff performing official controls and other official activities are free from any conflict of interest as regards the operators in respect of which they perform those official controls and other official activities;

(c)

have, or have access to, a sufficient number of suitably qualified, trained and experienced staff so that official controls and other official activities can be performed efficiently and effectively;

(d)

have appropriate and properly maintained facilities and equipment to ensure that their staff can perform official controls and other official activities efficiently and effectively;

(e)

have the legal powers to perform official controls and other official activities and to take the action provided for in this Regulation;

(f)

have legal procedures in place in order to ensure that their staff have access to the premises of, and documents and computerised information management systems kept by, operators so as to be able to carry out their tasks properly.

(a)

the purpose of official controls or investigations;

(b)

the protection of commercial interests of an operator or any other natural or legal person;

(c)

the protection of court proceedings and legal advice.

(a)

the risk of non-compliance with the rules provided for in this Regulation;

(b)

the past records of operators as regards the results of official controls performed in their respect and their compliance with the rules provided for in this Regulation;

(c)

the reliability and results of self-checks performed by the operators, or by third parties at their request, for the purpose of verifying compliance with the rules provided for in this Regulation;

(d)

any information that might indicate non-compliance with the rules provided for in this Regulation.

(a)

originate in the Member State where the official controls are performed or in another Member State; or

(b)

are entering the Union.

(a)

a description of the purpose of the official control;

(b)

the control methods applied;

(c)

the results of the official control;

(d)

where appropriate, action that the competent authorities require the operators to take as a result of the official control.

(a)

their equipment, premises and other places under their control;

(b)

their computerised information management systems;

(c)

their breeding animals and the germinal products thereof under their control;

(d)

their documents and any other relevant information.

(a)

take any action necessary to determine the origin and extent of that non-compliance and to establish the responsibilities of the operators concerned;

(b)

take appropriate measures to ensure that the operators concerned remedy the non-compliance and prevent further occurrences of it.

(a)

order that the breed society postpones the entry in breeding books of purebred breeding animals or that the breeding operation postpones the registration in breeding registers of hybrid breeding pigs;

(b)

order that the breeding animals or their germinal products shall not be used for breeding in accordance with this Regulation;

(c)

suspend the issuing of zootechnical certificates by the breed society or the breeding operation;

(d)

suspend or withdraw the approval of a breeding programme carried out by a breed society or breeding operation, where the activities of that breed society or breeding operation repeatedly, continuously or generally fail to comply with the requirements of the breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12;

(e)

withdraw the recognition of the breed society or breeding operation granted in accordance with Article 4(3), where that breed society or breeding operation repeatedly, continuously or generally fails to comply with the requirements referred to in Article 4(3);

(f)

take any other measures that they deem to be appropriate to ensure compliance with the rules provided for in this Regulation.

(a)

a written notification of their decision concerning the action or measure to be taken in accordance with paragraph 1, together with the reasons for that decision;

(b)

information on any right of appeal against such decisions, and on the applicable procedure and time limits.

(a)

the reasoned request by a competent authority of a Member State (‘requesting competent authority’) for information from a competent authority of another Member State (‘requested competent authority’) that is needed in order to perform official controls or to follow them up;

(b)

in the case of a non-compliance which might have implications in other Member States, the notification of the competent authorities of those other Member States by the competent authority aware of the non-compliance;

(c)

the provision, by the requested competent authority, of necessary information and documents to the requesting competent authority, without undue delay when the relevant information and documents become available;

(d)

the performance of investigations or official controls by the requested competent authority that are necessary to:

(e)

by agreement between the competent authorities concerned, participation by a competent authority of a Member State in on-the-spot official controls that the competent authorities of another Member State perform.

(a)

applicable to the release of documents that are the object of, or related to, judicial proceedings;

(b)

aimed at the protection of commercial interests vested in natural or legal persons.

(a)

notify such information to the competent authorities of the other Member States known to be concerned by that non-compliance;

(b)

where such information is or might be relevant at Union level, communicate such information to the Commission.

(a)

the competent authorities which have provided the information consent to such communication;

(b)

relevant Union and national rules applicable to the communication of personal data to third countries are complied with.

(a)

information available to the Commission indicates the existence of activities that are, or appear to be, non-compliant with the rules provided for in this Regulation and that concern more than one Member State;

(b)

the competent authorities in the Member States concerned are unable to agree on appropriate actions to address the non-compliance with the rules provided for in this Regulation.

(a)

request that the competent authorities of the Member States concerned by the activities that are, or appear to be, non-compliant with the rules provided for in this Regulation, provide it with a report on the measures that they have taken;

(b)

in collaboration with the Member States concerned by the activities that are, or appear to be, non-compliant with the rules provided for in this Regulation, send an inspection team to perform an on-the-spot Commission control;

(c)

request that the competent authorities of the Member State of dispatch and, where appropriate, in other Member States concerned, appropriately intensify their official controls and provide it with a report on the measures that they have taken;

(d)

submit information concerning such cases to the Committee referred to in Article 62(1), together with a proposal for measures to remedy the cases of non-compliance referred to in point (a) of paragraph 1 of this Article;

(e)

take any other appropriate measures.

(a)

verify the application of the rules provided for in this Regulation;

(b)

verify enforcement practices and the functioning of official control systems and of the competent authorities which operate them;

(c)

investigate and collect information:

(a)

prepare a draft report on the findings and on the recommendations addressing the shortcomings identified by its experts during the controls provided for in Article 53(1);

(b)

send to the Member State where those controls were performed a copy of the draft report referred to in point (a) for its comments;

(c)

take the comments of the Member State referred to in point (b) of this paragraph into account in preparing the final report on the findings resulting from the controls provided for in Article 53(1) performed by its experts in that Member State;

(d)

make publicly available the final report referred to in point (c) and the comments of the Member State referred to in point (b).

(a)

at the request of the Commission experts, provide the necessary technical assistance and the available documentation and other technical support to enable those experts to perform the controls referred to in Article 53(1) efficiently and effectively;

(b)

provide necessary assistance to ensure that Commission experts have access to all premises, including parts thereof, and to other places, to equipment and to information, including computerised information management systems, as well as, where appropriate, to breeding animals and the germinal products thereof, necessary to perform the controls referred to in Article 53(1).

(a)

special conditions for, or a prohibition on, trade in the breeding animals or the germinal products thereof concerned by the disruption in the official control system;

(b)

any other appropriate temporary measures.

(a)

verify the compliance or equivalence of the third country's legislation and systems with the requirements laid down in this Regulation;

(b)

verify the capacity of the third country's control system to ensure that consignments of breeding animals and the germinal products thereof entering into the Union comply with relevant requirements in Chapter VIII of this Regulation;

(c)

collect information and data to elucidate the causes of recurring or emerging problems in relation to breeding animals and their germinal products from the third country entering into the Union.

(a)

the zootechnical and genealogical legislation of the third country concerning breeding animals and their germinal products;

(b)

the organisation of the competent authorities of the third country, their powers and independence, the supervision to which they are subject and the authority they have to enforce the applicable legislation effectively;

(c)

the training of the staff in the third country responsible for the performance of the controls on, or the supervision of, breeding bodies;

(d)

the resources that are available to the competent authorities of the third country;

(e)

the existence and operation of documented control procedures and control systems based on priorities;

(f)

the extent and operation of controls performed by the competent authorities of the third country on breeding animals and their germinal products arriving from other third countries;

(g)

the assurances which the third country is able to give regarding compliance with, or equivalence to, the requirements laid down in this Regulation.

(a)

the principles and objectives of the rules provided for in this Regulation;

(b)

the volume and nature of breeding animals and the germinal products thereof entering the Union from that third country;

(c)

the results of controls referred to in Article 57(1) that have already been performed;

(d)

the results of official controls on breeding animals and the germinal products thereof entering the Union from the third country and of any other official controls performed by the competent authorities of Member States;

(e)

any other information that the Commission deems to be appropriate.

(a)

the information referred to in Article 34(2) or in Article 35(2)(a);

(b)

where appropriate and necessary, the written records on the controls performed by the competent authorities of that third country.

(a)

prohibiting the entry into the Union, as breeding animals, or the germinal products thereof, of animals, or their semen, oocytes or embryos originating from that third country;

(b)

prohibiting the entry in breeding books maintained by breed societies or the registration in breeding registers maintained by breeding operations of breeding animals, and the offspring produced from the germinal products thereof, originating from that third country.

(a)

delete that third country or the breeding bodies of that third country from the list provided for in Article 34(1);

(b)

take any other appropriate measures.

(a)

the information collected in accordance with Article 58(2);

(b)

any other information that the third country concerned by the non-compliance referred to in paragraph 1 has provided;

(c)

where necessary, the results of controls referred to in Article 57(1).

(1)

the heading is replaced by the following:

‘European Union reference laboratories and centres’;

(2)

paragraph 1 is replaced by the following:

‘1.   Grants may be awarded to the European Union reference laboratories referred to in Article 32 of Regulation (EC) No 882/2004 and to the European Union reference centres referred to in Article 29 of Regulation (EU) 2016/1012 of the European Parliament and of the Council (*) for the costs that they incur in implementing the work programmes approved by the Commission.

(*)  Regulation (EU) 2016/1012 of the European Parliament and of the Council of 8 June 2016 on zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of purebred breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and 90/425/EEC and repealing certain acts in the area of animal breeding (“Animal Breeding Regulation”) (OJ L 171, 29.6.2016, p. 66).’;"

(3)

in paragraph 2, point (a) is replaced by the following:

(1)

the title is replaced by the following:

‘Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary matters’;

(2)

Article 1 is replaced by the following:

‘Article 1

The Directive lays down the ways in which the competent authorities responsible in the Member States for monitoring legislation on veterinary matters shall cooperate with those in the other Member States and with the relevant Commission departments in order to ensure compliance with such legislation.’;

(3)

in Article 2(1), the second indent is deleted;

(4)

in Article 4(1), the first indent is replaced by the following:

(5)

Article 5(1) is replaced by the following:

‘1.   At the request of the applicant authority, the requested authority shall, while observing the rules in force in the Member State in which it is situated, notify the applicant authority or have it notified of all instruments or decisions which emanate from the competent authorities and concern the application of legislation on veterinary matters.’;

(6)

Article 7 is replaced by the following:

‘Article 7

At the request of the applicant authority, the requested authority shall supply to it any relevant information in its possession or which it obtains in accordance with Article 4(2), in particular in the form of reports and other documents or certified copies of or extracts from such reports or documents, concerning operations actually detected which appear to the applicant authority to be contrary to legislation on veterinary matters.’;

(7)

Article 8(2) is replaced by the following:

‘2.   Where they consider it useful in connection with compliance with the legislation on veterinary matters, the competent authorities of each Member State shall:

(8)

Article 9 is replaced by the following:

‘Article 9

1.   The competent authorities of each Member State shall communicate to the Commission as soon as it is available to them:

2.   The Commission shall communicate to the competent authorities of each Member State, as soon as it is available to it, any information which is such as to enable compliance with legislation on veterinary matters to be enforced.’;

(9)

Article 10 is amended as follows:

(10)

in Article 11, the introductory phrase is replaced by the following:

‘The Commission and the Member States meeting within the Standing Veterinary Committee shall:’;

(11)

in Article 15(2), the first subparagraph is replaced by the following:

‘2.   Paragraph 1 shall not impede the use of information obtained pursuant to this Directive in any legal actions or proceedings subsequently instituted for failure to comply with legislation on veterinary matters on or in the prevention and discovery of irregularities detrimental to Union funds.’.

(1)

the title is replaced by the following:

‘Council Directive 90/425/EEC of 26 June 1990 concerning veterinary checks applicable in intra-Union trade in certain live animals and products with a view to the completion of the internal market’;

(2)

in Article 1, the second paragraph is deleted;

(3)

Article 2 is amended follows:

(4)

in Article 3(1), the second subparagraph of point (d) is replaced by the following:

‘Those certificates or documents, issued by the official veterinarian responsible for the holding, centre or organisation of origin must accompany the animals and products to their destination.’;

(5)

Article 4 is amended as follows:

(6)

Article 19 is deleted;

(7)

in Annex A, Chapter II is deleted.