EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

The Union zootechnical legislation aims at the promotion of free trade in breeding animals and their genetic material considering the sustainability of breeding programs and preservation of genetic resources.

At present Union zootechnical legislation consists of four species specific (vertical) basic acts laying down the fundamental principles, concerning breeding animals of the bovine, porcine, ovine, caprine and equine species. These Council Directives provide the legal bases for the adoption by the Commission of detailed measures on:

– the approval or recognition and listing of breeding organisations, breeders associations and private undertakings,

– the registration and classification of animals in herd-books, flock-books, stud-books and, in the case of hybrid breeding pigs in registers,

– on performance testing and genetic evaluation and

– for the content and format of zootechnical certificates for breeding animals and their semen, ova and embryos.

However, technical requirements of identical nature for acceptance of breeding animals for breeding are currently regulated in three Council Directives and a Commission Decision.

In addition, no implementing measures have been adopted for Council Directive 91/174/EEC establishing the principles of trade in purebred breeding animals of other animal species.

A horizontal Directive, complemented by implementing measures, provides rules on imports from third countries of breeding animals and their germinal products.

Finally, a specific Council Decision provides rules on the designation of a reference centre for breeding of bovine animals.

The present proposal consists of twelve Chapters and five technical Annexes.

Chapters I to VIII of the proposal combine the provisions of Council Directives 2009/157/EC (bovine animals), 88/661/EEC (purebred and hybrid breeding pigs), 89/361/EEC (sheep and goats), 90/427/EEC (equidae), 91/174/EEC (other animals) and 94/28/EC (imports) as indicated in the correlation table.

In particular, Chapter III contains provisions describing the relationship between breeders and breed societies and the settling of disputes taking into account the procedures currently laid down in Commission Decision 92/354/EEC.

In particular, Chapter IV includes the provisions on acceptance of breeding animals for breeding purposes and artificial insemination currently laid down in Council Directives 87/328/EEC (bovine), 90/118/EEC (purebred pigs) and 90/119/EEC (hybrid breeding pigs), as indicated in the correlation table, but also in Commission Decision 90/257/EEC (sheep and goats).

In particular, Chapter V on performance testing includes the provisions of Council Decision 96/463/EC designating the reference body for testing methods for purebred bovine animals.

Chapters IX and X of the proposal establish a legal basis for the execution of official controls in the zootechnical field and the cooperation between competent authorities, taking into account general principles applied to such controls. These provisions were included with a view to the new Animal Health Law and a proposal for a Regulation on official controls and other official activities. Because of those legal initiatives, the legislation on checks on animals and their germinal products in intra-Union trade (Council Directive 90/425/EEC) and as regards imports from third countries (Council Directive 91/496/EEC) and on cooperation between competent authorities (Council Directive 89/608/EEC) will no longer apply to zootechnical aspects. The proposed text follows closely in particular Title II on official controls, Title IV on administrative assistance, Title VI on Commission controls and Title VII on enforcement measures of the proposal for a new Regulation on official controls and other official activities.

Chapter XI reflects the entry into force of the Lisbon Treaty, which requires that enabling provisions in the basic acts of the Union zootechnical legislation are aligned with Article 290 and Article 291 of the Treaty on the Functioning of the European Union (TFEU). To this end, it is necessary to identify for each measure to be adopted on powers provided by the basic act the delegated powers in accordance with Article 290 TFEU or implementing powers in accordance with Article 291 TFEU needed.

Chapter XII provides the final provisions on repeals and dates for entry into force and application.

Annex I (detailed criteria for the recognition of breed societies and approval of breeding programmes) includes the provisions currently laid down in the Annexes to Commission Decisions 84/247/EEC (bovine), 89/501/EEC (purebred breeding pigs) 89/504/EEC (hybrid breeding pigs), 90/257/EEC (sheep and goats) and 92/353/EEC (equidae).

Annex II (detailed criteria for the entry of breeding animals in breeding books) includes the provisions currently laid down in Commission Decisions 84/419/EEC (bovine), 89/502/EEC (purebred breeding pigs), 89/505/EEC (hybrid breeding pigs) 90/255/EEC (sheep and goats) and 96/78/EC (equidae).

Annex III (detailed criteria for performance testing and genetic evaluation) includes the provisions currently laid down in Commission Decisions 2006/427/EC (bovine), 89/507/EEC (purebred and hybrid breeding pigs) and 90/256/EEC (sheep and goats).

Annex IV (Functions and duties of EU Reference Centres) reflects Annex II to Council Decision 96/463/EC.

Annex V (zootechnical certificate) includes the principle information requirements currently laid down in the Annexes to Commission Decisions 2005/379/EC (bovine) 89/503/EEC (purebred breeding pigs), 89/506/EEC (hybrid breeding pigs), 90/258/EEC (sheep and goats), 96/79/EC (equidae), 96/509/EC (imports of semen of purebred breeding animals of bovine, porcine, ovine and caprine species) and 96/510/EC (imports of breeding animals, semen, ova and embryos).

2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

The basic principles and main rules of Union zootechnical legislation have shown to be adequate and sufficiently adapted to technical developments in the area of animal breeding and have therefore been maintained in the proposal. However, because the current Union zootechnical legislation is organised vertically according to species, the almost identical provisions have been streamlined, drafted in a more precise and consistent language in the format of a Regulation, in order to avoid obstacles to trade resulting from national transposition.

Over the past twenty years, the Commission had regularly meetings with Member States to discuss zootechnical matters in the Standing Committee on Zootechnics, and together the legislation has been developed. Cross border activities of approved breed societies have remained a controversial issue because certain Member States pointed to the differences in national transposition of the underlying Directives. This situation has not changed until the last meeting of the zootechnical working group in February 2012 where the main content, the structure and the new elements of the proposal were presented and discussed.

In addition, the Commission has been dealing with numerous problems raised by breeders, breed societies and competent authorities because of different interpretation of the existing provisions by competent authorities in Member States. The Commission is therefore well aware of the needs of the breeding sector and of the supervising competent authorities.

The proposed provisions on official controls in the zootechnical field are fully aligned, with the necessary adaptations, to those proposed, after intensive consultation with stakeholders, by the Commission for a Regulation on official controls and activities in the veterinary field.

3. LEGAL ELEMENTS OF THE PROPOSAL

The proposed regulation provides in a single legal framework the principles of recognition and listing of breeding organisations, breeders associations and private undertakings, approval of their breeding programmes, entering of animals in herd-books, flock-books, stud-books and their classification according to merits, registration of hybrid breeding pigs in registers, performance testing and genetic evaluation as well as the content of zootechnical certificates for breeding animals and their semen, ova and embryos.

In addition it provides rules on imports from third countries of breeding animals, their semen, ova and embryos, and the designation of reference centres for breeding of animals.

Provisions are laid down in this Regulation to carry out official controls and zootechnical checks and to resolve disputes arising where zootechnical checks disclose non-compliance with zootechnical requirements.

However, the rules hereby proposed mirror those laid down in the Commission proposal for a new Regulation on official controls that is currently discussed in the European Parliament and in the Council. In order to prevent inconsistencies between the two texts and to ensure a harmonised approach in the field of controls, the Commission will closely follow the evolution of the discussions on the two texts, and will make the necessary proposals in due time in order to ensure that the provisions on official controls in the field of zootechnics are included in the forthcoming Regulation on official controls.

The proposed Regulation provides the legal base for the adoption of delegated and implementing measure, in accordance with Articles 290 and 291 of the Treaty on the Functioning of the European Union.

4. BUDGETARY IMPLICATION

None.

5. OPTIONAL ELEMENTS

None.

2014/0032 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the zootechnical and genealogical conditions for trade in and imports into the Union of breeding animals and their germinal products

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the European Commission[1],

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

Having regard to the opinion of the European Economic and Social Committee[2],

Having obtained the opinion of the Committee of the Regions[3],

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) The breeding of domestic animals of the bovine, porcine, ovine, caprine and equine species, and to a lesser extent the breeding of animals of other species, occupy an important place in Union agriculture and is a source of income for the agricultural community. The breeding of animals of those species is best encouraged if purebred breeding animals or hybrid breeding pigs of recorded high genetic quality are used.

(2) Member States have thus consistently endeavoured, as part of their agricultural policy, to promote, sometimes through public investment, the production of livestock of particular genetic characteristic that meets defined performance standards. Disparities between those standards have the potential to create technical barriers to trade in breeding animals and their germinal products and their imports into the Union.

(3) Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species[4], Council Directive 89/361/EEC of 30 May 1989 concerning pure-bred breeding sheep and goats[5], Council Directive 90/427/EEC of 26 June 1990 on the zootechnical and genealogical conditions governing intra-Community trade in equidae[6], Council Directive 91/174/EEC of 25 March 1991 laying down zootechnical and pedigree requirements for the marketing of pure-bred animals and amending Directives 77/504/EEC and 90/425/EEC[7], Council Directive 94/28/EC of 23 June 1994 laying down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species[8] and Council Directive 2009/157/EC of 30 November 2009 on pure-bred breeding animals of the bovine species[9] provide the legal framework for Union legislation on the breeding of pure-bred breeding animals of the bovine, porcine, ovine, caprine and equine species and hybrid breeding pigs. These Directives are aimed at the development of livestock breeding in the Union, while at the same time regulating trade in breeding animals and their germinal products and their imports into the Union and thus maintaining the competitiveness of the sector on breeding animals and their germinal products in the Union.

(4) Council Directive 87/328/EEC of 18 June 1987 on the acceptance for breeding purposes of pure-bred breeding animals of the bovine species[10], Council Directive 90/118/EEC of 5 March 1990 on the acceptance of pure-bred breeding pigs for breeding[11] and Council Directive 90/119/EEC of 5 March 1990 of hybrid breeding pigs for breeding[12] were adopted to prevent 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 constituting a prohibition or restriction on intra-Union trade or an obstacle thereto whether in the case of natural services, artificial insemination or the collection of semen, oocytes or embryos.

(5) On the basis of the Directives referred to in recital 3, the Commission, after consulting Member States in the framework of the Standing Committee on Zootechnics established in accordance with Council Decision 77/505/EEC of 25 July 1977 setting up a Standing Committee on Zootechnics[13], adopted a number of Decisions providing species-specific criteria for the approval or recognition of breeding organisations and breeders' associations (hereinafter "breed societies"), the entry of breeding animals in herd-books, flock-books and stud-books (hereinafter "breeding books"), the acceptance of pure-bred 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 the establishment of pedigree certificates for trade in breeding animals and their germinal products.

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

(7) Union legislation on the breeding of animals has also contributed to the preservation of animal genetic resources, the protection of genetic biodiversity and to the production of typical quality regional products that rely on the specific hereditary characteristics of local breeds of domestic animals.

(8) 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 simplicity and consistency of Union legislation, it is appropriate to streamline the Union rules laid down in them.

(9) During the past twenty years, the Commission has had to respond to a significant number of complaints raised by breeders and breeding organisations in relation to the national transposition and interpretation of Union law on 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 Directives, Union legislation on zootechnical and genealogical conditions for trade in breeding animals and their germinal products and their imports into the Union should be laid down in a Regulation.

(10) In addition, experience has shown that in order to facilitate the application of the rules provided for in those Directives a number of the provisions require more precise wording and consistent terminology. In the interests of clarity and consistency of Union legislation, it is also appropriate to provide for more definitions.

(11) However, the terminus "breed" should remain an undetermined legal concept allowing breed societies to describe the group of animals of sufficient genetic uniformity that they consider as distinct from other animals of that species and to enter them with mention of their known ascendants in breeding books in order to reproduce their inherited characteristics by way of reproduction, exchange and selection within the framework of an established breeding programme.

(12) This Regulation should establish the rules on trade in breeding animals and their germinal products and their imports into the Union to promote viable breeding programmes for the improvement of breeds and to preserve the genetic biodiversity of domestic animals.

(13) Accordingly, the rules on purebred breeding animals laid down in this Regulation should aim at granting 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 criteria governing the entry of purebred breeding animals in the different classes of the main section of breeding books, rules for performance testing and genetic evaluation and criteria for the acceptance of breeding animals for breeding as well as the content of the zootechnical certificates.

(14) Similarly, the rules on hybrid breeding pigs laid down in this Regulation should aim at granting access to trade based on agreed principles applicable to the recognition of breeding operations managing different crosses of hybrid breeding pigs and the approval of their respective breeding programmes. This Regulation should also lay down criteria governing the entry of hybrid breeding pigs in the main section of breed registers, rules for performance testing, genetic evaluation and criteria for the acceptance of hybrid breeding pigs for breeding as well as the content of the zootechnical certificates.

(15) Since the objective of this Regulation, namely to ensure a harmonised approach to trade in breeding animals and their germinal products and their imports into the Union and 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 at national level and can therefore, by reason of its effect, complexity, trans-border 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. Since the scope of this Regulation is limited to what is necessary in order to achieve its objectives, it also respects the principle of proportionality as referred to in Article 5(4) of that Treaty.

(16) The quality of the services provided by breed societies and breeding operations and the way that they evaluate and classify animals has an impact on the value of breeding animals on the market. Accordingly, rules should be laid down for the recognition of breed societies and breeding operations based on harmonised Union criteria and their supervision by the competent authority of Member States in order to ensure that the rules established by them do not create disparities between breeding programmes and breeding standards and thereby create technical barriers to intra-Union trade.

(17) 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.

(18) The right of recognition of a breed society or breeding operation which meets the established criteria is a fundamental principle of Union zootechnical legislation. The protection of the economic activity of an existing recognised breed society should no longer justify the refusal by the competent authority of the recognition of a further breed society for the same breed. The same applies for the approval of the geographical extension of a breeding programme, which is carried out on the same breed or on breeding animals that can be recruited from the breeding population of the existing breed society. However, the competent authority should have the legal base to refuse recognition or approval where there is a substantiated risk that such recognition or approval would compromise the preservation of a rare breed or the protection of the genetic diversity.

(19) Because the preservation of rare breeds requires to set up and to recognise breed societies with a limited number of breeding animals in their breeding books, the number of breeding animals entered in breeding books should in general not be an essential condition for the recognition of a breed society and the approval of its breeding programme, even more that the recognition is carried out nationally while appropriate breeding animals may have been entered in breeding books in other Member States or third countries.

(20) 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 utilisation of breeding animals of high genetic value as an important production factor within the Union. To this end a simple notification procedure should ensure that the competent authority in the other Member State is aware of the intended activity.

(21) To prevent future conflicts between breed societies seeking to provide their services to breeders and authorities refusing recognition of new breed societies competing with existing ones, it was necessary to separate the formal recognition of the breed society or breeding organisation from the approval of the intended breeding programme.

(22) From various complaints the Commission had to deal with during the past years it appears that this Regulation should provide for clear rules governing the relationship between the breed society establishing a filial breeding book for a particular breed of purebred breeding animals of the equines species and the breed society that claims to have established the breeding book of the origin of that breed.

(23) The Commission should be empowered to adopt delegated acts amending Annex I in order to adapt the criteria for the recognition of breed societies and breeding operations and for the approval of breeding programmes to developments in the breeding sector.

(24) It is necessary to clarify the relationship between breeders and breed societies and breeding operations notably to ensure their right of membership in breed societies and breeding operations and their right to participate in the breeding programme within the geographical area where it is carried out. Breed societies should have rules that prevent discrimination of breeders because of their origin and must provide a minimum of service.

(25) Experience gained, particularly in the application of Directive 90/427/EEC, and to a lesser extend 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 a clearly established rules of procedure and described rights and duties of members. This is best achieved, if the disputes are settled within the legal system of the Member State where they arise. The Commission should only be involved in disputes which arise between those entities located in different Member States and which cannot be settled effectively by the legal systems of the Member States where they arise.

(26) Breed societies which establish and maintain breeding books for purebred breeding animals of the bovine, porcine, ovine, caprine and equine species and breeding operations which establish and maintain breed registers for hybrid breeding pigs should enter in their breeding books and breed registers breeding animals without discrimination as regards the Member State of origin of the animals or their owners and classify where foreseen in the breeding programme those animals according to their merits.

(27) Breed societies should also be allowed to establish supplementary sections to upgrade within their breeding programme those animals that do not meet the criteria for purebred breeding animals of the breed concerned.

(28) However, breed societies maintaining breeding books for certain purebred breeding animals of the equine species should be permitted to continue laying down criteria for entry in those breeding books of purebred animals of the equine species on the basis of the need to regulate the entry of such equine animals when they are produced using artificial reproduction methods.

(29) With the exception of equidae, purebred breeding animals entered in breeding books are identified in accordance with Union animal health legislation on identification. In the case of purebred breeding animals of the equine species, breed societies also carry out the identification of horses and donkeys they enter or register for entry in their breeding books and issue identification documents (passports). They thus provide a service not only to breeders, but also to the competent authority responsible for the identification and registration of farmed animals. However, this system has led to a multitude of passport issuing bodies that has proven to complicate official controls on compliance with Union legislation on food hygiene and veterinary medicines in those cases where essential information was not readily available to the competent veterinary authorities, for example in the absence of a central database, common high standards for the quality of the identification documents were not observed and official supervision was lacking. It is therefore necessary to require that also purebred breeding animals of the equine species are entered in their respective breeding books under their animal health identification, while providing the possibility to competent veterinary authorities to delegate under certain conditions to recognised breed societies the official issuing of identification documents for purebred breeding animals of the equine species.

(30) In order to ensure that the conditions for entry in breeding books of purebred breeding animals and the registration of hybrid breeding pigs in breed registers can be adapted to developments in the breeding sector, the Commission should be empowered to adopt delegated acts to amend Annex II accordingly.

(31) The acceptance of breeding animals for breeding purposes, 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 thereto.

(32) 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 limited number of traits, the versatile 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.

(33) The Commission should be empowered to lay down conditions for performance testing and genetic evaluation also for purebred breeding animals of the equine species and to amend the current conditions in Annex III in order to take account of technical and scientific advances or of developments in the legal environment influencing the testing, such as Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation)[14], or to include, on request of Member States, conditions for the performance testing and the genetic evaluation of purebred breeding animals of the equine species.

(34) Performance testing and genetic evaluation may be carried out by institutions designated by the breed society or the breeding operation. Those designated institutions shall cooperate with the European Union reference centres designated by the Commission. The Commission should therefore be empowered to designate by way of implementing acts European Union reference centres and the necessary powers should be granted to the Commission to adopt delegated acts describing their duties and functions, where necessary by amending Annex IV. Those reference centres qualify for Union aid in accordance with Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field[15]. In the case of purebred breeding animals of the bovine species, performance testing and genetic evaluation carried out by a breed society are at present assisted by the Interbull Centre, the European Union reference body designated by Council Decision 96/463/EC of 23 July 1996 designating the reference body responsible for collaborating in rendering uniform the testing methods and the assessment of the results for purebred breeding animals of the bovine species[16].

(35) Since detailed provisions are made in this Regulation for the breeding of animals of the bovine, porcine, ovine, caprine and equine species only, it is necessary to empower the Commission to adopt delegated acts on the recognition of breed societies, approval of breeding programmes, entry of breeding animals in breeding books, performance testing and genetic evaluation and the acceptance for breeding as well as to adopt implementing acts for the zootechnical certificates pertaining to trade in breeding animals of other species and their germinal products and their imports into the Union should this be required to remove obstacles to trade.

(36) The import of breeding animals and their germinal products is essential for the European agriculture. Imports of breeding animals and their germinal products should therefore be carried out under conditions closely in line with those rules applicable to trade between Member States. However, breeding animals and their germinal products should only be entitled for entry in the main section of a breeding book or breed register in the Union, if the level of official controls carried out in the exporting third country ensures the same certainty of pedigree details and the results of performance testing and genetic evaluation as in the Union. In addition, breeding bodies in third countries should accept as a matter of reciprocity breeding animals and their germinal products from the respective breed society or breeding operation recognised in the Union.

(37) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff[17] 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 exempted 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.

(38) Upon entry in the Union breeding animals and their germinal products undergo the veterinary checks in accordance with Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC[18] and Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries[19]. In addition those commodities should also undergo the necessary zootechnical checks provided for in this Regulation.

(39) The Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013, and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)[20]. That Regulation is intended to repeal Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules[21] and Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable to intra-Community trade in certain live animals and products with a view to the completion of the internal market[22] and Directives 91/496/EEC and 97/78/EC and incorporate certain rules laid down in those acts in that new Regulation, with the necessary adaptations. However, it is not intended to include the zootechnical and genealogical conditions for trade in breeding animals and their germinal products and imports into the Union of breeding animals and their germinal products in the scope of that Regulation. Therefore, it is necessary to lay down rules on official controls and other official activities concerning breeding animals and their germinal products in this Regulation.

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

(41) Where official controls in Member States or checks on imports into the Union of breeding animals and their germinal products have revealed non-compliance with the zootechnical and genealogical requirements laid down for such imports in this Regulation likely to cause disturbances to trade in breeding animals and their germinal products in the Union, the Commission should be empowered by this Regulation to adopt special measures in order to limit the impact of such non-compliance.

(42) The competent authority of the Member States should also have the necessary powers to enforce Union zootechnical and genealogical rules on breeding animals laid down in this Regulation, including the suspension of 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 zootechnical and genealogical rules laid down in this Regulation.

(43) The Commission should carry out controls in Member States as appropriate and in particular in the light of the results of the official controls carried out by Member States to ensure the application of the zootechnical and genealogical rules laid down in this Regulation in all Member States.

(44) With a view to establishing the lists of third countries from where imports into the Union of breeding animals and their semen, oocytes and embryos should be allowed, to drawing up the conditions for such imports, to obtaining information relating to the functioning of bilateral agreements and where any serious infringement of the conditions for such imports laid down in this Regulation so warrants, the Commission should be empowered to carry out controls in third countries on behalf of the Union, as appropriate.

(45) 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 replace them by either delegated acts or implementing acts adopted pursuant to this Regulation. Accordingly, the Commission should be empowered to adopt those delegated and implemented acts.

(46) In order to ensure the proper application of this Regulation and to supplement it, or to amend Annexes I to V to it, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the procedures and criteria employed and conditions required to recognise breed societies and breeding operations, approve breeding programmes, enter animals in breeding books and breed registers, accept breeding animals for breeding, natural and assisted reproduction, carry out performance testing and genetic evaluations, define zootechnical and genealogical requirements for trade in breeding animals and their germinal products and their imports from third countries, describe the duties and functions of reference centre.

(47) The power to adopt acts in accordance with Article 290 of the Treaty in relation to trade in purebred breeding animals and their germinal products of species other than bovine, porcine, ovine, caprine and equine species and in relation to their imports into the Union should be delegated to the Commission in order to allow Member States to react to disturbances in trade but much more important to react where a rare breed is on the verge of extinct or a there is a risk for the protection of genetic diversity.

(48) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council.

(49) In order to ensure uniform conditions for the implementation of the provisions in this Regulation concerning the listing of breed societies and breeding operations, the designation of reference centres to ensure that performance testing and genetic evaluation methods for breeding animals are uniformly applied, the models for zootechnical certificates accompanying breeding animals and their germinal products and certain rules on the carrying out of official controls, 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 of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers[23].

(50) The rules laid down in Council 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 Council 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 this Regulation. Accordingly, those legal acts should therefore be repealed.

(51) Commission Decision 84/247/EEC of 27 April 1984 laying down the criteria for the recognition of breeders' organizations and associations which maintain or establish herd-books for pure-bred breeding animals of the bovine species[24], Commission Decision 84/419/EEC of 19 July 1984 laying down the criteria for entering cattle in herd-books[25], Commission Decision 2006/427/EC of 20 June 2006 laying down performance monitoring methods and methods for assessing cattle's genetic value for pure-bred breeding animals of the bovine species[26], Commission Decision 89/501/EEC of 18 July 1989 laying down the criteria for approval and supervision of breeders' associations and breeding organizations which establish or maintain herd-books for pure-bred breeding pigs[27], Commission Decision 89/502/EEC of 18 July 1989 laying down the criteria governing entry in herd-books for pure-bred breeding pigs[28], Commission Decision 89/504/EEC of 18 July 1989 laying down the criteria for approval and supervision of breeders' associations, breeding organizations and private undertakings which establish or maintain registers for hybrid breeding pigs[29], Commission Decision 89/505/EEC of 18 July 1989 laying down the criteria governing entry in registers for hybrid breeding pigs[30], Commission Decision 89/507/EEC of 18 July 1989 laying down methods for monitoring performance and assessing the genetic value of pure-bred and hybrid breeding pigs[31], Commission Decision 90/254/EEC of 10 May 1990 laying down the criteria for approval of breeders' organizations and associations which establish or maintain flock-books for pure-bred breeding sheep and goats[32], Commission Decision 90/255/EEC of 10 May 1990 laying down the criteria governing entry in flock-books for pure-bred breeding sheep and goats[33], Commission Decision 90/256/EEC of 10 May 1990 laying down methods for monitoring performance and assessing the genetic value of pure-bred breeding sheep and goats[34], Commission Decision 90/257/EEC of 10 May 1990 laying down the criteria for the acceptance for breeding purposes of pure-bred breeding sheep and goats and the use of their semen, ova or embryos[35], Commission Decision 92/353/EEC of 11 June 1992 laying down the criteria for the approval or recognition of organizations and associations which maintain or establish stud-books for registered equidae[36], Commission Decision 96/78/EC of 10 January 1996 laying down the criteria for entry and registration of equidae in stud-books for breeding purposes[37] have been adopted pursuant the basic acts referred to in recital 46 with species-specific criteria for the approval or recognition of breed societies and breeding operations, the entry of breeding animals in breeding books, the acceptance for breeding and artificial insemination, for performance testing and genetic evaluation. This Regulation provides for rules replacing those laid down in the aforementioned Commission acts.

(52) Similar rules to those laid down in Commission Decision 92/354/EEC of 11 June 1992 laying down certain rules to ensure coordination between organizations and associations which maintain or establish stud-books for registered equidae[38] are laid down in this Regulation.

(53) Commission Decision 89/503/EEC of 18 July 1989 laying down the certificate of pure-bred breeding pigs, their semen, ova and embryos[39], Commission Decision 89/506/EEC of 18 July 1989 laying down the certificate of hybrid breeding pigs, their semen, ova and embryos[40], Commission Decision 90/258/EEC of 10 May 1990 laying down the zootechnical certificates for pure-bred breeding sheep and goats, their semen, ova and embryos[41], Commission Decision 96/79/EC of 12 January 1996 laying down the zootechnical certificates of semen, ova and embryos from registered equidae[42], Commission Decision 2005/379/EC of 17 May 2005 on pedigree certificates and particulars for pure-bred breeding animals of the bovine species, their semen, ova and embryos[43], Commission Regulation (EC) No 504/2008 of 6 June 2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards methods for the identification of equidae[44], Commission Decision 96/509/EC of 18 July 1996 laying down pedigree and zootechnical requirements for the importation of semen of certain animals[45] were adopted pursuant to basic acts referred to in recital 45.

(54) To ensure legal clarity and to avoid duplication, the repeal of the Council acts should only take effect when the Commission Decisions providing species-specific criteria for the approval or recognition of breed societies and breeding operations, the entry of breeding animals in breeding books, the acceptance for breeding and artificial insemination, for performance testing and genetic evaluation, which are included in this Regulation, are repealed by delegated act and the model zootechnical certificates for trade in breeding animals and their germinal products and for imports into the Union of breeding animals and their germinal products from third countries are established by implementing acts. It is therefore necessary to ensure that this Regulation is applicable not less than eighteen months after the date it came into force.

HAVE ADOPTED THIS REGULATION:

CHAPTER I General Provisions

Article 1 Subject-Matter and Scope

1. This Regulation lays down:

(a) zootechnical and genealogical rules for trade in breeding animals and their semen, oocytes and embryos and imports into the Union of breeding animals and their semen, oocytes and embryos;

(b) the rules of membership and dispute settling in breed societies and breeding operations;

(c) general rules for the performance of official controls on breed societies and breeding operations and the breeding programmes they carry out on breeding animals, including the use of semen, oocytes and embryos, in order to verify compliance with the rules referred to in point (a), for other official activities, administrative assistance, cooperation and enforcement by Member States;

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

2. This Regulation shall not apply to trade in and imports into the Union of breeding animals and their semen, oocytes and embryos where they are intended for technical or scientific experiments carried out under the control of the competent authority.

3. Pending the adoption of any delegated or implementing measures provided for in this Regulation, Member States may continue to apply their national zootechnical and genealogical rules governing trade in breeding animals and their semen, oocytes and embryos and imports into the Member State concerned of breeding animals and their semen, oocytes and embryos, provided that, as regards imports, those rules are not more favourable than those governing trade in the Union.

Article 2 Definitions

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

(a) "animal" means a domestic animal of

(i) the bovine species (Bos taurus and Bubalus bubalis), porcine species (Sus scrofa), ovine species (Ovis aries), caprine species (Capra hircus);

(ii) the equine species (Equus caballus and Equus asinus);

(iii) species other than those referred to in points (i) and (ii) for which delegated acts have been adopted pursuant to Articles 35(1) or 45(1);

(b) "breeding animal" means a purebred breeding animal or a hybrid breeding pig;

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

(d) "breed society" means any breeding organisation or breeders' association which is recognised by the competent authority of a Member State in accordance with Article 4(2) for the purpose of carrying out a breeding programme on purebred breeding animals entered in the breeding book(s) it maintains or establishes;

(e) "breeding operation" means any breeding organisation, breeders' association or private undertaking which is recognised by the competent authority of a Member State in accordance with Article 4(2) for the purpose of carrying out a breeding programme on hybrid breeding pigs registered in the breed register(s) it maintains or establishes;

(f) "breeding body" means any breeding organisation, breeders' association, 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 an official service in a third country for the purpose of imports into the Union of breeding animals for breeding;

(g) "competent authority" means the central authority of a Member State and any other authority to which that responsibility has been conferred, responsible for:

(i) the recognition of breed societies and breeding operations and the approval of the breeding programmes they carry out on breeding animals;

(ii) the organisation of official controls on breed societies and breeding operations in accordance with the rules provided for in Article 46 and in delegated acts adopted pursuant to Article 52(1);

(iii) the provision of assistance to other Member States and third countries in case of detected non-compliances as provided for in Articles 53, 54, 55 and 56;

(iv) the organisation of other official activities, in accordance with the rules provided for in this Regulation;

(h) "recognition" means the formal and official declaration by the competent authority that, following an evaluation, a breed society or breeding operation complies with the requirements of Article 4(2);

(i) "purebred breeding animal" means a domestic animal

(i) of the species referred to in point (a)(i) which descents from parents and grandparents entered in the main section of a breeding book of the same breed and which is itself entered or registered and eligible for entry in the main section of such a breeding book in accordance with Article 19;

(ii) of the species referred to in point (a)(ii) which descents from parents entered in the main section of a breeding book of the same breed and which is itself entered or registered and eligible for entry in the main section of such a breeding book in accordance with Article 19;

(iii) of a species other than those referred to in (i) and (ii) of this point for which the specific zootechnical and genealogical rules for trade in those breeding animals and their germinal products and their imports into the Union are laid down in delegated acts adopted pursuant to Articles 35(1) and 45(1) respectively;

(j) "hybrid breeding pig" means an animal of the porcine species registered in a breed register, which is produced by deliberate cross-breeding between:

(i) purebred breeding pigs of different breeds or lines;

(ii) breeding pigs which are themselves the outcome of a cross (hybrid) between different breeds or lines;

(iii) breeding pigs belonging to one or other of the categories referred to in (i) or (ii);

(k) “breeding book” means any herd-book, flock-book, stud-book, file or data medium which is maintained by a breed society in which purebred breeding animals are entered or registered for entry with mention of details of their ascendants and where applicable their merits, to be subject of a breeding programme;

(l) "approval" means the permission granted by the competent authority to a breed society or breeding operation to carry out its breeding programme in accordance with Article 8(1);

(m) “main section” means the section of a breeding book in which purebred breeding animal are entered or registered for entry;

(n) "class" means a horizontal subdivision of the main section in which breeding animals are entered according to their merits;

(o) "merit" means a quantifiable heritable characteristic of a breeding animal;

(p) “breed register” means any file or data medium which is maintained by a breeding operation in which hybrid breeding pigs are registered with details of their ascendants, to be subject of a breeding programme;

(q) "official control" means any form of control that the competent authority or the Commission perform for the verification of compliance with the zootechnical and genealogical rules provided for in this Regulation;

(r) "other official activities" means any activity, other than an official control, which is performed by competent authorities in accordance with this Regulation to ensure the application of the zootechnical and genealogical rules provided for in this Regulation;

(s) "zootechnical certificate" means official breeding certificates, official attestations or certified commercial documentation which provide information on the pedigree, the identification and where applicable the genetic evaluation of breeding animals or their germinal products and which are required to accompany breeding animals or their germinal products when they are moved from one Member to another or imported into the Union;

(t) "unique life number" means a unique 15-digit alphanumeric code compiling information on the individual equine animal and the database and country where such information is first recorded in accordance with the coding system of the Universal Equine Life Number[46] (UELN) and comprising:

(i) a six-digit UELN-compatible identification code for the database maintained by the passport issuing body which issued the identification document in accordance with Union animal health legislation followed by

(ii) a nine-digit individual identification number assigned to the equine animal;

(u) "import" means the action of bringing breeding animals and their germinal products into one of the territories listed in Annex VI;

(v) "zootechnical check" means the documentary and identity checks carried out on breeding animals and their germinal products imported into to the Union to verify compliance with the zootechnical conditions provided for in Articles 42 and the zootechnical and genealogical rules laid down in delegated acts adopted pursuant to Article 45(1);

(w) "documentary check" means the examination of the official certificates, official attestations and other document(s) including documents of a commercial nature, which are required to accompany consignments of:

(i) breeding animals and their germinal products imported into the Union, as provided for in Article 39;

(ii) purebred breeding animals and their germinal products when imported into the Union as provided for in delegated acts adopted pursuant to Article 45(1);

(x) "identity check" means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, seals and means of transport, correspond with the information provided in the zootechnical certificates, official attestations and other documents accompanying it;

(y) "non-compliance" means failure to comply with the with the zootechnical and genealogical rules provided for in this Regulation.

Article 3 General zootechnical and genealogical rules for trade in and imports into the Union of breeding animals and their germinal products

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

Breeding animals and their germinal products, owners or breeders of breeding animals, breed societies, breeding operations or breeding bodies shall not be discriminated on the basis of their country of origin.

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

Section 1 Recognition of breed societies and breeding operations

Article 4 Recognition of breed societies and breeding operations

1. Breed societies and breeding operations may apply to the competent authority for recognition in accordance with paragraph 2.

2. The competent authority shall recognise any breed society or breeding operation that applies to it for recognition provided that it complies with the following requirements:

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

(b) it demonstrates in its application that it complies with the requirements set out in Part 1 of Annex I;

(c) it defines in its application:

(i) the nature of its breeding programme, which must be aimed at:

– the preservation of the breed, or

– the improvement of the breed or cross;

(ii) the scope of its breeding programme and the rules it has established in accordance with the requirements of Part 2, and in the cases of purebred equine animals Part 3, of Annex I;

(iii) the geographical territory where it intends to carry out its breeding programme.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning amendments to the requirements for the recognition of breed societies and breeding operations set up in Part 1 and, in the case of purebred breeding animals of the equine species, in Part 3 of Annex I to take account of the variety of breed societies and breeding operations affected by them.

Article 5 Derogation from Article 4(2)(b) concerning the recognition of breed societies

1. By way of derogation from Article 4(2)(b), the competent authority may refuse to recognise a breed society that complies with the requirements set out in Part 1 of Annex I where the breeding programme of that breed society would compromise the preservation or the genetic diversity of purebred breeding animals entered, or registered and eligible for entry, in the breeding book established for that breed by a breed society that has already been recognised in that Member State.

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

(a) the number of breed societies already recognised for that breed in the Member State where the applicant breed society is located;

(b) the size of the population of purebred breeding animals of that breed in that Member State;

(c) the possible genetic input from other breed societies for the same breed recognised in other Member States or in third countries.

Article 6 Refusal of the recognition of breed societies and breeding operations

1. Where the competent authority referred to in Article 4 intends to refuse the recognition of a breed society or breeding operation, it shall provide the latter with a reasoned explanation for its intended refusal and at the same time grant the breed society or breeding operation the right to appeal against that intended refusal within 30 days from the date of receipt of the reasoned explanation.

2. Where, in the light of the appeal referred to in paragraph 1 the competent authority upholds its decision, it shall provide the breed society or breeding operation with a reasoned explanation of its decision to refuse recognition within 30 days of the date of receipt of any appeal and inform the Commission at the same time of its decision to refuse recognition and of the reasons for doing so.

Article 7 Lists of recognised breed societies and breeding operations

1. Member States shall draw up and keep up-to-date a list of breed societies and breeding operations that their competent authority has recognised in accordance with Article 4(2) and make such list available to the public.

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

(a) the name, contact details and Internet site of the breed society or breeding operation;

(b) the breed or cross for which their breeding programme has been approved;

(c) in the case of purebred breeding animals of the equine species, the name and contact details of the breed society which maintains the breeding book of the origin of the breed.

3. Member States shall indicate in the list provided for in paragraph 1 the suspension of the approval of a breeding programme ordered in accordance with Article 61(2)(f).

4. Member States shall immediately remove from the list provided for in paragraph 1 any breed society or breeding operation for which recognition has been withdrawn in accordance with Article 61(2)(g).

5. The Commission may, by means of implementing acts, draw up model forms for the information to be provided by Member States to the public on the list of recognised breed societies and breeding operations provided for in paragraph 1.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 72(2).

Section 2 approval of breeding programmes

Article 8 Approval of breeding programmes carried out by breed societies and breeding operations

1. The competent authority shall approve the breeding programme of a breed society or breeding operation recognised by it in accordance with Article 4(2), provided that the breed society or breeding operation submits an application for approval of its breeding programme, demonstrating compliance with the requirements provided for in Article 4(2)(c) and set out in Part 2, and in the case of purebred equine animals in Part 3 of Annex I.

2. The competent authority referred to in Article 4 may authorise breed societies and breeding operations to outsource the technical management of their breeding book or breed register and other specific aspects of their breeding programme to a third party, provided that:

(a) the breed societies and breeding operations remain responsible vis-à-vis the competent authority for ensuring compliance with the requirements provided for in Article 4(2)(c);

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

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning amendments to the requirements for the approval of breeding programmes set up in Part 2 and, in the case of purebred equine animals, in Part 3 of Annex I to take account of the variety of breeding programmes carried out by breed societies and breeding operations.

Article 9 Notification and approval of breeding programmes carried out in Member States other than the Member State where the breed society or breeding operation is recognised

1. Where the scope of a breeding programme or the geographical territory where it is to be carried out indicates that a breed society or breeding operation intends to carry it out on breeding animals resident in another Member State, the competent authority referred to in Article 8(1) shall:

(a) notify the competent authority of that other Member State at least 90 calendar days before the intended commencement date of the breeding programme;

(b) provide the competent authority referred to in point (a), together with that notification, with a copy of the application for approval of the breeding programme provided for in Article 8(1).

2. The competent authority referred to in paragraph 1(a) of this Article may, within 90 days from the date of receipt of the notification referred to in that paragraph, refuse the approval for the carrying out on its territory of a breeding programme by a breed society recognised by the competent authority referred to in Article 8(1), where:

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

(b) the approval of a further breeding programme would fragment the population of purebred breeding animals available in that Member State to an extend that would compromise the preservation or the genetic diversity of that breed.

3. Failure by the competent authority referred to in paragraph 1(a) to reply within 90 days to the notification provided for in that paragraph shall imply approval.

4. The competent authority of the Member State where the breed society or breeding operation is recognised, or where it has filed an application for recognition in accordance with Article 4, shall inform the breed society or breeding operation of the result of the notification provided for in paragraph 1(a) of this Article without undue delay.

5. Where the competent authority referred to in paragraph 1(a) intends to refuse approval in accordance with paragraph 2, it shall inform the Commission of its intention to refuse approval together with a reasoned explanation.

CHAPTER III Rights and obligations of breeders, breed societies and breeding operations

Article 10 Rights of breeders participating in breeding programmes approved in accordance with Article 8(1) or Article 9

1. Where the rules of a breed society or breeding operation provide for membership, breeders may apply:

(a) for membership of such breed societies or breeding operations;

(b) to participate in the breeding programme within the scope and the geographical area of activity approved in accordance with Article 8(1) or Article 9.

2. Where the rules of a breed society or breeding operation do not provide for membership, breeders participating in a breeding programme approved in accordance with Article 8(1) or Article 9 may apply:

(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 Article 17(1);

(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 17(3);

(c) to have their hybrid breeding pigs registered in a breed register established for the cross by a breeding operation in accordance with Articles 24;

(d) to participate in performance testing and genetic evaluation in accordance with Article 27;

(e) to be provided with a zootechnical certificate in accordance with Article 33(1) and (2).

3. Breeders shall have the right to choose the breeding book or breed register in which they wish to have their breeding animals entered or registered in accordance with Articles 19 and 24.

Article 11 Rights of breeders disputing a decision taken by a breed society

1. Breeders may have recourse to the measures provided for in Article 13 where they claim that any of the following have been unduly refused by a breed society:

(a) an application in accordance with Article 10(1);

(b) an application for the entry of a purebred breeding animal in the main section of a breeding book as provided for in Article 19;

(c) an application for the recording of an animal in a supplementary section of a breeding book as provided for in Article 20(3);

(d) the acceptance of a purebred breeding animal for:

(i) breeding as provided for in Article 21; or

(ii) artificial insemination as provided for in Article 23(1);

(e) the acceptance of a purebred breeding animal or its semen for official performance testing and genetic evaluation as provided for in Article 23(2);

(f) the acceptance of the results of the performance testing and genetic evaluation carried out in accordance with Article 27.

2. Breeders may have recourse to the measures provided for in Article 13 where they claim that a breed society has failed to carry out performance testing or genetic evaluation in accordance with Article 27.

Article 12 Rights of breeders disputing a decision taken by a breeding operation

1. Breeders may have recourse to the measures provided for in Article 13 where they claim that any of the following have been unduly refused by a breeding operation:

(a) an application for the registration of a hybrid breeding pig in a breed register as provided for in Article 24;

(b) the acceptance of a hybrid breeding pig for artificial insemination as provided for in Article 26(1);

(c) the acceptance of a hybrid breeding pig or its semen for performance testing as provided for in Article 26(2);

(d) the acceptance of the results of the performance testing carried out in accordance with Article 27.

2. Breeders may have recourse to the measures provided for in Article 13 where they claim that a breeding operation has failed to carry out performance testing or genetic evaluation in accordance with Article 27.

Article 13 Measures available to breeders disputing a decision taken by a breed society or breeding operation

1. In the cases referred to in Articles 11 and 12, breeders may:

(a) obtain the opinion of an independent expert;

(b) appeal against the refusals referred to in Articles 11(1) and 12(1) or against the results of performance testing and genetic evaluation referred to in Articles 11(2) and 12(2) within 30 days from the date of receipt of the refusal or results from the breed society or breeding operation.

2. In the appeal referred to in paragraph 1(b), the breeder shall describe the facts and the grounds, where available based on the opinion of the independent expert referred to in paragraph 1(a), on which it considers that:

(a) the refusal by the breed society or breeding operation does not comply with Articles 19, 21, 23, 27, 28, 30 or 32; or

(b) the results of the performance testing and genetic evaluation have not been obtained in accordance with Article 27.

Article 14 Dispute settling

1. Where a breed society or breeding operation refuses the appeal by a breeder provided for in Article 13(1)(b), it shall notify the breeder and the competent authority that recognised the breed society or breeding operation in accordance with Article 4(2), within 30 days from the date of its decision to refuse the appeal.

2. The competent authority referred to in Article 8(1) or 9 may reverse the decision of the breed society or breeding operation, where it considers that that decision does not comply with Articles 19, 21, 23, 27, 28, 30 or 32.

3. Member States shall ensure that an appeal procedure is available and that appeal decisions are rendered within a reasonable period of time.

To that end, the competent authority may decide to establish a specific tribunal with the authority to reverse decisions of a breed society or breeding operation where the tribunal considers that the refusal by the breed society or breeding operation of an appeal lodged by a breeder was unjustified.

Article 15 Rights of breed societies and breeding operations

1. Breed societies and breeding operations shall have the following rights as regards their breeding programmes approved in accordance with Article 8(1) or 9:

(a) to carry out their breeding programmes within the scope and geographical area of activity defined in accordance with Article 4(2)(c);

(b) to be autonomous in the definition and conduct of their breeding programmes, subject to the supervision by the competent authority with regard to compliance with Article 4(2).

2. Breed societies or breeding operation which provide for membership shall have the right to

(a) refuse an application for membership if the breeding animals do not fall under the scope of the breeding programme or the geographical area as referred to in points (ii) and (iii) of Article 4(2)(c);

(b) exclude breeders from membership where those breeders fail to comply with their duties set out in the rules of procedure in accordance with point 3(e) of Part 1 of Annex I.

Article 16 Obligations of breed societies and breeding operations

1. Breed societies and breeding operations, which provide for membership, shall set out the rights and duties of their members in their rules of procedure in accordance with point 3(e) of Part 1 of Annex I.

2. Within the scope of their breeding programme approved in accordance with Article 8(1) or 9, breed societies shall enter in their breeding books purebred breeding animals and breeding operations shall register in their breed registers hybrid breeding pigs which are kept on holdings situated within the geographical area of activity defined in accordance with Article 4(2)(c).

3. Breed societies and breeding operations shall have the primary responsibility to prevent and where necessary to settle disputes that may arise between breeders and between breeders and the breed society or breeding operation in the process of carrying out breeding programmes approved in accordance with Article 8(1) or 9, in accordance with the rules established pursuant to Article 14(3) by the Member State where the dispute arises and the rules set out in point 3 of Part 1 of Annex I.

CHAPTER IV Entry of breeding animals in breeding books and breed registers and acceptance for breeding, artificial insemination and testing

Section 1 Entry of purebred breeding animals in breeding books maintained by breed societies and acceptance for breeding, artificial insemination and testing

Article 17 Structure of breeding books

1. Breeding books shall consist of a main section in which purebred breeding animals complying with the requirements set out in Chapters I and II of Part 1 of Annex II may be entered or registered for entry.

2. Breed societies may subdivide the main section into classes where different criteria or procedures are established by the breed society for the entry of purebred breeding animals according to their merits in different classes.

Those criteria and procedures may require the purebred breeding animal to undergo performance testing or genetic evaluation as provided for in Article 27 or set out in the delegated act adopted pursuant to Article 28(1) or any other assessment described in the breeding programme approved in accordance with Article 8(1) or Article 9 prior to entry into a specific class of the main section.

Breed societies may subdivide classes according to gender and age.

3. Breed societies may, in addition to the main section provided for in paragraph 1 of this Article, establish one or more supplementary sections of the breeding book for animals of the same species that are not eligible for entry in the main section, provided the animals meet the requirements of Article 20(1), and the rules of the breed society allow the progeny of those animals to be entered in the main section in accordance with the rules set up in:

(a) point 3 of Chapter III of Part 1 of Annex II, in the case of female animals of the bovine, porcine, ovine and caprine species; or

(b) in point 4 of Chapter III of Part 1 of Annex II, in the case of male and female animals of the equine species.

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning amendments to the rules set out in points 3 and 4 of Chapter III of Part 1 of Annex II under which the progeny of animals recorded in a supplementary section is allowed to be entered in the main section.

Article 18 Specific section in the breeding book

1. The competent authority may approve a breeding programme which requires, by way of derogation from Article 17(2), the entry in a specific section of the breeding book of certain purebred breeding animals of the porcine, ovine and caprine species which:

(a) are entered in the main section of a breeding book of that breed maintained by a breed society in another Member State or third country;

(b) have a specific characteristics distinguishing them from the population of the same breed in the Member State where the breeding programme is approved.

2. Member States intending to make use of the derogation provided for in paragraph 1 shall inform beforehand the Commission and the other Member States thereof and provide a reasoned explanation.

Article 19 Entry of purebred breeding animals in the main section

1. Breed societies shall, on application by breeders, enter or register for entry in the main section any purebred breeding animals of the breed covered by their breeding programme that meet the requirements set out in Part 1 of Annex II.

2. Breed societies shall not refuse the entry in the main section of their breeding books of a purebred breeding animal on the grounds that it is already entered in the main section of a breeding book for the same or, in the case of a cross-breeding programme of a different breed, established by a breed society recognised in accordance with Article 4(2) in another Member State or by a breeding body in accordance with Article 36(1) in a third country.

3. Where the main section is divided into classes, purebred breeding animals meeting the criteria for entry in the main section shall be entered by the breed society in the class that corresponds to the merits of those purebred breeding animals, without discrimination on the grounds of their origin in another Member State or in a third country.

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning amendments to the requirements for the entry of purebred breeding animals in the main section of breeding books set out in Chapter I and II of Part 1 of Annex II.

Article 20 Record of animals in supplementary sections

1. Breed societies shall, on application by breeders, record in the appropriate supplementary section provided for in Article 17(3) animals of the species covered by its breeding programme that are not eligible for entry in the main section, provided that those animals meet the conditions set out in points 1 and 2 of Chapter III of Part 1 of Annex II.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning amendments to the conditions for the recording of animals in supplementary sections of breeding books set out in Chapter III of Part 1 of Annex II.

Article 21 Acceptance of purebred breeding animals for breeding

1. Breed societies shall not exclude on zootechnical or genealogical grounds, other than those resulting from the application of Article 19, the use of purebred breeding animals entered in the main section of their breeding book for breeding using the following reproduction techniques:

(a) natural service;

(b) collection and use for breeding purposes of oocytes and embryos;

(c) collection of semen from breeding animals which have undergone, where applicable, performance testing and genetic evaluation in accordance with Article 27 or set out in the delegated act adopted pursuant to Article 28(1);

(d) artificial insemination using semen referred to in point (c);

(e) in vitro production and use for breeding purposes of embryos produced from oocytes referred to in point (b) and conceived by use of semen referred to in point (c).

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning criteria for:

(a) the acceptance by breed societies of purebred breeding animals for breeding;

(b) the collection and use of germinal products of purebred breeding animals for breeding purposes.

Article 22 Methods for identity verification

1. Breed societies shall require that purebred breeding animals of the bovine species and male purebred breeding animals of dairy breeds of the ovine and caprine species are identified by analysis of their blood group or by any other appropriate method providing at least the same degree of certainty when they are used for:

(a) the collection of semen for artificial insemination;

(b) the collection of oocytes and embryos.

2. On request of a Member State or a European association of breed societies for purebred animals of the species concerned, the Commission may, by means of implementing acts, approve methods for the verification of the identity of purebred breeding animals of the bovine species and male purebred breeding animals of dairy breeds of the ovine and caprine species that provide at least the same degree of certainty as the analysis of the blood group of those purebred breeding animals, taking into account technical advances and the recommendations of the European reference centres referred to in Article 31.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 72(2).

Article 23 Acceptance of semen for artificial insemination and in-vitro fertilisation of oocytes and of purebred breeding animals and their germinal products for testing

1. Breed societies shall not prohibit the use of semen for the artificial insemination of female purebred breeding animals or the in-vitro fertilisation of oocytes collected from female purebred breeding animals, provided that the semen was collected from donor purebred breeding animals of:

(a) the bovine, porcine, ovine and caprine species which were accepted for the collection of semen for artificial insemination or in-vitro fertilization of oocytes in a Member State on the basis of performance testing and genetic evaluation carried out in accordance with Article 27 and Annex III;

(b) the equine species, which were accepted for the collection of semen for artificial insemination or in-vitro fertilization of oocytes on the basis of the breeding programme approved in accordance with Article 8(1) or Article 9.

2. Purebred breeding animals and their germinal products, which are entered in the main section of a breeding book established by a breed society recognised in one Member State, shall be accepted by a breed society carrying out a breeding programme on the same breed in another Member State for performance testing, and where appropriate genetic evaluation, under the same conditions and quantitative limitations as applied to purebred breeding animals and their germinal products, entered in a breeding book established for the same breed by a breed society recognised in the Member State where the performance testing and genetic evaluation are to be carried out in accordance with Article 27.

3. For the purpose of paragraph 1 and 2, the germinal products of the purebred breeding animals referred to in those paragraphs shall be collected, treated and stored by a semen collection or storage centre or by an embryo collection and production team officially approved for intra-Union trade in these commodities in accordance with Union animal health legislation.

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning the conditions for the acceptance of:

(a) purebred breeding animals of the equine species of certain breeds for artificial insemination and in-vitro fertilisation of oocytes;

(b) purebred breeding animals of the equine species of certain breeds and their germinal products for performance testing and genetic evaluation.

Section 2 Registration of hybrid breeding pigs in breed registers maintained by breeding operations and acceptance for breeding, artificial insemination and testing

Article 24 Registration of hybrid –breeding pigs in breed registers

1. Breeding operations shall, where applicable on application by their members, register in their breed register any hybrid breeding pig of the same cross that meets the requirements set out in Part 2 of Annex II.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning amendments to the requirements for the registration of hybrid breeding pigs in breed registers set out in Part 2 of Annex II.

Article 25 Acceptance of hybrid breeding pigs for breeding

1. Breeding operations shall not exclude on zootechnical or genealogical grounds, other than those resulting from the application of Article 27, the use of hybrid breeding pigs registered in their breed registers for breeding using the following reproduction techniques:

(a) natural service;

(b) collection and use for breeding purposes of oocytes and embryos ;

(c) collection and use of semen from breeding animals which have undergone, performance testing and genetic evaluation in accordance with Article 27 or set out in the delegated act adopted pursuant to Article 28(1);

(d) artificial insemination using semen referred to in point (c);

(e) in vitro production and use for breeding purposes of embryos produced from oocytes referred to in point (b) and conceived by use of semen referred to in point (c).

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning criteria for:

(a) the acceptance by breeding operations of hybrid breeding pigs for breeding;

(b) the collection and use of semen, oocytes or embryos of hybrid breeding pigs for breeding purposes.

Article 26 Acceptance of hybrid breeding pigs for artificial insemination and testing

1. Breeding operations shall not prohibit the use of semen for artificial insemination or the in-vitro fertilisation of oocytes collected from female hybrid breeding pigs, provided that the semen was collected from donor hybrid breeding pigs whose line has undergone performance testing and genetic evaluation in accordance with Article 27 and Annex III.

2. Male hybrid breeding pigs and their semen, which are registered in a breed register established by a breeding operation recognised in one Member State shall be accepted by a breeding operation carrying out a breeding programme on the same cross in another Member State for performance testing, and where appropriate genetic evaluation, under the same conditions and quantitative limitations as applied to male hybrid breeding pigs and their semen registered in a breed register established for the same cross by a breeding operation recognised in the Member State where the performance testing and genetic evaluation are to be carried out in accordance with Article 27.

3. For the purpose of paragraph 1 and 2, the semen referred to in those paragraphs shall be collected, treated and stored by a semen collection or storage centre officially approved for intra-Union trade in these commodities in accordance with Union animal health legislation.

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning the conditions for the acceptance of hybrid breeding pigs for artificial insemination and testing.

CHAPTER V Performance testing, genetic evaluation and zootechnical certificates

Article 27 Methods for performance testing and genetic evaluation

1. Where a breeding programme approved in accordance with Article 8(1) or Article 9 requires performance testing and genetic evaluation for the classification of purebred breeding animals of the bovine, porcine, ovine and caprine species in breeding books and for the acceptance for breeding of male breeding animals of those species and their semen, breed societies shall ensure that such performance testing and genetic evaluation are carried out in accordance with the following rules set out in Annex III:

(a) for purebred breeding animals of the bovine species, in Part 1;

(b) for purebred breeding animals of the porcine species, in Chapter I of Part 2 and in point 1 of Chapter II of Part 2;

(c) for purebred breeding animals of the ovine and caprine species, in Part 3.

2. Where a breeding programme approved in accordance with Article 8(1) or Article 9 requires performance testing and genetic evaluation for the classification of purebred breeding animals of the equine species in breeding books and for the acceptance for breeding of male breeding animals of the equine species and their semen, breed societies shall ensure that such performance testing and genetic evaluation are carried out in accordance with the following rules set out in Annex I:

(a) in point (1)(e) of Part 2;

(b) in points (1)(a)(i) and (b)(i) and point (2)(b) of Part 3.

3. Where a breeding programme approved in accordance with Article 8(1) or Article 9 requires genetic evaluation for the classification of hybrid breeding pigs in breed registers and for the acceptance for breeding of male hybrid breeding pigs and their semen, breeding operations shall ensure that the genetic evaluation is carried out in accordance with the rules set out in point 2 of Chapter II of Part 2 of Annex III.

Article 28 Delegated powers and implementing powers concerning the requirements for performance testing and genetic evaluation

1. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning the rules for performance testing and genetic evaluation, and where necessary to amend Annex III, to take account of:

(a) scientific advances;

(b) technical developments;

(c) the functioning of the internal market; or

(d) the needs to protect valuable genetic resources.

2. In the light of the opinion of the independent expert referred to in Article 13(1)(a), the Commission may, by means of an implementing act, lay down uniform rules for performance testing and genetic evaluations and the interpretation of the results thereof.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 72(2).

Article 29 Designated institutions for performance testing and genetic evaluation

1. Breed societies and breeding operations shall, where necessary to carry out their breeding programme approved in accordance with Article 8(1) or Article 9, designate the institution which carries out the performance testing and the genetic evaluation of breeding animals provided for in Article 27.

2. The institutions provided for in paragraph 1 may either:

(a) operate as specialised units under the responsibility of a breed society or breeding operation; or

(b) be authorised by the competent authority which has approved the breeding programme.

3. Breed societies and breeding operations shall keep an up-to-date list of institutions designated by them in accordance with paragraph 1 and make such information publicly available.

Article 30 Obligations of institutions designated in accordance with Article 29(1)

1. Institutions designated by breed societies or breeding operations as provided for in Article 29(1) shall provide the following information on request of the competent authority:

(a) records of all data on performance tests carried out;

(b) the identity of the designating breed society or breeding operation and of the competent authority referred to in Article 29(2)(b);

(c) details of the recording methods for traits;

(d) details on the model of performance description used for the analysis of the results of performance testing;

(e) details on the statistical method used for the analysis of the results of performance testing for each evaluated trait ;

(f) details on genetic parameters used for each evaluated trait.

2. The institutions designated by breed societies or breeding operations as provided for in Article 29(1) shall make publicly available and keep up-to-date the results of the genetic evaluation of breeding animals whose semen is used for artificial insemination.

Article 31 Designation of European Union reference centres

1. The Commission shall, by means of implementing acts, designate the European Union reference centre responsible for collaborating with breed societies in rendering uniform the methods for performance testing and genetic evaluation of purebred breeding animals of the bovine species.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 72(2).

2. The Commission may, by means of implementing acts, designate the European Union reference centres responsible for harmonising the methods for performance testing and genetic evaluation of purebred breeding animals of the species other than bovine species.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 72(2).

Article 32 Requirements for and duties and functions of European Union reference centres

1. European Union reference centres designated in accordance with Article 31 shall:

(a) comply with the requirements set out in point 1 of Annex IV;

(b) carry out the duties and functions set out in point 2 of Annex IV;

(c) work with breed societies and institutions designated by breed societies in accordance with Article 29(1) to facilitate the uniform application of performance testing and genetic evaluation methods for purebred breeding animals as provided for in Article 27.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning amendments to:

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

(b) the duties and functions of European Union reference centres set out in point 2 of Annex IV.

The delegated acts provided for in paragraph 2 shall take due account of the species of purebred breeding animals for which the methods of performance testing and genetic evaluation are to be rendered uniform and the scientific and technical advances in the area of genetic evaluation.

3. The Commission may audit European Union reference centres designated in accordance with paragraph 1 or paragraph 2 of Article 31 to verify that:

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

(b) they fulfil their duties and functions set out in point 2 of Annex IV.

If those audits find that a European Union reference centre is not fulfilling its functions and duties set out in point 2 of Annex IV, the Commission may reduce the Union financial contribution granted in accordance with Article 31 of Council Decision 2009/470/EC or withdraw the designation in accordance with the procedure referred to in Article 72(2).

Article 33 Issuing, content and format of zootechnical certificates for intra –Union trade in breeding animals and their germinal products

1. For the purpose of the entry of breeding animals and their germinal products in breeding books or their registration in breed registers, breed societies and breeding operations shall issue zootechnical certificates which:

(a) provide the information set out in Annex V;

(b) comply with the corresponding model forms of zootechnical certificates provided for in implementing acts adopted pursuant to paragraph 4.

2. Breed societies and breeding operations that carry out performance testing and genetic evaluation in accordance with their breeding programme approved in accordance with Article 8(1) or Article 9 shall state in the zootechnical certificate issued for a breeding animal or its germinal products:

(a) all available results of performance tests;

(b) up-to-date results of the genetic evaluation;

(c) any genetic peculiarities and genetic defects affecting the actual animal and its parents and grandparents as required by the approved breeding programme.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning the information required in accordance with paragraph 1(a) and where necessary the amendments to the contents of zootechnical certificates provided for in Annex V.

4. The Commission shall, by means of implementing acts, draw up model forms of zootechnical certificates for breeding animals and their semen, oocytes and embryos.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 72(2).

Article 34 Derogations from issuing, content and format of zootechnical certificates for intra –Union trade in breeding animals and their germinal products

1. By way of derogation from Article 33(1), the competent authority may authorise that:

(a) zootechnical certificates are issued by semen collection centres and embryo collection or production teams approved for trade in those germinal products in accordance with Union animal health legislation;

(b) the information required to be included in the zootechnical certificate is contained in other documents accompanying purebred breeding animals of the bovine, porcine, ovine or caprine species and hybrid breeding pigs, provided that the breed society or breeding operation keeping the breeding book or breed register certifies the content of those other documents in accordance with point 2 of Part 1 of Annex V;

(c) the information required to be included in the zootechnical certificate is contained in the identification document issued by the breed society in accordance with Union animal health legislation on the identification of equidae.

2. By way of derogation from Article 33(2)(b), if the results of the genetic evaluation are publicly available on the Internet, breed societies or breeding operations may, in the zootechnical certificate, refer to the website where those results can be accessed.

CHAPTER VI Zootechnical and genealogical rules for trade in purebred breeding animals of other species

Article 35 Delegated powers and implementing powers concerning the zootechnical and genealogical rules for trade in purebred breeding animals referred to in Article 2(i)(iii) and their germinal products

1. The Commission shall be empowered to adopt delegated acts in accordance with Article 71 concerning the zootechnical and genealogical rules for trade in purebred breeding animals referred to in Article 2(i)(iii) and their germinal products where this is necessary either for the functioning of the internal market or for the protection of valuable genetic resources, as regards:

(a) the recognition of breed societies;

(b) the approval of breeding programmes;

(c) the conditions for the entry of those purebred breeding animals in breeding books;

(d) the acceptance by breed societies of those purebred breeding animals for breeding, artificial insemination and the collection and use of their germinal products;

(e) the methods for performance testing and genetic evaluation of those purebred breeding animals;

(f) the information to be contained in zootechnical certificates that must accompany those purebred breeding animals.

2. Insofar as the Commission has adopted the delegated acts referred to in paragraph 1, it shall, by means of implementing acts, draw up model forms of zootechnical certificates referred to in paragraph 1(f) of this Article for purebred breeding animals referred to in Article 2(i)(iii) and their semen, oocytes and embryos.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 72(2).

CHAPTER VII Imports from third countries

Article 36 Breeding bodies

1. On application by the breeder, breed societies or breeding operations shall enter or register in their breeding books or breed registers any breeding animals imported into the Union and the offspring produced from germinal products imported into the Union provided that the breeding animals or the donors of the germinal products are entered in a breeding book or registered in a breed register of a breeding body in a third country which:

(a) meets the criteria for listing breeding bodies provided for in Article 37;

(b) is included in a list of breeding bodies which have been notified to the Commission by the third country of origin of the breeding animals or their germinal products.

2. The Commission shall maintain, update and publish lists of breeding bodies in third counties referred to in paragraph 1(b).

Article 37 Criteria for listing breeding bodies

1. The Commission shall only include in the list provided for in Article 36(2) breeding bodies for which it has received from an official service of the third country documentation demonstrating that the breeding bodies that the third country wishes to be listed meet the following requirements:

(a) they carry out breeding programmes that are equivalent to breeding programmes carried out on the same breed or cross by breed societies or breeding operations as regards:

(i) the rules applicable to the entry of breeding animals and their germinal products in breeding books or their registration in breed registers;

(ii) the rules applicable to the acceptance of breeding animals for breeding purposes;

(iii) the rules applicable to the use of germinal products of breeding animals for testing and breeding;

(iv) the methods used for performance testing and genetic evaluation;

(b)