CELEX: 52014PC0005
Language: en
Date: 2014-02-11
Title: 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

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		52014PC0005
		
			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 /* COM/2014/05 final - 2014/0032 (COD) */
			
				
		
		
			
			   	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)     they are supervised and controlled by
an official service in the third country that has the necessary powers to enforce
rules equivalent to the rules provided for in this Regulation pertaining to:
(i)      the recognition of breed societies
and breeding operations;
(ii)     the approval of their breeding
programmes;
(iii)    the entry of purebred breeding
animals in breeding books and the registration of hybrid breeding pigs in breed
registers;
(iv)    their methods of performance testing
and genetic evaluation.
2.           The Commission shall only include
in the list provided for in Article 36(2), breeding bodies of third countries for
which it has received from the official service referred to in paragraph 1 of
the third country documentation demonstrating that the breeding bodies that the
third country wishes to be listed have rules of procedure to ensure that:
(a)     purebred breeding animals entered in
breeding books by breed societies are entered or eligible for entry without
discrimination in the breeding books of the same breed established by breeding
bodies in that third country; 
(b)     hybrid breeding pigs registered in a
breed register by breeding operations are registered or eligible for registration
without discrimination in the breed registers of the same cross established by
breeding bodies in that third country.
Article 38
Equivalence agreements
1.           The Commission may, by means of
implementing acts, recognise that measures applied in a third country are
equivalent to those required by Union zootechnical legislation in relation to the
following:
(a)     the recognition and supervision of
breed societies and breeding operations provided for in Article 4 or set out in
the delegated act adopted pursuant to Article 35(1);
(b)     the approval of breeding programmes of
breed societies and breeding operations provided for in Article 8(1) or set out
in the delegated act adopted pursuant to Article 35(1);
(c)     the entry of breeding animals in
breeding books and breed registers provided for in Articles 19 and 24 or set
out in the delegated act adopted pursuant to Article 35(1);
(d)     the acceptance of breeding animals for
breeding provided for in Articles 21 and 25 or set out in the delegated act
adopted pursuant to Article 35(1);
(e)     the use of germinal products for
breeding provided for in Article 23(1) or set out in the delegated act adopted
pursuant to Article 35(1);
(f)     the use of semen for testing provided
for in Article 23(2) or set out in the delegated act adopted pursuant to
Article 35(1);
(g)     the performance testing and genetic
evaluation provided for in Article 27 or set out in the delegated act adopted
pursuant to Article 35(1).
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 72(2).
2.           The implementing acts referred to
in paragraph 1 shall be adopted on the basis of:
(a)     a thorough examination of information
and data provided by the third country concerned pursuant to Article 37(1);
(b)     where appropriate, the satisfactory
outcome of a control performed in accordance with Article 67.
3.           The implementing acts referred to
in paragraph 1 may set out the modalities governing the entry of breeding
animals and germinal products thereof into the Union from the third country
concerned and may include:
(a)     the nature and content of the
zootechnical certificates or documents in accordance with the requirements set
out in Annex V that must accompany the breeding animals or the germinal
products thereof;
(b)     specific requirements applicable to
the entry into the Union of the breeding animals or germinal products thereof
and the official controls to be performed at entry into the Union;
(c)     where necessary, procedures for
drawing up and amending lists of breeding bodies in the third country concerned
from which the entry of breeding animals and germinal products thereof into the
Union is permitted.
4.           The Commission shall, by means of implementing acts repeal the implementing acts referred to in paragraph 1 without
delay where any of the conditions for the recognition of equivalence of
guarantees established at the time of their adoption cease to be fulfilled.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 72(2).
Article 39
Zootechnical conditions for
imports into the Union of 
breeding animals and their germinal products
1.           Breeders may import into the Union
breeding animals and their germinal products entered in a breeding book or
registered in a breed register of a breeding body included in the list set up
in accordance with Article 36(2) or in accordance with Article 7 where
equivalence has been established in accordance with Article 38(1), which are accompanied
by a zootechnical certificate as provided for in Article 40 and comply with the
following additional conditions:
(a)     the breeding animals are accompanied
by evidence that they are to be entered in a breeding book of a breed society
or registered in a breed register of a breeding operation;
(b)     the semen:
(i)      was collected from breeding animals
which have been subject to performance testing and genetic evaluation in
accordance with Annex III where such testing and evaluation are required
by Article 27(1); or
(ii)     is imported in quantities necessary
for the performance testing and genetic evaluation as provided for in Article 23(2);
(c)     the oocytes and embryos were collected
or produced from breeding animals which have been subject to performance testing
and genetic evaluation in accordance with Annex III where such testing and
evaluation are required by Article 27(1).
2.           The Commission
shall be empowered to adopt delegated acts in accordance with Article 71
concerning the zootechnical and genealogical rules for imports into the Union of
breeding animals and their germinal products to take into account the specific
zootechnical situation in a third country of origin of a breeding animal.
Article 40
Issuing, content and format
of zootechnical certificates for imports into the Union of 
breeding animals and their germinal products
1.           For the purpose of the entry of
breeding animals and germinal products in breeding books or their registration
in breed registers, the zootechnical certificates referred to in Article 39(1) shall:
(a)     be issued by the breeding body listed
in accordance with Article 36(2);
(b)     provide the information set out in
Annex V;
(c)     be drawn up in accordance with the
model form of zootechnical certificate provided for in an implementing act
adopted pursuant to paragraph 2.
2.           The
Commission shall, by means of implementing acts, draw up model forms of zootechnical
certificates for imports into the Union of 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 41
Derogations from issuing,
content and format of zootechnical certificates for 
imports into the Union of breeding animals and their germinal products
1.           By way of derogation from Article
40(1)(a), germinal products may be accompanied by a zootechnical certificate
issued on behalf of the breeding body referred to in Article 40(1)(a) by semen
collection centres or embryo collection or production teams approved for imports
into the Union of those germinal products in accordance with Union animal
health legislation.
2.           By way
of derogation from Article 40(1)(b), the information required to be
included in the zootechnical certificate may be 
(a)     contained in other documents accompanying the breeding animal or the
germinal products thereof provided that the breeding body keeping the breeding
book or breed register has certified the content of those documents in
accordance with point 2 of Part 1 of Annex V;
(b)     a reference to the website where those
results can be accessed, provided the results of the genetic evaluation are
publicly available on Internet.
Article 42
Zootechnical checks on
breeding animals and germinal products thereof
imported into the Union
1.           Member States shall carry out
zootechnical checks on consignments of breeding animals and their germinal
products imported into the Union from third countries at the border control
post in which the documentary, identity and physical checks are carried out in
accordance with Articles 42 of Regulation (EU) No […] [COM/2013/0265 final -
2013/0140 (COD)].
2.           For the purpose of paragraph 1,
importers of breeding animals and their germinal products shall present to the
official carrying out the documentary, identity and physical checks referred to
in paragraph 1 the zootechnical certificate, which must accompany the
consignment in accordance with Article 39(1).
Article 43
Conditions for entry in
breeding books of purebred breeding animals imported into the Union
1.           Breed societies shall enter in
the main section of their breeding book purebred breeding animals:
(a)     imported into the Union in accordance
with Article 39(1)(a);
(b)     born in a Member State as the result
of assisted reproduction using
(i)      semen, imported in accordance with
Article 39(1)(b);
(ii)     oocytes or embryos, imported in
accordance with Article 39(1)(c).
2.           Breed societies may enter in the
main section of their breeding book purebred breeding animals imported into the
Union which meet the standards set out for the breed in the breeding programme approved
in accordance with Article 8(1) or Article 9 and provided that:
(a)     the breeding body complies with the
criteria for listing breeding bodies provided for in Article 37;
(b)     the entry of such purebred breeding animals
in the main section of the breeding book is foreseen in the approved breeding
programme;
(c)     the purebred breeding animals are
accompanied by a zootechnical certificate:
(i)      issued by the breeding body referred
to in point (a); 
(ii)     which includes the information set out
in Annex V.
Article 44
Conditions for registration
in breed registers of hybrid breeding pigs
imported into the Union
1.           Breeding operations shall
register in their breed registers hybrid breeding pigs:
(a)     imported into the Union in accordance
with Article 39(1)(a);
(b)     born in a Member State as the result
of assisted reproduction using 
(i)      semen, imported in accordance with
Article 39(1)(b);
(ii)     oocytes or embryos, imported in
accordance with Article 39(1)(c).
2.           Breeding operations may register
in their breed registers hybrid breeding pigs imported into the Union which
meet the standards set out for the cross in the breeding programme approved in
accordance with Article 8(1) or Article 9 and provided that:
(a)     the breeding body established in the
third country meets the requirements of Article 37;
(b)     the registration of such hybrid
breeding pigs in the breed register is foreseen in the approved breeding
programme.
CHAPTER VIII
Zootechnical and genealogical conditions for imports into the Union of purebred
breeding animals of other species
Article 45
Delegated powers and
implementing powers concerning the zootechnical and genealogical rules for
imports into the Union of 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 specific rules
for imports into the Union of 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 listing of breeding bodies;
(b)     the conditions for the entry of those purebred
animals in breeding books established by breed societies;
(c)     the acceptance by breed societies of
those purebred breeding animals for breeding, artificial insemination and the
collection and use of their germinal products
(d)     the methods for performance testing
and genetic evaluation of those purebred animals;
(e)     the main information to be contained
in the zootechnical certificate that must accompany those purebred breeding
animals and their germinal products.
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) 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 IX
Official controls and other official activities, administrative assistance, cooperation
and enforcement by Member States
Article 46
General rules on official
controls
1.           The competent authority shall
perform official controls on breed societies and breeding operations regularly,
on a risk basis and with appropriate frequency, taking account of:
(a)     identified cases of non-compliance
associated with:
(i)      breeding animals and their germinal
products;
(ii)     the activities under the control of breed
societies and breeding operations;
(iii)    the location of the activities or
operations of breeders, breed societies and breeding operations;
(b)     the past records of breed societies
and breeding operations as regards the results of official controls performed
on them and their compliance with the zootechnical and genealogical rules
provided for in this Regulation;
(c)     the reliability and results of own
controls that have been performed by the breed societies and breeding
operations, or by third parties at their request, for the purpose of
ascertaining compliance with the zootechnical and genealogical rules provided
for in this Regulation;
(d)     any information that might indicate
non-compliance.
2.           The competent authority shall
perform official controls on a regular basis and with appropriate frequency to
identify possible intentional violations of the zootechnical and genealogical rules
provided for in this Regulation, taking into account, in addition to the
criteria referred to in paragraph 1, information regarding such possible
intentional violations shared through the mechanisms of administrative
assistance provided for in Article 53 any other information pointing to the
possibility of such violations.
3.           Official controls performed prior
to trade in certain breeding animals and their germinal products in view of the
issuance of the official certificates or official attestations required by the zootechnical
and genealogical rules provided for in this Regulation as a condition for trade
in breeding animals or their germinal products shall be performed in accordance
with:
(a)     the zootechnical and genealogical rules
provided for in this Regulation;
(b)     the delegated acts adopted by the
Commission in accordance with Articles 35 and 45.
4.           Official controls shall be
performed following prior notification of the breeder, breed society or
breeding operation unless there are serious reasons to carry out the controls
unannounced.
5.           Official controls shall be
performed as much as possible in a manner that minimises the burden on the breeder,
the breed society or breeding operation.
6.           The competent authority shall
perform official controls with the same care irrespective of whether the breeding
animals or the germinal products thereof are:
(a)     available on the Union market, whether
originating in the Member State where the official controls are performed or in
another Member State; or
(b)     entering the Union from third
countries.
Article 47
Transparency of official
controls
1.           The competent authority shall perform
official controls with a high level of transparency and make publicly available
relevant information concerning the organisation and the performance of
official controls.
It shall ensure the regular and timely
publication of information on the official controls that it performs and shall
publish at least the following information:
(a)     the type, number and outcome of
official controls performed by it;
(b)     the type and the number of cases of non-compliance
detected by it;
(c)     the cases where measures were taken by
it in accordance with Articles 61;
(d)     the cases where the penalties provided
for in Article 62 were imposed by it.
2.           The Commission shall, by means of
implementing acts, lay down and update as necessary the format in which the
information provided for in paragraph 1 must be published.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 72(2).
3.           The competent authority may publish
or make otherwise publicly available information on the rating of individual
breed societies and breeding operations based on an assessment of their
conformity with rating criteria and on the results of official controls,
provided that the following conditions are met:
(a)     the rating criteria are objective,
transparent and publicly available;
(b)     appropriate arrangements are in place
to ensure the consistency and transparency of the rating process.
Article 48
Documented control and control
verification procedures
1.           The competent authority shall perform
official controls in accordance with documented procedures, which shall contain
detailed instructions for staff performing official controls.
2.           The competent authority shall
have internal procedures in place to verify the consistency and effectiveness
of official controls and other official activities that it performs.
3.           The competent authority shall:
(a)     take corrective actions in all cases
where the internal procedures provided for in paragraph 2 identify shortcomings
in the consistency and effectiveness of official controls and other official
activities;
(b)     update the documented procedures
provided for in paragraph 1 as appropriate.
Article 49
Reports on official controls
1.           The competent authority shall
draw up reports on all official controls that it performs which shall contain:
(a)     a description of the purpose of the
official controls;
(b)     the control methods applied;
(c)     the results of the official controls;
(d)     where appropriate, action that the
competent authority requires the breeder, breed societies and breeding
operations to take as a result of the official controls.
2.           The competent authority shall
provide the breeder, breed society or breeding operation subject to an official
control with a copy of the report provided for in paragraph 1.
Article 50
Methods and techniques to
perform official controls
1.           The competent authority shall perform
official controls using control methods and techniques that include, where
appropriate, verification, inspections and audits.
2.           The competent authority shall perform
official controls of breeders, breed societies and breeding operations that include
the following, where appropriate:
(a)     an examination of the control systems
that breed societies and breeding operations have put in place and of the
results obtained by such control systems;
(b)     an inspection of:
(i)      the premises, offices and equipment
of breeders, breed societies and breeding operations;
(ii)     the breeding animals and their germinal
products of the breeders;
(iii)    labelling, presentation and
advertising of breeders, breed societies and breeding operations;
(c)     an examination of documents and other
records which may be relevant to the assessment of compliance with the zootechnical
and genealogical rules provided for in this Regulation;
(d)     interviews with members and staff of the
breed societies and breeding operations;
(e)     any other activity required to
identify case of non-compliances.
Article 51
Obligations of breeders,
breed societies and breeding operations
1.           Breeders, breed societies and
breeding operations shall give officials of the competent authority the
necessary access to the following, where necessary for the performance of
official controls or of other official activities:
(a)     premises, offices and equipment;
(b)     computerised information management
systems;
(c)     breeding animals and their germinal
products;
(d)     documents and any other relevant
information.
2.           During official controls and
other official activities, breeders, breed societies and breeding operations shall
assist the officials of the competent authority in the accomplishment of their
tasks.
3.           The Commission may, by means of
implementing acts, lay down rules establishing:
(a)     the arrangements for access by officials
of the competent authority to the computerised information management systems
referred to in paragraph 1(b);
(b)     uniform rules on the assistance
provided for in paragraph 2 by breeders, breed societies and breeding
operations to the competent authority.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 72(2).
Article 52
Delegation of powers concerning
specific rules on official controls and on action to be taken by the competent
authority in relation to breeding animals and their germinal products
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 71 concerning rules:
(a)     for the performance of official
controls on breeding animals and their germinal products to verify compliance
with the zootechnical and genealogical rules provided for in this Regulation;
(b)     on the action to be taken by the
competent authority in the light of the results obtained following the
performance of official controls.
2.           The delegated acts provided for in
paragraph 1 shall specify:
(a)     the specific responsibilities and
tasks of the competent authority, in addition to those provided for in Articles
46 to 50;
(b)     the cases where the competent authority,
in relation to specific cases of non-compliance shall take one or more of the
measures provided for in implementing acts adopted pursuant to Article 66(1) or
additional measures to those provided for in that Article.
Article 53
General rules for
administrative assistance and cooperation
1.           The competent authorities in the
Member States shall provide each other with administrative assistance in order
to ensure the correct application of the zootechnical and genealogical rules provided
for in this Regulation in cases of non-compliance having their origin,
extension and effects in more than one Member State.
2.           The administrative assistance provided
for in paragraph 1 shall include, where appropriate, participation by the
competent authority of a Member State in on-the-spot official controls that the
competent authority of another Member State performs.
3.           The provisions of this Article shall
apply without prejudice to national rules:
(a)     applicable to the release of documents
that are the object of, or related to, judicial proceedings;
(b)     aimed at the protection of commercial
interests vested to natural or legal persons.
4.           All communications between
competent authorities in accordance with Articles 54, 55 and 56 shall be in
writing.
Article 54
Assistance on request
1.           Where the competent authority ("requesting
competent authority") considers that it requires information from a
competent authority in another Member State ("requested competent
authority") for the performance or effective follow-up of official
controls, it shall submit a reasoned request to that competent authority.
The requested competent authority shall,
without undue delay:
(a)     acknowledge receipt of the reasoned request
and indicate the time necessary to provide the requested information;
(b)     perform official controls or
investigations necessary to 
(i)      provide the requesting competent
authority with all necessary information and the original documents or
certified copies thereof;
(ii)     verify, where necessary on-the-spot,
compliance with the zootechnical and genealogical rules provided for in this Regulation
within their jurisdiction.
2.           The requesting and requested
competent authorities may agree that officials designated by the former are present
during the official controls referred to in point (b)(i) of the second subparagraph
of paragraph 1.
In such cases the officials of the requesting
competent authority:
(a)     shall at all times be able to produce
written authority stating their identity and their official capacity;
(b)     shall have access to the same premises
and documents as the present official of the requested competent authority for
the sole purpose of the official controls being carried out;
(c)     may not, on their own initiative,
exercise the powers of performing official controls conferred on officials of
the requested competent authority.
Article 55
Assistance without request
1.           Where the competent authority
becomes aware of a case of non-compliance, and where such non-compliance may
have implications for another Member State, it shall notify such information to
the competent authority of that other Member State on its own initiative and
without undue delay.
2.           The competent authority notified
in accordance with paragraph 1 shall:
(a)     acknowledge receipt of the
notification without delay;
(b)     indicate within ten days from the date
of receipt of the notification:
(i)      the investigations that it intends to
carry out concerning the case of non-compliance referred to in paragraph 1; or
(ii)     the reasons why it considers that no
investigations are necessary.
3.           Where the competent authority
notified in accordance with paragraph 1 decides to carry out investigations in
accordance with paragraph 2, it shall without delay inform the notifying
competent authority of the results of any such investigations and, where
appropriate, any measures taken as a result.
Article 56
Assistance in the event of
non-compliance
1.           Where, during official controls
performed on breeding animals and their germinal products originating in
another Member State the competent authority establishes that such breeding animals
or their germinal products do not comply with the zootechnical and genealogical
rules provided for in this Regulation in such a way as to create a serious
infringement of those rules, it shall, without delay, notify the competent authority
of the Member State of dispatch and of any other concerned Member State in
order to enable them to undertake appropriate investigations.
2.           The competent authorities notified
in accordance with paragraph 1 shall, without undue delay:
(a)     acknowledge receipt of the
notification and indicate what investigations they intend to carry out
concerning the case of non-compliance referred to in paragraph 1;
(b)     investigate the matter, take all
necessary measures and inform the notifying competent authority of the nature
of the investigations and the official controls performed by them, of the
decisions taken and of the reasons for such decisions.
3.           If the notifying competent
authority referred to in paragraph 1 has reason to believe that the
investigations performed or the measures taken by the notified competent
authorities in accordance with paragraph 2 do not adequately address the case
of non-compliance established, they shall request the notified competent
authorities to carry out additional official controls or measures.
In such cases:
(a)     the competent authorities from the two
Member States shall seek ways and means of finding an agreed approach with the
aim of appropriately addressing the case of non-compliance referred to in
paragraph 1 of this Article, including through joint on-the-spot official
controls performed in accordance with Articles 53(2) and 54(2);
(b)     they shall inform the Commission
without undue delay where they are not able to agree on appropriate measures.
4.           Where official controls performed
on breeding animals or their germinal products originating in another Member
State show repeated cases of non-compliance with the rules referred to in
paragraph 1, the competent authority of the Member State of destination shall
inform the Commission and the competent authorities of the other Member States
without undue delay.
Article 57
Information concerning
non-compliance received from third countries
1.           Where a competent authority
receives information from a third country indicating a case of non-compliance with
the zootechnical and genealogical rules provided for in this Regulation, it shall,
without undue delay, notify such information:
(a)     to the Commission where it is or may
be relevant at Union level;
(b)     to the competent authority in other concerned
Member States.
2.           Information obtained through
official controls and investigations performed in accordance with this
Regulation may be communicated to the third country referred to in paragraph 1,
provided that:
(a)     the competent authorities which have
provided the information consent to such communication;
(b)     the third country has undertaken to
provide the assistance necessary to gather evidence of practices that are or
appear to be non-compliant with Union rules;
(c)     relevant Union and national rules
applicable to the communication of personal data to third countries are
complied with.
Article 58
Coordinated assistance and
follow-up by the Commission
1.           The Commission shall coordinate
without delay the measures undertaken by the competent authority in accordance
with this Chapter where:
(a)     information available to the
Commission indicates that activities that are, or appear to be, non-compliance:
(i)      have, or may have, ramifications in
more than one Member State; or
(ii)     may be taking place in more than one
Member State; 
(b)     the competent authorities in the
Member States concerned are unable to agree on appropriate action to address such
non-compliance.
2.           In the cases referred to in
paragraph 1, the Commission may:
(a)     in collaboration with the Member State
concerned, send an inspection team to perform an on-the-spot official control;
(b)     request that the competent authority of
the Member State of dispatch and, where appropriate, in other Member States
concerned, appropriately intensify their official controls and report to it on
the measures taken by them;
(c)     submit information concerning such cases
to the Committee referred to in Article 72(1), together with a proposal for
measures to remedy the cases of non-compliances referred to in paragraph 1(a).
Article 59
General principle for the
financing of official controls
1.           Member States shall ensure that
adequate financial resources are available to provide the staff and other
resources necessary to the competent authority to perform official controls and
other official activities.
2.           Member States
may collect fees to cover costs incurred by official controls carried out by
them.
Article 60
General obligations of the
competent authorities as regards enforcement action
1.           When acting in accordance with
this Chapter, the competent authorities shall give priority to action to be
taken to eliminate non-compliances or to minimise their effects to trade in
breeding animals and their germinal products.
2.           In case
of suspicion of non-compliance, the competent authorities shall perform an
investigation in order to confirm or to eliminate that suspicion.
3.           Where necessary for its purposes,
the investigation referred to in paragraph 2 shall include the performance of
intensified official controls on breeding animals and germinal product thereof
and breeders, breed societies and breeding operations for an appropriate period.
Article 61
Investigations and measures
in case of established non-compliance
1.           Where the non-compliance is
established, the competent authorities shall:
(a)     perform any further investigation
necessary to determine the origin and extent of the non-compliance and to
establish the responsibilities of breeders, breed societies and breeding
operations;
(b)     take appropriate measures to ensure
that breeders, breed societies and breeding operations remedy the
non-compliance and prevent further occurrences of it.
When deciding which measures to take, the
competent authorities shall take account of the nature of the non-compliance
and the past record of the breeder, breed society or breeding operation with
regard to compliance.
2.           When acting in accordance with
paragraph 1, competent authorities shall, as appropriate:
(a)     postpone the entry in breeding books
of purebred breeding animals or the registration in breed registers of hybrid
breeding pigs;
(b)     order the alteration of the status of
the animals or their germinal products as intended for breeding in accordance
with this Regulation or corrective information to be provided to breeders;
(c)     restrict or prohibit the trade in animals
and germinal products as breeding animals or germinal products defined in
Article 2 or their imports into the Union or exports to third countries or
prohibit or order their return to the Member State of dispatch;
(d)     order that the breeder, breed society
or breeding operation increases the frequency of own controls;
(e)     order that certain activities of the breeder,
breed society or breeding operation concerned be subject to increased or
systematic official controls;
(f)     order the cessation for an appropriate
period of time of all or part of the activities of the breeder, breed society
or breeding operation concerned and, where relevant, of the Internet sites it
operates or employs and suspend the approval of a breeding programme carried
out by a breed society or breeding operation, where that breed society or
breeding operation repeatedly, continuously or generally fails to comply with
the requirements of the breeding programme approved in accordance with Article 8(1)
or Article 9;
(g)     order the withdrawal of the recognition
of the breed society or breeding operation granted in accordance with Article
4(2), if the administrative practice of that breed society or breeding
operation indicates that it repeatedly, continuously or generally fails to
comply with the requirements of Article 4(2)(c);
(h)     take any other measure the competent
authorities deem appropriate to ensure compliance with the zootechncial and genealogical
rules provided for in this Regulation.
3.           The competent authorities shall
provide the breeder, breed society or breeding operation concerned, or its
representative, with:
(a)     written notification of their decision
concerning the action or measure to be taken in accordance with paragraphs 1
and 2, together with the reasons for that decision; and,
(b)     information on rights of appeal
against such decisions and on the applicable procedure and time limits.
4.           All expenditure incurred pursuant
to this Article shall be borne by the responsible breeder, breed society or breeding
operation.
Article 62
Penalties
Member States shall lay down the rules on
penalties applicable to infringements of the provisions of this Regulation and
shall take all measures necessary to ensure that they are implemented. The
penalties provided for must be effective, proportionate and dissuasive.
Member States shall
notify those provisions to the Commission by the date indicated in the second
paragraph of Article 74 at the latest and shall notify it without delay of any
subsequent amendment affecting them.
CHAPTER X
Controls by the Commission
Section 1
Commission controls in Member States
Article 63
Commission controls in Member
States
1.           Commission experts shall perform
controls in each Member State in order:
(a)     to verify the overall application of
the zootechnical and genealogical rules provided for in this Regulation;
(b)     to verify the functioning of national
control systems referred to in Article 46 and of the competent authority which
operates them;
(c)     to investigate and collect information:
(i)      on official controls and enforcement
practices;
(ii)     on important or recurring problems
with the application or enforcement of the zootechnical and genealogical rules
provided for in this Regulation;
(iii)    in relation to emerging problems or
new developments in the Member States.
2.           The Commission controls provided
for in paragraph 1 shall be organised in cooperation with the competent
authorities of the Member States and may include on-the-spot verifications in
cooperation with the staff of the competent authority performing official
controls.
3.           Experts from the Member States
may assist the Commission experts.
National experts accompanying Commission
experts shall be given the same rights of access as the Commission experts.
Article 64
Reports on Commission controls
in Member States
1.           The Commission shall:
(a)     prepare and send for comments to the
Member State where Commission controls were performed in accordance with
Article 63(1), a copy of its draft report on the findings of those Commission controls;
(b)     prepare the final report on the
findings of those Commission controls, taking into account the comments of the
Member State provided for in point (a);
(c)     make publicly available the final
report and the comments of the Member State provided for in points (a) and (b).
2.           Where appropriate, the Commission
may recommend in its final report provided for in paragraph 1(b) corrective or
preventive action to be taken by the Member States to address the specific or
systemic shortcomings identified during the Commission controls performed in
accordance with Article 63(1).
Article 65
Obligations of Member States
concerning Commission controls
1.           To assist the Commission in
carrying the Commission controls provided for in Article 63(1), Member States
shall:
(a)     provide the necessary assistance,
documentation and other technical support that Commission experts request to
enable them to carry out the Commission controls efficiently and effectively;
(b)     ensure that Commission experts have
access to all premises or parts of premises and to information, including
computing systems, necessary to carry out the Commission controls.
2.           Member States shall take appropriate
follow-up action in the light of the recommendations set out in the final
report provided for in Article 64(1)(b) in order to ensure compliance with the zootechnical
and genealogical rules provided for in this Regulation.
Article 66
Serious failure in the
control system of a Member State
1.           Where the Commission has evidence
of a serious failure in the control systems of a Member State and such failure
may result in a widespread infringement of the zootechnical and genealogical rules
provided for in this Regulation, it shall, by means of implementing acts, adopt
one or more of the following measures, to be applied until that failure has
been eliminated:
(a)     a prohibition on trade in the breeding
animals or their germinal products concerned by the failure in the official
control system;
(b)     imposing special conditions, in
addition to those provided for in Chapter II, for the recognition of breed
societies and breeding operations, the approval of breeding programmes or the trade
in breeding animals and their germinal products;
(c)     other appropriate temporary measures.
Those implementing acts shall be adopted in accordance
with the examination procedure referred to in Article 72(2).
2.           The measures provided for in
paragraph 1 shall be adopted only after the Member State concerned has failed
to correct the situation upon request and within the time limit set by the
Commission.
Section 2
Commission controls in third countries
Article 67
Commission controls in third
countries
1.           Commission experts may perform Commission
controls in third countries in order to:
(a)     verify that the zootechnical and
genealogical rules on breeding animals and their germinal products provided for
in the legislation of the third country provides equivalent guarantees to that
provided for in the Union by this Regulation;
(b)     verify that the control system in
place in the third country concerned can ensure that consignments of breeding
animals and their germinal products exported to the Union comply with relevant
requirements in Chapter VII of this Regulation;
(c)     collect information to elucidate the
causes of recurring cases where breeding animals and their germinal products
imported into the Union do not meet the zootechnical and genealogical requirements
for imports into the Union for which compliance was unduly certified.
2.           The Commission controls provided
for in paragraph 1 shall have particular regard to:
(a)     the zootechnical and genealogical legislation
on breeding animals and their germinal products of the third country;
(b)     the organisation of the competent
authority of the third country, its powers and independence, the supervision to
which it is subject and the authority it has to enforce the legislation referred
to in point (a) effectively;
(c)     the training of staff in the
performance of official controls;
(d)     the resources available to competent
authority in the third country;
(e)     the existence and operation of
documented control procedures and control systems based on priorities;
(f)     the extent and operation of official
controls performed on breeding animals and their germinal products arriving
from other third countries;
(g)     the assurances which the third country
can give regarding compliance with, or equivalence to, the requirements laid
down in the zootechnical and genealogical rules provided for in this
Regulation.
Article 68
Frequency and organisation of
Commission controls in third countries
1.           The frequency of Commission
controls in third countries shall be determined on the basis of:
(a)     the zootechnical and genealogical rules
provided for in this Regulation;
(b)     the volume and nature of breeding animals
and their germinal products entering the Union from the third country;
(c)     the results of Commission controls
already performed;
(d)     the results of official controls on breeding
animals and germinal products entering the Union from the third country and of
any other official controls that the competent authorities of Member States
have performed.
2.           In order to facilitate the
efficiency and effectiveness of the Commission controls provided for in
paragraph 1, the Commission may, prior to performing them, request that the
third country provides:
(a)     the information referred to in Article
37(1)(b);
(b)     where appropriate, the written records
on the official controls performed in that third country.
3.           The Commission may appoint
experts from the Member States to assist its own experts during the controls
provided for in paragraph 1.
Article 69
Reports by the Commission on
controls performed by its experts in third countries
1.           Where Commission controls have
been performed in accordance with Article 67(1), the Commission shall:
(a)     prepare and send for comments to the third
country where they were performed a copy of its draft report on the findings of
the Commission controls;
(b)     prepare the final report on the
findings of the Commission controls performed by its experts in the third country,
taking the comments of the third country where they were performed into account;
(c)     make publicly available the final
report and the comments of the third country where they were performed.
2.           Where appropriate, the Commission
may recommend in its final report provided for in paragraph 1 corrective or
preventive action to be taken by the third country to address the specific or
systemic shortcomings identified by its experts during Commission controls
performed in accordance with Article 67(1).
Article 70
Establishment of special
measures regarding the imports into the Union of
breeding animals and their germinal products
1.           Where there is evidence that
widespread serious non-compliance with the zootechnical and genealogical rules
provided for in this Regulation may be taking place, the Commission shall, by
means of implementing acts, adopt the special measures necessary to put an end
to such non-compliance.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 72(2).
2.           The special measures provided for
in paragraph 1 shall identify breeding animals and their germinal products by
referring to their codes from the Combined Nomenclature and may include:
(a)     a prohibition on zootechnical grounds of
imports into the Union of the breeding animals and germinal products
originating in or dispatched from the third countries concerned by the
non-compliance referred to in paragraph 1;
(b)     the requirement that the breeding animals
and germinal products referred to in paragraph 1 originating in or dispatched
from third countries concerned by the non-compliance referred to in paragraph 1
are
(i)      subject to specific controls carried
out prior to dispatch or upon entry into the Union;
(ii)     accompanied by an official
certificate or any other evidence attesting that the breeding animals or their
germinal products meet the requirements set out in Chapter VII of this
Regulation or in the delegated act adopted pursuant to Article 45(1);
(c)     the requirement that the evidence
referred to in point (b)(ii) be provided in accordance with a specific format;
(d)     other measures necessary to correct
the non-compliance referred to in paragraph 1.
3.           When adopting the special measures
provided for in paragraph 2, account shall be taken of:
(a)     the information collected in
accordance with Article 67(2);
(b)     any other information that the third
countries concerned by the non-compliance referred to in paragraph 1 have
provided;
(c)     where necessary, the results of
Commission controls provided for in Article 67(1).
4.           The Commission shall monitor the
situation and in accordance with the procedure laid down in Article 72(2) shall
amend or repeal the measures adopted, depending on how the situation develops.
CHAPTER XI
Delegation and implementation
Article 71
Exercise of the delegation
1.           The power to adopt delegated acts
is conferred on the Commission subject to the conditions laid down in this
Article.
2.           The power to adopt delegated acts
referred to in Articles 4(3), 8(3), 17(4), 19(4), 20(2), 21(2), 23(4), 24(2), 28(1),
32(2), 33(3), 35(1), 39(2), 45(1) and 52(1) shall be conferred on the
Commission for an indeterminate period from the date of entry into force of
this Regulation. 
3.           The delegation of power referred
to in Articles 4(3), 8(3), 17(4), 19(4), 20(2), 21(2), 23(4), 24(2), 28(1), 32(2),
33(3), 35(1), 39(2), 45(1) and 52(1) may be revoked at any time by the European
Parliament or by the Council. A decision to revoke shall put an end to the
delegation of the power specified in that decision. It shall take effect the
day following the publication of the decision in the Official Journal of
the European Union or at a later date specified therein. It shall not
affect the validity of any delegated acts already in force.
4.           As soon as it adopts a delegated
act, the Commission shall notify it simultaneously to the European Parliament
and to the Council.
5.           A delegated act adopted pursuant
to Articles 4(3), 8(3), 17(4), 19(4), 20(2), 21(2), 23(4), 24(2), 28(1), 32(2),
33(3), 35(1), 39(2), 45(1) and 52(1) shall enter into force only if no
objection has been expressed either by the European Parliament or the Council
within a period of two months of notification of that act to the European
Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed
the Commission that they will not object. That
period may be extended by two months at the initiative of the European
Parliament or of the Council.
Article 72
Committee Procedure
1.           The Commission shall be assisted by the Standing Committee on
Zootechnics established by Council Decision 77/505/EEC. That committee shall be
a committee within the meaning of Regulation (EU) No 182/2011.
2.           Where reference is made to this
paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the opinion of the committee is to be
obtained by written procedure, that procedure shall be terminated without
result when, within the time-limit for delivery of the opinion, the chair of
the committee so decides or a simple majority of committee members so requests.
3.           Where reference is made to this
paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with
Article 5 thereof, shall apply.
CHAPTER XII
Final Provisions
Article 73
Repeals
1.           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 repealed.
2.           References to the repealed
Directives and to the repealed Decision 96/463/EC shall be construed as
references to this Regulation and shall be read in accordance with the
correlation table in Annex VII.
Article 74
Entry into force and
applicability
This Regulation shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
It shall apply from [01/mm/yyyy] [date
to be inserted: please insert the first day of the eighteen month following the
date referred to in the first paragraph.]
This Regulation shall be binding
in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament                                                              For
the Council
The President                                                                                       The
President
ANNEX I
Breed Societies and Breeding
operations establishing or maintaining breeding books or breed registers
as referred to in Chapter II
Part 1
General requirements for the recognition of breed societies and breeding
operations as provided for in Article 4(2)
In order to be recognised in accordance
with Article 4(2), a breed society, which establishes or maintains a breeding
book or a breeding operation which establishes or maintains a breed register
shall:
1.           have legal personality in
accordance with the legislation in force in the Member State where the
application for recognition is made;
2.           be legally and financially
independent from the competent authority;
3.           submit documentation to the
competent authority demonstrating that it:
(a)     has sufficient and qualified staff and
adequate facilities and equipment to implement efficiently its breeding
programme to be approved in accordance with Article 8(1) and, where applicable,
Article 9;
(b)     can carry out or carries out the
checks necessary for recording pedigrees of the breeding animals on which it
carries out its breeding programme to be approved in accordance with Article 8(1)
and, where applicable, Article 9;
(c)     can have or has got a sufficiently
large population of breeding animals and a sufficient number of breeders within
the geographical area of activity in which the breeding programme to be
approved in accordance with Article 8(1) and, where applicable, Article 9 is
carried out for the improvement of the breed or cross or for the preservation of
the breed;
(d)     can generate and use the livestock
performance data of breeding animals necessary for carrying out its breeding
programme to be approved in accordance with Article 8(1) and, where applicable
Article 9;
(e)     in case where membership of breeders
is required by the breed society or breeding operation, has adopted rules of
procedure to provide for:
(i)      equal treatment of breeders having or
applying for membership, who keep their breeding animals on holdings situated
within the geographical area where the approved breeding programme is carried
out;
(ii)     certain services on request to member
breeders who move their breeding animals to holdings situated outside the
geographical area where the approved breeding programme is carried out;
(f)      has adopted rules of procedure to
settle disputes with breeders arising from the performance testing and genetic
evaluation of breeding animals, the entry into classes according to merits and
the acceptance of breeding animals for breeding and collection and use of
germinal products.
Part 2
General requirements for the approval of breeding programmes carried out by
breed societies and breeding operations as provided for in Articles 8(1) and 9
1.           In order to obtain approval of
its breeding programme, the breed society or breeding operation shall submit
the information on the following to the competent authority as provided for in
Articles 8(1) and 9:
(a)     the name and the detailed
characteristic of the breed or, in the case of hybrid breeding pigs, of the
cross covered by the breeding book or breed register to prevent confusion with
similar breeding animals entered or registered in other existing breeding books
or breed registers;
(b)     the system for identifying individual
breeding animals which ensures that breeding animals are only entered in a breeding
book or breed register when they are at least identified in accordance with
Union animal health legislation on the identification and registration of
animals of the species concerned;
(c)     the system for recording pedigrees of purebred
breeding animals entered or registered and eligible for entry into breeding
books or of hybrid breeding pigs registered in breed registers;
(d)     the objectives of the breeding
programme and detailed evaluation criteria concerning the selection of breeding
animals, which in the case of the establishment of a breeding book for a new
breed, must include information on the detailed circumstances justifying the
establishment of the new breed;
(e)     the systems to generate, record,
communicate and use the results of performance testing and, where required in
accordance with Article 27, to carry out a genetic evaluation in order to estimate
the genetic values of breeding animals with a view to the improvement,
selection or preservation of the breed or the improvement of the cross;
(f)     details of the rules for the division
of the main section of the breeding book into classes, where there are
different criteria or procedures for classifying purebred breeding animals
entered in the breeding book according to their merits;
(g)     where necessary, systems for entering
lineages in breeding books which are already entered in another breeding book.
2.           Breed
societies and breeding operations shall inform the competent authority, their
members, the breeders referred to in Article 10(2) of any changes to the
information referred to in point 1 in a transparent and timely manner.
Part 3
Specific requirements for breed societies establishing or maintaining
breeding books for purebred breeding animals of the equine species
1.           The following specific
requirements shall apply to purebred breeding animals of the equine species, in
addition to those set out in point 1 of Part 2:
(a)     A breed society may declare to the
competent authority that the breeding book it has established is the breeding
book of the origin of the breed covered by its breeding programme, provided
that the breed society:
(i)      has a historical record of having established
the rules set out in point 1 of Part 2 and has made them publicly available;
(ii)     demonstrates that there is, at the
time of application referred to in Article 4(1), no other known breed society
recognised in the same or another Member State or in a third country which has
established a breeding book for the same breed, and has established and
published the rules set out in point 1 of Part 2;
(iii)    cooperates closely with the breed
societies referred to in point (b), in particular for the purpose of the
general requirements set out in point 2 of Part 2;
(iv)    established, where necessary, non-discriminatory
rules as regards its conduct of business with respect to breeding books
established for the same breed by breeding bodies that are not listed in
accordance with Article 37(2).
(b)     A breed society may declare to the
competent authority that the breeding book it has established is a filial breeding
book of the breed covered by its breeding programme, provided that:
(i)      it has incorporate into its own
breeding programme the rules established by the breed society referred to in
point (a) that maintains the breeding book of the origin of the same breed;
(ii)     it has made the information regarding
the use of the rules referred to in point (i) and their source publicly available;
(iii)    it has mechanisms in place and
undertakes to adjust in due time the rules governing its breeding programme approved
in accordance with Article 8(1) or Article 9 to amendments made to those rules
by the breed society referred to in point (a) that maintains the breeding book
of the origin of the breed.
2.           The following derogations shall
apply to purebred breeding animals of the equine species:
(a)     By way of derogation from point 3(e)(i)
of Part 1, in the event that for one breed on the territory of the Union described
in Annex VI there are several breed societies which maintain breeding books for
that breed, and their breeding programmes approved in accordance with Article 8(1)
cover the whole of that territory, the rules referred to in point 3(e)(i) of that
Part established by those breed societies:
(i)      may provide that purebred breeding
animals of the equine species of that breed must be born in a specified part of
the territory of the Union to qualify for entry in the breeding book of that
breed for birth declaration purposes;
(ii)     must ensure that the restriction
provided for in point (i) does not apply to the entry in a breeding book of
that breed for reproduction purposes.
(b)     By way of derogation from point 1(a)
of this Part, where the rules referred to in point 1(d) of Part 2 are
established exclusively by an international organisation operating at a global
level and there is no breed society in a Member State or breeding body in a
third country that maintains the breeding book of the origin of that breed, the
competent authority in a Member State shall recognise breed societies
maintaining a filial-book for that breed, provided that the rules referred to
in point 1(d) of Part 2 established by that international organisation are:
(i)      made available by that breed society
to the competent authority referred to in Article 4(2) for verification
purposes;
(ii)     incorporated in the breeding
programme approved in accordance with Article 8(1) carried out by that breed
society.
(c)     By way of derogation from point 1(b)
of this Part, a breed society maintaining a filial-book may establish
additional classes according to merits, provided that the purebred breeding
animals of the equine species which are entered in classes in the main section
of the breeding book of the origin of the breed may be entered in the corresponding
classes of the main section of the filial book.
ANNEX II
Entry in breeding books and registration in breed
registers
as referred to in Chapter IV
Part 1
Entry of purebred breeding animals in breeding books
Chapter I
Main section
1.           On application by the breeder, a breed
society shall, as provided for in Article 19(1), enter or register for entry in
the main section of its breeding book any purebred breeding animal which
complies with the following conditions:
(a)     it meets the parentage criteria set
out:
(i)      in point (i) of Article 2(i) in the
case of purebred breeding animals of the bovine species (Bos taurus and Bubalus
bubalis), porcine species (Sus scrofa), ovine species (Ovis aries)
and caprine species (Capra hircus);
(ii)     in point (ii) of Article 2(i) in the
case of purebred breeding animals of the equine species (Equus caballus
and Equus asinus);
(ii)     in the delegated acts adopted
pursuant to Article 35(1) and 45(1) in the case of purebred breeding animals of
other species referred to in Article 2(i)(iii);
(b)     it has its pedigree established in
accordance with the rules set out in the breeding book in accordance with the breeding
programme approved in accordance with Article 8(1) or Article 9;
(c)     it has been identified after birth in
accordance with Union animal health legislation pertaining to the species
concerned and the rules set out in the breeding programme approved in accordance
with Article 8(1) or Article 9, which must require in the case of purebred
breeding animals of the equine species the identification as foal at foot and
at least a covering certificate;
(d)     it is accompanied, where required, by
a zootechnical certificate issued in accordance with Article 33(1).
2.           By way of derogation from point
1(a)(ii), a breed society which carries out a cross-breeding programme on purebred
breeding animals of the equine species may enter in the main section of its
breeding book a purebred breeding animal of the equine species which is entered
in the main section of a breeding book for a different breed, provided that the
other breed and the criteria for the entry of these purebred breeding animals are
referred to in the breeding programme approved in accordance with Article 8(1)
or Article 9.
3.           A breed society that enters in its
breeding book a purebred breeding animal of the equine species which has
already been entered in a breeding book established by a breed society in
another Member State, shall enter that purebred breeding animal under its unique
life number and, except where a derogation has been agreed by the two breed
societies concerned, the same name with an indication, in accordance with
international agreements for the breed concerned, of the code of the country of
foaling.
Chapter II
Derogations for newly established breeding books for
purebred breeding animals
1.           Where a breed society is being recognised
in accordance with Article 4(2) to establish a breeding book for a breed for
which there is no breeding book in a Member State, the competent authority may,
by way of derogation from point 1(a) of Chapter I, authorise the direct entry
in the main section of that newly established breeding book of purebred
breeding animals or descendants from purebred breeding animals of different breeds,
provided that:
(a)     a period of establishment of the new
breeding book, appropriate for the generation interval of the species concerned, is defined in
the breeding programme to be approved in accordance with Article 8(1) and
Article 9;
(b)     reference is made to any existing breeding book where the purebred breeding animals
or their parents were entered for the first time after birth, together with the
original registration number of that breeding book;
(c)     the breeding animals are entered in the main section, and where applicable in the appropriate
classes, according to the rules set out in the breeding programme to be approved
in accordance with Article 8(1) and Article 9.
2.           By the end of the period of
establishment referred to in point 1(a), the competent authority shall carry
out the official controls provided for in Article 50.
Chapter III
Supplementary sections
1.           A breed society maintaining a
breeding book may decide that an animal of the bovine, porcine, ovine, caprine
or equine species, which does not meet the conditions set out in point 1 of
Chapter I, may be entered in a supplementary section of that breeding book
established in accordance with Article 20(1), provided the animal meets the
following conditions:
(a)     it is identified in accordance with Union animal health legislation for the species
concerned and the rules established for that breeding book
by the breed society;
(b)     it is judged by the breed society to
conform to the characteristic of that breed referred to in point 1(a) of Part 2
of Annex I;
(c)     it has a minimum performance as laid down
by the rules established for that breeding book by the breed society for the performance
in the traits for which breeding animals of that species entered in the main
section are tested in accordance with Annex III.
2.           The breed society may apply
different requirements for the conformity with the breed characteristic
referred to in point 1(b) or the performance referred to in point 1(c) depending
on whether the animal:
(a)     belongs to the breed, although it has
no known origin; or
(b)     was obtained from a cross-breeding
programme approved by the breed society.
3.           Breed societies shall not refuse
the entry in accordance with the conditions set out in Chapter I in the main
section of the breeding book they have established of any female animal of the
bovine, porcine, ovine or caprine species which is regarded as purebred under
the following conditions:
(a)     its mother and maternal grandmother are
entered in a supplementary section of a breeding book of the same breed as
provided for in point 1;
(b)     its father and two grandfathers are
entered in the main section of a breeding book of the same breed.
4.           Breed societies which have
established breeding books for purebred breeding animals of the equine species
shall lay down in their breeding programme approved in accordance with Article 8(1)
and Article 9 the conditions for entry in the main section of male and female
breeding animals recorded in the supplementary section. 
In the case of female purebred breeding animals
of the equine species, those conditions shall not be stricter than the
conditions set out in point 3(a) and (b) of this Chapter.
Part 2
Registration of hybrid breeding pigs in breed registers
1.           On application by a breeder, a
breeding operation recognised in accordance with Article 4(2) shall register in
its breed register any hybrid breeding pig of the same cross which:
(a)     was identified after birth in
accordance with Union animal health legislation for the species concerned and
the rules of that breed register; 
(b)     has parentage established in
accordance with the rules of the breed register in which the animal is intended
to be registered.
(c)     it is accompanied, where required, by
a zootechnical certificate issued in accordance with Article 33(1).
2.           Breeding operations shall not
refuse the registration in their breed registers of hybrid breeding pigs
registered in accordance with point 1 in a breed register established for the
same cross by a breeding operation recognised in accordance with Article 4(2)
in the same or another Member State.
ANNEX
III
Performance Testing and Genetic Evaluation
AS REFERRED TO IN CHAPTER V
Part 1
Bovine animals
Chapter I
Performance testing
Breed societies shall carry out performance
testing to establish the genetic value of purebred breeding animals of the
bovine species using one or a combination of the methods set out in this
Chapter.
Performance
testing shall follow the rules and standards established by the relevant
European Union reference centre provided for in Article 31(1) in cooperation
with the International Committee for Animal Recording (ICAR).
Section
1
Beef production traits
1.           For individual performance testing
of a breeding animal or its progeny ("the test animals") at a test station,
the following information shall be indicated:
(a)     the test method and the number of test
animals tested;
(b)     the test protocol shall including the
following details:
(i)      the terms of admission of the test
animals into the test station;
(ii)     previous results of tests carried out
on the test animals, including, if applicable, on-farm performance of the test
animals;
(iii)    the identity of the owner of the test
animals ;
(iv)    the maximum age for the test animals
entering the test station and the age range of contemporary animals on the test
station;
(v)     the length of adaptation and test
periods at the test station;
(vi)    the type of diet and system of feeding
employed during the test;
(c)     the traits to be recorded in the test shall
include live weight gain and muscular development (beef conformation) and may
include, if available, other traits such as feed conversion and carcass trait.
2.           Testing in the field (on-farm)
The test method and the method to validate test
results shall be provided by the designated institution provided for in Article
29(1).
The traits to be recorded in the test shall
include live weight and age and may include, if available, other traits such as
beef conformation.
3.           Testing through survey data from
farms and points of sale and slaughter
If available, the breed society shall record
the live and slaughter weights, sales prices, carcass conformation class
according to the Union scales for the classification of carcasses set out in Article
42 of Council Regulation (EC) No 1234/2007, meat quality and other beef traits.
Section
2
Dairy traits
Breed societies shall record milk
production data according to the rules and standards established by the
relevant European Union reference centre provided for in Article 31(1) in
cooperation with ICAR.
Section
3
Non-production traits
1.           Where breed societies include in
the genetic evaluation fertility, calving aptitude and longevity, those traits
shall be assessed on the basis of the non-return rate or other fertilisation
data, calving score and length of productive life and culling age.
2.           The inclusion in the genetic
evaluation of temperament, morphological rating data and disease resistance
shall only be considered if the data are generated on the basis of a recording
system approved by the designated institution as provided for in Article 29(1).
Chapter II
Genetic evaluation
1.           The genetic evaluation of
breeding animals shall be carried out by the designated institution as provided
for in Article 29(1) and shall include the following production traits
according to the selection objectives set out in the breeding programme approved
in accordance with Article 8(1) and Article 9.
(a)     dairy production traits for breeding
animals of dairy breeds;
(b)     beef production traits for breeding
animals of beef breeds;
(c)     dairy and beef production traits for
dual-purpose breeds.
2.           The genetic evaluation shall
include the non-production traits referred to in Section 3 of Chapter I for the
breeds in which recording of these traits is being practised by breed societies
in accordance with their breeding programme approved in accordance with Article
8(1) and Article 9.
The breeding value of a breeding animal shall
be calculated on the basis of the results of the performance testing of the
individual or of its relatives and the confidence in such a breeding value may
be enhanced by the use of genomic information or based on
another method validated by the European Union reference centre referred to in Article 31(1).
3.           The statistical methods applied
in genetic evaluation shall comply with the rules and standards established by
the relevant European Union reference centre provided for in Article 31(1) in
cooperation with ICAR and guarantee a genetic evaluation unbiased from the influences
of the main environmental factors and data structure.
The reliability of the genetic evaluation shall
be measured as the coefficient of determination in accordance with rules and
standards established by the relevant European Union reference centre provided
for in Article 31(1) in cooperation with ICAR. When publishing the evaluation
results, the reliability as well as the date of evaluation shall be given.
4.           Genetic peculiarities and genetic
defects of a breeding animal as defined by the breed society shall be
published.
5.           Bulls intended for artificial
insemination, with the exception of bulls belonging to breeds threatened with
extinction, shall be subjected to a genetic evaluation on compulsory traits as
described in point 6 or 7. Those breeding values shall be published by the
breed society.
Other available breeding values of bulls
intended for artificial insemination shall also be published by the breed
society.
6.           Genetic evaluation for dairy
traits of bulls intended for artificial insemination shall include:
(a)     the milk yield and the content of butterfat
and protein;
(b)     other available and relevant
production and non-production traits.
The minimum reliability of the genetic
evaluation of bulls for artificial insemination of the dairy breeds shall be at
least 0,5 for the traits milk yield, butterfat and protein content, according
to the rules and standards established by the relevant European Union reference
centre provided for in Article 31(1) in cooperation with ICAR for the
evaluation of the main production traits, taking into account all information
available from progeny and collaterals.
Genomically evaluated young bulls, without
progeny performance records, shall be considered suitable for artificial
insemination if their genomic evaluation is validated according to rules and
standards established by the relevant European Union reference centre provided
for in Article 31(1) in cooperation with ICAR.
7.           Genetic evaluation for beef
production traits of bulls intended for artificial insemination shall be
carried out on the basis of one of the following testing methods:
(a)     individual performance testing on
station;
(b)     progeny or collaterals performance
test on test station or in specialised units;
(c)     progeny or collaterals performance
test on farm; in such a way that the offspring are distributed among the
recorded herds to allow a valid comparison of bulls to be made;
(d)     progeny or collateral performance test
by means of collecting data on farms, in auction sales or in slaughter houses
in such a way that a valid comparison of bulls can be made;
(e)     genomic evaluation or any other
method, including a combination of these methods, validated in accordance with
the rules and standards established by the relevant European Union reference
centre provided for in Article 31(1) in cooperation with ICAR.
If carcass weight and, where appropriate,
traits of meat quality, growth performance and calving aptitude are being
recorded, those traits as well as any other relevant trait shall be included in
the genetic evaluation of the bull.
The minimum reliability of the genetic
evaluation of bulls for artificial insemination of beef breeds shall be at
least 0,5 for the traits live weight gain and muscular development (beef
conformation) according to the rules and standards established by the relevant European
Union reference centre provided for in Article 31(1) in cooperation with
ICAR for the evaluation of the main production traits,
Where genomic breeding values are calculated,
those values shall be validated for the traits concerned according to the rules
and standards established by the relevant European Union reference centre
provided for in Article 31(1) in cooperation with ICAR.
Revalidation of these values shall be required
at regular intervals and at any time when there are major changes either in the
genomic evaluation or in the conventional evaluation or in the reference
population.
Part
2
Porcine animals
Chapter I
Performance testing
1.           Performance testing at a test station
For performance testing of a breeding animal or
its progeny ("the test animals") at a test station, the following
information shall be indicated:
(a)     the name of the breed society,
breeding operation or of the competent authority responsible for the test
station;
(b)     the test method and the number of test
animals tested;
(c)     the test protocol, which shall include
the following details:
(i)      the terms of admission of the test
animals into the test station;
(ii)     the maximum age for the test animals
entering the test station and the age range of contemporary animals on the test
station;
(iii)    the length of the test period on the
test station;
(iv)    the type of diet and system of feeding
employed during the test;
(v)     the identity of the owner of the test
animals in the case of individual performance testing;
(d)     the traits recorded, which shall
include live weight, feed conversion and an estimator of the body composition and
may include other relevant data;
(e)     the method used for estimating genetic
merits, which shall be stated as a breeding value or contemporary comparison
for each trait, shall be scientifically acceptable according to established
zootechnical principles.
2.           Performance testing on a farm
Where a performance test is carried out on a
farm, the breed society or breeding operation shall ensure that at the end of
the test a breeding value can be calculated following established zootechnical
principles taking into account Union scales for the classification of carcasses
set out in Article 42 of Council Regulation (EC) No 1234/2007.
Chapter II
Genetic evaluation
1.           Progeny or collaterals testing
(a)     the genetic merit of the breeding
animal shall be calculated by assessing the qualities of a suitable number of
progeny or collaterals in relation to production characteristics: 
(i)      a detailed description of the test
method shall be given or quoted;
(ii)     the progeny or the collaterals shall not
be treated selectively;
(iii)    three types of progeny or collaterals
tests shall be recognised:
–              
central testing in a progeny or collaterals
testing station; 
–              
planned progeny or collateral testing on a farm,
provided the progeny or the collaterals had been distributed amongst herds in
such a way that a valid comparison between breeding animals was possible;
–              
data collected on identified progeny or collateral
carcases;
(b)     the progeny or collaterals shall be
chosen in an unbiased manner. All relevant data shall be used in assessing the
breeding value of the breeding animals. Influences other than the genetic merit
shall be eliminated by appropriate procedures in the determination of the
breeding value;
(c)     the traits recorded, such as the live
weight gain, feed conversion, carcase quality, reproduction characteristics,
fertility, prolificacy, viability of the progeny or collaterals or any other
relevant data, shall be stated;
(d)     the method used for estimating genetic
merit shall be scientifically acceptable according to established zootechnical
principles.
2.           Contemporaries testing for hybrid
breeding pigs
If performance data or genetic values are
indicated on a zootechnical certificate accompanying hybrid breeding pigs or
their germinal products, the conditions applicable to the progeny or the
collaterals defined in points (a), (b), (c) and (d) of point 1, shall apply, the necessary changes having been made, to
contemporaries of hybrid lines of hybrid breeding pigs.
Part 3
Ovine and caprine animals
Chapter I
Performance testing
1.           Performance testing on a station
(a)     The method used for estimating genetic
merit shall be scientifically acceptable according to established zootechnical
principles. The genetic merit of tested breeding animals shall be stated as a
breeding value or contemporary comparison for each trait.
(b)     The following items shall be clearly
stated:
(i)      the terms of admission into the
station;
(ii)     the maximum age or maximum weight of
young breeding animals at the start of the test and number of animals;
(iii)    the length of the test period in the
station or final weight;
(iv)    the type of diet and system of feeding
employed during the test.
2.           Performance testing on a farm
Where a performance test is carried out on a
farm, the breed society shall ensure that at the end of the test a breeding
value can be calculated following established zootechnical principles taking
into account Union scales for the classification of carcasses set out in
Article 42 of Council Regulation (EC) No 1234/2007.
3.           Milk recording and the assessment
of the genetic merit of females for dairy traits shall be carried out as
follows:
(a)     the traits recorded in conformity with
the principles agreed by the ICAR, such as milk production, milk composition or
any other relevant data, shall be stated;
(b)     milk records used in the determination
of the genetic merits of females shall: 
(i)      relate to a period of time which
conforms to the norm laid down by ICAR for recording productivity of milk
animals;
(ii)     be adjusted for any important
environmental influences.
Chapter II
Genetic evaluation
The genetic merit of a breeding animal
shall be calculated by assessing the qualities of a suitable number of progeny
and, where appropriate, collaterals as follows:
(a)          in relation to meat production traits:
(i)      a detailed description of the test
method shall be given or quoted;
(ii)     the progeny or the collaterals shall be
treated equally;
(iii)    three types of progeny or collaterals
tests shall be recognised:
–              
central testing in progeny or collaterals
testing station;
–              
planned progeny or collaterals testing on a farm,
provided the progeny or the collaterals had been distributed amongst herds in
such a way that a valid comparison between breeding animals was possible;
–              
data collected on identified progeny or
collaterals carcases;
(b)          in relation to dairy traits:
(i)      the design of the test shall to be
stated;
(ii)     the females shall not be treated
selectively;
(iii)    the milk production and milk
composition shall be included in the calculation of the genetic merits;
(c)          the progeny or collaterals shall
be chosen in an unbiased manner. All relevant data shall be used in assessing
the breeding value of the breeding animals. Influences other than genetic merit
shall be eliminated by appropriate procedures in the determination of the
breeding value;
(d)          the traits recorded, such as live
weight gain, feed conversion, carcase quality taking into account Union scales for
the classification of carcasses set out in Council Regulation (EC) No 1234/2007,
milk production, milk composition, quality of wool production, reproduction
characteristics, fertility, prolificacy, viability of the progeny and/or
collaterals or any other relevant data, shall be stated;
(e)          the method used for estimating
genetic merits shall be scientifically acceptable according to established
zootechnical principles.
ANNEX IV
European Union Reference Centres
1.           European Union reference centres
designated in accordance with Article 31(1) must have:
(a)     suitably qualified staff with adequate
training in performance testing and genetic evaluation of purebred breeding
animals;
(b)     appropriate administrative
infrastructure;
(c)     staff been instructed to respect the
confidential nature of certain subjects, results or communications; 
(d)     staff with sufficient knowledge of
research activities at national, Union and international level;
(e)     the equipment and instruments needed
to carry out the duties and functions referred to in point (2).
2.           The duties and functions of the European
Union reference centres designated in accordance with
Article 31(1) shall be as follows:
(a)     to inform Member States on methods of
performance testing and genetic evaluation of purebred breeding animals based
on:
(i)      regularly receiving and reviewing the
results of performance testing and genetic evaluations carried out by breed
societies and the data on which they were based;
(ii)     comparing the various methods of
performance testing and genetic evaluation of purebred breeding animals;
(b)     at the request of the Commission or a
Member State to provide assistance:
(i)      in view of harmonising the various
methods of performance testing and genetic evaluation of purebred breeding
animals, in particular to recommend calculation methods to be used;
(ii)     in establishing a platform for the
comparison of the results of the methods of performance testing and genetic
evaluation of purebred breeding animals in Member States, in particular by:
–              
developing control protocols for performance
testing and genetic evaluation of purebred breeding animals carried out in
Member States to improve the comparability of results and the effectiveness of
breeding programmes;
–              
carrying out an international assessment of
livestock on the basis of the combined results of performance testing and
genetic evaluation of purebred breeding animals carried out in Member States;
–              
disseminating the individual results of the
international assessments;
–              
publishing the conversion formulae and all
related genetic work;
(iii)    in providing data on the genetic
evaluation of purebred breeding animals and training to support the designated
institution as provided for in Article 29(1) participating in international
comparisons of the results of genetic evaluations;
(iv)    in facilitating the resolution of
emerging problems in Member States linked to the genetic evaluation of purebred
breeding animals;
(v)     in providing, on request by the
Commission, technical expertise to the Standing Committee on Zootechnics.
ANNEX v
information to be provided in the zootechnical
certificates AS REFERRED TO IN CHAPTERs VI and VII
Part 1
General requirements
1.           Where the results of the genetic
evaluation of a breeding animal are publicly available on the Internet, it
shall be sufficient to refer in the zootechnical certificates referred to in
Parts 2 and 3 to the website where those results can be accessed.
2.           Where the information to be
provided in the zootechnical certificate in accordance with Chapters I and II
of Part 2 or Chapters I and II of Part 3 of this Annex is contained in other
documents accompanying the breeding animal or its germinal products, the breed
society or breeding operation shall:
(a)     certify the contents of that document with
a declaration that the document contains the information required by the
implementing act adopted pursuant to Article 33(4);
(b)     add to that declaration an exhaustive
list of the relevant attachments.
3.           The title of the zootechnical
certificate shall:
(a)     for live breeding animals, their
semen, oocytes or embryos make reference to the taxonomic species;
(b)     indicate if the consignment is intended
for intra-Union trade or for imports into the Union.
Part 2
Zootechnical certificates for purebred breeding animals,
their semen, oocytes and embryos
Chapter
I
Zootechnical certificates for purebred breeding animals
1.           Zootechnical certificates for purebred
breeding animals shall contain the following information:
(a)     the name of the issuing breed society
or, in case of imports into the Union, the breeding body;
(b)     the name of the breeding book; 
(c)     the breed;
(d)     the sex; 
(e)     the entry number in the breeding book
("Breeding-book No");
(f)     the system of identification of the purebred
breeding animal;
(g)     the identification number accorded to
the purebred breeding animal either in accordance with Union animal health
legislation pertaining to the identification of animals of the species covered
by the zootechnical certificate or, in case of imports into the Union, in
accordance with national legislation;
(h)     the date of birth of the purebred
breeding animal;
(i)      the name, address and e-mail of the
breeder;
(j)      the name and address of the owner;
(k)     the pedigree:
 Sire || Grandsire || Granddam 
 Breeding-book No || Breeding-book No || Breeding-book No 
 Dam || Grandsire || Granddam 
 Breeding-book No || Breeding-book No || Breeding-book No 
(l)      all available results of performance
tests and up-to-date results of the genetic evaluation including genetic
peculiarities and genetic defects on the purebred breeding animal itself and
its parents and grandparents as required in the breeding programme approved in
accordance with Art 8(1) or Article 9 for the category and the purebred
breeding animal in question;
(m)    in the case of pregnant females, the
date of insemination or mating and the identification of the fertilising male;
(n)     the name and title of the signatory,
the date and place of issue of the certificate and the signature of the
individual authorised by the issuing breed society, or in case of imports into the
Union, of the breeding body.
2.           By way of derogation from point 1
of this Chapter, the zootechnical certificate for trade in purebred breeding
animals of the equine species may be the identification document in accordance
with Union animal health legislation, provided:
(a)     it contains in addition to the
information required by Union animal health and public health legislation at
least the information in accordance with point 1 (a) to (k) and (n);
(b)     was issued by a breed society to which
the task of issuing the identification document was delegated by the competent
authority.
(c)     the information on the identity of
purebred breeding animals of the equine species and on the issuance of
identification documents is available to the competent veterinary authorities
in a central database established in accordance with Union animal health
legislation.
Chapter II
Zootechnical certificates for semen of purebred breeding animals
Zootechnical certificates for semen shall
contain the following information:
(a)          all the particulars referred to
in Chapter I of this Annex concerning the purebred breeding animal that
provided the semen as well as its blood group or test results providing
equivalent scientific guarantees to verify its identity and parentage in
accordance with any implementing acts adopted pursuant to Article 22(2);
(b)          information allowing the identification
of the semen, the date of its collection and the names and addresses of the
semen collection centre or semen storage centre and of the consignee;
(c)          for semen intended for official
testing of purebred breeding animals, the name and address of the breed society
or the institution designated in accordance with Article 29(1) responsible for
carrying out the performance testing in accordance with Article 27;
(d)          the name and title of the
signatory, the date and place of issue of the zootechnical certificate and the
signature of the individual authorised by the issuing breed society, or in case
of imports into the Union, of the breeding body.
Chapter
III
Zootechnical certificates for oocytes of purebred breeding animals
Zootechnical certificates for oocytes from purebred
breeding animals shall contain the following information:
(a)          all the information referred to
in Chapter I concerning the donor female that provided the oocytes as well as
its blood group or test results providing equivalent scientific guarantees to
verify its identity and parentage;
(b)          information allowing the identification
of the oocytes, the date of their collection and the names and addresses of the
embryo collection and production team and of the consignee;
(c)          where there is more than one oocyte
in a straw, a clear indication of the number of oocytes which must all have been
collected from the same purebred breeding animal;
(d)          the name and title of the
signatory, the date and place of issue of the zootechnical certificate and the
signature of the individual authorised by the issuing breed society, or in case
of imports into the Union, of the breeding body.
Chapter
IV
Zootechnical certificates for embryos of purebred breeding animals
Zootechnical certificates for embryos shall
contain the following information:
(a)          all the information referred to
in Chapter I concerning the donor female and the fertilising male as well as
both their blood groups or test results providing equivalent scientific
guarantees to verify their identity and parentage;
(b)          information allowing
identification of the embryo, the date of their collection or production and
the names and addresses of the embryo collection or production team and of the
consignee;
(c)          where there is more than one
embryo in a straw, a clear indication of the number of embryos which must all
have the same parentage;
(d)          the name and title of the
signatory, the date and place of issue of the zootechnical certificate and the
signature of the individual authorised by the issuing breed society, or in case
of imports into the Union, of the breeding body.
Part
3
Zootechnical certificates for hybrid breeding pigs and their semen, oocytes and
embryos
Chapter
I
Zootechnical certificates for hybrid breeding pigs
Zootechnical certificates for hybrid
breeding pigs shall contain the following information.
(a)          the name of the issuing breeding
operation or, in case of imports into the Union, the breeding body;
(b)          the name of the breed register; 
(c)          the genetic type or the line;
(d)          the sex; 
(e)          the entry number in the breed
register;
(f)          the system of identification of
the animal;
(g)          the identification number accorded
to the hybrid breeding pig either in accordance with Union animal health
legislation pertaining to the identification of animals of the porcine species
or, in the case of imports into the Union, in accordance with national
legislation;
(h)          the date of birth of the animal;
(i)           the name and address of the
breeder;
(j)           the name and address of the
owner;
(k)          the name and title of the
signatory, the date and place of issue of the zootechnical certificate and the
signature of the individual authorised by the issuing breeding operation, or in
case of imports into the Union, of the breeding body.
Chapter
II
Zootechnical certificates for semen from hybrid breeding pigs
Zootechnical certificates for semen of
hybrid breeding pigs shall contain the following information.
(a)          all the information referred to in
Chapter I concerning the hybrid breeding pig that provided the semen;
(b)          information allowing the identification
of the semen, the date of its collection and the names and addresses of the
semen collection centre and of the consignee;
(c)          the name and title of the
signatory, the date and place of issue of the zootechnical certificate and the
signature of the individual authorised by the issuing breeding operation or, in
case of imports into the Union, the breeding body.
Chapter III
Zootechnical certificates for oocytes from hybrid breeding pigs
Zootechnical certificates for oocytes of
hybrid breeding pigs shall contain the following information.
(a)          all the information referred to
in Chapter I concerning the hybrid breeding pig that provided the oocytes;
(b)          information allowing
identification of the oocytes, the date of their collection and the names and
addresses of the embryo collection or production team and of the consignee;
(c)          the name and title of the
signatory, the date and place of issue of the zootechnical certificate and the
signature of the individual authorised by the issuing breeding operation or, in
case of imports into the Union, the breeding body.
Chapter
IV
Zootechnical certificates for embryos from hybrid breeding pigs
Zootechnical certificates for embryos
collected or produced from hybrid breeding pigs shall contain the following information.
(a)          all the information referred to
in Chapter I concerning the donor female and the fertilising male;
(b)          the date of embryo or oocyte collection,
the names and addresses of the embryo collection or production team and of the
consignee; the identification of the semen used for artificial insemination or
the fertilisation of the oocytes;
(c)          where there is more than one
embryo in a straw, a clear indication of the number of embryos which must all
have the same parentage;
(d)          the name and title of the
signatory, the date and place of issue of the zootechnical certificate and the
signature of the individual authorised by the issuing breeding operation or, in
case of imports into the Union, the breeding body.
ANNEX VI
TERRITORIES
REFERRED TO IN ARTICLE 2(u)
1.           The territory of the Kingdom of
Belgium
2.           The territory of the Republic of
Bulgaria
3.           The territory of the Czech
Republic
4.           The territory of the Kingdom of
Denmark with the exception of the Faroe Islands and Greenland
5.           The territory of the Federal
Republic of Germany
6.           The territory of the Republic of
Estonia
7.           The territory of Ireland
8.           The territory of the Hellenic
Republic
9.           The territory of the Kingdom of
Spain with the exception of Ceuta and Melilla
10.         The territory of the French
Republic
11.         The territory of the Republic of
Croatia
12.         The territory of the Italian
Republic
13.         The territory of the Republic of
Cyprus
14.         The territory of the Republic of
Latvia
15.         The territory of the Republic of
Lithuania
16.         The territory of the Grand Duchy
of Luxembourg
17.         The territory of Hungary
18.         The territory of the Republic of
Malta
19.         The territory of the Kingdom of
the Netherlands in Europe
20.         The territory of the Republic of
Austria
21.         The territory of the Republic of
Poland
22.         The territory of the Portuguese
Republic
23.         The territory of Romania
24.         The territory of the Republic of
Slovenia
25.         The territory of the Slovak
Republic
26.         The territory of the Republic of
Finland
27.         The territory of the Kingdom of
Sweden
28.         The territory of the United
Kingdom of Great Britain and Northern Ireland
ANNEX VII
Correlation
Table
 Legal Act || Provisions || Corresponding provisions in this Regulation 
 Council Directive 2009/157/EC (ex 77/504/EEC) (Bovine) || Article 1 || Article 2 
 Article 2(a),(b), (e) || Article 3, first paragraph 
 Article 2(c) || Article 8(1) 
 Article 2(d) || Article 4(2) 
 Article 3 || Article 19(1) 
 Article 4(1) || Article 7(1) 
 Article 4(2) || Article 7(5) 
 Article 5 || Article 33(1) and point 1(d) of Chapter I of Part 1 of Annex II 
 Article 6 || Articles 28(1), 4(3), 8(3), 17(4), 19(4), 20(2) and 24(2) 
 Article 7(1) || Article 72(1) 
 Article 7(2) || Article 72(2) 
 Article 8 || n.a. 
 Article 9 || n.a. 
 Article 10 || n.a. 
 Article 11 || n.a. 
 Council Directive 87/328/EEC (acceptance for breeding) || Article 1 || Article 21 
 Article 2(1) || Article 23(1) and (2) 
 Article 2(2) || Articles 12, 13, and 28(2) 
 Article 2(3) || - 
 Article 3 || Article 22 
 Article 4 || Article 23(3) 
 Article 5 || Article 31(1) 
 Article 6 || n.a 
 Article 7 || n.a. 
 Council Decision 96/463/EC (Interbull) || Article 1(2) || Article 32(1) 
 Article 2 || - 
 Annex II || Annex IV 
 Council Directive 88/661/EEC (Porcine) || Article 1 || Article 2 
 Article 2(1) || Articles 3, first paragraph, 4(2) and 8(1) 
 Article 2(2) || Article 1(3) 
 Article 3 || Article 21(2) 
 Article 4(1) || Article 19(1) 
 Article 4(2) || Article 18(1) 
 Article 4a, first paragraph || Article 7(1) 
 Article 4a, second paragraph || Article 7(5) 
 Article 5 || Article 33(1) and point 1(d) of Chapter I of Part 1 of Annex II 
 Article 6(1) || Articles 28(1), 8(3), 17(4), 19(4), 4(3), and 33(3) 
 Article 6(2) || n.a. 
 Article 7(1) || Articles 3, 8(1) and 4(2), 
 Article 7(2) || Article 1(3) 
 Article 7a || Article 7(1) 
 Article 8 || Article 25(2) 
 Article 9 || Article 33(1) and point 1(c) of Part 2 of Annex II 
 Article 10 (1) || Articles 28(1), 8(3), 17(4), 19(4), 4(3), and 33(3) 
 Article 10 (2) || n.a. 
 Article 11(1) || Article 72(1) 
 Article 11(2) || Article 72(2) 
 Article 11(3) || Article 72(2) 
 Article 12 || Article 1(3) 
 Article 13 || n.a. 
 Article 14 || n.a. 
 Council Directives 90/118/EEC (acceptance for breeding – purebred || Article 1 || Article 21(1) 
 Article 2(1) || Article 23(1) and (2) 
 Article 2(2) || Articles 12, 13 and 28(2) 
 Article 2(3) || Articles 14 and 28(2) 
 Article 3 || Article 23(3) 
 Article 4 || Article 72(1) 
 Article 5 || n.a. 
 Article 6 || n.a. 
 Council Directive 90/119/EEC (acceptance for breeding – hybrid) || Article 1 || Article 25(1) and Article 26(1) and(2) 
 Article 2 || Article 23(3) 
 Article 3 || n.a. 
 Article 4 || n.a. 
 Council Directive 89/361/EEC (Ovine & Caprine) || Article 1(1) || Article 1(1) 
 Article 1(2) || Article 1(3) 
 Article 2 || Article 2 
 Article 3(1) || Articles 3, first paragraph, and 4(2), 
 Article 3(2) || Article 1(3) 
 Article 4 || Articles 4(3), 19(4), 28(1) and 21(2) 
 Article 5 || Article 7(1) 
 Article 6 || Article 33(1) and point 1(d) of Chapter I of Part 1 of Annex II 
 Article 7 || Article 1(3) 
 Article 8 || Article 72(1) 
 Article 9 || n.a. 
 Article 10 || n.a. 
 Council Directive 90/427/EEC (Equidae) || Article 1 || Article 1(1) 
 Article 2 || Article 2 
 Article 3, first paragraph || Article 3, first paragraph 
 Article 3, second paragraph || Article 1(3) 
 Article 4(1)(a) || Part 1 and point 1(a) of Part 3 of Annex I 
 Article 4(1)(b) || Point 1(c) of Chapter I of Part 1 of Annex II 
 Article 4(2) || Articles 4(3), 19(4), 33, 34(1)(c), 14 and point 1(c) of Chapter I of Part 1 of Annex II 
 Article 5 || Article 7(1) 
 Article 6 || Point 3 of Chapter I of Part 1 of Annex II 
 Article 7 || Articles 28(1) and 21(2) 
 Article 8(1) || Point 1(c) of Chapter I of Part 1 of Annex II 
 Article 8(2) || Article 33(1) 
 Article 9 || Article 1(3) 
 Article 10 || Article 72(1) 
 Article 11 || n.a. 
 Article 12 || n.a. 
 Annex || n.a. 
 Council Directive 91/174/EEC (all) || Article 1 || Article 2 
 Article 2 || Articles 3, 35(1) and 45(1) 
 Article 3 || n.a. 
 Article 4 || n.a. 
 Article 5 || n.a. 
 Article 6 || n.a. 
 Article 7 || n.a. 
 Article 8 || n.a. 
 Council Directive 94/28/EC Imports || Article 1 || Article 1 
 Article 2 || Article 2 
 Article 3 || Articles 37 
 Article 4 || Articles 39(1)(a) and 40(1) 
 Article 5 || Articles 39(1)(b) and 40(1) 
 Article 6 || Articles 39(1)(c) and 40(1) 
 Article 7 || Articles 39(1)(c) and 40(1) 
 Article 8 || Article 39(2) 
 Article 9(1) and (2) || Article 42 
 Article 9(3) || - 
 Article 10 || Articles 67 and 70 
 Article 11 || n.a. 
 Article 12 || Article 72(1) 
 Article 13 || n.a. 
 Article 14 || n.a. 
 Article 15 || n.a. 
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[46]             http://www.ueln.net/