Post on 23-Nov-2021
Information session on the New Animal Breeding Regulation
(ABR)
20 February 2018
Nicola Hobson
Agriculture Inspector
Livestock Breeding, Production and Trade Division
1
Zootechnical: a Definition
• Zootechny is the scientific art of maintaining
and improving animals under domestication,
including breeding, genetics, nutrition and
housing.
2
Agenda
• Overview of Animal Breeding legislation
– Context
– Regulation 2016/1012
– Zootechnical Certificates
• Commission Implementing Regulation 2017/717
• What happens next?
• Questions and Answers
3
CONTEXT OF CURRENT LEGISLATION
• The aims of Union zootechnical legislation is for the promotion
of free trade in breeding animals and their genetic material
considering the sustainability of breeding programs and
preservation of genetic resources
• Existing legislation for the bovine, equine, ovine and caprine,
porcines and other breeding animals consists of Council
Directives and Commission Decisions (approx 33 pieces of
legislation)
• Considerable amount of overlap between different pieces of
legislation
4
Animal Breeding Regulation
What is it?
• provides a single legal framework for the rules applicable to the
breeding, trade and entry into the Union of breeding animals of the
bovine, porcine, ovine, caprine and equine species and their
germinal products
• Known as “Regulation (EU) 2016/1012 Animal Breeding Regulation”
• Consists of 13 Chapters, 69 Articles, 7 Annexes in 143 pages
• Opportunity for harmonisation between Member States
5
Purpose of the Regulation?
• to consolidate existing rules for the promotion of free trade in
breeding animals and their germinal products, and to update
those rules to technical advances and established practices
while protecting genetic diversity
• to promote cross-border activities of breed societies providing
their services under fair competition conditions
• to simplify the legislative framework in a single Regulation
• to establish rules on official controls and activities
6
The Process –
• First working group meeting of Member States
representatives was held in March 2014 and continued to
October 2015
• Draft legislation was examined article by article, amended and
re-examined at working group meetings
• Throughout process draft versions were circulated to
stakeholders for observations
• Final version voted by EU Parliament and EU Council
• Was published in the EU Official Journal on 29 June 2016
• Came in to force on 19 July 2016 which gives it legal basis
• Applies from 1 November 2018
• Number of information meetings hosted by Commission
7
CHAPTER I (Articles1-3) General
Provisions
• Definitions (26)
– ‘breed’ means a population of animals sufficiently uniform to be
considered to be distinct from other animals of the same
species by one or more groups of breeders which have agreed
to enter those animals in breeding books with details of their
known ascendants for the purpose of reproducing their
inherited characteristics by way of reproduction, exchange and
selection within the framework of a breeding programme;
– ‘breeding animal’ means a purebred breeding animal or a
hybrid breeding pig
– ‘purebred breeding animal’ means an animal which is entered
or registered and eligible for entry in the main section of a
breeding book;
– ‘germinal products’ means semen, oocytes and embryos
collected or produced from breeding animals for the purpose of
assisted reproduction
8
- ‘hybrid breeding pig’ means an animal of the porcine species
registered in a breeding register, which is produced by deliberate
cross-breeding or used for deliberate cross-breeding between:
a) purebred breeding pigs of different breeds or lines;
b) breeding pigs which are themselves the outcome of a cross
(hybrid) between different breeds or lines;
c) breeding pigs belonging to one or the other of the categories
referred to in (a) or (b);
- ‘line’ means a genetically stable and uniform subpopulation of
purebred breeding animals of a particular breed;
- ‘private undertaking operating in a closed production
system’ means a private undertaking with a breeding
programme in which participate either no breeders or a restricted
number of breeders who are bound to that private undertaking to
accept from it the supply of hybrid breeding pigs or to supply
hybrid breeding pigs to it;
9
– ‘breed society’ (BS) means any breeders' association, breeding
organisation or public body, other than competent authorities, which
is recognised by the CA of a MS… for the purpose of carrying out a
breeding programme on purebred breeding animals entered in the
breeding book(s) it maintains or establishes;
– ‘breeding operation’ (BO) means any breeders' association,
breeding organisation, private undertaking operating in a closed
production system or public body, other than CA, which is recognised
by the competent authority of a MS… for the purpose of carrying out
a breeding programme on hybrid breeding pigs registered in the
breeding register(s) it maintains or establishes;
– ‘breeding body’ means any breeders' association, breeding
organisation, private undertaking, stock-rearing organisation or
official service in a third country which, in respect of purebred
breeding animals of the bovine, porcine, ovine, caprine or equine
species or of hybrid breeding pigs, has been accepted by that third
country in connection with the entry into the Union of breeding
animals for breeding;
10
– ‘competent authority’ (CA) means the authorities of a MS
which are responsible, …(a) the recognition … and the
approval…; (b) official controls…; (c) the provision of
assistance…; (d) official activities …;
– ‘breeding book’ means:
(a) any herd-book, flock-book, stud-book, file or data medium
which is maintained by a breed society consisting of a main
section and, where the breed society so decides, of one or
more supplementary sections for animals of the same
species that are not eligible for entry in the main section;
(b) where appropriate, any corresponding book maintained by
a breeding body;
- ‘breeding register’ means:
(a) any file or data medium which is maintained by a breeding
operation in which hybrid breeding pigs are registered with
details of their ascendants;
(b) where appropriate, any corresponding register maintained
by a breeding body;
11
– ‘breeding programme’ means a set of systematic actions,
including recording, selection, breeding and exchange of
breeding animals and their germinal products, designed and
implemented to preserve or enhance desired phenotypic and/or
genotypic characteristics in the target breeding population.
– ‘main section’ means the section of a breeding book in which
purebred breeding animals are entered or registered and
eligible for entry with details of their ascendants and, where
applicable, their merits;
– ‘zootechnical certificate’ means breeding certificates,
attestations or commercial documentation which are issued on
paper or in electronic form for breeding animals and their
germinal products and which provide information on pedigree,
identification and, where available, results of performance
testing or genetic evaluation;
– ‘trade’ means the action of buying, selling, exchanging or
otherwise acquiring or releasing animals or their germinal
products within the Union, including within a Member State;
12
13
• Provides legal basis for – Trade in breeding animals and their germinal products within
EU and entry into the Union*
– Rules for recognition of BS and BO and approvals of their
breeding programmes
– Rights of obligations of breeders, BS and BO*
– Rules for entry of breeding animals
– Rules of performance and genetic evaluation of breeding
animals
– Rules for the issuing of zootechnical certificates
– Rules for performance of official controls*
– Rules for assistance and cooperation between MSs*
– Rules for the performance of controls by the Commission in
MSs and third countries*
*new
• Regulation applies to – breeding animals and their germinal products where those
animals or the offspring resulting from those germinal
products are intended to be entered as purebred breeding
animals in a breeding book or registered as hybrid breeding
pigs in a breeding register
– Exceptions (technical/scientific experiments, BO in closed
production systems)
14
CHAPTER II (Articles 4-12)
Recognition and approval
• Two stage process
– 1) recognition of BS/BO
– 2) approval of breeding programmes
• Application process for each stage (paper or electronic)
• Can be simultaneous applications
15
Recognition Process of BS/BO
• Head office where CA located
• Requirements listed in Annex 1Part 1(BS/BO)
– legal personality
– adequate resources
– procedures in place for recording pedigree
– sufficient population of breeding animals
– capable of generating and using data necessary
for carrying out breeding programme
16
• BS shall also
– Sufficient number of breeders participating
in breeding programme
– Rules of procedures including appeal, non-
discrimination and rights and obligations
• Minimum draft breeding programme
which includes details outlined in Annex
1 Part 2
• Refusal /appeal process
• MSs to publically list recognised BS/BO
17
Approval of Breeding Programmes
• Breeding programme evaluated on • the aims
• the selection and breeding objectives
• requirements listed in Annex 1 Part 2
• Provision to outsource to third parties
• Significant changes require approval
• Provision for CA to refuse
18
Annex 1 Part 2 – main points • Information on its aim
• Name of breed
• Detailed characteristics including indication of it essential traits
• Information on the geographical territory covered
• System of identification
• System for recording pedigrees
• Selection and breeding objectives
• Systems of performance testing and genetic testing where
required
• Division of the breeding book
• Details where outsourcing of technical activities
• Zootechnical certificate – derogation
19
Extension of Geographical Activity
• Where a BS/BO intend to carry out their
breeding programme on breeding animals in
another MS
• DAFM must notify the CA of other MS
• May have to provide a translation of the breeding
programme in language of the other MS
• Timelines
• Provide up-to-date information on request
• Provision to refuse/withdraw approval
20
CHAPTER III (Articles 13 - 14)
Rights and Obligations • Breeders shall have rights
– to participate in the breeding programme if their
animals are located in the geographical territory
and covered by the breeding programme
– to have their animals
entered/recorded/registered in the appropriate
section
– to participate in performance testing and genetic
evaluation and obtain up-to-date results where
available
21
22
– to be provided with a zootechnical
certificate
– avail of the services as outlined in the
breeding programme
– where members, right to participate in
defining and developing the breeding
programme
• BS/BO shall have the rights
– to exclude breeders that fail to comply with
the rules of the breeding programme
– to exclude breeders where members do
not comply with obligations set out in the
rules of procedure
– BS/BO have an obligation to settle
disputes between breeders and between
breeders and the BS/BO
23
CHAPTER IV (Articles 15 - 24)
Entry of breeding animals and
acceptance of breeding • Structure of breeding book – (Annex II)
– No change from current legislation
– Main section: parents and grandparents entered,
pedigree established, identified according to union
animal health law and rules of breeding programme,
zootechnical certificate where traded or entered into
Union
– Supplementary section: identified according to union
animal health law and rules of breeding programme,
judged to conform to breed characteristics, meet
minimum performance requirements for traits tested
24
25
• Upgrading of progeny:
• females only
• father and two grandfathers entered in main section of same
breed, mother and maternal grandmother recorded in
supplementary section of same breed
• first generation offspring from this female and purebred male
shall be regarded as purebred i.e. eligible to be entered in
main section
• Hybrid Breeding Pigs: parents and grandparents
entered in breeding books or registered in breeding
register, identified according to union animal health
law and rules of breeding programme
• Derogations regards entry in relation to creation
of a new breed, reconstruction of a breed for
endangered breeds
• List of conditions for acceptance e.g. • For AI, a breed society shall accept semen collected from purebred breeding
animals which have undergone genetic evaluation (Exception test sires);
• As above for embryos and oocytes
• For intra-Union trade germinal products must be from approved
collection/storage centres or approved collection/production teams
• DNA analysis required of purebred breeding
animals where semen (except porcines) and
oocytes and embryos are collected
• Specific requirements for registration of hybrid
pigs (Articles 23 and 24)
26
CHAPTER V (Articles 25 - 28)
Performance testing and genetic
evaluation
• Performance testing or genetic evaluation carried out
according to the rules set out in Annex III (e.g. rules
and standards established by Interbull/principles
agreed by ICAR)
• Details to be included in breeding programme
• Breed societies have option to outsource
performance testing or genetic evaluation to
designated third parties
27
28
• MS must authorise and designate the third party and
MS shall oversee their compliance
• BS/BO to make publicly available who is carrying out
the performance testing or genetic evaluation
• Require that the results of the genetic evaluation of
breeding animals whose semen is used for AI are
publicly available and keep up-to-date
CHAPTER VI (Article 29)
EU reference centre
• Designation of European Union
reference centre
• Public call took place regarding the
bovine species
• Commission Implementing Regulation
2017/1422 designated Interbull Centre
29
CHAPTER VII (Article 30 - 33)
Zootechnical Certificates
• Concern the issuing, content and format
of zootechnical certificates
• Relates to
– Commission Delegated Regulation
2017/1940 (equine only)
– Commission Implementing Regulation
2017/717
(other species including all germinal products)
• Return to it at end!
30
CHAPTER VIII (Article 34 - 37)
Entry into the Union
• Commission shall maintain, update and
publish a list of breeding bodies
• Breeding animal entitled to enter where
– Entered in breeding book of third country
which is listed by EU
– Germinal products meet the conditions of
the breeding programme where specified
– Meet the characteristics of the breed
31
CHAPTER IX (Article 38)
CA carrying out a breeding
programme
• Outlines where a CA can carry out a
breeding programme
32
CHAPTER X (Article 39 - 52)
Official Controls
• Up to date list of designated competent
authorities (CA) maintained by
Commission
• Section on official controls to be
performed by CA
• Written records to be maintained
• Access and assistance by operators
33
• Provides for actions where non-
compliance is established
• Right to appeal
• Cooperation and administrative assistance
between MSs
• Non-compliance by third countries
• Involvement by Commission
34
CHAPTER XI (Article 53 - 60)
Commission Controls
• Provisions for Commission to undertake
controls in
– MSs and
– third countries
35
CHAPTER XII (Article 61 - 63)
Delegation and implementation
• Confers powers on the Commission to
adopt delegated acts and implementing
acts
• Lists the Articles which refers to these
requirements
• Requires Commission to consult with
MS’s experts for delegated acts
36
CHAPTER XIII (Article 64 - 69)
Final provisions
• Lists Directives to be repealed
• Organisations and breeding programmes
approved under existing Directives shall be
considered to be recognised under this Regulation
• However, subject to rules of this Regulation
• Notification of geographical extension
• Requirement of MS to provide national laws
• Regulation applicable from 1 NOVEMBER 2018
37
Zootechnical Certificates
• Zootechnical Certificates Chapter VII (Article
30 - 33)
• Commission Implementing Regulation
2017/717 (other species and germinal
products for all species)
38
CHAPTER VII (Article 30 - 33) • Zootechnical certificates to be issued in a timely
manner
– on request by breeders for their breeding
animals/hybrid breeding pigs or
– where the breeding animal/germinal products
are traded
• Not applicable to supplementary section animals
• Breeding animals/hybrid breeding pigs/germinal
products entering EU must be accompanied by a
zootechnical certificate
39
• Format and Layout
– Annex V sets out the information to be included
– Commission Implementing Regulation 2017/717 lays down the
model form of the zootechnical certificate to be used
– Inclusion of results (in accordance with breeding programme)
of performance testing/genetic evaluations/genetic defects and
genetic peculiarities
• Derogations
– the CA may authorise that for germinal products the
zootechnical certificate can be issued by an approved semen
collection or storage centre, or by an embryo collection or
production team, on the basis of the information received from
the BS/BO
– the CA may authorise the non-use of the model form where
information in other documents
– reference to website where results can be accessed
40
Commission Implementing Regulation
2017/717
• Contains three annexes
1. For purebred breeding animals (excl
equines) and their germinal products
2. For hybrid breeding pigs and their
germinal products
3. For all above to accompany
consignments on entry into the Union
• Each annex split into sections
41
Draft Zootechnical Certificates
• Based on the model format provided
– Dairy
• Other options
– Dairy
– Beef
• Semen model format
42
Clarifications submitted to the Commission
• Portrait vs landscape?
• Moving of boxes?
• Inclusion of headings and numbers?
• Inclusion of numbering system for each point with
corresponding heading printed on reverse i.e. like a
footnote?
• Combining of headings e.g. 2&3 ‘name of breeding
book’ and ‘name of breed of purebred animal’?
• Point 14 on ‘Insemination/mating’ included on a
different document e.g. AI docket??
• Derogation for non-use of model forms – how is this
to be interpreted?
53
What next?
• Breed Societies/Breed Operations
– Review structures in relation to requirements for
recognition (Annex 1 Part 1)
– Review breeding programmes and amend accordingly
– Where any activities outsourced establish a service level
agreement
– Develop format and layout of zootechnical certificates
according to model formats
– Consider extent of geographical activity
– Send in any queries/clarifications now
54
• Department
– Have commenced developing national legislation to
transpose CR 2016/1012
– Clarifications on the impact of Brexit
– Amending list of recognised BS/BO according to
Commission Implementing Regulation 2017/716
– Designation of third parties for performance testing and
genetic evaluation (bovines and ovines) (Chapter V)
– Determining geographical activity for BS/BO
– Review zootechnical certificates in advance
– Updating our internal control procedures
– Next working group meeting in Brussels 8 March
Everything to be in place by
1 November 2018
255 days to go
55