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

Model Format - Dairy

43

44

45

Landscape - Dairy

46

47

Landscape Beef

48

49

Commission Implementing Regulation 2017/717 Annex I Section B (page15)

Semen

50

51

52

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

If not

Any questions??

Thank you!

56