2003/100/EC: Commission Decision of 13 February 2003 laying down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep (Text with EEA relevance) (notified under document number C(2003) 498)
Date: 2003-02-13
Institutions: European Commission
Subjects: agricultural policy, disease prevention, exchange of information, livestock farming, sheep, veterinary legislation

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(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 13 February 2003

laying down minimum requirements for the establishment of breeding programmes for resistance
to transmissible spongiform encephalopathies in sheep

(notified under document number C(2003) 498)

(Text with EEA relevance)

(2003/100/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty establishing the European
Community,

the
Having regard to Regulation (EC) No 999/2001 of
European Parliament and of the Council of 22 May 2001 laying
down rules for the prevention, control and eradication of
certain transmissible spongiform encephalopathies (1), as last
amended by Commission Regulation (EC) No 1494/2002 (2),
and in particular Article 23 thereof,

Whereas:

(1)

(2)

(3)

Scrapie poses a considerable animal health problem
within the Community's ovine and caprine population.

There is no validated routine diagnostic method to
distinguish between Bovine spongiform encephalopathy
(BSE) and scrapie infection in ovine and caprine animals.
BSE infection has not been proven to exist in ovine and
caprine animals under natural conditions. However,
there is some uncertainty as to whether BSE may have
infected the ovine and caprine population and may still
be present in that population. Accordingly transmissible
spongiform encephalopathy (TSE)
infections in ovine
and caprine animals also pose a potential risk to public
health.

Research has shown that certain prion protein genotypes
in sheep confer resistance to scrapie. Evidence to date
indicates that a similar genetically determined resistance
to BSE exists in sheep when challenged orally with BSE
infection under experimental conditions.

The opinion of the Scientific Steering Committee (SSC)
of 4 and 5 April 2002 on safe sourcing of small rumi-
nant materials laid down guidelines for the main points
in a breeding programme for TSE resistance in sheep.
The SSC considers that such a programme should be
targeted at populations at risk or risk areas.

(5)

(6)

(7)

One requirement for such a breeding programme is an
approximation of the frequency of ARR/ARR sheep for
each important breed. To obtain this
information,
Commission Decision 2002/1003/EC (3) has introduced
a survey of the sheep breeds in the Member States.

It should be possible to derogate from the requirement
to establish a breeding programme in accordance with
this Decision for certain breeds with a low natural level
of resistance and for local breeds indigenous to the area
and in danger of being lost to farming as referred to in
Regulation (EC) No 445/2002 of 26 February 2002
laying down detailed rules for the application of Council
Regulation (EC) No 1257/1999 on support for rural
development from the European Agricultural Guidance
and Guarantee Fund (EAGGF) (4).

In its opinion, the SSC recommended the establishment
of the certification of flocks with a negligible risk of
scrapie/BSE. One of the options recommended is the
certification of flocks based on full genetic resistance to
TSEs combined with regular TSE testing.

(1) OJ L 147, 31.5.2001, p. 1.
(2) OJ L 225, 28.8.2002, p. 3.

(3) OJ L 349, 24.12.2002, p. 105.
(4) OJ L 74, 15.3.2002, p. 1.

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(8)

(9)

The SSC recommended a comprehensive list of tissues in
ovine and caprine animals which might be considered to
pose a risk to human and animal health in the event of
BSE being confirmed or considered probable. However,
the opinion considered that these tissues would not pose
any significant risk when derived from resistant and
semi-resistant animals under the age of 18 and 6 months
respectively. It is appropriate to promote the develop-
ment of certified flocks along these lines.

The Commission will propose to the Council and Parlia-
ment an amendment to Regulation (EC) No 999/2001 to
provide a legal basis in that Regulation for the measures
contained in this Decision. In the meantime, it is appro-
priate to adopt this Decision as a transitional measure.

(10)

The measures provided for in this Decision are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Definitions

— when the Commission has recognised its territory as being
free from scrapie in accordance with point (c) of Part I of
Chapter A of Annex VIII to Regulation (EC) No 999/2001,
based on the results of a conclusive statistical survey.

The derogation provided for in paragraph 1 shall be
2.
adopted in accordance with the procedure referred to in Article
24(2) of Regulation (EC) No 999/2001.

Article 4

Framework to recognise the TSE-resistant status of certain
sheep flocks

1.
By 1 January 2004, each Member State shall establish a
framework for the recognition of the TSE-resistant status of
certain sheep flocks.

This framework shall follow the criteria set out in Annex II.

2.
The recognition of the TSE-resistant status of a flock
under the framework provided for in paragraph 1 shall not be
considered a necessary criterion to exclude the presence of a
TSE in that flock.

Article 5

For the purposes of this Decision the definitions set out in
Annex I to Commission Decision 2002/1003/EC shall apply.

Reports to be provided to the Commission by the Member
States

Article 2

Member States
following reports:

shall provide

the Commission with the

Breeding programme for TSE resistance in pure-bred
sheep

(a) report on the requirements of their breeding programmes

as provided for in Article 2 by 1 April 2004;

1.
By 1 January 2004, on the basis of the outcome of the
survey provided for in Decision 2002/1003/EC, each Member
State shall introduce a breeding programme to select for resis-
tance to TSEs in each of its sheep breeds which are native, or
which form a significant population in its territory. The
minimum requirements for such a programme shall be those
set out in Annex I.

The Member State may decide that participation by flock
2.
owners in the breeding programme referred to in paragraph 1
shall be voluntary until 1 April 2005. However, after that date,
it shall be compulsory for all flocks of high genetic merit to
participate in the breeding programme.

(b) an annual progress report to be provided for the first time
by 1 April 2005, of the progress made in the breeding
programmes.

Article 6

Summary of reports by the Commission to the Member
States

The Commission shall present to the Member States a summary
of the reports it receives under Article 5, within three months
of the deadline for the receipt of the reports.

Article 3

Derogations

Article 7

Review

1. Member States may be granted a derogation from the
requirement to establish a breeding programme as provided for
in Article 2:

— on the basis of a national scrapie control programme
submitted and approved in accordance with point (b) of
Part I of Chapter A of Annex VIII to Regulation (EC) No
999/2001, which includes continuous active monitoring of
dead-on-farm ovine and caprine animals in all flocks in the
Member State, or

The requirements of this Decision shall be reviewed:

(a) on the basis of reports referred to in Article 5,

(b) in respect of breeds for which a serious negative genetic
effect has been demonstrated during the course of
the
breeding programme,

(c) in any event before 1 April 2005, to take account of any

new scientific advice.

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Article 8

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 13 February 2003.

For the Commission

David BYRNE

Member of the Commission

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MINIMUM REQUIREMENTS FOR A BREEDING PROGRAMME FOR RESISTANCE TO TSEs IN SHEEP

ANNEX I

Part 1 — General requirements

1. The breeding programme shall concentrate on flocks of high genetic merit.

2. A database shall be established containing at least the following information:

(a) the identity, breed and number of animals in all flocks participating in the breeding programme;

(b) the identification of the individual animals sampled under the breeding programme;

(c) the results of any genotyping tests.

3. A system of uniform certification shall be established in which the genotype of each animal sampled under the

breeding programme is certified by reference to its individual identification number.

4. Sampling shall be carried out by personnel specifically designated for this purpose under the breeding programme.

5. A system for the identification of animals and samples, the processing of samples and the delivery of results shall be
established which minimises the possibility of human error. The efficiency of this system shall be subject to regular
random checking.

6. Genotyping of blood or other tissues collected for the purposes of the breeding programme shall be carried out in

laboratories that have been approved under the scheme.

7. The competent authority of the Member State may assist breed societies who wish to do so, to establish genetic banks
consisting of semen, ova and/or embryos representative of prion protein genotypes which are likely to become rare
as a result of the breeding programme.

8. Breeding programmes shall be drawn up for each breed, taking account of:

(a) frequencies of the different alleles within the breed;

(b) rarity of the breed;

(c) avoidance of inbreeding or genetic drift.

Part 2 — Specific rules for participating flocks

1. The breeding programme shall be aimed at increasing the frequency of the ARR allele within the sheep flock, while

reducing the prevalence of those alleles which have been shown to contribute to susceptibility to TSEs.

2. The minimum rules for participating flocks shall be:

(a) all animals in the flock that are to be genotyped shall be individually identified using secure means;

(b) it shall be compulsory for all rams intended for breeding within the flock to be genotyped before being used for

breeding;

(c) it shall be compulsory to slaughter or castrate, within six months following the determination of its genotype,

any male animal carrying the VRQ allele; any such animal shall not leave the holding except for slaughter;

(d) it shall be prohibited for female animals that are known to carry the VRQ allele to leave the holding except for

slaughter;

(e) it shall be prohibited for male animals, including semen donors used for artificial insemination, other than those

certified under the programme, to be used for breeding within the flock.

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Part 3 — Protection of breeds and production traits

1. Member States may decide to grant a derogation from the requirements of point 2(c) and (d) of Part 2, in the case of

breeds:

(a) which display a level of the ARR allele below 25 % in the survey referred to in Decision 2002/1003/EC; or

(b) which are in danger of being lost to farming, as referred to in Article 14(1)(a) of Regulation (EC) No 445/2002.

2. In the case of breeds which display an absence, or a level of less than 10 %, of the ARR allele in the survey referred
to in Commission Decision 2002/1003/EC, Member States may decide to grant a derogation from Parts 1 and 2,
subject to the condition that such breeds shall be subject to scrapie control programmes.

3. Member States shall inform the Commission of derogations granted under points 1 and 2 and of the criteria used.

ANNEX II

THE FRAMEWORK FOR THE RECOGNITION OF THE TSE-RESISTANT STATUS OF FLOCKS OF SHEEP

1. The framework shall recognise the TSE-resistant status of flocks of sheep that, whether as a result of participation in

the breeding programme as provided for in Article 2 or otherwise, satisfy certain criteria.

This recognition shall be granted on at least two levels:

(a) level I flocks shall be flocks composed entirely of sheep of the ARR/ARR genotype;

(b) level II flocks shall be flocks whose progeny have been sired exclusively by rams of the ARR/ARR genotype.

Member States may decide to grant recognition on further levels to suit national requirements.

2. Regular random sampling of sheep from TSE-resistant flocks shall be carried out:

(a) either on the farm or at the slaughterhouse to verify their genotype;

(b) in the case of level I flocks, in animals over 18 months of age at the slaughterhouse, for TSE testing in accordance

with Annex III to Regulation (EC) No 999/2001.