Commission Regulation (EC) No 2245/2003 of 19 December 2003 amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in ovine and caprine animals
Date: 2003-12-19
Institutions: European Commission
Subjects: animal disease, disease prevention, goat, health control, public health, sheep

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COMMISSION REGULATION (EC) No 2245/2003

of 19 December 2003

amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the
Council as regards monitoring of transmissible spongiform encephalopathies in ovine and caprine
animals

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 999/2001 of the Euro-
pean Parliament and of the Council of 22 May 2001 laying
down rules for the prevention, control and eradication of
certain transmissible spongiform encephalopathies (1), and in
particular the first paragraph of Article 23 thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 999/2001 lays down rules for the
monitoring of transmissible spongiform encephalopathy
(TSE) in ovine and caprine animals.

for ovine and
Separate sample sizes should be set
caprine animals to make it easier to interpret results of
testing for TSEs.

Monitoring of large numbers of ovine animals slaugh-
tered for human consumption in Member States with
large sheep populations has made it possible to estimate
the prevalence of TSEs in those populations. The level of
monitoring in large sheep populations should therefore
be reduced. Monitoring of ovine animals slaughtered for
human consumption in Member States with small sheep
populations provides limited information and should
therefore no longer be compulsory.

Monitoring of sufficiently large numbers of caprine
animals slaughtered for human consumption to detect
the likely prevalence of TSEs in this group is difficult or
impractical in most Member States. Monitoring in that
group should therefore no longer be compulsory.

(5)

(6)

(7)

Monitoring of dead-on-farm stock in both ovine and
caprine animals should be increased, to provide informa-
tion on prevalence of TSE and to aid eradication of the
disease. Member States should take measures to ensure
that
infected animals are not diverted away from
sampling.

Regulation (EC) No 999/2001 should therefore be
amended accordingly. For practical reasons, it is appro-
priate to replace the amended Annex III as a whole.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Annex III to Regulation (EC) No 999/2001 is amended in
accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter
into force on the 20th day
following its publication in the Official Journal of the European
Union.

It shall apply from 1 January 2004.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 December 2003.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 147, 31.5.2001, p. 1; Regulation as last amended by Commis-
sion Regulation (EC) No 1915/2003 (OJ L 283, 31.10.2003, p. 29).

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Annex III to Regulation (EC) No 999/2001 is replaced by the following:

ANNEX

‘ANNEX III

MONITORING SYSTEM

CHAPTER A

I. MONITORING IN BOVINE ANIMALS

1. General

Monitoring in bovine animals shall be carried out in accordance with the laboratory methods laid down in
Annex X, Chapter C, point 3(1)(b).

2. Monitoring in animals slaughtered for human consumption

2.1. All bovine animals over 24 months of age:

— subject to “special emergency slaughtering” as defined in Article 2(n) of Council Directive 64/433/EEC (1), or

— slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, except animals

without clinical signs of disease slaughtered in the context of a disease eradication campaign,

shall be tested for BSE.

2.2. All bovine animals over 30 months of age:

— subject to normal slaughter for human consumption, or

— slaughtered in the context of a disease eradication campaign in accordance with Annex I, Chapter VI, point

28(c), to Directive 64/433/EEC, but showing no clinical signs of disease,

shall be tested for BSE.

2.3. By way of derogation from point 2.2, and with regard to bovine animals born, reared and slaughtered on its
territory, Sweden may decide to examine only a random sample. The sample shall comprise at least 10 000
animals per year.

3. Monitoring in animals not slaughtered for human consumption

3.1. All bovine animals over 24 months of age which have died or been killed but which were not:

— killed for destruction pursuant to Commission Regulation (EC) No 716/96 (2),

— killed in the framework of an epidemic, such as foot-and-mouth disease,

— slaughtered for human consumption,

shall be tested for BSE.

3.2. Member States may decide to derogate from the provisions of point 3.1 in remote areas with a low animal
density, where no collection of dead animals is organised. Member States making use of this derogation shall
inform the Commission thereof, and submit a list of the derogated areas. The derogation shall not cover more
than 10 % of the bovine population in the Member State.

(1) OJ 121, 29.7.1964, p. 2012/64.
(2) OJ L 99, 20.4.1996, p. 14.

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4. Monitoring in animals purchased for destruction pursuant to Regulation (EC) No 716/96

4.1. All animals subject to casualty slaughter or found sick at ante mortem inspection shall be tested for BSE.

4.2. All animals over 42 months of age born after 1 August 1996 shall be tested for BSE.

4.3. A random sample comprising at least 10 000 animals annually of animals not covered by point 4.1 or 4.2 shall

be tested for BSE.

5. Monitoring in other animals

In addition to the testing referred to in points 2 to 4, Member States may on a voluntary basis decide to test
other bovine animals on their territory, in particular where those animals originate from countries with indi-
genous BSE, have consumed potentially contaminated feedingstuffs or were born or derived from BSE infected
dams.

6. Measures following testing

6.1. Where an animal slaughtered for human consumption has been selected for testing for BSE, the health marking
provided for in Chapter XI of Annex I to Directive 64/433/EEC shall not be carried out on the carcase of that
animal until a negative result to the rapid test has been obtained.

6.2. Member States may derogate from the provisions of point 6.1 where an official system is in place in the slaugh-
terhouse ensuring that no parts of examined animals bearing the health mark leave the slaughterhouse until a
negative result to the rapid test has been obtained.

6.3. All parts of the body of an animal tested for BSE including the hide shall be retained under official control until
a negative result to the rapid test has been obtained, unless they are disposed of in accordance with Article
4(2)(a) and (b) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council (1).

6.4. All parts of the body of an animal found positive to the rapid test including the hide shall be disposed of in
accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002, apart from material to be retained in
conjunction with the records provided for in Chapter B(III).

6.5. Where an animal slaughtered for human consumption is found positive to the rapid test, at least the carcase
immediately preceding the test-positive carcase and two carcases immediately following the test-positive carcase
on the same slaughterline shall be destroyed in accordance with point 6.4, in addition to the test-positive
carcase.

6.6. Member States may derogate from the provisions of point 6.5 where a system is in place in the slaughterhouse

preventing contamination between carcase.

II. MONITORING IN OVINE AND CAPRINE ANIMALS

1. General

Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid
down in Annex X, Chapter C, point 3.2(b).

2. Monitoring in ovine animals slaughtered for human consumption

Member States in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals shall
test a minimum annual sample of 10 000 ovine animals which are slaughtered for human consumption (2). The
animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.
The sampling shall be representative for each region and season. The sample selection shall be designed with a
view to avoiding the over-representation of any group as regards the origin, age, breed, production type or any
other characteristic. The age of the animals shall be estimated based on dentition, obvious signs of maturity or
other reliable information. Multiple sampling in the same flock shall be avoided, where possible.

(1) OJ L 273, 10.10.2002, p. 1.
(2) The sample size has been calculated to detect a prevalence of 0,03 % with a 95 % confidence in slaughtered animals. The sample is

restricted to Member States with a large sheep population.

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3. Monitoring in ovine and caprine animals not slaughtered for human consumption

Ovine and caprine animals over 18 months of age or which have more than two permanent incisors erupted
through the gum which have died or been killed, but which were not:

— killed in the framework of a disease eradication campaign,

— slaughtered for human consumption,

shall be tested in accordance with the sample sizes indicated in table A and table B respectively. The sampling
shall be representative for each region and season. The sample selection shall be designed with a view to
avoiding the over-representation of any group as regards the origin, age, breed, production type or any other
characteristic. The age of the animal shall be estimated based on dentition, obvious signs of maturity or other
reliable information. Multiple sampling in the same flock shall be avoided, where possible. The Member State
shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from
sampling

Member States may decide to exclude remote areas with a low animal density, where no collection of dead
animals is organised, from the sampling. Member States making use of this derogation shall
inform the
Commission thereof, and submit a list of the derogated areas. The derogation shall not cover more than 10 %
of the ovine and caprine population in the Member State.

Table A

Member State population of ewes and ewe lambs put to the
ram

Minimum sample size of dead ovine animals (1)

> 750 000

100 000-750 000

40 000-100 000

< 40 000

10 000

1 500

500

100

(1) Sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended
to provide achievable targets. The sample sizes of 10 000, 1 500, 500 and 100 animals will allow the detection of a preva-
lence of 0,03%, 0,2 %, 0,6 % and 3 % respectively with a 95 % confidence.

Table B

Member State population of goats which have already
kidded and goats mated

Minimum sample size of dead caprine animals (1)

> 750 000

250 000-750 000

40 000-250 000

< 40 000

5 000

1 500

500

50

(1) Sample sizes are set to take account of the size of the caprine populations in the individual Member States and are intended
to provide achievable targets. The sample sizes of 5 000, 1 500, 500 and 50 animals will allow the detection of a preva-
lence of 0,06 %, 0,2 %, 0,6 % and 6 % respectively with a 95 % confidence. Where a Member State experiences difficulty in
collecting sufficient numbers of dead caprine animals to reach its allotted sample size, it may choose to supplement its
sample by testing caprine animals slaughtered for human consumption over the age of 18 months at the ratio of three
caprine animals slaughtered for human consumption to one dead caprine animal.

4. Monitoring in infected flocks

From 1 October 2003, animals over 12 months or which have a permanent incisor erupted through the gum,
which are killed in accordance with the provisions of Annex VII, point 2(b)(i) or (ii) or point 2(c), shall be tested
based on the selection of a simple random sample, in accordance with the sample size indicated in the table

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Number of culled animals over 12 months in the herd or
flock

Minimum sample size (1)

70 or less

All eligible animals

80

90

100

120

140

160

180

200

250

300

350

400

450

500 or more

68

73

78

86

92

97

101

105

112

117

121

124

127

150

(1) The sample size is calculated to be 95 % certain of including at least one positive if the disease is present at a minimum

prevalence of 2 % in the test population.

5. Monitoring in other animals

In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary
basis carry out monitoring in other animals, in particular:

— animals used for dairy production,

— animals originating from countries with indigenous TSEs,

— animals which have consumed potentially contaminated feedingstuffs,

— animals born or derived from TSE-infected dams,

6. Measures following testing of ovine and caprine animals

6.1. Where an ovine or caprine animal slaughtered for human consumption has been selected for testing for TSE,
the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC shall not be carried out on
the carcase of that animal until a negative result to the rapid test has been obtained.

6.2. Member States may derogate from point 6.1 where an official system is in place in the slaughterhouse ensuring
that no parts of examined animals bearing the health mark leave the slaughterhouse until a negative result to
the rapid test has been obtained.

6.3. All parts of the body of a tested animal including the hide shall be retained under official control until a nega-
tive result to the rapid test has been obtained, unless they are disposed of in accordance with Article 4.2(a) and
(b) of Regulation (EC) No 1774/2002.

6.4. All parts of the body of an animal found positive to the rapid test including the hide shall be disposed of in
accordance with Article 4.(2)(a) and (b) of Regulation (EC) No 1774/2002, apart from material to be retained in
conjunction with the records provided for in Chapter B(III).

7. Genotyping

7.1. The prion protein genotype shall be determined for each positive TSE case in sheep. TSE cases found in resis-
tant genotypes (sheep of genotypes which encode alanin on both alleles at codon 136, arginin on both alleles
at codon 154 and arginin on both alleles at codon 171) shall immediately be reported to the Commission.
Where possible, such cases shall be submitted for strain-typing. Where strain-typing of such cases is not
possible, the herd of origin and all other herds where the animal has been shall be subjected to enhanced moni-
toring with a view to find other TSE cases for strain-typing.

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7.2. In addition to the animals genotyped under the provisions of point 7.1, the prion protein genotype of a sample
of ovine animals shall be determined. In the case of Member States with an adult sheep population of more
than 750 000 adult animals, this sample shall consist of at least 600 animals. In the case of other Member
States the sample shall consist of at least 100 animals. The samples may be chosen from animals slaughtered
for human consumption, from animals dead-on farm or from live animals. The sampling should be representa-
tive of the entire ovine population.

III. MONITORING IN OTHER ANIMAL SPECIES

Member States may on a voluntary basis carry out monitoring for TSE in animal species other than bovine, ovine
and caprine animals.

I.

INFORMATION TO BE PRESENTED BY MEMBER STATES IN THEIR REPORT

CHAPTER B

1. The number of suspected cases per animal species placed under movement restrictions in accordance with

Article 12(1)

2. The number of suspected cases per animal species subject to laboratory examination in accordance with Article

12(2) and the outcome of the examination

3. The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated

pursuant to Article 12(1) and (2)

4. The estimated size of each subpopulation referred to in Chapter A(I)(3) and (4)

5. The number of bovine animals tested within each subpopulation referred to in Chapter A(I)(2) to (5) the

method for sample selection and the outcome of the tests.

6. The estimated size of those subpopulations referred to in Chapter A(II)(2) and (3) which have been selected for

sampling.

7. The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter

A(II)(2) to (5) the method for sample selection and the outcome of the tests.

8. Number, age distribution and geographical distribution of positive cases of BSE and scrapie. The country of
origin, if not the same as the reporting country, of positive cases of BSE and scrapie. Number and geographical
distribution of scrapie positive flocks. The year and, where possible, month of birth should be given for each
BSE case

9. Positive TSE cases confirmed in animals other than bovine, ovine and caprine animals

10. The genotype and where possible breed of each animal sampled within each subpopulation referred to in

Chapter A(II)(7.1) and (7.2)

II.

INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS SUMMARY

The summary shall be presented in a tabled format covering at least the information referred to in part I for each
Member State.

III. RECORDS

1. The competent authority shall keep, for seven years, records of:

— the number and types of animals placed under movement restrictions as referred to in Article 12(1),

— the number and outcome of clinical and epidemiological investigations as referred to in Article 12(1),

— the number and outcome of laboratory examinations as referred to in Article 12(2),

— the number, identity and origin of animals sampled in the framework of the monitoring programmes as

referred to in Chapter A and, where possible, age, breed and anamnestic information,

— the prion protein genotype of positive TSE cases in sheep.

2. The investigating laboratory shall keep, for seven years, all records of testing, in particular laboratory workbooks

and, where appropriate, paraffin blocks and photographs of western blots.’