Commission Regulation (EC) No 1494/2002 of 21 August 2002 amending Annexes III, VII and XI to Regulation (EC) No 999/2001 of the European Parliament and the Council as regards monitoring of bovine spongiform encephalopathy, eradication of transmissible spongiform encephalopathy, removal of specified risk materials and rules for importation of live animals and products of animal origin (Text with EEA relevance)
Date: 2002-08-21
Institutions: European Commission
Subjects: animal disease, animal product, bovine spongiform encephalopathy, disease prevention, health control, health risk, import, live animal

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COMMISSION REGULATION (EC) No 1494/2002

of 21 August 2002

amending Annexes III, VII and XI to Regulation (EC) No 999/2001 of the European Parliament and
the Council as regards monitoring of bovine spongiform encephalopathy, eradication of transmis-
sible spongiform encephalopathy, removal of specified risk materials and rules for importation of
live animals and products of animal origin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 999/2001 of
the
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 270/2002 (2), and
in particular Article 23 thereof,

Whereas:

(1)

Rules for monitoring of bovine spongiform encephalo-
pathy (BSE) in bovine animals, for destruction of bovine
embryos and ova of BSE cases,
for trade in bovine
embryos and ova, and for removal of specified BSE risk
material are laid down in Regulation (EC) No 999/2001.

(2) When the BSE monitoring programme in bovine animals
was amended by Commission Regulation (EC) No 1248/
2001 (3), provision was made for a review of the moni-
toring programme in the light of the results obtained
during the first six months.

(3)

(4)

(5)

During the second half of 2001, more than five million
bovine animals were tested for BSE, 457 of which were
positive. Most positive cases were found in dead-on-farm
animals, emergency slaughtered animals and animals the
slaughter of which was deferred due to a suspected
disease or disorder of their general conditions.

To ensure the uniform application of the monitoring
programme, it is necessary to clarify under Annex III,
Chapter A.I.2, the definition of animals the slaughter of
which was deferred due to a suspected disease or
disorder of their general conditions.

All dead-on-farm animals over 24 months of age have
been tested for BSE during a one-year statistical survey
set out as a transitional measure in Regulation (EC) No
999/2001. To ensure the effective detection of BSE cases,
all dead-on-farm animals above 24 months of age should
continue to be tested on a permanent basis. To avoid
disproportionate costs, a derogation should be provided
for animals dying in remote areas where no collection of
dead animals has been organised.

is important

to follow the evolution of

It
the BSE
epidemic in animals born after the introduction of the
reinforced feed ban in the United Kingdom. To this end
the testing of animals slaughtered and destroyed under
the Over Thirty Months Scheme should be expanded to
cover all animals born after the feed ban. However, the
detection of positive cases in animals below 42 months
of age is highly unlikely and it would, therefore, be
disproportionate to require the testing of healthy animals
below that age intended for destruction under the excep-
tional scheme provided for by Commission Regulation
(EC) No 716/96 of 19 April 1996 adopting exceptional
support measures for the beef market in the United
Kingdom (4) as last amended by Regulation (EC) No
1176/2000 (5).

It is necessary to clarify the rules on health marking of
carcasses selected for testing for transmissible spongi-
form encephalopathy.

To avoid disproportionate costs
in the monitoring
programme for small ruminants, a derogation should be
provided for animals dying in remote areas where no
collection of dead animals has been organised.

provisions

voluntary monitoring
The
programmes in animal species other than bovine, ovine
and caprine animals should be clarified.

regarding

the

Scientific

Steering Committee

In its opinion of 16 May 2002 on the safety of bovine
embryos,
(SSC)
concluded that there is no need for measures other than
those prescribed by the International Embryo Transfer
Society protocols. In its general session of May 2002, the
world animal health organisation Office international des
Epizooties (OIE) decided on similar scientific grounds to
delete all trade conditions related to bovine embryos and
ova. The provisions on the destruction of bovine
embryos and ova from BSE cases and the BSE-related
trade conditions for bovine embryos and ova should
therefore be repealed.

(7)

(8)

(9)

(10)

(11)

It is necessary to clarify the rules on the removal and
control of specified risk material.

(1) OJ L 147, 31.5.2001, p. 1.
(2) OJ L 45, 15.2.2002, p. 4.
(3) OJ L 173, 27.6.2001, p. 12.

(4) OJ L 99, 20.4.1996, p. 14.
(5) OJ L 131, 1.6.2000, p. 37.

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(12)

(13)

(14)

In its opinion of 27 June 2002 on the Geographical BSE
Risk of certain third countries, the SSC concluded that,
in addition to previously evaluated countries, the occur-
rence of BSE in native cattle is highly unlikely in Iceland
and in Vanuatu. Therefore Iceland and Vanuatu should
from the trade conditions related to live
be exempt
bovine animals and products of bovine, ovine and
caprine origin.

Regulation (EC) No 999/2001 should therefore be
amended accordingly.

HAS ADOPTED THIS REGULATION:

Article 1

Annexes III, VII and XI to Regulation (EC) No 999/2001 are
amended in accordance with the Annex to this Regulation.

Article 2

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

This Regulation shall enter into force on the third day following
that of its publication in the Official Journal of the European
Communities.

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

Done at Brussels, 21 August 2002.

For the Commission

David BYRNE

Member of the Commission

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ANNEX

‘ANNEX III

MONITORING SYSTEM

CHAPTER A

1. Annex III is replaced by the following:

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.

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 points 4.1 or

4.2 shall be tested for BSE.

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

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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
indigenous 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
carcass 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
slaughterhouse ensuring that no parts of examined animals bearing the health mark leave the slaughter-
house 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 destroyed in accordance with
Annex V, point 3 or 4.

6.4. All parts of the body of an animal found positive to the rapid test including the hide shall be destroyed in
accordance with Annex V, point 3 or 4, apart from material to be retained in conjunction with the records
provided for in Chapter B, section III.

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

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 carcasses.

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 animals slaughtered for human consumption

Animals over 18 months of age or which have more than two permanent incisors erupted through the gum
and which are slaughtered for human consumption shall be tested in accordance with the sample size indicated
in the table. The sampling shall be representative for each region and season. The sample selection shall be
designed with a view to avoid the over-representation of any group as regards the origin, species, 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.

Member State

Minimum annual sample size
Slaughtered animals (*)

Belgium

Denmark

Germany

Greece

Spain

France

Ireland

Italy

Luxembourg

3 750

3 000

60 000

60 000

60 000

60 000

60 000

60 000

250

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Member State

Minimum annual sample size
Slaughtered animals (*)

Netherlands

Austria

Portugal

Finland

Sweden

United Kingdom

39 000

8 200

22 500

1 900

5 250

60 000

(*) The sample size has been calculated to detect a prevalence of 0,005 % with a 95 % confidence in slaughtered animals in
Member States which slaughter a large number of adult sheep. In those Member States which slaughter a smaller number of
adult sheep, the sample size is calculated as 25 % of the estimated or recorded number of cull ewes slaughtered in 2000.

3. Monitoring in animals not slaughtered for human consumption

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 an epidemic, such as foot-and-mouth disease,

— slaughtered for human consumption,

shall be tested in accordance with the sample size indicated in the table. The sampling shall be representative
for each region and season. The sample selection shall be designed with a view to avoid the over-representation
of any group as regards the origin, species, 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.

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.

Member State

Minimum annual sample size
Dead animals (*)

Belgium

Denmark

Germany

Greece

Spain

France

Ireland

Italy

Luxembourg

Netherlands

450

400

6 000

6 000

6 000

6 000

6 000

6 000

30

5 000

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Member State

Minimum annual sample size
Dead animals (*)

Austria

Portugal

Finland

Sweden

United Kingdom

1 100

6 000

250

800

6 000

(*) The sample size has been calculated to detect a prevalence of 0,05 % with a 95 % confidence in dead animals in Member
States with a large sheep population. In those Member States with a smaller sheep population, the sample size is calculated as
50 % of the estimated number of dead animals (estimated mortality 1 %).

4. Monitoring in other animals

In addition to the monitoring programmes set out in points 2 and 3, 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,

— animals from flocks infected with TSE

5. Measures following testing of ovine and caprine animals

5.1. Where an 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
carcass of that animal until a negative result to the rapid test has been obtained.

5.2. Member States may derogate from the provisions of point 5.1 where an official system is in place in the
slaughterhouse ensuring that no parts of examined animals bearing the health mark leave the slaughter-
house until a negative result to the rapid test has been obtained.

5.3. All parts of the body of a tested animal including the hide shall be retained under official control until a
negative result to the rapid test has been obtained, unless they are destroyed in accordance with Annex V,
point 3 or 4.

5.4. All parts of the body of an animal found positive to the rapid test including the hide shall be destroyed in
accordance with Annex V, point 3 or 4, apart from material to be retained in conjunction with the records
provided for in Chapter B, Section III.

6. Genotyping

6.1. The prion protein genotype shall be determined for each positive TSE case in sheep. TSE cases found in
resistant 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 monitoring with a view to find other TSE cases for strain-typing.

6.2. In addition to the animals genotyped under the provisions of point 6.1, the prion protein genotype of a
random sub-sample of the ovine animals tested under the provisions of Chapter A, Section II, point 2 shall
be determined. This sub-sample shall represent at least one per cent of the total sample for each Member
State, and shall not be less than 100 animals per Member State. By derogation, Member States may choose
to genotype an equivalent number of live animals of a similar age.

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.

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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, Section I, points 3 and 4.

5. The number of bovine animals tested within each subpopulation referred to in Chapter A, Section I, point 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, Section II, points 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, Section II, points 2 to 4, 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, part II, points 6.1 and 6.2.

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 work-

books and, where appropriate, paraffin blocks and photographs of Western blots.’

2. Annex VII is amended as follows:

(a)

in point 1(a), the second indent is replaced by the following:

‘— where the disease was confirmed in a female animal, its progeny born within two years prior to, or after,

clinical onset of the disease;’

(b)

in point 1(a), the words ‘embryos and ova’ are deleted in the fifth indent;

(c)

in point 2(a), the words ‘and the destruction of embryos and ova’ are deleted.

3. Annex XI is amended as follows:

(a)

in part A, point 1(a)(i) is replaced by the following:

‘(i) the skull including the brain and eyes, the tonsils, the vertebral column excluding the vertebrae of the tail, the
transverse processes of the lumbar and thoracic vertebrae and the wings of the sacrum, but including dorsal
root ganglia, and spinal cord of bovine animals aged over 12 months, and the intestines from the duodenum
to the rectum and the mesentery of bovine animals of all ages;’

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(b)

in part A, point 5(a) is replaced by the following:

‘(a) slaughterhouses, or, as appropriate, other places of slaughter;’

(c)

in part A, the list of countries referred to in point 10(b) is replaced by the following:
‘Argentina
Australia
Botswana
Brazil
Chile
Costa Rica
El Salvador
Iceland
Namibia
New-Zealand
Nicaragua
Panama
Paraguay
Singapore
Swaziland
Uruguay
Vanuatu.’

(d)

In part A, point 12(a) is replaced by the following:

‘(a) when removal of the vertebral column is not required, carcasses or parts of carcasses, as defined by Directive
64/433/EEC, of bovine animals containing vertebral column, shall be identified by a blue stripe on the label
referred to in Regulation (EC) No 1760/2000, except at the delivery stage to the final consumer;’

(e) Part B is deleted.

(f)

In part D, point 3 is replaced by the following:

‘3. Point 2 shall not apply to imports of bovine animals born and continuously reared in the following countries:

Argentina
Australia
Botswana
Brazil
Chile
Costa Rica
El Salvador
Iceland
Namibia
New-Zealand
Nicaragua
Panama
Paraguay
Singapore
Swaziland
Uruguay
Vanuatu.’

(g)

In part D, point 4 is deleted.