2001/8/EC: Commission Decision of 29 December 2000 amending Decision 2000/764/EC on the testing of bovine animals for the presence of bovine spongiform encephalopathy and updating Annex IV of Decision 98/272/EC on epidemio-surveillance for transmissible spongiform encephalopathies (Text with EEA relevance) (notified under document number C(2000) 4411)
Date: 2000-12-29
Institutions: European Commission
Subjects: animal disease, cattle, health control, slaughter of animals, veterinary inspection

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COMMISSION DECISION

of 29 December 2000

amending Decision 2000/764/EC on the testing of bovine animals for the presence of bovine
spongiform encephalopathy and updating Annex IV of Decision 98/272/EC on epidemio-
surveillance for transmissible spongiform encephalopathies

(notified under document number C(2000) 4411)

(Text with EEA relevance)

(2001/8/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/662/EEC of 11
December 1989 concerning veterinary checks
in intra-
Community trade with a view to the completion of the internal
market (1), as last amended by Directive 92/118/EEC (2), and in
particular Article 9(4) thereof,

Having regard to Council Directive 90/425/EEC of 26 June
1990 concerning veterinary and zootechnical checks applicable
in intra-Community trade in certain live animals and products
with a view to the completion of the internal market (3), as last
amended by Directive 92/118/EEC, and in particular Article
10(4) thereof,

Whereas:

(1)

(2)

(3)

Commission Decision 2000/764/EC of 29 November
2000 on the testing of bovine animals for the presence
of bovine spongiform encephalopathy (4),
lays down
reinforced rules
the testing of bovine animals
entering the food chain.

for

for

Commission Decision 98/272/EC of 23 April 1998 on
spongiform
epidemio-surveillance
encephalopathies (5), as last amended by Decision 2000/
764/EC,
lays down the methods and protocols to be
followed when examining bovine animals for the pres-
ence of bovine spongiform encephalopathy (BSE).

transmissible

Commission Regulation (EC) No 2777/2000 of 18
December 2000 adopting exceptional support measures
for the beef market (6) provides for a scheme where
bovine animals over 30 months of age can be purchased
for destruction instead of being slaughtered for human
consumption. It is necessary to clarify that the obligation
to examine certain groups of animals at risk applies
where such animals are purchased for destruction.

The Council has invited the Commission to specify the
modalities under which laboratory testing for bovine
spongiform encephalopathy (BSE) shall be carried out
and the methods by which the testing shall be controlled
by competent
and monitored by the
Commission.

authorities

Decision 2000/764/EC and Decision 98/272/EC need to
be amended accordingly.

The measures provided for in this Decision are in
accordance with the opinion of the Standing Veterinary
Committee,

(6)

(7)

HAS ADOPTED THIS DECISION:

Article 1

Decision 2000/764/EC is amended as follows:

1. Article 1(1) is replaced by the following:

‘1. Member States shall ensure that all bovine animals
over 30 months of age:

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

— slaughtered in accordance with Annex I, Chapter VI,

point 28(c) to Directive 64/433/EEC

are examined by one of the approved rapid tests listed in
Annex IVA to decision 98/272/EC as of 1 January 2001.

The provisions of this paragraph shall also apply to animals,
as referred to in the first subparagraph, which are purchased
for destruction in accordance with Regulation (EC) No
2777/2000.

(*) OJ 121, 29.7.1964, p. 2012/64.’

(4)

It
is appropriate to clarify the rules on the health
marking of carcases from animals having been examined
for BSE.

2. Article 2 is replaced by the following:

‘Article 2

(1) OJ L 395, 30.12.1989, p. 13.
(2) OJ L 62, 15.3.1993, p. 49.
(3) OJ L 224, 18.8.1990, p. 29.
(4) OJ L 305, 6.12.2000, p. 35.
(5) OJ L 122, 24.4.1998, p. 59.
(6) OJ L 321, 19.12.2000, p. 47.

the body,

All parts of
including the hide, of animals
examined in accordance with Article 1 shall be retained
under official supervision until a negative test result has
it has been destroyed by inciner-
been obtained or until
circumstances, burned or
tion or, under

exceptional

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buried in strict compliance with the conditions laid down
in Article 3(2) of Council Directive 90/667/EEC (**).
Where an animal slaughtered for human consumption is
examined, the health marking provided for in Chapter XI
of Annex I to Directive 64/433/EC shall not be carried
out on the carcase of that animal until a negative test
result has been obtained, unless an official system is in
place ensuring that no parts of examined animals leave
the slaughterhouse before a negative test result has been
obtained except when they are sent under official supervi-
sion for destruction by incineration.

(**) OJ L 363, 27.12.1990, p. 51.’

3. Article 3 is replaced by the following:

laid down in Annex IV(2) and (3)

‘Article 3
1. Member States shall ensure that any sampling for
BSE in bovine animals is carried out in accordnce with
Annex IV(1) to Decision 98/272/EC, as amended by the
present Decision.
2. Member States
shall ensure that any laboratory
testing for BSE in bovine animals is carried out in labora-
tories approved for that purpose and using the methods
to
and protocols
Decision 98/272/EC, as amended by the present Decision.
3.
The national reference laboratory in each Member
State, as set out in Annex V to Decision 98/272/EC, shall
ensure coordination of diagnostic methods and protocols
between laboratories approved for carrying out laboratory
testing for BSE in bovine animals, regularly verify the
correct use of
those diagnostic methods and protocols,
and, as appropriate, organise periodical comparative tests.
The Commission shall monitor the sampling and
4.
laboratory testing for BSE in bovine animals carried out
in the Member States by regular inspections on the spot

in accordance with Commission Decision 98/139/EC (***)
and by organising a comparative test
for the national
reference laboratories.

(***) OJ L 38, 12.2.1998, p. 10.’

Article 2

Decision 98/272/EC is amended as follows:

1. Annex IV is replaced by the text in the Annex to this

Decision.

2. In Annex V, the following national reference laboratory is

added for Spain:

‘Laboratorio Central de Veterinaria de Algete
Madrid
Spain
(only BSE tests as referred to in Annex IVA)’.

Article 3

This Decision shall apply from 1 January 2001.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 29 December 2000.

For the Commission

David BYRNE

Member of the Commission

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ANNEX

‘ANNEX IV

SAMPLING AND LABORATORY TESTING FOR THE PRESENCE OF BSE IN BOVINE ANIMALS

1. Collection of samples

The competent authority shall ensure that samples ae collected using the methods and protocols laid down in the
Manual of standards for diagnostic tests and vaccines of the World Organisation for Animal Health (Office
International des Epizooties), latest edition. In the absence of such methods and protocols, the competent authority
shall ensure that the samples are collected in a manner appropriate for the correct application of tests.

The competent authority shall ensure that samples are correctly marked as to the identity of the sampled animal.

2.

Laboratory testing

2.1. Suspect cases

Tissues from bovine animals sent for laboratory testing pursuant to the provisions of Article 3(2) shall be subject to
a histopathology examination as laid down in the Manual of standards for diagnostic tests and vaccines of the World
Organisation for Animal Health (Office International des Epiziooties), latest edition, except where the material is
autolysed. Where the result of the histopathology examination is inconclusive or negative or where the material
autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the
above Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron micro-
scopy).

2.2. Animals examined in the framework of the annual monitoring programme or subject to routine examination at slaughter

Bovine animals examined in the framework of the annual monitoring programme as laid down in Annex I(A), the
targeted surveillance programme as laid down in Annex I(C) or examined in accordance with Article 1 of Decision
2000/764/EC shall be examined in an approved laboratory by one of the tests listed in Annex IVA.

Where the result of the monitoring test is inconclusive or positive, the tissues shall immediately be subject to
confirmatory examinations in an official laboratory. The confirmatory examination shall start by a hystopathology
examination of the brainstem as laid down in the Manual of standards for diagnostic tests and vaccines of the World
Organisation for Animal Health (Office International des Epizooties), latest edition, except where the material is
autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathology
examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an
examination by one of the other diagnostic methods mentioned in point 2.1, however, the method must not be the
same as the method used in the monitoring test.

3.

Interpretation of results

An animal examined as referred to in point 2.1 shall be regarded a positive BSE case, if the result of one of the tests
is positive.

An animal examined as referred to in point 2.2 shall be regarded as a positive BSE case if the result of the
monitoring test is positive or inconclusive, and

— the result of the subsequent histopathology examination is positive, or

— the result of another diagnostic method mentioned in point 2.1.

is positive.

4. Reporting of results

All positive BSE cases shall immediately be reported to the competent authority. The competent authority shall
notify positive BSE cases in accordance with Directive 82/894/EEC (1).

(1) OJ L 378, 31.12.1982, p. 58.

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ANNEX IVA

1. Immunoblotting test based on a western blotting procedure for the detection of the protease-resistant fragment PrPRes

(prionics check test).

2. Chemiluminiscent ELISA involving an extraction procedure and an ELISA technique, using an enhanced chemi-

luminiscent reagent (Enfer test).

3. Sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad).’