Commission Regulation (EC) No 253/2006 of  14 February 2006  amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid tests and measures for the eradication of TSEs in ovine and caprine animals   (Text with EEA relevance)
Date: 2006-02-14
Institutions: European Commission
Subjects: analytical chemistry, animal disease, disease prevention, goat, sheep

15.2.2006

EN

Official Journal of the European Union

L 44/9

COMMISSION REGULATION (EC) No 253/2006

of 14 February 2006

amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards
rapid tests and measures for the eradication of TSEs in ovine and caprine animals

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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), and in particular
the first paragraph of Article 23 thereof,

Whereas:

(1)

(2)

(3)

Regulation (EC) No 999/2001 lays down rules for the
eradication of transmissible spongiform encephalopathies
(TSEs) after confirmation of TSEs in a flock of ovine or
caprine animals and sets out a list of rapid tests approved
for TSE monitoring.

In accordance with Regulation (EC) No 999/2001,
as
amended by Commission Regulation (EC) No
260/2003 (2), since 1 October 2003 certain measures
have applied following the confirmed presence of a
TSE in ovine or caprine flocks. At the time, two types
of TSE potentially present in ovine or caprine animals,
namely scrapie and bovine spongiform encephalopathy
(BSE), could not be routinely discriminated in ovine
or
therefore
introduced on the grounds
that every TSE case in
ovine or caprine animals could be BSE.

caprine animals. Strict measures were

In accordance with Regulation (EC) No 999/2001,
as
amended by Commission Regulation (EC) No
36/2005 (3), since January 2005 discriminatory testing
has been mandatory in all confirmed TSE cases in
ovine and caprine animals. Following the stepping-up
of surveillance in ovine and caprine animals in 2005
in accordance with Regulation (EC) No 999/2001,
amended by Commission Regulation (EC) No
as
214/2005 (4), preliminary results indicate that BSE can
be ruled out in all positive TSE cases to date. Measures
for the eradication of TSEs in ovine and caprine animals

will be reconsidered in the framework of the TSE road
map. Discussion on the subject will, however, not be
finalised before the end of 2005.

In order to prevent stricter measures to eradicate TSEs in
ovine animals becoming applicable despite ongoing
discussion
transitional
possible
measures currently applying until 1 January 2006 on
the restocking of flocks culled in connection with TSE
eradication should be extended.

review,

their

on

In its report of 2 September 2005, the European Food
Safety Authority (EFSA) recommended the approval of a
new BSE rapid post-mortem test. That test should be
included in the list of rapid tests for monitoring BSE.

Until now, no formal evaluation of tests specifically for
the purpose of testing ovine or caprine animals has been
completed. Five rapid tests currently listed in Annex X
to Regulation (EC) No 999/2001 were provisionally
approved, pending
the monitoring
evaluation,
programme in ovine and caprine animals on the basis
of data provided by the test manufacturers.

for

In its reports of 17 May and 26 September 2005 on the
evaluation of rapid post-mortem tests intended for ovine
the EFSA recommended the
and caprine
animals,
approval of
eight new rapid post-mortem tests,
including the five provisionally approved rapid tests.
These tests should be included in the list of rapid tests
for monitoring TSEs in ovine and caprine animals.

Changes to rapid tests and to test protocols may only be
made with the approval of the Community Reference
for TSEs. The CRL has approved
Laboratory (CRL)
changes
to the BSE rapid post-mortem test called
‘Inpro CDI’. The CRL has also accepted the change of
name to ‘Beckman Coulter InPro CDI kit’.

(4)

(5)

(6)

(7)

(8)

(9)

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

(1) OJ L 147, 31.5.2001, p. 1. Regulation as

(EC) No 1974/2005 (OJ

last amended by
L 317,

Commission Regulation
3.12.2005, p. 4).

(2) OJ L 37, 13.2.2003, p. 7.
(3) OJ L 10, 13.1.2005, p. 9.
(4) OJ L 37, 10.2.2005, p. 9.

(10)

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

opinion

the

the

of

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Official Journal of the European Union

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HAS ADOPTED THIS REGULATION:

Article 1

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

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

Article 2

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

Done at Brussels, 14 February 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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Official Journal of the European Union

L 44/11

ANNEX

1. In Annex VII to Regulation (EC) No 999/2001, point 6 is replaced by the following:

‘6. During a transitional period until 1 January 2007 at the latest and by way of derogation from the restriction set
out in point 4(b), where it is difficult to obtain replacement ovine animals of a known genotype, Member States
may decide to allow non-pregnant ewes of an unknown genotype to be introduced onto the holdings to which the
measures referred to in point 2(b)(i) and (ii) apply.’

2. In Annex X to Regulation (EC) No 999/2001, Chapter C, point 4 is replaced by the following:

‘4. Rapid tests

For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods
shall be used as rapid tests for the monitoring of BSE in bovine animals:

— immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K resistant

fragment PrPRes (Prionics-Check Western test),

— chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced

chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),

— sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad TeSeE

test),

— microplate based immunoassay (ELISA) which detects Proteinase Kresistant PrPRes with monoclonal antibodies

(Prionics-Check LIA test),

— conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),

— chemiluminescent ELISA for qualitative determination of PrPSc (CediTect BSE test),

— immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody

directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA),

— microplate based chemiluminiscent immunoassay for the detection of PrPSc in bovine tissues (Institut Pourquier

Speed’it BSE),

— lateral flow immunoassay using two different monoclonal antibodies to detect Proteinase K resistant PrP

fractions (Prionics Check PrioSTRIP),

— two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in

a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit),

— sandwich ELISA for the detection of Proteinase K resistant PrPSc (Roche Applied Science PrionScreen),

— antigen-capture ELISA using two different monocloncal antibodies to detect Proteinase K resistant PrP fractions

(Fujirebio FRELISA BSE post-mortem rapid BSE Test).

For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods
shall be used as rapid tests for the monitoring of TSE ovine and caprine animals:

— conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),

— sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad TeSeE

test),

— sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad TeSeE

Sheep/Goat test),

— chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced

chemiluminescent reagent (Enfer TSE Kit version 2.0),

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— immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody
directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),

— microplate based chemiluminiscent immunoassay for the detection of PrPSc in ovine tissues (POURQUIER’S-

LIA Scrapie),

— immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K resistant

fragment PrPRes (Prionics-Check Western Small Ruminant test),

— microplate based chemiluminescent immunoassay for the detection of Proteinase K resistant PrPSc (Prionics

Check LIA Small Ruminants).

In the case of all tests, sample tissue on which the test must be applied must comply with the manufacturer’s
instructions for use.

The producer of the rapid tests must have put in place a quality assurance system, approved by the Community
Reference Laboratory (CRL) that ensures that the test performance does not change. The producer must provide
the test protocol to the Community Reference Laboratory.

Changes to rapid tests and to test protocols may only be made after prior notification to the Community
Reference Laboratory and provided that the Community Reference Laboratory finds that the change does not
alter the sensitivity, specificity or reliability of
finding shall be communicated to the
Commission and to the national reference laboratories.’

the rapid test. That