Commission Regulation (EC) No 260/2005 of 16 February 2005 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid testsText with EEA relevance
Date: 2005-02-16
Institutions: European Commission
Subjects: animal disease, disease prevention, food safety, veterinary legislation

17.2.2005

EN

Official Journal of the European Union

L 46/31

COMMISSION REGULATION (EC) No 260/2005

of 16 February 2005

amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards
rapid tests

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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 subparagraph of Article 23 thereof,

Whereas:

(1)

(2)

(3)

Regulation (EC) No 999/2001 sets out a list of rapid tests
approved for TSE monitoring.

In its opinion of 16 November 2004, the European Food
Safety Authority (EFSA) recommended the inclusion of
seven new BSE rapid post mortem tests in the list of
rapid tests approved for monitoring of bovine spon-
giform encephalopathy (BSE).

The rapid tests currently listed in Annex X to Regulation
(EC) No 999/2001 have been approved for sheep based
on data provided by the test manufacturers showing that
their tests may also be used for monitoring of TSE in
sheep.

The EFSA is currently evaluating rapid post mortem tests
intended for small ruminants. A list of approved rapid
tests for use in the surveillance programme for small
ruminants is to be established on the basis of
the
opinion to be published. Accordingly,
the currently
approved rapid tests should be used for detecting TSE
in small ruminants, until the publication of that opinion.

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

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

opinion

the

the

of

(5)

(6)

HAS ADOPTED THIS REGULATION:

Article 1

Annex X 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 twentieth day
following its publication in the Official Journal of the European
Union.

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

Done at Brussels, 16 February 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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

(EC) No 1993/2004 (OJ

last amended by
L 344,

Commission Regulation
20.11.2004, p. 12).

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Official Journal of the European Union

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ANNEX

In Annex X, Chapter C, point 4 is replaced by the following:

‘4. Rapid tests

For the purposes of carrying out the rapid tests in accordance with Article 5(3) and Article 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 protease-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 protease resistant PrPRes with monoclonal antibodies

(Prionics-Check LIA test),

— automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the
protease sensitive and protease resistant forms of PrPSc (some fraction of the protease resistant PrPSc is
equivalent to PrPRes) and to PrPC (InPro CDI-5 test),

— 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 (PK) resistant PrPSc (Roche Applied Science PrionScreen).

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

— immuno-blotting test based on a Western blotting procedure for the detection of the protease-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),

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

test, the former Bio-Rad Platelia test),

— microplate based immunoassay (ELISA) which detects protease resistant PrPRes with monoclonal antibodies

(Prionics-Check LIA test),

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— automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the
protease sensitive and protease resistant forms of PrPSc (some fraction of the protease resistant PrPSc is
equivalent to PrPRes) and to PrPC (InPro CDI-5 test).

The producer of the rapid tests must have a quality assurance system in place agreed by the Community reference
laboratory, which ensures that the test performance does not change. The producer must provide the test protocol
to the Community reference laboratory.

Modifications to rapid tests or to test protocols may only be made following advance notification to the
Community reference laboratory, and provided that the Community reference laboratory finds that the modification
does not reduce the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the
Commission and to the national reference laboratories.’