Commission Regulation (EC) No 315/2008 of 4 April 2008 amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the lists of rapid tests (Text with EEA relevance)
Date: 2008-04-04
Institutions: European Commission
Subjects: analytical chemistry, animal disease, cattle, disease prevention, goat, sheep

5.4.2008

EN

Official Journal of the European Union

L 94/3

COMMISSION REGULATION (EC) No 315/2008

of 4 April 2008

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

(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:

(4)

(5)

encephalopathy (BSE). It is therefore appropriate to delete
that test (Institut Pourquier Speed’it BSE) from the list of
rapid tests for the monitoring of BSE in bovine animals
in Chapter C of Annex X to Regulation (EC) No
999/2001.

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

(1)

(2)

(3)

Regulation (EC) No 999/2001 lays down rules for the
transmissible
prevention, control and eradication of
It
spongiform encephalopathies
applies to the production and placing on the market of
live animals and products of animal origin and in certain
specific cases to exports thereof.

in animals.

(TSEs)

Point 4 of Chapter C of Annex X to Regulation (EC) No
999/2001 sets out a list of rapid tests approved for the
monitoring of TSEs in bovine, ovine and caprine animals.

HAS ADOPTED THIS REGULATION:

Article 1

In Chapter C of Annex X to Regulation (EC) No 999/2001,
point 4 is replaced by the text in the Annex to this Regulation.

On 30 August 2007,
laboratory informed the
a
Commission that it will cease marketing the approved
rapid test for the monitoring of the bovine spongiform

Article 2

This Regulation shall enter into force on the third 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, 4 April 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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

last amended by
Commission Regulation (EC) No 21/2008 (OJ L 9, 12.1.2008, p. 3).

L 94/4

EN

Official Journal of the European Union

5.4.2008

ANNEX

In Annex X, Chapter C, to Regulation (EC) No 999/2001, 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),

— microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),

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

test),

— microplate-based immunoassay (ELISA) which detects Proteinase K-resistant 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),

— 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 monoclonal 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 in 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 Te-SeE

test),

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

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),

— microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),

— 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),

5.4.2008

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Official Journal of the European Union

L 94/5

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

Producers of rapid tests must have a quality assurance system in place that has been approved by the Community
Reference Laboratory (CRL) and ensures that the test performance does not change. Producers must provide the CRL
with the test protocols.

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