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14.11.2012 Official
Journal
of
the
European
Union L
314/13
COMMISSION REGULATION (EU) No 1064/2012
of 13 November 2012
amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council
as regards the list of rapid tests
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
test Prionics - Check PrioSTRIP SR (visual reading
protocol) be considered suitable for approval as rapid
Having regard to the Treaty on the Functioning of the European
test for detection of TSE in small ruminants’ central
Union,
nervous system.
Having regard to Regulation (EC) No 999/2001 of the European
(4)
It is therefore appropriate to amend accordingly the lists
Parliament and of the Council of 22 May 2001 laying down
of rapid tests approved for the monitoring of TSE in
rules for the prevention, control and eradication of certain
small ruminants, set out in point 4 of Chapter C of
transmissible spongiform encephalopathies ( 1 ), and in particular
Annex X to Regulation (EC) No 999/2001.
the first paragraph of Article 23 and the introductory phrase
and point (a) of Article 23a thereof,
(5) Regulation
(EC)
No
999/2001
should
therefore
be
Whereas:
amended accordingly.
(1) Regulation
(EC)
No
999/2001
lays
down
rules
for
the (6) The
measures
provided
for
in
this
Regulation
are
in
prevention, control and eradication of transmissible
accordance with the opinion of the Standing
spongiform encephalopathies (TSEs) in animals. It
Committee on the Food Chain and Animal Health,
applies to the production and placing on the market of
live animals and products of animal origin and in certain
HAS ADOPTED THIS REGULATION:
specific cases to exports thereof.
Article 1
(2)
Point 4 of Chapter C of Annex X to Regulation (EC) No
999/2001 sets out a list of rapid tests approved for the
In Chapter C of Annex X to Regulation (EC) No 999/2001,
monitoring of TSEs in bovine, ovine and caprine animals.
point 4 is replaced by the text in the Annex to this Regulation.
(3) On
8
May
2012,
the
European
Food
Safety
Authority
Article 2
(EFSA) published an opinion on the evaluation of new
TSE rapid tests submitted in the framework of the
This Regulation shall enter into force on the third day following
Commission call for expression of interest 2007/S204-
that of its publication in the Official Journal of the European
247339 ( 2 ). EFSA recommended in this opinion that the
Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 November 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 147, 31.5.2001, p. 1.
( 2 ) OJ/S S204, 23.10.2007, 247339-2007-EN.

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L 314/14
EN
Official Journal of the European Union
14.11.2012
ANNEX
Point 4 of Chapter C of Annex X 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), only the following
methods shall be used as rapid tests for the monitoring of BSE in bovine animals:
— the immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase
K-resistant fragment PrPRes (Prionics-Check Western test),
— the 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),
— the microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),
— the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation
and concentration steps (Bio-Rad TeSeE SAP rapid test),
— the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal
antibodies (Prionics-Check LIA test),
— the immunoassay using a chemical polymer for selective PrP Sc capture and a monoclonal detection antibody
directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA & IDEXX
HerdChek BSE-Scrapie Antigen Test Kit, EIA),
— the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP
fractions (Prionics Check PrioSTRIP),
— the two-sided immunoassay using two different monoclonal antibodies directed against two epitopes
presented in a highly unfolded state of bovine PrP Sc (Roboscreen Beta Prion BSE EIA Test Kit),
— the sandwich ELISA for the detection of Proteinase K-resistant PrP Sc (Roche Applied Science PrionScreen).
For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following
methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:
— the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation
and concentration steps (Bio-Rad TeSeE SAP rapid test),
— the sandwich immunoassay for PrPRes detection with the TeSeE Sheep/Goat Detection kit carried out
following denaturation and concentration steps with the TeSeE Sheep/Goat Purification kit (Bio-Rad TeSeE
Sheep/Goat rapid test),
— the immunoassay using a chemical polymer for selective PrP Sc capture and a monoclonal detection antibody
directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),
— the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP
fractions (rapid test Prionics - Check PrioSTRIP SR, visual reading protocol).
In all rapid 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 European
Union Reference Laboratory and ensures that the test performance does not change. Producers must provide the
European Union Reference Laboratory with the test protocols.
Changes to rapid tests and to test protocols may only be made after prior notification to the European Union
Reference Laboratory and provided that the European Union Reference Laboratory 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.'

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Document Outline

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