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.
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)
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)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
Article 2
This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX In Annex X, Chapter C, to Regulation (EC) No 999/2001, point 4 is replaced by the following: β4.Β Β Β 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: β immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test), β 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), β microplate-based immunoassay for the detection of PrP Sc (Enfer TSE Version 3), β sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test), β microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test), β conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit), β chemiluminescent ELISA for qualitative determination of PrP Sc (CediTect BSE test), β 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), β lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP), β 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), β sandwich ELISA for the detection of Proteinase K-resistant PrP Sc (Roche Applied Science PrionScreen), β 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: β conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit), β sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test), β sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE Sheep/Goat test), β chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer TSE Kit version 2.0), β microplate-based immunoassay for the detection of PrP Sc (Enfer TSE Version 3), β 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), β microplate-based chemiluminiscent immunoassay for the detection of PrP Sc in ovine tissues (POURQUIERβS-LIA Scrapie), β 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), β microplate-based chemiluminescent immunoassay for the detection of Proteinase K-resistant PrP Sc (Prionics Check LIA Small Ruminants). In all tests, sample tissue on which the test must be applied must comply with the manufacturerβs 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.β
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.
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