Article 1
Annex X to Regulation (EC) No 999/2001 is amended in accordance with the Annex to this Regulation.
Commission Regulation (EC) No 1053/2003 of 19 June 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid tests (Text with EEA relevance)
Commission Regulation (EC) No 1053/2003 of 19 June 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards 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 20th day following that of 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, 19 June 2003. For the Commission David Byrne Member of the Commission (1) OJ L 147, 31.5.2001, p. 1. (2) OJ L 37, 13.2.2003, p. 7.
Supplementary provisions
ANNEXSupplementary provisions
Annex X is amended as follows: (a) In Chapter A, point 3, the text concerning Greece is replaced by the following: ">TABLE>" (b) In 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: - 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). However, existing stocks bearing the name 'Bio-Rad Platelia test' may be used within nine months from the date of entry into force of this Regulation, - 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). 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 the rapid test or to the test protocol 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."
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.
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