ANNEXU.K.

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:

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:

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.