Article 12 Approval of laboratories, quality requirements and approved testing methods

Laboratories participating in control programmes pursuant to Articles 5 and 7 shall, for the purposes of analysing samples to test for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1:

Laboratories shall regularly participate in collaborative testing organised or coordinated by the F3... reference laboratory.

F4Subject to paragraph 4, testing for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1, shall be carried out using the methods and protocols recommended by international standardisation bodies, as reference methods.

Alternative methods may be used if they have been validated in accordance with internationally recognised rules and offer equivalent results to those obtained by the relevant reference method.

F5...

Where in the opinion of the appropriate authority it is necessary to do so, the appropriate authority may, by regulations, approve other methods for testing.