CHAPTER VILABORATORIES
Article 12Approval of laboratories, quality requirements and approved testing methods
1
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:
a
be designated by the competent authority; and
b
apply quality assurance systems that conform to the requirements of the current EN/ISO standard at the latest within 24 months of entry into force of this Regulation or within 24 months of the addition of new zoonoses or zoonotic agents to Annex I, column 1.
2
Laboratories shall regularly participate in collaborative testing organised or coordinated by the national reference laboratory.
3
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.
F1Where necessary, other methods for testing may be approved by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).