The Transmissible Spongiform Encephalopathies (Scotland) Regulations 2010

Approval of laboratories S

10.—(1) The Scottish Ministers must approve laboratories to test samples taken under paragraph 8 if the Scottish Ministers are satisfied that the laboratory—

(a) will carry out the testing in accordance with Chapter C of Annex X to the EU TSE Regulation (sampling and laboratory testing);

(b) has adequate quality control procedures; and

(c) has adequate procedures to ensure the correct identification of the samples and notification of the test results to the consigning slaughterhouse and to the Scottish Ministers.

(2) The Scottish Ministers may charge the fees set out in the following table for the initial approval and ongoing quality assessment of a laboratory—

Fees for laboratory approvals and quality assessment

	Fee (£)
Initial approval	29,770
Annual proficiency testing and follow�??up inspection for the first year after approval	8,834
Annual proficiency testing from the second year after approval	4,135
Single proficiency test (in the event of a failure in the annual proficiency testing)	1,385
Rate of an inspector per hour or part thereof (for any additional inspections that are necessary to check for compliance with the matters set out at sub�??paragraph (1)(a) to (c))	87.24

(3) For the purposes of this paragraph and paragraphs 8 and 9, “approved testing laboratory” means—

(a) a laboratory approved under this paragraph;

(b) a laboratory approved under corresponding legislation elsewhere in the United Kingdom;

(c) an EU National Reference laboratory M1 ; or

(d) a diagnostic laboratory approved by a Member State in accordance with Annex X to the EU TSE Regulation (reference laboratories, sampling and laboratory analysis methods).

Marginal Citations

M1 Designated under Article 33(1) of Regulation (EC) No. 882/2004 (O.J. No. L 165, 30.4.2004, p.1).