21.—(1) The Scottish Ministers shall approve laboratories under this regulation to carry out one or more of the tests referred to in this regulation if they are satisfied that those laboratories have the necessary facilities, personnel and operating procedures to do so.
(2) In deciding whether to grant or continue an approval, the Scottish Ministers may require the laboratory to successfully undertake any quality control tests as they reasonably think fit.
(3) The operator of a laboratory approved under this regulation carrying out tests for the purposes of these Regulations or the Community Regulation shall do so in accordance with this regulation, and failure to do so shall be an offence.
(4) A test for Clostridium perfringens shall be carried out in accordance with the method in Schedule 2 or (if specified in the approval) with a method which conforms with ISO 7937/1997 (BS-EN 13401:1999) (Enumeration of Clostridium perfringens) or equivalent(1).
(5) A test for Salmonella shall be carried out in accordance with the method in Schedule 2 or (if specified in the approval) with a method which conforms with–
(a)ISO 6579/2002 (BS-EN 12824:1998) (Detection of Salmonella) or equivalent(2); or
(b)NMKL 71: 1993 or equivalent(3).
(6) A test for Enterobacteriaceae shall be carried out in accordance with the method in Schedule 2 or (if specified in the approval) with a method which conforms with ISO 7402/1993 (BS 5763: Part 10: 1993) (Enumeration of Enterobacteriaceae) or equivalent(4).
(7) Where tests are carried out for the detection of any of the following, the operator of a laboratory approved under this regulation shall immediately notify the Scottish Ministers and the operator of the premises if–
(a)the tests fail to establish that the material is free from Clostridium perfringens;
(b)the tests fail to establish that the material is free from Salmonella; or
(c)the material successfully passes the test for Enterobacteriaceae in paragraph 5 of Part 3 of Schedule 2,
and failure to so notify shall be an offence.
(8) The operator of a laboratory approved under this regulation shall in relation to processed material notify the Scottish Ministers immediately after the last day of each month of the number, type and results of tests carried out during that month, and failure to do so shall be an offence.
(9) Reprocessing in accordance with Article 25(2)(c) and (d) of the Community Regulation shall be carried out under the supervision of the Scottish Ministers.
(10) If the sample has been sent to the approved laboratory from premises outside Scotland, the requirements in this regulation to notify the Scottish Ministers shall be construed as a requirement to notify the competent authority for the premises from which the sample was sent.
Published by the British Standards Institute, British Standards House, 389 Chiswick High Road, London W4 4AL.
Published by the British Standards Institute; see above.
Published by the British Standards Institute, British Standards House, 389 Chiswick High Road, London W4 4AL.
Published by the British Standards Institute; see above.