CHAPTER IIIU.K.TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE

Article 10U.K.Testing of methods of analysis and validation of methods of analysis

1.The [F1reference laboratory] shall indicate in its evaluation report to the [F2Food Safety Authority], as provided for in Article 5(2), and shall inform the applicant and the [F3appropriate authority], if it considers that the following are necessary:

(a)testing of methods of analysis;

(b)validation of methods of analysis.

In doing so, the [F1reference laboratory] shall provide the applicant with a document describing the work to be carried out through [F4scientific experts or official laboratories] including a time schedule and an estimate of a special fee to be paid by the applicant. The applicant shall inform the [F1reference laboratory] about his agreement to the document within 15 days of receipt of the communication.

2.The [F1reference laboratory] shall supplement the report to the [F2Food Safety Authority], as provided for in Article 5(1), with an addendum concerning the outcome of the application of the procedure foreseen in paragraph 1 within 30 days of the availability to the [F1reference laboratory] of the results of the testing and validation work.

Textual Amendments

Article 11U.K.Reporting

The [F5reference laboratory] shall be responsible for preparing an annual report on each year’s activities carried out for the implementation of this Regulation and shall submit it to the [F6appropriate authority]. The [F7scientific experts or official laboratories] shall contribute to this annual report.

The [F5reference laboratory] may also organise an annual meeting with the [F7scientific experts or official laboratories], in view of the establishment of the annual report.

Textual Amendments

Article 12U.K.Guidance

1.The [F8reference laboratory] may establish detailed guidance for applicants concerning:

(a)reference samples;

(b)the testing of methods of analysis, including in particular criteria about when such testing may be required;

(c)the validation of methods of analysis, including in particular criteria about when such validation may be required[F9;]

[F10(d)requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.]

2.The [F8reference laboratory] shall establish detailed guidance for [F11scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratories].

Textual Amendments