CHAPTER IIITESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE
Article 10Testing 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.
Article 11Reporting
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.
Article 12Guidance
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 requiredF9;
F10(d)
requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.