CHAPTER III

TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE

Testing of methods of analysis and validation of methods of analysis
Article 10
1
The reference laboratory shall indicate in its evaluation report to the Food Safety Authority, as provided for in Article 5(2), and shall inform the applicant and the appropriate 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 reference laboratory shall provide the applicant with a document describing the work to be carried out through scientific 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 reference laboratory about his agreement to the document within 15 days of receipt of the communication.
2
The reference laboratory shall supplement the report to the Food 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 reference laboratory of the results of the testing and validation work.

Reporting
Article 11
The reference 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 appropriate authority. The scientific experts or official laboratories shall contribute to this annual report.
The reference laboratory may also organise an annual meeting with the scientific experts or official laboratories, in view of the establishment of the annual report.

Guidance
Article 12
1
The reference 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;
d
requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.
2
The reference laboratory shall establish detailed guidance for scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratories.
Substituted by Commission Regulation (EC) No 885/2009 of 25 September 2009 amending Regulation (EC) No 378/2005 as regards reference samples, fees and the laboratories listed in Annex II (Text with EEA relevance).
Inserted by Commission Regulation (EC) No 885/2009 of 25 September 2009 amending Regulation (EC) No 378/2005 as regards reference samples, fees and the laboratories listed in Annex II (Text with EEA relevance).
Words in Art. 10 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 72(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 10 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 72(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 10(1) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 72(c); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 11 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 73(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 11 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 73(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 74; 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 10(1) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(5)
Words in Art. 11 substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(6)
Words in Art. 12(2) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(7)