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Commission Regulation (EC) No 378/2005Show full title
Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (Text with EEA relevance)
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Changes over time for: CHAPTER III
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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
F1Words 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)
F2Words 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)
F3Words 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)
F4Words 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)
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
F5Words 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)
F6Words 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)
F7Words 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)
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
F8Words 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)
F9Substituted 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).
F10Inserted 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).
F11Words 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)
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