CHAPTER I

GENERAL PROVISIONS

Evaluation reports by the reference laboratory
Article 5
1
The
reference laboratory
shall submit a full evaluation report to the
Food Safety Authority
for each application, or for each group of applications, within three months from the date of receipt of a valid application as referred to in Article 8(1) of Regulation (EC) No 1831/2003 and the payment of the fee.
However, if the
reference laboratory
considers the application to be very complex, it may extend that period by an additional month. The
reference laboratory
shall inform the
appropriate authority
, the
Food Safety Authority
, and the applicant when the period is extended.
The time limits provided for in this paragraph may be further extended with the agreement of the
Food Safety Authority
, whenever the
reference laboratory
requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the
reference laboratory
within those time limits.
However, the time limit for the
reference laboratory
to submit the evaluation report to the
Food Safety Authority
shall not exceed the time limit for
Food Safety Authority
to provide its opinion, as provided for in Article 8(1) of Regulation (EC) No 1831/2003.
2
The evaluation report provided for in paragraph 1 shall include in particular:
a
an evaluation indicating if the methods of analysis in the data submitted in the application are suitable to be used for official controls;
b
an indication if testing of a method of analysis is considered necessary;
c
an indication if a validation of a method of analysis by an intercomparison study is considered necessary.
3
The evaluation report provided for in paragraph 1 may be amended by the
reference laboratory
at the request of the
appropriate authority
or the
Food Safety Authority
where:
a
the conditions for placing the feed additive on the market resulting from the Authority's opinion in accordance with Article 8(3)(a) of Regulation (EC) No 1831/2003 differ from those originally proposed by the applicant;
b
supplementary information relevant to the method of analysis have been provided by the applicant to the
Food Safety Authority
.
4
An evaluation report shall not be required for:
a
applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the
reference laboratory
;
b
applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the
reference laboratory
;
c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notwithstanding paragraph 4, the
appropriate authority
, the
reference laboratory
or the
Food Safety Authority
may, on the basis of legitimate factors relevant to the application, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the
reference laboratory
.
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).
Substituted by Commission Implementing Regulation (EU) 2015/1761 of 1 October 2015 amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto (Text with EEA relevance).
Words in Art. 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 5(1) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(c); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(d); 2020 c. 1, Sch. 5 para. 1(1)
Art. 5(4)(c) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 4(3) (with regs. 23, 24)