Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilShow full title

Article 8 U.K. Opinion of the [F1 Food Safety Authority]

1. The [F1 Food Safety Authority] shall give an opinion within six months of receipt of a valid application. This time limit shall be extended whenever the [F1 Food Safety Authority] seeks supplementary information from the applicant under paragraph 2.

2. The [F1 Food Safety Authority] may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the [F1 Food Safety Authority] after consultation with the applicant.

3. In order to prepare its opinion, the [F1 Food Safety Authority]:

(a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 7 and undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5;

(b) shall verify the report of the [F2 reference laboratory].

4. In the event of an opinion in favour of authorising the feed additive, the opinion shall also include the following elements:

(a) the name and address of the applicant;

(b) the designation of the feed additive including its categorisation and allocation within functional groups provided for in Article 6, its specification, including, where applicable, purity criteria and method of analysis;

(c) depending on the outcome of the assessment, specific conditions or restrictions in relation to handling, post-market monitoring requirements and use, including animal species and categories of animal species for which the additive is to be used;

(d) specific additional requirements for the labelling of the feed additive necessary as a result of conditions and restrictions imposed under (c);

(e) a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin, unless the opinion of the [F1 Food Safety Authority] concludes that the establishment of MRLs is not necessary for the protection of consumers or MRLs have already been established in [F3 Regulation (EC) No 470/2009].

[F4 5. The Food Safety Authority must without delay forward its opinion to the appropriate authority including a report describing its assessment of the feed additive and stating the reasons for its conclusion.]

6. The [F1 Food Safety Authority] shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 18(2).

Textual Amendments

F1 Words in Art. 8 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 15(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 8(3)(b) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 15(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 8(4)(e) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(7)

F4 Art. 8(5) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 15(c); 2020 c. 1, Sch. 5 para. 1(1)