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Regulation (EC) No 396/2005 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (Text with EEA relevance)

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SECTION 2U.K.[F1Assessment of existing MRLs by the competent authority]

F2Article 10U.K.The Authority's opinion on applications concerning MRLs

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F3Article 11U.K.Time limits for the Authority's opinion on applications concerning MRLs

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[F4Article 12U.K.Assessment of existing MRLs by the competent authority

1.A competent authority must produce a reasoned opinion within a period of 36 months beginning with the date on which an active substance approval decision is made in respect of an active substance in relation to its constituent territory, except where paragraph 2 applies.

2.Where at the end of the 36 month period described in paragraph 1 there are outstanding renewals of authorisations under Article 43 of Regulation (EC) No 1107/2009 relating to that active substance in relation to its constituent territory, a competent authority must instead produce a reasoned opinion before the end of the period of 6 months beginning with the date on which the last of those outstanding renewals is concluded.

3.The reasoned opinion must be based in particular on the relevant assessment report prepared under Regulation (EC) No 1107/2009, and must include—

(a)existing MRLs for that active substance set out in Part 2 or 3 of the MRLs register in relation to the competent authority's constituent territory;

(b)the necessity of setting a new MRL for that active substance, or its inclusion in Part 4 of the MRLs register;

(c)specific processing factors as referred to in Article 20(2) that may be needed for that active substance;

(d)MRLs which the competent authority may consider including in Part 2 or 3 of the MRLs register and those MRLs related to that active substance which may be deleted.

4.In paragraph 1, an “active substance approval decision” means a decision by the competent authority under Article 13(1) or 20(1) of Regulation (EC) No 1107/2009.

5.The Secretary of State may produce a reasoned opinion under this Article instead of a competent authority—

(a)in relation to Wales, with the consent of the Welsh Ministers;

(b)in relation to Scotland, with the consent of the Scottish Ministers.

6.Where the Secretary of State produces a reasoned opinion in accordance with paragraph 5—

(a)a reference in paragraphs 1 to 3 to the competent authority is to be read as a reference to the Secretary of State;

(b)the Secretary of State must send a copy of the produced reasoned opinion to the competent authority.]

F5Article 13U.K.Administrative review

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