CHAPTER IIPROCEDURE FOR APPLICATIONS FOR MRLS
SECTION 3Setting, modifying or deletion of MRLs
F1Article 15Setting of new MRLs
(1)
This Article applies where the competent authority decides to set a new MRL in accordance with Article 14(1B)(a).
(2)
The competent authority—
(a)
may set a temporary MRL in relation to its constituent territory—
(i)
for an active substance which is not approved under Regulation (EC) No 1107/2009 in relation to that territory, or
(ii)
in the circumstances described in Article 16(1);
(b)
otherwise, must set an MRL in relation to its constituent territory.
(3)
A temporary MRL set in accordance with paragraph 2(a)(i) expires after 12 months unless—
(a)
deleted in accordance with Article 14(1B)(b), or
(b)
extended in accordance with paragraphs 4 or 5.
(4)
A competent authority may extend a temporary MRL set in accordance with paragraph 2(a)(i) by a further 12 months where confirmation is pending that any scientific studies necessary for supporting an application for setting an MRL have been undertaken.
(5)
Where the confirmation described in paragraph 4 is received, a competent authority may extend the temporary MRL by a further 24 months provided that no unacceptable safety concerns for consumers have been identified.
(6)
Where the competent authority extends the period of the temporary MRL in accordance with paragraph 4 or 5, the competent authority must update the MRLs register accordingly.
(7)
Where the Secretary of State makes a decision under Article 14(5) to set a new MRL in accordance with Article 14(1B)(a), a reference to the competent authority in paragraphs 1 and 2 is to be read as a reference to the Secretary of State.
(8)
The Secretary of State may extend a temporary MRL in accordance with paragraphs 4 or 5 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.
(9)
Where the Secretary of State extends a temporary MRL in accordance with paragraph 8, a reference in paragraph 6 to the competent authority is to be read as a reference to the Secretary of State.