CHAPTER II

PROCEDURE FOR APPLICATIONS FOR MRLS
SECTION 2

Assessment of existing MRLs by the competent authority

The Authority's opinion on applications concerning MRLs
Article 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time limits for the Authority's opinion on applications concerning MRLs
Article 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Assessment of existing MRLs by the competent authority
Article 12
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.

Administrative review
Article 13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ch. 2 Section 2 heading substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(7); 2020 c. 1, Sch. 5 para. 1(1)
Art. 10 omitted (31.12.2020) by virtue of The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(8); 2020 c. 1, Sch. 5 para. 1(1)
Art. 11 omitted (31.12.2020) by virtue of The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(8); 2020 c. 1, Sch. 5 para. 1(1)
Art. 12 substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(9) (with Sch. 1 para. 11) (as amended by S.I. 2019/1410, regs. 1(2), 7(3)(b) and S.I. 2020/1376, regs. 1(4), 6(3)(b)(9)(e)); 2020 c. 1, Sch. 5 para. 1(1)
Art. 13 omitted (31.12.2020) by virtue of The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(10); 2020 c. 1, Sch. 5 para. 1(1)