CHAPTER IIPROCEDURE FOR APPLICATIONS FOR MRLS
SECTION 3Setting, modifying or deletion of MRLs
Article 16Procedure for setting temporary MRLs in certain circumstances
1.
F1The competent authority may set a temporary MRL in the following circumstances—
(a)
in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to F2Article 53 of Regulation (EC) No 1107/2009; or
(b)
where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals; or
(c)
for honey; or
(d)
for herbal infusions; or
(e)
where essential uses of plant protection products have been identified by F3the competent authority in deciding to refuse approval or the renewal of approval, or to withdraw approval, for an active substance under Regulation (EC) No 1107/2009; or
(f)
where new products, product groups and/or parts of products have been included in F4the list in Part 1 of the MRLs register in relation to its constituent territory, in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified.
2.
The inclusion of temporary MRLs as referred to in paragraph 1 shall be based on the opinion of the F5competent authority, monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals.
The continued validity of the temporary MRLs referred to in paragraphs 1(a), (b), (c) and (d) shall be reassessed at least once every 10 years F6....
The MRLs referred to in paragraph 1(e) shall be reassessed at the expiry of the period for which the essential use was authorised. The MRLs referred to in paragraph 1(f) shall be reassessed when the scientific studies have been completed and evaluated, but no later than four years after their inclusion in F7Part 3 of the MRLs register.
F8(3.
Upon reassessment of a temporary MRL in accordance with paragraph 2, the competent authority—
(a)
may modify or delete the temporary MRL, and
(b)
where the competent authority does so, must update the MRLs register accordingly.
(4.
Where the Secretary of State makes a decision in accordance with Article 15(2)(a)(ii), a reference to the competent authority in paragraphs 1 and 2 is to be read as a reference to the Secretary of State.
(5.
The Secretary of State may reassess a temporary MRL in accordance with the second or third subparagraph of paragraph 2 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 reassesses a temporary MRL in accordance with paragraph 5, a reference in paragraph 3 to the competent authority is to be read as a reference to the Secretary of State.