Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilShow full title

[F1 Article 13 U.K. Approval Decision

1. Within six months of the relevant conclusion date, a competent authority for a constituent territory to which the application relates must decide to do one of the following—

(a) approve the active substance, subject to conditions or restrictions, as referred to in Article 6(1), where appropriate;

(b) amend the conditions of the approval; or

(c) refuse to approve the active substance.

2. In making a decision under paragraph 1, the competent authority must have regard to—

(a) the conclusion of the assessing competent authority;

(b) any comments received by the assessing competent authority in relation to the application, including any environmental monitoring information submitted by an appropriate agency;

(c) where the competent authority considers it appropriate to obtain it, any independent scientific advice obtained;

(d) where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety are relevant, the precautionary principle;

(e) any other matters which the competent authority considers relevant to the competent authority's decision.

3. As soon as reasonably practicable after making a decision under paragraph 1, the competent authority must—

(a) notify the applicant and the other competent authorities in writing of the decision and the reasons for it, and

(b) update the approvals register accordingly.

4. The Secretary of State may make a decision under paragraph 1 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;

5. Where the Secretary of State makes a decision in accordance with paragraph 4—

(a) a reference in paragraphs 2 and 3 to the competent authority is to be read as a reference to the Secretary of State;

(b) paragraph 3(a) is to be read as if “other” were omitted.

6. In paragraph 1, the “relevant conclusion date” means—

(a) where the competent authority is the assessing competent authority, the date on which the competent authority adopts a conclusion under Article 12(2);

(b) otherwise, the date on which the competent authority receives the conclusion of the assessing competent authority in accordance with Article 12(2).

7. In paragraph 2(b), “appropriate agency” means one of the following—

(a) the Environment Agency;

(b) the Natural Resources Body for Wales;

(c) the Scottish Environment Protection Agency.]

Textual Amendments

F1 Art. 13 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(20) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)