The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019
| Year | 2019 |
2019 No. 556
Exiting The European Union
Pesticides
The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019
Made 20th March 2019
Coming into force in accordance with regulation 1(1)
The Secretary of State makes these Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 20181.
In accordance with paragraph 1(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.
PART 1
Introductory
Citation, commencement and interpretation
1.—(1) These Regulations may be cited as the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019, and come into force on exit day.
(2) In these Regulations—
“Regulation (EC) No 1107/2009” means Regulation (EC) No 1107/2009of the European Parliament and of the Council concerning the placing of plant protection products on the market;
“competent authority” and “constituent territory” have the meanings given in Article 3A of Regulation (EC) No 1107/2009(as inserted by regulation 3(5)).
PART 2
Amendment of retained direct EU legislation
CHAPTER 1
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
2. Regulation (EC) No 1107/2009is amended in accordance with regulations 3 to 14.
Chapter 1
3.—(1) Chapter 1 is amended as follows.
(2) In Article 1—
(a)
(a) in paragraph 1, for “Community” substitute “United Kingdom”;
(b)
(b) in paragraph 3, omit “internal”;
(c)
(c) in paragraph 4, in the second sentence—
(i) for “Member States” substitute “a competent authority”;
(ii) after “authorised in their” insert “constituent”.
(3) In Article 2(1)(c), for “special Community” substitute “retained EU law”.
(4) In Article 3—
(a)
(a) for the heading substitute “Definitions: general”;
(b)
(b) in paragraph 4, in the definition of “substance of concern”, in the second subparagraph—
(i) for “dangerous” substitute “hazardous”;
(ii) for “Article 3 of Directive 1999/45/EC2” substitute “that Regulation”;
(c)
(c) in paragraph 9, in the definition of “placing on the market”—
(i) in the first sentence, for “Community” substitute “United Kingdom”;
(ii) in the second sentence, for “into the territory of the Community” substitute “in the United Kingdom”;
(d)
(d) in paragraph 10, in the definition of “authorisation of a plant protection product”—
(i) for “the competent authority of a Member State” substitute “a competent authority”;
(ii) after “product in its” insert “constituent”;
(e)
(e) in paragraph 16, at the end insert “, as last amended by Directive (EU) 2015/412 of the European Parliament and of the Council3”;
(f)
(f) omit paragraphs 17 and 22;
(g)
(g) in paragraph 25, in the definition of “professional user”, after “ Directive 2009/128/EC4” insert “, and for these purposes, Directive 2009/128/ECis to be read as if Article 3(10)(b) were omitted”;
(h)
(h) in paragraph 26, in the definition of “minor use”—
(i) in the words before point (a), omit “in a particular Member State”;
(ii) in point (a), for “that Member State” substitute “the United Kingdom”;
(i)
(i) omit paragraph 30;
(j)
(j) after paragraph 31 insert—
“31A. 'the Department' means the Department of Agriculture, Environment and Rural Affairs in Northern Ireland;
31B. ‘approvals register’ means the register maintained in accordance with Article 27A;
31C. ‘unacceptable co-formulants register’ means the register maintained in accordance with Article 27B;
31D. ‘EU-derived domestic legislation’ has the meaning given by section 2(2) of the European Union (Withdrawal) Act 2018;”.
(5) After Article 3 insert—
“Definitions: competent authority, constituent territory and appropriate authority
Article 3A.—(1) In this Regulation, a reference to a competent authority or a constituent territory is to be interpreted in accordance with the provisions of this Article.
(2) The Secretary of State is the competent authority for the constituent territory of England.
(3) The Welsh Ministers are the competent authority for the constituent territory of Wales.
(4) The Scottish Ministers are the competent authority for the constituent territory of Scotland.
(5) The Department is the competent authority for the constituent territory of Northern Ireland.
(6) In this Regulation, “the appropriate authority” means—
(a)
(a) for regulations applying in relation to England, the Secretary of State;
(b)
(b) for regulations applying in relation to Wales, the Welsh Ministers;
(c)
(c) for regulations applying in relation to Scotland, the Scottish Ministers;
(d)
(d) for regulations applying in relation to Northern Ireland, the Department.
(7) But the appropriate authority is the Secretary of State if consent is given by—
(a)
(a) for regulations applying in relation to Wales, the Welsh Ministers;
(b)
(b) for regulations applying in relation to Scotland, the Scottish Ministers;
(c)
(c) for regulations applying in relation to Northern Ireland, the Department.”.
Chapter 2
4.—(1) Chapter 2 is amended as follows.
(2) In Article 4—
(a)
(a) in paragraphs 2(a) and 3(b) and (e), for “by the Authority” substitute “in accordance with paragraph 8”;
(b)
(b) in paragraph 4, for “Article 29(6)” substitute “Article 29(6)(a) which apply to each constituent territory to which approval of the active substance relates”;
(c)
(c) in paragraph 7—
(i) in the third subparagraph—
(aa) for “Member States” substitute “A competent authority”;
(bb) for “their” substitute “its constituent”;
(ii) in the fourth subparagraph—
(aa) for “they” substitute “the competent authority”;
(bb) for “transmit that plan to the Commission” substitute “publish that plan in a manner which the competent authority considers appropriate”;
(d)
(d) after paragraph 7 insert—
“8. For the purposes of paragraphs 2(a) and 3(b) and (e), scientific methods are accepted if they are accepted—
(a) in relation to England, by the Secretary of State;
(b) in relation to Wales—
(i) by the Secretary of State with the consent of the Welsh Ministers, or
(ii) by the Welsh Ministers;
(c) in relation to Scotland—
(i) by the Secretary of State with the consent of the Scottish Ministers, or
(ii) by the Scottish Ministers;
(d) in relation to Northern Ireland—
(i) by the Secretary of State with the consent of the Department, or
(ii) by the Department.”.
(3) For Article 5 substitute—
“First approval
Article 5.—(1) First approval must be for a period not exceeding—
(a)
(a) 10 years for an active substance, safener or synergist;
(b)
(b) 15 years for a low-risk active substance (see Article 22);
(c)
(c) 7 years for a candidate for substitution (see Article 24).
(2) Paragraph 1 is subject to Article 17.
(3) Approval for a basic substance (see Article 23) is for an unlimited period.”.
(4) In Article 6—
(a)
(a) the existing text becomes paragraph 1;
(b)
(b) in that paragraph, in point (f), for the words from “Member States” to “(the Authority)” substitute “each specified competent authority within a specified period”;
(c)
(c) after that paragraph insert—
“2. A competent authority may request from a specified competent authority a copy of any confirmatory information received in accordance with paragraph 1(f), which the specified competent authority must provide as soon as reasonably practicable.
3. In this Article, “specified” means specified in the condition referred to in paragraph 1(f).”.
(5) In Article 7—
(a)
(a) for paragraph 1 substitute—
“1. An application for the approval of an active substance may be submitted by the producer of the active substance to a competent authority.
1A. An application for an amendment to the conditions of an approval may be submitted by the producer of the active substance to a competent authority for a constituent territory to which the approval applies.
1B. A joint application may be submitted under paragraph 1 or 1A by an association of producers designated by the producers for the purpose of compliance with this Regulation.
1C. For the purposes of this Subsection, “the assessing competent authority” in relation to an application is the competent authority referred to in paragraph 1 or 1A respectively, except where a transfer has been agreed under Article 12A(1).
1D. An application under paragraph 1 or 1A must be submitted together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.”;
(b)
(b) omit paragraph 2;
(c)
(c) in paragraph 3, in the second subparagraph—
(i) in the first sentence for “Member States” substitute “The assessing competent authority”;
(ii) in the second sentence, for “rapporteur Member State” substitute “assessing competent authority”;
(d)
(d) for paragraph 5, substitute—
“5. When assessing the application the assessing competent authority may obtain independent scientific advice, where the assessing competent authority considers it appropriate to do so.”.
(6) In Article 8—
(a)
(a) in paragraph 1—
(i) in point (a)—
(aa) for “widely grown crop in each zone” substitute “crop grown in the United Kingdom”;
(bb) omit “cover all zones or”;
(cc) omit “which is not widely grown”;
(ii) in point (b), after “substance” insert “which apply in each of the constituent...
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