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The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019

Type Statutory-Instrument

Publication 2019-03-20

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

Reform history JSON API PDF

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 2018 .

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.

(1A) Regulation 28 and Schedule 1 extend to Great Britain.

(2) In these Regulations—

“Regulation (EC) No 1107/2009” means Regulation (EC) No 1107/2009 of 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 1107/2009 is amended in accordance with regulations 3 to 14.

Chapter 1

3

(1) Chapter 1 is amended as follows.

(2) In Article 1—

(a) in paragraph 1, for “ the Community ” substitute “ Great Britain ”;

(b) in paragraph 3, omit “internal”;

(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) for the heading substitute “ Definitions: general ”;

(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/EC ” substitute “ that Regulation ”;

(i) in the first sentence, for “ the Community ” substitute “ Great Britain ”;

(ii) in the second sentence, for “into the territory of the Community” substitute “ in Great Britain ”;

(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) in paragraph 16, at the end insert “ , as last amended by Directive (EU) 2015/412 of the European Parliament and of the Council ”;

(f) omit paragraphs 17 and 22;

(g) in paragraph 25, in the definition of “professional user”, after “Directive 2009/128/EC ” insert “ , and for these purposes, Directive 2009/128/EC is to be read as if Article 3(10)(b) were omitted ”;

(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 “ Great Britain ”;

(i) omit paragraph 30;

(j) after paragraph 31 insert—

(31A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (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—

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (6) In this Regulation, “the appropriate authority” means— (a) for regulations applying in relation to England, the Secretary of State; (b) for regulations applying in relation to Wales, the Welsh Ministers; (c) for regulations applying in relation to Scotland, the Scottish Ministers; (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7) But the appropriate authority is the Secretary of State if consent is given by— (a) for regulations applying in relation to Wales, the Welsh Ministers; (b) for regulations applying in relation to Scotland, the Scottish Ministers; (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 2

4

(1) Chapter 2 is amended as follows.

(2) In Article 4—

(a) in paragraphs 2(a) and 3(b) and (e), for “by the Authority” substitute “ in accordance with paragraph 8 ”;

(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 ”;

(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) 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) For Article 5 substitute—

(1) First approval must be for a period not exceeding— (a) 10 years for an active substance, safener or synergist; (b) 15 years for a low-risk active substance (see Article 22); (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) the existing text becomes paragraph 1;

(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 ”;

(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) 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) omit paragraph 2;

(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) 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) 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 territories to which the application relates ”;

(iii) in point (c), after “product” insert “ which apply in each of the constituent territories to which the application relates ”;

(b) omit paragraph 3;

(4) The appropriate authority may by regulations prescribe the data requirements for— (a) one or more active substances, safeners and synergists for the purposes of paragraph 1(b); (b) plant protection products for the purposes of paragraph 1(c).

(d) in paragraph 5, for “determined by the Authority” substitute “ described in guidance issued under Article 77 ”.

(7) In Article 9—

(a) in paragraph 1, in the first sentence, for “rapporteur Member State” substitute “ assessing competent authority ”;

(b) in paragraph 2—

(i) for “rapporteur Member State” in both places it occurs substitute “ assessing competent authority ”;

(ii) in the second subparagraph, for “, the other Member States and the Commission” substitute “ and the other competent authorities ”;

(i) in the first subparagraph—

(aa) for “rapporteur Member State” substitute “ assessing competent authority ”;

(bb) for “, the other Member States, the Commission and the Authority” substitute “ and the other competent authorities ”;

(ii) in the second subparagraph—

(aa) for “shall immediately” substitute “ must on request ”;

(bb) for “Member States, the Commission and the Authority” substitute “ competent authorities ”.

(8) In Article 10, for “Authority” substitute “ assessing competent authority ”.

(9) In Article 11—

(a) in paragraph 1—

(i) for “rapporteur Member State” substitute “ assessing competent authority ”;

(ii) for “Commission, with a copy to the Authority,” substitute “ other competent authorities ”;

(b) in paragraph 2, in the second subparagraph, for “rapporteur Member State” substitute “ assessing competent authority ”;

(i) in the first subparagraph—

(aa) for “rapporteur Member State” in each place it occurs substitute “ assessing competent authority ”;

(bb) in the fourth sentence, for “Commission and the Authority” substitute “ other competent authorities ”;

(ii) in the second subparagraph—

(aa) for “rapporteur Member State” substitute “ assessing competent authority ”;

(bb) for “, the Commission and the Authority” substitute “ and the other competent authorities, ”;

(d) omit paragraph 4.

(10) Article 12 is amended in accordance with paragraphs (11) to (18).

(11) In the heading, for “Authority” substitute “ assessing competent authority ”.

(12) In paragraph 1—

(a) for the first subparagraph substitute—

(a) The assessing competent authority must circulate the draft assessment report to the applicant and the other competent authorities at the latest 30 days after its completion. The assessing competent authority may ask the applicant to circulate any updated dossier to the assessing competent authority and the other competent authorities.

(b) the existing second and third subparagraphs become points (b) and (c);

(13) In paragraph 2—

(a) omit the first subparagraph;

(b) in the second subparagraph—

(i) in the first sentence—

(aa) for “Authority” substitute “ assessing competent authority ”;

(bb) for “, the Member States and the Commission” substitute “ and the other competent authorities, ”;

(ii) for the second sentence substitute—

In the event that independent scientific advice is obtained by the assessing competent authority in accordance with Article 7(5), the 120-day period must be extended by 90 days.

(14) In paragraph 3—

(a) the existing first subparagraph becomes point (a);

(b) in that point (a)—

(i) for “Authority” in the first place it occurs substitute “ assessing competent authority ”;

(ii) for “Member States, the Commission and the Authority” substitute “ assessing competent authority and the other competent authorities ”;

(b) The assessing competent authority must assess the additional information, and for that purpose the period provided for in paragraph 2 may be extended by a maximum of 60 days.

(d) the existing third subparagraph becomes point (c);

(e) in that point (c)—

(i) for “Authority” substitute “ assessing competent authority ”;

(ii) omit “ask the Commission to”;

(iii) omit “Community” in both places it occurs.

(15) In paragraph 4, for “Authority” substitute “ assessing competent authority ”.

(16) Omit paragraph 5.

(17) In paragraph 6, for the words from “limits for the Authority's” to “Article 11 and” substitute “limit”.

(18) Omit paragraphs 7 and 8.

(19) After Article 12 insert—

(1) The assessing competent authority may by agreement transfer the functions listed in paragraph 2 in relation to an application for approval to another competent authority for a constituent territory in relation to which the same application has been made, and upon transfer that competent authority is the assessing competent authority for the purposes of this Subsection. (2) For the purposes of paragraph 1 the functions are the functions of the assessing competent authority under Articles 7(3) and (5), 9, 10, 11 and 12. (3) Following a transfer under paragraph 1, the assessing competent authority must notify the applicant of the transfer. (4) A transfer in accordance with paragraph 1 does not— (a) affect anything done by the assessing competent authority prior to transfer; (b) affect the timing of any requirements placed on the assessing competent authority under this Subsection.

(20) For Article 13, substitute—

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