The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

14.—(1) Schedule 1 is amended as follows. U.K.

(2) In paragraph 1—

[F1 (a) in the first sentence, after “product-related applications” insert “to a United Kingdom competent authority”;]

[F2 (b)] in the table—

(i) in item 4 in the second column, after “application⁽²⁾” omit “⁽³⁾”;

(ii) omit items 5, 5a and 5b;

(iii) in item 11 in the second column, for “for lead zonal re-registration and new product applications” substitute “ to discuss potential product applications ”;

(iv) omit item 12;

[F3 (c)] in the notes following the table—

(i) omit notes (3), (5) and (6);

(ii) in note (7) for “items 1-5, 10, 11 and 12” substitute “ items 1-4, 10 and 11 ”;

(iii) in note (16) omit “to the United Kingdom to act as lead zonal rapporteur”;

(iv) omit note (17);

(v) in note (18) for “the United Kingdom” substitute “ a United Kingdom competent authority ”.

[F4 (2A) After paragraph 1, insert—

“1A.   Fees for parallel trade applications to the Northern Ireland competent authority are in accordance with the following table, and each item is charged cumulatively.

Item	Chargeable item	Fee(£)
(1) Application for a parallel trade permit for other than personal use.
(2) Verification that the product to be traded is identical to a product authorised in accordance with Regulation 1107/2009.”
1	Preliminary consideration of an application to determine whether the application can proceed further	229
2	Parallel trade applications—
	(a) co-ordination of application for a new product or change to an existing product involving parallel trade(1)	728
	(b) parallel trade verification(2)	208
	(c) parallel trade permit for personal use	156.]

(3) In paragraph 2—

(a) in the heading, for “or synergist” substitute “ , synergist or basic substance ”;

[F5 (b) in the first sentence—

(i) after “The fees” insert “chargeable by a Great Britain competent authority”;

(ii) for “or synergist” substitute “, synergist or basic substance”.]

(c) in the table—

(i) in the heading before item 1, for “or synergist” substitute “ , synergist or basic substance ”;

(ii) omit item 2;

(iii) in item 3 for the words in the second column substitute “ Co-ordination of scientific advice and public consultation and finalising the draft assessment report ”;

(iv) in items 7 and 10, for the words in the second column substitute “ Co-ordination of scientific advice and public consultation, and finalising the draft assessment report ”;

(v) in item 12, in the second column, after “synergist,” insert “ basic substance, ”;

(d) in the notes following the table—

(i) omit note (2);

(ii) in note (3)—

(aa) at the beginning insert “ In relation to active substances, safeners or synergists, ”;

(bb) after the first sentence insert “ In relation to basic substances, a full data package comprises the complete dossier (the information referred to in Article 23(3) of Regulation 1107/2009) to support one or more uses of the basic substance. ”;

(cc) in the second sentence after “the product” insert “ or basic substance ”;

(iii) in note (4)—

(aa) omit paragraph (c);

(bb) in paragraph (d) at the beginning insert “ in relation to active substances, safeners or synergists, ”;

(cc) omit paragraph (e);

(dd) in paragraphs (f) and (g), at the beginning insert “ in relation to active substances, safeners or synergists, ”;

(ee) after paragraph (g) insert—

“(h) in relation to basic substances, resubmissions (for example where the previous application for approval under Regulation 1107/2009 has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission);

(i) in relation to basic substances, data to support a change to the conditions of approval of the basic substance.”;

(iv) for the final sentence substitute—

“The evaluation of scientific peer reviewed open literature on the active substance or basic substance and its relevant metabolites will be treated as a partial data package.”

[F6 (3A) In paragraph 3, after “organisation” insert “by a United Kingdom competent authority”.]

(4) Omit paragraph 4 (including the table, and the notes following the table, in that paragraph).

Textual Amendments

F1 Sch. 1 para. 14(2)(a) inserted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 1 para. 10(2)(b)

F2 Sch. 1 para. 14(2)(a) renumbered as Sch. 1 para. 14(2)(b) (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 1 para. 10(2)(a)

F3 Sch. 1 para. 14(2)(b) renumbered as Sch. 1 para. 14(2)(c) (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 1 para. 10(2)(a)

F4 Sch. 1 para. 14(2A) inserted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 1 para. 10(3)

F5 Sch. 1 para. 14(3)(b) substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 1 para. 10(4)

F6 Sch. 1 para. 14(3A) inserted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 1 para. 10(5)

Commencement Information

I1 Sch. 1 para. 14 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)