# The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019, Paragraph 14: Plant Protection Products (Fees and Charges) Regulations 2011


(1) Schedule 1 is amended as follows.
(2) In paragraph 1—
(a) 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;
(b) 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”.
(3) In paragraph 2—
(a) in the heading, for “or synergist” substitute “, synergist or basic substance”;
(b) in the first sentence, 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.”
(4) Omit paragraph 4 (including the table, and the notes following the table, in that paragraph).

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111181539/schedule/1/paragraph/14 (the official version)
Page: https://openlegislation.uk/draft-chemicals-health-and-safety-and-genetically-modified-organisms-contained-use-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.