Regulation 7
1. Schedule 1 to the 2019 Regulations (Amendments to subordinate legislation) is amended in accordance with paragraphs 2 to 24.
2. Omit paragraph 2 and the heading above it.
3. Omit paragraph 5 and the heading above it.
4. Omit paragraph 6 and the heading above it.
5.—(1) Paragraph 8 (amendment of regulation 2(1) of the PPP Fees and Charges Regulations(1)) is amended as follows.
(2) After sub-paragraph (2) insert—
“(2A) After the definition of “authorisation holder”, insert—
““Great Britain competent authorities” means—
in relation to England, the Secretary of State;
in relation to Wales, the Welsh Ministers;
in relation to Scotland, the Scottish Ministers;”;
(2B) In the definition of “import tolerance”, after “has” insert “, in relation to Great Britain,”;”.
(3) In sub-paragraph (3), for the definition of “MRL compliance” being inserted by that sub-paragraph substitute—
““MRL compliance” means, in relation to products placed on the market in Great Britain, compliance with the requirements of Article 18 of the MRL Regulation;”.
(4) After sub-paragraph (3) insert—
“(3A) For the definition of “the MRL Regulation” substitute—
““the MRL Regulation” means—
in relation to Great Britain, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC;
in relation to Northern Ireland, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC as it has effect in EU law”;”.
(5) In sub-paragraph (4), in the definition of “MRL supplementary information requirement” being inserted by that sub-paragraph, after “requested” insert “by a Great Britain competent authority”.
(6) After sub-paragraph (4) insert—
“(4A) After the definition of “nominated sales representative”, insert—
““Northern Ireland competent authority” means the Department of Agriculture, Environment and Rural Affairs;”.
(4B) For the definition of “Regulation 1107/2009” substitute—
““Regulation 1107/2009” means—
in relation to Great Britain, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market, as last amended by Regulation (EU) 2019/1009 of the European Parliament and of the Council;
in relation to Northern Ireland, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market, as last amended by Regulation (EU) 2019/1009 of the European Parliament and of the Council as it has effect in EU law;”;”.
(7) In sub-paragraph (5), in the definition of “standalone MRL application” being inserted by that sub-paragraph, after “application” insert “to a Great Britain competent authority”.
6. For paragraph 9 (omission of regulation 3 of the PPP Fees and Charges Regulations), substitute—
“9. Regulation 3 is amended as follows—
(a)for the heading, substitute “Functions in Article 74(1) of Regulation 1107/2009: Northern Ireland”;
(b)in paragraph (1)—
(i)omit “of the Member State”;
(ii)for “United Kingdom competent authorities” substitute “Northern Ireland competent authority”;
(c)omit paragraph (2).”.
7. For paragraph 10 (amendment of regulation 4 of the PPP Fees and Charges Regulations) substitute—
“10. Regulation 4 is amended as follows—
(a)in paragraph 1—
(i)omit sub-paragraph (b);
(ii)at the end, after “in accordance with” insert “paragraphs 1 and 3 respectively of”;
(b)after paragraph 1, insert—
“(1A) A Great Britain competent authority may charge fees for work carried out within the scope of Regulation 1107/2009 which relates to evaluating applications made to it for the approval of active substances, safeners, synergists or basic substances, and such fees are payable in accordance with paragraph 2 of Schedule 1.
(1B) The Northern Ireland competent authority may charge fees for work carried out within the scope of Regulation 1107/2009 which relates to evaluating parallel trade applications made to it and such fees are payable in accordance with paragraph 1A of Schedule 1.”;
(c)in paragraph 2—
(i)for “United Kingdom” substitute “Great Britain”;
(ii)after “applications for import tolerances” insert “and standalone MRL applications”;
(d)after paragraph 2, insert—
“(2A) A Great Britain competent authority may charge fees for the evaluation of supplementary information provided in accordance with Article 14(3) of the MRL Regulation and such fees are payable in accordance with Schedule 3.”;
(e)in paragraph (4), for “a United Kingdom” substitute “the relevant”;
(f)in paragraph (5), for “A United Kingdom” substitute “The relevant”;
(g)in paragraph (7), for “a United Kingdom” substitute “the relevant”.”.
8. In paragraph 12 (amendment of regulation 7(2) of the PPP Fees and Charges Regulations), after paragraph (a) insert—
“(aa)for “under regulation 4(1)” substitute “under regulations 4(1), 4(1A) or 4(1B)”;”.
9. For paragraph 13 (amendment of regulation 8(6) of the PPP Fees and Charges Regulations), substitute—
“13. In regulation 8(6), for the definition of “total costs incurred” substitute—
““total costs incurred” means the costs referred to in regulations 5 and 6, excluding any costs in respect of which a fee is payable under—
regulations 4(1), 4(1A) or 4(1B) and Schedule 1,
regulation 4(2) and Schedule 2, or
regulation 4(2A) and Schedule 3;”.”.
10.—(1) Paragraph 14 (amendment of Schedule 1 to the PPP Fees and Charges Regulations) is amended as follows.
(2) In sub-paragraph (2)—
(a)paragraph (a) becomes paragraph (b), and paragraph (b) becomes paragraph (c);
(b)above the paragraph re-numbered as paragraph (b), insert—
“(a)in the first sentence, after “product-related applications” insert “to a United Kingdom competent authority”;”;
(3) After sub-paragraph (2) insert—
“(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 | |
(4) In sub-paragraph (3), for paragraph (b) substitute—
“(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”.”.
(5) After sub-paragraph (3) insert—
“(3A) In paragraph 3, after “organisation” insert “by a United Kingdom competent authority”.”.
11.—(1) Paragraph 15 (amendment of Schedule 2 to the PPP Fees and Charges Regulations) is amended as follows.
(2) In sub-paragraph (5)—
(a)for paragraph (a) substitute—
“(a)in the first sentence, for the words from the start to “product-related applications” substitute “Fees chargeable by a Great Britain competent authority for import tolerances”;”;
(b)in paragraph (c)—
(i)in paragraph (i), in the note (1) which that paragraph substitutes, in both places it occurs, for “the United Kingdom” substitute “Great Britain”;
(ii)in paragraphs (ii)(bb) and (iii)(bb), for “the United Kingdom” substitute “Great Britain”.
(3) In sub-paragraph (6)—
(a)in the new paragraph 2 which that sub-paragraph inserts, in the sentence above the table, after “Fees” insert “chargeable by a Great Britain competent authority”;
(b)in the notes which follow the new paragraph 2 which that sub-paragraph inserts, in each place it occurs, for “the United Kingdom” substitute “Great Britain”.
12. In paragraph 16 (insertion of Schedule 3 to the PPP Fees and Charges Regulations), in the new Schedule 3 which that paragraph inserts, in the heading and in the sentence above the table, after “Fees” insert “chargeable by a Great Britain competent authority”.
13. In paragraph 18—
(a)in sub-paragraph (c), for “the United Kingdom” substitute “Great Britain”;
(b)in sub-paragraph (d), in the new definition of “Devolved Authority” which that sub-paragraph inserts—
(i)at the end of paragraph (a), insert “or”;
(ii)at the end of paragraph (b), omit “, or”;
(iii)omit paragraph (c);
(c)for sub-paragraph (e) substitute—
“(e)for the definition of “the PIC Regulation”, substitute—
““the PIC Regulation” means—
in relation to Great Britain, Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals, of which Annexes II, IV and VI are to be read as amended from time to time;
in relation to Northern Ireland, Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals as it has effect in EU law;”;”;
(d)after paragraph (e) insert—
“(f)after the definition of “the PIC Regulation” insert—
““the Review Regulation” means Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council”;”.
14. In paragraph 20—
(a)for the new regulation 7(2) which that paragraph inserts, substitute—
“(2) In accordance with Article 18 of the PIC Regulation, the Designated National Authority is responsible for controlling the export and import of the following chemicals—
(a)in relation to Great Britain, the chemicals listed in Parts 1, 2 and 3 of the GB PIC list;
(b)in relation to Northern Ireland, the chemicals listed in Annex I to the PIC Regulation;”;
(b)for the new paragraph 7(3) which that paragraph inserts, substitute—
“(3) In paragraph (2), “the GB PIC list” means the list established and maintained in accordance with Articles 7 and 23 of the PIC Regulation.”.
15. In paragraph 21(b), in the new paragraph (4) which that paragraph substitutes, for “the second subparagraph of 89(3)” substitute “79”.
16. In paragraph 22(a), in the new paragraph (1) which it inserts, for the words from “Article 22” to the end substitute “Article 22 of the Review Regulation”.
17. For paragraph 23 substitute—
“23.—(1) Regulation 14 is amended as follows.
(2) In paragraph (1)—
(a)for “paragraphs (3) and (4)” substitute “paragraph (4)”;
(b)at the end insert “or the Review Regulation listed in paragraph (2A)”.
(3) In paragraph (2)—
(a)at the start, for “The decisions” substitute “In relation to the Biocides Regulation, the decisions”;
(b)above paragraph (a) insert—
“(za)to prohibit or amend the terms and conditions under which a biocidal product may be made available on the market under Article 17A(2);”;
(c)omit sub-paragraphs (f), (g), (k) and (l);
(d)before sub-paragraph (m) insert—
“(la)to reject an application due to non-payment of fees under Article 54(3);
(lb)to establish technical equivalence under Article 54(4);
(lc)to reject an application for failure to provide additional information under Article 54(5);”;
(e)after paragraph (n) insert—
“(na)to give a prospective applicant data under Article 63(3);
(nb)to refuse a request under Article 63(3) where every effort has not been made to reach an agreement;”;
(f)after paragraph (o) insert—
“(oa)to allow a subsequent applicant to refer to data previously provided by P under Article 64(1);”.
(4) After paragraph (2) insert—
“(2A) In relation to the Review Regulation, the decision referred to in paragraph 9(1) is a decision to reject a notification made under Articles 14(2) or 16(5).”.
(5) Omit paragraph (3).
(6) In paragraph (4)—
(a)in sub-paragraph (a)—
(i)for “(g)” substitute “(e)”;
(ii)after “(j)” insert “(la), (lc),”;
(b)in sub-paragraph (b) omit “and 2(l)”;
(c)in sub-paragraph (d) omit “, (k)”;
(d)after sub-paragraph (d) insert—
“(e)in relation to paragraph (2)(za), the decision relates to a notification by P, or someone on behalf of P”;
(f)in relation to paragraph (2A), the decision relates to a notification by P, or by someone on behalf of P.”.
(7) In paragraph (7), for “Commission or another competent authority” substitute “Secretary of State or a Devolved Authority”.”.
18. Omit paragraphs 30 to 39, and the heading above paragraph 30.
19. In paragraph 40(3), in the new regulation 33A which that paragraph inserts, in both places it occurs, for “exit day” substitute “IP completion day”.
20. In paragraph 41(2), for “UK” substitute “GB”.
21. Omit paragraph 42 and the heading above it.
22. Omit paragraph 43 and the heading above it.
23. Omit paragraph 44 and the heading above it.
24. Omit paragraph 45 and the heading above it.
Here and in other parenthesised text throughout this instrument, “PPP” stands for “Plant Protection Products”.