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

Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

20.—(1) Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market is amended as follows.

(2) In Article 1—

(a) in paragraph 1, in the first subparagraph, for the words from “the rapporteur” to “of that Annex,” substitute “a competent authority for a constituent territory in relation to which the active substance is approved (in this Regulation, the “assessing competent authority”)”;

(b) omit paragraph 2.

(3) In Article 3—

(a) in paragraph 1—

(i) in the first subparagraph—

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

(bb) for “, the co-rapporteur Member State, the Commission and the Authority” substitute “and the other competent authorities”;

(ii) in the second subparagraph, for “rapporteur Member State” in both places it occurs substitute “assessing competent authority”;

(b) in paragraph 2—

(i) in the first subparagraph—

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

(bb) for “Rapporteur Member State and to the co-rapporteur Member State” substitute “assessing competent authority”;

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

(c) in paragraph 3—

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

(ii) for the words from “, the co-rapporteur” to “Authority” substitute “ and the other competent authorities”;

(d) in paragraph 4, for “Authority” in both places it occurs, substitute “assessing competent authority”;

(e) in paragraph 5—

(i) after “separately” insert “to the same assessing competent authority”;

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

(f) in paragraph 6, for “Commission” substitute “assessing competent authority”.

(4) In Article 4, for “rapporteur Member State and the co-rapporteur Member State” substitute “assessing competent authority”.

(5) In Article 5, for “Authority” substitute “assessing competent authority”.

(6) In Article 6—

(a) in paragraph 1—

(i) for “rapporteur Member State” in the first place it occurs substitute “assessing competent authority";

(ii) for the words from “rapporteur Member State" in the second place it occurs to the end substitute “assessing competent authority”;

(b) after paragraph 1 insert—

“1A.   The assessing competent authority must notify the other competent authorities as soon as reasonably practicable after receipt of the supplementary dossiers under paragraph 1.

1B.   A competent authority which receives a notification under paragraph 1A may request in writing from the applicant a copy of supplementary dossiers, which the applicant must provide as soon as reasonably practicable.”.

(7) In Article 7(1)—

(a) in point (c)—

(i) for “widely grown crop in each zone” substitute “crop grown in the United Kingdom”;

(ii) for the words from “cover all zones” to “widely grown” substitute “concern a”;

(b) in points (e) and (f)—

(i) for “a Regulation” substitute “legislation”;

(ii) after “Regulation (EC) No 1107/2009” insert “in relation to each constituent territory to which the application for renewal relates”.

(8) In Article 8—

(a) in paragraph 1—

(i) in the first subparagraph—

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

(bb) for the words from “, the co-rapporteur” to “Authority” substitute “and the other competent authorities”;

(ii) in the second subparagraph, for “rapporteur Member State” in both places it occurs substitute “assessing competent authority”;

(b) in paragraph 2—

(i) in the first subparagraph—

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

(bb) for “rapporteur Member State and co-rapporteur Member State” substitute “assessing competent authority”;

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

(c) in paragraph 3—

(i) omit the first subparagraph;

(ii) in the second subparagraph—

(aa) for “At the same time” substitute “Before the end of the period stated in paragraph 1”;

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

(d) in paragraph 4, for “Authority” substitute “assessing competent authority”;

(e) in paragraph 5, for “the Authority or a Member State” substitute “a competent authority”;

(f) in paragraph 6—

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

(ii) for the words from “, the co-rapporteur” to “Authority” substitute “and the other competent authorities”.

(9) In Article 9—

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

(b) in the second sentence, for the words from “co-rapporteur” to “Authority” substitute “other competent authorities”.

(10) For Article 10 substitute—

“Article 10 Refusal of renewal where applications are inadmissible

Where all of the applications submitted for renewal of the approval of an active substance in relation to a constituent territory are inadmissible in accordance with Article 3(3) or 8(6), the competent authority for that constituent territory must refuse to renew approval of the active substance in accordance with Article 20(1)(b) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.”.

(11) In Article 11—

(a) in the heading, for “rapporteur Member State and the co-rapporteur Member State” substitute “assessing competent authority”;

(b) in paragraph 1—

(i) for “rapporteur Member State shall, after consulting the co-rapporteur Member State” substitute “assessing competent authority must”;

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

(c) omit paragraph 2(g) and (h);

(d) in paragraphs 3 and 4, for “rapporteur Member State” substitute “assessing competent authority”;

(e) in paragraph 5—

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

(ii) omit the second sentence,

(f) after paragraph 5 insert—

“5A.   The 12 month period provided for in paragraph 1 is extended by any additional period set in accordance with paragraph 5.

5B.   The additional period described in paragraph 5 must be for no more than 6 months and ceases at the earlier of—

(a) the date on which the assessing competent authority receives the additional information;

(b) the expiry of the additional period.”;

(g) for paragraph 6 substitute—

“6.   The assessing competent authority may, as it considers appropriate—

(a) obtain independent scientific advice;

(b) consult with the other competent authorities.”;

(h) in paragraph 8—

(i) for the first subparagraph substitute—

“When submitting the draft renewal assessment report to the other competent authorities, the assessing competent authority must require the applicant to notify the other competent authorities of the existence of any updated supplementary summary dossiers. Article 15(4) of Regulation (EC) No 1107/2009 applies to a notification under this paragraph as it applies to a notification under Article 15(3) of that Regulation.”;

(ii) in the second subparagraph, in the second sentence, for “Authority” substitute “assessing competent authority”.

(12) In Article 12—

(a) in paragraph 1—

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

(ii) omit “received from the rapporteur Member State”;

(iii) for “Member States” substitute “competent authorities”;

(b) in paragraph 2, for “Authority” substitute “assessing competent authority”;

(c) in paragraph 3—

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

(ii) for “Commission” substitute “other competent authorities”;

(d) in paragraph 4, for “Authority” substitute “assessing competent authority”.

(13) In Article 13—

(a) in the heading, for “Authority” substitute “assessing competent authority”;

(b) in paragraph 1—

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

(ii) in the first subparagraph—

(aa) for the second sentence substitute—

“The assessing competent authority may obtain independent scientific advice where it considers it appropriate to do so.”;

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

(iii) omit the second subparagraph;

(c) in paragraph 2, for “Authority” in both places it occurs substitute “assessing competent authority”;

(d) in paragraph 3, in the first subparagraph—

(i) in the first sentence—

(aa) for “Authority” in both places it occurs substitute “assessing competent authority”;

(bb) omit “, in consultation with the rapporteur Member State,”;

(cc) for “one month” substitute “90 days”;

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

(ii) in the second sentence—

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

(bb) omit “and send its evaluation to the Authority”;

(e) in paragraph 4—

(i) in the first sentence—

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

(bb) omit “ask the Commission to”;

(cc) omit “European Union”;

(ii) in the second sentence, omit “European Union”.

(14) For Article 14 substitute—

“Article 14 Renewal decision

Article 20 of Regulation (EC) No 1107/2009 applies.”.

(15) In Article 15, for the words from “renewal” to the end substitute “existing renewal applications within the meaning of Article 1(2) of that Regulation”.

(16) Omit Article 16.

(17) After Article 16, omit the words from “This Regulation” to “Member States.”.

(18) In the Annex—

(a) in the “Format for applications, as provided for in Article 2(1)” section—

(i) in the first paragraph, for “rapporteur Member State and to the co-rapporteur Member State” substitute “assessing competent authority”;

(ii) omit the second paragraph;

(b) in the “Model” section, in point 2.5, for “Annex to Commission Implementing Regulation (EU) No 540/2011” substitute “approvals register in relation to each constituent territory to which the application relates”.