SCHEDULE 1AMENDMENTS TO SUBORDINATE LEGISLATION

Plant Protection Products (Fees and Charges) Regulations 201114

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).