Regulation 17 Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products

(1)

Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products is amended as follows.

(2)

Before Article 1, insert—

“Article A1
Scope and interpretation

1.

This Regulation applies—

(a)
in relation to an application under Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before exit day where—

(i)
paragraph 6 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and

(ii)
on or before 31st December 2013 dossiers were submitted in accordance with Article 8(1) and (2) of Regulation (EC) No 1107/2009 as it had effect immediately before exit day;

(b)
in relation to an application under Article 15 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before exit day where—

(i)
paragraph 7 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and

(ii)
on or before 31st December 2013 dossiers were submitted in accordance with Article 9 of Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances as it had effect immediately before exit day;

(c)
in relation to an application for authorisation of a plant protection product, as referred to in Article 28 of Regulation (EC) No 1107/2009, where—

(i)
the application was submitted before 31st December 2015, and

(ii)
the plant protection product contains at least one active substance to which point (a) or (b) applies;

(d)
in relation to the renewal of the authorisation of a plant protection product in accordance with Article 43(2) of Regulation (EC) No 1107/2009 following the renewal (whether before or after exit day) of an active substance in accordance with Commission Regulation (EU) No 1141/2010.

2.

Paragraph 1(c) or (d) does not apply where the applicant for the authorisation notifies the competent authority in writing when submitting the application that the data requirements of Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products apply instead.

3.

Paragraph 4 applies where Commission Regulation (EU) No 283/2013 setting out the data requirements for plant protection products applies in relation to an application by virtue of—

(a)
Article 1 of that Regulation, or

(b)
Article A1(2) of Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances.

4.

Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 544/2011, or a specified part of Commission Regulation (EU) No 544/2011, is to be read in relation to that application as a reference to Commission Regulation (EU) No 283/2013, or the equivalent part of Commission Regulation (EU) No 283/2013 (as the case may be).”.

(3)

Omit Article 2.

(4)

After Article 2, omit the words from “This Regulation shall” to “Member States”.

(5)

The Annex is amended in accordance with paragraphs (6) to (8).

(6)

In the Introduction—

(a)

in point 1.2, for the words from “the entry” to “Annex,” substitute “14th June 2011”;

(b)

in point 1.3, for “Member States” substitute “competent authorities”;

(c)

in point 1.6, for “Council Directive 86/609/EEC” substitute “the Animals (Scientific Procedures) Act 1986”;

(d)

in point 2.1, after “laid down in” insert “Annex 1 to”;

(e)

in point 2.2, in the seventh indent, for “Union” substitute “United Kingdom”;

(f)

in point 2.3—

(i)

in the first indent, for “to the relevant national authority” substitute “in accordance with the official recognition scheme”;

(ii)

in the second indent—

(aa)

for “Member State” substitute “competent authority”;

(bb)

after “on its” insert “constituent”;

(g)

in points 2.4 and 2.5—

(i)

for “Member States” substitute “the competent authority”;

(ii)

after “their” insert “constituent”;

(h)

in point 3, omit the words from “Directive 1999/45/EC” to “or with”;

(i)

in point 4, in the first indent, for “EU legislation” substitute “retained EU law”.

(7)

In Part A—

(a)

in point 1.1, in the second paragraph, for the words from “Member State” to “sought” substitute “United Kingdom”;

(b)

in point 1.4.1, for “Directive 1999/45/EC” substitute “Regulation (EC) No 1272/2008 of the European Parliament and of the Council”;

(c)

in point 6.5, after the heading “Test guideline”, in the second paragraph—

(i)

for “Member State” in the first place it occurs substitute “competent authority”;

(ii)

for “territory of this Member State” substitute “constituent territory of that competent authority”;

(d)

in points 7.1, 7.1.1 and 7.1.2, omit “Directive 1999/45/EC or”;

(e)

in point 7.2, after “the requirements of” insert “the EU-derived domestic legislation which transposed^f1”;

(f)

in point 7.2.1.1, omit “Directive 1999/45/EC or”;

(g)

in points 7.2.1.2 and 7.2.3.2, after “in accordance with” insert “the EU-derived domestic legislation which”;

(h)

in point 7.3, in the second paragraph, in the second indent, after “in accordance with” insert “the EU-derived domestic legislation which transposed”;

(i)

in point 8.9, in the first paragraph, omit “of the Member States”;

(j)

in section 11, omit “of the Member States”;

(k)

in point 12.3, in the heading, omit “and Directive 1999/45/EC”.

(8)

In Part B—

(a)

in point 1.1, in the second paragraph, for the words from “Member State” to “sought” substitute “United Kingdom”;

(b)

in point 1.4(ii), in the third subparagraph, for “Directive 1999/45/EC” substitute “Regulation (EC) No 1272/2008 of the European Parliament and of the Council”;

(c)

in point 6.5, after the heading “Test guideline”, in the second paragraph—

(i)

for “Member State” in the first place it occurs substitute “competent authority”;

(ii)

for “territory of this Member State” substitute “constituent territory of that competent authority”;

(d)

in points 7.1, 7.1.1 and 7.1.3, omit “Directive 1999/45/EC or”;

(e)

in Section 11, omit “of the Member States”.

Annotations

Footnotes

f1: In respect of Directive 2004/37/EC, see for example: S.I. 2007/3100, 2012/632 and 2013/1471; and in relation to Northern Ireland, S.R. 2012 No. 179.