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Regulation 18 Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products

Original text. Later amendments are not shown.

(1)

Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products is amended as follows.

(2)

Before Article 1, insert—

“Article A1

Interpretation

1.

Paragraph 2 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.

2.

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.

Paragraph 4 applies where Commission Regulation (EU) No 284/2013 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 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.

4.

Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 545/2011, or a specified part of Commission Regulation (EU) No 545/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 284/2013, or the equivalent part of Commission Regulation (EU) No 284/2013 (as the case may be).”.

(3)

In Article 1, for “Article 29(6)” substitute “Article 29(6)(a)”.

(4)

Omit Article 2.

(5)

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

(6)

The Annex is amended in accordance with paragraphs (7) to (9).

(7)

In the heading, for “Article 29(6)” substitute “Article 29(6)(a)”.

(8)

In Part 1—

(a)

in Part A—

(i)

in points 1, 2 and 4, for “Member States” substitute “competent authorities”;

(ii)

in point 5—

(aa)

in the first paragraph, for “Member States” substitute “competent authorities”;

(bb)

in the second paragraph, for “Member States” substitute “Competent authorities”;

(iii)

in point 6, omit “of the Member States”;

(b)

in Part B—

(i)

in points 1.1, 1.2, 1.3 and 1.4, for “Member States” in each place it occurs substitute “competent authorities”;

(ii)

in Section 2, in the text before point 2.1, for “Member States” substitute “Competent authorities”;

(iii)

in points 2.1.1 and 2.1.2, for “Member States” substitute “competent authorities”;

(iv)

in point 2.1.3, for “Member States” substitute “Competent authorities”;

(v)

in point 2.1.4—

(aa)

in the first paragraph, for “Member States” substitute “Competent Authorities”;

(bb)

in the second paragraph, for “Member States” substitute “competent authorities”;

(vi)

in point 2.1.5, for “Member States” in each place it occurs substitute “competent authorities”;

(vii)

in point 2.2.1, in the words before point (a), for “Member States” substitute “Competent authorities”;

(viii)

in points 2.2.2 and 2.3, for “Member States” substitute “competent authorities”;

(ix)

in points 2.4.1.1, 2.4.1.2, 2.4.1.3, 2.4.1.4, and 2.4.2.1 for “Member States” substitute “Competent authorities”;

(x)

in points 2.4.2.2 and 2.4.2.3, for “Member States” substitute “competent authorities”;

(xi)

in points 2.4.2.4, 2.4.2.5 and 2.4.2.6, for “Member States” substitute “Competent authorities”;

(xii)

in point 2.5.1, for “Member States” substitute “competent authorities”;

(xiii)

in points 2.5.1.1, in the first paragraph, for “Member States” substitute “Competent authorities”;

(xiv)

points 2.5.1.2 and 2.5.1.3 are amended as follows;

(xv)

in the first paragraph—

(aa)

for “Member States” substitute “Competent authorities”;

(bb)

for “suitable calculation model validated at EU level” substitute “suitable validated calculation model”;

(xvi)

in the second paragraph—

(aa)

omit “EU” in the first place it occurs;

(bb)

for “Member States” substitute “competent authorities”;

(xvii)

in points 2.5.1.4 and 2.5.1.5, for “Member States” substitute “Competent authorities”;

(xviii)

in point 2.5.2, for “Member States” substitute “competent authorities”;

(xix)

in points 2.5.2.1, 2.5.2.2, 2.5.2.3, 2.5.2.4, 2.5.2.5, 2.5.2.6, 2.6, 2.7.1 and 2.7.2, for “Member States” substitute “Competent authorities”;

(c)

in Part C—

(i)

in point 1.1, for “Member States” substitute “competent authorities”;

(ii)

in point 1.2—

(aa)

for “Member States” substitute “Competent authorities”;

(bb)

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

(iii)

in points 1.3 and 1.4, for “Member States” substitute “Competent authorities”;

(iv)

in point 1.5, for “Member States” substitute “competent authorities”;

(v)

in point 1.6—

(aa)

the first paragraph is amended as follows;

(bb)

in the words before the first indent, for “Member States” substitute “competent authorities”;

(cc)

in the second indent, for “EU legislation” substitute “retained EU law”;

(dd)

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

(vi)

in point 1.7—

(aa)

in the words before point (a), for “Member States” substitute “competent authorities”;

(bb)

in point (a), for “Directive 1999/45/EC” substitute “Regulation (EC) No 1272/2008”;

(vii)

in point 1.9—

(aa)

in the first paragraph, for “Member States” substitute “competent authorities”;

(bb)

in the second paragraph, for “Member States” substitute “Competent authorities”;

(viii)

in point 2.1.4, for “Member State” substitute “constituent territory of the competent authority”;

(ix)

in point 2.1.5, in the second paragraph, for “Member States” substitute “competent authorities”;

(x)

in point 2.4.1.1, in the second paragraph, after “in accordance with” in both places it occurs insert “the EU-derived domestic legislation which transposed”;

(xi)

in point 2.4.1.2, for “EU provisions” substitute “retained EU law”;

(xii)

in point 2.4.1.4, omit “EU”;

(xiii)

in points 2.4.2.2 and 2.4.2.3, for “Member States” substitute “competent authorities”;

(xiv)

in point 2.4.2.4, for “Member State” substitute “constituent territory of the competent authority”;

(xv)

in point 2.5.1.2(i), after “laid down by” insert “the EU-derived domestic legislation which transposedf1”;

(xvi)

in point 2.5.1.3, in the first indent, after “in accordance with” insert “the EU-derived domestic legislation which transposedf2”;

(xvii)

in point 2.6.2(v), in the table heading, for “or EU” substitute “MRL”.

(9)

In Part 2—

(a)

in Part A—

(i)

in points 1, 2 and 4, for “Member States” substitute “competent authorities”;

(ii)

in point 5—

(aa)

in the first paragraph, for “Member State” substitute “competent authority”;

(bb)

in the second paragraph, for “Member States” substitute “Competent authorities”;

(iii)

in point 6, omit “of the Member States”;

(iv)

in point 8—

(aa)

for “Member States” substitute “Competent authorities”;

(bb)

for the words from “taken note” to the end substitute “issued in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council or Regulation (EC) No 1107/2009 of the European Parliament and of the Council”;

(v)

in point 9—

(aa)

in the first sentence, after “micro-organisms,” insert “the EU-derived domestic legislation which transposedf3”;

(bb)

in the second sentence, for “Directive” substitute “legislation”;

(b)

in Part B—

(i)

in point 1.1, in the words before point (a), for “Member States” substitute “competent authorities”;

(ii)

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

(iii)

in point 1.4—

(aa)

for “Member States” in both places it occurs substitute “Competent authorities”;

(bb)

for “in that Member State” substitute “to that competent authority”;

(iv)

in points 1.5 and 1.6, for “Member States” in each place it occurs substitute “competent authorities”;

(v)

in Section 2, in the words before point 2.1, for “Member States” substitute “Competent authorities”;

(vi)

in point 2.1.2, for “Member States” substitute “Competent authorities”;

(vii)

in point 2.2.1.2, for “Member States” substitute “competent authorities”;

(viii)

in point 2.2.2.3, for “Member States” substitute “Competent authorities”;

(ix)

in point 2.4.1, for “Member States” substitute “competent authorities”;

(x)

in points 2.4.2 and 2.4.3, for “Member States” substitute “Competent authorities”;

(xi)

in points 2.4.4—

(aa)

in the first paragraph, for “Member States” substitute “Competent authorities”;

(bb)

in the second paragraph, for “Member States” substitute “competent authorities”;

(xii)

in point 2.4.5, for “Member States” substitute “Competent authorities”;

(xiii)

in points 2.4.6, 2.4.7 and 2.4.8, for “Member States” in each place it occurs substitute “competent authorities”;

(xiv)

in points 2.5, 2.5.1.1, 2.5.1.2, 2.5.2.1, and 2.5.2.2, in the first paragraph, for “Member States” substitute “Competent authorities”;

(xv)

in point 2.6, in the words before point (a), for “Member States” substitute “competent authorities”;

(xvi)

in point 2.6.1.1, in the words before point (a)—

(aa)

in the first sentence, for “Member States” substitute “Competent authorities”;

(bb)

omit the third sentence;

(xvii)

in points 2.6.1.2, 2.6.1.3 and 2.6.1.4, for “Member States” substitute “Competent authorities”;

(xviii)

in points 2.6.2.1 and 2.6.2.2, in points (a) and (b), for “Member States” substitute “Competent authorities”;

(xix)

in point 2.7, in the fourth paragraph, for “Member States” substitute “competent authorities”;

(xx)

in point 2.7.1—

(aa)

in the first paragraph, for “Member States” substitute “Competent authorities”;

(bb)

in the second paragraph, for “Member States” substitute “competent authorities”;

(xxi)

in point 2.7.2—

(aa)

in the first paragraph, for “Member States” substitute “Competent authorities”;

(bb)

in the second paragraph, in point (f), after “provided for in” insert “the EU-derived domestic legislation which transposed”;

(xxii)

in points 2.7.3, 2.7.4, 2.8, 2.8.1, 2.8.2, 2.8.3, 2.8.4, 2.8.5, 2.8.6, 2.8.6.2, and 2.9, for “Member States” in each place it occurs substitute “Competent authorities”;

(c)

in Part C—

(i)

in point 1.1, for “Member States” substitute “competent authorities”;

(ii)

in point 1.2—

(aa)

in the first sentence, for “Member States” substitute “Competent authorities”;

(bb)

in the second sentence, for “Member State in question” substitute “constituent territory of the competent authority”;

(iii)

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

(iv)

in point 1.4—

(aa)

for “Member States” substitute “Competent authorities”;

(bb)

for “control” substitute “management”;

(v)

in point 1.5, for “Member States” substitute “competent authorities”;

(vi)

in point 1.6—

(aa)

in the words before point (a), for “Member States” substitute “competent authorities”;

(bb)

in point (b), for “EU legislation” substitute “retained EU law”;

(cc)

in point (d), for “Articles 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC” substitute “Articles 19, 21 and 22 of, and part 4 of Annex 2 to Regulation (EC) No 1272/2008 of the European Parliament and of the Council”;

(vii)

in point 1.7—

(aa)

in the words before point (a), for “Member States” substitute “competent authorities”;

(bb)

in, point (a), for “Directive 1999/45/EC” substitute “Regulation (EC) No 1272/2008”;

(viii)

in point 1.9—

(aa)

in the first paragraph, for “Member States” substitute “competent authorities”;

(bb)

in the second paragraph, for “Member States” substitute “Competent authorities”;

(ix)

in point 1.10, for “Member States” substitute “Competent authorities”;

(x)

in point 1.11, after “in accordance with” in both places it occurs insert “the EU-derived domestic legislation which transposed”;

(xi)

in point 1.12, after “in accordance with” in the second place it occurs insert “the EU-derived domestic legislation which transposed”;

(xii)

in point 1.14, for “Member States” substitute “Competent authorities”;

(xiii)

in point 2.1, for “Member States” substitute “competent authorities”;

(xiv)

in point 2.2.1, in the third sentence, for “Member States” substitute “Competent authorities”;

(xv)

in point 2.4.1.4, for “Member State” substitute “constituent territory”;

(xvi)

in point 2.4.1.5, for “Member States” substitute “competent authorities”;

(xvii)

in point 2.4.1.6, for “Member State” substitute “competent authority”;

(xviii)

in point 2.6.1.2, for “Member States” substitute “competent authorities”;

(xix)

in point 2.6.1.3, for “EU provisions” substitute “retained EU law”;

(xx)

in point 2.6.1.9, after “in compliance with” in each place it occurs insert “the EU-derived domestic legislation which transposedf4”;

(xxi)

in point 2.7.2, after “provided for in” insert “the EU-derived domestic legislation which transposed”;

(xxii)

in point 2.7.3(a), after “laid down by” insert “the EU-derived domestic legislation which transposed”;

(xxiii)

in point 2.7.3(b) and 2.7.4, after “in accordance with” in each place it occurs insert “the EU-derived domestic legislation which transposed”;

(xxiv)

in point 2.8, for “Member States” in both places it occurs substitute “Competent authorities”.

Annotations

Footnotes

f1

See for example: in relation to England and Wales, S.I. 2003/666, 2007/2785, 2010/433, 896, 994 (W 99), 996, 2015/1867 (W 274), 2016/614, 618, 2017/1041 (W 270); in relation to Scotland, S.S.I 2006/209, 297, 2007/483, 2010/89, 95, 127, 2014/364, 2017/281, 282, 321; in relation to Northern Ireland, S.I. 2006/3336 (N.I. 21) and S.R. 2002 No.331, 2003 No. 369, 2010 No. 157, 2015 No. 365, 2017 No. 211 and 212.

f2

See for example: generally, the Coastal Protection Act 1949 (c 74), the Salmon and Freshwater Fisheries Act 1975 (c.51), the Food and Environment Protection Act 1985 (c.48), the Environmental Protection Act 1990 (c.43), the Water Industry Act 1991 (c.56), the Water Resources Act 1991 (c.57), the Land Drainage Act 1991 (c.59), the Environment Act 1995 (c.25), the Water Act 2003 (c.37), the Marine and Coastal Access Act 2009 (c.23), and S.I. 1986/1510, 1989/1263, 2007/1518, 2010/740, 2011/735, 2015/483, 668, 2016/614; in relation to England and Wales, S.I. 1994/2841, 2001/2954, 2003/3245, 2004/99, 2009/995 (W 81), 3104, 2010/639, 1493 (W 136), 2015/810, 2017/407, 2018/151; in relation to Scotland, the Water Environment and Water Services (Scotland) Act 2003 (asp 3) and S.S.I. 2003/610, 2004/516, 2010/10, 2011/209, 2013/29, 323; in relation to Northern Ireland, the Lough Neagh and Lower Bann Drainage and Navigation Act (Northern Ireland) 1955 (c.15) (N.I.), the Foyle Fisheries (Amendment) Act (Northern Ireland) 1962 (c.5) (N.I.), the Fisheries Act (Northern Ireland) 1966 (c.17) (N.I.), the Harbours Act (Northern Ireland) 1970 (c.1) (N.I.), the Lough Neagh Drainage (Amendment) Act (Northern Ireland) 1970 (c.7) (N.I.), S.I. 1973/69 (N.I. 1), 1991/1220 (N.I. 11), 1997/2778 (N.I. 19), 1999/662 (N.I. 6), 2002/3153 (N.I. 7), 2006/3336 (N.I. 21) and 2007/915 (N.I. 9), and S.R. 1990 No. 245, 1995 No. 380, 1996 No. 603, 1997 No. 469, 2003 No. 7, 136, 319, 493 and 496, 2004 No. 419, 2006 No. 34 and 482, 2007 No. 312, 2008 No. 304, 2009 No. 252, 254 and 376, 2010 No. 412, 2011 No. 81, 2017 No 81.

f3

See for example: generally, Part 6 of the Environmental Protection Act 1990 (c.43); in relation to England and Wales, S.I. 2002/2443, 3188 (W 304); in relation to Scotland, S.S.I. 2002/541; in relation to Northern Ireland, S.I. 1999/1714 (N.I. 19) and S.R. 2003 No. 167.

f4

In relation to Directive 2000/54/EC, see for example: S.I. 2002/2677, 2010/323, 2013/1471; and in relation to Northern Ireland, S.R. 2003 No. 34. In relation to Directive 89/656/EC: see for example: the Health and Safety at Work Act 1974 (c.37), and S.I. 1985/1333, 1992/2793, 2966, 3004, 1998/2306, 1999/2205, 3242, 2002/2676, 2677, 2012/632 and 2013/448; and in relation to Northern Ireland, S.I. 1978/1049 (N.I. 19) and S.R. 1985 No. 273, 1986 No. 36, 1988 No. 74, 1990 No. 374, 1993 No. 20, 2000 No. 388, and 2006 No. 1,