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Document 02011R0540-20180322

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (Text with EEA relevance)

ELI: http://data.europa.eu/eli/reg_impl/2011/540/2018-03-22

02011R0540 — EN — 22.03.2018 — 041.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011

of 25 May 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

(Text with EEA relevance)

(OJ L 153 11.6.2011, p. 1)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) No 541/2011 of 1 June 2011

  L 153

187

11.6.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 542/2011 of 1 June 2011

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189

11.6.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 702/2011 of 20 July 2011

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28

21.7.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 703/2011 of 20 July 2011

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33

21.7.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 704/2011 of 20 July 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 705/2011 of 20 July 2011

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43

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COMMISSION IMPLEMENTING REGULATION (EU) No 706/2011 of 20 July 2011

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50

21.7.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 736/2011 of 26 July 2011

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37

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COMMISSION IMPLEMENTING REGULATION (EU) No 740/2011 of 27 July 2011

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6

28.7.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 786/2011 of 5 August 2011

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11

6.8.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 787/2011 of 5 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 788/2011 of 5 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 797/2011 of 9 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 798/2011 of 9 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 800/2011 of 9 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 806/2011 of 10 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 807/2011 of 10 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 810/2011 of 11 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 820/2011 of 16 August 2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 974/2011 of 29 September 2011

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1

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COMMISSION IMPLEMENTING REGULATION (EU) No 993/2011 of 6 October 2011

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1

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COMMISSION IMPLEMENTING REGULATION (EU) No 1022/2011 of 14 October 2011

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15.10.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 1100/2011 of 31 October 2011

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10

1.11.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 1134/2011 of 9 November 2011

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1

10.11.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 1143/2011 of 10 November 2011

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26

11.11.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 1278/2011 of 8 December 2011

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49

9.12.2011

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COMMISSION IMPLEMENTING REGULATION (EU) No 87/2012 of 1 February 2012

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8

2.2.2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 127/2012 of 14 February 2012

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12

15.2.2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 287/2012 of 30 March 2012

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7

31.3.2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 359/2012 of 25 April 2012

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1

26.4.2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 369/2012 of 27 April 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 571/2012 of 28 June 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 582/2012 of 2 July 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 589/2012 of 4 July 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 595/2012 of 5 July 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 597/2012 of 5 July 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 608/2012 of 6 July 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 637/2012 of 13 July 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 735/2012 of 14 August 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 746/2012 of 16 August 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2012 of 7 November 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 1043/2012 of 8 November 2012

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9.11.2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 1197/2012 of 13 December 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 1237/2012 of 19 December 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 1238/2012 of 19 December 2012

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COMMISSION IMPLEMENTING REGULATION (EU) No 17/2013 of 14 January 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 22/2013 of 15 January 2013

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8

16.1.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 175/2013 of 27 February 2013

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4

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COMMISSION IMPLEMENTING REGULATION (EU) No 187/2013 of 5 March 2013

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6.3.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 188/2013 of 5 March 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 190/2013 of 5 March 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 200/2013 of 8 March 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 201/2013 of 8 March 2013

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6

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COMMISSION IMPLEMENTING REGULATION (EU) No 350/2013 of 17 April 2013

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18.4.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 355/2013 of 18 April 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 356/2013 of 18 April 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 365/2013 of 22 April 2013

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23.4.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 366/2013 of 22 April 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 367/2013 of 22 April 2013

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33

23.4.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 368/2013 of 22 April 2013

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36

23.4.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 369/2013 of 22 April 2013

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39

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COMMISSION IMPLEMENTING REGULATION (EU) No 373/2013 of 23 April 2013

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10

24.4.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 375/2013 of 23 April 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 378/2013 of 24 April 2013

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5

25.4.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 485/2013 of 24 May 2013

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25.5.2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 532/2013 of 10 June 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 533/2013 of 10 June 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 546/2013 of 14 June 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 568/2013 of 18 June 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 570/2013 of 17 June 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 762/2013 of 7 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 767/2013 of 8 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 781/2013 of 14 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 790/2013 of 19 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 798/2013 of 21 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 802/2013 of 22 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 826/2013 of 29 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 827/2013 of 29 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 828/2013 of 29 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 829/2013 of 29 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 832/2013 of 30 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 833/2013 of 30 August 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1031/2013 of 24 October 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1089/2013 of 4 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1124/2013 of 8 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1136/2013 of 12 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1150/2013 of 14 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1165/2013 of 18 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1166/2013 of 18 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1176/2013 of 20 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1178/2013 of 20 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1187/2013 of 21 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 1199/2013 of 25 November 2013

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COMMISSION IMPLEMENTING REGULATION (EU) No 85/2014 of 30 January 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 140/2014 of 13 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 141/2014 of 13 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 143/2014 of 14 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 144/2014 of 14 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 145/2014 of 14 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 149/2014 of 17 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 151/2014 of 18 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 154/2014 of 19 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 187/2014 of 26 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 192/2014 of 27 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 193/2014 of 27 February 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 462/2014 of 5 May 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 485/2014 of 12 May 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 563/2014 of 23 May 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 571/2014 of 26 May 2014

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COMMISSION IMPLEMENTING REGULATION (EU) No 629/2014 of 12 June 2014

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/51 of 14 January 2015

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/58 of 15 January 2015

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1201 of 22 July 2015

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1295 of 27 July 2015

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1885 of 20 October 2015

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21.11.2015

►M167

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2198 of 27 November 2015

  L 313

35

28.11.2015

►M168

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2233 of 2 December 2015

  L 317

26

3.12.2015

►M169

COMMISSION IMPLEMENTING REGULATION (EU) 2016/139 of 2 February 2016

  L 27

7

3.2.2016

►M170

COMMISSION IMPLEMENTING REGULATION (EU) 2016/146 of 4 February 2016

  L 30

7

5.2.2016

►M171

COMMISSION IMPLEMENTING REGULATION (EU) 2016/147 of 4 February 2016

  L 30

12

5.2.2016

►M172

COMMISSION IMPLEMENTING REGULATION (EU) 2016/177 of 10 February 2016

  L 35

1

11.2.2016

►M173

COMMISSION IMPLEMENTING REGULATION (EU) 2016/182 of 11 February 2016

  L 37

40

12.2.2016

►M174

COMMISSION IMPLEMENTING REGULATION (EU) 2016/370 of 15 March 2016

  L 70

7

16.3.2016

►M175

COMMISSION IMPLEMENTING REGULATION (EU) 2016/389 of 17 March 2016

  L 73

77

18.3.2016

►M176

COMMISSION IMPLEMENTING REGULATION (EU) 2016/548 of 8 April 2016

  L 95

1

9.4.2016

 M177

COMMISSION IMPLEMENTING REGULATION (EU) 2016/549 of 8 April 2016

  L 95

4

9.4.2016

►M178

COMMISSION IMPLEMENTING REGULATION (EU) 2016/560 of 11 April 2016

  L 96

23

12.4.2016

►M179

COMMISSION IMPLEMENTING REGULATION (EU) 2016/636 of 22 April 2016

  L 108

22

23.4.2016

►M180

COMMISSION IMPLEMENTING REGULATION (EU) 2016/638 of 22 April 2016

  L 108

28

23.4.2016

►M181

COMMISSION IMPLEMENTING REGULATION (EU) 2016/864 of 31 May 2016

  L 144

32

1.6.2016

►M182

COMMISSION IMPLEMENTING REGULATION (EU) 2016/871 of 1 June 2016

  L 145

4

2.6.2016

►M183

COMMISSION IMPLEMENTING REGULATION (EU) 2016/872 of 1 June 2016

  L 145

7

2.6.2016

 M184

COMMISSION IMPLEMENTING REGULATION (EU) 2016/950 of 15 June 2016

  L 159

3

16.6.2016

►M185

COMMISSION IMPLEMENTING REGULATION (EU) 2016/951 of 15 June 2016

  L 159

6

16.6.2016

►M186

COMMISSION IMPLEMENTING REGULATION (EU) 2016/952 of 15 June 2016

  L 159

10

16.6.2016

 M187

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1056 of 29 June 2016

  L 173

52

30.6.2016

 M188

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1313 of 1 August 2016

  L 208

1

2.8.2016

►M189

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1414 of 24 August 2016

  L 230

16

25.8.2016

►M190

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1423 of 25 August 2016

  L 231

20

26.8.2016

►M191

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1424 of 25 August 2016

  L 231

25

26.8.2016

►M192

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1425 of 25 August 2016

  L 231

30

26.8.2016

►M193

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1426 of 25 August 2016

  L 231

34

26.8.2016

►M194

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1429 of 26 August 2016

  L 232

1

27.8.2016

►M195

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1978 of 11 November 2016

  L 305

23

12.11.2016

►M196

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2016 of 17 November 2016

  L 312

21

18.11.2016

►M197

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2035 of 21 November 2016

  L 314

7

22.11.2016

►M198

COMMISSION IMPLEMENTING REGULATION (EU) 2017/157 of 30 January 2017

  L 25

5

31.1.2017

►M199

COMMISSION IMPLEMENTING REGULATION (EU) 2017/195 of 3 February 2017

  L 31

21

4.2.2017

►M200

COMMISSION IMPLEMENTING REGULATION (EU) 2017/239 of 10 February 2017

  L 36

39

11.2.2017

►M201

COMMISSION IMPLEMENTING REGULATION (EU) 2017/244 of 10 February 2017

  L 36

54

11.2.2017

►M202

COMMISSION IMPLEMENTING REGULATION (EU) 2017/270 of 16 February 2017

  L 40

48

17.2.2017

►M203

COMMISSION IMPLEMENTING REGULATION (EU) 2017/359 of 28 February 2017

  L 54

8

1.3.2017

►M204

COMMISSION IMPLEMENTING REGULATION (EU) 2017/360 of 28 February 2017

  L 54

11

1.3.2017

►M205

COMMISSION IMPLEMENTING REGULATION (EU) 2017/375 of 2 March 2017

  L 58

3

4.3.2017

►M206

COMMISSION IMPLEMENTING REGULATION (EU) 2017/406 of 8 March 2017

  L 63

83

9.3.2017

►M207

COMMISSION IMPLEMENTING REGULATION (EU) 2017/407 of 8 March 2017

  L 63

87

9.3.2017

►M208

COMMISSION IMPLEMENTING REGULATION (EU) 2017/408 of 8 March 2017

  L 63

91

9.3.2017

►M209

COMMISSION IMPLEMENTING REGULATION (EU) 2017/409 of 8 March 2017

  L 63

95

9.3.2017

►M210

COMMISSION IMPLEMENTING REGULATION (EU) 2017/419 of 9 March 2017

  L 64

4

10.3.2017

►M211

COMMISSION IMPLEMENTING REGULATION (EU) 2017/428 of 10 March 2017

  L 66

1

11.3.2017

►M212

COMMISSION IMPLEMENTING REGULATION (EU) 2017/438 of 13 March 2017

  L 67

67

14.3.2017

►M213

COMMISSION IMPLEMENTING REGULATION (EU) 2017/555 of 24 March 2017

  L 80

1

25.3.2017

►M214

COMMISSION IMPLEMENTING REGULATION (EU) 2017/725 of 24 April 2017

  L 107

24

25.4.2017

►M215

COMMISSION IMPLEMENTING REGULATION (EU) 2017/753 of 28 April 2017

  L 113

24

29.4.2017

►M216

COMMISSION IMPLEMENTING REGULATION (EU) 2017/755 of 28 April 2017

  L 113

35

29.4.2017

►M217

COMMISSION IMPLEMENTING REGULATION (EU) 2017/781 of 5 May 2017

  L 118

1

6.5.2017

►M218

COMMISSION IMPLEMENTING REGULATION (EU) 2017/805 of 11 May 2017

  L 121

26

12.5.2017

►M219

COMMISSION IMPLEMENTING REGULATION (EU) 2017/806 of 11 May 2017

  L 121

31

12.5.2017

►M220

COMMISSION IMPLEMENTING REGULATION (EU) 2017/831 of 16 May 2017

  L 124

27

17.5.2017

►M221

COMMISSION IMPLEMENTING REGULATION (EU) 2017/841 of 17 May 2017

  L 125

12

18.5.2017

►M222

COMMISSION IMPLEMENTING REGULATION (EU) 2017/842 of 17 May 2017

  L 125

16

18.5.2017

►M223

COMMISSION IMPLEMENTING REGULATION (EU) 2017/843 of 17 May 2017

  L 125

21

18.5.2017

►M224

COMMISSION IMPLEMENTING REGULATION (EU) 2017/855 of 18 May 2017

  L 128

10

19.5.2017

►M225

COMMISSION IMPLEMENTING REGULATION (EU) 2017/856 of 18 May 2017

  L 128

14

19.5.2017

►M226

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1113 of 22 June 2017

  L 162

27

23.6.2017

►M227

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1114 of 22 June 2017

  L 162

32

23.6.2017

►M228

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1115 of 22 June 2017

  L 162

38

23.6.2017

►M229

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1125 of 22 June 2017

  L 163

10

24.6.2017

►M230

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1186 of 3 July 2017

  L 171

131

4.7.2017

►M231

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1455 of 10 August 2017

  L 208

28

11.8.2017

►M232

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1491 of 21 August 2017

  L 216

15

22.8.2017

►M233

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1496 of 23 August 2017

  L 218

7

24.8.2017

►M234

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1506 of 28 August 2017

  L 222

21

29.8.2017

►M235

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1511 of 30 August 2017

  L 224

115

31.8.2017

►M236

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1527 of 6 September 2017

  L 231

3

7.9.2017

►M237

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1529 of 7 September 2017

  L 232

1

8.9.2017

►M238

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1530 of 7 September 2017

  L 232

4

8.9.2017

►M239

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1531 of 7 September 2017

  L 232

6

8.9.2017

►M240

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2066 of 13 November 2017

  L 295

43

14.11.2017

►M241

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2069 of 13 November 2017

  L 295

51

14.11.2017

►M242

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2090 of 14 November 2017

  L 297

22

15.11.2017

►M243

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2091 of 14 November 2017

  L 297

25

15.11.2017

►M244

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2324 of 12 December 2017

  L 333

10

15.12.2017

►M245

COMMISSION IMPLEMENTING REGULATION (EU) 2018/84 of 19 January 2018

  L 16

8

20.1.2018

►M246

COMMISSION IMPLEMENTING REGULATION (EU) 2018/112 of 24 January 2018

  L 20

3

25.1.2018

►M247

COMMISSION IMPLEMENTING REGULATION (EU) 2018/113 of 24 January 2018

  L 20

7

25.1.2018

►M248

COMMISSION IMPLEMENTING REGULATION (EU) 2018/184 of 7 February 2018

  L 34

10

8.2.2018

►M249

COMMISSION IMPLEMENTING REGULATION (EU) 2018/185 of 7 February 2018

  L 34

13

8.2.2018

►M250

COMMISSION IMPLEMENTING REGULATION (EU) 2018/291 of 26 February 2018

  L 55

30

27.2.2018

►M251

COMMISSION IMPLEMENTING REGULATION (EU) 2018/309 of 1 March 2018

  L 60

16

2.3.2018


Corrected by:

►C1

Corrigendum, OJ L 026, 28.1.2012, p.  38 (540/2011)

►C2

Corrigendum, OJ L 235, 4.9.2013, p.  12 (200/2013)

►C3

Corrigendum, OJ L 277, 22.10.2015, p.  60 (140/2014)

►C4

Corrigendum, OJ L 002, 5.1.2018, p.  15 (2017/842)




▼B

COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011

of 25 May 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

(Text with EEA relevance)



▼M1

Article 1

The active substances, as set out in Part A of the Annex, shall be deemed to have been approved under Regulation (EC) No 1107/2009.

▼M166

The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation. The low-risk active substances approved under Regulation (EC) No 1107/2009 are as set out in Part D of the Annex to this Regulation. The candidates for substitution approved under Regulation (EC) No 1107/2009 are as set out in Part E of the Annex to this Regulation.

▼B

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 14 June 2011.

This Regulation shall be binding in its entirety and directly applicable in all Member States.




▼M110

ANNEX ACTIVE SUBSTANCES

▼M1

PART A

Active substances deemed to have been approved under Regulation (EC) No 1107/2009

General provisions applying to all substances listed in this Part:

▼B

 for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;

 Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.



Number

Common name, identification numbers

IUPAC name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

▼M6 —————

▼M4 —————

▼M18 —————

▼M13 —————

▼M5 —————

▼M8 —————

▼M169 —————

▼M3 —————

▼M181 —————

▼M162 —————

▼B

11

Bentazone

CAS No 25057-89-0

CIPAC No 366

3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide

960  g/kg

1 August 2001

►M221  30 June 2018 ◄

Only uses as herbicide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular attention to the protection of groundwater.

Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.

▼M170 —————

▼M155 —————

▼M182 —————

▼B

15

Diquat

CAS No 2764-72-9 (ion), 85-00-7 (dibromide)

CIPAC No 55

9,10-Dihydro-8a,10a-diazoniaphenanthrene ion (dibromide)

950  g/kg

1 January 2002

►M221  30 June 2018 ◄

On the basis of currently available information, only uses as terrestrial herbicide and desiccant may be authorised. Uses in aquatic weed control shall not be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the Review report on diquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

— must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

— must pay particular attention to operator safety as related to non-professional use and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

▼M148 —————

▼M198 —————

▼M136 —————

▼M233 —————

▼M175 —————

▼M22

21

Cyclanilide

CAS No 113136-77-9

CIPAC No 586

Not available

960  g/kg

1 November 2001

31 October 2011

Only uses as a plant growth regulator may be authorised.

The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

▼M152 —————

▼B

23

Pymetrozine

CAS No 123312-89-0

CIPAC No 593

(E)-6-methyl-4-[(pyridin-3-ylmetylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one

950  g/kg

1 November 2001

►M221  30 June 2018 ◄

Only uses as an insecticide may be authorised.

In decision making according to the Uniform Principles Member States must pay particular attention to the protection of aquatic organisms.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

▼M173 —————

▼M244 —————

▼M191 —————

▼M161 —————

▼M183 —————

▼M193 —————

▼M171 —————

▼M205 —————

▼M150 —————

▼M24

33

Cinidon-ethyl

CAS No 142891-20-1

CIPAC No 598

(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate

940  g/kg

1 October 2002

30 September 2012

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions,

— should pay particular attention to the protection of aquatic organisms.

Conditions of authorisation must include risk mitigation measures, where appropriate.

▼M215 —————

▼B

35

Famoxadone

CAS No 131807-57-3

CIPAC No 594

3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione

960  g/kg

1 October 2002

►M221  30 June 2018 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms;

— Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

— Member States should pay particular attention to the protection of operators.

▼M159 —————

▼B

37

Metalaxyl-M

CAS No 70630-17-0

CIPAC No 580

Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate

910  g/kg

1 October 2002

►M221  30 June 2018 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

— particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.

▼M190 —————

▼B

39

Flumioxazine

CAS No 103361-09-7

CICAP No 578

N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide

960  g/kg

1 January 2003

►M221  30 June 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States:

— must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate.

40

Deltamethrin

CAS No 52918-63-5

CIPAC No 333

(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate

980  g/kg

1 November 2003

►M235  31 October 2018 ◄

Only uses as insecticide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States:

— must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures,

— should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels,

— must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.

▼M239 —————

▼B

42

Oxasulfuron

CAS No 144651-06-9

CIPAC No 626

Oxetan-3-yl 2[(4,6-dimethylpyrimidin-2-yl) carbamoyl-sulfamoyl] benzoate

930  g/kg

1 July 2003

►M221  31 July 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxasulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions.

Risk mitigation measures should be applied, where appropriate.

43

Ethoxysulfuron

CAS No 126801-58-9

CIPAC No 591

3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea

950  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

Member States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate.

44

Foramsulfuron

CAS No 173159-57-4

CIPAC No 659

1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea

940  g/kg

1 July 2003

►M221  31 July 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on foramsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied, where appropriate.

45

Oxadiargyl

CAS No 39807-15-3

CIPAC No 604

5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one

980  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate.

46

Cyazofamid

CAS No 120116-88-3

CIPAC No 653

4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide

935  g/kg

1 July 2003

►M221  31 July 2018 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms;

— Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions.

Risk mitigation measures or use restrictions should be applied where appropriate.

▼M232 —————

▼B

48

Beta-cyfluthrin

CAS No 68359-37-5 (unstated stereochemistry)

CIPAC No 482

(1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylic acid (SR)-α-cyano- (4-fluoro-3-phenoxy-phenyl)methyl ester

965  g/kg

1 January 2004

►M235  31 October 2018 ◄

Only use as insecticide may be authorised

Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops.

For the implementation of the uniform principles, the conclusions of the review report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.

49

Cyfluthrin

CAS No 68359-37-5 (unstated stereochemistry)

CIPAC No 385

(RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate

920  g/kg

1 January 2004

31 December 2013

Only use as insecticide may be authorised

Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops.

For the implementation of the uniform principles, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.

▼M243 —————

▼M201 —————

▼M234 —————

▼M227 —————

▼M251 —————

▼B

55

Propyzamide

CAS No 23950-58-5

CIPAC No 315

3,5-dichloro-N-(1,1-dimethyl-prop-2-ynyl)benzamide

920  g/kg

1 April 2004

►M245  31 January 2019 ◄

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propyzamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health 26 February 2003 shall be taken into account. In this overall assessment, Member States:

— must pay particular attention to the protection of operators and must ensure that conditions of authorisation include risk mitigation measures, where appropriate

— must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season. Conditions of authorisation should include risk mitigation measures, where appropriate

56

Mecoprop

CAS No 7085-19-0

CIPAC No 51

(RS)-2-(4-chloro-o-tolyloxy)-propionic acid

930  g/kg

1 June 2004

31 May 2014

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate.

57

Mecoprop-P

CAS No 16484-77-8

CIPAC No 475

(R)-2-(4-chloro-o-tolyloxy)-propionic acid

860  g/kg

1 June 2004

►M245  31 January 2019 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

58

Propiconazole

CAS No 60207-90-1

CIPAC No 408

(±)-1-[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole

920  g/kg

1 June 2004

►M245  31 January 2019 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States should pay particular attention to the protection of soil organisms for applications rates exceeding 625 g a.i./ha (e.g. uses in lawn). Conditions of authorisation should include risk mitigation measures (e.g. spotwise application scheme), where appropriate.

59

Trifloxystrobin

CAS No 141517-21-7

CIPAC No 617

Methyl (E)-methoxyimino-{(E)-a-[1-a-(a,a,a-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate

960  g/kg

1 October 2003

►M221  31 July 2018 ◄

Only use as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions.

Risk mitigation measures should be applied and/or monitoring programs may be initiated where appropriate.

60

Carfentrazone ethyl

CAS No 128639-02.1

CIPAC No 587

Ethyl (RS)-2-chloro-3-[2-chloro-5-(4-difluoromethyl-4,5-dihydro-3-methyl-5oxo-1H 1,2,4-triazol-1-yl)-4-fluorophenyl]propionate

900  g/kg

1 October 2003

►M221  31 July 2018 ◄

Only use as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carfentrazone-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions.

Risk mitigation measures should be applied where appropriate.

▼M214 —————

▼B

62

Fenamidone

CAS No 161326-34-7

CIPAC No 650

(S)-5-methyl-2-methylthio-5-phenyl-3-phenylamino-3,5-dihydroimidazol-4-one

975  g/kg

1 October 2003

►M221  31 July 2018 ◄

Only use as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenamidone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

— should pay particular attention to the protection of non-target arthropods,

— should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

63

Isoxaflutole

CAS No 141112-29-0

CIPAC No 575

5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole

950  g/kg

1 October 2003

►M221  31 July 2018 ◄

Only use as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isoxaflutole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States:

— must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures or monitoring programs should be applied where appropriate.

64

Flurtamone

CAS No 96525-23-4

(RS)-5-methylamino-2-phenyl-4-(a,a,a-trifluoro-m-tolyl) furan-3 (2H)-one

960  g/kg

1 January 2004

►M235  31 October 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flurtamone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

— should pay particular attention to the protection of algae and other aquatic plants.

Risk mitigation measures should be applied where appropriate.

65

Flufenacet

CAS No 142459-58-3

CIPAC No 588

4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide

950  g/kg

1 January 2004

►M235  31 October 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

— should pay particular attention to the protection of algae and aquatic plants,

— should pay particular attention to the protection of operators.

Risk mitigation measures should be applied where appropriate.

▼M207 —————

▼B

67

Dimethenamid-p

CAS No 163515-14-8

CIPAC No 638

S-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy-1-methylethyl)-acetamide

890 g/kg (preliminary value based on a pilot plant)

1 January 2004

►M235  31 October 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethenamid-p, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the potential of the metabolites of dimethenamid-p for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

— should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants.

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

▼M231 —————

▼B

69

Fosthiazate

CAS No 98886-44-3

CIPAC No 585

(RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate

930  g/kg

1 January 2004

►M235  31 October 2018 ◄

Only uses as insecticide or nematicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States

— should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions;

— should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season;

— should pay particular attention to the protection of non-target soil organisms.

Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

70

Silthiofam

CAS No 175217-20-6

CIPAC No 635

N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide

950  g/kg

1 January 2004

►M235  31 October 2018 ◄

Only uses as fungicide may be authorised.

Uses other than seed treatments are currently not adequately supported by data. To support authorisations for such uses, data and information to prove their acceptability for consumers, operators and the environment will have to be generated and submitted to the Member States.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on silthiofam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of operators. Risk mitigation measures must be applied, where appropriate.

▼M222 —————

▼B

72

Molinate

CAS No 2212-67-1

CIPAC No 235

S-ethyl azepane-1-carbothioate;

S-ethyl perhydroazepine-1-carbothioate;

S-ethyl perhydroazepine-1-thiocarboxilate

950  g/kg

1 August 2004

31 July 2014

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on molinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States should pay particular attention to the possibility of short-range transport of the active substance in air.

73

Thiram

CAS No 137-26-8

CIPAC No 24

tetramethylthiuram disulfide;

bis (dimethylthiocarbamoyl)-disulfide

960  g/kg

1 August 2004

►M196  30 April 2018 ◄

Only uses as fungicide or as repellent may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied, where appropriate,

— Member States should pay particular attention to the protection of small mammals and birds when the substance is used as a seed treatment in spring uses. Risk mitigation measures should be applied, where appropriate.

74

Ziram

CAS No 137-30-4

CIPAC No 31

Zinc bis (dimethyldithiocarbamate)

950 g/kg (FAO-specification)

Arsenic: maximum 250 mg/kg

Water: maximum 1,5 %

1 August 2004

►M196  30 April 2018 ◄

Only uses as fungicide or as repellent may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate,

— Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels.

▼M216 —————

▼M228 —————

▼B

77

Zoxamide

CAS No 156052-68-5

CIPAC No 640

(RS)-3,5-Dichloro-N-(3-chloro-1-ethyl-1-methylacetonyl)-p-toluamide

950  g/kg

1 April 2004

►M245  31 January 2019 ◄

Only use as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on zoxamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account.

78

Chlorpropham

CAS No 101-21-3

CIPAC No 43

Isopropyl 3-chlorophenylcarbamate

975  g/kg

1 February 2005

►M221  31 July 2018 ◄

Only uses as herbicide and sprout suppression may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorpropham, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, consumers and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate.

▼M226 —————

▼M218 —————

▼B

81

Pyraclostrobin

CAS No 175013-18-0

CIPAC No 657

methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate

975 g/kg

The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.

1 June 2004

►M245  31 January 2019 ◄

Only uses as fungicide or plant growth regulator may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the protection of aquatic organisms, especially fish,

— should pay particular attention to the protection of terrestrial arthropods and earthworms.

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

82

Quinoxyfen

CAS No 124495-18-7

CIPAC No 566

5, 7-dichloro-4 (ρ-fluorophenoxy) quinoline

970  g/kg

1 September 2004

►M196  30 April 2018 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quinoxyfen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003, shall be taken into account.

Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures must be applied and monitoring programmes must be initiated in vulnerable zones where appropriate.

83

Alpha-cypermethrin

CAS No 67375-30-8

CIPAC No

Racemate comprising

(S)-α- cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate

and

(R)-α- cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate

(= cis-2 isomer pair of cypermethrin)

930 g/kg CIS-2

1 March 2005

►M221  31 July 2018 ◄

Only uses as insecticide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures.

— Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures.

84

Benalaxyl

CAS No 71626-11-4

CIPAC No 416

Methyl N-phenylacetyl–N-2, 6–xylyl–DL-alaninate

960  g/kg

1 March 2005

►M221  31 July 2018 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

85

Bromoxynil

CAS No 1689-84-5

CIPAC No 87

3,5 dibromo – 4- hydroxybenzonitrile

970  g/kg

1 March 2005

►M221  31 July 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bromoxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals, in particular if the substance is applied in winter, and of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

86

Desmedipham

CAS No 13684-56-5

CIPAC No 477

ethyl 3′-phenylcarbamoyloxycarbanilate

ethyl 3-phenylcarbamoyloxyphenylcarbamate

Min. 970 g/kg

1 March 2005

►M221  31 July 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on desmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms and earthworms. Risk mitigation measures should be applied if appropriate

87

Ioxynil

CAS No 13684-83-4

CIPAC No 86

4- hydroxy- 3,5- di-iodobenzonitrile

960  g/kg

1 March 2005

28 February 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

88

Phenmedipham

CAS No 13684-63-4

CIPAC No 77

methyl 3-(3-methylcarbaniloyloxy)carbanilate;

3-methoxycarbonylaminophenyl 3′-methylcarbanilate

Min. 970 g/kg

1 March 2005

►M221  31 July 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

89

Pseudomonas chlororaphis

Strain: MA 342

CIPAC No 574

Not applicable

The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l).

1 October 2004

►M196  30 April 2018 ◄

Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised.

When granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

In this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate.

90

Mepanipyrim

CAS No 110235-47-7

CIPAC No 611

N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline

960  g/kg

1 October 2004

►M196  30 April 2018 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.

▼M247 —————

▼B

92

Thiacloprid

CAS No 111988-49-9

CIPAC No 631

(Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide

≥ 975 g/kg

1 January 2005

►M196  30 April 2018 ◄

Only uses as insecticide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Thiacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account.

In this overall assessment Member States:

— should pay particular attention to the protection of non-target arthropods,

— should pay particular attention to the protection of aquatic organisms,

— should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Risk mitigation measures should be applied where appropriate.

93

Ampelomyces quisqualis

Strain: AQ 10

Culture collection No CNCM I-807

CIPAC No

Not allocated

Not applicable

 

1 April 2005

►M221  31 July 2018 ◄

Only uses as fungicide may be authorised.

When granting authorisations, the conclusions of the review report on Ampelomyces quisqualis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

94

Imazosulfuron

CAS No 122548-33-8

CIPAC No 590

1-(2-chloroimidazo[1,2-α]pyridin-3-ylsul-phonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea

≥ 980 g/kg

1 April 2005

►M43  31. July 2017 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic and terrestrial non-target plants. Risk mitigation measures should be applied where appropriate.

▼M246 —————

▼B

96

Methoxyfenozide

CAS No 161050-58-4

CIPAC No 656

N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide

≥ 970 g/kg

1 April 2005

►M221  31 July 2018 ◄

Only uses as insecticide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methoxyfenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of terrestrial and aquatic non-target arthropods.

Risk mitigation measures should be applied where appropriate.

97

S-metolachlor

CAS No 87392-12-9

(S-isomer)

178961-20-1 (R-isomer)

CIPAC No 607

Mixture of:

(aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %)

and:

(aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %)

≥ 960 g/kg

1 April 2005

►M221  31 July 2018 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

In this overall assessment Member States:

— should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— should pay particular attention to the protection of aquatic plants.

Risk mitigation measures should be applied where appropriate.

98

Gliocladium catenulatum

Strain: J1446

Culture collection No DSM 9212

CIPAC No

Not allocated

Not applicable

 

1 April 2005

►M221  31 July 2018 ◄

Only uses as fungicide may be authorised.

When granting authorisations, the conclusions of the review report on Gliocladium catenulatum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

In this overall assessment, Member States should pay particular attention to the protection of operators and workers. Risk mitigation measures should be applied where appropriate.

99

Etoxazole

CAS No 153233-91-1

CIPAC No 623

(RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole

≥ 948 g/kg

1 June 2005

►M221  31 July 2018 ◄

Only uses as acaricide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

100

Tepraloxydim

CAS No 149979-41-9

CIPAC No 608

(EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one

≥ 920 g/kg

1 June 2005

►M134  31. May 2015 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account.

In this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods.

Risk mitigation measures should be applied where appropriate.

101

Chlorothalonil

CAS No 1897-45-6

CIPAC No 288

Tetrachloroisophthalonitrile

985 g/kg

— Hexachlorobenzene: not more than 0,04 g/kg

— Decachlorobiphenyl: not more than 0,03 g/kg

1 March 2006

►M235  31 October 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorothalonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee onthe Food Chain and Animal Health on 15 February 2005 shall be taken into account.

In this overall assessment Members States must pay particular attention to the protection of:

— aquatic organisms,

— groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions.

Conditions of use should include risk mitigation measures, where appropriate.

102

Chlorotoluron (unstated stereochemistry)

CAS No 15545-48-9

CIPAC No 217

3-(3-chloro-p-tolyl)-1,1-dimethylurea

975  g/kg

1 March 2006

►M235  31 October 2018 ◄

PART A

Only uses as herbicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

103

Cypermethrin

CAS No 52315-07-8

CIPAC No 332

(RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate

(4 isomer pairs: cis-1, cis-2, trans-3, trans-4)

900  g/kg

1 March 2006

►M235  31 October 2018 ◄

PART A

Only uses as insecticide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate

104

Daminozide

CAS No 1596-84-5

CIPAC No 330

N-dimethylaminosuccinamic acid

990 g/kg

Impurities:

— N-nitrosodimethylamine: not more than 2,0 mg/kg

— 1,1-dimethylhydrazide: not more than 30 mg/kg

1 March 2006

►M235  31 October 2018 ◄

PART A

Only uses as growth regulator in non-edible crops may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate

105

Thiophanate-methyl (unstated stereochemistry)

CAS No 23564-05-8

CIPAC No 262

Dimethyl 4,4′-(o-phenylene)bis(3-thioallophanate)

950  g/kg

1 March 2006

►M235  31 October 2018 ◄

PART A

Only uses as fungicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiophanate-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of aquatic organisms, earthworms and other soil macro-organisms. Conditions of authorisation should include risk mitigation measures, where appropriate

106

Tribenuron

CAS No 106040-48-6 (tribenuron)

CIPAC No 546

2-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid

950 g/kg (expressed as tribenuron-methyl)

1 March 2006

►M235  31 October 2018 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tribenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of non-target terrestrial plants, higher aquatic plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.

107

MCPA

CAS No 94-74-6

CIPAC No 2

4-chloro-o-tolyloxyacetic acid

≥ 930 g/kg

1 May 2006

►M235  31 October 2018 ◄

PART A

Only uses as herbicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account

Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones

108

MCPB

CAS No 94-81-5

CIPAC No 50

4-(4-chloro-o-tolyloxy)butyric acid

≥ 920 g/kg

1 May 2006

►M235  31 October 2018 ◄

PART A

Only uses as herbicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account

Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones

109

Bifenazate

CAS No 149877-41-8

CIPAC No 736

Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate

≥ 950 g/kg

1 December 2005

►M221  31 July 2018 ◄

PART A

Only uses as acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

110

Milbemectin

Milbemectin is a mixture of M.A3 and M.A4

CAS No

M.A3: 51596-10-2

M.A4: 51596-11-3

CIPAC No 660

M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one

M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one

≥ 950 g/kg

1 December 2005

►M221  31 July 2018 ◄

PART A

Only uses as acaricide or insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

111

Chlorpyrifos

CAS No 2921-88-2

CIPAC No 221

O,O-diethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate

≥ 970 g/kg

The impurity O,O,O,O-tetraethyl dithiopyrophosphate (Sulfotep) was considered of toxicological concern and a maximum level of 3 g/Kg is established.

1 July 2006

►M245  31 January 2019 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorpyrifos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request chlorpyrifos has been included in this Annex provide such studies to the Commission within two years from the approval.

112

Chlorpyrifos-methyl

CAS No 5598-13-0

CIPAC No 486

O,O-dimethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate

≥ 960 g/kg

The impurities O,O,O,O-tetramethyl dithiopyrophosphate (Sulfotemp) and OOO-trimethyl-O-(3,5,6-trichloro-2-pyridinyl) diphosphorodithioate (Sulfotemp -ester) were considered of toxicological concern and a maximum level of 5 g/Kg is established for each impurity.

1 July 2006

►M245  31 January 2019 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorpyrifos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals in case of outdoor uses. They shall ensure that the notifiers at whose request chlorpyrifos-methyl has been included in this Annex provide such studies to the Commission within two years from the approval.

113

Maneb

CAS No 12427-38-2

CIPAC No 61

manganese ethylenebis (dithiocarbamate) (polymeric)

≥ 860 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content.

1 July 2006

►M197  31 January 2017 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity.

They shall ensure that the notifiers at whose request maneb has been included in this Annex provide such studies to the Commission within two years from the approval.

114

Mancozeb

CAS No 8018-01-7 (formerly 8065-67-5)

CIPAC No 34

Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt

≥ 800 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content.

1 July 2006

►M245  31 January 2019 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity.

They shall ensure that the notifiers at whose request mancozeb has been included in this Annex provide such studies to the Commission within two years from the approval.

115

Metiram

CAS No 9006-42-2

CIPAC No 478

Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)]

≥ 840 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content.

1 July 2006

►M245  31 January 2019 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval.

116

Oxamyl

CAS No 23135-22-0

CIPAC No 342

N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide

970  g/kg

1 August 2006

►M245  31 January 2019 ◄

PART A

Only uses as nematicide and insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment,

— Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations.

Conditions of authorisation should include risk mitigation measures, where appropriate.

— Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval.

117

1-methylcyclopropene (an ISO Common Name will not be considered for this active substance)

CAS No 3100-04-7

CIPAC No not allocated

1-methylcyclopropene

≥ 960 g/kg

The manufacturing impurities 1-chloro-2-methylpropene and 3-chloro-2-methylpropene are of toxicological concern and each of them must not exceed 0,5 g/kg in the technical material.

1 April 2006

►M235  31 October 2018 ◄

PART A

Only uses as plant growth regulator for post harvest storage in sealable warehouse may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-methylcyclopropene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

118

Forchlorfenuron

CAS No 68157-60-8

CIPAC No 633

1-(2-chloro-4-pyridinyl)-3-phenylurea

≥ 978 g/kg

1 April 2006

►M235  31 October 2018 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

In assessing applications to authorise plant protection products containing forchlorfenuron for uses other than in kiwi plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on forchlorfenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

In this overall assessment Member States must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Risk mitigation measures should be applied where appropriate.

119

Indoxacarb

CAS No 173584-44-6

CIPAC No 612

methyl (S)-N-[7-chloro-2,3,4a,5-tetrahydro-4a-(methoxycarbonyl)indeno[1,2-e][1,3,4]oxadiazin-2-ylcarbonyl]-4′-(trifluoromethoxy)carbanilate

TC (Technical Material): ≥ 628 g/kg indoxacarb

1 April 2006

►M235  31 October 2018 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on indoxacarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

In this overall assessment Member States must pay particular attention to the protection of aquatic organisms.

Conditions of use should include risk mitigation measures, where appropriate.

120

Warfarin

CAS No 81-81-2

CIPAC No 70

(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin

≥ 990 g/kg

1 October 2006

30 September 2013

PART A

Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals.

Risk mitigation measures should be applied where appropriate.

121

Clothianidin

CAS No 210880-92-5

CIPAC No 738

(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

≥ 960 g/kg

1 August 2006

►M245  31 January 2019 ◄

►M65

 

PART A

Only professional uses as insecticide may be authorised.

Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:

barley, millet, oats, rice, rye, sorghum, triticale, wheat.

Foliar treatments shall not be authorised for the following cereals:

barley, millet, oats, rice, rye, sorghum, triticale, wheat.

Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatments after flowering:

Alfalfa (Medicago sativa)

almonds (Prunus amygdalus; P. communis; Amygdalus communis)

anise (Pimpinella anisum); badian or star anise (Illicium verum); caraway (Carum carvi); coriander (Coriandrum sativum); cumin (Cuminum cyminum); fennel (Foeniculum vulgare); juniper berries (Juniperus communis)

apples (Malus pumila; M. sylvestris; M. communis; Pyrus malus)

apricots (Prunus armeniaca)

avocados (Persea americana)

bananas (Musa sapientum; M. cavendishii; M. nana);

beans (Phaseolus spp.)

blackberry (Rubus fruticosus)

blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum)

broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor)

buckwheat (Fagopyrum esculentum)

carobs, carob-tree, locust bean (Ceratonia siliqua)

castor oil seed (Ricinus communis)

cherries (Prunus avium)

chestnuts (Castanea spp.)

chick peas (Cicer arietinum)

chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis)

clovers (Trifolium spp.)

coffee (Coffea spp. arabica, robusta, liberica)

cotton (Gossypium spp.)

cowpeas, black eyed peas (Vigna unguiculata)

cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus)

cucumbers (Cucumis sativus)

currants black (Ribes nigrum); red and white (R. rubrum)

dates (Phoenix dactylifera)

elderberries (Sambucus nigra)

gooseberries (Ribes uva-crispa)

grapefruit (C. paradisi)

grapes (Vitis vinifera)

groundnuts/peanuts (Arachis hypogea)

hazelnut (Corylus avellana)

hemp (Cannabis sativa)

japanese rose (Rosa rugosa)

kiwi fruit (Actinidia chinensis)

leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium)

lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta)

lentils (Lens esculenta; Ervum lens)

linseed (Linum usitatissimum)

lupins (Lupinus spp.)

maize/corn (Zea mays)

melon seeds (Cucumis melo)

mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra)

okra (Abelmoschus esculentus); gombo (Hibiscus esculentus)

olives (Olea europaea)

oranges: sweet orange (Citrus sinensis); bitter orange (C. aurantium)

peaches and nectarines (Prunus persica; Amygdalus persica; Persica laevis)

pears (Pyrus communis)

peas garden pea (Pisum sativum); field pea (P. arvense)

peppermint (Mentha spp.: M. piperita)

persimmons (Diospyros kaki: D. virginiana)

pistachios (Pistacia vera)

plums and sloes greengage, mirabelle, damson (Prunus domestica); sloe (P. spinosa)

poppy seed (Papaver somniferum)

pumpkins, squash, gourds and marrows (Cucurbita spp.)

pyrethrum, (Chrysanthemum cinerariifolium)

quinces (Cydonia oblonga; C. vulgaris; C. japonica)

rapeseed (Brassica napus var. oleifera)

raspberries (Rubus idaeus)

safflower seed (Carthamus tinctorius)

serradella/birds foot (Ornithopus sativus)

sesame seed (Sesamum indicum)

soybeans (Glycine soja)

spices: bay leaves (Laurus nobilis); dill seed (Anethum graveolens); fenugreek seed (Trigonella foenumgraecum); saffron (Crocus sativus); thyme (Thymus vulgaris); turmeric (Curcuma longa)

strawberries (Fragaria spp.)

sunflower seed (Helianthus annuus)

tangerine (Citrus tangerina); mandarin (Citrus reticulata); clementine (C. unshiu);

turnips and turnip rapes (Brassica rapa var. rapifera and oleifera spp.)

vetches Spring/common vetch (Vicia sativa)

viper’s Grass (Scorzonera hispanica)

walnuts (Jugland spp.: J. regia)

watermelons (Citrullus vulgaris)

ornamentals flowering in year of treatment.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 and the conclusions of the addendum of the review report on clothianidin as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

— the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

— the risk to granivorous birds and mammals when the substance is used as a seed dressing.

Member States shall ensure that:

— the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised,

— adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission,

— the conditions of the authorisation include, where appropriate, risk mitigation measures to protect bees,

— monitoring programmes are initiated to verify the real exposure of bees to clothianidin in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  the risk to pollinators other than honey bees;

(b)  the risk to honey bees foraging in nectar or pollen in succeeding crops;

(c)  the potential uptake via roots to flowering weeds;

(d)  the risk to honey bees foraging on insect honey dew;

(e)  the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

(f)  the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

(g)  the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen.

The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014.

 ◄

122

Pethoxamid

CAS No 106700-29-2

CIPAC No 655

2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide

≥ 940 g/kg

1 August 2006

►M245  31 January 2019 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pethoxamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

In this overall assessment Member States

— must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

— must pay particular attention to the protection of the aquatic environment, in particular higher aquatic plants.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

123

Clodinafop

CAS No 114420-56-3

CIPAC No 683

(R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid

≥ 950 g/kg (expressed as clodinafop-propargyl)

1 February 2007

►M113  30. April 2018 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

124

Pirimicarb

CAS No 23103-98-2

CIPAC No 231

2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate

≥ 950 g/kg

1 February 2007

►M113  30. April 2018 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

Member States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment.

Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the approval.

125

Rimsulfuron

CAS No 122931-48-0 (rimsulfuron)

CIPAC No 716

1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea

≥ 960 g/kg (expressed as rimsulfuron)

1 February 2007

►M113  30. April 2018 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.

126

Tolclofos-methyl

CAS No 57018-04-9

CIPAC No 479

O-2,6-dichloro-p-tolyl O,O-dimethyl phosphorothioate

O-2,6-dichloro-4-methylphenyl O,O-dimethyl phosphorothioate

≥ 960 g/kg

1 February 2007

►M113  30. April 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing tolclofos-methyl for uses other than pre-planting tuber (seed) treatment in potato and soil treatment in lettuce within greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tolclofos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

127

Triticonazole

CAS No 131983-72-7

CIPAC No 652

(±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

≥ 950 g/kg

1 February 2007

►M113  30. April 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States:

— must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate,

— must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones,

— must pay particular attention to the protection of granivorous birds (long term risk).

Conditions of authorisation should include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval.

128

Dimoxystrobin

CAS No 149961-52-4

CIPAC No 739

(E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide

≥ 980 g/kg

1 October 2006

►M245  31 January 2019 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

In this overall assessment Member States

— must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions;

— must pay particular attention to the protection of aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of

— a refined risk assessment for birds and mammals considering the formulated active substance;

— a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage.

They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

129

Clopyralid

CAS No 1702-17-6

CIPAC No 455

3,6-dichloropyridine-2-carboxylic acid

≥ 950 g/kg

1 May 2007

►M120  30. April 2018 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing clopyralid for uses other than spring applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the results on animal metabolism. They shall ensure that the notifiers at whose request clopyralid has been included in this Annex provide such studies to the Commission within two years from the approval.

130

Cyprodinil

CAS No 121522-61-2

CIPAC No 511

(4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine

≥ 980 g/kg

1 May 2007

►M120  30. April 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval.

131

Fosetyl

CAS No 15845-66-6

CIPAC No 384

Ethyl hydrogen phosphonate

≥ 960 g/kg (expressed as fosetyl-Al)

1 May 2007

►M120  30. April 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods.

Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval.

132

Trinexapac

CAS No 104273-73-6

CIPAC No 732

4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid

≥ 940 g/kg (expressed as trinexapac-ethyl)

1 May 2007

►M120  30. April 2018 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds and mammals.

Conditions of authorisation should include risk mitigation measures, where appropriate.

133

Dichlorprop-P

CAS No 15165-67-0

CIPAC No 476

(R)-2-(2,4-dichlorophenoxy) propanoic acid

≥ 900 g/kg

1 June 2007

►M121  30. April 2018 ◄

►M89  
PART A
Only uses as herbicide may be authorised.
As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.
Use on grassland shall not be authorised.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.
Conditions of authorisation shall include risk mitigation measures, where appropriate.  ◄

134

Metconazole

CAS No 125116-23-6 (unstated stereo-chemistry)

CIPAC No 706

(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol

≥ 940 g/kg

(sum of cis-and trans-isomers)

1 June 2007

►M121  30. April 2018 ◄

PART A

Only uses as fungicide and plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.

In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.

135

Pyrimethanil

CAS No 53112-28-0

CIPAC No not allocated

N-(4,6-dimethylpyrimidin-2-yl) aniline

≥ 975 g/kg

(the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material)

1 June 2007

►M120  30. April 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones,

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval.

136

Triclopyr

CAS No 055335-06-3

CIPAC No 376

3,5,6-trichloro-2-pyridyloxyacetic acid

≥ 960 g/kg

(as Triclopyr butoxyethyl ester)

1 June 2007

►M121  30. April 2018 ◄

►M137

 

PART A

Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account.

In this overall assessment Member States:

— shall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate,

— shall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate.

 ◄

137

Metrafenone

CAS No 220899-03-6

CIPAC No 752

3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone

≥ 940 g/kg

1 February 2007

►M113  30. April 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

138

Bacillus subtilis

(Cohn 1872)

Strain QST 713, identical with strain AQ 713

Culture collection No: NRRL B -21661

CIPAC No not allocated

Not applicable

 

1 February 2007

►M113  30. April 2018 ◄

►M158  
PART A
Only uses as fungicide and bactericide may be authorised.  ◄
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

139

Spinosad

CAS No 131929-60-7 (Spinosyn A)

131929-63-0 (Spinosyn D)

CIPAC No 636

Spinosyn A:

(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

Spinosyn D:

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D

≥ 850 g/kg

1 February 2007

►M113  30. April 2018 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

In this overall assessment Member States

— must pay particular attention to the protection of aquatic organisms;

— must pay particular attention to the risk to earthworms when the substance is used in glasshouses.

Conditions of use shall include risk mitigation measures, where appropriate.

140

Thiamethoxam

CAS No 153719-23-4

CIPAC No 637

(E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine

≥ 980 g/kg

1 February 2007

►M113  30. April 2018 ◄

►M65

 

PART A

Only professional uses as insecticide may be authorised.

Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:

barley, millet, oats, rice, rye, sorghum, triticale, wheat.

Foliar treatments shall not be authorised for the following cereals:

barley, millet, oats, rice, rye, sorghum, triticale, wheat.

Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatment after flowering:

Alfalfa (Medicago sativa)

almonds (Prunus amygdalus; P. communis; Amygdalus communis)

anise (Pimpinella anisum); badian or star anise (Illicium verum); caraway (Carum carvi); coriander (Coriandrum sativum); cumin (Cuminum cyminum); fennel (Foeniculum vulgare); juniper berries (Juniperus communis)

apples (Malus pumila; M. sylvestris; M. communis; Pyrus malus)

apricots (Prunus armeniaca)

avocados (Persea americana)

bananas (Musa sapientum; M. cavendishii; M. nana)

beans (Phaseolus spp.)

blackberry (Rubus fruticosus)

blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum)

broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor)

buckwheat (Fagopyrum esculentum)

carobs, carob-tree, locust bean (Ceratonia siliqua)

castor oil seed (Ricinus communis)

cherries (Prunus avium)

chestnuts (Castanea spp.)

chick peas (Cicer arietinum)

chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis)

clovers (Trifolium spp.)

coffee (Coffea spp. arabica, robusta, liberica)

cotton (Gossypium spp.)

cowpeas, black eyed peas (Vigna unguiculata)

cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus)

cucumbers (Cucumis sativus)

currants black (Ribes nigrum); red and white (R. rubrum)

dates (Phoenix dactylifera)

elderberries (Sambucus nigra)

gooseberries (Ribes uva-crispa)

grapefruit (C. paradisi)

grapes (Vitis vinifera)

groundnuts/peanuts (Arachis hypogea)

hazelnut (Corylus avellana)

hemp (Cannabis sativa)

japanese rose (Rosa rugosa)

kiwi fruit (Actinidia chinensis)

leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium)

lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta)

lentils (Lens esculenta; Ervum lens)

linseed (Linum usitatissimum)

lupins (Lupinus spp.)

maize/corn (Zea mays)

melon seeds (Cucumis melo)

mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra)

okra (Abelmoschus esculentus); gombo (Hibiscus esculentus)

olives (Olea europaea)

oranges: sweet orange (Citrus sinensis); bitter orange (C. aurantium)

peaches and nectarines (Prunus persica; Amygdalus persica; Persica laevis)

pears (Pyrus communis)

peas garden pea (Pisum sativum); field pea (P. arvense)

peppermint (Mentha spp.: M. piperita)

persimmons (Diospyros kaki: D. virginiana)

pistachios (Pistacia vera)

plums and sloes greengage, mirabelle, damson (Prunus domestica); sloe (P. spinosa)

poppy seed (Papaver somniferum)

pumpkins, squash, gourds and marrows (Cucurbita spp.)

pyrethrum, (Chrysanthemum cinerariifolium)

quinces (Cydonia oblonga; C. vulgaris; C. japonica)

rapeseed (Brassica napus var. oleifera)

raspberries (Rubus idaeus)

safflower seed (Carthamus tinctorius)

serradella/birds foot(Ornithopus sativus)

sesame seed (Sesamum indicum)

soybeans (Glycine soja)

spices: bay leaves (Laurus nobilis); dill seed (Anethum graveolens); fenugreek seed (Trigonella foenumgraecum); saffron (Crocus sativus); thyme (Thymus vulgaris); turmeric (Curcuma longa)

strawberries (Fragaria spp.)

sunflower seed (Helianthus annuus)

tangerine (Citrus tangerina); mandarin (Citrus reticulata) clementine (C. unshiu);

turnips andturnip rapes (Brassica rapa var. rapifera and oleifera spp.)

vetches Spring/common vetch (Vicia sativa)

viper’s Grass (Scorzonera hispanica)

walnuts (Jugland spp.: J. regia)

watermelons (Citrullus vulgaris)

ornamentals flowering in year of treatment.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 and the conclusions of the addendum of the review report on thiamethoxam as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the potential for groundwater contamination, particularly of the active substance and its metabolites NOA 459602, SYN 501406 and CGA 322704, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of aquatic organisms,

— the long-term risk to small herbivorous animals if the substance is used for seed treatment.

Member States shall ensure that:

— the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised,

— adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission,

— the conditions of the authorisation include, where appropriate, risk mitigation measures to protect bees,

— monitoring programmes are initiated to verify the real exposure of bees to thiamethoxam in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  the risk to pollinators other than honey bees;

(b)  the risk to honey bees foraging in nectar or pollen in succeeding crops;

(c)  the potential uptake via roots to flowering weeds;

(d)  the risk to honey bees foraging on insect honey dew;

(e)  the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

(f)  the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

(g)  the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen.

The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014.

 ◄

141

Fenamiphos

CAS No 22224-92-6

CIPAC No 692

(RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate

≥ 940 g/kg

1 August 2007

►M140  31. July 2018 ◄

PART A

Only uses as nematicide applied by drip irrigation in greenhouses with permanent structure may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenamiphos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.

142

Ethephon

CAS No 16672-87-0

CIPAC No 373

2-chloroethyl-phosphonic acid

≥ 910 g/kg (technical material — TC)

The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material.

1 August 2007

►M140  31. July 2018 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

143

Flusilazole (2)

CAS No 85509-19-9

CIPAC No 435

Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane

925  g/kg

1 January 2007

30 June 2008 (2)

PART A

Only uses as fungicide on the following crops may be authorised:

— cereals other than rice (2),

— maize (2),

— rape seed (2),

— sugar beet (2),

at rates not exceeding 200 g active substance per hectare per application.

The following uses must not be authorised:

— air application,

— knapsack and hand-held applications, neither by amateur nor by professional users,

— home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

— aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,

— birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,

— operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account.

Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained.

Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shallensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.

▼M2

144

Carbendazim

CAS No 10605-21-7

CIPAC No 263

Methyl benzimidazol-2-ylcarbamate

≥ 980 g/kg

Relevant impurities

2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg

2,3-diaminophenazine (DAP): not more than 0,003 g/kg

1 June 2011

30 November 2014

PART A

Only uses as fungicide on the following crops may be authorised:

— cereals

— rape seed

— sugar and fodder beet

— maize

at rates not exceeding

— 0,25 kg active substance per hectare per application for cereals and rape seed;

— 0,075 kg active substance per hectare per application for sugar and fodder beet

— 0,1 kg active substance per hectare per application for maize.

The following uses must not be authorised:

— air application;

— knapsack and handheld applications neither by amateur nor by professional users;

— home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

— aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices;

— earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance;

— birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary;

— operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbendazim, and in particular Appendices I and II thereof, shall be taken into account.

The Member States concerned shall request that the applicant provides the following to the Commission:

— by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197;

— by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 ‘Further information’, pp. 155 – 157);

— by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.

▼B

145

Captan

CAS No 133-06-02

CIPAC No 40

N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide

≥ 910 g/kg

Impurities:

Perchloromethylmercaptan (R005406): not more than 5 g/kg

Folpet: not more than 10 g/kg

Carbon tetrachloride not more than 0,1 g/Kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

— the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

— the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;

— the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval.

146

Folpet

CAS No 133-07-3

CIPAC No 75

N-(trichloromethylthio) phthalimide

≥ 940 g/kg

Impurities:

Perchloromethylmercaptan (R005406): not more than 3,5 g/kg

Carbon tetrachloride not more than 4 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

— the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

— the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval.

147

Formetanate

CAS No 23422-53-9

CIPAC No 697

3-dimethylaminomethyleneaminophenyl methylcarbamate

≥ 910 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

— must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval.

148

Methiocarb

CAS No 2032-65-7

CIPAC No 165

4-methylthio-3,5-xylyl methylcarbamate

≥ 980 g/kg

1 October 2007

►M139  31. July 2018 ◄

►M107

 

PART A

Only uses as repellent in seed treatment and insecticide may be authorised.

PART B

In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

— the protection of birds, mammals and non-target arthropods, ensuring that the conditions of authorisation include risk mitigation measures, where appropriate;

— the operator and bystander safety, ensuring that the conditions of use prescribe the application of adequate personal protective equipment;

— the dietary exposure of consumers.

 ◄

149

Dimethoate

CAS No 60-51-5

CIPAC No 59

O,O-Dimethyl-S-(N-methylcarbamoylmethyl) phosphorodithioate; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide

≥ 950 g/kg

Impurities:

— omethoate: not more than 2 g/kg

— isodimethoate: not more than 3 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethoate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds, mammals, aquatic organisms and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water;

— must pay particular attention to the dietary exposure of consumers;

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops.

They shall ensure that the notifier at whose request dimethoate has been included in this Annex provides such studies to the Commission within two years from the approval.

150

Dimethomorph

CAS No 110488-70-5

CIPAC No 483

(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine

≥ 965 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

— to the protection of birds, mammals and aquatic organisms.

Conditions of authorisation should include risk mitigation measures, where appropriate.

151

Glufosinate

CAS No 77182-82-2

CIPAC No 437.007

ammonium(DL)-homoalanin-4-yl(methyl)phosphinate

950  g/kg

1 October 2007

►M139  31. July 2018 ◄

►M57  
PART A
Only uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year.
PART B
In assessing applications to authorise plant protection products containing glufosinate, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006, shall be taken into account. In this overall assessment Member States shall pay particular attention to:
(a)  the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate;
(b)  the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions;
(c)  the protection of mammals, non-target arthropods and non-target plants.
Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.  ◄

152

Metribuzin

CAS No 21087-64-9

CIPAC No 283

4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one

≥ 910 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval.

153

Phosmet

CAS No 732-11-6

CIPAC No 318

O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide

≥ 950 g/kg

Impurities:

— phosmet oxon: not more than 0,8 g/kg

— iso phosmet: not more than 0,4 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water,

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval.

154

Propamocarb

CAS No 24579-73-5

CIPAC No 399

Propyl 3-(dimethylamino) propylcarbamate

≥ 920 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate;

— the transfer of soil residues for rotating or succeeding crops;

— the protection of surface and groundwater in vulnerable zones;

— the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

155

ethoprophos

CAS No 13194-48-4

CIPAC No 218

O-ethyl S,S-dipropyl phosphorodithioate

> 940 g/kg

1 October 2007

►M139  31. July 2018 ◄

►M93  
PART A
Only uses as nematicide and insecticide in soil application may be authorised. Only one application per season may be authorised, at a rate not exceeding 6 kg active substance/ha.
Authorisations shall be limited to professional users.
PART B
In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in Article 29(1) of Regulation (EC) No 1107/2009 and shall ensure that any necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a)  the dietary exposure of consumers;
(b)  the operator safety, ensuring that the conditions of use prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of a closed transfer system for the distribution of the product;
(c)  the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions.
Conditions of authorisation shall include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil.  ◄

156

Pirimiphos-methyl

CAS No 29232-93-7

CIPAC No 239

O-2-diethylamino-6-methylpyrimidin-4-yl

O,O-dimethylphosphorothioate

> 880 g/kg

1 October 2007

►M139  31. July 2018 ◄

PART A

Only uses as insecticide for post harvest storage can be authorised.

Hand-held applications shall not be authorised.

PART B

In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure;

— the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

157

Fipronil

CAS No 120068-37-3

CIPAC No 581

(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile

≥ 950 g/kg

1 October 2007

►M197  30 September 2017 ◄

►M73  
PART A
Only uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a)  the packaging of the marketed products to avoid the generation of photodegradation products of concern;
(b)  the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;
(c)  the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.
Member States shall also ensure that:
(a)  the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised;
(b)  adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission;
(c)  the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation;
(d)  monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.
Conditions of use shall include risk mitigation measures, where appropriate.
The notifier shall submit confirmatory information as regards:
(a)  the risk to pollinators other than honey bees;
(b)  the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites;
(c)  the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift;
(d)  the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew;
(e)  the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development, and the risk to bee brood;
(f)  the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950).
The notifier shall submit that information to the Commission, the Member States and the Authority by 30 March 2015.  ◄

158

Beflubutamid

CAS No 113614-08-7

CIPAC No 662

(RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide

≥ 970 g/kg

1 December 2007

►M139  31. July 2018 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

159

Spodoptera exigua nuclear polyhedrosis virus

CIPAC No

Not allocated

Not applicable

 

1 December 2007

30 November 2017

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.

160

Prosulfocarb

CAS No 52888-80-9

CIPAC No 539

S-benzyl dipropyl(thiocarbamat)

970  g/kg

1 November 2008

31 October 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone,

— the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone.

161

Fludioxonil

CAS No 131341-86-1

CIPAC No 522

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

950  g/kg

1 November 2008

31 October 2018

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and:

— must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones,

— must pay particular attention to the protection of fish and aquatic invertebrates.

Conditions of authorisation should include risk mitigation measures, where appropriate.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

162

Clomazone

CAS No 81777-89-1

CIPAC No 509

2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one

960  g/kg

1 November 2008

31 October 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones.

163

Benthiavalicarb

CAS No 413615-35-7

CIPAC No 744

[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid

≥ 910 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg

bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety,

— the protection of non-target arthropods.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

164

Boscalid

CAS No 188425-85-6

CIPAC No 673

2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide

≥ 960 g/kg

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention

— to the operator safety,

— to the long term risk to birds and soil organisms,

— to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

165

Carvone

CAS No 99-49-0 (d/l mixture)

CIPAC No 602

5-isopropenyl-2-methylcyclohex-2-en-1-one

≥ 930 g/kg with a d/l ratio of at least 100:1

1 August 2008

31 July 2018

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carvone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to the operator safety.

Conditions of use shall include risk mitigation measures, where appropriate.

166

Fluoxastrobin

CAS No 361377-29-9

CIPAC No 746

(E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime

≥ 940 g/kg

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield,

— the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

— the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate,

— the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

— data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures,

— data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff.

They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

167

Paecilomyces lilacinus (Thom)

Samson 1974 strain 251 (AGAL: No 89/030550)

CIPAC No 753

Not applicable

 

1 August 2008

31 July 2018

PART A

Only uses as nematicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers),

— the protection of leaf dwelling non-target arthropods.

Conditions of use shall include risk mitigation measures, where appropriate.

168

Prothioconazole

CAS No 178928-70-6

CIPAC No 745

(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione

≥ 970 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

— Toluene: < 5 g/kg

— Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety in spray applications. Conditions of use shall include adequate protective measures,

— the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

— the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

— information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin,

— a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds,

— information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment.

They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval.

169

Amidosulfuron

CAS No 120923-37-7

CIPAC No 515

3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea

or

1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea

≥ 970 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of aquatic plants.

In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

170

Nicosulfuron

CAS No 111991-09-4

CIPAC No 709

2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide

or

1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea

≥ 910 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions,

— the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones,

— the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone,

— the protection of groundwater and surface water under vulnerable soil and climatic conditions.

171

Clofentezine

CAS No 74115-24-5

CIPAC No 418

3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine

≥ 980 g/kg (dry material)

1 January 2009

31 December 2018

PART A

Only uses as acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;

— the potential for long range transport via air;

— the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013.

The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012.

▼M23

172

Dicamba

CAS No 1918-00-9

CIPAC No 85

3,6-dichloro-2-methoxybenzoic acid

≥ 850 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of non-target plants.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  the identification and quantification of a group of soil transformation products formed in a soil incubation study;

(b)  the potential for long range transport through the atmosphere.

The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013.

173

Difenoconazole

CAS No 119446-68-3

CIPAC No 687

3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether

≥ 940g/kg

Toluene maximum content: 5 g/kg

1 January 2009

31 December 2018

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  further data on the specification of the technical material;

(b)  residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin;

(c)  the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (16);

(d)  the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.

The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance.

▼B

174

Diflubenzuron

CAS No 35367-38-5

CIPAC No 339

1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea

≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline

1 January 2009

31 December 2018

PART A

►M224  Only uses as insecticide in non-edible crops may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the protection of aquatic organisms, terrestrial organisms and non-target arthropods including bees;

— the potential unintended exposure of food and feed crops to diflubenzuron from uses on non-edible crops (e.g. through spray drift);

— the protection of workers, residents and bystanders.

Member States shall ensure that crops treated with diflubenzuron do not enter the food and feed chain.

Conditions of use shall include adequate risk mitigation measures, where appropriate. ◄

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as finalised inthe Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the protection of aquatic organisms;

— the protection of terrestrial organisms;

— the protection of non-target arthropods including bees.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further studies to address the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.

▼M23

175

Imazaquin

CAS No 81335-37-7

CIPAC No 699

2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid

≥ 960 g/kg (racemic mixture)

1 January 2009

31 December 2018

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account

The notifier shall submit confirmatory information as regards:

(a)  further data on the specification of the technical material;

(b)  the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.

The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012 and the information set out in point (b) within 2 years from the adoption of specific guidance.

▼B

176

Lenacil

CAS No 2164-08-1

CIPAC No 163

3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione

≥ 975 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies;

— the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.

177

Oxadiazon

CAS No 19666-30-9

CIPAC No 213

5-tert-butyl-3-(2,4-dichloro-5-isopropoxyphenyl)-1,3,4-oxadiazol-2(3H)-one

≥ 940 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the potential for ground water contamination by the metabolite AE0608022 where the active substance is applied in situations for which prolonged anaerobic conditions may be expected to occur or in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission:

— further studies to address the potential toxicological relevance of an impurity in the proposed technical specification;

— information to further clarify the occurrence of metabolite AE0608033 in primary crops and rotational crops;

— further trials on rotational crops (namely root crops and cereals) and a metabolism study on ruminants to confirm the consumer risk assessment;

— information to further address the risk to earthworm-eating birds and mammals, and the long-term risk to fish.

They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

178

Picloram

CAS No 1918-02-1

CIPAC No 174

4-amino-3,5,6-trichloropyridine-2-carboxylic acid

≥ 920 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In the overall assessment Member States must pay particular attention to:

— the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate;

The Member States concerned shall ensure that the notifier submits to the Commission:

— further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates;

— a soil photolysis study to confirm the evaluation of picloram degradation.

They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

179

Pyriproxyfen

CAS No 95737-68-1

CIPAC No 715

4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether

≥ 970 g/kg

1 January 2009

31 December 2018

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyriproxyfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In the overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;

— the risk to aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information confirming the risk assessment in respect of two points, namely the risk posed to aquatic insects by pyriproxfen and the metabolite DPH-pyr and the risk posed by pyriproxfen to pollinators. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

180

Bifenox

CAS No 42576-02-3

CIPAC No 413

Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate

≥ 970 g/kg impurities:

max. 3 g/kg 2,4-dichlorophenol

max. 6 g/kg 2,4-dichloroanisole

1 January 2009

31 December 2018

►M85  
PART A
Only uses as herbicide may be authorised.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a)  the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;
(b)  the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops;
(c)  the environmental conditions leading to the potential formation of nitrofen.
Member States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c).  ◄

181

Diflufenican

CAS No 83164-33-4

CIPAC No 462

2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide

≥ 970 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

— the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate.

182

Fenoxaprop-P

CAS No 113158-40-0

CIPAC No 484

(R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid

≥ 920 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of non target plants,

— the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure,

— the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur.

Conditions of authorisation should include risk mitigation measures, where appropriate.

183

Fenpropidin

CAS No 67306-00-7

CIPAC No 520

(R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine

≥ 960 g/kg (racemate)

1 January 2009

31 December 2018

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone.

The Member States concerned shall request the submission of:

— information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

184

Quinoclamine

CAS No 2797-51-5

CIPAC No 648

2-amino-3-chloro-1,4-naphthoquinone

≥ 965 g/kg impurity:

dichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms,

— the protection of birds and small mammals.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

185

Chloridazon

CAS No 1698-60-8

CIPAC No 111

5-amino-4-chloro-2-phenylpyridazin-3(2H)-one

920 g/kg

The manufacturing impurity 4-amino-5-chloro-isomer is considered to be of toxicological concern and a maximum level of 60 g/kg is established.

1 January 2009

31 December 2018

PART A

Only uses as herbicide in application max. of 2,6 kg/ha only every third year on the same field may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chloridazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 December 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination from metabolites B and B1 in vulnerable zones, where appropriate.

186

Tritosulfuron

CAS No 142469-14-5

CIPAC No 735

1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea

≥ 960 g/kg

The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material:

2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg

1 December 2008

30 November 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of aquatic organisms,

— the protection of small mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

187

Flutolanil

CAS No 66332-96-5

CIPAC No 524

α,α,α-trifluoro-3′-isopropoxy-o-toluanilide

≥ 975 g/kg

1 March 2009

28 February 2019

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation should include risk mitigation measures, where appropriate.

188

Benfluralin

CAS No 1861-40-1

CIPAC No 285

N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine

≥ 960 g/kg

Impurities:

— ethyl-butyl-nitrosamine: max. 0,1 mg/kg

1 March 2009

28 February 2019

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report onbenfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of the operators’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

— the protection of birds, mammals, surface waters and aquatic organisms. In relauion to these identified risks, sisk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the approval.

189

Fluazinam

CAS No 79622-59-6

CIPAC No 521

3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine

≥ 960 g/kg

Impurities:

5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine

— not more than 2 g/kg

1 March 2009

28 February 2019

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of the operators’ and workers’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

— the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the approval.

190

Fuberidazole

CAS No 3878-19-1

CIPAC No 525

2-(2′-furyl)benzimidazole

≥ 970 g/kg

1 March 2009

28 February 2019

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

191

Mepiquat

CAS No 15302-91-7

CIPAC No 440

1,1-dimethylpiperidinium chloride (mepiquat chloride)

≥ 990 g/kg

1 March 2009

28 February 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.

192

Diuron

CAS No 330-54-1

CIPAC No 100

3-(3,4-dichlorophenyl)-1,1-dimethylurea

≥ 930 g/kg

1 October 2008

30 September 2018

PART A

Only uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety; conditions of use shall prescribe the use of personal protective equipment, if appropriate,

— the protection of aquatic organisms and non-target plants.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

193

Bacillus thuringiensis subsp. aizawai

STRAIN: ABTS-1857

Culture collection: No SD-1372,

STRAIN: GC-91

Culture collection: No NCTC 11821

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp.Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

194

Bacillus thuringiensis subsp. israeliensis (serotype H-14)

STRAIN: AM65-52

Culture collection: No ATCC-1276

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52(SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

195

Bacillus thuringiensis subsp. kurstaki

STRAIN: ABTS 351

Culture collection: No ATCC SD-1275

STRAIN: PB 54

Culture collection: No CECT 7209

STRAIN: SA 11

Culture collection: No NRRL B-30790

STRAIN: SA 12

Culture collection: No NRRL B-30791

STRAIN: EG 2348

Culture collection: No NRRL B-18208

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

196

Bacillus thuringiensis subsp. Tenebrionis

STRAIN: NB 176 (TM 141)

Culture collection: No SD-5428

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

197

Beauveria bassiana

STRAIN: ATCC 74040

Culture collection: No ATCC 74040

STRAIN: GHA

Culture collection: No ATCC 74250

Not applicable

Max level of beauvericin: 5 mg/kg

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

198

Cydia pomonella Granulovirus (CpGV)

Not applicable

►M122  Minimum concentration: 1 × 1013 OB/l (occlusion bodies/l) and Contaminating microorganisms (Bacillus cereus) in the formulated product < 1 × 107 CFU/g ◄

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

199

Lecanicillium muscarium

(formerly Verticilium lecanii)

STRAIN: Ve 6

Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

200

Metarhizium anisopliae var. anisopliae

(formerly Metarhizium anisopliae)

STRAIN: BIPESCO 5/F52

Culture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

201

Phlebiopsis gigantea

STRAIN: VRA 1835

Culture collection: No ATCC 90304

STRAIN: VRA 1984

Culture collection: No DSM16201

STRAIN: VRA 1985

Culture collection: No DSM 16202

STRAIN: VRA 1986

Culture collection: No DSM 16203

STRAIN: FOC PG B20/5

Culture collection: No IMI 390096

STRAIN: FOC PG SP log 6

Culture collection: No IMI 390097

STRAIN: FOC PG SP log 5

Culture collection: No IMI 390098

STRAIN: FOC PG BU 3

Culture collection: No IMI 390099

STRAIN: FOC PG BU 4

Culture collection: No IMI 390100

STRAIN: FOC PG 410.3

Culture collection: No IMI 390101

STRAIN: FOC PG97/1062/116/1.1

Culture collection: No IMI 390102

STRAIN: FOC PG B22/SP1287/3.1

Culture collection: No IMI 390103

STRAIN: FOC PG SH 1

Culture collection: No IMI 390104

STRAIN: FOC PG B22/SP1190/3.2

Culture collection: No IMI 390105

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

202

Pythium oligandrum

STRAINS: M1

Culture collection No ATCC 38472

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

203

Streptomyces K61 (formerly S. griseoviridis)

STRAIN: K61

Culture collection: No DSM 7206

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

204

Trichoderma atroviride

(formerly T. harzianum)

STRAIN: IMI 206040

Culture collection No IMI 206040, ATCC 20476;

STRAIN: T11

Culture collection: No

Spanish type culture collection CECT 20498, identical with IMI 352941

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

205

Trichoderma polysporum

STRAIN: Trichoderma polysporum IMI 206039

Culture collection No IMI 206039, ATCC 20475

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

206

Trichoderma harzianum Rifai

STRAIN:

Trichoderma harzianum T-22;

Culture collection No ATCC 20847

STRAIN: Trichoderma harzianum ITEM 908;

Culture collection No CBS 118749

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

207

Trichoderma asperellum

(formerly T. harzianum)

STRAIN: ICC012

Culture collection No CABI CC IMI 392716

STRAIN: Trichoderma asperellum

(formerly T. viride T25) T25

Culture collection No CECT 20178

STRAIN: Trichoderma asperellum

(formerly T. viride TV1) TV1

Culture collection No MUCL 43093

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

208

Trichoderma gamsii (formerly T. viride)

STRAINS:

ICC080

Culture collection No IMI CC number 392151 CABI

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

209

Verticillium albo-atrum

(formerly Verticillium dahliae)

STRAIN: Verticillium albo-atrum isolate WCS850

Culture collection No CBS 276.92

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Verticillium albo-atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

210

Abamectin

CAS No 71751-41-2

avermectin B1a

CAS No 65195-55-3

Avermectin B1b

CAS No 65195-56-4

abamectin

CIPAC No 495

AvermectinB1a

(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

AvermectinB1b

(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

≥ 850 g/kg

1 May 2009

30 April 2019

►M212

 

PART A

Only uses as insecticide, acaricide and nematicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information are provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 and of the addendum to the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed dated 24 January 2017 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the residues in food of plant origin and evaluate the dietary exposure of consumers,

— the protection of bees, non-target arthropods, soil organisms, birds, mammals and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones and waiting periods, should be applied where appropriate.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water by two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

 ◄

211

Epoxiconazole

CAS No 135319-73-2 (formerly 106325-08-0)

CIPAC No 609

(2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole

≥ 920 g/kg

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

— the dietary exposure of consumers to the epoxiconazole (triazole) metabolites,

— the potential for long-range transport via air,

— the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

The Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest.

The concerned Member States shall ensure that the notifier submits within two years from the approval, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals.

212

Fenpropimorph

CAS No 67564-91-4

CIPAC No 427

(RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

≥ 930 g/kg

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles.

The Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the approval.

213

Fenpyroximate

CAS No 134098-61-6

CIPAC No 695

tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate

> 960 g/kg

1 May 2009

30 April 2019

PART A

Only uses as acaricide may be authorised.

The following uses must not be authorised:

— applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall request the submission of information to further address:

— the risk to aquatic organisms from metabolites containing the benzyl moiety,

— the risk of biomagnification in aquatic food chains.

They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the approval.

214

Tralkoxydim

CAS No 87820-88-0

CIPAC No 544

(RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one

≥ 960 g/kg

1 May 2009

30 April 2019

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of herbivorous mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of:

— information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim.

They shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the approval.

215

Aclonifen

CAS No 74070-46-5

CIPAC No 498

2-chloro-6-nitro-3-phenoxyaniline

≥ 970 g/kg

The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.

1 August 2009

►M199  31 July 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

— the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the residues in rotational crops and evaluate the dietary exposure of consumers,

— the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

216

Imidacloprid

CAS No 138261-41-3

CIPAC No 582

(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine

≥ 970 g/kg

1 August 2009

►M199  31 July 2022 ◄

►M65

 

PART A

Only professional uses as insecticide may be authorised.

Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:

barley, millet, oats, rice, rye, sorghum, triticale, wheat.

Foliar treatments shall not be authorised for the following cereals:

barley, millet, oats, rice, rye, sorghum, triticale, wheat.

Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatment after flowering:

Alfalfa (Medicago sativa)

almonds (Prunus amygdalus; P. communis; Amygdalus communis)

anise (Pimpinella anisum); badian or star anise (Illicium verum); caraway (Carum carvi); coriander (Coriandrum sativum); cumin (Cuminum cyminum); fennel (Foeniculum vulgare); juniper berries (Juniperus communis)

apples (Malus pumila; M. sylvestris; M. communis; Pyrus malus)

apricots (Prunus armeniaca)

avocados (Persea americana)

bananas (Musa sapientum; M. cavendishii; M. nana)

beans (Phaseolus spp.)

blackberry (Rubus fruticosus)

blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum)

broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor)

buckwheat (Fagopyrum esculentum)

carobs, carob-tree, locust bean (Ceratonia siliqua)

castor oil seed (Ricinus communis)

cherries (Prunus avium)

chestnuts (Castanea spp.)

chick peas (Cicer arietinum)

chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis)

clovers (Trifolium spp.)

coffee (Coffea spp. arabica, robusta, liberica)

cotton (Gossypium spp.)

cowpeas, black eyed peas (Vigna unguiculata)

cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus)

cucumbers (Cucumis sativus)

currants black (Ribes nigrum); red and white (R. rubrum)

dates (Phoenix dactylifera)

elderberries (Sambucus nigra)

gooseberries (Ribes uva-crispa)

grapefruit (C. paradisi)

grapes (Vitis vinifera)

groundnuts/peanuts (Arachis hypogea)

hazelnut (Corylus avellana)

hemp (Cannabis sativa)

japanese rose (Rosa rugosa)

kiwi fruit (Actinidia chinensis)

leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium)

lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta)

lentils (Lens esculenta; Ervum lens)

linseed (Linum usitatissimum)

lupins (Lupinus spp.)

maize/corn (Zea mays)

melon seeds (Cucumis melo)

mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra)

okra (Abelmoschus esculentus); gombo (Hibiscus esculentus)

olives (Olea europaea)

oranges: sweet orange (Citrus sinensis); bitter orange (C. aurantium)

peaches and nectarines (Prunus persica; Amygdalus persica; Persica laevis)

pears (Pyrus communis)

peas garden pea (Pisum sativum); field pea (P. arvense)

peppermint (Mentha spp.: M. piperita)

persimmons (Diospyros kaki: D. virginiana)

pistachios (Pistacia vera)

plums and sloes greengage, mirabelle, damson (Prunus domestica); sloe (P. spinosa)

poppy seed (Papaver somniferum)

pumpkins, squash, gourds and marrows (Cucurbita spp.)

pyrethrum, (Chrysanthemum cinerariifolium)

quinces (Cydonia oblonga; C. vulgaris; C. japonica)

rapeseed (Brassica napus var. oleifera)

raspberries (Rubus idaeus)

safflower seed (Carthamus tinctorius)

serradella/birds foot (Ornithopus sativus)

sesame seed (Sesamum indicum)

soybeans (Glycine soja)

spices: bay leaves (Laurus nobilis); dill seed (Anethum graveolens); fenugreek seed (Trigonella foenumgraecum); saffron (Crocus sativus); thyme (Thymus vulgaris); turmeric (Curcuma longa)

strawberries (Fragaria spp.)

sunflower seed (Helianthus annuus)

tangerine (Citrus tangerina); mandarin (Citrus reticulata) clementine (C. unshiu);

turnips andturnip rapes (Brassica rapa var. rapifera and oleifera spp.)

vetches Spring/common vetch (Vicia sativa)

viper’s Grass (Scorzonera hispanica)

walnuts (Jugland spp.: J. regia)

watermelons (Citrullus vulgaris)

ornamentals flowering in year of treatment.

PART B

In assessing applications to authorise plant protection products containing imidacloprid, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 and the conclusions of the addendum of the review report on imidacloprid as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Member States shall ensure that:

— the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised,

— adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission,

— the conditions of the authorisation, include, where appropriate, risk mitigation measures to protect bees,

— monitoring programmes are initiated to verify the real exposure of bees to imidacloprid in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  the risk to pollinators other than honey bees;

(b)  the risk to honey bees foraging in nectar or pollen in succeeding crops;

(c)  the potential uptake via roots to flowering weeds;

(d)  the risk to honey bees foraging on insect honey dew;

(e)  the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

(f)  the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

(g)  the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen.

The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014.

 ◄

217

Metazachlor

CAS No 67129-08-2

CIPAC No 411

2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide

≥ 940 g/kg

The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established.

1 August 2009

►M199  31 July 2021 ◄

►M28

 

PART A

Only uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field.

 ◄

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.

If metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.

They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.

▼M74

218

Acetic acid

CAS No 64-19-7

CIPAC 838

acetic acid

≥ 980 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of operators, the protection of groundwater and the protection of aquatic organisms.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards:

— the acute and long-term risk to birds and mammals,

— the risk to honeybees,

— the risk to non-target arthropods.

The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2015.

▼M36

219

Aluminium ammonium sulphate

CAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous)

CIPAC No 840

Aluminium ammonium sulphate

≥ 960 g/kg (expressed as dodecahydrate)

≥ 502 g/kg (anhydrous)

1 September 2009

►M199  31 August 2020 ◄

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards:

(a)  the impact on the environment of the transformation/dissociation products of aluminium ammonium sulphate;

(b)  the risk to non-target terrestrial organisms other than vertebrates and aquatic organisms.

This information shall be submitted to the Member States, the Commission and the Authority by 1 January 2016.

▼M32

220

Aluminium silicate

CAS No 1332-58-7

CIPAC No 841

Not available

Chemical name: Aluminium silicate

≥ 999,8 g/kg

1 September 2009

►M199  31 August 2020 ◄

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium silicate (SANCO/2603/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operator safety; conditions of use shall include the application of adequate personal and respiratory protective equipment, where appropriate.

Conditions of use shall include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

(a)  the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;

(b)  the relevance of the test material used in the toxicity dossier in view of the specification of the technical material.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 1 May 2013.

▼B

221

Ammonium acetate

CAS No 631-61-8

CIPAC No not allocated

Ammonium acetate

≥ 970 g/kg

Relevant impurity: Heavy metals as Pb maximum 10 ppm

1 September 2009