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
Modified by
  • Commission Implementing Regulation (EU) No 541/2011of 1 June 2011amending Implementing Regulation (EU) No 540/2011 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), 32011R0541, June 11, 2011
  • Commission Implementing Regulation (EU) No 542/2011of 1 June 2011amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances to take into account Directive 2011/58/EU amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance(Text with EEA relevance), 32011R0542, June 11, 2011
  • Commission Implementing Regulation (EU) No 702/2011of 20 July 2011approving the active substance prohexadione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0702, July 21, 2011
  • Commission Implementing Regulation (EU) No 703/2011of 20 July 2011approving the active substance azoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0703, July 21, 2011
  • Commission Implementing Regulation (EU) No 704/2011of 20 July 2011approving the active substance azimsulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0704, July 21, 2011
  • Commission Implementing Regulation (EU) No 705/2011of 20 July 2011approving the active substance imazalil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0705, July 21, 2011
  • Commission Implementing Regulation (EU) No 706/2011of 20 July 2011approving the active substance profoxydim, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0706, July 21, 2011
  • Commission Implementing Regulation (EU) No 736/2011of 26 July 2011approving the active substance fluroxypyr, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0736, July 27, 2011
  • Commission Implementing Regulation (EU) No 740/2011of 27 July 2011approving the active substance bispyribac, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0740, July 28, 2011
  • Commission Implementing Regulation (EU) No 786/2011of 5 August 2011approving the active substance 1-naphthylacetamide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/941/EC(Text with EEA relevance), 32011R0786, August 6, 2011
  • Commission Implementing Regulation (EU) No 787/2011of 5 August 2011approving the active substance 1-naphthylacetic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/941/EC(Text with EEA relevance), 32011R0787, August 6, 2011
  • Commission Implementing Regulation (EU) No 788/2011of 5 August 2011approving the active substance fluazifop-P, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC(Text with EEA relevance), 32011R0788, August 6, 2011
  • Commission Implementing Regulation (EU) No 797/2011of 9 August 2011approving the active substance spiroxamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0797, August 10, 2011
  • Commission Implementing Regulation (EU) No 798/2011of 9 August 2011approving the active substance oxyfluorfen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC(Text with EEA relevance), 32011R0798, August 10, 2011
  • Commission Implementing Regulation (EU) No 800/2011of 9 August 2011approving the active substance tefluthrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and amending Commission Decision 2008/934/EC(Text with EEA relevance), 32011R0800, August 10, 2011
  • Commission Implementing Regulation (EU) No 806/2011of 10 August 2011approving the active substance fluquinconazole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC(Text with EEA relevance), 32011R0806, August 11, 2011
  • Commission Implementing Regulation (EU) No 807/2011of 10 August 2011approving the active substance triazoxide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0807, August 11, 2011
  • Commission Implementing Regulation (EU) No 810/2011of 11 August 2011approving the active substance kresoxim-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0810, August 12, 2011
  • Commission Implementing Regulation (EU) No 820/2011of 16 August 2011approving the active substance terbuthylazine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC(Text with EEA relevance), 32011R0820, August 17, 2011
  • Commission Implementing Regulation (EU) No 974/2011of 29 September 2011approving the active substance acrinathrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC(Text with EEA relevance), 32011R0974, October 1, 2011
  • Commission Implementing Regulation (EU) No 993/2011of 6 October 2011approving the active substance 8-hydroxyquinoline, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R0993, October 7, 2011
  • Commission Implementing Regulation (EU) No 1022/2011of 14 October 2011concerning the non-renewal of the approval of the active substance cyclanilide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R1022, October 15, 2011
  • Commission Implementing Regulation (EU) No 1100/2011of 31 October 2011amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances dicamba, difenoconazole, and imazaquin(Text with EEA relevance), 32011R1100, November 1, 2011
  • Commission Implementing Regulation (EU) No 1134/2011of 9 November 2011concerning the non-renewal of the approval of the active substance cinidon-ethyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32011R1134, November 10, 2011
  • Commission Implementing Regulation (EU) No 1143/2011of 10 November 2011approving the active substance prochloraz, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC(Text with EEA relevance), 32011R1143, November 11, 2011
  • Commission Implementing Regulation (EU) No 1278/2011of 8 December 2011approving the active substance bitertanol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC(Text with EEA relevance), 32011R1278, December 9, 2011
  • Commission Implementing Regulation (EU) No 87/2012of 1 February 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clethodim(Text with EEA relevance), 32012R0087, February 2, 2012
  • Commission Implementing Regulation (EU) No 127/2012of 14 February 2012amending Implementing Regulation (EU) No 540/2011 as regards an extension of the use of the active substance metazachlor(Text with EEA relevance), 32012R0127, February 15, 2012
  • Commission Implementing Regulation (EU) No 287/2012of 30 March 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triflusulfuron(Text with EEA relevance), 32012R0287, March 31, 2012
  • Commission Implementing Regulation (EU) No 359/2012of 25 April 2012approving the active substance metam, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R0359, April 26, 2012
  • Commission Implementing Regulation (EU) No 369/2012of 27 April 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand(Text with EEA relevance), 32012R0369, April 28, 2012
  • Commission Implementing Regulation (EU) No 571/2012of 28 June 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine)(Text with EEA relevance), 32012R0571, June 29, 2012
  • Commission Implementing Regulation (EU) No 582/2012of 2 July 2012approving the active substance bifenthrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R0582, July 3, 2012
  • Commission Implementing Regulation (EU) No 589/2012of 4 July 2012approving the active substance fluxapyroxad, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R0589, July 5, 2012
  • Commission Implementing Regulation (EU) No 595/2012of 5 July 2012approving the active substance fenpyrazamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R0595, July 6, 2012
  • Commission Implementing Regulation (EU) No 597/2012of 5 July 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea(Text with EEA relevance), 32012R0597, July 6, 2012
  • Commission Implementing Regulation (EU) No 608/2012of 6 July 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil(Text with EEA relevance), 32012R0608, July 7, 2012
  • Commission Implementing Regulation (EU) No 637/2012of 13 July 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch(Text with EEA relevance), 32012R0637, July 14, 2012
  • Commission Implementing Regulation (EU) No 735/2012of 14 August 2012amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance potassium hydrogen carbonate(Text with EEA relevance), 32012R0735, August 15, 2012
  • Commission Implementing Regulation (EU) No 746/2012of 16 August 2012approving the active substance Adoxophyes orana granulovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R0746, August 17, 2012
  • Commission Implementing Regulation (EU) No 1037/2012of 7 November 2012approving the active substance isopyrazam, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R1037, November 8, 2012
  • Commission Implementing Regulation (EU) No 1043/2012of 8 November 2012approving the active substance phosphane, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R1043, November 9, 2012
  • Commission Implementing Regulation (EU) No 1197/2012of 13 December 2012amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram(Text with EEA relevance), 32012R1197, December 14, 2012
  • Commission Implementing Regulation (EU) No 1237/2012of 19 December 2012approving the active substance Zucchini Yellow Mosaic Virus — weak strain, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R1237, December 20, 2012
  • Commission Implementing Regulation (EU) No 1238/2012of 19 December 2012approving the active substance Trichoderma asperellum (strain T34), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32012R1238, December 20, 2012
  • Commission Implementing Regulation (EU) No 17/2013of 14 January 2013approving the active substance Trichoderma atroviride strain I-1237, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0017, January 15, 2013
  • Commission Implementing Regulation (EU) No 22/2013of 15 January 2013approving the active substance cyflumetofen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0022, January 16, 2013
  • Commission Implementing Regulation (EU) No 175/2013of 27 February 2013amending Implementing Regulation (EU) No 540/2011 as regards the withdrawal of the approval of the active substance didecyldimethylammonium chloride(Text with EEA relevance), 32013R0175, February 28, 2013
  • Commission Implementing Regulation (EU) No 187/2013of 5 March 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance ethylene(Text with EEA relevance), 32013R0187, March 6, 2013
  • Commission Implementing Regulation (EU) No 188/2013of 5 March 2013approving the active substance mandipropamid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0188, March 6, 2013
  • Commission Implementing Regulation (EU) No 190/2013of 5 March 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sodium hypochlorite(Text with EEA relevance), 32013R0190, March 6, 2013
  • Commission Implementing Regulation (EU) No 200/2013of 8 March 2013approving the active substance ametoctradin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance)Corrigendum to Commission Implementing Regulation (EU) No 200/2013 of 8 March 2013 approving the active substance ametoctradin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Official Journal of the European Union L 67 of 9 March 2013), 32013R020032013R0200R(01), March 9, 2013
  • Commission Implementing Regulation (EU) No 201/2013of 8 March 2013amending Implementing Regulations (EU) No 788/2011 and (EU) No 540/2011 as regards an extension of the uses for which the active substance fluazifop-P is approved(Text with EEA relevance), 32013R0201, March 9, 2013
  • Commission Implementing Regulation (EU) No 350/2013of 17 April 2013approving the active substance bixafen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0350, April 18, 2013
  • Commission Implementing Regulation (EU) No 355/2013of 18 April 2013approving the active substance maltodextrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0355, April 19, 2013
  • Commission Implementing Regulation (EU) No 356/2013of 18 April 2013approving the active substance halosulfuron-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0356, April 19, 2013
  • Commission Implementing Regulation (EU) No 365/2013of 22 April 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glufosinate(Text with EEA relevance), 32013R0365, April 23, 2013
  • Commission Implementing Regulation (EU) No 366/2013of 22 April 2013approving the active substance Bacillus firmus I-1582, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0366, April 23, 2013
  • Commission Implementing Regulation (EU) No 367/2013of 22 April 2013approving the active substance Spodoptera littoralis nucleopolyhedrovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0367, April 23, 2013
  • Commission Implementing Regulation (EU) No 368/2013of 22 April 2013approving the active substance Helicoverpa armigera nucleopolyhedrovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0368, April 23, 2013
  • Commission Implementing Regulation (EU) No 369/2013of 22 April 2013approving the active substance potassium phosphonates, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0369, April 23, 2013
  • Commission Implementing Regulation (EU) No 373/2013of 23 April 2013approving the active substance Candida oleophila strain O, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0373, April 24, 2013
  • Commission Implementing Regulation (EU) No 375/2013of 23 April 2013approving the active substance spiromesifen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0375, April 24, 2013
  • Commission Implementing Regulation (EU) No 378/2013of 24 April 2013approving the active substance Paecilomyces fumosoroseus strain FE 9901, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0378, April 25, 2013
  • Commission Implementing Regulation (EU) No 485/2013of 24 May 2013amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances(Text with EEA relevance), 32013R0485, May 25, 2013
  • Commission Implementing Regulation (EU) No 532/2013of 10 June 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance carbon dioxide(Text with EEA relevance), 32013R0532, June 11, 2013
  • Commission Implementing Regulation (EU) No 533/2013of 10 June 2013amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methyl-cyclopropene, chlorothalonil, chlorotoluron, cypermethrin, daminozide, forchlorfenuron, indoxacarb, thiophanate-methyl and tribenuron(Text with EEA relevance), 32013R0533, June 11, 2013
  • Commission Implementing Regulation (EU) No 546/2013of 14 June 2013approving the active substance eugenol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0546, June 15, 2013
  • Commission Implementing Regulation (EU) No 568/2013of 18 June 2013approving the active substance thymol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0568, June 19, 2013
  • Commission Implementing Regulation (EU) No 570/2013of 17 June 2013approving the active substance geraniol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0570, June 20, 2013
  • Commission Implementing Regulation (EU) No 762/2013of 7 August 2013amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, MCPA, MCPB and metiram(Text with EEA relevance), 32013R0762, August 8, 2013
  • Commission Implementing Regulation (EU) No 767/2013of 8 August 2013withdrawing the approval of the active substance bitertanol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0767, August 9, 2013
  • Commission Implementing Regulation (EU) No 781/2013of 14 August 2013amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this active substance(Text with EEA relevance), 32013R0781, August 15, 2013
  • Commission Implementing Regulation (EU) No 790/2013of 19 August 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance acetic acid(Text with EEA relevance), 32013R0790, August 20, 2013
  • Commission Implementing Regulation (EU) No 798/2013of 21 August 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance pyrethrins(Text with EEA relevance), 32013R0798, August 22, 2013
  • Commission Implementing Regulation (EU) No 802/2013of 22 August 2013approving the active substance fluopyram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0802, August 23, 2013
  • Commission Implementing Regulation (EU) No 826/2013of 29 August 2013approving the active substance sedaxane, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0826, August 30, 2013
  • Commission Implementing Regulation (EU) No 827/2013of 29 August 2013approving the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0827, August 30, 2013
  • Commission Implementing Regulation (EU) No 828/2013of 29 August 2013approving the active substance emamectin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0828, August 30, 2013
  • Commission Implementing Regulation (EU) No 829/2013of 29 August 2013approving the active substance Pseudomonas sp. strain DSMZ 13134, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0829, August 30, 2013
  • Commission Implementing Regulation (EU) No 832/2013of 30 August 2013approving the active substance disodium phosphonate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0832, August 31, 2013
  • Commission Implementing Regulation (EU) No 833/2013of 30 August 2013approving the active substance pyriofenone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R0833, August 31, 2013
  • Commission Implementing Regulation (EU) No 1031/2013of 24 October 2013approving the active substance penflufen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1031, October 25, 2013
  • Commission Implementing Regulation (EU) No 1089/2013of 4 November 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance kieselgur (diatomaceous earth)(Text with EEA relevance), 32013R1089, November 5, 2013
  • Commission Implementing Regulation (EU) No 1124/2013of 8 November 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance bifenox(Text with EEA relevance), 32013R1124, November 9, 2013
  • Commission Implementing Regulation (EU) No 1136/2013of 12 November 2013amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clothianidin, dimoxystrobin, oxamyl and pethoxamid(Text with EEA relevance), 32013R1136, November 13, 2013
  • Commission Implementing Regulation (EU) No 1150/2013of 14 November 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance rape seed oil(Text with EEA relevance), 32013R1150, November 15, 2013
  • Commission Implementing Regulation (EU) No 1165/2013of 18 November 2013approving the active substance orange oil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1165, November 19, 2013
  • Commission Implementing Regulation (EU) No 1166/2013of 18 November 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance dichlorprop-P(Text with EEA relevance), 32013R1166, November 19, 2013
  • Commission Implementing Regulation (EU) No 1175/2013of 20 November 2013approving the active substance benalaxyl-M, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1175, November 21, 2013
  • Commission Implementing Regulation (EU) No 1176/2013of 20 November 2013approving the active substance pyroxsulam, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1176, November 21, 2013
  • Commission Implementing Regulation (EU) No 1177/2013of 20 November 2013approving the active substance spirotetramat, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1177, November 21, 2013
  • Commission Implementing Regulation (EU) No 1178/2013of 20 November 2013amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance ethoprophos(Text with EEA relevance), 32013R1178, November 21, 2013
  • Commission Implementing Regulation (EU) No 1187/2013of 21 November 2013approving the active substance penthiopyrad, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1187, November 22, 2013
  • Commission Implementing Regulation (EU) No 1192/2013of 22 November 2013approving the active substance tembotrione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1192, November 23, 2013
  • Commission Implementing Regulation (EU) No 1195/2013of 22 November 2013approving the active substance sodium silver thiosulfate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1195, November 26, 2013
  • Commission Implementing Regulation (EU) No 1199/2013of 25 November 2013approving the active substance chlorantraniliprole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32013R1199, November 26, 2013
  • Commission Implementing Regulation (EU) No 85/2014of 30 January 2014amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance copper compounds(Text with EEA relevance), 32014R0085, January 31, 2014
  • Commission Implementing Regulation (EU) No 140/2014of 13 February 2014approving the active substance spinetoram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance)Corrigendum to Commission Implementing Regulation (EU) No 140/2014 of 13 February 2014 approving the active substance spinetoram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Official Journal of the European Union L 44 of 14 February 2014), 32014R014032014R0140R(01), February 14, 2014
  • Commission Implementing Regulation (EU) No 141/2014of 13 February 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/clove oil(Text with EEA relevance), 32014R0141, February 14, 2014
  • Commission Implementing Regulation (EU) No 143/2014of 14 February 2014approving the active substance pyridalyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0143, February 15, 2014
  • Commission Implementing Regulation (EU) No 144/2014of 14 February 2014approving the active substance valifenalate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0144, February 15, 2014
  • Commission Implementing Regulation (EU) No 145/2014of 14 February 2014approving the active substance thiencarbazone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0145, February 15, 2014
  • Commission Implementing Regulation (EU) No 149/2014of 17 February 2014approving the active substance L-ascorbic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0149, February 18, 2014
  • Commission Implementing Regulation (EU) No 151/2014of 18 February 2014approving the active substance S-abscisic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0151, February 19, 2014
  • Commission Implementing Regulation (EU) No 154/2014of 19 February 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance extract from tea tree(Text with EEA relevance), 32014R0154, February 20, 2014
  • Commission Implementing Regulation (EU) No 187/2014of 26 February 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance methiocarb(Text with EEA relevance), 32014R0187, February 27, 2014
  • Commission Implementing Regulation (EU) No 192/2014of 27 February 2014approving the active substance 1,4-dimethylnaphthalene, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0192, February 28, 2014
  • Commission Implementing Regulation (EU) No 193/2014of 27 February 2014approving the active substance amisulbrom, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0193, February 28, 2014
  • Commission Implementing Regulation (EU) No 462/2014of 5 May 2014approving the basic substance Equisetum arvense L., in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0462, May 7, 2014
  • Commission Implementing Regulation (EU) No 485/2014of 12 May 2014approving the active substance Bacillus pumilus QST 2808, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0485, May 13, 2014
  • Commission Implementing Regulation (EU) No 486/2014of 12 May 2014withdrawing the approval of the active substance fenbutatin oxide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0486, May 13, 2014
  • Commission Implementing Regulation (EU) No 487/2014of 12 May 2014amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, metrafenone, pirimicarb, rimsulfuron, spinosad, thiamethoxam, tolclofos-methyl and triticonazole(Text with EEA relevance), 32014R0487, May 13, 2014
  • Commission Implementing Regulation (EU) No 496/2014of 14 May 2014approving the active substance acequinocyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0496, May 15, 2014
  • Commission Implementing Regulation (EU) No 504/2014of 15 May 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/citronella oil(Text with EEA relevance), 32014R0504, May 16, 2014
  • Commission Implementing Regulation (EU) No 563/2014of 23 May 2014approving the basic substance chitosan hydrochloride in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0563, May 24, 2014
  • Commission Implementing Regulation (EU) No 571/2014of 26 May 2014approving the active substance ipconazole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0571, May 27, 2014
  • Commission Implementing Regulation (EU) No 629/2014of 12 June 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance methyl nonyl ketone(Text with EEA relevance), 32014R0629, June 13, 2014
  • Commission Implementing Regulation (EU) No 632/2014of 13 May 2014approving the active substance flubendiamide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0632, June 14, 2014
  • Commission Implementing Regulation (EU) No 678/2014of 19 June 2014amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clopyralid, cyprodinil, fosetyl, pyrimethanil and trinexapac(Text with EEA relevance), 32014R0678, June 20, 2014
  • Commission Implementing Regulation (EU) No 878/2014of 12 August 2014amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances dichlorprop-P, metconazole and triclopyr(Text with EEA relevance), 32014R0878, August 13, 2014
  • Commission Implementing Regulation (EU) No 880/2014of 12 August 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Cydia pomonella Granulovirus (CpGV)(Text with EEA relevance), 32014R0880, August 13, 2014
  • Commission Implementing Regulation (EU) No 890/2014of 14 August 2014approving the active substance metobromuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0890, August 15, 2014
  • Commission Implementing Regulation (EU) No 891/2014of 14 August 2014approving the active substance aminopyralid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0891, August 15, 2014
  • Commission Implementing Regulation (EU) No 916/2014of 22 August 2014approving the basic substance sucrose in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0916, August 23, 2014
  • Commission Implementing Regulation (EU) No 917/2014of 22 August 2014approving the active substance Streptomyces lydicus strain WYEC 108 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0917, August 23, 2014
  • Commission Implementing Regulation (EU) No 918/2014of 22 August 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Straight Chain Lepidopteran Pheromones(Text with EEA relevance), 32014R0918, August 23, 2014
  • Commission Implementing Regulation (EU) No 921/2014of 25 August 2014amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole(Text with EEA relevance), 32014R0921, August 26, 2014
  • Commission Implementing Regulation (EU) No 922/2014of 25 August 2014approving the active substance metaflumizone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R0922, August 26, 2014
  • Commission Implementing Regulation (EU) No 1316/2014of 11 December 2014approving the active substance Bacillus amyloliquefaciens subsp. plantarum strain D747, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that active substance(Text with EEA relevance), 32014R1316, December 12, 2014
  • Commission Implementing Regulation (EU) No 1330/2014of 15 December 2014approving the active substance meptyldinocap, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32014R1330, December 16, 2014
  • Commission Implementing Regulation (EU) No 1334/2014of 16 December 2014approving the active substance gamma-cyhalotrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that active substance(Text with EEA relevance), 32014R1334, December 17, 2014
  • Commission Implementing Regulation (EU) 2015/51of 14 January 2015approving the active substance chromafenozide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that active substance(Text with EEA relevance), 32015R0051, January 15, 2015
  • Commission Implementing Regulation (EU) 2015/58of 15 January 2015amending Implementing Regulation (EU) No 540/2011 as regards the expiry date of the approval of the active substance tepraloxydim(Text with EEA relevance), 32015R0058, January 16, 2015
  • Commission Implementing Regulation (EU) 2015/232of 13 February 2015amending and correcting Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance copper compounds(Text with EEA relevance), 32015R0232, February 14, 2015
  • Commission Implementing Regulation (EU) 2015/306of 26 February 2015renewing the approval of the active substance Isaria fumosorosea strain Apopka 97 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R0306, February 27, 2015
  • Commission Implementing Regulation (EU) 2015/307of 26 February 2015amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triclopyr(Text with EEA relevance), 32015R0307, February 27, 2015
  • Commission Implementing Regulation (EU) 2015/308of 26 February 2015amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate(Text with EEA relevance), 32015R0308, February 27, 2015
  • Commission Implementing Regulation (EU) 2015/404of 11 March 2015amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, captan, dimethoate, dimethomorph, ethoprophos, fipronil, folpet, formetanate, glufosinate, methiocarb, metribuzin, phosmet, pirimiphos-methyl and propamocarb(Text with EEA relevance), 32015R0404, March 12, 2015
  • Commission Implementing Regulation (EU) 2015/415of 12 March 2015amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances ethephon and fenamiphos(Text with EEA relevance), 32015R0415, March 13, 2015
  • Commission Implementing Regulation (EU) 2015/418of 12 March 2015amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Z-13-hexadecen-11-yn-1-yl acetate(Text with EEA relevance), 32015R0418, March 13, 2015
  • Commission Implementing Regulation (EU) 2015/543of 1 April 2015approving the active substance COS-OGA, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R0543, April 2, 2015
  • Commission Implementing Regulation (EU) 2015/553of 7 April 2015approving the active substance cerevisane, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R0553, April 8, 2015
  • Commission Implementing Regulation (EU) 2015/762of 12 May 2015approving the basic substance calcium hydroxide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R0762, May 13, 2015
  • Commission Implementing Regulation (EU) 2015/1106of 8 July 2015amending Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 as regards the conditions of approval of the active substance isopyrazam(Text with EEA relevance), 32015R1106, July 9, 2015
  • Commission Implementing Regulation (EU) 2015/1107of 8 July 2015approving the basic substance Salix spp. cortex, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1107, July 9, 2015
  • Commission Implementing Regulation (EU) 2015/1108of 8 July 2015approving the basic substance vinegar in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1108, July 9, 2015
  • Commission Implementing Regulation (EU) 2015/1115of 9 July 2015renewing the approval of the active substance pyridate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1115, July 10, 2015
  • Commission Implementing Regulation (EU) 2015/1116of 9 July 2015approving the basic substance lecithins, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1116, July 10, 2015
  • Commission Implementing Regulation (EU) 2015/1154of 14 July 2015renewing the approval of the active substance sulfosulfuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1154, July 15, 2015
  • Commission Implementing Regulation (EU) 2015/1165of 15 July 2015approving the active substance halauxifen-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1165, July 16, 2015
  • Commission Implementing Regulation (EU) 2015/1166of 15 July 2015renewing the approval of the active substance ferric phosphate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1166, July 16, 2015
  • Commission Implementing Regulation (EU) 2015/1176of 17 July 2015approving the active substance Pepino mosaic virus strain CH2 isolate 1906, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1176, July 18, 2015
  • Commission Implementing Regulation (EU) 2015/1192of 20 July 2015approving the active substance terpenoid blend QRD 460, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1192, July 21, 2015
  • Commission Implementing Regulation (EU) 2015/1201of 22 July 2015renewing the approval of the active substance fenhexamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1201, July 23, 2015
  • Commission Implementing Regulation (EU) 2015/1295of 27 July 2015approving the active substance sulfoxaflor, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1295, July 29, 2015
  • Commission Implementing Regulation (EU) 2015/1392of 13 August 2015approving the basic substance fructose in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1392, August 14, 2015
  • Commission Implementing Regulation (EU) 2015/1396of 14 August 2015correcting Implementing Regulation (EU) No 540/2011 as regards the active substance Bacillus subtilis (Cohn 1872) strain QST 713, identical with strain AQ 713(Text with EEA relevance), 32015R1396, August 15, 2015
  • Commission Implementing Regulation (EU) 2015/1397of 14 August 2015renewing the approval of the active substance florasulam in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R1397, August 15, 2015
  • Commission Implementing Regulation (EU) 2015/1885of 20 October 2015amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-D, acibenzolar-s-methyl, amitrole, bentazone, cyhalofop butyl, diquat, esfenvalerate, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), glyphosate, iprovalicarb, isoproturon, lambda-cyhalothrin, metalaxyl-M, metsulfuron methyl, picolinafen, prosulfuron, pymetrozine, pyraflufen-ethyl, thiabendazole, thifensulfuron-methyl and triasulfuron(Text with EEA relevance), 32015R1885, October 21, 2015
  • Commission Implementing Regulation (EU) 2015/2033of 13 November 2015renewing the approval of the active substance 2,4-D in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R2033, November 14, 2015
  • Commission Implementing Regulation (EU) 2015/2047of 16 November 2015renewing the approval of the active substance esfenvalerate, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R2047, November 17, 2015
  • Commission Implementing Regulation (EU) 2015/2069of 17 November 2015approving the basic substance sodium hydrogen carbonate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R2069, November 18, 2015
  • Commission Implementing Regulation (EU) 2015/2084of 18 November 2015approving the active substance flupyradifurone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R2084, November 19, 2015
  • Commission Implementing Regulation (EU) 2015/2085of 18 November 2015approving the active substance mandestrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R2085, November 19, 2015
  • Commission Implementing Regulation (EU) 2015/2105of 20 November 2015approving the active substance flumetralin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R2105, November 21, 2015
  • Commission Implementing Regulation (EU) 2015/2198of 27 November 2015approving the active substance rescalure, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32015R2198, November 28, 2015
  • Commission Implementing Regulation (EU) 2015/2233of 2 December 2015amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance haloxyfop-P(Text with EEA relevance), 32015R2233, December 3, 2015
  • Commission Implementing Regulation (EU) 2016/139of 2 February 2016renewing the approval of the active substance metsulfuron-methyl, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0139, February 3, 2016
  • Commission Implementing Regulation (EU) 2016/146of 4 February 2016renewing the approval of the active substance lambda-cyhalothrin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0146, February 5, 2016
  • Commission Implementing Regulation (EU) 2016/147of 4 February 2016renewing the approval of the active substance iprovalicarb in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0147, February 5, 2016
  • Commission Implementing Regulation (EU) 2016/177of 10 February 2016approving the active substance benzovindiflupyr, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0177, February 11, 2016
  • Commission Implementing Regulation (EU) 2016/182of 11 February 2016renewing the approval of the active substance pyraflufen-ethyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0182, February 12, 2016
  • Commission Implementing Regulation (EU) 2016/370of 15 March 2016approving the active substance pinoxaden, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing the Member States to extend provisional authorisations granted for that active substance(Text with EEA relevance), 32016R0370, March 16, 2016
  • Commission Implementing Regulation (EU) 2016/389of 17 March 2016renewing the approval of the active substance acibenzolar-S-methyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0389, March 18, 2016
  • Commission Implementing Regulation (EU) 2016/548of 8 April 2016approving the basic substance diammonium phosphate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0548, April 9, 2016
  • Commission Implementing Regulation (EU) 2016/549of 8 April 2016amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bentazone, cyhalofop butyl, diquat, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), metalaxyl-M, picolinafen, prosulfuron, pymetrozine, thiabendazole and thifensulfuron-methyl(Text with EEA relevance), 32016R0549, April 9, 2016
  • Commission Implementing Regulation (EU) 2016/560of 11 April 2016approving the basic substance whey in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0560, April 12, 2016
  • Commission Implementing Regulation (EU) 2016/636of 22 April 2016withdrawing the approval of the active substance Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0636, April 23, 2016
  • Commission Implementing Regulation (EU) 2016/638of 22 April 2016withdrawing the approval of the active substance Z-13-hexadecen-11-yn-1-yl acetate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0638, April 23, 2016
  • Commission Implementing Regulation (EU) 2016/864of 31 May 2016concerning the non-renewal of approval of the active substance triasulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0864, June 1, 2016
  • Commission Implementing Regulation (EU) 2016/871of 1 June 2016concerning the non-renewal of approval of the active substance amitrole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0871, June 2, 2016
  • Commission Implementing Regulation (EU) 2016/872of 1 June 2016concerning the non-renewal of approval of the active substance isoproturon, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0872, June 2, 2016
  • Commission Implementing Regulation (EU) 2016/950of 15 June 2016amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-P, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin(Text with EEA relevance), 32016R0950, June 16, 2016
  • Commission Implementing Regulation (EU) 2016/951of 15 June 2016approving the low-risk active substance Trichoderma atroviride strain SC1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0951, June 16, 2016
  • Commission Implementing Regulation (EU) 2016/952of 15 June 2016approving the low-risk active substance Saccharomyces cerevisiae strain LAS02 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R0952, June 16, 2016
  • Commission Implementing Regulation (EU) 2016/1056of 29 June 2016amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance glyphosate(Text with EEA relevance), 32016R1056, June 30, 2016
  • Commission Implementing Regulation (EU) 2016/1313of 1 August 2016amending Implementation Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate(Text with EEA relevance), 32016R1313, August 2, 2016
  • Commission Implementing Regulation (EU) 2016/1414of 24 August 2016approving the active substance cyantraniliprole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R1414, August 25, 2016
  • Commission Implementing Regulation (EU) 2016/1423of 25 August 2016renewing approval of the active substance picolinafen in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R1423, August 26, 2016
  • Commission Implementing Regulation (EU) 2016/1424of 25 August 2016renewing the approval of the active substance thifensulfuron-methyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R1424, August 26, 2016
  • Commission Implementing Regulation (EU) 2016/1425of 25 August 2016approving the active substance isofetamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R1425, August 26, 2016
  • Commission Implementing Regulation (EU) 2016/1426of 25 August 2016renewing the approval of the active substance ethofumesate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R1426, August 26, 2016
  • Commission Implementing Regulation (EU) 2016/1429of 26 August 2016approving the active substance Bacillus amyloliquefaciens strain MBI 600, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R1429, August 27, 2016
  • Commission Implementing Regulation (EU) 2016/1978of 11 November 2016approving the basic substance sunflower oil in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32016R1978, November 12, 2016
  • Commission Implementing Regulation (EU) 2016/2016of 17 November 2016amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, benzoic acid, flazasulfuron, mecoprop-P, mepanipyrim, mesosulfuron, propineb, propoxycarbazon, propyzamide, propiconazole, Pseudomonas chlororaphis Strain: MA 342, pyraclostrobin, quinoxyfen, thiacloprid, thiram, ziram, zoxamide(Text with EEA relevance), 32016R2016, November 18, 2016
  • Commission Implementing Regulation (EU) 2016/2035of 21 November 2016amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances fipronil and maneb(Text with EEA relevance), 32016R2035, November 22, 2016
  • Commission Implementing Regulation (EU) 2017/157of 30 January 2017renewing the approval of the active substance thiabendazole in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0157, January 31, 2017
  • Commission Implementing Regulation (EU) 2017/195of 3 February 2017amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of several active substances listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012 (AIR IV renewal programme)(Text with EEA relevance), 32017R0195, February 4, 2017
  • Commission Implementing Regulation (EU) 2017/239of 10 February 2017approving the active substance oxathiapiprolin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0239, February 11, 2017
  • Commission Implementing Regulation (EU) 2017/244of 10 February 2017concerning the non-renewal of approval of the active substance linuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0244, February 11, 2017
  • Commission Implementing Regulation (EU) 2017/270of 16 February 2017amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sulfuryl fluoride(Text with EEA relevance), 32017R0270, February 17, 2017
  • Commission Implementing Regulation (EU) 2017/359of 28 February 2017amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance oxyfluorfen(Text with EEA relevance), 32017R0359, March 1, 2017
  • Commission Implementing Regulation (EU) 2017/360of 28 February 2017amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance buprofezin(Text with EEA relevance), 32017R0360, March 1, 2017
  • Commission Implementing Regulation (EU) 2017/375of 2 March 2017renewing the approval of the active substance prosulfuron, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0375, March 4, 2017
  • Commission Implementing Regulation (EU) 2017/406of 8 March 2017approving the low-risk active substance Mild Pepino Mosaic Virus isolate VX1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0406, March 9, 2017
  • Commission Implementing Regulation (EU) 2017/407of 8 March 2017renewing the approval of the active substance iodosulfuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0407, March 9, 2017
  • Commission Implementing Regulation (EU) 2017/408of 8 March 2017approving the low-risk active substance Mild Pepino Mosaic Virus isolate VC1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0408, March 9, 2017
  • Commission Implementing Regulation (EU) 2017/409of 8 March 2017approving the basic substance hydrogen peroxide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0409, March 9, 2017
  • Commission Implementing Regulation (EU) 2017/419of 9 March 2017approving the basic substance Urtica spp. in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0419, March 10, 2017
  • Commission Implementing Regulation (EU) 2017/428of 10 March 2017approving the basic substance clayed charcoal in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0428, March 11, 2017
  • Commission Implementing Regulation (EU) 2017/438of 13 March 2017amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance abamectin(Text with EEA relevance), 32017R0438, March 14, 2017
  • Commission Implementing Regulation (EU) 2017/555of 24 March 2017amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of several active substances listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012 (AIR IV renewal programme)(Text with EEA relevance), 32017R0555, March 25, 2017
  • Commission Implementing Regulation (EU) 2017/725of 24 April 2017renewing the approval of the active substance mesotrione in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0725, April 25, 2017
  • Commission Implementing Regulation (EU) 2017/753of 28 April 2017renewing the approval of the active substance cyhalofop-butyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0753, April 29, 2017
  • Commission Implementing Regulation (EU) 2017/755of 28 April 2017renewing the approval of the active substance mesosulfuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0755, April 29, 2017
  • Commission Implementing Regulation (EU) 2017/781of 5 May 2017withdrawing the approval of the active substance methyl nonyl ketone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0781, May 6, 2017
  • Commission Implementing Regulation (EU) 2017/805of 11 May 2017renewing the approval of the active substance flazasulfuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0805, May 12, 2017
  • Commission Implementing Regulation (EU) 2017/806of 11 May 2017approving the low-risk active substance Bacillus amyloliquefaciens strain FZB24, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0806, May 12, 2017
  • Commission Implementing Regulation (EU) 2017/831of 16 May 2017approving the active substance Beauveria bassiana strain 147, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0831, May 17, 2017
  • Commission Implementing Regulation (EU) 2017/841of 17 May 2017amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 (flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron, Gliocladium catenulatum strain: j1446, imazamox, imazosulfuron, isoxaflutole, laminarin, metalaxyl-m, methoxyfenozide, milbemectin, oxasulfuron, pendimethalin, phenmedipham, pymetrozine, s-metolachlor, and trifloxystrobin(Text with EEA relevance), 32017R0841, May 18, 2017
  • Commission Implementing Regulation (EU) 2017/842of 17 May 2017renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance)Corrigendum to Commission Implementing Regulation (EU) 2017/842 of 17 May 2017 renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Official Journal of the European Union L 125 of 18 May 2017), 32017R084232017R0842R(01), May 18, 2017
  • Commission Implementing Regulation (EU) 2017/843of 17 May 2017approving the active substance Beauveria bassiana strain NPP111B005, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R0843, May 18, 2017
  • Commission Implementing Regulation (EU) 2017/855of 18 May 2017amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance diflubenzuron(Text with EEA relevance), 32017R0855, May 19, 2017
  • Commission Implementing Regulation (EU) 2017/856of 18 May 2017amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fluroxypyr(Text with EEA relevance), 32017R0856, May 19, 2017
  • Commission Implementing Regulation (EU) 2017/1113of 22 June 2017renewing the approval of the active substance benzoic acid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1113, June 23, 2017
  • Commission Implementing Regulation (EU) 2017/1114of 22 June 2017renewing the approval of the active substance pendimethalin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1114, June 23, 2017
  • Commission Implementing Regulation (EU) 2017/1115of 22 June 2017renewing the approval of the active substance propoxycarbazone in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1115, June 23, 2017
  • Commission Implementing Regulation (EU) 2017/1125of 22 June 2017withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil pitch, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1125, June 24, 2017
  • Commission Implementing Regulation (EU) 2017/1186of 3 July 2017withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil crude, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1186, July 4, 2017
  • Commission Implementing Regulation (EU) 2017/1455of 10 August 2017concerning the non-renewal of approval of the active substance picoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1455, August 11, 2017
  • Commission Implementing Regulation (EU) 2017/1491of 21 August 2017renewing the approval of the active substance 2,4-DB in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1491, August 22, 2017
  • Commission Implementing Regulation (EU) 2017/1496of 23 August 2017concerning the non-renewal of approval of the active substance DPX KE 459 (flupyrsulfuron-methyl), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1496, August 24, 2017
  • Commission Implementing Regulation (EU) 2017/1506of 28 August 2017renewing the approval of the active substance maleic hydrazide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1506, August 29, 2017
  • Commission Implementing Regulation (EU) 2017/1511of 30 August 2017amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, deltamethrin, dimethenamid-p, flufenacet, flurtamone, forchlorfenuron, fosthiazate, indoxacarb, iprodione, MCPA, MCPB, silthiofam, thiophanate-methyl and tribenuron(Text with EEA relevance), 32017R1511, August 31, 2017
  • Commission Implementing Regulation (EU) 2017/1527of 6 September 2017amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances cyflufenamid, fluopicolide, heptamaloxyloglucan and malathion(Text with EEA relevance), 32017R1527, September 7, 2017
  • Commission Implementing Regulation (EU) 2017/1529of 7 September 2017approving the basic substance sodium chloride in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1529, September 8, 2017
  • Commission Implementing Regulation (EU) 2017/1530of 7 September 2017amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance quizalofop-p-tefuryl(Text with EEA relevance), 32017R1530, September 8, 2017
  • Commission Implementing Regulation (EU) 2017/1531of 7 September 2017renewing the approval of the active substance imazamox, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R1531, September 8, 2017
  • Commission Implementing Regulation (EU) 2017/2066of 13 November 2017concerning the approval of mustard seeds powder as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R2066, November 14, 2017
  • Commission Implementing Regulation (EU) 2017/2069of 13 November 2017amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances flonicamid (IKI-220), metalaxyl, penoxsulam and proquinazid(Text with EEA relevance), 32017R2069, November 14, 2017
  • Commission Implementing Regulation (EU) 2017/2090of 14 November 2017concerning the approval of beer as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R2090, November 15, 2017
  • Commission Implementing Regulation (EU) 2017/2091of 14 November 2017concerning the non-renewal of approval of the active substance iprodione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R2091, November 15, 2017
  • Commission Implementing Regulation (EU) 2017/2324of 12 December 2017renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32017R2324, December 15, 2017
  • Commission Implementing Regulation (EU) 2018/84of 19 January 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide(Text with EEA relevance), 32018R0084, January 20, 2018
  • Commission Implementing Regulation (EU) 2018/112of 24 January 2018renewing the approval of the low-risk active substance laminarin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0112, January 25, 2018
  • Commission Implementing Regulation (EU) 2018/113of 24 January 2018renewing the approval of the active substance acetamiprid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0113, January 25, 2018
  • Commission Implementing Regulation (EU) 2018/184of 7 February 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride(Text with EEA relevance), 32018R0184, February 8, 2018
  • Commission Implementing Regulation (EU) 2018/185of 7 February 2018amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen(Text with EEA relevance), 32018R0185, February 8, 2018
  • Commission Implementing Regulation (EU) 2018/291of 26 February 2018amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance bifenthrin(Text with EEA relevance), 32018R0291, February 27, 2018
  • Commission Implementing Regulation (EU) 2018/309of 1 March 2018concerning the non-renewal of approval of the active substance propineb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0309, March 2, 2018
  • Commission Implementing Regulation (EU) 2018/524of 28 March 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram(Text with EEA relevance), 32018R0524, April 4, 2018
  • Commission Implementing Regulation (EU) 2018/660of 26 April 2018renewing the approval of the active substance bentazone in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0660, April 30, 2018
  • Commission Implementing Regulation (EU) 2018/670of 30 April 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bromuconazole, buprofezin, haloxyfop-P and napropamide(Text with EEA relevance), 32018R0670, May 3, 2018
  • Commission Implementing Regulation (EU) 2018/679of 3 May 2018renewing the approval of the active substance forchlorfenuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0679, May 4, 2018
  • Commission Implementing Regulation (EU) 2018/690of 7 May 2018amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fenazaquin(Text with EEA relevance), 32018R0690, May 8, 2018
  • Commission Implementing Regulation (EU) 2018/691of 7 May 2018approving the basic substance Talc E553B in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0691, May 8, 2018
  • Commission Implementing Regulation (EU) 2018/692of 7 May 2018renewing the approval of the active substance zoxamide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0692, May 8, 2018
  • Commission Implementing Regulation (EU) 2018/710of 14 May 2018renewing the approval of the active substance silthiofam in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0710, May 15, 2018
  • Commission Implementing Regulation (EU) 2018/755of 23 May 2018renewing the approval of the active substance propyzamide, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R0755, May 24, 2018
  • Commission Implementing Regulation (EU) 2018/783of 29 May 2018amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance imidacloprid(Text with EEA relevance), 32018R0783, May 30, 2018
  • Commission Implementing Regulation (EU) 2018/784of 29 May 2018amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin(Text with EEA relevance), 32018R0784, May 30, 2018
  • Commission Implementing Regulation (EU) 2018/785of 29 May 2018amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance thiamethoxam(Text with EEA relevance), 32018R0785, May 30, 2018
  • Commission Implementing Regulation (EU) 2018/917of 27 June 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor(Text with EEA relevance), 32018R0917, June 28, 2018
  • Commission Implementing Regulation (EU) 2018/1019of 18 July 2018concerning the non-renewal of approval of the active substance oxasulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1019, July 19, 2018
  • Commission Implementing Regulation (EU) 2018/1043of 24 July 2018concerning the non-renewal of approval of the active substance fenamidone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1043, July 25, 2018
  • Commission Implementing Regulation (EU) 2018/1060of 26 July 2018renewing the approval of the active substance trifloxystrobin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1060, July 27, 2018
  • Commission Implementing Regulation (EU) 2018/1061of 26 July 2018renewing the approval of the active substance carfentrazone-ethyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1061, July 27, 2018
  • Commission Implementing Regulation (EU) 2018/1075of 27 July 2018renewing the approval of the active substance Ampelomyces quisqualis strain AQ10, as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1075, July 31, 2018
  • Commission Implementing Regulation (EU) 2018/1260of 20 September 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances pyridaben, quinmerac and zinc phosphide(Text with EEA relevance), 32018R1260, September 21, 2018
  • Commission Implementing Regulation (EU) 2018/1262of 20 September 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron(Text with EEA relevance), 32018R1262, September 21, 2018
  • Commission Implementing Regulation (EU) 2018/1264of 20 September 2018renewing the approval of the active substance pethoxamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1264, September 21, 2018
  • Commission Implementing Regulation (EU) 2018/1265of 20 September 2018approving the active substance fenpicoxamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1265, September 21, 2018
  • Commission Implementing Regulation (EU) 2018/1266of 20 September 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide(Text with EEA relevance), 32018R1266, September 21, 2018
  • Commission Implementing Regulation (EU) 2018/1278of 21 September 2018approving the low-risk active substance Pasteuria nishizawae Pn1 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1278, September 24, 2018
  • Commission Implementing Regulation (EU) 2018/1295of 26 September 2018approving the basic substance Onion oil in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1295, September 27, 2018
  • Commission Implementing Regulation (EU) 2018/1495of 8 October 2018amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance malathion(Text with EEA relevance), 32018R1495, October 9, 2018
  • Commission Implementing Regulation (EU) 2018/1500of 9 October 2018concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1500, October 10, 2018
  • Commission Implementing Regulation (EU) 2018/1501of 9 October 2018concerning the non-renewal of approval of the active substance pymetrozine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1501, October 10, 2018
  • Commission Implementing Regulation (EU) 2018/1532of 12 October 2018concerning the non-renewal of approval of the active substance diquat, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1532, October 15, 2018
  • Commission Implementing Regulation (EU) 2018/1796of 20 November 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron(Text with EEA relevance), 32018R1796, November 21, 2018
  • Commission Implementing Regulation (EU) 2018/1865of 28 November 2018concerning the non-renewal of approval of the active substance propiconazole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1865, November 29, 2018
  • Commission Implementing Regulation (EU) 2018/1913of 6 December 2018renewing the approval of the active substance tribenuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1913, December 7, 2018
  • Commission Implementing Regulation (EU) 2018/1914of 6 December 2018concerning the non-renewal of approval of the active substance quinoxyfen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1914, December 7, 2018
  • Commission Implementing Regulation (EU) 2018/1915of 6 December 2018approving the active substance Metschnikowia fructicola strain NRRL Y-27328 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1915, December 7, 2018
  • Commission Implementing Regulation (EU) 2018/1916of 6 December 2018amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance bispyribac(Text with EEA relevance), 32018R1916, December 7, 2018
  • Commission Implementing Regulation (EU) 2018/1917of 6 December 2018concerning the non-renewal of approval of the active substance flurtamone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1917, December 7, 2018
  • Commission Implementing Regulation (EU) 2018/1981of 13 December 2018renewing the approval of the active substances copper compounds, as candidates for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32018R1981, December 14, 2018
  • Commission Implementing Regulation (EU) 2019/139of 29 January 2019approving the active substance Beauveria bassiana strain IMI389521, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0139, January 30, 2019
  • Commission Implementing Regulation (EU) 2019/147of 30 January 2019approving the active substance Beauveria bassiana strain PPRI 5339, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0147, January 31, 2019
  • Commission Implementing Regulation (EU) 2019/149of 30 January 2019amending Implementing Regulations (EU) 2015/1108 and (EU) No 540/2011 as regards the conditions of use of vinegar as a basic substance(Text with EEA relevance), 32019R0149, January 31, 2019
  • Commission Implementing Regulation (EU) 2019/151of 30 January 2019renewing the approval of the active substance Clonostachys rosea strain J1446 as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0151, January 31, 2019
  • Commission Implementing Regulation (EU) 2019/158of 31 January 2019renewing the approval of the active substance methoxyfenozide, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0158, February 1, 2019
  • Commission Implementing Regulation (EU) 2019/168of 31 January 2019amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram(Text with EEA relevance), 32019R0168, February 5, 2019
  • Commission Implementing Regulation (EU) 2019/291of 19 February 2019amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-naphthylacetamide, 1-naphthylacetic acid, acrinathrin, azoxystrobin, fluazifop p, fluroxypyr, imazalil, kresoxim-methyl, oxyfluorfen, prochloraz, prohexadione, spiroxamine, tefluthrin and terbuthylazine(Text with EEA relevance), 32019R0291, February 20, 2019
  • Commission Implementing Regulation (EU) 2019/324of 25 February 2019amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances bifenthrin, carboxin, FEN 560 (also called fenugreek or fenugreek seed powder), pepper dust extraction residue and sodium aluminium silicate(Text with EEA relevance), 32019R0324, February 26, 2019
  • Commission Implementing Regulation (EU) 2019/337of 27 February 2019approving the active substance mefentrifluconazole in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0337, February 28, 2019
  • Commission Implementing Regulation (EU) 2019/344of 28 February 2019concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0344, March 1, 2019
  • Commission Implementing Regulation (EU) 2019/481of 22 March 2019approving the active substance flutianil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0481, March 25, 2019
  • Commission Implementing Regulation (EU) 2019/676of 29 April 2019approving the low-risk active substance ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0676, April 30, 2019
  • Commission Implementing Regulation (EU) 2019/677of 29 April 2019concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0677, April 30, 2019
  • Commission Implementing Regulation (EU) 2019/706of 7 May 2019renewing the approval of the active substance carvone in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0706, May 8, 2019
  • Commission Implementing Regulation (EU) 2019/707of 7 May 2019amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, s-metolachlor and tebuconazole(Text with EEA relevance), 32019R0707, May 8, 2019
  • Commission Implementing Regulation (EU) 2019/716of 30 April 2019amending Implementing Regulations (EU) No 22/2013 and (EU) No 540/2011 as regards the conditions of approval of the active substance cyflumetofen(Text with EEA relevance), 32019R0716, May 10, 2019
  • Commission Implementing Regulation (EU) 2019/717of 8 May 2019renewing the approval of the active substance isoxaflutole in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0717, May 10, 2019
  • Commission Implementing Regulation (EU) 2019/989of 17 June 2019concerning the non-renewal of approval of the active substance chlorpropham, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R0989, June 18, 2019
  • Commission Implementing Regulation (EU) 2019/1085of 25 June 2019renewing the approval of the active substance 1-methylcyclopropene, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011, and amending the Annex to Commission Implementing Regulation (EU) 2015/408(Text with EEA relevance), 32019R1085, June 26, 2019
  • Commission Implementing Regulation (EU) 2019/1090of 26 June 2019concerning the non-renewal of approval of the active substance dimethoate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1090, June 27, 2019
  • Commission Implementing Regulation (EU) 2019/1100of 27 June 2019concerning the non-renewal of approval of the active substance desmedipham, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1100, June 28, 2019
  • Commission Implementing Regulation (EU) 2019/1101of 27 June 2019renewing the approval of the active substance tolclofos-methyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1101, June 28, 2019
  • Commission Implementing Regulation (EU) 2019/1137of 3 July 2019renewing the approval of the active substance dimethenamid-P in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1137, July 4, 2019
  • Commission Implementing Regulation (EU) 2019/1138of 3 July 2019approving the active substance florpyrauxifen-benzyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1138, July 4, 2019
  • Commission Implementing Regulation (EU) 2019/1589of 26 September 2019amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, beta-cyfluthrin, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflubenzuron, diflufenican, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, picloram, prosulfocarb, pyriproxyfen, thiophanate-methyl, triflusulfuron and tritosulfuron(Text with EEA relevance), 32019R1589, September 27, 2019
  • Commission Implementing Regulation (EU) 2019/1605of 27 September 2019approving the low-risk active substance Bacillus subtilis strain IAB/BS03, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1605, September 30, 2019
  • Commission Implementing Regulation (EU) 2019/1606of 27 September 2019concerning the non-renewal of the approval of the active substance methiocarb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1606, September 30, 2019
  • Commission Implementing Regulation (EU) 2019/1675of 4 October 2019renewing the approval of the active substance Verticillium albo-atrum strain WCS850 as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1675, October 8, 2019
  • Commission Implementing Regulation (EU) 2019/1690of 9 October 2019renewing the approval of the active substance alpha-cypermethrin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32019R1690, October 10, 2019
  • Commission Implementing Regulation (EU) 2019/2094of 29 November 2019amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mancozeb, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin(Text with EEA relevance), 32019R2094, December 9, 2019
  • Commission Implementing Regulation (EU) 2020/17of 10 January 2020concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0017, January 13, 2020
  • Commission Implementing Regulation (EU) 2020/18of 10 January 2020concerning the non-renewal of the approval of the active substance chlorpyrifos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0018, January 13, 2020
  • Commission Implementing Regulation (EU) 2020/23of 13 January 2020concerning the non-renewal of the approval of the active substance thiacloprid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0023, January 14, 2020
  • Commission Implementing Regulation (EU) 2020/421of 18 March 2020amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly Verticillium lecanii) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly S. griseoviridis), Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strains IMI 206040 and T11, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram(Text with EEA relevance), 32020R0421, March 20, 2020
  • Commission Implementing Regulation (EU) 2020/616of 5 May 2020renewing the approval of the active substance foramsulfuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0616, May 6, 2020
  • Commission Implementing Regulation (EU) 2020/617of 5 May 2020renewing the approval of the active substance metalaxyl-M, and restricting the use of seeds treated with plant protection products containing it, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0617, May 6, 2020
  • Commission Implementing Regulation (EU) 2020/642of 12 May 2020approving the basic substance L-cysteine in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0642, May 13, 2020
  • Commission Implementing Regulation (EU) 2020/646of 13 May 2020approving the active substance Lavandulyl senecioate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0646, May 14, 2020
  • Commission Implementing Regulation (EU) 2020/653of 14 May 2020correcting Implementing Regulations (EU) No 540/2011 and (EU) 2019/706 as regards the CAS number of the active substance carvone(Text with EEA relevance), 32020R0653, May 15, 2020
  • Commission Implementing Regulation (EU) 2020/869of 24 June 2020amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, dimethomorph, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and S-metolachlor(Text with EEA relevance), 32020R0869, June 25, 2020
  • Commission Implementing Regulation (EU) 2020/892of 29 June 2020concerning the non-renewal of the approval of the active substance beta-cyfluthrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0892, June 30, 2020
  • Commission Implementing Regulation (EU) 2020/968of 3 July 2020renewing the approval of the active substance pyriproxyfen in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R0968, July 6, 2020
  • Commission Implementing Regulation (EU) 2020/1003of 9 July 2020renewing the approval of the active substances Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3 as low-risk substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1003, July 10, 2020
  • Commission Implementing Regulation (EU) 2020/1004of 9 July 2020approving the basic substance cow milk in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1004, July 10, 2020
  • Commission Implementing Regulation (EU) 2020/1018of 13 July 2020approving ferric pyrophosphate as low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1018, July 14, 2020
  • Commission Implementing Regulation (EU) 2020/1160of 5 August 2020amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, blood meal, calcium carbonate, carbon dioxide, extract from tea tree, fat distillation residues, fatty acids C7 to C20, garlic extract, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, kieselgur (diatomaceous earth), plant oils/rape seed oil, potassium hydrogen carbonate, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, Straight Chain Lepidopteran Pheromones, tebuconazole and urea(Text with EEA relevance), 32020R1160, August 6, 2020
  • Commission Implementing Regulation (EU) 2020/1246of 2 September 2020concerning the non-renewal of the approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1246, September 3, 2020
  • Commission Implementing Regulation (EU) 2020/1263of 10 September 2020approving the active substance sodium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1263, September 11, 2020
  • Commission Implementing Regulation (EU) 2020/1276of 11 September 2020concerning the non-renewal of the approval of the active substance bromoxynil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1276, September 14, 2020
  • Commission Implementing Regulation (EU) 2020/1280of 14 September 2020concerning the non-renewal of the approval of the active substance benalaxyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1280, September 15, 2020
  • Commission Implementing Regulation (EU) 2020/1293of 15 September 2020amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance azadirachtin(Text with EEA relevance), 32020R1293, September 16, 2020
  • Commission Implementing Regulation (EU) 2020/1498of 15 October 2020concerning the non-renewal of approval of the active substance thiophanate-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R1498, October 16, 2020
  • Commission Implementing Regulation (EU) 2020/1511of 16 October 2020amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, picloram, prosulfocarb, sulphur, triflusulfuron and tritosulfuron(Text with EEA relevance), 32020R1511, October 19, 2020
  • Commission Implementing Regulation (EU) 2020/1643of 5 November 2020amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances calcium phosphide, denathonium benzoate, haloxyfop-P, imidacloprid, pencycuron and zeta-cypermethrin(Text with EEA relevance), 32020R1643, November 6, 2020
  • Commission Implementing Regulation (EU) 2020/2007of 8 December 2020amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1,4-dimethylnaphthalene, 6-benzyladenine, acequinocyl, Adoxophyes orana granulovirus, aluminium sulfate, amisulbrom, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), azadirachtin, Bacillus pumilus QST 2808, benalaxyl-M, bixafen, bupirimate, Candida oleophila strain O, chlorantraniliprole, disodium phosphonate, dithianon, dodine, emamectin, flubendiamide, fluometuron, fluxapyroxad, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, penflufen, penthiopyrad, potassium phosphonates, prosulfuron, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam, quinmerac, S-abscisic acid, sedaxane, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, Streptomyces lydicus strain WYEC 108, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate, zinc phosphide, 32020R2007, December 9, 2020
  • Commission Implementing Regulation (EU) 2020/2087of 14 December 2020concerning the non-renewal of the approval of the active substance mancozeb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R2087, December 15, 2020
  • Commission Implementing Regulation (EU) 2020/2101of 15 December 2020renewing the approval of the active substance kieselgur (diatomaceous earth) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R2101, December 16, 2020
  • Commission Implementing Regulation (EU) 2020/2104of 15 December 2020amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance paraffin oil(Text with EEA relevance), 32020R2104, December 16, 2020
  • Commission Implementing Regulation (EU) 2020/2105of 15 December 2020renewing the approval of the active substance etoxazole as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32020R2105, December 16, 2020
  • Commission Implementing Regulation (EU) 2021/52of 22 January 2021amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin(Text with EEA relevance), 32021R0052, January 25, 2021
  • Commission Implementing Regulation (EU) 2021/81of 27 January 2021approving the basic substance Allium cepa L. bulb extract in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32021R0081, January 28, 2021
  • Commission Implementing Regulation (EU) 2021/129of 3 February 2021renewing the approval of the active substance garlic extract in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32021R0129, February 4, 2021
  • Commission Implementing Regulation (EU) 2021/134of 4 February 2021renewing the approval of the low-risk active substance Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32021R0134, February 5, 2021
  • Commission Implementing Regulation (EU) 2021/413of 8 March 2021renewing the approval of the low-risk active substance blood meal in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32021R0413, March 9, 2021
  • Commission Implementing Regulation (EU) 2021/427of 10 March 2021approving the active substance 24-epibrassinolide as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance), 32021R0427, March 11, 2021
Corrected by
  • Corrigendum to 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, 32011R0540R(03), January 28, 2012
  • Corrigendum to Commission Implementing Regulation (EU) No 200/2013 of 8 March 2013 approving the active substance ametoctradin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011, 32013R0200R(01), September 4, 2013
  • Corrigendum to Commission Implementing Regulation (EU) No 140/2014 of 13 February 2014 approving the active substance spinetoram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011, 32014R0140R(01), October 22, 2015
  • Corrigendum to Commission Implementing Regulation (EU) 2017/842 of 17 May 2017 renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011, 32017R0842R(01), January 5, 2018
Commission Implementing Regulation (EU) No 540/2011of 25 May 2011implementing 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)
Article 1The active substances, as set out in Part A of the Annex, shall be deemed to have been approved under Regulation (EC) No 1107/2009.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.
Article 2This 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.ANNEX ACTIVE SUBSTANCESPART AActive substances deemed to have been approved under Regulation (EC) No 1107/2009General provisions applying to all substances listed in this Part: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.
Further details on identity and specification of active substances are provided in their review reports.Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767.OJ L 353, 31.12.2008, p. 1.2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.De-ethyl-bupirimate.2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.(4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one.1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol.OJ L 300, 14.11.2009, p. 1.OJ L 54, 26.2.2011, p. 1.Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
NumberCommon name, identification numbersIUPAC namePurityDate of approvalExpiration of approvalSpecific provisions
1ImazalilCAS No 73790-28-0, 35554-44-0CIPAC No 335(+)-1-(β-allyloxy-2,4-dichlorophenylethyl)imidazole or (+)-allyl 1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether975 g/kg1 January 199931 December 2011Only uses as fungicide may be authorized.For the following uses the following particular conditions apply:post-harvest fruit, vegetable and potato treatments may only be authorised when an appropriate decontamination system is available or a risk assessment has demonstrated to the authorizing Member State that the discharge of the treatment solution does not have an unacceptable risk to the environment and in particular to aquatic organisms,post-harvest treatment of potatoes may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the discharge of the processing waste from treated potatoes does not have an unacceptable risk to aquatic organisms,outdoor foliar uses may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the use has no unacceptable effects on human and animal health and the environment.Date of Standing Committee on Plant Health at which the review report was finalised: 11 July 1997.
2AzoxystrobinCAS No 131860-33-8CIPAC No 571Methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy] phenyl}-3-methoxyacrylate930 g/kg (Z isomer max. 25 g/kg)1 July 199831 December 2011Only uses as fungicide may be authorised.In the decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, particular attention should be given to the impact on aquatic organisms. Authorisation conditions should include appropriate risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 22 April 1998.
3Kresoxim-MethylCAS No 143390-89-0CIPAC No 568Methyl (E)-2-methoxyimino-2-[2-(o-tolyloxymethyl) phenyl]acetate910 g/kg1 February 199931 December 2011Only uses as fungicide 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 shall pay particular attention to the protection of groundwater under vulnerable conditions.Date of Standing Committee on Plant Health at which the review report was finalised: 16 October 1998.
4SpiroxamineCAS No 1181134-30-8CIPAC No 572(8-tert-Butyl-1,4-dioxa-spiro [4.5] decan-2-ylmethyl)-ethyl-propyl-amine940 g/kg (diastereomers A and B combined)1 September 199931 December 2011Only uses as a fungicide 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 operator safety and must ensure that the conditions of authorisation include appropriate protective measures,must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 12 May 1999.
5AzimsulfuronCAS No 120162-55-2CIPAC No 5841-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea980 g/kg1 October 199931 December 2011Only uses as herbicide may be authorised.Aerial applications may not 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 impact on aquatic organisms and terrestrial non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures (e.g. in rice cultivation minimum holding periods for water prior to discharge).Date of Standing Committee on Plant Health at which the review report was finalised: 2 July 1999.
6FluroxypyrCAS No 69377-81-7CIPAC No 4314-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid950 g/kg1 December 200031 December 2011Only 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:shall take into account the additional information requested in point 7 of the Review Report,must pay particular attention to the protection of groundwater,must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Member States shall inform the Commission if the requested additional trials and information as outlined in point 7 of the Review Report were not submitted by 1 December 2000.Date of Standing Committee on Plant Health at which the review report was finalised: 30 November 1999.
7Metsulfuron methylCAS No 74223-64-6Methyl-2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl)benzoate960 g/kg1 July 200130. June 2016Only 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 Statesmust pay particular attention to the protection of groundwater;must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000.
8Prohexadione CalciumCAS No 127277-53-6CIPAC No 567Calcium 3,5-dioxo-4-propionylcyclohexanecarboxylate890 g/kg1 October 200031 December 2011Only uses as plant growth regulator may be authorised.Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000.
9TriasulfuronCAS No 82097-50-5CIPAC No 4801-[2-(2-chloroethoxy)phenylsulfonyl]-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea940 g/kg1 August 200130. June 2016Only 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;must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
10EsfenvalerateCAS No 66230-04-4CIPAC No 481(S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate830 g/kg1 August 200130. June 2016Only uses as insecticide 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 potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
11BentazoneCAS No 25057-89-0CIPAC No 3663-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide960 g/kg1 August 200130 June 2018Only 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.
12Lambda-cyhalothrinCAS No 91465-08-6CIPAC No 463A 1:1 mixture of:(S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate,and(R)-α-cyano-3-phenoxybenzyl (Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate810 g/kg1 January 200230. June 2016Only uses as insecticide 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 operator safety;must pay particular attention to the potential impact on aquatic organisms and non-target arthropods including bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;must pay particular attention to the residues in food and especially the acute effects thereof.Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.
13FenhexamidCAS No 126833-17-8CIPAC No 603N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexanecarboxamide≥ 950 g/kg1 June 200131 December 2015Only uses as a fungicide may be authorized.In 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 potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.
14AmitroleCAS No 61-82-5CIPAC No 90H-[1,2,4]-triazole-3-ylamine900 g/kg1 January 200230. June 2016Only uses as herbicide may be authorisedFor 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 amitrole, 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 protection of operators;must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses;must pay particular attention to the protection of beneficial arthropods;must pay particular attention to the protection of birds and wild mammals. Use of amitrole during the breeding season may only be authorised when an appropriate risk assessment has demonstrated that there is no unacceptable impact and when the conditions of authorisation include, where appropriate, risk mitigation measures.
15DiquatCAS No 2764-72-9 (ion), 85-00-7 (dibromide)CIPAC No 559,10-Dihydro-8a,10a-diazoniaphenanthrene ion (dibromide)950 g/kg1 January 200230 June 2019On 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.
16PyridateCAS No 55512-33.9CIPAC No 4476-Chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate900 g/kg1 January 200231 December 2015Only uses as herbicide may be authorized.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 Pyridate, 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 protection of groundwater;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.
17ThiabendazoleCAS No 148-79-8CIPAC No 3232-Thiazol-4-yl-1H-benzimidazole985 g/kg1 January 200230. June 2017Only uses as fungicide may be authorised. Foliar spray applications 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 thiabendazole, 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 protection of aquatic and sediment-dwelling organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Suitable risk mitigation measures (e.g. depuration with diatom earth or activated carbon) have to be implemented to protect surface waters from unacceptable levels of contamination via wastewater.
18Paecilomyces fumosoroseusApopka strain 97, PFR 97 or CG 170, ATCC20874Not applicableThe absence of secondary metabolites should be checked in each fermentation broth by HPLC1 July 200131 December 2015Only uses as an insecticide may be authorised.Each fermentation broth should be checked by HPLC to ensure that no secondary metabolites are present.Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.
19DPX KE 459 (flupyrsulfuron-methyl)CAS No 144740-54-5CIPAC No 5772-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt903 g/kg1 July 200130 June 2018Only uses as a herbicide may be authorised.In decision making according to the Uniform Principles 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: 27 April 2001.
20Acibenzolar-s-methylCAS No 135158-54-2CIPAC No 597Benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester970 g/kg1 November 200130. June 2016Only uses as a plant activator may be authorised.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001
21CyclanilideCAS No 113136-77-9CIPAC No 586Not available960 g/kg1 November 200131 October 2011Only 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.
22Ferric phosphateCAS No 10045-86-0CIPAC No 629Ferric phosphate990 g/kg1 November 200131 December 2015Only uses as a molluscicide may be authorised.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
23PymetrozineCAS No 123312-89-0CIPAC No 593(E)-6-methyl-4-[(pyridin-3-ylmetylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one950 g/kg1 November 200130 June 2019Only 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.
24Pyraflufen-ethylCAS No 129630-19-9CIPAC No 605Ethyl-2-chloro-5-(4-chloro-5-difluoromethoxy-1-mhypyrazol-3-yl)-4-fluorophenoxyacetate956 g/kg1 November 200130. June 2016Only uses as a herbicide may be authorised.In decision making according to the Uniform Principles Member States must pay particular attention to the protection of algae and aquatic plants and should apply, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
25GlyphosateCAS No 1071-83-6CIPAC No 284N-(phosphonomethyl)-glycin950 g/kg1 July 20026 months from the date of receipt of the opinion of the Committee for Risk Assessment of the European Chemicals Agency by the Commission or 31 December 2017, whichever is the earlierOnly 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 glyphosate, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 27 June 2016 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses,must pay particular attention to risks from the use in specific areas referred to in Article 12(a) of Directive 2009/128/EC,must pay particular attention to compliance of pre-harvest uses with good agricultural practices.Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).
26Thifensulfuron-methylCAS No 79277-27-3CIPAC No 452Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoyl-sulfamoyl) thiophene-2-carboxylate960 g/kg1 July 200230 June 2017Only uses as herbicide may be authorisedFor 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 thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of groundwater;must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
272,4-DCAS No 94-75-7CIPAC No 1(2,4-dichlorophenoxy) acetic acid960 g/kg1 October 200230. June 2016Only uses as herbicide may be authorisedFor 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 2,4-D, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 October 2001 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;must pay particular attention to the dermal absorption;must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
28IsoproturonCAS No 34123-59-6CIPAC No 3363-(4-isopropylphenyl)-1,1-dimethylurea970 g/kg1 January 200330. June 2016Only uses as herbicide may be authorisedFor 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 isoproturon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 7 December 2001 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions or at use rates higher than those described in the review report and must apply risk mitigation measures, where appropriate;must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
29EthofumesateCAS No 26225-79-6CICAP No 223(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate960 g/kg1 March 200331 July 2017Only uses as herbicide may be authorisedFor 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 ethofumesate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States may pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and must apply risk mitigation measures, where appropriate.
30IprovalicarbCAS No 140923-17-7CICAP No 620{2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl] propyl}-carbamic acid isopropylester950 g/kg (provisional specification)1 July 200230. June 2016Only 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 iprovalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment:the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossier should be compared and verified against this specification of the technical material;Member States must pay particular attention to the protection of operators.
31ProsulfuronCAS No 94125-34-5CICAP No 5791-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea950 g/kg1 Juli 200230. June 2017Only 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 prosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States:must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. Risk mitigation measures should be applied where appropriate;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.
32SulfosulfuronCAS No 141776-32-1CICAP No 6011-(4,6-dimethoxypyrimidin-2-yl)-3-[2-ethanesulfonyl-imidazo[1,2-a]pyridine) sulfonyl]urea980 g/kg1 July 200231 December 2015Only uses as a 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 sulfosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment:Member States must pay particular attention to the protection of aquatic plants and algae. Where appropriate, risk mitigation measures should be applied;Member States must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
33Cinidon-ethylCAS No 142891-20-1CIPAC No 598(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate940 g/kg1 October 200230 September 2012Only 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.
34Cyhalofop butylCAS No 122008-85-9CIPAC No 596Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate950 g/kg1 October 200230. June 2017Only 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 cyhalofop butyl, 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 carefully consider the potential impact of aerial applications to non-target organisms and in particular to aquatic species. Conditions of authorisation must include restrictions or risk mitigation measures, where appropriate.Member States must carefully consider the potential impact of terrestrial applications on aquatic organisms within paddy fields. Conditions of authorisation must include risk mitigation measures, where appropriate.
35FamoxadoneCAS No 131807-57-3CIPAC No 5943-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione960 g/kg1 October 200230 June 2021Only 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.
36FlorasulamCAS No 145701-23-1CIPAC No 6162′, 6′, 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c] pyrimidine-2-sulphonanilide970 g/kg1 October 200231 December 2015Only 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 florasulam, 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 and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.
37Metalaxyl-MCAS No 70630-17-0CIPAC No 580Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate910 g/kg1 October 200230 June 2020Only 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.
38PicolinafenCAS No 137641-05-5CIPAC No 6394′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide970 g/kg1 October 200230 June 2017Only 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 picolinafen, 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 the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
39FlumioxazineCAS No 103361-09-7CICAP No 578N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide960 g/kg1 January 200330 June 2021Only 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.
40DeltamethrinCAS No 52918-63-5CIPAC No 333(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate980 g/kg1 November 200331 October 2021Only uses as insecticide may be authorisedFor 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.
41ImazamoxCAS No 114311-32-9CIPAC No 619(±)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-(methoxymethyl) nicotinic acid950 g/kg1 July 200331 July 2018Only 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 imazamox, 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 potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.
42OxasulfuronCAS No 144651-06-9CIPAC No 626Oxetan-3-yl 2[(4,6-dimethylpyrimidin-2-yl) carbamoyl-sulfamoyl] benzoate930 g/kg1 July 200331 July 2018Only 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.
43EthoxysulfuronCAS No 126801-58-9CIPAC No 5913-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea950 g/kg1 July 200330 June 2013Only 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.
44ForamsulfuronCAS No 173159-57-4CIPAC No 6591-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea940 g/kg1 July 200331 July 2020Only 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.
45OxadiargylCAS No 39807-15-3CIPAC No 6045-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one980 g/kg1 July 200330 June 2013Only 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.
46CyazofamidCAS No 120116-88-3CIPAC No 6534-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide935 g/kg1 July 200331 July 2021Only 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.
472,4-DBCAS No 94-82-6CIPAC No 834-(2,4-dichlorophenoxy) butyric acid940 g/kg1 January 200431. October 2017Only use as herbicide may be authorisedFor 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 2,4-DB, 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 groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.
48Beta-cyfluthrinCAS 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 ester965 g/kg1 January 200431 October 2020Only use as insecticide may be authorisedUses 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.
49CyfluthrinCAS 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-dimethycyclopropanecarboxylate920 g/kg1 January 200431 December 2013Only use as insecticide may be authorisedUses 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.
50IprodioneCAS No 36734-19-7CIPAC No 2783-(3,5-dichlorophenyl)-Nisopropyl-2,4-dioxo-imidazolidine-1-carboximide960 g/kg1 January 200431 October 2018Only uses as fungicide and 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 iprodione, 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 potential for groundwater contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions,must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate.
51LinuronCAS No 330-55-2CIPAC No 763-(3,4-dichlorophenyl)-1-methoxy-1-methylurea900 g/kg1 January 200431. July 2017Only use as herbicide may be authorisedFor 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 linuron, 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 wild mammals, non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate,must pay particular attention to the protection of operators.
52Maleic hydrazideCAS No 123-33-1CIPAC No 3106-hydroxy-2H-pyridazin-3-one940 g/kg.1 January 200431. October 2017Only use as growth regulator may be authorisedFor 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 maleic hydrazide, 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 and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate,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.
53PendimethalinCAS No 40487-42-1CIPAC No 357N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene900 g/kg1 January 200431 July 2018Only use as herbicide may be authorisedFor 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 pendimethalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health 3 December 2002 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of aquatic organisms and non-target terrestrial plants. Conditions of authorisation must include risk mitigation measures, where appropriate,must pay particular attention to the possibility of short-range transport of the active substance in air.
54PropinebCAS No 12071-83-9 (monomer), 9016-72-2 (homopolymer)CIPAC No 177Polymeric zinc 1,2-propylenebis(dithiocarbamate)The technical active substance should comply with the FAO specification1 April 200431 January 2019Only uses as fungicide may be authorisedFor 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 propineb, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2003 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 soils and/or extreme climatic conditionsMember States should pay particular attention to the protection of small mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriateMember States should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels
55PropyzamideCAS No 23950-58-5CIPAC No 3153,5-dichloro-N-(1,1-dimethyl-prop-2-ynyl)benzamide920 g/kg1 April 200431 January 2019Only uses as herbicide may be authorisedFor 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 appropriatemust 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
56MecopropCAS No 7085-19-0CIPAC No 51(RS)-2-(4-chloro-o-tolyloxy)-propionic acid930 g/kg1 June 200431 May 2014Only 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.
57Mecoprop-PCAS No 16484-77-8CIPAC No 475(R)-2-(4-chloro-o-tolyloxy)-propionic acid860 g/kg1 June 200431 January 2022Only 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.
58PropiconazoleCAS No 60207-90-1CIPAC No 408(±)-1-[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole920 g/kg1 June 200431 January 2019Only 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.
59TrifloxystrobinCAS No 141517-21-7CIPAC No 617Methyl (E)-methoxyimino-{(E)-a-[1-a-(a,a,a-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate960 g/kg1 October 200331 July 2018Only 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.
60Carfentrazone ethylCAS No 128639-02.1CIPAC No 587Ethyl (RS)-2-chloro-3-[2-chloro-5-(4-difluoromethyl-4,5-dihydro-3-methyl-5oxo-1H 1,2,4-triazol-1-yl)-4-fluorophenyl]propionate900 g/kg1 October 200331 July 2018Only 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.
61MesotrioneCAS No 104206-8CIPAC No 6252-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione920 g/kgThe manufacturing impurity 1-cyano-6-(methylsulfonyl)-7-nitro-9H-xanthen-9-one is considered to be of toxicological concern and must remain below 0,0002 % (w/w) in the technical product.1 October 200331. July 2017Only 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 mesotrione, 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.
62FenamidoneCAS No 161326-34-7CIPAC No 650(S)-5-methyl-2-methylthio-5-phenyl-3-phenylamino-3,5-dihydroimidazol-4-one975 g/kg1 October 200331 July 2019Only 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.
63IsoxaflutoleCAS No 141112-29-0CIPAC No 5755-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole950 g/kg1 October 200331 July 2019Only 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.
64FlurtamoneCAS No 96525-23-4(RS)-5-methylamino-2-phenyl-4-(a,a,a-trifluoro-m-tolyl) furan-3 (2H)-one960 g/kg1 January 200431 October 2019Only 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.
65FlufenacetCAS No 142459-58-3CIPAC No 5884′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide950 g/kg1 January 200431 October 2021Only 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.
66IodosulfuronCAS No 185119-76-0 (parent)144550-36-7 (iodosulfuron-methyl-sodium)CIPAC No 634 (parent)634.501 (iodosulfuron-methyl-sodium)4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-ureidosulfonyl]benzoate910 g/kg1 January 200431. October 2017Only 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 iodosulfuron, 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 iodosulfuron and its metabolites 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 plants.Risk mitigation measures should be applied where appropriate.
67Dimethenamid-pCAS No 163515-14-8CIPAC No 638S-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy-1-methylethyl)-acetamide890 g/kg (preliminary value based on a pilot plant)1 January 200431 October 2019Only 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.
68PicoxystrobinCAS No 117428-22-5CIPAC No 628Methyl (E)-3-methoxy-2-{2-[6-(trifluoromethyl) -2- pyridyloxymethyl]phenyl} acrylate950 g/kg (preliminary value based on a pilot plant)1 January 200431. October 2017Only 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 picoxystrobin, 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 soil organisms,should pay particular attention to the protection of aquatic ecosystems.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.
69FosthiazateCAS No 98886-44-3CIPAC No 585(RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate930 g/kg1 January 200431 October 2021Only 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 Statesshould 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.
70SilthiofamCAS No 175217-20-6CIPAC No 635N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide950 g/kg1 January 200431 October 2018Only 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.
71Coniothyrium minitansStrain CON/M/91-08 (DSM 9660)CIPAC No 614Not applicableFor details on purity and production control see Review Report1 January 200431. October 2017Only uses as fungicide may be authorised.When granting authorisations, the conclusions of the review report on Coniothyrium minitans, 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 operator and worker safety and must ensure that the conditions of authorisation include appropriate protective measures.
72MolinateCAS No 2212-67-1CIPAC No 235S-ethyl azepane-1-carbothioate;S-ethyl perhydroazepine-1-carbothioate;S-ethyl perhydroazepine-1-thiocarboxilate950 g/kg1 August 200431 July 2014Only 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.
73ThiramCAS No 137-26-8CIPAC No 24tetramethylthiuram disulfide;bis (dimethylthiocarbamoyl)-disulfide960 g/kg1 August 200430 April 2019Only 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.
74ZiramCAS No 137-30-4CIPAC No 31Zinc bis (dimethyldithiocarbamate)950 g/kg (FAO-specification)Arsenic: maximum 250 mg/kgWater: maximum 1,5 %1 August 200430 April 2021Only 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.
75MesosulfuronCAS No 400852-66-6CIPAC No 4412-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluic acid930 g/kg1 April 200431 January 2018Only 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 mesosulfuron, 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. In this overall assessment Member States:should pay particular attention to the protection of aquatic plants;should pay particular attention to the potential of mesosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions.Risk mitigation measures should be applied where appropriate.
76PropoxycarbazoneCAS No 145026-81-9CIPAC No 6552-(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl) carboxamidosulfonylbenzoicacid-methylester≥ 950 g/kg (expressed as propoxy-carbazone-sodium)1 April 200431 January 2018Only 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 propoxycarbazone, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States:should pay particular attention to the potential of propoxycarbazone and its metabolites 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.
77ZoxamideCAS No 156052-68-5CIPAC No 640(RS)-3,5-Dichloro-N-(3-chloro-1-ethyl-1-methylacetonyl)-p-toluamide950 g/kg1 April 200431 January 2019Only 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.
78ChlorprophamCAS No 101-21-3CIPAC No 43Isopropyl 3-chlorophenylcarbamate975 g/kg1 February 200531 July 2019Only 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.
79Benzoic acidCAS No 65-85-0CIPAC No 622benzoic acid990 g/kg1 June 200431 January 2018Only uses as disinfectant 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 benzoic acid, 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.
80FlazasulfuronCAS No 104040-78-0CIPAC No 5951-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea940 g/kg1 June 200431 January 2018Only 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 flazasulfuron, 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. In this overall assessment Member Statesshould pay particular attention to the potential 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 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.
81PyraclostrobinCAS No 175013-18-0CIPAC No 657methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate975 g/kgThe 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 200431 January 2022Only 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.
82QuinoxyfenCAS No 124495-18-7CIPAC No 5665, 7-dichloro-4 (ρ-fluorophenoxy) quinoline970 g/kg1 September 200430 April 2019Only 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.
83Alpha-cypermethrinCAS No 67375-30-8CIPAC NoRacemate comprising(S)-α- cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylateand(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-21 March 200531 July 2020Only 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.
84BenalaxylCAS No 71626-11-4CIPAC No 416Methyl N-phenylacetyl–N-2, 6–xylyl–DL-alaninate960 g/kg1 March 200531 July 2021Only 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.
85BromoxynilCAS No 1689-84-5CIPAC No 873,5 dibromo – 4- hydroxybenzonitrile970 g/kg1 March 200531 July 2021Only 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.
86DesmediphamCAS No 13684-56-5CIPAC No 477ethyl 3′-phenylcarbamoyloxycarbanilateethyl 3-phenylcarbamoyloxyphenylcarbamateMin. 970 g/kg1 March 200531 July 2020Only 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
87IoxynilCAS No 13684-83-4CIPAC No 864- hydroxy- 3,5- di-iodobenzonitrile960 g/kg1 March 200528 February 2015Only 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.
88PhenmediphamCAS No 13684-63-4CIPAC No 77methyl 3-(3-methylcarbaniloyloxy)carbanilate;3-methoxycarbonylaminophenyl 3′-methylcarbanilateMin. 970 g/kg1 March 200531 July 2021Only 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.
89Pseudomonas chlororaphisStrain: MA 342CIPAC No 574Not applicableThe 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 200430 April 2021Only 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.
90MepanipyrimCAS No 110235-47-7CIPAC No 611N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline960 g/kg1 October 200430 April 2021Only 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.
91AcetamipridCAS No 160430-64-8CIPAC No Not yet allocated(E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine≥ 990 g/kg1 January 200530 April 2018Only 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 Acetamiprid, 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 Statesshould pay particular attention to worker exposure,should pay particular attention to the protection of aquatic organisms.Risk mitigation measures should be applied where appropriate.
92ThiaclopridCAS No 111988-49-9CIPAC No 631(Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide≥ 975 g/kg1 January 200530 April 2020Only 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.
93Ampelomyces quisqualisStrain: AQ 10Culture collection No CNCM I-807CIPAC NoNot allocatedNot applicable1 April 200531 July 2018Only 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.
94ImazosulfuronCAS No 122548-33-8CIPAC No 5901-(2-chloroimidazo[1,2-α]pyridin-3-ylsul-phonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea≥ 980 g/kg1 April 200531. July 2017Only 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.
95LaminarinCAS No 9008-22-4CIPAC No 671(1→3)-β-D-glucan(according to IUPAC-IUB Joint Commission on Biochemical Nomenclature)≥ 860 g/kg on dry matter1 April 200531 July 2018Only uses as elicitor of the crop's self-defence mechanisms 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 laminarin, 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.
96MethoxyfenozideCAS No 161050-58-4CIPAC No 656N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide≥ 970 g/kg1 April 200531 July 2019Only 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.
97S-metolachlorCAS No 87392-12-9(S-isomer)178961-20-1 (R-isomer)CIPAC No 607Mixture 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/kg1 April 200531 July 2021Only 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.
98Gliocladium catenulatumStrain: J1446Culture collection No DSM 9212CIPAC NoNot allocatedNot applicable1 April 200531 July 2019Only 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.
99EtoxazoleCAS No 153233-91-1CIPAC No 623(RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole≥ 948 g/kg1 June 200531 July 2021Only 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.
100TepraloxydimCAS No 149979-41-9CIPAC No 608(EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one≥ 920 g/kg1 June 200531. May 2015Only 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.
101ChlorothalonilCAS No 1897-45-6CIPAC No 288Tetrachloroisophthalonitrile985 g/kgHexachlorobenzene: not more than 0,04 g/kgDecachlorobiphenyl: not more than 0,03 g/kg1 March 200631 October 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
102Chlorotoluron (unstated stereochemistry)CAS No 15545-48-9CIPAC No 2173-(3-chloro-p-tolyl)-1,1-dimethylurea975 g/kg1 March 200631 October 2021PART AOnly uses as herbicide may be authorisedPART BFor 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
103CypermethrinCAS No 52315-07-8CIPAC 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/kg1 March 200631 October 2021PART AOnly uses as insecticide may be authorisedPART BFor 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
104DaminozideCAS No 1596-84-5CIPAC No 330N-dimethylaminosuccinamic acid990 g/kgImpurities:N-nitrosodimethylamine: not more than 2,0 mg/kg1,1-dimethylhydrazide: not more than 30 mg/kg1 March 200631 October 2021PART AOnly uses as growth regulator in non-edible crops may be authorisedPART BFor 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
105Thiophanate-methyl (unstated stereochemistry)CAS No 23564-05-8CIPAC No 262Dimethyl 4,4′-(o-phenylene)bis(3-thioallophanate)950 g/kg1 March 200631 October 2020PART AOnly uses as fungicide may be authorisedPART BFor 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
106TribenuronCAS No 106040-48-6 (tribenuron)CIPAC No 5462-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid950 g/kg (expressed as tribenuron-methyl)1 March 200631 October 2019PART AOnly uses as herbicide may be authorised.PART BFor 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.
107MCPACAS No 94-74-6CIPAC No 24-chloro-o-tolyloxyacetic acid≥ 930 g/kg1 May 200631 October 2021PART AOnly uses as herbicide may be authorisedPART BFor 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 accountMember 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 appropriateMember 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
108MCPBCAS No 94-81-5CIPAC No 504-(4-chloro-o-tolyloxy)butyric acid≥ 920 g/kg1 May 200631 October 2021PART AOnly uses as herbicide may be authorisedPART BFor 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 accountMember 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 appropriateMember 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
109BifenazateCAS No 149877-41-8CIPAC No 736Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate≥ 950 g/kg1 December 200531 July 2021PART AOnly uses as acaricide may be authorised.PART BIn 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.
110MilbemectinMilbemectin is a mixture of M.A3 and M.A4CAS NoM.A3: 51596-10-2M.A4: 51596-11-3CIPAC No 660M.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-oneM.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/kg1 December 200531 July 2021PART AOnly uses as acaricide or insecticide may be authorised.PART BFor 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.
111ChlorpyrifosCAS No 2921-88-2CIPAC No 221O,O-diethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate≥ 970 g/kgThe 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 200631 January 2020PART AOnly uses as insecticide may be authorised.PART BFor 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.
112Chlorpyrifos-methylCAS No 5598-13-0CIPAC No 486O,O-dimethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate≥ 960 g/kgThe 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 200631 January 2020PART AOnly uses as insecticide may be authorised.PART BFor 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.
113ManebCAS No 12427-38-2CIPAC No 61manganese ethylenebis (dithiocarbamate) (polymeric)≥ 860 g/kgThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content.1 July 200631 January 2017PART AOnly uses as fungicide may be authorised.PART BFor 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.
114MancozebCAS No 8018-01-7 (formerly 8065-67-5)CIPAC No 34Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt≥ 800 g/kgThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content.1 July 200631 January 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
115MetiramCAS No 9006-42-2CIPAC No 478Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)]≥ 840 g/kgThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content.1 July 200631 January 2022PART AOnly uses as fungicide may be authorised.PART BFor 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.
116OxamylCAS No 23135-22-0CIPAC No 342N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide970 g/kg1 August 200631 January 2022PART AOnly uses as nematicide and insecticide may be authorised.PART BFor 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.
1171-methylcyclopropene (an ISO Common Name will not be considered for this active substance)CAS No 3100-04-7CIPAC No not allocated1-methylcyclopropene≥ 960 g/kgThe 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 200631 October 2019PART AOnly uses as plant growth regulator for post harvest storage in sealable warehouse may be authorised.PART BFor 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.
118ForchlorfenuronCAS No 68157-60-8CIPAC No 6331-(2-chloro-4-pyridinyl)-3-phenylurea≥ 978 g/kg1 April 200631 October 2018PART AOnly uses as plant growth regulator may be authorised.PART BIn 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.
119IndoxacarbCAS No 173584-44-6CIPAC No 612methyl (S)-N-[7-chloro-2,3,4a,5-tetrahydro-4a-(methoxycarbonyl)indeno[1,2-e][1,3,4]oxadiazin-2-ylcarbonyl]-4′-(trifluoromethoxy)carbanilateTC (Technical Material): ≥ 628 g/kg indoxacarb1 April 200631 October 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
120WarfarinCAS No 81-81-2CIPAC No 70(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin≥ 990 g/kg1 October 200630 September 2013PART AOnly uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised.PART BFor 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.
121ClothianidinCAS No 210880-92-5CIPAC No 738(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine≥ 960 g/kg1 August 200631 January 2019PART AOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.PART BFor 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 revised addendum of the review report on clothianidin as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.In this overall assessment Member States must pay particular attention to:the risk to groundwater;the risk to bees and bumble bees released for pollination in permanent greenhouses;the exposure of bees via the consumption of contaminated water from the permanent greenhouses.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.Conditions of use shall include risk mitigation measures, where appropriate.
122PethoxamidCAS No 106700-29-2CIPAC No 6552-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide≥ 940 g/kg1 August 200631 January 2019PART AOnly uses as herbicide may be authorised.PART BFor 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 Statesmust 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.
123ClodinafopCAS No 114420-56-3CIPAC No 683(R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid≥ 950 g/kg (expressed as clodinafop-propargyl)1 February 200730 April 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
124PirimicarbCAS No 23103-98-2CIPAC No 2312-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate≥ 950 g/kg1 February 200730 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
125RimsulfuronCAS No 122931-48-0 (rimsulfuron)CIPAC No 7161-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea≥ 960 g/kg (expressed as rimsulfuron)1 February 200730 April 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
126Tolclofos-methylCAS No 57018-04-9CIPAC No 479O-2,6-dichloro-p-tolyl O,O-dimethyl phosphorothioateO-2,6-dichloro-4-methylphenyl O,O-dimethyl phosphorothioate≥ 960 g/kg1 February 200730 April 2020PART AOnly uses as fungicide may be authorised.PART BIn 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.
127TriticonazoleCAS No 131983-72-7CIPAC No 652(±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol≥ 950 g/kg1 February 200730 April 2021PART AOnly uses as fungicide may be authorised.PART BIn 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.
128DimoxystrobinCAS No 149961-52-4CIPAC No 739(E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide≥ 980 g/kg1 October 200631 January 2022PART AOnly uses as fungicide may be authorised.PART BIn 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 Statesmust 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 ofa 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.
129ClopyralidCAS No 1702-17-6CIPAC No 4553,6-dichloropyridine-2-carboxylic acid≥ 950 g/kg1 May 200730 April 2021PART AOnly uses as herbicide may be authorised.PART BIn 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.
130CyprodinilCAS No 121522-61-2CIPAC No 511(4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine≥ 980 g/kg1 May 200730 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
131FosetylCAS No 15845-66-6CIPAC No 384Ethyl hydrogen phosphonate≥ 960 g/kg (expressed as fosetyl-Al)1 May 200730 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
132TrinexapacCAS No 104273-73-6CIPAC No 7324-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid≥ 940 g/kg (expressed as trinexapac-ethyl)1 May 200730 April 2021PART AOnly uses as plant growth regulator may be authorised.PART BFor 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.
133Dichlorprop-PCAS No 15165-67-0CIPAC No 476(R)-2-(2,4-dichlorophenoxy) propanoic acid≥ 900 g/kg1 June 200730 April 2021PART AOnly 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 BFor 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.
134MetconazoleCAS 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 200730 April 2021PART AOnly uses as fungicide and plant growth regulator may be authorised.PART BFor 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.
135PyrimethanilCAS No 53112-28-0CIPAC No not allocatedN-(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 200730 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
136TriclopyrCAS No 055335-06-3CIPAC No 3763,5,6-trichloro-2-pyridyloxyacetic acid≥ 960 g/kg(as Triclopyr butoxyethyl ester)1 June 200730 April 2021PART AOnly 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 BFor 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.
137MetrafenoneCAS No 220899-03-6CIPAC No 7523′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone≥ 940 g/kg1 February 200730 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
138Bacillus subtilis(Cohn 1872)Strain QST 713, identical with strain AQ 713Culture collection No: NRRL B -21661CIPAC No not allocatedNot applicable1 February 200730 April 2021PART AOnly uses as fungicide and bactericide may be authorised.PART BFor 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.
139SpinosadCAS No 131929-60-7 (Spinosyn A)131929-63-0 (Spinosyn D)CIPAC No 636Spinosyn 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-dioneSpinosyn 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-dioneSpinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D≥ 850 g/kg1 February 200730 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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 Statesmust 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.
140ThiamethoxamCAS No 153719-23-4CIPAC No 637(E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine≥ 980 g/kg1 February 200730 April 2019PART AOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.PART BFor 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 revised addendum of the review report on thiamethoxam as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.In this overall assessment Member States must pay particular attention to:the risk to groundwater;the risk to aquatic organisms;the risk to bees and bumble bees released for pollination in permanent greenhouses;the exposure of bees via the consumption of contaminated water from the permanent greenhouses.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.Conditions of use shall include risk mitigation measures, where appropriate.
141FenamiphosCAS No 22224-92-6CIPAC No 692(RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate≥ 940 g/kg1 August 200731 July 2021PART AOnly uses as nematicide applied by drip irrigation in greenhouses with permanent structure may be authorised.PART BFor 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.
142EthephonCAS No 16672-87-0CIPAC No 3732-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 200731 July 2021PART AOnly uses as plant growth regulator may be authorised.PART BFor 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.
143FlusilazoleCAS No 85509-19-9CIPAC No 435Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane925 g/kg1 January 200730 June 2008PART AOnly uses as fungicide on the following crops may be authorised:cereals other than rice,maize,rape seed,sugar beet,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 BFor 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 shall ensure 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.
144CarbendazimCAS No 10605-21-7CIPAC No 263Methyl benzimidazol-2-ylcarbamate≥ 980 g/kgRelevant impurities2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg2,3-diaminophenazine (DAP): not more than 0,003 g/kg1 June 201130 November 2014PART AOnly uses as fungicide on the following crops may be authorised:cerealsrape seedsugar and fodder beetmaizeat rates not exceeding0,25 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 beet0,1 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 BFor 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.
145CaptanCAS No 133-06-02CIPAC No 40N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide≥ 910 g/kgImpurities:Perchloromethylmercaptan (R005406): not more than 5 g/kgFolpet: not more than 10 g/kgCarbon tetrachloride not more than 0,1 g/Kg1 October 200731 July 2021PART AOnly uses as fungicide can be authorised.PART BIn 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.
146FolpetCAS No 133-07-3CIPAC No 75N-(trichloromethylthio) phthalimide≥ 940 g/kgImpurities:Perchloromethylmercaptan (R005406): not more than 3,5 g/kgCarbon tetrachloride not more than 4 g/kg1 October 200731 July 2021PART AOnly uses as fungicide can be authorised.PART BIn 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.
147FormetanateCAS No 23422-53-9CIPAC No 6973-dimethylaminomethyleneaminophenyl methylcarbamate≥ 910 g/kg1 October 200731 July 2021PART AOnly uses as insecticide and acaricide may be authorised.PART BIn 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.
148MethiocarbCAS No 2032-65-7CIPAC No 1654-methylthio-3,5-xylyl methylcarbamate≥ 980 g/kg1 October 200731 July 2020PART AOnly uses as repellent in seed treatment and insecticide may be authorised.PART BIn 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.
149DimethoateCAS No 60-51-5CIPAC No 59O,O-Dimethyl-S-(N-methylcarbamoylmethyl) phosphorodithioate; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide≥ 950 g/kgImpurities:omethoate: not more than 2 g/kgisodimethoate: not more than 3 g/kg1 October 200731 July 2020PART AOnly uses as insecticide may be authorised.PART BFor 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.
150DimethomorphCAS No 110488-70-5CIPAC No 483(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine≥ 965 g/kg1 October 200731 July 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
151GlufosinateCAS No 77182-82-2CIPAC No 437.007ammonium(DL)-homoalanin-4-yl(methyl)phosphinate950 g/kg1 October 200731. July 2018PART AOnly 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 BIn 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.
152MetribuzinCAS No 21087-64-9CIPAC No 2834-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one≥ 910 g/kg1 October 200731 July 2021PART AOnly uses as herbicide may be authorised.PART BIn 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.
153PhosmetCAS No 732-11-6CIPAC No 318O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide≥ 950 g/kgImpurities:phosmet oxon: not more than 0,8 g/kgiso phosmet: not more than 0,4 g/kg1 October 200731 July 2021PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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.
154PropamocarbCAS No 24579-73-5CIPAC No 399Propyl 3-(dimethylamino) propylcarbamate≥ 920 g/kg1 October 200731 July 2021PART AOnly uses as fungicide may be authorised.PART BIn 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.
155ethoprophosCAS No 13194-48-4CIPAC No 218O-ethyl S,S-dipropyl phosphorodithioate> 940 g/kg1 October 200731 July 2019PART AOnly 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 BIn 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.
156Pirimiphos-methylCAS No 29232-93-7CIPAC No 239O-2-diethylamino-6-methylpyrimidin-4-ylO,O-dimethylphosphorothioate> 880 g/kg1 October 200731 July 2021PART AOnly uses as insecticide for post harvest storage can be authorised.Hand-held applications shall not be authorised.PART BIn 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.
157FipronilCAS No 120068-37-3CIPAC No 581(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile≥ 950 g/kg1 October 200730 September 2017PART AOnly 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 BFor 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.
158BeflubutamidCAS No 113614-08-7CIPAC No 662(RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide≥ 970 g/kg1 December 200731 July 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
159Spodoptera exigua nuclear polyhedrosis virusCIPAC NoNot allocatedNot applicable1 December 200730 November 2017PART AOnly uses as insecticide may be authorised.PART BFor 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.
160ProsulfocarbCAS No 52888-80-9CIPAC No 539S-benzyl dipropyl(thiocarbamat)970 g/kg1 November 200831 October 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
161FludioxonilCAS No 131341-86-1CIPAC No 5224-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile950 g/kg1 November 200831 October 2021PART AOnly uses as fungicide may be authorised.PART BIn 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.
162ClomazoneCAS No 81777-89-1CIPAC No 5092-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one960 g/kg1 November 200831 October 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
163BenthiavalicarbCAS No 413615-35-7CIPAC No 744[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid≥ 910 g/kgThe 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/kgbis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg1 August 200831 July 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
164BoscalidCAS No 188425-85-6CIPAC No 6732-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide≥ 960 g/kg1 August 200831 July 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 attentionto 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.
165CarvoneCAS No 99-49-0 (d/l mixture)CIPAC No 6025-isopropenyl-2-methylcyclohex-2-en-1-one≥ 930 g/kg with a d/l ratio of at least 100:11 August 200831 July 2019PART AOnly uses as plant growth regulator may be authorised.PART BFor 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.
166FluoxastrobinCAS No 361377-29-9CIPAC 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/kg1 August 200831 July 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
167Paecilomyces lilacinus (Thom)Samson 1974 strain 251 (AGAL: No 89/030550)CIPAC No 753Not applicable1 August 200831 July 2021PART AOnly uses as nematicide may be authorised.PART BFor 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.
168ProthioconazoleCAS No 178928-70-6CIPAC No 745(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione≥ 970 g/kgThe following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:Toluene: < 5 g/kgProthioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)1 August 200831 July 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
169AmidosulfuronCAS No 120923-37-7CIPAC No 5153-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)ureaor1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea≥ 970 g/kg1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BIn 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.
170NicosulfuronCAS No 111991-09-4CIPAC No 7092-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamideor1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea≥ 910 g/kg1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
171ClofentezineCAS No 74115-24-5CIPAC No 4183,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine≥ 980 g/kg (dry material)1 January 200931 December 2021PART AOnly uses as acaricide may be authorised.PART BFor 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.
172DicambaCAS No 1918-00-9CIPAC No 853,6-dichloro-2-methoxybenzoic acid≥ 850 g/kg1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
173DifenoconazoleCAS No 119446-68-3CIPAC No 6873-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/kgToluene maximum content: 5 g/kg1 January 200931 December 2021PART AOnly uses as fungicide may be authorised.PART BFor 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;(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.
174DiflubenzuronCAS No 35367-38-5CIPAC No 3391-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline1 January 200931 December 2020PART AOnly 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 BFor 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.
175ImazaquinCAS No 81335-37-7CIPAC No 6992-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid≥ 960 g/kg (racemic mixture)1 January 200931 December 2018PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 accountThe 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.
176LenacilCAS No 2164-08-1CIPAC No 1633-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione≥ 975 g/kg1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 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.
177OxadiazonCAS No 19666-30-9CIPAC No 2135-tert-butyl-3-(2,4-dichloro-5-isopropoxyphenyl)-1,3,4-oxadiazol-2(3H)-one≥ 940 g/kg1 January 200931 December 2018PART AOnly uses as herbicide may be authorised.PART BFor 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.
178PicloramCAS No 1918-02-1CIPAC No 1744-amino-3,5,6-trichloropyridine-2-carboxylic acid≥ 920 g/kg1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
179PyriproxyfenCAS No 95737-68-1CIPAC No 7154-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether≥ 970 g/kg1 January 200931 December 2020PART AOnly uses as insecticide may be authorised.PART BFor 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.
180BifenoxCAS No 42576-02-3CIPAC No 413Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate≥ 970 g/kg impurities:max. 3 g/kg 2,4-dichlorophenolmax. 6 g/kg 2,4-dichloroanisole1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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).
181DiflufenicanCAS No 83164-33-4CIPAC No 4622′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide≥ 970 g/kg1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
182Fenoxaprop-PCAS No 113158-40-0CIPAC No 484(R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid≥ 920 g/kg1 January 200931 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
183FenpropidinCAS No 67306-00-7CIPAC No 520(R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine≥ 960 g/kg (racemate)1 January 200931 December 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
184QuinoclamineCAS No 2797-51-5CIPAC No 6482-amino-3-chloro-1,4-naphthoquinone≥ 965 g/kg impurity:dichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg1 January 200931 December 2018PART AOnly uses as herbicide may be authorised.PART BIn 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.
185ChloridazonCAS No 1698-60-8CIPAC No 1115-amino-4-chloro-2-phenylpyridazin-3(2H)-one920 g/kgThe 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 200931 December 2018PART AOnly uses as herbicide in application max. of 2,6 kg/ha only every third year on the same field may be authorised.PART BFor 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.
186TritosulfuronCAS No 142469-14-5CIPAC No 7351-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea≥ 960 g/kgThe 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/kg1 December 200830 November 2021PART AOnly uses as herbicide may be authorised.PART BFor 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.
187FlutolanilCAS No 66332-96-5CIPAC No 524α,α,α-trifluoro-3′-isopropoxy-o-toluanilide≥ 975 g/kg1 March 200928 February 2022PART AOnly uses as fungicide may be authorised.PART BIn 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.
188BenfluralinCAS No 1861-40-1CIPAC No 285N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine≥ 960 g/kgImpurities:ethyl-butyl-nitrosamine: max. 0,1 mg/kg1 March 200928 February 2022PART AOnly uses as herbicide may be authorised.PART BIn 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.
189FluazinamCAS No 79622-59-6CIPAC No 5213-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine≥ 960 g/kgImpurities:5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidinenot more than 2 g/kg1 March 200928 February 2022PART AOnly uses as fungicide may be authorised.PART BIn 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.
190FuberidazoleCAS No 3878-19-1CIPAC No 5252-(2′-furyl)benzimidazole≥ 970 g/kg1 March 200928 February 2019PART AOnly uses as fungicide may be authorised.PART BIn 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.
191MepiquatCAS No 15302-91-7CIPAC No 4401,1-dimethylpiperidinium chloride (mepiquat chloride)≥ 990 g/kg1 March 200928 February 2022PART AOnly uses as plant growth regulator may be authorised.PART BIn 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.
192DiuronCAS No 330-54-1CIPAC No 1003-(3,4-dichlorophenyl)-1,1-dimethylurea≥ 930 g/kg1 October 200830 September 2020PART AOnly uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be authorised.PART BFor 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.
193Bacillus thuringiensis subsp. aizawaiSTRAIN: ABTS-1857Culture collection: No SD-1372,STRAIN: GC-91Culture collection: No NCTC 11821Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
194Bacillus thuringiensis subsp. israeliensis (serotype H-14)STRAIN: AM65-52Culture collection: No ATCC-1276Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
195Bacillus thuringiensis subsp. kurstakiSTRAIN: ABTS 351Culture collection: No ATCC SD-1275STRAIN: PB 54Culture collection: No CECT 7209STRAIN: SA 11Culture collection: No NRRL B-30790STRAIN: SA 12Culture collection: No NRRL B-30791STRAIN: EG 2348Culture collection: No NRRL B-18208Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
196Bacillus thuringiensis subsp. TenebrionisSTRAIN: NB 176 (TM 141)Culture collection: No SD-5428Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
197Beauveria bassianaSTRAIN: ATCC 74040Culture collection: No ATCC 74040STRAIN: GHACulture collection: No ATCC 74250Not applicableMax level of beauvericin: 5 mg/kg1 May 200930 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
198Cydia pomonella Granulovirus (CpGV)Not applicableMinimum concentration: 1 × 1013 OB/l (occlusion bodies/l) and Contaminating microorganisms (Bacillus cereus) in the formulated product < 1 × 107 CFU/g1 May 200930 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
199Lecanicillium muscarium(formerly Verticilium lecanii)STRAIN: Ve 6Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as insecticide may be authorised.PART BFor 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.
200Metarhizium anisopliae var. anisopliae(formerly Metarhizium anisopliae)STRAIN: BIPESCO 5/F52Culture 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 1095Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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.
201Phlebiopsis giganteaSTRAIN: VRA 1985Culture collection: No DSM 16202STRAIN: VRA 1986Culture collection: No DSM 16203STRAIN: FOC PG B20/5Culture collection: No IMI 390096STRAIN: FOC PG SP log 6Culture collection: No IMI 390097STRAIN: FOC PG SP log 5Culture collection: No IMI 390098STRAIN: FOC PG BU 3Culture collection: No IMI 390099STRAIN: FOC PG BU 4Culture collection: No IMI 390100STRAIN: FOC PG97/1062/116/1.1Culture collection: No IMI 390102STRAIN: FOC PG B22/SP1287/3.1Culture collection: No IMI 390103STRAIN: FOC PG SH 1Culture collection: No IMI 390104STRAIN: FOC PG B22/SP1190/3.2Culture collection: No IMI 390105Not applicableNo relevant impurities1 May 200930 April 2020PART 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.
202Pythium oligandrumSTRAINS: M1Culture collection No ATCC 38472Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as fungicide may be authorisedPART BFor 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.
203Streptomyces K61 (formerly S. griseoviridis)STRAIN: K61Culture collection: No DSM 7206Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
204Trichoderma atroviride(formerly T. harzianum)STRAIN: IMI 206040Culture collection No IMI 206040, ATCC 20476;STRAIN: T11Culture collection: NoSpanish type culture collection CECT 20498, identical with IMI 352941Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
205Trichoderma polysporumSTRAIN: Trichoderma polysporum IMI 206039Culture collection No IMI 206039, ATCC 20475Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
206Trichoderma harzianum RifaiSTRAIN:Trichoderma harzianum T-22;Culture collection No ATCC 20847STRAIN: Trichoderma harzianum ITEM 908;Culture collection No CBS 118749Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
207Trichoderma asperellum(formerly T. harzianum)STRAIN: ICC012Culture collection No CABI CC IMI 392716STRAIN: Trichoderma asperellum(formerly T. viride T25) T25Culture collection No CECT 20178STRAIN: Trichoderma asperellum(formerly T. viride TV1) TV1Culture collection No MUCL 43093Not applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
208Trichoderma gamsii (formerly T. viride)STRAINS:ICC080Culture collection No IMI CC number 392151 CABINot applicableNo relevant impurities1 May 200930 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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.
209Verticillium albo-atrum(formerly Verticillium dahliae)STRAIN: Verticillium albo-atrum isolate WCS850Culture collection No CBS 276.92Not applicableNo relevant impurities1 May 200930 April 2020PART AOnly uses as fungicide may be authorised.PART BFor 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.
210AbamectinCAS No 71751-41-2avermectin B1aCAS No 65195-55-3Avermectin B1bCAS No 65195-56-4abamectinCIPAC No 495AvermectinB1a(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-hexopyranosideAvermectinB1b(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/kg1 May 200930 April 2021PART AOnly uses as insecticide, acaricide and nematicide may be authorised.PART BIn 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.
211EpoxiconazoleCAS 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/kg1 May 200930 April 2020PART AOnly uses as fungicide may be authorised.PART BFor 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.
212FenpropimorphCAS No 67564-91-4CIPAC No 427(RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine≥ 930 g/kg1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
213FenpyroximateCAS No 134098-61-6CIPAC No 695tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate> 960 g/kg1 May 200930 April 2021PART AOnly 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 BFor 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.
214TralkoxydimCAS No 87820-88-0CIPAC No 544(RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one≥ 960 g/kg1 May 200930 April 2019PART AOnly uses as herbicide may be authorised.PART BFor 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.
215AclonifenCAS No 74070-46-5CIPAC No 4982-chloro-6-nitro-3-phenoxyaniline≥ 970 g/kgThe impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.1 August 200931 July 2022PART AOnly uses as herbicide may be authorised.PART BIn 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.
216ImidaclopridCAS No 138261-41-3CIPAC No 582(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine≥ 970 g/kg1 August 20091 December 2020PART AOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.PART BFor 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 revised addendum of the review report on imidacloprid as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.In this overall assessment Member States must pay particular attention to:the risk to bees and bumble bees released for pollination in permanent greenhouses,the impact on aquatic organisms,the exposure of bees via the consumption of contaminated water from the permanent greenhouses.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.Conditions of use shall include risk mitigation measures, where appropriate.
217MetazachlorCAS No 67129-08-2CIPAC No 4112-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide≥ 940 g/kgThe manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established.1 August 200931 July 2021PART AOnly 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 BFor 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.
218Acetic acidCAS No 64-19-7CIPAC 838acetic acid≥ 980 g/kg1 September 200931 August 2022PART AOnly uses as herbicide may be authorised.PART BFor 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.
219Aluminium ammonium sulphateCAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous)CIPAC No 840Aluminium ammonium sulphate≥ 960 g/kg (expressed as dodecahydrate)≥ 502 g/kg (anhydrous)1 September 200931 August 2021PART AOnly uses as repellent may be authorised.PART BFor 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.
220Aluminium silicateCAS No 1332-58-7CIPAC No 841Not availableChemical name: Aluminium silicate≥ 999,8 g/kg1 September 200931 August 2021PART AOnly uses as repellent may be authorised.PART BFor 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.
221Ammonium acetateCAS No 631-61-8CIPAC No not allocatedAmmonium acetate≥ 970 g/kgRelevant impurity: Heavy metals as Pb maximum 10 ppm1 September 200931 August 2019PART AOnly uses as attractant may be authorised.PART BFor 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 ammonium acetate (SANCO/2986/2008) 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.
222Blood mealCAS No: 90989-74-5CIPAC No: 909Not available≥ 990 g/Kg1 September 200931 August 2021PART AOnly uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 10Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.PART BIn assessing applications to authorise plant protection products containing blood meal for uses other than with direct application localised on individual 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 amended review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.
223Calcium carbideCAS No: 75-20-7CIPAC No: 910Calcium acetylide≥ 765 g/kgContaining 0,08 – 0,9 g/kg Calcium Phosphide1 September 200931 August 2022PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
224Calcium carbonateCAS No: 471-34-1CIPAC No: 843Calcium carbonate≥ 995 g/kg1 September 200931 August 2021PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards:further data on the specification of the technical material,analytical methods for the determination of calcium carbonate in the representative formulation and of the impurities in the technical material.These information shall be submitted to the Member States, the Commission and the Authority by 1 March 2013.
225Carbon dioxideCAS No: 124-38-9CIPAC No: 844Carbon dioxide≥ 99,9 %Relevant impurities:phosphane max. 0,3 ppm v/vbenzene max. 0,02 ppm v/vcarbon monoxide max. 10 ppm v/vmethanol max. 10 ppm v/vhydrogen cyanide max. 0,5 ppm v/v1 September 200931 August 2021PART AOnly uses as a fumigant may be authorised.PART BFor 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 carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
226Denathonium benzoateCAS No 3734-33-6CIPAC No 845Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate≥ 975g/kg1 September 20091 December 2020PART AOnly uses as repellent may be authorised.PART BIn assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, 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 denathonium benzoate (SANCO/2607/2008) 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.In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.Conditions of use shall include, where appropriate, risk mitigation measures.
227EthyleneCAS No 74-85-1CIPAC No 839Ethylene≥ 90 %Relevant impurity: ethylene oxide, max content 1 mg/kg1 September 200931 August 2022PART AOnly indoor uses as plant growth regulator by professional users may be authorised.PART BFor 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 ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the compliance of ethylene with the required specifications, irrespective of the form in which it is supplied to the user;(b)the protection of operators, workers and bystanders.Conditions of authorisation shall include, where appropriate, risk mitigation measures.
228Extract from tea treeCAS No Tea Tree Oil 68647-73-4Main components:terpinen-4-ol 562-74-3γ-terpinene 99-85-4α-terpinene 99-86-51,8-cineole 470-82-6CIPAC No 914Tea Tree Oil is a complex mixture of chemical substances.Main components:terpinen-4-ol ≥ 300 g/kgγ-terpinene ≥ 100 g/kgα-terpinene ≥ 50 g/kg1,8-cineole ≥ 1 g/kgRelevant impurity:Methyl eugenol: maximum 1 g/kg of the technical material1 September 200931 August 2021PART AOnly uses as fungicide in greenhouse may be authorised.PART BFor 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 extract from tea tree (SANCO/2609/2008 final) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention tothe protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the protection of surface water and aquatic organisms;the protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms.Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards:(a)the plant metabolism and consumer exposure;(b)the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol;(c)the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products;(d)the effects on biological methods of sewage treatment.The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 at latest.
229Fat distillation residuesCAS No: not allocatedCIPAC No 915Not available≥ 40 % of cleaved fatty acidsRelevant impurity: Ni maximum 200 mg/kg1 September 200931 August 2021PART AOnly uses as repellent may be authorised. Fat distillation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 (OJ L 54, 26.2.2011, p. 1).PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on fat distillation residues (SANCO/2610/2008) 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 the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.
230Fatty acids C7 to C20CAS No 112-05-0 (Pelargonic Acid)67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)124-07-2 (Caprylic Acid)334-48-5 (Capric Acid)143-07-7 (Lauric Acid)112-80-1 (Oleic Acid)85566-26-3 (Fatty acids C8-C10 Me esters)111-11-5 (Methyl octanoate)110-42-9 (Methyl decanoate)CIPAC No not allocatedNonanoic acidCaprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)Fatty acids, C7-C10, Me esters≥ 889 g/kg (Pelargonic Acid)≥ 838 g/kg fatty acids≥ 99 % fatty acid methyl esters1 September 200931 August 2021PART AOnly uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.PART BFor 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 fatty acids (SANCO/2610/2008) 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.
231Garlic extractCAS No 8008-99-9CIPAC No not allocatedFood grade garlic juice concentrate≥ 99,9 %1 September 200931 August 2021PART AOnly uses as repellent, insecticide and nematicide may be authorised.PART BFor 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 garlic extract (SANCO/2612/2008) 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.
232Gibberellic acidCAS No 77-06-5CIPAC No 307(3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acidAlt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid≥ 850 g/kg1 September 200931 August 2021PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 gibberellic acid (SANCO/2613/2008) 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.
233GibberellinsCAS No GA4: 468-44-0GA7: 510-75-8GA4A7 mixture: 8030-53-3CIPAC No not allocatedGA4:(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acidGA7:(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acidReview report (SANCO/2614/2008).1 September 200931 August 2021PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 gibberellins (SANCO/2614/2008) 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.
234Hydrolysed proteinsCAS No not allocatedCIPAC No 901Not availableReview report (SANCO/2615/2008)1 September 200931 August 2021PART AOnly uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 and Commission Regulation (EU) No 142/2011.PART BFor 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 hydrolysed proteins (SANCO/2615/08) 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 and worker safety; conditions of use shall include the application of adequate personal 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 specifications of the technical material, as commercially manufactured, supported by appropriate analytical data;(b)the risk to aquatic organisms.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013, the information set out in point (b) by 1 November 2013.
235Iron sulphate:Iron(II)sulfate anhydrous: CAS No 7720-78-7Iron(II)sulfate monohydrate: CAS No 17375-41-6Iron(II)sulfate heptahydrate: CAS No 7782-63-0CIPAC No 837Iron(II)sulphateoriron(2+) sulfateIron(II)sulfate anhydrous: ≥ 350 g/kg total iron.Relevant impurities:arsenic, 18 mg/kgcadmium, 1,8 mg/kgchromium, 90 mg/kglead, 36 mg/kgmercury, 1,8 mg/kgexpressed on the basis of the anhydrous variant1 September 200931 August 2021PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on iron sulphate (SANCO/2616/2008) 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.In this overall assessment Member States shall pay particular attention to:the risk for operator;the risk to children/residents playing on treated turf;the risk to surface waters and to aquatic organisms.Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers.The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013.
236Kieselgur (diatomaceous earth)CAS No 61790-53-2CIPAC No 647Kieselgur (no IUPAC name)Diatomaceous earthAmorphous silicon dioxideSilicaDiatomiteThe product consists of 100 % diatomaceous earth.Maximum 0,1 % of particles of crystalline silica with diameter below 50 μm1 September 200931 August 2021PART AOnly indoor uses as insecticide and acaricide by professional users may be authorised.PART BFor 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 kieselgur (diatomaceous earth) (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the safety of operators and workers. Conditions of use shall include the application of adequate personal and respiratory protective equipment. Where necessary, conditions of use shall prohibit the presence of workers after application of the product concerned for a period appropriate in view of the risks caused by that product.The Member States concerned shall ensure that the notifiers submit, by 25 November 2015, to the Commission, the Member States and the Authority information concerning the inhalation toxicity to confirm the occupational limits of kieselgur (diatomaceous earth).
237LimestoneCAS No: 1317-65-3CIPAC No: 852Calcium carbonate≥ 980 g/kg1 September 200931 August 2019PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
238Methyl nonyl ketoneCAS No 112-12-9CIPAC No 846Undecan-2-one≥ 985 g/kg1 September 200931 August 2019PART AOnly uses as repellent may be authorised.PART BFor 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 methyl nonyl ketone (SANCO/2619/2008) 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. Contact with food and feedcrops shall be avoided.The notifier shall submit confirmatory information as regards:(a)the specification of the material tested in the mammalian toxicology and ecotoxicology studies;(b)the specification with suporting batch data and validated methods of analysis;(c)an appropriate assessment of the fate and behaviour of methyl nonyl ketone and potential transformation products in the environment;(d)the risk to aquatic and to soil living organisms.The notifier shall submit to the Commission, the Member States and the Authority the information set out in points (a) and (b) by 30 April 2013 and the information set out in points (c) and (d) by 31 December 2015.
239Pepper dust extraction residue (PDER)CAS No: not allocatedCIPAC No: not allocatedSteam distilled and solvent extracted Black pepper – Piper nigrumIt is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %1 September 200931 August 2019PART AOnly uses as repellent may be authorised.PART BIn assessing applications to authorise plant protection products containing pepper dust extraction residue (PDER) for uses other than in home garden area, 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 amended review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measuresThe notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.
240Plant oils/citronella oilCAS No 8000-29-1CIPAC No 905Citronella Oil is a complex mixture of chemical substances.The main components are:Citronellal (3,7-dimethyl-6-octenal).Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).Citronellol (3,7-dimethyl-6-octan-2-ol).Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).The sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol.1 September 200931 August 2022PART AOnly uses as herbicide may be authorised.PART BFor 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 citronella oil (SANCO/2621/2008) 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.In this overall assessment Member States shall pay particular attention to:the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;the protection of groundwater, when the substance is applied in regions with vulnerable soil;the risk to non-target organisms.The notifier shall submit confirmatory information as regards:(a)the technical specification;(b)data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms;(c)the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol.The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016.
241Plant oils/clove oilCAS No 84961-50-2 (clove oil)97-53-0 (Eugenol — main component)CIPAC No 906Clove Oil is a complex mixture of chemical substances.The main component is eugenol.≥ 800 g/kgRelevant impurity: methyl eugenol maximum 0,1 % of the technical material1 September 200931 August 2022PART AOnly indoor uses as post-harvest fungicide and bactericide may be authorised.PART BFor 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 clove oil (SANCO/2622/2008) 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.In this overall assessment Member States shall pay particular attention to the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.The notifier shall submit confirmatory information as regards(a)the technical specification;(b)data comparing natural background exposure situations of plant oils/clove oil, eugenol and methyl eugenol in relation to exposure from the use of plant oils/clove oil as a plant protection product. This data shall cover human exposure.The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016.
242Plant oils/rape seed oilCAS No: 8002-13-9CIPAC No: not allocatedRape seed oilRape seed oil is a complex mixture of fatty acidsRelevant impurity: Maximum 2 % of erucic acid1 September 200931 August 2021PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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 rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
243Plant oils/spear mint oilCAS No 8008-79-5CIPAC No 908Spearmint oil≥ 550 g/kg as (R)-Carvone1 September 200931 August 2022PART AOnly uses as plant growth regulator for postharvest treatment of potatoes may be authorised.Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) 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.
244Potassium hydrogen carbonateCAS No 298-14-6CIPAC No 853Potassium hydrogen carbonate≥ 99,5 %Impurities:Pb max. 10 mg/kgAs max. 3 mg/kg1 September 200931 August 2021PART AOnly uses as fungicide and insecticide may be authorised.PART BFor 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 potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures.
2451,4-diaminobutane (putrescine)CAS No 110-60-1CIPAC No 854Butane-1,4-diamine≥ 990 g/kg1 September 200931 August 2019PART AOnly uses as attractant may be authorised.PART BFor 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 1,4-diaminobutane (putrescine) (SANCO/2626/08) 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.Conditions of use shall include, where appropriate, risk mitigation measures.
246Pyrethrins: 8003-34-7CIPAC No 32Extract A: extractives of Chrysanthemum cinerariaefolium:89997- 63-7Pyrethrin 1: CAS 121- 21-1Pyrethrin 2: CAS 121- 29-9Cinerin 1: CAS 25402- 06-6Cinerin 2: CAS 121- 20-0Jasmolin 1: CAS 4466- 14-2Jasmolin 2: CAS 1172- 63-0Extract B:Pyrethrin 1: CAS 121-21-1Pyrethrin 2: CAS 121- 29-9Cinerin 1: CAS 25402- 06-6Cinerin 2: CAS 121- 20-0Jasmolin 1: CAS 4466- 14-2Jasmolin 2: CAS 1172- 63-0Pyrethrins are a complex mixture of chemical substances.Extract A: ≥ 500 g/kg PyrethrinsExtract B: ≥ 480 g/kg Pyrethrins1 September 200931 August 2022PART AOnly uses as insecticide may be authorised.PART BFor 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 pyrethrins (SANCO/2627/2008) 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.In this overall assessment Member States shall pay particular attention to:(a)the risk to operators and workers;(b)the risk to non-target organisms.Conditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures.The applicant shall submit confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies;(2)the risk from inhalation;(3)the residue definition;(4)the representativeness of the major component "pyrethrin 1" as regards the fate and behaviour in soil and water.The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December 2015.
247Quartz sandCAS No: 14808-60-7, 7637-86-9CIPAC No: 855Quartz, Silicon dioxide≥ 915 g/kgMaximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)1 September 200931 August 2021PART AOnly uses as repellent may be authorised.PART BIn assessing applications to authorise plant protection products containing quartz sand for uses other than on trees in forestry, 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 of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) 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.
248Fish oilCAS No 100085-40-3CIPAC No 918Fish oil≥ 99 %Relevant impurity:Dioxine max. 6 pg/kg for animal feedHg max. 0,5 mg/kg feed derived from fish and other sea food processingCd max. 2 mg/kg feed of animal origin except in feed for domestic petsPb max. 10 mg/kgPCBs max. 5 mg/kg1 September 200931 August 2021PART AOnly uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.PART BFor 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 fish oil (SANCO/2629/2008) 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 the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.
249Repellents by smell of animal or plant origin/sheep fatCAS No 98999-15-6CIPAC No not allocatedSheep FatPure sheep fat containing a maximum of 0,18 % w/w/water.1 September 200931 August 2021PART AOnly uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1069/2009PART BFor 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 sheep fat (SANCO/2630/2008) 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.
250Repellents by smell of animal or plant origin/tall oil crude:CAS No 8002-26-4CIPAC No 911Not availableThe qualitative parameters below comprise the specification of repellents by smell of animal or plant origin/tall oil crude:acid number: min. 125 mgKOH/gwater content: max. 2 %rosin acid content: min. 35 % (proposed)ash content: max. 0,2 %pH: approx. min. 5,5unsaponifiables: max. 12 %free mineral acids: max. 0,02 %1 September 200931 August 2020PART AOnly uses as repellent applied by glove or brush may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on repellents by smell of animal or plant origin/tall oil crude (SANCO/2631/2008) 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.In assessing applications to authorise plant protection products containing Repellents by smell of animal or plant origin/tall oil crude for uses other than as a repellent in forestry, 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 information is provided before such an authorisation is granted.In this overall assessment Member States shall pay particular attention to:the protection of operator, worker and bystander;the risk to non target species.Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall request the submission of confirmatory information as regards:(a)the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;(b)the toxicological profile of repellents by smell of animal or plant origin/tall oil crude.The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.
251Repellents by smell of animal or plant origin/tall oil pitch:CAS No 8016-81-7CIPAC No 912Not availableComplex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids.1 September 200931 August 2020PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on repellents by smell of animal or plant origin/tall oil pitch (SANCO/2632/2008) 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.In assessing applications to authorise plant protection products containing repellents by smell of animal or plant origin/tall oil pitch for uses other than as a repellent in forestry applied by glove or brush, 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 information is provided before such an authorization is granted.In this overall assessment Member States shall pay particular attention to:the protection of operator, worker and bystander;the risk to non target species.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(a)the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;(b)the toxicological profile of repellents by smell of animal or plant origin/tall oil pitch.The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.
252Sea-algae extract (formerly sea algae extract and sea weeds)CAS No not allocatedCIPAC No not allocatedSee algae extractSee algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/20081 September 200931 August 2019PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 sea algae extract (SANCO/2634/2008) 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.
253Sodium aluminium silicateCAS No 1344-00-9CIPAC No not allocatedSodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O1000 g/kg1 September 200931 August 2019PART AOnly uses as repellent may be authorised.PART BFor 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 sodium aluminium silicate (SANCO/2635/2008) 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.
254Sodium hypochloriteCAS No: 7681-52-9CIPAC: 848Sodium hypochloriteSodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate10-12 % (w/w) expressed as chlorine1 September 200931 August 2019PART AOnly indoor uses as disinfectant may be authorised.PART BFor 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 sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to operator and workers;(b)the exposure of soil to sodium hypochlorite and its reaction products through spreading of treated compost on organic land shall be avoided.Conditions of use shall include risk mitigation measures, where appropriate.
255Straight Chain Lepidopteran PheromonesReview report (SANCO/2633/2008)Review report (SANCO/2633/2008)1 September 200931 August 2021PART AOnly uses as attractants may be authorised.PART BFor 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 straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards:(1)the genotoxic profile of aldehyde group compounds;(2)exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016.
256Trimethylamine hydrochlorideCAS No 593-81-7CIPAC No not allocatedTrimethylamine hydrochloride≥ 988 g/kg1 September 200931 August 2019PART AOnly uses as attractant may be authorised.PART BFor 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 trimethylamine hydrochloride (SANCO/2636/2008) 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.
257UreaCAS No 57-13-6CIPAC No 913Urea≥ 98 % w/w1 September 200931 August 2021PART AOnly uses as attractant and fungicide may be authorised.PART BFor 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 urea (SANCO/2637/2008) 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 analysis method for urea and for the impurity biuret;(b)the risk for operators, workers and bystanders.The information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016.
258Z-13-hexadecen-11-yn-1-yl acetateCAS No 78617-58-0CIPAC: 974Z-13-hexadecen-11-yn-1-yl acetate≥ 75 %1 September 200931 August 2019PART AOnly uses as attractant may be authorised.PART BFor 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 Z-13-hexadecen-11-yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured including information on any relevant impurities;(2)exposure risk assessment for operators, workers and bystanders;(3)environmental fate and behaviour of the substance;(4)exposure risk assessment for non-target organisms.The notifier shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2015 and the information set out in points (2), (3) and (4) by 31 December 2016.
259Z,Z,Z,Z-7,13,16,19- docosatetraen-1-yl isobutyrateCAS No 135459-81-3CIPAC: 973Z,Z,Z,Z-7,13,16,19- docosatetraen-1-yl isobutyrate≥ 90 %1 September 200931 August 2019PART AOnly uses as attractant may be authorised.PART BFor 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 Z,Z,Z,Z-7,13,16,19- docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured, including information on any relevant impurities;(2)exposure risk assessment for operators, workers and bystanders;(3)environmental fate and behaviour of the substance;(4)exposure risk assessment for non-target organisms.The notifier shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2015 and the information set out in points (2), (3) and (4) by 31 December 2016.
260Aluminium phosphideCAS No 20859-73-8CIPAC No 227Aluminium phosphide≥ 830 g/kg1 September 200931 August 2022PART AOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use aluminium phosphide containing products may be authorised.As rodenticide, talpicide and leporicide only outdoor uses may be authorised.Authorisations should be limited to professional users.PART BFor 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 phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;the protection of operators and workers during fumigation for indoor uses;the protection of workers at re-entry (after fumigation period) for indoor uses;the protection of bystanders against leaking of gas for indoor uses;the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.
261Calcium phosphideCAS No 1305-99-3CIPAC No 505Calcium phosphide≥ 160 g/kg1 September 20091 December 2020PART AOnly outdoor uses as rodenticide and talpicide in the form of ready-to-use calcium phosphide containing products may be authorised.Authorisations should be limited to professional users.PART BFor 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 calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 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 and respiratory protective equipment;the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.
262Magnesium phosphideCAS No 12057-74-8CIPAC No 228Magnesium phosphide≥ 880 g/kg1 September 200931 August 2022PART AOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use magnesium phosphide containing products may be authorised.As rodenticide, talpicide and leporicide only outdoor uses may be authorised.Authorisations should be limited to professional users.PART BFor 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 magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;the protection of operators and workers during fumigation for indoor uses;the protection of workers at re-entry (after fumigation period) for indoor uses;the protection of bystanders against leaking of gas for indoor uses;the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.
263CymoxanilCAS No 57966-95-7CIPAC No 4191-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea≥ 970 g/kg1 September 200931 August 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 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 the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.
264DodemorphCAS No 1593-77-7CIPAC No 300cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine≥ 950 g/kg1 September 200931 August 2022PART AOnly uses as fungicide on ornamentals in glasshouse may be authorised.PART BFor 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 dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 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 where appropriate;the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions;conditions of authorisation should include risk mitigation measures, where appropriate.
2652,5-Dichlorobenzoic acid methylesterCAS No 2905-69-3CIPAC No 686methyl-2,5-dichlorobenzoate≥ 995 g/kg1 September 200931 August 2022PART AOnly indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised.PART BFor 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 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
266MetamitronCAS No 41394-05-2CIPAC No 3814-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one≥ 960 g/kg1 September 200931 August 2022PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, 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 metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 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 personal protective equipment where appropriate;the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to birds and mammals, and non-target terrestrial plants.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.
267SulcotrioneCAS No 99105-77-8CIPAC No 7232-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione≥ 950 g/kgImpurities:hydrogen cyanide: not more than 80 mg/kgtoluene: not more than 4 g/kg1 September 200931 August 2022PART AOnly uses as herbicide may be authorised.PART BFor 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 sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 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 risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.
268TebuconazoleCAS No 107534-96-3CIPAC No 494(RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol≥ 905 g/kg1 September 200931 August 2021PART AOnly uses as fungicide and plant growth regulator may be authorised.PART BFor 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 tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 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 dietary exposure of consumers to the tebuconazole (triazole) metabolites;the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole;the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
269TriadimenolCAS No 55219-65-3CIPAC No 398(1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol≥ 920 g/kgisomer A (1RS,2SR), isomer B (1RS,2RS)Diastereomer A, RS + SR, range: 70 to 85 %Diastereomer B, RR + SS, range: 15 to 30 %1 September 200931 August 2019PART AOnly uses as fungicide may be authorised.PART BFor 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 triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure;the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission:further information on the specification;information to further address the risk assessment for birds and mammals.information to further address the risk of endocrine disrupting effects on fish.They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
270MethomylCAS No 16752-77-50CIPAC No 264S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate≥ 980 g/kg1 September 200931 August 2019PART AOnly uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season.Authorisations shall be limited to professional users.PART BFor 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 methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment,the protection of birds,the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles,the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied.Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents.Where appropriate, conditions of authorisation shall include further risk mitigation measures.
271BensulfuronCAS No 83055-99-6CIPAC No 502.201α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron)methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl)≥ 975 g/kg1 November 200931 October 2022PART AOnly uses as a herbicide may be authorised.PART BFor 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 bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to the following:the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions.The Member States concerned shall ensure that the notifier submits to the Commission:further studies on the specification,information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions,information to address the relevance of metabolites for the consumer risk assessment.They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
272Sodium 5-nitroguaiacolateCAS No 67233-85-6CIPAC number not allocatedSodium 2-methoxy-5-nitrophenolate≥ 980 g/kg1 November 200931 October 2022PART AOnly use as plant growth regulator may be authorised.PART BFor 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 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 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, where appropriate.The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
273Sodium o-nitrophenolateCAS No 824-39-5CIPAC number not allocatedSodium 2-nitrophenolate; sodium o-nitrophenolate≥ 980 g/kgThe following impurities are of toxicological concern:PhenolMax content: 0,1 g/kg2,4 dinitrophenolmax content: 0,14 g/kg2,6 dinitrophenolmax content: 0,32 g/kg1 November 200931 October 2022PART AOnly use as plant growth regulator may be authorised.PART BFor 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 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 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, where appropriate.The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
274Sodium p-nitrophenolateCAS No 824-78-2CIPAC number not allocatedSodium 4-nitrophenolate; sodium p-nitrophenolate≥ 998 g/kgThe following impurities are of toxicological concern:Phenolmax content: 0,1 g/kg2,4 dinitrophenolmax content: 0,07 g/kg2,6 dinitrophenolmax content: 0,09 g/kg1 November 200931 October 2022PART AOnly use as plant growth regulator may be authorised.PART BFor 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 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 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, where appropriate.The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
275TebufenpyradCAS No 119168-77-3CIPAC No 725N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide≥ 980 g/kg1 November 200931 October 2022PART AOnly uses as acaricide and insecticide may be authorised.PART BIn assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags 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 tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.The Member States concerned shall ensure that the notifier submits to the Commission:further information confirming that no relevant impurities are present,information to further address the risk to insectivorous birds.They shall ensure that the notifier provides such information to the Commission by 31 October 2011.
276ChlormequatCAS No 7003-89-6 (chlormequat)CAS No 999-81-5 (chlormequat chloride)CIPAC No 143 (chlormequat)CIPAC No 143.302 (chlormequat chloride)2-chloroethyltrimethylammonium (chlormequat)2-chloroethyltrimethylammonium chloride(chlormequat chloride)≥ 636 g/kgImpurities1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content)Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content)1 December 200930 November 2021PART AOnly uses as plant growth regulator on cereals and non edible crops may be authorised.PART BIn assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, 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 chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 birds and mammals.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.
277Copper compounds:1 December 200931 January 2019PART AOnly uses as bactericide and fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing copper for uses other than on tomatoes 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 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 copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009, shall be taken into account.In this overall assessment Member States shall 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 operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate,the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site.The notifiers shall present to the Commission, the Authority and the Member States a monitoring programme for vulnerable areas where the contamination of the soil and water (including sediments) by copper is a concern or may become one.That monitoring programme shall be submitted by 31 July 2015. The interim results of such monitoring programme shall be submitted as interim report to the Rapporteur Member State, the Commission and the Authority by 31 December 2016. Final results shall be submitted by 31 December 2017.
Copper hydroxideCAS No 20427-59-2CIPAC No 44.305Copper (II) hydroxide≥ 573 g/kg
Copper oxychlorideCAS No 1332-65-6 or 1332-40-7CIPAC No 44.602Dicopper chloride trihydroxide≥ 550 g/kg
Copper oxideCAS No 1317-39-1CIPAC No 44.603Copper oxide≥ 820 g/kg
Bordeaux mixtureCAS No 8011-63-0CIPAC No 44.604Not allocated≥ 245 g/kg
Tribasic copper sulphateCAS No 12527-76-3CIPAC No 44.306Not allocated≥ 490 g/kgThe following impurities are of toxicological concern and must not exceed the levels below (expressed in g/g):Lead max 0,0005 g/g of copper content;Cadmium max 0,0001 g/g of copper content;Arsenic max 0,0001 g/g of copper content.
278PropaquizafopCAS No 111479-05-1CIPAC No 1732-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate≥ 920 g/kgToluene maximum content 5 g/kg1 December 200930 November 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,the protection of non-target arthropods and ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.The Member States concerned shall ensure that the notifier submits to the Commission:further information on the relevant impurity Ro 41-5259,information to further address the risk to aquatic organisms and to non-target arthropods.They shall ensure that the notifier provides such information to the Commission by 30 November 2011.
279Quizalofop-P
Quizalofop-P-tefurylCAS No 119738-06-6CIPAC No 641.226(RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate≥ 795 g/kg1 December 200930 November 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.They shall ensure that the notifier provides such information to the Commission by 30 November 2011.
Quizalofop-P-ethylCAS No 100646-51-3CIPAC No 641.202ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate≥ 950 g/kg1 December 200930 November 2021
280TeflubenzuronCAS No 83121-18-0CIPAC No 4501-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea≥ 970 g/kg1 December 200930 November 2019PART AOnly uses as insecticide in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised.PART BIn assessing applications to authorise plant protection products containing teflubenzuron for uses other than on tomatoes 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 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 teflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to:the operator and workers safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate,the protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity,the protection of bees which should be prevented from accessing the glasshouse,the protection of pollinator colonies purposely placed in the glasshouse,the safe disposal of condensation water, drain water and substrate in order to preclude risks to non-target organisms and contamination of surface water and groundwater.Conditions of authorisation shall include risk mitigation measures, where appropriate.
281Zeta-cypermethrinCAS No 52315-07-8CIPAC No 733Mixture of the stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2 dimethylcyclopropanecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively≥ 850 g/kgImpurities:toluene: max 2 g/kgtars: max 12,5 g/kg1 December 20091 December 2020PART AOnly uses as insecticide may be authorised.PART BIn assessing applications to authorise plant protection products containing zeta-cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, 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 zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 protection of birds, aquatic organisms, bees, non-target arthropods and non-target soil macro-organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.
282ChlorsulfuronCAS No 64902-72-3CIPAC No 3911-(2-chlorophenylsulfonyl)-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea≥ 950 g/kgImpurities:2-Chlorobenzenesulfonamide (IN-A4097) not more than 5 g/kg and4-methoxy-6-methyl-1,3,5-triazin-2-amine (IN-A4098) not more than 6 g/kg1 January 201031 December 2019PART AOnly uses as herbicide may be authorised.PART BFor 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 chlorsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.The Member States concerned shall:ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.If chlorsulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-A4097, IN-A4098, IN-JJ998, IN-B5528 and IN-V7160 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.
283CyromazineCAS No 66215-27-8CIPAC No 420N-cyclopropyl-1,3,5-triazine-2,4,6-triamine≥ 950 g/kg1 January 201031 December 2019PART AOnly uses as insecticide in greenhouses may be authorised.PART BIn assessing applications to authorise plant protection products containing cyromazine for uses other than in tomatoes, notably as regards the exposure of consumers, 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 cyromazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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,the protection of aquatic organisms,the protection of pollinators.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite NOA 435343 and on the risk to aquatic organisms. They shall ensure that the notifier at whose request cyromazine has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.
284DimethachlorCAS No 50563-36-5CIPAC No 6882-chloro-N-(2-methoxyethyl)acet-2′,6′-xylidide≥ 950 g/kgImpurity 2,6-dimethylaniline: Not more than 0,5 g/kg1 January 201031 December 2021PART AOnly uses as herbicide in application max. of 1,0 kg/ha only every third year on the same field may be authorised.PART BFor 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 dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,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 metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate.The Member States concerned shall:ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.If dimethachlor is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.
285EtofenproxCAS No 80844-07-1CIPAC No 4712-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzylether≥ 980 g/kg1 January 201031 December 2021PART AOnly uses as insecticide may be authorised.PART BFor 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 etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,the protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate.The Member States concerned shall:ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification,the submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study).They shall ensure that the notifiers provide such studies to the Commission by 31 December 2011.
286LufenuronCAS No 103055-07-8CIPAC No 704(RS)-1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoro-propoxy)-phenyl]-3-(2,6-difluorobenzoyl)-urea≥ 970 g/kg1 January 201031 December 2019PART AOnly indoor uses or use in outdoor bait stations as insecticide may be authorised.PART BFor 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 lufenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to:the high persistency in the environment and the high risk for bioaccumulation and shall ensure that the use of lufenuron has no adverse long-term effects on non-target organisms,the protection of birds, mammals, soil non-target organisms, bees, non-target arthropods, surface waters and aquatic organisms in vulnerable situations.The Member States concerned shall:ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.
287PenconazoleCAS No 66246-88-6CIPAC No 446(RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole≥ 950 g/kg1 January 201031 December 2021PART AOnly uses as fungicides may be authorised.PART BFor 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 penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.
288Tri-allateCAS No 2303-17-5CIPAC No 97S-2,3,3-trichloroallyl di-isopropyl(thiocarbamate)≥ 940 g/kgNDIPA (Nitroso-diisopropylamine)max. 0,02 mg/kg1 January 201031 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 tri-allate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 dietary exposure of consumers to residues of tri-allate in treated crops as well as in succeeding rotational crops and in products of animal originthe protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,the potential for ground water contamination by the degradation products TCPSA when the active substance is applied in regions with vulnerable soil and/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 assess the primary plant metabolism,further information on the fate and behaviour of the soil metabolite diisopropylamine,further information on the potential for biomagnification in aquatic food chains,information to further address the risk to fish-eating mammals and the long-term risk to earthworms.They shall ensure that the notifier provides such information to the Commission by 31 December 2011.
289TriflusulfuronCAS No 126535-15-7CIPAC No 7312-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluic acid≥ 960 g/kg1 January 201031 December 2021PART AOnly uses as a herbicide may be authorised.PART BFor 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 triflusulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to:the dietary exposure of consumers to residues of metabolites IN-M7222 and IN-E7710 in succeeding rotational crops and in products of animal origin,the protection of aquatic organisms and aquatic plants from the risk arising from triflusulfuron and the metabolite IN-66036 and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,the potential for ground water contamination by the degradation products IN-M7222 and IN-W6725 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.If triflusulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-M7222, IN-D8526 and IN-E7710 with respect to cancer. They shall ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.
290DifenacoumCAS No 56073-07-5CIPAC No 5143-[(1RS,3RS;1RS,3SR)-3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl]-4-hydroxycoumarin≥ 905 g/kg1 January 201030 December 2019PART AOnly uses as rodenticide in the form of pre-prepared baits placed in specially constructed, tamper resistant and secured bait boxes are authorised.The nominal concentration of the active substance in the products shall not exceed 50 mg/kg.Authorisations shall be limited to professional users.PART BFor 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 difenacoum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of birds and non-target mammals from primary and secondary poisoning. Risk mitigation measures shall be applied where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on methods for the determination of residues of difenacoum in body fluids.They shall ensure that the notifier provides such information to the Commission by 30 November 2011.The Member States concerned shall ensure that the notifier submits to the Commission further information on the specification of the active substance as manufactured.They shall ensure that the notifier provides such information to the Commission by 31 December 2009.
291Didecyldimethylammonium chlorideCAS: not allocatedCIPAC: not allocatedDidecyldimethylammonium chloride is a mixture of alkyl-quaternary ammonium salts with typical alkyl chain lengths of C8, C10 and C12, with more than 90 % of C10≥ 70 % (Technical concentrate)1 January 201031 December 2019PART AOnly indoor uses for ornamental plants as bactericide, fungicide, herbicide and algaecide may be authorised.PART BFor 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 didecyldimethylammonium chloride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of the operator and worker safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,the protection of aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on the specification of the active substance as manufactured by 1 January 2010 and on the risk to aquatic organisms by 31 December 2011.
292sulphurCAS No 7704-34-9CIPAC No 18sulphur≥ 990 g/kg1 January 201031 December 2021PART AOnly uses as fungicide and acaricide may be authorised.PART BFor 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 sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 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 arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011.
293TetraconazoleCAS No 112281-77-3CIPAC No 726(RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether≥ 950 g/kg (racemic mixture)Impurity toluene: not more than 13 g/kg1 January 201031 December 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.The Member States concerned shall request:the submission of further information on a refined consumer risk assessment,further information on the specification regarding ecotoxicology,further information on the fate and behaviour of potential metabolites in all relevant compartments,the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods,further information on the potential for endocrine disrupting effects to birds, mammals and fish.They shall ensure that the notifier provides such information to the Commission by 31 December 2011.
294Paraffin oilsCAS No 64742-46-7CAS No 72623-86-0CAS No 97862-82-3CIPAC No n.a.paraffin oilEuropean Pharmacopoeia 6.01 January 201031 December 2021PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in particular Appendices I and II thereto shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall request:the submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0.They shall ensure that the notifiers provides such information to the Commission by 30 June 2010.
295Paraffin oilCAS No 8042-47-5CIPAC No n.a.paraffin oilEuropean Pharmacopoeia. 6,01 January 201031 December 2021PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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 paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall request:The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0They shall ensure that the notifier provides such information to the Commission by 30 June 2010.
296CyflufenamidCAS No 180409-60-3CIPAC No 759(Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide> 980 g/kg1 April 201031 March 2023PART AOnly uses as fungicide may be authorised.PART BFor 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 cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 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 shall include risk mitigation measures, where appropriate.
297FluopicolideCAS No239110-15-7CIPAC No 7872,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide≥ 970 g/kgThe impurity toluene must not exceed 3 g/kg in the technical material.1 June 201031 May 2023PART AOnly uses as fungicide may be authorised.PART BFor 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 fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.In this overall assessment, Member States must pay particular attention to:the protection of aquatic organisms,the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,to the risk to operators during application,the potential for long range transport via air.Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.
298HeptamaloxyloglucanCAS No870721-81-6CIPAC NoNot availableFull IUPAC name in footnote (1)Xyl p: xylopyranosylGlc p: glucopyranosylFuc p: fucopyranosylGal p: galactopyranosylGlc-ol: glucitol≥ 780 g/kgThe impurity Patulin must not exceed 50 μg/kg in the technical material.1 June 201031 May 2021PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.
2992-phenylphenol (including its salts such as the sodium salt)CAS No 90-43-7CIPAC No 246biphenyl-2-ol≥ 998 g/kg1 January 201031 December 2021PART AOnly uses as a post-harvest fungicide for indoor use may be authorised.PART BFor 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 2-phenylphenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009, as amended in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.In this overall assessment Member States must pay particular attention:to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment,to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out.The Member States concerned shall ensure that the notifier submits to the Commission:further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel,further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates.They shall ensure that the notifier provides such information to the Commission by 31 December 2011.Furthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers.They shall ensure that the notifier provides such information to the Commission by 31 December 2012.
300MalathionCAS No 121-75-5CIPAC No 12diethyl (dimethoxyphosphinothioylthio)succinateorS-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioateracemate≥ 950 g/kgImpurities:Isomalathion: not more than 2 g/kg1 May 201030 April 2022PART AOnly uses as an insecticide in greenhouses with a permanent structure may be authorised. Authorisations shall be limited to professional users.PART BFor 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 malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.In this overall assessment, Member States must pay particular attention to:(a)releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic organisms;(b)the protection of pollinator colonies purposely placed in the greenhouse;(c)the protection of operators and workers, so as to ensure that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;(d)the protection of consumers in the case of processed commodities.Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products.
301PenoxsulamCAS No 219714-96-2CIPAC No 7583-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-α,α,α-trifluorotoluene-2-sulfonamide> 980 g/kgThe impurityBis-CHYMP2-chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)hydrazino]-5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material1 August 201031 July 2023PART AOnly uses as herbicide may be authorised.PART BFor 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 penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention to:the protection of aquatic organisms,the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops,the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012.The Rapporteur Member State 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.
302ProquinazidCAS No 189278-12-4CIPAC No 7646-iodo-2-propoxy-3-propylquinazolin-4(3H)-one> 950 g/kg1 August 201031 July 2022PART AOnly uses as fungicide may be authorised.PART BFor 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 proquinazid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention:to the long-term risk to earthworm-eating birds for uses in grapevine,to the risk to aquatic organisms,the dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops,to the operator safety.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Rapporteur Member State 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.
303SpirodiclofenCAS No 148477-71-8CIPAC No 7373-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate> 965 g/kgThe following impurities must not exceed a certain amount in the technical material:3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4.5]dec-3-en-2-one (BAJ-2740 enol): ≤ 6 g/kgN,N-dimethylacetamide: ≤ 4 g/kg1 August 201031 July 2020PART AOnly uses as acaricide or insecticide may be authorised.PART BFor 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 spirodiclofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention:to the long-term risk to aquatic organisms,to the operator safety,to the risk to bee brood.Conditions of authorisation shall include risk mitigation measures, where appropriate.
304MetalaxylCAS No 57837-19-1CIPAC No 365Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate950 g/kgThe impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established.1 July 201030 June 2023PART AOnly uses as fungicide may be authorised.PART BFor 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, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.Member States must pay particular attention to the potential contamination of groundwater 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.
305Flonicamid (IKI-220)CAS No 158062-67-0CIPAC No 763N-cyanomethyl-4-(trifluoromethyl)nicotinamide≥ 960 g/kgThe impurity toluene must not exceed 3 g/kg in the technical material.1 September 201031 August 2023PART AOnly uses as insecticide may be authorised.PART BFor 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 flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account.In this overall assessment, Member States must pay particular attention to:the risk to operators and re-entry workers,the risk to bees.Conditions of authorisation 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.
306TriflumizoleCAS No 99387-89-0CIPAC No 730(E)-4-chloro-α,α,α-trifluoro-N-(1-imidazol-1-yl-2-propoxyethylidene)-o-toluidine≥ 980 g/kgImpurities:Toluene: not more than 1 g/kg1 July 201030 June 2020PART AOnly uses as fungicide in greenhouses on artificial substrates may be authorised.PART BFor 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 triflumizole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment,the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, as appropriate, risk mitigation measures.
307Sulfuryl fluorideCAS No 002699-79-8CIPAC No 757Sulfuryl fluoride> 994 g/kg1 November 201031 October 2023PART AOnly uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures may be authorised insofar:(a)these structures are empty; or(b)where food or feed commodities are present in a fumigated facility, the users and the food business operators ensure that only the food or feed commodities compliant with the existing maximum residue levels for sulfuryl fluoride and fluoride ion set by Regulation (EC) No 396/2005 of the European Parliament and of the Council may enter the food and feed chain; to this purpose, the users and the food business operators shall fully implement measures equivalent to the HACCP principles as laid down in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council; in particular, the users shall identify the critical control point at which control is essential to prevent maximum residue levels to be exceeded, and establish and implement effective monitoring procedures at that critical control point.PART BFor 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 sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 7 December 2016 shall be taken into account.In this overall assessment, Member States must pay particular attention to:the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that only products complying with the existing MRLs enter the food and feed chain;the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self-containing breathing apparatus or other appropriate personal protective equipment;the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure.Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit to the Commission, Member States and the Authority monitoring data on tropospheric concentrations of sulfuryl fluoride every fifth year, starting from 30 June 2017. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air).
308FEN 560 (also called fenugreek or fenugreek seed powder)CAS NoNoneCIPAC NoNoneThe active substance is prepared from the seed powder of Trigonella foenum-graecum L. (fenugreek).Not applicable100 % fenugreek seed powder without any additive and no extraction; the seed being of human food grade quality.1 November 201031 October 2020PART AOnly uses as elicitor of the crop's self-defence mechanisms may be authorised.PART BFor 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 FEN 560 (fenugreek seed powder), 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 operators, workers and bystanders.Conditions of authorisation shall include risk mitigation measures where appropriate.
309Haloxyfop-PCAS No Acid: 95977-29-0Ester: 72619-32-0CIPAC No Acid: 526Ester: 526.201Acid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy]propanoic acidEster: Methyl (R)-2-{}{4-[3-chloro-5-(trifluoromethyl)-2-pyridyloxy]phenoxy}}propionate≥ 940 g/kg(Haloxyfop-P-methyl ester)1 January 201131 December 2020PART AOnly uses as herbicide may be authorised at rates not exceeding 0,052 kg active substance per hectare per application, and only one application may be authorised every 3 years.PART BFor 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 haloxyfop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater from the relevant soil metabolite DE-535 pyridinone when the active substance is applied in regions with vulnerable soil and/or climatic conditions,the safety of operators and ensure that conditions of use prescribe the use of adequate personal protective equipment,the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,the consumer safety as regards the occurrence in groundwater of metabolite DE-535 pyridinol.
310NapropamideCAS No 15299-99-7(RS)-N,N-diethyl-2-(1-naphthyloxy)propionamide≥ 930 g/kg(Racemic mixture)Relevant impurityToluene: not more than 1,4 g/kg1 January 201131 December 2023PART AOnly uses as herbicide may be authorised.PART BFor 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 napropamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.In this overall assessment Member States shall pay particular attention to:operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary,protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,consumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter "NOPA".The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants.
311QuinmeracCAS No 90717-03-6CIPAC No 5637-chloro-3-methylquinoline-8-carboxylic acid≥ 980 g/kg1 May 201131 July 2024PART AOnly uses as herbicide may be authorised.PART BFor 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 quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 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 climatic conditions;the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational cropsthe risk to aquatic organisms and the long term risk for earthworms.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of information as regards:the potential of plant metabolism to result in an opening of the quinoline ring;residues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5.They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013.
312MetosulamCAS No 139528-85-1CIPAC No 7072′,6′-dichloro-5,7-dimethoxy-3′-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonanilide≥ 980 g/kg1 May 201130 April 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 metosulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 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 climatic conditions;the risk to aquatic organisms;the risk to non-target plants in the off-field area.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission, by 30 October 2011, further information on the specification of the active substance as manufactured.The Member States concerned shall ensure that the applicant submits to the Commission, by 30 April 2013, confirmatory information as regards:potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02;potential genotoxicity of one impurity.
313PyridabenCAS No 96489-71-3CIPAC No 5832-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one>980 g/kg1 May 201130 April 2023PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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 pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall 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 and mammals,the risk to non target arthropods including honeybees.Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.The Member States concerned shall request the submission of confirmatory information as regards:the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,the potential long term risk for mammals,the assessment of fat soluble residues.They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.
314Zinc phosphideCAS No 1314-84-7CIPAC No 69Trizinc diphosphide≥ 800 g/kg1 May 201131 July 2024PART AOnly uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations may be authorised.PART BFor 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 zinc phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States should pay particular attention to:the protection of non target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed.
315FenbuconazoleCAS No 114369-43-6CIPAC No 694(R,S) 4-(4-chlorophenyl)-2-phenyl-2-(1H-1,2,4-triazol-1-ylmethyl)butyronitrile≥ 965 g/kg1 May 201130 April 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 fenbuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall 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 residues of triazole derivative metabolites (TDMs),the risk to aquatic organisms and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory data on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin.They shall ensure that the applicant provides such studies to the Commission by 30 April 2013.The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of fenbuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
316CycloxydimCAS No 101205-02-1CIPAC No 510(5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)-thian-3-yl]cyclohex-2-en-1-one≥ 940 g/kg1 June 201131 May 2023PART AOnly uses as herbicide may be authorised.PART BFor 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 cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products.The Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013.
3176-BenzyladenineCAS No 1214-39-7CIPAC No 829N6-benzyladenine≥ 973 g/kg1 June 201131 August 2024PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 6-benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate.
318BromuconazoleCAS No 116255-48-2CIPAC No 6801-[(2RS,4RS:2RS,4SR)-4-bromo-2-(2,4-dichlorophenyl)tetrahydrofurfuryl]-1H-1,2,4-triazole≥ 960 g/kg1 February 201131 January 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 bromuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment, Member States shall pay particular attention to:operator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones.The Member States concerned shall ensure that the applicant presents to the Commission:further information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;information to further address the long term risk to herbivorous mammals.They shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31 January 2013 at the latest.The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
319MyclobutanilCAS No 88671-89-0CIPAC No 442RS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile≥ 925 g/kgThe impurity 1-methylpyrrolidin-2-one shall not exceed 1 g/kg in the technical material1 June 201131 May 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 myclobutanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.
320BuprofezinCAS No 953030-84-7CIPAC No 681(Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one≥ 985 g/kg1 February 201131 January 2023PART AOnly uses as insecticide and acaricide on non-edible crops may be authorised.PART BFor 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 buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.In this overall assessment, Member States must pay particular attention to:the operators' and workers' safety and ensure that conditions of use impose the use of adequate personal protective equipment where appropriate,the application of an appropriate waiting period for rotational crops in greenhouses,the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate.Conditions of authorisation shall include risk mitigation measures, where appropriate.
321TriflumuronCAS No 64628-44-0CIPAC No: 5481-(2-chlorobenzoyl)-3-[4-trifluoromethoxyphenyl]urea≥ 955 g/kgImpurities:N,N′-bis-[4-(trifluoromethoxy)phenyl]urea: not more than 1 g/kg4-trifluoro-methoxyaniline: not more than 5 g/kg1 April 201131 March 2021PART AOnly uses as insecticide may be authorised.PART BFor 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 triflumuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment, Member States shall pay particular attention to:the protection of the aquatic environment;the protection of honey bees. Conditions of authorisation shall include risk mitigation measures, where appropriate.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards the long-term risk to birds, the risk to aquatic invertebrates and the risk to bee brood development.The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 March 2013.
322HymexazolCAS No 10004-44-1CIPAC No 5285-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol)≥985 g/kg1 June 201131 May 2023PART AOnly uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities may be authorised.PART BFor 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 hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate,the risk to granivorous birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
323DodineCAS No 2439-10-3CIPAC No 1011-dodecylguanidinium acetate≥ 950 g/kg1 June 201131 August 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the potential long-term risk to birds and mammals;the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures;the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures;the monitoring of residue levels in pome fruit.The Member States concerned shall request the submission of confirmatory information as regards:long-term risk assessment for birds and mammals,risk assessment in natural surface water systems where major metabolites have potentially formed.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
324DiethofencarbCAS No 87130-20-9CIPAC No 513isopropyl 3,4-diethoxycarbanilate≥ 970 g/kgImpurities:Toluene: not more than 1 g/kg1 June 201131 May 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 diethofencarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target arthropods and shall ensure that conditions of use include the application of adequate risk mitigation measures.The Member States concerned shall request the submission of confirmatory information as regards:the potential uptake of the metabolite 6-NO2-DFC in succeeding crops;the risk assessment for non-target arthropod species.The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.
325EtridiazoleCAS No 2593-15-9CIPAC No 518ethyl-3-trichloromethyl-1,2,4-thiadiazol-5-yl ether≥ 970 g/kg1 June 201131 May 2021PART AOnly uses as fungicide in non-soil bound systems in greenhouse may be authorised.PART BIn assessing applications to authorise plant protection products containing etridiazole for uses other than on ornamental 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 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 etridiazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall:pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of appropriate risk mitigation measures;ensure that appropriate waste management practices are applied as regards waste water from irrigation of non-soil bound growing systems; Member States permitting the release of waste water into the sewage system or into natural water bodies, shall ensure that an appropriate risk assessment is carried out;pay particular attention to the risk to aquatic organisms and ensure that conditions of use include the application of appropriate risk mitigation measures.The Member States concerned shall request the submission of confirmatory information as regards:1.the specification of the technical material, as commercially manufactured, by appropriate analytical data;2.the relevance of the impurities;3.the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the ecotoxicity dossiers;4.the relevance of the plant metabolites 5-hydroxy-ethoxyetridiazole acid and 3-hydroxymethyletridiazole;5.indirect exposure of groundwater and soil-dwelling organisms to etridiazole and to its soil metabolites dichloro-etridiazole and etridiazole acid;6.long-range and short-range transport through the atmosphere of etridiazole acid.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 30 November 2011 and the information set out in points (4), (5) and (6) by 31 May 2013.
326Indolylbutyric acidCAS No 133-32-4CIPAC No 8304-(1H-indol-3-yl)butyric acid≥ 994 g/kg1 June 201131 May 2023PART AOnly uses as plant growth regulator in ornamentals may be authorised.PART BFor 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 indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operators and workers safety. Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure.The Member States concerned shall request the submission of further information to confirm:the absence of clastogenicity potential of indolylbutyric acid;the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study;the natural background concentration of indolylbutyric acid in the soil.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
327OryzalinCAS No 19044-88-3CIPAC No 5373,5-dinitro-N4,N4-dipropylsulfanilamide≥ 960 g/kgN-nitrosodipropylamine:≤ 0,1 mg/kgToluene: ≤ 4 g/kg1 June 201131 May 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 oryzalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the operator safety and ensure that conditions of use include the application of adequate personal protective equipment;the protection of aquatic organisms and non target plants;the protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to herbivorous birds and mammals;the risk to bees, in the flowering season.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolites OR13 and OR15 in vulnerable zones, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12;(2)the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;(3)the risk assessment for aquatic organisms;(4)the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, if oryzalin is classified under Regulation (EC) No 1272/2008 as "suspected of causing cancer".The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013. The information set out in point (4) shall be submitted within six month of notification of a decision classifying oryzalin.
328Tau-fluvalinateCAS No 102851-06-9CIPAC No 786(RS)-α-cyano-3-phenoxybenzyl N-(2-chloro- α,α α- trifluoro-p-tolyl)-D-valinate(Isomer ratio 1:1)≥ 920 g/kg(1:1 ratio of R-α-cyano and S-α-cyano isomers)Impurities:Toluene: not more than 5 g/kg1 June 201131 August 2024PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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 tau-fluvalinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures;the risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures;the test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured.The Member States concerned shall request the submission of confirmatory information as regards:the risk of bioaccumulation/biomagnification in the aquatic environment;the risk to non-target arthropods;The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.The Member States concerned shall ensure that the applicant submits confirmatory information, two years after the adoption of specific guidance, as regards:the possible impact on the environment of the potential enantio-selective degradation in environmental matrices.
329ClethodimCAS No 99129-21-2CIPAC No 508(5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one≥ 930 g/kgImpurities:toluene max. 4 g/kg1 June 201131 May 2023PART AOnly uses as herbicide may be authorised.PART BFor 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 clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 December 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures.The Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards:the soil and groundwater exposure assessments,the residue definition for risk assessment.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
330BupirimateCAS No 41483-43-6CIPAC No 2615-butyl-2-ethylamino-6-methylpyrimidine-4-yl dimethylsulfamate≥ 945 g/kgImpurities:Ethirimol: max. 2 g/kgToluene: max. 3 g/kg1 June 201131 August 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 bupirimate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,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 mitigations, where appropriate,the in-field risk to non-target arthropods.The Member States concerned shall request the submission of confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured, by appropriate analytical data; including information on the relevance of the impurities,(2)the equivalence between the specifications of the technical material; as commercially manufactured, and those of the test material used in the toxicity dossiers,(3)the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B.The Member States concerned shall ensure that the applicant submits such confirmatory data and information to the Commission set out in point (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013.
331Fenbutatin oxideCAS No 13356-08-6CIPAC No 359bis[tris(2-methyl-2-phenylpropyl)-tin]oxide≥ 970 g/kgImpurities:bis[hydroxybis(2-methyl-2-phenylpropyl)tin]oxide (SD 31723): not more than 3 g/kg1 June 201131 May 2021PART AOnly uses as acaricide in greenhouses may be authorised.PART BFor 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 fenbutatin oxide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the technical specification of the impurity content,the residue levels in small tomato varieties (cherry tomatoes),the operator safety. Conditions of use shall prescribe the application of adequate personal protective equipment, where appropriate;the risk to aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of information confirming the results of the risk assessment, on the basis of most recent scientific knowledge, as regards the impurity SD 31723. That information shall concern the following points:genotoxicological potential;ecotoxicological relevance;spectra, storage stability and methods of analysis in the formulation.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
332FenoxycarbCAS No 79127-80-3CIPAC No: 425Ethyl 2-(4-phenoxyphenoxy)ethyl carbamate≥ 970 g/kgImpurities:Toluene: max. 1 g/kg1 June 201131 May 2021PART AOnly uses as insecticide may be authorised.PART BFor 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 fenoxycarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,the risk to bees and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of information confirming the risk assessment for non-target arthropods and for bee brood.The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.
3331-decanolCAS No 112-30-1CIPAC No 831Decan-1-ol≥ 960 g/kg1 June 201131 August 2024PART AOnly uses as plant growth regulator may be authorised.PART BFor 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-decanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to consumers from residues in case of use on food or feed crops;the risk for operator and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms;the risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application.Risk mitigation measures shall be applied, where appropriate.The Member States concerned shall request the submission of confirmatory information, as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
334IsoxabenCAS No 82558-50-7CIPAC No 701N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide≥ 910 g/kgToluene: ≤ 3 g/kg1 June 201131 August 2024PART AOnly uses as herbicide may be authorised.PART BFor 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 isoxaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, the risk to non-target terrestrial plants and the potential leaching of metabolites to groundwater.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(a)the specification of the technical material, as commercially manufactured,(b)the relevance of the impurities;(c)the residues in rotational crops;(d)the potential risk to aquatic organisms.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a) and (b) by 30 November 2011 and the information set out in points (c) and (d) by 31 May 2013.
335FluometuronCAS No: 2164-17-2CIPAC No: 1591,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea≥ 940 g/kg1 June 201131 August 2024PART AOnly uses as herbicide on cotton may be authorised.PART BFor 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 fluometuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall:pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate;pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards:(a)the toxicological properties of the plant metabolite trifluoroacetic acid;(b)the analytical methods for the monitoring of fluometuron in air;(c)the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water;(d)the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as "suspected of causing cancer".The Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within six months from the notification of the decision classifying fluometuron.
336CarbetamideCAS No 16118-49-3CIPAC No 95(R)-1-(Ethylcarbamoyl)ethyl carbanilate≥ 950 g/kg1 June 201131 May 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 carbetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(b)the risk to non-target plants;(c)the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
337CarboxinCAS No 5234-68-4CIPAC No 2735,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide≥ 970 g/kg1 June 201131 May 2021PART AOnly uses as fungicide for seed treatment may be authorised.Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.PART BFor 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 carboxin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to operators;the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(a)the specification of the technical material, as commercially manufactured, -including appropriate analytical data-;(b)the relevance of the impurities;(c)comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;(d)analytical methods for the monitoring of the metabolite M6 in soil, groundwater and surface water and for the monitoring of metabolite M9 in groundwater;(e)additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 and P/V-55,(f)rotational crop metabolism,(g)the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals;(h)the relevance for ground water of the soil metabolites P/V-54, P/V-55 and M9 if carboxin is classified under Regulation (EC) No 1272/2008 as "suspected of causing cancer"The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a), (b) and (c) by 30 November 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) six months after the notification of decision classifying carboxin.
338CyproconazoleCAS No 94361-06-5CIPAC No 600(2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol≥ 940 g/kg1 June 201131 May 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 cyproconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(a)the toxicological relevance of the impurities in the technical specification;(b)analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues;(c)residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;(d)the long term risk to herbivorous mammals;(e)the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b), (c) and (d) by 31 May 2013 and the information set out in point (e) two years after the adoption of specific guidance.
339DazometCAS No 533-74-4CIPAC No 1463,5-dimethyl-1,3,5-thiadiazinane-2-thioneortetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione≥ 950 g/kg1 June 201131 May 2023PART AOnly uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year.PART BFor 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 dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to operators, workers and bystanders;the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(a)the potential groundwater contamination by methyl isothiocyanate;(b)the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks;(c)the acute risk to insectivorous birds;(d)the long term risk to birds and mammals.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.
340MetaldehydeCAS No 108-62-3 (tetramer)9002-91-9 (homopolymer)CIPAC No 62r-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane≥ 985 g/kgacetaldehyde max. 1,5 g/kg1 June 201131 May 2023PART AOnly uses as molluscicide may be authorised.PART BFor 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 metaldehyde, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to operators and workers;the dietary exposure situation of consumers in view of future revisions of maximum residue levels;the acute risk and long term risk to birds and mammals.Member States shall ensure that authorisations shall contain an effective dog repellent agent.Conditions of use shall include risk mitigation measures, where appropriate.
341SintofenCAS No 130561-48-7CIPAC No 7171-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid≥ 980 g/kgImpurities:2-methoxyethanol, not more than 0,25 g/kgN,N-dimethylformamide, not more than 1,5 g/kg1 June 201131 August 2024PART AOnly uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption may be authorised.PART BFor 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 sintofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain.The Member States concerned shall request the submission of confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;(2)the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide;(3)the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material;(4)the metabolic profile of sintofen in rotational crops.The Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 30 November 2011 and the information set out in point (4) by 31 May 2013.
342FenazaquinCAS No 120928-09-8CIPAC No 6934-tert-butylphenethyl quinazolin-4-yl ether≥ 975 g/kg1 June 201131 May 2023PART AOnly uses as acaricide in greenhouses may be authorised.PART BFor 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 fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011, and of the addendum to the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 22 March 2018, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of aquatic organisms;(b)the protection of operators, also ensuring that the conditions of the use include the application of adequate personal protective equipment;(c)the protection of bees;(d)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;(e)the risk to consumers, in particular from the residues generated during processing;(f)the conditions of use to avoid exposure to residues of fenazaquin with respect to crops for human and animal consumption.Conditions of use shall include risk mitigation measures, where appropriate.
343AzadirachtinCAS No 11141-17-6 (azadirachtin A)CIPAC No 627 (azadirachtin A)Azadirachtin A:dimethyl (2aR,3S,4S,4aR,5S,7aS,8S,10R,10aS,10bR)-10-acetoxy-3,5-dihydroxy-4-[(1aR,2S,3aS,6aS,7S,7aS)-6a-hydroxy-7a-methyl-3a,6a,7,7a-tetrahydro-2,7-methanofuro[2,3-b]oxireno[e]oxepin-1a(2H)-yl]-4-methyl-8-{[(2E)-2-methylbut-2-enoyl]oxy}octahydro-1H-naphtho[1,8a-c:4,5-b′c′]difuran-5,10a(8H)-dicarboxylate.Expressed as azadirachtin A:≥ 111 g/kgSum of the aflatoxins B1, B2, G1, G2 must not exceeding 300 μg/kg of the azadirachtin A content.1 June 201131 August 2024PART AFor 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 azadirachtin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 and of the addendum to the review report on azadirachtin, and in particular Appendices I and II thereto, as finalised by the Standing Committee on Plants, Animals, Food and Feed on 17 July 2020 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(1)the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;(2)the protection of non-target arthropods and aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.PART BFor 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 azadirachtin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;the protection of non target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment.The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013.
344DiclofopCAS No 40843-25-2 (parent)CAS No 257-141-8 (diclofop-methyl)CIPAC No 358 (parent)CIPAC No 358.201 (diclofop-methyl)Diclofop(RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acidDiclofop-methylmethyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate≥ 980 g/kg (expressed as diclofop-methyl)1 June 201131 May 2023PART AOnly uses as herbicide may be authorised.PART BFor 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 diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall:pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment;pay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied.The Member States concerned shall request the submission of confirmatory information as regards:(a)a metabolism study on cereals;(b)an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest two years after the adoption of a specific guidance document on evaluation of isomers mixtures.
345Lime sulphurCAS No 1344 - 81 - 6CIPAC No 17Calcium polysulfide≥ 290 g/Kg.1 June 201131 August 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 lime sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:operator safety and shall ensure that the conditions of authorisation include appropriate protective measures;to the protection of aquatic organisms and non target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate.
346Aluminium sulfateCAS No 10043-01-3CIPAC not availableAluminium sulfate970 g/kg1 June 201131 August 2024PART AOnly indoor uses as post-harvest bactericide for ornamental plants may be authorised.PART BFor 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 sulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.The Member States concerned shall request the submission of confirmatory information as regards the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data.The Member States concerned shall ensure that the applicant submits such information to the Commission by 30 November 2011.
347BromadioloneCAS No 28772-56-7CIPAC No 3713-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin≥ 970 g/kg1 June 201131 May 2021PART AOnly uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels may be authorised.The nominal concentration of the active substance in the plant protection products shall not exceed 50 mg/kg.Authorisations shall be granted for uses by professional users only.PART BFor 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 bromadiolone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall:pay particular attention to the risk to professional operators and ensure that conditions of use include the application of adequate personal protective equipment where appropriate;pay particular attention to the risk to birds and non-target mammals from primary and secondary poisoning.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(a)the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data;(b)the relevance of the impurities;(c)the determination of bromadiolone in water with a limit of quantification of 0,01 μg/l;(d)the effectiveness of proposed mitigation measures to reduce risk to birds and non-target mammals;(e)the groundwater exposure assessment in respect of metabolites.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 30 November 2011 and the information set out in points (d) and (e) by 31 May 2013.
348PaclobutrazolCAS No 76738-62-0CIPAC No 445(2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol≥ 930 g/kg1 June 201131 May 2023PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 paclobutrazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured;(2)the analytical methods in soil and surface water for the metabolite NOA457654;(3)the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;(4)the potential endocrine disrupting properties of paclobutrazol;(5)the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance.
349PencycuronCAS No 66063-05-6CIPAC No 4021-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea≥ 980 g/kg1 June 201131 May 2021PART AOnly uses as fungicide may be authorised.PART BFor 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 pencycuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of large omnivorous mammals.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(1)the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of pencycuron;(2)the fate and behaviour in natural surface water and sediment systems of the chlorophenyl and phenyl portions of pencycuron;(3)the long-term risk to large omnivorous mammals.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 31 May 2013.
350TebufenozideCAS No 112410-23-8CIPAC No 724N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide≥ 970 g/kgRelevant impurityt-butyl hydrazine < 0,001 g/kg1 June 201131 August 2024PART AOnly uses as insecticide may be authorised.PART BFor 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 tebufenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall:pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment;pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;pay particular attention to the protection of aquatic organism and ensure that conditions of use prescribe adequate mitigation measures;pay particular attention to the risk to Lepidoptera non-target insects.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information, as regards:(1)the relevance of metabolites RH-6595, RH-2651, M2;(2)the degradation of tebufenozide in anaerobic soils and soils of alkaline pH.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013.
351DithianonCAS No 3347-22-6CIPAC No 1535,10-dihydro-5,10-dioxonaphtho[2,3-b]-1,4-dithiine-2,3-dicarbonitrile≥ 930 g/kg1 June 201131 August 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 dithianon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 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 risk mitigation measures, where appropriate,pay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate,pay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:the storage stability and the nature of residues in processed products,the aquatic and groundwater exposure assessment for phthalic acid,the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.
352HexythiazoxCAS No 78587-05-0CIPAC No 439(4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide≥ 976 g/kg(1:1 mixture of (4R, 5R) and (4S, 5S))1 June 201131 August 2024PART AOnly uses as acaricide may be authorised.PART BFor 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 hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 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 risk mitigation measures, where appropriate;the operators and workers safety. Conditions of use shall include protective measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:(a)the toxicological relevance of the metabolite PT-1-3;(b)the potential occurrence of the metabolite PT-1-3 in processed commodities;(c)the potential adverse effects of hexythiazox on bee brood;(d)the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) two years after the adoption of specific guidance.
353FlutriafolCAS No 76674-21-0CIPAC No 436(RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol≥ 920 g/kg(racemate)Relevant impurities:dimethyl sulphate: max content 0,1 g/kgdimethylformamide: max content 1 g/kgmethanol: max content 1 g/kg1 June 201131 August 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 flutriafol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall:pay particular attention to the protection of the workers’ safety and ensure that conditions of use include the application of adequate personal protective equipment;pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;pay particular attention to the long-term risk to insectivorous birds.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:(a)the relevance of the impurities present in the technical specifications;(b)the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;(c)the long-term risk to insectivorous birds.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b) and (c) by 31 May 2013.
354FlurochloridoneCAS No 61213-25-0CIPAC No 430(3RS,4RS;3RS,4SR)-3-chloro-4-chloromethyl-1-(α,α,α-trifluoro-m-tolyl)-2-pyrrolidone≥ 940 g/kg.Relevant impurities:Toluene: max 8 g/kg1 June 201131 May 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 flurochloridone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 February 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:1.the risk for non-target plants and aquatic organisms;2.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, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission further confirmatory information as regards:1.the relevance of impurities other than toluene;2.the compliance of ecotoxicological test material with the technical specifications;3.the relevance of the groundwater metabolite R42819;4.the potential endocrine disrupting properties of flurochloridone.The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 1 December 2011, the information set out in point (3) by 31 May 2013 and the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption.
PART BActive substances approved under Regulation (EC) No 1107/2009General provisions applying to all substances listed in this Part: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.
Further details on identity and specification of active substance are provided in the review report.2-hydroxy-4,6-dimethoxypyrimidine.2,4-dihydroxy-6-methoxypyrimidine.sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.5-(trifluoromethyl)-2(1H)-pyridinone.4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol.3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid.2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene.4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid.3-phenoxybenzaldehyde.Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid.3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1H-pyrazole-4-carboxylic acid.3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid.p-methyl-phenethylamine.OJ L 353, 31.12.2008, p. 1.Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33).https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdfGuidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN.Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311
NumberCommon Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
1BispyribacCAS No125401-75-4CIPAC No7482,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid≥ 930 g/kg (referred to as bispyribac-sodium)1 August 201131 July 2023PART AOnly uses as herbicide in rice may be authorised.PART BFor 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 bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 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 climatic conditions.Conditions of authorisation shall include risk mitigation measures where appropriate.The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03, M04 and M10.They shall ensure that the applicant provides such information to the Commission by 31 July 2013.
2ProfoxydimCAS No 139001-49-3CIPAC No 6212 - [(1 E/Z) - [(2 R S) – 2 - (4 – chlorophenoxy) propoxyimino] butyl] – 3 – hydroxy – 5 - [(3 R S; 3 S R) – tetrahydro – 2 H – thiopyran – 3 – yl] cyclohex – 2 - enone≥ 940 g/kg1 August 201131 July 2021PART AOnly uses as herbicide in rice may be authorised.PART BFor 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 profoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 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 climatic conditions,the long-term risk to non-target organisms.Conditions of authorisation shall include risk mitigation measures where appropriate.
3AzimsulfuronCAS No 120162-55-2CIPAC No 5841-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea≥ 980 g/kgmaximum level of the impurity phenol 2 g/kg1 January 201231 December 2021PART AOnly uses as herbicide may be authorised.Aerial applications may not be authorised.PART BFor 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 azimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(1)the protection of non-target plants;(2)the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions;(3)the protection of aquatic organisms.Member States shall ensure that the conditions of authorisation include risk mitigation measures, where appropriate (e.g. buffer zones, in rice cultivation minimum holding periods for water prior to discharge).The notifier shall submit confirmatory information as regards:(a)the risk assessment on aquatic organisms;(b)the identification of the degradation products in the aqueous photolysis of the substance.The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
4AzoxystrobinCAS No 131860-33-8CIPAC No 571methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate≥ 930 g/kgToluene maximum content 2 g/kgZ-isomer maximum content 25 g/kg1 January 201231 December 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(1)the fact that the specification of the technical material as commercially manufactured 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;(2)the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(3)the protection of aquatic organisms.The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
5ImazalilCAS No 35554-44-073790-28-0 (replaced)CIPAC No 335(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazoleorallyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether≥ 950 g/kg1 January 201231 December 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall:(1)pay particular attention to the fact that the specification of the technical material as commercially manufactured 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;(2)pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels;(3)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;(4)ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out;(5)pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals.Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards:(a)route of degradation of imazalil in soil and surface water systems;(b)environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible;(c)a hydrolysis study to investigate the nature of residues in processed commodities.The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
6ProhexadioneCAS No 127277-53-6 (prohexadione-calcium)CIPAC No 567 (prohexadione)No 567.020 (prohexadione-calcium)3,5-dioxo-4-propionylcyclohexanecarboxylic acid≥ 890 g/kg(expressed as prohexadione-calcium)1 January 201231 December 2022PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
7SpiroxamineCAS No 1181134-30-8CIPAC No 5728-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO)≥ 940 g/kg(diastereomers A and B combined)1 January 201231 December 2023PART AOnly uses as fungicide may be authorised.PART BFor 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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(1)the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;(2)the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(3)the risk to aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards:(a)the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment;(b)the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;(c)the groundwater exposure assessment for metabolite M03;(d)the risk to aquatic organisms.The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.
8Kresoxim-methylCAS No 143 390-89-0CIPAC No 568methyl (E)-methoxyimino[a-(o-tolyloxy)-o-tolyl]acetate≥ 910 g/kgMethanol: max. 5 g/kgMethyl chloride: max. 1 g/kgToluene: max. 1 g/kg1 January 201231 December 2024PART AOnly uses as fungicide may be authorised.PART BFor 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 kresoxim-methyl and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.Member States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures.The applicant shall submit confirmatory information as regards:Groundwater exposure risk assessment, and in particular:on the lysimeter study to support the statement that the two unidentified peaks observed do not correspond to metabolites individually exceeding the trigger value of 0,1 μg/L,on the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L,on a groundwater exposure risk assessment for the late application in apples, pears and grapes.The applicant shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
9FluroxypyrCAS No 69377-81-7CIPAC No 4314-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid≥ 950 g/kg (fluroxypyr-meptyl)The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material:N-methyl-2-pyrrolidone (NMP): < 3 g/kg1 January 201231 December 2024PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised 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 potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil or with vulnerable climatic conditions;the risk to aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.
10TefluthrinCAS No: 79538-32-2CIPAC No: 4512,3,5,6-tetrafluoro-4-methylbenzyl (1RS, 3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylateTefluthrin is a 1:1 mixture of Z-(1R, 3R) and Z-(1S, 3S) enantiomers.≥ 920 g/kgHexachlorobenzene: not more than 1 mg/kg1 January 201231 December 2024PART AOnly uses as insecticide may be authorised.The seed coating shall only be performed in professional seed treatment facilities. These facilities shall apply the best available techniques in order to exclude the release of dust clouds during storage, transport and application.PART BFor 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 tefluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the operators and workers safety and include among the authorised conditions of use the application of adequate personal protective equipment as well as respiratory protective equipment,the risk to birds and mammals. Risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage,ensure that the label of treated seed includes the indication that the seeds were treated with tefluthrin and sets out the risk mitigation measures provided for in the authorisation.The applicant shall submit confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured;(2)a validated analytical method for water;(3)the possible environmental impact of the preferential degradation/conversion of the isomers and an estimation of the relative toxicity and risk assessment for the workers.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in point (2) by 31 December 2012, and the information set out in point (3) 2 years after the adoption of a specific guidance document on evaluation of isomers mixture.
11OxyfluorfenCAS No 42874-03-3CIPAC No 5382-chloro-α,α,α-trifluoro-p-tolyl 3-ethoxy-4-nitrophenyl ether≥ 970 g/kgImpurities:N,N-dimethylnitrosamine: not more than 50 μg/kg1 January 201231 December 2024PART AOnly uses as herbicide for banded applications close to ground from autumn to early spring may be authorised, at a rate not exceeding 150 g active substance per hectare, per year.PART BFor 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 oxyfluorfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed, shall be taken into account.In this overall assessment, Member States must pay particular attention to:operator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate,the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.Conditions of authorisation shall include risk mitigation measures such as no-spray buffer zones and drift reducing nozzles and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.
121-naphthylacetamideCAS No 86-86-2CIPAC No 2822-(1-naphthyl)acetamide≥ 980 g/kg1 January 201231 December 2023PART AOnly uses as plant growth regulator may be authorised.PART BFor 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-naphthylacetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.In this overall assessment Member States:(a)shall pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(c)shall pay particular attention to the risk to aquatic organisms;(d)shall pay particular attention to the risk to non-target plants;(e)shall pay particular attention to the risk to birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the risk to non-target plants;(2)the long-term risk to birds.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
131-naphthylacetic acidCAS No 86-87-3CIPAC No 3131-naphthylacetic acid≥ 980 g/kg1 January 201231 December 2023PART AOnly uses as plant growth regulator may be authorised.PART BFor 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-naphthylacetic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States:(a)shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)shall pay particular attention to the dietary exposure situation of consumers in view of future revisions of maximum residue levels;(c)shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(d)shall pay particular attention to the risk to aquatic organisms;(e)shall pay particular attention to the risk to birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the route and rate of degradation in soil including an assessment of the potential for photolysis;(2)the long-term risk to birds.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
14FluquinconazoleCAS No 136426-54-5CIPAC No 4743-(2,4-dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4(3H)-one≥ 955 g/kg1 January 201231 December 2021PART AOnly uses as fungicide may be authorisedPART BFor 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 fluquinconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States:(a)shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);(c)shall pay particular attention to the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;(2)the contribution of the potential residues of the metabolite dione in rotational crops to the overall consumer exposure;(3)the acute risk to insectivorous mammals;(4)the long-term risk to insectivorous and herbivorous birds and mammals;(5)the risk to earthworm-eating mammals;(6)the endocrine disruption potential in aquatic organisms (fish full life cycle study).The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
15Fluazifop PCAS No 83066-88-0 (fluazifop-P)CIPAC No 467 (fluazifop-P)(R)-2-{4-[5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionic acid (fluazifop-P)≥ 900 g/kg in fluazifop P-butylThe following impurity 2-chloro-5-(trifluoromethyl)pyridine must not exceed 1,5 g/kg in the material as manufactured.1 January 201231 December 2023PART AOnly uses as herbicide may be authorised.PART BFor 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 fluazifop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.In this overall assessment Member States shall:pay particular attention to consumer safety as regards the occurrence in groundwater of the metabolite compound X;pay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;pay particular attention to the protection of surface water and groundwater in vulnerable zones;pay particular attention to the risk for non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;(2)the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;(3)the potential long-term risk to herbivorous mammals;(4)the fate and behaviour in the environment of the metabolite compounds X and IV;(5)the potential risk to fish and aquatic invertebrates for the metabolite compound IV.The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013.
16TerbuthylazineCAS No 5915-41-3CIPAC No 234N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine≥ 950 g/kgImpurities:Propazine not more than 10 g/kgAtrazine not more than 1 g/kgSimazine not more than 30 g/kg1 January 201231 December 2024PART AOnly uses as herbicide may be authorised.PART BFor 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(b)the risk to mammals and earthworms.Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards:(1)the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities;(2)the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;(3)groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6;(4)the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC) No 1272/2008 as "suspected of causing cancer".The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012, the information set out in point (3) by 30 June 2013 and the information set out in point (4) within six months from the notification of the classification decision concerning that substance.
17TriazoxideCAS No 72459-58-6CIPAC No 7297-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide≥ 970 g/kgImpurities:toluene: not more than 3 g/kg1 October 201130 September 2021PART AOnly uses as fungicide for use as seed treatment may be authorised.PART BFor 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 triazoxide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.In this overall assessment Member States:(a)shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)shall pay particular attention to the risk to granivorous birds and shall ensure that conditions of authorisation include risk mitigation measures.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the long-term risk to granivorous mammals by 30 September 2013.
188-hydroxyquinolineCAS No148-24-3 (8-hydroxyquinoline)CIPAC No 677(8-hydroxyquinoline)8-quinolinol≥ 990 g/kg1 January 201231 December 2021PART AOnly uses as fungicide and bactericide in greenhouses may be authorised.PART BFor 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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate.The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards:(1)the method of analysis for air;(2)a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
19AcrinathrinCAS No 101007-06-1CIPAC No 678(S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3S)-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate or(S)-α-cyano-3-phenoxybenzyl (Z)-(1R)-cis-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate≥ 970 g/kgImpurities:1,3-dicyclohexylurea: not more than 2 g/kg1 January 201231 December 2023PART AOnly uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application.PART BFor 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 acrinathrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.In this overall assessment Member States:(a)shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)shall pay particular attention to the risk to aquatic organisms, in particular fish, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;(c)shall pay particular attention to the risk to non-target arthropods and bees and shall ensure that conditions of authorisation include risk mitigation measures.The applicant shall submit confirmatory information as regards:(1)the potential risk to groundwater from the metabolite 3-PBAld;(2)the chronic risk to fish;(3)the risk assessment for non-target arthropods;(4)the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment.The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 December 2013 and the information set out in point 4 2 years after the adoption of specific guidance.
20ProchlorazCAS No 67747-09-5CIPAC No 407N-propyl-N-[2-(2,4,6-trichlorophenoxy)ethyl]imidazole-1-carboxamide≥ 970 g/kgImpurities:Sum of dioxins and furans (WHO-PCDD/T TEQ): not more than 0,01 mg/kg1 January 201231 December 2023PART AOnly uses as fungicide may be authorised. In the case of outdoor uses, rates shall not exceed 450 g/ha per application.PART BFor 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 prochloraz, 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:(a)shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)shall pay particular attention to the risk to aquatic organisms, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;(c)shall pay particular attention to the long-term risk to mammals and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate.The applicants shall submit confirmatory information as regards:(1)comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;(2)the environmental risk assessment for the metal complexes of prochloraz;(3)the potential endocrine disrupting properties of prochloraz on birds.The notifier shall submit to the Commission, the Member States and the Authority the information set out in points 1 and 2 by 31 December 2013 and the information set out in point 3 within 2 years after the adoption of the pertinent OECD test guidelines on endocrine disruption.
21BitertanolCAS No: 55179-31-2CIPAC No: 386(1RS,2RS;1RS,2SR)-1-(biphenyl-4-yloxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (20:80 ratio of (1RS,2RS)- and (1RS,2SR)-isomers)≥ 970 g/kg (A ≥ 80, B ≤ 20)RS + SR 80 – 90 %RR + SS 10 – 20 %1 January 201230 June 2015PART AOnly uses as fungicide for seed treatment may be authorised.Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.PART BFor 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 bitertanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 October 2011 shall be taken into account.In this overall assessment Member States:(a)shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);(c)shall pay particular attention to the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the toxicological relevance of the impurities BUE 1662, thus referred to for confidentiality reasons, and 3-chlorophenoxy compound;(2)the acute and short-term risk to granivorous birds;(3)the long-term risk to granivorous mammals;(4)residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;(5)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 the environmental risk assessment.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in points (2), (3) and (4) by 31 December 2013 and the information set out in point (5) two years after the adoption of specific guidance.
22MetamCAS No 144-54-7CIPAC No 20Methyldithiocarbamic acid≥ 965 g/kgExpressed as metam-sodium on a dry weight basis≥ 990 g/kgExpressed as metam-potassium on a dry weight basisRelevant impurities:methylisothiocyanate (MITC)max. 12 g/kg on dry weight basis (metam-sodium),max. 0,42 g/kg on dry weight basis (metam-potassium).N,N’-dimethylthiourea (DMTU)max. 23 g/kg on a dry weight basis (metam-sodium),max. 6 g/kg on a dry weight basis (metam-potassium).1 July 201230 June 2022PART AOnly uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field.The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed.The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.Authorisations shall be limited to professional users.PART BFor 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 metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account.In this overall assessment Member States:(a)shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate;(b)shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate;(c)shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers;(d)shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone;(e)shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information on methyl isothiocyanate as regards:(1)the assessment of the long-range atmospheric transport potential and related environmental risks;(2)the potential groundwater contamination.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.
23BifenthrinCAS No82657-04-3CIPAC No 4152-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylateor2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate≥ 930 g/kgImpurities:Toluene: not more than 5 g/kg1 August 201231 July 2019PART AOnly uses as insecticide in greenhouses with a permanent structure may be authorised.PART BFor 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 bifenthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.In this overall assessment, Member States must pay particular attention to:(a)releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic and other non-target organisms;(b)the protection of pollinator colonies purposely placed in the greenhouse;(c)the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products.
24FluxapyroxadCAS No 907204-31-3CIPAC No 8283-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide≥ 950 g/kgThe impurity toluene must not exceed 1 g/kg in the technical material1 January 201331 May 2025For 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 fluxapyroxad, 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 risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The purity given in this entry is based on a pilot plant production. The examining Member State 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.
25FenpyrazamineCAS No 473798-59-3CIPAC No 832S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate≥ 940 g/kg1 January 201331 December 2022For 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 fenpyrazamine, 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.The purity given in this entry is based on a pilot plant production. The examining Member State 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.
26Adoxophyes orana granulovirusCulture collection No DSM BV-0001CIPAC No 782Not applicableNo relevant impurities1 February 201331 January 2024For 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 Adoxophyes orana granulovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.
27IsopyrazamCAS No 881685-58-1(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)CIPAC No 963A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(syn-isomer – 50:50 mix of two enantiomers)and3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(anti-isomer– 50:50 mix of two enantiomers)In a range of 78:15 % to 100:0 % syn to anti.≥ 920 g/kgIn a range of 78:15 % to 100:0 % syn- to anti-isomers1 April 201331 March 2023For 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 isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic organisms;(b)the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.
28PhosphaneCAS No 7803-51-2CIPAC No 127Phosphane≥ 994 g/kgThe relevant impurity arsane must not exceed 0,023 g/kg in the technical material1 April 201331 March 2023Authorisations shall be limited to professional users.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 phosphane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators in and around the treated premises during the treatment as well as during and after the aeration;the protection of workers in and around the treated premises during the treatment as well as during and after the aeration;the protection of bystanders around the treated premises during the treatment as well as during and after the aeration.Conditions of use shall include risk mitigation measures, like permanent monitoring of the phosphane concentration by automatic devices, the use of personal protection equipment and setting-up an area around the treated premise where bystanders are denied, where appropriate.
29Trichoderma asperellum (strain T34)CECT number: 20417Not applicable1 × 1010 cfu/g1 June 201331 May 2023For 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 asperellum (strain T34), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma asperellum (strain T34) is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures where appropriate.
30Zucchini Yellow Mosaic Virus — weak strainATCC accession number: PV-593Not applicable≥ 0,05 mg/l1 June 201331 May 2023For 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 Zucchini Yellow Mosaic Virus — weak strain, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to non-target plants, if the crop plants are co-infected with another virus which can be transmitted by aphids.Conditions of use shall include risk mitigation measures, where appropriate.
31CyflumetofenCAS No 400882-07-7CIPAC No 7212-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate≥ 975 g/kg (racemic)1 June 201331 May 2023Plant protection products containing cyflumetofen shall only be authorised for uses where the level of metabolite B3 in groundwater is expected to be below 0,1 μg/L.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 cyflumetofen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.In this overall assessment, Member States shall pay particular attention to:the protection of operators and workers;the protection of groundwater, in particular for metabolite B3, when the substance is applied in regions with vulnerable soils and/or climatic conditions;the protection of drinking water;the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
32Trichoderma atroviride strain I-1237CNCM number: I-1237Not applicable02011R0540-20210401_en_img_1 cfu/g (02011R0540-20210401_en_img_2 spores/g)1 June 201331 May 2023For 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 atroviride strain I-1237, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma atroviride strain I-1237 is to be considered a potential sensitiser.Conditions of use shall include risk mitigation measures where appropriate.
33AmetoctradinCAS No 865318-97-4CIPAC No 8185-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine≥ 980 g/kgThe impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 mg/kg and 2 g/kg respectively in the technical material.1 August 201331 July 2023For 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 ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04 to groundwater under vulnerable conditions.Conditions of use shall include risk mitigation measures, where appropriate.
34MandipropamidCAS No 374726-62-2CIPAC No 783(RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide≥ 930 g/kgThe impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material.1 August 201331 July 2023For 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 mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015.
35Halosulfuron-methylCAS No 100785-20-1CIPAC No 785.201methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate≥ 980 g/kg1 October 201330 September 2023For 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 halosulfuron-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 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk of leakage to groundwater of the metabolite "halosulfuron" rearrangement (HSR) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron,the risk to non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and the test material used in the toxicological and ecotoxicological studies;(b)information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured;(c)data to clarify the potential genotoxic properties of chlorosulfonamide acid.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
36Bacillus firmus I-1582Collection number: CNCMI-1582Not applicableMinimum concentration: 7,1 × 1010 CFU/g1 October 201330 September 2023For 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 firmus I-1582, and in particular Appendices I and II thereof, 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 operators and workers, taking into account that Bacillus firmus I-1582 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.
37Candida oleophila strain OCollection number: MUCL40654Not applicableNominal content: 3 × 1010 CFU/g dried productRange: 6 × 109 – 1 × 1011 CFU/g dried product1 October 201331 December 2024For 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 Candida oleophila strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
38Helicoverpa armigera nucleopolyhedrovirusDSMZ number: BV-0003Not applicableMinimum concentration: 1,44 × 1013 OB/l (occlusion bodies/l)1 June 201331 May 2023For 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 Helicoverpa armigera nucleopolyhedrovirus, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.
39Paecilomyces fumosoroseus strain FE 9901Collection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490Not applicableMinimum 1,0 × 109 CFU/gMaximum 3,0 × 109 CFU/g1 October 201331 December 2024For 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 fumosoroseus strain FE 9901, and in particular Appendices I and II thereof, 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 operators and workers, taking into account that Paecilomyces fumosoroseus strain FE 9901 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.
40Potassium phosphonates (no ISO name)CAS No13977-65-6 for potassium hydrogen phosphonate13492-26-7 for dipotassium phosphonateMixture: noneCIPAC No 756 (for potassium phosphonates)Potassium hydrogen phosphonate,Dipotassium phosphonate31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions)17,8 to 20,0 % potassium≥ 990 g/kg on dry weight basis1 October 201331 January 2026For 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 potassium phosphonates, and in particular Appendices I and II thereof, 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 risk to birds and mammals,the risk of eutrophication of surface water, if the substance is applied in regions or under conditions favouring a quick oxidation of the active substance in surface water.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
41SpiromesifenCAS No 283594-90-1CIPAC No 7473-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate≥ 965 g/kg (racemic)The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.1 October 201330 September 2023For 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 spiromesifen, and in particular Appendices I and II thereof, 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 long-term risk to aquatic invertebrates,the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,the protection of workers and operators.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
42Spodoptera littoralis nucleopolyhedrovirusDSMZ number: BV-0005Not applicableMaximum concentration: 1 × 1012 OB/l (occlusion bodies/l)1 June 201331 May 2023For 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 littoralis nucleopolyhedrovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
43BixafenCAS No 581809-46-3CIPAC No 819N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide≥ 950 g/kg1 October 201331 May 2025For 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 bixafen, and in particular Appendices I and II thereof, 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:(a)the residues of bixafen and of its metabolites in rotational crops;(b)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(c)the risk to aquatic organisms;(d)the risk to soil and sediment-dwelling organisms.Conditions of use shall include risk mitigation measures, where appropriate.
44MaltodextrinCAS No 9050-36-6CIPAC No 801None allocated≥ 910 g/kg1 October 201330 September 2023For 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 maltodextrin, and in particular Appendices I and II thereof, 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:(a)the potential increased growth of fungi and possible presence of mycotoxins on the surface of treated fruits;(b)the potential risk to honeybees and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.
45Eugenol CAS No 97-53-0CIPAC No 9674-allyl-2-methoxyphenol≥ 990 g/kgRelevant impurity: methyl eugenol maximum 0,1 % of the technical material1 December 201330 November 2023For 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 eugenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,the risk to aquatic organisms,the risk to insectivorous birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)the storage stability (2 years) at ambient temperature on the formulated product;(b)data comparing natural background exposure situations of eugenol and methyl eugenol in relation to exposure from the use of eugenol as a plant protection product. This data shall cover human exposure as well as exposure of birds and aquatic organisms;(c)the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
46Geraniol CAS No 106-24-1CIPAC No 968(E) 3,7-dimethyl-2,6-octadien-1-ol≥ 980 g/kg1 December 201330 November 2023For 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 geraniol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention tothe protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms;the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a)data comparing natural background exposure situations of geraniol in relation to exposure from the use of geraniol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;(b)the groundwater exposure.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
47ThymolCAS No89-83-8CIPAC No9695-methyl-2-propan-2-yl-phenol≥ 990 g/kg1 December 201330 November 2023For 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 thymol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention tothe protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms;the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a)data comparing natural background exposure situations of thymol in relation to exposure from the use of thymol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;(b)the long-term and reproductive toxicity, in a form of a full report (in English) of the Combined Test of Repeated Oral-Administration Toxicity and Reproductive Toxicity of Thymol;(c)the groundwater exposure.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
48SedaxaneCAS No 874967-67-6(trans isomer: 599197-38-3/cis isomer: 599194-51-1)CIPAC No 833mixture of 2 cis-isomers 2′-[(1RS,2RS)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide and 2 trans-isomers 2′-[(1RS,2SR)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide≥ 960 g/kg Sedaxane(range 820-890 g/kg for the 2 trans-isomers 50:50 mixture of enantiomers and range 100-150 g/kg for the 2 cis-isomers 50:50 mixture of enantiomers)1 February 201431 May 2025PART AOnly uses for seed treatment may be authorised.PART BFor 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 sedaxane, 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:(a)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(b)the long-term risk to birds and mammals.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite CSCD465008 in vulnerable zones, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the relevance of the metabolite CSCD465008, and the corresponding groundwater risk assessment, if sedaxane is classified under Regulation (EC) No 1272/2008 as "suspected of causing cancer".The notifier shall submit to the Commission, the Member States and the Authority the relevant information within six months from the application date of the Regulation classifying sedaxane.
49EmamectinCAS Noemamectin: 119791-41-2(formerly 137335-79-6) and 123997-28-4emamectin benzoate: 155569-91-8(formerly 137512-74-4 and 179607-18-2)emamectin B1a benzoate: 138511-97-4emamectin B1b benzoate: 138511-98-5CIPAC Noemamectin: 791emamectin benzoate: 791.412Emamectin B1a:(10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranosideEmamectin B1b:(10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranosideEmamectin B1a benzoate:(10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoateEmamectin B1b benzoate:(10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoate≥ 950 g/kgas emamectin benzoate anhydrous(a mixture of min. 920 g/kg emamectin B1a benzoate and max. 50 g/kg emamectin B1b benzoate)1 May 201430 November 2024For 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 emamectin, 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 risk to non-target invertebrates;the protection of workers and operators.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the risk of enantio-selective metabolisation or degradation.The applicant shall submit to the Commission, Member States and the Authority the relevant information two years after adoption of the pertinent guidance document on evaluation of isomer mixtures.
50Pseudomonas sp. strain DSMZ 13134Collection number: DSMZ 13134Not applicableMinimum concentration: 3×1014 cfu/kg1 February 201431 January 2025For 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 Pseudomonas sp. strain DSMZ 13134, 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 and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
51FluopyramCAS No 658066-35-4CIPAC No 807N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide≥ 960 g/kg1 February 201431 January 2024For 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 fluopyram, 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 risk to birds and aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the long-term risk to insectivorous birds;(2)the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals.The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.
52Aureobasidium pullulans (strains DSM 14940 and DSM 14941)Collection number: German Collection of Microorganisms and cell Cultures (DSMZ) with the accession numbers DSM 14940 and DSM 14941Not applicableMinimum 5,0 × 109 CFU/g for each strain;Maximum 5,0 × 1010 CFU/g for each strain1 February 201431 January 2025For 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 Aureobasidium pullulans (strains DSM 14940 and DSM 14941), 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 and workers, taking into account that Aureobasidium pullulans (strains DSM 14940 and DSM 14941) is to be considered as a potential sensitizer.Conditions of use shall include risk mitigation measures, where appropriate.
53Pyriofenone:CAS No 688046-61-9CIPAC No 827(5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone≥ 965 g/kg1 February 201431 January 2025For 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 pyriofenone, 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.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a)the identity of two impurities to fully support the provisional specification;(b)the toxicological relevance of the impurities present in the proposed technical specification except for the one impurity for which an acute oral study and an Ames test were provided.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
54Disodium phosphonateCAS No 13708-85-5CIPAC No 808disodium phosphonate281-337 g/kg (TK)≥ 917 g/kg (TC)1 February 201431 January 2026For 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 disodium phosphonate, 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 risk to eutrophication of surface water.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a)the chronic risk to fish;(b)the long term risk to earthworms and soil macro-organisms.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
55PenflufenCAS No 494793-67-8CIPAC No 8262’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide≥ 950 g/kg1:1 (R:S) ratio of enantiomers1 February 201431 May 2025PART AOnly uses to treat seeds or other propagating materials before or during sowing or planting, may be authorised, limited to one application every third year on the same field.PART BFor 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 penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 and of the addendum to the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 13 December 2017 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of operators;(b)the long-term risk to birds;(c)the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions;(d)to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council as "carcinogen category 2". That information shall be submitted to the Commission, the Member States and the Authority within 6 months from the notification of the classification decision concerning that substance.
56Orange oilCAS No 8028-48-6 (Orange extract)5989-27-5 (D-limonene)CIPAC No 902(R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene≥ 945 g/kg (of D-limonene)The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E)1 May 201431 July 2024For 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of operators and workers;(b)the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment.The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.
57PenthiopyradCAS No 183675-82-3CIPAC No 824(RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)pyrazole-4-carboxamide≥ 980 g/kg(50:50 racemic mixture)1 May 201431 May 2025For 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 penthiopyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of operators and workers;(b)the risk to aquatic and soil organisms;(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(d)the level of residues in rotational crops following consecutive application of the active substance over several years.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid) for groundwater with the exception of evidence related to the risk of carcinogenicity, which is dependent on the classificationof the parent and specified separately at (3) below;(2)the toxicological profile and the reference values of the metabolite PAM;(3)the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid), DM-PCA (3-trifluoromethyl-1H-pyrazole-4- carboxylic acid), PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide) and PCA (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxylic acid) and their risk to contaminate groundwater, if penthiopyrad is classified under Regulation (EC) No 1272/2008 as carcinogenic cat. 2.The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) and (2) by 30 April 2016 and the information set out in point (3) within six months from the notification of the classification decision concerning penthiopyrad.
58Benalaxyl-MCAS No 98243-83-5CIPAC No 766Methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate≥ 950 g/kg1 May 201430 April 2025For 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-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of workers at re-entry,the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.
59TembotrioneCAS No 335104-84-2CIPAC No 7902-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione≥ 945 g/kgThe following relevant impurities must not exceed a certain threshold in the technical material:Toluene: ≤ 10 g/kgHCN: ≤ 1 g/kg1 May 201431 July 2024For 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 tembotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of operators and workers;(b)the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
60SpirotetramatCAS No 203313-25-1CIPAC No 795cis-4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-xylyl)-1-azaspiro[4.5]dec-3-en-2-one≥ 970 g/kg1 May 201431 July 2024For 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 spirotetramat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to insectivorous birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential for endocrine disruptor effects in birds and fish to the Commission, the Member States and the Authority within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
61PyroxsulamCAS No 422556-08-9CIPAC No 793N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide≥ 965 g/kg1 May 201430 April 2025For 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 pyroxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to groundwater, when the active substance is applied in regions with vulnerable soil or climatic conditions;(b)the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the toxicological relevance of impurity number 3 (as referred to in the review report);(2)the acute toxicity of the metabolite PSA;(3)the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742.The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.
62ChlorantraniliproleCAS No 500008-45-7CIPAC No 7943-bromo-4'-chloro-1-(3-chloro-2-pyridyl)-2'-methyl-6'-(methylcarbamoyl) pyrazole-5-carboxanilide≥ 950 g/kgThe following relevant impurities must not exceed a certain threshold in the technical material:Acetonitrile: ≤ 3 g/kg3-picoline: ≤ 3 g/kgMethanesulfonic acid: ≤ 2 g/kg1 May 201431 December 2024For 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 chlorantraniliprole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and to soil macroorganisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the risk to groundwater from the active substance and its metabolites IN-EQW78 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-b]quinazolin-11-one), IN-F6L99 (3-bromo-N-methyl-1H-pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquinazolin-4(1H)-one) and IN-F9N04 (3-bromo-N-(2-carbamoyl-4-chloro-6-methylphenyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxamide);(2)the risk to aquatic organisms from the photolysis metabolites IN-LBA22 (2-{[(4Z)-2-bromo-4H-pyrazolo[1,5-d]pyrido[3,2-b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-dimethylbenzamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one) and IN-LBA24 (2-(3-bromo-1H-pyrazol-5-yl)-6-chloro-3,8-dimethylquinazolin-4(3H)-one).The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.
63Sodium silver thiosulfateCAS No not allocatedCIPAC No 762Not applicable≥ 10,0 g Ag/kgExpressed as silver (Ag)1 May 201431 July 2024PART AOnly indoor uses in non-edible crops shall be authorised.PART BFor 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 sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to(a)the protection of operators and workers;(b)limiting the possible release of silver ions through disposal of used solutions;(c)the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture.Conditions of use shall include risk mitigation measures, where appropriate.
64PyridalylCAS No 179101-81-6CIPAC No 7922,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether≥ 910 g/kg1 July 201430 June 2025PART AOnly uses in greenhouses with permanent structure may be authorised.PART BFor 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 pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to re-entry workers;(b)the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions;(c)the risk to birds, mammals and aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23;(2)the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse;(3)the risk to aquatic invertebrates.The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016.The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018.
65S-abscisic acidCAS No21293-29-8CIPAC NoNot allocated(2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acidor(7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid960 g/kg1 July 201430 September 2024For 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-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, 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 risk mitigation measures, where appropriate.
66L-ascorbic acidCAS No 50-81-7CIPAC No 774(5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one≥ 990 g/kgThe following relevant impurities shall not exceed:Methanol: ≤ 3 g/kgHeavy Metals: ≤ 10 mg/kg (expressed as Pb)1 July 201430 September 2024For 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 L-ascorbic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic and soil organisms;(b)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms;(2)the risk to contaminate groundwater.The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
67SpinetoramCAS No 935545-74-7CIPAC No 802XDE-175-J (Major factor)(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dioneXDE_175-L (Minor factor)(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione≥ 830 g/kg50-90 % XDE-175-J;and50-10 % XDE-175-LTolerance limits (g/kg):XDE-175-J = 581-810XDE-175-L = 83-2701 July 201430 September 2024For 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 spinetoram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic and soil organisms;(b)the risk to non-target arthropods in-field;(c)the risk to bees during the application (overspray) and subsequently.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies.The applicant shall submit to the Commission, the Member States and the Authority the relevant information within 6 months after the adoption of pertinent guidance on the assessment of isomers.
681,4-dimethylnaphthaleneCAS No 571-58-4CIPAC No 8221,4-dimethylnaphthalene≥ 980 g/kg1 July 201430 June 2025For 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 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of operators and of workers at re-entry and during inspection of the warehouse;(b)the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the residue definition for the active substance.The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
69AmisulbromCAS No 348635-87-0CIPAC No 7893-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide≥ 985 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg1 July 201430 September 2024For 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 amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole and 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid to contaminate groundwater;(2)the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole, N,N-dimethyl-1H-1,2,4-triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido-4-fluoro-hydroxybenzoic acid and 2,2′-oxybis(6-fluoro-2-methyl-1,2-dihydro-3H-indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff;(3)depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water;(4)the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole;(5)the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole.The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption.
70ValifenalateCAS No 283159-90-0CIPAC No 857Methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate≥ 980 g/kg1 July 201430 September 2024For 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 valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater.The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
71ThiencarbazoneCAS No 317815-83-1CIPAC No 797Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate≥ 950 g/kg1 July 201430 September 2024For 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 thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to(a)the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions;(b)the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts.That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018.
72Acequinocyl CAS No 57960-19-7 CIPAC No 7603-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate≥ 960 g/kg1 September 201430 November 2024For 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 acequinocyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of workers and operators;the risk to birds, mammals and aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)an analytical method for residues in body fluids and tissues;(b)the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards;(c)the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.
73IpconazoleCAS No125225-28-7 (mixture of diastereoisomers)115850-69-6 (ipconazole cc, cis isomer)115937-89-8 (ipconazole ct, trans isomer)CIPAC No 798(1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol≥ 955 g/kgIpconazole cc: 875 – 930 g/kgIpconazole ct: 65 – 95 g/kg1 September 201430 November 2024For 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 ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:1.the risk to granivorous birds;2.the protection of workers and operators;3.the risk to fish.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)the acceptability of the long-term risk to granivorous birds;(b)the acceptability of the risk to soil macro-organisms;(c)the risk of enantio-selective metabolisation or degradation;(d)the potential endocrine disrupting properties of ipconazole for birds and fish.The applicant shall submit to the Commission, the Member States and the Authority the information under (a) and (b) by 31 August 2016, the information under (c) within two years after adoption of the pertinent guidance document on evaluation of isomer mixtures and the information under (d) within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of test guidelines agreed at EU level.
74FlubendiamideCAS No 272451-65-7CIPAC No 7883-iodo-N'-(2-mesyl-1,1-dimethylethyl)-N-{4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-o-tolyl}phthalamide≥ 960 g/kg1 September 201430 November 2024For 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 flubendiamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic invertebrates;(b)the potential presence of residues in rotational crops.Conditions of use shall include risk mitigation measures, where appropriate.
75Bacillus pumilus QST 2808USDA Agricultural Research Service (NRRL) Patent culture collection in Peoria Illinois, USA under the reference number B-30087Not applicable≥ 1 × 1012 CFU/kg1 September 201431 August 2025For 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 pumilus QST 2808, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus pumilus QST 2808 is to be considered as a potential sensitizer.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)the identification of the aminosugar produced by Bacillus pumilus QST 2808;(b)analytical data for the content of that aminosugar in the production batches.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.
76MetobromuronCAS No 3060-89-7CIPAC No 1683-(4-bromophenyl)-1-methoxy-1-methylurea≥ 978 g/kg1 January 201531 December 2024For 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 metobromuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of workers and operators;(b)the risk to birds, mammals, aquatic organisms and terrestrial non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)the toxicological assessment of the metabolites CGA 18236, CGA 18237, CGA 18238 and 4-bromoaniline;(b)the acceptability of the long-term risk to birds and mammals.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 December 2016.
77AminopyralidCAS No 150114-71-9CIPAC No 7714-amino-3,6-dichloropyridine-2-carboxylic acid≥ 920 g/kgThe following relevant impurity shall not exceed a certain threshold:Picloram ≤ 40 g/kg1 January 201531 December 2024For 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 aminopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;(b)the risk to aquatic macrophytes and terrestrial non-target plants;(c)chronic risk to fish.Conditions of use shall include risk mitigation measures, where appropriate.
78MetaflumizoneCAS No 139968-49-3CIPAC No 779(EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide≥ 945 g/kg(90-100 % E-isomer10-0 % Z-isomer)The following relevant impurities shall not exceed a certain threshold:Hydrazine ≤ 1 mg/kg4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kgToluene ≤ 2 g/kg1 January 201531 December 2024For 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 metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to fish and sediment dwelling organisms;(b)the risk to snail- or earthworm-eating birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;(2)information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 2016.
79Streptomyces lydicus strain WYEC 108Collection number: American Type Culture Collection (USDA)ATCC 55445Not applicableMinimum concentration: 5,0 × 108 CFU/g1 January 201531 December 2025For 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 lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic organisms;(b)the risk to soil dwelling organisms.Conditions of use shall include risk mitigation measures, where appropriate.
80MeptyldinocapCAS No 6119-92-2CIPAC No 811Mixture of 75-100 % (RS)-2-(1-methylheptyl)-4,6-dinitrophenyl crotonate and 25-– 0 % (RS)-2-(1-methylheptyl)-4,6-dinitrophenyl isocrotonate≥ 900 g/kg (mixture of trans- and cis-isomers with a defined ratio range of 25:1 to 20:1)Relevant impurity:2,6-dinitro-4-[(4RS)-octan-4-yl]phenyl (2E/Z)-but-2-enoatemax content 0,4 g/kg1 April 201531 March 2015For 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 meptyldinocap, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 May 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to operators;(b)the risk to aquatic invertebrates.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)the groundwater exposure assessment for metabolites (3RS)-3-(2-hydroxy-3,5-dinitro-phenyl)-butanoic acid (X103317) and (2RS)-2-(2-hydroxy-3,5-dinitro-phenyl)-propionic acid (X12335709);(b)the possible impact of any preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (a) by 31 March 2017 and the information set out in point (b) two years after the adoption of specific guidance by the Commission.
81ChromafenozideCAS No 143807-66-3CIPAC No 775N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide≥ 935 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg1 April 201531 March 2025For 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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;(b)the risk to non-target Lepidoptera in off-crop areas;(c)the risk to sediment-dwelling organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;(2)the assessment of the risk to sediment dwelling organisms from metabolite M-010;(3)the leaching potential of metabolites M-006 and M-023 to groundwater.The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.
82Gamma-cyhalothrinCAS No 76703-62-3CIPAC No 768(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or(S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate≥ 980 g/kg1 April 201531 March 2025For 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 gamma-cyhalothrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the safety of operators and workers;(b)the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices;(2)the toxicity profile of the metabolites CPCA, PBA and PBA(OH);(3)the long-term risk to wild mammals;(4)the potential for biomagnification in terrestrial and aquatic food chains.The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March 2017.
83Bacillus amyloliquefaciens subsp. plantarum strain D747Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234.Not applicableMinimum concentration: 2,0 × 1011 CFU/g1 April 201531 March 2025For 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 amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
84Terpenoid blend QRD 460CIPAC No: 982Terpenoid blend QRD 460 is a blend of three components:α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene;p-cymene: 1-isopropyl-4-methylbenzene;d-limonene: (R)-4-isopropenyl-1-methylcyclohexene.The nominal concentration of each component in the active substance as manufactured should be as follows:α-terpinene: 59,7 %;p-cymene: 22,4 %;d-limonene: 17,9 %.Each component should have a minimum purity as follows:α-terpinene: 89 %;p-cymene: 97 %;d-limonene: 93 %.10 August 201510 August 2025For 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 terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the stability of formulations on storage;(b)the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(d)the protection of surface water and aquatic organisms;(e)the protection of bees and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis. It should be confirmed that there are no relevant impurities present in the technical material;(2)the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.
85FenhexamidCAS No: 126833-17-8CIPAC No: 603N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexane-1-carboxamide≥ 975 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:toluene: max. 1 g/kg,4-amino-2,3-dichlorophenol: max. 3 g/kg.1 January 201631 December 2030For 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 fenhexamid, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators during field crop handheld operations,the protection of workers re-entering indoor-treated crops,the risk to aquatic organisms,the long-term risk to mammals for field uses.Conditions of use shall include risk mitigation measures, where appropriate.
86Halauxifen-methylCAS No:943831-98-9CIPAC No: 970.201 (halauxifen-methyl) 970 (halauxifen)methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)pyridine-2-carboxylate≥ 930 g/kg5 August 20155 August 2025For 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 halauxifen-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:The risk to aquatic and non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:The technical specification of the active substance as manufactured (based on commercial scale production). The relevance of impurities present in the technical material should be confirmed,The compliance of the toxicity batches with the technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 5 February 2016.
87PyridateCAS No: 55512-33-9CIPAC No: 447O-6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate≥ 900 g/kg1 January 201631 December 2030For 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 pyridate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, non-target terrestrial plants, and herbivorous mammals.Conditions of use shall include risk mitigation measures, where appropriate.
88SulfoxaflorCAS No: 946578-00-3CIPAC No: 820[methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide≥ 950 g/kg18 August 201518 August 2025For 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 sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to bees and other non-target arthropods;(b)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a)the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust;(b)risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds;(c)the risk to pollinators other than honey bees;(d)the risk to bee brood.The applicant shall submit that information to the Commission, the Member States and the Authority by 18 August 2017.
89SulfosulfuronCAS No: 141776-32-1CIPAC No: 6011-(4,6-dimethoxypyrimidin-2-yl)-3-(2-ethylsulfonylimidazo[1,2-a]pyridine-3-ylsulfonyl)urea≥ 980 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:Phenol: < 2 g/kg1 January 201631 December 2030For 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 sulfosulfuron, and in particular Appendices I and II thereof shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to soil non-target macro-organisms other than earthworms, non-target terrestrial plants and aquatic organisms.
90FlorasulamCAS No 145701-23-1CIPAC No 6162′,6′,8-trifluoro-5-methoxy[1,2,4]triazolo[1,5-c]pyrimidine-2-sulfonanilide≥ 970 g/kgImpurity: 2,6-DFA, not more than 2 g/kg1 January 201631 December 2030For 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 florasulam, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
91FlupyradifuroneCAS No: 951659-40-8CIPAC No: 9874-[(6-chloro-3-pyridylmethyl)(2,2-difluoroethyl) amino]furan-2(5H)-one≥ 960 g/kg9 December 20159 December 2025For 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 flupyradifurone, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of workers and operators,the risk to non-target arthropods, aquatic invertebrates and small herbivorous mammals,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,residues in animal matrices and rotational crops.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities,(2)the compliance of the toxicity batches with the confirmed technical specification,(3)the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water.The applicant shall submit to the Commission, the Member States and the Authority the information requested under point (1) and (2) by 9 June 2016, the information requested under point (3) within 2 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.
92RescalureCAS No: 67601-06-3CIPAC No:Not available(3S,6R)-(3S,6S)-6-isopropenyl-3-methyldec-9-en-1-yl acetate≥ 750 g/kgThe ratio of (3S,6R)/(3S,6S) shall be in a range of 55/45 to 45/55. The purity range for each isomer shall be 337,5 g/kg to 412,5 g/kg.18 December 201518 December 2025For 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 rescalure, and in particular Appendices I and II thereof, shall be taken into account.
93MandestrobinCAS No: 173662-97-0CIPAC No: Not available(RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide≥ 940 g/kg (on a dry weight basis)Xylenes (ortho, meta, para), ethyl benzene max. 5 g/kg (TK)9 December 20159 December 2025For 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 mandestrobin, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to aquatic organisms,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities;(2)the compliance of the toxicity batches with the confirmed technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 9 June 2016.
942,4-DCAS No: 94-75-7CIPAC No: 1(2,4-dichlorophenoxy) acetic acid≥ 960 g/kgImpurities:Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.Sum of dioxins and furans (WHO-TCDD TEQ): not more than 0,01 mg/kg.1 January 201631 December 2030For 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 2,4-D, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha.Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit to the Commission, the Member States and the Authority:(1)confirmatory information in the form of the submission of the complete study results from the existing extended one-generation study;(2)confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance.The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017.
95Pyraflufen-ethylCAS No 129630-19-9CIPAC No 605.202ethyl [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxy]acetate≥ 956 g/kg1 April 201631 March 2031For 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 pyraflufen-ethyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms,the protection of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
96IprovalicarbCAS No 140923-17-7CIPAC No 620isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate≥ 950 g/kgImpurities:Toluene: not more than 3 g/kg1 April 201631 March 2031For 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 iprovalicarb, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater from the relevant soil metabolite PMPA when the active substance is applied in regions with low clay containing soil types,the safety of operators and workers,the protection of aquatic organisms in the case of formulated products containing other active substances.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority, confirmatory information as regards the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016.
97PinoxadenCAS No 243973-20-8CIPAC No 7768-(2,6-diethyl-p-tolyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropionate≥ 970 g/kgToluene max. content 1 g/kg1 July 201630 June 2026For 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 pinoxaden, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 January 2016 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite M2 in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards:(a)a validated method of analysis of metabolites M11, M52, M54, M55 and M56 in ground water;(b)the relevance of the metabolites M3, M11, M52, M54, M55 and M56, and the corresponding groundwater risk assessment, if pinoxaden is classified under Regulation (EC) No 1272/2008 as H361d (suspected of damaging the unborn child).The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in point (a) by 30 June 2018 and the information set out in point (b) within six months from the notification of the classification decision under Regulation (EC) No 1272/2008 concerning pinoxaden.
98Acibenzolar-S-methylCAS No 135158-54-2CIPAC No 597S-methyl benzo[1,2,3]thiadiazole-7-carbothioate970 g/kgToluene: max. 5 g/kg1 April 201631 March 2031For 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 acibenzolar-S-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk for consumers via food intake;(b)the protection of operators and workers;(c)the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall by 1 June 2017 submit to the Commission, the Member States and the Authority, confirmatory information as regards the relevance and reproducibility of the morphometric changes observed in the cerebellum of foetuses linked to exposure to acibenzolar-S-methyl and whether these changes may be produced via an endocrine mode of action. The information to be submitted shall includea systematic review of the available evidence assessed on the basis of available guidance (e.g. EFSA GD on Systematic Review methodology, 2010).
99CyantraniliproleCAS No:736994-63-1CIPAC No: Not allocated.3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide≥ 940 g/kgIN-Q6S09 max. 1 mg/kgIN-RYA13 max. 20 mg/kgmethanesulfonic acid max. 2 g/kgacetonitrile max. 2 g/kgheptane max. 7 g/kg3-picoline max. 3 g/kg.14 September 201614 September 2026For 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 cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to operators;(b)the risk to aquatic organisms, bees and other non-target arthropods;(c)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;(d)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water within 2 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.
100IsofetamidCAS No: 875915-78-9CIPAC No: 972N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide≥ 950 g/kg15 September 201615 September 2026For 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 isofetamid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to operators, workers and aquatic organisms, in particular fish.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;(2)the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;(3)the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water.The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 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.
101Bacillus amyloliquefaciens strain MBI 600.Accession number in the National Collection of Industrial, Marine and Food Bacteria Ltd (NCIMB), Scotland: NCIMB 12376Deposit number in the American Type Culture Collection (ATCC): SD-1414Not applicableMinimum concentration:5,0 × 1014 CFU/kg16 September 201616 September 2026For 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 amyloliquefaciens strain MBI 600, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;(b)the protection of operators and workers, taking into account that Bacillus amyloliquefaciens strain MBI 600 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
102EthofumesateCAS No 26225-79-6CIPAC No 233(RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate≥ 970 g/kgThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:EMS; ethyl methane sulfonate: maximum of 0,1 mg/kgiBMS; iso-butyl methane sulfonate: maximum of 0,1 mg/kg1 November 201631 October 2031For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on ethofumesate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
103PicolinafenCAS No 137641-05-5CIPAC No 6394′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide≥ 980 g/kg1 November 201630 June 2031For 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 picolinafen, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the impurities in the technical active substance;the protection of mammals, especially of large herbivorous mammals;the protection of non-target terrestrial plants;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the protection of aquatic organisms, especially to algae.Conditions of use shall include risk mitigation measures, where appropriate.
104Thifensulfuron-methylCAS No 79277-27-3CIPAC No 452methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate≥ 960 g/kg1 November 201631 October 2031For 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 thifensulfuron-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater;the protection of non-target plants and aquatic organisms.Conditions of use shall include risk mitigation measures and the obligation to monitor the groundwater, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1)the absence of genotoxicity of metabolites IN-A4098 and its derivative IN-B5528, IN-A5546 and IN-W8268;(2)mechanistic data to rule out an endocrine mediated mode of action for mammary gland tumours;(3)the risk to aquatic organisms from thifensulfuron-methyl and metabolite IN-D8858 and the risk to soil organisms from metabolites IN-JZ789 and 2 acid 3 triuret;(4)the relevance of the metabolites IN-A4098, IN-L9223 and IN-JZ789 if thifensulfuron-methyl is classified as reprotoxic category 2 under Regulation (EC) No 1272/2008 and the risk that those metabolites contaminate groundwater.The applicant shall submit the information requested under point (1) by 31 March 2017, under points (2) and (3) by 30 June 2017 and under point (4) within six months after the notification of the classification decision concerning thifensulfuron-methyl.
105Thiabendazole2-(thiazol-4-yl)benzimidazole≥ 985 g/kg1 April 201731 March 2032For 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 thiabendazole, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and consumers,the protection of groundwater,the control of waste water from post-harvest uses.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit by 31 March 2019 to the Commission, the Member States and the Authority confirmatory information regarding Level 2 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of thiabendazole.
CAS No 148-79-8CIPAC No 323
106OxathiapiprolinCAS No:1003318-67-9CIPAC No: 9851-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone≥ 950 g/kg3 March 20173 March 2027For 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 oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;(2)the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification.The applicant shall submit the information requested under points (1) and (2) by 3 September 2017.
107IodosulfuronCAS No 185119-76-0 (parent)CAS No 144550-36-7 (iodosulfuron-methyl-sodium)CIPAC No 634 (parent)CIPAC No 634.501 (iodosulfuron-methyl-sodium)4-iodo-2-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoylsulfamoyl]benzoic acid(iodosulfuron)sodium ({[5-iodo-2-(methoxycarbonyl)phenyl]sulfonyl}carbamoyl)(4-methoxy-6-methyl-1,3,5-triazin-2-yl)azanide(iodosulfuron-methyl-sodium)≥ 910 g/kg (expressed as iodosulfuron-methyl-sodium)1 April 201731 March 2032For 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 iodosulfuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to consumers,the risk to non-target terrestrial plants,the risk to aquatic plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1)the genotoxic potential of the metabolite triazine-amine (IN-A4098), in order to confirm that this metabolite is not genotoxic and not relevant for the risk assessment;(2)the effect of water treatment processes on the nature of residues present in drinking water.The applicant shall submit the information requested under point (1) 1 October 2017 and the information requested under point (2) 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.
108FlazasulfuronCAS No 104040-78-0CIPAC No 5951-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea≥ 960 g/kg1 August 201731 July 2032For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on flazasulfuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic plants,the protection of non-target terrestrial plants,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, 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 within a period of two years a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
109Beauveria bassiana strain NPP111B005Accession number in the CNCM (Collection Nationale de Culture de Microorganismes) — Institut Pasteur, Paris, France: I-2961.Not applicableMax. level of beauvericin 24 μg/L7 June 20177 June 2027For 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 strain NPP111B005, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that Beauveria bassiana strain NPP111B005 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation,the maximum level of the metabolite beauvericin in the formulated product.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
110Beauveria bassiana strain 147Accession number in the CNCM (Collection nationale de cultures de micro-organismes) — Institut Pasteur, Paris, France: I-2960.Not applicableMax. level of beauvericin: 24 μg/L6 June 20176 June 2027For 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 strain 147, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that Beauveria bassiana strain 147 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation,the maximum level of the metabolite beauvericin in the formulated product.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
111Mesosulfuron (parent)Mesosulfuron-methyl (variant)CAS No 208465-21-8(mesosulfuron-methyl)CIPAC No 663(mesosulfuron)CIPAC No 663.201(mesosulfuron-methylMesosulfuron-methyl:methyl-2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluateMesosulfuron:2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-methanesulfonamido-p-toluic acid≥ 930 g/kg(expressed as mesosulfuron-methyl)1 July 201730 June 2032For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on mesosulfuron and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms and non-target terrestrial plants;the protection of groundwater.Conditions of use shall include risk mitigation measures, 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 within a period of two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
112MesotrioneCAS No 104206-82-8CIPAC No 625Mesotrione2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione≥ 920 g/kgR287431 max 2 mg/kgR287432 max 2 g/kg1,2-dichloroethane max 1 g/kg1 June 201731 May 2032For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on mesotrione, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators,the protection of groundwater in vulnerable regions,the protection of mammals, aquatic and non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:1.the genotoxic profile of the metabolite AMBA;2.the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors;3.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under point 1 by 1 July 2017 and the relevant information requested under point 2 by 31 December 2017. The applicant shall submit to the Commission, the Member States and the Authority the confirmatory information requested under point 3 within a period of two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
113Cyhalofop-butylCAS No 122008-85-9CIPAC No 596butyl (R)-2-[4-(4-cyano-2-fluorophenoxy) phenoxy]propionate950 g/kg1 July 201730 June 2032For 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 cyhalofop-butyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators,the technical specification,the protection of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
114Propoxycarbazone (parent)Propoxycarbazone-sodium (variant)CAS No 145026-81-9 (propoxycarbazone)CAS No 181274-15-7 (propoxycarbazone-sodium)CIPAC No 655 (propoxycarbazone)CIPAC No 655.011 (propoxycarbazone-sodium)Propoxycarbazone:methyl 2-[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazole-1-carboxamido)sulfonyl]benzoatePropoxycarbazone-sodium:sodium {[2-(methoxycarbonyl)phenyl]sulfonyl}[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]azanide≥ 950g/kg(expressed as Propoxycarbazone-sodium)1 September 201731 August 2032For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on propoxycarbazone, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms, in particular aquatic plants and of and non-target terrestrial plants,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, 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 within a period of 2 years of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
115Benzoic acidCAS No 65-85-0CIPAC No 622Benzoic acid≥ 990 g/kg1 September 201731 August 2032For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on benzoic acid and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators, ensuring that conditions of use impose the use of adequate personal protective equipment.Conditions of use shall include risk mitigation measures, where appropriate.
1162,4-DBCAS No 94-82-6CIPAC No 834-(2,4-dichlorophenoxy) butyric acid≥ 940 g/kgImpurities:Free phenols (expressed as 2,4-dichlorophenol (2,4-DCP)): max. 15 g/kg.Dibenzo-p-dioxins and polychlorinated dibenzofurans (TCDD toxic equivalents (TEQ)): max. 0,01 mg/kg.1 November 201731 October 2032For 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 2,4-DB, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers,the protection of consumers from products of animal origin,the protection of wild mammals,the protection of soil non-target organisms,the protection of aquatic organisms,the protection of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
117Maleic hydrazideCAS No 123-33-1CIPAC No 3106-hydroxy-2H-pyridazin-3-one≥ 979 g/kgUntil 1 November 2018, the impurity hydrazine shall not exceed 1 mg/kg in the technical material.From 1 November 2018, the impurity hydrazine shall not exceed 0,028 mg/kg in the technical material.1 November 201731 October 2032For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on maleic hydrazide, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of consumers,the operator and worker safety; the conditions of the use should include the application of adequate personal protective equipment.Member States shall ensure, where appropriate, that the label of the treated crops includes the indication that the crops were treated with maleic hydrazide, and the accompanying instructions to avoid exposure of the livestock.Conditions of use shall include risk mitigation measures, where appropriate.
118GlyphosateCAS No 1071-83-6CIPAC No 284N-(phosphonomethyl)glycine≥ 950 g/kgImpurities:Formaldehyde, less than 1 g/kgN-Nitroso-glyphosate, less than 1 mg/kg16 December 201715 December 2022Only 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 glyphosate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses,the protection of operators and amateur users,the risk to terrestrial vertebrates and non-target terrestrial plants,the risk to diversity and abundance of non-target terrestrial arthropods and vertebrates via trophic interactions,compliance of pre-harvest uses with good agricultural practices.Conditions of use shall include risk mitigation measures, where appropriate.Member States shall ensure that use of plant protection products containing glyphosate is minimised in the specific areas listed in Article 12(a) of Directive 2009/128/EC.Member States shall ensure equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicological studies.Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).
119AcetamipridCAS No 135410-20-7CIPAC No 649(E)-N1-[(6-Chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine≥ 990 g/kg1 March 201828 February 2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on acetamiprid, and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the risk to aquatic organisms, bees and other non-target arthropods,the risk to birds and mammals,the risk to consumers,the risk to operators.Conditions of use shall include risk mitigation measures, where appropriate.
120BentazoneCAS No 25057-89-0CIPAC No 3663-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2- dioxide≥ 960 g/kg1,2-dichloroethane < 3 mg/kg1 June 201831 May 2025For 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 bentazone, and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the technical specification,the protection of operators and workers,the risk to birds and mammals,the protection of groundwater, particularly but not only in drinking water protected areas, and shall carefully consider the timing of application, soil and/or climatic conditions.Conditions of use shall include risk mitigation measures where appropriate.The applicant shall submit by 1 February 2019 to the Commission, the Member States and the Authority confirmatory information as regards Level 2/3 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of bentazone.
121SilthiofamCAS No 175217-20-6CIPAC No 635N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide≥ 980 g/kg1 July 201830 June 2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on silthiofam and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the protection of operators,the protection of groundwater in vulnerable regions,the protection of birds, mammals and earthworms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water;2.the relevance of the metabolites M2 and M6 taking into account any relevant classification for silthiofam in accordance with Regulation (EC) No 1272/2008, in particular as reprotoxic category 2.The applicant shall submit the information mentioned in point (1) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission and the information requested under point (2) within one year after the publication in the European Chemicals Agency (ECHA) webpage of the opinion adopted by the Committee for risk assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to silthiofam.
122ForchlorfenuronCAS No 68157-60-8CIPAC No 6331-(2-chloro-4-pyridyl)-3-phenylurea≥ 978 g/kg1.6.201831.5.2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on forchlorfenuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to consumers as regards the potential risk from metabolites in fruit crops with edible peels.Conditions of use shall include risk mitigation measures, where appropriate.
123ZoxamideCAS No 156052-68-5CIPAC No 640(RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide≥ 953 g/kg1 July 201830 June 2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on zoxamide, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater from metabolite RH-141455,the protection of bees, aquatic organisms and earthworms.Conditions of use shall include risk mitigation measures, 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 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission.
124TrifloxystrobinCAS No 141517-21-7CIPAC No 617methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate≥ 975 g/kgAE 1344136 (max. 4 g/kg)1 August 201831 July 2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trifloxystrobin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;the protection of aquatic organisms, bees, and of fish-eating birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1)the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for trifloxystrobin in accordance with Regulation (EC) No 1272/2008, in particular as toxic for reproduction category 2;(2)the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water.The applicant shall submit the information requested under point (1) within one year after the publication, on the website of the European Chemicals Agency (ECHA), of the opinion adopted by the Committee for Risk Assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to trifloxystrobin.The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
125Carfentrazone-ethylCAS No 128639-02-1CIPAC No 587.202Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate≥ 910 g/kg1 August 201831 July 2033For 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, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;the protection of soil non-target organisms;the protection of aquatic organisms;the protection of non-target terrestrial higher plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1)the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council, in particular as carcinogen category 2;(2)the effect of water treatment processes on the nature of residues present in drinking water.The applicant shall submit the information mentioned in point (1) within one year after the publication on the website of the European Chemicals Agency of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to carfentrazone-ethyl.The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
126FenpicoxamidCAS No: 517875-34-2CIPAC No: 991(3S,6S,7R,8R)-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate≥ 750 g/kg11 October 201811 October 2028For 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 fenpicoxamid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the impact of processing on the consumer risk assessment,the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:1.the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;2.the effect of water treatment processes on the nature of residues present in drinking water;3.the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605, whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action.The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.
127PethoxamidCAS No 106700-29-2CIPAC No 6652-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide≥ 940 g/kgImpurities:Toluene: max 3 g/kg.1 December 201830 November 2033PART AUse shall be limited to one application every two years in the same field at a maximum dose of 1200 g active substance per hectare.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pethoxamid, and in particular Appendices I and II thereto, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms and earthworms;the risk to consumers from residues in the succeeding crops or in case of crop failure.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1.the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council, in particular as carcinogen category 2;2.the effect of water treatment processes on the nature of residues present in drinking water;3.the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action.The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested.The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.
128Tribenuron (parent)CAS No 106040-48-6CIPAC No 5462-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid≥ 960 g/kg (expressed as tribenuron-methyl)1 February 201930 January 2034For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tribenuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of consumers, in particular to residues on animal products,the protection of groundwater,the protection of aquatic organisms and of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
129Metschnikowia fructicola strain NRRL Y-27328Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USANot applicableMinimum concentration:1 × 1010 CFU/g27 December 201827 December 2028For 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 Metschnikowia fructicola strain NRRL Y-27328, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
130Beauveria bassiana strain IMI389521Accession number in the CABI Genetic Resource Collection: IMI389521Not applicableMax. level of beauvericin: 0,09 mg/kg19 February 201919 February 2029For 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 strain IMI389521, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the storage stability of the formulation(s) containing B. bassiana strain IMI389521 including the level of the metabolite beauvericin content after storage;the content of the metabolite beauvericin produced under the application conditions;the risk posed by beauvericin in infected insects present in the stored grain. Measures are required to ensure that such products do not enter the food and feed chain, taking into account the natural background level of beauvericin on cereal grains;the protection of operators and workers, taking into account that B. bassiana strain IMI389521 is to be considered, as any micro-organism, as a potential sensitiser.The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include risk mitigation measures where appropriate.
131Beauveria bassiana strain PPRI 5339Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757Not applicableMax. level of beauvericin: 0,5 mg/kg20 February 201920 February 2029For 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 strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339;the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval;the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer.The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include risk mitigation measures where appropriate.
132MefentrifluconazoleCAS No: 1417782-03-6CIPAC No: Not assigned(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol≥ 970 g/kgThe impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material.The impurity toluene shall not exceed 1 g/kg in the technical materialThe impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material20 March 201920 March 2029For 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 mefentrifluconazole, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment;the protection of aquatic organisms.Conditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1.the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;2.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.The applicant shall submit the information referred to in point 1 by 20 March 2020 and the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
133FlutianilCAS No [958647-10-4]CIPAC No 835(Z)-[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene](α,α,α,4-tetrafluoro-m-tolylthio)acetonitrile≥ 985 g/kg14 April 201914 April 2029For 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 flutianil, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers,the risk to aquatic organisms,the risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1.the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;2.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water;3.an updated assessment of the information submitted and, where relevant further information, confirming that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, applying also the ECHA and EFSA guidance for identification of endocrine disruptors.The applicant shall submit the information:referred to in point 1 by 14 April 2020;referred to in point 2 within two years from the date of publication, from the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater; andreferred to in point 3 by 14 April 2021.
134IsoxaflutoleCAS No 141112-29-0CIPAC No 575(5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone≥ 972 g/kg1 August 201931 July 2034For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on isoxaflutole, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment, Member States shall pay particular attention to:the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,the protection of aquatic organisms, wild mammals and non-target terrestrial plants.Conditions of use shall include risk mitigation measures, 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 surface and groundwater, when surface water or groundwater is abstracted for drinking water. The applicant shall submit this information within 2 years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.The applicant shall also provide an updated assessment to confirm that isoxaflutole is not an endocrine disruptor within the meaning of points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 and in accordance with the guidance for identification of endocrine disruptors by 10 May 2021.
135carvone2244-16-8 (d-carvone = S-carvone = (+)-carvone)Carvone: 602d-carvone: not allocated(S)-5-isopropenyl-2-methylcyclohex-2-en-1-oneOr(S)-p-mentha-6,8-dien-2-one923 g/kg d-carvone1 August 201931 July 2034For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carvone, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment.Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone.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 surface and groundwater, when surface water is abstracted for drinking water.The applicant shall submit that information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
1361-methylcyclopropeneCAS No 3100-04-7CIPAC No 7671-methylcyclopropene≥ 980 g/kg (technical concentrate)The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate):1-chloro-2-methylpropene: maximum of 0,2 g/kg,3-chloro-2-methylpropene: maximum of 0,2 g/kg.For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %.1 August 201931 July 2034Only uses as plant growth regulator for post-harvest storage in sealable warehouse 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 renewal report on 1-methycyclopropene, and in particular Appendices I and II thereto, shall be taken into account.
137Dimethenamid-PCAS No 163515-14-8CIPAC No 638(S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide≥ 930 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg1 September 201931 August 2034For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on dimethenamid-P, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;the protection of groundwater, in particular regarding the metabolites of dimethenamid-P;the protection of aquatic organisms and small herbivorous mammals.Conditions of use shall include risk mitigation measures, 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 surface and groundwater, when surface water or ground water is abstracted for drinking water.The applicant shall submit the requested information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
138Tolclofos-methylCAS No 57018-04-9CIPAC No 479O-2,6-dichloro-p-tolylO, O-dimethyl phosphorothioateO-2,6-dichloro-4-methylphenyl O, O-dimethyl phosphorothioate≥ 960 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:Methanol max. 1 g/kg1 September 201931 August 2034Only for use on ornamentals and on potatoes.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tolclofos-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to aquatic organisms and mammals,the risk to consumers, in particular the potential risk from metabolite DM-TM-CH2OH in potatoes,the risk to operators, workers and bystanders;Conditions of use shall include risk mitigation measures, where appropriate.
139Florpyrauxifen-benzylCAS No: 1390661-72-9CIPAC No: 990.227benzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate≥ 920 g/kgThe impurity toluene shall not exceed 3 g/kg in the technical material.24 July 201924 July 2029For 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 22 March 2019, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic and terrestrial non-target plants.Conditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 24 July 2021.
140Metalaxyl-Mmethyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate≥ 920 g/kg1 June 202031 May 2035When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised.
CAS No 70630-17-0 (R)CIPAC No 580The following impurities are of toxicological concern and must not exceed the following levels in the technical material:2,6-dimethylphenylamine:max. content 0,5 g/kg4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide:max. content 1 g/kg2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester:max. content 0,18 g/kgFor 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 thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of the technical material as commercially manufactured;the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the protection of non-target arthropods, birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 by 26 May 2022.
141ForamsulfuronCAS No 173159-57-4CIPAC No 6591-(4,6-dimethoxypyrimidin-2-yl)-3-[2-(dimethylcarbamoyl)-5-formamidophenylsulfonyl]urea≥ 973 g/kg1 June 202031 May 2035For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on foramsulfuron, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to consumers and operators,the risk to aquatic organisms and non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water, within 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.
142Pyriproxyfen.2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine.CIPAC No: 715.CAS No: 95737-68-1.EC No (Einecs or ELINCS): 429-800-14-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether≥ 970 g/kg Max. impurity: Toluene5 g/Kg1 August 202031 July 2035For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the dietary exposure of consumers to residues of pyriproxyfen,the protection of sediment-dwelling organisms and aquatic organisms,the protection of bees.As regards the protection of sediment-dwelling organisms and aquatic organisms, for outdoor use of the plant protection products containing pyriproxyfen Member States shall include in the specific conditions appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for sediment-dwelling organisms and aquatic organisms.As regards the protection of bees, for outdoor use of plant protection products containing pyriproxyfen Member States shall include in the specific conditions a restriction of application to periods outside of the flowering of bee attractive crops, and appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for bees and bee larvae.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 surface and groundwater, when surface water is abstracted for drinking water.The applicant shall submit the requested confirmatory information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
143Kieselgur (Diatomaceous earth)CAS No 61790-53-2CIPAC No 647No IUPAC name exists for kieselgurOther synonyms:Diatomaceous earth,Diatomite1000 g/kgMinimum content of amorphous silica of 800 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:Crystalline silica with particle size below 10 μm – maximum of 1 g/kg1 February 202131 January 2036For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate.Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EU) No 546/2011. Conditions of use shall include risk mitigation measures, where appropriate.
144Garlic extract Marker components: diallylsulfide (DAS1), diallyldisulfide (DAS 2), diallyltrisulfide (DAS3), diallyltetrasulfide (DAS 4)CAS No 8000-78-08008-99-9CIPAC No 916Garlic extract1000 g/kg1 March 202129 February 2036For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on garlic extract, and in particular Appendices I and II thereto, shall be taken into account.On the basis of the proposed and supported uses (as listed in Appendix II), the following issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate:The risk to aquatic organisms.
PART CBasic SubstancesGeneral provisions applying to all substances listed in this Part: the Commission 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 them available to them on specific request.
Further details on identity, specification and manner of use of basic substance are provided in the review report.Available online: http://www.fao.org/fao-who-codexalimentarius/standards/list-of-standards/en/Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species (OJ L 289, 31.10.2013, p. 33).
NumberCommon Name,Identification NumbersIUPAC NamePurityDate of approvalSpecific provisions
1Equisetum arvense L.CAS No: not allocatedCIPAC No: not allocatedNot applicableEuropean Pharmacopeia1 July 2014Equisetum arvense L. may be used in accordance with the specific conditions included in the conclusions of the review report on Equisetum arvense L. (SANCO/12386/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.
2Chitosan hydrochlorideCAS no: 9012-76-4Not applicableEuropean PharmacopeiaMax content of heavy metals: 40 ppm1 July 2014Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on Chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.
3SucroseCAS no: 57-50-1α-D-glucopyranosyl-(1→2)-β-D-fructofuranoside or β-D-fructofuranosyl-(2→1)-α-D-glucopyranosideFood grade1 January 2015Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved.Sucrose shall be used in accordance with the specific conditions included in the conclusions of the review report on sucrose (SANCO/11406/2014) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014.
4Calcium HydroxideCAS No 1305-62-0Calcium Hydroxide920 g/kgFood gradeThe following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter):Barium 300 mg/kgFluoride 50 mg/kgArsenic 3 mg/kgLead 2 mg/kg.1 July 2015Calcium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on Calcium Hydroxide (SANCO/10148/2015) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015.
5VinegarCAS No: 90132-02-8Not availableFood grade containing a maximum of 10 % acetic acid.1 July 2015Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof.
6LecithinsCAS No: 8002-43-5CIPAC No: not allocatedEinecs232-307-2Not allocatedAs described in the Annex to Regulation (EU) No 231/2012.1 July 2015Only uses as basic substance being a fungicide are approved.Lecithins shall be used in accordance with the specific conditions included in the conclusions of the review report on lecithins (SANCO/12798/2014) and in particular Appendices I and II thereof.
7Salix spp. cortexCAS No: not allocatedCIPAC No: not allocatedNot applicableEuropean Pharmacopeia1 July 2015Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof.
8FructoseCAS No: 57-48-7β-D-fructofuranoseFood grade1 October 2015Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved.Fructose shall be used in accordance with the specific conditions included in the conclusions of the review report on fructose (SANCO/12680/2014) and in particular Appendices I and II thereof.
9Sodium hydrogen carbonateCAS no: 144-55-8Sodium hydrogen carbonateFood grade8 December 2015Sodium hydrogen carbonate shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium hydrogen carbonate (SANTE/10667/2015) and in particular Appendices I and II thereof.
10WheyCAS No: 92129-90-3Not availableCODEX STAN 289-19952 May 2016Whey shall be used in accordance with the specific conditions included in the conclusions of the review report on whey (SANTE/12354/2015) and in particular Appendices I and II thereof.
11Diammonium phosphateCAS No: 7783-28-0Diammonium hydrogen phosphateOenological grade29 April 2016Diammonium phosphate shall be used in accordance with the specific conditions included in the conclusions of the review report on diammonium phosphate (SANTE/12351/2015) and in particular Appendices I and II thereto.
12Sunflower oilCAS No: 8001-21-6Sunflower oilFood grade2 December 2016Sunflower oil shall be used in accordance with the specific conditions included in the conclusions of the review report on sunflower oil (SANTE/10875/2016) and in particular Appendices I and II thereof.
13Clayed charcoalCAS No 7440-44-0 231-153-3 (Einecs) (activated charcoal)CAS No 1333-86-4 215-609-9 (Einecs) (carbon black)CAS No 1302-78-9 215-108-5 (Einecs) (bentonite)Not available.Charcoal: Purity required by Regulation (EU) No 231/2012Bentonite: Purity required by Implementing Regulation (EU) No 1060/201331 March 2017Clayed charcoal shall be used in accordance with the specific conditions included in the conclusions of the review report on clayed charcoal (SANTE/11267/2016) and in particular Appendices I and II thereof.
14Urtica spp.CAS No 84012-40-8 (Urtica dioica extract)CAS No 90131-83-2 (Urtica urens extract)Urtica spp.European Pharmacopeia30 March 2017Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof.
15Hydrogen peroxideCAS No 7722-84-1Hydrogen peroxideSolution in water (< 5 %)The hydrogen peroxide used to manufacture the solution shall have a purity according to the FAO JECFA specifications.29 March 2017Hydrogen peroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on hydrogen peroxide (SANTE/11900/2016) and in particular Appendices I and II thereof.
16Sodium chlorideCAS No 7647-14-5Sodium chloride970 g/kgFood grade28 September 2017Only uses as basic substance being a fungicide and insecticide are approved.Sodium chloride shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium chloride (SANTE/10383/2017) and in particular Appendices I and II thereof.
17BeerCAS No 8029-31-0Not applicableFood grade5 December 2017Beer shall be used in accordance with the specific conditions included in the conclusions of the review report on beer (SANTE/11038/2017) and in particular Appendices I and II thereto.
18Mustard seeds powderNot applicableFood grade4 December 2017Mustard seeds powder shall be used in accordance with the specific conditions included in the conclusions of the review report on mustard seeds powder (SANTE/11309/2017) and in particular Appendices I and II thereof.
19Talc E553BCAS No: 14807-96-6Magnesium hydrogen metasilicatesilicate mineralFood grade in conformity with Commission Regulation (EU) No 231/2012.< 0,1 % of respirable Crystalline Silica28 May 2018Talc E553B shall be used in accordance with the specific conditions included in the conclusions of the review report on Talc E553B (SANTE/11639/2017) and in particular Appendices I and II thereof.
20Onion oilCAS No: 8002-72-0Not applicableFood grade17 October 2018Onion oil shall be used in accordance with the specific conditions included in the conclusions of the review report on Onion oil (SANTE/10615/2018) and in particular Appendices I and II thereto.
21L-cysteine (E 920)CAS No: 52-89-1EINECS: 200-157-7(L-cysteine hydrochloride)CAS No: 7048-04-6EINECS: 615-117-8(L-cysteine hydrochloride monohydrate)L-cysteine hydrochloride (1:1)Min. 98,0 % L-cysteine hydrochloride (on anhydrous basis)Food grade in conformity with Commission Regulation (EU) No 231/2012.max. 1,5 mg/kg Asmax. 5 mg/kg Pb2.6.2020L-cysteine (E 920) shall be used as a mixture with matrix (flour, food grade) at a concentration of maximum 8% (of L-cysteine hydrochloride, on anhydrous basis) in accordance with the specific conditions included in the conclusions of the review report on L-cysteine (SANTE/11056/2019) and in particular Appendices I and II thereto.
22Cow MilkCAS No: 8049-98-7Not available.Not applicable30.7.2020Cow milk shall comply with Regulation (EC) No 1069/2009 and Commission Regulation (EU) No 142/2011.Cow milk shall be used in accordance with the specific conditions included in the conclusions of the review report on cow milk (SANTE/12816/2019), and in particular Appendices I and II thereto.
23Allium cepa L. bulb extractCAS No: not allocatedCIPAC No: not allocatedNot applicableThe onion bulbs used to prepare the extracts shall be of food grade quality meeting the requirements of WHO monographs on selected medicinal plants (Volume 1, Geneva, 1999) on Bulbus Allii Cepae17.2.2021Allium cepa L. bulb extract shall be used in accordance with the specific conditions included in the conclusions of the review report on Allium cepa L. bulb extract (SANTE/10842/2020 Rev2) and in particular Appendices I and II thereof.
PART DLow-risk active substances'General provisions applying to all substances listed in this Part: the Commission 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 them available to them on specific request.
Further details on identity and specification of active substance are provided in the review report.https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdfCommission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127).The concerned active substance was initially approved as Verticillium lecanii, but later, for scientific reasons, its name was changed to Lecanicillium muscarium strain Ve6, which was later changed again to the name under which the approval was renewed, Akanthomyces muscarius strain Ve6.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
1Isaria fumosorosea strain Apopka 97Deposited in the American Type Culture Collection (ATCC) under the name Paecilomyces fumosoroseus Apopka ATCC 20874Not applicableMinimum concentration: 1,0 × 108 CFU/mlMaximum concentration: 2,5 × 109 CFU/ml1 January 201631 December 2030For 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 Isaria fumosorosea strain Apopka 97, 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 operators and workers, taking into account that Isaria fumosorosea strain Apopka 97 is to be considered as a potential sensitiser.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
2COS-OGACAS No: not allocatedCIPAC No: 979Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues).≥ 915 g/kgOGA/COS ratio comprised between 1 and 1,6Degree of polymerisation of COS comprised between 5 and 10Degree of polymerisation of OGA comprised between 9 and 20Degree of methylation of OGA < 10 %Degree of acetylation of COS < 50 %22 April 201522 April 2030For 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 COS-OGA, and in particular Appendices I and II thereof, shall be taken into account.
3Cerevisane (no ISO name adopted)CAS No: not allocatedCIPAC No: 980Not relevant≥ 924 g/kg23 April 201523 April 2030For 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 cerevisane, and in particular Appendices I and II thereof, shall be taken into account.
4Pepino mosaic virus strain CH2 isolate 1906GenBank, accession number JN835466CIPAC No: not allocatedNot applicableminimum concentration 5 × 105 viral genome copies per μL7 August 20157 August 2030Only the use in greenhouses 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 Pepino mosaic virus strain CH2 isolate 1906, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pepino mosaic virus strain CH2 isolate 1906 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
5Ferric phosphateCAS No: 10045-86-0CIPAC No: 629Ferric phosphateFerric phosphate 703 g/kg equivalent to 260 g/kg iron and 144 g/kg phosphorus1 January 201631 December 2030For 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 ferric phosphate, and in particular Appendices I and II thereof, shall be taken into account.
6Saccharomyces cerevisae strain LAS02Accession number in the collection of the "Collection Nationale de Cultures de Microorganismes" (CNCM) of the Pasteur Institute: CNCM I-3936Not applicableMinimum concentration: 1 × 1013 CFU/kg6 July 20166 July 2031For 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 Saccharomyces cerevisiae strain LAS02, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Saccharomyces cerevisiae strain LAS02 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
7Trichoderma atroviride strain SC1Accession number CBS 122089 in the collection of the Centraalbureau voor Schimmelcultures (CBS) in Utrecht, The NetherlandCIPAC No: 988Not applicableminimum concentration 1 × 1010 CFU/g6 July 20166 July 2031For 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 atroviride strain SC1, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
8Mild Pepino Mosaic Virus isolate VC1Reference number DSM 26973 in the German Collection of Micro-organisms and Cell Cultures (DSMZ)Not applicableNicotine < 0,1 mg/L29 March 201729 March 2032Only the use in greenhouses 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 Mild Pepino Mosaic Virus isolate VC1, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Mild Pepino Mosaic Virus isolate VC1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
9Mild Pepino Mosaic Virus isolate VX1Reference number DSM 26974 in the German Collection of Micro-organisms and Cell Cultures (DSMZ)Not applicableNicotine < 0,1 mg/L29 March 201729 March 2032Only the use in greenhouses 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 Mild Pepino Mosaic Virus isolate VX1, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Mild Pepino Mosaic Virus isolate VX1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
10Bacillus amyloliquefaciens strain FZB24.Accession number in the culture collection of the "Deutsche Sammlung von Mikroorganismen" (DSM), Germany: 10271Accession number at the Agricultural Research Service Culture Collection (NRRL), USA: B-50304Not applicableMinimum concentration:2 × 1014 CFU/kg1 June 20171 June 2032For 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 amyloliquefaciens strain FZB24, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
11Coniothyrium minitans strain CON/M/91-08Accession number in the culture collection of the "Deutsche Sammlung von Mikroorganismen" (DSM), Germany: DSM 9660CIPAC No 614Not applicableMinimum content of viable spores:1,17 × 1012 CFU/kg1 August 201731 July 2032For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Coniothyrium minitans strain CON/M/91-08, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
12LaminarinCAS No 9008-22-4CIPAC No 671(1→3)-β-D-glucan(according to IUPAC-IUB Joint Commission on Biochemical Nomenclature)≥ 860 g/kg on dry matter (TC)1 March 201828 February 2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on laminarin, and in particular Appendices I and II thereto, shall be taken into account.Conditions of use shall include risk mitigation measures, where appropriate.
13Pasteuria nishizawae Pn1Culture collection: ATCC Safe Deposit (SD-5833)CIPAC NoNot allocatedNot applicableminimum concentration 1 × 1011 spores/g14 October 201814 October 2033For 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 Pasteuria nishizawae Pn1, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pasteuria nishizawae Pn 1 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
14Ampelomyces quisqualis strain AQ10Not applicableMinimum content of viable spores:3,0 × 1012 CFU/kg1 August 20181 August 2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Ampelomyces quisqualis strain AQ10, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers and ensuring that adequate personal protective equipment is included as a condition of use.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
15Clonostachys rosea strain J1446Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212Not applicableNot applicableGliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.1 April 201931 March 2034For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Clonostachys rosea strain J1446, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include risk mitigation measures, where appropriate.
16ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)Not Applicable1000 g/kg (active substance)20 May 201920 May 2034For 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 ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) and in particular Appendices I and II thereof, shall be taken into account.
17Bacillus subtilis strain IAB/BS03Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682Not applicableMinimum concentration:1 × 1013 CFU/kgMaximum concentration:5 × 1013 CFU/kg20 October 201920 October 2034For 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 strain IAB/BS03, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:a)the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites;b)the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers, and ensuring that adequate personal protective equipment is included as a condition of use.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Working Document SANCO/12116/2012.Conditions of use shall include risk mitigation measures, where appropriate.
18Verticillium albo-atrum strain WCS850 (culture collection No CBS 276.92)Not applicableMinimum concentration:0,7 × 107 CFU/ml distilled waterMaximum concentration:1,5 × 107 CFU/ml distilled waterNo relevant impurity1 November 201931 October 2034For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Verticillium albo-atrum strain WCS850, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Verticillium albo-atrum strain WCS850 is to be considered as a potential sensitiser.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012.
19Lavandulyl senecioateCAS No: 23960-07-8CIPAC No: n.a.(RS)-5-methyl-2-(prop-1-en-2-yl)hex-4-en-1-yl 3-methylbut-2-enoate≥ 894 g/kg3 June 20203 June 2035For 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 Lavandulyl senecioate, and in particular Appendices I and II thereto, shall be taken into account.Member State shall assess any extension of the use pattern beyond passive dispensers, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Commission Regulation (EU) No 546/2011.
20Ferric pyrophosphateCAS No: 10058-44-3CIPAC No: —iron(3+) diphosphate≥ 802 g/kgThe following impurities are of toxicological and enviromental concern and must not exceed the following levels in the technical material:Lead: 3 mg/kgMercury: 0,1 mg/kgCadmium: 1 mg/kg3.8.20203.8.2035For 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 ferric pyrophosphate, and in particular Appendices I and II thereto, shall be taken into account.
21Phlebiopsis gigantea strain VRA 1835Not applicableNo relevant impurities1 September 202031 August 2035For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain VRA 1835, and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention to the protection of operators and workers.Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.
22Phlebiopsis gigantea strain VRA 1984Not applicableNo relevant impurities1 September 202031 August 2035For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain VRA 1984, and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention to the protection of operators and workers.Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.
23Phlebiopsis gigantea strain FOC PG 410.3Not applicableNo relevant impurities1 September 202031 August 2035For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain FOC PG 410.3, and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention to the protection of operators and workers.Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.
24Sodium hydrogen carbonateCAS No: 144-55-8Sodium hydrogen carbonate≥ 990 g/kgArsenic ≤ 3 mg/kgLead ≤ 2 mg/kgMercury ≤ 1 mg/kg1 October 20201 October 2035For 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 sodium hydrogen carbonate, and in particular Appendices I and II thereof, shall be taken into account.
25Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6)Not applicableNo relevant impurities1 March 202129 February 2036For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.
26Blood meal90989-74-5909Not applicable100 % blood meal haemoglobin content: min 80 %.1 April 202131 March 2036For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on blood meal, and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention:to the protection of fish and aquatic invertebrates when less targeted spraying techniques are used, andon the need of blood meal-containing plant protection products to be swirled before use to wet the product.
2724-epibrassinolideCAS No: 78821-43-9CIPAC No: Not applicable(3aS,5R,6S,7aR,7bS,9aS,10R,12aS,12bS)-10((2S,3R,4R,5R)-3,4-dihydroxy-5,6-dimethylheptan-2-yl)5,6-dihydroxy-7a,9a-dimethylhexadecahydro-3Hbenzo[c]indeno[5,4-e]oxepin-3-one≥ 900 g/kg31 March 202131 March 2036For 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 4 December 2020, and in particular Appendices I and II thereto, shall be taken into account.
PART ECandidates for substitution
Further details on identity and specification of active substance are provided in the review report.Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33).
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
1FlumetralinCAS No 62924-70-3CIPAC No 971N-(2-chloro-6-fluorobenzyl)-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine980 g/kgThe impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material.11 December 201511 December 2022For 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 flumetralin, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;(b)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(c)the risk to herbivorous mammals;(d)the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:1.the technical specification of the active substance as manufactured (based on commercial scale production);2.the compliance of the toxicity batches with the confirmed technical specification.The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016.
2EsfenvalerateCAS No: 66230-04-4CIPAC No: 481(αS)-α-cyano-3-phenoxybenzyl (2S)-2-(4-chlorophenyl)-3-methylbutyrate830 g/kgThe impurity toluene shall not exceed 10 g/kg in the technical material.1 January 201631 December 2022For 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 esfenvalerate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk from esfenvalerate and the 2SαR-isomer of fenvalerate to aquatic organisms including the risk for bio-accumulation through the food chain,the risk to honeybees and non-target arthropods,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.
3Metsulfuron-methylCAS No 74223-64-6CIPAC No 441.201Methyl 2-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)benzoate967 g/kg1 April 201631 March 2023For 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 metsulfuron-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of consumers,the protection of groundwater,the protection of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority by 30 September 2016 confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (IN-A4098) to confirm that this metabolite is not genotoxic and not relevant for risk assessment.
4BenzovindiflupyrCAS No: 1072957-71-1CIPAC No: not availableN-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide960 g/kg (50/50) racemate2.3.20162.3.2023For 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 benzovindiflupyr, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;(2)the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;(3)the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water.The applicant shall submit to the Commission, the Member States and the Authority the information requested under points (1) and (2) by 2 September 2016 and the information requested under point (3) within 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.
5Lambda-CyhalothrinCAS No 91465-08-6CIPAC No 463A 1:1 mixture of:(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or of (R)-α-cyano-3-phenoxybenzyl (1S)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate900 g/kg1 April 201631 March 2023For 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 lambda-cyhalothrin, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the:(a)protection of operators, workers and bystanders;(b)metabolites potentially formed in processed commodities;(c)risk to aquatic organisms, mammals and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.The applicants shall submit confirmatory information as regards:1.a systematic review to assess the evidence available as regards potential sperm effects linked to exposure to lambda-cyhalothrin using guidance available (e.g. EFSA GD on Systematic Review methodology, 2010);2.toxicological information to assess the toxicological profile of the metabolites V (PBA) and XXIII (PBA(OH)).The applicants shall submit those information to the Commission, the Member States and the Authority by 1 April 2018.
6ProsulfuronCAS No 94125-34-5CIPAC No 5791-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3- trifluoropropyl)-phenylsulfonyl]-urea950 g/kgThe impurity 2-(3,3,3-trifluoro-propyl)-benzene sulphonamide shall not exceed 10 g/kg in the technical material.1 May 201731 July 2024PART AUse shall be limited to one application every three years on the same field at a maximum dose of 20 g active substance per hectare.PART BFor 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 prosulfuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to non-target terrestrial and aquatic plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (CGA150829) to confirm that this metabolite is not genotoxic and not relevant for risk assessment.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 October 2017.
7PendimethalinCAS No 40487-42-1CIPAC No 357N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene900 g/kg1,2-dichloroethane≤ 1 g/kgTotal N-Nitroso compounds: max 100 ppm, of which N-Nitroso-pendimethalin: < 45 ppm.1 September 201730 November 2024For 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 pendimethalin, and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall 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 the specification of the technical material,the protection of operators,the protection of birds, mammals and aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator.The applicant shall submit confirmatory information to the Commission, the Member States and the Authority as regards:1.the potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish (Lepomis macrochirus);2.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.The applicant shall submit the confirmatory information requested under point 1 by 31 December 2018. The applicant shall submit the confirmatory information requested under point 2 within a period of two years of the publication by the Commission of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
8ImazamoxCAS No 114311-32-9CIPAC No 6192-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]-5-methoxymethylnicotinic acid≥ 950 g/kgThe impurity cyanide ion (CN) shall not exceed 5 mg/kg in the technical material.1 November 201731 January 2025For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on imazamox, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of consumers;the protection of aquatic plants and of non-target terrestrial plants;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of authorisation shall include risk mitigation measures and monitoring programs shall be initiated to verify potential groundwater contamination from imazamox and metabolites CL 312622 and CL 354825 in vulnerable zones, where appropriate.
9PropyzamideCAS No 23950-58-5CIPAC No 3153,5-dichloro-N-(1,1-dimethylprop-2-ynyl) benzamide920 g/kg1 July 201830 June 2025For 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, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the protection of operators,the protection of groundwater in vulnerable areas,the protection of birds, mammals, non-target plants, soil and aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1.the completion of assessment of toxicological profile of metabolites identified in significant concentration in primary and rotational crops;2.the soil degradation of major metabolite RH- 24580;3.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.The applicant shall submit the information mentioned under point (1) by 31 October 2018 and the information mentioned under point (2) by 30 April 2019. The applicant shall submit the confirmatory information mentioned in point (3) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater be made public by the Commission.
10Copper compounds:1 January 201931 December 2025Only uses resulting in a total application of maximum 28 kg of copper per hectare over a period of 7 years shall be authorised.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, the conclusions of the review report on copper compounds and in particular Appendices I and II thereto, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment and other mitigation measures as appropriate;the protection of water and non-target organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate;the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, do not exceed the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site, and, where the information is available, copper input from other sources. Member States may in particular decide to set a maximum annual application rate not exceeding 4 kg/ha of copper.
Copper hydroxide CAS No 20427-59-2 CIPAC No 44.305Copper (II) hydroxide≥ 573 g/kg
Copper oxychloride CAS No 1332-65-6 or 1332-40-7 CIPAC No 44.602Dicopper chloride trihydroxide≥ 550 g/kg
Copper oxide CAS No 1317-39-1 CIPAC No 44.603Copper oxide≥ 820 g/kg
Bordeaux mixture CAS No 8011-63-0 CIPAC No 44.604Not allocated≥ 245 g/kg
Tribasic copper sulphate CAS No 12527-76-3 CIPAC No 44.306Not allocated≥ 490 g/kgThe following impurities shall not exceed the following levels:Arsenic max. 0,1 mg/g CuCadmium max. 0,1 mg/g CuLead max. 0,3 mg/g CuNickel max. 1 mg/g CuCobalt max. 3 mg/kgMercury max. 5 mg/kgChromium max. 100 mg/kgAntimony max. 7 mg/kg
11MethoxyfenozideCAS No 161050-58-4CIPAC No 656N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide≥ 970 g/kgThe following impurities must not exceed the following levels in the technical material:Tert-butylhydrazine < 0,001 g/kgRH-116267 < 2 g/kg1 April 201931 March 2026Only uses in greenhouses shall 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 thereto, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;the risk of accumulation in soil;the protection of non-target arthropods, sediment dwelling and aquatic organisms;Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1.a comparative in vitro metabolism study on methoxyfenozide, by 1 April 2020;2.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water, within 2 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.The applicant shall also provide an updated assessment of the information submitted and, where relevant, further information to confirm the absence of thyroid endocrine activity in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 1 February 2021.
12alpha-cypermethrinCAS No 67375-30-8CIPAC No 454Racemate comprising:(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylateor(R)-α-cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylateand (S)-α-cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate≥ 980 g/kgThe manufacturing impurity hexane is considered to be of toxicological concern and must not exceed 1 g/kg in the technical material1 November 201931 October 2026For the implementation of the uniform principles, as referred to in Article 9(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on alpha-cypermethrin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, ensuring that the conditions of use prescribe the application of adequate personal protective equipment;the consumer risk assessment;the protection of aquatic organisms, bees and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1.the toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety;2.the potential relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR);3.the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water;4.Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605.The applicant shall submit the information referred to in point 1 by 30 October 2020; the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of isomer mixtures; and the information referred to in point 3 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.As regards Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of androgenic endocrine activity shall be submitted by 30 October 2021.
13etoxazoleCAS No 153233-91-1CIPAC No 623(RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro1,3-oxazol-4-yl]phenetole≥ 948 g/kg1 February 202131 January 2028Only uses on ornamental plants in permanent greenhouses shall 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 renewal report on etoxazole, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:possible uptake of persistent soil metabolites in rotational crops;the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment.The applicant shall submit to the Commission, the Member States and the Authority by 5 January 2023 confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, including an updated assessment of the information already submitted and, where relevant, further information.

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