{
  "url": "https://openlegislation.uk/eu-regulation-2011-540/annex-1/part-B",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-540/annex-1/part-B.json",
  "legislation": "eur/2011/540",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-540",
  "path": "annex/1/part/B",
  "kind": "part",
  "number": "B",
  "heading": "Active substances approved under Regulation (EC) No 1107/2009",
  "text": "General provisions applying to all substances listed in this Part:\nfor 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;\nMember 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.\nFurther details on identity and specification of active substance are provided in the review report.\n2-hydroxy-4,6-dimethoxypyrimidine.\n2,4-dihydroxy-6-methoxypyrimidine.\nsodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.\n5-(trifluoromethyl)-2(1H)-pyridinone.\n4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.\nM03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.\n5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol.\n3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid.\n2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene.\n4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid.\n3-phenoxybenzaldehyde.\nDioxins (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)).\n7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid.\n3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1 H -pyrazole-4-carboxylic acid.\n3-chloro-1-methyl-5-sulfamoyl-1 H -pyrazole-4-carboxylic acid.\np -methyl-phenethylamine.\nOJ L 353, 31.12.2008, p. 1.\nRegulation (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).\nCommission 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 ).\nhttps://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf\nGuidance 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.\nGuidance 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\nNumber\nCommon Name, Identification Numbers\nIUPAC Name\nPurity\nDate of approval\nExpiration of approval\nSpecific provisions\n1\nBispyribac\nCAS No\n125401-75-4\nCIPAC No\n748\n2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid\n≥ 930 g/kg (referred to as bispyribac-sodium)\n1 August 2011\n31 July 2023\nPART A\nOnly uses as herbicide in rice may be authorised.\nPART B\nFor the implementation 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.\nIn 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.\nConditions of authorisation shall include risk mitigation measures where appropriate.\nThe Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03, M04 and M10.\nThey shall ensure that the applicant provides such information to the Commission by 31 July 2013.\n2\nProfoxydim\nCAS No 139001-49-3\nCIPAC No 621\n2 - [(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\n≥ 940 g/kg\n1 August 2011\n31 July 2021\nPART A\nOnly uses as herbicide in rice may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment, Member States shall pay particular attention to:\nthe protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe long-term risk to non-target organisms.\nConditions of authorisation shall include risk mitigation measures where appropriate.\n3\nAzimsulfuron\nCAS No 120162-55-2\nCIPAC No 584\n1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea\n≥ 980 g/kg\nmaximum level of the impurity phenol 2 g/kg\n1 January 2012\n31 December 2021\nPART A\nOnly uses as herbicide may be authorised.\nAerial applications may not be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(1)the protection of non-target plants;\n(2)the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions;\n(3)the protection of aquatic organisms.\nMember 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).\nThe notifier shall submit confirmatory information as regards:\n(a)the risk assessment on aquatic organisms;\n(b)the identification of the degradation products in the aqueous photolysis of the substance.\nThe notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.\n4\nAzoxystrobin\nCAS No 131860-33-8\nCIPAC No 571\nmethyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate\n≥ 930 g/kg\nToluene maximum content 2 g/kg\nZ-isomer maximum content 25 g/kg\n1 January 2012\n31 December 2024\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(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;\n(2)the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\n(3)the protection of aquatic organisms.\nThe Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.\nThe notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.\n5\nImazalil\nCAS No 35554-44-0\n73790-28-0 (replaced)\nCIPAC No 335\n(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole\nor\nallyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether\n≥ 950 g/kg\n1 January 2012\n31 December 2024\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall:\n(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;\n(2)pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels;\n(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;\n(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;\n(5)pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe notifier shall submit confirmatory information as regards:\n(a)route of degradation of imazalil in soil and surface water systems;\n(b)environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible;\n(c)a hydrolysis study to investigate the nature of residues in processed commodities.\nThe notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.\n6\nProhexadione\nCAS No 127277-53-6 (prohexadione-calcium)\nCIPAC No 567 (prohexadione)\nNo 567.020 (prohexadione-calcium)\n3,5-dioxo-4-propionylcyclohexanecarboxylic acid\n≥ 890 g/kg\n(expressed as prohexadione-calcium)\n1 January 2012\n31 December 2022\nPART A\nOnly uses as plant growth regulator may be authorised.\nPART B\nFor the implementation 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.\n7\nSpiroxamine\nCAS No 1181134-30-8\nCIPAC No 572\n8- tert -butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO)\n≥ 940 g/kg\n(diastereomers A and B combined)\n1 January 2012\n31 December 2023\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(1)the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;\n(2)the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\n(3)the risk to aquatic organisms.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe notifier shall submit confirmatory information as regards:\n(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;\n(b)the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;\n(c)the groundwater exposure assessment for metabolite M03;\n(d)the risk to aquatic organisms.\nThe 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.\n8\nKresoxim-methyl\nCAS No 143 390-89-0\nCIPAC No 568\nmethyl (E)-methoxyimino[a-(o-tolyloxy)-o-tolyl]acetate\n≥ 910 g/kg\nMethanol: max. 5 g/kg\nMethyl chloride: max. 1 g/kg\nToluene: max. 1 g/kg\n1 January 2012\n31 December 2024\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nFor the implementation 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.\nMember States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures.\nThe applicant shall submit confirmatory information as regards:\nGroundwater exposure risk assessment, and in particular:\non 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,\non the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L,\non a groundwater exposure risk assessment for the late application in apples, pears and grapes.\nThe applicant shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.\n9\nFluroxypyr\nCAS No 69377-81-7\nCIPAC No 431\n4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid\n≥ 950 g/kg (fluroxypyr-meptyl)\nThe following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material:\nN-methyl-2-pyrrolidone (NMP): < 3 g/kg\n1 January 2012\n31 December 2024\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nFor 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.\nIn this overall assessment, Member States must pay particular attention to:\nthe 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;\nthe risk to aquatic organisms.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\n10\nTefluthrin\nCAS No: 79538-32-2\nCIPAC No: 451\n2,3,5,6-tetrafluoro-4-methylbenzyl (1 RS, 3RS )-3-[( Z )-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate\nTefluthrin is a 1:1 mixture of Z -(1 R , 3 R ) and Z -(1 S , 3 S ) enantiomers.\n≥ 920 g/kg\nHexachlorobenzene: not more than 1 mg/kg\n1 January 2012\n31 December 2024\nPART A\nOnly uses as insecticide may be authorised.\nThe 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.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe 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,\nthe risk to birds and mammals. Risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage,\nensure 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.\nThe applicant shall submit confirmatory information as regards:\n(1)the specification of the technical material, as commercially manufactured;\n(2)a validated analytical method for water;\n(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.\nThe 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.\n11\nOxyfluorfen\nCAS No 42874-03-3\nCIPAC No 538\n2-chloro-α,α,α-trifluoro- p -tolyl 3-ethoxy-4-nitrophenyl ether\n≥ 970 g/kg\nImpurities:\nN,N-dimethylnitrosamine: not more than 50 μg/kg\n1 January 2012\n31 December 2024\nPART A\nOnly 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.\nPART B\nFor the implementation 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.\nIn this overall assessment, Member States must pay particular attention to:\noperator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate,\nthe risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.\nConditions 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.\n12\n1-naphthylacetamide\nCAS No 86-86-2\nCIPAC No 282\n2-(1-naphthyl)acetamide\n≥ 980 g/kg\n1 January 2012\n31 December 2023\nPART A\nOnly uses as plant growth regulator may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States:\n(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;\n(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;\n(c)shall pay particular attention to the risk to aquatic organisms;\n(d)shall pay particular attention to the risk to non-target plants;\n(e)shall pay particular attention to the risk to birds.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the risk to non-target plants;\n(2)the long-term risk to birds.\nThe applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.\n13\n1-naphthylacetic acid\nCAS No 86-87-3\nCIPAC No 313\n1-naphthylacetic acid\n≥ 980 g/kg\n1 January 2012\n31 December 2023\nPART A\nOnly uses as plant growth regulator may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States:\n(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;\n(b)shall pay particular attention to the dietary exposure situation of consumers in view of future revisions of maximum residue levels;\n(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;\n(d)shall pay particular attention to the risk to aquatic organisms;\n(e)shall pay particular attention to the risk to birds.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the route and rate of degradation in soil including an assessment of the potential for photolysis;\n(2)the long-term risk to birds.\nThe applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.\n14\nFluquinconazole\nCAS No 136426-54-5\nCIPAC No 474\n3-(2,4-dichlorophenyl)-6-fluoro-2-(1 H -1,2,4-triazol-1-yl)quinazolin-4(3 H )-one\n≥ 955 g/kg\n1 January 2012\n31 December 2021\nPART A\nOnly uses as fungicide may be authorised\nPART B\nFor the implementation 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.\nIn this overall assessment Member States:\n(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;\n(b)shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);\n(c)shall pay particular attention to the risk to birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;\n(2)the contribution of the potential residues of the metabolite dione in rotational crops to the overall consumer exposure;\n(3)the acute risk to insectivorous mammals;\n(4)the long-term risk to insectivorous and herbivorous birds and mammals;\n(5)the risk to earthworm-eating mammals;\n(6)the endocrine disruption potential in aquatic organisms (fish full life cycle study).\nThe applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.\n15\nFluazifop P\nCAS No 83066-88-0 (fluazifop-P)\nCIPAC No 467 (fluazifop-P)\n( R )-2-{4-[5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionic acid (fluazifop-P)\n≥ 900 g/kg in fluazifop P-butyl\nThe following impurity 2-chloro-5-(trifluoromethyl)pyridine must not exceed 1,5 g/kg in the material as manufactured.\n1 January 2012\n31 December 2023\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall:\npay particular attention to consumer safety as regards the occurrence in groundwater of the metabolite compound X;\npay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;\npay particular attention to the protection of surface water and groundwater in vulnerable zones;\npay particular attention to the risk for non-target plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;\n(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;\n(3)the potential long-term risk to herbivorous mammals;\n(4)the fate and behaviour in the environment of the metabolite compounds X and IV;\n(5)the potential risk to fish and aquatic invertebrates for the metabolite compound IV.\nThe 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.\n16\nTerbuthylazine\nCAS No 5915-41-3\nCIPAC No 234\nN2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine\n≥ 950 g/kg\nImpurities:\nPropazine not more than 10 g/kg\nAtrazine not more than 1 g/kg\nSimazine not more than 30 g/kg\n1 January 2012\n31 December 2024\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\n(b)the risk to mammals and earthworms.\nConditions 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.\nThe applicant shall submit confirmatory information as regards:\n(1)the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities;\n(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;\n(3)groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6;\n(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’.\nThe 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.\n17\nTriazoxide\nCAS No 72459-58-6\nCIPAC No 729\n7-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide\n≥ 970 g/kg\nImpurities:\ntoluene: not more than 3 g/kg\n1 October 2011\n30 September 2021\nPART A\nOnly uses as fungicide for use as seed treatment may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States:\n(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;\n(b)shall pay particular attention to the risk to granivorous birds and shall ensure that conditions of authorisation include risk mitigation measures.\nThe 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.\n18\n8-hydroxyquinoline\nCAS No\n148-24-3 (8-hydroxyquinoline)\nCIPAC No 677\n(8-hydroxyquinoline)\n8-quinolinol\n≥ 990 g/kg\n1 January 2012\n31 December 2021\nPART A\nOnly uses as fungicide and bactericide in greenhouses may be authorised.\nPART B\nFor the implementation 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.\nIn 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.\nThe applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards:\n(1)the method of analysis for air;\n(2)a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.\nThe applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.\n19\nAcrinathrin\nCAS No 101007-06-1\nCIPAC No 678\n( S )-α-cyano-3-phenoxybenzyl (Z)-(1 R ,3 S )-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate or\n( S )-α-cyano-3-phenoxybenzyl ( Z )-(1 R )- cis -2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate\n≥ 970 g/kg\nImpurities:\n1,3-dicyclohexylurea: not more than 2 g/kg\n1 January 2012\n31 December 2023\nPART A\nOnly uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States:\n(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;\n(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;\n(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.\nThe applicant shall submit confirmatory information as regards:\n(1)the potential risk to groundwater from the metabolite 3-PBAld;\n(2)the chronic risk to fish;\n(3)the risk assessment for non-target arthropods;\n(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.\nThe 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.\n20\nProchloraz\nCAS No 67747-09-5\nCIPAC No 407\nN -propyl- N -[2-(2,4,6-trichlorophenoxy)ethyl]imidazole-1-carboxamide\n≥ 970 g/kg\nImpurities:\nSum of dioxins and furans (WHO-PCDD/T TEQ): not more than 0,01 mg/kg\n1 January 2012\n31 December 2023\nPART A\nOnly uses as fungicide may be authorised. In the case of outdoor uses, rates shall not exceed 450 g/ha per application.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States:\n(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;\n(b)shall pay particular attention to the risk to aquatic organisms, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;\n(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.\nThe applicants shall submit confirmatory information as regards:\n(1)comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;\n(2)the environmental risk assessment for the metal complexes of prochloraz;\n(3)the potential endocrine disrupting properties of prochloraz on birds.\nThe 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.\n22\nMetam\nCAS No 144-54-7\nCIPAC No 20\nMethyldithiocarbamic acid\n≥ 965 g/kg\nExpressed as metam-sodium on a dry weight basis\n≥ 990 g/kg\nExpressed as metam-potassium on a dry weight basis\nRelevant impurities:\nmethylisothiocyanate (MITC)\nmax. 12 g/kg on dry weight basis (metam-sodium),\nmax. 0,42 g/kg on dry weight basis (metam-potassium).\nN,N’ -dimethylthiourea (DMTU)\nmax. 23 g/kg on a dry weight basis (metam-sodium),\nmax. 6 g/kg on a dry weight basis (metam-potassium).\n1 July 2012\n30 June 2022\nPART A\nOnly 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.\nThe 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.\nThe maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.\nAuthorisations shall be limited to professional users.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States:\n(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;\n(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;\n(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;\n(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;\n(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.\nThe applicant shall submit confirmatory information on methyl isothiocyanate as regards:\n(1)the assessment of the long-range atmospheric transport potential and related environmental risks;\n(2)the potential groundwater contamination.\nThe applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.\n23\nBifenthrin\nCAS No\n82657-04-3\nCIPAC No 415\n2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate\nor\n2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate\n≥ 930 g/kg\nImpurities:\nToluene: not more than 5 g/kg\n1 August 2012\n31 July 2019\nPART A\nOnly uses as insecticide in greenhouses with a permanent structure may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment, Member States must pay particular attention to:\n(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;\n(b)the protection of pollinator colonies purposely placed in the greenhouse;\n(c)the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.\nConditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products.\n24\nFluxapyroxad\nCAS No 907204-31-3\nCIPAC No 828\n3-(difluoromethyl)-1-methyl- N -(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide\n≥ 950 g/kg\nThe impurity toluene must not exceed 1 g/kg in the technical material\n1 January 2013\n31 December 2022\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n25\nFenpyrazamine\nCAS No 473798-59-3\nCIPAC No 832\nS-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate\n≥ 940 g/kg\n1 January 2013\n31 December 2022\nFor the implementation 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.\nThe 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.\n26\nAdoxophyes orana granulovirus\nCulture collection No DSM BV-0001\nCIPAC No 782\nNot applicable\nNo relevant impurities\n1 February 2013\n31 January 2023\nFor the implementation 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.\n27\nIsopyrazam\nCAS No 881685-58-1\n(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)\nCIPAC No 963\nA mixture of 3-(difluoromethyl)-1-methyl- N -[(1 RS ,4 SR ,9 RS )-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide\n( syn -isomer – 50:50 mix of two enantiomers)\nand\n3-(difluoromethyl)-1-methyl- N -[(1 RS ,4 SR ,9 SR )-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide\n( anti -isomer– 50:50 mix of two enantiomers)\nIn a range of 78:15 % to 100:0 % syn to anti .\n≥ 920 g/kg\nIn a range of 78:15 % to 100:0 % syn- to anti-isomers\n1 April 2013\n31 March 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to aquatic organisms;\n(b)the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;\n(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions 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.\nThe applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.\nThe applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.\n28\nPhosphane\nCAS No 7803-51-2\nCIPAC No 127\nPhosphane\n≥ 994 g/kg\nThe relevant impurity arsane must not exceed 0,023 g/kg in the technical material\n1 April 2013\n31 March 2023\nAuthorisations shall be limited to professional users.\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators in and around the treated premises during the treatment as well as during and after the aeration;\nthe protection of workers in and around the treated premises during the treatment as well as during and after the aeration;\nthe protection of bystanders around the treated premises during the treatment as well as during and after the aeration.\nConditions 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.\n29\nTrichoderma asperellum (strain T34)\nCECT number: 20417\nNot applicable\n1 × 10 10 cfu/g\n1 June 2013\n31 May 2023\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures where appropriate.\n30\nZucchini Yellow Mosaic Virus — weak strain\nATCC accession number: PV-593\nNot applicable\n≥ 0,05 mg/l\n1 June 2013\n31 May 2023\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\n31\nCyflumetofen\nCAS No 400882-07-7\nCIPAC No 721\n2-methoxyethyl ( RS )-2-(4- tert -butylphenyl)-2-cyano-3-oxo-3-( α,α,α -trifluoro-o-tolyl)propionate\n≥ 975 g/kg (racemic)\n1 June 2013\n31 May 2023\nPlant 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.\nFor the implementation 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.\nIn this overall assessment, Member States shall pay particular attention to:\nthe protection of operators and workers;\nthe protection of groundwater, in particular for metabolite B3, when the substance is applied in regions with vulnerable soils and/or climatic conditions;\nthe protection of drinking water;\nthe risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n32\nTrichoderma atroviride strain I-1237\nCNCM number: I-1237\nNot applicable\n1 × 109 cfu/g ( 1 × 1010 spores/g)\n1 June 2013\n31 May 2023\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures where appropriate.\n33\nAmetoctradin\nCAS No 865318-97-4\nCIPAC No 818\n5-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine\n≥ 980 g/kg\nThe 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.\n1 August 2013\n31 July 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04 to groundwater under vulnerable conditions.\nConditions of use shall include risk mitigation measures, where appropriate.\n34\nMandipropamid\nCAS No 374726-62-2\nCIPAC No 783\n(RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide\n≥ 930 g/kg\nThe 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.\n1 August 2013\n31 July 2023\nFor the implementation 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015.\n35\nHalosulfuron-methyl\nCAS No 100785-20-1\nCIPAC No 785.201\nmethyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate\n≥ 980 g/kg\n1 October 2013\n30 September 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe 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,\nthe risk to non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(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;\n(b)information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured;\n(c)data to clarify the potential genotoxic properties of chlorosulfonamide acid.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.\n36\nBacillus firmus I-1582\nCollection number: CNCMI-1582\nNot applicable\nMinimum concentration: 7,1 × 10 10 CFU/g\n1 October 2013\n30 September 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus firmus I-158\n2 is to be considered as a potential sensitiser.\nConditions of use shall include risk mitigation measures, where appropriate.\n37\nCandida oleophila strain O\nCollection number: MUCL40654\nNot applicable\nNominal content: 3 × 10 10 CFU/g dried product\nRange: 6 × 10 9 – 1 × 10 11 CFU/g dried product\n1 October 2013\n30 September 2023\nFor the implementation 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.\n38\nHelicoverpa armigera nucleopolyhedrovirus\nDSMZ number: BV-0003\nNot applicable\nMinimum concentration: 1,44 × 10 13 OB/l (occlusion bodies/l)\n1 June 2013\n31 May 2023\nFor the implementation 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.\n39\nPaecilomyces fumosoroseus strain FE 9901\nCollection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490\nNot applicable\nMinimum 1,0 × 10 9 CFU/g\nMaximum 3,0 × 10 9 CFU/g\n1 October 2013\n30 September 2023\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\n40\nPotassium phosphonates (no ISO name)\nCAS No\n13977-65-6 for potassium hydrogen phosphonate\n13492-26-7 for dipotassium phosphonate\nMixture: none\nCIPAC No 756 (for potassium phosphonates)\nPotassium hydrogen phosphonate,\nDipotassium phosphonate\n31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions)\n17,8 to 20,0 % potassium\n≥ 990 g/kg on dry weight basis\n1 October 2013\n30 September 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to birds and mammals,\nthe 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.\n41\nSpiromesifen\nCAS No 283594-90-1\nCIPAC No 747\n3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate\n≥ 965 g/kg (racemic)\nThe impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.\n1 October 2013\n30 September 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe long-term risk to aquatic invertebrates,\nthe risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,\nthe protection of workers and operators.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.\n42\nSpodoptera littoralis nucleopolyhedrovirus\nDSMZ number: BV-0005\nNot applicable\nMaximum concentration: 1 × 10 12 OB/l (occlusion bodies/l)\n1 June 2013\n31 May 2023\nFor the implementation 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.\n43\nBixafen\nCAS No 581809-46-3\nCIPAC No 819\nN -(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide\n≥ 950 g/kg\n1 October 2013\n30 September 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the residues of bixafen and of its metabolites in rotational crops;\n(b)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\n(c)the risk to aquatic organisms;\n(d)the risk to soil and sediment-dwelling organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n44\nMaltodextrin\nCAS No 9050-36-6\nCIPAC No 801\nNone allocated\n≥ 910 g/kg\n1 October 2013\n30 September 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the potential increased growth of fungi and possible presence of mycotoxins on the surface of treated fruits;\n(b)the potential risk to honeybees and non-target arthropods.\nConditions of use shall include risk mitigation measures, where appropriate.\n45\nEugenol CAS No 97-53-0\nCIPAC No 967\n4-allyl-2-methoxyphenol\n≥ 990 g/kg\nRelevant impurity: methyl eugenol maximum 0,1 % of the technical material\n1 December 2013\n30 November 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate,\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe risk to aquatic organisms,\nthe risk to insectivorous birds.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)the storage stability (2 years) at ambient temperature on the formulated product;\n(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;\n(c)the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.\n46\nGeraniol CAS No 106-24-1\nCIPAC No 968\n( E ) 3,7-dimethyl-2,6-octadien-1-ol\n≥ 980 g/kg\n1 December 2013\n30 November 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to\nthe protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to aquatic organisms;\nthe risk to birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards\n(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;\n(b)the groundwater exposure.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.\n47\nThymol\nCAS No\n89-83-8\nCIPAC No\n969\n5-methyl-2-propan-2-yl-phenol\n≥ 990 g/kg\n1 December 2013\n30 November 2023\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to\nthe protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to aquatic organisms;\nthe risk to birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards\n(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;\n(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;\n(c)the groundwater exposure.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.\n48\nSedaxane\nCAS No 874967-67-6\n(trans isomer: 599197-38-3/cis isomer: 599194-51-1)\nCIPAC No 833\nmixture 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\n≥ 960 g/kg Sedaxane\n(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)\n1 February 2014\n31 January 2024\nPART A\nOnly uses for seed treatment may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\n(b)the long-term risk to birds and mammals.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite CSCD465008 in vulnerable zones, where appropriate.\nThe 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’.\nThe 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.\n49\nEmamectin\nCAS No\nemamectin: 119791-41-2\n(formerly 137335-79-6) and 123997-28-4\nemamectin benzoate: 155569-91-8\n(formerly 137512-74-4 and 179607-18-2)\nemamectin B1a benzoate: 138511-97-4\nemamectin B1b benzoate: 138511-98-5\nCIPAC No\nemamectin: 791\nemamectin benzoate: 791.412\nEmamectin B1a:\n(10 E ,14 E ,16 E )-(1 R ,4S,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-6′-[( S )- sec -butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]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\nEmamectin B1b:\n(10 E ,14 E ,16 E )-(1 R ,4 S ,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]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-l yxo -hexapyranosyl)-α-L- arabino -hexapyranoside\nEmamectin B1a benzoate:\n(10 E ,14 E ,16 E )-(1 R ,4S,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-6′-[( S )- sec -butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]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\nEmamectin B1b benzoate:\n(10 E ,14 E ,16 E )-(1 R ,4 S ,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]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-l yxo -hexapyranosyl)-α-L- arabino -hexapyranoside benzoate\n≥ 950 g/kg\nas emamectin benzoate anhydrous\n(a mixture of min. 920 g/kg emamectin B1a benzoate and max. 50 g/kg emamectin B1b benzoate)\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to non-target invertebrates;\nthe protection of workers and operators.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards the risk of enantio-selective metabolisation or degradation.\nThe 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.\n50\nPseudomonas sp. strain DSMZ 13134\nCollection number: DSMZ 13134\nNot applicable\nMinimum concentration: 3×10 14 cfu/kg\n1 February 2014\n31 January 2024\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.\n51\nFluopyram\nCAS No 658066-35-4\nCIPAC No 807\nN-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide\n≥ 960 g/kg\n1 February 2014\n31 January 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the long-term risk to insectivorous birds;\n(2)the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals.\nThe 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.\n52\nAureobasidium pullulans (strains DSM 14940 and DSM 14941)\nCollection number: German Collection of Microorganisms and cell Cultures (DSMZ) with the accession numbers DSM 14940 and DSM 14941\nNot applicable\nMinimum 5,0 × 10 9 CFU/g for each strain;\nMaximum 5,0 × 10 10 CFU/g for each strain\n1 February 2014\n31 January 2024\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\n53\nPyriofenone:\nCAS No 688046-61-9\nCIPAC No 827\n(5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone\n≥ 965 g/kg\n1 February 2014\n31 January 2024\nFor the implementation 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards\n(a)the identity of two impurities to fully support the provisional specification;\n(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.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.\n54\nDisodium phosphonate\nCAS No 13708-85-5\nCIPAC No 808\ndisodium phosphonate\n281-337 g/kg (TK)\n≥ 917 g/kg (TC)\n1 February 2014\n31 January 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to eutrophication of surface water.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards\n(a)the chronic risk to fish;\n(b)the long term risk to earthworms and soil macro-organisms.\nThe applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.\n55\nPenflufen\nCAS No 494793-67-8\nCIPAC No 826\n2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide\n≥ 950 g/kg\n1:1 (R:S) ratio of enantiomers\n1 February 2014\n31 January 2024\nPART A\nOnly 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.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of operators;\n(b)the long-term risk to birds;\n(c)the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions;\n(d)to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n56\nOrange oil\nCAS No 8028-48-6 (Orange extract)\n5989-27-5 (D-limonene)\nCIPAC No 902\n( R )-4-isopropenyl-1-methylcyclohexene or p -mentha-1,8-diene\n≥ 945 g/kg (of D-limonene)\nThe active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 ( Aurantii dulcis aetheroleum ) and ISO 3140:2011(E)\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of operators and workers;\n(b)the risk to birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\nThe applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.\n57\nPenthiopyrad\nCAS No 183675-82-3\nCIPAC No 824\n(RS )- N -[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)pyrazole-4-carboxamide\n≥ 980 g/kg\n(50:50 racemic mixture)\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of operators and workers;\n(b)the risk to aquatic and soil organisms;\n(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\n(d)the level of residues in rotational crops following consecutive application of the active substance over several years.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(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;\n(2)the toxicological profile and the reference values of the metabolite PAM;\n(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.\nThe 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.\n58\nBenalaxyl-M\nCAS No 98243-83-5\nCIPAC No 766\nMethyl N -(phenylacetyl)- N -(2,6-xylyl)-D-alaninate\n≥ 950 g/kg\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of workers at re-entry,\nthe 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.\nConditions of use shall include risk mitigation measures, where appropriate.\n59\nTembotrione\nCAS No 335104-84-2\nCIPAC No 790\n2-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione\n≥ 945 g/kg\nThe following relevant impurities must not exceed a certain threshold in the technical material:\nToluene: ≤ 10 g/kg\nHCN: ≤ 1 g/kg\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of operators and workers;\n(b)the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n60\nSpirotetramat\nCAS No 203313-25-1\nCIPAC No 795\ncis -4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-xylyl)-1-azaspiro[4.5]dec-3-en-2-one\n≥ 970 g/kg\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to insectivorous birds.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n61\nPyroxsulam\nCAS No 422556-08-9\nCIPAC No 793\nN -(5,7-dimethoxy[1,2,4]triazolo[1,5- a ]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide\n≥ 965 g/kg\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to groundwater, when the active substance is applied in regions with vulnerable soil or climatic conditions;\n(b)the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the toxicological relevance of impurity number 3 (as referred to in the review report);\n(2)the acute toxicity of the metabolite PSA;\n(3)the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742.\nThe applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.\n62\nChlorantraniliprole\nCAS No 500008-45-7\nCIPAC No 794\n3-bromo-4'-chloro-1-(3-chloro-2-pyridyl)-2'-methyl-6'-(methylcarbamoyl) pyrazole-5-carboxanilide\n≥ 950 g/kg\nThe following relevant impurities must not exceed a certain threshold in the technical material:\nAcetonitrile: ≤ 3 g/kg\n3-picoline: ≤ 3 g/kg\nMethanesulfonic acid: ≤ 2 g/kg\n1 May 2014\n30 April 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and to soil macroorganisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(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);\n(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).\nThe applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.\n63\nSodium silver thiosulfate\nCAS No not allocated\nCIPAC No 762\nNot applicable\n≥ 10,0 g Ag/kg\nExpressed as silver (Ag)\n1 May 2014\n30 April 2024\nPART A\nOnly indoor uses in non-edible crops shall be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to\n(a)the protection of operators and workers;\n(b)limiting the possible release of silver ions through disposal of used solutions;\n(c)the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture.\nConditions of use shall include risk mitigation measures, where appropriate.\n64\nPyridalyl\nCAS No 179101-81-6\nCIPAC No 792\n2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether\n≥ 910 g/kg\n1 July 2014\n30 June 2024\nPART A\nOnly uses in greenhouses with permanent structure may be authorised.\nPART B\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to re-entry workers;\n(b)the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions;\n(c)the risk to birds, mammals and aquatic organisms.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23;\n(2)the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse;\n(3)the risk to aquatic invertebrates.\nThe 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.\nThe 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.\n65\nS-abscisic acid\nCAS No\n21293-29-8\nCIPAC No\nNot allocated\n(2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid\nor\n(7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid\n960 g/kg\n1 July 2014\n30 June 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n66\nL-ascorbic acid\nCAS No 50-81-7\nCIPAC No 774\n(5 R )-5-[(1 S )-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5 H )-one\n≥ 990 g/kg\nThe following relevant impurities shall not exceed:\nMethanol: ≤ 3 g/kg\nHeavy Metals: ≤ 10 mg/kg (expressed as Pb)\n1 July 2014\n30 June 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to aquatic and soil organisms;\n(b)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(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;\n(2)the risk to contaminate groundwater.\nThe applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.\n67\nSpinetoram\nCAS No 935545-74-7\nCIPAC No 802\nXDE-175-J (Major factor)\n(2 R ,3a R ,5a R ,5b S ,9 S ,13 S ,14 R ,16a S , 16b R )-2-(6-deoxy-3- O -ethyl-2,4-di- O -methyl-α-L-mannopyranosyloxy)-13-[(2 R ,5 S ,6 R )-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-1 H - as -indaceno[3,2- d ]oxacyclododecine-7,15-dione\nXDE_175-L (Minor factor)\n(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\n≥ 830 g/kg\n50-90 % XDE-175-J;\nand\n50-10 % XDE-175-L\nTolerance limits (g/kg):\nXDE-175-J = 581-810\nXDE-175-L = 83-270\n1 July 2014\n30 June 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to aquatic and soil organisms;\n(b)the risk to non-target arthropods in-field;\n(c)the risk to bees during the application (overspray) and subsequently.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\nThe 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.\n68\n1,4-dimethylnaphthalene\nCAS No 571-58-4\nCIPAC No 822\n1,4-dimethylnaphthalene\n≥ 980 g/kg\n1 July 2014\n30 June 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of operators and of workers at re-entry and during inspection of the warehouse;\n(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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards the residue definition for the active substance.\nThe applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.\n69\nAmisulbrom\nCAS No 348635-87-0\nCIPAC No 789\n3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)- N , N -dimethyl-1 H -1,2,4-triazole-1-sulfonamide\n≥ 985 g/kg\nThe following relevant impurity must not exceed a certain threshold in the technical material:\n3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg\n1 July 2014\n30 June 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1 H -1,2,4-triazol-3-ylsulfonyl)-1 H -indole and 1-(dimethylsulfamoyl)-1 H -1,2,4-triazole-3-sulfonic acid to contaminate groundwater;\n(2)the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1 H -1,2,4-triazole-3-sulfonic acid, 1 H -1,2,4-triazole-3-sulfonic acid, 1 H -1,2,4-triazole, N , N -dimethyl-1 H -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-3 H -indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff;\n(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;\n(4)the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1 H -1,2,4-triazol-3-ylsulfonyl)-1 H -indole;\n(5)the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1 H -1,2,4-triazol-3-ylsulfonyl)-1 H -indole.\nThe 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.\n70\nValifenalate\nCAS No 283159-90-0\nCIPAC No 857\nMethyl N -(isopropoxycarbonyl)-L-valyl-(3 RS )-3-(4-chlorophenyl)-β-alaninate\n≥ 980 g/kg\n1 July 2014\n30 June 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater.\nThe notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.\n71\nThiencarbazone\nCAS No 317815-83-1\nCIPAC No 797\nMethyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1 H -1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate\n≥ 950 g/kg\n1 July 2014\n30 June 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to\n(a)the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions;\n(b)the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts.\nThat 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.\n72\nAcequinocyl CAS No 57960-19-7 CIPAC No 760\n3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate\n≥ 960 g/kg\n1 September 2014\n31 August 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of workers and operators;\nthe risk to birds, mammals and aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)an analytical method for residues in body fluids and tissues;\n(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;\n(c)the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals.\nThe applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.\n73\nIpconazole\nCAS No\n125225-28-7 (mixture of diastereoisomers)\n115850-69-6 (ipconazole cc, cis isomer)\n115937-89-8 (ipconazole ct, trans isomer)\nCIPAC No 798\n(1 RS ,2 SR ,5 RS ;1 RS ,2 SR ,5 SR )-2-(4-chlorobenzyl)-5-isopropyl-1-(1 H -1,2,4-triazol-1-ylmethyl) cyclopentanol\n≥ 955 g/kg\nIpconazole cc: 875 – 930 g/kg\nIpconazole ct: 65 – 95 g/kg\n1 September 2014\n31 August 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n1..the risk to granivorous birds;\n2..the protection of workers and operators;\n3..the risk to fish.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)the acceptability of the long-term risk to granivorous birds;\n(b)the acceptability of the risk to soil macro-organisms;\n(c)the risk of enantio-selective metabolisation or degradation;\n(d)the potential endocrine disrupting properties of ipconazole for birds and fish.\nThe 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.\n74\nFlubendiamide\nCAS No 272451-65-7\nCIPAC No 788\n3-iodo- N '-(2-mesyl-1,1-dimethylethyl)- N -{4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-o-tolyl}phthalamide\n≥ 960 g/kg\n1 September 2014\n31 August 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to aquatic invertebrates;\n(b)the potential presence of residues in rotational crops.\nConditions of use shall include risk mitigation measures, where appropriate.\n75\nBacillus pumilus QST 2808\nUSDA Agricultural Research Service (NRRL) Patent culture collection in Peoria Illinois, USA under the reference number B-30087\nNot applicable\n≥ 1 × 10 12 CFU/kg\n1 September 2014\n31 August 2024\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)the identification of the aminosugar produced by Bacillus pumilus QST 2808;\n(b)analytical data for the content of that aminosugar in the production batches.\nThe applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.\n76\nMetobromuron\nCAS No 3060-89-7\nCIPAC No 168\n3-(4-bromophenyl)-1-methoxy-1-methylurea\n≥ 978 g/kg\n1 January 2015\n31 December 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the protection of workers and operators;\n(b)the risk to birds, mammals, aquatic organisms and terrestrial non-target plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)the toxicological assessment of the metabolites CGA 18236, CGA 18237, CGA 18238 and 4-bromoaniline;\n(b)the acceptability of the long-term risk to birds and mammals.\nThe applicant shall submit that information to the Commission, the Member States and the Authority by 31 December 2016.\n77\nAminopyralid\nCAS No 150114-71-9\nCIPAC No 771\n4-amino-3,6-dichloropyridine-2-carboxylic acid\n≥ 920 g/kg\nThe following relevant impurity shall not exceed a certain threshold:\nPicloram ≤ 40 g/kg\n1 January 2015\n31 December 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;\n(b)the risk to aquatic macrophytes and terrestrial non-target plants;\n(c)chronic risk to fish.\nConditions of use shall include risk mitigation measures, where appropriate.\n78\nMetaflumizone\nCAS No 139968-49-3\nCIPAC No 779\n(EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide\n≥ 945 g/kg\n(90-100 % E-isomer\n10-0 % Z-isomer)\nThe following relevant impurities shall not exceed a certain threshold:\nHydrazine ≤ 1 mg/kg\n4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg\nToluene ≤ 2 g/kg\n1 January 2015\n31 December 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to fish and sediment dwelling organisms;\n(b)the risk to snail- or earthworm-eating birds.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;\n(2)information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.\nThe 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.\n79\nStreptomyces lydicus strain WYEC 108\nCollection number: American Type Culture Collection (USDA)\nATCC 55445\nNot applicable\nMinimum concentration: 5,0 × 10 8 CFU/g\n1 January 2015\n31 December 2024\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to aquatic organisms;\n(b)the risk to soil dwelling organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n80\nMeptyldinocap\nCAS No 6119-92-2\nCIPAC No 811\nMixture of 75-100 % ( RS )-2-(1-methylheptyl)-4,6-dinitrophenyl crotonate and 25-– 0 % ( RS )-2-(1-methylheptyl)-4,6-dinitrophenyl isocrotonate\n≥ 900 g/kg (mixture of trans- and cis- isomers with a defined ratio range of 25:1 to 20:1)\nRelevant impurity:\n2,6-dinitro-4-[(4 RS )-octan-4-yl]phenyl (2 E/Z )-but-2-enoate\nmax content 0,4 g/kg\n1 April 2015\n31 March 2015\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to operators;\n(b)the risk to aquatic invertebrates.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)the groundwater exposure assessment for metabolites (3 RS )-3-(2-hydroxy-3,5-dinitro-phenyl)-butanoic acid (X103317) and (2 RS )-2-(2-hydroxy-3,5-dinitro-phenyl)-propionic acid (X12335709);\n(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.\nThe 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.\n81\nChromafenozide\nCAS No 143807-66-3\nCIPAC No 775\nN′-tert -butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide\n≥ 935 g/kg\nThe following relevant impurity must not exceed a certain threshold in the technical material:\nButyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg\n1 April 2015\n31 March 2025\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;\n(b)the risk to non-target Lepidoptera in off-crop areas;\n(c)the risk to sediment-dwelling organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(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;\n(2)the assessment of the risk to sediment dwelling organisms from metabolite M-010;\n(3)the leaching potential of metabolites M-006 and M-023 to groundwater.\nThe 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.\n82\nGamma-cyhalothrin\nCAS No 76703-62-3\nCIPAC No 768\n( S )-α-cyano-3-phenoxybenzyl (1 R ,3 R )-3-[( Z )-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or\n( S )-α-cyano-3-phenoxybenzyl (1 R )- cis -3-[( Z )-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate\n≥ 980 g/kg\n1 April 2015\n31 March 2025\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the safety of operators and workers;\n(b)the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices;\n(2)the toxicity profile of the metabolites CPCA, PBA and PBA(OH);\n(3)the long-term risk to wild mammals;\n(4)the potential for biomagnification in terrestrial and aquatic food chains.\nThe applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March 2017.\n83\nBacillus amyloliquefaciens subsp. plantarum strain D747\nAccession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405\nDeposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234.\nNot applicable\nMinimum concentration: 2,0 × 10 11 CFU/g\n1 April 2015\n31 March 2025\nFor the implementation 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.\nIn 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.\nStrict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.\n84\nTerpenoid blend QRD 460\nCIPAC No: 982\nTerpenoid blend QRD 460 is a blend of three components:\nα-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene;\np -cymene: 1-isopropyl-4-methylbenzene;\nd -limonene: ( R )-4-isopropenyl-1-methylcyclohexene.\nThe nominal concentration of each component in the active substance as manufactured should be as follows:\nα-terpinene: 59,7 %;\np -cymene: 22,4 %;\nd -limonene: 17,9 %.\nEach component should have a minimum purity as follows:\nα-terpinene: 89 %;\np -cymene: 97 %;\nd -limonene: 93 %.\n10 August 2015\n10 August 2025\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the stability of formulations on storage;\n(b)the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;\n(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\n(d)the protection of surface water and aquatic organisms;\n(e)the protection of bees and non-target arthropods.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(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;\n(2)the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification.\nThe applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.\n85\nFenhexamid\nCAS No: 126833-17-8\nCIPAC No: 603\nN-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexane-1-carboxamide\n≥ 975 g/kg\nThe following relevant impurity must not exceed a certain threshold in the technical material:\ntoluene: max. 1 g/kg,\n4-amino-2,3-dichlorophenol: max. 3 g/kg.\n1 January 2016\n31 December 2030\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators during field crop handheld operations,\nthe protection of workers re-entering indoor-treated crops,\nthe risk to aquatic organisms,\nthe long-term risk to mammals for field uses.\nConditions of use shall include risk mitigation measures, where appropriate.\n86\nHalauxifen-methyl\nCAS No:943831-98-9\nCIPAC No: 970.201 (halauxifen-methyl) 970 (halauxifen)\nmethyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)pyridine-2-carboxylate\n≥ 930 g/kg\n5 August 2015\n5 August 2025\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nThe risk to aquatic and non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\nThe 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,\nThe compliance of the toxicity batches with the technical specification.\nThe applicant shall submit that information to the Commission, the Member States and the Authority by 5 February 2016.\n87\nPyridate\nCAS No: 55512-33-9\nCIPAC No: 447\nO-6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate\n≥ 900 g/kg\n1 January 2016\n31 December 2030\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, non-target terrestrial plants, and herbivorous mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\n88\nSulfoxaflor\nCAS No: 946578-00-3\nCIPAC No: 820\n[methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ 6 -sulfanylidene]cyanamide\n≥ 950 g/kg\n18 August 2015\n18 August 2025\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to bees and other non-target arthropods;\n(b)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust;\n(b)risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds;\n(c)the risk to pollinators other than honey bees;\n(d)the risk to bee brood.\nThe applicant shall submit that information to the Commission, the Member States and the Authority by 18 August 2017.\n89\nSulfosulfuron\nCAS No: 141776-32-1\nCIPAC No: 601\n1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-ethylsulfonylimidazo[1,2-a]pyridine-3-ylsulfonyl)urea\n≥ 980 g/kg\nThe following relevant impurity must not exceed a certain threshold in the technical material:\nPhenol: < 2 g/kg\n1 January 2016\n31 December 2030\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to soil non-target macro-organisms other than earthworms, non-target terrestrial plants and aquatic organisms.\n90\nFlorasulam\nCAS No 145701-23-1\nCIPAC No 616\n2′,6′,8-trifluoro-5-methoxy[1,2,4]triazolo[1,5- c ]pyrimidine-2-sulfonanilide\n≥ 970 g/kg\nImpurity: 2,6-DFA, not more than 2 g/kg\n1 January 2016\n31 December 2030\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\n91\nFlupyradifurone\nCAS No: 951659-40-8\nCIPAC No: 987\n4-[(6-chloro-3-pyridylmethyl)(2,2-difluoroethyl) amino]furan-2(5H)-one\n≥ 960 g/kg\n9 December 2015\n9 December 2025\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of workers and operators,\nthe risk to non-target arthropods, aquatic invertebrates and small herbivorous mammals,\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,\nresidues in animal matrices and rotational crops.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities,\n(2)the compliance of the toxicity batches with the confirmed technical specification,\n(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.\nThe 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.\n92\nRescalure\nCAS No: 67601-06-3\nCIPAC No:\nNot available\n(3 S ,6 R )-(3 S ,6 S )-6-isopropenyl-3-methyldec-9-en-1-yl acetate\n≥ 750 g/kg\nThe 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.\n18 December 2015\n18 December 2025\nFor the implementation 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.\n93\nMandestrobin\nCAS No: 173662-97-0\nCIPAC No: Not available\n( RS )-2-methoxy- N -methyl-2-[α-(2,5-xylyloxy)- o -tolyl]acetamide\n≥ 940 g/kg (on a dry weight basis)\nXylenes (ortho, meta, para), ethyl benzene max. 5 g/kg (TK)\n9 December 2015\n9 December 2025\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to aquatic organisms,\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities;\n(2)the compliance of the toxicity batches with the confirmed technical specification.\nThe applicant shall submit that information to the Commission, the Member States and the Authority by 9 June 2016.\n94\n2,4-D\nCAS No: 94-75-7\nCIPAC No: 1\n(2,4-dichlorophenoxy) acetic acid\n≥ 960 g/kg\nImpurities:\nFree phenols (expressed as 2,4-DCP): not more than 3 g/kg.\nSum of dioxins and furans (WHO-TCDD TEQ): not more than 0,01 mg/kg.\n1 January 2016\n31 December 2030\nFor the implementation 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe notifier shall submit to the Commission, the Member States and the Authority:\n(1)confirmatory information in the form of the submission of the complete study results from the existing extended one-generation study;\n(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.\nThe 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.\n95\nPyraflufen-ethyl\nCAS No 129630-19-9\nCIPAC No 605.202\nethyl [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxy]acetate\n≥ 956 g/kg\n1 April 2016\n31 March 2031\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic organisms,\nthe protection of non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\n96\nIprovalicarb\nCAS No 140923-17-7\nCIPAC No 620\nisopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate\n≥ 950 g/kg\nImpurities:\nToluene: not more than 3 g/kg\n1 April 2016\n31 March 2031\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of groundwater from the relevant soil metabolite PMPA when the active substance is applied in regions with low clay containing soil types,\nthe safety of operators and workers,\nthe protection of aquatic organisms in the case of formulated products containing other active substances.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n97\nPinoxaden\nCAS No 243973-20-8\nCIPAC No 776\n8-(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\n≥ 970 g/kg\nToluene max. content 1 g/kg\n1 July 2016\n30 June 2026\nFor the implementation 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.\nIn 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.\nThe Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite M2 in vulnerable zones, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n(a)a validated method of analysis of metabolites M11, M52, M54, M55 and M56 in ground water;\n(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).\nThe 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.\n98\nAcibenzolar-S-methyl\nCAS No 135158-54-2\nCIPAC No 597\nS-methyl benzo[1,2,3]thiadiazole-7-carbothioate\n970 g/kg\nToluene: max. 5 g/kg\n1 April 2016\n31 March 2031\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk for consumers via food intake;\n(b)the protection of operators and workers;\n(c)the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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).\n99\nCyantraniliprole\nCAS No:\n736994-63-1\nCIPAC No: Not allocated.\n3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide\n≥ 940 g/kg\nIN-Q6S09 max. 1 mg/kg\nIN-RYA13 max. 20 mg/kg\nmethanesulfonic acid max. 2 g/kg\nacetonitrile max. 2 g/kg\nheptane max. 7 g/kg\n3-picoline max. 3 g/kg.\n14 September 2016\n14 September 2026\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the risk to operators;\n(b)the risk to aquatic organisms, bees and other non-target arthropods;\n(c)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;\n(d)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n100\nIsofetamid\nCAS No: 875915-78-9\nCIPAC No: 972\nN -[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide\n≥ 950 g/kg\n15 September 2016\n15 September 2026\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to the risk to operators, workers and aquatic organisms, in particular fish.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;\n(2)the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;\n(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.\nThe 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.\n101\nBacillus amyloliquefaciens strain MBI 600.\nAccession number in the National Collection of Industrial, Marine and Food Bacteria Ltd (NCIMB), Scotland: NCIMB 12376\nDeposit number in the American Type Culture Collection (ATCC): SD-1414\nNot applicable\nMinimum concentration:\n5,0 × 10 14 CFU/kg\n16 September 2016\n16 September 2026\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\n(a)the specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;\n(b)the protection of operators and workers, taking into account that Bacillus amyloliquefaciens strain MBI 600 is to be considered as a potential sensitiser.\nConditions of use shall include risk mitigation measures, where appropriate.\nStrict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.\n102\nEthofumesate\nCAS No 26225-79-6\nCIPAC No 233\n(RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate\n≥ 970 g/kg\nThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:\nEMS; ethyl methane sulfonate: maximum of 0,1 mg/kg\niBMS; iso-butyl methane sulfonate: maximum of 0,1 mg/kg\n1 November 2016\n31 October 2031\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n103\nPicolinafen\nCAS No 137641-05-5\nCIPAC No 639\n4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide\n≥ 980 g/kg\n1 November 2016\n30 June 2031\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe impurities in the technical active substance;\nthe protection of mammals, especially of large herbivorous mammals;\nthe protection of non-target terrestrial plants;\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe protection of aquatic organisms, especially to algae.\nConditions of use shall include risk mitigation measures, where appropriate.\n104\nThifensulfuron-methyl\nCAS No 79277-27-3\nCIPAC No 452\nmethyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate\n≥ 960 g/kg\n1 November 2016\n31 October 2031\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of groundwater;\nthe protection of non-target plants and aquatic organisms.\nConditions of use shall include risk mitigation measures and the obligation to monitor the groundwater, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n(1)the absence of genotoxicity of metabolites IN-A4098 and its derivative IN-B5528, IN-A5546 and IN-W8268;\n(2)mechanistic data to rule out an endocrine mediated mode of action for mammary gland tumours;\n(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;\n(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.\nThe 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.\n105\nThiabendazole\n2-(thiazol-4-yl)benzimidazole\n≥ 985 g/kg\n1 April 2017\n31 March 2032\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators and consumers,\nthe protection of groundwater,\nthe control of waste water from post-harvest uses.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\nCAS No 148-79-8\nCIPAC No 323\n106\nOxathiapiprolin\nCAS No:\n1003318-67-9\nCIPAC No: 985\n1-(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\n≥ 950 g/kg\n3 March 2017\n3 March 2027\nFor the implementation 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.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n(1)the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;\n(2)the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification.\nThe applicant shall submit the information requested under points (1) and (2) by 3 September 2017.\n107\nIodosulfuron\nCAS No 185119-76-0 (parent)\nCAS No 144550-36-7 (iodosulfuron-methyl-sodium)\nCIPAC No 634 (parent)\nCIPAC No 634.501 (iodosulfuron-methyl-sodium)\n4-iodo-2-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoylsulfamoyl]benzoic acid\n(iodosulfuron)\nsodium ({[5-iodo-2-(methoxycarbonyl)phenyl]sulfonyl}carbamoyl)(4-methoxy-6-methyl-1,3,5-triazin-2-yl)azanide\n(iodosulfuron-methyl-sodium)\n≥ 910 g/kg (expressed as iodosulfuron-methyl-sodium)\n1 April 2017\n31 March 2032\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to consumers,\nthe risk to non-target terrestrial plants,\nthe risk to aquatic plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n(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;\n(2)the effect of water treatment processes on the nature of residues present in drinking water.\nThe 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.\n108\nFlazasulfuron\nCAS No 104040-78-0\nCIPAC No 595\n1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea\n≥ 960 g/kg\n1 August 2017\n31 July 2032\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic plants,\nthe protection of non-target terrestrial plants,\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n109\nBeauveria bassiana strain NPP111B005\nAccession number in the CNCM (Collection Nationale de Culture de Microorganismes) — Institut Pasteur, Paris, France: I-2961.\nNot applicable\nMax. level of beauvericin 24 μg/L\n7 June 2017\n7 June 2027\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe 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,\nthe maximum level of the metabolite beauvericin in the formulated product.\nStrict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.\nConditions of use shall include risk mitigation measures, where appropriate.\n110\nBeauveria bassiana strain 147\nAccession number in the CNCM (Collection nationale de cultures de micro-organismes) — Institut Pasteur, Paris, France: I-2960.\nNot applicable\nMax. level of beauvericin: 24 μg/L\n6 June 2017\n6 June 2027\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe 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,\nthe maximum level of the metabolite beauvericin in the formulated product.\nStrict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.\nConditions of use shall include risk mitigation measures, where appropriate.\n111\nMesosulfuron (parent)\nMesosulfuron-methyl (variant)\nCAS No 208465-21-8\n(mesosulfuron-methyl)\nCIPAC No 663\n(mesosulfuron)\nCIPAC No 663.201\n(mesosulfuron-methyl\nMesosulfuron-methyl:\nmethyl-2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)- p -toluate\nMesosulfuron:\n2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-methanesulfonamido- p -toluic acid\n≥ 930 g/kg\n(expressed as mesosulfuron-methyl)\n1 July 2017\n30 June 2032\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic organisms and non-target terrestrial plants;\nthe protection of groundwater.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n112\nMesotrione\nCAS No 104206-82-8\nCIPAC No 625\nMesotrione\n2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione\n≥ 920 g/kg\nR287431 max 2 mg/kg\nR287432 max 2 g/kg\n1,2-dichloroethane max 1 g/kg\n1 June 2017\n31 May 2032\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators,\nthe protection of groundwater in vulnerable regions,\nthe protection of mammals, aquatic and non-target plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n1..the genotoxic profile of the metabolite AMBA;\n2..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;\n3..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.\nThe 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.\n113\nCyhalofop-butyl\nCAS No 122008-85-9\nCIPAC No 596\nbutyl ( R )-2-[4-(4-cyano-2-fluorophenoxy) phenoxy]propionate\n950 g/kg\n1 July 2017\n30 June 2032\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators,\nthe technical specification,\nthe protection of non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\n114\nPropoxycarbazone (parent)\nPropoxycarbazone-sodium (variant)\nCAS No 145026-81-9 (propoxycarbazone)\nCAS No 181274-15-7 (propoxycarbazone-sodium)\nCIPAC No 655 (propoxycarbazone)\nCIPAC No 655.011 (propoxycarbazone-sodium)\nPropoxycarbazone:\nmethyl 2-[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazole-1-carboxamido)sulfonyl]benzoate\nPropoxycarbazone-sodium:\nsodium {[2-(methoxycarbonyl)phenyl]sulfonyl}[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]azanide\n≥ 950g/kg\n(expressed as Propoxycarbazone-sodium)\n1 September 2017\n31 August 2032\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic organisms, in particular aquatic plants and of and non-target terrestrial plants,\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n115\nBenzoic acid\nCAS No 65-85-0\nCIPAC No 622\nBenzoic acid\n≥ 990 g/kg\n1 September 2017\n31 August 2032\nFor 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.\nIn 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.\nConditions of use shall include risk mitigation measures, where appropriate.\n116\n2,4-DB\nCAS No 94-82-6\nCIPAC No 83\n4-(2,4-dichlorophenoxy) butyric acid\n≥ 940 g/kg\nImpurities:\nFree phenols (expressed as 2,4-dichlorophenol (2,4-DCP)): max. 15 g/kg.\nDibenzo- p -dioxins and polychlorinated dibenzofurans (TCDD toxic equivalents (TEQ)): max. 0,01 mg/kg.\n1 November 2017\n31 October 2032\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators and workers,\nthe protection of consumers from products of animal origin,\nthe protection of wild mammals,\nthe protection of soil non-target organisms,\nthe protection of aquatic organisms,\nthe protection of non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\n117\nMaleic hydrazide\nCAS No 123-33-1\nCIPAC No 310\n6-hydroxy-2H-pyridazin-3-one\n≥ 979 g/kg\nUntil 1 November 2018, the impurity hydrazine shall not exceed 1 mg/kg in the technical material.\nFrom 1 November 2018, the impurity hydrazine shall not exceed 0,028 mg/kg in the technical material.\n1 November 2017\n31 October 2032\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of consumers,\nthe operator and worker safety; the conditions of the use should include the application of adequate personal protective equipment.\nMember 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.\nConditions of use shall include risk mitigation measures, where appropriate.\n118\nGlyphosate\nCAS No 1071-83-6\nCIPAC No 284\nN-(phosphonomethyl)glycine\n≥ 950 g/kg\nImpurities:\nFormaldehyde, less than 1 g/kg\nN -Nitroso-glyphosate, less than 1 mg/kg\n16 December 2017\n15 December 2022\nOnly uses as herbicide may be authorised.\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses,\nthe protection of operators and amateur users,\nthe risk to terrestrial vertebrates and non-target terrestrial plants,\nthe risk to diversity and abundance of non-target terrestrial arthropods and vertebrates via trophic interactions,\ncompliance of pre-harvest uses with good agricultural practices.\nConditions of use shall include risk mitigation measures, where appropriate.\nMember 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.\nMember 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.\nMember States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).\n119\nAcetamiprid\nCAS No 135410-20-7\nCIPAC No 649\n(E)-N1-[(6-Chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine\n≥ 990 g/kg\n1 March 2018\n28 February 2033\nFor 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.\nIn their overall assessment Member States shall pay particular attention to:\nthe risk to aquatic organisms, bees and other non-target arthropods,\nthe risk to birds and mammals,\nthe risk to consumers,\nthe risk to operators.\nConditions of use shall include risk mitigation measures, where appropriate.\n120\nBentazone\nCAS No 25057-89-0\nCIPAC No 366\n3-isopropyl-1 H -2,1,3-benzothiadiazin-4(3 H )-one 2,2- dioxide\n≥ 960 g/kg\n1,2-dichloroethane < 3 mg/kg\n1 June 2018\n31 May 2025\nFor the implementation 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.\nIn their overall assessment Member States shall pay particular attention to:\nthe technical specification,\nthe protection of operators and workers,\nthe risk to birds and mammals,\nthe 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.\nConditions of use shall include risk mitigation measures where appropriate.\nThe 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.\n121\nSilthiofam\nCAS No 175217-20-6\nCIPAC No 635\nN-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide\n≥ 980 g/kg\n1 July 2018\n30 June 2033\nFor 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.\nIn their overall assessment Member States shall pay particular attention to:\nthe protection of operators,\nthe protection of groundwater in vulnerable regions,\nthe protection of birds, mammals and earthworms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n1..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;\n2..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.\nThe 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.\n122\nForchlorfenuron\nCAS No 68157-60-8\nCIPAC No 633\n1-(2-chloro-4-pyridyl)-3-phenylurea\n≥ 978 g/kg\n1.6.2018\n31.5.2033\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to consumers as regards the potential risk from metabolites in fruit crops with edible peels.\nConditions of use shall include risk mitigation measures, where appropriate.\n123\nZoxamide\nCAS No 156052-68-5\nCIPAC No 640\n(RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide\n≥ 953 g/kg\n1 July 2018\n30 June 2033\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of groundwater from metabolite RH-141455,\nthe protection of bees, aquatic organisms and earthworms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n124\nTrifloxystrobin\nCAS No 141517-21-7\nCIPAC No 617\nmethyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate\n≥ 975 g/kg\nAE 1344136 (max. 4 g/kg)\n1 August 2018\n31 July 2033\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;\nthe protection of aquatic organisms, bees, and of fish-eating birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n(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;\n(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.\nThe 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.\nThe 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.\n125\nCarfentrazone-ethyl\nCAS No 128639-02-1\nCIPAC No 587.202\nEthyl (RS) -2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H - 1,2,4-triazol-1-yl]phenyl]propionate\n≥ 910 g/kg\n1 August 2018\n31 July 2033\nFor the implementation 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.\nIn their overall assessment Member States shall pay particular attention to:\nthe protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;\nthe protection of soil non-target organisms;\nthe protection of aquatic organisms;\nthe protection of non-target terrestrial higher plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n(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;\n(2)the effect of water treatment processes on the nature of residues present in drinking water.\nThe 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.\nThe 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.\n126\nFenpicoxamid\nCAS No: 517875-34-2\nCIPAC No: 991\n(3 S ,6 S ,7 R ,8 R )-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate\n≥ 750 g/kg\n11 October 2018\n11 October 2028\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe impact of processing on the consumer risk assessment,\nthe risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit confirmatory information as regards:\n1..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;\n2..the effect of water treatment processes on the nature of residues present in drinking water;\n3..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.\nThe 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.\n127\nPethoxamid\nCAS No 106700-29-2\nCIPAC No 665\n2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide\n≥ 940 g/kg\nImpurities:\nToluene: max 3 g/kg.\n1 December 2018\n30 November 2033\nPART A\nUse shall be limited to one application every two years in the same field at a maximum dose of 1 200 g active substance per hectare.\nPART B\nFor 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.\nIn their overall assessment Member States shall pay particular attention to:\nthe risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to aquatic organisms and earthworms;\nthe risk to consumers from residues in the succeeding crops or in case of crop failure.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n1..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;\n2..the effect of water treatment processes on the nature of residues present in drinking water;\n3..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.\nThe 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.\nThe 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.\nThe 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.\n128\nTribenuron (parent)\nCAS No 106040-48-6\nCIPAC No 546\n2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid\n≥ 960 g/kg (expressed as tribenuron-methyl)\n1 February 2019\n30 January 2034\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of consumers, in particular to residues on animal products,\nthe protection of groundwater,\nthe protection of aquatic organisms and of non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\n129\nMetschnikowia fructicola strain NRRL Y-27328\nAccession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA\nNot applicable\nMinimum concentration:\n1 × 10 10 CFU/g\n27 December 2018\n27 December 2028\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.\nStrict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.\nConditions of use shall include risk mitigation measures, where appropriate.\n130\nBeauveria bassiana strain IMI389521\nAccession number in the CABI Genetic Resource Collection: IMI389521\nNot applicable\nMax. level of beauvericin: 0,09 mg/kg\n19 February 2019\n19 February 2029\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe storage stability of the formulation(s) containing B. bassiana strain IMI389521 including the level of the metabolite beauvericin content after storage;\nthe content of the metabolite beauvericin produced under the application conditions;\nthe 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;\nthe 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.\nThe 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.\nConditions of use shall include risk mitigation measures where appropriate.\n131\nBeauveria bassiana strain PPRI 5339\nAccession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757\nNot applicable\nMax. level of beauvericin: 0,5 mg/kg\n20 February 2019\n20 February 2029\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339;\nthe effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval;\nthe 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.\nThe 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.\nConditions of use shall include risk mitigation measures where appropriate.\n132\nMefentrifluconazole\nCAS No: 1417782-03-6\nCIPAC No: Not assigned\n(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol\n≥ 970 g/kg\nThe impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material.\nThe impurity toluene shall not exceed 1 g/kg in the technical material\nThe impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material\n20 March 2019\n20 March 2029\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment;\nthe protection of aquatic organisms.\nConditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n1..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;\n2..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.\nThe 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.\n133\nFlutianil\nCAS No [958647-10-4]\nCIPAC No 835\n( Z )-[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene](α,α,α,4-tetrafluoro- m -tolylthio)acetonitrile\n≥ 985 g/kg\n14 April 2019\n14 April 2029\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators and workers,\nthe risk to aquatic organisms,\nthe risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\n1..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;\n2..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;\n3..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.\nThe applicant shall submit the information:\nreferred to in point 1 by 14 April 2020;\nreferred 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; and\nreferred to in point 3 by 14 April 2021.\n134\nIsoxaflutole\nCAS No 141112-29-0\nCIPAC No 575\n(5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone\n≥ 972 g/kg\n1 August 2019\n31 July 2034\nFor 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.\nIn this overall assessment, Member States shall pay particular attention to:\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of aquatic organisms, wild mammals and non-target terrestrial plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\nThe 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.\n135\ncarvone\n2244-16-8 (d-carvone = S-carvone = (+)-carvone)\nCarvone: 602\nd-carvone: not allocated\n( S )-5-isopropenyl-2-methylcyclohex-2-en-1-one\nOr\n(S)-p-mentha-6,8-dien-2-one\n923 g/kg d-carvone\n1 August 2019\n31 July 2034\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment.\nConditions 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.\nThe applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:\nthe effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water.\nThe 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.\n136\n1-methylcyclopropene\nCAS No 3100-04-7\nCIPAC No 767\n1-methylcyclopropene\n≥ 980 g/kg (technical concentrate)\nThe following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate):\n1-chloro-2-methylpropene: maximum of 0,2 g/kg,\n3-chloro-2-methylpropene: maximum of 0,2 g/kg.\nFor 1-methylcyclopropene generated in situ , Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %.\n1 August 2019\n31 July 2034\nOnly uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised.\nFor 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.\n137\nDimethenamid-P\nCAS No 163515-14-8\nCIPAC No 638\n(S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide\n≥ 930 g/kg\nThe following impurity is of toxicological concern and must not exceed the following level in the technical material:\n1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg\n1 September 2019\n31 August 2034\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;\nthe protection of groundwater, in particular regarding the metabolites of dimethenamid-P;\nthe protection of aquatic organisms and small herbivorous mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\nThe 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.\n138\nTolclofos-methyl\nCAS No 57018-04-9\nCIPAC No 479\nO-2,6-dichloro-p-tolylO, O-dimethyl phosphorothioate\nO-2,6-dichloro-4-methylphenyl O, O-dimethyl phosphorothioate\n≥ 960 g/kg\nThe following impurity is of toxicological concern and must not exceed the following level in the technical material:\nMethanol max. 1 g/kg\n1 September 2019\n31 August 2034\nOnly for use on ornamentals and on potatoes.\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to aquatic organisms and mammals,\nthe risk to consumers, in particular the potential risk from metabolite DM-TM-CH 2 OH in potatoes,\nthe risk to operators, workers and bystanders;\nConditions of use shall include risk mitigation measures, where appropriate.\n139\nFlorpyrauxifen-benzyl\nCAS No: 1390661-72-9\nCIPAC No: 990.227\nbenzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate\n≥ 920 g/kg\nThe impurity toluene shall not exceed 3 g/kg in the technical material.\n24 July 2019\n24 July 2029\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic and terrestrial non-target plants.\nConditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate.\nThe 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.\n140\nMetalaxyl-M\nmethyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate\n≥ 920 g/kg\n1 June 2020\n31 May 2035\nWhen used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised.\nCAS No 70630-17-0 (R)\nCIPAC No 580\nThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:\n2,6-dimethylphenylamine:\nmax. content 0,5 g/kg\n4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide:\nmax. content 1 g/kg\n2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester:\nmax. content 0,18 g/kg\nFor the implementation 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe specification of the technical material as commercially manufactured;\nthe protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe protection of non-target arthropods, birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n141\nForamsulfuron\nCAS No 173159-57-4\nCIPAC No 659\n1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-(dimethylcarbamoyl)-5-formamidophenylsulfonyl]urea\n≥ 973 g/kg\n1 June 2020\n31 May 2035\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to consumers and operators,\nthe risk to aquatic organisms and non-target plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe 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.\n142\nPyriproxyfen.\n2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine.\nCIPAC No: 715.\nCAS No: 95737-68-1.\nEC No (Einecs or ELINCS): 429-800-1\n4-phenoxyphenyl ( RS) -2(2-pyridyloxy) propyl ether\n≥ 970 g/kg Max. impurity: Toluene\n5 g/Kg\n1 August 2020\n31 July 2035\nFor 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.\nIn this overall assessment Member States shall pay particular attention to:\nthe dietary exposure of consumers to residues of pyriproxyfen,\nthe protection of sediment-dwelling organisms and aquatic organisms,\nthe protection of bees.\nAs 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.\nAs 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.\nThe 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.\nThe 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.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Inserted by Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending 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)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted by Commission Implementing Regulation (EU) No 740/2011 of 27 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Substituted by Commission Implementing Regulation (EU) No 201/2013 of 8 March 2013 amending 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)."
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Inserted by Commission Implementing Regulation (EU) No 797/2011 of 9 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Inserted by Commission Implementing Regulation (EU) No 798/2011 of 9 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Inserted by Commission Implementing Regulation (EU) No 974/2011 of 29 September 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1143/2011 of 10 November 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Inserted by 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 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Inserted by Commission Implementing Regulation (EU) No 356/2013 of 18 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/147 of 4 February 2016 renewing 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)."
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/185 of 7 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/1061 of 26 July 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F13",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/1265 of 20 September 2018 approving 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)."
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/1264 of 20 September 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F15",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/139 of 29 January 2019 approving 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)."
    },
    {
      "type": "F",
      "label": "F16",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/481 of 22 March 2019 approving 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)."
    },
    {
      "type": "F",
      "label": "F17",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/717 of 8 May 2019 renewing 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)."
    },
    {
      "type": "F",
      "label": "F18",
      "text": "Deleted by Commission Implementing Regulation (EU) No 740/2011 of 27 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F19",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/1916 of 6 December 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance bispyribac (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F20",
      "text": "Inserted by Commission Implementing Regulation (EU) No 706/2011 of 20 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F21",
      "text": "Inserted by Commission Implementing Regulation (EU) No 704/2011 of 20 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F22",
      "text": "Inserted by Commission Implementing Regulation (EU) No 703/2011 of 20 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F23",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/291 of 19 February 2019 amending 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)."
    },
    {
      "type": "F",
      "label": "F24",
      "text": "Inserted by Commission Implementing Regulation (EU) No 705/2011 of 20 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F25",
      "text": "Inserted by Commission Implementing Regulation (EU) No 702/2011 of 20 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F26",
      "text": "Inserted by Commission Implementing Regulation (EU) No 810/2011 of 11 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F27",
      "text": "Inserted by Commission Implementing Regulation (EU) No 736/2011 of 26 July 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F28",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/856 of 18 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fluroxypyr (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F29",
      "text": "Inserted by Commission Implementing Regulation (EU) No 800/2011 of 9 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F30",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/359 of 28 February 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance oxyfluorfen (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F31",
      "text": "Inserted by Commission Implementing Regulation (EU) No 786/2011 of 5 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F32",
      "text": "Inserted by Commission Implementing Regulation (EU) No 787/2011 of 5 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F33",
      "text": "Inserted by Commission Implementing Regulation (EU) No 806/2011 of 10 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F34",
      "text": "Inserted by Commission Implementing Regulation (EU) No 788/2011 of 5 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F35",
      "text": "Inserted by Commission Implementing Regulation (EU) No 820/2011 of 16 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F36",
      "text": "Inserted by Commission Implementing Regulation (EU) No 807/2011 of 10 August 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F37",
      "text": "Inserted by Commission Implementing Regulation (EU) No 993/2011 of 6 October 2011 approving 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)."
    },
    {
      "type": "F",
      "label": "F38",
      "text": "Deleted by Commission Implementing Regulation (EU) No 767/2013 of 8 August 2013 withdrawing 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)."
    },
    {
      "type": "F",
      "label": "F39",
      "text": "Inserted by Commission Implementing Regulation (EU) No 359/2012 of 25 April 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F40",
      "text": "Inserted by Commission Implementing Regulation (EU) No 582/2012 of 2 July 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F41",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/324 of 25 February 2019 amending 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)."
    },
    {
      "type": "F",
      "label": "F42",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/291 of 26 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance bifenthrin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F43",
      "text": "Inserted by Commission Implementing Regulation (EU) No 589/2012 of 4 July 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F44",
      "text": "Inserted by Commission Implementing Regulation (EU) No 595/2012 of 5 July 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F45",
      "text": "Inserted by Commission Implementing Regulation (EU) No 746/2012 of 16 August 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F46",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1037/2012 of 7 November 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F47",
      "text": "Substituted by Commission Implementing Regulation (EU) 2015/1106 of 8 July 2015 amending 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)."
    },
    {
      "type": "F",
      "label": "F48",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1043/2012 of 8 November 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F49",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1238/2012 of 19 December 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F50",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1237/2012 of 19 December 2012 approving 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)."
    },
    {
      "type": "F",
      "label": "F51",
      "text": "Inserted by Commission Implementing Regulation (EU) No 22/2013 of 15 January 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F52",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/716 of 30 April 2019 amending 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)."
    },
    {
      "type": "F",
      "label": "F53",
      "text": "Inserted by Commission Implementing Regulation (EU) No 17/2013 of 14 January 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F54",
      "text": "Inserted by Commission Implementing Regulation (EU) No 188/2013 of 5 March 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F55",
      "text": "Inserted by Commission Implementing Regulation (EU) No 366/2013 of 22 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F56",
      "text": "Inserted by Commission Implementing Regulation (EU) No 373/2013 of 23 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F57",
      "text": "Inserted by Commission Implementing Regulation (EU) No 368/2013 of 22 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F58",
      "text": "Inserted by Commission Implementing Regulation (EU) No 378/2013 of 24 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F59",
      "text": "Inserted by Commission Implementing Regulation (EU) No 369/2013 of 22 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F60",
      "text": "Inserted by Commission Implementing Regulation (EU) No 375/2013 of 23 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F61",
      "text": "Inserted by Commission Implementing Regulation (EU) No 367/2013 of 22 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F62",
      "text": "Inserted by Commission Implementing Regulation (EU) No 350/2013 of 17 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F63",
      "text": "Inserted by Commission Implementing Regulation (EU) No 355/2013 of 18 April 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F64",
      "text": "Inserted by Commission Implementing Regulation (EU) No 546/2013 of 14 June 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F65",
      "text": "Inserted by Commission Implementing Regulation (EU) No 570/2013 of 17 June 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F66",
      "text": "Inserted by Commission Implementing Regulation (EU) No 568/2013 of 18 June 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F67",
      "text": "Inserted by Commission Implementing Regulation (EU) No 826/2013 of 29 August 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F68",
      "text": "Inserted by Commission Implementing Regulation (EU) No 828/2013 of 29 August 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F69",
      "text": "Inserted by Commission Implementing Regulation (EU) No 829/2013 of 29 August 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F70",
      "text": "Inserted by Commission Implementing Regulation (EU) No 802/2013 of 22 August 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F71",
      "text": "Inserted by Commission Implementing Regulation (EU) No 827/2013 of 29 August 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F72",
      "text": "Inserted by Commission Implementing Regulation (EU) No 833/2013 of 30 August 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F73",
      "text": "Inserted by Commission Implementing Regulation (EU) No 832/2013 of 30 August 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F74",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1031/2013 of 24 October 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F75",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/185 of 7 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F76",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1165/2013 of 18 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F77",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1187/2013 of 21 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F78",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1175/2013 of 20 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F79",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1192/2013 of 22 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F80",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1177/2013 of 20 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F81",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1176/2013 of 20 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F82",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1199/2013 of 25 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F83",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1195/2013 of 22 November 2013 approving 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)."
    },
    {
      "type": "F",
      "label": "F84",
      "text": "Inserted by Commission Implementing Regulation (EU) No 143/2014 of 14 February 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F85",
      "text": "Inserted by Commission Implementing Regulation (EU) No 151/2014 of 18 February 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F86",
      "text": "Inserted by Commission Implementing Regulation (EU) No 149/2014 of 17 February 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F87",
      "text": "Inserted by 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 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F88",
      "text": "Inserted by Commission Implementing Regulation (EU) No 192/2014 of 27 February 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F89",
      "text": "Inserted by Commission Implementing Regulation (EU) No 193/2014 of 27 February 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F90",
      "text": "Inserted by Commission Implementing Regulation (EU) No 144/2014 of 14 February 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F91",
      "text": "Inserted by Commission Implementing Regulation (EU) No 145/2014 of 14 February 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F92",
      "text": "Inserted by Commission Implementing Regulation (EU) No 496/2014 of 14 May 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F93",
      "text": "Inserted by Commission Implementing Regulation (EU) No 571/2014 of 26 May 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F94",
      "text": "Inserted by Commission Implementing Regulation (EU) No 632/2014 of 13 May 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F95",
      "text": "Inserted by Commission Implementing Regulation (EU) No 485/2014 of 12 May 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F96",
      "text": "Inserted by Commission Implementing Regulation (EU) No 890/2014 of 14 August 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F97",
      "text": "Inserted by Commission Implementing Regulation (EU) No 891/2014 of 14 August 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F98",
      "text": "Inserted by Commission Implementing Regulation (EU) No 922/2014 of 25 August 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F99",
      "text": "Inserted by Commission Implementing Regulation (EU) No 917/2014 of 22 August 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F100",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1330/2014 of 15 December 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F101",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/51 of 14 January 2015 approving 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)."
    },
    {
      "type": "F",
      "label": "F102",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1334/2014 of 16 December 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F103",
      "text": "Inserted by Commission Implementing Regulation (EU) No 1316/2014 of 11 December 2014 approving 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)."
    },
    {
      "type": "F",
      "label": "F104",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/1192 of 20 July 2015 approving 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)."
    },
    {
      "type": "F",
      "label": "F105",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/1201 of 22 July 2015 renewing 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)."
    },
    {
      "type": "F",
      "label": "F106",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/1165 of 15 July 2015 approving 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)."
    },
    {
      "type": "F",
      "label": "F107",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/1115 of 9 July 2015 renewing 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)."
    },
    {
      "type": "F",
      "label": "F108",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/1295 of 27 July 2015 approving 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)."
    },
    {
      "type": "F",
      "label": "F109",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/1154 of 14 July 2015 renewing 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)."
    },
    {
      "type": "F",
      "label": "F110",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/1397 of 14 August 2015 renewing 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)."
    },
    {
      "type": "F",
      "label": "F111",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/2084 of 18 November 2015 approving 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)."
    },
    {
      "type": "F",
      "label": "F112",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/2198 of 27 November 2015 approving 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)."
    },
    {
      "type": "F",
      "label": "F113",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/2085 of 18 November 2015 approving 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)."
    },
    {
      "type": "F",
      "label": "F114",
      "text": "Inserted by Commission Implementing Regulation (EU) 2015/2033 of 13 November 2015 renewing 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)."
    },
    {
      "type": "F",
      "label": "F115",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/182 of 11 February 2016 renewing 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)."
    },
    {
      "type": "F",
      "label": "F116",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/370 of 15 March 2016 approving 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)."
    },
    {
      "type": "F",
      "label": "F117",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/389 of 17 March 2016 renewing 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)."
    },
    {
      "type": "F",
      "label": "F118",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/1414 of 24 August 2016 approving 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)."
    },
    {
      "type": "F",
      "label": "F119",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/1425 of 25 August 2016 approving 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)."
    },
    {
      "type": "F",
      "label": "F120",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/1429 of 26 August 2016 approving 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)."
    },
    {
      "type": "F",
      "label": "F121",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/1426 of 25 August 2016 renewing 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)."
    },
    {
      "type": "F",
      "label": "F122",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/1423 of 25 August 2016 renewing 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)."
    },
    {
      "type": "F",
      "label": "F123",
      "text": "Inserted by Commission Implementing Regulation (EU) 2016/1424 of 25 August 2016 renewing 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)."
    },
    {
      "type": "F",
      "label": "F124",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/157 of 30 January 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F125",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/239 of 10 February 2017 approving 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)."
    },
    {
      "type": "F",
      "label": "F126",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/407 of 8 March 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F127",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/805 of 11 May 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F128",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/843 of 17 May 2017 approving 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)."
    },
    {
      "type": "F",
      "label": "F129",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/831 of 16 May 2017 approving 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)."
    },
    {
      "type": "F",
      "label": "F130",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/755 of 28 April 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F131",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/725 of 24 April 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F132",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/753 of 28 April 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F133",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/1115 of 22 June 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F134",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/1113 of 22 June 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F135",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/1491 of 21 August 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F136",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/1506 of 28 August 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F137",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017 renewing 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)."
    },
    {
      "type": "F",
      "label": "F138",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/113 of 24 January 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F139",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/660 of 26 April 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F140",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/710 of 14 May 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F141",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/679 of 3 May 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F142",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/692 of 7 May 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F143",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/1060 of 26 July 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F144",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/1264 of 20 September 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F145",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/1913 of 6 December 2018 renewing 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)."
    },
    {
      "type": "F",
      "label": "F146",
      "text": "Inserted by Commission Implementing Regulation (EU) 2018/1915 of 6 December 2018 approving 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)."
    },
    {
      "type": "F",
      "label": "F147",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/147 of 30 January 2019 approving 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)."
    },
    {
      "type": "F",
      "label": "F148",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/337 of 27 February 2019 approving 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)."
    },
    {
      "type": "F",
      "label": "F149",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/653 of 14 May 2020 correcting Implementing Regulations (EU) No 540/2011 and (EU) 2019/706 as regards the CAS number of the active substance carvone (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F150",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/1085 of 25 June 2019 renewing 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)."
    },
    {
      "type": "F",
      "label": "F151",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/1137 of 3 July 2019 renewing 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)."
    },
    {
      "type": "F",
      "label": "F152",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/1101 of 27 June 2019 renewing 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)."
    },
    {
      "type": "F",
      "label": "F153",
      "text": "Inserted by Commission Implementing Regulation (EU) 2019/1138 of 3 July 2019 approving 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)."
    },
    {
      "type": "F",
      "label": "F154",
      "text": "Inserted by Commission Implementing Regulation (EU) 2020/617 of 5 May 2020 renewing 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)."
    },
    {
      "type": "F",
      "label": "F155",
      "text": "Inserted by Commission Implementing Regulation (EU) 2020/616 of 5 May 2020 renewing 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)."
    },
    {
      "type": "F",
      "label": "F156",
      "text": "Inserted by Commission Implementing Regulation (EU) 2020/968 of 3 July 2020 renewing 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)."
    },
    {
      "type": "X",
      "label": "X1",
      "text": "Substituted by 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)."
    },
    {
      "type": "X",
      "label": "X2",
      "text": "Substituted by 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)."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Further details on identity and specification of active substance are provided in the review report."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "2-hydroxy-4,6-dimethoxypyrimidine."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "2,4-dihydroxy-6-methoxypyrimidine."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "5-(trifluoromethyl)-2(1H)-pyridinone."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "3-phenoxybenzaldehyde."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "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))."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid."
    },
    {
      "type": "footnote",
      "label": "f11",
      "text": "3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1 H -pyrazole-4-carboxylic acid."
    },
    {
      "type": "footnote",
      "label": "f12",
      "text": "3-chloro-1-methyl-5-sulfamoyl-1 H -pyrazole-4-carboxylic acid."
    },
    {
      "type": "footnote",
      "label": "f13",
      "text": "OJ L 353, 31.12.2008, p. 1."
    },
    {
      "type": "footnote",
      "label": "f14",
      "text": "p -methyl-phenethylamine."
    },
    {
      "type": "footnote",
      "label": "f15",
      "text": "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)."
    },
    {
      "type": "footnote",
      "label": "f16",
      "text": "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 )."
    },
    {
      "type": "footnote",
      "label": "f17",
      "text": "https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf"
    },
    {
      "type": "footnote",
      "label": "f18",
      "text": "Guidance 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."
    },
    {
      "type": "footnote",
      "label": "f19",
      "text": "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"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/540/annex/1/part/B",
    "retrieved_at": "2026-11-01T14:50:07.354761+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}