{
  "url": "https://openlegislation.uk/eu-regulation-2011-540/annex-1/part-A",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-540/annex-1/part-A.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/A",
  "kind": "part",
  "number": "A",
  "heading": "Active substances deemed to have been 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 substances are provided in their review reports.\nSuspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767.\nOJ L 353, 31.12.2008, p. 1.\n2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.\n2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.\nDe-ethyl-bupirimate.\n2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.\n(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.\n2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.\n2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.\n2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.\n2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.\n(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.\n(4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.\nR42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one.\n1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol.\nOJ L 300, 14.11.2009, p. 1 .\nOJ L 54, 26.2.2011, p. 1 .\nRegulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ).\nRegulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( OJ L 139, 30.4.2004, p. 1 ).\nNumber\nCommon name, identification numbers\nIUPAC name\nPurity\nDate of approval\nExpiration of approval\nSpecific provisions\n21\nCyclanilide\nCAS No 113136-77-9\nCIPAC No 586\nNot available\n960 g/kg\n1 November 2001\n31 October 2011\nOnly uses as a plant growth regulator may be authorised.\nThe maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg.\nDate of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001 .\n33\nCinidon-ethyl\nCAS No 142891-20-1\nCIPAC No 598\n(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate\n940 g/kg\n1 October 2002\n30 September 2012\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 cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:\nshould pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions,\nshould pay particular attention to the protection of aquatic organisms.\nConditions of authorisation must include risk mitigation measures, where appropriate.\n35\nFamoxadone\nCAS No 131807-57-3\nCIPAC No 594\n3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione\n960 g/kg\n1 October 2002\n30 June 2021\nOnly uses as fungicide 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 famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:\nMember States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms;\nMember States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;\nMember States should pay particular attention to the protection of operators.\n39\nFlumioxazine\nCAS No 103361-09-7\nCICAP No 578\nN-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide\n960 g/kg\n1 January 2003\n30 June 2021\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 flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States:\nmust carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate.\n40\nDeltamethrin\nCAS No 52918-63-5\nCIPAC No 333\n(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate\n980 g/kg\n1 November 2003\n31 October 2021\nOnly uses as insecticide 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 deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States:\nmust pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures,\nshould observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels,\nmust pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.\n43\nEthoxysulfuron\nCAS No 126801-58-9\nCIPAC No 591\n3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea\n950 g/kg\n1 July 2003\n30 June 2013\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 ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.\nMember States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate.\n45\nOxadiargyl\nCAS No 39807-15-3\nCIPAC No 604\n5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one\n980 g/kg\n1 July 2003\n30 June 2013\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 oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.\nIn this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate.\n46\nCyazofamid\nCAS No 120116-88-3\nCIPAC No 653\n4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide\n935 g/kg\n1 July 2003\n31 July 2021\nOnly uses as fungicide 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 cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:\nMember States must pay particular attention to the protection of aquatic organisms;\nMember States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions.\nRisk mitigation measures or use restrictions should be applied where appropriate.\n49\nCyfluthrin\nCAS No 68359-37-5 (unstated stereochemistry)\nCIPAC No 385\n(RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate\n920 g/kg\n1 January 2004\n31 December 2013\nOnly use as insecticide may be authorised\nUses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops.\nFor the implementation of the uniform principles, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:\nMember States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.\n56\nMecoprop\nCAS No 7085-19-0\nCIPAC No 51\n(RS)-2-(4-chloro-o-tolyloxy)-propionic acid\n930 g/kg\n1 June 2004\n31 May 2014\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 mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:\nMember States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,\nMember States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate.\n57\nMecoprop-P\nCAS No 16484-77-8\nCIPAC No 475\n(R)-2-(4-chloro-o-tolyloxy)-propionic acid\n860 g/kg\n1 June 2004\n31 January 2021\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 mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:\nMember States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.\n65\nFlufenacet\nCAS No 142459-58-3\nCIPAC No 588\n4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide\n950 g/kg\n1 January 2004\n31 October 2021\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 flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:\nshould pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,\nshould pay particular attention to the protection of algae and aquatic plants,\nshould pay particular attention to the protection of operators.\nRisk mitigation measures should be applied where appropriate.\n69\nFosthiazate\nCAS No 98886-44-3\nCIPAC No 585\n(RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate\n930 g/kg\n1 January 2004\n31 October 2021\nOnly uses as insecticide or nematicide 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 fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States\nshould pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions;\nshould pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season;\nshould pay particular attention to the protection of non-target soil organisms.\nRisk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved.\nThe Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.\n72\nMolinate\nCAS No 2212-67-1\nCIPAC No 235\nS-ethyl azepane-1-carbothioate;\nS-ethyl perhydroazepine-1-carbothioate;\nS-ethyl perhydroazepine-1-thiocarboxilate\n950 g/kg\n1 August 2004\n31 July 2014\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 molinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:\nMember States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,\nMember States should pay particular attention to the possibility of short-range transport of the active substance in air.\n74\nZiram\nCAS No 137-30-4\nCIPAC No 31\nZinc bis (dimethyldithiocarbamate)\n950 g/kg (FAO-specification)\nArsenic: maximum 250 mg/kg\nWater: maximum 1,5 %\n1 August 2004\n30 April 2021\nOnly uses as fungicide or as repellent 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 ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:\nMember States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate,\nMember States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels.\n81\nPyraclostrobin\nCAS No 175013-18-0\nCIPAC No 657\nmethyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate\n975 g/kg\nThe manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.\n1 June 2004\n31 January 2021\nOnly uses as fungicide or plant growth regulator 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 pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States:\nshould pay particular attention to the protection of aquatic organisms, especially fish,\nshould pay particular attention to the protection of terrestrial arthropods and earthworms.\nRisk mitigation measures should be applied where appropriate.\nThe Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.\n87\nIoxynil\nCAS No 13684-83-4\nCIPAC No 86\n4- hydroxy- 3,5- di-iodobenzonitrile\n960 g/kg\n1 March 2005\n28 February 2015\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 ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.\n88\nPhenmedipham\nCAS No 13684-63-4\nCIPAC No 77\nmethyl 3-(3-methylcarbaniloyloxy)carbanilate;\n3-methoxycarbonylaminophenyl 3′-methylcarbanilate\nMin. 970 g/kg\n1 March 2005\n31 July 2021\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 phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.\n89\nPseudomonas chlororaphis\nStrain: MA 342\nCIPAC No 574\nNot applicable\nThe amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l).\n1 October 2004\n30 April 2021\nOnly uses as fungicide for seed dressing in closed seed dressing machinery may be authorised.\nWhen granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.\nIn this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate.\n90\nMepanipyrim\nCAS No 110235-47-7\nCIPAC No 611\nN-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline\n960 g/kg\n1 October 2004\n30 April 2021\nOnly uses as fungicide 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 mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.\nIn this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.\n94\nImazosulfuron\nCAS No 122548-33-8\nCIPAC No 590\n1-(2-chloroimidazo[1,2-α]pyridin-3-ylsul-phonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea\n≥ 980 g/kg\n1 April 2005\n31. July 2017\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 imazosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.\nIn this overall assessment Member States should pay particular attention to the protection of aquatic and terrestrial non-target plants. Risk mitigation measures should be applied where appropriate.\n97\nS-metolachlor\nCAS No 87392-12-9\n(S-isomer)\n178961-20-1 (R-isomer)\nCIPAC No 607\nMixture of:\n(aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %)\nand:\n(aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %)\n≥ 960 g/kg\n1 April 2005\n31 July 2021\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 s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.\nIn this overall assessment Member States:\nshould pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nshould pay particular attention to the protection of aquatic plants.\nRisk mitigation measures should be applied where appropriate.\n99\nEtoxazole\nCAS No 153233-91-1\nCIPAC No 623\n(RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole\n≥ 948 g/kg\n1 June 2005\n31 July 2021\nOnly uses as acaricide 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 etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account.\nIn this overall assessment Member States should pay particular attention to the protection of aquatic organisms.\nRisk mitigation measures should be applied where appropriate.\n100\nTepraloxydim\nCAS No 149979-41-9\nCIPAC No 608\n(EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one\n≥ 920 g/kg\n1 June 2005\n31. May 2015\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 tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account.\nIn this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods.\nRisk mitigation measures should be applied where appropriate.\n102\nChlorotoluron (unstated stereochemistry)\nCAS No 15545-48-9\nCIPAC No 217\n3-(3-chloro-p-tolyl)-1,1-dimethylurea\n975 g/kg\n1 March 2006\n31 October 2021\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 chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate\n103\nCypermethrin\nCAS No 52315-07-8\nCIPAC No 332\n(RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate\n(4 isomer pairs: cis-1, cis-2, trans-3, trans-4)\n900 g/kg\n1 March 2006\n31 October 2021\nPART A\nOnly uses as insecticide 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 cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment:\nMember States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate,\nMember States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate\n104\nDaminozide\nCAS No 1596-84-5\nCIPAC No 330\nN-dimethylaminosuccinamic acid\n990 g/kg\nImpurities:\nN-nitrosodimethylamine: not more than 2,0 mg/kg\n1,1-dimethylhydrazide: not more than 30 mg/kg\n1 March 2006\n31 October 2021\nPART A\nOnly uses as growth regulator in non-edible crops 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 daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate\n107\nMCPA\nCAS No 94-74-6\nCIPAC No 2\n4-chloro-o-tolyloxyacetic acid\n≥ 930 g/kg\n1 May 2006\n31 October 2021\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 MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account\nMember States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate\nMember States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones\n108\nMCPB\nCAS No 94-81-5\nCIPAC No 50\n4-(4-chloro-o-tolyloxy)butyric acid\n≥ 920 g/kg\n1 May 2006\n31 October 2021\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 MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account\nMember States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate\nMember States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones\n109\nBifenazate\nCAS No 149877-41-8\nCIPAC No 736\nIsopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate\n≥ 950 g/kg\n1 December 2005\n31 July 2021\nPART A\nOnly uses as acaricide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.\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 bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.\n110\nMilbemectin\nMilbemectin is a mixture of M.A3 and M.A4\nCAS No\nM.A3: 51596-10-2\nM.A4: 51596-11-3\nCIPAC No 660\nM.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one\nM.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one\n≥ 950 g/kg\n1 December 2005\n31 July 2021\nPART A\nOnly uses as acaricide or insecticide 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 milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.\nIn this overall assessment Member States should pay particular attention to the protection of aquatic organisms.\nRisk mitigation measures should be applied where appropriate.\n113\nManeb\nCAS No 12427-38-2\nCIPAC No 61\nmanganese ethylenebis (dithiocarbamate) (polymeric)\n≥ 860 g/kg\nThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content.\n1 July 2006\n31 January 2017\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 maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.\nMember States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.\nMember States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.\nMember States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures.\nMember States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity.\nThey shall ensure that the notifiers at whose request maneb has been included in this Annex provide such studies to the Commission within two years from the approval.\n114\nMancozeb\nCAS No 8018-01-7 (formerly 8065-67-5)\nCIPAC No 34\nManganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt\n≥ 800 g/kg\nThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content.\n1 July 2006\n31 January 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 mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.\nMember States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.\nMember States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.\nMember States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures.\nMember States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity.\nThey shall ensure that the notifiers at whose request mancozeb has been included in this Annex provide such studies to the Commission within two years from the approval.\n115\nMetiram\nCAS No 9006-42-2\nCIPAC No 478\nZinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)]\n≥ 840 g/kg\nThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content.\n1 July 2006\n31 January 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 metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.\nMember States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.\nMember States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.\nMember States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures.\nMember States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval.\n116\nOxamyl\nCAS No 23135-22-0\nCIPAC No 342\nN,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide\n970 g/kg\n1 August 2006\n31 January 2021\nPART A\nOnly uses as nematicide and insecticide 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 oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment,\nMember States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations.\nConditions of authorisation should include risk mitigation measures, where appropriate.\nMember States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.\nThe concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval.\n119\nIndoxacarb\nCAS No 173584-44-6\nCIPAC No 612\nmethyl (S)-N-[7-chloro-2,3,4a,5-tetrahydro-4a-(methoxycarbonyl)indeno[1,2-e][1,3,4]oxadiazin-2-ylcarbonyl]-4′-(trifluoromethoxy)carbanilate\nTC (Technical Material): ≥ 628 g/kg indoxacarb\n1 April 2006\n31 October 2021\nPART A\nOnly uses as insecticide 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 indoxacarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to the protection of aquatic organisms.\nConditions of use should include risk mitigation measures, where appropriate.\n120\nWarfarin\nCAS No 81-81-2\nCIPAC No 70\n(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin\n≥ 990 g/kg\n1 October 2006\n30 September 2013\nPART A\nOnly uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are 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 warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals.\nRisk mitigation measures should be applied where appropriate.\n121\nClothianidin\nCAS No 210880-92-5\nCIPAC No 738\n(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine\n≥ 960 g/kg\n1 August 2006\n31 January 2019\nPART A\nOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.\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 clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 and the conclusions of the revised addendum of the review report on clothianidin as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe risk to groundwater;\nthe risk to bees and bumble bees released for pollination in permanent greenhouses;\nthe exposure of bees via the consumption of contaminated water from the permanent greenhouses.\nMember States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised.\nConditions of use shall include risk mitigation measures, where appropriate.\n123\nClodinafop\nCAS No 114420-56-3\nCIPAC No 683\n(R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid\n≥ 950 g/kg (expressed as clodinafop-propargyl)\n1 February 2007\n30 April 2021\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 clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.\n124\nPirimicarb\nCAS No 23103-98-2\nCIPAC No 231\n2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate\n≥ 950 g/kg\n1 February 2007\n30 April 2021\nPART A\nOnly uses as insecticide 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 pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.\nMember States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment.\nMember States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.\nThe concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the approval.\n125\nRimsulfuron\nCAS No 122931-48-0 (rimsulfuron)\nCIPAC No 716\n1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea\n≥ 960 g/kg (expressed as rimsulfuron)\n1 February 2007\n30 April 2021\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 rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.\nMember States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.\n127\nTriticonazole\nCAS No 131983-72-7\nCIPAC No 652\n(±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol\n≥ 950 g/kg\n1 February 2007\n30 April 2021\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States:\nmust pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate,\nmust pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones,\nmust pay particular attention to the protection of granivorous birds (long term risk).\nConditions of authorisation should include risk mitigation measures, where appropriate.\nThe concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval.\n128\nDimoxystrobin\nCAS No 149961-52-4\nCIPAC No 739\n(E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide\n≥ 980 g/kg\n1 October 2006\n31 January 2021\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.\nIn this overall assessment Member States\nmust pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions;\nmust pay particular attention to the protection of aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe concerned Member States shall request the submission of\na refined risk assessment for birds and mammals considering the formulated active substance;\na comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage.\nThey shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval.\n129\nClopyralid\nCAS No 1702-17-6\nCIPAC No 455\n3,6-dichloropyridine-2-carboxylic acid\n≥ 950 g/kg\n1 May 2007\n30 April 2021\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing clopyralid for uses other than spring applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 clopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.\nThe concerned Member States shall request the submission of further studies to confirm the results on animal metabolism. They shall ensure that the notifiers at whose request clopyralid has been included in this Annex provide such studies to the Commission within two years from the approval.\n130\nCyprodinil\nCAS No 121522-61-2\nCIPAC No 511\n(4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine\n≥ 980 g/kg\n1 May 2007\n30 April 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 cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nmust pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones.\nThe concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval.\n131\nFosetyl\nCAS No 15845-66-6\nCIPAC No 384\nEthyl hydrogen phosphonate\n≥ 960 g/kg (expressed as fosetyl-Al)\n1 May 2007\n30 April 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 fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods.\nConditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones.\nThe concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval.\n132\nTrinexapac\nCAS No 104273-73-6\nCIPAC No 732\n4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid\n≥ 940 g/kg (expressed as trinexapac-ethyl)\n1 May 2007\n30 April 2021\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 trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the protection of birds and mammals.\nConditions of authorisation should include risk mitigation measures, where appropriate.\n133\nDichlorprop-P\nCAS No 15165-67-0\nCIPAC No 476\n(R)-2-(2,4-dichlorophenoxy) propanoic acid\n≥ 900 g/kg\n1 June 2007\n30 April 2021\nPART A\nOnly uses as herbicide may be authorised.\nAs regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.\nUse on grassland shall 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 dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\n134\nMetconazole\nCAS No 125116-23-6 (unstated stereo-chemistry)\nCIPAC No 706\n(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol\n≥ 940 g/kg\n(sum of cis-and trans-isomers)\n1 June 2007\n30 April 2021\nPART A\nOnly uses as fungicide and 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 metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.\nIn this overall assessment:\nMember States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate,\nMember States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.\n135\nPyrimethanil\nCAS No 53112-28-0\nCIPAC No not allocated\nN-(4,6-dimethylpyrimidin-2-yl) aniline\n≥ 975 g/kg\n(the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material)\n1 June 2007\n30 April 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 pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones,\nmust pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.\nThe Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval.\n136\nTriclopyr\nCAS No 055335-06-3\nCIPAC No 376\n3,5,6-trichloro-2-pyridyloxyacetic acid\n≥ 960 g/kg\n(as Triclopyr butoxyethyl ester)\n1 June 2007\n30 April 2021\nPART A\nOnly uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised.\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 triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account.\nIn this overall assessment Member States:\nshall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate,\nshall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nshall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate.\n137\nMetrafenone\nCAS No 220899-03-6\nCIPAC No 752\n3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone\n≥ 940 g/kg\n1 February 2007\n30 April 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 metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.\nThe Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.\n138\nBacillus subtilis\n(Cohn 1872)\nStrain QST 713, identical with strain AQ 713\nCulture collection No: NRRL B -21661\nCIPAC No not allocated\nNot applicable\n1 February 2007\n30 April 2021\nPART A\nOnly uses as fungicide and bactericide 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 Bacillus subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.\n139\nSpinosad\nCAS No 131929-60-7 (Spinosyn A)\n131929-63-0 (Spinosyn D)\nCIPAC No 636\nSpinosyn A:\n(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione\nSpinosyn D:\n(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione\nSpinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D\n≥ 850 g/kg\n1 February 2007\n30 April 2021\nPART A\nOnly uses as insecticide 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 spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.\nIn this overall assessment Member States\nmust pay particular attention to the protection of aquatic organisms;\nmust pay particular attention to the risk to earthworms when the substance is used in glasshouses.\nConditions of use shall include risk mitigation measures, where appropriate.\n140\nThiamethoxam\nCAS No 153719-23-4\nCIPAC No 637\n(E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine\n≥ 980 g/kg\n1 February 2007\n30 April 2019\nPART A\nOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.\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 thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 and the conclusions of the revised addendum of the review report on thiamethoxam as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe risk to groundwater;\nthe risk to aquatic organisms;\nthe risk to bees and bumble bees released for pollination in permanent greenhouses;\nthe exposure of bees via the consumption of contaminated water from the permanent greenhouses.\nMember States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised.\nConditions of use shall include risk mitigation measures, where appropriate.\n142\nEthephon\nCAS No 16672-87-0\nCIPAC No 373\n2-chloroethyl-phosphonic acid\n≥ 910 g/kg (technical material — TC)\nThe manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material.\n1 August 2007\n31 July 2021\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 ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.\n143\nFlusilazole\nCAS No 85509-19-9\nCIPAC No 435\nBis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane\n925 g/kg\n1 January 2007\n30 June 2008\nPART A\nOnly uses as fungicide on the following crops may be authorised:\ncereals other than rice,\nmaize,\nrape seed,\nsugar beet,\nat rates not exceeding 200 g active substance per hectare per application.\nThe following uses must not be authorised:\nair application,\nknapsack and hand-held applications, neither by amateur nor by professional users,\nhome gardening.\nMember States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:\naquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,\nbirds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,\noperators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.\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 flusilazole, and in particular Appendices I and II thereof, shall be taken into account.\nMember States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained.\nMember States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.\n144\nCarbendazim\nCAS N o 10605-21-7\nCIPAC N o 263\nMethyl benzimidazol-2-ylcarbamate\n≥ 980 g/kg\nRelevant impurities\n2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg\n2,3-diaminophenazine (DAP): not more than 0,003 g/kg\n1 June 2011\n30 November 2014\nPART A\nOnly uses as fungicide on the following crops may be authorised:\ncereals\nrape seed\nsugar and fodder beet\nmaize\nat rates not exceeding\n0,25 kg active substance per hectare per application for cereals and rape seed;\n0,075 kg active substance per hectare per application for sugar and fodder beet\n0,1 kg active substance per hectare per application for maize.\nThe following uses must not be authorised:\nair application;\nknapsack and handheld applications neither by amateur nor by professional users;\nhome gardening.\nMember States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:\naquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices;\nearthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance;\nbirds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary;\noperators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.\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 carbendazim, and in particular Appendices I and II thereof, shall be taken into account.\nThe Member States concerned shall request that the applicant provides the following to the Commission:\nby 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197;\nby 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 ‘ Further information ’ , pp. 155 – 157);\nby 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.\n145\nCaptan\nCAS No 133-06-02\nCIPAC No 40\nN-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide\n≥ 910 g/kg\nImpurities:\nPerchloromethylmercaptan (R005406): not more than 5 g/kg\nFolpet: not more than 10 g/kg\nCarbon tetrachloride not more than 0,1 g/Kg\n1 October 2007\n31 July 2021\nPART A\nOnly uses as fungicide can be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe 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;\nthe dietary exposure of consumers in view of future revisions of Maximum Residue Levels;\nthe protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;\nthe protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.\nThe Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval.\n146\nFolpet\nCAS No 133-07-3\nCIPAC No 75\nN-(trichloromethylthio) phthalimide\n≥ 940 g/kg\nImpurities:\nPerchloromethylmercaptan (R005406): not more than 3,5 g/kg\nCarbon tetrachloride not more than 4 g/kg\n1 October 2007\n31 July 2021\nPART A\nOnly uses as fungicide can be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\noperators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;\nthe dietary exposure of consumers in view of future revisions of Maximum Residue Levels;\nthe protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.\nThe Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval.\n147\nFormetanate\nCAS No 23422-53-9\nCIPAC No 697\n3-dimethylaminomethyleneaminophenyl methylcarbamate\n≥ 910 g/kg\n1 October 2007\n31 July 2021\nPART A\nOnly uses as insecticide and acaricide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;\nmust pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;\nmust pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.\nThe Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval.\n150\nDimethomorph\nCAS No 110488-70-5\nCIPAC No 483\n(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine\n≥ 965 g/kg\n1 October 2007\n31 July 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 dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;\nto the protection of birds, mammals and aquatic organisms.\nConditions of authorisation should include risk mitigation measures, where appropriate.\n151\nGlufosinate\nCAS No 77182-82-2\nCIPAC No 437.007\nammonium(DL)-homoalanin-4-yl(methyl)phosphinate\n950 g/kg\n1 October 2007\n31. July 2018\nPART A\nOnly uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year.\nPART B\nIn assessing applications to authorise plant protection products containing glufosinate, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 , shall be taken into account. In this overall assessment Member States shall pay particular attention to:\n(a) the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate;\n(b) the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions;\n(c) the protection of mammals, non-target arthropods and non-target plants.\nConditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.\n152\nMetribuzin\nCAS No 21087-64-9\nCIPAC No 283\n4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one\n≥ 910 g/kg\n1 October 2007\n31 July 2021\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.\nmust pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.\nThe Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval.\n153\nPhosmet\nCAS No 732-11-6\nCIPAC No 318\nO,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide\n≥ 950 g/kg\nImpurities:\nphosmet oxon: not more than 0,8 g/kg\niso phosmet: not more than 0,4 g/kg\n1 October 2007\n31 July 2021\nPART A\nOnly uses as insecticide and acaricide 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 phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water,\nmust pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment.\nThe Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval.\n154\nPropamocarb\nCAS No 24579-73-5\nCIPAC No 399\nPropyl 3-(dimethylamino) propylcarbamate\n≥ 920 g/kg\n1 October 2007\n31 July 2021\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operators and workers safety. Conditions of authorisation should include protective measures, where appropriate;\nthe transfer of soil residues for rotating or succeeding crops;\nthe protection of surface and groundwater in vulnerable zones;\nthe protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.\n156\nPirimiphos-methyl\nCAS No 29232-93-7\nCIPAC No 239\nO-2-diethylamino-6-methylpyrimidin-4-yl\nO,O-dimethylphosphorothioate\n> 880 g/kg\n1 October 2007\n31 July 2021\nPART A\nOnly uses as insecticide for post harvest storage can be authorised.\nHand-held applications shall not be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure;\nthe dietary exposure of consumers in view of future revisions of Maximum Residue Levels.\n157\nFipronil\nCAS No 120068-37-3\nCIPAC No 581\n(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile\n≥ 950 g/kg\n1 October 2007\n30 September 2017\nPART A\nOnly uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.\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 fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n(a) the packaging of the marketed products to avoid the generation of photodegradation products of concern;\n(b) the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\n(c) the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.\nMember States shall also ensure that:\n(a) the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised;\n(b) adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission;\n(c) the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation;\n(d) monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe notifier shall submit confirmatory information as regards:\n(a) the risk to pollinators other than honey bees;\n(b) the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites;\n(c) the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift;\n(d) the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew;\n(e) the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development, and the risk to bee brood;\n(f) the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950).\nThe notifier shall submit that information to the Commission, the Member States and the Authority by 30 March 2015 .\n158\nBeflubutamid\nCAS No 113614-08-7\nCIPAC No 662\n(RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide\n≥ 970 g/kg\n1 December 2007\n31 July 2021\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 beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.\nIn this overall assessment Member States:\nmust pay particular attention to the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n159\nSpodoptera exigua nuclear polyhedrosis virus\nCIPAC No\nNot allocated\nNot applicable\n1 December 2007\n30 November 2017\nPART A\nOnly uses as insecticide 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 Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.\n160\nProsulfocarb\nCAS No 52888-80-9\nCIPAC No 539\nS-benzyl dipropyl(thiocarbamat)\n970 g/kg\n1 November 2008\n31 October 2021\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 prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone,\nthe protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone.\n161\nFludioxonil\nCAS No 131341-86-1\nCIPAC No 522\n4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile\n950 g/kg\n1 November 2008\n31 October 2021\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and:\nmust pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones,\nmust pay particular attention to the protection of fish and aquatic invertebrates.\nConditions of authorisation should include risk mitigation measures, where appropriate.\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 fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.\n162\nClomazone\nCAS No 81777-89-1\nCIPAC No 509\n2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one\n960 g/kg\n1 November 2008\n31 October 2021\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 clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones.\n163\nBenthiavalicarb\nCAS No 413615-35-7\nCIPAC No 744\n[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid\n≥ 910 g/kg\nThe following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:\n6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg\nbis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg\n1 August 2008\n31 July 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 benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety,\nthe protection of non-target arthropods.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\nIn assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\nThe Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.\n164\nBoscalid\nCAS No 188425-85-6\nCIPAC No 673\n2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide\n≥ 960 g/kg\n1 August 2008\n31 July 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 boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention\nto the operator safety,\nto the long term risk to birds and soil organisms,\nto the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\n166\nFluoxastrobin\nCAS No 361377-29-9\nCIPAC No 746\n(E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime\n≥ 940 g/kg\n1 August 2008\n31 July 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 fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield,\nthe protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,\nthe levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate,\nthe risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe concerned Member States shall request the submission of:\ndata to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures,\ndata on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff.\nThey shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval.\n167\nPaecilomyces lilacinus (Thom)\nSamson 1974 strain 251 (AGAL: No 89/030550)\nCIPAC No 753\nNot applicable\n1 August 2008\n31 July 2021\nPART A\nOnly uses as nematicide 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 Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers),\nthe protection of leaf dwelling non-target arthropods.\nConditions of use shall include risk mitigation measures, where appropriate.\n168\nProthioconazole\nCAS No 178928-70-6\nCIPAC No 745\n(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione\n≥ 970 g/kg\nThe following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:\nToluene: < 5 g/kg\nProthioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)\n1 August 2008\n31 July 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 prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety in spray applications. Conditions of use shall include adequate protective measures,\nthe protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,\nthe protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe concerned Member States shall request the submission of:\ninformation to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin,\na comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds,\ninformation to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment.\nThey shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval.\n169\nAmidosulfuron\nCAS No 120923-37-7\nCIPAC No 515\n3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea\nor\n1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea\n≥ 970 g/kg\n1 January 2009\n31 December 2021\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of aquatic plants.\nIn relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.\n170\nNicosulfuron\nCAS No 111991-09-4\nCIPAC No 709\n2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide\nor\n1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea\n≥ 910 g/kg\n1 January 2009\n31 December 2021\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 nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions,\nthe protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones,\nthe protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone,\nthe protection of groundwater and surface water under vulnerable soil and climatic conditions.\n171\nClofentezine\nCAS No 74115-24-5\nCIPAC No 418\n3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine\n≥ 980 g/kg (dry material)\n1 January 2009\n31 December 2021\nPART A\nOnly uses as acaricide 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 clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;\nthe potential for long range transport via air;\nthe risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013.\nThe Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012.\n172\nDicamba\nCAS No 1918-00-9\nCIPAC No 85\n3,6-dichloro-2-methoxybenzoic acid\n≥ 850 g/kg\n1 January 2009\n31 December 2021\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 dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection of non-target plants.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\nThe notifier shall submit confirmatory information as regards:\n(a) the identification and quantification of a group of soil transformation products formed in a soil incubation study;\n(b) the potential for long range transport through the atmosphere.\nThe notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013 .\n173\nDifenoconazole\nCAS No 119446-68-3\nCIPAC No 687\n3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether\n≥ 940g/kg\nToluene maximum content: 5 g/kg\n1 January 2009\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 difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\nThe notifier shall submit confirmatory information as regards:\n(a) further data on the specification of the technical material;\n(b) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin;\n(c) the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 ;\n(d) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.\nThe notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012 , the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance.\n174\nDiflubenzuron\nCAS No 35367-38-5\nCIPAC No 339\n1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea\n≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline\n1 January 2009\n31 December 2020\nPART A\nOnly uses as insecticide in non-edible crops 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 diflubenzuron, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;\nthe protection of aquatic organisms, terrestrial organisms and non-target arthropods including bees;\nthe potential unintended exposure of food and feed crops to diflubenzuron from uses on non-edible crops (e.g. through spray drift);\nthe protection of workers, residents and bystanders.\nMember States shall ensure that crops treated with diflubenzuron do not enter the food and feed chain.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\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 diflubenzuron, and in particular Appendices I and II thereof, as finalised inthe Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;\nthe protection of aquatic organisms;\nthe protection of terrestrial organisms;\nthe protection of non-target arthropods including bees.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission further studies to address the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.\n175\nImazaquin\nCAS No 81335-37-7\nCIPAC No 699\n2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid\n≥ 960 g/kg (racemic mixture)\n1 January 2009\n31 December 2018\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 imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account\nThe notifier shall submit confirmatory information as regards:\n(a) further data on the specification of the technical material;\n(b) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.\nThe notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012 and the information set out in point (b) within 2 years from the adoption of specific guidance.\n176\nLenacil\nCAS No 2164-08-1\nCIPAC No 163\n3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione\n≥ 975 g/kg\n1 January 2009\n31 December 2021\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 lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies;\nthe protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.\nIf a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.\n177\nOxadiazon\nCAS No 19666-30-9\nCIPAC No 213\n5-tert-butyl-3-(2,4-dichloro-5-isopropoxyphenyl)-1,3,4-oxadiazol-2(3H)-one\n≥ 940 g/kg\n1 January 2009\n31 December 2018\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 oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;\nthe potential for ground water contamination by the metabolite AE0608022 where the active substance is applied in situations for which prolonged anaerobic conditions may be expected to occur or in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther studies to address the potential toxicological relevance of an impurity in the proposed technical specification;\ninformation to further clarify the occurrence of metabolite AE0608033 in primary crops and rotational crops;\nfurther trials on rotational crops (namely root crops and cereals) and a metabolism study on ruminants to confirm the consumer risk assessment;\ninformation to further address the risk to earthworm-eating birds and mammals, and the long-term risk to fish.\nThey shall ensure that the notifier provides such information to the Commission by 30 June 2012.\n178\nPicloram\nCAS No 1918-02-1\nCIPAC No 174\n4-amino-3,5,6-trichloropyridine-2-carboxylic acid\n≥ 920 g/kg\n1 January 2009\n31 December 2021\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 picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.\nIn the overall assessment Member States must pay particular attention to:\nthe potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate;\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates;\na soil photolysis study to confirm the evaluation of picloram degradation.\nThey shall ensure that the notifier provides such information to the Commission by 30 June 2012.\n180\nBifenox\nCAS No 42576-02-3\nCIPAC No 413\nMethyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate\n≥ 970 g/kg impurities:\nmax. 3 g/kg 2,4-dichlorophenol\nmax. 6 g/kg 2,4-dichloroanisole\n1 January 2009\n31 December 2021\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 bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n(a) the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;\n(b) the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops;\n(c) the environmental conditions leading to the potential formation of nitrofen.\nMember States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c).\n181\nDiflufenican\nCAS No 83164-33-4\nCIPAC No 462\n2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide\n≥ 970 g/kg\n1 January 2009\n31 December 2021\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 diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,\nthe protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate.\n182\nFenoxaprop-P\nCAS No 113158-40-0\nCIPAC No 484\n(R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid\n≥ 920 g/kg\n1 January 2009\n31 December 2021\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 fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of non target plants,\nthe presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure,\nthe persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur.\nConditions of authorisation should include risk mitigation measures, where appropriate.\n183\nFenpropidin\nCAS No 67306-00-7\nCIPAC No 520\n(R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine\n≥ 960 g/kg (racemate)\n1 January 2009\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 fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone.\nThe Member States concerned shall request the submission of:\ninformation to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin.\nThey shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.\n184\nQuinoclamine\nCAS No 2797-51-5\nCIPAC No 648\n2-amino-3-chloro-1,4-naphthoquinone\n≥ 965 g/kg impurity:\ndichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg\n1 January 2009\n31 December 2018\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms,\nthe protection of birds and small mammals.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\n185\nChloridazon\nCAS No 1698-60-8\nCIPAC No 111\n5-amino-4-chloro-2-phenylpyridazin-3(2H)-one\n920 g/kg\nThe manufacturing impurity 4-amino-5-chloro-isomer is considered to be of toxicological concern and a maximum level of 60 g/kg is established.\n1 January 2009\n31 December 2018\nPART A\nOnly uses as herbicide in application max. of 2,6 kg/ha only every third year on the same field 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 chloridazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 December 2007 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination from metabolites B and B1 in vulnerable zones, where appropriate.\n186\nTritosulfuron\nCAS No 142469-14-5\nCIPAC No 735\n1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea\n≥ 960 g/kg\nThe following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material:\n2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg\n1 December 2008\n30 November 2021\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 tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of aquatic organisms,\nthe protection of small mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\n187\nFlutolanil\nCAS No 66332-96-5\nCIPAC No 524\nα,α,α-trifluoro-3′-isopropoxy-o-toluanilide\n≥ 975 g/kg\n1 March 2009\n28 February 2021\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of authorisation should include risk mitigation measures, where appropriate.\n188\nBenfluralin\nCAS No 1861-40-1\nCIPAC No 285\nN-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine\n≥ 960 g/kg\nImpurities:\nethyl-butyl-nitrosamine: max. 0,1 mg/kg\n1 March 2009\n28 February 2021\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 onbenfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of the operators’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,\nthe residues in food of plant and animal origin and evaluate the dietary exposure of consumers,\nthe protection of birds, mammals, surface waters and aquatic organisms. In relauion to these identified risks, sisk mitigation measures, such as buffer zones, should be applied where appropriate.\nThe Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the approval.\n189\nFluazinam\nCAS No 79622-59-6\nCIPAC No 521\n3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine\n≥ 960 g/kg\nImpurities:\n5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine\nnot more than 2 g/kg\n1 March 2009\n28 February 2021\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of the operators’ and workers’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,\nthe residues in food of plant and animal origin and evaluate the dietary exposure of consumers,\nthe protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.\nThe Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the approval.\n190\nFuberidazole\nCAS No 3878-19-1\nCIPAC No 525\n2-(2′-furyl)benzimidazole\n≥ 970 g/kg\n1 March 2009\n28 February 2019\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nlong-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\n191\nMepiquat\nCAS No 15302-91-7\nCIPAC No 440\n1,1-dimethylpiperidinium chloride (mepiquat chloride)\n≥ 990 g/kg\n1 March 2009\n28 February 2021\nPART A\nOnly uses as plant growth regulator may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nThe Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.\n192\nDiuron\nCAS No 330-54-1\nCIPAC No 100\n3-(3,4-dichlorophenyl)-1,1-dimethylurea\n≥ 930 g/kg\n1 October 2008\n30 September 2020\nPART A\nOnly uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) 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 diuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety; conditions of use shall prescribe the use of personal protective equipment, if appropriate,\nthe protection of aquatic organisms and non-target plants.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\n193\nBacillus thuringiensis subsp. aizawai\nSTRAIN: ABTS-1857\nCulture collection: No SD-1372,\nSTRAIN: GC-91\nCulture collection: No NCTC 11821\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide 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 Bacillus thuringiensis subsp.Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n194\nBacillus thuringiensis subsp. israeliensis (serotype H-14)\nSTRAIN: AM65-52\nCulture collection: No ATCC-1276\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide 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 Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52(SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n195\nBacillus thuringiensis subsp. kurstaki\nSTRAIN: ABTS 351\nCulture collection: No ATCC SD-1275\nSTRAIN: PB 54\nCulture collection: No CECT 7209\nSTRAIN: SA 11\nCulture collection: No NRRL B-30790\nSTRAIN: SA 12\nCulture collection: No NRRL B-30791\nSTRAIN: EG 2348\nCulture collection: No NRRL B-18208\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide 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 Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n196\nBacillus thuringiensis subsp. Tenebrionis\nSTRAIN: NB 176 (TM 141)\nCulture collection: No SD-5428\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2019\nPART A\nOnly uses as insecticide 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 Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n197\nBeauveria bassiana\nSTRAIN: ATCC 74040\nCulture collection: No ATCC 74040\nSTRAIN: GHA\nCulture collection: No ATCC 74250\nNot applicable\nMax level of beauvericin: 5 mg/kg\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide 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 Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n198\nCydia pomonella Granulovirus (CpGV)\nNot applicable\nMinimum concentration: 1 × 10 13 OB/l (occlusion bodies/l) and Contaminating microorganisms ( Bacillus cereus ) in the formulated product < 1 × 10 7 CFU/g\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide 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 Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n199\nLecanicillium muscarium\n(formerly Verticilium lecanii)\nSTRAIN: Ve 6\nCulture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide 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 Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n200\nMetarhizium anisopliae var. anisopliae\n(formerly Metarhizium anisopliae)\nSTRAIN: BIPESCO 5/F52\nCulture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide and acaricide 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 Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n201\nPhlebiopsis gigantea\nSTRAIN: VRA 1985\nCulture collection: No DSM 16202\nSTRAIN: VRA 1986\nCulture collection: No DSM 16203\nSTRAIN: FOC PG B20/5\nCulture collection: No IMI 390096\nSTRAIN: FOC PG SP log 6\nCulture collection: No IMI 390097\nSTRAIN: FOC PG SP log 5\nCulture collection: No IMI 390098\nSTRAIN: FOC PG BU 3\nCulture collection: No IMI 390099\nSTRAIN: FOC PG BU 4\nCulture collection: No IMI 390100\nSTRAIN: FOC PG97/1062/116/1.1\nCulture collection: No IMI 390102\nSTRAIN: FOC PG B22/SP1287/3.1\nCulture collection: No IMI 390103\nSTRAIN: FOC PG SH 1\nCulture collection: No IMI 390104\nSTRAIN: FOC PG B22/SP1190/3.2\nCulture collection: No IMI 390105\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2020\nPART A Only uses as fungicide may be authorised.\nPART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures.\n202\nPythium oligandrum\nSTRAINS: M1\nCulture collection No ATCC 38472\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 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 Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n203\nStreptomyces K61 (formerly S. griseoviridis)\nSTRAIN: K61\nCulture collection: No DSM 7206\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 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 Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n204\nTrichoderma atroviride\n(formerly T. harzianum)\nSTRAIN: IMI 206040\nCulture collection No IMI 206040, ATCC 20476;\nSTRAIN: T11\nCulture collection: No\nSpanish type culture collection CECT 20498, identical with IMI 352941\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 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 reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n205\nTrichoderma polysporum\nSTRAIN: Trichoderma polysporum IMI 206039\nCulture collection No IMI 206039, ATCC 20475\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 2019\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 Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n206\nTrichoderma harzianum Rifai\nSTRAIN:\nTrichoderma harzianum T-22;\nCulture collection No ATCC 20847\nSTRAIN: Trichoderma harzianum ITEM 908;\nCulture collection No CBS 118749\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 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 reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n207\nTrichoderma asperellum\n(formerly T. harzianum)\nSTRAIN: ICC012\nCulture collection No CABI CC IMI 392716\nSTRAIN: Trichoderma asperellum\n(formerly T. viride T25) T25\nCulture collection No CECT 20178\nSTRAIN: Trichoderma asperellum\n(formerly T. viride TV1) TV1\nCulture collection No MUCL 43093\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 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 reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n208\nTrichoderma gamsii (formerly T. viride)\nSTRAINS:\nICC080\nCulture collection No IMI CC number 392151 CABI\nNot applicable\nNo relevant impurities\n1 May 2009\n30 April 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 Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n210\nAbamectin\nCAS No 71751-41-2\navermectin B1a\nCAS No 65195-55-3\nAvermectin B1b\nCAS No 65195-56-4\nabamectin\nCIPAC No 495\nAvermectinB1a\n(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside\nAvermectinB1b\n(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside\n≥ 850 g/kg\n1 May 2009\n30 April 2021\nPART A\nOnly uses as insecticide, acaricide and nematicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information are provided before such an authorisation is granted.\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 abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 and of the addendum to the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed dated 24 January 2017 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe residues in food of plant origin and evaluate the dietary exposure of consumers,\nthe protection of bees, non-target arthropods, soil organisms, birds, mammals and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones and waiting periods, should be applied where appropriate.\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 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.\n211\nEpoxiconazole\nCAS No 135319-73-2 (formerly 106325-08-0)\nCIPAC No 609\n(2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole\n≥ 920 g/kg\n1 May 2009\n30 April 2020\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 epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,\nthe dietary exposure of consumers to the epoxiconazole (triazole) metabolites,\nthe potential for long-range transport via air,\nthe risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.\nThe Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest.\nThe concerned Member States shall ensure that the notifier submits within two years from the approval, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals.\n212\nFenpropimorph\nCAS No 67564-91-4\nCIPAC No 427\n(RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine\n≥ 930 g/kg\n1 May 2009\n30 April 2019\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 fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles.\nThe Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the approval.\n213\nFenpyroximate\nCAS No 134098-61-6\nCIPAC No 695\ntert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate\n> 960 g/kg\n1 May 2009\n30 April 2021\nPART A\nOnly uses as acaricide may be authorised.\nThe following uses must not be authorised:\napplications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications.\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 fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.\nThe Member States concerned shall request the submission of information to further address:\nthe risk to aquatic organisms from metabolites containing the benzyl moiety,\nthe risk of biomagnification in aquatic food chains.\nThey shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the approval.\n214\nTralkoxydim\nCAS No 87820-88-0\nCIPAC No 544\n(RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one\n≥ 960 g/kg\n1 May 2009\n30 April 2019\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 tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of herbivorous mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of:\ninformation to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim.\nThey shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the approval.\n215\nAclonifen\nCAS No 74070-46-5\nCIPAC No 498\n2-chloro-6-nitro-3-phenoxyaniline\n≥ 970 g/kg\nThe impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.\n1 August 2009\n31 July 2022\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,\nthe protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,\nthe residues in rotational crops and evaluate the dietary exposure of consumers,\nthe protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.\nThe Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.\nThey shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.\n216\nImidacloprid\nCAS No 138261-41-3\nCIPAC No 582\n(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine\n≥ 970 g/kg\n1 August 2009\n1 December 2020\nPART A\nOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.\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 imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 and the conclusions of the revised addendum of the review report on imidacloprid as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe risk to bees and bumble bees released for pollination in permanent greenhouses,\nthe impact on aquatic organisms,\nthe exposure of bees via the consumption of contaminated water from the permanent greenhouses.\nMember States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised.\nConditions of use shall include risk mitigation measures, where appropriate.\n217\nMetazachlor\nCAS No 67129-08-2\nCIPAC No 411\n2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide\n≥ 940 g/kg\nThe manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established.\n1 August 2009\n31 July 2021\nPART A\nOnly uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field.\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 metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.\nIf metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.\nThey shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.\n218\nAcetic acid\nCAS No 64-19-7\nCIPAC 838\nacetic acid\n≥ 980 g/kg\n1 September 2009\n31 August 2022\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 acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 , shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection of operators, the protection of groundwater and the protection of aquatic organisms.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit confirmatory information as regards:\nthe acute and long-term risk to birds and mammals,\nthe risk to honeybees,\nthe risk to non-target arthropods.\nThe notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2015 .\n219\nAluminium ammonium sulphate\nCAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous)\nCIPAC No 840\nAluminium ammonium sulphate\n≥ 960 g/kg (expressed as dodecahydrate)\n≥ 502 g/kg (anhydrous)\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent 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 aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit confirmatory information as regards:\n(a) the impact on the environment of the transformation/dissociation products of aluminium ammonium sulphate;\n(b) the risk to non-target terrestrial organisms other than vertebrates and aquatic organisms.\nThis information shall be submitted to the Member States, the Commission and the Authority by 1 January 2016 .\n220\nAluminium silicate\nCAS No 1332-58-7\nCIPAC No 841\nNot available\nChemical name: Aluminium silicate\n≥ 999,8 g/kg\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent 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 aluminium silicate (SANCO/2603/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the operator safety; conditions of use shall include the application of adequate personal and respiratory protective equipment, where appropriate.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:\n(a) the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;\n(b) the relevance of the test material used in the toxicity dossier in view of the specification of the technical material.\nThe Member States concerned shall ensure that the applicant submits such information to the Commission by 1 May 2013 .\n221\nAmmonium acetate\nCAS No 631-61-8\nCIPAC No not allocated\nAmmonium acetate\n≥ 970 g/kg\nRelevant impurity: Heavy metals as Pb maximum 10 ppm\n1 September 2009\n31 August 2019\nPART A\nOnly uses as attractant 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 ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n222\nBlood meal\nCAS No: 90989-74-5\nCIPAC No: 909\nNot available\n≥ 990 g/Kg\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 10Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011 .\nPART B\nIn assessing applications to authorise plant protection products containing blood meal for uses other than with direct application localised on individual plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.\nFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013 .\n223\nCalcium carbide\nCAS No: 75-20-7\nCIPAC No: 910\nCalcium acetylide\n≥ 765 g/kg\nContaining 0,08 – 0,9 g/kg Calcium Phosphide\n1 September 2009\n31 August 2022\nPART A\nOnly uses as repellent 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 amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n224\nCalcium carbonate\nCAS No: 471-34-1\nCIPAC No: 843\nCalcium carbonate\n≥ 995 g/kg\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent 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 amended review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit confirmatory information as regards:\nfurther data on the specification of the technical material,\nanalytical methods for the determination of calcium carbonate in the representative formulation and of the impurities in the technical material.\nThese information shall be submitted to the Member States, the Commission and the Authority by 1 March 2013 .\n225\nCarbon dioxide\nCAS No: 124-38-9\nCIPAC No: 844\nCarbon dioxide\n≥ 99,9 %\nRelevant impurities:\nphosphane max. 0,3 ppm v/v\nbenzene max. 0,02 ppm v/v\ncarbon monoxide max. 10 ppm v/v\nmethanol max. 10 ppm v/v\nhydrogen cyanide max. 0,5 ppm v/v\n1 September 2009\n31 August 2021\nPART A\nOnly uses as a fumigant 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 carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n226\nDenathonium benzoate\nCAS No 3734-33-6\nCIPAC No 845\nBenzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate\n≥ 975g/kg\n1 September 2009\n1 December 2020\nPART A\nOnly uses as repellent may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.\nConditions of use shall include, where appropriate, risk mitigation measures.\n227\nEthylene\nCAS No 74-85-1\nCIPAC No 839\nEthylene\n≥ 90 %\nRelevant impurity: ethylene oxide, max content 1 mg/kg\n1 September 2009\n31 August 2022\nPART A\nOnly indoor uses as plant growth regulator by professional users 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 ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 , shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n(a) the compliance of ethylene with the required specifications, irrespective of the form in which it is supplied to the user;\n(b) the protection of operators, workers and bystanders.\nConditions of authorisation shall include, where appropriate, risk mitigation measures.\n228\nExtract from tea tree\nCAS No Tea Tree Oil 68647-73-4\nMain components:\nterpinen-4-ol 562-74-3\nγ-terpinene 99-85-4\nα-terpinene 99-86-5\n1,8-cineole 470-82-6\nCIPAC No 914\nTea Tree Oil is a complex mixture of chemical substances.\nMain components:\nterpinen-4-ol ≥ 300 g/kg\nγ-terpinene ≥ 100 g/kg\nα-terpinene ≥ 50 g/kg\n1,8-cineole ≥ 1 g/kg\nRelevant impurity:\nMethyl eugenol: maximum 1 g/kg of the technical material\n1 September 2009\n31 August 2021\nPART A\nOnly uses as fungicide in greenhouse 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 extract from tea tree (SANCO/2609/2008 final) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.\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, where appropriate;\nthe protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe protection of surface water and aquatic organisms;\nthe protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe notifier shall submit confirmatory information as regards:\n(a) the plant metabolism and consumer exposure;\n(b) the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol;\n(c) the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products;\n(d) the effects on biological methods of sewage treatment.\nThe notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 at latest.\n229\nFat distillation residues\nCAS No: not allocated\nCIPAC No 915\nNot available\n≥ 40 % of cleaved fatty acids\nRelevant impurity: Ni maximum 200 mg/kg\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent may be authorised. Fat distillation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 ( OJ L 54, 26.2.2011, p. 1 ).\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 amended review report on fat distillation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013 .\n230\nFatty acids C7 to C20\nCAS No 112-05-0 (Pelargonic Acid)\n67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)\n124-07-2 (Caprylic Acid)\n334-48-5 (Capric Acid)\n143-07-7 (Lauric Acid)\n112-80-1 (Oleic Acid)\n85566-26-3 (Fatty acids C8-C10 Me esters)\n111-11-5 (Methyl octanoate)\n110-42-9 (Methyl decanoate)\nCIPAC No not allocated\nNonanoic acid\nCaprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)\nOctanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)\nFatty acids, C7-C10, Me esters\n≥ 889 g/kg (Pelargonic Acid)\n≥ 838 g/kg fatty acids\n≥ 99 % fatty acid methyl esters\n1 September 2009\n31 August 2021\nPART A\nOnly uses as insecticide, acaricide, and herbicide and 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 fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n231\nGarlic extract\nCAS No 8008-99-9\nCIPAC No not allocated\nFood grade garlic juice concentrate\n≥ 99,9 %\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent, insecticide and nematicide 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 garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n232\nGibberellic acid\nCAS No 77-06-5\nCIPAC No 307\n(3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid\nAlt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid\n≥ 850 g/kg\n1 September 2009\n31 August 2021\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 gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n233\nGibberellins\nCAS No GA4: 468-44-0\nGA7: 510-75-8\nGA4A7 mixture: 8030-53-3\nCIPAC No not allocated\nGA4:\n(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid\nGA7:\n(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid\nReview report (SANCO/2614/2008).\n1 September 2009\n31 August 2021\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 gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n234\nHydrolysed proteins\nCAS No not allocated\nCIPAC No 901\nNot available\nReview report (SANCO/2615/2008)\n1 September 2009\n31 August 2021\nPART A\nOnly uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 and Commission Regulation (EU) No 142/2011 .\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 hydrolysed proteins (SANCO/2615/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the operator and worker safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:\n(a) the specifications of the technical material, as commercially manufactured, supported by appropriate analytical data;\n(b) the risk to aquatic organisms.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013 , the information set out in point (b) by 1 November 2013 .\n235\nIron sulphate :\nIron(II)sulfate anhydrous: CAS No 7720-78-7\nIron(II)sulfate monohydrate: CAS No 17375-41-6\nIron(II)sulfate heptahydrate: CAS No 7782-63-0\nCIPAC No 837\nIron(II)sulphate\nor\niron(2+) sulfate\nIron(II)sulfate anhydrous: ≥ 350 g/kg total iron.\nRelevant impurities:\narsenic, 18 mg/kg\ncadmium, 1,8 mg/kg\nchromium, 90 mg/kg\nlead, 36 mg/kg\nmercury, 1,8 mg/kg\nexpressed on the basis of the anhydrous variant\n1 September 2009\n31 August 2021\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 amended review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk for operator;\nthe risk to children/residents playing on treated turf;\nthe risk to surface waters and to aquatic organisms.\nConditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers.\nThe Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013 .\n236\nKieselgur (diatomaceous earth)\nCAS No 61790-53-2\nCIPAC No 647\nKieselgur (no IUPAC name)\nDiatomaceous earth\nAmorphous silicon dioxide\nSilica\nDiatomite\nThe product consists of 100 % diatomaceous earth.\nMaximum 0,1 % of particles of crystalline silica with diameter below 50 μm\n1 September 2009\n31 August 2021\nPART A\nOnly indoor uses as insecticide and acaricide by professional users 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 kieselgur (diatomaceous earth) (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the safety of operators and workers. Conditions of use shall include the application of adequate personal and respiratory protective equipment. Where necessary, conditions of use shall prohibit the presence of workers after application of the product concerned for a period appropriate in view of the risks caused by that product.\nThe Member States concerned shall ensure that the notifiers submit, by 25 November 2015 , to the Commission, the Member States and the Authority information concerning the inhalation toxicity to confirm the occupational limits of kieselgur (diatomaceous earth).\n237\nLimestone\nCAS No: 1317-65-3\nCIPAC No: 852\nCalcium carbonate\n≥ 980 g/kg\n1 September 2009\n31 August 2019\nPART A\nOnly uses as repellent 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 amended review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n239\nPepper dust extraction residue (PDER)\nCAS No: not allocated\nCIPAC No: not allocated\nSteam distilled and solvent extracted Black pepper – Piper nigrum\nIt is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %\n1 September 2009\n31 August 2019\nPART A\nOnly uses as repellent may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing pepper dust extraction residue (PDER) for uses other than in home garden area, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.\nFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures\nThe notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013 .\n240\nPlant oils/citronella oil\nCAS No 8000-29-1\nCIPAC No 905\nCitronella Oil is a complex mixture of chemical substances.\nThe main components are:\nCitronellal (3,7-dimethyl-6-octenal).\nGeraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).\nCitronellol (3,7-dimethyl-6-octan-2-ol).\nGeranyl acetate (3,7-dimethyl-6-octen-1yl acetate).\nThe sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol.\n1 September 2009\n31 August 2022\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 citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\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;\nthe risk to non-target organisms.\nThe notifier shall submit confirmatory information as regards:\n(a) the technical specification;\n(b) data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms;\n(c) the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol.\nThe notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 .\n241\nPlant oils/clove oil\nCAS No 84961-50-2 (clove oil)\n97-53-0 (Eugenol — main component)\nCIPAC No 906\nClove Oil is a complex mixture of chemical substances.\nThe main component is eugenol.\n≥ 800 g/kg\nRelevant impurity: methyl eugenol maximum 0,1 % of the technical material\n1 September 2009\n31 August 2022\nPART A\nOnly indoor uses as post-harvest fungicide and bactericide 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 clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.\nThe notifier shall submit confirmatory information as regards\n(a) the technical specification;\n(b) data comparing natural background exposure situations of plant oils/clove oil, eugenol and methyl eugenol in relation to exposure from the use of plant oils/clove oil as a plant protection product. This data shall cover human exposure.\nThe notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 .\n242\nPlant oils/rape seed oil\nCAS No: 8002-13-9\nCIPAC No: not allocated\nRape seed oil\nRape seed oil is a complex mixture of fatty acids\nRelevant impurity: Maximum 2 % of erucic acid\n1 September 2009\n31 August 2021\nPART A\nOnly uses as insecticide and acaricide 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 rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n243\nPlant oils/spear mint oil\nCAS No 8008-79-5\nCIPAC No 908\nSpearmint oil\n≥ 550 g/kg as (R)-Carvone\n1 September 2009\n31 August 2022\nPART A\nOnly uses as plant growth regulator for postharvest treatment of potatoes may be authorised.\nMember States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.\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 amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n244\nPotassium hydrogen carbonate\nCAS No 298-14-6\nCIPAC No 853\nPotassium hydrogen carbonate\n≥ 99,5 %\nImpurities:\nPb max. 10 mg/kg\nAs max. 3 mg/kg\n1 September 2009\n31 August 2021\nPART A\nOnly uses as fungicide and insecticide 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 potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures.\n245\n1,4-diaminobutane (putrescine)\nCAS No 110-60-1\nCIPAC No 854\nButane-1,4-diamine\n≥ 990 g/kg\n1 September 2009\n31 August 2019\nPART A\nOnly uses as attractant 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 1,4-diaminobutane (putrescine) (SANCO/2626/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n246\nPyrethrins: 8003-34-7\nCIPAC No 32\nExtract A: extractives of Chrysanthemum cinerariaefolium:\n89997- 63-7\nPyrethrin 1: CAS 121- 21-1\nPyrethrin 2: CAS 121- 29-9\nCinerin 1: CAS 25402- 06-6\nCinerin 2: CAS 121- 20-0\nJasmolin 1: CAS 4466- 14-2\nJasmolin 2: CAS 1172- 63-0\nExtract B:\nPyrethrin 1: CAS 121-21-1\nPyrethrin 2: CAS 121- 29-9\nCinerin 1: CAS 25402- 06-6\nCinerin 2: CAS 121- 20-0\nJasmolin 1: CAS 4466- 14-2\nJasmolin 2: CAS 1172- 63-0\nPyrethrins are a complex mixture of chemical substances.\nExtract A: ≥ 500 g/kg Pyrethrins\nExtract B: ≥ 480 g/kg Pyrethrins\n1 September 2009\n31 August 2022\nPART A\nOnly uses as insecticide 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 pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n(a) the risk to operators and workers;\n(b) the risk to non-target organisms.\nConditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures.\nThe applicant shall submit confirmatory information as regards:\n(1) the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies;\n(2) the risk from inhalation;\n(3) the residue definition;\n(4) the representativeness of the major component ‘ pyrethrin 1 ’ as regards the fate and behaviour in soil and water.\nThe applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December 2015 .\n247\nQuartz sand\nCAS No: 14808-60-7, 7637-86-9\nCIPAC No: 855\nQuartz, Silicon dioxide\n≥ 915 g/kg\nMaximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing quartz sand for uses other than on trees in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n248\nFish oil\nCAS No 100085-40-3\nCIPAC No 918\nFish oil\n≥ 99 %\nRelevant impurity:\nDioxine max. 6 pg/kg for animal feed\nHg max. 0,5 mg/kg feed derived from fish and other sea food processing\nCd max. 2 mg/kg feed of animal origin except in feed for domestic pets\nPb max. 10 mg/kg\nPCBs max. 5 mg/kg\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.\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 fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013 .\n249\nRepellents by smell of animal or plant origin/sheep fat\nCAS No 98999-15-6\nCIPAC No not allocated\nSheep Fat\nPure sheep fat containing a maximum of 0,18 % w/w/water.\n1 September 2009\n31 August 2021\nPART A\nOnly uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1069/2009\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 sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n252\nSea-algae extract (formerly sea algae extract and sea weeds)\nCAS No not allocated\nCIPAC No not allocated\nSee algae extract\nSee algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008\n1 September 2009\n31 August 2019\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 sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n253\nSodium aluminium silicate\nCAS No 1344-00-9\nCIPAC No not allocated\nSodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O\n1 000 g/kg\n1 September 2009\n31 August 2019\nPART A\nOnly uses as repellent 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 sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n254\nSodium hypochlorite\nCAS No: 7681-52-9\nCIPAC: 848\nSodium hypochlorite\nSodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate\n10-12 % (w/w) expressed as chlorine\n1 September 2009\n31 August 2019\nPART A\nOnly indoor uses as disinfectant 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 sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n(a) the risk to operator and workers;\n(b) the exposure of soil to sodium hypochlorite and its reaction products through spreading of treated compost on organic land shall be avoided.\nConditions of use shall include risk mitigation measures, where appropriate.\n255\nStraight Chain Lepidopteran Pheromones\nReview report (SANCO/2633/2008)\nReview report (SANCO/2633/2008)\n1 September 2009\n31 August 2021\nPART A\nOnly uses as attractants 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 straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit confirmatory information as regards:\n(1) the genotoxic profile of aldehyde group compounds;\n(2) exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones.\nThe applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016 .\n256\nTrimethylamine hydrochloride\nCAS No 593-81-7\nCIPAC No not allocated\nTrimethylamine hydrochloride\n≥ 988 g/kg\n1 September 2009\n31 August 2019\nPART A\nOnly uses as attractant 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 trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\n257\nUrea\nCAS No 57-13-6\nCIPAC No 913\nUrea\n≥ 98 % w/w\n1 September 2009\n31 August 2021\nPART A\nOnly uses as attractant and 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 urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe notifier shall submit confirmatory information as regards:\n(a) the analysis method for urea and for the impurity biuret;\n(b) the risk for operators, workers and bystanders.\nThe information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016 .\n260\nAluminium phosphide\nCAS No 20859-73-8\nCIPAC No 227\nAluminium phosphide\n≥ 830 g/kg\n1 September 2009\n31 August 2022\nPART A\nOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use aluminium phosphide containing products may be authorised.\nAs rodenticide, talpicide and leporicide only outdoor uses may be authorised.\nAuthorisations should 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 aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;\nthe protection of operators and workers during fumigation for indoor uses;\nthe protection of workers at re-entry (after fumigation period) for indoor uses;\nthe protection of bystanders against leaking of gas for indoor uses;\nthe protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;\nthe protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.\n261\nCalcium phosphide\nCAS No 1305-99-3\nCIPAC No 505\nCalcium phosphide\n≥ 160 g/kg\n1 September 2009\n1 December 2020\nPART A\nOnly outdoor uses as rodenticide and talpicide in the form of ready-to-use calcium phosphide containing products may be authorised.\nAuthorisations should 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 calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;\nthe protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;\nthe protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.\n262\nMagnesium phosphide\nCAS No 12057-74-8\nCIPAC No 228\nMagnesium phosphide\n≥ 880 g/kg\n1 September 2009\n31 August 2022\nPART A\nOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use magnesium phosphide containing products may be authorised.\nAs rodenticide, talpicide and leporicide only outdoor uses may be authorised.\nAuthorisations should 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 magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;\nthe protection of operators and workers during fumigation for indoor uses;\nthe protection of workers at re-entry (after fumigation period) for indoor uses;\nthe protection of bystanders against leaking of gas for indoor uses;\nthe protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;\nthe protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.\n263\nCymoxanil\nCAS No 57966-95-7\nCIPAC No 419\n1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea\n≥ 970 g/kg\n1 September 2009\n31 August 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 cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.\n264\nDodemorph\nCAS No 1593-77-7\nCIPAC No 300\ncis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine\n≥ 950 g/kg\n1 September 2009\n31 August 2022\nPART A\nOnly uses as fungicide on ornamentals in glasshouse 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 dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions;\nconditions of authorisation should include risk mitigation measures, where appropriate.\n265\n2,5-Dichlorobenzoic acid methylester\nCAS No 2905-69-3\nCIPAC No 686\nmethyl-2,5-dichlorobenzoate\n≥ 995 g/kg\n1 September 2009\n31 August 2022\nPART A\nOnly indoor uses as plant growth regulator and fungicide for grafting of grapevines 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 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\n266\nMetamitron\nCAS No 41394-05-2\nCIPAC No 381\n4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one\n≥ 960 g/kg\n1 September 2009\n31 August 2022\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate;\nthe protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to birds and mammals, and non-target terrestrial plants.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.\n267\nSulcotrione\nCAS No 99105-77-8\nCIPAC No 723\n2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione\n≥ 950 g/kg\nImpurities:\nhydrogen cyanide: not more than 80 mg/kg\ntoluene: not more than 4 g/kg\n1 September 2009\n31 August 2022\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 sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;\nthe risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.\n268\nTebuconazole\nCAS No 107534-96-3\nCIPAC No 494\n(RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol\n≥ 905 g/kg\n1 September 2009\n31 August 2021\nPART A\nOnly uses as fungicide and 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 tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;\nthe dietary exposure of consumers to the tebuconazole (triazole) metabolites;\nthe potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole;\nthe protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;\nthe protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.\n269\nTriadimenol\nCAS No 55219-65-3\nCIPAC No 398\n(1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol\n≥ 920 g/kg\nisomer A (1RS,2SR), isomer B (1RS,2RS)\nDiastereomer A, RS + SR, range: 70 to 85 %\nDiastereomer B, RR + SS, range: 15 to 30 %\n1 September 2009\n31 August 2019\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 triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure;\nthe protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther information on the specification;\ninformation to further address the risk assessment for birds and mammals.\ninformation to further address the risk of endocrine disrupting effects on fish.\nThey shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.\nThe Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.\n270\nMethomyl\nCAS No 16752-77-50\nCIPAC No 264\nS-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate\n≥ 980 g/kg\n1 September 2009\n31 August 2019\nPART A\nOnly uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season.\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 methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment,\nthe protection of birds,\nthe protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles,\nthe protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied.\nMember States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents.\nWhere appropriate, conditions of authorisation shall include further risk mitigation measures.\n271\nBensulfuron\nCAS No 83055-99-6\nCIPAC No 502.201\nα-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron)\nmethyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl)\n≥ 975 g/kg\n1 November 2009\n31 October 2022\nPART A\nOnly uses as a 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 bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to the following:\nthe protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,\nthe protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther studies on the specification,\ninformation to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions,\ninformation to address the relevance of metabolites for the consumer risk assessment.\nThey shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.\n272\nSodium 5-nitroguaiacolate\nCAS No 67233-85-6\nCIPAC number not allocated\nSodium 2-methoxy-5-nitrophenolate\n≥ 980 g/kg\n1 November 2009\n31 October 2022\nPART A\nOnly use 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,\nthe protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.\n273\nSodium o-nitrophenolate\nCAS No 824-39-5\nCIPAC number not allocated\nSodium 2-nitrophenolate; sodium o-nitrophenolate\n≥ 980 g/kg\nThe following impurities are of toxicological concern:\nPhenol\nMax content: 0,1 g/kg\n2,4 dinitrophenol\nmax content: 0,14 g/kg\n2,6 dinitrophenol\nmax content: 0,32 g/kg\n1 November 2009\n31 October 2022\nPART A\nOnly use 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,\nthe protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.\n274\nSodium p-nitrophenolate\nCAS No 824-78-2\nCIPAC number not allocated\nSodium 4-nitrophenolate; sodium p-nitrophenolate\n≥ 998 g/kg\nThe following impurities are of toxicological concern:\nPhenol\nmax content: 0,1 g/kg\n2,4 dinitrophenol\nmax content: 0,07 g/kg\n2,6 dinitrophenol\nmax content: 0,09 g/kg\n1 November 2009\n31 October 2022\nPART A\nOnly use 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,\nthe protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.\n275\nTebufenpyrad\nCAS No 119168-77-3\nCIPAC No 725\nN-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide\n≥ 980 g/kg\n1 November 2009\n31 October 2022\nPART A\nOnly uses as acaricide and insecticide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,\nthe protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther information confirming that no relevant impurities are present,\ninformation to further address the risk to insectivorous birds.\nThey shall ensure that the notifier provides such information to the Commission by 31 October 2011.\n276\nChlormequat\nCAS No 7003-89-6 (chlormequat)\nCAS No 999-81-5 (chlormequat chloride)\nCIPAC No 143 (chlormequat)\nCIPAC No 143.302 (chlormequat chloride)\n2-chloroethyltrimethylammonium (chlormequat)\n2-chloroethyltrimethylammonium chloride\n(chlormequat chloride)\n≥ 636 g/kg\nImpurities\n1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content)\nChloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content)\n1 December 2009\n30 November 2021\nPART A\nOnly uses as plant growth regulator on cereals and non edible crops may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;\nthe protection of birds and mammals.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.\n278\nPropaquizafop\nCAS No 111479-05-1\nCIPAC No 173\n2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate\n≥ 920 g/kg\nToluene maximum content 5 g/kg\n1 December 2009\n30 November 2021\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 propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,\nthe protection of non-target arthropods and ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther information on the relevant impurity Ro 41-5259,\ninformation to further address the risk to aquatic organisms and to non-target arthropods.\nThey shall ensure that the notifier provides such information to the Commission by 30 November 2011.\n279\nQuizalofop-P\nQuizalofop-P-tefuryl\nCAS No 119738-06-6\nCIPAC No 641.226\n(RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate\n≥ 795 g/kg\n1 December 2009\n30 November 2021\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 quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.\nThey shall ensure that the notifier provides such information to the Commission by 30 November 2011 .\nQuizalofop-P-ethyl\nCAS No 100646-51-3\nCIPAC No 641.202\nethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate\n≥ 950 g/kg\n1 December 2009\n30 November 2021\n280\nTeflubenzuron\nCAS No 83121-18-0\nCIPAC No 450\n1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea\n≥ 970 g/kg\n1 December 2009\n30 November 2019\nPART A\nOnly uses as insecticide in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing teflubenzuron for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 teflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and workers safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate,\nthe protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity,\nthe protection of bees which should be prevented from accessing the glasshouse,\nthe protection of pollinator colonies purposely placed in the glasshouse,\nthe safe disposal of condensation water, drain water and substrate in order to preclude risks to non-target organisms and contamination of surface water and groundwater.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\n281\nZeta-cypermethrin\nCAS No 52315-07-8\nCIPAC No 733\nMixture of the stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2 dimethylcyclopropanecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively\n≥ 850 g/kg\nImpurities:\ntoluene: max 2 g/kg\ntars: max 12,5 g/kg\n1 December 2009\n1 December 2020\nPART A\nOnly uses as insecticide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing zeta-cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate,\nthe protection of birds, aquatic organisms, bees, non-target arthropods and non-target soil macro-organisms.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.\n282\nChlorsulfuron\nCAS No 64902-72-3\nCIPAC No 391\n1-(2-chlorophenylsulfonyl)-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea\n≥ 950 g/kg\nImpurities:\n2-Chlorobenzenesulfonamide (IN-A4097) not more than 5 g/kg and\n4-methoxy-6-methyl-1,3,5-triazin-2-amine (IN-A4098) not more than 6 g/kg\n1 January 2010\n31 December 2019\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 chlorsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nThe Member States concerned shall:\nensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.\nIf chlorsulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-A4097, IN-A4098, IN-JJ998, IN-B5528 and IN-V7160 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.\n283\nCyromazine\nCAS No 66215-27-8\nCIPAC No 420\nN-cyclopropyl-1,3,5-triazine-2,4,6-triamine\n≥ 950 g/kg\n1 January 2010\n31 December 2019\nPART A\nOnly uses as insecticide in greenhouses may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing cyromazine for uses other than in tomatoes, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.\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 cyromazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of aquatic organisms,\nthe protection of pollinators.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite NOA 435343 and on the risk to aquatic organisms. They shall ensure that the notifier at whose request cyromazine has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.\n284\nDimethachlor\nCAS No 50563-36-5\nCIPAC No 688\n2-chloro-N-(2-methoxyethyl)acet-2′,6′-xylidide\n≥ 950 g/kg\nImpurity 2,6-dimethylaniline: Not more than 0,5 g/kg\n1 January 2010\n31 December 2021\nPART A\nOnly uses as herbicide in application max. of 1,0 kg/ha only every third year on the same field 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 dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate.\nThe Member States concerned shall:\nensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.\nIf dimethachlor is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.\n285\nEtofenprox\nCAS No 80844-07-1\nCIPAC No 471\n2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl\nether\n≥ 980 g/kg\n1 January 2010\n31 December 2021\nPART A\nOnly uses as insecticide 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 etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,\nthe protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate.\nThe Member States concerned shall:\nensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification,\nthe submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study).\nThey shall ensure that the notifiers provide such studies to the Commission by 31 December 2011.\n286\nLufenuron\nCAS No 103055-07-8\nCIPAC No 704\n(RS)-1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoro-propoxy)-phenyl]-3-(2,6-difluorobenzoyl)-urea\n≥ 970 g/kg\n1 January 2010\n31 December 2019\nPART A\nOnly indoor uses or use in outdoor bait stations as insecticide 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 lufenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe high persistency in the environment and the high risk for bioaccumulation and shall ensure that the use of lufenuron has no adverse long-term effects on non-target organisms,\nthe protection of birds, mammals, soil non-target organisms, bees, non-target arthropods, surface waters and aquatic organisms in vulnerable situations.\nThe Member States concerned shall:\nensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.\n287\nPenconazole\nCAS No 66246-88-6\nCIPAC No 446\n(RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole\n≥ 950 g/kg\n1 January 2010\n31 December 2021\nPART A\nOnly uses as fungicides 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 penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe 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 on the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.\n288\nTri-allate\nCAS No 2303-17-5\nCIPAC No 97\nS-2,3,3-trichloroallyl di-isopropyl\n(thiocarbamate)\n≥ 940 g/kg\nNDIPA (Nitroso-diisopropylamine)\nmax. 0,02 mg/kg\n1 January 2010\n31 December 2021\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 tri-allate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe dietary exposure of consumers to residues of tri-allate in treated crops as well as in succeeding rotational crops and in products of animal origin\nthe protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,\nthe potential for ground water contamination by the degradation products TCPSA when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther information to assess the primary plant metabolism,\nfurther information on the fate and behaviour of the soil metabolite diisopropylamine,\nfurther information on the potential for biomagnification in aquatic food chains,\ninformation to further address the risk to fish-eating mammals and the long-term risk to earthworms.\nThey shall ensure that the notifier provides such information to the Commission by 31 December 2011.\n289\nTriflusulfuron\nCAS No 126535-15-7\nCIPAC No 731\n2-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluic acid\n≥ 960 g/kg\n1 January 2010\n31 December 2021\nPART A\nOnly uses as a 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 triflusulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe dietary exposure of consumers to residues of metabolites IN-M7222 and IN-E7710 in succeeding rotational crops and in products of animal origin,\nthe protection of aquatic organisms and aquatic plants from the risk arising from triflusulfuron and the metabolite IN-66036 and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,\nthe potential for ground water contamination by the degradation products IN-M7222 and IN-W6725 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.\nIf triflusulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-M7222, IN-D8526 and IN-E7710 with respect to cancer. They shall ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.\n290\nDifenacoum\nCAS No 56073-07-5\nCIPAC No 514\n3-[(1RS,3RS;1RS,3SR)-3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl]-4-hydroxycoumarin\n≥ 905 g/kg\n1 January 2010\n30 December 2019\nPART A\nOnly uses as rodenticide in the form of pre-prepared baits placed in specially constructed, tamper resistant and secured bait boxes are authorised.\nThe nominal concentration of the active substance in the products shall not exceed 50 mg/kg.\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 difenacoum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of birds and non-target mammals from primary and secondary poisoning. Risk mitigation measures shall be applied where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission further information on methods for the determination of residues of difenacoum in body fluids.\nThey shall ensure that the notifier provides such information to the Commission by 30 November 2011.\nThe Member States concerned shall ensure that the notifier submits to the Commission further information on the specification of the active substance as manufactured.\nThey shall ensure that the notifier provides such information to the Commission by 31 December 2009.\n292\nsulphur\nCAS No 7704-34-9\nCIPAC No 18\nsulphur\n≥ 990 g/kg\n1 January 2010\n31 December 2021\nPART A\nOnly uses as fungicide and acaricide 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 sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011.\n293\nTetraconazole\nCAS No 112281-77-3\nCIPAC No 726\n(RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether\n≥ 950 g/kg (racemic mixture)\nImpurity toluene: not more than 13 g/kg\n1 January 2010\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 tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nThe Member States concerned shall request:\nthe submission of further information on a refined consumer risk assessment,\nfurther information on the specification regarding ecotoxicology,\nfurther information on the fate and behaviour of potential metabolites in all relevant compartments,\nthe refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods,\nfurther information on the potential for endocrine disrupting effects to birds, mammals and fish.\nThey shall ensure that the notifier provides such information to the Commission by 31 December 2011.\n294\nParaffin oils\nCAS No 64742-46-7\nCAS No 72623-86-0\nCAS No 97862-82-3\nCIPAC No n.a.\nparaffin oil\nEuropean Pharmacopoeia 6.0\n1 January 2010\n31 December 2021\nPART A\nOnly uses as insecticide and acaricide 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in particular Appendices I and II thereto shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe Member States concerned shall request:\nthe submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0.\nThey shall ensure that the notifiers provides such information to the Commission by 30 June 2010.\n295\nParaffin oil\nCAS No 8042-47-5\nCIPAC No n.a.\nparaffin oil\nEuropean Pharmacopoeia. 6,0\n1 January 2010\n31 December 2021\nPART A\nOnly uses as insecticide and acaricide 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 paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account.\nConditions of use shall include, where appropriate, risk mitigation measures.\nThe Member States concerned shall request:\nThe submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0\nThey shall ensure that the notifier provides such information to the Commission by 30 June 2010.\n296\nCyflufenamid\nCAS No 180409-60-3\nCIPAC No 759\n(Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide\n> 980 g/kg\n1 April 2010\n31 March 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 cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\n297\nFluopicolide\nCAS No\n239110-15-7\nCIPAC No 787\n2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide\n≥ 970 g/kg\nThe impurity toluene must not exceed 3 g/kg in the technical material.\n1 June 2010\n31 May 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 fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.\nIn this overall assessment, Member States must pay particular attention to:\nthe protection of aquatic organisms,\nthe protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nto the risk to operators during application,\nthe potential for long range transport via air.\nConditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.\n298\nHeptamaloxyloglucan\nCAS No\n870721-81-6\nCIPAC No\nNot available\nFull IUPAC name in footnote (1)\nXyl p: xylopyranosyl\nGlc p: glucopyranosyl\nFuc p: fucopyranosyl\nGal p: galactopyranosyl\nGlc-ol: glucitol\n≥ 780 g/kg\nThe impurity Patulin must not exceed 50 μg/kg in the technical material.\n1 June 2010\n31 May 2021\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 heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.\n299\n2-phenylphenol (including its salts such as the sodium salt)\nCAS No 90-43-7\nCIPAC No 246\nbiphenyl-2-ol\n≥ 998 g/kg\n1 January 2010\n31 December 2021\nPART A\nOnly uses as a post-harvest fungicide for indoor use 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 2-phenylphenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009, as amended in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.\nIn this overall assessment Member States must pay particular attention:\nto the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nto put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out.\nThe Member States concerned shall ensure that the notifier submits to the Commission:\nfurther information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel,\nfurther information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates.\nThey shall ensure that the notifier provides such information to the Commission by 31 December 2011.\nFurthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers.\nThey shall ensure that the notifier provides such information to the Commission by 31 December 2012.\n300\nMalathion\nCAS No 121-75-5\nCIPAC No 12\ndiethyl (dimethoxyphosphinothioylthio)succinate\nor\nS-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate\nracemate\n≥ 950 g/kg\nImpurities:\nIsomalathion: not more than 2 g/kg\n1 May 2010\n30 April 2022\nPART A\nOnly uses as an insecticide in greenhouses with a permanent structure may be authorised. Authorisations 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 malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.\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 organisms;\n(b) the protection of pollinator colonies purposely placed in the greenhouse;\n(c) the protection of operators and workers, so as to ensure that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;\n(d) the protection of consumers in the case of processed commodities.\nMember States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.\nConditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products.\n301\nPenoxsulam\nCAS No 219714-96-2\nCIPAC No 758\n3-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-α,α,α-trifluorotoluene-2-sulfonamide\n> 980 g/kg\nThe impurity\nBis-CHYMP\n2-chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)hydrazino]-5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material\n1 August 2010\n31 July 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 penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.\nIn this overall assessment, Member States must pay particular attention to:\nthe protection of aquatic organisms,\nthe dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops,\nthe 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 ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012.\nThe Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.\n302\nProquinazid\nCAS No 189278-12-4\nCIPAC No 764\n6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one\n> 950 g/kg\n1 August 2010\n31 July 2022\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 proquinazid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.\nIn this overall assessment, Member States must pay particular attention:\nto the long-term risk to earthworm-eating birds for uses in grapevine,\nto the risk to aquatic organisms,\nthe dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops,\nto the operator safety.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.\n303\nSpirodiclofen\nCAS No 148477-71-8\nCIPAC No 737\n3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate\n> 965 g/kg\nThe following impurities must not exceed a certain amount in the technical material:\n3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4.5]dec-3-en-2-one (BAJ-2740 enol): ≤ 6 g/kg\nN,N-dimethylacetamide: ≤ 4 g/kg\n1 August 2010\n31 July 2020\nPART A\nOnly uses as acaricide or insecticide 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 spirodiclofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.\nIn this overall assessment, Member States must pay particular attention:\nto the long-term risk to aquatic organisms,\nto the operator safety,\nto the risk to bee brood.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\n304\nMetalaxyl\nCAS No 57837-19-1\nCIPAC No 365\nMethyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate\n950 g/kg\nThe impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established.\n1 July 2010\n30 June 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 metalaxyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.\nMember States must pay particular attention to the potential contamination of groundwater by the active substance or its degradation products CGA 62826 and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate.\n305\nFlonicamid (IKI-220)\nCAS No 158062-67-0\nCIPAC No 763\nN-cyanomethyl-4-(trifluoromethyl)nicotinamide\n≥ 960 g/kg\nThe impurity toluene must not exceed 3 g/kg in the technical material.\n1 September 2010\n31 August 2023\nPART A\nOnly uses as insecticide 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 flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account.\nIn this overall assessment, Member States must pay particular attention to:\nthe risk to operators and re-entry workers,\nthe risk to bees.\nConditions of authorisation shall include risk mitigation measures where appropriate.\nThe Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.\n306\nTriflumizole\nCAS No 99387-89-0\nCIPAC No 730\n(E)-4-chloro-α,α,α-trifluoro-N-(1-imidazol-1-yl-2-propoxyethylidene)-o-toluidine\n≥ 980 g/kg\nImpurities:\nToluene: not more than 1 g/kg\n1 July 2010\n30 June 2020\nPART A\nOnly uses as fungicide in greenhouses on artificial substrates 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 triflumizole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment,\nthe potential impact on aquatic organisms and must ensure that the conditions of authorisation include, as appropriate, risk mitigation measures.\n307\nSulfuryl fluoride\nCAS No 002699-79-8\nCIPAC No 757\nSulfuryl fluoride\n> 994 g/kg\n1 November 2010\n31 October 2023\nPART A\nOnly uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures may be authorised insofar:\n(a) these structures are empty; or\n(b) where food or feed commodities are present in a fumigated facility, the users and the food business operators ensure that only the food or feed commodities compliant with the existing maximum residue levels for sulfuryl fluoride and fluoride ion set by Regulation (EC) No 396/2005 of the European Parliament and of the Council may enter the food and feed chain; to this purpose, the users and the food business operators shall fully implement measures equivalent to the HACCP principles as laid down in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council ; in particular, the users shall identify the critical control point at which control is essential to prevent maximum residue levels to be exceeded, and establish and implement effective monitoring procedures at that critical control point.\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 sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 7 December 2016 shall be taken into account.\nIn this overall assessment, Member States must pay particular attention to:\nthe risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that only products complying with the existing MRLs enter the food and feed chain;\nthe risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self-containing breathing apparatus or other appropriate personal protective equipment;\nthe risk to bystanders by applying an appropriate exclusion zone around the fumigated structure.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe notifier shall submit to the Commission, Member States and the Authority monitoring data on tropospheric concentrations of sulfuryl fluoride every fifth year, starting from 30 June 2017 . The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m 3 of tropospheric air).\n308\nFEN 560 (also called fenugreek or fenugreek seed powder)\nCAS No\nNone\nCIPAC No\nNone\nThe active substance is prepared from the seed powder of Trigonella foenum-graecum L. (fenugreek).\nNot applicable\n100 % fenugreek seed powder without any additive and no extraction; the seed being of human food grade quality.\n1 November 2010\n31 October 2020\nPART A\nOnly uses as elicitor of the crop's self-defence mechanisms 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 FEN 560 (fenugreek seed powder), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.\nIn this overall assessment, Member States must pay particular attention to the risk to operators, workers and bystanders.\nConditions of authorisation shall include risk mitigation measures where appropriate.\n309\nHaloxyfop-P\nCAS No Acid: 95977-29-0\nEster: 72619-32-0\nCIPAC No Acid: 526\nEster: 526.201\nAcid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy]propanoic acid\nEster: Methyl (R)-2-{}{4-[3-chloro-5-(trifluoromethyl)-2-pyridyloxy]phenoxy}}propionate\n≥ 940 g/kg\n(Haloxyfop-P-methyl ester)\n1 January 2011\n31 December 2020\nPART A\nOnly uses as herbicide may be authorised at rates not exceeding 0,052 kg active substance per hectare per application, and only one application may be authorised every 3 years.\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 haloxyfop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of groundwater from the relevant soil metabolite DE-535 pyridinone when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe safety of operators and ensure that conditions of use prescribe the use of adequate personal protective equipment,\nthe protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,\nthe consumer safety as regards the occurrence in groundwater of metabolite DE-535 pyridinol.\n310\nNapropamide\nCAS No 15299-99-7\n(RS)-N,N-diethyl-2-(1-naphthyloxy)propionamide\n≥ 930 g/kg\n(Racemic mixture)\nRelevant impurity\nToluene: not more than 1,4 g/kg\n1 January 2011\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 napropamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\noperator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary,\nprotection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,\nconsumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’.\nThe Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants.\n311\nQuinmerac\nCAS No 90717-03-6\nCIPAC No 563\n7-chloro-3-methylquinoline-8-carboxylic acid\n≥ 980 g/kg\n1 May 2011\n30 April 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 quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.\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 dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops\nthe risk to aquatic organisms and the long term risk for earthworms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of information as regards:\nthe potential of plant metabolism to result in an opening of the quinoline ring;\nresidues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5.\nThey shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013.\n312\nMetosulam\nCAS No 139528-85-1\nCIPAC No 707\n2′,6′-dichloro-5,7-dimethoxy-3′-methyl[1,2,4]triazolo\n[1,5-a]pyrimidine-2-sulfonanilide\n≥ 980 g/kg\n1 May 2011\n30 April 2021\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 metosulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.\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 risk to aquatic organisms;\nthe risk to non-target plants in the off-field area.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the applicant submits to the Commission, by 30 October 2011, further information on the specification of the active substance as manufactured.\nThe Member States concerned shall ensure that the applicant submits to the Commission, by 30 April 2013, confirmatory information as regards:\npotential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02;\npotential genotoxicity of one impurity.\n313\nPyridaben\nCAS No 96489-71-3\nCIPAC No 583\n2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one\n>980 g/kg\n1 May 2011\n30 April 2023\nPART A\nOnly uses as insecticide and acaricide 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 pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,\nthe risk to aquatic organisms and mammals,\nthe risk to non target arthropods including honeybees.\nConditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\nthe risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,\nthe potential long term risk for mammals,\nthe assessment of fat soluble residues.\nThey shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.\n314\nZinc phosphide\nCAS No 1314-84-7\nCIPAC No 69\nTrizinc diphosphide\n≥ 800 g/kg\n1 May 2011\n30 April 2024\nPART A\nOnly uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations 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 zinc phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.\nIn this overall assessment Member States should pay particular attention to:\nthe protection of non target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed.\n315\nFenbuconazole\nCAS No 114369-43-6\nCIPAC No 694\n(R,S) 4-(4-chlorophenyl)-2-phenyl-2-(1H-1,2,4-triazol-1-ylmethyl)butyronitrile\n≥ 965 g/kg\n1 May 2011\n30 April 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 fenbuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,\nthe dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs),\nthe risk to aquatic organisms and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory data on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin.\nThey shall ensure that the applicant provides such studies to the Commission by 30 April 2013.\nThe Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of fenbuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.\n316\nCycloxydim\nCAS No 101205-02-1\nCIPAC No 510\n(5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)-thian-3-yl]cyclohex-2-en-1-one\n≥ 940 g/kg\n1 June 2011\n31 May 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 cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the risk to non-target plants.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products.\nThe Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013.\n317\n6-Benzyladenine\nCAS No 1214-39-7\nCIPAC No 829\nN6-benzyladenine\n≥ 973 g/kg\n1 June 2011\n31 May 2024\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 6-benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate.\n318\nBromuconazole\nCAS No 116255-48-2\nCIPAC No 680\n1-[(2RS,4RS:2RS,4SR)-4-bromo-2-(2,4-dichlorophenyl)tetrahydrofurfuryl]-1H-1,2,4-triazole\n≥ 960 g/kg\n1 February 2011\n31 January 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 bromuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.\nIn this overall assessment, Member States shall pay particular attention to:\noperator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;\nprotection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones.\nThe Member States concerned shall ensure that the applicant presents to the Commission:\nfurther information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;\ninformation to further address the long term risk to herbivorous mammals.\nThey shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31 January 2013 at the latest.\nThe Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.\n319\nMyclobutanil\nCAS No 88671-89-0\nCIPAC No 442\nRS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile\n≥ 925 g/kg\nThe impurity 1-methylpyrrolidin-2-one shall not exceed 1 g/kg in the technical material\n1 June 2011\n31 May 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 myclobutanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition.\nThe Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.\n320\nBuprofezin\nCAS No 953030-84-7\nCIPAC No 681\n(Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one\n≥ 985 g/kg\n1 February 2011\n31 January 2023\nPART A\nOnly uses as insecticide and acaricide on non-edible crops 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 buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.\nIn this overall assessment, Member States must pay particular attention to:\nthe operators' and workers' safety and ensure that conditions of use impose the use of adequate personal protective equipment where appropriate,\nthe application of an appropriate waiting period for rotational crops in greenhouses,\nthe risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\n321\nTriflumuron\nCAS No 64628-44-0\nCIPAC No: 548\n1-(2-chlorobenzoyl)-3-[4-trifluoromethoxyphenyl]urea\n≥ 955 g/kg\nImpurities:\nN,N′-bis-[4-(trifluoromethoxy)phenyl]urea: not more than 1 g/kg\n4-trifluoro-methoxyaniline: not more than 5 g/kg\n1 April 2011\n31 March 2021\nPART A\nOnly uses as insecticide 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 triflumuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment, Member States shall pay particular attention to:\nthe protection of the aquatic environment;\nthe protection of honey bees. Conditions of authorisation shall include risk mitigation measures, where appropriate.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards the long-term risk to birds, the risk to aquatic invertebrates and the risk to bee brood development.\nThe Member States concerned shall ensure that the applicant submits such information to the Commission by 31 March 2013.\n322\nHymexazol\nCAS No 10004-44-1\nCIPAC No 528\n5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol)\n≥985 g/kg\n1 June 2011\n31 May 2023\nPART A\nOnly uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities 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 hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate,\nthe risk to granivorous birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals.\nThe Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.\n323\nDodine\nCAS No 2439-10-3\nCIPAC No 101\n1-dodecylguanidinium acetate\n≥ 950 g/kg\n1 June 2011\n31 May 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 dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe potential long-term risk to birds and mammals;\nthe risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures;\nthe risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures;\nthe monitoring of residue levels in pome fruit.\nThe Member States concerned shall request the submission of confirmatory information as regards:\nlong-term risk assessment for birds and mammals,\nrisk assessment in natural surface water systems where major metabolites have potentially formed.\nThe Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.\n324\nDiethofencarb\nCAS No 87130-20-9\nCIPAC No 513\nisopropyl 3,4-diethoxycarbanilate\n≥ 970 g/kg\nImpurities:\nToluene: not more than 1 g/kg\n1 June 2011\n31 May 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 diethofencarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target arthropods and shall ensure that conditions of use include the application of adequate risk mitigation measures.\nThe Member States concerned shall request the submission of confirmatory information as regards:\nthe potential uptake of the metabolite 6-NO2-DFC in succeeding crops;\nthe risk assessment for non-target arthropod species.\nThe Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.\n325\nEtridiazole\nCAS No 2593-15-9\nCIPAC No 518\nethyl-3-trichloromethyl-1,2,4-thiadiazol-5-yl ether\n≥ 970 g/kg\n1 June 2011\n31 May 2021\nPART A\nOnly uses as fungicide in non-soil bound systems in greenhouse may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing etridiazole for uses other than on ornamental plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorization is granted.\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 etridiazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the risk to operators and workers and ensure that conditions of use include the application of appropriate risk mitigation measures;\nensure that appropriate waste management practices are applied as regards waste water from irrigation of non-soil bound growing systems; Member States permitting the release of waste water into the sewage system or into natural water bodies, shall ensure that an appropriate risk assessment is carried out;\npay particular attention to the risk to aquatic organisms and ensure that conditions of use include the application of appropriate risk mitigation measures.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n1..the specification of the technical material, as commercially manufactured, by appropriate analytical data;\n2..the relevance of the impurities;\n3..the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the ecotoxicity dossiers;\n4..the relevance of the plant metabolites 5-hydroxy-ethoxyetridiazole acid and 3-hydroxymethyletridiazole;\n5..indirect exposure of groundwater and soil-dwelling organisms to etridiazole and to its soil metabolites dichloro-etridiazole and etridiazole acid;\n6..long-range and short-range transport through the atmosphere of etridiazole acid.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 30 November 2011 and the information set out in points (4), (5) and (6) by 31 May 2013.\n326\nIndolylbutyric acid\nCAS No 133-32-4\nCIPAC No 830\n4-(1H-indol-3-yl)butyric acid\n≥ 994 g/kg\n1 June 2011\n31 May 2023\nPART A\nOnly uses as plant growth regulator in ornamentals 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 indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the operators and workers safety. Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure.\nThe Member States concerned shall request the submission of further information to confirm:\nthe absence of clastogenicity potential of indolylbutyric acid;\nthe vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study;\nthe natural background concentration of indolylbutyric acid in the soil.\nThe Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.\n327\nOryzalin\nCAS No 19044-88-3\nCIPAC No 537\n3,5-dinitro-N4,N4-dipropylsulfanilamide\n≥ 960 g/kg\nN-nitrosodipropylamine:\n≤ 0,1 mg/kg\nToluene: ≤ 4 g/kg\n1 June 2011\n31 May 2021\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 oryzalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe operator safety and ensure that conditions of use include the application of adequate personal protective equipment;\nthe protection of aquatic organisms and non target plants;\nthe protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to herbivorous birds and mammals;\nthe risk to bees, in the flowering season.\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 metabolites OR13 and OR15 in vulnerable zones, where appropriate.The Member States concerned shall request the submission of 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 which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12;\n(2)the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;\n(3)the risk assessment for aquatic organisms;\n(4)the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, if oryzalin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013. The information set out in point (4) shall be submitted within six month of notification of a decision classifying oryzalin.\n328\nTau-fluvalinate\nCAS No 102851-06-9\nCIPAC No 786\n(RS)-α-cyano-3-phenoxybenzyl N-(2-chloro- α,α α- trifluoro-p-tolyl)-D-valinate\n(Isomer ratio 1:1)\n≥ 920 g/kg\n(1:1 ratio of R-α-cyano and S-α-cyano isomers)\nImpurities:\nToluene: not more than 5 g/kg\n1 June 2011\n31 May 2024\nPART A\nOnly uses as insecticide and acaricide 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 tau-fluvalinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures;\nthe risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures;\nthe test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured.\nThe Member States concerned shall request the submission of confirmatory information as regards:\nthe risk of bioaccumulation/biomagnification in the aquatic environment;\nthe risk to non-target arthropods;\nThe Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.\nThe Member States concerned shall ensure that the applicant submits confirmatory information, two years after the adoption of specific guidance, as regards:\nthe possible impact on the environment of the potential enantio-selective degradation in environmental matrices.\n329\nClethodim\nCAS No 99129-21-2\nCIPAC No 508\n(5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one\n≥ 930 g/kg\nImpurities:\ntoluene max. 4 g/kg\n1 June 2011\n31 May 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 clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 December 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures.\nThe Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards:\nthe soil and groundwater exposure assessments,\nthe residue definition for risk assessment.\nThe Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013 .\n330\nBupirimate\nCAS No 41483-43-6\nCIPAC No 261\n5-butyl-2-ethylamino-6-methylpyrimidine-4-yl dimethylsulfamate\n≥ 945 g/kg\nImpurities:\nEthirimol: max. 2 g/kg\nToluene: max. 3 g/kg\n1 June 2011\n31 May 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 bupirimate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigations, where appropriate,\nthe in-field risk to non-target arthropods.\nThe Member States concerned shall request the submission of 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 those of the test material used in the toxicity dossiers,\n(3)the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B.\nThe Member States concerned shall ensure that the applicant submits such confirmatory data and information to the Commission set out in point (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013.\n332\nFenoxycarb\nCAS No 79127-80-3\nCIPAC No: 425\nEthyl 2-(4-phenoxyphenoxy)ethyl carbamate\n≥ 970 g/kg\nImpurities:\nToluene: max. 1 g/kg\n1 June 2011\n31 May 2021\nPART A\nOnly uses as insecticide 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 fenoxycarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,\nthe risk to bees and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of information confirming the risk assessment for non-target arthropods and for bee brood.\nThe Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.\n333\n1-decanol\nCAS No 112-30-1\nCIPAC No 831\nDecan-1-ol\n≥ 960 g/kg\n1 June 2011\n31 May 2024\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-decanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to consumers from residues in case of use on food or feed crops;\nthe risk for operator and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;\nthe protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to aquatic organisms;\nthe risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application.\nRisk mitigation measures shall be applied, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information, as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments.\nThe Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.\n334\nIsoxaben\nCAS No 82558-50-7\nCIPAC No 701\nN-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide\n≥ 910 g/kg\nToluene: ≤ 3 g/kg\n1 June 2011\n31 May 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 isoxaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, the risk to non-target terrestrial plants and the potential leaching of metabolites to groundwater.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a)the specification of the technical material, as commercially manufactured,\n(b)the relevance of the impurities;\n(c)the residues in rotational crops;\n(d)the potential risk to aquatic organisms.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a) and (b) by 30 November 2011 and the information set out in points (c) and (d) by 31 May 2013.\n335\nFluometuron\nCAS No: 2164-17-2\nCIPAC No: 159\n1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea\n≥ 940 g/kg\n1 June 2011\n31 May 2024\nPART A\nOnly uses as herbicide on cotton 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 fluometuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;\npay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate;\npay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards:\n(a)the toxicological properties of the plant metabolite trifluoroacetic acid;\n(b)the analytical methods for the monitoring of fluometuron in air;\n(c)the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water;\n(d)the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.\nThe Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within six months from the notification of the decision classifying fluometuron.\n336\nCarbetamide\nCAS No 16118-49-3\nCIPAC No 95\n(R)-1-(Ethylcarbamoyl)ethyl carbanilate\n≥ 950 g/kg\n1 June 2011\n31 May 2021\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 carbetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\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 non-target plants;\n(c)the risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\n337\nCarboxin\nCAS No 5234-68-4\nCIPAC No 273\n5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide\n≥ 970 g/kg\n1 June 2011\n31 May 2021\nPART A\nOnly uses as fungicide for seed treatment may be authorised.\nMember States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.\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 carboxin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to operators;\nthe protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to birds and mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a)the specification of the technical material, as commercially manufactured, -including appropriate analytical data-;\n(b)the relevance of the impurities;\n(c)comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;\n(d)analytical methods for the monitoring of the metabolite M6 in soil, groundwater and surface water and for the monitoring of metabolite M9 in groundwater;\n(e)additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 and P/V-55,\n(f)rotational crop metabolism,\n(g)the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals;\n(h)the relevance for ground water of the soil metabolites P/V-54, P/V-55 and M9 if carboxin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a), (b) and (c) by 30 November 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) six months after the notification of decision classifying carboxin.\n338\nCyproconazole\nCAS No 94361-06-5\nCIPAC No 600\n(2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol\n≥ 940 g/kg\n1 June 2011\n31 May 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 cyproconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);\nthe risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a)the toxicological relevance of the impurities in the technical specification;\n(b)analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues;\n(c)residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;\n(d)the long term risk to herbivorous mammals;\n(e)the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b), (c) and (d) by 31 May 2013 and the information set out in point (e) two years after the adoption of specific guidance.\n339\nDazomet\nCAS No 533-74-4\nCIPAC No 146\n3,5-dimethyl-1,3,5-thiadiazinane-2-thione\nor\ntetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione\n≥ 950 g/kg\n1 June 2011\n31 May 2023\nPART A\nOnly uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year.\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 dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to operators, workers and bystanders;\nthe protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\nthe risk to aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a)the potential groundwater contamination by methyl isothiocyanate;\n(b)the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks;\n(c)the acute risk to insectivorous birds;\n(d)the long term risk to birds and mammals.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.\n340\nMetaldehyde\nCAS No 108-62-3 (tetramer)\n9002-91-9 (homopolymer)\nCIPAC No 62\nr-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane\n≥ 985 g/kg\nacetaldehyde max. 1,5 g/kg\n1 June 2011\n31 May 2023\nPART A\nOnly uses as molluscicide 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 metaldehyde, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe risk to operators and workers;\nthe dietary exposure situation of consumers in view of future revisions of maximum residue levels;\nthe acute risk and long term risk to birds and mammals.\nMember States shall ensure that authorisations shall contain an effective dog repellent agent.\nConditions of use shall include risk mitigation measures, where appropriate.\n341\nSintofen\nCAS No 130561-48-7\nCIPAC No 717\n1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid\n≥ 980 g/kg\nImpurities:\n2-methoxyethanol, not more than 0,25 g/kg\nN,N-dimethylformamide, not more than 1,5 g/kg\n1 June 2011\n31 May 2024\nPART A\nOnly uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption 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 sintofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(1)the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;\n(2)the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide;\n(3)the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material;\n(4)the metabolic profile of sintofen in rotational crops.\nThe Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 30 November 2011 and the information set out in point (4) by 31 May 2013.\n342\nFenazaquin\nCAS No 120928-09-8\nCIPAC No 693\n4-tert-butylphenethyl quinazolin-4-yl ether\n≥ 975 g/kg\n1 June 2011\n31 May 2023\nPART A\nOnly uses as acaricide 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 fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 , and of the addendum to the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 22 March 2018 , shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n(a) the protection of aquatic organisms;\n(b) the protection of operators, also ensuring that the conditions of the use include the application of adequate personal protective equipment;\n(c) the protection of bees;\n(d) the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;\n(e) the risk to consumers, in particular from the residues generated during processing;\n(f) the conditions of use to avoid exposure to residues of fenazaquin with respect to crops for human and animal consumption.\nConditions of use shall include risk mitigation measures, where appropriate.\n343\nAzadirachtin\nCAS No 11141-17-6 (azadirachtin A)\nCIPAC No 627 (azadirachtin A)\nAzadirachtin A:\ndimethyl (2aR,3S,4S,4aR,5S,7aS,8S,10R,10aS,10bR)-10-acetoxy-3,5-dihydroxy-4-[(1aR,2S,3aS,6aS,7S,7aS)-6a-hydroxy-7a-methyl-3a,6a,7,7a-tetrahydro-2,7-methanofuro[2,3-b]oxireno[e]oxepin-1a(2H)-yl]-4-methyl-8-{[(2E)-2-methylbut-2-enoyl]oxy}octahydro-1H-naphtho[1,8a-c:4,5-b′c′]difuran-5,10a(8H)-dicarboxylate.\nExpressed as azadirachtin A:\n≥ 111 g/kg\nSum of the aflatoxins B1, B2, G1, G2 must not exceeding 300 μg/kg of the azadirachtin A content.\n1 June 2011\n31 May 2024\nPART A\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 azadirachtin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 and of the addendum to the review report on azadirachtin, and in particular Appendices I and II thereto, as finalised by the Standing Committee on Plants, Animals, Food and Feed on 17 July 2020 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n(1) the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;\n(2) the protection of non-target arthropods and aquatic organisms.\nConditions of use shall include risk mitigation measures, where appropriate.\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 azadirachtin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe dietary exposure of consumers in view of future revisions of Maximum Residue Levels;\nthe protection of non target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\nthe relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment.\nThe Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013.\n344\nDiclofop\nCAS No 40843-25-2 (parent)\nCAS No 257-141-8 (diclofop-methyl)\nCIPAC No 358 (parent)\nCIPAC No 358.201 (diclofop-methyl)\nDiclofop\n(RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acid\nDiclofop-methyl\nmethyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate\n≥ 980 g/kg (expressed as diclofop-methyl)\n1 June 2011\n31 May 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 diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment;\npay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a)a metabolism study on cereals;\n(b)an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest two years after the adoption of a specific guidance document on evaluation of isomers mixtures.\n345\nLime sulphur\nCAS No 1344 - 81 - 6\nCIPAC No 17\nCalcium polysulfide\n≥ 290 g/Kg.\n1 June 2011\n31 May 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 lime sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\noperator safety and shall ensure that the conditions of authorisation include appropriate protective measures;\nto the protection of aquatic organisms and non target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate.\n346\nAluminium sulfate\nCAS No 10043-01-3\nCIPAC not available\nAluminium sulfate\n970 g/kg\n1 June 2011\n31 May 2024\nPART A\nOnly indoor uses as post-harvest bactericide for ornamental plants 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 aluminium sulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nThe Member States concerned shall request the submission of confirmatory information as regards the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data.\nThe Member States concerned shall ensure that the applicant submits such information to the Commission by 30 November 2011.\n347\nBromadiolone\nCAS No 28772-56-7\nCIPAC No 371\n3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin\n≥ 970 g/kg\n1 June 2011\n31 May 2021\nPART A\nOnly uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels may be authorised.\nThe nominal concentration of the active substance in the plant protection products shall not exceed 50 mg/kg.\nAuthorisations shall be granted for uses by professional users only.\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 bromadiolone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the risk to professional operators and ensure that conditions of use include the application of adequate personal protective equipment where appropriate;\npay particular attention to the risk to birds and non-target mammals from primary and secondary poisoning.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a)the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data;\n(b)the relevance of the impurities;\n(c)the determination of bromadiolone in water with a limit of quantification of 0,01 μg/l;\n(d)the effectiveness of proposed mitigation measures to reduce risk to birds and non-target mammals;\n(e)the groundwater exposure assessment in respect of metabolites.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 30 November 2011 and the information set out in points (d) and (e) by 31 May 2013.\n348\nPaclobutrazol\nCAS No 76738-62-0\nCIPAC No 445\n(2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol\n≥ 930 g/kg\n1 June 2011\n31 May 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 paclobutrazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(1)the specification of the technical material, as commercially manufactured;\n(2)the analytical methods in soil and surface water for the metabolite NOA457654;\n(3)the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;\n(4)the potential endocrine disrupting properties of paclobutrazol;\n(5)the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance.\n349\nPencycuron\nCAS No 66063-05-6\nCIPAC No 402\n1-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea\n≥ 980 g/kg\n1 June 2011\n31 May 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 pencycuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to the protection of large omnivorous mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(1)the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of pencycuron;\n(2)the fate and behaviour in natural surface water and sediment systems of the chlorophenyl and phenyl portions of pencycuron;\n(3)the long-term risk to large omnivorous mammals.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 31 May 2013.\n350\nTebufenozide\nCAS No 112410-23-8\nCIPAC No 724\nN-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide\n≥ 970 g/kg\nRelevant impurity\nt-butyl hydrazine < 0,001 g/kg\n1 June 2011\n31 May 2024\nPART A\nOnly uses as insecticide 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 tebufenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment;\npay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\npay particular attention to the protection of aquatic organism and ensure that conditions of use prescribe adequate mitigation measures;\npay particular attention to the risk to Lepidoptera non-target insects.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information, as regards:\n(1)the relevance of metabolites RH-6595, RH-2651, M2;\n(2)the degradation of tebufenozide in anaerobic soils and soils of alkaline pH.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013.\n351\nDithianon\nCAS No 3347-22-6\nCIPAC No 153\n5,10-dihydro-5,10-dioxonaphtho[2,3-b]-1,4-dithiine-2,3-dicarbonitrile\n≥ 930 g/kg\n1 June 2011\n31 May 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 dithianon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the protection of aquatic organisms; conditions of use shall include risk mitigation measures, where appropriate,\npay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate,\npay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\nthe storage stability and the nature of residues in processed products,\nthe aquatic and groundwater exposure assessment for phthalic acid,\nthe risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.\nThe Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.\n352\nHexythiazox\nCAS No 78587-05-0\nCIPAC No 439\n(4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide\n≥ 976 g/kg\n(1:1 mixture of (4R, 5R) and (4S, 5S))\n1 June 2011\n31 May 2024\nPART A\nOnly uses as acaricide 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 hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\nthe protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate;\nthe operators and workers safety. Conditions of use shall include protective measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a)the toxicological relevance of the metabolite PT-1-3;\n(b)the potential occurrence of the metabolite PT-1-3 in processed commodities;\n(c)the potential adverse effects of hexythiazox on bee brood;\n(d)the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) two years after the adoption of specific guidance.\n353\nFlutriafol\nCAS No 76674-21-0\nCIPAC No 436\n(RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol\n≥ 920 g/kg\n(racemate)\nRelevant impurities:\ndimethyl sulphate: max content 0,1 g/kg\ndimethylformamide: max content 1 g/kg\nmethanol: max content 1 g/kg\n1 June 2011\n31 May 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 flutriafol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the protection of the workers’ safety and ensure that conditions of use include the application of adequate personal protective equipment;\npay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;\npay particular attention to the long-term risk to insectivorous birds.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:\n(a)the relevance of the impurities present in the technical specifications;\n(b)the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;\n(c)the long-term risk to insectivorous birds.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b) and (c) by 31 May 2013.\n354\nFlurochloridone\nCAS No 61213-25-0\nCIPAC No 430\n(3RS,4RS;3RS,4SR)-3-chloro-4-chloromethyl-1-(α,α,α-trifluoro-m-tolyl)-2-pyrrolidone\n≥ 940 g/kg.\nRelevant impurities:\nToluene: max 8 g/kg\n1 June 2011\n31 May 2021\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 flurochloridone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 February 2011 shall be taken into account.\nIn this overall assessment Member States shall pay particular attention to:\n1.. the risk for non-target plants and aquatic organisms;\n2.. the protection of the 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 ensure that the applicant submits to the Commission further confirmatory information as regards:\n1.. the relevance of impurities other than toluene;\n2.. the compliance of ecotoxicological test material with the technical specifications;\n3.. the relevance of the groundwater metabolite R42819 ;\n4.. the potential endocrine disrupting properties of flurochloridone.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 1 December 2011 , the information set out in point (3) by 31 May 2013 and the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted 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 1100/2011 of 31 October 2011 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances dicamba, difenoconazole, and imazaquin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Inserted by Commission Implementing Regulation (EU) No 369/2012 of 27 April 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Inserted by Commission Implementing Regulation (EU) 2017/270 of 16 February 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sulfuryl fluoride (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Deleted 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": "F6",
      "text": "Deleted 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": "F7",
      "text": "Deleted 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": "F8",
      "text": "Deleted 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": "F9",
      "text": "Deleted 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": "F10",
      "text": "Deleted 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": "F11",
      "text": "Deleted by Commission Implementing Regulation (EU) 2016/139 of 2 February 2016 renewing the approval of the active substance metsulfuron-methyl, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Deleted 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": "F13",
      "text": "Deleted by Commission Implementing Regulation (EU) 2016/864 of 31 May 2016 concerning the non-renewal of approval of the active substance triasulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Deleted by Commission Implementing Regulation (EU) 2015/2047 of 16 November 2015 renewing the approval of the active substance esfenvalerate, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F15",
      "text": "Deleted 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": "F16",
      "text": "Deleted by Commission Implementing Regulation (EU) 2016/146 of 4 February 2016 renewing the approval of the active substance lambda-cyhalothrin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F17",
      "text": "Deleted 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": "F18",
      "text": "Deleted by Commission Implementing Regulation (EU) 2016/871 of 1 June 2016 concerning the non-renewal of approval of the active substance amitrole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F19",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1532 of 12 October 2018 concerning the non-renewal of approval of the active substance diquat, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F20",
      "text": "Deleted 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": "F21",
      "text": "Deleted 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": "F22",
      "text": "Deleted by Commission Implementing Regulation (EU) 2015/306 of 26 February 2015 renewing the approval of the active substance Isaria fumosorosea strain Apopka 97 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F23",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/1496 of 23 August 2017 concerning the non-renewal of approval of the active substance DPX KE 459 (flupyrsulfuron-methyl), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F24",
      "text": "Deleted 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": "F25",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1022/2011 of 14 October 2011 concerning the non-renewal of the approval of the active substance cyclanilide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F26",
      "text": "Deleted by Commission Implementing Regulation (EU) 2015/1166 of 15 July 2015 renewing the approval of the active substance ferric phosphate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F27",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1501 of 9 October 2018 concerning the non-renewal of approval of the active substance pymetrozine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F28",
      "text": "Deleted 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": "F29",
      "text": "Deleted 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": "F30",
      "text": "Deleted 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": "F31",
      "text": "Deleted 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": "F32",
      "text": "Deleted by Commission Implementing Regulation (EU) 2016/872 of 1 June 2016 concerning the non-renewal of approval of the active substance isoproturon, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F33",
      "text": "Deleted 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": "F34",
      "text": "Deleted 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": "F35",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/375 of 2 March 2017 renewing the approval of the active substance prosulfuron, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F36",
      "text": "Deleted 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": "F37",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1134/2011 of 9 November 2011 concerning the non-renewal of the approval of the active substance cinidon-ethyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F38",
      "text": "Deleted 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": "F39",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/869 of 24 June 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, dimethomorph, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and S-metolachlor (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F40",
      "text": "Deleted 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": "F41",
      "text": "Deleted 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": "F42",
      "text": "Deleted 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": "F43",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/1511 of 16 October 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, picloram, prosulfocarb, sulphur, triflusulfuron and tritosulfuron (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F44",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/1531 of 7 September 2017 renewing the approval of the active substance imazamox, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F45",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1019 of 18 July 2018 concerning the non-renewal of approval of the active substance oxasulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F46",
      "text": "Deleted 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": "F47",
      "text": "Deleted 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": "F48",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/892 of 29 June 2020 concerning the non-renewal of the approval of the active substance beta-cyfluthrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F49",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/2091 of 14 November 2017 concerning the non-renewal of approval of the active substance iprodione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F50",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/244 of 10 February 2017 concerning the non-renewal of approval of the active substance linuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F51",
      "text": "Deleted 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": "F52",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/1114 of 22 June 2017 renewing the approval of the active substance pendimethalin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F53",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/309 of 1 March 2018 concerning the non-renewal of approval of the active substance propineb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F54",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/755 of 23 May 2018 renewing the approval of the active substance propyzamide, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F55",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/2094 of 29 November 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mancozeb, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F56",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1865 of 28 November 2018 concerning the non-renewal of approval of the active substance propiconazole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F57",
      "text": "Deleted 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": "F58",
      "text": "Deleted 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": "F59",
      "text": "Deleted 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": "F60",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1043 of 24 July 2018 concerning the non-renewal of approval of the active substance fenamidone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F61",
      "text": "Deleted 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": "F62",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1917 of 6 December 2018 concerning the non-renewal of approval of the active substance flurtamone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F63",
      "text": "Deleted 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": "F64",
      "text": "Deleted 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": "F65",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/1455 of 10 August 2017 concerning the non-renewal of approval of the active substance picoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F66",
      "text": "Deleted 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": "F67",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/842 of 17 May 2017 renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F68",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1500 of 9 October 2018 concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F69",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/421 of 18 March 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘Verticillium lecanii’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F70",
      "text": "Deleted 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": "F71",
      "text": "Deleted 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": "F72",
      "text": "Deleted 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": "F73",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/989 of 17 June 2019 concerning the non-renewal of approval of the active substance chlorpropham, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F74",
      "text": "Deleted 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": "F75",
      "text": "Deleted 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": "F76",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1914 of 6 December 2018 concerning the non-renewal of approval of the active substance quinoxyfen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F77",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/1690 of 9 October 2019 renewing the approval of the active substance alpha-cypermethrin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F78",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/1280 of 14 September 2020 concerning the non-renewal of the approval of the active substance benalaxyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F79",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/1276 of 11 September 2020 concerning the non-renewal of the approval of the active substance bromoxynil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F80",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/1100 of 27 June 2019 concerning the non-renewal of approval of the active substance desmedipham, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F81",
      "text": "Deleted 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": "F82",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/23 of 13 January 2020 concerning the non-renewal of the approval of the active substance thiacloprid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F83",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1075 of 27 July 2018 renewing the approval of the active substance Ampelomyces quisqualis strain AQ10, as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F84",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1197/2012 of 13 December 2012 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F85",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/112 of 24 January 2018 renewing the approval of the low-risk active substance laminarin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F86",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/158 of 31 January 2019 renewing the approval of the active substance methoxyfenozide, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F87",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/151 of 30 January 2019 renewing the approval of the active substance Clonostachys rosea strain J1446 as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F88",
      "text": "Substituted by Commission Implementing Regulation (EU) 2015/58 of 15 January 2015 amending Implementing Regulation (EU) No 540/2011 as regards the expiry date of the approval of the active substance tepraloxydim (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F89",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F90",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/1498 of 15 October 2020 concerning the non-renewal of approval of the active substance thiophanate-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F91",
      "text": "Deleted 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": "F92",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/18 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F93",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/17 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F94",
      "text": "Substituted by Commission Implementing Regulation (EU) 2016/2035 of 21 November 2016 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances fipronil and maneb (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F95",
      "text": "Deleted 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": "F96",
      "text": "Deleted 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": "F97",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/84 of 19 January 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F98",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/784 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F99",
      "text": "Deleted 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": "F100",
      "text": "Deleted 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": "F101",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1166/2013 of 18 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance dichlorprop-P (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F102",
      "text": "Substituted by Commission Implementing Regulation (EU) 2015/307 of 26 February 2015 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triclopyr (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F103",
      "text": "Substituted by Commission Implementing Regulation (EU) 2015/1396 of 14 August 2015 correcting Implementing Regulation (EU) No 540/2011 as regards the active substance Bacillus subtilis (Cohn 1872) strain QST 713, identical with strain AQ 713 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F104",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F105",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/785 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance thiamethoxam (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F106",
      "text": "Deleted by Commission Implementing Regulation (EU) 2020/1246 of 2 September 2020 concerning the non-renewal of the approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F107",
      "text": "Substituted by Commission Implementing Regulation (EU) No 542/2011 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 to take into account Directive 2011/58/EU amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F108",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/1606 of 27 September 2019 concerning the non-renewal of the approval of the active substance methiocarb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F109",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/1090 of 26 June 2019 concerning the non-renewal of approval of the active substance dimethoate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F110",
      "text": "Substituted by Commission Implementing Regulation (EU) 2015/404 of 11 March 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, captan, dimethoate, dimethomorph, ethoprophos, fipronil, folpet, formetanate, glufosinate, methiocarb, metribuzin, phosmet, pirimiphos-methyl and propamocarb (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F111",
      "text": "Substituted by Commission Implementing Regulation (EU) No 365/2013 of 22 April 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glufosinate (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F112",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/344 of 28 February 2019 concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F113",
      "text": "Substituted by Commission Implementing Regulation (EU) No 781/2013 of 14 August 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this active substance (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F114",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/706 of 7 May 2019 renewing the approval of the active substance carvone in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F115",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1100/2011 of 31 October 2011 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances dicamba, difenoconazole, and imazaquin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F116",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/1589 of 26 September 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, beta-cyfluthrin, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflubenzuron, diflufenican, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, picloram, prosulfocarb, pyriproxyfen, thiophanate-methyl, triflusulfuron and tritosulfuron (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F117",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/855 of 18 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance diflubenzuron (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F118",
      "text": "Deleted 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": "F",
      "label": "F119",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1124/2013 of 8 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance bifenox (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F120",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/707 of 7 May 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, s-metolachlor and tebuconazole (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F121",
      "text": "Substituted by Commission Implementing Regulation (EU) No 880/2014 of 12 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Cydia pomonella Granulovirus (CpGV) (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F122",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/1003 of 9 July 2020 renewing the approval of the active substances Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3 as low-risk substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F123",
      "text": "Deleted by Commission Implementing Regulation (EU) 2019/1675 of 4 October 2019 renewing the approval of the active substance Verticillium albo-atrum strain WCS850 as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F124",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/438 of 13 March 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance abamectin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F125",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/168 of 31 January 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F126",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/195 of 3 February 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of several active substances listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012 (AIR IV renewal programme) (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F127",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/1643 of 5 November 2020 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances calcium phosphide, denathonium benzoate, haloxyfop-P, imidacloprid, pencycuron and zeta-cypermethrin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F128",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/783 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance imidacloprid (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F129",
      "text": "Substituted by Commission Implementing Regulation (EU) No 127/2012 of 14 February 2012 amending Implementing Regulation (EU) No 540/2011 as regards an extension of the use of the active substance metazachlor (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F130",
      "text": "Substituted by Commission Implementing Regulation (EU) No 790/2013 of 19 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance acetic acid (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F131",
      "text": "Substituted by Commission Implementing Regulation (EU) No 597/2012 of 5 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F132",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/1160 of 5 August 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, blood meal, calcium carbonate, carbon dioxide, extract from tea tree, fat distillation residues, fatty acids C7 to C20, garlic extract, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, kieselgur (diatomaceous earth), plant oils/rape seed oil, potassium hydrogen carbonate, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F133",
      "text": "Substituted by Commission Implementing Regulation (EU) No 571/2012 of 28 June 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine) (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F134",
      "text": "Substituted by Commission Implementing Regulation (EU) No 369/2012 of 27 April 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F135",
      "text": "Substituted by Commission Implementing Regulation (EU) No 532/2013 of 10 June 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance carbon dioxide (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F136",
      "text": "Substituted by Commission Implementing Regulation (EU) No 608/2012 of 6 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F137",
      "text": "Substituted by Commission Implementing Regulation (EU) No 187/2013 of 5 March 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance ethylene (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F138",
      "text": "Substituted by Commission Implementing Regulation (EU) No 154/2014 of 19 February 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance extract from tea tree (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F139",
      "text": "Substituted by Commission Implementing Regulation (EU) No 637/2012 of 13 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F140",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1089/2013 of 4 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance kieselgur (diatomaceous earth) (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F141",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/781 of 5 May 2017 withdrawing the approval of the active substance methyl nonyl ketone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F142",
      "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": "F143",
      "text": "Substituted by Commission Implementing Regulation (EU) No 504/2014 of 15 May 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/citronella oil (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F144",
      "text": "Substituted by Commission Implementing Regulation (EU) No 141/2014 of 13 February 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/clove oil (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F145",
      "text": "Substituted by Commission Implementing Regulation (EU) No 1150/2013 of 14 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance rape seed oil (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F146",
      "text": "Substituted by Commission Implementing Regulation (EU) No 735/2012 of 14 August 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance potassium hydrogen carbonate (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F147",
      "text": "Substituted by Commission Implementing Regulation (EU) No 798/2013 of 21 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance pyrethrins (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F148",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/1186 of 3 July 2017 withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil crude, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F149",
      "text": "Deleted by Commission Implementing Regulation (EU) 2017/1125 of 22 June 2017 withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil pitch, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F150",
      "text": "Substituted by Commission Implementing Regulation (EU) No 190/2013 of 5 March 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sodium hypochlorite (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F151",
      "text": "Substituted by Commission Implementing Regulation (EU) No 918/2014 of 22 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Straight Chain Lepidopteran Pheromones (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F152",
      "text": "Deleted by Commission Implementing Regulation (EU) 2016/638 of 22 April 2016 withdrawing the approval of the active substance Z-13-hexadecen-11-yn-1-yl acetate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F153",
      "text": "Deleted by Commission Implementing Regulation (EU) 2016/636 of 22 April 2016 withdrawing the approval of the active substance Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F154",
      "text": "Substituted by Commission Implementing Regulation (EU) No 921/2014 of 25 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F155",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/555 of 24 March 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of several active substances listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012 (AIR IV renewal programme) (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F156",
      "text": "Deleted by Commission Implementing Regulation (EU) 2018/1981 of 13 December 2018 renewing the approval of the active substances copper compounds, as candidates for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F157",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/1530 of 7 September 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance quizalofop-p-tefuryl (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F158",
      "text": "Substituted by Commission Implementing Regulation (EU) No 287/2012 of 30 March 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triflusulfuron (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F159",
      "text": "Deleted by Commission Implementing Regulation (EU) No 175/2013 of 27 February 2013 amending Implementing Regulation (EU) No 540/2011 as regards the withdrawal of the approval of the active substance didecyldimethylammonium chloride (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F160",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/2104 of 15 December 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance paraffin oil (Text with EEA relevance)"
    },
    {
      "type": "F",
      "label": "F161",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/1527 of 6 September 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances cyflufenamid, fluopicolide, heptamaloxyloglucan and malathion (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F162",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/1495 of 8 October 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance malathion (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F163",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/2069 of 13 November 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances flonicamid (IKI-220), metalaxyl, penoxsulam and proquinazid (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F164",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/184 of 7 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F165",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/270 of 16 February 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sulfuryl fluoride (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F166",
      "text": "Substituted by Commission Implementing Regulation (EU) 2015/2233 of 2 December 2015 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance haloxyfop-P (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F167",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/670 of 30 April 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bromuconazole, buprofezin, haloxyfop-P and napropamide (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F168",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/1260 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances pyridaben, quinmerac and zinc phosphide (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F169",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/1266 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F170",
      "text": "Substituted by Commission Implementing Regulation (EU) 2017/360 of 28 February 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance buprofezin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F171",
      "text": "Substituted by Commission Implementing Regulation (EU) No 87/2012 of 1 February 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clethodim (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F172",
      "text": "Deleted by Commission Implementing Regulation (EU) No 486/2014 of 12 May 2014 withdrawing the approval of the active substance fenbutatin oxide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F173",
      "text": "Substituted by Commission Implementing Regulation (EU) 2018/690 of 7 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fenazaquin (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F174",
      "text": "Substituted by Commission Implementing Regulation (EU) 2020/1293 of 15 September 2020 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance azadirachtin (Text with EEA relevance)."
    },
    {
      "type": "X",
      "label": "X1",
      "text": "Inserted by Corrigendum to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (Official Journal of the European Union L 153 of 11 June 2011)."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Further details on identity and specification of active substances are provided in their review reports."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ L 353, 31.12.2008, p. 1."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "OJ L 300, 14.11.2009, p. 1 ."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "OJ L 54, 26.2.2011, p. 1 ."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 )."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( OJ L 139, 30.4.2004, p. 1 )."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide."
    },
    {
      "type": "footnote",
      "label": "f11",
      "text": "De-ethyl-bupirimate."
    },
    {
      "type": "footnote",
      "label": "f12",
      "text": "2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate."
    },
    {
      "type": "footnote",
      "label": "f13",
      "text": "(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide."
    },
    {
      "type": "footnote",
      "label": "f14",
      "text": "2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide."
    },
    {
      "type": "footnote",
      "label": "f15",
      "text": "2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide."
    },
    {
      "type": "footnote",
      "label": "f16",
      "text": "2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide."
    },
    {
      "type": "footnote",
      "label": "f17",
      "text": "2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide."
    },
    {
      "type": "footnote",
      "label": "f18",
      "text": "(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide."
    },
    {
      "type": "footnote",
      "label": "f19",
      "text": "(4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one."
    },
    {
      "type": "footnote",
      "label": "f20",
      "text": "R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/540/annex/1/part/A",
    "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."
}