Number Common name, identification numbers IUPAC name Purity (1) Date of approval Expiration of approval Specific provisions

21 Cyclanilide CAS No 113136-77-9 CIPAC No 586 Not available 960 g/kg 1 November 2001 31 October 2011 Only uses as a plant growth regulator may be authorised. The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

33 Cinidon-ethyl CAS No 142891-20-1 CIPAC No 598 (Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate 940 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions, — should pay particular attention to the protection of aquatic organisms. Conditions of authorisation must include risk mitigation measures, where appropriate.

39 Flumioxazine CAS No 103361-09-7 CICAP No 578 N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide 960 g/kg 1 January 2003 ►M360 30 June 2022 ◄ Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States: — must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate.

40 Deltamethrin CAS No 52918-63-5 CIPAC No 333 (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate 980 g/kg 1 November 2003 ►M370 31 October 2022 ◄ Only uses as insecticide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures, — should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, — must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.

43 Ethoxysulfuron CAS No 126801-58-9 CIPAC No 591 3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea 950 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. Member States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate.

45 Oxadiargyl CAS No 39807-15-3 CIPAC No 604 5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one 980 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate.

49 Cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 385 (RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate 920 g/kg 1 January 2004 31 December 2013 Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.

56 Mecoprop CAS No 7085-19-0 CIPAC No 51 (RS)-2-(4-chloro-o-tolyloxy)-propionic acid 930 g/kg 1 June 2004 31 May 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate.

57 Mecoprop-P CAS No 16484-77-8 CIPAC No 475 (R)-2-(4-chloro-o-tolyloxy)-propionic acid 860 g/kg 1 June 2004 ►M375 31 January 2023 ◄ Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

65 Flufenacet CAS No 142459-58-3 CIPAC No 588 4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide 950 g/kg 1 January 2004 ►M370 31 October 2022 ◄ Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of algae and aquatic plants, — should pay particular attention to the protection of operators. Risk mitigation measures should be applied where appropriate.

69 Fosthiazate CAS No 98886-44-3 CIPAC No 585 (RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate 930 g/kg 1 January 2004 ►M370 31 October 2022 ◄ Only uses as insecticide or nematicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions; — should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season; — should pay particular attention to the protection of non-target soil organisms. Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

72 Molinate CAS No 2212-67-1 CIPAC No 235 S-ethyl azepane-1-carbothioate; S-ethyl perhydroazepine-1-carbothioate; S-ethyl perhydroazepine-1-thiocarboxilate 950 g/kg 1 August 2004 31 July 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on molinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States should pay particular attention to the possibility of short-range transport of the active substance in air.

74 Ziram CAS No 137-30-4 CIPAC No 31 Zinc bis (dimethyldithiocarbamate) 950 g/kg (FAO-specification) Arsenic: maximum 250 mg/kg Water: maximum 1,5 % 1 August 2004 ►M356 30 April 2022 ◄ Only uses as fungicide or as repellent may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate, — Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels.

81 Pyraclostrobin CAS No 175013-18-0 CIPAC No 657 methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate 975 g/kg The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product. 1 June 2004 ►M375 31 January 2023 ◄ Only uses as fungicide or plant growth regulator may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of aquatic organisms, especially fish, — should pay particular attention to the protection of terrestrial arthropods and earthworms. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

87 Ioxynil CAS No 13684-83-4 CIPAC No 86 4- hydroxy- 3,5- di-iodobenzonitrile 960 g/kg 1 March 2005 28 February 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

88 Phenmedipham CAS No 13684-63-4 CIPAC No 77 methyl 3-(3-methylcarbaniloyloxy)carbanilate; 3-methoxycarbonylaminophenyl 3′-methylcarbanilate Min. 970 g/kg 1 March 2005 ►M360 31 July 2022 ◄ Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

89 Pseudomonas chlororaphis Strain: MA 342 CIPAC No 574 Not applicable The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l). 1 October 2004 ►M356 30 April 2022 ◄ Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised. When granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate.

90 Mepanipyrim CAS No 110235-47-7 CIPAC No 611 N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline 960 g/kg 1 October 2004 ►M356 30 April 2022 ◄ Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.

94 Imazosulfuron CAS No 122548-33-8 CIPAC No 590 1-(2-chloroimidazo[1,2-α]pyridin-3-ylsul-phonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea ≥ 980 g/kg 1 April 2005 ►M43 31. July 2017 ◄ Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic and terrestrial non-target plants. Risk mitigation measures should be applied where appropriate.

97 S-metolachlor CAS No 87392-12-9 (S-isomer) 178961-20-1 (R-isomer) CIPAC No 607 Mixture of: (aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %) and: (aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %) ≥ 960 g/kg 1 April 2005 ►M360 31 July 2022 ◄ Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate.

100 Tepraloxydim CAS No 149979-41-9 CIPAC No 608 (EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one ≥ 920 g/kg 1 June 2005 ►M134 31. May 2015 ◄ Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods. Risk mitigation measures should be applied where appropriate.

102 Chlorotoluron (unstated stereochemistry) CAS No 15545-48-9 CIPAC No 217 3-(3-chloro-p-tolyl)-1,1-dimethylurea 975 g/kg 1 March 2006 ►M370 31 October 2022 ◄ PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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

104 Daminozide CAS No 1596-84-5 CIPAC No 330 N-dimethylaminosuccinamic acid 990 g/kg Impurities: — N-nitrosodimethylamine: not more than 2,0 mg/kg — 1,1-dimethylhydrazide: not more than 30 mg/kg 1 March 2006 ►M370 31 October 2022 ◄ PART A Only uses as growth regulator in non-edible crops may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate

107 MCPA CAS No 94-74-6 CIPAC No 2 4-chloro-o-tolyloxyacetic acid ≥ 930 g/kg 1 May 2006 ►M370 31 October 2022 ◄ PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones

108 MCPB CAS No 94-81-5 CIPAC No 50 4-(4-chloro-o-tolyloxy)butyric acid ≥ 920 g/kg 1 May 2006 ►M370 31 October 2022 ◄ PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones

109 Bifenazate CAS No 149877-41-8 CIPAC No 736 Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate ≥ 950 g/kg 1 December 2005 ►M360 31 July 2022 ◄ PART A Only uses as acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

110 Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No 660 M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one ≥ 950 g/kg 1 December 2005 ►M360 31 July 2022 ◄ PART A Only uses as acaricide or insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.

113 Maneb CAS No 12427-38-2 CIPAC No 61 manganese ethylenebis (dithiocarbamate) (polymeric) ≥ 860 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content. 1 July 2006 ►M197 31 January 2017 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request maneb has been included in this Annex provide such studies to the Commission within two years from the approval.

115 Metiram CAS No 9006-42-2 CIPAC No 478 Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)] ≥ 840 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content. 1 July 2006 ►M375 31 January 2023 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval.

116 Oxamyl CAS No 23135-22-0 CIPAC No 342 N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide 970 g/kg 1 August 2006 ►M375 31 January 2023 ◄ PART A Only uses as nematicide and insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment, — Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval.

120 Warfarin CAS No 81-81-2 CIPAC No 70 (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin ≥ 990 g/kg 1 October 2006 30 September 2013 PART A Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals. Risk mitigation measures should be applied where appropriate.

121 Clothianidin CAS No 210880-92-5 CIPAC No 738 (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine ≥ 960 g/kg 1 August 2006 ►M245 31 January 2019 ◄ ►M262 PART A Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 and the conclusions of the revised addendum of the review report on clothianidin as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the risk to groundwater; — the risk to bees and bumble bees released for pollination in permanent greenhouses; — the exposure of bees via the consumption of contaminated water from the permanent greenhouses. Member States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised. Conditions of use shall include risk mitigation measures, where appropriate. ◄

123 Clodinafop CAS No 114420-56-3 CIPAC No 683 (R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid ≥ 950 g/kg (expressed as clodinafop-propargyl) 1 February 2007 ►M356 30 April 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

124 Pirimicarb CAS No 23103-98-2 CIPAC No 231 2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate ≥ 950 g/kg 1 February 2007 ►M356 30 April 2022 ◄ PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. Member States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment. Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the approval.

125 Rimsulfuron CAS No 122931-48-0 (rimsulfuron) CIPAC No 716 1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea ≥ 960 g/kg (expressed as rimsulfuron) 1 February 2007 ►M356 30 April 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.

127 Triticonazole CAS No 131983-72-7 CIPAC No 652 (±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol ≥ 950 g/kg 1 February 2007 ►M356 30 April 2022 ◄ PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate, — must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones, — must pay particular attention to the protection of granivorous birds (long term risk). Conditions of authorisation should include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval.

128 Dimoxystrobin CAS No 149961-52-4 CIPAC No 739 (E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide ≥ 980 g/kg 1 October 2006 ►M375 31 January 2023 ◄ PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States — must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions; — must pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of — a refined risk assessment for birds and mammals considering the formulated active substance; — a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage. They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

130 Cyprodinil CAS No 121522-61-2 CIPAC No 511 (4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine ≥ 980 g/kg 1 May 2007 ►M356 30 April 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval.

131 Fosetyl CAS No 15845-66-6 CIPAC No 384 Ethyl hydrogen phosphonate ≥ 960 g/kg (expressed as fosetyl-Al) 1 May 2007 ►M356 30 April 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval.

132 Trinexapac CAS No 104273-73-6 CIPAC No 732 4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid ≥ 940 g/kg (expressed as trinexapac-ethyl) 1 May 2007 ►M356 30 April 2022 ◄ PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate.

133 Dichlorprop-P CAS No 15165-67-0 CIPAC No 476 (R)-2-(2,4-dichlorophenoxy) propanoic acid ≥ 900 g/kg 1 June 2007 ►M356 30 April 2022 ◄ ►M89

PART A

Only uses as herbicide may be authorised.

As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.

Use on grassland shall not be authorised.

PART B

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

In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.

Conditions of authorisation shall include risk mitigation measures, where appropriate. ◄

134 Metconazole CAS No 125116-23-6 (unstated stereo-chemistry) CIPAC No 706 (1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol ≥ 940 g/kg (sum of cis-and trans-isomers) 1 June 2007 ►M356 30 April 2022 ◄ PART A Only uses as fungicide and plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.

135 Pyrimethanil CAS No 53112-28-0 CIPAC No not allocated N-(4,6-dimethylpyrimidin-2-yl) aniline ≥ 975 g/kg (the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material) 1 June 2007 ►M356 30 April 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval.

136 Triclopyr CAS No 055335-06-3 CIPAC No 376 3,5,6-trichloro-2-pyridyloxyacetic acid ≥ 960 g/kg (as Triclopyr butoxyethyl ester) 1 June 2007 ►M356 30 April 2022 ◄ ►M137 PART A Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account. In this overall assessment Member States: — shall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate, — shall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. ◄

137 Metrafenone CAS No 220899-03-6 CIPAC No 752 3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone ≥ 940 g/kg 1 February 2007 ►M356 30 April 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

138 Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713 Culture collection No: NRRL B -21661 CIPAC No not allocated Not applicable 1 February 2007 ►M356 30 April 2022 ◄ ►M158

PART A

Only uses as fungicide and bactericide may be authorised. ◄

PART B

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

139 Spinosad CAS No 131929-60-7 (Spinosyn A) 131929-63-0 (Spinosyn D) CIPAC No 636 Spinosyn A: (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosyn D: (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D ≥ 850 g/kg 1 February 2007 ►M356 30 April 2022 ◄ PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. In this overall assessment Member States — must pay particular attention to the protection of aquatic organisms; — must pay particular attention to the risk to earthworms when the substance is used in glasshouses. Conditions of use shall include risk mitigation measures, where appropriate.

140 Thiamethoxam CAS No 153719-23-4 CIPAC No 637 (E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine ≥ 980 g/kg 1 February 2007 ►M252 30 April 2019 ◄ ►M263 PART A Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 and the conclusions of the revised addendum of the review report on thiamethoxam as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the risk to groundwater; — the risk to aquatic organisms; — the risk to bees and bumble bees released for pollination in permanent greenhouses; — the exposure of bees via the consumption of contaminated water from the permanent greenhouses. Member States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised. Conditions of use shall include risk mitigation measures, where appropriate. ◄

142 Ethephon CAS No 16672-87-0 CIPAC No 373 2-chloroethyl-phosphonic acid ≥ 910 g/kg (technical material — TC) The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material. 1 August 2007 ►M360 31 July 2022 ◄ PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

143 Flusilazole (2) CAS No 85509-19-9 CIPAC No 435 Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane 925 g/kg 1 January 2007 30 June 2008 (2) PART A Only uses as fungicide on the following crops may be authorised: — cereals other than rice (2), — maize (2), — rape seed (2), — sugar beet (2), at rates not exceeding 200 g active substance per hectare per application. The following uses must not be authorised: — air application, — knapsack and hand-held applications, neither by amateur nor by professional users, — home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: — aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, — birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, — operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account. Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained. Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They 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.

144 Carbendazim CAS No 10605-21-7 CIPAC No 263 Methyl benzimidazol-2-ylcarbamate ≥ 980 g/kg Relevant impurities 2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg 2,3-diaminophenazine (DAP): not more than 0,003 g/kg 1 June 2011 30 November 2014 PART A Only uses as fungicide on the following crops may be authorised: — cereals — rape seed — sugar and fodder beet — maize at rates not exceeding — 0,25 kg active substance per hectare per application for cereals and rape seed; — 0,075 kg active substance per hectare per application for sugar and fodder beet — 0,1 kg active substance per hectare per application for maize. The following uses must not be authorised: — air application; — knapsack and handheld applications neither by amateur nor by professional users; — home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: — aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices; — earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance; — birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary; — operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbendazim, and in particular Appendices I and II thereof, shall be taken into account. The Member States concerned shall request that the applicant provides the following to the Commission: — by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197; — by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 ‘Further information’, pp. 155 – 157); — by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.

145 Captan CAS No 133-06-02 CIPAC No 40 N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide ≥ 910 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 5 g/kg Folpet: not more than 10 g/kg Carbon tetrachloride not more than 0,1 g/Kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval.

146 Folpet CAS No 133-07-3 CIPAC No 75 N-(trichloromethylthio) phthalimide ≥ 940 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 3,5 g/kg Carbon tetrachloride not more than 4 g/kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval.

147 Formetanate CAS No 23422-53-9 CIPAC No 697 3-dimethylaminomethyleneaminophenyl methylcarbamate ≥ 910 g/kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as insecticide and acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval.

150 Dimethomorph CAS No 110488-70-5 CIPAC No 483 (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine ≥ 965 g/kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; — to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

151 Glufosinate CAS No 77182-82-2 CIPAC No 437.007 ammonium(DL)-homoalanin-4-yl(methyl)phosphinate 950 g/kg 1 October 2007 ►M139 31. July 2018 ◄ ►M57

PART A

Only uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year.

PART B

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

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

(a) the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate;

(b) the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions;

(c) the protection of mammals, non-target arthropods and non-target plants.

Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate. ◄

152 Metribuzin CAS No 21087-64-9 CIPAC No 283 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one ≥ 910 g/kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval.

153 Phosmet CAS No 732-11-6 CIPAC No 318 O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide ≥ 950 g/kg Impurities: — phosmet oxon: not more than 0,8 g/kg — iso phosmet: not more than 0,4 g/kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval.

154 Propamocarb CAS No 24579-73-5 CIPAC No 399 Propyl 3-(dimethylamino) propylcarbamate ≥ 920 g/kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate; — the transfer of soil residues for rotating or succeeding crops; — the protection of surface and groundwater in vulnerable zones; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

156 Pirimiphos-methyl CAS No 29232-93-7 CIPAC No 239 O-2-diethylamino-6-methylpyrimidin-4-yl O,O-dimethylphosphorothioate > 880 g/kg 1 October 2007 ►M360 31 July 2022 ◄ PART A Only uses as insecticide for post harvest storage can be authorised. Hand-held applications shall not be authorised. PART B In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

157 Fipronil CAS No 120068-37-3 CIPAC No 581 (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile ≥ 950 g/kg 1 October 2007 ►M197 30 September 2017 ◄ ►M73

PART A

Only uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.

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

(a) the packaging of the marketed products to avoid the generation of photodegradation products of concern;

(b) the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

(c) the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.

Member States shall also ensure that:

(a) the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised;

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

(c) the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation;

(d) monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

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

The notifier shall submit confirmatory information as regards:

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

(b) the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites;

(c) the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift;

(d) the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew;

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

(f) the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950).

The notifier shall submit that information to the Commission, the Member States and the Authority by 30 March 2015. ◄

158 Beflubutamid CAS No 113614-08-7 CIPAC No 662 (RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide ≥ 970 g/kg 1 December 2007 ►M360 31 July 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.

159 Spodoptera exigua nuclear polyhedrosis virus CIPAC No Not allocated Not applicable 1 December 2007 30 November 2017 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.

160 Prosulfocarb CAS No 52888-80-9 CIPAC No 539 S-benzyl dipropyl(thiocarbamat) 970 g/kg 1 November 2008 ►M370 31 October 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone.

161 Fludioxonil CAS No 131341-86-1 CIPAC No 522 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile 950 g/kg 1 November 2008 ►M370 31 October 2022 ◄ PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and: — must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, — must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

162 Clomazone CAS No 81777-89-1 CIPAC No 509 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one 960 g/kg 1 November 2008 ►M370 31 October 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones.

163 Benthiavalicarb CAS No 413615-35-7 CIPAC No 744 [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid ≥ 910 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: 6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg 1 August 2008 ►M360 31 July 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety, — the protection of non-target arthropods. Conditions of use shall include adequate risk mitigation measures, where appropriate. In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

164 Boscalid CAS No 188425-85-6 CIPAC No 673 2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide ≥ 960 g/kg 1 August 2008 ►M360 31 July 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention — to the operator safety, — to the long term risk to birds and soil organisms, — to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate.

166 Fluoxastrobin CAS No 361377-29-9 CIPAC No 746 (E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime ≥ 940 g/kg 1 August 2008 ►M360 31 July 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate, — the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures, — data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff. They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

167 Paecilomyces lilacinus (Thom) Samson 1974 strain 251 (AGAL: No 89/030550) CIPAC No 753 Not applicable 1 August 2008 ►M360 31 July 2022 ◄ PART A Only uses as nematicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers), — the protection of leaf dwelling non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate.

168 Prothioconazole CAS No 178928-70-6 CIPAC No 745 (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione ≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD) 1 August 2008 ►M360 31 July 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety in spray applications. Conditions of use shall include adequate protective measures, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, — a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, — information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval.

169 Amidosulfuron CAS No 120923-37-7 CIPAC No 515 3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea or 1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea ≥ 970 g/kg 1 January 2009 ►M370 31 December 2022 ◄ PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

170 Nicosulfuron CAS No 111991-09-4 CIPAC No 709 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide or 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea ≥ 910 g/kg 1 January 2009 ►M370 31 December 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions, — the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, — the protection of groundwater and surface water under vulnerable soil and climatic conditions.

171 Clofentezine CAS No 74115-24-5 CIPAC No 418 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine ≥ 980 g/kg (dry material) 1 January 2009 ►M370 31 December 2022 ◄ PART A Only uses as acaricide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; — the potential for long range transport via air; — the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012.

172 Dicamba CAS No 1918-00-9 CIPAC No 85 3,6-dichloro-2-methoxybenzoic acid ≥ 850 g/kg 1 January 2009 ►M370 31 December 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of non-target plants. Conditions of use shall include adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the identification and quantification of a group of soil transformation products formed in a soil incubation study; (b) the potential for long range transport through the atmosphere. The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013.

173 Difenoconazole CAS No 119446-68-3 CIPAC No 687 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether ≥ 940g/kg Toluene maximum content: 5 g/kg 1 January 2009 ►M370 31 December 2022 ◄ PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) further data on the specification of the technical material; (b) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin; (c) the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (16); (d) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance.

174 Diflubenzuron CAS No 35367-38-5 CIPAC No 339 1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea ≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline 1 January 2009 ►M313 31 December 2020 ◄ PART A ►M224 Only uses as insecticide in non-edible crops may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the protection of aquatic organisms, terrestrial organisms and non-target arthropods including bees; — the potential unintended exposure of food and feed crops to diflubenzuron from uses on non-edible crops (e.g. through spray drift); — the protection of workers, residents and bystanders. Member States shall ensure that crops treated with diflubenzuron do not enter the food and feed chain. Conditions of use shall include adequate risk mitigation measures, where appropriate. ◄ PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as finalised inthe Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the protection of aquatic organisms; — the protection of terrestrial organisms; — the protection of non-target arthropods including bees. Conditions of use shall include adequate risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further studies to address the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.

175 Imazaquin CAS No 81335-37-7 CIPAC No 699 2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid ≥ 960 g/kg (racemic mixture) 1 January 2009 31 December 2018 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account The notifier shall submit confirmatory information as regards: (a) further data on the specification of the technical material; (b) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012 and the information set out in point (b) within 2 years from the adoption of specific guidance.

176 Lenacil CAS No 2164-08-1 CIPAC No 163 3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione ≥ 975 g/kg 1 January 2009 ►M370 31 December 2022 ◄ PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies; — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012. If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.

177 Oxadiazon