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Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances Text with EEA relevance
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· 2011-05-25
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| 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 | 31 July 2021 | 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. |
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| 99 | Etoxazole CAS No 153233-91-1 CIPAC No 623 | (RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole | ≥ 948 g/kg | 1 June 2005 | 31 July 2021 | Only uses as acaricide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
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| 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 | 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. |
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| 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 | 31 January 2017 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request maneb has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 114 | Mancozeb CAS No 8018-01-7 (formerly 8065-67-5) CIPAC No 34 | Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt | ≥ 800 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content. | 1 July 2006 | 31 January 2021 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request mancozeb has been included in this Annex provide such studies to the Commission within two years from the approval. |
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| 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 | 31 January 2021 | 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 | 31 January 2021 | 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. |
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| 234 | Hydrolysed proteins CAS No not allocated CIPAC No 901 | Not available | Review report (SANCO/2615/2008) | 1 September 2009 | 31 August 2021 | PART A Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 (<sup>17</sup>) and Commission Regulation (EU) No 142/2011 (<sup>18</sup>). 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 hydrolysed proteins (SANCO/2615/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operator and worker safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards: (a) the specifications of the technical material, as commercially manufactured, supported by appropriate analytical data; (b) the risk to aquatic organisms. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013, the information set out in point (b) by 1 November 2013. |
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| 235 | *Iron sulphate*: Iron(II)sulfate anhydrous: CAS No 7720-78-7 Iron(II)sulfate monohydrate: CAS No 17375-41-6 Iron(II)sulfate heptahydrate: CAS No 7782-63-0 CIPAC No 837 | Iron(II)sulphate or iron(2+) sulfate | Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron. Relevant impurities: arsenic, 18 mg/kg cadmium, 1,8 mg/kg chromium, 90 mg/kg lead, 36 mg/kg mercury, 1,8 mg/kg expressed on the basis of the anhydrous variant | 1 September 2009 | 31 August 2021 | 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 amended review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk for operator; — the risk to children/residents playing on treated turf; — the risk to surface waters and to aquatic organisms. Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers. The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013. |
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| 236 | Kieselgur (diatomaceous earth) CAS No 61790-53-2 CIPAC No 647 | Kieselgur (no IUPAC name) Diatomaceous earth Amorphous silicon dioxide Silica Diatomite | The product consists of 100 % diatomaceous earth. Maximum 0,1 % of particles of crystalline silica with diameter below 50 μm | 1 September 2009 | 31 August 2021 | PART A Only indoor uses as insecticide and acaricide by professional users 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 kieselgur (diatomaceous earth) (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the safety of operators and workers. Conditions of use shall include the application of adequate personal and respiratory protective equipment. Where necessary, conditions of use shall prohibit the presence of workers after application of the product concerned for a period appropriate in view of the risks caused by that product. The Member States concerned shall ensure that the notifiers submit, by 25 November 2015, to the Commission, the Member States and the Authority information concerning the inhalation toxicity to confirm the occupational limits of kieselgur (diatomaceous earth). |
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| 237 | Limestone CAS No: 1317-65-3 CIPAC No: 852 | Calcium carbonate | ≥ 980 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
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| 292 | sulphur CAS No 7704-34-9 CIPAC No 18 | sulphur | ≥ 990 g/kg | 1 January 2010 | 31 December 2021 | PART A Only uses as fungicide 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 sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011. |
| 293 | Tetraconazole CAS No 112281-77-3 CIPAC No 726 | (RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether | ≥ 950 g/kg (racemic mixture) Impurity toluene: not more than 13 g/kg | 1 January 2010 | 31 December 2021 | 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 tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall request: — the submission of further information on a refined consumer risk assessment, — further information on the specification regarding ecotoxicology, — further information on the fate and behaviour of potential metabolites in all relevant compartments, — the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods, — further information on the potential for endocrine disrupting effects to birds, mammals and fish. They shall ensure that the notifier provides such information to the Commission by 31 December 2011. |
| 294 | Paraffin oils CAS No 64742-46-7 CAS No 72623-86-0 CAS No 97862-82-3 CIPAC No n.a. | paraffin oil | European Pharmacopoeia 6.0 | 1 January 2010 | 31 December 2021 | 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in particular Appendices I and II thereto shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request: — the submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0. They shall ensure that the notifiers provides such information to the Commission by 30 June 2010. |
| 295 | Paraffin oil CAS No 8042-47-5 CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2020 | 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 paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request: The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0 They shall ensure that the notifier provides such information to the Commission by 30 June 2010. |
| 295 | Paraffin oil CAS No 8042-47-5 CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2021 | 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 paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request: The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0 They shall ensure that the notifier provides such information to the Commission by 30 June 2010. |
| 296 | Cyflufenamid CAS No 180409-60-3 CIPAC No 759 | (Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide | > 980 g/kg | 1 April 2010 | 31 March 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 cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 297 | Fluopicolide CAS No 239110-15-7 CIPAC No 787 | 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide | ≥ 970 g/kg The impurity toluene must not exceed 3 g/kg in the technical material. | 1 June 2010 | 31 May 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 fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — to the risk to operators during application, — the potential for long range transport via air. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest. |
| 298 | Heptamaloxyloglucan CAS No 870721-81-6 CIPAC No Not available | Full IUPAC name in footnote (1) Xyl p: xylopyranosyl Glc p: glucopyranosyl Fuc p: fucopyranosyl Gal p: galactopyranosyl Glc-ol: glucitol | ≥ 780 g/kg The impurity Patulin must not exceed 50 μg/kg in the technical material. | 1 June 2010 | 31 May 2021 | 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 heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account. |
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| 141 | Foramsulfuron CAS No 173159-57-4 CIPAC No 659 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-(dimethylcarbamoyl)-5-formamidophenylsulfonyl]urea | ≥ 973 g/kg | 1 June 2020 | 31 May 2035 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on foramsulfuron, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to consumers and operators, — the risk to aquatic organisms and non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water, within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
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| 142 | Pyriproxyfen. 2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine. CIPAC No: 715. CAS No: 95737-68-1. EC No (Einecs or ELINCS): 429-800-1 | 4-phenoxyphenyl (*RS)*-2(2-pyridyloxy) propyl ether | ≥ 970 g/kg Max. impurity: Toluene 5 g/Kg | 1 August 2020 | 31 July 2035 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the dietary exposure of consumers to residues of pyriproxyfen, — the protection of sediment-dwelling organisms and aquatic organisms, — the protection of bees. As regards the protection of sediment-dwelling organisms and aquatic organisms, for outdoor use of the plant protection products containing pyriproxyfen Member States shall include in the specific conditions appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for sediment-dwelling organisms and aquatic organisms. As regards the protection of bees, for outdoor use of plant protection products containing pyriproxyfen Member States shall include in the specific conditions a restriction of application to periods outside of the flowering of bee attractive crops, and appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for bees and bee larvae. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water. The applicant shall submit the requested confirmatory information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
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| 143 | Kieselgur (Diatomaceous earth) CAS No 6*1790-53-2* CIPAC No 647 | No IUPAC name exists for kieselgur Other synonyms: Diatomaceous earth, Diatomite | 1 000 g/kg Minimum content of amorphous silica of 800 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: Crystalline silica with particle size below 10 μm – maximum of 1 g/kg | 1 February 2021 | 31 January 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate. Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EU) No 546/2011. Conditions of use shall include risk mitigation measures, where appropriate. |
| (<sup>1</sup>) Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>) 2-hydroxy-4,6-dimethoxypyrimidine. (<sup>3</sup>) 2,4-dihydroxy-6-methoxypyrimidine. (<sup>4</sup>) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (<sup>5</sup>) 5-(trifluoromethyl)-2(1H)-pyridinone. (<sup>6</sup>) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (<sup>7</sup>) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (<sup>8</sup>) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (<sup>9</sup>) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (<sup>10</sup>) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (<sup>11</sup>) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (<sup>12</sup>) 3-phenoxybenzaldehyde. (<sup>13</sup>) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (<sup>14</sup>) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (<sup>15</sup>) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1*H*-pyrazole-4-carboxylic acid. (<sup>16</sup>) 3-chloro-1-methyl-5-sulfamoyl-1*H*-pyrazole-4-carboxylic acid. (<sup>17</sup>) *p*-methyl-phenethylamine. (<sup>18</sup>) OJ L 353, 31.12.2008, p. 1. (<sup>19</sup>) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (<sup>20</sup>) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33). (<sup>21</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>22</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN. (<sup>23</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 | | | | | | |
### PART C
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| 11 | Methoxyfenozide CAS No 161050-58-4 CIPAC No 656 | N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide | ≥ 970 g/kg The following impurities must not exceed the following levels in the technical material: Tert-butylhydrazine < 0,001 g/kg RH-116267 < 2 g/kg | 1 April 2019 | 31 March 2026 | Only uses in greenhouses shall be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methoxyfenozide, and in particular Appendices I and II thereto, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions; — the risk of accumulation in soil; — the protection of non-target arthropods, sediment dwelling and aquatic organisms; Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. a comparative in vitro metabolism study on methoxyfenozide, by 1 April 2020; 2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water, within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. The applicant shall also provide an updated assessment of the information submitted and, where relevant, further information to confirm the absence of thyroid endocrine activity in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (<sup>2</sup>) by 1 February 2021. |
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| 12 | alpha-cypermethrin CAS No 67375-30-8 CIPAC No 454 | Racemate comprising: (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate or (R)-α-cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate | ≥ 980 g/kg The manufacturing impurity hexane is considered to be of toxicological concern and must not exceed 1 g/kg in the technical material | 1 November 2019 | 31 October 2026 | For the implementation of the uniform principles, as referred to in Article 9(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on alpha-cypermethrin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that the conditions of use prescribe the application of adequate personal protective equipment; — the consumer risk assessment; — the protection of aquatic organisms, bees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety; 2. the potential relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR); 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water; 4. Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605. The applicant shall submit the information referred to in point 1 by 30 October 2020; the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of isomer mixtures; and the information referred to in point 3 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. As regards Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of androgenic endocrine activity shall be submitted by 30 October 2021. |
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| 13 | etoxazole CAS No 153233-91-1 CIPAC No 623 | (RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro1,3-oxazol-4-yl]phenetole | ≥ 948 g/kg | 1 February 2021 | 31 January 2028 | Only uses on ornamental plants in permanent greenhouses shall be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on etoxazole, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — possible uptake of persistent soil metabolites in rotational crops; — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment. The applicant shall submit to the Commission, the Member States and the Authority by 5 January 2023 confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, including an updated assessment of the information already submitted and, where relevant, further information. |
| (<sup>1</sup>) Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33). | | | | | | |
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original version
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