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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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Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
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Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
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Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
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Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-07-31
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
Changes on 2024-07-31
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| 64 | Pyridalyl CAS No 179101-81-6 CIPAC No 792 | 2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether | ≥ 910 g/kg | 1 July 2014 | 30 June 2024 | PART A Only uses in greenhouses with permanent structure 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 pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to re-entry workers; (b) the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions; (c) the risk to birds, mammals and aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23; (2) the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse; (3) the risk to aquatic invertebrates. The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016. The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018. |
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| 65 | S-abscisic acid CAS No 21293-29-8 CIPAC No Not allocated | (2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid or (7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid | 960 g/kg | 1 July 2014 | 30 September 2024 | 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-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
| 65 | S-abscisic acid CAS No 21293-29-8 CIPAC No Not allocated | (2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid or (7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid | 960 g/kg | 1 July 2014 | 15 September 2026 | 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-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 66 | L-ascorbic acid CAS No 50-81-7 CIPAC No 774 | (5*R*)-5-[(1*S*)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5*H*)-one | ≥ 990 g/kg The following relevant impurities shall not exceed: Methanol: ≤ 3 g/kg Heavy Metals: ≤ 10 mg/kg (expressed as Pb) | 1 July 2014 | 30 June 2024 | 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 L-ascorbic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic and soil organisms; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms; (2) the risk to contaminate groundwater. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016. |
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| 68 | 1,4-dimethylnaphthalene CAS No 571-58-4 CIPAC No 822 | 1,4-dimethylnaphthalene | ≥ 980 g/kg | 1 July 2014 | 30 June 2025 | 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 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and of workers at re-entry and during inspection of the warehouse; (b) the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the residue definition for the active substance. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016. |
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| 69 | Amisulbrom CAS No 348635-87-0 CIPAC No 789 | 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-*N*,*N*-dimethyl-1*H*-1,2,4-triazole-1-sulfonamide | ≥ 985 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg | 1 July 2014 | 30 September 2024 | 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 amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1*H*-1,2,4-triazol-3-ylsulfonyl)-1*H*-indole and 1-(dimethylsulfamoyl)-1*H*-1,2,4-triazole-3-sulfonic acid to contaminate groundwater; (2) the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1*H*-1,2,4-triazole-3-sulfonic acid, 1*H*-1,2,4-triazole-3-sulfonic acid, 1*H*-1,2,4-triazole, *N*,*N*-dimethyl-1*H*-1,2,4-triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido-4-fluoro-hydroxybenzoic acid and 2,2′-oxybis(6-fluoro-2-methyl-1,2-dihydro-3*H*-indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff; (3) depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water; (4) the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1*H*-1,2,4-triazol-3-ylsulfonyl)-1*H*-indole; (5) the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1*H*-1,2,4-triazol-3-ylsulfonyl)-1*H*-indole. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption. |
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| 70 | Valifenalate CAS No 283159-90-0 CIPAC No 857 | Methyl *N*-(isopropoxycarbonyl)-L-valyl-(3*RS*)-3-(4-chlorophenyl)-β-alaninate | ≥ 980 g/kg | 1 July 2014 | 30 September 2024 | 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 valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater. The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016. |
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| 71 | Thiencarbazone CAS No 317815-83-1 CIPAC No 797 | Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1*H*-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate | ≥ 950 g/kg | 1 July 2014 | 30 September 2024 | 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 thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018. |
| 69 | Amisulbrom CAS No 348635-87-0 CIPAC No 789 | 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-*N*,*N*-dimethyl-1*H*-1,2,4-triazole-1-sulfonamide | ≥ 985 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg | 1 July 2014 | 15 September 2026 | 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 amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1*H*-1,2,4-triazol-3-ylsulfonyl)-1*H*-indole and 1-(dimethylsulfamoyl)-1*H*-1,2,4-triazole-3-sulfonic acid to contaminate groundwater; (2) the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1*H*-1,2,4-triazole-3-sulfonic acid, 1*H*-1,2,4-triazole-3-sulfonic acid, 1*H*-1,2,4-triazole, *N*,*N*-dimethyl-1*H*-1,2,4-triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido-4-fluoro-hydroxybenzoic acid and 2,2′-oxybis(6-fluoro-2-methyl-1,2-dihydro-3*H*-indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff; (3) depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water; (4) the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1*H*-1,2,4-triazol-3-ylsulfonyl)-1*H*-indole; (5) the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1*H*-1,2,4-triazol-3-ylsulfonyl)-1*H*-indole. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption. |
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| 70 | Valifenalate CAS No 283159-90-0 CIPAC No 857 | Methyl *N*-(isopropoxycarbonyl)-L-valyl-(3*RS*)-3-(4-chlorophenyl)-β-alaninate | ≥ 980 g/kg | 1 July 2014 | 1 March 2027 | 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 valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater. The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016. |
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| 71 | Thiencarbazone CAS No 317815-83-1 CIPAC No 797 | Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1*H*-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate | ≥ 950 g/kg | 1 July 2014 | 1 March 2027 | 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 thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018. |
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| 72 | Acequinocyl CAS No 57960-19-7 CIPAC No 760 | 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate | ≥ 960 g/kg | 1 September 2014 | 30 November 2024 | 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 acequinocyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers and operators; — the risk to birds, mammals and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) an analytical method for residues in body fluids and tissues; (b) the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards; (c) the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016. |
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| 96 | Iprovalicarb CAS No 140923-17-7 CIPAC No 620 | isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate | ≥ 950 g/kg Impurities: Toluene: not more than 3 g/kg | 1 April 2016 | 31 March 2031 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of groundwater from the relevant soil metabolite PMPA (<sup>17</sup>) when the active substance is applied in regions with low clay containing soil types, — the safety of operators and workers, — the protection of aquatic organisms in the case of formulated products containing other active substances. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority, confirmatory information as regards the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016. |
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| 97 | Pinoxaden CAS No 243973-20-8 CIPAC No 776 | 8-(2,6-diethyl-p-tolyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropionate | ≥ 970 g/kg Toluene max. content 1 g/kg | 1 July 2016 | 30 June 2026 | 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 pinoxaden, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 January 2016 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite M2 in vulnerable zones, where appropriate. The applicant shall submit confirmatory information as regards: (a) a validated method of analysis of metabolites M11, M52, M54, M55 and M56 in ground water; (b) the relevance of the metabolites M3, M11, M52, M54, M55 and M56, and the corresponding groundwater risk assessment, if pinoxaden is classified under Regulation (EC) No 1272/2008 as H361d (suspected of damaging the unborn child). The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in point (a) by 30 June 2018 and the information set out in point (b) within six months from the notification of the classification decision under Regulation (EC) No 1272/2008 concerning pinoxaden. |
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| 98 | Acibenzolar-S-methyl CAS No 135158-54-2 CIPAC No 597 | S-methyl benzo[1,2,3]thiadiazole-7-carbothioate | 970 g/kg Toluene: max. 5 g/kg | 1 April 2016 | 31 March 2031 | 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 acibenzolar-S-methyl, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk for consumers via food intake; (b) the protection of operators and workers; (c) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall by 1 June 2017 submit to the Commission, the Member States and the Authority, confirmatory information as regards the relevance and reproducibility of the morphometric changes observed in the cerebellum of foetuses linked to exposure to acibenzolar-S-methyl and whether these changes may be produced via an endocrine mode of action. The information to be submitted shall includea systematic review of the available evidence assessed on the basis of available guidance (e.g. EFSA GD on Systematic Review methodology, 2010). |
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| 99 | Cyantraniliprole CAS No: 736994-63-1 CIPAC No: Not allocated. | 3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide | ≥ 940 g/kg IN-Q6S09 max. 1 mg/kg IN-RYA13 max. 20 mg/kg methanesulfonic acid max. 2 g/kg acetonitrile max. 2 g/kg heptane max. 7 g/kg 3-picoline max. 3 g/kg. | 14 September 2016 | 14 September 2026 | 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 cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to operators; (b) the risk to aquatic organisms, bees and other non-target arthropods; (c) the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses; (d) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
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| 139 | Florpyrauxifen-benzyl CAS No: 1390661-72-9 CIPAC No: 990.227 | benzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate | ≥ 920 g/kg The impurity toluene shall not exceed 3 g/kg in the technical material. | 24 July 2019 | 24 July 2029 | 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 22 March 2019, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of aquatic and terrestrial non-target plants. Conditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 24 July 2021. |
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| 140 | Metalaxyl-M | methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate | ≥ 920 g/kg | 1 June 2020 | 31 May 2035 | When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised. |
| | CAS No 70630-17-0 (R) CIPAC No 580 | | The following impurities are of toxicological concern and must not exceed the following levels in the technical material: 2,6-dimethylphenylamine: max. content 0,5 g/kg 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide: max. content 1 g/kg 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester: max. content 0,18 g/kg | | | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured; — the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of non-target arthropods, birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 by 26 May 2022. |
| 140 | Metalaxyl-M CAS No 70630-17-0 (R) CIPAC No 580 | methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate | ≥ 920 g/kg The following impurities are of toxicological concern and must not exceed the following levels in the technical material: 2,6-dimethylphenylamine: max. content: 0,5 g/kg 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide: max. content: 1 g/kg 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester: max. content < 10 g/kg | 1 June 2020 | 31 May 2035 | When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured, — the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of non-target arthropods, birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine disrupting properties in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605, by 26 May 2022. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water, by 10 July 2026. |
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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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| 24 | Chitosan CAS No: 9012-76-4 EC No: 618-480-0 | Chemical name (not IUPAC): poly[4-O-(2-acetamido-2-deoxy-β-D-glucopyranosyl)-2-amino-2-deoxy-β-D-glucopyranose] | ≥ 85 % chitosan heavy metals: max. 20 mg/kg Food grade, meeting the specifications for ‘chitosan extract from fungi’ as set out in Commission Implementing Regulation (EU) 2017/2470 (<sup>5</sup>) | 11 April 2022 | Chitosan shall be used in accordance with the specific conditions included in the conclusions of the review report on chitosan (SANTE/10594/2021) and in particular Appendices I and II thereto. |
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| 25 | magnesium hydroxide E528 CAS No: 1309-42-8 CIPAC No: Not available | magnesium dihydroxide | 95 % Relevant impurities: Lead < 2 mg/kg Arsenic < mg/kg | 2 April 2024 | Magnesium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on magnesium hydroxide (PLAN/2023/2331 RR Rev2) and in particular Appendices I and II thereof. |
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| 26 | *Onobrychis viciifolia* (sainfoin) dried pellets CAS No: Not available CIPAC No: Not available | Not available | 1 000 g/kg Relevant impurities: Arsenic (1 g/kg), Cadmium (0,1 g/kg), Chromium-VI (0,1 g/kg), Mercury (1 g/kg), Nickel (0,1 g/kg), Lead (0,3 g/kg) | 17 July 2024 | *Onobrychis viciifolia* (sainfoin) dried pellets shall be used in accordance with the specific conditions included in the conclusions of the review report on *Onobrychis viciifolia* (sainfoin) dried pellets (PLAN/2024/790 RR rev1) and in particular Appendices I and II thereof. |
| (<sup>1</sup>) Further details on identity, specification and manner of use of basic substance are provided in the review report. (<sup>2</sup>) Available online: http://www.fao.org/fao-who-codexalimentarius/standards/list-of-standards/en/ (<sup>3</sup>) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1). (<sup>4</sup>) Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species (OJ L 289, 31.10.2013, p. 33). (<sup>5</sup>) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72). | | | | | |
### PART D
2024-05-23
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-05-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-12-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-08-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-04-18
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-01-20
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-12-12
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-09-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-03-27
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-12-19
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-10-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-04-06
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-12-12
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-11-26
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-10-20
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-10-06
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-08-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-06-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-04-09
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-02-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-12-29
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-05-30
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-04-14
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-02-20
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-12-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-10-17
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-08-14
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-06-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-03-22
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-01-23
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-12-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-12-05
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-09-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-06-08
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-04-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-12-12
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-09-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-08-22
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-07-06
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-05-13
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-05-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-12-09
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-11-10
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-09-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-08-18
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-07-30
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-04-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2014-09-15
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2014-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2014-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-06-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-07-23
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-05-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
original version
Text at this date