LegalizeCommission 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
| Number | Common Name, Identification Numbers | IUPAC Name | Purity 21 | Date of approval | Expiration of approval | Specific provisions | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| 50 | Pseudomonas sp. strain DSMZ 13134 Collection number: DSMZ 13134 | Not applicable | Minimum concentration: 3×1014 cfu/kg | 1 February 2014 | 30 June 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 Pseudomonas sp. strain DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016. | ||||
| 51 | Fluopyram CAS No 658066-35-4 CIPAC No 807 | N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide | ≥ 960 g/kg | 1 February 2014 | 15 June 2028 | 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 fluopyram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the long-term risk to insectivorous birds; (2) the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals. The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption. | ||||
| 52 | Aureobasidium pullulans (strains DSM 14940 and DSM 14941) Collection number: German Collection of Microorganisms and cell Cultures (DSMZ) with the accession numbers DSM 14940 and DSM 14941 | Not applicable | Minimum 5,0 × 109 CFU/g for each strain; Maximum 5,0 × 1010 CFU/g for each strain | 1 February 2014 | 30 June 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 Aureobasidium pullulans (strains DSM 14940 and DSM 14941), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Aureobasidium pullulans (strains DSM 14940 and DSM 14941) is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 53 | Pyriofenone: CAS No 688046-61-9 CIPAC No 827 | (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone | ≥ 965 g/kg | 1 February 2014 | 30 June 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 pyriofenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) the identity of two impurities to fully support the provisional specification; (b) the toxicological relevance of the impurities present in the proposed technical specification except for the one impurity for which an acute oral study and an Ames test were provided. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016. | ||||
| 54 | Disodium phosphonate CAS No 13708-85-5 CIPAC No 808 | disodium phosphonate | 281-337 g/kg (TK) ≥ 917 g/kg (TC) | 1 February 2014 | 31 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 disodium phosphonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to eutrophication of surface water. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) the chronic risk to fish; (b) the long term risk to earthworms and soil macro-organisms. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016. | ||||
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| 56 | Orange oil CAS No 8028-48-6 (Orange extract) 5989-27-5 (D-limonene) CIPAC No 902 | (R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene | ≥ 945 g/kg (of D-limonene) The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E) | 1 May 2014 | 31 December 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment. The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016. | ||||
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| 58 | Benalaxyl-M CAS No 98243-83-5 CIPAC No 766 | Methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate | ≥ 950 g/kg | 1 May 2014 | 30 September 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 benalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers at re-entry, — the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 59 | Tembotrione CAS No 335104-84-2 CIPAC No 790 | 2-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione | ≥ 945 g/kg The following relevant impurities must not exceed a certain threshold in the technical material: Toluene: ≤ 10 g/kg HCN: ≤ 1 g/kg | 1 May 2014 | 31 December 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 tembotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
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| 61 | Pyroxsulam CAS No 422556-08-9 CIPAC No 793 | N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide | ≥ 965 g/kg | 1 May 2014 | 30 September 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 pyroxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, when the active substance is applied in regions with vulnerable soil 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: (1) the toxicological relevance of impurity number 3 (as referred to in the review report); (2) the acute toxicity of the metabolite PSA; (3) the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742. The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016. | ||||
| 62 | Chlorantraniliprole CAS No 500008-45-7 CIPAC No 794 | 3-bromo-4'-chloro-1-(3-chloro-2-pyridyl)-2'-methyl-6'-(methylcarbamoyl) pyrazole-5-carboxanilide | ≥ 950 g/kg The following relevant impurities must not exceed a certain threshold in the technical material: Acetonitrile: ≤ 3 g/kg 3-picoline: ≤ 3 g/kg Methanesulfonic acid: ≤ 2 g/kg | 1 May 2014 | 31 May 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 chlorantraniliprole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and to soil macroorganisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the risk to groundwater from the active substance and its metabolites IN-EQW78 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-b]quinazolin-11-one), IN-F6L99 (3-bromo-N-methyl-1H-pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquinazolin-4(1H)-one) and IN-F9N04 (3-bromo-N-(2-carbamoyl-4-chloro-6-methylphenyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxamide); (2) the risk to aquatic organisms from the photolysis metabolites IN-LBA22 (2-{[(4Z)-2-bromo-4H-pyrazolo[1,5-d]pyrido[3,2-b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-dimethylbenzamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one) and IN-LBA24 (2-(3-bromo-1H-pyrazol-5-yl)-6-chloro-3,8-dimethylquinazolin-4(3H)-one). The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016. | ||||
| 63 | Sodium silver thiosulfate CAS No not allocated CIPAC No 762 | Not applicable | ≥ 10,0 g Ag/kg Expressed as silver (Ag) | 1 May 2014 | 31 December 2026 | PART A Only indoor uses in non-edible crops 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 sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the protection of operators and workers; (b) limiting the possible release of silver ions through disposal of used solutions; (c) the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
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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 | 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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| 68 | 1,4-dimethylnaphthalene CAS No 571-58-4 CIPAC No 822 | 1,4-dimethylnaphthalene | ≥ 980 g/kg | 1 July 2014 | 30 November 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 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. | ||||
| 69 | Amisulbrom CAS No 348635-87-0 CIPAC No 789 | 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-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-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole and 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid to contaminate groundwater; (2) the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole, N,N-dimethyl-1H-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-3H-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-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-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-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-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. | ||||
| 70 | Valifenalate CAS No 283159-90-0 CIPAC No 857 | Methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-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. | ||||
| 71 | Thiencarbazone CAS No 317815-83-1 CIPAC No 797 | Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-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. | ||||
| 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 | 15 November 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 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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| 76 | Metobromuron CAS No 3060-89-7 CIPAC No 168 | 3-(4-bromophenyl)-1-methoxy-1-methylurea | ≥ 978 g/kg | 1 January 2015 | 31 May 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 metobromuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of workers and operators; (b) the risk to birds, mammals, aquatic organisms and terrestrial non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the toxicological assessment of the metabolites CGA 18236, CGA 18237, CGA 18238 and 4-bromoaniline; (b) the acceptability of the long-term risk to birds and mammals. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 December 2016. | ||||
| 77 | Aminopyralid CAS No 150114-71-9 CIPAC No 771 | 4-amino-3,6-dichloropyridine-2-carboxylic acid | ≥ 920 g/kg The following relevant impurity shall not exceed a certain threshold: Picloram ≤ 40 g/kg | 1 January 2015 | 31 May 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 aminopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; (b) the risk to aquatic macrophytes and terrestrial non-target plants; (c) chronic risk to fish. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
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| 79 | Streptomyces lydicus strain WYEC 108 Collection number: American Type Culture Collection (USDA) ATCC 55445 | Not applicable | Minimum concentration: 5,0 × 108 CFU/g | 1 January 2015 | 30 June 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 Streptomyces lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic organisms; (b) the risk to soil dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
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| 83 | Bacillus amyloliquefaciens subsp. plantarum strain D747 Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405 Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234. | Not applicable | Minimum concentration: 2,0 × 1011 CFU/g | 1 April 2015 | 31 August 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 Bacillus amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. | ||||
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| 85 | Fenhexamid CAS No: 126833-17-8 CIPAC No: 603 | N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexane-1-carboxamide | ≥ 975 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: — toluene: max. 1 g/kg, — 4-amino-2,3-dichlorophenol: max. 3 g/kg. | 1 January 2016 | 31 December 2030 | 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 fenhexamid, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators during field crop handheld operations, — the protection of workers re-entering indoor-treated crops, — the risk to aquatic organisms, — the long-term risk to mammals for field uses. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 86 | Halauxifen-methyl CAS No:943831-98-9 CIPAC No: 970.201 (halauxifen-methyl) 970 (halauxifen) | methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)pyridine-2-carboxylate | ≥ 930 g/kg | 5 August 2015 | 5 January 2028 | 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 halauxifen-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: — The risk to aquatic and non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: — The technical specification of the active substance as manufactured (based on commercial scale production). The relevance of impurities present in the technical material should be confirmed, — The compliance of the toxicity batches with the technical specification. The applicant shall submit that information to the Commission, the Member States and the Authority by 5 February 2016. | ||||
| 87 | Pyridate CAS No: 55512-33-9 CIPAC No: 447 | O-6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate | ≥ 900 g/kg | 1 January 2016 | 31 December 2030 | 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 pyridate, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, non-target terrestrial plants, and herbivorous mammals. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 88 | Sulfoxaflor CAS No: 946578-00-3 CIPAC No: 820 | [methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide | ≥ 950 g/kg | 18 August 2015 | 18 January 2028 | Only uses in permanent 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 sulfoxaflor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 May 2015 and updated on 28 January 2022, shall be taken into account. In this overall assessment, Member States shall pay particular attention to the risk to bees and bumble bees released for pollination, when products containing the substance are applied in greenhouses. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 89 | Sulfosulfuron CAS No: 141776-32-1 CIPAC No: 601 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-ethylsulfonylimidazo[1,2-a]pyridine-3-ylsulfonyl)urea | ≥ 980 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: Phenol: < 2 g/kg | 1 January 2016 | 31 December 2030 | 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 sulfosulfuron, and in particular Appendices I and II thereof 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 risk to soil non-target macro-organisms other than earthworms, non-target terrestrial plants and aquatic organisms. | ||||
| 90 | Florasulam CAS No 145701-23-1 CIPAC No 616 | 2′,6′,8-trifluoro-5-methoxy[1,2,4]triazolo[1,5-c]pyrimidine-2-sulfonanilide | ≥ 970 g/kg Impurity: 2,6-DFA, not more than 2 g/kg | 1 January 2016 | 31 December 2030 | 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 florasulam, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 91 | Flupyradifurone CAS No: 951659-40-8 CIPAC No: 987 | 4-[(6-chloro-3-pyridylmethyl)(2,2-difluoroethyl) amino]furan-2(5H)-one | ≥ 960 g/kg | 9 December 2015 | 9 June 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 flupyradifurone, and in particular Appendices I and II thereof, 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 non-target arthropods, aquatic invertebrates and small herbivorous mammals, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — residues in animal matrices and rotational crops. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities, (2) the compliance of the toxicity batches with the confirmed technical specification, (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. The applicant shall submit to the Commission, the Member States and the Authority the information requested under point (1) and (2) by 9 June 2016, the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. | ||||
| 92 | Rescalure CAS No: 67601-06-3 CIPAC No: Not available | (3S,6R)-(3S,6S)-6-isopropenyl-3-methyldec-9-en-1-yl acetate | ≥ 750 g/kg The ratio of (3S,6R)/(3S,6S) shall be in a range of 55/45 to 45/55. The purity range for each isomer shall be 337,5 g/kg to 412,5 g/kg. | 18 December 2015 | 18 May 2028 | 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 rescalure, and in particular Appendices I and II thereof, shall be taken into account. | ||||
| 93 | Mandestrobin CAS No: 173662-97-0 CIPAC No: Not available | (RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide | ≥ 940 g/kg (on a dry weight basis) Xylenes (ortho, meta, para), ethyl benzene max. 5 g/kg (TK) | 9 December 2015 | 9 June 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 mandestrobin, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to aquatic organisms, — 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 technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities; (2) the compliance of the toxicity batches with the confirmed technical specification. The applicant shall submit that information to the Commission, the Member States and the Authority by 9 June 2016. | ||||
| 94 | 2,4-D CAS No: 94-75-7 CIPAC No: 1 | (2,4-dichlorophenoxy) acetic acid | ≥ 960 g/kg Impurities: Free phenols (expressed as 2,4-DCP): not more than 3 g/kg. Sum of dioxins and furans (WHO-TCDD TEQ) [^E0033]: not more than 0,01 mg/kg. | 1 January 2016 | 31 December 2030 | 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 2,4-D, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha. Conditions of use shall include risk mitigation measures, where appropriate. The notifier shall submit to the Commission, the Member States and the Authority: (1) confirmatory information in the form of the submission of the complete study results from the existing extended one-generation study; (2) confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance. The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017. | ||||
| 95 | Pyraflufen-ethyl CAS No 129630-19-9 CIPAC No 605.202 | ethyl [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxy]acetate | ≥ 956 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 pyraflufen-ethyl, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of aquatic organisms, — the protection of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 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 37 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. | ||||
| 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 | 31 December 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 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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| 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. | ||||
| 100 | Isofetamid CAS No: 875915-78-9 CIPAC No: 972 | N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide | ≥ 950 g/kg | 15 September 2016 | 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 isofetamid, 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 operators, workers and aquatic organisms, in particular fish. 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 technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; (2) the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; (3) the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water. The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. | ||||
| 101 | Bacillus amyloliquefaciens strain MBI 600. Accession number in the National Collection of Industrial, Marine and Food Bacteria Ltd (NCIMB), Scotland: NCIMB 12376 Deposit number in the American Type Culture Collection (ATCC): SD-1414 | Not applicable | Minimum concentration: 5,0 × 1014 CFU/kg | 16 September 2016 | 16 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 Bacillus amyloliquefaciens strain MBI 600, 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 specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites; (b) the protection of operators and workers, taking into account that Bacillus amyloliquefaciens strain MBI 600 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. | ||||
| 102 | Ethofumesate CAS No 26225-79-6 CIPAC No 233 | (RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate | ≥ 970 g/kg The following impurities are of toxicological concern and must not exceed the following levels in the technical material: — EMS; ethyl methane sulfonate: maximum of 0,1 mg/kg — iBMS; iso-butyl methane sulfonate: maximum of 0,1 mg/kg | 1 November 2016 | 31 October 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 renewal report on ethofumesate, and in particular Appendices I and II thereof, 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. | ||||
| 103 | Picolinafen CAS No 137641-05-5 CIPAC No 639 | 4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide | ≥ 980 g/kg | 1 November 2016 | 30 June 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 picolinafen, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the impurities in the technical active substance; — the protection of mammals, especially of large herbivorous mammals; — the protection of non-target terrestrial plants; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of aquatic organisms, especially to algae. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 104 | Thifensulfuron-methyl CAS No 79277-27-3 CIPAC No 452 | methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate | ≥ 960 g/kg | 1 November 2016 | 31 October 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 thifensulfuron-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: — the protection of groundwater; — the protection of non-target plants and aquatic organisms. Conditions of use shall include risk mitigation measures and the obligation to monitor the groundwater, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the absence of genotoxicity of metabolites IN-A4098 and its derivative IN-B5528, IN-A5546 and IN-W8268; (2) mechanistic data to rule out an endocrine mediated mode of action for mammary gland tumours; (3) the risk to aquatic organisms from thifensulfuron-methyl and metabolite IN-D8858 and the risk to soil organisms from metabolites IN-JZ789 and 2 acid 3 triuret; (4) the relevance of the metabolites IN-A4098, IN-L9223 and IN-JZ789 if thifensulfuron-methyl is classified as reprotoxic category 2 under Regulation (EC) No 1272/2008 and the risk that those metabolites contaminate groundwater. The applicant shall submit the information requested under point (1) by 31 March 2017, under points (2) and (3) by 30 June 2017 and under point (4) within six months after the notification of the classification decision concerning thifensulfuron-methyl. | ||||
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