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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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| 103 | Cypermethrin CAS No 52315-07-8 CIPAC No 332 | (RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate (4 isomer pairs: cis-1, cis-2, trans-3, trans-4) | 900 g/kg | 1 March 2006 | 31 October 2019 | PART A Only uses as insecticide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate |
| 104 | Daminozide CAS No 1596-84-5 CIPAC No 330 | N-dimethylaminosuccinamic acid | 990 g/kg Impurities: — N-nitrosodimethylamine: not more than 2,0 mg/kg — 1,1-dimethylhydrazide: not more than 30 mg/kg | 1 March 2006 | 31 October 2019 | PART A Only uses as growth regulator in non-edible crops may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate |
| 105 | Thiophanate-methyl (unstated stereochemistry) CAS No 23564-05-8 CIPAC No 262 | Dimethyl 4,4′-(o-phenylene)bis(3-thioallophanate) | 950 g/kg | 1 March 2006 | 31 October 2019 | 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 thiophanate-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of aquatic organisms, earthworms and other soil macro-organisms. Conditions of authorisation should include risk mitigation measures, where appropriate |
| 106 | Tribenuron CAS No 106040-48-6 (tribenuron) CIPAC No 546 | 2-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid | 950 g/kg (expressed as tribenuron-methyl) | 1 March 2006 | 31 October 2019 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tribenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of non-target terrestrial plants, higher aquatic plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. |
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| 107 | MCPA CAS No 94-74-6 CIPAC No 2 | 4-chloro-o-tolyloxyacetic acid | ≥ 930 g/kg | 1 May 2006 | 31 October 2019 | PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
| 108 | MCPB CAS No 94-81-5 CIPAC No 50 | 4-(4-chloro-o-tolyloxy)butyric acid | ≥ 920 g/kg | 1 May 2006 | 31 October 2019 | PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
| 109 | Bifenazate CAS No 149877-41-8 CIPAC No 736 | Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate | ≥ 950 g/kg | 1 December 2005 | 31 July 2019 | PART A Only uses as acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. |
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| 127 | Pethoxamid CAS No 106700-29-2 CIPAC No 665 | 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide | ≥ 940 g/kg Impurities: Toluene: max 3 g/kg. | 1 December 2018 | 30 November 2033 | PART A Use shall be limited to one application every two years in the same field at a maximum dose of 1 200 g active substance per hectare. 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 renewal report on pethoxamid, 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 risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms and earthworms; — the risk to consumers from residues in the succeeding crops or in case of crop failure. 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 relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council (<sup>19</sup>), in particular as carcinogen category 2; 2. the effect of water treatment processes on the nature of residues present in drinking water; 3. the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action. The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested. The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 (<sup>20</sup>) amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA. |
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| 128 | Tribenuron (parent) CAS No 106040-48-6 CIPAC No 546 | 2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid | ≥ 960 g/kg (expressed as tribenuron-methyl) | 1 February 2019 | 30 January 2034 | 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 tribenuron, 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 consumers, in particular to residues on animal products, — the protection of groundwater, — the protection of aquatic organisms and of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 129 | *Metschnikowia fructicola* strain NRRL Y-27328 Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA | Not applicable | Minimum concentration: 1 × 10<sup>10</sup> CFU/g | 27 December 2018 | 27 December 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 *Metschnikowia fructicola* strain NRRL Y-27328, 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 and workers, taking into account that *Metschnikowia fructicola* strain NRRL Y-27328 is to be considered as a potential sensitizer. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer. 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). | | | | | | |
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| 130 | *Beauveria bassiana* strain IMI389521 Accession number in the CABI Genetic Resource Collection: IMI389521 | Not applicable | Max. level of beauvericin: 0,09 mg/kg | 19 February 2019 | 19 February 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 *Beauveria bassiana* strain IMI389521, 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 storage stability of the formulation(s) containing *B. bassiana* strain IMI389521 including the level of the metabolite beauvericin content after storage; — the content of the metabolite beauvericin produced under the application conditions; — the risk posed by beauvericin in infected insects present in the stored grain. Measures are required to ensure that such products do not enter the food and feed chain, taking into account the natural background level of beauvericin on cereal grains; — the protection of operators and workers, taking into account that *B. bassiana* strain IMI389521 is to be considered, as any micro-organism, as a potential sensitiser. The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>21</sup>). Conditions of use shall include risk mitigation measures where appropriate. |
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| 131 | *Beauveria bassiana* strain PPRI 5339 Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757 | Not applicable | Max. level of beauvericin: 0,5 mg/kg | 20 February 2019 | 20 February 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 *Beauveria bassiana* strain PPRI 5339, 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 level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing *B. bassiana* strain PPRI 5339; — the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval; — the protection of operators and workers, taking into account that *B. bassiana* strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer. The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>21</sup>). 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 | | | | | | |
### PART C
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| 4 | Calcium Hydroxide CAS No 1305-62-0 | Calcium Hydroxide | 920 g/kg Food grade The following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter): Barium 300 mg/kg Fluoride 50 mg/kg Arsenic 3 mg/kg Lead 2 mg/kg. | 1 July 2015 | Calcium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on Calcium Hydroxide (SANCO/10148/2015) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015. |
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| 5 | Vinegar CAS No: 90132-02-8 | Not available | Food grade containing a maximum of 10 % acetic acid. | 1 July 2015 | Only uses as basic substance being a fungicide and bactericide are approved. Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof. |
| 5 | Vinegar CAS No: 90132-02-8 | Not available | Food grade containing a maximum of 10 % acetic acid. | 1 July 2015 | Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof. |
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| 6 | Lecithins CAS No: 8002-43-5 CIPAC No: not allocated Einecs 232-307-2 | Not allocated | As described in the Annex to Regulation (EU) No 231/2012. | 1 July 2015 | Only uses as basic substance being a fungicide are approved. Lecithins shall be used in accordance with the specific conditions included in the conclusions of the review report on lecithins (SANCO/12798/2014) and in particular Appendices I and II thereof. |
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original version
Text at this date