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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
100 versions
· 2011-05-25
2026-01-01
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Changes on 2021-08-01
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| 45 | Oxadiargyl CAS No 39807-15-3 CIPAC No 604 | 5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one | 980 g/kg | 1 July 2003 | 30 June 2013 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate. |
| 46 | Cyazofamid CAS No 120116-88-3 CIPAC No 653 | 4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide | 935 g/kg | 1 July 2003 | 31 July 2021 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms; — Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions. Risk mitigation measures or use restrictions should be applied where appropriate. |
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| 144 | Garlic extract Marker components: diallylsulfide (DAS1), diallyldisulfide (DAS 2), diallyltrisulfide (DAS3), diallyltetrasulfide (DAS 4) CAS No 8000-78-0 8008-99-9 CIPAC No 916 | Garlic extract | 1 000 g/kg | 1 March 2021 | 29 February 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on garlic extract, and in particular Appendices I and II thereto, shall be taken into account. On the basis of the proposed and supported uses (as listed in Appendix II), the following issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate: — The risk to aquatic organisms. |
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| 145 | *Streptomyces* strain K61 | Not applicable | No relevant impurities | 1 July 2021 | 30 June 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on *Streptomyces s*train K61 and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use. Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination (<sup>21</sup>). |
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| 146 | Cyazofamid CAS No: 120116-88-3 CIPAC No: 653 | 4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide | ≥ 935 g/kg | 01/08/2021 | 31/07/2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, 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; (b) the impact of processing on the consumer risk assessment; (c) the protection of non-target arthropods and earthworms. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. 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; 2. points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605. The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. As regards point 2 the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023 |
| (<sup>1</sup>) Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>) 2-hydroxy-4,6-dimethoxypyrimidine. (<sup>3</sup>) 2,4-dihydroxy-6-methoxypyrimidine. (<sup>4</sup>) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (<sup>5</sup>) 5-(trifluoromethyl)-2(1H)-pyridinone. (<sup>6</sup>) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (<sup>7</sup>) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (<sup>8</sup>) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (<sup>9</sup>) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (<sup>10</sup>) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (<sup>11</sup>) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (<sup>12</sup>) 3-phenoxybenzaldehyde. (<sup>13</sup>) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (<sup>14</sup>) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (<sup>15</sup>) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1*H*-pyrazole-4-carboxylic acid. (<sup>16</sup>) 3-chloro-1-methyl-5-sulfamoyl-1*H*-pyrazole-4-carboxylic acid. (<sup>17</sup>) *p*-methyl-phenethylamine. (<sup>18</sup>) OJ L 353, 31.12.2008, p. 1. (<sup>19</sup>) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (<sup>20</sup>) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33). (<sup>21</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>22</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN. (<sup>23</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 | | | | | | |
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original version
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