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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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2025-11-16
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2025-07-28
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Changes on 2025-05-28
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| 135 | carvone 2244-16-8 (d-carvone = S-carvone = (+)-carvone) Carvone: 602 d-carvone: not allocated | (*S*)-5-isopropenyl-2-methylcyclohex-2-en-1-one Or (S)-p-mentha-6,8-dien-2-one | 923 g/kg d-carvone | 1 August 2019 | 31 July 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 carvone, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment. Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: — the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water. The applicant shall submit that information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
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| 136 | 1-methylcyclopropene CAS No 3100-04-7 CIPAC No 767 | 1-methylcyclopropene | ≥ 980 g/kg (technical concentrate) The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate): — 1-chloro-2-methylpropene: maximum of 0,2 g/kg, — 3-chloro-2-methylpropene: maximum of 0,2 g/kg. For 1-methylcyclopropene generated *in situ*, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %. | 1 August 2019 | 31 July 2034 | Only uses as plant growth regulator for post-harvest storage in sealable warehouse 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 renewal report on 1-methycyclopropene, and in particular Appendices I and II thereto, shall be taken into account. |
| 136 | 1-methylcyclopropene CAS No 3100-04-7 CIPAC No 767 | 1-methylcyclopropene | ≥ 980 g/kg (technical concentrate) The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate): — 1-chloro-2-methylpropene: maximum of 0,2 g/kg, — 3-chloro-2-methylpropene: maximum of 0,2 g/kg. For 1-methylcyclopropene generated *in situ*, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %. | 1 August 2019 | 31 July 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 review report on 1-methylcyclopropene, 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, when the substance is applied in regions with vulnerable soil and climatic conditions. 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 presence of methallyl alcohol in soil and aquatic compartments and, if formed in relevant amounts, information on its toxicological properties and potential risk to aquatic and soil organisms and as regards the effect of water treatment processes on the nature of residues present in drinking water. The confirmatory information shall be submitted by 27 May 2027. |
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| 137 | Dimethenamid-P CAS No 163515-14-8 CIPAC No 638 | (S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide | ≥ 930 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: 1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg | 1 September 2019 | 31 August 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 dimethenamid-P, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of groundwater, in particular regarding the metabolites of dimethenamid-P; — the protection of aquatic organisms and small herbivorous mammals. 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 effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water. The applicant shall submit the requested information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
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| 50 | *Bacillus subtilis* RTI477 | Not applicable | No relevant impurities | 12 February 2025 | 12 February 2040 | 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 subtilis* RTI477, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, taking into account that microorganisms per se are considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use, — the strict maintenance by the producer of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (<sup>9</sup>) Conditions of use shall include risk mitigation measures, where appropriate. |
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| 51 | *Bacillus velezensis* RTI301 | Not applicable | No relevant impurities | 12 February 2025 | 12 February 2040 | 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 velezensis* RTI301, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use; — the strict maintenance by the producer of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (<sup>9</sup>). Conditions of use shall include risk mitigation measures, where appropriate. |
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| 52 | Elemental iron CAS No: 7439-89-6 CIPAC No: - | Iron | ≥ 989 g/kg of total iron The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: Arsenic: Max 0,003 g/kg Mercury: Max 0,001 g/kg Lead: Max 0,01 g/kg | 26.5.2025 | 26.5.2040 | 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 elemental iron, and in particular Appendices I and II thereto, shall be taken into account. 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>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>3</sup>) Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127). (<sup>4</sup>) The concerned active substance was initially approved as *Verticillium lecanii*, but later, for scientific reasons, its name was changed to *Lecanicillium muscarium* strain Ve6, which was later changed again to the name under which the approval was renewed, *Akanthomyces muscarius* strain Ve6. (<sup>5</sup>) https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>6</sup>) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10). (<sup>7</sup>) Expressed in World Health Organisation (WHO) toxic equivalents. (<sup>8</sup>) Organisation for Economic Cooperation and Development (2014), OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products, Series on Pesticides and Biocides, No 65, OECD Publishing, Paris, https://doi.org/10.1787/9789264221642-en. (<sup>9</sup>) Organisation for Economic Cooperation and Development (OECD): https://doi.org/10.1787/9789264221642-en. | | | | | | |
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original version
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