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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 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
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)
# 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)
#### Article 1
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| 246 | Pyrethrins: 8003-34-7 CIPAC No 32 Extract A: extractives of Chrysanthemum cinerariaefolium: 89997- 63-7 Pyrethrin 1: CAS 121- 21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0 Extract B: Pyrethrin 1: CAS 121-21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0 | Pyrethrins are a complex mixture of chemical substances. | Extract A: ≥ 500 g/kg Pyrethrins Extract B: ≥ 480 g/kg Pyrethrins | 1 September 2009 | 15 June 2026 | 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 pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to operators and workers; (b) the risk to non-target organisms. Conditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures. The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies; (2) the risk from inhalation; (3) the residue definition; (4) the representativeness of the major component ‘pyrethrin 1’ as regards the fate and behaviour in soil and water. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December 2015. |
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| 247 | Quartz sand CAS No: 14808-60-7, 7637-86-9 CIPAC No: 855 | Quartz, Silicon dioxide | ≥ 915 g/kg Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) | 1 September 2009 | 31 August 2023 | PART A Only uses as repellent may be authorised. PART B In assessing applications to authorise plant protection products containing quartz sand for uses other than on trees in forestry, 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 of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
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| 42 | *Trichoderma atroviride* AGR2 | n.a. | The nominal content of *Trichoderma atroviride* AGR2 in the technical product and formulation is Minimal: 5 x 10<sup>11</sup> CFU/kg Nominal: 1 x 10<sup>12</sup> CFU/kg Maximal: 1 x 10<sup>13</sup> CFU/kg No relevant impurities | 22 February 2023 | 21 February 2038 | 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 *Trichoderma atroviride* AGR2 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 specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites; — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be recommended to reduce dermal and inhalation exposure. |
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| 43 | *Trichoderma atroviride* AT10 | n.a. | The nominal content of *Trichoderma atroviride* AT10 in the technical product and formulation is Minimal: 1 x 10<sup>11</sup> CFU/kg Nominal: 5 x 10<sup>11</sup>CFU/kg Maximal: 1 x 10<sup>12</sup> CFU/kg No relevant impurities | 20 February 2023 | 20 February 2038 | 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 *Trichoderma atroviride* AT10 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 used in plant protection products, including full characterisation of relevant secondary metabolites; — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be considered to reduce dermal and inhalation exposure. |
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| 44 | Quartz sand (there is no ISO common name) (1) 7631-86-9 (CAS) (2) 14808-60-7 (CAS) 855 (CIPAC) [*So far they have been indicated as:* CAS No: 14808-60-7 CIPAC No: not allocated] | (1) Silicon dioxide (2) Quartz | 915 g/kg The impurity crystalline silica with a particle diameter ≤ 10 μm is of toxicological concern and shall not exceed a level of 0,1 % of particles in the technical material. | 1 September 2023 | 31 August 2038 | 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 quartz sand, and in particular Appendices I and II thereof, 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. | | | | | | |
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original version
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