Commission Directive 2006/132/EC of 11 December 2006 amending Council Directive 91/414/EEC to include procymidone as active substance (Text with EEA relevance)
Modified by
  • Commission Decisionof 29 June 2007correcting Directive 2006/132/EC amending Council Directive 91/414/EEC to include procymidone as active substance(notified under document number C(2007) 3066)(Text with EEA relevance)(2007/452/EC), 32007D0452, June 30, 2007
  • Regulation (EC) No 1107/2009 of the European Parliament and of the Councilof 21 October 2009concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, 32009R1107, November 24, 2009
Commission Directive 2006/132/ECof 11 December 2006amending Council Directive 91/414/EEC to include procymidone as active substance(Text with EEA relevance)
Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2Member States shall adopt and publish by 30 June 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.They shall apply those provisions from 1 July 2007.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 31.Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing procymidone as an active substance by 30 June 2007. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to procymidone are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.2.By derogation from paragraph 1, for each authorised plant protection product containing procymidone, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning procymidone. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.Following that determination Member States shall for products containing procymidone, where necessary, amend or withdraw the authorisation by 30 June 2008.
Article 4This Directive shall enter into force on 1 January 2007.
Article 5This Directive is addressed to the Member States.
nullANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC:
Further details on identity and specification of active substance are provided in the review report.
NoCommon name, identification numbersIUPAC namePurityEntry into forceExpiration of inclusionSpecific provisions
"146ProcymidoneCAS No 32809-16-8CIPAC No 383N-(3,5-dichlorophenyl)-1,2-dimethylcyclopropane-1,2-dicarboximide985 g/kg1 January 200730 June 2008PART AOnly uses as fungicide on the following crops may be authorised:cucumbers in greenhouses (closed hydroponic systems),plums (for processing).at rates not exceeding0,75 kg active substance per hectare per application.The following uses must not be authorised:air application,knapsack and hand-held applications neither by amateur nor by professional users,home gardening.Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:aquatic organisms. Where relevant, an appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,consumers, the acute dietary exposure of which must be controlled,groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures,operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment,workers, who must wear suitable protective clothing, in particular gloves, if they must enter a treated area before the specific re-entry period has expired.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on procymidone, and in particular Appendices I and II thereof, shall be taken into account.Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of procymidone can be obtained.Member States shall request the submission of further confirmatory data and information to prove the acceptability of the active substance when applied in situations where there is a likelihood of long term exposure of wild mammals, and on the sewage treatment applied in the case of greenhouse applications.Member States shall request the submission of further studies to address the potential endocrine disrupting properties of procymidone within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request procymidone has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines."
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Further details on identity and specification of active substance are provided in the review report.
Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2Member States shall adopt and publish by 30 June 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.They shall apply those provisions from 1 July 2007.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 31.Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing procymidone as an active substance by 30 June 2007. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to procymidone are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.2.By derogation from paragraph 1, for each authorised plant protection product containing procymidone, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning procymidone. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.Following that determination Member States shall for products containing procymidone, where necessary, amend or withdraw the authorisation by 30 June 2008.
Article 4This Directive shall enter into force on 1 January 2007.
Article 5This Directive is addressed to the Member States.
nullANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC:
Further details on identity and specification of active substance are provided in the review report.
NoCommon name, identification numbersIUPAC namePurityEntry into forceExpiration of inclusionSpecific provisions
"146ProcymidoneCAS No 32809-16-8CIPAC No 383N-(3,5-dichlorophenyl)-1,2-dimethylcyclopropane-1,2-dicarboximide985 g/kg1 January 200730 June 2008PART AOnly uses as fungicide on the following crops may be authorised:cucumbers in greenhouses (closed hydroponic systems),plums (for processing).at rates not exceeding0,75 kg active substance per hectare per application.The following uses must not be authorised:air application,knapsack and hand-held applications neither by amateur nor by professional users,home gardening.Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:aquatic organisms. Where relevant, an appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,consumers, the acute dietary exposure of which must be controlled,groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures,operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment,workers, who must wear suitable protective clothing, in particular gloves, if they must enter a treated area before the specific re-entry period has expired.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on procymidone, and in particular Appendices I and II thereof, shall be taken into account.Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of procymidone can be obtained.Member States shall request the submission of further confirmatory data and information to prove the acceptability of the active substance when applied in situations where there is a likelihood of long term exposure of wild mammals, and on the sewage treatment applied in the case of greenhouse applications.Member States shall request the submission of further studies to address the potential endocrine disrupting properties of procymidone within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request procymidone has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines."
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Further details on identity and specification of active substance are provided in the review report.