Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (Text with EEA relevance)
Modified by
  • 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 2009/146/ECof 26 November 2009correcting Directive 2008/125/EC amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances(Text with EEA relevance), 32009L0146, November 27, 2009
Commission Directive 2008/125/ECof 19 December 2008amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances(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 28 February 2010 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 March 2010.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 aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances by 28 February 2010.By that date they shall in particular verify that the conditions in Annex I to that Directive relating to aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol 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 of that Directive.2.By way of derogation from paragraph 1, for each authorised plant protection product containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2009 at the latest, 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 aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol respectively. 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:(a)in the case of a product containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole or triadimenol as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2014 at the latest; or(b)in the case of a product containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole or triadimenol as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2014 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
Article 4This Directive shall enter into force on 1 September 2009.
Article 5This Directive is addressed to the Member States.
nullANNEXThe following entry shall be added at the end of the table in Annex I to Directive 91/414/ECC:
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
"266Aluminium phosphideCAS No 20859-73-8CIPAC No 227Aluminium phosphide≥ 830 g/kg1 September 200931 August 2019PART AOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use aluminium phosphide containing products may be authorised.As rodenticide, talpicide and leporicide only outdoor uses may be authorised.Authorisations should be limited to professional users.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;the protection of operators and workers during fumigation for indoor uses;the protection of workers at re-entry (after fumigation period) for indoor uses;the protection of bystanders against leaking of gas for indoor uses;the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.
267Calcium phosphideCAS No 1305-99-3CIPAC No 505Calcium phosphide≥ 160 g/kg1 September 200931 August 2019PART AOnly outdoor uses as rodenticide and talpicide in the form of ready-to-use calcium phosphide containing products may be authorised.Authorisations should be limited to professional users.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.
268Magnesium phosphideCAS No 12057-74-8CIPAC No 228Magnesium phosphide≥ 880 g/kg1 September 200931 August 2019PART AOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use magnesium phosphide containing products may be authorised.As rodenticide, talpicide and leporicide only outdoor uses may be authorised.Authorisations should be limited to professional users.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;the protection of operators and workers during fumigation for indoor uses;the protection of workers at re-entry (after fumigation period) for indoor uses;the protection of bystanders against leaking of gas for indoor uses;the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.
269CymoxanilCAS No 57966-95-7CIPAC No 4191-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea≥ 970 g/kg1 September 200931 August 2019PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.
270DodemorphCAS No 1593-77-7CIPAC No 300cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine≥ 950 g/kg1 September 200931 August 2019PART AOnly uses as fungicide on ornamentals in glasshouse may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions;Conditions of authorisation should include risk mitigation measures, where appropriate.
2712,5-Dichlorobenzoic acid methylesterCAS No 2905-69-3CIPAC No 686methyl-2,5-dichlorobenzoate≥ 995 g/kg1 September 200931 August 2019PART AOnly indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
272MetamitronCAS No 41394-05-2CIPAC No 3814-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one≥ 960 g/kg1 September 200931 August 2019PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(1) (b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate;the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to birds and mammals, and non-target terrestrial plants.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.
273SulcotrioneCAS No 99105-77-8CIPAC No 7232-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione≥ 950 g/kgImpurities:hydrogen cyanide: not more than 80 mg/kgtoluene: not more than 4 g/kg1 September 200931 August 2019PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.
274TebuconazoleCAS No 107534-96-3CIPAC No 494(RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol≥ 905 g/kg1 September 200931 August 2019PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;the dietary exposure of consumers to the tebuconazole (triazole) metabolites;the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.The Member States concerned shall request the submission of further information to confirm the risk assessment for birds and mammals. They shall ensure that the notifier at whose request tebuconazole has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
275TriadimenolCAS No 55219-65-3CIPAC No 398(1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol≥ 920 g/kgisomer A (1RS,2SR), isomer B (1RS,2RS)Diastereomer A, RS + SR, range: 70 to 85 %Diastereomer B, RR + SS, range: 15 to 30 %1 September 200931 August 2019PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October shall be taken into account.In this overall assessment Member States must pay particular attention to:the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure;the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriateThe Member States concerned shall ensure that the notifier submits to the Commissionfurther information on the specification;information to further address the risk assessment for birds and mammals.information to further address the risk of endocrine disrupting effects on fish.They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines."
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Further details on identity and specification of active substance are provided in the review report.
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