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Commission Directive 2007/52/ECShow full title

Commission Directive 2007/52/EC of 16 August 2007 amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances (Text with EEA relevance)

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Further details on identity and specification of active substance are provided in the review report.

NoCommon name, identification NosIUPAC NamePurityaEntry into forceExpiration of inclusionSpecific provisions
‘161

ethoprophos

CAS No: 13194-48-4

CIPAC No: 218

O-ethyl S,S-dipropyl phosphorodithioate> 940 g/kg1 October 200730 September 2017

PART A

Only uses as nematicide and insecticide in soil application can be authorised.

Authorisations should be limited to professional users.

PART B

In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, 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 ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

  • the residues and evaluate the dietary exposure of consumers in view of future revisions of Maximum Residue Levels,

  • the operator safety. Authorised conditions of use must prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of closed transfer system for the distribution of the product,

  • the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil.

The concerned Member States shall request the submission of further studies to confirm the short and long term risk assessment for birds and for earthworms eating mammals. They shall ensure that the notifiers at whose request ethoprophos has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

162

pirimiphos-methyl

CAS No: 29232-93-7

CIPAC No: 239

O-2-diethylamino-6-methylpyrimidin-4-yl

O,O-dimethylphosphorothioate

> 880 g/kg1 October 200730 September 2017

PART A

Only uses as insecticide for post-harvest storage can be authorised.

PART B

In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, 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 pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

  • the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure,

  • the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

The Member States concerned shall request the submission of further studies to confirm the operator exposure assessment. They shall ensure that the notifiers at whose request pirimiphos-methyl has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

163

Fipronil

CAS No: 120068-37-3

CIPAC No: 581

(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile≥ 950 g/kg1 October 200730 September 2017

PART A

Only uses as insecticide for use as seed treatment may be authorised. The seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to:

  • the packaging of the marketed products to avoid the generation of photo-degradation products of concern,

  • the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

  • the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees,

  • the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application.

Conditions of authorisation should include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds and mammals, and honey bees, especially bee brood. They shall ensure that the notifier at whose request fipronil has been included in this Annex provide such studies to the Commission within one year from the entry into force of this Directive.’

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