
Article 1 
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2 
Member States shall adopt and publish by 31 March 2008 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 April 2008.
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 3 

1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing ethoprophos, pirimiphos-methyl and fipronil as active substances by 31 March 2008.By that date they shall in particular verify that the conditions in Annex I to that Directive relating to ethoprophos, pirimiphos-methyl and fipronil 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 ethoprophos, pirimiphos-methyl and fipronil 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 30 September 2007 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 ethoprophos, pirimiphos-methyl and fipronil 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 ethoprophos, pirimiphos-methyl or fipronil as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or
(b) in the case of a product containing ethoprophos, pirimiphos-methyl or fipronil as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 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 4 
This Directive shall enter into force on 1 October 2007.
Article 5 
This Directive is addressed to the Member States.
Done at Brussels, 16 August 2007.
For the Commission
Markos KYPRIANOU
Member of the Commission
ANNEX

The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

No Common name, identification Nos IUPAC Name Purity Entry into force Expiration of inclusion Specific provisions
‘161 ethoprophosCAS No: 13194-48-4CIPAC No: 218 O-ethyl S,S-dipropyl phosphorodithioate > 940 g/kg 1 October 2007 30 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-methylCAS No: 29232-93-7CIPAC No: 239 O-2-diethylamino-6-methylpyrimidin-4-ylO,O-dimethylphosphorothioate > 880 g/kg 1 October 2007 30 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 FipronilCAS No: 120068-37-3CIPAC No: 581 (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile ≥ 950 g/kg 1 October 2007 30 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.’


