
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 October 2009 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 November 2009.
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 abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances by 31 October 2009.By that date they shall in particular verify that the conditions in Annex I to that Directive relating to abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim 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 abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim 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 April 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 abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim 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 abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2013 at the latest; or
(b) in the case of a product containing abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2013 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 May 2009.
Article 5 
This Directive is addressed to the Member States.
Done at Brussels, 25 November 2008.
For the Commission
Androulla VASSILIOU
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 numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions
‘216 AbamectinCAS No 71751-41-2avermectin B1aCAS No 65195-55-3Avermectin B1bCAS No 65195-56-4abamectinCIPAC No 495 AvermectinB1a(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranosideAvermectinB1b(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside ≥ 850 g/kg 1 May 2009 30 April 2019 
PART A Only uses as insecticide, acaricide.

PART B In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information are provided before such an authorisation is granted.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on (abamectin), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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,
— the residues in food of plant origin and evaluate the dietary exposure of consumers,
— the protection of bees, non-target arthropods, birds, mammals and aquatic organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, waiting periods, should be applied where appropriate.
The Member States concerned shall request the submission of:

— further studies on the specification,
— information to further address the risk assessment for birds and mammals,
— information to address the risk to aquatic organisms with respect to the major soil metabolites,
— information to address the risk to groundwater with respect to the metabolite U8.
They shall ensure that the notifiers provide such studies to the Commission within two years from the entry into force of this Directive.

217 EpoxiconazoleCAS No 135319-73-2 (formerly 106325-08-0)CIPAC No 609 (2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole ≥ 920 g/kg 1 May 2009 30 April 2019 
PART A Only uses as fungicide may be authorised.

PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 dietary exposure of consumers to the epoxiconazole (triazole) metabolites,
— the potential for long-range transport via air,
— the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.
The Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
The Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest.
The concerned Member States shall ensure that the notifier submits within two years from the entry into force of this Directive, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals.

218 FenpropimorphCAS No 67564-91-4CIPAC No 427 (RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine ≥ 930 g/kg 1 May 2009 30 April 2019 
PART A Only uses as fungicide may be authorised.

PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.
In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate,
— 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. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles.
The Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

219 FenpyroximateCAS No 134098-61-6CIPAC No 695 tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate > 960 g/kg 1 May 2009 30 April 2019 
PART A Only uses as acaricide may be authorised.
The following uses must not be authorised:

— applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications.

PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
The Member States concerned shall request the submission of information to further address:

— the risk to aquatic organisms from metabolites containing the benzyl moiety,
— the risk of biomagnification in aquatic food chains.
They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the entry into force of this Directive.

220 TralkoxydimCAS No 87820-88-0CIPAC No 544 (RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one ≥ 960 g/kg 1 May 2009 30 April 2019 
PART A Only uses as herbicide may be authorised.

PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.
In this overall assessment Member States must pay particular attention to:

— the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
— the protection of herbivorous mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of:

— information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim.
They shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the entry into force of this Directive.’


