
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 August 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 September 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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as active substances by 31 August 2009.By that date they shall in particular verify that the conditions in Annex I to that Directive relating to flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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 28 February 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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2013 at the latest; or
(b) in the case of a product containing flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 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 March 2009.
Article 5 
This Directive is addressed to the Member States.
Done at Brussels, 26 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
‘193 FlutolanilCAS No 66332-96-5CIPAC No 524 α,α,α-trifluoro-3′-isopropoxy-o-toluanilide ≥ 975 g/kg 1 March 2009 28 February 2019 
PART A Only uses as fungicide may be authorised.

PART B In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, 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 flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
In this overall assessment Member States must pay particular attention to:

— the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
Conditions of authorisation should include risk mitigation measures, where appropriate.

194 BenfluralinCAS No 1861-40-1CIPAC No 285 N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine ≥ 960 g/kgImpurities:
— ethyl-butyl-nitrosamine: max. 0,1 mg/kg 1 March 2009 28 February 2019 
PART A Only uses as herbicide may be authorised.

PART B In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, 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 benfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
In this overall assessment Member States must pay particular attention to:

— the protection of the operators' safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,
— the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,
— the protection of birds, mammals, surface waters and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.
The Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

195 FluazinamCAS No 79622-59-6CIPAC No 521 3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine ≥ 960 g/kgImpurities:5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine
— not more than 2 g/kg 1 March 2009 28 February 2019 
PART A Only uses as fungicide may be authorised.

PART B In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, 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 fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
In this overall assessment Member States must pay particular attention to:

— the protection of 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,
— the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,
— the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.
The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

196 FuberidazoleCAS No 3878-19-1CIPAC No 525 2-(2′-furyl)benzimidazole ≥ 970 g/kg 1 March 2009 28 February 2019 
PART A Only uses as fungicide may be authorised.

PART B In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, 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 fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 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,
— long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply.
Conditions of use shall include adequate risk mitigation measures, where appropriate.

197 MepiquatCAS No 15302-91-7CIPAC No 440 1,1-dimethylpiperidinium chloride (mepiquat chloride) ≥ 990 g/kg 1 March 2009 28 February 2019 
PART A Only uses as plant growth regulator may be authorised.

PART B In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, 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 mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.’


