
Article 1 
The active substance fluroxypyr, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2 

1. Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing fluroxypyr as an active substance by 30 June 2012.By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing fluroxypyr as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product still satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.Following that determination Member States shall:
(a) in the case of a product containing fluroxypyr as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or
(b) in the case of a product containing fluroxypyr as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
Article 3 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 4 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 26 July 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
FluroxypyrCAS No 69377-81-7CIPAC No 431 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid ≥ 950 g/kg(fluroxypyr-meptyl) 1 January 2012 31 December 2021 
PART A Only uses as herbicide may be authorised.

PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
In this overall assessment Member States shall:

((1)) pay particular attention to the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil and/or with vulnerable climatic conditions;
((2)) pay particular attention to the risk to aquatic organisms.
Conditions of authorisation shall include risk mitigation measures, where appropriate.
The notifier shall submit confirmatory information as regards:

((a)) the relevance of the impurities present in the technical specifications;
((b)) the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;
((c)) the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr methoxypyridine;
((d)) the residue analytical methods for plants;
((e)) the fate of fluroxypyr esters in animal matrices;
((f)) the long-term risk for earthworms and soil organisms.
The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) and (b) by 1 July 2012 and the information set out in points (c), (d), (e) and (f) by 31 December 2013.


ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

((1)) in Part A, the entry relating to fluroxypyr is deleted;
((2)) in Part B, the following entry is added:

No Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘9 FluroxypyrCAS No 69377-81-7CIPAC No 431 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid ≥ 950 g/kg(fluroxypyr-meptyl) 1 January 2012 31 December 2021 
PART A Only uses as herbicide may be authorised.

PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
In this overall assessment Member States shall:

((1)) pay particular attention to the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil and/or with vulnerable climatic conditions;
((2)) pay particular attention to the risk to aquatic organisms.
Conditions of authorisation shall include risk mitigation measures, where appropriate.
The notifier shall submit confirmatory information as regards:

((a)) the relevance of the impurities present in the technical specifications;
((b)) the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;
((c)) the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr methoxypyridine;
((d)) the residue analytical methods for plants;
((e)) the fate of fluroxypyr esters in animal matrices;
((f)) the long-term risk for earthworms and soil organisms.
The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) and (b) by 1 July 2012 and the information set out in points (c), (d), (e) and (f) by 31 December 2013.’


