
Article 1 
The active substance oxyfluorfen, 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 oxyfluorfen 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 oxyfluorfen 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 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 oxyfluorfen 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 oxyfluorfen 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 
The line concerning oxyfluorfen in the Annex to Decision 2008/934/EC is deleted.
Article 5 
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, 9 August 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
OxyfluorfenCAS No 42874-03-3CIPAC No 538 2-chloro-α,α,α-trifluoro-p-tolyl 3-ethoxy-4-nitrophenyl ether ≥ 970 g/kgImpurities:N,N-dimethylnitrosamine: not more than 50 μg/kg 1 January 2012 31 December 2021 
PART A Only uses as herbicide for banded applications close to ground from autumn to early spring 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 oxyfluorfen, 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:

((a)) pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;
((b)) pay particular attention to the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:

((1)) the specification of the technical material, as commercially manufactured including information on the relevance of the impurities;
((2)) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;
((3)) the potential risk to aquatic organisms for the active substance and for the metabolites RH-45469, MW 306, MW 347, MW 274 and for the unidentified metabolite Deg 27;
((4)) the potential risk from bioaccumulation and biomagnification in the aquatic food chain, including sediment dwellers;
((5)) exposure data for banded application adequate for use as drift mitigation values.
The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3) to (5) by 31 December 2013.






ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

‘11 OxyfluorfenCAS No 42874-03-3CIPAC No 538 2-chloro-α,α,α-trifluoro-p-tolyl 3-ethoxy-4-nitrophenyl ether ≥ 970 g/kgImpurities:N,N-dimethylnitrosamine: not more than 50 μg/kg 1 January 2012 31 December 2021 
PART A Only uses as herbicide for banded applications close to ground from autumn to early spring 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 oxyfluorfen, 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:

((a)) pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;
((b)) pay particular attention to the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:

((1)) the specification of the technical material, as commercially manufactured including information on the relevance of the impurities;
((2)) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;
((3)) the potential risk to aquatic organisms for the active substance and for the metabolites RH-45469, MW 306, MW 347, MW 274 and for the unidentified metabolite Deg 27;
((4)) the potential risk from bioaccumulation and biomagnification in the aquatic food chain, including sediment dwellers;
((5)) exposure data for banded application adequate for use as drift mitigation values.
The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3) to (5) by 31 December 2013.





