
Article 1 
The active substance profoxydim, 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 profoxydim as active substance by 31 January 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 profoxydim 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 July 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 profoxydim as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2013 at the latest; or
(b) in the case of a product containing profoxydim as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2013 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 
Directive 2011/14/EU is repealed.
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 August 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 20 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
 ProfoxydimCAS No 139001-49-3CIPAC No 621 2 - [(1 E/Z) - [(2 R S) – 2 - (4 – chlorophenoxy) propoxyimino] butyl] – 3 – hydroxy – 5 - [(3 R S; 3 S R) – tetrahydro – 2 H – thiopyran – 3 – yl] cyclohex – 2 - enone ≥ 940 g/kg 1 August 2011 31 July 2021 
PART A Only uses as herbicide in rice 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 profoxydim, 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 pay particular attention to:

— the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
— the long-term risk to non-target organisms.
Conditions of authorisation shall include risk mitigation measures where appropriate.


ANNEX II

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

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘2 ProfoxydimCAS No 139001-49-3CIPAC No 621 2 - [(1 E/Z) - [(2 R S) – 2 - (4 – chlorophenoxy) propoxyimino] butyl] – 3 – hydroxy – 5 - [(3 R S; 3 S R) – tetrahydro – 2 H – thiopyran – 3 – yl] cyclohex – 2 - enone ≥ 940 g/kg 1 August 2011 31 July 2021 
PART A Only uses as herbicide in rice 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 profoxydim, 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 pay particular attention to:

— the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
— the long-term risk to non-target organisms.
Conditions of authorisation shall include risk mitigation measures where appropriate.’


