
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 January 2012 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 February 2012.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall 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 profoxydim as active substance by 31 January 2012. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to profoxydim are met, with the exception of those identified in Part B of the entry concerning the 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(2) of that Directive.
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 Annex I to Directive 91/414/EEC by 31 July 2011 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 profoxydim. 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 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 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 August 2011.
Article 5 
This Directive is addressed to the Member States.
Done at Brussels, 24 February 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX

In Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

No Common Name, Identification Numbers IUPAC Name Purity Entry into force Expiration of inclusion Specific provisions
‘330 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 of Annex VI, 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 28 January 2011 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,
— the long term risk to non-target organisms.
Conditions of authorisation shall include risk mitigation measures where appropriate.’


