
Article 1 
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2 
The line concerning oryzalin in the Annex to Decision 2008/934/EC is deleted.
Article 3 
Member States shall adopt and publish by 30 November 2011 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 December 2011.
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 4 

1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing oryzalin as an active substance by 30 November 2011.By that date they shall in particular verify that the conditions in Annex I to that Directive relating to oryzalin 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 oryzalin 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 May 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 oryzalin. 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 oryzalin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
(b) in the case of a product containing oryzalin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 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 5 
This Directive shall enter into force on 1 June 2011.
Article 6 
This Directive is addressed to the Member States.
Done at Brussels, 4 March 2011.
For the Commission
The President
José Manuel BARROSO
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
‘334 OryzalinCAS No: 19044-88-3CIPAC No: 537 3,5-dinitro-N4,N4-dipropylsulfanilamide ≥ 960 g/kgN-nitrosodipropylamine:≤ 0,1 mg/kgToluene: ≤ 4 g/kg 1 June 2011 31 May 2021 
PART A Only uses as herbicide may be authorised.

PART B For the implementation of the uniform principles of Annex VI the conclusions of the review report on oryzalin, 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 shall pay particular attention to:

1.. the operator safety and ensure that conditions of use include the application of adequate personal protective equipment;
2.. the protection of aquatic organisms and non-target plants;
3.. the protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions;
4.. the risk to herbivorous birds and mammals;
5.. the risk to bees, in the flowering season.
Conditions of authorisation shall include risk mitigation measures, where appropriate.
The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolites OR13 (2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide) and OR15 (2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide) in vulnerable zones, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards:

1.. the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12;
2.. the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;
3.. the risk assessment for aquatic organisms;
4.. the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, provided that oryzalin becomes classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (OJ L 353, 31.12.2008, p. 1) as “suspected of causing cancer”.
The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points 1 and 2 by 1 December 2011, and the information set out in point 3 by 31 May 2013. The information set out in point 4 shall be submitted within 6 months of notification of a decision classifying oryzalin.’


