
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 azadirachtin in the Annex to Decision 2008/941/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 azadirachtin 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 azadirachtin 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 azadirachtin 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 30 April 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 azadirachtin. 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 azadirachtin 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 azadirachtin 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, 13 April 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/EC:

No Common Name, Identification Numbers IUPAC Name Purity Entry into force Expiration of inclusion Specific provisions
‘350 AzadirachtinCAS No: 11141-17-6 as azadirachtin ACIPAC No: 627 as azadirachtin A Azadirachtin A:dimethyl (2aR,3S,4S,4aR,5S,7aS,8S,10R,10aS,10bR)-10-acetoxy-3,5-dihydroxy-4-[(1aR,2S,3aS,6aS,7S,7aS)-6a-hydroxy-7a-methyl-3a,6a,7,7a-tetrahydro-2,7-methanofuro[2,3-b]oxireno[e]oxepin-1a(2H)-yl]-4-methyl-8-{[(2E)-2-methylbut-2-enoyl]oxy}octahydro-1H-naphtho[1,8a-c:4,5-b′c′]difuran-5,10a(8H)-dicarboxylate. Expressed as azadirachtin A:≥ 111 g/kgSum of the aflatoxins B1, B2, G1 and G2 must not exceed 300 μg/kg of the azadirachtin A content. 1 June 2011 31 May 2021 
PART A Only uses as insecticide may be authorised.

PART B For the implementation of the uniform principles of Annex VI the conclusions of the review report on azadirachtin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:

— the dietary exposure of consumers in view of future revisions of Maximum Residue Levels,
— the protection of non-target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate.
The Member States concerned shall request the submission of confirmatory information as regards:

— the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment.
The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013.’


