# Commission Implementing Directive 2011/44/EU of 13 April 2011 amending Council Directive 91/414/EEC to include azadirachtin as active substance and amending Commission Decision 2008/941/EC (Text with EEA relevance), Annex

Extent: E+W+S+N.I.

The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:
Further details on identity and specification of active substance are provided in the review report.
No
Common Name, Identification Numbers
IUPAC Name
Purity
Entry into force
Expiration of inclusion
Specific provisions
‘350
Azadirachtin
CAS No: 11141-17-6 as azadirachtin A
CIPAC 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/kg
Sum 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.’

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Source: https://www.legislation.gov.uk/eudr/2011/44/annex (the official version)
Page: https://openlegislation.uk/eu-directive-2011-44/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.