ANNEXU.K.

The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:

^a Further details on identity and specification of active substance are provided in the review report.
No	Common Name, Identification Numbers	IUPAC Name	Purity^a	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.’

Further details on identity and specification of active substance are provided in the review report.

Common Name, Identification Numbers

IUPAC Name

Purity^a

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.’