Commission Directive 2010/90/EU of 7 December 2010 amending Council Directive 91/414/EEC to include pyridaben as active substance and amending Decision 2008/934/EC (Text with EEA relevance) (c. 90)

ANNEXU.K.

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

^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
‘318	Pyridaben CAS No: 96489-71-3 CIPAC No: 583	2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one	> 980 g/kg	1 May 2011	30 April 2021	PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, the risk to aquatic organisms and mammals, the risk to non target arthropods including honeybees. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate. The Member States concerned shall request the submission of confirmatory information as regards: the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3, the potential long term risk for mammals, the assessment of fat soluble residues. They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 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

‘318

Pyridaben

CAS No: 96489-71-3

CIPAC No: 583

2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one

> 980 g/kg

1 May 2011

30 April 2021

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,
the risk to aquatic organisms and mammals,
the risk to non target arthropods including honeybees.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,
the potential long term risk for mammals,
the assessment of fat soluble residues.

They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.’