Commission Directive 2010/57/EU of 26 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of imazalil as active substance (Text with EEA relevance) (repealed) (c. 57)

ANNEXU.K.

In Annex I to Directive 91/414/EEC, row No 1 is replaced by the following:

^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
‘1	imazalil CAS No 35554-44-0 73790-28-0 (replaced) CIPAC No 335	(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole or allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether	≥ 950 g/kg	1 August 2011	31 July 2021	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 July 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out, risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular confirmatory data on: route of degradation of imazalil in soil and surface water systems, environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible, a hydrolysis study to investigate the nature of residues in processed commodities. They shall ensure that the notifier provides such information to the Commission by 31 October 2012.’

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

‘1

imazalil

CAS No 35554-44-0

73790-28-0 (replaced)

CIPAC No 335

(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole

allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether

≥ 950 g/kg

1 August 2011

31 July 2021

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 July 2010 shall be taken into account.

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

the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,
the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels,
the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,
ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out,
risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular confirmatory data on:

route of degradation of imazalil in soil and surface water systems,
environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible,
a hydrolysis study to investigate the nature of residues in processed commodities.

They shall ensure that the notifier provides such information to the Commission by 31 October 2012.’