Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance (Text with EEA relevance) (c. 133)

ANNEXU.K.

The following entries 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
‘147	Flusilazole CAS No 85509-19-9 CIPAC No 435	Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane	925 g/kg	1 January 2007	30 June 2008	PART A Only uses as fungicide on the following crops may be authorised: cereals other than rice, maize, rape seed, sugar beet, at rates not exceeding 200 g active substance per hectare per application. The following uses must not be authorised: air application, knapsack and hand-held applications, neither by amateur nor by professional users, home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account. Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained. Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.’

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

‘147

Flusilazole

CAS No 85509-19-9

CIPAC No 435

Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane

925 g/kg

1 January 2007

30 June 2008

PART A

Only uses as fungicide on the following crops may be authorised:

cereals other than rice,
maize,
rape seed,
sugar beet,

at rates not exceeding 200 g active substance per hectare per application.

The following uses must not be authorised:

air application,
knapsack and hand-held applications, neither by amateur nor by professional users,
home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,
birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,
operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account.

Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained.

Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.’