Commission Directive 2010/91/EU of 10 December 2010 amending Council Directive 91/414/EEC to include metosulam as active substance and amending Decision 2008/934/EC Text with EEA relevance

• CELEX: Directive 2010/91/EU
• Articles: 7

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2

The line concerning metosulam in the Annex to Decision 2008/934/EC is deleted.

Article 3

Member States shall adopt and publish by 31st October 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 November 2011.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 4

1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing metosulam as an active substance by 1 November 2011. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to metosulam are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing metosulam as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning metosulam. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

(a)

in the case of a product containing metosulam as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or

(b)

in the case of a product containing metosulam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 5

This Directive shall enter into force on 1 May 2011.

Article 6

This Directive is addressed to the Member States.

Schedules & Appendices

ANNEX

ANNEX

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

No

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Entry into force

Expiration of inclusion

Specific provisions

‘317

Metosulam

CAS No: 139528-85-1

CIPAC No: 707

2′,6′-dichloro-5,7-dimethoxy-3′-methyl[1,2,4]triazolo

[1,5-a]pyrimidine-2-sulfonanilide

≥ 980 g/kg

1 May 2011

30 April 2021

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metosulam, 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 protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

—

the risk to aquatic organisms;

—

the risk to non-target plants in the off-field area.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the applicant submits to the Commission, by 30 October 2011, further information on the specification of the active substance as manufactured.

The Member States concerned shall ensure that the applicant submits to the Commission, by 30 April 2013, confirmatory information as regards:

—

potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02;

—

potential genotoxicity of one impurity.’

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