Commission Directive 2010/58/EU of 23 August 2010 amending Council Directive 91/414/EEC as regards an extension of the use of the active substance iprodione  Text with EEA relevance
Date: 2010-08-23
Institutions: European Commission
Subjects: administrative formalities, chemical product, disclosure of information, health risk, marketing, pharmaceutical product, plant health control, plant health product, toxic substance








L_2010221EN.01001201.xml










24.8.2010   


EN


Official Journal of the European Union


L 221/12








            COMMISSION DIRECTIVE 2010/58/EU
of 23 August 2010
         
amending Council Directive 91/414/EEC as regards an extension of the use of the active substance iprodione
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof,

Whereas:







(1)


By Commission Directive 2003/31/EC (2) iprodione was included as active substance in Annex I to Directive 91/414/EEC.












(2)


When applying for the inclusion of iprodione its sole notifier Bayer submitted data on uses as fungicide which supported the overall conclusion that it may be expected that plant protection products containing iprodione will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.












(3)


In addition to that use, another notifier Devgen has applied for an amendment to allow iprodione to be used as nematicide. In order to support such an extension of the use, the notifier Devgen submitted additional information.












(4)


France has evaluated the information submitted and informed the Commission on 12 January 2010 about its conclusions that the requested extension of use does not cause any risks in addition to those already taken into account in the specific provisions for iprodione in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. In particular, France has prepared several addenda to the assessment report in the concerned areas of the risk assessment, whose conclusions confirm the acceptability of such extension of use.












(5)


Therefore, it is justified to modify the specific provisions for iprodione.












(6)


It is therefore appropriate to amend Directive 91/414/EEC accordingly.












(7)


The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,





HAS ADOPTED THIS DIRECTIVE:



Article 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.


Article 2
Member States shall adopt and publish by 24 December 2010 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 25 December 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall 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 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.


Article 4
This Directive is addressed to the Member States.




Done at Brussels, 23 August 2010.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 230, 19.8.1991, p. 1.

(2)  
            OJ L 101, 23.4.2003, p. 3.




ANNEX
In Annex I to Directive 91/414/EEC, row 50 is replaced by the following:












No


Common name, identification numbers


IUPAC name


Purity (1)



Entry into force


Expiration of inclusion


Specific provisions




‘50


Iprodione
CAS No 36734-19-7
CIPAC No 278


3-(3,5-dichlorophenyl)-Nisopropyl-2,4-dioxo-imidazolidine-1-carboximide


960  g/kg


1 January 2004


31 December 2013


Only uses as fungicide and nematicide may be authorised.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States:






—


should pay particular attention to the potential for groundwater contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions,










—


must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate.’











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