Commission Directive 2011/79/EU of 20 September 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include fipronil as an active substance in Annex I thereto Text with EEA relevance

• Published date: 21 September 2011
• Subject Matter: Plant health legislation
• Official Gazette Publication: Official Journal of the European Union, L 243, 21 September 2011

21.9.2011 EN Official Journal of the European Union L 243/10

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COMMISSION DIRECTIVE 2011/79/EU

of 20 September 2011

amending Directive 98/8/EC of the European Parliament and of the Council to include fipronil as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

(1) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes fipronil for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to the Directive.

(2) Pursuant to Regulation (EC) No 1451/2007, fipronil has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18.

(3) France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007 on 6 February 2009.

(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 6 May 2011, in an assessment report.

(5) It appears from the evaluations that biocidal products used as insecticides and containing fipronil may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include fipronil in Annex I to that Directive.

(6) Not all potential uses have been evaluated in the Union level assessment, which only addressed professional use indoors by application in locations normally inaccessible to man and domestic animals after application. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when

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