Commission Directive 2009/93/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include alphachloralose as an active substance in Annex I thereto (Text with EEA relevance)

Published date01 August 2009
Subject MatterPlant health legislation,Environment,Approximation of laws,Internal market - Principles,Free movement of goods
Official Gazette PublicationOfficial Journal of the European Union, L 201, 01 August 2009
L_2009201EN.01004601.xml
1.8.2009 EN Official Journal of the European Union L 201/46

COMMISSION DIRECTIVE 2009/93/EC

of 31 July 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 alphachloralose.
(2) Pursuant to Regulation (EC) No 1451/2007, alphachloralose has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.
(3) Portugal was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 November 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(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 30 May 2008, in an assessment report.
(5) It appears from the examinations made that biocidal products used as rodenticides and containing alphachloralose may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include alphachloralose in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing alphachloralose can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
(6) Not all potential uses have been evaluated at the Community level. It is therefore appropriate that Member States assess those risks to the compartments and populations that have not been representatively addressed in the Community level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels.
(7) In the light of the conclusions of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing alphachloralose and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals as well as the long-term effects of the substance on the environment.
(8) It is important that the
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