Commission Directive 2009/99/EC of 4 August 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include chlorophacinone as an active substance in Annex I thereto (Text with EEA relevance)

• Published date: 05 August 2009
• Subject Matter: Free movement of goods,Internal market - Principles,Approximation of laws,Plant health legislation,Environment
• Official Gazette Publication: Official Journal of the European Union, L 203, 05 August 2009

5.8.2009 EN Official Journal of the European Union L 203/62

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COMMISSION DIRECTIVE 2009/99/EC

of 4 August 2009

amending Directive 98/8/EC of the European Parliament and of the Council to include chlorophacinone 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 chlorophacinone.

(2) Pursuant to Regulation (EC) No 1451/2007, chlorophacinone 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) Spain was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 31 January 2006 in accordance with 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 20 February 2009, in an assessment report.

(5) It appears from the examinations made that biocidal products used as rodenticides and containing chlorophacinone may be expected not to present a risk to humans except for accidental incidents with children. A risk has been identified regarding non-target animals. However, chlorophacinone is for the time being considered essential for reasons of public health and hygiene. It is therefore justified to include chlorophacinone in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing chlorophacinone can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

(6) In the light of the findings of the assessment report, it is necessary to require that specific risk mitigation measures are applied at product authorisation level to products containing chlorophacinone and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans, non-target animals and the environment. To this end, certain constraints such as the maximum concentration, the prohibition on marketing the active substance in products which are not ready to use and the use of aversive agents should be imposed across the board, while other conditions should be

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