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EU proposes to postpone expiry date of approval for three rodenticidesqrcode

Jan. 14, 2016

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Jan. 14, 2016
The EU Standing Committee on Biocidal Products proposed to postpone the expiry date of approval of flocoumafen, brodifacoum and warfarin for use in biocidal products as rodenticide.
 
Approval will expire on 30 September 2016 for flocoumafen and 31 January 2017 for brodifacoum and warfarin. In accordance with Article 13(1) of Regulation (EU) No 528/2012, applications have been submitted for the renewal of the approval of these active substances.
 
Because of the risks identified when using the active substances flocoumafen, brodifacoum and warfarin, the renewal of their approval is subject to an assessment of an alternative active substance or substances. In addition, due to those risks, the approval of those active substances may be renewed only if it is shown that at least one of the conditions of the first subparagraph of Article 5(2) of Regulation (EU) No 528/2012 is fulfilled.
 
The Commission has launched a study on the risk-mitigation measures that may be applied to anticoagulant rodenticides with a view to proposing the measures that are most suitable for mitigating the risks associated to the properties of those active substances.
 
The possibility should be given to the applicants for the renewal of approval of these active substances to address the conclusions of the study in their application. Furthermore, the conclusions of that study should be taken into account when deciding on the renewal of the approval of all anticoagulant rodenticides.
 
In order to facilitate the review and comparison of the risks and benefits of all anticoagulant rodenticides as well as of the risk-mitigation measures applied to them, the assessment of these active substances should be performed in parallel to the assessment of the other anticoagulant rodenticides.
 
Consequently, for reasons beyond the control of the applicants, the approval of flocoumafen, brodifacoum and warfarin is likely to expire before a decision has been taken on a possible renewal of their approval. It is, therefore, appropriate to postpone the expiry date of approval of those active substances for a period of time sufficient to enable the examination of the applications.
 
Except for the expiry date of the approval, those substances should remain approved subject to the specifications and conditions set out in Annex I to Directive 98/8/EC.


 

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