(Utkast) Kommisjonens gjennomføringsforordning om forlenget godkjenning av warfarin som et aktivt stoff for bruk i biocidprodukter i produkttype 14
(Draft) Commission Implementing Regulation renewing the approval of warfarin as an active substance for use in biocidal products of product-type 14
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 10.8.2017
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) The active substance warfarin is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
(2) In accordance with Article 13(1) of Regulation (EU) No 528/2012, an application was submitted to the European Chemicals Agency ('the Agency') for the renewal of the approval of that active substance. This application was evaluated by the competent authority of Ireland as the evaluating competent authority.
(3) On 25 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of warfarin to the Agency.
(4) On 16 June 2016, the opinion of the Agency was formulated by its Biocidal Products Committee , having regard to the conclusions of the evaluating competent authority.
(5) According to that opinion, warfarin meets the criteria in Regulation (EC) No 1272/2008 of the European Parliament and of the Council to be classified as toxic for reproduction category 1A. Warfarin therefore meets the exclusion criterion set in Article 5(1)(c) of Regulation (EU) No 528/2012.
(6) In addition, the use of products containing warfarin raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied and therefore warfarin also satisfies the criterion to be a candidate for substitution in accordance with Article 10(1)(e) of that Regulation.
(7) Pursuant to Article 12 of Regulation (EU) No 528/2012, the approval of active substances meeting the exclusion criteria may only be renewed when at least one of the conditions for derogation set out in Article 5(2) of that Regulation continues to be satisfied.
(8) In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation in order to collect relevant information on warfarin, including information on available substitutes.
(9) The Commission also carried out a specific public consultation in order to gather information as to whether the conditions for derogation set out in Article 5(2) of Regulation (EU) No 528/2012 were satisfied. The Commission made the contributions to that consultation publicly available.
(10) The contributions to the two above-mentioned public consultations, as well as the information regarding the availability of alternatives to anticoagulant rodenticides included in Annex 1 to the Commission report on risk mitigation measures for anticoagulant rodenticides , were discussed with Member States in the Standing Committee on Biocidal Products.
(11) Rodents can carry pathogens that are responsible for many zoonoses, which can pose serious dangers for human or animal health. Non-chemical controls or prevention methods for rodent control, such as mechanical, electrical or glue traps, may not be sufficiently efficient and may raise further questions as to whether they are humane or whether they cause unnecessary suffering to rodents. Alternative active substances approved for use as rodenticides may not be suitable for all user categories or efficient for all rodent species. As effective rodent control cannot rely on those non-chemical controls or prevention methods only, warfarin is considered essential to ensure appropriate rodent control in support of those alternatives. As a consequence the use of warfarin would be to prevent or control a serious danger to human and animal health in which rodents are involved. Therefore, the condition set out in Article 5(2)(b) is satisfied.
(12) Rodent control currently relies largely on the use of anticoagulant rodenticides, the non-approval of which could lead to insufficient rodent control. This may not only cause significant negative impacts on human or animal health or the environment, but also affect the public's perception of its safety with regard to exposure to rodents or the security of a number of economic activities that could be vulnerable to rodents, resulting in economic and social consequences. On the other hand, the risks to human health, animal health or the environment arising from use of products containing warfarin can be mitigated if they are used according to certain specifications and conditions. Therefore, the non-approval of warfarin as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance. The condition set out in Article 5(2)(c) is thus also satisfied.
(13) It is therefore appropriate to renew the approval of warfarin for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
(14) Warfarin is a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012 and therefore the period of renewal set out in Article 10(4) of that Regulation should apply.
(15) By Commission Implementing Decision (EU) 2016/135 , the initial expiry date of approval of flocoumafen, brodifacoum and warfarin for use in biocidal products of product-type 14 was postponed until 30 June 2018. As the examination of the applications for the renewal of those approvals is now finalised, it is appropriate to repeal Implementing Decision (EU) (EU) 2016/135.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
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