# L_2016025EN.01006501.xml

| 2.2.2016 | EN | Official Journal of the European Union | L 25/65 |
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2.2.2016

EN

Official Journal of the European Union

L 25/65

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COMMISSION IMPLEMENTING DECISION (EU) 2016/135

of 29 January 2016

postponing the expiry date of approval of flocoumafen, brodifacoum and warfarin for use in biocidal products for product-type 14

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,

Whereas:

| (1) | The active substances flocoumafen, brodifacoum and warfarin were included into Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products for product-type 14, and pursuant to Article 86 of Regulation (EU) No 528/2012 are considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive. |
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(1)

The active substances flocoumafen, brodifacoum and warfarin were included into Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products for product-type 14, and pursuant to Article 86 of Regulation (EU) No 528/2012 are considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.

| (2) | Their 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. |
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(2)

Their 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.

| (3) | 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. |
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(3)

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.

| (4) | 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. |
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(4)

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.

| (5) | The possibility should be given to the applicants for the renewal of approval of those 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. |
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(5)

The possibility should be given to the applicants for the renewal of approval of those 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.

| (6) | 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 flocoumafen, brodifacoum and warfarin should be performed in parallel to the assessment of the other anticoagulant rodenticides. |
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(6)

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 flocoumafen, brodifacoum and warfarin should be performed in parallel to the assessment of the other anticoagulant rodenticides.

| (7) | 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. |
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(7)

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.

| (8) | 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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(8)

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.

| (9) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DECISION:

Article 1

The expiry date of approval of flocoumafen, brodifacoum and warfarin for use in biocidal products for product-type 14 is postponed to 30 June 2018.

Article 2

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 29 January 2016.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  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 (OJ L 123, 24.4.1998, p. 1).

2

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