Introductory text

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^f1, and in particular first subparagraph of Article 23(5) thereof,

Whereas:

At the 60th meeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 held on 20 and 21 May 2015, all Member States submitted to the Commission a number of questions to be addressed at Union level in the context of the comparative assessment to be carried out at the renewal of anticoagulant rodenticide biocidal products (‘anticoagulant rodenticides’).

The questions submitted were the following: (a) Is the chemical diversity of the active substances in authorised rodenticides in the Union adequate to minimise the occurrence of resistance in the target harmful organisms?; (b) For the different uses specified in the applications for renewal, are alternative authorised biocidal products or non-chemical means of control and prevention methods available?; (c) Do these alternatives present a significantly lower overall risk for human health, animal health and the environment?; d) Are these alternatives sufficiently effective?; (e) Do these alternatives present no other significant economic or practical disadvantages?

The answers to these questions are relevant for any receiving competent authority for the purpose of deciding whether the criteria in Article 23(3)(a) and (b) of Regulation (EU) No 528/2012 are met and, as a consequence, whether it shall prohibit or restrict the making available on the market or the use of anticoagulant rodenticides.

Pursuant to Article 75(1)(g) of Regulation (EU) No 528/2012, the Commission requested from the European Chemicals Agency (‘Agency’) to formulate an opinion addressing the questions for the different uses that may be authorised in anticoagulant rodenticides according to the conditions and risk mitigation measures referred to in the opinions^f2 adopted by the Biocidal Products Committee of the Agency at its 16^th meeting for the renewal of the active substance approvals.

On 2 March 2017, the Biocidal Products Committee of the Agency adopted its opinion^f3.

According to that opinion, in the absence of anticoagulant rodenticides, the use of rodenticide biocidal products containing other active substances would lead to an inadequate chemical diversity to minimize the occurrence of resistance in the target harmful organisms. These products also showed some significant practical or economical disadvantages for the relevant uses.

The opinion also considered a number of non-chemical control or prevention methods (‘non-chemical alternatives’), which may provide sufficient efficacy in certain circumstances on their own or in a combination of them. However, there is insufficient scientific evidence to prove that those non-chemical alternatives are sufficiently effective according to the criteria established in agreed Union guidance^f4 with a view to prohibit or restrict the authorised uses of anticoagulant rodenticides.

Nevertheless the Commission notes the recommendation in the opinion that the use of non-chemical alternatives is a fundamental part of sustainable pest management for rodent control and proper use of anticoagulant rodenticides in accordance with Article 17(5) of Regulation (EU) No 528/2012.

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

HAS ADOPTED THIS DECISION: