ANNEX

Information addressing the questions referred by Member States to the Commission concerning the comparative assessment of anticoagulant rodenticide biocidal products.

For the purpose of those questions, the specified uses referred to in Article 23(3)(a) of Regulation (EU) No 528/2012 are listed in Table 1.

Table 1

Specified uses for anticoagulant rodenticides

Question (a): Is the chemical diversity of the active substances in authorised rodenticides in the EU adequate to minimise the occurrence of resistance in the target harmful organisms?

There are five approved active substances in biocidal products for product-type 14 with a mode of action different from that of anticoagulant rodenticides (alpha chloralose, aluminium phosphide releasing phosphine, carbon dioxide, hydrogen cyanide and powdered corn cob).

According to the opinion, the minimum requirement in agreed Union guidance of having three different alternatives with a different mode of action is not reached for any of the specified uses listed in Table 1. Therefore, in the absence of anticoagulant rodenticides, the condition in Article 23(3)(b) of Regulation (EU) No 528/2012 that the chemical diversity of the active substances is adequate to minimize the occurrence of resistance in the target harmful organisms is not met.

Question (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?

Tables 2 and 3 provide an overview of the alternatives considered in the opinion in order to address this question.

Table 2

Overview of the alternative authorised biocidal products to the specified uses of anticoagulant rodenticides

The alternative authorised biocidal products do not cover all the uses specified for anticoagulant rodenticides (see Table 2). For some uses (uses number #2, #3, #5, #6 and #10), no alternative authorised biocidal products are available. For use #7, there are alternative authorised biocidal products only for mice, and for uses #8 and #9 there are alternative authorised biocidal products only for rats (R. norvegicus).

Table 3

Overview of the identified non-chemical alternatives to the specified uses of anticoagulant rodenticides

Question (c) Do these alternatives present a significantly lower overall risk for human health, animal health and the environment?

According to agreed Union guidance, this question should only be addressed if the considered alternatives are sufficiently effective and do not present other significant economic or practical disadvantages (see sections addressing Questions (d) and (e)).

Based on the conclusions reached for questions (a), (b), (d) and (e), the opinion considered that addressing Question (c) was not necessary.

Question (d): Are these alternatives sufficiently effective?

The authorised biocidal products identified under Question (b) include active substances that have been approved and therefore considered effective for the specified uses. Since being sufficiently effective is a criterion for granting an authorisation in Article 19(1)(b)(i) of Regulation (EU) No 528/2012, those products are considered as being sufficiently effective.

Regarding the non-chemical alternatives identified under Question (b), according to the opinion each of the alternatives, on their own or in combination with other alternatives may provide sufficient efficacy in certain, perhaps limited, circumstances. However, there is insufficient scientific evidence to prove that any of the non-chemical alternatives reviewed are sufficiently effective according to agreed Union guidance (i.e. providing similar levels of protection or control of rodent populations under field conditions) to negate the need for anticoagulant rodenticides for the specified uses. As the condition of being sufficiently effective in Article 23(3)(a) of Regulation (EU) No 528/2012 is not met, no further investigation was made for the identified non-chemical alternatives.

Question (e): Do these alternatives present no other significant economic or practical disadvantages?

According to agreed Union guidance, the assessment of the practical and economical disadvantages is to be done with those alternatives meeting the eligibility criteria. Therefore, only the authorised biocidal products identified in table 2 were assessed for the purpose of this question.

According to the opinion, the use of aluminium phosphide releasing phosphine and carbon dioxide leads to significant practical or economical disadvantages compared to anticoagulant rodenticides, as the control of target organisms would be at very high efforts and/or disproportionate cost. Therefore, the condition of presenting no other significant economic or practical disadvantage in Article 23(3)(a) of Regulation (EU) No 528/2012 is not met for the above-mentioned authorised biocidal products.

Concerning alpha chloralose products, their temperature-dependent efficacy would compromise the use of this alternative in locations where the temperature cannot be controlled, resulting in a practical disadvantage for use in warm environments. Moreover, considering the lack of chemical diversity (see section addressing Question (a), replacing or restricting the use of anticoagulant rodenticides with only this substance would not be advised in order to minimize the occurrence of resistance.