Commission Implementing Decision (EU) 2017/1532 of 7 September 2017 addressing questions regarding the comparative assessment of anticoagulant rodenticides in accordance with Article 23(5) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance. )
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For the purpose of Article 23(3) of Regulation (EU) No 528/2012, the receiving competent authorities of the Member States shall consider the information addressing the questions referred to the Commission concerning the comparative assessment of anticoagulant rodenticide biocidal products provided in the Annex.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
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 Use number Target organism(s) Field of use Category(ies) of users Application method #1 Mus musculus (house mice) (Other target organisms may be added) Indoor General public Ready-to-use bait to be used in tamper-resistant bait stations #2 Rattus norvegicus (brown rat) Rattus rattus (black or roof rat) Indoor General public Ready-to-use bait to be used in tamper-resistant bait stations #3 Rattus norvegicus (brown rat) Rattus rattus (black or roof rat) (Other target organisms — except house mice — may be added (e.g. voles)) Outdoor around buildings General public Ready-to-use bait to be used in tamper-resistant bait stations #4 Mus musculus (house mice) (Other target organisms may be added) Indoor Professionals Ready-to-use bait to be used in tamper-resistant bait stations #5 Rattus norvegicus (brown rat) Rattus rattus (black or roof rat) Indoor Professionals Ready-to-use bait to be used in tamper-resistant bait stations #6 Mus musculus (house mice) Rattus norvegicus (brown rat) Rattus rattus (black or roof rat) Outdoor around buildings Professionals Ready-to-use bait to be used in tamper-resistant bait stations #7 Mus musculus (house mice) Rattus norvegicus (brown rat) Rattus rattus (black or roof rat) Indoor Trained professionals Ready-to-use bait or Ready-to-use contact formulations #8 Mus musculus (house mice) Rattus norvegicus (brown rat) Rattus rattus (black or roof rat) Outdoor around buildings Trained professionals Ready-to-use bait #9 Rattus norvegicus (brown rat) Rattus rattus (black or roof rat) Outdoor open areas Outdoor waste dumps Trained professionals Ready-to-use bait #10 Rattus norvegicus (brown rat) Sewers Trained professionals Ready-to-use bait 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 Use number as described in Table 1 Active substance in the alternative biocidal products Application type #1 #2 #3 #4 #5 #6 #7 #8 #9 #10 Alpha chloralose Bait yes yes Only mice Aluminium phosphide releasing phosphine Fumigant Only for R. norvegicus Only for R. norvegicus Carbon dioxide Cannister for trapping device Only mice 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 Reported non-chemical alternative Mode of action Uses potentially covered Curative treatments Electrical rodent traps Traps with electrical current killing the rodent entering the trap. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 Glue boards Rodents are captured in glue, killing has to be done separately. 1, 4, 6, 7, 8 Mechanical traps (spring traps or break-back traps) Traps with mechanical weight are killing the entering rodent. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 Shooting Shooting the rodents. 6, 8, 9 Preventive treatments Habitat modification Preventing rodent populations from establishing by limiting the supply of food/water/harbourage 1,2, 3, 4, 5, 6, 7, 8, 9 Rodent proofing Preventing access of rodents to buildings by blocking entering routes. 1, 2, 4, 5, 7 Ultra-sound Repelling rodents with an ultrasonic output at 70-140 dB. 1, 2, 3, 4, 5, 6, 7, 8, 9 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.
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