Anticoagulant rodenticide products have been approved as biocidal products, even though they pose a risk to other animals. Rodents may also develop a resistance to anticoagulant rodenticide products. For these reasons, rodenticides have only been approved for five years, and national risk mitigation measures can be applied to them.
New risk mitigation measures for anticoagulant rodenticide products
Tukes defined national risk mitigation practices for anticoagulant rodenticide products in 2011, when they were first authorised in accordance with the Biocidal Products Directive (98/8/EC). National risk mitigation measures were needed because other animals were exposed to rodenticides and it was not possible to agree upon detailed risk mitigation methods due to the different conditions in the Member States.
The active substances in anticoagulant rodenticide products have been re-evaluated, with special attention paid to the risk mitigation measures. The opinions approved by the Biocidal Products Committee of the European Chemicals Agency (ECHA) in June 2016 define user-group-specific conditions, and the opinions also contain elements to be taken into account in connection with the approval of substances. The opinions state that Member States can make exceptions to the conditions defined in mutually recognised authorisations based on Article 37 of the Biocidal Product Regulation (528/2012). Active substances will be authorised in a vote by the Standing Committee on Biocides in March 2017 at the latest. Usually, the conditions specified in the opinions are included as is in the implementing regulations on active substances that constitute binding legislation in the Member States. Tukes also intends to follow the elements given in the opinions as far as possible.
In connection with the re-authorisation of anticoagulant rodenticides, Tukes will reform the risk mitigation practices. Many of the current risk mitigation measures have now been included in the opinions. The aim of the new risk mitigation measures is to prevent the exposure of other animals to rodenticides more effectively. The reform is also influenced by the qualification of an exterminator (Chemicals Act 599/2013) that is becoming mandatory for professional exterminators, and farmers being able to use rodenticides intended for professional use in their own agricultural activities after acquiring a plant protection certification (Act Amending the Chemicals Act 746/2016). More information about the use of rodenticides, the species to be controlled, and the presence of rodenticides in other animals has accumulated after the current risk mitigation measures were introduced.
All anticoagulant rodenticide products have been classified as toxic for reproduction in categories 1A or 1B (Commission Regulation (EU) 2016/1179). The classification applies to all products with a concentration of 0.003% or more of the active substance. Products classified as toxic for reproduction are not approved for consumer use (Biocidal Product Regulation 528/2012, Article 19). The classification is likely to reduce the selection of products approved for consumer use.
The new risk mitigation measures concern the rodenticide re-authorisation applications, which must be completed by the end of February 2017. The new risk mitigation measures will become valid for the users of rodenticides in early 2018, when the new rodenticide products that have been granted an authorisation enter the market.
The national risk mitigation practices that apply to rodenticide products to be re-authorised
||Two user groups:
2. Trained professionals
Trained professionals include
1. Exterminators who have completed a qualification in accordance with the Chemicals Act (Chemicals Act 599/2013, Government Decree 418/2014)
2. Persons who have acquired a plant protection certification and who control rodents in their own agricultural activities (Act Amending the Chemicals Act 746/2016, Plant Protection Products Act 1563/2011)
The third user group ‘Other Professionals’, or professionals without training in the use of rodenticides, is removed. The removal of this group makes monitoring easier and simplifies the permit procedure.
||In the future, only products for controlling mice indoors will be approved for consumers.
Consumers mainly use anticoagulant rodenticide products to control mice. Their use indoors reduces the exposure of other animals to rodenticides.
||In the future, only pre-filled bait stations will be approved for consumers.
Pre-filled bait stations ensure that consumers only use rodenticides in bait stations.
||Products containing brodifacoum, flocoumafen and difethialone are approved for consumer use
Products containing these active substances are permitted for consumers, because the concentration of these active substances can be lowered under 0.003% without reducing their effectiveness.
||The effectiveness of products intended for controlling mice must be tested using yellow-necked wood mice (Apodemus flavicollis). Further, the use of bank voles (Myodes glareolus) to test the effectiveness is recommended. Products intended for professional use against mice can only be used outdoors, i.e. in the vicinity of buildings, if their effectiveness against yellow-necked wood mice has been proven.
Yellow-necked wood mice are much more common in Finland than house mice (Mus musculus). In professional extermination, yellow-necked wood mice constitute 85–90% out of all mouse control.
||In the future, it will also be possible to apply for authorisation to use products containing brodifacoum, flocoumafen and difethialone outdoors in the vicinity of buildings in addition to indoors.
Tukes has defined the following risk mitigation measures for Finland:
- the use of products containing difethialone, brodifacoum or flocoumafen are restricted to trained professional use only
- starting from 19 September 2016, persons who have acquired a plant protection certification (Plant Protection Products Act (1563/2011)) and who control rodents in their own agricultural activities can also use products that contain difethialone, brodifacoum, and flocoumafen
- non-professionals are allowed to use only first generation anticoagulants against rats and in addition difenacoum and bromadiolone products against mice
- products for non-professional use have to be packed in ready-to-use bait boxes or packages to be placed into reusable bait boxes
- products for non-professional use against mice can be used indoors only
More information on risk mitigation measures