Current procedure for the renewal of authorisations of product type 14 rodenticides containing anticoagulant active substances

A distinction is made between first generation active substances (warfarin, chlorophacinone and coumatetralyl) and the more potent second generation active substances (bromadiolone, difenacoum, brodifacoum, difethialone and flocoumafen).

Anticoagulants

All anticoagulants are classified as toxic for reproduction. In addition, they are classified as specific target organ toxic due to their mode of action to inhibit blood coagulation. Furthermore, second generation anticoagulants are classified as PBT substances, which means that they are hardly degradable in the environment (persistent, P), accumulate in biota (bioaccumulative, B), and are toxic (T). Anticoagulants therefore fulfil the exclusion criteria for the approval of biocidal active substances (cf.  Article 5 (1) of Regulation No. 528/2012 (Biocidal Products Regulation, BPR)). In addition, anticoagulants have been identified as candidates for substitution in accordance with Article 10 of the BPR. In the long term, they are to be replaced by less hazardous alternatives. Anticoagulant rodenticides are harmful for all vertebrates, meaning that there is a high risk of primary and secondary poisoning for pets and wild animals, when being exposed to these chemicals.

At present, however, anticoagulant rodenticides are still necessary for rodent control, even though effective chemical and non-chemical alternatives are already available. Therefore, it has been decided throughout the EU to authorize anticoagulant rodenticides as biocidal products - despite their hazardous characteristics - under strict risk mitigation measures (RMM) for a maximum period of 5 years. These provisions were documented in the EU-wide harmonised Summary of Product Characteristics (SPC) for anticoagulant rodenticides. An SPC is a central part of every authorisation of a biocidal product in the EU. It contains, among other things, all authorised uses for the respective product and the respective instructions for use. The authorisation for a specific product in Germany and the associated SPC may deviate from the harmonised SPC, e.g. if fewer uses have been applied for or if additional, product-specific risk mitigation measures are included. National derogations can also be taken into account. This includes, for example, the definition of a trained professional user, with reference to the German Hazardous Substances Ordinance.

Since 2018, every new authorisation or renewal of an existing authorisation of an anticoagulant rodenticide entailed a harmonised SPC including the national provisions applicable in Germany.

Current procedure for the renewal of authorisations of product type 14 rodenticides containing anticoagulant active substances (March 2024):

The authorisation of anticoagulant rodenticides belonging to the product type 14 is granted for a maximum period of 5 years. The renewal applications for rodenticides with anticoagulant active substances are currently evaluated throughout the EU. This involves a comprehensive re-evaluation of the existing authorisations, taking into account new scientific findings and new guidelines, including for instance guidelines on environmental and efficacy assessment: (ECHA: Revised Emission Scenario Document for Product Type 14 (PDF, 1 MB) / Guidance on the Biocidal Products Regulation (PDF, 3 MB)).

In order to ensure that this process is completed before the existing authorisations expire, it was determined during discussions at EU level that the currently existing authorisations can initially be extended until 1 July 2024. In Germany, the expiry date of all existing authorisations for which an application for renewal was submitted on time (i.e. at least 550 days before the authorisation expires) was therefore initially extended to 1 July 2024 without any changes. At the same time, a comparative assessment was carried out on EU level in accordance with Article 23 (1) of the BPR to examine whether anticoagulants could be replaced by chemical or non-chemical alternatives. The comparative assessment was carried out on behalf of the European Commission by the European Chemicals Agency (ECHA) with the involvement of the EU Member States. The results were implemented by the Commission in March 2024 in an Implementing Decision (EU) 2024/816, which is addressed to the Member States and must be taken into account by them as part of the ongoing re-evaluation of anticoagulant rodenticides on national level. In order to ensure that the current renewal process is completed before the existing authorisations expire, the applications for authorisation that are assessed by Germany as the responsible Member State will initially be extended to 31.12.2025 without any further changes.

Announcement of changes within the second extension of the authorisation of anticoagulant rodenticides in Germany

The changes listed below will come into effect with the final decision to extend the existing authorisations of the respective products, i.e. after 31.12.2025 (see above). In addition to the changes listed below, the ongoing re-evaluation of the existing authorisations may result in further product-specific adaptations in individual cases.

1. Authorisation of anticoagulant rodenticides for trained professional users

This amendment concerns the authorisation of biocidal products in accordance with the German Ordinance on the Notification and Distribution of Biocidal Products and on the Implementation of Regulation (EU) No 528/2012 (Biocide Law Implementation Ordinance, ChemBiozidDV). According to § 15 ChemBiozidDV biocidal products that contain active substances that fulfil an exclusion criterion in accordance with Article 5 (1) of the BPR may only be authorised for use by trained professional users, unless an authorisation is required for other user categories on the basis of the conditions specified in Article 5 passage 2 sentence 1 letter b and c of the BPR. As all anticoagulants fulfil at least one exclusion criterion, anticoagulant rodenticides will only be intended for use by trained professional users with expert knowledge in accordance with §15 c of the German Hazardous Substances Ordinance in the future. For an authorization for users other than competent users, the applicant must demonstrate that the conditions specified in Article 5 (2) sentence 1 letters b and c of the BPR are fulfilled according to § 15 ChemBiozidDV.

2. No use of anticoagulants without previously detected infestation

Before using anticoagulant rodenticides, it will always be necessary in the future to detect an infestation. Anticoagulant rodenticides will only be allowed to be used if an infestation with the target has been detected beforehand. Accordingly, anticoagulant rodenticides will no longer be authorised for permanent baiting (i.e. infestation-independent application of bait), for the prevention of a rodent infestation, for detecting an infestation or for monitoring rodent activity. To monitor rodent activity and detect infestations, regular visual inspections by appropriately trained personnel, the use of non-toxic baits and the use of remotely monitored systems such as traps or devices equipped with sensors and radio transmission technology are recommended. The current exceptions enabling permanent baiting under certain circumstances  will therefore no longer be permitted.

3. Specification of RMMs for the protection of the aquatic environment

During the last re-authorisation of anticoagulant rodenticides in 2018/2019 it was determined that when baits are used in the sewer system, near water bodies and in the vicinity of water drainage systems, they must not come into contact with (waste) water. Thereby releases of anticoagulant rodenticides into the aquatic environment should have been minimised. However, no specifications were made within the product authorisation for the practical implementation of these provisions. This has created legal uncertainty among users and contractors of pest control measures with regard to the proper use of these biocidal products. Against this background, the existing RMMs and instructions for use are adjusted as follows:

  1. Anticoagulant rodenticides shall only be used within a distance of 5 meters to the edge of surface water bodies (e.g. rivers, channels, streams, irrigation ditches, drainage channels, lakes and ponds) as well as marine and coastal waters in tamper-resistant bait protection stations, that prevent contact of bait with water during the entire application.
  2. Anticoagulant rodenticides shall only be used within a distance of 5 meters of outdoor water drainage systems (e.g. drainage channels, manhole covers, floor and road drains, infiltration shafts) in tamper-resistant bait protection stations that prevent the bait from coming into contact with water during the entire application.
  3. Anticoagulant rodenticides shall only be used in the sewer system in bait protection stations that prevent contact of bait with (waste) water during the entire application.

Uses of anticoagulant rodenticides for controlling house mice indoor

As all anticoagulants fulfil the substitution criteria for biocidal active substances according to Article 10 (1) of the BPR, a comparative assessment must be carried out within the renewal of their product authorisations. In accordance with Article 23 (1) of the BPR, a comparative assessment was carried out on behalf of the European Commission by the European Chemicals Agency (ECHA) with the involvement of the EU Member States. It was reviewed whether there are other authorised biocidal products or non-chemical control or prevention methods that pose a significantly lower overall risk to human and animal health and the environment, are sufficiently effective and do not entail any significant economic or practical disadvantages in comparison to anticoagulant rodenticides.

As part of this review, it was found that snap traps for the control of house mice basically fulfil these requirements, if these traps were successfully tested according to previously defined criteria with regard to efficacy and animal welfare (Umweltbundesamt: NoCheRo-Guidance for the Evaluation of Rodent Traps). It was also established that chemical alternatives to anticoagulants are currently available in the form of rodenticides containing alphachloralose and cholecalciferol. The result of the comparative assessment must be taken into account by the Member States for the ongoing re-authorisation of anticoagulant rodenticides at national level.

However, when comparing the consequences of not authorising anticoagulant rodenticides for indoor use to control house mice with the risks they pose, the authorities involved decided on the basis of Article 19 (5) of the BPR to continue to renew the authorisation of anticoagulant rodenticides for this use in Germany. For the use of non-chemical alternatives, there is currently a lack of reliable data on effectiveness under field conditions. The same applies to the control of brown rats and house rats. As a result of the comparative assessment, anticoagulant rodenticides may continue to be used against these target rodents in all areas of use by trained professional users in Germany. The chemical diversity of rodenticides is currently not sufficient to replace anticoagulants for the control of brown rats and house rats. In addition, there is a lack of reliable data on the efficacy of non-chemical alternatives under field conditions.

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