HEALTH AND FOOD SAFETY DIRECTORATE GENERAL
Safety of the food chain
Pesticides and Biocides
Notefor discussion with Competent Authorities for Biocidal Products
This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with Member States' Competent Authorities for biocidal products. Please note,however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.
Subject:Concept of "tamper-resistant" bait station for the use of anticoagulant rodenticides
1.- Background and purpose of the document
(1)In the context of the renewal of the approval of anticoagulant rodenticides active substances (ASs), a number of the agreed risk mitigation measures (RMMs) are linked to the different user categories[1].
(2)Regarding the use of anticoagulant rodenticides both by the general public and professional users[2], the AS approvals will make it mandatory to use bait products in "tamper-resistant" bait stations (i.e. "Products shall only be authorised for use in tamper-resistant bait stations").
(3)In the context of the discussions held at the 16th meeting of the Biocidal Products Committee (BPC), BPC members identified the need to develop a CA document in order to ensure that there is a clear and common understanding of what "tamper-resistant" means. As the concept of tamper-resistant bait stations was addressed by experts in the Commission report[3] on risk mitigation measures for anticoagulant rodenticides (the "RMM report"), the Commission committed to prepare such a document for an upcoming CA meeting.
(4)This paper aims atproviding such common understanding of the concept of tamper-resistant bait stations in the context of use of anticoagulant rodenticides.
2.- Elements available in the RMM report
(5)Section 4.2.1.4 of the RMM report (pages 56 to 60) addresses the use of bait stations within the use of anticoagulant rodenticides.
(6)This section describes "tamper-resistant" bait stations as those which are resistant against manipulation by humans (especially children), non-target species (e.g. pets) and typical non-catastrophic weather conditions (e.g. rain, moisture). Moreover, the bait may be placed in a way that it cannot be spilled or removed from the bait stations.
(7)The principal purpose of tamper-resistant bait stations is to prevent access to bait contained in them by humans or non-target animals that are larger[4] than the target rodentspecies (and therefore cannot pass through the access apertures), as well as to deter them from entering the stations because of their confined nature.
(8)The RMM report (at page 59) also proposes a classification of tamper-resistant bait stations in 4 tiers or categories, which is inspired on the criteria established in the United States by US EPA[5] to consider a bait station as temper-resistant.
(9)Therefore, it is proposed to follow those 4 categories for the classification of tamper-resistant bait stations in the EU:
(a)Category 1: resistant to tampering by children and dogs and weather-resistant[6],
(b)Category 2:resistant to tampering by children and dogs but not weather–resistant(to be used indoors only),
(c)Category 3: resistant to tampering by children only (to be used indoors only),
(d)Category 4: where tamper-resistance is unknown, so tamper-resistance cannot be claimed (to be only used indoors in areas not accessible to children and pets).
3.- Proposed way forward
(10)Anticoagulant rodenticides authorised for the general public or professional users shall be used in tamper-resistant bait stations of:
(a)Category 1, for products to be authorised for use in and around buildings,
(b)Category 2, for products to be authorised for indoor use only.
(11)Tamper-resistant bait stations may be refillable or non-refillable.
(12)It is recommended that tamper-resistant bait stations include a transparent window on the top, which gives users a view on the bait chamber and bait consumption.
(13)It has to be noted that:
(a)The BPR does not lay down the manufacturing and sale of bait stations, unless they are sold filled with rodenticide baits[7].
(b)Label requirements for bait stations[8] do not apply to bait station manufacturers, but either to:
–The AH, where the bait station is sold filled with rodenticide baits,
–The users who place bait sold as refills in refillable bait stations.
3.- Action requested
(14)The Commission services invite MSs and stakeholders to discussthe proposal outlined in this paper.
Annex. Criteria for resistance to tampering by children and dogs and weather resistance(adapted from US EPA PRN 94-7)
1. Resistant to tampering by children and dogs:
a)Strong enough to prohibit entry or destruction by dogs and by children under six years of age using their hands, their feet, or objects commonly found in the use environment (e.g., sticks, stones, broken glass, etc.);
b)Capable of being locked or sealed so that children and non-target animals cannot gain access through the opening or procedures used to fill the bait compartment(s).
2. Weather-resistant:resistant to destruction or weakening by elements of typical non-catastrophic weather (e.g. snow, rain, extremes of temperature and humidity, direct sunshine, etc.).
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[1]See the BPC opinions, available at
[2]Within the meaning of document CA-May16-Doc.5.4.a-Final, available at
[3]Available at
[4]Tamper-resistant bait stations have no mitigation influence on mammals smaller than the target species, as they can enter bait stations and feed on bait.
[5]PRN 94-7: Label Improvement Program for the Revision of Use Directions for Commensal Rodenticides and Statement of the Agency's Policies on the Use of Rodenticide Bait Stations, available here
[6]See the annex to this document for the criteria to be met.
[7]I.e. where the bait station is considered as the packaging of the rodenticide product (see Type C products in document CG-18-2016-12 AP 13.1 - carrier based products).
[8] See section 2.4 of the BPC opinions: "Bait stations should be clearly labelled to show they contain rodenticides (including product name, active substance and a contact phone number) and that they should not be moved".