New efficacy testing requirements for biocidal products
In the EU biocidal products are regulated under the Biocidal Products Regulation (BPR). The BPR requires that products are sufficiently effective against the target organisms that they are intended to control. Efficacy testing of biocidal products is a requirement of product authorisation and a key step in ensuring that products are able to be placed on the market. This article looks at some of the more recent changes in the guidance for the selection of relevant efficacy methods. It examines some of the available methods for disinfectants, repellents and biocides used in applications such as industrial water treatment and as slimicides in paper manufacturing. The application of efficacy test methods for the evaluation of treated articles is also discussed.
The Biocidal Products Regulation (Regulation (EU) No. 528/2012 or BPR) regulates the placing of biocidal products and the active substances that they contain on the market within the EU. Within the EU, biocides are considered as non-agricultural pesticides and are intended to be used to destroy, deter or otherwise have a controlling effect on harmful organisms such as bacteria, fungi and viruses as well as higher organisms such as insects and some vertebrates (e.g. rodents). Under the BPR biocides are broken down into 22 product types (PTs) within four main groups: disinfectants, preservatives, pest control and “other biocidal products”, which include antifouling agents and embalming fluids. Proof of efficacy is essential before these products can be approved.
The approval of active substances and the authorisation of biocidal products containing those substances require the submission of a dossier to the European Chemical Agency (ECHA). Annexes II and III of the BPR list the requirements for information to be included in the dossiers for active substances and products, respectively. One key part of the information require ...