New efficacy testing requirements for biocidal products

Introduction
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 required is efficacy data supporting any claims for effectiveness against the target organism(s).

While indicative efficacy must be proven for active substances the proof of biocidal efficacy is a more detailed essential step in the authorization of biocidal products. The efficacy testing of biocidal products has been traditionally undertaken for a number of reasons such as supporting label claims, comparative testing against competitor products, new product development, compliance with national or international norms or for quality control purposes. However, the tests developed for these purposes may not be sufficient to meet the needs of a regulatory assessment. A number of different organisations and bodies have been very active in developing efficacy methods and standards on a global basis (e.g., CEN, OECD, ASTM etc); these standards and methods are now being critically reviewed in light of their suitability for regulatory purposes.