Efficacy is fundamental to the approval of a biocidal product. Data must be submitted and evaluated to ascertain if the efficacy claims of the biocidal product can be substantiated before a biocidal product can be authorised. Efficacy must also be proven in the Annex I dossier both for the active substance and the representative product. Currently there is much uncertainty over the selection of appropriate efficacy methods to support regulatory submission. We can advise on the appropriate selection of efficacy studies and the incorporation of these into both active substance and biocidal product dossiersJSC is actively involved in a number of expert groups developing methodology and guidelines at EU level (BSi, CEN) as well as through industry associations.
We can also advise on label claims, as the dossier needs to include the proposed label claims for the product and efficacy data to support these claims, including any available standard protocols used, laboratory tests or field trials, where appropriate. Evaluation of efficacy also needs to include any known limitations on efficacy including resistance. Resistance and particularly the potential for cross resistance is becoming a significant concern for regulators and JSC can help in addressing these concerns both during discussions with the regulators and within the dossier.