EFFICACY EVALUATION UNDER THE PROPOSED EC BIOCIDES DIRECTIVE

Abstract:
The current proposal for a EU Biocidal Products Directive aims to establish a single market in biocides that provides a high level of control for man and the environment by ensuring that requirements for authorisation of products are equal across all Member States. The UK Regulatory Authority welcomes such a directive which will ensure that controls are commensurate with risk. An integral part of such controls will be the requirement that products will be effective in use. Article 4 of the proposed directive states that an authorisation of a product will only be achieved if the biocidal product is shown to be ""sufficiently effective"" (when used according to the label conditions). However, given the diverse nature of the different product types currently under the scope of the directive (Annex V) this inevitably poses many challenging questions and may lead to differing degrees of interpretation of the data requirements by the various Regulatory Authorities operating the scheme. Clarification is needed as to what is meant by ""suficiently effective"", and as to the detailed requirements for eficacy testing. Typical questions include: are there standard protocols for testing available for each area of use? What are the benefits of laboratory testing as opposed to the need for field trial data? How should the labelling claims be interpreted and who should be responsible for undertaking the testing? The UK is currently one of the few member states that has a regulatory framework in place for biocidal products (although not covering the entire scope of the proposed directive). As such we can share our expertise with those other few member states who also have experience in biocide regulation. The UK system works extremely well in practice and this has been achieved by a degree of adaptation and refinement.