EFFICACY ASSESSMENT UNDER THE BIOCIDAL PRODUCTS DIRECTIVE: AN UPDATE FROM THE ICUP, EDINBURGH 1996

Abstract:
In 1993 the European Commission put forward a proposal for a mandatory authorisation scheme to cover the supply of biocides. The Directive aims to establish a single market in biocides and provide a high level of control for man and the environment by ensuring that requirements for authorisation are equal across Member States. An integral part of such controls is the requirement that products will be effective in use. Negotiations have been completed and The Biocidal Products Directive (98/8/EC) was adopted by the European Parliament and Council in February 1998 and entered into force on 14 May 1998. All Member States now have until May 2000 to implement this complex and technical Directive. To facilitate implementation of the Directive, technical guidance is being prepared by Sweden, Finland and the UK under contract from the Commission, concerning listing of actives substances on Annex I, data requirements and procedures for authorisation and registration of biocidal products. The HSE as Competent Authority for the UK, is preparing the technical guidance for risk assessments for authorisation of biocidal products. This contains guidance on assessment of efficacy. The UK has experience of producing guidance documents and has produced detailed documents outlining efficacy data requirements for wood preservatives, antifouling products, public hygiene insecticides and surface biocides. These documents are aimed at compliance with current national legislation, i.e. the UK Control of Pesticides Regulations 1986. Technical guidance drafted for efficacy assessment is in two parts: a generic chapter providing general guidance for assessment and evaluation of data required to substantiate a label claim; a series of technical annexes relevant to specific product types.