The EU Biocidal Products Directive and the consequences for Dinsinfectants

The title of my presentation suggests or at least anticipates that the EU legislative process, to provide a harmonised regulatory platform for biocides in the EU, has been finalised when this symposium takes place. When adapted and subsequently implemented in the EU member states (estimation Q3 1999), this directive will have a major impact on the market of disinfectants for both the suppliers of active substances and formulators supplying disinfectant products to customers and consumers. This presentation will focus on (technical) regulatory consequences rather than economical or business effects. On the basis of the information available the following key issues will be addressed:• • scope: which products will fall under the regime of this directive, which are excluded?• • principle: one product—one authorization and mutual recognition; lead times involved?• • procedure: how will the simplified procedures foreseen (hopefully) help the disinfectant supplier?• • data requirements: why do the dossier requirements for products and particularly actives need to be so excessively costly and what is the role of risk assessment?• • transitional arrangements: what can and canʹt disinfectant suppliers do to keep their products on the market or to introduce new products?• • review programme: what will happen to the availability of active substances? The directive itself will not give sufficiient answers to all issues mentioned above to allow a harmonised interpretation across the EU. A number of technical guidance documents is therefore being developed covering Common Principles, Data Requirements and Conditions to include an Active Substance on Annex I. The workability of the whole directive will very much be dependent on the practical details to be dealt with in these documents. Disinfectant suppliers also do recognize the merits of the directive (improved protection of man and the environment, harmonisation across EU, etc.), provided however that it does not undermine the efforts of our industry to deliver better hygiene with safe, effective but also affordable disinfectants.