Environmental risk assessment of wood preservatives in the Netherlands
E Smit, P van der Zandt, J Appelman
Before biocides can be introduced to the Dutch market, they have to be authorised under the Pesticides Act (1962). The criteria for authorisation of biocides have been laid down in the Dutch Decree on Environmental Requirements for the Authorisation of Pesticides Used in Fields Other than Agriculture. In 1998, the EU Biocides Directive (98/9/EC) entered into force, and it was implemented in May 2000. The authorisation currently is a national procedure. The inclusion of an active substance of a product in Annex 1 or 1a of the Biocides Directive, will follow the required EU steps. According to the first Review Regulation, existing active substances of wood preservatives are among the first to be evaluated at EU level. In the Netherlands, the Agency responsible for the authorisation is the Board for the Authorisation of Pesticides (CTB). The CTB is an independent regulatory body. With the request for authorisation, a complete dossier has to be submitted by the applicant. After a check of the admissibility of the dossier, the CTB commissions independent institutes for the evaluation of the dossier and to perform the risk assessment. In general, risk assessments are based on the information that is submitted by the applicant, but CTB can decide to include additional (literature) sources when necessary. One of the evaluating institutes is the National Institute of Public Health and the Environment (RIVM), that covers the aspects of both human and environmental health. This paper is concerned with the environmental risk assessment as it is done in the Netherlands. The environmental risk assessment consists of an exposure assessment, resulting in predicted environmental concentrations (PECs) and an effects assessment, resulting in predicted no-effects concentrations (PNECs). In the Netherlands, the active ingredient of the biocidal product is the main subject of the assessment, other components or metabolites are dealt with if they may present a concern. One of the basic tools for risk assessment in the Netherlands is the USES computer program, in which models and methods for the assessment of exposure and effects are implemented. The USES program has been developed under the supervision of a steering committee with members from government, institutes, academia and industry and is approved by CTB. USES includes EUSES and is fully in line with published EU-Technical Guidance Documents (TGDs).