Experiences with environmental risk assessment within the Biocidal Products Directive
IRG/WP 05-50224-21
P Blancquaert
The Biocidal Products Directive (98/8/EC, the BPD) aims to authorize biocidal products based on risk assessment for both man and the environment. Active substances for wood preservation products and rodenticides were selected for the first list under the review program (Regulations EC 1896/2000 and EC 2032/2003) because several member states had experience with the evaluation and authorization of such products under existing national law. The main difference with the BPD approach is the introduction of risk based decision making. This required the development of models to estimate exposure, guidelines for measuring exposure and several guidance documents for risk assessment for man and environment.
The preparation of dossiers to support the listing of active substances for use in wood preservatives in annex I of directive 98/8/EC revealed strengths and weaknesses in the current approach and allows suggestions for improvement.
Products had to be selected covering the current uses and the uses for the future. This at a time that most of the guidance documents were in draft form or not yet available. Emission scenarios had to be selected and the data for input. Leaching data are critical and harmonized laboratory test methods were not available. Field leaching data and monitoring data, if already available, are difficult to bring into the models.
A close cooperation within industry on one side, from manufacturers of active substances over formulators to the end users, and consultation with competent authorities on the other side is a prerequisite to successfully market wood preservatives within the scope of the biocides directive. Resource and investments are becoming so significant that a global approach is the only way forward.