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Risk mitigation measures for biocidal products – How to develop a harmonised approach for product authorisation?

corresponding

STEFAN GARTISER1, ISMENE JÄGER1, JÜRGEN FISCHER2*, KRISTINA ZIEGLER2
*Corresponding author
1. Hydrotox GmbH, Boetzinger Str. 29, Freiburg, D-79111, Germany
2. German Federal Environment Agency, Section IV 1.2 Biocides, Wörlitzer Platz 1, Dessau, D-06844, Germany

Abstract

In assessing the impact of biocides on the environment, specific measures to reduce the identified risks for the environment may be required. This research project contributes to establish risk mitigation measures for a harmonised assessment of biocidal products in the EU and compiles appropriate solutions to minimise or even to prevent risks for the environment. This is elaborated exemplarily on biocidal products used as wood preservatives and for the control of insecticides.


INTRODUCTION

The Directive 98/8/EC (BPD) concerning the placing of biocidal products on the market requires that a biocidal product shall only be authorised when it has no unacceptable effects on human or animal health and on the environment (Article 5 of the BPD). In assessing the impact of biocides on the environment, specific measures to reduce a risk to the environmental compartments may be required. First experiences in the evaluation of active substances in the EU review program showed that the rapporteur member states have followed different approaches of risk mitigation measures (RMM). Also the efficiency and practicability of RMM was not discussed in detail. For the environmental area, a harmonisation of possible RMM or rather a coordinated approach to RMM is currently missing at EU level. However, harmonised as well as adequate RMM are urgently needed for the authorisation of biocidal products followed by the mutual recognition process.
The completed research project funded by the German Federal Environment Agency (UBA) contributes to establish RMM required for a harmonised assessment of biocidal products in the EU and compiles appropri ...