Proposal for environmental mixture risk assessment in the context of the biocidal product authorization in the EU

Thomas Backhaus,Daniel Frein,Tobias Frische,Tobias Porsbring,Michael Faust,Rolf Altenburger,Anja Kehrer,Per Johansson

doi:10.1186/2190-4715-25-4

Abstract

Background The EU Council and Parliament recently agreed on a new regulation that will implement a new EU-wide, harmonized system for the authorization for biocidal products. Such products are in most cases multi-component mixtures of one or more active substances plus a range of co-formulants that serve different purposes, e.g. as stabilizers or preservatives. They are only allowed on the European market if their intended use does not lead to unacceptable risks for the environment. Consequently, the assessment of possible combination effects is a critically important step during the regulatory environmental risk assessment of biocidal products. However, no specific guidance is at hand on how combination effects should be accounted for during the regulatory environmental risk assessment of biocidal products.

Highlights

The EU Council and Parliament recently agreed on a new regulation that will implement a new EU-wide, harmonized system for the authorization for biocidal products
Products that contain active substances that are listed in Annex I/IA are allowed on the EU-market, and the risk from their intended use to man and the environment is assessed at the national level, complemented by the mutual recognition of authorizations between the EU member states
Tiered approach for biocide product assessment In view of the different options for the environmental risk assessment of a chemical mixture, we suggest the following approach for biocidal product assessment (Figures 1 and 2)

Summary

Introduction

The EU Council and Parliament recently agreed on a new regulation that will implement a new EU-wide, harmonized system for the authorization for biocidal products Such products are in most cases multi-component mixtures of one or more active substances plus a range of co-formulants that serve different purposes, e.g. as stabilizers or preservatives. Earlier in 2012 the European Parliament and the EU Council of Ministers adopted the new regulation (EU) No 528/2012 on the authorization of biocidal products (BPR) [1] It will apply from 1 September 2013 and will replace and repeal the BPD and will implement a new EU-wide, harmonized system for the authorization for biocidal products. The BPR provisions will apply to existing active substances being evaluated under the BPD review program

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Discussion

Conclusion