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The BIOEXPO project is focussed on test data, required for the authorization of biocidal products. The draft EC Biocidal Products Directive distinguishes between a common core data set (Annex II) and an additional data set, with specific data requirements for biocidal product types (Annex III). The BIOEXPO study aims to provide an input to the European discussions on Annex III, by proposing data requirements for 23 biocidal product types. In the project, the life cycles of the 23 biocidal product types were studied, in order to identify the environmental compartments that are exposed due to the application, use and disposal of the biocidal product and treated materials. This is described in another report ("part 2: Release estimation for 23 biocidal product types"). This report describes the criteria for setting data requirements, and data requirements for the environmental compartments fresh surface water, marine surface water, soil, STP and air. For a biocide released to one of these environmental compartments, data requirements are proposed to enable or improve an environmental risk assessment in that compartment. These data items are discussed on their benefits (enable a compartment-specific assessment, enable a chemical-specific assessment or increase the field-relevance of the assessment), on their compatibility (with current risk assessment methods) and their feasibility (are test-protocols available, or do they have to be developed?). As transport from one environmental compartment to another can occur after release, a tiered approach is proposed to identify all relevant environmental compartments |
