Suchergebnisse

Authorisation of biocidal products in the European Union is a two-stage process, where the biocidal active substances are approved in a first step at the European level, and the biocidal products are authorised in a second step at member state level. If an active substance is designated as Candidate for Substitution (CFS) during this process, a comparative assessment must be carried out for each biocidal product containing this CFS by the competent authority. The aim of the current project was to evaluate the practicability of the existing technical guidance for this procedure by conducting a number of exemplary comparative assessments, and to develop recommendations for improvements. The analysis of the existing guidance revealed that essential concepts are only vaguely defined and would need considerable expert judgement and ad hoc decisions to be applied within a comparative assessment. The here developed recommendations relate to the definition of a product's intended uses, which are subject to a comparative assessment, and the requirement for chemical diversity of active substances in authorised products that currently often leads to a stop of the comparative assessment. Further recommendations relate to the use of risk mitigation measures and various hazard indices for a qualitative comparative assessment, and a standardised process of a quantitative, risk-based comparative assessment using recalculated risk quotients as decisive step. It is acknowledged that particularly the recommendations regarding the risk-based comparison may result in a considerable workload related to the comparative assessment of biocidal products. However, such efforts appear to be a precondition for a sound and defensible comparison of environmental risks. This could not be obtained by comparing risk quotients that were derived using different assumptions for the products within the assessment.