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The environmental risk assessment (ERA) and human health risk assessment (HHRA) for biocides are an important part of the dossier for active substance approval as well as for biocidal product authorisation. In the changing landscape of the regulatory requirements for ERA and HHRA it becomes more and more challenging for industry to stay up-to-date and to meet constantly rising standards.
This training course offers two days of intensive training, providing a comprehensive overview of ERA and HHRA. The training course is designed for environmental and human health risk assessors and regulators from industry, authorities and consultancies. Both days consist of a theoretical and a practical session. In the theoretical sessions, the essential principles of an ERA or an HHRA are demonstrated, while in the practical sessions, the participants learn how to use software tools and models. Participants can attend either day or both days.
On day one, participants will be introduced to the key principles of ERA – from basic aspects to more complex issues. They will become familiar with relevant input parameters, different emission pathways and product types. They will also get to know available guidance documents. In the practical part, participants will learn how to estimate emissions and exposure to the environment, either using the software tool EUSES or generated EXCEL- sheets. At the end of the day, participants will gain a complex idea of ERA, having developed understanding of which parameters might influence the results of the environmental risk assessment and which refinement options can help get a safe ERA.
Day two is focused on HHRA including livestock exposure (LE) and dietary risk assessment (DRA). The requirements for HHRA are constantly changing and getting increasingly complex which raises the bar for passing the HHRA. While new guidance has been published during the past years, guidance is still lacking the description of major uses in several product types. This applies especially to LE and DRA, but also to the assessment of disinfection by-products. The aim of this course is to familiarise participants with the key concepts of HHRA, starting with the very basics and ending up with non-standard assessments. The participants will learn to use TNsG, BEAT or generic models as well as the software tools ConsExpo, ART and RISKofDERM to estimate exposure for different types of substances, intended uses and product types.