Learn about the regulatory requirements for ERA and HHRA
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 is becoming increasingly challenging for those in the 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:
Day one will introduce you to the key principles of ERA – from basic aspects to more complex issues.
You will become familiar with relevant input parameters, different emission pathways, and will get to know available guidance documents. In the practical part, you will learn how to estimate emissions and exposure to the environment, either by using the software tool EUSES or generated EXCEL-sheets. During the sessions, different product types and emission pathways are addressed. At the end of the day, you will gain a complex idea of ERA, having developed understanding which parameters might influence the results of the environmental risk assessment and which refinement options can help achieve 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. You will become familiar with the key concepts of HHRA, starting with the very basics and ending up with non-standard assessments. You 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.