Human Exposure and Risk

Depending on the product type and application the use of biocidal products must be shown to be safe by conducting an in depth risk assessment, considering both chronic and acute exposure. JSC is able to help you use the latest approaches to evaluate critically both the hazard and exposure based on your proposed use.

Acceptable consumer risk for at least one representative use of the biocidal active substance must be demonstrated for successful Annex I listing. JSC performs risk assessment based on determination of end points from toxicology studies. This requires skilful interpretation of the data. Once endpoints are set it is very difficult to have them overturned, so seeking expert advice during the evaluation process is critical for future registrations, even if a successful Annex I is achieved.

 

Exposure to the active substance can occur both during and after use of the product, a range of scenarios need to be considered and appropriate models such as CONSEXPO and BEAT may be needed to quantify the exposures. In some instances additional studies, for example metabolism in livestock, may be needed. Not only can we predict what the regulatory authorities are expecting, but we also have considerable practical experience of conducting studies, and know what is achievable and how it should be presented.

Although Annex I only requires acceptable consumer risk to be demonstrated for representative uses, additional risk assessments will be required for product authorisation to include all uses in each Member State. JSC is experienced in conducting consumer risk assessments and can advise on the best strategy for obtaining a successful risk assessment for your compound.

Human risk assessment requires a multidisciplinary approach, whether supporting AOELs from toxicological studies, modelling exposure scenarios, or generating higher tier data such as dermal absorption or actual field studies. Whether you are pursuing Annex I listing or applying for product authorisation, we are able to provide expert advice at all stages.