ll new and reviewed biocidal products intended for notification must undergo a rigorous risk assessment to examine the potential risks posed to humans and the environment. This assessment should follow the framework set out in Regulation (EC) 1488/94, and implemented in the detailed Technical Guidance Documents on Risk Assessment for New and Existing Substances.
Exposure assessments for biocidal products present a unique set of challenges and need to be assembled with great care. The diversity of potential usage scenarios and routes of entry into the environment imply that a wide range of exposure assessment techniques may be required
Environmental Emission Scenario Documents (ESDs) provide a tool to estimate the quantities of active substances that may be released into the environment during the lifecycle of a biocidal product. The Emission Scenario Documents provide a relatively simplistic approach to exposure assessment based upon product use scenarios and realistic worst case default assumptions of product loadings and transport processes. CEA experts are familiar with the range of available ESDs and are able to incorporate these product-specific approaches into the more generalised exposure estimation frameworks provided in the Technical Guidance Document.
ARCHE experts are skilled in utilising such information in order to provide a better understanding and estimate of risk. This will allow the generation of a more refined risk assessment where the degree of uncertainty surrounding that risk is reduced to an acceptable level.
Our experienced environmental modellers are familiar with models relevant to the prediction of biocide concentrations in the environment, including EUSES, USES, FOCUS. Our experience also includes human exposure modelling using deterministic and probabilistic models to predict exposure via dermal, inhalation, and (incidental) ingestion routes, including CONSEXPO, EASE. This expert knowledge also enables us to ascertain when exposure scenarios may be unsuitable for a particular application and to present alternatives to regulators with confidence.
We also have the capability to use (Q)SARs to assist with dossier preparation and reduce the cost of testing for mammalian toxicology and ecotoxicology.
We offer advice on regulatory strategy, including regulatory support, product stewardship, and total product management.
We can assist you with dossier preparation under the Biocidal Products Directive in the following areas:
- Review of existing data and identify data gaps
- Preparation, submission and follow-up in relation to whole or part dossiers
- Risk assessments for human health and the environment, including the development of approaches where Emission Scenario Documents (ESDs) are not available
- Development of data waivers and reasoned scientific justifications for non-submission of data, where appropriate
- Preparation of IUCLID dataset
- Liaison with the RMS and other authorities throughout evaluation
Design, implementation and completion of cost-effective testing programmes: management of study programmes, from single studies to large programmes involving several test facilities at different global locations
- Preparation and submission of applications for registrations under existing national rules at Member State level
- Representation of clients in meetings with regulatory authorities and at Evaluation Meetings at an EU level
- Representation of clients in data access negotiations with other companies or task forces
- Classification and labelling of preparations, and preparation of MSDS
