Exponent has considerable experience in assisting clients with the Biocidal Products Directive legislation and data requirements, from both the EU and individual Member State perspectives. The majority of data requirements for biocides have their origin in pesticide legislation, and because many of our scientific staff worked previously as pesticide regulators or in the pesticide industry, we have a unique and valuable perspective on dealing with the regulatory requirements.
Exponent scientists have written numerous summary dossiers and partial dossiers for Lists 1, 2, and 3 of the biocide review compounds, as well as for new biocidal active substances, and have successfully constructed scientifically defensible data waiving arguments and undertaken complex risk assessments. We have proven success in achieving biocide dossier completeness on behalf of our clients and have contributed toward positive Annex I inclusion decisions.
Risk Assessments
Exponent has a vast amount of experience in human health and environmental risk assessments to support Annex I inclusion and product registrations. We have expert knowledge of a large range of environmental, operator, residential, and consumer exposure models used around the world, and are fully familiar with the environmental Emission Scenario Documents (EUBEES ESDs). We have significant experience in generating bespoke product-specific emission/exposure scenarios.
Our experienced environmental modellers are familiar with models relevant to the prediction of biocide concentrations in the environment, including EUSES, USES, and the less widely used TOXSWA, EXAMS, and FOCUS air, surface, and groundwater models. 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, and EUROPOEM. 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:
- Maximiing the benefit of existing data to address requirements through data gap analysis, (Q)SAR modelling, use of public literature, and preparation of data waivers and bridging arguments
- Interpretation and study summary preparation of physico-chemical, analytical methods, efficacy, environmental fate, toxicology, and ecotoxicology data
- Proposals for classification and labelling of substances/products
- Compilation of summary dossiers, including IUCLID database files and regulatory submissions for both Annex I listing and product authorisations
- Environmental exposure assessments:
- Advice on appropriate routes of environmental exposure
- Interpretation of core, additional, and PT-specific data
- Exposure assessments and integration with effects endpoints to produce risk assessments
- Simulation modelling
- Strategies for dealing with unfavourable PEC/PNEC ratios
- Human exposure assessments:
- Advice on appropriate routes of potential human exposure
- Interpretation of core, additional, and PT-specific data
- Human exposure assessments and integration with toxic endpoints to produce risk assessments
- Simulation modelling
- Strategies for dealing with unacceptable margins of exposure or margins of safety
- Dietary risk assessments, where appropriate:
- Animal and consumer intake assessments
- Deterministic and probabilistic modelling
- Study placement and monitoring
- Peer review of protocols and summaries
We also offer a service that is complementary to your in-house expertise. This may have the advantage of a "fresh pair of eyes" and/or "inside track" views from former regulators on the likely acceptability of proposed courses of action. These aspects include:
- Peer reviewing documents
- Acting as a sounding board on potential courses of action/strategies
- Providing a "neutral viewpoint" to obtain views on particular issues from EU Regulatory Authorities without the need to disclose the compound of interest