Exponent has considerable experience in assisting clients with the Biocidal Products Directive 98/8/EC legislation (BPD) and data requirements, from both the EU and individual Member State perspectives. Many of our scientific staff have previously worked as regulators, in industry, or in contract laboratories, therefore we have a unique and valuable perspective on dealing with the regulatory requirements.
Exponent scientists have written numerous summary dossiers and partial dossiers for active substances and representative products within the EU biocides review under the BPD, as well as for new biocidal active substances. We 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 achieving positive Annex I inclusion decisions.
We offer advice on regulatory strategy, including regulatory support, product stewardship, and total product management.
How We Can Help
Product Authorisation and Mutual Recognition
- Product Authorisation Dossiers & R4BP - All Product Types
- Frame and Family Formulation Assessment
- Data Gap Analysis, Waiving Strategy & Bridging Arguments
- Data Interpretation, Summaries, IUCLID 5
- Post Submission Support
Exposure Modelling and Risk Assessments
Advice on Regulatory Strategy
Product Authorisation Dossiers & R4BP
We can assist you with dossier preparation and submission under the Biocidal Products Directive and the forthcoming Biocidal Products Regulations (BPR) in the following areas:
- 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
Frame and Family Formulation Assessment
- Chemical composition
- Efficacy comparison
- Hazard and classification
- Risk characterisation
Data Gap Analysis, Waiving Strategy, and Bridging Arguments
- Maximising 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
- Reduce the cost of testing for mammalian toxicology and ecotoxicology
Exposure Modelling and 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) used for biocide products. We also 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, 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, BEAT 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.
Post Submission Support
- Addressing Competent Authorities Queries
- Defending approaches to regulators
- Attending TM and CA meetings with or on behalf of clients
Advice on Regulatory Strategy
- Regulatory support under BPD
- Regulatory advice with respect to forthcoming BPR
- Product stewardship
- Total product management
Complementary Service
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