In the absence of additional data on product ingredients, un-validated assumptions will be used to estimate both ingredient technical function and weight fraction (concentration) information. These approaches may lead to incorrect or overly conservative exposure predictions.
Overly conservative exposure will inevitably lead to chemical restriction through legislation, including unnecessary bans on chemicals. This would result in costly reformulation efforts for industry – and potentially block new innovation. On the other hand, adequate and realistic exposure predictions may support regulatory decisions on adaptation for hazard information requirements (e.g. under REACH). In situations where human or environmental exposure is absent, or so low that additional effects information will not lead to improvement of risk management, exposure-based waiving may be considered to avoid unnecessary animal testing.
Exposure-driven risk assessment has long been included in the risk assessment of chemicals. Reliable descriptions of human external exposure and internal dose through modelling, facilitates the targeted use of emerging toxicological tools for risk assessments. Benefits of reliable exposure assessments include:
- Reduced uncertainty, enabling risk assessment to be a more representative reflection of the actual situation.
- Improved integrity of the assessment by enabling more targeted risk management decisions, based on detailed exposure assessment.
- Prevention/reduction of the need for animal testing.
Implementing refined approaches to exposure assessment requires consideration of:
- Data availability.
- Specialised tools, data sets and computational power.
- (Standard) approaches for the collection and sharing of appropriate data on consumer exposure.
- Criteria for selecting suitable exposure databases and modelling tools available.
The aims of this workshop were to:
- Present and review the current state of consumer exposure science by examining data needs, sources (including novel data sources), tools, gaps and the latest innovations.
- Develop consensus on key gaps that should be filled and identify what the major research needs are, including how to address aggregate consumer exposure.
With the help of case studies, examine the potential for the refinement of exposure assessment using appropriate tools and techniques which are fit for purpose.