Proposals to overcome limitations in the EU chemical risk assessment scheme

The notification of new chemicals in the European Union requires a risk assessment. A Technical Guidance Document (TGD) was prepared for assistance. The TGD proposes QSARs, regressions and models from various sources. Each method has its own range of applicability and its own restrictions. Regressions used in the assessment of indirect human exposure have a common regression range from log K(OW), 3.0-4.6. Most models are compartment models, which do not consider a spatial distribution of the chemical, and were originally developed for non-dissociating, lipophilic persistent chemicals with measurable vapor pressure. Taking this into account, the TGD is only applicable for a minority of chemical classes. Dissociating compounds, ions, polar and very non-polar compounds do not belong to them. The effect of mixtures cannot be considered, except for hydrocarbons. Using the example of plant uptake, it is shown that in certain cases uptake is underestimated by the model due to processes not considered. This may lead to a wrong security in risk assessment. To overcome these limitations, a set of alternative models with different application ranges should be developed. When no applicable method is available, it might be better not to use a model at all instead of an inadequate model, and look for other sources of information.