ABSTRACT
This chapter represents the main interdisciplinary part of this book, dealing primarily with the role of regulatory toxicology in REACH. The tendency to bypass the technical and scientific understanding of how the safety concept is determined, is common in legal scholarship. Yet, REACH operates through formulas such as ‘high levels of protection’ or ‘adequately controlled risks’ which offer little substantial understanding on how the actual levels of safety are determined, if read exclusively through a legalistic lens.
The chapter presents an analysis of the concepts of hazard and risk within the RA model of REACH, together with some reflection on the nature and magnitude of nano-risks. Risk assessment models used in chemical legislation are deconstructed to the most elementary units, which are then tested with regard to their suitability for nanosubstances’ risks. The chapter concludes on how uncertainty is accounted for by REACH’s uncertainty analysis models, and how this impacts the regulation of highly uncertain risks such as those of nanosubstances. It is this chapter’s argument that an anticipation of precaution in the initial phases of the risk analysis, i.e. risk assessment, and transparency about the assumption therein, are necessary for the effective regulation of nano-risks in REACH.
