Regulation and Risk Assessment of Nanomaterials – Too Little, Too Late?

Acknowledgements There are a number of people that I would like to thank for their help and guidance in the past three years. First of all, I would like to thank my co-authors along with Abstract Nanotechnology is the latest in a long series of technologies heralded as ushering in a new era and current and future applications of nanotechnology are expected to hold immense societal and environmental benefits. Concerns have been raised about the safety and regulation of nanomaterials following a number of studies which indicated that some nanomaterials can cause adverse effects on laboratory animals. Data on nanoparticles, such as increasing production volumes and commercialization, capabilities to cross biological barriers, and increased biological activities of nanoparticles when compared to bulk counterparts, have worried some scientists, policy-makers, members of the public and industry and investors about their potential impacts on the health and safety of both humans and the environment. The aim of this PhD Thesis is to: 1) investigate whether existing regulation is adequate in the short and the long term, 2) explore the feasibility of risk assessment for the purpose of dealing with the complex emerging risks of nanomaterials, and finally, 3) provide recommendations on how to govern nanotechnologies. The short and long term development of nanotechnologies and nanomaterials was investigated and an in-depth analysis was performed of key pieces of regulation in the EU such as REACH, pharmaceutical regulation, and the worker safety directives, and waste directives. The applicability of each of the four individual steps of risk assessment (i.e. hazard identification, dose-response assessment, exposure assessment, and risk characterization) was evaluated in the light of the current state of knowledge. It is found that although nanomaterials might be covered by the general scope of many of the existing legislative frameworks it is often unclear, if current regulation is actually applicable when it comes to specific nanomaterials and their diverse applications. The main problems seem to be: that requirements to do safety evaluations are triggered by production volumes by tonnage not tailored to the nanoscale, the profound lack of (eco)toxicological data, and that no risk thresholds and occupational exposure limits cannot be established with existing methodologies. So far, the only amendment that has been implemented is to annul the exemption status of carbon and graphite under REACH, which is deemed inadequate to address the potential risks of nanomaterials and the current regulatory uncertainty. Several governments have opted …