Regulating nanoparticles: A complex balancing act

Abstract

Regulation is a key part of product commercialisation, where different stakeholders must continually negotiate what are often conflicting regulatory drivers. High technology regulation is particularly problematic as is found in nanotechnology, and nanoparticle products, where there is much misunderstanding about what these products are and how they work. Nanotechnology is the application of small products, ranging between one hundred million and one billion times smaller than a metre, considered as the next 'industrial revolution'. At the vanguard of nanotechnology products, nanoparticles are examined in this study, where rapid technological advances are creating much debate within the discipline of law for how to best regulate the nuanced physicality of these products. Extant arguments have focused on how to regulate the R&D, production, sale, consumption and end-of-life of these products, with varying considerations of physicality which is pivotal to this endeavour. Critically, and fundamental to any discussion about regulating nanotechnology is whether these products sit inside of current regulations, or whether they require new regulatory approaches to more adequately capture their physicality. Confusingly, there has often been an erroneous presupposition that nanotechnology will function as a direct mirror of larger products, which is often not the case. On this basis, this study engages with the physicality of nanoparticles to build a foundation of knowledge, asking pivotal questions about regulation, to better inform academic and industrial regulatory discourses. Attention is given to regulatory frameworks including the Precautionary Principle, Regulation, Evaluation, Authorisation and Restriction of CHemicals (REACH), and potential for nanotechnology registries for monitoring nanoparticle physicality. Importantly, for any collection of highly nuanced novel physical products as found within nanotechnology, there can be no 'one-size-fits-all' with in depth examinations being made with different specific sectors to draw out the major challenges related to the physicality of this wide ranging collection of products.