Defining Nanomaterials for the Purpose of Regulation within the European Union

Abstract

Consumer desire for superior and new products has provided industry with the opportunity and market demand to incorporate and experiment with new technologies, including nanotechnologies. While these products and processes have fallen under the scope of existing regulatory frameworks, potential health and safety concerns has prompted some stakeholders to call for new, nano-specific regulations. Until now, governments have been hesitant to respond to such demands given the evolving state of the scientific art and limited international agreement as to what nanotechnologies or nanomaterials “are”. Despite these challenges, in November 2009 the European Union formally embraced the idea of specifically regulating the use of nanomaterials in cosmetic formulations. To achieve this objective, the Parliament and Council had to define what they meant by nanomaterials within the context of the adopted text in order to regulate them. It appears likely that other instruments will be similarly amended so as to include nano-specific provisions, including definitions. This article explores this policy shift within the European Union and the implications of the Parliament and Council's stance at this stage due to the absence of a generally accepted definition within the international community.