What’s in a Name? – Defining a 'Nanomaterial' for Regulatory Purposes in Europe

Abstract

Attempts at suitable identification of a generally accepted definition of a ‘nanomaterial’ have been going on in Europe and worldwide for some time. Definitions are important from a regulatory perspective as ‘they assist in establishing the subject matter and scope of what is to be regulated’. However, considering the complexities associated with nanoscience and also the differing opinions on various definitions, this has not been an easy task. Reaching an agreement on fundamental terms and definitions such as ‘nanotechnology', 'nanoparticle', ‘nanoscale', and a ‘nanomaterial’ is both complex and contested. To date, there is no internationally recognised and accepted definition of a ‘nanomaterial’ even though several definitions have been discussed and proposed by national authorities, scientific committees, international organisations, and other bodies.

The current paucity of data on the effects of nanomaterials, particularly nanoparticles, on human health and the environmental has led to increased concern, while bodies such as the ISO, the British Standards Institution (BSI) and American Society for Testing and Materials (ATSM) have continued to grapple with the process of developing standardised definitions for many key terms. The European Parliament has, however, forged ahead with its attempt to regulate particular product areas in which nanotechnologies are used. This can be seen in the European Union’s (EU) recast of the Cosmetic Directive and the Novel Foods Regulation. It must be noted that the recast of these sector-specific instruments were scheduled for other reasons, including reducing the regulatory burden and fragmentation of EU laws, and not specifically to address nanotechnologies. Subsequently in 2010, the European Commission’s Joint Research Centre (JRC), the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the European Commission respectively released various definitions of a ‘nanomaterial’ to be used as a broadly applicable reference term for any European Union communication or legislation addressing nanomaterials.

Keywords: Nanotechnology, Nanomaterial, Definitions, European Union, Risk, Regulation