The first part of any legal document is concerned with defining the terms used, what do terms such as ‘the company’ or ‘the client’ refer to for example. Most of these issues are fairly straightforward, but when you get to the level of international legislation defining terms becomes rather more complex, as the European Commission is just finding out.
After many years of the slow but inexorable march towards the regulation of nanomaterials, the European Commission is now trying to understand what a nanomaterial actually is, and has launched a consultation process “to collect stakeholders’ views on the envisaged definition.” According to the Commission
The definition of the term “nanomaterial” should be based on available scientific knowledge and should be used for regulatory purposes. The definition should determine when a material should be considered as a nanomaterial for legislative and policy purposes in the European Union.
The problem comes from the previous standard definition of a nanomaterial having particles in the size range 1-100nm. Anyone who has worked with nanomaterials will know that in many cases there is a wide range of particle sizes present, some of which may be above 100nm or even below 1nm and the situation becomes even more complex when you start working with compounds and agglomerations. The EU seems to be moving towards a definition involving both size distribution and surface area:
The opinion “Scientific basis for the definition of the term ‘Nanomaterial'” was adopted for public consultation on 6 July 20106. SCENIHR concluded that size is universally applicable to nanomaterials and is a key element to a definition. A defined size range would facilitate a uniform interpretation. The lower limit was proposed at 1 nm. An upper limit of 100 nm is commonly used by general consensus but there is no scientific evidence to qualify the appropriateness of this value. The use of a single upper limit value might be too limiting for the classification of nanomaterials and a differentiated approach might be more appropriate. For regulatory purposes, the number size distribution should also be considered using the mean size and its standard deviation to refine the definition. In addition the SCENIHR identifies certain specific cases where the application of the definition can be facilitated by using the volume specific surface area as proxy for the internal or surface structure.
Defining a nanomaterial at this stage may seem rather silly to some, after all they have been around for 15 years in their man made form, but when you consider the implications of regulation, whether restricting the use of nanomaterials, or requiring labelling for cosmetics, the stakes are high and an accurate definition is needed to remove another layer of uncertainty surrounding their use.