The European Commission has just released a reference report for a definition of nanomaterials which will set the base for a regulatory framework in Europe. From the news item on Nanowerk,
Despite the growing utilisation of engineered nanomaterials in consumer products and innovative technological applications, there is at present no widely accepted definition of the term “nanomaterial” that is suitable as a basis for legislation on their safe use. Responding to a request of the European Parliament, the Joint Research Centre (JRC) published today a reference report entitled “Considerations on a definition of nanomaterial for regulatory purposes” (pdf download).
The report discusses possible elements of a definition aiming at reducing ambiguity and confusion for regulators, industry and the general public. It recommends that the specific term “particulate nanomaterial” should be employed in legislation to avoid inconsistencies with other definitions and that size should be used as the only defining property. [emphases mine]
I have to say I’m a little underwhelmed, especially so after reading (very quickly) the report. The best I can say about the report is that it provides a good summary of the definitions for nanomaterials that have been proposed by various international organizations, government entities, and countries in Europe, as well as, including the US, Canada, and Australia. (I have my fingers crossed that one day there’ll be a report that mentions some other jurisdictions as well.)
Here’s the definition as recommended in the report,
For a definition aimed for regulatory purposes the term ‘nanomaterial’ in its current general understanding is not considered appropriate. Instead, the more specific term ‘particulate nanomaterial’ is suggested.
The term ‘material’ is proposed to refer to a single or closely bound ensemble of substances at least one of which is a condensed phase, where the constituents of substances are atoms and molecules.
For a basic and clear definition of ‘particulate nanomaterial’, which is broadly applicable and enforceable, it is recommended not to include properties other than size.
For the size range of the nanoscale, a lower limit of 1 nm and an upper limit of 100 nm or higher should be chosen.
The questions of size distribution, shape, and state of agglomeration or aggregation, may need to be addressed specifically in subsequently developed legislation. It is also likely that certain particulate materials of concern that fall outside a general definition might have to be listed in specific legislation.
Additional qualifiers, like specific physico-chemical properties or attributes such as ‘engineered’ or ‘manufactured’ may be relevant in the scope of specific regulations. (p. 31 print version, p. 33 PDF)
Given the work in the report, this seems a remarkably modest recommendation that could almost have been written prior. It’s almost as if they made a survey of the current recommendations and pulled together the most commonly occurring and least contentious versions to create a relatively innocuous definition.
Tags: Considerations on a definition of nanomaterial for regulatory purposes, Europe, European Commission, European Parliament, Joint Research Centre, nano definitions, nanomaterials, Regulatory Framework