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The good news is that both the European Union and Australia are moving toward adopting definitions of “nanomaterials” that will be used for setting standards for and developing regulation of these substances. The news that may give some people cause for thought is that the definitions are not identical.
This post is an update to my original post on the subject and looks at two definitions. Consider the following.
The European Commission, in a draft recommendation currently available for public consultation, has defined “nanomaterial” as
“a material that meets at least one of the following criteria:
– consists of particles, with one or more external dimensions in the size range 1 nm – 100 nm for more than 1% of their number size distribution;
– has internal or surface structures in one or more dimensions in the size range 1 nm – 100 nm;
– has a specific surface area by volume greater than 60 m²/cm³, excluding materials consisting of particles with a size lower than 1 nm.” (Art. 2, Sec. 1)
The European Commission’s draft also indicated that the definition will be used “as an overarching, broadly applicable reference term for any Union communication or legislation addressing nanomaterials.” (Preamble, 12) Moreover, the Commission has recommended that the definition be reviewed frequently and adjusted to reflect scientific advances. (Preamble, 7)
The Australian government is using a different definition, however, in a new administrative process published by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The procedure requires new chemical manufacturers and importers to notify NICNAS of their intent to manufacture or import nanoscale chemicals and defines “nanomaterials” as
“industrial materials intentionally produced, manufactured, or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is structured (i.e. having an internal or surface structure at the nanoscale”
Further, the Notes to the working definition add that “where size distribution shows 10% or more of a substance (based on number of particles) is at the nanoscale, NICNAS will consider this substance to be a nanomaterial for risk assessment purposes.”
The different definitions raise several issues:
● The difference between 1%, per the European Commission, and 10%, per Australia’s NICNAS, could mean that many more substances would fall within the definition under EU standards than under Australia’s standards.
● In an increasingly global economy, should manufacturers of nanomaterials be required to meet separate standards based upon definitions that vary from government to government? One answer to this question is, Why not? Manufacturers of chemicals and other products are frequently asked to meet different standards around the world, where some countries may be quite stringent and others lenient. The tobacco industry moved a large segment of its business to Asia in response to litigation and regulation in the U.S., hoping to take advantage of a different regulatory climate. Conversely, however, varying regulatory standards for chemicals can create difficulties and confusion for manufacturers and importers.
● Nanotechnology is not only new to regulation as a discrete category, but will also be regulated in the international arena in the first instance. Wouldn’t consistency, at least in the definition of nanomaterials, best serve this process?
● Nanotechnology is widely viewed as beneficial with broad potential across all sectors of modern life. Consistent definitions of what constitutes nanomaterials would assist firms in making business decisions going forward.
Perhaps different definitions are only a step along the way toward ultimate agreement and consistency in the global arena. Let’s hope so.
The European Commission draft is available at
http://ec.europa.eu/environment/consultations/nanomaterials.htm
The NICNAS processes are available at
http://www.nicnas.gov.au/Publications/Chemical_Gazette/pdf/2010oct_whole.pdf#page=14
