In an October 5, 2010, Chemical Gazette notice, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that it is introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:
. . . 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 [nanometer (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 nanostructured (i.e. having an internal or surface structure at the nanoscale).
The notice includes the following notes to the working definition:
- Intentionally produced, manufactured, or engineered materials are distinct from accidentally produced materials;
- “Unique properties” refers to chemical and/or physical properties that are different because of its nanoscale features as compared to the same material without nanoscale features, and result in unique phenomena (e.g., increased strength, chemical reactivity or conductivity) that enable novel applications;
- Aggregates and agglomerates are considered to be nanostructured substances; and
- Where size distribution shows ten percent 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.
Currently, all regulatory requirements applicable to conventional chemicals also apply to their nano-forms. Specific amendments to current processes and practices vary between new chemicals exemptions and new chemical certificates and permits. NICNAS may require additional information, on a case-by-case basis, on the nano-specific characteristics of chemical. NICNAS may also require further additional data such as surface area, impurity profile, and surface properties (such as charge and coatings), on a case-by-case basis.