Australian Government Reviews Notification Process for Industrial Nanomaterials

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) recently announced new administrative processes for the notification and assessment of industrial nanomaterials that are considered new chemicals, which will be of interest to companies introducing nanomaterials as new chemicals in Australia. NICNAS is the governmental, industrial chemical notification system in Australia and is responsible for the management of the Australian Inventory of Chemical Substances.

After convening consultations between November 2009 and February 2010, NICNAS is now introducing new administrative processes for notifying and assessing industrial nanomaterials that are considered new chemicals under Part 3 of the Industrial Chemicals Notification and Assessment Act 1989 (the Act). The information was published in the Australian government’s October 5, 2010, Chemical Gazette, which can be viewed online.

The Chemical Gazette contains information on the working definition of “industrial nanomaterial,” which is “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 nanostructured (i.e., having an internal or surface structure at the nanoscale),” and the January 1, 2011, commencement of the new processes of notification.

Some important points regarding the above definition are as follows:

• 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 their 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 nano-structured substances; and
   
• Where size distribution shows 10 percent or more of a substance (based on the number of particles) is at the nanoscale, NICNAS will consider this substance a nanomaterial for risk assessment purposes.

The administrative changes that take place starting January 1, 2011, will cover exemption, certificate, and permit categories. Introducers will also be required to provide additional information under certain circumstances.

NICNAS will amend its Handbook for Notifiers to implement the process revisions. Changes will be implemented administratively, by amendments to the Act or regulations made under the Act.

NICNAS is committed to reviewing the suitability of any amendments to current administrative arrangements for at least 12 months after initial implementation and will also offer training/outreach. Further information and details will be made available via the NICNAS website.

While many of the novel properties of nanomaterials may be beneficial, concerns have also been raised about the uncertainty that nanomaterials present to health, safety, and the environment due to the lack of adequate international research. To date, there is limited research into the potential hazards of these materials, but research is increasing.

In some instances this research is starting to identify possible health concerns relating to specific kinds of nanomaterials. Use of these materials is uncertain and therefore the changes in notification will be the start of data collection and formation of a national inventory.

The consultation documents can be viewed online.