Biomedical Engineering Reference
In-Depth Information
published literature on the toxicity of CNTs and concluded that multi-walled CNTs may cause
damage to lungs through prolonged or repeated inhalation exposure. The report recommends clas-
sification as hazardous for repeated or prolonged inhalation exposure and for carcinogenicity. For
all other endpoints, NICNAS found that CNTs either were not classified as hazardous, or cannot be
classified as insufficient data are available. The information sheet summarizes the key findings from
the report and discusses implications for manufacturers, importers, persons in control of a business
or undertaking, and workers manufacturing or using products containing CNTs.
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15.11.7 c
aNada
The Canadian Government regulates medical and pharmaceutical products through Health Canada.
Canada indicates in its official materials that nanotechnology and products derived from nanotech-
nology have a wide range of applications and the potential to impact many sectors, including the
health and food sectors. In the health sector, the applications of nanotechnology impact new natural
health products, medical devices, drugs, drug delivery systems, regenerative medicines, and diag-
nostic devices for improved detection and treatment of illnesses. In the food sector, nanomaterials
could be used to preserve food, improve nutritional values, and enhance flavors. One of the most
active components of Health Canada as it relates to nanotechnology is the Health Products and
Food Branch (HPFB). HPFB participates in an interdepartmental Health Portfolio Nanotechnology
Working Group, which gathers information and acts as a discussion forum for issues related to
nanotechnology. This working group contains members from Health Canada, the Public Health
Agency of Canada (PHAC), and the Canadian Institutes of Health Research (CIHR). Additionally,
HPFB participates in the interdepartmental network chaired by Industry Canada.
Health Canada participates in a number of international initiatives, such as the Working Party
on Manufactured Nanomaterials of the Organization for Economic Co-operation and Development
(OECD) and the Technical Committee 229 of the International Organization for Standardization
(ISO), and collaborates with international counterparts.
The authority to regulate nanotechnology in health-related products comes in part from the adop-
tion of a broad working definition for nanomaterials to provide a consistent approach across several
diverse regulatory program areas to identify regulated products and substances that may contain
nanomaterials. The working definition enables the Department to establish internal inventories, to
ask for additional information, and to integrate that new knowledge into regulatory decision-making
processes. The first step to assuring adequate risk assessment and risk management is to identify
potential nanomaterials using the working definition as a tool. The Canadian regulatory track is in
line with what other countries are doing.
Currently, there are no regulations specific to nanotechnology-based health and food prod-
ucts. Health Canada relies on authorities within existing legislative and regulatory frameworks,
which require the assessment of potential risks and benefits of products to the health and safety of
Canadians before they can be authorized for sale.
According to Health Canada's working definition for nanomaterial, the term “nanoscale” means
1-100 nm inclusive. However, individual regulatory programs may request information above the
100 nm size range to an upper limit of 1000 nm in order to maintain flexibility to assess poten-
tial nanomaterials, including suspected nanoscale properties and phenomena. The 1000 nm cut-off
attempts to separate characteristics attributable to macro-scaled materials from those of nanomate-
rials. In addition, for any regulated product or substance that contains nanomaterial and measures
beyond 1 μm in size (e.g., bundles of CNTs that are very long), information may be requested for
risk assessment purposes, regardless of the size.
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Safe Work Australia. 2012. Classification of carbon nanotubes as hazardous chemicals. http://www.safeworkaustralia.
gov.au/sites/swa/about/publications/pages/classification-of-carbon-nanotubes-as-hazardous-chemicals.
