At present, Health Canada’s regulations do not contain any information specific to nanomaterials, and the regulatory body’s publication of an interim policy statement gives manufacturers an idea of the format any final regulation may take.
“This acting definition gives us something to work with,” explained Mike Patton from the Canadian cosmetics trade association, the CTFA.
The interim policy statement defines nanomaterials as a manufactured products, material, substance, ingredient, device, system or structure, that has at least one spatial dimension in the nanoscale (1-100nm); or that exhibit one or more nanoscale phenomena, regardless of size.
Health Canada said the definition is purposefully wide and as the discussion progresses definitions may change and become more sector specific.
The regulatory body has also said it may require information about the nanomaterials including its physico-chemical properties and toxicological data, as well as risk assessment and risk managements strategies if appropriate.
Furthermore, Health Canada is encouraging manufacturers and stakeholders to communicate with the body early on in the product development process that will contain nanomaterials.
Full ramifications are unknown
For the moment, the ramifications of this working policy for the cosmetics industry, which often uses nanoparticles of titanium dioxide as a UV filter, are not fully known, Patton told CosmeticsDesign.com-USA.
“However, the interim policy statement gives us an idea of what is being discussed and what might be expected in the future. It makes it easier for industry to comply and be co-operative,” he said.
Health Canada has published the interim policy document on its website and is encouraging interested parties to provide feedback and comments about the document until August 31 2010.
In addition, it will work on guidance documents and workshops with the aim of illustrating how the document should be applied to each sector.
Updates to the policy document will be made as and when comments are received and the body of scientific evidence increases. It can be found here.