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October 13, 2011

Health Canada Announces Policy Statement Concerning Working Definition for Nanomaterial

Lynn L. Bergeson

On October 11, 2011, Health Canada announced the availability of its Policy Statement on Health Canada’s Working Definition for Nanomaterials. Health Canada received 29 comments from stakeholders on its March 2010 Interim Policy Statement, which it revised based on stakeholders’ feedback. According to Health Canada, other revisions were prompted by developments in international norms, evolving scientific evidence, and regulatory program needs. Health Canada states that it will update its Policy Statement “as the body of scientific evidence and international norms progress.” The Policy Statement on Health Canada’s Working Definition for Nanomaterial, summary of comments received, and frequently asked questions are available online.

The Policy Statement states: 

Health Canada considers any manufactured substance or product and any component material, ingredient, device, or structure to be nanomaterial if:

a.         It is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale; or

b.         It is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.

For the purposes of this definition:

i.          The term “nanoscale” means 1 to 100 nanometers, inclusive;

ii.          The term “nanoscale properties/phenomena” means properties which are attributable to size and their effects; these properties are distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and

iii.         The term “manufactured” includes engineering processes and the control of matter.