REGULATORY MEMORANDUM

Health Canada Adopts Interim Policy Statement on Health Canada's Working Definition for Nanomaterials

On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy "is effective immediately." In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments. Comments are due August 31, 2010, and Health Canada intends to use the comments to update the Interim Policy as necessary. More information is available online.

According to Health Canada, currently the Acts and Regulations administered by Health Canada have no explicit reference to nanomaterials. The key objectives of the Interim Policy are to:

  1. Establish a working means of identifying nanomaterials;
  2. Assist Health Canada to collect information and establish internal inventories regarding products, materials, substances, ingredients, devices, systems, or structures that are, contain, or make use of nanomaterials;
  3. Support communications about nanomaterials with the broader community of interested stakeholders; and
  4. Support the administration of the legislative and regulatory frameworks under the authority of Health Canada and to help further the development of policy, guidance, and programs applicable to nanomaterials. Note that Health Canada's responsibilities for foods, cosmetics, drugs, and medical devices are similar to those of the Food and Drug Administration in the United States, and for pesticides, Health Canada's responsibilities are similar to those of the U.S. Environmental Protection Agency. Regarding chemicals, Health Canada is responsible for human health aspects and shares responsibility with Environment Canada, which handles environmental aspects.

Under the Interim Policy, Health Canada will consider any manufactured product, material, substance, ingredient, device, system, or structure to be nanomaterial if:

  • It is at or within the nanoscale in at least one spatial dimension; or
  • It is smaller or larger than the nanoscale in all spatial dimensions and exhibits one or more nanoscale phenomena.

For the purposes of this definition:

  • The term "nanoscale" means 1 to 100 nanometres, inclusive;
  • The term "nanoscale phenomena" means properties of the product, material, substance, ingredient, device, system, or structure that are attributable to its size and distinguishable from the chemical or physical properties of individual atoms, individual molecules, and bulk material; and
  • The term "manufactured" includes engineering processes and control of matter and processes at the nanoscale.

Health Canada states that it will post on its website the results of the consultation. Health Canada intends to take further steps to illustrate how the Interim Policy will be applied in specific contexts, including guidance documents for specific products or substances, targeted workshops, and postings of answers to frequently asked questions. According to Health Canada, it will update the Interim Policy "as comments are received, as the body of scientific evidence increases, and as international norms progress."

 
BERGESON & CAMPBELL, P.C.
2200 Pennsylvania Ave, N.W. Suite 100W | Washington, D.C. 20037 | (202) 557-3800 • (202) 557-3836 (fax) | www.lawbc.com
© 2022 Bergeson & Campbell, P.C. All Rights Reserved