Recent Developments in the Regulation of Nanomaterials, Part 4 of 5 - Canada

A five part series by Linda Jensen

Part 4 of 5

In Canada, the manufacture and import of nanomaterials is controlled through the New Substances Notification Regulations (Chemicals and Polymers), enacted pursuant to the Canadian Environmental Protection Act, 1999. The Regulations are intended to ensure that no new substances, either chemical or polymer, are introduced into the Canadian market without first being assessed for toxicity to humans and the environment, and having appropriate control measures imposed.[i]

To this end, the Regulations require anyone planning to manufacture or import a substance not already listed on the Domestic Substances List (DSL) to file a notification with the Minister of the Environment and provide certain information about the substance as stipulated in the Act and Regulations. Currently, there are approximately 23,000 substances registered on the DSL.[ii]

In an Advisory Note issued in 2007, Environment Canada (EP) clarified its position concerning how the Regulations apply to nanomaterials.[iii] In essence, the Canadian regime considers the nanoscale form of a substance to be “new” and different from its conventional counterpart if it presents a unique structure or molecular arrangement. Thus, notification requirements will apply to the nanoscale form of the substance even if the conventional form is already listed on the DSL. Notification requirements are not triggered, however, if the nanoscale form is consistent in structure and molecular arrangement with its conventional equivalent.

In addition, Health Canada has recently issued an interim policy statement aimed at establishing a working definition of “nanomaterial” to assist in the application of regulatory measures in various contexts.[iv] Revisions to the definition are currently being considered following a consultation period, and further information from Health Canada to clarify the intended use of the policy statement is anticipated in the near future. 

This article provides general information about the subject matter and does not constitute legal advice. Any individual or business affected by regulatory measures should seek advice from competent counsel or other qualified specialists.

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[i] See guidance documents and other compliance materials provided on the Environment Canada website: http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=5981665E-1.

[ii] Environment Canada website,http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=5F213FA8-1.

[iii] Environment Canada, “New Substances Program Advisory Note 2007-06: Requirements for nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers)”, http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=3C32F773-1.  

[iv] Interim Policy Statement on Health Canada's Working Definition for Nanomaterials, http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/draft-ebauche-eng.php.