Environment Canada (EC) recently posted a New Substances Program Advisory Note entitled “Requirements for nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers).” The Advisory Note was signed in June 2007 and states that the Canadian Environmental Protection Act, 1999 (CEPA) and the New Substances Notification Regulations (Chemicals and Polymers) (Regulations) “apply to new nanomaterials just as any other substance, whether a chemical or a polymer.
The Note includes the following questions and answers:
What are the requirements under the Regulations for nanomaterials which are manufactured or imported?
Nanomaterials which are manufactured in or imported into Canada are subject to the same regulatory requirements as chemicals and polymers, and notifiers must submit a New Substances Notification package prior to the manufacture in or import into Canada of the new substance.
Although not required, Environment Canada and Health Canada recommend notifiers request a Pre-notification Consultation (PNC) during the planning or preparation of a notification. For example, a notifier can request a PNC to assist with determining whether the substance is notifiable, as well as to clarify notification procedures or information requirements, and to determine the acceptability of waiver requests and/or test protocols.
What nanomaterials are subject to the Regulations?
Nanomaterials which are manufactured in or imported into Canada that are not listed on the Domestic Substances List (DSL) are considered new. The nanoscale form of a substance on the DSL is considered a “new” substance if it has unique structures or molecular arrangements. New nanomaterials are subject to notification under the Regulations. For example, the nanomaterial fullerene (CAS No. 99685-96-8) is not listed on the DSL and is considered a “new” substance under the Regulations.
What nanomaterials are not subject to the Regulations?
Substances listed on the DSL whose nanoscale forms do not have unique structures or molecular arrangements are considered existing. Existing nanomaterials are not subject to the Regulations and do not require notification. For example, titanium dioxide (CAS No. 13463-67-7) is listed on the DSL and since its nanoscale form does not have unique structures or molecular arrangements, it is not subject to the Regulations.
In addition, incidentally produced or naturally occurring nanomaterials are not subject to notification.