Canada Seeks Comment on Proposed Approach to Address Nanoscale Substances on the DSL

Environment Canada and Health Canada have released a February 2015 consultation document entitled Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List.  Environment Canada and Health Canada propose a stepwise approach to address nanoscale forms of substances on the Domestic Substances List (DSL):

  1. Establishment of a list of existing nanomaterials in Canada;
  2. Prioritization of existing nanomaterials for action; and
  3. Action on substances identified for further work.

The proposed criteria for defining existing nanomaterials include, but are not limited to:

  • The substance has a chemical composition that is identical to that of a bulk substance already listed on the DSL; AND
  • The substance is in commerce in Canada at quantities above 100 kilograms (kg)/year; AND
  • The substance is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale; OR
  • The substance is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.

Proposed criteria for substances to be excluded, unless they are intentionally manufactured to exhibit one or more nanoscale properties/phenomena, include, but are not limited to:

  • Polymers;
  • Organic or organo-metallic pigments and dyes;
  • Naturally occurring or incidentally produced nanomaterials; and
  • Deoxyribonucleic acid, ribonucleic acid, proteins, peptides, liposomes, antibodies, viruses or a virus-like particles, organelles or other biological materials.

Questions for stakeholders include:

List of Existing Nanomaterials:

  • Is the list of nanomaterials in Appendix A of this document a good preliminary reference list of existing nanomaterials in Canada?
  • What additional criteria could be considered to identify existing nanomaterials?
  • What methods can be used to collect information to develop a more comprehensive list or verify information on existing nanomaterials in commerce in Canada?
  • What other sources of information are available to determine the commercial status of existing nanomaterials in Canada?
  • What barriers exist to obtaining/providing information on existing nanomaterials in Canada?

Prioritization

  • What factors should Environment Canada and Health Canada consider when prioritizing nanomaterials?
  • What outcomes should Environment Canada and Health Canada consider when prioritizing nanomaterials?

Comments will be due 60 days after the document is posted on the Canadian Environmental Protection Act (CEPA) Environmental Registry.  In June 2015, Environment Canada and Health Canada intend to conduct an information gathering survey and hold a stakeholder workshop to discuss the proposed approach and the information gathering survey. 

Canada Adds Nanosubstance to DSL

In a November 21, 2012, Canada Gazette notice, Canada amended the Domestic Substances List (DSL). The amendments include the addition of cellulose, hydrogen sulphate, sodium salt, obtained from sulphuric acid hydrolysis of the bleached pulp, with the substance having the following characteristics:

  • (a) Nominal length of 100 ± 50 nanometres;
  • (b) Cross section dimension less than or equal to 10 nanometres; and
  • (c) Sulphur content of greater than or equal to 0.5 percent and less than or equal to 1.0 percent by weight.

Canada added the substance with substance identity number 91343, rather than a Chemical Abstracts Service (CAS) Registry Number. Substances on the DSL do not require notification unless they are proposed for a significant new activity (SNAc) as indicated on the DSL. Substances not appearing on the DSL are considered to be new to Canada and are subject to notification.

Environment Canada Publishes Advisory Note Regarding Nanomaterials

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.