Approach to nanoscale forms of substances on the domestic substances list: chapter 4

4. List of existing nanomaterials in Canada

4.1 Purpose

The first phase of the approach requires acquisition of data in order to establish a list of existing nanomaterials in Canada. This list could be considered a reference list to support decision making on activities related to nanoscale forms of substances on the Domestic Substances List (DSL). To create this list, Environment Canada and Health Canada would like to work with stakeholders and other sources to gather information on which nanomaterials are currently in commerce in Canada. The information-gathering efforts will also inform the approach for addressing those nanomaterials and will provide a basis to enable additional stakeholder cooperation.

4.2 Current status

Environment Canada and Health Canada already have some knowledge about the status of certain nanomaterials in Canada addressed through the New Substances program. To date, Canada has assessed 20 nanomaterials under the regulations. The most prevalent uses have been in composite materials and coatings. The individual production volumes of each of the notified nanomaterials in Canada have ranged from 100 kilograms per year (kg/year) to 350,000 kg/year.

As described in Section 2, information has also been obtained on certain nanomaterials in Canada and the United States through the Regulatory Cooperation Council (RCC) Nanotechnology Initiative. Under Work Element 4 - Commercial Information, the Nanomaterials Use Matrix was developed to identify nanomaterials which are likely to be in commerce in Canada and the United States.  This Matrix was developed using a number of sources (such as the Industry Canada Company Directory for Nanotechnologies,^{Footnote 17} the Nanowerk database,^{Footnote 18} interactions with provincial nanotechnology associations and external contractors). The Matrix was vetted through consultations with knowledgeable stakeholder groups such as the Nanotechnology Sub-Committee of the Industry Coordinating Group for the Canadian Environmental Protection Act and the RCC Nanotechnology Technical Team. It is important to note, however, that the information in the Matrix has not been verified through any formal process. Nevertheless, it does provide a preliminary reference to facilitate discussions on developing a list of existing nanomaterials in Canada.

Canada has also been engaged with the Organisation for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials Sponsorship Programme for the Testing of Manufactured Nanomaterials.^{Footnote 19} The Sponsorship Programme was created to pool global expertise and establish a foundation of knowledge on human health and environmental safety for a representative set of nanomaterials. The representative set was based on a list of nanomaterials which are or soon to be in use globally. This list also provides a reference to facilitate identification of existing nanomaterials in Canada.

4.3 List of existing nanomaterials

As a first step in this approach, a list of existing nanomaterials in Canada needs to be established to serve as an administrative tool to enable further decision making. The list of nanomaterials initiated under the RCC Nanotechnology Initiative is used as a starting point and is cross-referenced with the DSL to identify the likely types of existing nanomaterials in Canada (see Appendix A). While this list provides a preliminary reference, it has not been validated and may not be a comprehensive list of all nanomaterials. Information about the commercial status of nanomaterials in Canada needs to be further verified for completeness. Moreover, there is currently a lack of quantitative information on the volumes of these nanomaterials in Canada. A proposed set of criteria has been developed to describe nanomaterials that could be added to and excluded from this list.

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 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
• deoxyribonucleic acid, ribonucleic acid, proteins, peptides, liposomes, antibodies, viruses or a virus-like particles, organelles or other biological materials

A mandatory survey under section 71 of the act will be used to obtain the essential data needs to support the development of the list of the existing nanomaterials in Canada and subsequent prioritization activities for those substances. This will ensure that future decision making is based on the best available information. The survey will be designed in consultation with key stakeholders to ensure the scope and objectives are appropriate and achievable. Wherever possible, the timing and/or content of a section 71 notice would be aligned with similar mandatory information-gathering initiatives taking place in Canada and other jurisdictions. In parallel, other approaches for collecting data would also be considered, such as sectoral submission of information or obtaining information prepared by industry for submission to other jurisdictions. Information submitted voluntarily would be excluded from any mandatory survey that is issued.

Environment Canada and Health Canada would like to work with stakeholders to explore these approaches for collecting information to create and verify the list of existing nanomaterials and to inform decision making on potential actions. Stakeholders are invited to contact the departments to discuss ideas and opportunities for information sharing via the contact information provided in Section 7.

Environment Canada and Health Canada will also continue to examine information from available sources to further refine the preliminary list of nanomaterials identified in the Nanomaterials Use Matrix.