Graphene Added to Domestic Substances List

Summary#

This is Order 2021-87-08-01 Amending the Domestic Substances List, which adds the substance known as graphene (CAS 1034343-98-0) to Canada’s Domestic Substances List while keeping special reporting rules in place for certain new uses. One part of the rule phases in and comes fully into force on January 1, 2023.

What it does#

• Adds the substance (CAS 1034343-98-0) to Part 2 of the Domestic Substances List and keeps it subject to the Significant New Activity (SNAc) requirements under the Canadian Environmental Protection Act, 1999.
• Sets which forms of this graphene must trigger a SNAc notification by defining the particle and chemical characteristics:
  • primary particle size distribution: 0.3 to 10 micrometres
  • number of atomic layers: 2 to 15 layers
  • carbon to oxygen (C:O) ratio: greater than or equal to 89
  • purity: greater than or equal to 84%
  • surface modification: with sodium dodecyl sulphate
• Lists activities that require advance notification (a Significant New Activity Notification) at least 90 days before the activity begins, including:
  • making a consumer product or a cosmetic that is intended to release the substance as a spray, mist or aerosol when the substance is greater than or equal to 1% by weight;
  • importing the substance contained in such products in a quantity greater than 10 kg in a calendar year;
  • using 100 kg or more (during the transitional period) or more generally specified amounts in the manufacture of consumer products from which the substance may be released as respirable particles (examples given: face masks and air filters) — with a transitional threshold of 100 kg that changes on January 1, 2023 to a lower threshold of 10 kg for certain uses;
  • any activity involving the substance that exceeds quantity bands when it has at least one different characteristic (e.g., different size, layers, C:O, purity, or surface treatment): (a) more than 100 kg but up to 1,000 kg; (b) more than 1,000 kg but up to 10,000 kg; (c) more than 10,000 kg.
• Specifies the kinds of information and studies that must be provided with a notification. Some required studies are named by their OECD test numbers: Test No. 413, Test No. 403, Test No. 476 or Test No. 490. Studies must follow Good Laboratory Practice and OECD guidance for nanomaterials.
• Exempts certain activities from notification: uses as research and development substances, site-limited intermediates, export-only products, and certain things already regulated under other federal acts (for example, the Pest Control Products Act, Fertilizers Act, and Feeds Act).

Who's affected#

• Companies that make, import or use this form of graphene in Canada — especially manufacturers and importers of:
  • consumer products that could release the substance as spray, mist or aerosol (regulated by the Canada Consumer Product Safety Act);
  • cosmetics that could release the substance as spray, mist or aerosol (as defined under the Food and Drugs Act);
  • products from which respirable particles could be released, such as face masks and air filters.
• Laboratories and testing organizations that would carry out the required studies (OECD-style inhalation and genetic/toxicity tests).
• Suppliers and downstream users who may need to track composition and quantities to know whether notification is required.
• The order does not affect activities that already fall under R&D, export-only manufacturing, or other listed federal regulations.

Why it matters#

• Health concern: the government identified potential adverse pulmonary (lung) effects if people inhale this form of graphene, so it wants advance notice before new uses that could increase inhalation exposure.
• Practical effect: companies planning to import or start using this substance in the ways described will need to prepare and submit detailed data — including specific laboratory studies — 90 days before starting the activity. That can delay market entry and add testing costs.
• Public protection: the rule gives regulators time to assess the risk of a proposed new use and to impose controls if needed before large-scale manufacturing, import, or consumer uses proceed.
• Access for industry: adding the substance to the Domestic Substances List also means it is no longer subject to initial “new substance” notification rules, which the government says will facilitate access for business while maintaining oversight of risky new uses.