Graphene: Significant New Activity Rules

Summary#

The Government of Canada has issued a Significant New Activity (SNAc) notice for the substance graphene (CAS RN 1034343-98-0) under the Canadian Environmental Protection Act, 1999. The notice, in force as of November 28, 2020, requires people to tell the federal government before starting certain new uses of this form of graphene so health and environmental risks can be assessed.

What it does#

• Applies SNAc rules to graphene and requires a notification (a Significant New Activity notification) to the Minister of the Environment at least 90 days before starting a covered new use.
• Sets specific kinds of new uses that trigger the notification requirement:
  • Any manufacture or sale of a consumer product or cosmetic that is applied as a spray, mist or aerosol and that contains the substance at or above 1% by weight, when the total amount for sale in Canada is more than 10 kg in a calendar year.
  • Any use of the substance in Canada in quantities that fall into one of these annual bands: more than 100 kg up to 1 000 kg; more than 1 000 kg up to 10 000 kg; or more than 10 000 kg.
• Defines which physical and chemical forms of graphene trigger the lower spray/aerosol thresholds (examples of required characteristics include):
  • primary particle lateral size distribution 0.3 to 10 micrometres
  • number of atomic layers 2 to 15 layers
  • carbon-to-oxygen ratio of at least 89
  • purity of at least 84%
  • surface modified with sodium dodecyl sulphate
• Says the substance falls into the other (volume-based) categories if it has at least one different characteristic (for example, particle size or layer count outside the ranges above, lower purity, different surface modification).
• Lists what must be sent in a notification, including plain and technical information such as:
  • a description of the proposed activity and the anticipated annual quantity
  • measurements of particle size, shape, aggregation/agglomeration state, surface area and charge, and degree of oxidation (carbon:oxygen)
  • any existing toxicity or environmental test data and lab reports
  • certain inhalation and mutagenicity test reports prepared to international test and lab-practice standards (Organisation for Economic Co‑operation and Development / OECD methods and Good Laboratory Practice)
  • contact information and a signed certification that the submission is complete and accurate
• Exemptions and transitional rules:
  • Use as research and development, as a site-limited intermediate, or in products for export only is not treated as a significant new activity.
  • A transitional allowance means that, between publication and November 27, 2021, some spray/aerosol uses are only subject to notification if they involve at least 100 kg in a year (instead of the lower 10 kg threshold). The notice otherwise came into force immediately on November 28, 2020.

Who's affected#

• Manufacturers, importers and distributors of graphene and products that contain it — especially makers of consumer products and cosmetics sold as sprays, mists or aerosols (for example, hair sprays).
• Companies or labs that plan to use graphene at the nanoscale or in larger volumes in Canada.
• Downstream users and suppliers who handle mixtures or parts containing graphene, since components of mixtures can be subject to the notice.
• Research and export-only activities are generally excluded, so typical academic R&D or products made solely for export are less likely to be affected.
• It may be unclear for some specific products or mixtures whether the notice applies; companies are expected to use information they have access to in order to decide.

Why it matters#

• The notice makes the government aware of planned new uses of this specific form of graphene before those uses start. That lets Health Canada and Environment Canada assess potential human-health and environmental risks, especially where inhalation exposure (sprays, aerosols, nanoscale forms) is possible.
• For businesses, it means they may need to gather technical test data and wait at least 90 days for an assessment before introducing some products or high-volume uses in Canada. That can affect product development timelines and supply decisions.
• For the public, the measure is intended to reduce the chance that new uses of graphene will reach the market without an up-front safety review, particularly for products that could release the material into the air.