Phenacetin Significant New Activity Rules

Summary#

This is Order 2019-87-24-01 Amending the Domestic Substances List. It applies the “significant new activity” rules under the Canadian Environmental Protection Act, 1999 to the chemical commonly called phenacetin (62-44-2). The Order was registered June 30, 2020 and published in the Gazette on July 22, 2020.

What it does#

• Adds phenacetin (62-44-2) to Part 2 of the Domestic Substances List, so certain new uses must be reported before they start.
• Triggers notification requirements when the substance is used in the manufacture of:
  • a consumer product covered by the Canada Consumer Product Safety Act, or
  • a cosmetic as defined in section 2 of the Food and Drugs Act (except hair colour products), if the substance is present at a concentration equal to or greater than 0.1% by weight.
• Also requires notification for other activities that use the substance in those products if the total amount used is greater than 10 kg in a calendar year and the product contains at least 0.1% by weight.
• Exempts certain situations from notification, including:
  • research and development uses,
  • site-limited intermediates,
  • products made only for export,
  • uses already covered by other federal acts listed in CEPA (e.g., pesticide, fertilizer, feed regulations).
• Anyone proposing a significant new activity must give the Minister specified information at least 90 days before the activity starts. This includes a description of the activity, anticipated quantities, test data, product details, expected sales, contact information, and a signed certification.
• The Minister will assess the submitted information within 90 days of receiving a complete notification.

Who's affected#

• Companies that make, import, formulate or sell consumer products or cosmetics that might start using phenacetin at or above 0.1% by weight.
• Importers or users who would handle more than 10 kg of the substance in a year in such products.
• Laboratories or suppliers that would move into those new uses.
• The Order does not apply to existing, identified uses that were already assessed (for example, certain hair products were considered in the screening assessment and are not targeted by this Order).

If it’s unclear whether a specific use is covered, the Order’s definitions and exemptions should be checked or the Departments contacted.

Why it matters#

• The screening assessment found current Canadian uses of phenacetin are not posing an undue risk, but the chemical has properties (including a potential to cause cancer) that mean increased or new uses could raise health concerns.
• This Order creates an early-warning step. It forces companies to notify the government before starting certain new uses. That gives regulators time to assess risk and, if needed, set controls before Canadians or the environment are exposed to higher levels.
• The government expects little immediate cost or disruption for current business. Costs could arise only if someone wants to begin a covered new activity and must generate data for the required notification.