SNAc Controls for Cosmetic Ingredient CAN 19501-9

Summary#

The federal government added one chemical, identified as CAN 19501-9 (the substance alkanoic acid, trialkyl-, mixed polyesters with alkylalkanoic acid and poly(substituted alkyl)alkanepolyol), to the Order 2023-87-03-01 Amending the Domestic Substances List under the Canadian Environmental Protection Act, 1999. The Order keeps special reporting requirements for certain new uses of this substance and is in force now, with one part coming into force on July 9, 2023.

What it does#

• Adds the chemical CAN 19501-9 to Part 4 of the Domestic Substances List.
• Keeps Significant New Activity (SNAc) rules for this substance so that the government must be notified and can assess certain new uses before they happen.
• Sets thresholds and timing:
  • Transitional period (from registration day until July 8, 2023) requires notification if a person uses or imports 1 000 kg or more of the substance in the manufacture or import of a cosmetic where the substance is at least 0.1% by weight.
  • After the transition, notification is required if a person imports 10 kg or more in a calendar year in a cosmetic at ≥ 0.1% by weight. (The calendar year excludes the period January 1, 2023 to July 8, 2023.)
• Requires those planning a covered “significant new activity” to give the Minister detailed information at least 90 days before starting. That includes exposure estimates, function of the substance in the product, and several toxicity studies (including skin absorption tests and a 21/28‑day repeated dermal toxicity study).
• Exempts certain activities from notification, including research and development, site-limited intermediates, export-only products, and uses already regulated under specific federal laws (for example, the Food and Drugs Act for cosmetics).

Who's affected#

• Cosmetic manufacturers and importers that use or bring into Canada the substance in products meeting or exceeding 0.1% concentration.
• Chemical suppliers and distributors who handle this substance for cosmetic uses.
• Businesses planning to use or import larger quantities (see 1 000 kg transitional threshold and 10 kg annual threshold).
• Researchers and firms using the substance only for research and development, site-limited intermediates, or export-only products are generally not affected by the notification rules.
• It is not clear from the Order whether other specific sectors (outside cosmetics) might be affected; the SNAc requirements target the listed activities.

Why it matters#

• The government and health authorities flagged potential human health concerns if this chemical were used in cosmetics at certain levels. Keeping SNAc rules means the government can review proposed new uses before they happen.
• Companies that want to start a covered use will need to provide data (including animal and in vitro skin studies) and wait 90 days for assessment. That can mean time and testing costs for businesses.
• For the public, the rule is a precaution: it aims to reduce the chance that a new cosmetic use of this chemical could lead to harmful exposure before the substance has been fully assessed.
• The Order also removes the chemical from the New Substances Notification Regulations list, which the government says should make lawful access to the substance easier for existing uses while keeping controls on certain new activities.