Octanamide N-hydroxy cosmetic limits

Summary#

This notice publishes Ministerial Condition No. 20655, which allows a specific notifier to manufacture or import the chemical octanamide, N-hydroxy- (CAS RN 7377-03-9) under strict limits. The Minister of the Environment and the Minister of Health say they suspect the substance may be toxic under the Canadian Environmental Protection Act, 1999, and the conditions came into force on February 13, 2024.

What it does#

• Allows the notifier named in the filing on October 19, 2023 to manufacture or import the substance, but only under these conditions.
• Limits how the substance can be used in cosmetics. Manufacture or use is allowed only for:
  • rinse-off cosmetics not for children under 14 at up to 0.3% by weight;
  • rinse-off cosmetics intended for children under 14 at up to 0.15% by weight;
  • face cream or face lotion at up to 0.12% by weight;
  • eyebrow pencil, eyeliner or eye shadow at up to 0.2% by weight;
  • aerosol or pump hair spray at up to 0.075% by weight;
  • liquid or lotion makeup remover at up to 0.15% by weight.
• Limits imports of the substance to either:
  • importing it for making one of the products listed above, or
  • importing it already contained in those types of cosmetics.
• Requires the notifier to inform any person they transfer the substance to, in writing, about these conditions and to get written confirmation that the recipient will comply — except when the substance is already in a finished cosmetic of the allowed types.
• Requires the notifier to keep records showing:
  • how the substance is used, its concentration and quantities in products, and who received it;
  • the written confirmations from transfer recipients.
• Sets timing and storage rules for records:
  • update recipient address information within 30 days of learning of a change;
  • create records no later than 30 days after the information becomes available;
  • keep records in English, French, or both, at the notifier’s principal place of business in Canada for at least five years;
  • electronic records must be in an electronically readable format.

Who's affected#

• Primarily the unnamed notifier who filed the information on October 19, 2023. The notice identifies this single notifier as the party allowed to manufacture or import the substance. The public notice does not name that person or company.
• Cosmetic manufacturers, formulators and importers who might buy the substance from that notifier, or who make the listed product types, could be indirectly affected because of the concentration limits and transfer rules.
• Federal regulators will use these conditions to track and enforce limits. It’s unclear from the notice if any other businesses or the wider supply chain are directly authorized.

Why it matters#

• The government suspects the chemical may be harmful, so it is allowing limited use while keeping tight controls. The rules are meant to reduce potential exposure by restricting where and at what concentrations the substance can be used.
• The record-keeping and transfer requirements make it easier for regulators to trace how much of the substance is circulating and who is handling it.
• For companies, the limits could require reformulating products, changing suppliers, or keeping new types of records. For consumers, the notice is intended to reduce the chance of harmful exposure from cosmetics, though the document does not discuss health effects in detail.