Ministerial conditions for octanamide N‑hydroxy

Summary#

This notice records Ministerial Condition No. 21911 under the Canadian Environmental Protection Act, 1999 that allows the manufacture or import of the substance octanamide, N‑hydroxy‑ (CAS 7377-03-9) but only under specific conditions. The ministers responsible reviewed information (the notifier provided material on June 25, 2024) and suspect the substance may be toxic, so they set limits and record-keeping rules that came into force on August 23, 2024.

What it does#

• Allows the person who provided information on June 25, 2024 (the “notifier”) to manufacture or import the substance, but only under the listed conditions.
• Prohibits the substance from being imported or manufactured for use in a cosmetic as defined in the Food and Drugs Act.
• Requires the notifier to transfer physical possession or control of the substance only to people who agree to use it only for non‑cosmetic purposes.
• Requires the notifier to:
  • inform each recipient in writing of these conditions before transfer, and
  • get written confirmation, before the first transfer, that the recipient was informed and agrees to the non‑cosmetic use restriction.
• Requires the notifier to keep records showing:
  • how the substance is used;
  • quantities manufactured, imported, purchased, distributed, sold and used;
  • the name and address of each person who received the substance;
  • the written confirmations from recipients.
• Sets rules about those records:
  • create records no later than 30 days after the information or documents become available;
  • update recipient addresses within 30 days after learning of a change;
  • keep records in English, French, or both;
  • store records at the notifier’s principal place of business in Canada (or their representative’s) for at least five years;
  • if electronic, keep them in an electronically readable format.

Who's affected#

• The main party affected is the notifier — the person who supplied the required information to the government on June 25, 2024.
• Manufacturers and importers of octanamide, N‑hydroxy‑ (CAS 7377-03-9) will be affected if they are the notifier, or if they receive the substance from the notifier.
• Businesses that might receive the substance from the notifier must agree in writing to the non‑cosmetic use restriction and keep the notifier’s required records.
• It is unclear from this notice whether other companies that separately import or make the substance (and who are not the notifier) are covered; the conditions specifically apply to the notifier.

Why it matters#

• The government suspects the substance could be harmful, so it is allowing limited commercial activity while controlling how it is used and tracked.
• Banning cosmetic uses could concern companies in personal‑care supply chains that might otherwise want to use this chemical.
• The record-keeping rules give regulators a paper trail to see who handled the substance and how much moved through the market.
• For the general public, these measures aim to reduce the chance the substance ends up in consumer cosmetics and to support oversight of a chemical that may pose risks.