Permission for N-hydroxy-octanamide Manufacture

Summary#

This Canada Gazette notice (Ministerial Condition No. 21985) allows one named notifier to manufacture or import the chemical octanamide, N-hydroxy- (CAS 7377-03-9), but only under specific conditions set by the federal government. The ministers overseeing the file say they suspect the substance may be toxic, and the permission is limited by bans on use in cosmetics and by record-keeping and transfer rules that came into force on November 13, 2024.

What it does#

• Defines the “notifier” as the person who supplied required information on September 19, 2024 and limits the permission to that notifier.
• Allows that notifier to manufacture or import the substance, subject to conditions.
• Prohibits:
  • using the substance to make a cosmetic, as defined in the Food and Drugs Act, and
  • importing the substance when it is already contained in a cosmetic.
• Requires the notifier to transfer the substance only to people who agree to follow the ban on cosmetic uses.
• Before any transfer, the notifier must:
  • give the recipient a written copy of the ministerial conditions, and
  • get written confirmation that the recipient was informed and agrees to comply.
• Sets out record-keeping rules. The notifier must keep records showing:
  • the uses of the substance;
  • quantities manufactured, imported, bought, distributed, sold and used;
  • the name and address of every person receiving physical possession or control of the substance;
  • the written confirmations from recipients.
• Record timing and storage rules:
  • update recipient address changes within 30 days of learning of them;
  • create records within 30 days after the information becomes available;
  • keep records in English, French, or both at the notifier’s principal place of business in Canada (or their Canadian representative) for at least five years;
  • electronic records must be in a readable format.

Who's affected#

• The principal party affected is the notifier (the person who provided the information on September 19, 2024) — they are the only entity explicitly allowed to manufacture or import the substance under these conditions.
• Other manufacturers or importers who are not the notifier are not granted this permission by this notice.
• Companies or people involved in making or selling cosmetics are affected because the substance cannot be used in, or imported as part of, cosmetics.
• Any business or person who receives the substance from the notifier must agree in writing to follow the cosmetic ban and other conditions, and will appear in the notifier’s records.

Why it matters#

• The government suspects the chemical may be harmful, so it is allowing limited commercial activity while keeping control and traceability.
• The ban on cosmetic uses is a direct consumer-safety safeguard: the substance cannot enter products applied to people as cosmetics.
• The record-keeping and transfer rules create a paper trail so regulators can see how much of the substance is in Canada, who has it, and how it’s being used.
• The permission and rules took effect on November 13, 2024, so any relevant manufacturing, importing or transfers after that date must follow these conditions.