Ministerial Conditions for 2H-isoindole-2-hexaneperoxoic acid

Summary#

The Government of Canada has published Ministerial Condition No. 22494 under the Canadian Environmental Protection Act, 1999 that allows one notifier to manufacture or import the chemical 2H-isoindole-2-hexaneperoxoic acid, 1,3-dihydro-1,3-dioxo- (CAS 128275-31-0) but only under specific limits and record‑keeping rules. The same Gazette issue also publishes Order 2026-66-12-02 removing two CAS numbers from Part I of the Non-domestic Substances List; that Order takes effect when the Gazette is published (October 24, 2026).

What it does#

• Ministerial Condition No. 22494 (for 2H-isoindole-2-hexaneperoxoic acid, 1,3-dihydro-1,3-dioxo- (CAS 128275-31-0)):
  • Allows only the person who supplied information to the government on April 27, 2026 (the “notifier”) to manufacture or import the substance, and only under the listed conditions.
  • Prohibits manufacture or import of the substance for use in most cosmetics, with limited exceptions for oral-care products that meet concentration limits:
    • toothpaste or tooth powder at ≤ 0.11% by weight;
    • mouthwash at ≤ 0.27% by weight;
    • tooth whitening products at ≤ 1.2% by weight.
  • Prohibits manufacture or import for use in diapers and sanitary napkins.
  • Requires the notifier to inform anyone they transfer the substance to, and to get written confirmation that the transferee knows and will follow the conditions (unless the substance is already in a finished product).
  • Requires the notifier to keep records (use, concentration, quantity, recipients, and the written confirmations), create records within 30 days of getting information, and keep them for at least five years at their Canadian principal place of business.
  • These conditions came into force on October 6, 2026.
• Order 2026-66-12-02:
  • Deletes two entries from Part I of the Non-domestic Substances List: 93964-99-9 and 97808-07-6.
  • The Order was signed on October 8, 2026 and comes into force when published in the Canada Gazette (October 24, 2026).

Who's affected#

• The single person or company that is the notifier (the one who filed information on April 27, 2026). They are the only party explicitly allowed to make or bring the substance into Canada under these conditions.
• Manufacturers, importers, distributors, and retailers of oral-care products (toothpaste, mouthwash, tooth powders, and tooth whitening products) who might consider using this chemical. They must meet the concentration limits if the chemical is present.
• Businesses that might have used the chemical in diapers or sanitary napkins — that use is explicitly banned.
• Any organization that would receive transfers of the substance — they must be told about the conditions and confirm in writing they will comply.
• Companies or importers dealing with substances listed under CAS 93964-99-9 and 97808-07-6 may notice a regulatory change because those CAS numbers were removed from Part I of the Non-domestic Substances List. The notice does not spell out further practical consequences.

Why it matters#

• This notice shows the government is allowing limited, controlled manufacture/import of a chemical it suspects could be hazardous. The limits and record rules are meant to reduce risk and keep track of who has the substance.
• If your employer makes or imports oral-care products, the concentration caps could affect product formulation choices and testing.
• The ban on use in diapers and sanitary napkins removes one possible application and could matter to companies working in those product lines.
• The removal of two CAS numbers from the Non-domestic Substances List is an administrative change that could change how those specific substances are treated under federal chemical rules, but the Gazette notice does not explain detailed effects beyond the deletion.