Canada Publishes Notifier-Specific Conditions For An Oral-Care Chemical

Canada published Ministerial Condition No. 22494 on 24 October 2026, setting conditions for the notifier's manufacture or import of CAS 128275-31-0. The conditions took effect on 6 October 2026. Publication is therefore later than commencement. Canada Gazette notice.

The substance is 2H-isoindole-2-hexaneperoxoic acid, 1,3-dihydro-1,3-dioxo-. The notice defines the notifier as the person who supplied the prescribed information on 27 April 2026. These are conditions on that notifier, not a market-wide authorisation for oral-care products. Annex, paragraphs 1–2.

Cosmetic Uses And Concentration Limits

The notifier may not manufacture or import the substance for cosmetic manufacture except in these products and concentrations:

• Toothpaste or tooth powder: no more than 0.11% by weight.
• Mouthwash: no more than 0.27% by weight.
• Tooth-whitening products: no more than 1.2% by weight.

The notifier may not manufacture or import it for use in diapers or sanitary napkins, or import it already contained in the prohibited products. Annex, paragraphs 3–4.

Transfers And Records

Before transferring the substance, the notifier must provide the conditions in writing. Before the first transfer, it must obtain written confirmation that the recipient has been informed and agrees to comply. This requirement does not apply when the substance is contained in a product. Annex, paragraph 5.

The notifier must keep the specified supporting records for at least five years after making them, at its principal Canadian business location or that of its Canadian representative. Annex, paragraph 6.