In Canada, tooth whitening products sold as cosmetics fall under the Food and Drugs Act, the Cosmetic Regulations and Health Canada’s Cosmetic Ingredient Hotlist. The Hotlist does not set a single maximum peroxide percentage for these products. Instead, it sets conditions: a minimum pH, required label warnings and, above 3% hydrogen peroxide or its equivalent, clinical evidence on salivary peroxide levels.
Who is responsible for compliance
The manufacturer or importer, called the notifier, must file a Cosmetic Notification Form with Health Canada within 10 days of first selling a product in Canada. Health Canada does not approve cosmetics for sale, but it can ask for evidence that a product is safe. Clinics are not usually the notifier, yet they should still confirm that any dental whitening gel they buy has been properly notified and labelled.
What the Hotlist says about peroxide
Health Canada’s guidance on tooth whitening products containing peroxide and peroxide-generating compounds summarizes the Hotlist conditions:
- pH: The Hotlist entry, citing Section 13 of the Cosmetic Regulations, calls for a pH greater than or equal to 4.0 for the product as applied to the teeth, backed by a laboratory report.
- Over 3% hydrogen peroxide equivalent: The notifier must submit a clinical study showing that salivary peroxide levels do not exceed 3% when the product is used as directed.
- Conversions: Other peroxides count by their hydrogen peroxide equivalent. Health Canada notes that 10% carbamide (urea) peroxide is about 3% hydrogen peroxide.
- Exact concentration: Notifiers must report the peroxide concentration to two decimal places.
Required label warnings
The Hotlist lists cautionary statements to the effect of: stop use and consult an oral health professional if gum or mouth irritation occurs; peroxide products are not recommended for children under 12; consult an oral health professional before prolonged use; avoid swallowing; avoid contact with the eyes; and avoid direct contact of the active surface with the gums or salivary flow. Labels must be in English and French and include clear directions for use.
Watch your claims
Health Canada’s guidance states that tooth whitening products sold as cosmetics cannot carry therapeutic claims, such as anti-cavity or sensitivity protection, on labels, inserts or websites. Keep your clinic’s marketing focused on cosmetic results.
A practical checklist for clinics
- Buy gel from suppliers who can confirm the product has been notified to Health Canada.
- Check that labels are bilingual and include directions and the required warnings.
- Follow the manufacturer’s directions for use exactly, including application time.
- Screen clients and refer anyone with dental concerns to a dentist.
If you plan to launch your own brand, work with a teeth whitening manufacturer that understands Canadian notification and labelling requirements, since the notifier carries responsibility for compliance.
Rules can change, so check Health Canada’s current Cosmetic Ingredient Hotlist and its tooth whitening guidance before buying or launching a product. This article is general information, not legal or regulatory advice.
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