What Is the Cosmetic Hotlist?
Health Canada maintains the Cosmetic Ingredient Hotlist — an administrative tool listing substances that are:
- Prohibited from use in cosmetics sold in Canada
- Restricted — allowed only under specific conditions (concentration limits, use types, labeling requirements)
The Hotlist is not a regulation itself but reflects Health Canada's interpretation of the Food and Drugs Act and the Cosmetic Regulations. Using a prohibited ingredient is a violation that can result in product seizure or market removal.
Why the Hotlist Matters for U.S. Brands
Many ingredients that are permitted in the U.S. are prohibited or restricted in Canada. If you are selling the same formula in both markets, you may have a compliance problem you are not aware of.
Categories of Hotlist Restrictions
Prohibited Substances (Examples)
- Mercury compounds — including thimerosal and phenylmercuric salts (except in specific eye area products with limits)
- Formaldehyde — prohibited above 0.2% (except nail hardeners at up to 5% with warnings)
- Lead and lead compounds — prohibited as ingredients
- Certain hair dye intermediates — numerous aromatic amines prohibited
- PFAS (certain per- and polyfluoroalkyl substances) — increasingly restricted
Restricted Substances (Examples)
- Hydroquinone — permitted only in nail products (up to 0.02%); prohibited in skin-lightening cosmetics
- Salicylic acid — limited to 2% in rinse-off hair products, 3% in foot care products with warnings; not permitted in products for children under 3
- Fluoride compounds — permitted in oral hygiene products under specific limits
- Resorcinol — permitted in hair dyes with concentration limits and mandatory warnings
How to Screen Your Formula
- List all ingredients by INCI name
- Cross-reference each ingredient against the current Hotlist (available on Health Canada's website)
- Check concentration against any applicable limits
- Review labeling requirements for restricted substances (many require specific warnings)
- Document your screening — keep records showing you verified compliance
Common Mistakes
- Screening against an outdated version of the Hotlist (Health Canada updates it regularly)
- Checking INCI names but missing trade-name ingredients that contain restricted actives
- Assuming EU compliance means Canadian compliance (the lists differ)
- Not checking the concentration of restricted substances in the finished formula
When Reformulation Is Needed
If a formula screen reveals a prohibited ingredient, reformulation is necessary before entering the Canadian market. For restricted substances, you may be able to adjust the concentration or add required label warnings instead.
How United Regulatory Can Help
We conduct comprehensive Hotlist screenings for your cosmetic formulas, identify required label warnings, and advise on reformulation strategies where needed. Contact us before launching in Canada.