Cosmetic Allergen Labelling and Notifications

Summary#

These are final federal rules that change how ingredients in cosmetics must be disclosed in Canada. The amendments to the Cosmetic Regulations add new labelling and notification requirements (including a rule to list certain fragrance allergens), clarify who is considered a manufacturer or importer, and give Health Canada stronger tools to oversee products. Most changes take effect on October 9, 2024; the specific rule about expanded fragrance-allergen labelling comes into force on April 12, 2026.

What it does#

• Requires certain fragrance ingredients to be named in the ingredient list when they are present above set limits:
  • 0.01% for rinse-off products.
  • 0.001% for leave-on products.
• Lets companies put a product’s full ingredient list on a website for items in very small packages, as long as the outer label points consumers to that site.
• Clarifies roles and contact details:
  • Adds a definition of importer and revises the definition of manufacturer so it’s clear who is responsible in Canada.
  • Labels must include a phone number, email, website or other way for consumers to contact the responsible person.
• Tightens what must be sent to Health Canada in a cosmetic notification and the timelines for doing so:
  • Notifiers must send required information within 10 days of first sale and update Health Canada within 10 days if information changes.
  • If Health Canada asks for safety evidence and it’s not provided, it can order a stop-sale.
• Changes the cosmetic notification form:
  • Requires ingredients to be identified by their INCI name when available.
  • Adds a checkbox to say whether a product is a “rinse-off” or “leave-on” product.
  • Replaces the old concentration table with 13 narrower concentration ranges (for example, >80% to 100%, >65% to 80%, down to >0% to 0.001%).
• Makes small administrative updates (e.g., modernizes wording, updates an ingredient schedule, and edits the related Cannabis Regulations so labelling rules match).

Who's affected#

• Health Canada (as regulator) — will use the updated notification and enforcement powers.
• Cosmetic brand owners, manufacturers, and importers who sell products in Canada. Small businesses that make or import cosmetics may feel the impact most.
• People who buy and use cosmetics, especially:
  • Those with skin allergies or sensitivities to fragrances.
  • Users of small-packaged items (e.g., travel-sized toiletries, eyeliners, lipsticks) who may need to follow a website link to see ingredients.
• The changes also touch cosmetic-like cannabis products because similar labelling terms in the Cannabis Regulations were updated.

If it’s unclear whether a specific product is covered (for example a product sold as both a cosmetic and something else), the source notes Health Canada will provide guidance.

Why it matters#

• Consumers with fragrance allergies get clearer information. Naming specific allergenic fragrance ingredients helps people avoid products that may trigger allergic contact dermatitis.
• Companies will need to check formulations and update labels or packaging. Health Canada estimates industry costs as:
  • $2.66M in annualized costs (about $18.71M present value over 10 years).
  • An annualized net cost after savings of $2.61M (about $18.31M present value over 10 years).
  • The rule also creates an annualized industry saving of $57,556 (about $404,253 present value over 10 years) from the option to use websites for small-package ingredient lists.
• Small businesses may face higher per-product costs and some operational challenges. The analysis estimates a per-impacted-small-business cost of about $3,179 annually (about $22,324 present value over 10 years).
• Health Canada gains clearer, more useful product information (INCI names, concentration ranges, and “leave-on” vs “rinse-off”), which should speed up safety screening and let the department act more quickly when safety questions arise.
• Start dates matter:
  • Most of the regulatory changes take effect on October 9, 2024.
  • The new fragrance-allergen labelling rule comes into force on April 12, 2026.