Fragrance Allergen Labelling for Cosmetics

Summary#

Health Canada is proposing changes to the Cosmetic Regulations (published in the Canada Gazette, Part I on February 11, 2023). The main practical effect would be to require certain fragrance chemicals to be named on cosmetic labels, give small packages a website option for ingredient lists, and tighten rules about who must notify Health Canada about a product. This is a proposal, not law; comments were invited for 70 days after publication.

What it does#

• Requires listing certain fragrance allergens from the European list (Annex III) on the product ingredient list when they are present above set limits:
  • rinse-off products: greater than 0.01%
  • leave-on products: greater than 0.001%
  • The proposal refers to the European Commission’s Cosmetic Products Regulation so future EU updates would apply here on a similar timetable.
• Lets makers put the full ingredient list (including those fragrance allergens) on a website instead of on tiny packages. The label must show a bilingual statement pointing to that website.
• Clarifies who counts as a manufacturer and adds a formal definition of importer.
• Changes the product notification form to Health Canada so it must:
  • say whether a product is “rinse-off” or “leave-on”,
  • use INCI names for ingredients when available,
  • use narrower concentration ranges (expanding from 7 to 13 ranges).
• Gives Health Canada more tools to enforce notification and safety rules, including the ability to stop sale if required notifications or information are not provided, and to request safety evidence from importers as well as manufacturers.
• Administrative updates (publisher names, wording, schedule entries) and a small, matching change to the Cannabis Regulations.

Timing proposed in the text:

• Most changes would come into force 180 days after registration.
• The new fragrance-allergen labelling would come into force two years after registration.

Who's affected#

• People with fragrance allergies or sensitivities. The changes make it easier to know which products contain known contact allergens.
• Cosmetic companies, especially those that manufacture or import products that contain the listed fragrance allergens. Health Canada estimated:
  • industry compliance cost of about $1.44M (annualized) or $10.14M present value over 10 years,
  • cost savings from the website option of about $48,064 (annualized) or $337,581 present value over 10 years,
  • net cost estimated at $1.42M (annualized) or $9.94M present value over 10 years.
• Small businesses. The proposal estimates about 647 small businesses would be affected, with an average compliance cost of about $14,363 (present value) per small business over 10 years.
• Importers, manufacturers and other supply-chain actors who must update notifications and labels. Health Canada estimated the Canadian market includes about 228,466 cosmetic SKUs and that roughly 5% of products (by value in the survey) contain one or more of the specified fragrance allergens.
• The federal department that enforces the rules (Health Canada) will have added enforcement and administrative work, but some changes are expected to reduce follow-up work (for example, if INCI names are used consistently).

If it’s unclear who is affected: the requirement to list fragrance allergens only applies when a product contains one of those listed substances above the thresholds. Products that do not contain those substances would not need label changes for this specific rule.

Why it matters#

• For consumers with allergies, the change makes avoidance simple. Seeing a named allergen on the label or on an accessible website reduces guesswork and the risk of repeat contact reactions (rashes, itching).
• It should improve public health and could reduce visits to doctors, medication use, missed work, and time spent managing allergic reactions.
• For industry, it means label redesign, ingredient checks, and some paperwork changes. Some firms might reformulate or withdraw products rather than list allergens.
• It brings Canada closer to the EU practice on fragrance-allergen disclosure. That can help companies that sell in both markets and may reduce trade friction over time.
• The website option for small packages aims to avoid extra packaging waste and give a practical way to include longer ingredient lists on tiny items. There are equity concerns because not everyone has ready internet access; the proposal notes that consumers can request ingredient lists from companies directly.