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The global landscape of cosmetic regulation is shifting toward unprecedented transparency, and Health Canada has indeed introduced significant updates to the Cosmetic Regulations (specifically through amendment SOR/2024-63), which fundamentally change how fragrance allergens must be disclosed on product labels. This indication about flexibility is creating confusion across the industry. Let us help you with this update.
Following the 2024 amendments to the Cosmetic Regulations (SOR/2024-63), Health Canada is phasing in mandatory disclosure for fragrance allergens—a move that significantly mirrors the European Union’s Annex III requirements.
Key requirements & tresholds
The primary goal is to align Canadian standards with the European Union (EU), ensuring that consumers with sensitivities can identify specific allergens rather than seeing them grouped under generic terms like “parfum” or “fragrance.”
Fragrance allergens must be listed individually in the International Nomenclature for Cosmetic Ingredients (INCI) list if they exceed the following concentration thresholds:
- Rinse-off products (e.g., shampoos, soaps): > 0.01%
- Leave-on products (e.g., lotions, perfumes): > 0.001%
The evolution of transparency: from "parfum" to precision
For decades, the term “Parfum” or “Fragrance” served as a protective umbrella for proprietary aromatic blends. While this protected trade secrets, it left consumers with sensitivities in the dark. Health Canada’s new mandate changes this dynamic. Brands can no longer simply list “Parfum” if specific allergens are present above defined thresholds.
This regulatory update aims to empower consumers, allow individuals with known allergies to identify and avoid triggers, and aims for global harmonization, aligning Canadian standards with the EU’s Regulation (EC) No 1223/2009, simplifying compliance for brands operating in both markets. All of this is to enhance safety and reduce the incidence of allergic contact dermatitis across the Canadian population.
Implementation timeline
The requirements are being rolled out in phases to allow manufacturers time to update their packaging and formulations.
| Phase | Effective Date | Scope | Requirements |
| Phase 1 | 12th April 2026 | New & Existing Products | Disclosure of the initial 24 fragrance allergens. |
| Phase 2 | 1st August 2026 | New Products Only | Disclosure of the expanded list (81+ allergens). |
| Phase 3 | 1st August 2028 | All Products on Market | Full compliance for the expanded list across all inventories. |
NOTE: New Products are those entering the market for the first time after the deadline. For products already on the market, the “compliance-time” approach provides a 12-month grace period for the initial allergen list, making 1st August 2028, the final date for full compliance for existing stock.
Summary of changes
Label Placement: Qualifying allergens must appear in the ingredient list, typically following “Fragrance (Parfum)” in descending order of concentration.
- Notification Requirements: Starting 12th April 2026, the allergens must also be disclosed individually in the Cosmetic Notification Form (CNF) submitted to Health Canada.
- Bilingualism: Requirements for English and French labelling remain. If the INCI name is the same in both languages (which is common for chemical names), a single listing is sufficient.
- Small Packages: For tiny containers (like eyeliners or lipsticks), manufacturers may use a tag, tape, or card, or provide a website URL on the outer label where the full ingredient list can be viewed.
Canada’s bilingual labelling requirements continue to apply. Where the INCI name does not differ between English and French, one listing is sufficient.
Cosmetic Notification Form (CNF) requirements updated
When selling a product in Canada, the CNF must be filed with Health Canada within 10 days of the first sale. Starting 12th April 2026, if a cosmetic formula contains any of the 24 qualifying fragrance allergens above the threshold, they must be disclosed individually in the Cosmetic Notification Form (CNF) ingredient list.
After 1st August 2026, the list will be the expanded one, the 81 allergens listed at Annex III of the European Regulation 1223/2009. In that moment, the “expanded list” of allergens cannot be grouped under “fragrance” in the notification.
In a recent clarification (March 2026), Health Canada noted that while the allergens must be listed in the CNF, the disclosure of their exact concentrations is generally optional unless the substance is also restricted under the Canadian Cosmetic Ingredient Hotlist. This provides some relief for brands concerned about revealing precise fragrance “recipes” to the regulator.
Cosmeservice: support in your canadian compliance journey
At Cosmeservice, we understand that navigating these overlapping deadlines can be a logistical challenge for international brands. With the first major milestone for “new-to-market” expanded lists arriving on 1st August 2026, now is the time to audit your formulations and prepare your artwork.
We can also act as your Responsible Person in Canada. If your brand is based in Canada or has significant distribution there, now is the time to audit your product portfolio. Staying ahead of these regulations ensures that your products remain a trusted choice for Canadian consumers. For expert guidance, contact us at info@cosmeservice.com.
This article is intended for informational purposes and does not constitute legal advice. For specific compliance strategies, always consult us.
FAQs
What is SOR/2024-63?
SOR/2024-63 is the Health Canada regulation, published in the Canada Gazette in April 2024, that amends the Cosmetic Regulations to mandate individual disclosure of fragrance allergens on cosmetic labels, aligning Canada with the EU’s Annex III allergen list.
When do the new fragrance allergen disclosure rules take effect in Canada?
The rules apply in three phases: from 12 April 2026, the initial 24 allergens must be disclosed on new and existing products; from 1 August 2026, new products must disclose the expanded list of 81+ allergens; and from 1 August 2028, all products on the market must fully comply with the expanded list.
At what concentration must fragrance allergens be disclosed in Canada?
Fragrance allergens must be listed individually in the INCI list when they exceed 0.01% in rinse-off products (such as shampoos and soaps) or 0.001% in leave-on products (such as lotions and perfumes), matching the EU’s thresholds.
Do I need to disclose the exact concentration of allergens to Health Canada?
Generally no. Following a March 2026 clarification, Health Canada confirmed that allergens must be listed in the Cosmetic Notification Form (CNF), but disclosing their exact concentration is optional unless the substance is also restricted under the Canadian Cosmetic Ingredient Hotlist.
Can small cosmetic packages still use the generic term ‘Parfum’?
For small containers, such as eyeliners or lipsticks, manufacturers may disclose the full ingredient list, including allergens, via a tag, tape, card, or a website URL referenced on the outer label, instead of printing it directly on the small package.
