New Fragrance Allergen Rules in the EU and Canada: What Cosmetic Brands Need to Know
Contact dermatitis linked to cosmetics is frequently traced back to fragrance allergens, and regulators are responding with stricter disclosure rules. The latest changes in the European Union and Canada show two of the world's biggest cosmetic markets moving toward the same goal: clearer labels, better-informed consumers, and closer alignment between regional regulatory frameworks.
EU Regulation 2023/1545: A Much Broader Allergen List
Under Commission Regulation (EU) 2023/1545, the number of fragrance allergens that must be individually named on a label has jumped from 24 to more than 80. The change reflects newer safety data from the Scientific Committee on Consumer Safety (SCCS), which had flagged additional substances as significant contact-allergy risks.
Two deadlines matter most for compliance planning:
| Deadline | Requirement |
|---|---|
| July 31, 2026 | New products entering the EU market must meet the expanded labeling rules |
| July 31, 2028 | Products already on the market must be fully compliant |
Disclosure of fragrance allergens isn't new — it's the scope that's changed. Many substances that used to be legally hidden inside the umbrella term "parfum" will now have to appear on the label by name. For brands, that means going back through formulations, checking with fragrance suppliers, and rebuilding label artwork before the deadlines hit.
Canada Brings Its Rules Closer to the EU's
Canada is following a similar path through amendments to its Cosmetic Regulations (SOR/2024-63), rolled out in three phases rather than two:
| Deadline | Requirement |
|---|---|
| April 12, 2026 | The original 24 fragrance allergens must be disclosed above threshold, for all products |
| August 1, 2026 | The expanded list (~81 allergens) becomes mandatory for new products |
| August 1, 2028 | The expanded list becomes mandatory for existing products already on the market |
The thresholds that trigger disclosure match the EU exactly: 0.001% for leave-on products, 0.01% for rinse-off products. For companies selling in both regions, that shared threshold makes it much easier to run one compliance process instead of two.
Health Canada's CNF Form Gets an Update Too
The Cosmetic Notification Form (CNF) — Health Canada's required post-market filing — has been revised to match the new allergen rules. The key changes:
- Allergens must be listed by name. Once a fragrance allergen is present above threshold, it can no longer be grouped under a generic "fragrance" entry in the CNF.
- Faster correction timeline. Any inaccurate product information in a CNF filing must be corrected within 10 days.
- Less paperwork on concentrations. Reporting the exact concentration of an allergen is now optional in most cases — unless the ingredient appears on the Cosmetic Ingredient Hotlist.
The intent is to keep proprietary fragrance formulas reasonably protected while still giving regulators and consumers the information they need.
Why This Matters Now
Taken together, these updates point to a clear trend: fragrance allergen disclosure is becoming more consistent across major markets, not less. For cosmetic companies, that's more than a labeling exercise — it touches formulation decisions, supplier contracts, and internal compliance tracking. Getting ahead of these deadlines, rather than scrambling as they approach, is the difference between a smooth transition and a last-minute scramble — and it's also a chance to build real trust with consumers who are paying closer attention to what's actually in their products.
Freyr's regulatory experts can help you navigate fragrance allergen disclosure requirements across the EU, Canada, and other markets — reach out for tailored guidance.
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