June 5, 2026 · Regulatory Affairs
Cosmetic Fragrance Allergen Disclosure and the 2026 Hotlist Update: A Reformulation Roadmap for Canadian Cosmetics Brands
By Mussarat Fatima

Executive Summary
If you make, import or sell cosmetics in Canada, the way you handle fragrance just changed. As of 12 April 2026, you can no longer tuck every scent ingredient behind the single word "parfum." Twenty-four specific fragrance allergens now have to be named in your ingredient list whenever they cross a set concentration. On 1 August 2026 that list grows to 81 allergens for any new product, and your existing stock has until 1 August 2028 to catch up.
While you are sorting out fragrance, Health Canada is also reshaping the Cosmetic Ingredient Hotlist, the list of ingredients that are banned or restricted. The proposed changes touch PHMB in sprays, two hair dyes (Basic Violet 4 and Basic Blue 7), comfrey, furocoumarins and brucine. That consultation closed on 17 February 2026, so a final version could land at any time.
This is a practical guide, not a recitation of the regulation. We will walk through what actually changed, how to turn a fragrance supplier's certificate into the right entries on your label and Cosmetic Notification Form, what the Hotlist proposals mean for your formulas, and a workflow you can hand to your team. One number to keep in your head throughout: the disclosure thresholds never move. They sit above 0.01% in rinse-off products and above 0.001% in leave-on products.
Introduction
For years, a Canadian ingredient list could end with "parfum" and leave it at that. A consumer with a fragrance allergy had no way of knowing whether the product contained the specific ingredient that flared their skin. Health Canada has now closed that gap, lining Canada up with the European Union by requiring named disclosure of the fragrance allergens most often linked to allergic contact dermatitis.
Here is the part that catches brands off guard: a regulated allergen rarely arrives as a tidy line item you chose. It hides inside a fragrance oil, a "natural" essential oil, or a botanical extract three suppliers up the chain. Linalool and limonene, for instance, turn up in all sorts of citrus and lavender materials. Finding them means going back to your fragrance house, reading the right certificate, doing a little arithmetic for every product, and then updating the label and the notification at the same time, in both English and French.
We wrote this for the people who actually have to make that happen: founders, regulatory and quality leads, and product developers. It draws on the questions we field most often from brands in the cosmetics and personal care market. Every regulatory point here is sourced to Health Canada or the European Commission, and because the EU list is pulled in "as amended from time to time," it is always worth confirming the current published lists before you sign off on artwork.
What changed on 12 April 2026 and what changes on 1 August 2026
In plain terms: certain fragrance allergens now have to be named in the ingredient list, on their own, outside "parfum," whenever they exceed the disclosure limit. It arrives in three waves between April 2026 and August 2028. The thresholds stay the same the whole way through. What grows is the length of the list and who it applies to.
The mechanism is worth understanding, because it explains why the list will keep changing. Canada's Cosmetic Regulations (as amended by SOR/2024-63) do not spell out the allergens themselves. They point to Annex III of the European Commission's Cosmetic Products Regulation (EC 1223/2009) and adopt whatever is flagged there for ingredient-list disclosure. When the EU expanded its allergen list from 24 to 81 entries in July 2023, Canada effectively inherited that expansion and set its own phase-in dates.
A few things to hold on to. An allergen has to be disclosed no matter what job it does in the formula, and even when it rides in on a botanical extract. Because it counts as an ingredient, it also has to appear in your Cosmetic Notification Form, not just on the label.
The three phases
| Date | Who it applies to | What must be disclosed |
| 12 April 2026 | New and existing cosmetics | The 24 allergens (List 1), above threshold |
| 1 August 2026 | New cosmetics only | The full 81 allergens (List 2), above threshold |
| 1 August 2028 | Existing products | The full 81 allergens (List 2), above threshold |
There is one trap in that tidy table. Inside List 2, a handful of allergens are marked with an asterisk, and those have to be disclosed from 12 April 2026, the same day as List 1, even though the rest of the 81-entry list does not bite for new products until August. Read the appendix line by line so an early-trigger allergen does not slip past you.
The thresholds (the same in every phase)
- Rinse-off products such as shampoo, body wash and cleansers: disclose above 0.01% (100 ppm).
- Leave-on products such as creams, lotions, fragrances and makeup: disclose above 0.001% (10 ppm).
When several related substances share a single "grouped" entry, the limit applies to their combined total. If the sum clears the threshold, you list the group name. You are welcome to spell out the individual substances as well, but you do not have to.
Where the allergens sit on the label
Health Canada is specific about order. Ingredients run in descending order of concentration; then come any named fragrance allergens; then "parfum"; then "aroma" or flavour; and finally the "may contain / peut contenir" colourants. The allergens themselves slot into the descending-order list like any other ingredient, and Canada's bilingual labelling rules apply throughout.
The 24 vs 81 lists, and turning an IFRA certificate into CNF entries
The short version: List 1 is the original EU set of 24; List 2 is the 2023 expansion to 81. To work out which ones apply to you, you need an allergen declaration from your fragrance supplier showing each Annex III substance and its level in the fragrance. Then you scale those figures down to how much fragrance you actually use.
List 1 (the 24 allergens, mandatory from 12 April 2026): Amyl Cinnamal, Amylcinnamyl Alcohol, Anise Alcohol, Benzyl Alcohol, Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Cinnamal, Cinnamyl Alcohol, Citral, Citronellol, Coumarin, Eugenol, Farnesol, Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Isoeugenol, Alpha-Isomethyl Ionone, Limonene, Linalool, Methyl 2-Octynoate, Evernia Furfuracea (Treemoss) Extract, and Evernia Prunastri (Oakmoss) Extract.
List 2 (the expanded 81): it keeps all 24 above and adds 57 more, including names like Acetyl Cedrene, Amyl Salicylate, Anethole, Benzaldehyde, Carvone, Menthol and Vanillin, plus grouped botanical entries such as citrus peel oils and rose flower oil/extract. Because it is long and the grouped names matter, work from the official appendix rather than from memory.
Two certificates that are easy to confuse
Your fragrance house usually sends two documents, and brands regularly reach for the wrong one. An IFRA Conformity Certificate confirms the fragrance is safe at your use level under IFRA Standards. That is useful, but it is not your allergen list. The document you actually need is the Allergen Declaration (Annex III) Certificate, which lists each regulated allergen and its percentage in the fragrance concentrate.
A worked example
Say your leave-on face cream contains a fragrance oil at 0.50%, and the allergen certificate shows that fragrance is 4.0% Linalool and 0.15% Citronellol. You simply multiply each allergen's share by how much fragrance you used:
| Allergen | In the fragrance | In your finished cream | Over the 0.001% limit? |
| Linalool | 4.0% | 0.0200% | Yes, name it |
| Citronellol | 0.15% | 0.00075% | No, stays in "parfum" |
So Linalool gets named in the ingredient list and added to the CNF; Citronellol does not. Now run that same arithmetic for every allergen on the certificate, for every product, using the right rinse-off or leave-on threshold. It is repetitive, but it is the whole job.
Updating the Cosmetic Notification Form
Because disclosed allergens are ingredients, they belong in section 5 of the CNF and can no longer hide under "fragrance/parfum" in the notification. There is some welcome relief here: in a clarification published on 6 March 2026, Health Canada confirmed that while you must declare each qualifying allergen, supplying its exact concentration in the CNF is now generally optional. One important caveat: that flexibility does not extend to ingredients already restricted on the Hotlist, where concentration data may still be required. Either way, keep your calculations on file; they are how you justify which allergens crossed the line if an inspector ever asks. If filing or amending notifications is not where you want your team spending its week, this is exactly what our regulatory affairs, licensing and import/export team handles day to day.
The 2026 Hotlist amendments at a glance
Running alongside the allergen rules, Health Canada has proposed updates to the Cosmetic Ingredient Hotlist, its list of prohibited and restricted ingredients. The consultation closed on 17 February 2026. These are still proposals, so treat them as a strong signal rather than settled law, but the direction is clear enough to plan around.
| Ingredient | What's proposed | What it means for you |
| PHMB (Polyaminopropyl Biguanide) | Restrict; ban in sprays and aerosols; cap concentration in leave-on use | Reformulate any spray that relies on PHMB as a preservative |
| Basic Violet 4 | Add as restricted on carcinogenicity grounds; not allowed in leave-on hair products; limited in dyes and rinse-off | Review hair colourants and rinse-off formulas |
| Basic Blue 7 | Add as restricted; ban in leave-on hair products; caps for dyes, rinse-off hair care, nail, bath and other formats | Check colourant use across several product types |
| Comfrey (Symphytum spp.) | Proposed restriction or prohibition (pyrrolizidine alkaloids) | Look at botanical and herbal skincare for comfrey extracts |
| Furocoumarins | Proposed restriction (phototoxicity) | Review citrus and botanical extracts that may carry them |
| Brucine and its salts | Proposed prohibition | Remove from any affected formulation |
Because the Hotlist is administrative guidance rather than a regulation, Health Canada can move on it fairly quickly once a consultation closes. Put a recurring reminder in your regulatory calendar so a final amendment does not arrive mid-production run. If you would rather have a second set of eyes on it, this is the kind of focused screen we run as part of our audit and gap assessment services.
The grace period and the final 2028 cut-off
New products carry the tighter deadline; existing products get breathing room. Anything launched from 1 August 2026 has to ship with full 81-allergen disclosure from day one, while products already on the market have until 1 August 2028 to get there. In practice that is a transition window: it lets current stock sell through and gives you time to reformulate and reprint.
It helps to picture three buckets. A brand-new product after August 2026 needs the full 81-allergen treatment immediately. A product already on shelves shows the 24 from April 2026 and then upgrades to the full 81 by August 2028. And every product, new or old, must carry the asterisked early-trigger allergens from April 2026.
The quiet risk in all of this is artwork lead time. Redrawing a label, translating it, getting regulatory sign-off, cutting new plates and printing can eat several months, and you will almost certainly want to fold any Hotlist-driven reformulation into the same artwork pass so you only pay for new plates once. The brands that wait until 2028 tend to discover, all at once, that print queues are full, stock on hand is non-compliant, and supplier certificates are slow to arrive. The eighteen-month runway disappears. Starting now is the cheapest decision you can make.
A reformulation and CNF-update workflow
Treat this as a small project with a clear sequence, not a last-minute label edit. The path that holds up is: inventory, gather certificates, calculate, decide, update, verify.
- Inventory your portfolio. Every SKU, whether it is rinse-off or leave-on, every fragrance and botanical input, and the use level of each.
- Collect the allergen certificates. Get the Annex III declaration for every fragrance, essential oil and botanical extract. The IFRA conformity certificate alone will not do.
- Do the arithmetic. Calculate the finished-product level of each allergen, apply the right threshold, and remember to sum grouped entries.
- Decide: disclose or reformulate. If naming an allergen would clutter a "fragrance-free"-style positioning, you may prefer to drop the fragrance below the limit instead of disclosing.
- Cross-check the Hotlist. Confirm nothing in the formula is caught by the PHMB, Basic Violet 4, Basic Blue 7, comfrey, furocoumarin or brucine proposals, and reformulate where it is.
- Update the label. Correct order, both official languages, allergens named outside "parfum."
- Update the CNF. Add each qualifying allergen to section 5, and keep your concentration maths on file even though entering it is now optional.
- Verify and document. Have a second person check the maths, the bilingual artwork and the CNF before plates are cut, and retain the certificates and calculations as your record.
- Sequence your print runs so the allergen and Hotlist changes land in a single artwork revision.
Done well, this workflow is also your audit defence. If Health Canada ever questions a label, a clean trail from supplier certificate to calculation to CNF entry to finished artwork is the strongest answer you can give. It is the same discipline we wrote about in our guide to front-of-package nutrition labelling: the deadline is fixed, but the panic is optional.
Compliance Checklist
Use this as a quick self-audit before anything goes to print:
- Every SKU is classed as rinse-off or leave-on.
- Annex III allergen certificates are on file for all fragrances, essential oils and botanical extracts.
- Finished-product concentrations are calculated for every relevant allergen.
- The right threshold is applied (above 0.01% rinse-off; above 0.001% leave-on), with grouped entries summed.
- Asterisked early-trigger List 2 allergens are disclosed from 12 April 2026.
- The 24-allergen disclosure (List 1) is live on all products from 12 April 2026.
- The 81-allergen disclosure is on all new products from 1 August 2026.
- There is a plan for existing products to reach 81-allergen disclosure by 1 August 2028.
- Allergens are listed outside "parfum," in descending order, in English and French.
- CNF section 5 lists every qualifying allergen.
- Formulas have been screened against the proposed 2026 Hotlist amendments.
- Calculations and certificates are retained as compliance records.
- A second reviewer has signed off before printing.
Common Mistakes
The errors we see most often are small and avoidable:
- Reaching for the IFRA conformity certificate when you need the Annex III allergen declaration. They are different documents.
- Forgetting the allergens hiding in botanicals: limonene, linalool and citronellol usually arrive inside essential oils, not the fragrance compound.
- Applying one threshold to everything. Rinse-off and leave-on limits differ tenfold.
- Treating each substance in a grouped entry on its own when the threshold applies to their sum.
- Updating the label but not the CNF. A disclosed allergen is an ingredient, so it belongs in section 5.
- Missing the asterisked List 2 allergens that already apply from 12 April 2026.
- Reading 2028 as the only deadline. New products must comply from 1 August 2026.
- Fixing fragrance while ignoring the Hotlist, then having to reprint a second time.
- Skipping the French. Bilingual labelling is mandatory; an English-only allergen list is not compliant.
Frequently Asked Questions
When does fragrance allergen disclosure start in Canada?
The 24-allergen requirement (List 1) applies to new and existing cosmetics from 12 April 2026. The expanded 81-allergen requirement (List 2) applies to new cosmetics from 1 August 2026 and to existing products from 1 August 2028.
What are the disclosure thresholds?
Name an allergen when it exceeds 0.01% in rinse-off products or 0.001% in leave-on products. For grouped entries, the threshold applies to the combined total of the substances in the group.
Where do the allergens go on the label?
In the list of ingredients, in descending order of concentration, outside the word "parfum," and in both English and French.
Do I have to enter the concentration in the CNF?
Each qualifying allergen must be declared in section 5 of the Cosmetic Notification Form, but as of Health Canada's 6 March 2026 clarification, entering the exact concentration is generally optional, except for ingredients already restricted on the Hotlist. Keep your calculations on file regardless.
What is the difference between the 24 and 81 allergen lists?
The 24-entry list is the original EU Annex III set. The European Commission expanded it to 81 entries in July 2023, and Canada adopted both lists with staggered start dates.
What is the Cosmetic Ingredient Hotlist?
It is Health Canada's administrative list of prohibited and restricted cosmetic ingredients. The 2026 proposal would restrict PHMB in sprays and tighten controls on Basic Violet 4, Basic Blue 7, comfrey, furocoumarins and brucine. The consultation closed 17 February 2026.
Does this apply to imported cosmetics?
Yes. Any cosmetic sold in Canada must meet the Cosmetic Regulations, and the importer is responsible for compliant labelling and notification.
How MFLRC Can Help
We are a Canadian regulatory and quality consultancy, and a good part of our cosmetics work right now is helping brands land this transition cleanly. That usually looks like a few connected pieces: mapping allergens across your portfolio by reading the supplier certificates and running the finished-product maths for each SKU; reviewing your bilingual artwork before it goes to print; preparing and amending CNFs through our regulatory affairs and licensing team; screening formulas against the current and proposed Hotlist as part of an audit or gap assessment; and building the SOPs and review steps that make all of this repeatable next time.
If you are juggling labelling change across more than one category, our recent pieces on exosome skincare classification and front-of-package nutrition labelling show how we help brands turn a hard deadline into a calm, on-time launch.
Facing the 2026 fragrance allergen and Hotlist deadlines? Talk to MFLRC and we will tailor a plan to your portfolio.
Conclusion
None of this is exotic. It is detail work with fixed dates. Twenty-four allergens from 12 April 2026, eighty-one for new products from 1 August 2026, and eighty-one for existing products by 1 August 2028. The thresholds do not move: 0.01% rinse-off, 0.001% leave-on. The effort goes into chasing certificates, doing the arithmetic for every SKU, updating labels and CNFs in two languages, and keeping half an eye on the Hotlist so you only reprint once.
Handle it as a project this quarter and it becomes routine. Leave it to 2028 and you will be queuing for print capacity behind everyone else who left it too. Pull your inventory, ask your suppliers for the right certificates, and start running the numbers now.
Sources and References
- Health Canada. Industry Guide for the labelling of cosmetics (Section 8.3.8 and Appendix 1, Lists 1 and 2).
- Health Canada. Notification of Cosmetics: Guide for Cosmetic Notifications.
- Health Canada. Cosmetic Notification Form.
- Health Canada. Proposed updates to the Cosmetic Ingredient Hotlist (consultation closed 17 February 2026).
- Health Canada. Notice to Stakeholders concerning review of the Cosmetic Ingredient Hotlist.
- European Commission. Cosmetic Products Regulation (EC) No 1223/2009, Annex III (consolidated).
Regulatory details were verified against Health Canada and European Commission sources as of June 2026. Because the EU allergen list is incorporated by reference "as amended from time to time," confirm the current published lists before finalizing labels. The amending regulation is SOR/2024-63; Health Canada's concentration-reporting clarification was published 6 March 2026.
Downloadable Resource
The Canada Fragrance Allergen Compliance Toolkit
A free 7-page toolkit: the 2026 to 2028 deadline timeline, the 24-allergen list, an allergen calculation worksheet, a pre-print compliance checklist and a copy-paste supplier email template.
File: MFLRC-Fragrance-Allergen-Compliance-Toolkit-2026.pdf
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