Short answer: from 31 July 2026, every cosmetic newly placed on the EU market must declare over 80 fragrance allergens on the label when present above threshold — five years after Regulation (EU) 2023/1545 was adopted, the grace period ends and old labels become non-compliant.
Fragrance allergen labelling is the compliance change most likely to catch a brand between factories in 2026–2028, because the work sits in the ingredient documentation chain — your fragrance supplier, your manufacturer, your label artwork — rather than in the formula itself. This guide gives you the thresholds, the dates, and a checklist you can run against your current SKUs.
What changed
EU Cosmetics Regulation 1223/2009 has required declaration of 26 named fragrance allergens on the ingredient list when they exceed set thresholds. Commission Regulation (EU) 2023/1545 expands that list substantially — adding dozens of allergens, taking the declarable total to more than 80 — and extends the same declaration logic to rinse-off as well as leave-on products, which previously declared a smaller set.
Two consequences follow:
- Formulas you never had to fully document now generate declarations. An allergen at 0.002% in a leave-on product was invisible under the old rules; it becomes a label line under the new ones.
- The information must come from the fragrance house. The manufacturer's bulk formula is not the source of allergen data — the fragrance compound inside it is. If that link in your documentation chain is weak, this is where projects stall.
The thresholds
Declaration is triggered when the allergen exceeds:
| Product type | Old regime (26 allergens) | New regime (80+ allergens) |
|---|---|---|
| Leave-on | 0.001% (10 ppm) | 0.001% (10 ppm) |
| Rinse-off | 0.01% (100 ppm) | 0.01% (100 ppm) |
The thresholds themselves did not move — what changed is how many substances they now apply to, and the full extension to rinse-off products. A practical read: if your product contains a meaningful fragrance, assume new allergen lines will appear on the label, and get the compound's allergen breakdown before designing the artwork.
The key dates
- 26 August 2023 — Regulation (EU) 2023/1545 entered into force. The countdown started here; the obligations below hang off this baseline.
- 31 July 2026 — every cosmetic product placed on the EU market from this date must carry the expanded allergen labelling. New launches after this date have no legacy option.
- 31 July 2028 — end of the sell-off allowance: products already placed on the market before the 2026 date may still be made available until this date. After it, the old label is simply illegal stock.
The planning trap is in the word placed. The obligation attaches when the product enters the market, not when it is manufactured or when it reaches the consumer. Stock produced in June 2026 for a September placement needs the new label.
Compliance checklist
Work through this against every SKU you sell into the EU:
- Collect the full allergen breakdown of every fragrance compound you use, at the delivered concentration in your formula — not the neat compound spec. Your manufacturer or fragrance house supplies this; if they can't, that is the first problem to fix.
- Run the thresholds. At leave-on 0.001% and rinse-off 0.01%, against the 80+ list. A fragrance at 0.5% in a leave-on product routinely triggers several declarations.
- Update the ingredient list artwork, in the regulated order and format alongside your existing INCI declaration — allergens are declared by their listed name within the ingredient list.
- Re-verify the safety assessment — the CPSR underpinning your CPNP notification must reflect the current formulation documentation; the allergen expansion feeds into the information your safety assessor holds.
- Plan the label transition against stock: anything placed on market before July 2026 can sell through to July 2028; anything after needs the new label from day one.
- Reconcile with the rest of your label obligations — the allergen lines sit inside the same ingredient panel governed by the broader US and EU labelling requirements.
The most common wrong statements about this rule
- "It only affects leave-on products." The new regime applies the declaration logic across rinse-off products as well — shampoo and body wash labels change too.
- "Fragrance-free means no allergen labelling." Allergens can arrive via essential oils and botanical extracts, not only fragrance compounds. An essential-oil-scented "fragrance-free" product can still trigger declarations.
- "My old stock is fine forever." The sell-through window closes on 31 July 2028. Warehousing non-compliant labels past that date converts a packaging asset into a write-off.
- "The manufacturer handles it automatically." The data originates with the fragrance compound; the label is your artwork. The chain has three links, and the one most often missing is between the fragrance house and the label file.
FAQ
Q: What is Regulation (EU) 2023/1545? A: It is the EU regulation amending Annex III of Cosmetics Regulation 1223/2009 to expand the list of declarable fragrance allergens from 26 to more than 80 substances, with labelling required above 0.001% in leave-on and 0.01% in rinse-off products.
Q: When do I need the new allergen labelling? A: Products placed on the EU market from 31 July 2026 must carry the expanded declarations. Products placed before that date can sell through until 31 July 2028, after which old-labelled stock cannot be made available.
Q: Do rinse-off products need allergen labelling? A: Yes. The rinse-off threshold is 0.01% (100 ppm), and the expanded allergen list applies to rinse-off products under the new regime, so shampoos, body washes and cleansers with meaningful fragrance content are affected.
Q: Does "fragrance-free" exempt a product from allergen declaration? A: No. Allergens can be present in essential oils and botanical extracts independently of added fragrance compound. Declaration is triggered by the substance's concentration, not by whether you market the product as fragranced.