The EU just expanded fragrance allergen labeling from 26 to 80+. Here's what indie formulators actually have to do.
Regulation (EU) 2023/1545 added 56 fragrance allergens to Annex III of the EU Cosmetics Regulation. If you sell — or plan to sell — into the EU, products placed on the market from 31 July 2026 must declare them on the label. This guide is the practical version.
Deadlines
31 July 2026
Products placed on the EU market from this date must carry the new allergen declarations.
31 July 2028
Sell-through ends: products already on shelves must also comply to remain on the market.
What must be declared
Any listed allergen present above 0.001% in a leave-on product or 0.01% in a rinse-off product must appear by name in the ingredient list. The old list had 26 entries (linalool, limonene, citronellol…); the expanded list adds 56 more — including whole naturals like rose ketones, and common essential-oil constituents — bringing the total to 80+ label-relevant entries. Most indie formulas using essential oils are affected, because the new allergens are dominant constituents of everyday oils: lavender, rose, geranium, ylang-ylang, and citrus among them.
The relabeling checklist
- List every fragrance, essential oil, absolute, and natural extract in each formula — the new allergens hide in naturals (rose, jasmine, ylang, citrus…), not just in fragrance oils.
- Ask each supplier for an updated allergen declaration / IFRA certificate that covers Regulation (EU) 2023/1545's expanded list — declarations from before 2023 won't include the new entries.
- For each formula, compute the concentration of every allergen in the finished product (allergen % in the oil × oil % in the formula).
- Apply the thresholds: declare anything above 0.001% in leave-on products or 0.01% in rinse-off products on the ingredient label.
- Update label artwork and your Product Information File, and re-print — descending order rules still apply.
- Batch made before vs. after the deadline matters: keep lot records showing when each unit was placed on the market.
The parts that trip people up
Do the new EU allergen rules apply in the UK?
Not yet. Great Britain still requires the original 26 allergens — the expanded 80+ list applies to the EU (and, via the Windsor Framework, to Northern Ireland). If you sell into both markets you are running a dual-regime label: the EU list is a superset, so most small brands declare to the EU standard everywhere rather than print two labels.
Is compliance judged per batch made or per unit sold?
Per unit placed on the market. A batch made in June 2026 but placed on the EU market after 31 July 2026 must carry the new declarations — which is why lot records showing when each unit was placed on the market matter. Stock already on the market has sell-through until 31 July 2028.
My supplier's SDS doesn't list the new allergens — what do I ask for?
An SDS is a safety document, not an allergen declaration. Ask for an allergen declaration or IFRA certificate that explicitly references Regulation (EU) 2023/1545's expanded list; anything issued before 2023 will only cover the old 26 entries.
What if all the allergens don't physically fit on my label?
The regulation permits the established alternatives small labels already use: the ingredient list may appear on an enclosed leaflet, tag, or peel-back label referenced by the hand-in-book symbol. For very small packs, check the specific derogations with your responsible person — but 'it doesn't fit' is a design problem with known solutions, not an exemption.
How do I calculate whether an essential-oil allergen crosses the threshold?
Multiply the allergen's percentage in the oil (from the supplier's allergen declaration) by the oil's percentage in your formula. Example: lavender oil is commonly 30–45% linalool, so at 1% lavender in a leave-on product you have roughly 0.3–0.45% linalool — hundreds of times over the 0.001% leave-on threshold, so it must be declared.
Labels derived from the formula, not from memory
Formalitic builds the INCI declaration and allergen flags from the formula you actually make — change an essential oil's percentage and the label preview updates with it, with allergens called out for review. Your supplier documents (SDS, COA, allergen declarations) live on the ingredient, so the paper trail for each lot is one click away.
This guide is general information, not legal or regulatory advice. Verify requirements for your products with your responsible person or a cosmetic regulatory professional.