From 26 to More Than 80: What Changed?
The list we memorised for years as "the 26 allergens" is now the old list. The European Union has raised the number of fragrance allergens that must be named individually on the label to more than 80.
The change was introduced by Commission Regulation (EU) 2023/1545, published in summer 2023. The Regulation updated the restricted substances annex of the Cosmetics Regulation (1223/2009), adding 56 new substances to the existing 26 allergens. The newcomers include not only individual molecules but also natural extracts and essential oils: many natural raw materials used in perfumery every day are now on the declaration list.
What has not changed is the thresholds. If an allergen exceeds the following level in the finished product, it is listed by name in the ingredient list.
| Product type | Declaration threshold | Example products |
|---|---|---|
| Leave-on | 0.001% (10 ppm) | Perfume, cologne, body mist, cream, deodorant |
| Rinse-off | 0.01% (100 ppm) | Shampoo, shower gel, liquid soap |
Transition Timeline: Two Dates
The Regulation entered into force in 2023 but gave the industry a two-stage period to comply.
| Date | Applies to | What it means |
|---|---|---|
| 31 July 2026 | Products newly placed on the EU market | The label of a product first placed on the market after this date must comply with the new list |
| 31 July 2028 | Products already on the market | The last date on which products with the old label may remain on shelves |
The first date has passed. If you are placing a new product on the EU market today, its label must have been prepared against the new list. The second date is for running down stock: the last day by which products made with the old label must have left the distribution chain.
The Turkish side: Türkiye runs its cosmetics legislation in alignment with the EU, and the Turkish Medicines and Medical Devices Agency (TİTCK) has published guidance on the labelling of fragrance allergens. If you sell on the domestic market, verify the applicable list and dates against the current TİTCK text; the dates in this article are for the EU market.
Impact on the Manufacturer: Longer Labels, Different Maths
The list tripling in size has three practical consequences.
The label gets longer. In a perfume rich in natural oils, the number of allergens to declare can easily double. On a small bottle, the space available for the ingredient list becomes a real design problem; the box, a fold-out label or a leaflet come into the picture.
The calculation is made on the finished product, not on the fragrance oil. The threshold is the allergen's concentration in the final product. If your fragrance oil contains 2% linalool and you use 20% oil in a perfume, the linalool in the product is 0.4%; far above the threshold, so it is declared. If you use the same oil at 0.3% in a shampoo, the level falls to 0.006%; below the rinse-off threshold, so no declaration is needed.
The same substance comes from more than one source. Linalool comes both from synthetic linalool in the fragrance oil and from lavender and bergamot oils. The threshold comparison is made on the total; you cannot assess the sources separately. Some new entries group isomers and derivatives under a single heading for declaration.
What to Do: Six Steps
Compliance is more a matter of paperwork than laboratory work.
- Request an up-to-date allergen declaration
For every fragrance oil and natural oil you use, obtain from your supplier an allergen declaration prepared against the new list. The old 26-substance declaration is no longer enough.
- Calculate per product
Multiply each allergen's level in the oil by the oil's level in the product. If you use more than one scented raw material, add up the same allergen.
- Compare with the threshold
Depending on whether the product is rinse-off or leave-on, compare with 0.01% or 0.001%. Those that exceed it go into the ingredient list under their INCI name.
- Re-set the label
Check whether the new ingredient list fits on the bottle or box. If it does not, plan the packaging solution now.
- Update the product file
The Product Information File (PIF) and the safety assessment must be consistent with the new declaration. Also update the label image in your notification records.
- Plan your stock
Work out when product and printed packaging with the old label will run out; take action for stock that will not clear before the 2028 deadline.
Frequently Asked Questions
This article is for general information; for binding obligations, rely on the text of the Regulation and current TİTCK announcements.
How many substances are on the new allergen list?
Has the declaration threshold changed?
Have these substances been banned?
I only sell in Türkiye; does this concern me?
I use natural essential oils; am I affected?
How do I find out the allergen level?
What if it does not fit on the label?
My fragrance oil is IFRA compliant; is that enough?
Until when can I sell my stock with the old label?
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