For nearly two decades, EU cosmetic labels had to call out 24 specific fragrance allergens by name. That list has now expanded dramatically. New fragrance allergen labelling rules introduced by Regulation (EU) 2023/1545 raise the number of individually declarable allergens to around 80, and the first hard deadline — 31 July 2026 — is now weeks away. If your ingredient lists still show only the old 26 entries, your labels are on course to become non-compliant.
This guide explains what changed, the two deadlines you must plan around, how the declaration thresholds work, and the practical steps to get your labels updated before enforcement begins. It is written for brand owners and responsible persons who need a clear picture without wading through the legal text.
Key takeaways
- Regulation (EU) 2023/1545 amended Annex III of the Cosmetic Regulation, expanding the list of fragrance allergens that must be named on the label from 24 to roughly 80.
- Two deadlines apply: new products placed on the market must comply by 31 July 2026; products already on the market may remain until 31 July 2028.
- The declaration thresholds are unchanged: an allergen is named when it exceeds 0.001% in leave-on products or 0.01% in rinse-off products.
- The newly listed allergens must appear by their INCI name in the ingredient list, in the same way the original allergens already do.
- You need updated allergen data from your fragrance supplier to know which of the new substances your formula contains — this is the first practical step.
What actually changed
Fragrance mixtures are made of many individual aroma chemicals, some of which are known skin sensitisers. To help allergic consumers avoid the substances that affect them, the EU requires certain fragrance allergens to be declared by name in the ingredient list rather than hidden under the generic word “parfum”. Until now, that obligation covered 24 named substances (plus two natural extracts, which is why you often see “26 allergens” referenced).
Regulation (EU) 2023/1545, which entered into force in 2023, substantially expanded Annex III. Based on updated scientific opinions on contact allergens, it added a large set of additional fragrance substances — bringing the total that must be individually labelled, when present above the thresholds, to approximately 80. The mechanism has not changed; the list has simply grown a great deal longer, which means many existing products that previously declared only “parfum” plus a handful of allergens now need several more names added.
This is a labelling change, not a ban. The new substances are not prohibited — they simply have to be named on the label when present above the declaration threshold, so allergic consumers can identify them.
The two deadlines — and why both matter now
The regulation gives the industry a phased transition with two distinct dates, and confusing them is the easiest way to get caught out.
| Deadline | Applies to | What it means |
|---|---|---|
| 31 July 2026 | Products placed on the market (newly made available) | From this date, products entering the market must carry the updated allergen labelling |
| 31 July 2028 | Products already made available on the market | Older stock already on shelves may continue to be sold until this date |
In practice, any product you launch, reformulate or send into a new production run should already be on the new labelling — the 2026 date is effectively now. The 2028 date is a sell-through window for existing stock, not an excuse to delay updating artwork you are about to reprint anyway.
How the declaration thresholds work
An allergen on the list only has to be named when it is present above a concentration threshold, and those thresholds depend on whether the product stays on the skin:
- Leave-on products (creams, serums, perfumes, make-up): declare the allergen if it exceeds 0.001% (10 ppm).
- Rinse-off products (shampoo, shower gel, cleansers): declare the allergen if it exceeds 0.01% (100 ppm).
These figures are unchanged by the new regulation — what has changed is the number of substances you must screen your formula against. A fragrance that comfortably needed only two declared allergens under the old list might now cross the threshold for five or six under the expanded one.
Where the new allergens go on the label
The newly listed allergens are declared exactly like the originals: by their INCI name, within the ingredient list, after the generic “parfum”/”aroma” entry. They are listed in descending order of concentration alongside the other ingredients where applicable. There is no separate “allergen box” — they sit in the standard ingredient declaration, which is why expanding the list often lengthens the ingredient list noticeably. Our guides on EU cosmetic ingredient labelling and the existing allergen labelling rules cover how the ingredient list is built.
You cannot work out which new allergens apply from the old documentation. Ask your fragrance supplier for an updated allergen declaration covering Regulation (EU) 2023/1545. Without current data per fragrance, you cannot know which of the ~80 substances exceed the threshold in your specific formula — and guessing risks both under- and over-declaration.
Your practical update checklist
Getting compliant is a sequence, not a single edit. Work through it product by product:
- Request updated allergen statements from every fragrance supplier, referencing the new regulation.
- Recalculate which allergens exceed 0.001% (leave-on) or 0.01% (rinse-off) in each finished formula.
- Revise the INCI list to add the newly triggered allergen names in the correct order.
- Update artwork and your digital listings so the printed label and online ingredient list match.
- Refresh your PIF and CPNP entry if the labelling change affects the documents held for the product.
Bringing it all together
The expanded fragrance allergen list is one of the most widespread labelling changes the cosmetics industry has faced in years: around 80 substances now declarable by name, a 31 July 2026 cut-off for new products and a 31 July 2028 sell-through for existing stock. The thresholds are the same, but the screening job is much bigger — and it starts with getting fresh allergen data from your fragrance houses. With the 2026 deadline now imminent, any label you are reprinting should already be on the new list.
If you would like a specialist to audit your ingredient lists against the new Annex III and reissue compliant artwork, Lexora’s Cosmetic Label Review service checks every label element against the current rules, and our Full Compliance Pack keeps your labelling, PIF and notification aligned as the requirements change.
Frequently asked questions
How many fragrance allergens must now be labelled in the EU?
Regulation (EU) 2023/1545 expanded the list to roughly 80 individually declarable fragrance allergens, up from the 24 named substances (often cited as 26 including two natural extracts) that applied before. Each must be named on the label when present above the declaration threshold for the product type.
When is the deadline for the new fragrance allergen labelling?
There are two dates. New products placed on the market must comply by 31 July 2026, and products already made available on the market may continue to be sold until 31 July 2028. In practice any product you are launching or reprinting now should already use the updated list.
What are the concentration thresholds for declaring an allergen?
An allergen must be named when it exceeds 0.001% (10 ppm) in leave-on products such as creams and perfumes, or 0.01% (100 ppm) in rinse-off products such as shampoo and shower gel. These thresholds are unchanged by the new regulation — only the list of substances to check against has grown.
Do the new allergens go in a separate section of the label?
No. They are declared by their INCI name within the normal ingredient list, after the “parfum” or “aroma” entry, in the usual descending order of concentration. There is no separate allergen box, which is why adding them often makes the ingredient list noticeably longer.
How do I find out which new allergens are in my product?
Request an updated allergen declaration from your fragrance supplier that reflects Regulation (EU) 2023/1545. The supplier holds the composition of the fragrance and can tell you the concentration of each listed allergen, which you then compare against the leave-on or rinse-off threshold for your finished product.
