Fragrance Allergens Labelling: EU Rules Explained
You have finished the formula, the juice has macerated, the bottles are ordered, and then a stockist in Germany asks a simple question: "Is your allergen declaration up to date with the new rules?" If that question makes your stomach drop, you're not alone. Many small perfume brands only meet fragrance allergens labelling when a retailer, a safety assessor or a customer with sensitive skin brings it up.
The good news is that the logic behind the rules is straightforward. The EU sets a list of fragrance substances that are known to cause allergic reactions in some people, and when one of them is present in your finished product above a small threshold, it has to be named in the ingredient list. The harder part is the arithmetic and the paperwork, especially now that the list has grown. This guide explains the current EU rules in plain English and shows how to work out what your label needs.
This article is general information, not legal advice. For products you sell, your safety assessor and responsible person have the final word.
What Are Fragrance Allergens?
Fragrance allergens are specific substances, found in both synthetic aroma chemicals and natural materials, that can trigger contact allergies in people who have become sensitised to them. Familiar examples include linalool, limonene, geraniol, citral, coumarin, eugenol and cinnamal, as well as some natural extracts such as oakmoss and treemoss.
An important point: many of these substances occur naturally in essential oils. Lavender, bergamot, rose and lemon oils all contain allergens. "Natural" does not mean "allergen-free", and a 100% natural perfume can easily need a longer allergen declaration than a synthetic one.
Labelling them doesn't mean a product is unsafe. As the European Commission puts it, individual labelling helps consumers who are already sensitised identify and avoid the specific substances they react to.
The EU Fragrance Allergen Labelling Rules
In the EU, cosmetics (including perfumes, body lotions, soaps and shampoos) fall under the Cosmetics Regulation (EC) No 1223/2009. Its Annex III lists the fragrance allergens that must be individually declared.
The original 26 allergens
For years, the reference list was the "26 allergens": 24 individual substances plus the oakmoss and treemoss extracts. If any of them exceeded the threshold in the finished product, it had to appear by name in the ingredient list instead of hiding behind the word "parfum" or "fragrance". Many perfumers still think of allergen labelling in terms of these 26.
The expanded list under Regulation (EU) 2023/1545
In July 2023, the Commission adopted Regulation (EU) 2023/1545, which amends Annex III. According to the European Commission, it introduces individual labelling requirements for 56 additional fragrance allergens and updates existing entries, including grouping certain substances under a single declaration name. Ireland's regulator, the HPRA, describes the result as an expanded list of more than 80 fragrance allergens requiring on-pack disclosure.
The new entries include individual aroma chemicals as well as a number of essential oils and extracts. Because some entries are grouped, the declaration names you use on the label must follow the exact Annex III entry, not your supplier's trade name.
The labelling thresholds: 0.001% and 0.01%
The thresholds didn't change. An allergen must be named in the ingredient list when its concentration in the finished product exceeds:
0.001% in leave-on products (10 parts per million), such as perfume, body mist, lotion or solid perfume
0.01% in rinse-off products (100 parts per million), such as shower gel, shampoo or soap
Two details trip people up. First, the threshold applies to the finished product, not to your perfume concentrate. Second, it applies to the total amount of each allergen, added up across every raw material that contains it.
Key deadlines: 2026 and 2028
The regulation gave businesses a transition period:
Since 31 July 2026, cosmetic products that don't comply with the new allergen labelling may no longer be placed on the EU market. Any product launched in the EU now must follow the expanded list.
Until 31 July 2028, products that were already placed on the market before 31 July 2026 can still be made available (for example, sold through by distributors and shops), subject to the conditions in the regulation.
After 31 July 2028, non-compliant stock has to be off the market.
If you have older EU stock in shops, now is the time to plan relabelling and talk to your stockists so nothing is left on shelves after the 2028 cut-off.
How to Calculate Allergens in Your Perfume
The calculation follows the formula from the top down: how much of each material is in the concentrate, how much allergen each material contains, and how much concentrate is in the finished product.
Step 1: Get allergen data for every material
For each raw material, you need to know which Annex III allergens it contains and at what percentage. Reputable suppliers provide this in an allergen statement or certificate, and IFRA documentation often comes with it. Make sure the document reflects the expanded list, not just the original 26. Single aroma chemicals are simpler: a bottle of linalool is essentially linalool, adjusted for any dilution.
Step 2: Calculate the allergen content of your concentrate
Multiply each material's percentage in the formula by its allergen content, then add up the contributions for each allergen across all materials.
Step 3: Apply your dosage in the finished product
Multiply the allergen level in the concentrate by the percentage of concentrate in the finished product. Then compare the result with the 0.001% or 0.01% threshold.
A worked example (example figures)
Imagine an Eau de Parfum with 18% concentrate in alcohol. Your concentrate contains 5% of an essential oil, and the supplier's allergen statement says that oil contains 30% linalool. These are example figures for illustration only.
Linalool in the concentrate from this oil: 5% x 30% = 1.5%
Linalool in the finished perfume: 18% x 1.5% = 0.27%
Threshold for a leave-on product: 0.001%
At 0.27%, linalool is far above the threshold and must be declared. In practice, almost any fine fragrance that contains essential oils or common aroma chemicals will need several allergens on the label.
Now take the same logic to a body wash with 1% fragrance, where the fragrance contains 0.5% eugenol in total. In the finished product, that's 1% x 0.5% = 0.005%. For a rinse-off product the threshold is 0.01%, so in this example eugenol would not need to be declared individually.
If you dilute materials before weighing them, remember to account for the dilution. A 10% dilution of a material contributes only a tenth of the allergen content per gram. Our guide to perfume concentration percentages explains how concentrate and dilution percentages fit together.
How Allergens Appear on the Label
Declared allergens are added to the ingredient list (the INCI list) using the names set out in Annex III. In practice, the list typically shows "Parfum" (or "Aroma") for the fragrance as a whole, followed by the individual allergens that exceed the threshold, in line with the usual ingredient ordering rules.
A typical perfume label structure looks like this:
Alcohol denat. (or Alcohol)
Parfum
Aqua (if used)
The declared allergens, for example Linalool, Limonene, Coumarin, Geraniol
Any colourants or other additives
Your safety assessor or regulatory consultant should confirm the exact names and order before artwork goes to print, especially for grouped entries in the expanded list.
Allergen Labelling vs IFRA Limits
Allergen labelling and IFRA compliance are often confused, but they answer different questions:
Allergen labelling (EU law) asks: is this substance present above the threshold, and is it named on the label? Declaring an allergen does not make an unsafe level acceptable.
IFRA Standards (industry standards) ask: is the level of a material safe for this type of product? They set maximum use levels, which depend on the product category.
Annex III restrictions (EU law) can also set maximum concentrations or conditions for certain substances, separately from the labelling duty.
A compliant product needs all of them to line up. If you want a refresher, read our guides to IFRA standards and IFRA categories.
Common Mistakes Indie Perfumers Make
Calculating on the concentrate, not the finished product. The threshold applies to what the customer actually uses.
Forgetting natural sources. One allergen can come from five different essential oils. You have to add them all up.
Using outdated supplier data. Allergen statements written for the original 26 don't cover the expanded list.
Ignoring dilutions. Treating a 10% dilution as if it were the neat material overstates allergens, and the opposite mistake understates them.
Assuming the EU rules apply everywhere. Other markets have their own requirements. The UK, for example, has its own cosmetics regulation, so check the rules for each country you sell into.
Not updating labels after reformulating. A small tweak to the formula can push an allergen over or under the threshold.
Keep Your Formula Data Ready for Labelling
Every allergen calculation depends on accurate formula data: exact percentages, the dilution of each material and the dosage in the finished product. That's where most indie perfumers lose time, rebuilding numbers from notebooks or old spreadsheets every time a stockist or assessor asks.
With the ScentLabs formula creator, your percentages are calculated automatically from your weights, you record dilutions and purity for each material, and you keep versions of each formula. When it's time to prepare an allergen calculation or hand data to your safety assessor, the numbers are already organised in one place instead of scattered across files.
Frequently Asked Questions
What is the fragrance allergen labelling threshold in the EU?
An allergen listed in Annex III must be named in the ingredient list when it exceeds 0.001% in a leave-on product or 0.01% in a rinse-off product. The percentage refers to the finished product.
How many fragrance allergens must be labelled in the EU now?
Regulation (EU) 2023/1545 added 56 allergens to the original list, and the HPRA describes the expanded list as more than 80 fragrance allergens. Some substances are grouped under one declaration name, so always check the exact Annex III entries.
When do the new EU allergen labelling rules apply?
New products placed on the EU market since 31 July 2026 must comply. Products placed on the market before that date can continue to be made available until 31 July 2028, subject to the conditions in the regulation.
Do natural perfumes need allergen labelling?
Yes. Many essential oils naturally contain allergens such as linalool, limonene, citral or geraniol. The rules apply to the substance, whatever its source.
Does declaring an allergen mean my product is safe?
No. Labelling only informs consumers. Your product still needs to respect IFRA Standards, any Annex III restrictions and a cosmetic safety assessment.
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