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Fragrance allergens: the 80+ substances to declare on your cosmetic labels
Does your cream contain lavender essential oil? Your lip balm, vanillin? Your toothpaste, menthol?
Since 31 July 2026, these ingredients are among the fragrance allergens that the label must name once they exceed a threshold.
Regulation (EU) 2023/1545 takes the list from around 24 substances to more than 80. It is the biggest change to fragrance labelling since the “26 allergens” arrived in 2003.
The essentials in 30 seconds
• More than 80 allergens to name, including essential oils.
• Unchanged thresholds: 0.001% leave-on, 0.01% rinse-off.
• Since 31/07/2026: no more non-compliant products placed on the market.
• 31/07/2028: end of sales of existing stock.
Key terms to know
Fragrance allergen: a fragrance substance that can trigger contact allergy in a person who is already sensitised. The list is in Annex III to Regulation (EC) No 1223/2009.
“Parfum” or “Aroma”: the single word that covers the whole fragrance composition in the ingredient list. Allergens above the threshold are added separately, under their own name.
Leave-on product: stays on the skin, hair or nails (cream, serum, deodorant, perfume, make-up).
Rinse-off product: washed off with water right after use (shampoo, shower gel, soap).
Labelling threshold: the concentration in the finished product above which the allergen must be listed.
Group name: a single name required for several closely related substances. Example: geranial and neral are both written “Citral”.
Placing on the market: the very first supply of a unit in the EU. Each unit has its own date.
Making available on the market: any later supply of that unit, all the way to the consumer.
Allergen declaration: the supplier document giving the content of each allergen in its raw material. It is the basis of the whole calculation.
Key point: an allergen listed on the label does not mean the product is unsafe. It is information for people who are already allergic. A missing allergen, however, is a non-compliance.
1. What Regulation (EU) 2023/1545 changes
In short: the list grows from around 24 to more than 80 substances and groups of substances. The thresholds and the way they are written stay the same.
The text was adopted on 26 July 2023, published in the Official Journal the next day, and entered into force on 16 August 2023. It amends Annex III to the Cosmetics Regulation.
It builds on an opinion of the Scientific Committee on Consumer Safety (SCCS). That opinion identified substances with established allergenic potential in humans that had no labelling requirement until then.
In practice, the regulation:
adds 56 allergens, spread over 45 new entries (No 327 to 371);
rewrites 17 existing entries: updated identification, CAS numbers, groupings;
deletes 10 old entries that are no longer needed.
The real novelty: essential oils and natural extracts enter the list in their own right. Lavender, peppermint, lemon, bergamot, orange, rose, ylang-ylang, patchouli, sandalwood, clove, eucalyptus…
The typical mistake: thinking “my product is natural, so it has no allergens to declare”. It is often the opposite.
The fragrance allergen reform in numbers
2. The timeline: 2026 has passed, 2028 is coming
In short: since 31 July 2026, no non-compliant product can be placed on the market. Those placed before that date can still be sold until 31 July 2028.
31 July 2026, end of placing on the market. Any unit supplied for the first time from that date must carry the new labelling. No tolerance.
31 July 2028, end of making available. Units placed on the market before 31/07/2026 can circulate until that date. After that, they must be withdrawn, including from distributors.
An often-overlooked detail: for allergens already listed before the reform, this grace period only applies if the product complied with the rules in force on 15 August 2023.
Two other dates to know:
30 July 2026: the new EU glossary of common ingredient names (Decision (EU) 2025/1175) became mandatory. Check your INCI names at the same time.
11 November 2025: a corrigendum corrected three entries of the regulation (details in section 5).
The typical mistake: thinking the date refers to manufacturing. A batch made in June 2026 but shipped from the Responsible Person's warehouse in September 2026 had to be compliant.
Key dates of the reform, from 2023 to 2028
3. Thresholds: must the allergen be listed?
In short: the allergen must be named once it exceeds 0.001% in a leave-on product, or 0.01% in a rinse-off product.
Leave-on: 0.001%, i.e. 10 ppm. Cream, serum, deodorant, perfume, make-up, lip balm.
Rinse-off: 0.01%, i.e. 100 ppm. Shampoo, shower gel, soap, rinse-off mask.
Three rules to keep in mind:
The threshold applies to the finished product, not to the fragrance.
Allergen by allergen: linalool alone, limonene alone, and so on.
All sources add up: fragrance, essential oil, extract.
The calculation: fragrance dose in the formula × allergen content in the fragrance.
Example: a cream with 0.8% fragrance, containing 0.2% linalool. Result: 0.0016%, above 0.001%. “Linalool” must appear on the label.
The same fragrance in a shower gel: 0.0016% stays below 0.01%. Listing it is optional.
The typical mistake: doing the calculation once at launch and never again. A new dose, a new batch or a new supplier declaration can change everything.
How to calculate the threshold, with a worked example
4. Ingredients you already use
In short: the new allergens are not rare. Many are everyday ingredients, especially in natural cosmetics.
Examples of allergens now covered
An essential oil raises a double question: it may itself be an allergen to name, and its constituents (linalool, limonene, citral…) also count in the threshold calculation.
The typical mistake: only asking the perfumer. An essential oil added directly to the formula also brings allergens.
5. The right name on the label
In short: for several fragrance allergens, the regulation requires a single group name. That is the name that must appear in the ingredient list.
Geranial, Neral → Citral
Lavandula Angustifolia, Hybrida, Intermedia (oils and extracts) → Lavandula Oil/Extract
Citrus Aurantium Dulcis Peel Oil, Citrus Sinensis Peel Oil, Citrus Aurantium Amara Peel Oil → Citrus Aurantium Peel Oil
Citrus Aurantium Amara or Dulcis Flower Oil → Citrus Aurantium Flower Oil
Cymbopogon Citratus, Flexuosus, Schoenanthus → Lemongrass Oil
Rosa Damascena, Centifolia, Alba, Gallica, Canina, Moschata, Rugosa → Rose Flower Oil/Extract
Jasminum Grandiflorum or Officinale → Jasmine Oil/Extract
Cananga Odorata (ylang-ylang) → Cananga Odorata Oil/Extract
Eugenia Caryophyllus Leaf, Flower, Stem or Bud Oil → Eugenia Caryophyllus Oil
Eucalyptus Globulus Leaf Oil, Leaf/Twig Oil → Eucalyptus Globulus Oil
Alpha-Damascone and other “Rose ketones” → Rose Ketones
Source: Annex to Regulation (EU) 2023/1545. The most common groupings; not exhaustive.
The November 2025 corrigendum
Published in the Official Journal on 11 November 2025, it corrects three entries without changing the dates:
Entry 157: “Rose ketone 4 (Damascone)” becomes “Rose ketone 4 (Damascenone)”.
Entry 364: rose geranium also covers Pelargonium Graveolens Oil and Leaf Oil.
Entry 365: patchouli also covers Pogostemon Cablin Leaf Oil.
For these two oils, Cosmetics Europe recommends using the most general INCI name, for example “Pelargonium Graveolens Oil”.
The typical mistake: copying the name from the supplier sheet. For a fragrance allergen, “Citrus Sinensis Peel Oil” is not the required name: it is “Citrus Aurantium Peel Oil”.
6. Four pitfalls we still see in audits
1. Forgetting stock held by distributors. After 31 July 2028, non-compliant units must be withdrawn everywhere, marketplaces included.
2. Leaving the old list on the e-commerce site. Online buyers must see the same information as on the bottle. Update both at the same time.
3. Forgetting the PIF and the safety report. The Commission points out that the PIF and the safety assessment must stay consistent with the composition and labelling.
4. Confusing “to declare” with “free to use”. Some entries also set a maximum: 0.4% for Peru balsam, 0.2% for verbena absolute, product-specific limits for methyl salicylate.
7. Are you exposed? The 3-question test
A single “yes” is enough for your labels to deserve a check.
Do your formulas contain fragrance, essential oils or scented extracts?
Do your supplier allergen declarations not yet refer to Regulation (EU) 2023/1545?
Do you have stock or labels printed before 31 July 2026?
The real work starts after that: cross-checking every raw material against more than 80 entries, adding up the sources, applying group names, then aligning label, PIF and CPSR.
It is technical, time-consuming, and a single mistake is enough to make a label non-compliant.
What Reguloo takes care of
Review of your supplier declarations against the new list
Calculation of each allergen in the finished product, all sources combined
Corrected INCI list with the required names, ready for your proof
Update of your PIF and CPSR
Review of your existing stock before the 31 July 2028 deadline
Have your labels checked before an inspection.
Send us your formulas and supplier declarations: we tell you exactly what needs to change, product by product.
The path to follow for each product
Frequently asked questions
My product has no added fragrance. Am I affected?
Yes, if it contains essential oils, scented plant extracts or molecules such as vanillin or menthol. What matters is the allergen above the threshold, not the word “Parfum”.
Can I just write “contains allergens”?
No. Each allergen above the threshold must be named individually, using the name set by the regulation, in the ingredient list.
I still have labels in the old format. What should I do?
They can no longer be used for units placed on the market after 31 July 2026. Units placed on the market before that date can still be sold until 31 July 2028.
Did the 2025 corrigendum move the deadlines?
No. It corrects three entries (Rose ketones, rose geranium, patchouli), but the 31 July 2026 and 31 July 2028 dates stay the same.
Where can I find the official list?
The only legally binding list is Annex III to Regulation (EC) No 1223/2009, consolidated version. The Commission's CosIng database is useful but for information only.
Need an expert eye on your labels?
Reguloo reviews your supplier declarations, recalculates your allergens product by product and updates your labelling, PIF and CPSR. You know exactly where you stand before 31 July 2028. Contact us.
Also read: Cosmetic labelling: the 10 most common mistakes.
Sources
Commission Regulation (EU) 2023/1545 of 26 July 2023, OJ of 27 July 2023
Corrigendum to Regulation (EU) 2023/1545, OJ L 2025/90876 of 11 November 2025
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