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by Nathan Motylinski 11 min read
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U.S. and EU perfume labels diverge on one requirement above all others: the EU makes you name individual fragrance allergens in the ingredient list, and the U.S. does not. EU cosmetic labels must declare 26 named fragrance allergens today, and Regulation (EU) 2023/1545 expands that list to more than 80 entries, applying to products placed on the EU market from 31 July 2026 and to products made available on the market by 31 July 2028. In the U.S., the entire fragrance may still appear as the single word "Fragrance" — MoCRA directs FDA to write allergen-disclosure rules, but no proposed rule has been published and no effective date is set. |
The same bottle, two ingredient lists — an EU label must name individual fragrance allergens; a U.S. label may still say only “Fragrance.” |
Key Takeaways
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United States
"Fragrance" is one word
Named allergens not required on cosmetic labels today.
MoCRA (2022) directs FDA to develop allergen-labeling rules — disclosure is coming.
No fixed effective date for the new disclosure framework.
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European Union
26 named allergens → 80+ by 2028
Mandatory disclosure when allergens exceed set thresholds.
≥ 0.001% leave-on · ≥ 0.01% rinse-off (10 / 100 ppm).
Naturals included — many essential oils are newly caught.
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Same product, same fragrance — two different ingredient lists depending on the market. The examples below illustrate the practical effect of the rules.
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U.S. Label
Ingredients
Alcohol Denat., Aqua/Water, Parfum/Fragrance. Three ingredients. The entire fragrance — including its allergenic components — sits inside "Parfum."
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EU Label · Same Product
Ingredients
Alcohol Denat., Aqua/Water, Parfum/Fragrance, Citronellol, Geraniol, Linalool, Citral, Eugenol, Limonene, Benzyl Alcohol, Hydroxycitronellal. Eight named allergens added — each exceeds the 0.001% leave-on threshold at this 8% fragrance use level.
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U.S. Label
Ingredients
Aqua/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Sodium Chloride, Parfum/Fragrance, Citric Acid, Sodium Benzoate. No fragrance allergens broken out.
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EU Label · Same Product
Ingredients
Aqua/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Sodium Chloride, Parfum/Fragrance, Linalool, Limonene, Citric Acid, Sodium Benzoate. Only two allergens listed — the rinse-off threshold (0.01%) is ten times the leave-on threshold, so fewer components exceed it.
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The ingredient lists above are illustrative. The exact allergens that appear on any label depend on the specific fragrance composition and the use level in the finished product. Your supplier's EU allergen breakdown is what determines the named allergens for your label.
Mandatory EU fragrance allergen disclosure has applied to cosmetic labels since 11 March 2005, under Directive 2003/15/EC. Regulation (EU) 2023/1545 is the first substantial expansion of that list, and it draws on clinical data accumulated across the eighteen years of consumer-facing labeling that followed.
For fragrance brands selling in both regions — or planning to expand internationally — labeling sits at the intersection of compliance, supply-chain documentation, and consumer trust. The rest of this guide walks through each requirement in detail, with the long allergen lists tucked into expandable drawers for reference.
One product, many markets — the label rules that apply are the rules of the market where the product is sold.
In the U.S., perfumes are regulated as cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Cosmetic labels must include:
Currently, U.S. cosmetic regulations do not require brands to list individual fragrance allergens on the label. Allergenic components like limonene, linalool, or citral may be captured under the single word "Fragrance."
What's changing: The Modernization of Cosmetics Regulation Act (MoCRA, 2022) directs FDA to identify which substances count as fragrance allergens, to require them on cosmetic labels, and to consider existing international requirements — the EU's included — when it does (21 U.S.C. 364e(b)). The statute set an 18-month deadline for a proposed rule from its 29 December 2022 enactment; as of August 2026 no proposed rule has appeared in the Federal Register, so U.S. labels carry no allergen-disclosure obligation yet. FDA’s 2026 Unified Agenda now targets a proposed rule for November 2026 — an agenda projection, not a binding date. Brands that already maintain detailed allergen documentation today will be better positioned when those rules land.
In the European Union, perfumes and fragranced cosmetics are regulated under Cosmetics Regulation (EC) No 1223/2009. The label requirements are similar to the U.S. — identity, net contents, responsible person, ingredient list — but the EU adds mandatory fragrance allergen disclosure above set thresholds.
These thresholds apply whether the allergens come from natural essential oils or synthetic ingredients. Many naturals contain several listed allergens at once — which is why supplier documentation matters.
"Natural doesn't mean exempt. Many essential oils contain multiple listed allergens — and they must be counted in total when calculating disclosure thresholds."
The EU's allergen list has two layers. The original list of 26 named fragrance allergens is what cosmetic labels must declare today; two of those, Lilial (butylphenyl methylpropional) and HICC (Lyral), have since been banned from EU cosmetics outright, leaving 24 in active use. Regulation (EU) 2023/1545, in force since 16 August 2023, expands the list to more than 80 entries, adding individual chemical substances and named plant species and extracts whose composition makes them inherent allergen carriers.
That expansion is not yet in force for every product: new products placed on the EU market must comply from 31 July 2026, and products already on the market must comply, or be withdrawn, by 31 July 2028.
The two banned substances are starting to fall in the U.S. as well: California’s AB 496 bans butylphenyl methylpropional (Lilial — listed there as lily aldehyde, CAS 80-54-6) from cosmetics sold in the state beginning 1 January 2027.
| When | What EU cosmetic labels must declare |
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| Today | The original list of 26 named allergens (24 of which are still permitted in cosmetics), wherever they exceed 0.001% leave-on or 0.01% rinse-off. |
| From 31 July 2026 | The expanded list of 80+ entries applies to new products placed on the EU market. |
| From 31 July 2028 | The expanded list applies to all products made available on the EU market; non-compliant stock must be withdrawn. |
The original list of 26 included two substances now banned in EU cosmetics — Butylphenyl methylpropional (Lilial) and Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC / Lyral) — leaving 24 in active use. Those two are excluded from the list above, which shows the 24 still permitted.
Individual chemical entries added to Annex III by Regulation (EU) 2023/1545. Some are isomers of substances already in the original 26 (Damascenone is a rose ketone, for example), and several appear in widely used essential oils.
This list covers the major individual chemical entries. The regulation also captures certain specific isomers and constituent forms separately; consult Annex III for the authoritative text.
The expansion's biggest practical impact is on natural fragrance work: many widely used essential oils and extracts now appear in Annex III by name. A single oil can trigger several allergens at once because of its inherent chemical composition.
Lavender (Lavandula angustifolia) is one of the botanical species Regulation (EU) 2023/1545 names directly — the oil itself is a disclosure trigger.
A natural rose absolute typically carries citronellol, geraniol, eugenol, farnesol, and linalool — all individually named EU allergens — plus the newly listed rose ketones (damascones, damascenone). One drop of rose, five or more disclosure entries.
Headline categories — visible to anyone formulating with naturals:
Named botanical sources added to Annex III by Regulation (EU) 2023/1545. Entries cover oils, absolutes, and extracts from the specified plant species.
For the authoritative complete enumeration — including exact substance forms, CAS numbers, and specific isomer designations — refer to Regulation (EU) 2023/1545 on EUR-Lex and Annex III of Cosmetics Regulation (EC) No 1223/2009.
| Requirement | United States | European Union |
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| Regulatory framework | FD&C Act (cosmetics); MoCRA (2022) rulemaking still pending. | Cosmetics Regulation (EC) 1223/2009; expanded by (EU) 2023/1545. |
| Ingredient list | Required; "Fragrance" allowed as a catch-all. | Required; "Parfum" allowed, but named allergens must appear separately. |
| Allergen disclosure | Not required — no FDA rule published under MoCRA as of August 2026; FDA’s regulatory agenda targets a proposed rule for November 2026. | Mandatory: 26 named allergens today (24 still permitted), expanding to 80+ entries — 31 July 2026 for products placed on the market, 31 July 2028 for products made available. |
| Thresholds | Not applicable today. | 0.001% leave-on (10 ppm); 0.01% rinse-off (100 ppm). |
| Naturals treated differently? | N/A. | No — naturals and synthetics are evaluated the same way. |
| Documentation expected | IFRA Certificate, SDS, basic ingredient declaration. | IFRA Certificate, SDS, EU allergen breakdown by use level. |
Every Stock Fragrance oil is backed by an IFRA Certificate, SDS, and EU allergen breakdown — posted on its product page or available on request. The collections below filter by the regulatory framework or product application that fits your project.
Use level decides which allergens cross the disclosure thresholds, so the label follows the formula. Our fragrance oil calculator turns a container size, a target dosage percentage and a unit count into the fragrance weight a batch needs, and the fragrance oil knowledge center gathers our regulatory and formulation guides in one place.
Often yes. The EU requires named allergen disclosure above specific thresholds, while the U.S. is still evolving toward allergen transparency under MoCRA. Many brands use region-specific labels or region-specific outer cartons to manage the differences without redesigning the primary bottle.
Not yet. Great Britain kept the UK Cosmetics Regulation after Brexit and, as of August 2026, still works from the original 26-allergen list — the 2023/1545 expansion has not been adopted for Great Britain. Brands selling into both markets typically label to the stricter EU list rather than manage two allergen strategies.
Twenty-six named fragrance allergens are declarable on EU cosmetic labels today. Two of the original 26 — Butylphenyl methylpropional (Lilial) and Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC / Lyral) — are banned from EU cosmetics outright, leaving 24 in active use. Regulation (EU) 2023/1545 expands the list to more than 80 entries, applying to products placed on the EU market from 31 July 2026 and to products made available on the market by 31 July 2028.
Not yet. A U.S. cosmetic label may still declare the whole fragrance as “Fragrance” or “Parfum.” MoCRA directs FDA to identify fragrance allergens and require them on labels, and to consider international requirements including the EU's, but no proposed rule has appeared in the Federal Register and no effective date is set.
No. Allergen rules apply regardless of whether components are natural or synthetic. Many essential oils contain multiple listed allergens — and must be considered in total when calculating thresholds. A lavender oil rich in linalool, for example, can trigger linalool disclosure on its own.
Regulation (EU) 2023/1545 names botanical sources directly, so oils, absolutes and extracts from rose (Rosa centifolia, damascena, gallica), jasmine, ylang-ylang, citrus (bergamot, lemon, sweet and bitter orange), lavender and lavandin, mint, patchouli, sandalwood, cedarwood, eucalyptus and verbena all appear in Annex III. A single oil can trigger several disclosure entries at once because of its inherent composition.
Your fragrance supplier should provide an EU allergen breakdown alongside the IFRA Certificate and SDS. These documents help you determine which allergens appear above threshold at the use level in your finished product — which is what drives the label.
Yes. Our Fragrance Design Services team can create or adapt fragrances with EU allergen disclosure, IFRA categories, and retailer standards in mind from the first sketch.
Documentation — IFRA Certificates, SDS, and EU allergen lists — is posted on each fragrance product page under the Documentation tab. For additional formats or consolidated files, use our Documentation Request form.
Have questions about allergen disclosure, regional requirements, or how to plan for the MoCRA changes ahead? Contact us — we answer every inquiry personally.
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