Fragrance Allergen Labeling: The 26 EU Allergens Explained

Fragrance allergen labeling is one of the most frequently misunderstood compliance requirements in the B2B fragrance supply chain. The EU Cosmetics Regulation (EC) No 1223/2009, Annex III, mandates the declaration of specific fragrance allergens on cosmetic product labels when they exceed defined threshold concentrations. For manufacturers, private-label suppliers, and importers, accurate allergen documentation is a non-negotiable part of product compliance.

The Regulatory Basis

Annex III of Regulation 1223/2009 lists substances that cosmetic products may contain subject to restrictions. Entries 67 through 92 (originally) specify 26 fragrance ingredients that must be declared on the label by their INCI name when present above threshold concentrations. These were identified by the EU Scientific Committee on Consumer Safety (SCCS) based on clinical evidence of contact allergy.

The requirement applies to all cosmetic products sold in the EU/EEA, including:

• Fine fragrances (eau de parfum, eau de toilette, cologne)
• Scented body care (lotions, shower gels, soaps)
• Hair care products with fragrance
• Home fragrance products that contact skin (scented candles are generally exempt unless marketed for skin contact)
• Aromatherapy products applied topically

The 26 Listed Allergens

The original 26 allergens and their INCI names:

#	INCI Name	Common Name	CAS Number
1	Amyl Cinnamal	Amyl cinnamaldehyde	122-40-7
2	Amylcinnamyl Alcohol	Amylcinnamyl alcohol	101-85-9
3	Anise Alcohol	Anise alcohol	105-13-5
4	Benzyl Alcohol	Benzyl alcohol	100-51-6
5	Benzyl Benzoate	Benzyl benzoate	120-51-4
6	Benzyl Cinnamate	Benzyl cinnamate	103-41-3
7	Benzyl Salicylate	Benzyl salicylate	118-58-1
8	Cinnamal	Cinnamaldehyde	104-55-2
9	Cinnamyl Alcohol	Cinnamyl alcohol	104-54-1
10	Citral	Citral (geranial + neral)	5392-40-5
11	Citronellol	Citronellol	106-22-9
12	Coumarin	Coumarin	91-64-5
13	Eugenol	Eugenol	97-53-0
14	Farnesol	Farnesol	4602-84-0
15	Geraniol	Geraniol	106-24-1
16	Hexyl Cinnamal	Hexyl cinnamaldehyde	101-86-0
17	Hydroxycitronellal	Hydroxycitronellal	31906-04-4
18	Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde	Lyral / HICC	31906-04-4
19	Isoeugenol	Isoeugenol	97-54-1
20	Limonene	d-Limonene	5989-27-5
21	Linalool	Linalool	78-70-6
22	Methyl 2-Octynoate	Methyl heptine carbonate	111-12-6
23	Alpha-Isomethyl Ionone	Alpha-isomethyl ionone	127-51-5
24	Evernia Prunastri Extract	Oakmoss extract	90028-68-5
25	Evernia Furfuracea Extract	Treemoss extract	90028-67-4
26	Butylphenyl Methylpropional	Lilial / BMHCA	80-54-6

Important updates:

• BMHCA (Lilial): Banned in EU cosmetics since March 2022 (Regulation 2021/1902). It remains on the allergen list but cannot be used at any concentration.
• HICC (Lyral): Banned since August 2021 (Regulation 2019/1396).
• Oakmoss and Treemoss: Restricted to atranol and chloroatranol content below 100 ppm each.

Threshold Concentrations for Labeling

The allergen must be declared on the ingredient list when its concentration exceeds:

• 0.001% (10 ppm) in leave-on products (perfumes, lotions, creams)
• 0.01% (100 ppm) in rinse-off products (shampoos, shower gels, soaps)

These thresholds apply to the concentration of the individual allergen in the finished product, not in the fragrance concentrate.

Calculation example:

A fragrance concentrate contains 15% linalool. It is used at 10% in an eau de parfum (leave-on product).

Linalool in finished product = 15% x 10% = 1.5%

Since 1.5% is far above the 0.001% threshold, “Linalool” must appear on the label.

A second example: A fragrance concentrate contains 0.05% citral. It is used at 2% in a shower gel (rinse-off).

Citral in finished product = 0.05% x 2% = 0.001%

Since 0.001% is below the 0.01% rinse-off threshold, citral does not require declaration.

Labeling Format

Allergens are listed within the INCI ingredient list, not in a separate section. They appear at their position in descending order of concentration (for ingredients above 1%) or in any order after the 1% line.

Example label for an eau de parfum:

Ingredients: Alcohol Denat., Aqua (Water), Parfum (Fragrance), Linalool, Limonene, Citronellol, Geraniol, Coumarin, Citral, Eugenol

The word “Parfum” or “Fragrance” covers the bulk of the fragrance compound. Individual allergens are then listed separately by their INCI names.

The 2023 SCCS Expansion: 80+ Additional Allergens

In 2023, the SCCS published opinion SCCS/1655/23 recommending the addition of over 56 new fragrance allergens to the mandatory labeling list, bringing the total to over 80. The European Commission is expected to adopt an amendment to Annex III. Key implications:

• New allergens include substances like pinene, terpinolene, menthol, and vanillin.
• The same thresholds (0.001% leave-on, 0.01% rinse-off) are expected to apply.
• Transition periods of 3-5 years after adoption are anticipated for industry adaptation.
• B2B suppliers should begin updating allergen screening now to prepare for the expanded list.

Practical Obligations for B2B Suppliers

For fragrance manufacturers (selling concentrates):

1. Provide a full allergen declaration for every fragrance compound, listing all 26 (soon 80+) allergens with exact concentrations.
2. Update declarations when formulations change or raw material specifications shift.
3. Use GC-MS analytical verification for allergen content, not just theoretical calculations from raw material specs.
4. State the declaration basis (calculated vs. analytical) on the document.

For finished product brands and importers:

1. Obtain allergen declarations from your fragrance supplier for every batch or formulation revision.
2. Calculate finished-product allergen concentrations using the usage level.
3. Verify label ingredient lists include all allergens above threshold.
4. Retain documentation for the Product Information File (PIF) as required by Article 11 of Regulation 1223/2009.

Analytical Methods

The standard analytical approach for allergen quantification:

• GC-MS (Gas Chromatography-Mass Spectrometry): The reference method. Detection limits typically 1-5 ppm for individual allergens.
• GC-FID: Acceptable for routine QC when methods are validated against GC-MS.
• HPLC: Used for non-volatile allergens (e.g., oakmoss constituents atranol, chloroatranol).

Aromiso conducts GC-MS allergen screening on all fragrance compounds with a reporting threshold of 5 ppm, well below the 10 ppm leave-on labeling threshold.

How Aromiso Supports Allergen Compliance

Every Aromiso fragrance shipment includes:

• Full allergen declaration with individual concentrations (GC-MS verified)
• IFRA compliance certificate cross-referencing allergen content
• Allergen calculation worksheets for common usage levels (1%, 5%, 10%, 20%)
• Proactive notification when raw material changes affect allergen profiles
• Formulation support to reduce allergen load where technically feasible

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The allergen regulatory landscape is expanding. Monitor the EU Official Journal for the adoption of SCCS/1655/23 and plan formulation and labeling updates accordingly.