The EU's Expanded Fragrance Allergen List: What Changed and What Your Label Needs Now

Quick Answer

Since 2005, the EU has required 26 specific fragrance allergens to be individually named on cosmetic labels above set thresholds. Commission Regulation (EU) 2023/1545 expanded that list by adding 56 new fragrance allergens, bringing the total to roughly 82 substances and substance groups. The compliance deadline for new products placed on the EU market was 31 July 2026  which has now passed  and the deadline for products already on the market is 31 July 2028. If your formula contains fragrance or essential oils, this almost certainly affects your label.

Why the List Was Expanded

The original 26-allergen list dates back to 2005, based on scientific assessment available at the time. The Scientific Committee on Consumer Safety (SCCS) subsequently reviewed the evidence and confirmed that the original allergens remained relevant, while identifying 56 additional fragrance substances with clear evidence of causing allergic contact dermatitis in humans but no existing individual labelling requirement. With fragrance allergy affecting an estimated 1 to 9% of the EU population, the Commission concluded consumers needed to be informed about these additional substances too.

What Actually Changed in Annex III

Regulation (EU) 2023/1545 amends Annex III of the Cosmetics Regulation (EC) No 1223/2009 in three ways: it replaces 17 existing entries with updated wording or identification, deletes 10 entries no longer considered relevant on their own, and adds 45 new entries covering the additional allergens identified by the SCCS. The net effect takes the declarable list from 26 to approximately 82 substances and substance groups.

Prehaptens and Prohaptens: The Part Most Formulators Miss

One of the more technical but important changes concerns substances known as prehaptens and prohaptens compounds that aren't allergenic in their original form, but which convert into known contact allergens through air oxidation or skin bioactivation. Common examples include limonene, linalool, geraniol, eugenol, isoeugenol, and cinnamyl alcohol. Under the updated rules, these are treated as equivalent to their activated allergen forms for labelling purposes meaning a natural essential oil containing these precursor compounds can trigger multiple declarable allergens even before accounting for the allergens already naturally present.

The Labelling Thresholds (Unchanged)

The concentration thresholds that trigger individual labelling remain the same as under the original rules:

• 0.001% in leave-on products (moisturisers, serums, perfumes)
• 0.01% in rinse-off products (shampoos, shower gels, soaps)

Above these thresholds, each declarable allergen must appear by its specific name in the ingredient list, not folded into a general "parfum" or "aroma" entry.

Why a Single Essential Oil Can Trigger Multiple Declarations

This is the detail that catches natural and "clean beauty" formulators off guard most often. A complex natural essential oil lavender, bergamot, ylang-ylang is rarely a single chemical compound; it's a blend of dozens of naturally occurring constituents. Several of those constituents, plus their prehapten/prohapten conversions, can each individually cross the labelling threshold. A single essential oil used at a modest percentage can therefore require three, five, or more separate allergen declarations on your ingredient list, even though your label simply says "lavender oil" as the headline ingredient.

Compliance Timeline

If you're launching a new product now, the expanded list already applies to you in full. If you have existing stock or formulas already on the EU market, you have until mid-2028 to bring labelling into line but reviewing your formulas now, rather than waiting, avoids a scramble as the deadline approaches.

What to Actually Do About It

• Request updated supplier documentation. Ask fragrance and essential oil suppliers to confirm their declarations against the expanded 82-substance list, not just the original 26.
• Re-screen every fragrance-containing formula, including ones that were fully compliant before 2023, since several newly added substances appear in common natural ingredients.
• Update your Product Information File and ingredient list documentation to reflect the current Annex III, not an archived version.
• Revise your printed ingredient list to include any newly triggered allergen declarations above threshold, in the correct INCI terminology.
• Don't assume synthetic-only formulas are unaffected several of the newly added entries are synthetic fragrance compounds too, not just natural extracts.

How This Connects to Your Wider Labelling Compliance

Fragrance allergen declarations are one specific element within the broader ingredient list requirement we've covered in our guide to cosmetic product labelling requirements  getting the allergen list right doesn't replace the need to get the rest of the mandatory label content correct too.

Frequently Asked Questions

Has the compliance deadline for new products already passed?

Yes. The deadline for new cosmetic products placed on the EU market was 31 July 2026. Any new product entering the market now must already comply with the expanded allergen list.

Do the concentration thresholds for declaring allergens change?

No. The thresholds remain 0.001% for leave-on products and 0.01% for rinse-off products, consistent with the original rules — what changed is the number of substances that count as declarable allergens, not the threshold itself.

Does this only affect synthetic fragrance ingredients?

No. The expanded list includes both synthetic compounds and a significant number of natural extracts and essential oil constituents, so natural and "clean beauty" formulations are affected just as much as synthetic fragrance blends.

What happens if my product already on the market isn't updated by 2028?

It would fall out of compliance with the Cosmetics Regulation's labelling requirements once the transition period ends, so it's worth planning the label update well ahead of the 2028 deadline rather than leaving it until the last stock runs out.

Final Word

This is one of the most consequential labelling changes the cosmetics industry has seen in two decades, and it affects natural and synthetic fragrance formulations alike. The practical risk isn't understanding the headline number it's assuming a formula that passed allergen review years ago is still fully compliant today without actually re-checking it against the current, expanded Annex III.

Need your formulas re-screened against the expanded allergen list? NestQual reviews fragrance allergen compliance as part of CPSR and labelling review services, so your products meet the current Annex III requirements, not an outdated version.

Get a CPSR for your product See the Complete Compliance Pack

Sources

1. European Commission, Commission Regulation (EU) 2023/1545 amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens — eur-lex.europa.eu
2. European Parliament and Council, Regulation (EC) No 1223/2009 on cosmetic products, Annex III — eur-lex.europa.eu
3. Our guide to Cosmetic Product Labelling Requirements in the UK & EU
4. Cosmetic, Toiletry and Perfumery Association (CTPA), Safety of Cosmetics — ctpa.org.uk

This article is for general information and does not constitute legal advice. Always confirm current requirements for your specific product and market with a qualified safety assessor or Responsible Person.