Understanding the EU Allergen List Expansion: What Fragrance Brands Need to Know
The EU Cosmetics Regulation has expanded the mandatory fragrance allergen disclosure list from 26 substances to 81. Here's what changes, when, and what to do about it.
For nearly two decades, the EU Cosmetics Regulation has required fragrance brands to declare 26 specific allergens on the product label whenever those substances exceed defined thresholds. That list — first published in 2003 and refined under Regulation (EC) No 1223/2009 — was familiar territory for anyone working in fragrance compliance. Linalool, citronellol, geraniol, limonene, and the other usual suspects.
That era is ending. Commission Regulation (EU) 2023/1545, published in the Official Journal in July 2023, expanded the list to 81 fragrance allergens. For the industry, this is the largest single change to fragrance labelling rules since the 26-allergen regime was introduced. Every brand selling into the EU/EEA needs to understand it.
What changed
The expansion adds 56 new substances to the existing 26. The new entries fall into three broad groups:
- Single chemical substances that have been identified as fragrance allergens by the SCCS in its 2012 opinion (SCCS/1459/11) — for example, acetylcedrene, 2-methoxy-4-methylphenol, and carvone.
- Natural extracts that are now individually listed — including jasmine absolute, cassia oil, and lemongrass oil. Previously, these were captured indirectly via their constituent allergens (linalool inside lavender, for example). Now several extracts are listed in their own right.
- Substance groups where related compounds are bundled — e.g. isomers of methylundecenal.
The new list also adds a few clarifications: some entries that were previously a single line (like "oak moss extract") are now split into more specific INCI names with their own thresholds.
When does it apply
The transitional periods are generous, but tight when you account for reformulation timelines:
- 31 July 2026 — last date to place on the market products that don't comply with the new list. After this date, any product manufactured for the EU/EEA must carry the expanded label declarations.
- 31 July 2028 — last date to make available on the market non-compliant stock. After this date, retailers cannot sell through old inventory.
In practice, that means brands need to be running new compliance assessments and updating labels through 2025 and into early 2026.
The thresholds haven't changed
The thresholds that trigger declaration are the same as the existing 26-allergen list:
- 0.001% (10 ppm) for leave-on cosmetics — fine fragrance, body lotion, face cream, lip products.
- 0.01% (100 ppm) for rinse-off products — soap, shower gel, shampoo, conditioner.
Where this gets complicated is in Natural Complex Substances (NCS). A leave-on body lotion at 3% dosage that includes 0.5% lavender oil contains roughly 0.075-0.135% linalool by weight (since lavender oil is typically 25-45% linalool). That's well above the 0.001% leave-on threshold — so linalool must be declared, even though "linalool" never appears on the formula sheet directly.
The expansion makes this calculation harder. Several of the newly listed substances are themselves found as constituents of common naturals. Carvone, for example, is the main constituent of caraway and dill oils, and a notable component of spearmint oil. Anyone using mint or caraway naturals needs to recompute their declarations.
What brands should do now
The work breaks into three streams:
1. Audit your existing portfolio. Run every formula through a compliance check that uses the expanded list. Anything currently flagged as "no allergen disclosures required" may need its label updated. Pay particular attention to natural-heavy compositions — these are where the new allergens are most likely to surface.
2. Update your label artwork pipeline. The new INCI declarations can add five or ten lines to a fragrance compound's label. Brands with tight artwork space (small bottles, sachets, lip products) may need to redesign before the 2026 deadline. Talk to your printer early.
3. Brief your suppliers. Fragrance houses are working through the same process. Ask them for updated allergen disclosures for every compound you buy, with the new list applied. If you're unsure whether your supplier has updated their data, request a fresh allergen sheet referencing Regulation (EU) 2023/1545.
Common misconceptions
We hear two recurring confusions:
"We're a UK brand, so this doesn't apply to us."
The UK has not formally adopted Regulation (EU) 2023/1545 at the time of writing. However, products placed on both GB and EU markets need to meet the EU rules for the EU side. The UK Office for Product Safety and Standards (OPSS) is widely expected to align with the new list — but no statutory instrument is yet in force. Watch the gov.uk consultation page if your range crosses both markets.
"If our formula tests below the threshold, we don't need to declare."
Correct — but the threshold is on the finished consumer product, not on the raw fragrance compound. A compound containing 5% linalool, used at 0.1% dosage in a body wash, contributes 0.005% linalool to the finished product. That's below the 0.01% rinse-off threshold and doesn't need to be declared. But the same compound used at 1% dosage in a leave-on serum contributes 0.05% — well above the 0.001% leave-on threshold.
The dosage level matters as much as the compound composition. This is exactly the calculation a compliance check should automate for you.
Looking ahead
The 2023 expansion is unlikely to be the last. The SCCS continues to assess fragrance ingredients and the Commission has signalled that further additions are possible if new evidence emerges. The smart approach is to build your compliance workflow around the assumption that the allergen list will keep growing — and to make sure you can re-check every formula in your portfolio when it does.
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