Cosmetic Fragrance Allergen Labelling under EU Regulation 2023/1545
Get allergen declarations from fragrance suppliers, calculate finished-product levels and update labels before 31 July 2026.
In Short
- Leave-on: over 0.001%. Rinse-off: 0.01%.
- New placing ends 31 Jul 2026.
- Sell-through ends 31 Jul 2028.
Commission Regulation (EU) 2023/1545 amended Annex III of the EU Cosmetics Regulation (EC) 1223/2009 to extend the list of fragrance allergens that must be named on the label. A listed allergen must be indicated when its concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. Non-compliant products may be placed on the EU market until 31 July 2026 and made available until 31 July 2028. This guide covers how to prepare; it is orientation, not legal advice. Sources checked 4 Oct 2026.
What 2023/1545 changed
The amendment extended Annex III with additional fragrance substances whose presence must be indicated in the list of ingredients when their concentration exceeds set thresholds. The recitals explain this follows scientific advice on contact allergy.
More on what 2023/1545 changed
The thresholds are 0.001% in leave-on products and 0.01% in rinse-off products. Some entries also carry other restrictions, and a small number have different transition terms, so read each Annex III entry that applies to your fragrance rather than relying on a summary list.
Transition Dates
For most entries, products that do not comply may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028. Placing on the market is the first supply in the EU; making available covers later supply by distributors and retailers.
Transition dates (most entries)
- NowCollect declarations, calculate, update artwork
- 31 Jul 2026Last date to place non-compliant products on the EU market
- 31 Jul 2028Last date to make non-compliant products available
More on transition Dates
As of this check, the placing deadline is close. Plan label changes so that every batch first supplied in the EU after 31 July 2026 carries the updated ingredient list, and agree a sell-through plan for existing stock.
Get the numbers from the fragrance supplier
You cannot calculate allergen levels without the fragrance composition. Ask each fragrance supplier for an allergen declaration covering the full current Annex III list, stated as a percentage of the fragrance compound.
Worked example: serum CS-330 (leave-on, fragrance at 0.5%)
| Allergen in fragrance FR-12 | In fragrance | In product | Over 0.001%? |
|---|---|---|---|
| Allergen A | 1.2% | 0.006% | Yes: name on label |
| Allergen B | 0.15% | 0.00075% | No |
| Allergen C | 0.4% | 0.002% | Yes: name on label |
- Allergen A
- In fragrance
- 1.2%
- In product
- 0.006%
- Over 0.001%?
- Yes: name on label
- Allergen B
- In fragrance
- 0.15%
- In product
- 0.00075%
- Over 0.001%?
- No
- Allergen C
- In fragrance
- 0.4%
- In product
- 0.002%
- Over 0.001%?
- Yes: name on label
More on get the numbers from the fragrance supplier
Multiply by the fragrance inclusion rate in your formula to get the finished-product level, then compare with the leave-on or rinse-off threshold. Record the declaration version, the calculation and the person who checked it. Repeat when the supplier changes the compound or you change the dose.
Label Artwork and Change Control
Each product version needs a reviewed ingredient list. Treat the allergen update like any other label change: new artwork version, check against the calculation, approval by the responsible person or delegate, and a clear first-production date.
More on label Artwork and Change Control
Keep old and new versions so you can show which batches carried which list. If a product is sold in Great Britain too, check the UK version of the Cosmetics Regulation separately; this guide does not assess whether the UK has adopted the same amendment.
Where V5 fits and where people decide
V5 keeps supplier allergen declarations, formula versions, label artwork versions and batch records linked, with approval history. It does not calculate legal conclusions for you or decide whether a label complies.
More on where V5 fits and where people decide
Your responsible person, safety assessor and regulatory team decide on the allergen calculation, the wording and when a label is approved. When a complaint suggests an allergic reaction, your team decides on investigation and any serious undesirable effect reporting.
Questions
What are the thresholds for naming a fragrance allergen?
A listed allergen must be indicated when it exceeds 0.001% in leave-on products or 0.01% in rinse-off products.
Until when can non-compliant products be sold?
For most entries, they may be placed on the EU market until 31 July 2026 and made available until 31 July 2028.
Where do allergen figures come from?
From your fragrance supplier's allergen declaration multiplied by the fragrance inclusion rate in your formula, checked and recorded by your team.
Does this guide cover Great Britain?
No. Check the UK version of the Cosmetics Regulation separately; this guide does not assess whether the same amendment applies there.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global Cosmetics Regulatory Readiness: EU, UK, US, ISO 22716
Cosmetic Microbiological Quality (ISO 17516) Readiness Guide
Cosmetic Stability and Preservative Efficacy (ISO 11930)
EU Cosmetics Regulation 1223/2009: Responsible Person, Safety Report, PIF and CPNP
ISO 22716 Cosmetics GMP Guide: Structure, EU Role and Practical Controls
MoCRA Guide: US Cosmetics Registration, Listing, Adverse Events and GMP Status