Fragrance allergens and EU cosmetic labelling rules explained
Fragrance allergens in EU cosmetics must be listed when concentrations exceed set thresholds. Check the 2026 and 2028 deadlines and US or UK rules.
In EU cosmetics, specified fragrance allergens must be declared individually when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. Commission Regulation (EU) 2023/1545 amends Annex III to Regulation (EC) No 1223/2009 and expands that duty. The act's recitals record 24 allergens already individually labelled, and 56 additional allergens identified by SCCS.
As of 31 October 2026, the EU's 31 July 2026 first-placement deadline has passed. Making products covered by the transition available has a separate deadline of 31 July 2028. Those are different market actions, and the permission depends on the relevant Annex entry. Check the United States, Great Britain and Northern Ireland separately. Do not assume the EU dates apply to these markets.
Which EU fragrance allergens must be listed?
Use the relevant Annex III entries, including corrected names, rather than a copied EU allergen list. Regulation (EU) 2023/1545 changes both the scope of individual declaration and the wording of some entries. A substance name alone does not show the conditions that apply.
The familiar search "26 fragrance allergens list" is what trips label reviews. Recital 5 describes 24 fragrance allergens, in entries 45 and 67 to 92 of Annex III, as already individually labelled. Recital 6 records that SCCS identified 56 additional fragrance allergens, which have clearly caused allergies in humans and which, before this act, had no individual labelling requirement. Those statements explain the change. They do not give a simple count of mandatory label names.
The act also groups similar substances in one entry. A substance, an Annex row and the name printed on a label are different counting units. Don't turn "56 additional allergens" into "56 new rows", or describe the rules as exactly 80 compulsory label names. The recitals explain the change. The Annex sets the requirements. This is a labelling rule, not a ranking of common cosmetic allergens.
For a label review, identify the entry that covers the ingredient, then read its required declaration name. Reconcile the supplier's description with the corrected entry rather than assuming the wording matches. Also read any conditions and transition footnotes on that entry. A historical count cannot replace that review.
Declaration thresholds for leave-on and rinse-off products
The Annex entries use these concentration triggers:
| Product type | Individual declaration trigger |
|---|---|
| Leave-on | Concentration exceeds 0.001% |
| Rinse-off | Concentration exceeds 0.01% |
Keep the word "exceeds". Swapping in "at or above" changes the trigger. Read the entry as well as the product category before you decide which declaration is needed.
These figures trigger ingredient declarations. They are not general maximum permitted concentrations. And the expansion is not a blanket ban on the listed fragrance ingredients. Other restrictions still need their own review. Recital 10 says operators should continue to apply existing restrictions during the transition.
Don't use the thresholds to claim that a product below them cannot cause allergy. The provision is about when specified ingredients must appear individually in the ingredient list. Keep that labelling question separate from claims about product safety.
What changed in July 2026, and what remains until July 2028?
The regulation entered into force on 16 August 2023. Entry into force did not end the transition. Its Annex footnotes allow designated products that do not comply with the new restrictions to be placed on the Union market until 31 July 2026 and made available until 31 July 2028, where the entry's conditions are met.
| Market action in the transition | Latest date |
|---|---|
| Placing products covered by the transition on the Union market | 31 July 2026 |
| Making those products available on the Union market | 31 July 2028 |
First placement and later supply are different actions. Don't substitute a manufacture date or an import order date for either one. The 2028 date does not extend the first-placement permission beyond July 2026.
Eligibility is a separate check. For specified amended existing entries, footnote (*2) requires compliance with the restrictions applicable on 15 August 2023. Footnotes (*1) and (*4) give the same transition dates for their designated substances. These are entry-specific permissions, not an exemption for every cosmetic product.
When you review stock, separate products already placed on the market from new first placements. Then read the transition on each relevant entry. A single "compliant until 2028" note drops the distinction that decides whether the permission applies.
Use the corrected ingredient names
The 11 November 2025 corrigendum corrects several ingredient names. For example:
- Entry 157 changes the parenthetical name from Damascone to Damascenone, so the substance name reads Rose ketone 4 (Damascenone). That corrected entry says the presence of the substance or substances is indicated in the ingredient list as "Rose Ketones" when their concentration exceeds the declaration triggers.
- Entry 364 adds Pelargonium Graveolens Oil and Pelargonium Graveolens Leaf Oil alongside Pelargonium Graveolens Flower Oil.
- Entry 365 adds Pogostemon Cablin Leaf Oil alongside Pogostemon Cablin Oil.
The corrected tables still use the 0.001% and 0.01% declaration triggers. Use these examples as a reason to open the corrected entries, not as a complete allergen list. Reconcile supplier allergen information against those entries before you sign off label names.
US fragrance labeling requirements need a separate check
FDA's fragrances in cosmetics page, dated 28 February 2022, says fragrance and flavor ingredients can be listed simply as "Fragrance" or "Flavor". Its allergens page also describes general declarations such as "fragrance" or "perfume".
That background does not settle the current allergen-specific position. FDA's MoCRA page, content current as of 29 October 2026, lists fragrance allergen labeling requirements among the regulations FDA must establish. The mandate on that page does not give an allergen list, a threshold or a compliance date.
For US perfume labeling requirements, check the applicable US provisions on their own. Don't copy the EU thresholds or transition dates into a US schedule. An older general page is not proof that no later allergen rule exists.
Separate Great Britain from Northern Ireland
The government's Great Britain cosmetics guidance covers England, Scotland and Wales. It was published on 4 October 2021. It identifies Regulation (EC) No 1223/2009, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, as the GB framework. It does not cover making cosmetic products available in Northern Ireland.
That publication date does not show whether GB later adopted the expanded EU list. OPSS also lists separate GB and Northern Ireland guidance. Establish the intended market before you approve a UK label. Then read the guidance and legal text that apply to its allergen requirements. Don't call the EU's July 2026 and July 2028 dates "UK deadlines".
ICCR describes its reports as consensus documents of its members at the time. An ICCR report is not a substitute for the legal text that governs a label in a particular market.
A practical fragrance allergen label review
For an EU review, use this sequence:
- Establish whether the product is leave-on or rinse-off.
- Reconcile supplier allergen information with the relevant corrected Annex entries.
- Check whether concentrations exceed the applicable declaration triggers.
- Review existing restrictions separately from declaration requirements.
- For transitional stock, read the entry's eligibility terms and separate first placement from later supply.
This is a practical review sequence, not a requirement to obtain a particular supplier certificate or use a prescribed software format. Keep the Annex wording beside the review rather than relying on a count-based checklist. RegAffairs AI has a public answer on fragrance allergen declarations.