EU fragrance allergen labeling: the thresholds and the expanded list

Short answer: in the EU, 26+ named fragrance allergens must be listed individually in the ingredient list when they exceed 0.001% in leave-on and 0.01% in rinse-off products (Regulation 1223/2009, Annex III entries such as No 84 and No 88, labeling per Article 19(1)(g); consolidated 18.05.2026). Regulation (EU) 2023/1545 added further allergens to Annex III. The US has no allergen-specific labeling rule.

The numbers

Rule	EU	US
Leave-on labeling threshold	0.001% per named allergen	No allergen rule
Rinse-off labeling threshold	0.01% per named allergen	No allergen rule
Where it appears	In the ingredient list (Article 19(1)(g)), in order of concentration after the "parfum" entry rules	Fragrance may be declared as a single word, “fragrance” (21 CFR 701.3)
Example entries	Linalool (No 84), Limonene (No 88), Benzyl benzoate, Vanillin (No 346)	—

Details that decide most cases:

The threshold applies per allergen, not to the fragrance blend as a whole. Linalool at 0.002% in a face cream must be named even though the whole parfum is 0.3%.
Limonene carries an extra quality condition in its entry: a peroxide value below 20 mmol/L.
The classic list was 26 allergens; the 2023/1545 amendment added more named entries to Annex III (Vanillin, for example, is now entry No 346 in the consolidated text). Check every allergen against the current consolidated text, not an old summary.

US vs EU

A US label may declare all fragrance materials under the single word “fragrance”, and there is no federal allergen-threshold labeling rule for cosmetics (MoCRA directed FDA to set fragrance-allergen labeling requirements, but no such rule was in effect as of our last check — see the FDA MoCRA page for the current status). The same formula sold in the EU may therefore need a longer ingredient list: each allergen over its threshold gets its own name, in the ingredient order.

Common mistakes

Declaring only “fragrance” on an EU label. Named allergens over threshold must appear individually.
Applying the rinse-off threshold (0.01%) to a leave-on product. The leave-on threshold is ten times lower (0.001%).
Copying the old 26-allergen list from a pre-2023 blog post. The list has grown; the consolidated Annex III is the reference.
Thinking the allergen entry bans the substance. These are labeling triggers, not bans.

Sources

Regulation (EC) No 1223/2009, Annex III No 84, No 88 and No 346; Article 19(1)(g) — consolidated text 18.05.2026
Commission Regulation (EU) 2023/1545 of 26 July 2023 — eur-lex.europa.eu (its application dates are not covered by our snapshot; check the regulation text directly before relying on them)
21 CFR 701.3, ingredient designation — eCFR, issue 2026-11-06
FDA, MoCRA overview — fda.gov

Last verified: 2026-11-10. The application/transition dates of Regulation 2023/1545 were not verified against the regulation text — treat them as unverified until checked on EUR-Lex.

Not legal advice, and not a guarantee of compliance or of acceptance by any authority.

Want this checked against your own formula? Run the free label check. It flags allergens that cross the EU thresholds and rebuilds the ingredient list for the EU. It returns an issue list, not a print-ready label.