RegulationsEU · Cosmetics labelling
Lire en françaisHow many fragrance allergens must EU cosmetic labels list, and by when?
Checked against the legal texts on
The short answer
Commission Regulation (EU) 2023/1545 expands individual fragrance allergen labelling from 24 to 81 Annex III entries of Regulation (EC) No 1223/2009. Each listed allergen must be named in the ingredient list above 0.001% in leave-on products and 0.01% in rinse-off products. Non-compliant products could be placed on the EU and Northern Ireland markets only until 31 July 2026. Units placed on the market by then may be sold until 31 July 2028; Great Britain and US federal law have no equivalent labelling rule yet (California requires reporting, not labelling, of the EU-listed allergens).
At a glance
| Market | Requirement | Limit | Applies from | Legal text |
|---|---|---|---|---|
| European Union | Name each of the 81 Annex III fragrance allergen entries in the ingredient list when present above the threshold. | >0.001% leave-on; >0.01% rinse-off | Products placed on the market after 31 July 2026 | Regulation (EU) 2023/1545, Annex |
| European Union | Non-compliant units placed on the market by 31 July 2026 may be made available only until 31 July 2028. | — | Sell-through ends 31 July 2028 | Regulation (EU) 2023/1545, Annex, footnotes (*1), (*2), (*4) |
| European Union | Label grouped entries under the name the entry prescribes, e.g. 'Citral', 'Rose Ketones', 'Lavandula Oil/ Extract'. | — | Products placed on the market after 31 July 2026 | Regulation (EC) No 1223/2009, Annex III (consolidated 18 May 2026) |
| European Union | Respect new maximum concentrations by product type for Citral (entry 70) and Benzyl Salicylate (entry 75). | e.g. 0.6% Citral and 4% Benzyl Salicylate in fragrance products | 1 January 2027 (placing); 1 July 2028 (making available) | Regulation (EU) 2026/909, Annex, point (2)(a) |
| European Union | Respect new maximum concentrations by product type for Acetylated Vetiver Oil (entry 382), with the raw material stabilised with 1% alpha-tocopherol. | e.g. 0.9% in fragrance products; 0.05% in deodorants and make-up | 1 January 2027 (placing); 1 July 2028 (making available) | Regulation (EC) No 1223/2009, Annex III, entry 382 (consolidated 18 May 2026) |
| Northern Ireland | EU Regulation (EC) No 1223/2009 as amended applies under the Windsor Framework, so the EU list and dates apply. | >0.001% leave-on; >0.01% rinse-off | Products placed on the market after 31 July 2026 | OPSS, Regulation 1223/2009 guide: Northern Ireland |
| Great Britain | No equivalent adopted; the UK Cosmetics Regulation keeps only the original fragrance allergen entries in Annex III. | >0.001% leave-on; >0.01% rinse-off (original list) | No date set | Regulation (EC) No 1223/2009 as it applies in GB, Annex III |
| United States (federal) | MoCRA requires labels to identify fragrance allergens once FDA defines them by rule; no proposed rule published yet. | Not yet set | Not in force (proposed rule targeted November 2026) | FD&C Act § 609(b), 21 U.S.C. § 364e(b) |
| California | No labelling rule, but manufacturers of cosmetics sold in the state must report to CDPH each fragrance allergen listed in EU Annex III. | ≥0.001% leave-on; ≥0.01% rinse-off | EU timelines (2026 or 2028), per CDPH | California Health and Safety Code § 111792.6 (CFFIRKA), CDPH compliance FAQ |
Who must comply
The responsible person (Article 4 of Regulation (EC) No 1223/2009) must ensure each product's ingredient list meets Annex III.
Distributors must check that the ingredient list is present before supplying a product (Article 6(2)). They must not supply a product they believe is non-compliant (Article 6(3)).
The duty applies to any cosmetic containing a listed substance above the threshold, whatever its function. Allergens brought in by essential oils and botanical extracts count too.
What changes on the label
Before the amendment, 24 fragrance allergens in entries 45 and 67–92 of Annex III had to be named (recital 5). Today 81 Annex III entries carry that labelling condition.
The 57 newly labelled entries are 45 new entries (327 to 371) and 12 existing restricted entries. The Commission presents this as 56 additional fragrance allergens.
The thresholds are unchanged: above 0.001% in leave-on and above 0.01% in rinse-off finished products.
- New single substances include Linalyl Acetate, Menthol, Vanillin, Camphor, Benzaldehyde, Terpineol and Pinene (entries 327–346 and 368–371).
- New botanical entries cover oils and extracts such as lemon peel, lavender, peppermint, ylang-ylang, rose, jasmine and sandalwood (entries 347–367).
- Existing entries newly labelled include 6-Methylcoumarin (46), Turpentine (124), Peru balsam (154), Rose Ketones (157) and Methyl Salicylate (324).
- Grouped entries use one prescribed label name, e.g. 'Citral' for geranial and neral, or 'Lemongrass Oil' for three Cymbopogon oils.
- Isomers now sit inside their entry, e.g. d-, l- and dl-limonene under 'Limonene' (88) and cis/trans isomers under 'Isoeugenol' (73).
Timeline
The transition is set in footnotes to the amended Annex III entries, not in the articles. Where an entry already had limits, those limits stayed binding during the transition.
Regulation (EU) 2026/909 replaced entry 70 (Citral) in full. Its geranial and neral rows now carry that act’s transitional footnote (placing from 1 January 2027, making available from 1 August 2028) instead of the 2023/1545 footnote. This guide keeps 31 July 2026 for Citral labelling, the stricter reading.
- 26 July 2023: Regulation (EU) 2023/1545 adopted; published 27 July 2023 (OJ L 188, p. 1).
- 16 August 2023: entry into force, on the 20th day after publication (Article 2).
- 11 November 2025: corrigendum 2025/90876 corrects 'Rose ketone 4 (Damascone)' to 'Rose ketone 4 (Damascenone)' in entry 157 and adds INCI names to entries 364 and 365.
- 31 July 2026: end of the window for placing non-compliant products on the EU market.
- 1 January 2027: Citral, Benzyl Salicylate and Acetylated Vetiver Oil maximum concentrations apply to new placings (Regulation (EU) 2026/909).
- 1 July 2028: non-compliant Citral, Benzyl Salicylate and Acetylated Vetiver Oil products may no longer be made available (1 August 2028 for the geranial and neral rows).
- 31 July 2028: end of sell-through for non-compliant units placed on the market before the 2026 deadline.
Related restrictions and later amendments
Regulation (EU) 2023/1545 adds no Annex II bans. It only cross-refers to existing Annex II entries 450 (verbena oils) and 359 (Laurus nobilis seed oil).
It sets no new percentage limits. It merges existing entries, such as six damascone entries into Rose Ketones (157) and l- and dl-limonene into Limonene (88), keeping their limits.
Some entries gain isomers, so existing limits now cover more CAS numbers, e.g. cis-isoeugenol under the 0.02% Isoeugenol limit (entry 73).
The starting count is 24 rather than the historical 26 because two allergens were banned earlier.
- HICC, atranol and chloroatranol: Annex II entries 1380–1382 (Regulation (EU) 2017/1410). No placing from 23 August 2019, no supply from 23 August 2021.
- Butylphenyl Methylpropional ('Lilial'): Annex II entry 1666 under Regulation (EU) 2021/1902, applicable from 1 March 2022.
- Citral and Benzyl Salicylate: product-type maximum concentrations added by Regulation (EU) 2026/909, in force since 18 May 2026.
- Hexyl Salicylate, a fragrance ingredient outside the allergen list, is restricted under Annex III entry 380 from 1 May 2026 (Regulation (EU) 2026/78).
- Acetylated Vetiver Oil, also outside the allergen list: new Annex III entry 382 (Regulation (EU) 2026/909, renumbered by corrigendum 2026/90354). Maximum 0.9% in fragrance products, 0.05% in deodorants and make-up, 0.1% in other leave-on and 0.2% in rinse-off products; raw material stabilised with 1% alpha-tocopherol. From 1 January 2027 (placing) and 1 July 2028 (making available).
Northern Ireland, Great Britain and the United States
Under the Windsor Framework, Regulation (EC) No 1223/2009 as amended applies in Northern Ireland. The 81-entry list and the EU dates therefore apply there.
Great Britain has not adopted an equivalent rule. No GB cosmetics statutory instrument from 2022 to 2026 extends allergen labelling, and no OPSS consultation on it was found.
GB does adopt fragrance-ingredient limits on its own timetable, e.g. Hexyl Salicylate from 15 August 2026 (SI 2026/109).
In the US, MoCRA added section 609(b) to the FD&C Act. FDA missed the 29 June 2024 deadline for a proposed rule; the 2026 Unified Agenda targets November 2026 (RIN 0910-AI90).
California imposes a reporting duty, not a labelling rule. Under the Cosmetic Fragrance and Flavor Ingredient Right to Know Act (Health and Safety Code § 111792.6), manufacturers of cosmetics sold in the state must report to CDPH each fragrance allergen listed in EU Annex III. This applies at 0.001% or more in leave-on and 0.01% or more in rinse-off products, by the EU timelines (2026 or 2028, per CDPH).
What to do now and common pitfalls
The EU placing deadline has passed, so every unit placed on the market now must carry the expanded list.
- Get a breakdown of all 81 entries from each fragrance compound and essential-oil supplier.
- Recalculate each allergen in the finished product against 0.001% (leave-on) or 0.01% (rinse-off).
- Use the prescribed group name for grouped entries; listing each member INCI name instead is a common error.
- Check dates unit by unit: stock still held by the manufacturer on 31 July 2026 had not yet been placed on the market.
- Plan withdrawal of remaining non-compliant units before 31 July 2028; distributors must stop supplying them.
- Check Citral, Benzyl Salicylate and Acetylated Vetiver Oil levels against Regulation (EU) 2026/909 before 1 January 2027.
- Decide deliberately whether GB packs use the EU list or the shorter GB list.
Frequently asked questions
- Can we still sell products labelled with the old 24-allergen list?
- Only units placed on the EU market by 31 July 2026. They may be made available until 31 July 2028 and must then leave the supply chain.
- Do allergens from essential oils count toward the threshold?
- Yes. The condition applies to the substance's concentration in the finished product, whatever its source. Ask suppliers for the allergen content of each oil and compound.
- How should grouped allergens such as citral be labelled?
- Use the name the Annex III entry prescribes. Geranial and neral appear as 'Citral', and the damascones as 'Rose Ketones'.
- Did Regulation (EU) 2023/1545 set new concentration limits?
- No new percentage limits. It merged existing entries and added isomers, so existing limits can cover more substances. The Citral and Benzyl Salicylate limits come from Regulation (EU) 2026/909.
- Does Great Britain require the expanded allergen list?
- No. As of 26 October 2026, GB law has no equivalent of Regulation (EU) 2023/1545. Northern Ireland follows the EU list under the Windsor Framework.
- Is fragrance allergen labelling required in the United States?
- Not at federal level yet. MoCRA requires it, but FDA must first list the allergens by regulation. No proposed rule had been published by 26 October 2026. California does not require labelling, but manufacturers must report the EU Annex III fragrance allergens to CDPH.
Sources
- Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens (OJ L 188, 27.7.2023, p. 1)
- Corrigendum to Regulation (EU) 2023/1545 (OJ L, 2025/90876, 11.11.2025)
- Regulation (EC) No 1223/2009 on cosmetic products, consolidated text of 18 May 2026
- Commission Regulation (EU) 2026/909 of 27 April 2026 (Benzyl Salicylate, Citral, Acetylated Vetiver Oil and other substances)
- Corrigendum to Regulation (EU) 2026/909 (OJ L, 2026/90354, 5.5.2026)
- Commission Regulation (EU) 2026/78 of 12 January 2026 (CMR substances, Hexyl Salicylate)
- Commission Regulation (EU) 2017/1410 of 2 August 2017 (HICC, atranol, chloroatranol)
- Commission Regulation (EU) 2021/1902 of 29 October 2021 (Butylphenyl Methylpropional)
- European Commission, DG GROW: Fragrance allergens labelling
- OPSS: Regulation 1223/2009 and the Cosmetic Products Enforcement Regulations 2013, Northern Ireland (updated 29 June 2026)
- OPSS: Regulation 1223/2009 and the Cosmetic Products Enforcement Regulations 2013, Great Britain (updated 29 June 2026)
- legislation.gov.uk: Regulation (EC) No 1223/2009, Annex III, as it applies in Great Britain
- The Cosmetic Products Regulation (EC) No 1223/2009 (Restriction of Chemical Substances) (Amendment and Transitional Provisions) (No. 2) Regulations 2026, SI 2026/109
- 21 U.S.C. § 364e (FD&C Act § 609, labeling), as added by MoCRA
- Unified Agenda 2026: Disclosure of Fragrance Allergens in Cosmetic Labeling, RIN 0910-AI90
- FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- CDPH, California Safe Cosmetics Program: Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (SB 312)
- CDPH, California Safe Cosmetics Program: Compliance information and FAQ (EU fragrance allergens)
This page is general regulatory information, not legal advice. Rely on the legal texts linked above and on your own regulatory experts before making a compliance decision.