EU fragrance allergen labelling: the substances and what the rules require

Why the list was expanded

Fragrance contact allergy is not a passing irritation. Recital 2 of the Regulation describes contact allergy as a life-long, altered reactivity of the immune system: once a person is sensitised, re-exposure to a much smaller amount of the allergen is enough to trigger allergic contact dermatitis. The Commission estimates that between 1 and 9% of the EU population is allergic to fragrance allergens.

The Regulation frames its purpose in two layers. Primary prevention protects the whole population from becoming sensitised in the first place, and for that a concentration restriction may be enough. Secondary prevention protects people who are already sensitised, and they can react below the maximum permitted levels. The only effective protection for that group is information: if an allergen is named on the label, a sensitised person can read it and avoid the product. That is the logic for individual labelling, and it is set out in recitals 3 and 4.

At the Commission's request, the Scientific Committee on Consumer Safety reviewed the evidence and adopted its opinion SCCS/1459/11 at its plenary meeting of 26 to 27 June 2012. It confirmed that the allergens already listed in entries 45 and 67 to 92 of Annex III remained relevant, and it identified 56 further fragrance allergens that have clearly caused allergies in humans but carried no individual labelling requirement. Those 56 are what Regulation (EU) 2023/1545 adds.

The amendment also reaches substances that are not themselves the allergen. Recital 7 treats prehaptens and prohaptens, substances that convert into known contact allergens through air oxidation or metabolic bioactivation, as equivalent to the allergens they become. This is why several of the terpene entries carry a peroxide value limit: it is the oxidation products, not the fresh material, that sensitise.

The legal mechanism

The Regulation is made under Article 31(1) of Regulation (EC) No 1223/2009, the safeguard that lets the Commission amend the annexes where a risk to human health is established. It amends Annex III, the list of substances that cosmetics may contain only subject to the restrictions set against them.

The labelling duty itself sits in Article 19(1), point (g), which requires the list of ingredients on the packaging. Perfume and aromatic compositions are normally declared collectively as "parfum" or "aroma". The allergens on this list are the exception: where one is present above its threshold, the collective term is no longer sufficient and the substance must also appear in the ingredient list under its own name. Before this amendment, 24 fragrance allergens were individually labelled in this way. The expanded list brings the total to around 80, the exact figure depending on how the grouped entries are counted.

The thresholds, and how to read them

An allergen must be named in the ingredient list once its concentration in the finished product exceeds:

• 0.001% (10 ppm) in leave-on products;
• 0.01% (100 ppm) in rinse-off products.

The figure that matters is the concentration in the finished product, not in the fragrance oil. An allergen present at 2% within a fragrance that is itself dosed at 1% of the formula is present at 0.02% in the finished product, which is above the leave-on threshold and below none of them. This is why a brand cannot assess its labelling from the formula alone: it needs the allergen breakdown of every fragrance and flavour from its suppliers, then multiplies through.

Three points of detail recur across the list. First, several entries are grouped: a family of related substances, or the several isomers and named constituents of an essential oil, share one entry and one label name. Where that applies, the Regulation states the single name to use, for example "Citral", "Rose Ketones", "Lemongrass Oil" or "Rose Flower Oil/Extract", and the threshold is tested against the combined concentration. Second, some entries carry a maximum concentration or a product-type restriction in addition to labelling. Third, the monoterpene entries carry a peroxide value limit, because their sensitising potential rises sharply as they oxidise.

The transition timeline

Regulation (EU) 2023/1545 was adopted on 26 July 2023, published in the Official Journal (L 188) on 27 July 2023, and entered into force on 16 August 2023. The compliance dates reflect the scale of reformulation and relabelling involved:

• 31 July 2026: products that do not meet the new requirements may no longer be placed on the EU market (a three-year window).
• 31 July 2028: non-compliant products already on the market may no longer be made available, that is, sold (a five-year window).

A related deadline sits alongside it: the updated EU Common Ingredients Glossary becomes mandatory from 30 July 2026, and several of the entries below specify which glossary name must be used on the label.

Substances that are banned, not labelled

Some former members of the fragrance allergen list are no longer labelled because they are prohibited outright, and they belong in Annex II rather than Annex III. Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC, the material once sold as Lyral), together with atranol and chloroatranol, the principal sensitisers in oakmoss and treemoss, were prohibited by Commission Regulation (EU) 2017/1410. Butylphenyl methylpropional (Lilial) was reclassified as a CMR substance and prohibited by Commission Regulation (EU) 2021/1902. These must not be present in a product placed on the EU market at all. Oakmoss and treemoss extracts themselves remain permitted and labelled, but must be of the low atranol and chloroatranol grade the prohibition requires.

The historic list: the substances already individually labelled

These are the fragrance allergens listed in entries 45 and 67 to 92 of Annex III before the amendment. Two, marked prohibited, are included for completeness; the remaining 24 are the figure the Regulation refers to as currently individually labelled.

The 56 substances added by Regulation (EU) 2023/1545

These are the new entries, 327 to 371 of Annex III. The label name is the Common Ingredients Glossary name to be shown in the list of ingredients; where an entry groups several substances under one name, that name is noted. CAS numbers and entry references are taken directly from the Regulation.

Existing entries that were tightened

Alongside the new substances, the amendment updated a number of existing entries, aligning their names to the glossary, adding isomers, and in these cases adding or revising a restriction beyond the labelling duty.

Great Britain has not adopted the change

This is a point of live divergence for any brand selling into both markets. Regulation (EU) 2023/1545 amends the EU Cosmetics Regulation only. Great Britain, governed since Brexit by the assimilated UK Cosmetics Regulation, has not adopted the 56-substance expansion, and continues to require individual labelling of the historic set rather than the additions.

Position as at June 2026. Great Britain has not adopted the 2023/1545 allergen expansion. The point needs care, because the UK has been amending its cosmetics annexes actively through 2026 on other matters: the prohibition of 4-Methylbenzylidene Camphor, a tranche of CMR substances, and tighter rules on formaldehyde releasers and certain salicylates. Some commercial sources have read those changes as bringing the 56 fragrance allergens into GB law. They have not. Because this is the kind of position that can move, confirm the live OPSS position before relying on it.

A single product sold in both the EU and GB therefore faces two different ingredient-list obligations. The pragmatic course for most brands is to label to the stricter EU standard across both, but that is a commercial and regulatory decision to take deliberately rather than by default.

What this means in practice

The work is rarely reformulation. For most products it is a recalculation and a relabel. The sequence is: obtain a full allergen declaration for every fragrance and flavour in the formula from the supplier, ideally aligned to Regulation (EU) 2023/1545; multiply each allergen's concentration in the fragrance by the fragrance's dose in the formula; compare the result against the leave-on or rinse-off threshold; and add any allergen above it to the ingredient list under the correct glossary name. Where a grouped entry applies, sum the members before testing. Where a peroxide value or maximum concentration applies, that becomes a specification on the raw material, not just a label question.

The safety documentation has to keep pace. The Cosmetic Product Safety Report and Product Information File should reflect the expanded allergen assessment, and where new allergens appear or levels change the Responsible Person may need to revisit the safety assessor's evaluation. We handle this as part of label and ingredient-list review and, for brands we represent, within the Responsible Person service. For the labelling rules in the round, see our guide to cosmetic labelling requirements.

Written by Allison Wild, Clinical Pharmacologist, MSc (University of Oxford). Substance data, thresholds and dates are drawn from Commission Regulation (EU) 2023/1545 and Regulation (EC) No 1223/2009. This page is a technical reference, not a substitute for a product-specific assessment.