Beauty

Fragrance allergens in cosmetics: what must be on the label

In the European Union a cosmetic must name individual fragrance allergens in its ingredient list once they exceed 0.001 percent in a leave-on product or 0.01 percent in a rinse-off one, which is 10 and 100 parts per million. A regulation adopted on 26 July 2023 added the 56 allergens a scientific committee had identified to the 24 already named, taking the total to 80: 45 new annex entries, 327 to 371, of which 21 are botanical oils and extracts, plus 12 older entries brought under the same duty. Products placed on the Union market after 31 July 2026 must carry the longer list, while older stock may still be sold until 31 July 2028, so 2 generations of label sit on the shelf at once.

What the law makes a label say

Every cosmetic made available in the European Union carries a list headed by the word ingredients, written in the common glossary names required by Article 19 of Regulation (EC) No 1223/2009. It runs in descending order of weight, but only to a point: everything below 1 percent may be listed in any order. Perfume and aromatic compositions and their raw materials are gathered under 2 words, parfum or aroma, so 1 term can stand for a mixture of many substances.

The named allergens are an exception carved out of that anonymity. Annex III of the same Regulation carries a column headed Other, which requires their presence to be shown in the ingredient list in addition to parfum once the concentration exceeds 0.001 percent in a leave-on product or 0.01 percent in a rinse-off one. A shower gel may therefore hold 10 times as much of a substance as a face cream before it has to be named.

Two things follow. The order of the fragrance names tells you little about quantity, since in an ordinary cream or shampoo they all fall in the zone below 1 percent that may be listed in any order. And a long tail of them means a more informative label, not a more allergenic product.

How 24 names became 80

The first list came from a committee opinion of 8 December 1999, which set out 26 fragrance substances with a well recognised potential to cause allergy, written into the annexes by the 7th amendment of the old Cosmetics Directive, 2003/15/EC. The 2 thresholds attached to them, 0.001 and 0.01 percent, were described at the time as a pragmatic administrative decision, because dose response data did not exist.

Two of the 26 have since been banned rather than merely labelled. Hydroxyisohexyl 3-cyclohexene carboxaldehyde, the most reported fragrance allergen of that period with more than 1,500 published cases, now sits in the prohibited annex as entry 1380, beside atranol and chloroatranol at 1381 and 1382, and 2-(4-tert-butylbenzyl)propionaldehyde is prohibited as entry 1666. That left 24 substances to be named, across Annex III entries 45 and 67 to 92.

The Scientific Committee on Consumer Safety reviewed the field on 26 and 27 June 2012, confirmed the existing list and identified 56 further fragrance allergens that had clearly caused allergy in people. Regulation (EU) 2023/1545 of 26 July 2023 carried them into the annex as 45 new entries, 327 to 371, several of which group related substances under 1 name, and as a duty added to 12 older entries. Operators got 3 years to change labels and 5 years to clear stock: products outside the new rules could be placed on the market until 31 July 2026 and sold until 31 July 2028.

How to read an ingredient list

Turn the pack over and find the block that starts with the word ingredients. In a cream or a shampoo the fragrance compound is 0.1 to 1 percent of the product and sits near the end of the list, while in an eau de toilette it can reach 30 percent. It begins with parfum or aroma, and everything around that word which reads like a chemical or a plant name is what you can act on.

The names you meet most often are limonene and linalool, the 2 most commonly used fragrance chemicals in cosmetics, along with citronellol, geraniol, coumarin, eugenol, benzyl alcohol, benzyl salicylate, benzyl benzoate, citral, hexyl cinnamal and alpha-isomethyl ionone. Since the 2023 amendment you also meet words most shoppers never read as perfume: menthol, camphor, vanillin, salicylaldehyde, amyl salicylate, terpineol and pinene, plus esters such as linalyl acetate and isoeugenyl acetate, named because skin can convert them into the allergen they derive from.

What the list cannot tell you is the dose: 0.002 percent and 0.9 percent look identical on the pack. Nor does it bind a product bought outside the Union, so the same formula can travel with a shorter list. If you know your allergen, read the list at every repurchase, because reformulation is silent.

An essential oil is a fragrance too

Botanical does not mean non-allergenic. The 2012 opinion classified 82 substances as established contact allergens in humans on clinical evidence alone, 54 single chemicals and 28 natural extracts. Of those, 12 chemicals and 8 extracts counted as of special concern, each with at least 100 published cases: oak moss, tree moss, ylang ylang, clove oil, jasmine, sandalwood, balsam of Peru and turpentine oil.

The 2023 amendment follows that logic. Entries 347 to 367 put 21 botanical oils and extracts under the same labelling duty as any synthetic aroma chemical, among them lavandin, peppermint, spearmint, lemon, bergamot, bitter orange, eucalyptus, geranium, patchouli, rose, cedarwood, bay laurel, narcissus, lemongrass and 2 kinds of cinnamon.

Age matters as much as origin. Limonene and linalool are weak sensitisers as they leave the still and become allergenic as they oxidise in air, which is why the committee suggested holding the oxidised fraction to 10 parts per million and why the new entry for pinene sets a peroxide value below 10 millimoles per litre. A bottle opened 2 years ago is not the product that was tested. The Shelf-Life Tracker and the guide to open jar symbols and shelf life cover that side.

What fragrance free and hypoallergenic mean in law

None of the 3 words shoppers rely on are defined in the Cosmetics Regulation. Article 20 says only that labelling must not imply characteristics a product does not have, and the Commission adopted 6 common criteria for claims in 2013: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision making. The detail sits in a technical document agreed by a claims working group, version of 3 July 2017, a best practice tool rather than binding law.

That document is blunt about scent. A free from perfume claim should not be used when a product contains an ingredient that exerts a perfuming function, whatever else that ingredient does. A claim of being free from allergenic or sensitising substances is not allowed at all, because a complete absence of the risk of an allergic reaction cannot be assured.

Hypoallergenic is a design aim, not a result measured on your skin. It may be used only where the product was designed to minimise its allergenic potential, the responsible person holds sound and statistically reliable data, and known allergens and allergen precursors are avoided, including substances classified as skin sensitisers of category 1, 1A or 1B. Unscented sits outside all of this, which is why the ingredient list beats the front of the pack.

When guessing should stop and patch testing start

Contact allergy is a lifelong change in the immune system, and once you are sensitised a much smaller amount provokes eczema, most often on the face, the armpits or the hands. That is why label reading matters at 0.001 percent: the substance you react to may be 1 of 80 names, or 1 of the many that stay under the threshold.

Patch testing is done in a dermatology department over 3 appointments in 1 week. About 50 common substances from the baseline series go on the back in discs roughly 1 cm across, taped in place for 48 hours, the first visit taking up to 2 hours. Bring the products you use, with the packaging showing the ingredient list. Testing is usually deferred in pregnancy and breastfeeding, with extensive eczema on the back, after a sunbed or sunbathing in the previous 6 weeks, after a steroid cream on the back within 72 hours, or on drugs that suppress the immune system.

The fragrance markers are mixtures, not single substances: fragrance mix I holds 8 substances at 1 percent each, fragrance mix II holds 6. In a Danish series of 12,302 patients, 10.6 percent reacted to at least 1 marker, and the reaction was judged clinically relevant in 71.0 percent of those positive to the first mix. See a doctor if a rash spreads, blisters or keeps returning after you change products.

Reading a label when scent is the suspect

Frequently asked

Does parfum on a label mean the product is perfumed?

Yes. Perfume and aromatic compositions and their raw materials must be shown as parfum or aroma, and a single word can stand for a mixture of dozens of substances. The named allergens printed beside it are part of that same compound, not extra additions.

Is a product listing limonene and linalool worse than one that does not?

Not necessarily. Those 2 are among the most widely used fragrance materials, and they appear only once they pass 0.001 percent in a leave-on product or 0.01 percent in a rinse-off one. A product with no allergen names may still contain fragrance substances below their thresholds, or substances that are not on the list of 80.

Can I rely on the word hypoallergenic?

It is not defined anywhere in the Cosmetics Regulation. The agreed guidance allows it only where a product has been designed to minimise its allergenic potential and the responsible person holds supporting data, and it states plainly that the claim does not remove the risk of an allergic reaction.

Are essential oils a safer choice for reactive skin?

The European scientific committee classified 28 natural extracts as established contact allergens in humans, 8 of them of special concern with at least 100 published cases each. The 2023 amendment puts 21 botanical oils and extracts under the individual labelling duty for exactly that reason.

Why do two similar products carry different allergen lists?

The 2023 rules apply to products placed on the Union market after 31 July 2026, and stock placed before that date may still be sold until 31 July 2028. Thresholds also differ by product type, so the same fragrance compound triggers naming in a face cream at 0.001 percent and in a shampoo only at 0.01 percent.

I react to perfumed products. What is the sensible next step?

Ask for referral to a dermatology department for patch testing rather than guessing, since about 50 substances from the baseline series are applied for 48 hours and read over 3 appointments in 1 week. Bring the products you use with their packaging, and mention pregnancy, recent sunbed use or steroid creams on the back, which can postpone testing.

Sources

• Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in cosmetic products · Official Journal text, read in full including the annex. Source of the 24 fragrance allergens previously listed in entries 45 and 67 to 92, the 56 additional allergens identified by the committee, the 45 new entries 327 to 371 (of which 347 to 367 are botanical oils and extracts) and the labelling duty added to 12 existing entries, the labelling thresholds of 0.001 percent in leave-on and 0.01 percent in rinse-off products, the peroxide value below 10 millimoles per litre for pinene, the estimate that 1 to 9 percent of the Union population is allergic to fragrance allergens, and the transition period of 3 and 5 years, with non-compliant products placed on the market until 31 July 2026 and made available until 31 July 2028.
• Regulation (EC) No 1223/2009 on cosmetic products, consolidated text of 1 May 2024 · Consolidated regulation with all annexes, searched and read for the labelling and claims articles. Source of Article 19(1)(g) on the ingredient list, the terms parfum and aroma, descending order of weight with ingredients below 1 percent in any order, Article 19(6) on common glossary names, Article 20 on product claims, and the prohibited annex entries 1380 to 1382 for hydroxyisohexyl 3-cyclohexene carboxaldehyde, atranol and chloroatranol and entry 1666 for 2-(4-tert-butylbenzyl)propionaldehyde. A text search of the whole consolidated version returns 0 occurrences of hypoallergenic, unscented and fragrance free.
• Scientific Committee on Consumer Safety, opinion on fragrance allergens in cosmetic products, SCCS/1459/11, adopted 26 and 27 June 2012 · European Commission committee opinion, 334 pages, read for the clinical and epidemiological chapters and the conclusions. Source of the 26 substances identified in the opinion of 8 December 1999 and their entry into the annexes by amendment 2003/15/EC as a pragmatic administrative decision, the 82 established human contact allergens (54 chemicals and 28 natural extracts, with 12 chemicals and 8 extracts of special concern at 100 or more reported cases), the composition and test concentrations of fragrance mix I (8 percent), fragrance mix II (14 percent), hydroxyisohexyl 3-cyclohexene carboxaldehyde (5 percent) and Myroxylon pereirae (25 percent), the patch test frequencies quoted in the table, the overall figure of 16.2 percent, the Danish series of 12,302 patients with 10.6 percent positive and 71.0 percent relevance, the general population figure of 1 to 3 percent, the fragrance compound at 0.1 to 1 percent of ordinary cosmetics and up to 30 percent of eau de toilette and eau de parfum, the oxidation of limonene and linalool with the 10 parts per million peroxide suggestion, and the general threshold of 0.8 micrograms per square centimetre.
• Technical document on cosmetic claims, agreed by the Sub-Working Group on Claims, version of 3 July 2017 · Best practice document of the working group on cosmetic products, read in full, expressly not legally binding. Source of the 6 common criteria, the rule that a free from perfume claim should not be used when a product contains an ingredient exerting a perfuming function, the statement that a free from allergenic or sensitising substances claim is not allowed, and the conditions attached to hypoallergenic, including the avoidance of known sensitisers and of substances in skin sensitiser category 1, 1A and 1B.
• British Association of Dermatologists, patient information leaflet on patch testing · Patient leaflet of the national dermatology association, read in full. Source of the practical description of patch testing: about 50 common substances in the baseline series, discs about 1 cm across taped to the back for 48 hours, 3 appointments in 1 week with up to 2 hours for the first, the instruction to bring products and their ingredient packaging, and the reasons testing may be deferred, including pregnancy and breastfeeding, extensive eczema on the back, sunbed use or sunbathing in the previous 6 weeks, steroid creams on the back within 72 hours and immune suppressing drugs.

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This guide is for general information. It does not replace advice from a dermatologist, physician or qualified practitioner, or an examination.