Fragrance allergens: the declarable list, the thresholds and what to do about it

The EU declarable fragrance allergen list has grown from 26 to over 80 substances. The 0.001 percent leave on threshold, the deadlines and the main offenders.

A fragrance allergen is a substance the EU makes you name on the ingredient list. It is not a banned material and the declaration is not a warning. The list grew from 26 entries to more than 80 in 2023, and because the duty attaches to the molecule rather than to where it came from, a balm scented with nothing but lavender oil now declares more allergens than one built on a compounded fragrance. This page gives the list, the two thresholds, the arithmetic that decides what goes on your label, and what patch test clinics actually record.

• Leave-on threshold 0.001% (10 ppm)
• Rinse-off threshold 0.01%
• 80 substances, 81 entries
• EU and NI, not GB
• Labelling duty, not a ban

What a declarable fragrance allergen actually is

Annex III of Regulation (EC) No 1223/2009 lists substances that may be used in cosmetics subject to conditions. Most entries set a maximum concentration. The fragrance allergen entries mostly do not: their condition is that the presence of the substance has to be indicated in the list of ingredients once it exceeds a stated concentration. Materials that are genuinely forbidden sit in Annex II, and a handful of fragrance materials carry both a concentration cap and a declaration duty.

Three consequences follow, and each one catches people out.

The duty is indifferent to origin. Linalool declares at the same threshold whether it arrived as a synthetic isolate, inside a compounded parfum, or as roughly a third of the lavender oil you bought from a small distiller. There is no natural exemption, and the point is elaborated in essential oils in balms. The declaration also goes in the ingredient list itself rather than in a separate box, positioned by weight like any other ingredient, which is why a scented balm label often ends with a short tail of names most buyers do not recognise. How that list is assembled and ordered is covered in INCI names explained.

Finally, the declaration is information for a small group, not a hazard notice. Someone already sensitised to geraniol needs to know that a product contains it. For everyone else the name carries no meaning, which is why "contains 12 allergens" reads as alarming and is not.

From 26 to 80: what Regulation (EU) 2023/1545 changed

The familiar figure of 26 was never 26 chemicals. Annex III entries 67 to 92, in place since Directive 2003/15/EC, covered 24 individually named substances plus two botanical extracts, oakmoss (Evernia prunastri) and treemoss (Evernia furfuracea). Regulation (EU) 2023/1545 adds 45 new entries covering 56 new substances, replaces 17 and deletes 10, which leaves 80 substances across 81 entries.

The additions fall into three groups, and only one of them is a surprise.

The first is aroma chemicals already in wide use: vanillin, menthol, camphor, carvone, salicylaldehyde, acetylcedrene, the damascones and damascenone among them. The second is balsamic and hive materials, including Myroxylon pereirae (balsam of Peru) extract and propolis extract, which matters to anyone who works with hive products and is discussed in propolis.

The third group is the one that reshapes craft labels. Whole essential oils are now named by INCI as declarable substances in their own right: lavender, peppermint, spearmint, eucalyptus, clove, ylang ylang, jasmine, rose, sandalwood, patchouli, geranium, cedarwood, bay laurel and turpentine, among others. Two entries in particular retire long-standing folklore. Lavender is covered including Lavandula angustifolia, so "true lavender does not need declaring" is false, and peppermint has its own entry. Tea tree does not appear, which is a labelling fact and not a safety endorsement.

The two thresholds, and what they look like on a bench

Leave-on products declare above 0.001%, which is 10 parts per million or 10 mg per kilogram of finished product. Rinse-off products declare above 0.01%, ten times looser. Both figures survived the 2023 amendment unchanged.

Put those into balm quantities and the tightness becomes obvious. On a 4.25 g lip tube, 0.001% is 0.043 mg. On a 54 g body balm tin it is 0.54 mg. Almost everything you can smell in a product is present well above that. The rinse-off threshold is only relevant to one balm category: a cleansing balm that is emulsified and washed off is a rinse-off product, so the same fragrance at the same percentage may be declarable in a body balm and not in a cleanser.

The test is one multiplication. Multiply the allergen's share of the scent material by the percentage of that material in your formula. Read the other way, it tells you how pure an allergen has to be in a fragrance before your use level makes it declarable.

The seven that account for most declarations

Eighty substances is a long list, but the same handful does most of the work, because they are the dominant constituents of the cheapest and most popular aromatic materials.

Two of those, linalool and limonene, appear in a clear majority of scented cosmetic products on the European market. That ubiquity is exactly why their oxidation chemistry matters more than their intrinsic potency.

Oxidation is what makes the allergen

Fresh linalool and fresh limonene are weak sensitisers. Their hydroperoxides are not. Air oxidation of the parent terpene produces hydroperoxides that are potent contact allergens, and it is those degradation products, not the material you bought, that most fragrance-allergic patients react to. This is why the standard patch test preparations are made from deliberately air-exposed material rather than from fresh.

The law recognises the mechanism as a specification rather than a concentration limit. Annex III entries 129 and 130 require terpenes and terpenoids to have a peroxide value below 10 mmol per litre, and entry 88 requires limonene to be below 20 mmol per litre. You meet those by adding an antioxidant at production and by controlling storage, not by using less of the material.

What drives the rate is mundane: dissolved and headspace oxygen, temperature, light and time. A half-empty 100 mL bottle opened weekly for a year is a different material at the end of that year from the same oil in a full, cold, dark, sealed bottle. Practical controls are to buy quantities you will finish inside a year, decant into smaller bottles as the level drops, refrigerate citrus and conifer oils, date every bottle on opening, and add roughly 0.1% BHT or mixed tocopherols to the fragrance phase at production. The wider mechanism is set out in rancidity and oxidation, the choice of antioxidant in vitamin E and antioxidants, and the sensory endpoint in essential oil smell turned.

Reading a supplier allergen certificate

Two different documents get confused, and you need both. An IFRA conformity certificate tells you the maximum percentage of that material you may use in each product category. An allergen declaration, sometimes called an allergen statement or allergen data sheet, tells you what is in it. Only the second one lets you write a label. How the first is read is covered in fragrance oils in balms.

A usable allergen statement has five things on it: the material name and a specification or batch reference, an issue date, an explicit statement of which version of Annex III it was written against, each listed allergen with its percentage by weight in the material, and a statement that the remaining listed substances are below a named limit of detection. Percentages given to two or three significant figures are normal. A statement that gives only "present" or "absent" is not enough to calculate with.

Three red flags are worth acting on. A statement covering only 26 substances was written against the pre-2023 annex and is out of date for the EU. A bare assertion that a material is "allergen free" with no figures and no limit of detection is not evidence. And an undated document tells you nothing, because annexes change. If a supplier cannot produce a current statement, you cannot complete an EU product information file, and the practical answer is a different supplier. What that file has to contain is set out in safety assessment and the CPSR.

Worked example: a lip balm at 0.5 percent lavender

Take a lip balm containing 0.5% Lavandula angustifolia oil, filled into 4.25 g tubes. The supplier's allergen statement gives the constituent shares. Multiply each by 0.5% and compare with 0.001%.

The ingredient list therefore ends with the oil and four allergen names: Lavandula Angustifolia Oil, Linalool, Limonene, Geraniol, Coumarin. Three points are worth taking from the table. The largest single constituent, linalyl acetate, is not declarable at all, so label length is a poor guide to composition. Coumarin lands exactly on the threshold, and since the condition reads "exceeds", a value on the nose is a judgement call that you should resolve by declaring and by recording why. And two constituents present at only a few tenths of a percent of the oil still made the label, which is the general pattern at use levels of half a percent and above.

Separately from labelling, several of these constituents carry concentration limits that bind hardest in lip products. Run the oil through the essential oil dilution calculator before you settle a use level, because a formula can be perfectly labelled and still over the limit.

What patch test clinics actually see

Fragrance is consistently among the top causes of allergic contact dermatitis from cosmetics in European and North American surveillance data. The figures below come from consecutively tested dermatitis patients, which is a selected population: these are people who already had a rash worth investigating, so the rates are far above the general population, where European studies put fragrance contact allergy at roughly 1 to 3%.

Two caveats keep these numbers honest. Fragrance mix II still contains hydroxyisohexyl 3-cyclohexene carboxaldehyde, a material the EU prohibited in cosmetics under Regulation (EU) 2017/1410 alongside atranol and chloroatranol, so a positive there reflects historic exposure rather than anything you could currently buy in a European product. And a mix result names a group, not a molecule: it takes testing with the individual constituents to identify what a person actually reacts to.

On a balm, sensitisation to a fragrance constituent usually presents slowly. On lips it appears as allergic contact cheilitis, with dryness, scaling and fissuring that get worse the more product is applied, which is the real mechanism behind the belief described in does lip balm dry your lips. Immediate stinging is a different problem, triaged in balm stings or burns. Home testing lowers risk without proving safety; the method is in how to patch test a balm.

Where the EU, GB and the US now stand

The EU transition dates have both partly passed. Products not complying with 2023/1545 could be placed on the market until 31 July 2026 and may be made available until 31 July 2028, so stock already in the distribution chain is still lawful while anything newly supplied is not.

Great Britain has not adopted the amendment. The GB Annex III stops at entry 325, which means a GB label declares the original set and an EU label for the identical balm declares up to 80 substances. Northern Ireland continues to follow EU law. If you sell in both places you can either run two labels or label everything to the EU requirement, which is legal in GB because declaring more than required is not an offence. The market-specific detail is in labelling cosmetics in the UK, and the practical workflow in fragrance allergen labelling.

The United States has no equivalent duty. "Fragrance" on its own remains an acceptable ingredient declaration, and the Modernization of Cosmetics Regulation Act directed the FDA to develop a fragrance allergen labelling rule that has not been finalised. Until it is, an American label carries far less fragrance information than a European one for the same product. See labelling cosmetics in the US.

Getting the allergen count down without going unscented

Declaring is cheap. Reducing genuine exposure is the useful goal, and there are four routes that work.

1. Choose materials whose main constituents are not on the list. Vetiver, sandalwood-free woods, frankincense and copaiba carry far less of the big seven than lavender or citrus. Ask for the allergen statement before you buy, not after.
2. Dose below the threshold where the arithmetic allows it. A material whose largest listed allergen is 0.2% of the oil is non-declarable below a 0.5% use level. A lavender oil at 30% linalool would have to drop to 0.003% of the formula, which is not a scent, it is a rounding error. Check which case you are in before assuming either.
3. Ask a fragrance house for a low-allergen compound. Compounders can build to a brief that keeps every listed substance under 0.001% at a stated use level. Get that statement in writing at your use level, not at theirs.
4. Let the base do the work. Unrefined cocoa butter at 15 to 25% brings real chocolate character with no fragrance allowance at all, and unrefined shea and yellow beeswax both carry their own scent.

The honest limits of a declaration

The decision rule is arithmetic, not judgement. Get a current allergen statement, multiply each figure by your use level, and name everything above 0.001% for a leave-on product or 0.01% for a rinse-off one. If a supplier will not give you figures against the current annex, you cannot label for the EU, and that is a sourcing decision rather than a labelling one.

What the declaration cannot do is worth being clear about. It is a labelling convention, not a no-effect level: a person sensitised to a potent allergen can react below 10 ppm, and the threshold was set to keep labels usable, not to mark the point where reactions stop. It says nothing about oxidation state, which is often the variable that decides whether a material provokes a reaction. It does not cover materials outside the list, so an unlisted sensitiser can be present with no trace on the label. And there is no published evidence tying the length of an allergen tail to consumer outcomes, so treat a long list as a description of composition rather than as a measure of risk. If a customer reacts to your balm, the label narrows the candidates and a dermatologist identifies the cause; nothing here is a substitute for that, as set out in the safety disclaimer.

Reviewed and updated 6 September 2026. Spotted an error? Tell us and we will fix and log it.