EU fragrance allergen labeling

What the rule actually says

Article 19 of the EU Cosmetics Regulation says a cosmetic sold in the European Union must carry a list of its ingredients. The fragrance itself does not have to be broken open: you write Parfum, and the formula behind it stays yours. That is the trade the regulation makes, and it is a generous one.

The exception is a list of fragrance materials known to cause allergic contact dermatitis in some people. Those have to be named individually, alongside Parfum, whenever they are present above a threshold. The reasoning is that somebody who reacts to a specific material has no way to avoid it if it is hidden inside a single word.

That list has just been rewritten, and it is the biggest change to fragrance labeling in twenty years.

The two thresholds, and what they are a percentage of

An allergen must be named when its concentration exceeds 0.001 percent in a leave-on product, or 0.01 percent in a rinse-off product. A perfume is a leave-on product, so the number that matters to most people reading this is 0.001 percent, which is ten parts per million.

Both figures are percentages of the finished product as sold. Not of the concentrate. This is the mistake that ruins more allergen declarations than any other, and it goes wrong in both directions.

Say you have an eau de parfum at 20 percent concentrate. A material sitting at 0.004 percent of your concentrate arrives in the bottle at 0.0008 percent, which is under the threshold and does not go on the label. A material at 0.006 percent of the concentrate arrives at 0.0012 percent, which is over, and does. Screen the concentrate directly against 0.001 percent and you will over-declare by a factor of five: a longer label, a more alarming one, and a claim about your product that is not true.

The reverse error is worse. Take a concentrate that was assessed for a 20 percent eau de parfum and use it at 100 percent as a perfume oil, and every figure quintuples. Materials that were comfortably under are now over, and the label is short by however many of them crossed.

The list was rewritten

Commission Regulation (EU) 2023/1545 rewrote the list, and it is far longer than the one it replaced. It is written as a list of amendments to Annex III, entry by entry, and that is how it is used: a product file is cross-referenced against the individual Annex III entry numbers and their CAS and EC numbers. Work from the entry and its identifiers, never from a material's name alone, because one entry can carry several botanical variants or a pre-hapten beside the parent allergen it turns into.

One thing about the old list is worth knowing, because it decides a material you may still have on the shelf. Two of the fragrance allergens on it have since been banned from cosmetics altogether rather than merely declared: HICC, which the trade knew as Lyral, and Butylphenyl methylpropional, which the trade knew as Lilial. A banned material needs no declaration threshold, so both moved out of Annex III and into the prohibited list. Neither is declared today, because neither may be used at all.

It is worth saying plainly, because it is the pattern behind this whole subject: a material can move from unrestricted, to declarable, to restricted, to banned. Farnesol and Lilial were both once ordinary working materials.

The naturals are now on the list, by name

Here is the part that changes the working day. The 2003 list was almost entirely single chemicals: linalool, geraniol, coumarin. If you worked with essential oils you declared their constituents, which meant you needed a composition for each oil, but the oil itself was not the thing being named.

Regulation 2023/1545 puts naturals on the list under their own INCI names, and the table below has all of them. These are not obscure materials. They are the natural perfumer's entire working palette.

The remaining 31 additions are single materials, and several of them are used at levels where the threshold is reached easily: vanillin, menthol, camphor, benzaldehyde, anethole, carvone, linalyl acetate, terpineol, santalol, methyl salicylate, amyl salicylate, geranyl acetate, alpha-terpinene, terpinolene, pinene, beta-caryophyllene and sclareol among them.

The consequence for anybody working with naturals is that a material can now reach the label by two routes at once. Lavender oil above 0.001 percent of the finished product is declared as Lavandula Oil/Extract. The linalool inside that lavender, summed with the linalool from everything else on the formula, is separately declared as Linalool if that total is also over. They are two entries and they are both true.

Grouped entries: sum first, then decide

Some entries cover more than one substance and are declared under a single name. Citral is the clearest case: the entry covers citral together with its two isomers, geranial and neral. What decides the label is the sum of all three, and what is printed is the group name, Citral. Declaring geranial and neral separately does not satisfy the entry. The rose ketones entry works the same way across eight related substances.

Handled one substance at a time, a grouped entry produces three figures that are each under the threshold, when the number the regulation actually asks about is over it. The entry, not the substance, is the unit of decision.

The two dates, and which one has passed

Regulation 2023/1545 was published in July 2023 and entered into force that August, with a long transition. It gives two dates, and they are two different acts rather than a deadline and an extension.

• 31 July 2026, now passed. A product that does not meet the new labeling could be placed on the Union market up to this date. From it, anything entering the market must comply. Placing on the market is the first supply into the EU, which for a maker is the moment the goods leave you.
• 31 July 2028. Stock that was already placed on the market before the first date may continue to be made available to the end customer until this one. It is a sell-through allowance for goods already in the chain, not a grace period for new production.

What that means today: if you are making and shipping now, the expanded list applies to you already. The 2028 date protects a retailer's existing shelf, not your next batch.

What actually goes on the carton

The declarable allergens are named in the ingredient list, using the INCI name from the regulation rather than the trade name you buy under. They sit alongside Parfum, which stays. Naming them does not oblige you to disclose anything else about the formula.

The ingredient list runs in descending order of weight down to 1 percent, and below 1 percent the order is free. Nearly every fragrance allergen is under 1 percent of a finished cosmetic, so in practice they are grouped at the end of the list after Parfum. What matters is that each one is there and spelled as the regulation spells it.

One practical warning about labels. The declaration is a consequence of the formula and the strength together, so a label printed for a 20 percent eau de parfum is not valid for the same juice bottled at 15 percent, and a print run ordered before the formula was finalized is a print run you may have to throw away.

Great Britain has not followed this

Great Britain did not adopt Regulation 2023/1545. It retains the shorter pre-2023 list, so a label built for the EU declares materials that GB law does not ask for, and a label built for GB is short of what the EU now requires. Northern Ireland follows the EU rules under the Windsor Framework, which means the phrase UK label has two possible meanings and it is worth being explicit about which one you mean.

Declaring more than a market requires is not itself a breach there, so a single label for both markets is possible. It is a decision to make deliberately, with the GB rules on language and legibility checked against the longer list, rather than something to arrive at by accident.

How Orris Bench handles this

Orris Bench produces the allergen declaration from the formula that was actually made, at the strength it was actually made at. The threshold is applied to the finished product, with the concentrate percentage taken into account, so the two conversion errors described further up this page cannot happen.

It counts an allergen by every route it arrives by: as a line of its own, as a constituent of a natural on the formula, and through a bench dilution where only part of what was weighed is material. Grouped entries are summed as entries and printed under the group name. The names come out in the form the regulation uses, ready for the ingredient list, alongside Parfum.

Where a formula holds something whose composition is not known, the declaration says which lines it could not see into rather than reporting a clean result that was only clean because nobody looked. It also flags the lines that sit close to the threshold, and the ones whose answer depends on whether solvent carried in from dilutions stays in the blend, because those are the two places a declaration changes from batch to batch.

The list is held by regulation rather than overwritten, so a batch labeled in 2025 against the old list still resolves against the old list, and its paperwork keeps making sense.

Sources

The entries, their numbers and their INCI names are taken from the EUR-Lex text of Commission Regulation (EU) 2023/1545 of 26 July 2023, which amends Annex III of Regulation (EC) No 1223/2009. The thresholds are Annex III column i of Regulation 1223/2009, applied under Article 19(1)(g). EUR-Lex texts are reproduced under the Commission's open data terms. This page is written for people who make fragrances and it is not legal advice; the Official Journal text is the authority and it is free to read.