A fragrance allergen declaration is arithmetic, not paperwork. Your fragrance supplier states how much of each listed allergen sits inside the fragrance compound; you multiply that by the percentage of compound in your formula, compare the result against 0.001% for leave-on products and 0.01% for rinse-off, and every substance that clears the line has to be printed by name in the ingredient list. From 31 July 2026 the EU list runs to roughly 80 substances instead of 24, which means most fragranced products placed on the EU market need a recalculated declaration and, very often, a new label. Ask your manufacturer for the allergen statement at your dosage before you approve artwork, not after.
Key takeaways
- The threshold applies to the finished product, not to the fragrance compound. A compound containing 6.5% linalool tells you nothing on its own. Dosed at 0.8% it puts 520 ppm of linalool in the product; dosed at 0.05% it puts 33 ppm. One is declarable in a rinse-off, the other is not.
- Allergens add up across every source in the formula. The duty attaches to the substance, not to the fragrance. Essential oils, botanical extracts and masking agents contribute to the same total, and a “naturally fragranced” product often carries the longest declaration on the shelf.
- The same fragrance produces two different labels. The leave-on threshold is ten times stricter than the rinse-off one, so a cream and a shower gel built from the identical compound at the identical dose can legitimately print different allergen lists.
- An IFRA certificate is not an allergen declaration. One tells you whether you may use the compound at that dose in that product category; the other tells you what to print. Suppliers routinely send the first when you ask for the second.
- Responsibility sits with the name on the pack. You can contract your supplier to provide accurate, current data, but in the EU and UK the responsible person answers for what the ingredient list says. Get the declaration reissued whenever the formula, the dose or the list changes.
What is a fragrance allergen, and what changed for 2026?
A fragrance allergen, in labelling terms, is a specific substance named in Annex III of the EU Cosmetics Regulation that must be declared individually in the ingredient list once it exceeds a set concentration in the finished product. It is a regulatory category, not a medical one. The list exists because contact-allergy data identified particular fragrance materials as frequent sensitisers, and because a consumer already diagnosed with an allergy to, say, isoeugenol cannot avoid it if the label says only PARFUM.
For nearly two decades that list contained 24 individual substances plus two natural extracts, oak moss (Evernia prunastri) and tree moss (Evernia furfuracea) — the set the industry still calls “the 26 allergens”. Commission Regulation (EU) 2023/1545 amended Annex III and expanded that set to roughly 80 entries, drawing on opinions from the Scientific Committee on Consumer Safety. It also tidied nomenclature, so several substances now have to be printed under a different name from the one on an older declaration, and it introduced group entries covering more than one isomer.
The transition runs on two dates. Products placed on the EU market from 31 July 2026 must carry a declaration built on the expanded list. Products already in the supply chain may continue to be made available until 31 July 2028. In practice that means new production and new artwork are on the 2026 clock, while stock sitting in a distributor’s warehouse has a longer runway. It does not mean you can keep printing the old list until 2028.
Two consequences matter commercially. The first is physical: a fragranced leave-on product that previously declared four allergens may now declare nine or twelve, and that block has to fit on the pack. The second is positional — a longer visible allergen list changes how a product reads to a cautious shopper, which is a real problem for anything marketed around gentleness. We looked at that specific tension in our piece on sensitive-skin claims and how they are substantiated.
Who has to give you the numbers, and what document are you asking for?
The numbers originate with the fragrance house that composed the compound, and they normally reach you through your manufacturer rather than directly. What you are asking for is an allergen declaration (also called an allergen statement or allergen certificate) for that specific compound, issued against the current Annex III list, stating the percentage of each listed allergen present in the compound — and, ideally, restated at your dosage in your finished formula.
That is a narrow request, and it is worth making it precisely, because at least five different documents get sent in response to it. Only one of them answers the question.
| Document | What it actually tells you | Who issues it | What to check | The objection you should expect |
|---|---|---|---|---|
| Allergen declaration | Which listed allergens the compound contains, and at what percentage | Fragrance house, usually forwarded by your OEM | The list version it was issued against, and whether percentages are stated in the compound or in the finished product — confusing the two is the single most common error | “This is the standard 26 declaration” — issued before the Annex III amendment and no longer sufficient for the EU |
| IFRA Certificate of Conformity | Whether the compound may be used at your dose, in your product category, under the IFRA Standards | Fragrance house | The amendment number it is issued against and the IFRA category used — the limit for a face cream is not the limit for a rinse-off cleanser | “It is IFRA compliant”, with no certificate, no amendment and no stated category |
| Full fragrance composition | The complete compound formula | Fragrance house, released under confidentiality | That your safety assessor can obtain it directly. You do not need to hold it yourself, and asking for it as a brand owner usually stalls the conversation | “That is proprietary” — which is legitimate; route the request to the assessor instead |
| Safety data sheet (SDS) | Hazard classification and handling information for the raw material | Fragrance house | That it is not being offered as a substitute. An SDS may name some allergens, but at chemical-hazard cut-offs, not cosmetic labelling thresholds | “The allergens are on the SDS” |
| Printed ingredient list | The exact INCI string your artwork must carry | Your OEM or regulatory adviser, from the declaration plus the formula | That allergen names match current glossary spelling and sit in the right order — a renamed substance printed under its old name is a re-print | “Just reuse the list from the last run” |
| Certificate of analysis | That the delivered lot matches specification | Fragrance house, via the filler | Lot number traceable to your production batch, so the declaration you printed maps to the material actually used | “We keep those internally” |
If you are unsure how to read what comes back, the conventions are the same ones covered in our tutorial on reading a cosmetic spec sheet and certificate of analysis, and the wider document set is listed in our checklist of documents to request from a manufacturer. Ask for all of it at quotation stage. A supplier who cannot produce a current allergen declaration for a compound they are already selling is telling you something about how recently they reviewed their raw-material file.
How do you calculate whether an allergen must be declared?
You multiply the allergen’s concentration in the compound by the compound’s concentration in your formula, then compare the result against the threshold for your product type: 0.001% (10 ppm) for products left on the skin and 0.01% (100 ppm) for products rinsed off. Anything at or above the threshold is declared by name; anything below it is not.
The worked example below uses one illustrative fragrance compound dosed at 0.80% — a realistic level for a scented face cream — and shows what the same compound at the same dose produces in a leave-on product versus a rinse-off one. The figures are constructed to demonstrate the arithmetic, not taken from a commercial compound.
| Allergen | % in compound (as declared) | In product at 0.80% dose | Leave-on (limit 10 ppm) | Rinse-off (limit 100 ppm) |
|---|---|---|---|---|
| Linalool | 6.50% | 520 ppm | Declare | Declare |
| Limonene | 3.20% | 256 ppm | Declare | Declare |
| Citronellol | 0.40% | 32 ppm | Declare | Below limit |
| Geraniol | 0.09% | 7.2 ppm | Below limit | Below limit |
| Coumarin | 0.05% | 4 ppm | Below limit | Below limit |
Three things fall out of that table. The cream declares three allergens and the cleanser declares two, from one identical compound — so a brand launching a matched set cannot assume a single ingredient panel covers both. Halving the dose to 0.40% would drop citronellol to 16 ppm, still declarable in the leave-on, while a dose of 0.10% would leave only linalool and limonene. And a substance sitting at 8 ppm is not comfortably below the line; it is one formula tweak away from crossing it.
The calculation is also cumulative. If the same cream contains 0.15% lavender oil, and that oil is roughly 30% linalool, it contributes a further 450 ppm of linalool — taking the total near 1,000 ppm even though the fragrance compound and the essential oil were sourced separately and quoted separately. The Annex III duty attaches to the substance wherever it comes from, which is why botanical extracts, plant oils, masking agents and some functional ingredients have to be swept into the same arithmetic. That is a good reason to have the calculation done by whoever holds the complete formula rather than assembling it yourself from supplier PDFs; if you are still deciding how much of the formula you control, our explainer on custom formulation in cosmetics manufacturing sets out where that responsibility usually lands.
The declaration is not a standalone exercise either. The same numbers feed the safety assessment, and a safety assessor will expect the allergen content to be consistent with what the ingredient list says. Our explainer on the cosmetic product safety report describes where that reconciliation happens, and the wider pre-production evidence set is covered in our checklist of product testing before a first batch.
Where does the declaration go, and what does it do to your artwork?
Declared allergens go in the ingredient list itself, using the name given in the EU glossary of common ingredient names, in addition to — not instead of — the entry for PARFUM or AROMA. Because almost all of them sit below 1% of the formula, they fall into the part of the list where ingredients may be given in any order, which is why they conventionally appear as a block at the end, after PARFUM.
The artwork consequence is usually underestimated. Going from four declared allergens to eleven can add sixty or more characters to an ingredient panel already set at the minimum legible size, and on small primary packs — a 15 ml serum, a lip product, a sample sachet — there may be no room to absorb it without moving the list to an outer carton, a leaflet or a tag. That is a structural packaging decision, not a typesetting one, and it has to be made before tooling and print files are committed. The mechanics of getting from a decision like that to a printable file are covered in our walkthrough of getting cosmetic packaging artwork print-ready, and the full set of mandatory elements competing for the same panel is in our checklist of packaging and label requirements.
Two sequencing rules save money here. Freeze the fragrance and its dose before you commission artwork, because any change to either invalidates the declaration and therefore the printed list. And leave deliberate slack in the ingredient panel — a panel laid out with no spare lines will need a redraw the first time a raw material is reformulated upstream. If you are also fixing durability markings and batch coding on the same pack, our explainer on shelf life, PAO and batch codes covers what else is competing for that space, and the underlying rules on how the list is constructed are in our tutorial on setting up cosmetic labels for compliance.
Which markets actually require what?
Only the EU requires the expanded list. Great Britain, the ASEAN markets and the United States each sit in a different position, and the gap between them is widening rather than closing — a change from the years when one European ingredient panel served most export markets.
| Market | What must appear | Threshold | Which list | Status, and what it means for artwork |
|---|---|---|---|---|
| European Union | Each listed allergen named individually in the ingredient list, in addition to PARFUM | 0.001% leave-on / 0.01% rinse-off | Annex III as amended by Regulation (EU) 2023/1545 — roughly 80 entries | Mandatory for products placed on the market from 31 July 2026; existing stock may be made available until 31 July 2028. Size the ingredient panel for the longest declaration you may need. |
| Great Britain | Same mechanism under the retained cosmetics regulation | Same two thresholds | The retained Annex III — GB does not automatically adopt EU amendments | Confirm the current GB list with the Office for Product Safety and Standards before committing GB-specific artwork. Many brands simply print to the EU list for both, which is permitted but produces a longer GB label than the law requires. |
| Northern Ireland | As EU | As EU | As EU | NI-destined stock follows the EU position even where GB diverges. Treat it as an EU pack, not a GB one. |
| ASEAN (Malaysia, Singapore, Thailand and others) | The 26 substances named in the ingredient list | 0.001% / 0.01% | ASEAN Cosmetic Directive Annex III | Shorter list. An EU-format panel is over-declared here rather than wrong, so a single EU-compliant label can normally be notified into ASEAN — confirm with the national authority, since member states differ on other label elements. |
| United States | No federal fragrance-allergen labelling requirement at the time of writing | — | — | MoCRA directs the FDA to establish fragrance-allergen disclosure requirements; the rule was not final as at August 2026. Separately, California’s Cosmetic Fragrance and Flavor Ingredient Right to Know Act requires listed fragrance allergens to be reported to the state, which is a filing obligation rather than a printing one. Design US artwork that can absorb an allergen block later. |
The practical read: build the declaration once, to the EU list, then decide per market whether to print it in full or trim it. Trimming saves label space but multiplies your artwork versions, your approval cycles and your chances of shipping the wrong carton to the wrong country. For most emerging brands, one panel built to the strictest market is cheaper than three panels built to three. The wider sequencing of a second-market launch is covered in our guide to expanding a beauty brand into the EU, UK and US.
What should your supplier commit to in writing?
An allergen declaration is only useful while it is current, and it stops being current without anyone telling you — a fragrance house reformulates a compound to secure a raw material, the percentages shift, and the label you printed six months ago is now wrong. The fix is contractual, and it is short. Put these six questions to your fragrance supplier and your manufacturer before the first production order, and put the answers in the supply agreement:
- Which version of Annex III is this declaration issued against, and on what date? A declaration with no issue date is not evidence of anything.
- Are the percentages given in the compound or in the finished product? Ask for both, restated at your actual dose, in writing.
- Will you notify us in advance of any change to the compound that alters the declaration? Advance notice is the whole point; notice after a batch has shipped is a recall conversation.
- Which IFRA amendment and which product category does the certificate cover? If your product moves category — a body oil reformulated as a face oil, for instance — the certificate may no longer support the dose.
- Who recalculates the declaration when we change the dose, add an extract or swap a supplier? Name the party and the turnaround time.
- How long will the declaration and the corresponding lot records be retained, and can we call for them? This is the same retention question that governs batch records generally, and it is best settled once for all documents.
Where you are still choosing between suppliers, the ability to answer these without a two-week delay is a reasonable proxy for regulatory maturity. Our directory of cosmetic OEM and private-label manufacturers is a starting point for building that shortlist, and our notes on quality-control practices in cosmetics manufacturing cover how the same documentation discipline shows up elsewhere in the relationship.
What goes wrong most often?
Most allergen-declaration failures are administrative rather than technical, and they cluster into a short list of recurring patterns.
- Percentages read at the wrong basis. Someone takes “linalool 6.5%” from the compound declaration and prints it as if the finished product contained 6.5%, or conversely applies the 0.001% threshold to the compound rather than to the product. The second error under-declares and is the more dangerous of the two.
- Naturals excluded from the calculation. The fragrance compound is assessed, the 0.2% of rose extract added for marketing reasons is not, and the total is understated.
- An old declaration reused after a reformulation. The formula changed, the fragrance dose moved from 0.8% to 0.5%, and nobody reissued the paperwork. The printed list is now over- or under-declared, and neither is defensible.
- A renamed substance printed under its previous name. The 2023 amendment adjusted nomenclature; a list copied from a 2022 artwork file will carry names that no longer match the glossary.
- Leave-on rules applied to a rinse-off product, or the reverse. Usually a copy-paste between two products in the same range. Applying the leave-on threshold to a cleanser is harmless but adds label clutter; the reverse is a compliance failure.
- The declaration held only by the factory. If a market authority asks the responsible person for it and the only copy sits in a supplier’s inbox, the delay itself becomes the problem. Keep your own copy of every version.
None of these is expensive to prevent and all of them are expensive to discover after a print run. The cheapest control is a single rule: the ingredient list is not final until the allergen declaration in your file is dated after the last change to the formula.
Frequently asked questions
Do I still write PARFUM if I declare the allergens separately?
Yes. PARFUM (or AROMA where the material performs a flavouring function) remains in the ingredient list, and the declarable allergens are named in addition to it, not in place of it. Removing PARFUM because you have listed its allergens is a common misreading and leaves the list incomplete. The allergen names conventionally appear as a block after PARFUM, since almost all of them fall below the 1% level at which order becomes free.
Does the threshold apply to the fragrance compound or the finished product?
The finished product. This is the error that produces most incorrect labels. A compound containing 3% of an allergen is not automatically declarable — dosed at 0.2% in a cream it contributes 60 ppm, which is declarable in a leave-on product but not in a rinse-off. Always ask your supplier to restate the declaration at your actual dosage rather than working from the compound percentages yourself.
Can a natural or essential-oil-only fragrance avoid the declaration?
No, and it frequently makes the declaration longer. The obligation attaches to the substance regardless of origin, and common essential oils are rich in listed allergens — lavender and bergamot in linalool and limonene, citrus oils in limonene, clove in eugenol. A product fragranced entirely with essential oils can carry a longer allergen block than an equivalent product using a synthetic compound designed to sit under the thresholds. If a short allergen list is a positioning requirement, say so at the brief stage so the compound can be built for it.
My supplier will only give me the 26 allergens. What should I do?
Ask in writing for a declaration issued against Annex III as amended by Regulation (EU) 2023/1545, with an issue date, and give a deadline tied to your artwork freeze. Most fragrance houses have reissued their portfolios; a supplier who cannot is either using a compound they have not reviewed or is not the originator. If the answer does not arrive, treat it as a sourcing signal rather than a paperwork delay — you cannot lawfully place the product on the EU market without it, and the deadline does not move.
Who is legally responsible if the declaration is wrong, my factory or me?
In the EU and UK the responsible person named on the pack answers to the authority, and for a private-label brand that is normally the brand owner or its appointed representative, not the contract manufacturer. You can and should place an obligation on the supplier to provide accurate, current data and to indemnify you for failures, but that is a contractual remedy between you and them; it does not move the regulatory obligation. Hold your own copy of every declaration, dated and matched to a formula version.
Sources and limitations
The EU position described here rests on Regulation (EC) No 1223/2009 and its amendment by Commission Regulation (EU) 2023/1545; the Commission’s cosmetics legislation portal is the entry point for the consolidated text and its annexes, and CosIng is the database for glossary names and Annex III entries. The scientific basis for the expanded list sits with the Scientific Committee on Consumer Safety. For Great Britain, enforcement of the retained regulation runs through the Cosmetic Products Enforcement Regulations 2013, with current guidance published by the Office for Product Safety and Standards. The ASEAN position follows the ASEAN Cosmetic Directive. For the United States, see the Modernization of Cosmetics Regulation Act of 2022 and the FDA Cosmetics Labeling Guide; for the California reporting obligation, the Cosmetic Fragrance and Flavor Ingredient Right to Know Act and the state’s designated fragrance allergen list. Use limits for fragrance materials by product category are set in the IFRA Standards. Good manufacturing practice for cosmetics is ISO 22716.
Limitations. The worked calculation is illustrative and constructed to demonstrate the arithmetic; the allergen percentages shown do not describe any commercial fragrance compound, and your own supplier’s declaration is the only valid input for your product. The count of “roughly 80” entries reflects the amended Annex III at the time of writing and should be read from the consolidated text rather than from this article. Regulatory positions diverge and change — the Great Britain list and the pending United States rule in particular were unsettled as at 28 August 2026, and national requirements within ASEAN differ on other label elements. We did not audit any manufacturer, fragrance house or laboratory in preparing this article. Confirm your own product’s position against the primary sources above, or with a qualified safety assessor or regulatory adviser in your destination market, before approving artwork. Last reviewed 28 August 2026.
This article is general information for brand owners, formulators and sourcing teams, not legal, regulatory or toxicological advice. Fragrance allergen labelling obligations differ by product type, market and formula and change over time — confirm your own product’s position with the relevant authority or a qualified adviser before placing it on any market.