Declaring fragrance allergens and staying inside IFRA limits in practice

The expanded fragrance allergen list under Regulation (EU) 2023/1545, the declaration thresholds, and how to read an IFRA certificate and an allergen data sheet.

Two pieces of paper decide whether a scented balm can be sold in the European Union. The allergen statement fixes what has to appear on the label. The IFRA conformity certificate fixes how much of the material you are allowed to use. They come from different places, answer different questions and neither one substitutes for the other. This page is the workflow: which document to ask for, how to read the category and the exposure assumption behind it, and what to do when a supplier has neither.

• Leave-on: 10 ppm
• Rinse-off: 100 ppm
• EU and Northern Ireland
• IFRA 51st Amendment
• Two documents, not one

The two documents that matter, and the three that do not

Most compliance failures at craft scale are not arithmetic errors. They are a maker holding the wrong document and believing it says something it does not. Suppliers send whatever they have, the files all carry logos and dates, and only two of them let you finish the job.

A safety data sheet is the one that wastes the most time. It exists because the material is a chemical being moved and stored, not because it is going on a lip, and a supplier who answers a request for an allergen statement by attaching an SDS has not answered it. A gas chromatography profile is genuinely useful, but only as raw material: someone still has to check each named constituent against the current Annex III list and each restricted constituent against the IFRA Standards Library. That mapping is the work, and it is why the declarable allergen list and the IFRA limits that bind inside essential oils are separate reference problems.

What an IFRA limit assumes about the dose

An IFRA restriction is a percentage in the finished consumer product, and the category is the reason one material can sit at 2% in one product and be prohibited in another. The category is not a description of the ingredient. It is a description of how much product reaches how much skin, how often, and whether any of it is swallowed.

The underlying quantity in dermal sensitisation risk assessment is dose per unit area, in micrograms of the substance per square centimetre of skin per application. That is why the categories rank the way they do, and the ranking is much steeper than it looks.

A body balm delivers the largest mass and the smallest dose per square centimetre. A lip product delivers roughly 27 times the dose per unit area of a body lotion, on a thin, frequently reapplied, partly mucosal surface, and a measurable share of it is eaten. Category 1 also carries a condition that has nothing to do with skin at all: the materials must be acceptable as flavouring ingredients, which is why many compounded fragrances carry no Category 1 figure whatever their skin data looks like. The flavour side of that problem is set out in lip balm flavour and sweeteners.

Rinse-off products sit at the other end because the assessment applies a retention factor: only a small fraction of what you apply stays on the skin. A cleansing balm designed to be emulsified and washed off is a Category 9 product with a rinse-off allergen threshold, while the same fragrance at the same percentage in a leave-on balm is a Category 5A product declaring at a tenth of the level. Category 5D, covering products marketed for babies, is tighter again, and the defensible fragrance level for that market is zero.

Reading the certificate without making the two common errors

Work down the certificate in a fixed order: the amendment it was written against, the material name and code, the date, then your category row. The 51st Amendment is the current set of Standards and a certificate issued against the 49th or 50th needs reissuing. A blank, a dash or "not supported" in your row is a prohibition for that use, not missing data. The line-by-line reading, including what a generic range-wide certificate is worth, is in fragrance oils in balms.

Two arithmetic errors then account for most of the rest.

The dilution error. The certificate figure applies to the finished consumer product, not to your fragrance phase and not to a predilution. If a compound is capped at 0.8% in Category 5A and you make a 10% solution of it in jojoba to help weigh small amounts, your finished balm may contain 8% of that solution, because 8% of a 10% solution is 0.8% of the compound. Makers routinely read the cap as applying to the bottle in their hand and lose a factor of ten in either direction. Do the conversion on paper, or use the essential oil dilution calculator, and record which number is which.

The blending error. Limits do not stack. Where two materials in your formula both contribute the same restricted constituent, the contributions add, and IFRA's summation rule requires that the sum of each material's concentration expressed as a percentage of its own limit stays at or below 100. Two fragrances each used at 60% of their permitted level is a fail, not a pass with margin. That rule bites hardest in a solid perfume, where the total fragrance load is high and the blend is complex.

Worked example: 0.8 percent lavender in a body balm

Take a body balm at 0.8% Lavandula angustifolia oil, filled into 50 g tins. Convert once at the start: 0.8% of the product is 8,000 ppm of lavender oil, and every constituent share is a fraction of that. The declaration threshold for a leave-on product is 10 ppm, so the question for each row is whether the constituent exceeds one eight-hundredth of the oil.

The ingredient list therefore ends with the oil and four constituent names. Three things in that table are worth taking away. The single largest constituent is not declarable, so label length says nothing about composition. Citronellol at 8 ppm is inside normal batch variation of the threshold, which means a different harvest of the same oil can change your label, and that is a reason to hold a supplier to a specification rather than to a one-off certificate. And two constituents present at only a few tenths of a percent of the oil still made the list, which is the general pattern above about half a percent of aromatic material.

Why the declaration threshold and the IFRA limit are a hundred times apart

Run the same formula against the restriction side and the picture inverts. Coumarin appears on the label at 16 ppm, while the Category 5A limit for coumarin is 0.38%, which is 3,800 ppm. The balm is using about four tenths of one percent of its allowance. Lavender oil has no IFRA Standard of its own, so nothing in this formula is close to a restriction at all.

Change the oil and the balance flips. Lemongrass at the same 0.8% carries roughly 70% citral, which is 5,600 ppm in the finished product against a Category 5A citral limit of 0.15%, or 1,500 ppm. That balm is non-conforming by nearly four times before anyone looks at the label, and in a lip product, where the citral limit is 0.11%, it is worse. The oils where the restriction binds first are the citral, eugenol and isoeugenol carriers and the expressed citrus peels, and they are individually tabulated in essential oils in balms, where phototoxicity from expressed citrus peel is a third and separate axis.

Chasing the data, and what to do when there is none

Ask before you buy, not after you have 5 kg of it. A usable request names the material and code, and asks for four things: the IFRA conformity certificate against the 51st Amendment with a numeric figure for your category, an allergen declaration written against Annex III as amended by Regulation (EU) 2023/1545, the percentage by weight of each listed substance with a stated limit of detection for the rest, and the issue date. A supplier who sells to cosmetic manufacturers has these as PDFs and sends them the same day.

Small distillers and farm-gate sellers frequently have neither, and that is where makers get stuck. The options, in descending order of sense:

1. Buy from a supplier who documents. Cheapest by a wide margin, and the reason documentation belongs in the sourcing decision rather than after it. Treat paperwork as a specification alongside price and origin, as in sourcing ingredients.
2. Commission a gas chromatography analysis. A GC-MS profile from a commercial laboratory gives you the constituent shares to calculate from. It costs more than the oil for a hobby quantity, it describes only the batch tested, and you still need someone to map the peaks to Annex III entries.
3. Use published composition ranges, and only defensively. Literature ranges for a species are wide, so they can tell you that lavender will declare linalool. They cannot tell you whether your batch crosses 10 ppm of citronellol. Your safety assessor may accept a range with a worst-case assumption; that is the assessor's call, not yours.
4. Reformulate. Substitute a documented material, or build the scent from the base itself. Unrefined cocoa butter, unrefined shea and yellow beeswax all carry character with no fragrance allowance and no allergen arithmetic, and the fully unscented route is set out in fragrance free balm.

What you cannot do is estimate and print. Without figures you cannot complete Part A of the safety report, and an assessor cannot sign Part B on a guess. The structure of that file is in safety assessment and the CPSR.

Getting the names onto the label correctly

Declarable allergens go in the list of ingredients itself, positioned by descending weight like any other ingredient, not in a separate warning box and not in a footnote. In practice they land at the end, because they are present at fractions of a percent, and ingredients below 1% may be listed in any order among themselves. The oil and its constituents both appear where the oil is itself a listed entry, which is why a lavender balm now shows the oil followed by a short tail of names.

Three practical points. Use the INCI name exactly as it appears in the annex entry, not a common name or a chemical synonym; the INCI list builder keeps the forms consistent across a range. Where the pack is too small for a full list, Article 19(2) allows the information to move to an enclosed or attached leaflet, tag or card, which is the normal solution for a lip tube. And a value sitting exactly on the threshold is a judgement call, because the condition reads "exceeds": declare it, and write down why. The full label anatomy is in labelling cosmetics in the EU, and how a buyer reads the result is in reading a balm label.

The dates, and what they mean for stock you already own

Regulation (EU) 2023/1545 set two deadlines and they do different jobs. Products not complying could be placed on the market until 31 July 2026, meaning first supply into the EU by the manufacturer or importer. They may be made available until 31 July 2028, meaning subsequent supply down the chain.

So a batch you first supplied to a stockist in June 2026 with an old label can lawfully be sold by that stockist until July 2028, and a batch you supply now cannot carry the old label at all. The consequences are mundane and worth planning: old artwork has to come out of circulation for anything newly supplied, printed label stock ordered against the 26-substance list is scrap for new production, and a stockist holding your product needs to know which batch codes are affected if a question arises. That is a traceability problem as much as a labelling one, and it is why the batch code links a label version to a production record, as set out in batch records.

The United States runs on a different footing again: "Fragrance" alone remains an acceptable declaration and the allergen labelling rule directed by the Modernization of Cosmetics Regulation Act is not finalised, so an American label for the identical balm carries far less information. See labelling cosmetics in the US.

The record that shows you did the work

Compliance is not a state, it is a file. For each scented product keep the supplier's IFRA certificate and allergen statement as issued, dated; your own calculation sheet showing the multiplication from constituent share to product percentage; a dated note of which Annex III consolidation and which IFRA amendment you checked against; the label artwork version and the date it went into use; and the batch codes made against each artwork version.

That set answers the two questions anyone will ever ask. An enforcement officer asks why a name is or is not on the label, and the calculation sheet answers it. A customer reporting a reaction asks what was in the tin they bought, and the batch code plus the artwork version answers that. Neither question is answerable from memory a year later. Where the file sits inside the wider pre-market obligations is set out in selling balms in the UK and EU.

What this page cannot settle for you

The decision rule is short. Get a current allergen statement, multiply each figure by your use level, declare everything above 10 ppm for a leave-on balm or 100 ppm for a rinse-off one, and separately check that no restricted constituent exceeds the IFRA figure for your category. If the supplier will not give you numbers, that is a sourcing decision, not a labelling one.

What cannot happen here is the certification itself. No reference page can certify your fragrance, issue an IFRA conformity statement or stand in place of one: those come from the party that knows the confidential composition, and only they can write them. Nor can any of this replace the signed safety report, where a qualified assessor evaluates the finished product and may land on a lower use level than the certificate allows. The categories in the table are the common cases and unusual products can be argued either way; where a classification is genuinely ambiguous, the tighter category is the defensible one and your assessor decides. And a compliant label is a composition statement, not a promise: it says nothing about oxidation state, nothing about materials outside the list, and nothing about whether a particular person will react. The limits of what this site can tell you are set out in the safety disclaimer.

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