Short answer
In the EU, cosmetic products — including perfume — must name certain fragrance allergens individually in the ingredient list when their concentration in the finished product exceeds 0.001% in leave-on products or 0.01% in rinse-off products. Commission Regulation (EU) 2023/1545 added 56 substances to that list. Products placed on the EU market from 31 July 2026 must comply, and products already on the market before then may be made available until 31 July 2028. This article explains the rule and the records it requires; it is not legal advice.
The rule in brief
Under the EU Cosmetics Regulation (EC) No 1223/2009, a fragrance is normally declared on the label simply as "parfum". The exception is a list of fragrance substances, in Annex III, whose presence must be indicated by name when they exceed a threshold:
| Product type | Threshold in the finished product | Equivalent |
|---|---|---|
| Leave-on (e.g. perfume, lotion) | above 0.001% | 10 ppm |
| Rinse-off (e.g. shower gel, shampoo) | above 0.01% | 100 ppm |
The thresholds apply to the substance in the finished product, from every source — including allergens naturally present in essential oils and other naturals. For a perfume, that means the allergen's level in the concentrate multiplied by the concentrate's dosage.
What Regulation 2023/1545 changed
- 56 additional substances must now be labeled individually, on top of those already listed.
- Some entries were grouped. Certain substances are declared under one collective name; the isomers geranial and neral, for example, are declared as "Citral".
- Names and identifiers were updated to align with the Commission's ingredient glossary, including CAS and EC numbers.
- Transition dates: products that do not comply may not be placed on the EU market from 31 July 2026; products placed on the market before that date may continue to be made available until 31 July 2028.
Secondary sources give slightly different totals for the size of the list after the change (often around 80), depending on how grouped entries are counted. Use the Annex III text itself, not a count.
Why it matters even for small batches
The thresholds are low. 0.001% of a finished perfume is 10 mg per kilogram. Many common fragrance materials and natural oils contain listed substances — linalool, limonene, citral, geraniol, eugenol and coumarin among the longer-established entries — so almost any perfume will have several to declare. In a leave-on perfume at 18% concentrate, a listed substance present at as little as about 0.0056% of the concentrate (0.001 ÷ 0.18) already reaches the threshold in the product.
How to calculate what to declare
- For each material in the formula, find the listed allergens it contains and their levels. For single chemicals that is usually the chemical itself; for naturals and purchased compounds, ask the supplier for an allergen statement.
- Multiply each allergen's level in each material by that material's pure share of the concentrate (its absolute %), and sum across materials.
- Multiply the total by the concentrate's dosage in the finished product.
- Compare with 0.001% (leave-on) or 0.01% (rinse-off). Anything above is declared by its Annex III name.
This is the same arithmetic as an IFRA check, with a different threshold and a different purpose — see how to check IFRA limits in a perfume formula for the method, including diluted ingredients. Use the identifiers carefully: naming is one of the places errors arise, and fragrance material names and CAS numbers explains how to keep them consistent.
The original 26 allergens and where each typically comes from are listed in the fragrance allergens list; options for formulating with fewer declarations are in formulating to reduce declarable fragrance allergens.
Records to keep
- An allergen statement for every purchased compound and natural, from the supplier, dated.
- For each finished product: the calculation of each listed allergen's level, the version of the formula it was done for, and the resulting label declaration.
- A note of which version of Annex III you worked to, and a review when it changes.
- The label artwork that went with each formula version — a reformulation can change the declaration.
In the EU, these calculations belong in the product information file and support the safety assessment that the Responsible Person must hold before a product is placed on the market.
Beyond the EU
The rule applies to products placed on the EU market and, under the Windsor Framework, in Northern Ireland. Great Britain has its own Cosmetics Regulation; check the current GB position on the expanded list before assuming it matches — selling perfume in Great Britain covers the UK. In the United States, MoCRA requires FDA to issue rules on fragrance allergen labeling; at the time of writing (October 2026) we have not found a published rule, so check FDA's MoCRA page for current status.
The industry's own safety framework, which is separate from labelling, is explained in the IFRA Standards guide.
How these rules compare with those of other markets — and the topics that cut across them, from claims to shipping — is set out in perfume regulations by market.
Sources
- European Commission — Fragrance allergens labelling
- EUR-Lex — Commission Regulation (EU) 2023/1545
- EUR-Lex — Regulation (EC) No 1223/2009 on cosmetic products
Frequently asked questions
Does the rule apply to perfume sold in small quantities or by hand-made brands?
The Cosmetics Regulation applies to cosmetic products made available on the EU market, regardless of the size of the business. Perfume is a cosmetic product.
Is a declared allergen banned?
No. Labelling informs consumers who are sensitized to a particular substance. Some substances are also restricted or prohibited, which is a separate rule.
Do candles need allergen labelling under this rule?
Candles are not cosmetics, so the Cosmetics Regulation does not apply to them. Other EU rules, such as chemical classification and labelling (CLP), may — check with a regulatory specialist.
Written and reviewed by the RUŌOD Lab team. This article is general education about perfume formulation and record-keeping; it is not legal, regulatory or safety advice, and the examples are illustrations, not validated commercial formulas. How we write and check these guides.