How to make an EU allergen declaration for a perfume
By Omer Siton, founder of PerfuMate · Updated
In the EU a perfume's list of ingredients names the fragrance with one word, "parfum", and beside it every listed fragrance allergen whose concentration in the finished product exceeds 0.001 percent (0.01 percent in a product that is rinsed off). An allergen declaration is the working sheet behind that list: each allergen summed across the whole formula, as a share of the perfume in the bottle, and whether it crosses the line. Below are the rule, the arithmetic and a worked example computed by the same engine as PerfuMate's free calculator. This page is orientation, not legal advice.
What does the law require?
Regulation (EC) No 1223/2009 on cosmetic products requires a list of ingredients on the packaging (Article 19(1)(g)). Perfume and aromatic compositions and their raw materials are named by the term "parfum" or "aroma", and the substances that Annex III marks for mention are indicated in the list in addition to that term. For each fragrance allergen in Annex III the condition reads the same way: its presence must be indicated in the list of ingredients when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
The regulation defines a leave-on product as one intended to stay in prolonged contact with the skin, the hair or the mucous membranes. A perfume is leave-on, so the 0.001% threshold is the one that applies.
What changed with Regulation (EU) 2023/1545?
Commission Regulation (EU) 2023/1545 of 26 July 2023 amended Annex III: it replaced a number of existing entries, deleted others and added entries 327 to 371, extending individual labelling to further fragrance allergens, following an opinion of the Scientific Committee on Consumer Safety. Some are single chemicals, such as Linalyl Acetate, Vanillin and Tetramethyl Acetyloctahydronaphthalenes, the entry that covers Iso E Super's CAS number. Others are named natural oils and extracts, where the whole oil is the allergen: lemon peel oil, for one, is declared as Citrus Limon Peel Oil. For some grouped entries the regulation also sets the exact name to print. The long-standing allergens stay on the list: Linalool, Limonene, Citral, Coumarin, Geraniol, Eugenol and the rest. The allergen index shows which catalog materials carry each one.
When does the expanded list apply?
The regulation was published in the Official Journal on 27 July 2023. Under the footnotes to its entries, a cosmetic product that does not meet the new requirements could be placed on the EU market until 31 July 2026 and can be made available on that market until 31 July 2028; for some entries only if the product meets the restrictions that applied on 15 August 2023. So a perfume first placed on the EU market after 31 July 2026 has to carry the expanded declaration, and after 31 July 2028 a perfume that does not comply may no longer be made available there.
What are the rules for fragrance allergens in the US, Canada and the UK?
The US has no allergen labelling rule yet, Canada aligns its list with the EU's, and Great Britain, as of 6 October 2026, still applies its own older list.
- United States. A label may declare the whole fragrance as "fragrance" (21 CFR 701.3). The 2022 MoCRA law requires each fragrance allergen to be named on the label and leaves it to the FDA to decide, by regulation, which substances count; the FDA's regulatory agenda lists the proposed rule, "Disclosure of Fragrance Allergens in Cosmetic Labeling", but none had appeared in the Federal Register by 6 October 2026.
- Canada. From 12 April 2026, 24 fragrance allergens must be listed when above 0.001 percent in a leave-on product or 0.01 percent in a rinse-off one; from 1 August 2026 the list grows to 81 for new cosmetics, and existing products follow by 1 August 2028 (Health Canada).
- Great Britain. GB keeps its own copy of Annex III. On legislation.gov.uk, in the version in force from 15 August 2026, it carries the long-standing entries, such as Linalool and Farnesol, at the same thresholds, and none of the 45 entries the EU added as numbers 327 to 371, such as Linalyl Acetate or Vanillin. Northern Ireland follows the EU list.
- The science behind the EU list. The expansion follows an opinion of the Scientific Committee on Consumer Safety, adopted on 26 and 27 June 2012, which confirmed the allergens already listed and identified 56 more that had clearly caused allergies in people.
Read on 6 October 2026: FDA, MoCRA, regulatory agenda, RIN 0910-AI90, Federal Register search.
How is each share worked out?
For each allergen, three shares multiply and the results add up across the formula: the allergen inside each material, that material inside the concentrate, and the concentrate inside the bottle. A material that is itself on the list, a bottle of linalool or a lemon oil, counts at its full weight. A natural also counts through its composition, so the linalool inside a lemon oil joins the same linalool total as a bottle of linalool. A dilution counts at its strength: one gram of a 10% dilution is a tenth of a gram of the material, and its solvent carries no allergen. The sum is a share of the concentrate; multiplied by the concentration, it is the share of the finished perfume that the threshold is about.
What does a worked example look like?
A small formula of real catalog materials, weighed in grams. Every figure below comes from the calculator's own engine, which is held to the PerfuMate app's allergen arithmetic by exported test cases. The naturals count through the typical compositions in PerfuMate's catalog, listed beside them, and the tables round their figures the way the calculator prints them.
The formula, 10 g in all, to be bottled at 18%:
| Material | Weighed | What it brings |
|---|---|---|
| Lemon Essential Oil | 0.5 g | On the list itself, as Citrus Limon Peel Oil; and typically carries Limonene 66%, Citral 2.5%, Linalool 0.3% and Geraniol 0.1% |
| Linalool | 0.8 g | On the list itself, as Linalool |
| Hedione | 4 g | Nothing on the list |
| Iso E Super | 2.5 g | On the list itself, as Tetramethyl Acetyloctahydronaphthalenes |
| Coumarin | 0.2 g | On the list itself, as Coumarin |
| Ethylene Brassylate | 2 g | Nothing on the list |
The declaration the calculator writes for it: each allergen summed across the lines, its share of the concentrate, its share of the perfume at 18%, and whether that reaches 0.001%.
| Allergen | In the concentrate | In the perfume at 18% | Label |
|---|---|---|---|
| Tetramethyl Acetyloctahydronaphthalenes | 25.00% | 4.50% | Yes |
| Linalool | 8.02% | 1.44% | Yes |
| Citrus Limon Peel Oil | 5.00% | 0.900% | Yes |
| Limonene | 3.30% | 0.594% | Yes |
| Coumarin | 2.00% | 0.360% | Yes |
| Citral | 0.125% | 0.022% | Yes |
| Geraniol | 0.0050% | 0.0009% | No |
Two of those rows worked by hand:
- Linalool comes from the 0.8 g of Linalool, and 0.3% of the 0.5 g of Lemon Essential Oil, 0.0015 g. Together that is 0.8015 g in 10 g of concentrate, 8.015%; and 8.015% of a perfume at 18% is 1.4427% of the perfume. Over 0.001%: it goes on the label.
- Geraniol comes only from 0.1% of the 0.5 g of Lemon Essential Oil, 0.0005 g: 0.005% of the concentrate, over 0.001%. But the threshold is a share of the finished perfume, and at 18% it is 0.0009%, under 0.001%: Geraniol stays off this label.
For the label: Tetramethyl Acetyloctahydronaphthalenes, Linalool, Citrus Limon Peel Oil, Limonene, Coumarin, Citral.
Open this formula in the calculator (at 18%, the same table appears under the IFRA result).
Where does the composition come from?
- Your supplier's allergen declaration for the material, often called an allergen certificate or statement: the share of each listed allergen in the material as supplied. When you have one for your lot, build the label from it.
- A GC-MS analysis of your own batch, which measures what is actually in it.
- A typical composition from published data, as PerfuMate's catalog carries for its naturals. Good for seeing where a formula stands while you compose, not for printing: batches vary with origin, season and distillation, and a typical composition can list only the main constituents.
A single synthetic molecule is simpler: it is on the list or it is not. Bases and specialties are mixtures, and need their supplier's declaration like any natural.
What goes on the label?
The list of ingredients carries the carrier and the other ingredients, "parfum" for the fragrance, and the name of every allergen over the threshold. The list runs in descending order of weight; ingredients below 1 percent may follow in any order after those above it (Article 19(1)(g)). A perfume's list might read: Alcohol Denat., Parfum, Linalool, Limonene, Citral. How to label a perfume for sale covers the rest of the label: the responsible person, the batch code and the safety assessment.
What does "contains fragrance allergens" mean on a label?
It means that the substances named are on the regulatory list of fragrance allergens and are present above the labelling threshold, which for a perfume in the EU is 0.001 percent of the product. Regulation (EU) 2023/1545 gives the reason: people already sensitised to an allergen can react to amounts below the permitted maximum, so naming it lets them avoid the substance they are allergic to.
Three things the names do not mean. They are not a warning that the product is unsafe: a cosmetic has to be safe to be sold at all. They are not a full list, because an allergen below the threshold is not named. And "contains fragrance allergens" is not wording the regulation requires: what it asks for is the names themselves, in the list of ingredients beside "parfum". If you know you are allergic to one of them, the label tells you whether it is present above the threshold.
What are the common mistakes?
- Forgetting the allergens inside naturals. In the example, Limonene and Citral arrive only inside the lemon oil, and part of the Linalool with them; no line of the formula is named after them.
- Working on the concentrate instead of the finished product. The threshold is a share of the product as sold. In the example, Geraniol is over 0.001% of the concentrate and under it in the perfume, so it stays off the label; bottle the same concentrate stronger and the answer can change.
- Counting a dilution at its full weight. A gram of a 10% dilution is a tenth of a gram of the material, and the solvent that makes up the rest declares nothing.
- Treating unknown as zero. A natural or a base with no composition on file adds nothing to a calculation, which is not the same as containing nothing. Get its declaration; the calculator lists such materials as not fully counted.
- Keeping an old declaration. A new lot, another supplier, a different strength or one swapped material can move an allergen across the line. Redo the declaration for every version you sell.
Can a calculator do it?
The free IFRA calculator writes this declaration under every result: bring a formula as a file or a paste, enter the concentration, and read every declarable allergen as a share of the finished perfume, whether it reaches 0.001%, and the names for the label, ready to copy. It runs in your browser; nothing is uploaded. Check the names against Annex III and your suppliers' declarations before you print. In PerfuMate the same declaration sits on each formula's IFRA sheet and follows every change as you compose. Start a formula, free.
Which texts is this based on?
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59): Article 19(1)(g), Annex III and the preamble to Annexes II to VI. Commission Regulation (EU) 2023/1545 of 26 July 2023 amending it as regards labelling of fragrance allergens in cosmetic products (OJ L 188, 27.7.2023, p. 1): its recitals, its Annex and the footnotes to the Annex. Both read in their official texts on 6 October 2026: Regulation (EC) No 1223/2009 on EUR-Lex, Regulation (EU) 2023/1545 on EUR-Lex.