The new EU fragrance allergen labeling rules (Reg. 2023/1545)

For years, cosmetic labels in the EU had to call out 24 specific fragrance allergens by name. That list has now expanded dramatically — to around 80 substances and groups. For any brand whose products contain fragrance, Regulation (EU) 2023/1545 means a wave of label changes, and a checking task far larger than before.

What changed

Fragrance allergen labeling in the EU sits within the Cosmetics Regulation (EC) No 1223/2009. Historically, a defined set of 24 fragrance allergens had to be declared individually in the ingredient list when present above certain thresholds. Regulation (EU) 2023/1545 amended the rules to greatly expand that set — adding many more individual substances and groups that must now be named.

The principle is unchanged: when a listed fragrance allergen is present above the relevant threshold, it must be declared by name so a sensitised consumer can identify it. What has changed is how many substances that principle now covers.

Why the thresholds still matter

The individual-declaration requirement is tied to concentration thresholds — the familiar distinction between leave-on and rinse-off products. Below the threshold, an allergen does not need to be named individually; above it, it does. The expansion of the list does not remove this logic, but it means the threshold check now has to be run against a much longer list of substances.

For a formula containing a fragrance compound, that means knowing which of the now roughly 80 listed allergens it contains, at what concentration each ends up in the finished product, and which therefore cross the threshold for individual declaration.

The transition timeline

Changes of this scale come with transition periods so brands can adapt. The regulation set timeframes for placing newly compliant products on the market and for selling through existing stock. The practical takeaway is that there is a window to update labels — but it is finite, and products that are not relabeled in time become non-compliant.

Because exact dates and transitional arrangements matter and can be subject to interpretation, confirm the current deadlines for your specific products and markets rather than relying on a general summary.

Where the information comes from

Most brands do not formulate their own fragrance — they buy a fragrance compound from a supplier, who provides an allergen declaration stating which listed allergens the compound contains and at what level. The expanded list means these supplier declarations themselves had to grow, and brands need the updated versions to know their true allergen picture.

An out-of-date supplier declaration is now a real risk: it may list only the old 24, leaving newly regulated allergens undeclared on your label.

Why manual checking does not scale here

Declaring fragrance allergens has always been fiddly. Expanding the list from 24 to around 80 multiplies the fiddliness. For each product, you now have to take the fragrance's allergen breakdown, calculate each allergen's concentration in the finished formula, compare it against the threshold for that product type, and add the ones that qualify to the ingredient list — in the correct INCI naming and position.

Across a range of products, each with its own fragrance load and product type, doing this by hand is slow and easy to get wrong. A single missed allergen is a labeling non-compliance.

Rolling allergens up from the formula

The sustainable approach is the same principle that handles food allergens: attach the allergen profile to the fragrance ingredient, and let the system roll it up across the formula automatically. When the fragrance carries its declared allergens and their levels, the finished product's allergen declaration can be calculated — applying the right thresholds for the product type — without anyone manually working through 80 substances.

When the regulated list grows again, as it has before, the work is to update the underlying data, not to re-derive every label by hand.

The takeaway

Regulation (EU) 2023/1545 expanded the EU's labeled fragrance allergens from 24 to around 80, with transition periods to relabel. The rule is the same — declare listed allergens above the threshold — but the scale of the checking is far larger, and it depends on current supplier allergen data. Rolling the allergen profile up from the formula, against the right thresholds, is what keeps the ingredient list compliant as the list keeps growing.

Lemoniq attaches allergen data to every ingredient — fragrance included — and rolls it up across the formula against the right thresholds, so your INCI list reflects the expanded allergen rules automatically. We solve this exact problem. See how it works