Fragrance allergen labelling in cosmetics: the new rules under Regulation (EU) 2023/1545

Under Article 19(1)(g) of the EU Cosmetics Regulation, perfume and aromatic compositions are listed in the ingredient list as “parfum” or “aroma”. Substances that must be mentioned under the column “Other” in Annex III have to be named individually in addition. That way people who are allergic to a specific fragrance substance can see whether it is in the product.

Until the amendment this covered 24 fragrance allergens, listed in entries 45 and 67 to 92 of Annex III. Regulation (EU) 2023/1545 explains the extension by noting that sensitised people can react to concentrations below the permitted maximum levels and therefore need information on individual allergens.

In its 2012 opinion SCCS/1459/11, the Scientific Committee on Consumer Safety (SCCS) confirmed that the 24 allergens labelled so far remain relevant and identified 56 further fragrance substances that have clearly caused allergies in humans. The Regulation introduces an individual labelling obligation for them.

It also aligns the common names of the substances with the glossary of common ingredient names, groups similar substances in one entry, specifies which name is to be used in the list, and adds isomers as well as CAS and EC numbers. Formally it replaces 17 existing entries in Annex III, deletes some and adds new ones.

An allergen must be indicated in the ingredient list when its concentration in the cosmetic product exceeds 0.001% in products that stay on the skin or hair, or 0.01% in products that are rinsed off. What counts is the finished product, not the fragrance composition.

The concentration in the product follows from the share of the perfume or raw material in the formula and the allergen content of that raw material. The second figure usually comes from the supplier of the fragrance composition. Without current supplier information, the obligation cannot be assessed reliably.

The Regulation provides two transitional periods, which its recitals put at three and five years. Products that do not meet the new requirements could be placed on the Union market until 31 July 2026. Since 1 August 2026, every product newly placed on the market must carry the new labelling.

Products placed on the market before then may continue to be made available on the Union market until 31 July 2028. For some entries this applies only if they comply with the restrictions applicable on 15 August 2023. So there is still time to sell off existing stock, but not for new batches.

A leave-on body lotion contains 0.3% perfume. According to the supplier, the perfume contains 0.5% of one of the listed allergens. In the finished product that is 0.3% times 0.5%, i.e. 0.0015%. That is above 0.001%, so the allergen must appear in the list.

The same perfume is used at 1% in a rinse-off shower gel. In the finished product that is 0.005%, below the 0.01% threshold, so individual listing is not required there. The same composition can therefore lead to different labels depending on product type and dosage.

First, request current allergen information from all fragrance suppliers that covers the extended list. Second, calculate per formula and product type which allergens exceed the threshold. Third, update the ingredient list and artwork, using the names each entry prescribes.

Fourth, check which products were placed on the market after 31 July 2026 without the new labelling. Fifth, plan stock that must be sold by 31 July 2028. Sixth, check the safety report and the Product Information File for changes if formulas are reformulated as a result.

A development system that knows the composition of the raw materials can show the content of individual substances in the finished product per formula version and display regulatory notices on the raw material. Supplier information remains the basis. The decision on labelling is made by the responsible person.