EU fragrance-allergen labelling is a formula-data and artwork-control task. Commission Regulation (EU) 2023/1545 expanded the substances that may require individual declaration and introduced transition periods. Brands should obtain an updated allergen breakdown for each fragrance and let the safety assessor determine the label from the finished concentration.
Apply the threshold to the finished cosmetic
The regulation uses declaration thresholds of 0.001% for leave-on products and 0.01% for rinse-off products. Fine fragrance is normally evaluated as leave-on. A percentage in the fragrance compound must therefore be converted through the compound dose in the finished product; copying the supplier sheet directly onto artwork can be wrong.
Understand the transition dates
Products that do not comply with the new restrictions may be placed on the Union market only until 31 July 2026 and made available only until 31 July 2028, subject to the regulation's conditions. A product launch or long packaging run after the first date needs artwork prepared for the expanded rules. Confirm the current consolidated Annex III rather than relying on an old “26 allergens” template.
Request usable supplier data
- Fragrance code and exact revision
- Allergen names and maximum concentrations in the compound
- Statement of the regulatory amendment or dataset used
- IFRA conformity for the correct finished-product category
- Change-notification commitment for reformulation
Control artwork by market and formula
Build the INCI list only after the formula and fragrance dose are locked. Review ingredient order, required allergen names, language and pack legibility with the Responsible Person. If one master carton serves several markets, verify that the combined text remains readable and legally correct in each destination.
What triggers a new review?
A fragrance revision, concentration change, second supplier, format extension or updated regulatory entry can change the declaration. Connect each artwork version to the formula and allergen file used to generate it. An IFRA certificate supports safe use within its scope but does not itself create the legal ingredient list.