New Fragrance Allergen Labelling Requirements for Cosmetics in the EU
European regulations on cosmetic products and fragrance allergen labelling continue to evolve with the aim of providing consumers with greater transparency and information.
Regulation (EU) 2023/1545, which amends Regulation (EC) No 1223/2009 on cosmetic products, expands the number of fragrance allergens subject to individual labelling from 24 to 81 when present in a cosmetic product above the established thresholds.
This update is particularly relevant for cosmetic manufacturers, formulation specialists, regulatory affairs departments and companies working with essential oils, fragrances and aromatic ingredients.
When Must Fragrance Allergens Be Declared?
The new requirements maintain the established thresholds for the individual declaration of fragrance allergens:
✔ 0.001% in leave-on products
✔ 0.01% in rinse-off products
When substances subject to declaration are present in a cosmetic product above these levels, they must be individually identified in the ingredient list in accordance with the applicable regulations.
What Is the Relationship Between Essential Oils and Fragrance Allergens?
Essential oils are complex natural mixtures composed of various aromatic constituents. Some of the substances covered by EU fragrance allergen regulations may occur naturally in certain essential oils.
For this reason, the expansion of the fragrance allergen list is particularly relevant for companies using essential oils as raw materials in cosmetic formulations.
Cosmetic product manufacturers should assess their formulations and determine the labelling requirements applicable to each finished product according to its composition, concentration and intended use.
Which Companies Are Affected?
The regulatory update is particularly relevant for professionals across the cosmetic industry value chain, including:
✔ Cosmetic product manufacturers
✔ Laboratories and formulation developers
✔ Regulatory Affairs departments
✔ Quality departments
✔ Essential oil manufacturers and suppliers
✔ Suppliers of fragrances and aromatic ingredients
✔ Distributors of raw materials for the cosmetics industry
For these companies, the evolving regulatory framework reinforces the importance of reviewing the raw materials used, product formulations and the information required to correctly determine the labelling of the finished cosmetic product.
Key Dates for the New Requirements
The new requirements apply to cosmetic products placed on the European Union market from 1 August 2026.
Products legally placed on the market up to 31 July 2026 may continue to be made available on the market until 31 July 2028, even if they do not yet comply with the new labelling requirements.
From 1 August 2028, cosmetic products made available on the market must comply with the new requirements established by the regulation.
An Important Change for the European Cosmetics Industry
The expansion of fragrance allergens subject to individual labelling represents a significant change for the European cosmetics industry and highlights the importance of manufacturers, formulators and regulatory affairs departments reviewing their products in line with the new requirements.
To determine the specific obligations applicable to each cosmetic product, we recommend consulting Regulation (EU) 2023/1545, the information published by the Spanish Agency for Medicines and Medical Devices (AEMPS) and, where appropriate, seeking specialised regulatory advice.
Official Sources
Spanish Agency for Medicines and Medical Devices (AEMPS)
Information on the new fragrance allergens subject to mandatory declaration.
Regulation (EU) 2023/1545
European regulations on the labelling of fragrance allergens in cosmetic products.