EU expands mandatory fragrance allergen labels for cosmetics from 24 to 81 substances

Disclosure list expands from 24 to 81 allergens

The European cosmetics industry faces a major labeling deadline on August 1, 2026. From that date, cosmetics placed on the European Union market for the first time must meet the fragrance allergen disclosure requirements established by Regulation (EU) 2023/1545. The regulation expands the number of substances subject to individual declaration in ingredient lists from 24 to 81.

According to Interempresas, the change does not alter the concentration thresholds that trigger disclosure. A fragrance allergen must be named individually when its concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. The broader list means that manufacturers must reassess affected formulations even though the numerical thresholds remain unchanged.

The regulation is intended to help sensitized consumers identify ingredients that could cause allergic reactions. Its expanded scope covers not only individual aromatic compounds but also many essential oils, botanical extracts and other natural substances commonly used in perfumery and cosmetic formulations.

Natural ingredients fall within the expanded scope

The additional substances include ingredients derived from citrus fruits, such as bergamot, lemon and orange oils. The list also covers aromatic plants including lavender, mint, eucalyptus and bay, as well as flower-derived extracts and oils such as jasmine, rose, ylang-ylang and narcissus.

Other affected raw materials include derivatives of clove, patchouli, sandalwood and several pine and cedar species. New synthetic aromatic compounds used in fragrances are also covered. This breadth makes the regulation relevant to suppliers of natural extracts and fragrance compounds as well as finished-product manufacturers.

Companies must determine whether any of the newly covered allergens exceed the applicable threshold in each formulation. Where disclosure is required, they must revise ingredient lists and final packaging artwork. Interempresas reports that the work also extends to regulatory documentation, internal controls and coordination of existing inventory.

Market-entry date determines compliance

The Spanish Agency for Medicines and Medical Devices, or AEMPS, has emphasized that the decisive date is when each unit is first placed on the EU market, not when it was manufactured. This distinction will determine whether stock can use the previous labeling during the transition and will require companies to retain evidence showing when products entered the market.

Products placed on the EU market before August 1, 2026, may continue to be made available until July 31, 2028. From August 1, 2028, every cosmetic product sold in the European Union must comply with the expanded labeling requirements. The transition therefore gives companies two years to sell qualifying stock already placed on the market, but it does not permit newly introduced units to use the old labels after the 2026 deadline.

Manufacturers face a portfolio-wide review

The practical burden will extend beyond printing replacement packaging. Manufacturers and responsible persons must obtain adequate composition data, identify allergens in natural and synthetic fragrance materials, update regulatory files and align internal release procedures with the market-entry rule. Suppliers may also face more requests for detailed ingredient information so customers can determine whether declaration thresholds are exceeded.

The timetable makes inventory segmentation especially important. Companies will need to distinguish units introduced before August 1, 2026, from those introduced later, while ensuring that all products remaining in commercial channels comply by August 1, 2028. AEMPS has issued a questions-and-answers document to help the industry apply the new requirements.

For producers selling multiple formulas and package formats across the EU, the expansion from 24 to 81 allergens can create a large volume of artwork and documentation changes. Early formulation screening will show which products require revised labels and which remain below the thresholds, allowing manufacturers, fragrance suppliers and distributors to plan packaging orders and stock movements before the first deadline.