EU fragrance allergen rules take effect and more than triple disclosure list

The three-year transition period of EU Commission Regulation 2023/1545 closes today, and “natural beauty” positioned brands may face the sharpest consequences. Now, cosmetic products containing any of the 56 fragrance allergens added to Annex III of the regulation cannot be placed on the EU market unless each substance appears individually in the ingredient list when its concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off. 

Between 1% and 9% of the EU population is allergic to fragrance allergens, according to the European Commission. The requirements reach beyond fine fragrance, covering skin care, body care, shampoos, conditioners, shower gels, and any formula built on essential oils or aromatic botanical extracts.

The in-effect rules trace back to a 2012 Scientific Committee on Consumer Safety (SCCS) opinion. At the time, the SCCS confirmed that 24 fragrance allergens, then subject to individual labeling, remained relevant, and identified 56 more that had caused allergic reactions in humans but did not have a label declaration requirement. The commission acted on that advice in July 2023, adopting the amendment that takes full effect today. 

Today’s cutoff applies to newly placed cosmetics on the market. Companies have a two-year sell-through window for legacy stock. Products that were placed on the market before today can continue to be sold through distributors and retailers until July 31, 2028. 

Beauty brands selling in the EU no longer have any route to introduce non-compliant new batches, including imported goods and products sold online.

Essential oils must be named

A major challenge for formulators is that the new entries are not confined to single molecules. Alongside additions, such as menthol, vanillin, camphor, benzaldehyde, carvone, linalyl acetate, santalol, terpineol, and geranyl acetate, the regulation gives individual entries to a long list of botanical materials. 

The botanicals include lavender, rose, ylang ylang, bergamot, lemon peel oil, lemongrass, eucalyptus, clove, jasmine, peppermint, spearmint, geranium, patchouli, sandalwood, cedarwood, narcissus, bay laurel, and cassia and Ceylon cinnamon oils.The 56 additions take the EU’s declarable allergen list to around 80. 

Several of the listed ingredients must appear under a prescribed collective name rather than the name the supplier uses. Where a material has more than one INCI name, or where several related materials share an entry, the regulation prescribes a single name that must be used. 

For example, the three Cymbopogon oils in the entry are all declared as “Lemongrass Oil.” Rose oils and extracts — damask, cabbage, dog, and musk rose among them — are declared as “Rose Flower Oil/Extract.” True lavender and lavandin materials are declared as “Lavandula Oil/Extract.”

These distinctions put natural and clean-positioned products under pressure. A formula built on three or four essential oils can cross the threshold on several entries at once. The result may be a long, chemical-sounding ingredient list, which natural beauty brands built their positioning to avoid. 

Impact beyond the label

Reworking ingredient lists is only one step for beauty companies. Several of the new entries also set limits on the condition of raw materials.

Pinene must sit below a peroxide value of 10 mmoles/L, and limonene below 20. Peroxide value measures how far a material has oxidized, and terpenes (like those mentioned) become considerably more allergenic as they age and react with air. A fresh cosmetic batch and a degraded one can have varying sensitizing potential, even when the ingredient list reads the same.

This impacts cosmetic ingredient suppliers, as they must certify the specification. Meanwhile, brands have to keep oxidation in check across the product’s entire shelf life. 

The regulation applies the same logic to prehaptens and prohaptens. These are substances that can turn into known allergens once exposed to air or metabolized by the skin. The regulation treats them as equivalent to fragrance allergens and subjects them to the same restrictions.

Beauty brands must also update Product Information Files, and where labeling changes affect the notification, their Cosmetic Product Notification Portal entries.

A late correction could be missed

Companies that finished their label adjustments early may have one more thing to check. The commission published a corrigendum to the regulation in the Official Journal on November 11, 2025 — over two years after the original text, and with the same deadlines.

The update made three small amendments, each of which can change what has to appear on beauty product packaging. Lavender oil is among the botanicals now requiring individual declaration. 

Two of them widen the scope of botanical entries. Geranium oil previously covered only Pelargonium graveolens flower oil — it now also covers the plant’s oil and leaf oil. Patchouli previously covered only Pogostemon cablin oil — it now covers the leaf oil too. 

Brands using either material need to re-check their supplier declarations, because a fraction that fell outside the entry in 2023 may now fall inside it. 

The third amendment is a naming fix. One of the rose ketones was listed as Damascone and should have read Damascenone, a different compound. Labels carrying the original spelling need correcting.

Canada follows, Great Britain does not

Beauty brands with international portfolios have a second date to watch.

Starting tomorrow, new-to-market cosmetics in Canada must disclose the same 56 additional allergens at the same thresholds. Existing products on the market will follow by April 11, 2027. Health Canada adopted its fragrance allergen list directly from the EU’s Annex III.

Canada’s new labeling timeline holds despite Health Canada easing its notification requirements this March. 

Under the 2024 amendments to Canada’s Cosmetic Regulations, brands had to disclose the concentration of each fragrance allergen in the Cosmetic Notification Form (CNF) above the same thresholds the EU uses. Health Canada has since made that largely optional, with mandatory concentration disclosure now limited to allergens restricted under the Cosmetic Ingredient Hotlist. Allergens must still be listed in the CNF, and the obligation to declare them on the label is unchanged.

Great Britain has not adopted the EU and Canada’s expanded list. The UK Cosmetics Regulation still runs on the previous allergen list. However, Northern Ireland continues to follow EU rules. 

Brands supplying both markets face two different ingredient list requirements for the same formula. The UK’s Cosmetic, Toiletry and Perfumery Association has signaled alignment may follow, but has not committed to a date.