Fragrance allergens — new EU rules expand the list from 26 to over 80 substances

If you've ever turned over a bottle of perfume or a lotion and spotted names like linalool, limonene or citronellol at the end of the INCI list, you were looking at fragrance allergens — substances that EU law requires to be declared separately because they can trigger contact allergy. In 2023, the European Commission radically changed the rules of the game. Here's what you need to know.

The previous system: 26 allergens since 2003

The obligation to declare fragrance allergens on cosmetic labels was introduced by Directive 2003/15/EC (the so-called 7th amendment to the Cosmetics Directive 76/768/EEC) and subsequently transferred to Annex III of Regulation 1223/2009. The list covered 26 substances — 24 individual chemical compounds and 2 natural extracts (Evernia prunastri extract and Evernia furfuracea extract, i.e. oakmoss and treemoss).

The thresholds triggering the declaration obligation were:

• 0.001% (10 ppm) — for leave-on products such as creams, lotions and perfumes.
• 0.01% (100 ppm) — for rinse-off products such as shampoos and shower gels.

For two decades, this system served as the primary tool for protecting consumers allergic to fragrance substances. But science doesn't stand still — as early as 2012, the Scientific Committee on Consumer Safety (SCCS) had, in its opinion SCCS/1459/11, identified dozens of additional allergens in need of regulation.

Regulation 2023/1545 — a turning point after a decade of debate

On 26 July 2023, the European Commission adopted Commission Regulation (EU) 2023/1545, amending Annexes III and V to Regulation 1223/2009. This is the most significant change to fragrance allergen regulation in two decades. The key changes:

Expanding the list to over 80 substances

The new list covers 56 individual chemical substances and 28 natural extracts subject to the declaration obligation. The newly added allergens include, among others:

• Benzaldehyde — common in essential oils from bitter almonds.
• Carvone — the main component of spearmint oil.
• Damascenone and damascone (alpha-) — fragrance components with a rosy profile.
• Trans-anethole — characteristic of anise and fennel.
• Linalyl acetate — the dominant component of lavender oil.

The inclusion of natural extracts is particularly significant for the natural and organic cosmetics sector, which until now had benefited from the fact that many allergenic substances in extract form were not subject to a separate declaration obligation.

Changes to the declaration thresholds

Regulation 2023/1545 maintains the existing thresholds of 0.001% for leave-on products and 0.01% for rinse-off products, but extends their application to the newly added substances. For certain particularly potent allergens (e.g. atranol and chloroatranol from oakmoss), maximum concentrations have additionally been introduced — not merely a declaration obligation, but an outright ban on exceeding a defined level.

Transition periods — the implementation timeline

The European Commission has provided relatively long transition periods to give the industry time to reformulate products and update labels:

• From 31 July 2026 — new products placed on the market must comply with the new labelling requirements.
• From 31 July 2028 — products already on the market must be brought into compliance (i.e. products with "old" labels may no longer be sold).

This means that during the transition period (2026–2028), products with both "old" and "new" allergen declarations will be on the market simultaneously. Consumers should be aware of this — the absence of a new allergen on the label of a product bought in 2026 does not necessarily mean the substance is absent from the formula.

What does this mean for consumers with allergies?

Expanding the allergen list is good news for people with a confirmed contact allergy to fragrance substances. The concrete benefits:

1. Better allergen identification — more substances on the label make it easier to avoid the ones a patient reacts to (once confirmed by patch testing at a dermatologist).
2. Driving reformulation — some manufacturers will choose to remove problematic ingredients rather than declare them on the label, which will in effect reduce consumer exposure.
3. An end to "hiding" allergens in extracts — until now, a manufacturer could use lavender oil without declaring the linalyl acetate it contains. The new rules change this.

Impact on natural and organic cosmetics

Paradoxically, natural cosmetics may be more affected by the new rules than synthetic products. Essential oils — basil, lavender, citrus, mint — naturally contain many of the newly regulated allergens. The labels of natural products may grow considerably longer, and some formulas will require changes.

This does not mean that natural cosmetics are "worse" — fragrance allergens can be present in both natural and synthetic ingredients. What matters is the information on the label, which allows consumers to make an informed decision. Check product compositions in the PurScore search engine to see how many allergens your favourite cosmetic contains.

How to prepare?

If you have a confirmed contact allergy to fragrance substances:

• Update your list of substances to avoid with your dermatologist — the new INCI names may differ from the ones you know from your patch tests.
• Learn to read INCI lists — our guide to ingredient lists will help you understand what to look out for.
• Use the PurScore ingredient database to quickly identify the function and regulatory status of each ingredient.

The new rules come into force gradually, but it's worth getting familiar with them now, before full implementation becomes a reality in 2028.