EU fragrance allergens: which ones your cosmetic label must name, and from when

Fragrance allergens are perfume substances that can cause contact allergy. The EU Cosmetics Regulation, Regulation (EC) No 1223/2009Regulation (EC) No 1223/2009, Cosmetic Products RegulationThe whole regulationClick opens the law on the EU Publications Office., makes you name the listed ones in the ingredient list, so a person who is already allergic can avoid them (recital 4 of Regulation (EU) 2023/1545).

What Regulation (EU) 2023/1545 changed

Before 2023, Annex III to the Cosmetics Regulation named 24 fragrance allergens that had to appear in the ingredient list, in entries 45 and 67 to 92 (recital 5 of Regulation (EU) 2023/1545). Sellers often still call that list “the 26 allergens”. The Scientific Committee on Consumer Safety confirmed those 24 and identified 56 more that have clearly caused allergies in humans (recital 6). Regulation (EU) 2023/1545 introduces a labelling duty for them, with the same limits as the old list (recital 7). The Annex names 57 entries for the first time: 12 existing entries and 45 new ones.

It did this in three ways, all in Annex III (Annex to Regulation (EU) 2023/1545, points (1) to (3)):

• 17 entries replaced. Entries such as Citral, Limonene and Isoeugenol kept their labelling duty and gained isomers, CAS and EC numbers, and for some a set label name (recitals 8 and 9). Others that were already restricted, such as Turpentine, Methyl Salicylate and the rose ketones, gained the labelling duty for the first time.
• 10 entries deleted. Entries 125, 126, 158, 160 to 163, 165, 167 and 168 went, their substances grouped into other entries.
• 45 entries added, numbers 327 to 371: single substances and essential oils.

The Regulation entered into force on 16 August 2023, the twentieth day after its publication on 27 July 2023 (Article 2 of Regulation (EU) 2023/1545). Some fragrance substances are prohibited outright, not labelled: 3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC) and 2-(4-tert-butylbenzyl) propionaldehyde (CAS 80-54-6), entries 1380 and 1666 of Annex II. Atranol and chloroatranol, entries 1381 and 1382, are prohibited too. A product may not contain a substance listed in Annex II (Art. 14(1)(a)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 14, paragraph 1, point (a)Click opens the article on EUR-Lex.).

Which fragrance allergens must be named

The names below are the label names: the common ingredient name, or the name the entry itself sets for a group of substances.

Vanillin and Menthol are on the list. So are lavender, peppermint, lemon, bergamot, rose, clove and patchouli oils: a “natural” product scented only with essential oils is caught. No entry makes an exception for a substance that comes in through a natural oil.

Two of the old entries got new maximum concentrations in 2026, on top of the labelling duty. Regulation (EU) 2026/909 limits Citral (entry 70), for example to 0.6% in fragrance products and 0.032% in deodorants, and Benzyl Salicylate (entry 75), for example to 4% in fragrance products. A product that does not meet those limits may not be placed on the market from 1 January 2027, nor made available from 1 July 2028; for the two Citral isomers, Geranial and Neral, from 1 August 2028 (footnotes () and (*) to its Annex).

The limits: 0.001% leave-on, 0.01% rinse-off

Each entry reads the same way: “The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds: 0,001 % in leave-on products, 0,01 % in rinse-off products” (Annex to Regulation (EU) 2023/1545). 0.001% is 10 mg per kg of product; 0.01% is 100 mg per kg.

A rinse-off product “is intended to be removed after application on the skin, the hair or the mucous membranes”: shampoo, shower gel, soap. A leave-on product “is intended to stay in prolonged contact” with them: cream, lotion, perfume, deodorant, lip balm (Preamble to Annexes II to VI, point 1(a) and (b)).

The limit is measured in the finished product, not in the fragrance oil. Three worked cases:

At 1% fragrance oil in a leave-on product, any listed allergen above 0.1% of the oil is named. A product with no perfume and no listed substance needs none of this.

How fragrance allergens appear in the ingredient list

The list is headed “ingredients”. Perfume and aromatic compositions are named “parfum” or “aroma”, and the substances an Annex III entry requires are named in the list as well (Art. 19(1)(g)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 19, paragraph 1, point (g)Click opens the article on EUR-Lex.). Ingredients go in descending order of weight; those below 1% may follow in any order, so the allergens usually sit near the end:

Ingredients: Aqua, Glycerin, Cetearyl Alcohol, Parfum, Linalool, Limonene, Citral, Lavandula Oil/ Extract

Each name is the common ingredient name from the Commission’s glossary, or, where there is none, a name from a generally accepted nomenclature (Art. 19(6)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 19, paragraph 6Click opens the article on EUR-Lex., Art. 33Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 33Click opens the article on EUR-Lex.). That glossary takes account of the International Nomenclature of Cosmetic Ingredients (INCI). Where an entry groups several substances, it sets the one name to use: “Citral” for Citral, Geranial and Neral; “Rose Ketones” for the damascones; “Lavandula Oil/ Extract” for the three lavender species; “Pinus Mugo”, “Pinus Pumila”, “Cedrus Atlantica Oil/ Extract”, “Myroxylon Pereirae Oil/ Extract”, “Cananga Odorata Oil/Extract”, “Citrus Aurantium Flower Oil”, “Citrus Aurantium Peel Oil”, “Lemongrass Oil”, “Eucalyptus Globulus Oil”, “Eugenia Caryophyllus Oil”, “Jasmine Oil/Extract”, “Juniperus Virginiana Oil”, “Narcissus Extract” and “Rose Flower Oil/Extract” (Annex to Regulation (EU) 2023/1545).

The list may be on the outer packaging alone (Art. 19(1)(g)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 19, paragraph 1, point (g)Click opens the article on EUR-Lex.). Where the longer list cannot fit, it goes on an enclosed leaflet, label, tape, tag or card, referred to on the pack by the symbol of a hand pointing to an open book (Art. 19(2)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 19, paragraph 2Click opens the article on EUR-Lex., Annex VII point 1). For soap, bath balls and other small products where even that is impossible, it goes on a notice right next to the container the product is displayed in (Art. 19(3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 19, paragraph 3Click opens the article on EUR-Lex.).

When the new labelling applies

“Making available” is any supply in the EU in the course of a commercial activity, paid or free. “Placing on the market” is the first making available (Art. 2(1)(g)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 1, point (g)Click opens the article on EUR-Lex., Art. 2(1)(h)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 1, point (h)Click opens the article on EUR-Lex.). The first date stops new stock with the old label; the second date stops old stock still in the supply chain. The Commission set three and five years so that formulas and containers could be changed and old stock withdrawn (recital 11 of Regulation (EU) 2023/1545).

What the responsible person does

Every cosmetic product placed on the EU market has a responsible person in the EU, who ensures compliance with the Regulation (Art. 4(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 4, paragraph 1Click opens the article on EUR-Lex., Art. 4(2)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 4, paragraph 2Click opens the article on EUR-Lex.). The labelling of fragrance allergens is that person’s duty: it covers the ingredient list and the Annex III restrictions (Art. 5(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 5, paragraph 1Click opens the article on EUR-Lex., Art. 14(1)(b)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 14, paragraph 1, point (b)Click opens the article on EUR-Lex., Art. 19(1)(g)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 19, paragraph 1, point (g)Click opens the article on EUR-Lex.). For an imported product it is the importer, or a person in the EU it mandates in writing (Art. 4(5)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex.). Who that is when you ship from outside the EU is set out in the EU Cosmetics Regulation guide.

For the allergen change, the responsible person:

• has the label and the artwork changed, for every product with perfume or a listed essential oil;
• keeps the cosmetic product safety report (CPSR) up to date as new information arrives (Art. 10(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 10, paragraph 1Click opens the article on EUR-Lex., point (c)), and the product information file with it (Art. 11(2)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 11, paragraph 2Click opens the article on EUR-Lex.);
• updates the CPNP notification without delay when any of its information changes, such as the frame formulation after a reformulation (Art. 13(7)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 13, paragraph 7Click opens the article on EUR-Lex.);
• makes the name and code number of the perfume composition and the identity of its supplier easily accessible to the public, along with the product’s composition (Art. 21Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 21Click opens the article on EUR-Lex.);
• brings into conformity, withdraws or recalls any product it placed on the market that does not comply (Art. 5(2)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 5, paragraph 2Click opens the article on EUR-Lex.).

What a reseller checks

A business that resells cosmetics someone else placed on the EU market is a distributor (Art. 2(1)(e)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 1, point (e)Click opens the article on EUR-Lex.). Before selling, it verifies that the ingredient list is on the pack (Art. 6(2)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 6, paragraph 2Click opens the article on EUR-Lex.). It does not sell a product it believes does not comply (Art. 6(3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 6, paragraph 3Click opens the article on EUR-Lex.), which after 31 July 2028 includes any unit with the old list. Put your own brand on the product and you become its responsible person (Art. 4(6)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 4, paragraph 6Click opens the article on EUR-Lex.).

Candles, diffusers and room sprays are not cosmetics

A cosmetic is placed in contact with the external parts of the body or the mouth (Art. 2(1)(a)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 1, point (a)Click opens the article on EUR-Lex.). A candle, a wax melt, a reed diffuser or a room spray scents the air, so the Cosmetics Regulation and its allergen list do not apply to it. Its label may come from CLP, depending on whether it is a mixture or an article (Art. 2(8)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 8Click opens the article on EUR-Lex., Art. 2(9)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 9Click opens the article on EUR-Lex.). A fragrance oil or a diffuser oil is a mixture, “a mixture or solution composed of two or more substances” (Art. 2(8)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 8Click opens the article on EUR-Lex.), and CLP decides whether it needs a hazard label. How that works is in the EU CLP Regulation guide.

Whether a finished candle or wax melt is a mixture or an article is not settled in CLP: an article is an object whose shape, surface or design decides its function more than its chemical composition (Art. 2(9)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 9Click opens the article on EUR-Lex.). The reasoning and the safe course are in CLP label requirements.

The reverse also holds: CLP does not apply to a finished cosmetic product intended for the final user (Art. 1(5)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 1, paragraph 5Click opens the article on EUR-Lex., point (c)). A perfume, a body oil or a scented lotion carries the cosmetics label, not a CLP one.

Who owes what

What happens if you do nothing

A missing allergen is a breach of the labelling rules and of the Annex III restrictions. The authority requires the responsible person to bring the product into conformity, withdraw it or recall it, within a time limit it sets (Art. 25(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 25, paragraph 1Click opens the article on EUR-Lex., points (f) and (h)), and across the whole EU (Art. 25(3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 25, paragraph 3Click opens the article on EUR-Lex.). Each EU country sets the penalties, which must be effective, proportionate and dissuasive (Art. 37Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 37Click opens the article on EUR-Lex.). From 1 August 2028, stock with the old list may not be sold by anyone.

What the law leaves open

• Whether the transition is counted per unit or per product. “Placing on the market” is “the first making available of a cosmetic product” (Art. 2(1)(h)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 1, point (h)Click opens the article on EUR-Lex.). The footnotes to the Annex of Regulation (EU) 2023/1545 do not say whether a product line counts as placed once its first unit was sold, or each unit counts on its own. Meanwhile: give the longer list to every unit you supply to anyone from 1 August 2026.
• Whether a listed oil and the listed substances inside it are each named. Lavender oil has its own entry, and so do substances it contains, such as Linalool and Linalyl Acetate. Each entry has its own limit, and no entry says the name of the oil covers the substances in it. Meanwhile: name the oil and each listed substance that is above its limit.
• Whether a label-only change is notified again. The update duty covers the information of Art. 13(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 13, paragraph 1Click opens the article on EUR-Lex., (3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 13, paragraph 3Click opens the article on EUR-Lex. and (4)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 13, paragraph 4Click opens the article on EUR-Lex. (Art. 13(7)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 13, paragraph 7Click opens the article on EUR-Lex.). The original label and pack photograph are notified under Art. 13(2)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 13, paragraph 2Click opens the article on EUR-Lex., which that list does not name. Meanwhile: upload the new label whenever the label changes.

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