Regulation 2023/1545, which addresses the labeling of fragrance allergens on cosmetic products, was published by the European Union.
It takes effect in July 2026 and mandates the labeling of a total of 80 compounds that have been classified as allergens.
This Regulation introduces several changes to Annex III of Cosmetic Regulation (EC) No 1223/2009.
The list of labeled allergens now comprises 80 entries, and all of the compounds in question must be listed in the ingredients list on the packaging as soon as their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
The purpose of this additional labelling is to inform those sensitized individuals who have been tested and know which ingredients to avoid.
An allergen can be present in a cosmetic product due to:
a) Its presence in the fragrance or aroma mixture either added directly or as part of a natural complex substance (e.g., essential oil, botanical extract)
b) Its presence as constituent of a natural complex substance (NCS) (e.g., essential oil, botanical extract)
c) Its presence as an impurity or contaminant
d) A combination of two or more of the above (no contribution as cosmetic ingredient)
e) Its intentional addition as a cosmetic ingredient (i.e., not a fragrance or aroma mixture)
f) Combination of (e) and one or more of the above.
The new substances that must be declared on the labels when present are:
- Pinus Mugo
- Pinus Pumila
- Cedrus Atlantica Oil/Extract
- Myroxylon Pereirae Oil/Extract
- Rose Ketones
- Lippia citriodora absolute
- Methyl Salicylate
- Acetyl Cedrene
- Amyl Salicylate
- Dimethyl Phenethyl Acetate
- Linalyl Acetate
- Trimethylcyclopentenyl Methylisopentenol
- Tetramethyl acetyloctahydronaphthalenes
- Cananga Odorata Oil/Extract
- Cinnamomum Cassia Leaf Oil
- Cinnamomum Zeylanicum Bark Oil
- Citrus Aurantium Flower Oil
- Citrus Aurantium Peel Oil
- Citrus Aurantium Bergamia Peel Oil
- Citrus Limon Peel Oil
- Lemongrass Oil
- Eucalyptus Globulus Oil
- Eugenia Caryophyllus Oil
- Jasmine Oil/Extract
- Juniperus Virginiana Oil
- Laurus Nobilis Leaf Oil
- Lavandula Oil/Extract
- Mentha Piperita Oil
- Mentha Viridis Leaf Oil
- Narcissus Extract
- Pelargonium Graveolens Flower Oil
- Pogostemon Cablin Oil
- Rose Flower Oil / Extract
- Santalum Album Oil
- Eugenyl Acetate
- Geranyl Acetate
- Isoeugenyl Acetate
These provisions come into force on 31 July 2026 for products placed on the market, and on 31 July 2028 for products made available on the market.
Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No.1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products
Guidelines on the ‘fragrance allergens’ requirements, Cosmetics Europe, 2023. FINAL_Fragrance_allergens_guide_02_11_2023-1