From 26 to 80+: EU's Huge Move to Expand Allergen Listings in Cosmetic Products

2024.08.13

The European Union (EU) has adopted Regulation (EU) 2023/1545 to update the labelling of fragrance allergens in cosmetic products. This regulation aims to inform consumers about potential allergens present in these products.

WHAT ARE THE CHANGES IN ALLERGEN ENTRIES?

Replaces 17 entries
Deletes 10 entries
Adds 45 new entries

HOW LONG IS THE TRANSITION TIMELINE?

New cosmetic products placed on the EU market must comply by July 31, 2026 (within 3 years).
Existing cosmetic products already on the market must comply by July 31, 2028 (within 5 years).

AT WHAT LEVEL SHALL THE ALLERGENS BE LABELLED?

According to Article 19 of Cosmetic Regulation (EC) No. 1223/2009, Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’. The presence of substances under Annex III shall be indicated in the list of ingredients in addition to the terms.
Allergens must be declared on the label if their concentration exceeds labelling threshold of 0.001% in leave-on products or 0.01% in rinse-off products.

WHAT IS THE COMPLETE LIST OF ALLERGENS FOR LABELLING?

Allergens	Status	Allergens	Status
Benzyl Alcohol	Current	Santalol	New
6-Methyl Coumarin	New	Sclareol	New
Citral	Current	Terpineol	New
Isoeugenol	Current	Tetramethyl acetyloctahydronaphthalenes	New
Citronellol	Current	Trimethylbenzenepropanol	New
Limonene	Current	Vanillin	New
Pinus Mugo	New	Cananga Odorata Oil/Extract	New
Pinus Pumila	New	Cinnamomum Cassia Leaf Oil	New
Cedrus Atlantica Oil/ Extract	New	Cinnamomum Zeylanicum Bark Oil	New
Turpentine	New	Citrus Aurantium Flower Oil	New
Alpha-Terpinene	New	Citrus Aurantium Peel Oil	New
Terpinolene	New	Citrus Aurantium Bergamia Peel Oil	New
Myroxylon Pereirae Oil/Extract	New	Citrus Limon Peel Oil	New
Rose Ketones	New	Lemongrass Oil	New
3-Propylidenephthalide	New	Eucalyptus Globulus Oil	New
Lippia citriodora absolute	New	Eugenia Caryophyllus Oil	New
Methyl Salicylate	New	Jasmine Oil/Extract	New
Acetyl Cedrene	New	Juniperus Virginiana Oil	New
Amyl Salicylate	New	Laurus Nobilis Leaf Oil	New
Anethole	New	Lavandula Oil/ Extract	New
Benzaldehyde	New	Mentha Piperita Oil	New
Camphor	New	Mentha Viridis Leaf Oil	New
BetaCaryophyllene	New	Narcissus Extract	New
Carvone	New	Pelargonium Graveolens Flower Oil	New
Dimethyl Phenethyl Acetate	New	Pogostemon Cablin Oil	New
Hexadecanolac tone	New	Rose Flower Oil/Extract	New
Hexamethylinda nopyran	New	Santalum Album Oil	New
Linalyl Acetate	New	Eugenyl Acetate	New
Menthol	New	Geranyl Acetate	New
Trimethylcyclopentenyl Methylisopentenol	New	Isoeugenyl Acetate	New
Salicylaldehyde	New	Pinene	New
Amyl cinnamal	Current	Benzyl cinnamate	Current
Cinnamyl alcohol	Current	Farnesol	Current
Eugenol	Current	Linalool	Current
Hydroxycitronellal	Current	Benzyl benzoate	Current
Amylcinnamyl alcohol	Current	Hexyl cinnamal	Current
Benzyl salicylate	Current	Methyl 2-Octynoate	Current
Cinnamal	Current	alpha-Isomethyl ionone	Current
Coumarin	Current	Evernia prunastri extract	Current
Geraniol	Current	Evernia furfuracea extract	Current
Anise alcohol	Current

HOW SHOULD THE ALLERGENS BE LABELLED?

The regulation grouped similar substances into one entry. It also sets individual labelling requirement which name is to be used in the list of ingredients when there are multiple common ingredient names for a substance. Allergen will be either labelled,

individually for one specific substance (e.g. Benzyl Alcohol as ‘BENZYL ALCOHOL’), or
by grouping for similar substances (e.g. Citral, Geranial and Neral as ‘CITRAL’)

ACTION NOW!

For manufacturers and fragrance suppliers:

Expand the scope of documents to cover new allergens.
Ensure product labels, cosmetic product safety reports (CPSR), and product information files (PIF) are up-to-date.

All industry players, including brands and responsible persons, must comply with the new labelling requirements by the specified transition timeline. It is important to declare allergens accurately and ensure compliance with concentration thresholds.

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