EU Expands the List of Fragrance Allergens in Cosmetic Products

On 26th July 2023, the European Union (EU) adopted Regulation (EU) 2023/1545 to update labelling of fragrance allergens under Annex III to Regulation (EC) 1223/2009 on cosmetic products.

This regulation came into force on 16th August 2023. A long transition period of 3 or 5 years is given to the industry to adapt the new requirements in response to Regulation (EU) 2023/1545. 

Expansion of Allergen List

This amendment contains several important changes:

1. Replaces 17 entries
2. Deletes 10 entries
3. Adds 45 entries

Transition Timeline

For new cosmetic products to be placed onto the EU market, they shall comply with the new requirement by 31st Jul 2026 (within 3 years). 

For existing cosmetic products already on the EU market, they shall comply with the new requirement by 31st July 2028 (within 5 years).

Allergens must be declared on the label when it is present in a concentration that exceeds:

• 0,001% in leave-on products
• 0,01% in rinse-off products

The below table shows the expanded list of fragrance allergens:

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
Reference source: Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No. 1223/2009

Grouping of Similar Substances

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’)

What to Do?

Manufacturers and fragrance suppliers are suggested to expand the scope of document to cover new allergens. All industry players, including brands and responsible person, shall make sure the product label, cosmetic product safety report (CPSR) and product information file (PIF) up-to-dated and in compliance with the new requirement by the end of transition timeline. 

 

SGS specialists provide expertise in all aspects of cosmetic, household care and hygiene testing and regulatory guidance with our state-of-the-art facilities and technology, helping you bring safe, effective and compliant products to market.

 

For enquiries, please contact our Customer Service Team.

To obtain a copy in PDF, please click here.