EU Expands the List of Fragrance Allergens in Cosmetic Products

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 update came into force on 16 August 2023. In this article, we shall examine the detailed list of fragrance allergens under the new rule.

Key changes include:

  1. Replaced 17 entries
  2. Deleted 10 entries
  3. Added 45 entries

Cosmetic Industry Transition Timeline

A long grace period of 3 or 5 years is given to the industry to comply with the new requirements in response to Regulation (EU) 2023/1545:

  • For new cosmetic products to be placed onto the EU market: Within 3 years (by 31 July 2026)
  • For existing cosmetic products already on the EU market: Within 5 years (by 31 July 2028)

Expanded Fragrance Allergens Coverage

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

  • 0.001% in leave-on products
  • 0.01% in rinse-off products
The new EU allergen labelling law safeguards cosmetic wearers to a greater extent.

The following table shows the detailed list:

Benzyl AlcoholCurrentSantalolNew
6-Methyl CoumarinNewSclareolNew
CitralCurrent TerpineolNew 
IsoeugenolCurrentTetramethyl acetyloctahydronaphthalenesNew
Pinus MugoNewCananga Odorata Oil/ExtractNew
Pinus PumilaNew Cinnamomum Cassia Leaf OilNew 
Cedrus Atlantica Oil/ ExtractNewCinnamomum Zeylanicum Bark OilNew
TurpentineNewCitrus Aurantium Flower OilNew
Alpha-TerpineneNewCitrus Aurantium Peel OilNew
TerpinoleneNewCitrus Aurantium Bergamia Peel OilNew
Myroxylon Pereirae Oil/ExtractNewCitrus Limon Peel OilNew
Rose KetonesNewLemongrass OilNew
3-PropylidenephthalideNewEucalyptus Globulus OilNew
Lippia Citriodora absoluteNewEugenia Caryophyllus Oil New
Methyl SalicylateNewJasmine Oil/ExtractNew
Acetyl CedreneNewJuniperus Virginiana Oil New
Amyl SalicylateNewLaurus Nobilis Leaf OilNew
AnetholeNewLavandula Oil/ ExtractNew
BenzaldehydeNewMentha Piperita OilNew
CamphorNewMentha Viridis Leaf OilNew
BetaCaryophylleneNewNarcissus ExtractNew
CarvoneNewPelargonium Graveolens Flower OilNew
Dimethyl Phenethyl AcetateNewPogostemon Cablin OilNew
Hexadecanolac toneNewRose Flower Oil/ExtractNew
Hexamethylinda nopyranNewSantalum Album OilNew
Linalyl AcetateNewEugenyl AcetateNew
MentholNewGeranyl AcetateNew
Trimethylcyclopentenyl MethylisopentenolNewIsoeugenyl AcetateNew
Amyl CinnamalCurrentBenzyl CinnamateCurrent
Cinnamyl AlcoholCurrentFarnesolCurrent
HydroxycitronellalCurrentBenzyl BenzoateCurrent
Amylcinnamyl AlcoholCurrentHexyl CinnamalCurrent
Benzyl SalicylateCurrentMethyl 2-OctynoateCurrent
CinnamalCurrentAlpha-Isomethyl IononeCurrent
CoumarinCurrentEvernia Prunastri ExtractCurrent
GeraniolCurrentEvernia Furfuracea ExtractCurrent
Anise AlcoholCurrent  

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Grouping of Similar Substances

The new regulation grouped similar substances into one entry. It also sets individual labelling requirement when there are multiple common ingredient names for a substance. 

For example:

  • Benzyl Alcohol as ‘BENZYL ALCOHOL’; or
  • Citral, Geranial and Neral as ‘CITRAL’

How Does This Affect You?

All cosmetic industry players, including brands and responsible persons, should make sure the product label, cosmetic product safety report (CPSR) and product information file (PIF) are up-to-date and in compliance with the new requirement by the end of the respective transition timeline. 

For manufacturers and fragrance suppliers, they are suggested to expand the scope of document to cover new allergens.

This article is originally published by SGS:

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