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.
Allergen List Amendments
Key changes include:
- Replaced 17 entries
- Deleted 10 entries
- 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 following table shows the detailed list:
| Allergen | Status | Allergen | 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 |
Learn More:
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:
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH0002497458, Reuters SGSN.S, Bloomberg SGSN:SW).
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