COSMETIC REGULATION, ALLERGEN / 23-09-25
Fragrance Allergens List: All About the New Regulation
A new fragrance allergens list of cosmetics came into effect, on August 2023. Here's what you need to know about the regulation and how to ensure compliance.
On august 2023, an amended list of fragrance allergens that require proper labeling when used in cosmetic formulations came into effect. The new Regulation added 56 references to the original allergens list of 26 ingredients. Here's what cosmetic manufacturers need to know.
Perfumes and scented cosmetics contain fragrances. Combined in various proportions, these fragrances can create an infinity of scents that cosmetic manufacturers add to their products to make them more distinctive and pleasant to use. There exist over 2,500 fragrance ingredients considered safe to add to cosmetic formulations… in the right concentration. And even below that threshold, some were found to cause skin irritations or allergic reactions in some people. These ingredients known as 'fragrance allergens' include synthetic fragrances as well as natural plant extracts and essential oils.
The Scientific Committee on Consumer Safety estimates that 16% of eczema sufferers were sensitized to these compounds and that up to 3% of Europeans show allergic reactions to them. This is why fragrance allergens need to be visibly mentioned on ingredient lists. Annex III of the (EC) No 1223/2009 Regulation makes labeling compulsory for – up until now – a list of 26 of these allergens if used in concentrations exceeding:
The updated allergens list adds around 56 substances to the scope of the regulation, under Annex III:
By covering 82 fragrance allergens, the update seeks to benefit and protect consumers. It gives them access to better, more useful information and helps them understand what they apply to their skin. The additional transparency will also foster trust in the safety of the products.
The adoption of the expansion was originally set to happen in 2020. Yet, several factors – the COVID-19 pandemic being one of them – postponed its implementation. As the expansion has now been set into motion, manufacturers need to update their processes and make sure their packaging is relevant.
For products that were placed on the market prior to the application of the new labeling provisions, companies will be granted additional time to adapt. Five years after the Regulation goes into effect, all non-compliant products will have been phased out as manufacturers will be required to withdraw any non-compliant references from the market.
What About the New Cosmetic Fragrance Allergens List and Label?
The European Commission in charge of Cosmetic Regulations announced, on 15 September 2022, that they were amending Regulation (EC) No 1223/2009. This text, which refers to the labeling of fragrance allergens in cosmetic products, is being updated to reflect the growing list of fragrance allergens that should be labeled individually. While still relevant, the allergens list that originally included 26 entries received the addition of 56 references identified by the SCCS as causing allergies in humans. What are fragrance allergens? How does this update to the regulation impact cosmetic manufacturers? Here's what you need to know.What Are Fragrance Allergens?
So, what are fragrance allergens, exactly?Perfumes and scented cosmetics contain fragrances. Combined in various proportions, these fragrances can create an infinity of scents that cosmetic manufacturers add to their products to make them more distinctive and pleasant to use. There exist over 2,500 fragrance ingredients considered safe to add to cosmetic formulations… in the right concentration. And even below that threshold, some were found to cause skin irritations or allergic reactions in some people. These ingredients known as 'fragrance allergens' include synthetic fragrances as well as natural plant extracts and essential oils.
The Scientific Committee on Consumer Safety estimates that 16% of eczema sufferers were sensitized to these compounds and that up to 3% of Europeans show allergic reactions to them. This is why fragrance allergens need to be visibly mentioned on ingredient lists. Annex III of the (EC) No 1223/2009 Regulation makes labeling compulsory for – up until now – a list of 26 of these allergens if used in concentrations exceeding:
- 0.001% of the total concentration for leave-in products, such as make-up or body lotions.
- 0.01% of the total concentration for rinse-off products, such as shampoo or shower gel.
What Changes Were Made to the Allergens List?
The nature of the labeling requirements remains the same. Fragrance allergens must be indicated on the ingredients list and plainly identified by the terms 'parfum' or 'aroma' on the container itself or its packaging.The updated allergens list adds around 56 substances to the scope of the regulation, under Annex III:
| Pinus Mugo leaf and twig oil and extract | Pinus Mugo Leaf oil |
| Pinus Pumila leaf and twig oil and extract | Pinus Pumila Needle Extract |
| Cedrus Atlantica oil and extract | Cedrus Atlantica Bark Extract; Cedrus Atlantica Bark Oil; Cedrus Atlantica Bark Water; Cedrus Atlantica Leaf Extract; Cedrus Atlantica Wood Extract; Cedrus Atlantica Wood Oil |
| Turpentine gum (Pinus spp.); Turpentine oil and rectified oil; Turpentine, steam distilled (Pinus spp.) | Turpentine |
| 2,6,6-Trimethylbi-cyclo[3.1.1]hept-2-ene; (alpha-Pinene) 6,6-Dimethyl- 2-methylenebicyclo[3.1.1]heptane (beta-Pinene) | Pinene |
| p- Mentha-1,3-diene | alpha-Terpinene |
| p-Mentha-1,4(8)-diene; Terpinolene | Terpinolene |
| Myroxylon balsamum var. pereirae; extracts and distillates; Balsam Peru oil, absolute and anhydrol (Balsam Oil Peru) | Myroxylon Balsamum Pereirae Balsam Extract; Myroxylon Balsamum Pereirae Balsam Oil; Myroxylon Pereirae Oil; Myroxylon Pereirae Resin Extract |
| 1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one 1- (2,6,6-Trimethylcyclohexa-1,3-dien-1- yl)-2-buten-1-one 1- (2,6,6-Trimethyl-3- cyclohexen-1-yl)-2- buten-1-one (Z)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one | Rose ketone 1 (alpha-Damascone) cis-Rose ketone 1 trans-Rose ketone 1 Rose ketone 4 (Damascenone) Rose ketone 3 (delta-Damascone) trans-Rose ketone 3 cis Rose ketone 2 (cis-beta-Damascone) trans-Rose ketone 2 (trans-beta-Damascone) |
| 3-Propylidene-phthalide | Propylidene phthalide |
| Verbena absolute (Lippia citriodora Kunth.) | Lippia citriodora absolute |
| [3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one | Acetylcedrene |
| Pentyl-2-hydroxy-benzoate | Amyl salicylate |
| 1-Methoxy-4-(1E)-1-propen-1-yl-benzene (trans-Anethole) | Anethole |
| Benzaldehyde | Benzaldehyde |
| Bornan-2-one; 1,7,7-Trimethylbi-cyclo[2.2.1]-2-heptanone | Camphor |
| (1R,4E,9S)-4,11,11-Trimethyl-8-methylenebicyclo[ 7.2.0]undec-4-ene; | beta-Caryophyllene |
| 2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one; (5R)-2-Methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one; 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone | Carvone |
| 2-Methyl-1-phenyl-2-propyl acetate | Dimethylbenzyl Carbinyl Acetate |
| Oxacyclohepta-decan-2-one | Hexadecanolactone |
| 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta- γ-2-benzopyran | Hexamethylindanopyran |
| 3,7-Dimethyl octa-1,6-diene-3-yl acetate | Linalyl acetate |
| Menthol; dl-menthol; l-menthol; d-menthol | Menthol |
| Methyl 2- hydroxy benzoate; Methyl salicylate | Methyl salicylate |
| 3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl)pent-4-en-2-ol | 3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl)pent-4-en-2-ol |
| o-Hydroxy-benzaldehyde | Salicylaldehyde |
| 5-(2,3-Dimethyl-tricyclo[2.2.1.02,6]-hept-3-yl)-2-methylpent-2-en-1-ol (alpha-Santalol); (1S-(1a,2a(Z),4a))-2-Methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol (beta-Santalol) | alpha-Santalol beta-Santanol |
| [1R-(1alpha)]-alpha-Ethenyldecahydro-2-hydroxy-a,2,5,5,8a-pentamethyl-1-naphthalenepropanol | Sclareol |
| Terpineol; p-Menth-1-en-8-ol (alpha-Terpineol); 1-methyl-4-(1-methylvinyl)cyclohexan-1-ol (beta-Terpineol); 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol (gamma-Terpineol) | Terpineol |
| 1-(1,2,3,4,5,6,7,8-Octahydro-2,3,8,8-tetramethyl- 2-naphthalenyl)-ethanone ; 1-(1,2,3,4,5,6,7,8-Octahydro-2,3,5,5-tetramethyl- 2-naphthalenyl)-ethanone ; 1-(1,2,3,5,6,7,8,8a-Octahydro-2,3,8,8-tetramethyl- 2-naphthalenyl)-ethanone; 1-(1,2,3,4,6,7,8,8a-Octahydro-2,3,8,8-tetramethyl- 2-naphthalenyl)-ethanone | Tetramethyl acetyloctahydro-naphthalenes |
| 3-(2,2-Dimethyl-3-hydroxypropyl)toluene | Trimethyl-benzenepropanol |
| 4-Hydroxy-3-methoxybenz-aldehyde | Vanillin |
| Cananga Odorata flower oil; Cananga Odorata Flower Extract; Ylang Ylang Flower oil and Extract | Cananga Odorata Flower Extract; Cananga Odorata Flower Oil; Cananga Odorata Flower Wax; Cananga Odorata Leaf Oil |
| Cinnamomum Cassia Leaf Oil | Cinnamomum Cassia Leaf Oil |
| Cinnamomum Zeylanicum Bark Oil | Cinnamomum Zeylanicum Bark Oil |
| Citrus Aurantium Flower oil | Citrus Aurantium Amara Flower Oil; Citrus Aurantium Dulcis Flower Oil; |
| Citrus Aurantium Peel Oil | Citrus Aurantium Amara Peel Oil; Citrus Aurantium Dulcis Peel Oil; Citrus Sinensis Peel Oil |
| Bergamot oil | Citrus Aurantium Bergamia Peel Oil; Citrus Aurantium Bergamia Fruit Extract; Citrus Aurantium Bergamia Fruit Oil |
| Citrus Limon oil | Citrus Limon Peel Oil |
| Cymbopogon Citratus / Schoenanthus/Flexuosus Oils | Cymbopogon Schoenanthus Oil; Cymbopogon Flexuosus Oil; Cymbopogon Citratus Leaf Oil; Cymbopogon Citratus Extract |
| Eucalyptus Globulus Oil | Eucalyptus Globulus Leaf Oil; Eucalyptus Globulus Leaf/Twig Oil |
| Eugenia Caryophyllus Leaf Oil | Eugenia Caryophyllus Leaf Oil; Eugenia Caryophyllus Flower Oil; Eugenia Caryophyllus Stem Oil; Eugenia Caryophyllus Bud Oil; |
| Jasminum Grandiflorum / Officinale oil and extract | Jasminum Grandiflorum Flower Extract; Jasminum Officinale Oil; Jasminum Officinale Flower Extract |
| Juniperus Virginiana oil | Juniperus Virginiana Oil; Juniperus Virginiana Wood Oil |
| Laurus Nobilis oil (with the exception of the substance in Annex II, reference number 359) | Laurus Nobilis Leaf Oil |
| Lavandula Hybrida oil; Lavandula intermedia oil; Lavandula Angustifolia Oil | Lavandula Hybrida Oil; Lavandula Hybrida Extract; Lavandula Hybrida Flower Extract; Lavandula Hybrida Flower Water Lavandula Intermedia Flower/Leaf/Stem Extract; Lavandula Intermedia Flower/Leaf/Stem Oil; Lavandula Intermedia Flower/Leaf/Stem Water; Lavandula Intermedia Oil Lavandula Angustifolia Oil; Lavandula Angustifolia Flower/Leaf/Stem Extract |
| Mentha Piperita oil | Mentha Piperita Oil |
| Spearmint oil/Spearmint ext. | Mentha Viridis Leaf Oil Mentha Spicata Oil |
| Narcissus extract | Narcissus Poeticus Extract Narcissus Pseudonarcissus Flower Extract Narcissus Jonquilla Extract Narcissus Tazetta Extract |
| Pelargonium Graveolens oil | Pelargonium Graveolens Flower Oil |
| Pogostemon Cablin oil | Pogostemon Cablin Oil |
| Rosa Damascena Flower Oil/Extract; Rosa Alba Flower Oil/Extract Rosa Canina Flower Oil; Rosa Centifolia Flower Oil/Extract; Rosa Gallica Flower Oil; Rosa Moschata Flower Oil; Rosa Rugosa Flower Oil | Rosa Damascena Flower Oil; Rosa Damascena Flower Extract; Rosa Alba Flower Oil; Rosa Alba Flower Extract; Rosa Canina Flower Oil; Rosa Centifolia Flower Oil; Rosa Centifolia Flower Extract; Rosa Gallica Flower Oil; Rosa Moschata Flower Oil; Rosa Rugosa Flower Oil |
| Santalum Album oil | Rosa Damascena Flower Oil; Rosa Damascena Flower Extract; Rosa Alba Flower Oil; Rosa Alba Flower Extract; Rosa Canina Flower Oil; Rosa Centifolia Flower Oil; Rosa Centifolia Flower Extract; Rosa Gallica Flower Oil; Rosa Moschata Flower Oil; Rosa Rugosa Flower Oil |
| Santalum Album oil | Santalum Album Oil; Santalum Album Wood Oil |
| Phenol, 2-methoxy-4-(2-propenyl)-, acetate | Eugenyl acetate |
| 2,6-Octadien-1-ol, 3,7-dimethyl-,1-acetate, (2E)- | Geranyl acetate |
| 2-Methoxy-4-prop-1-enylphenyl acetate | Isoeugenyl acetate |
| 6-Methylcoumarin | 6-Methylcoumarin |
By covering 82 fragrance allergens, the update seeks to benefit and protect consumers. It gives them access to better, more useful information and helps them understand what they apply to their skin. The additional transparency will also foster trust in the safety of the products.
The adoption of the expansion was originally set to happen in 2020. Yet, several factors – the COVID-19 pandemic being one of them – postponed its implementation. As the expansion has now been set into motion, manufacturers need to update their processes and make sure their packaging is relevant.
What Is the Fragrance Allergens List Timeline?
The amendment came fully into effect on August 17, 2023. From this point on, manufacturers have three years to adjust their product formulations and packaging to ensure compliance before they place their cosmetics on the Union market.For products that were placed on the market prior to the application of the new labeling provisions, companies will be granted additional time to adapt. Five years after the Regulation goes into effect, all non-compliant products will have been phased out as manufacturers will be required to withdraw any non-compliant references from the market.
