Since July 26, 2023, the list of allergens has evolved and fifty new substances have been added to the 24 previously listed in Annex III of the European Cosmetic Regulation No 1223/2009 - No. 89. These additions were decided following the advice of the Scientific Committee for Consumer Safety or SCCS. What are the newly listed allergens? What does the new legislation say? Discover everything there is to know about cosmetic regulation in terms of allergens.
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Everything you need to know about the new allergen regulation.
Summary
- Cosmetology: What is an Allergen?
- A closer look at the new cosmetic regulation concerning allergens
- What is the complete list of allergens?
- Sources
Published February 9, 2024,
by
Pauline, Head of Scientific Communication
—
12 min read
Cosmetology: What is an Allergen?
An allergen, which can be of natural or synthetic origin, is a substance foreign to the body that can trigger a hyperactive response from the immune system. In cosmetics, allergens are primarily fragrances and essential oils incorporated into the formulation. The allergenic nature of a substance comes from its ability to bind to proteins present in the skin, which results in the production of antibodies. To avoid allergic reactions in consumers, the dosage of allergenic substances must be quantified. Therefore, every cosmetic manufacturer is obligated to disclose their presence on the product labeling.
A closer look at the new cosmetic regulation concerning allergens.
On July 26, 2023, the European Commission published Regulation No 1545/2023, amending the historic Regulation No 1223/2009 of the European Parliament and Council regarding the labeling of allergenic fragrance substances in cosmetic products. New allergens have been added to the list, with the aim of protecting consumers. According to the latest estimates, the percentage of the population allergic to fragrance substances in the European Union is approximately 1 to 9%. Furthermore, an increase in the prevalence of eczema in the population has been observed in recent years, justifying the implementation of new protective measures.
What are the rules regarding allergens?
The dosage and labeling of allergens are strictly regulated by the European Commission. Indeed, there are thresholds that must not be exceeded regarding the concentration of allergenic substances in a skincare product. These thresholds depend on each allergen, the type of product, and the level of exposure. They are defined by the IFRA (International Fragrance Association), an international association whose mission is to promote safer use of fragrances. Moreover, it is mandatory to mention allergens in the INCI list of cosmetic products if their concentration exceeds 0.01% in rinse-off products and 0.001% in leave-on products.
When will this new regulation take effect?
We will have to wait until July 31, 2026 for the new allergen regulation to take effect. The new cosmetics that will be introduced to the market from this date will have to comply with the new legislation, and this will apply to both European companies and those introducing their product for the first time in the European Union market.
After which, the July 31, 2028, these provisions will become applicable to the products already offered for distribution. Manufacturers will then have three to five years to withdraw from the market any cosmetic products that do not comply with the new labeling provisions.
What is the complete list of allergens?
Nowadays, more than 80 allergenic substances have been identified by the Scientific Committee for Consumer Safety (SCCS) and officially listed in the European cosmetic regulation. They are grouped together in the table below.
| Chemical Name | Common Denomination |
|---|---|
| Benzyl Alcohol | Benzyl Alcohol |
| Methyl-6-coumarin (Toncarine) | 6-Methyl Coumarin |
| 3,7-Dimethyl-2,6-octadienal | Citral |
| (E)-3,7-Dimethylocta-2,6-dienal | Geranial |
| (Z)-3,7-Dimethylocta-2,6-dienal | Neral |
| 2-Methoxy-4-(1-propenyl)phenol | Isoeugenol |
| (E)-2-Methoxy-4-(1-propenyl)phenol (trans-isoeugenol) | Isoeugenol |
| (Z)-2-Methoxy-4-(1-propenyl)phenol (cis-isoeugenol) | Isoeugenol |
| Citronellol / (±) 3,7-dimethyl-6-octen-1-ol | Citronellol |
| (3R)-3,7-Dimethyl-6-octen-1-ol | Citronellol |
| (3S)-3,7-Dimethyl-6-octen-1-ol | Citronellol |
| 1-Methyl-4-prop-1-en-2-ylcyclohexene; dl-limonene (racemic); dipentene | Limonene |
| (R)-p-Mentha-1,8-diene; (d-limonene) | Limonene |
| (S)-p-Mentha-1,8-diene; (l-limonene) | Limonene |
| Oil and extract from the leaves and twigs of Pinus mugo | Pinus Mugo Leaf Oil; Pinus Mugo Twig Leaf Extract; Pinus Mugo Twig Oil |
| Oil and extract from the leaves and twigs of Pinus pumila | Pinus Pumila Needle Extract; Pinus Pumila Twig Leaf Extract; Pinus Pumila Twig Leaf Oil |
| Oil and Extract of Cedrus Atlantica | Extract of Cedrus Atlantica Bark; Oil of Cedrus Atlantica Bark; Water from Cedrus Atlantica Bark; Extract of Cedrus Atlantica Leaf; Extract of Cedrus Atlantica Wood; Oil of Cedrus Atlantica Wood |
| Turpentine essence (Pinus spp.); turpentine oil and rectified turpentine oil; steam-distilled turpentine (Pinus spp.) | Turpentine |
| p-Mentha-1,3-diene | Alpha-Terpinene |
| p-Mentha-1,4(8)-diene | Terpinolene |
| Myroxylon balsamum var. pereirae; extracts and distillation products; Peru balsam, absolute and anhydrol | Myroxylon Balsamum Pereirae Balsam Extract; Myroxylon Balsamum Pereirae Balsam Oil; Myroxylon Pereirae Oil; Myroxylon Pereirae Resin Extract; Myroxylon Pereirae Resin |
| 1-(2,6,6-Trimethyl-2-cyclohexene-1-yl)-2-buten-1-one1 | Alpha-Damascone; |
| 1-(2,6,6-Trimethylcyclohexa-1,3-diene-1-yl)-2-buten-1-one | Rose Ketone 4 (Damascone) |
| 1-(2,6,6-Trimethyl-3-cyclohexene-1-yl)-2-buten-1-one | Rose Ketone 3 (delta-Damascone); trans-Rose Ketone 3 |
| (Z)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one | cis-Rose Ketone 2 (cis-beta-Damascone) |
| (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one | trans-Rose Ketone 2 (trans-beta-Damascone) |
| 3-Propylidene-1(3H)-isobenzofuranone; 3-propylidenephthalide | 3-Propylidenephthalide |
| Absolute Verbena | Absolute of Lippia citriodora |
| Methyl 2-Hydroxybenzoate | Methyl Salicylate |
| [3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-Hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene-5-yl)ethan-1-one | Acetyl Cedrene |
| 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-trimethylbicyclo[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; (5S)-2-methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one | Carvone |
| 2-methyl-1-phenyl-2-propyl acetate; dimethylbenzylcarbinyl acetate | Dimethyl Phenethyl Acetate |
| Oxacycloheptadecan-2-one | Hexadecanolactone |
| 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-gamma-2-benzopyran | Hexamethylindanopyran |
| 3,7-Dimethylocta-1,6-dien-3-yl Acetate | Linalyl Acetate |
| Menthol | Menthol |
| 3-Methyl-5-(2,2,3-trimethyl-3-cyclopentenyl)pent-4-en-2-ol | Trimethylcyclopentenyl Methylisopentenol |
| o-Hydroxybenzaldehyde | Salicylaldehyde |
| 5-(2,3-Dimethyl-tricyclo[2.2.1.02,6]-hept-3-yl)-2-methylpent-2-en-1-ol (α-santalol); (1S-(1a,2a(Z),4a))-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol (β-santalol) | Santalol |
| [1R-(1α)]-α-Vinyldodecahydro-2-hydroxy-a,2,5,5,8a-pentamethyl-1-naphthalenepropanol | Sclareol |
| 2-(4-Methylcyclohex-3-en-1-yl)propan-2-ol p-menth-1-en-8-ol (α-terpineol); 1-methyl-4-(1-methylviny)cyclohexan-1-ol (β-terpineol); 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol (γ-terpineol) | Terpineol |
| 1-(1,2,3,4,5,6,7,8-Octahydro-2,3,8,8-tetramethyl-2-naphthyl)ethan-1-one; 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthyl)ethan-1-one; 1-(1,2,3,5,6,7,8,8a-octahydro-2,3,8,8-tetramethyl-2-naphthyl)ethan-1-one; 1-(1,2,3,4,6,7,8,8a-octahydro-2,3,8,8-tetramethyl-2-naphthyl)ethan-1-one | Tetramethyl Acetyloctahydronaphthalenes |
| 3-(2,2-Dimethyl-3-hydroxypropyl)toluene | Trimethylbenzenepropanol |
| 4-Hydroxy-3-methoxybenzaldehyde | Vanillin |
| Oil and extract of Cananga odorata flowers; oil and extract of ylang-ylang flowers | Cananga Odorata Flower Extract; Cananga Odorata Flower Oil |
| Cinnamomum Cassia Leaf Oil | Cinnamomum Cassia Leaf Oil |
| Cinnamomum Zeylanicum Bark Oil | Cinnamomum Zeylanicum Bark Oil |
| Oil of Citrus aurantium flowers, both amara and dulcis | Bitter Orange Flower Oil; Sweet Orange Flower Oil |
| Oil from the peels of Citrus aurantium, both amara and dulcis varieties | Bitter Orange Peel Oil; Sweet Orange Peel Oil; Orange Peel Oil |
| Citrus aurantium bergamia oil (bergamot oil) | Bergamot Citrus Aurantium Peel Oil |
| Citrus Limon Oil | Citrus Limon Peel Oil |
| Essential oils from Cymbopogon, citratus, schoenanthus, or flexuosus | Cymbopogon Schoenanthus Oil; Cymbopogon Flexuosus Oil; Cymbopogon Citratus Leaf Oil |
| Globulus Eucalyptus Oil | Eucalyptus Globulus Leaf Oil; Eucalyptus Globulus Leaf/Twig Oil |
| Eugenia Caryophyllus Oil | Eugenia Caryophyllus Leaf Oil; Eugenia Caryophyllus Flower Oil; Eugenia Caryophyllus Stem Oil; Eugenia Caryophyllus Bud Oil; |
| Jasmine Oil and Extract, Grandiflorum or Officinale | Jasminum Grandiflorum Flower Extract; Jasminum Officinale Oil; Jasminum Officinale Flower Extract |
| Juniperus virginiana Oil | Juniperus Virginiana Oil; Juniperus Virginiana Wood Oil |
| Laurus nobilis Oil | Laurus Nobilis Leaf Oil |
| Oil and extract of Lavandula hybrida; | Lavandula Hybrida Oil; Lavandula Hybrida Extract; Lavandula Hybrida Flower Extract; |
| Oil and extract of Lavandula intermedia; | Lavandula Intermedia Flower/Leaf/Stem Extract; Lavandula Intermedia Flower/Leaf/Stem Oil; Lavandula Intermedia Oil |
| Lavandula angustifolia Oil and Extract | Lavandula Angustifolia Oil; Lavandula Angustifolia Flower/Leaf/Stem Extract |
| Peppermint Oil | Peppermint Oil |
| Mentha spicata oil (spearmint oil) | Spearmint Leaf Oil |
| Extract from Narcissus, poeticus, pseudonarcissus, jonquilla, or tazetta | Extract of Narcissus Poeticus |
| Extract from Narcissus, poeticus, pseudonarcissus, jonquilla, or tazetta | Daffodil Pseudonarcissus Flower Extract |
| Extract from Narcissus, poeticus, pseudonarcissus, jonquilla, or tazetta | Narcissus Jonquilla Extract; Narcissus Tazetta Extract |
| Pelargonium graveolens Oil | Pelargonium Graveolens Flower Oil |
| Pogostemon Cablin Oil | Pogostemon Cablin Oil |
| Oil and extract of Rosa damascena flowers; | Rosa Damascena Flower Oil; Rosa Damascena Flower Extract |
| Oil and extract of Rosa alba flowers; | Rosa Alba Flower Oil; Rosa Alba Flower Extract |
| Rosa canina flower oil; | Rosa Canina Flower Oil |
| Rosa centifolia Oil and Extract | Rosa Centifolia Flower Oil; Rosa Centifolia Flower Extract |
| Rosa gallica flower oil; | Rosa Gallica Flower Oil |
| Rosa moschata flower oil | Rosa Moschata Flower Oil |
| Rosa rugosa flower oil | Rosa Rugosa Flower Oil |
| Santalum album Oil | Sandalwood Album Oil |
| 2-Methoxy-4-(2-propenyl)-phenol Acetate | Eugenyl Acetate |
| (2E)-3,7-Dimethyl-2,6-octadien-1-ol Acetate | Geranyl Acetate |
| 2-Methoxy-4-prop-1-enylphenyl Acetate | Isoeugenyl Acetate |
| 2,6,6-Trimethylbicyclo[3.1.1]hept-2-ene (α-pinene); 6,6-Dimethyl-2-methylenebicyclo[3.1.1]heptane (β-pinene) | Pinene |
Sources
Regulation (EC) No 1223/2009 of the European Parliament and the Council.
Regulation (EC) No 1545/2023 of the European Parliament and Council.
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