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Nouvelle réglementation allergènes.

Everything you need to know about the new allergen regulations.

Since the 26th of July 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 - n°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.

Summary
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. Consequently, every cosmetic manufacturer is obliged to disclose their presence on the labelling.

A closer look at the new cosmetic regulation concerning allergens.

On 26th July 2023, the European Commission published regulation No 1545/2023, amending the historic regulation No 1223/2009 of the European Parliament and Council regarding the labelling 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 around 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 concerning allergens?

The measurement and labelling 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 come into effect?

We will have to wait until the 31st of July 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 to the European Union market for the first time.

After which, the 31st of July 2028, these provisions will become applicable for the products already on offer for distribution. Manufacturers will then have three to five years to withdraw non-compliant cosmetic products from the market in accordance with the new labelling provisions.

What is the complete list of allergens?

There are now over 80 allergenic substances that 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 NameCommon Denomination
Benzyl AlcoholBenzyl Alcohol
Methyl-6-coumarin (Toncarine)6-Methyl Coumarin
3,7-Dimethyl-2,6-octadienalCitral
(E)-3,7-Dimethylocta-2,6-dienalGeranial
(Z)-3,7-Dimethylocta-2,6-dienalNeral
2-Methoxy-4-(1-propenyl)phenolIsoeugenol
(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-olCitronellol
(3R)-3,7-Dimethyl-6-octen-1-olCitronellol
(3S)-3,7-Dimethyl-6-octen-1-olCitronellol
1-Methyl-4-prop-1-en-2-ylcyclohexene; dl-limonene (racemic); dipenteneLimonene
(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 mugoPinus Mugo Leaf Oil; Pinus Mugo Twig Leaf Extract; Pinus Mugo Twig Oil
Oil and extract from the leaves and twigs of Pinus pumilaPinus Pumila Needle Extract; Pinus Pumila Twig Leaf Extract; Pinus Pumila Twig Leaf Oil
Oil and Extract of Cedrus AtlanticaCedrus Atlantica Bark Extract; Cedrus Atlantica Bark Oil; Cedrus Atlantica Bark Water; Cedrus Atlantica Leaf Extract; Cedrus Atlantica Wood Extract; Cedrus Atlantica Wood Oil
Turpentine essence (Pinus spp.); turpentine essence and rectified turpentine essence; steam-distilled turpentine (Pinus spp.)Turpentine
p-Mentha-1,3-dieneAlpha-Terpinene
p-Mentha-1,4(8)-dieneTerpinolene
Myroxylon balsamum var. pereirae; extracts and distillation products; Peru balsam, absolute and anhydrolMyroxylon 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-one1Alpha-Damascone;
1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-oneRose Ketone 4 (Damascone)
1-(2,6,6-Trimethyl-3-cyclohexene-1-yl)-2-buten-1-oneRose Ketone 3 (delta-Damascone); trans-Rose Ketone 3
(Z)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-onecis-Rose Ketone 2 (cis-beta-Damascone)
(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-onetrans-Rose Ketone 2 (trans-beta-Damascone)
3-Propylidene-1(3H)-isobenzofuranone; 3-propylidenephthalide3-Propylidenephthalide
Absolute VerbenaAbsolute of Lippia citriodora
Methyl 2-HydroxybenzoateMethyl 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-oneAcetyl Cedrene
Pentyl-2-hydroxy-benzoateAmyl Salicylate
1-Methoxy-4-(1E)-1-propen-1-yl-benzene (trans-anethole)Anethole
BenzaldehydeBenzaldehyde
Bornan-2-one; 1,7,7-trimethylbicyclo[2.2.1]-2-heptanoneCamphor
(1R,4E,9S)-4,11,11-Trimethyl-8-methylenebicyclo[7.2.0]undec-4-eneBeta-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-oneCarvone
2-methyl-1-phenyl-2-propyl acetate; dimethylbenzylcarbinyl acetateDimethyl Phenethyl Acetate
Oxacycloheptadecan-2-oneHexadecanolactone
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-gamma-2-benzopyranHexamethylindanopyran
3,7-Dimethylocta-1,6-dien-3-yl AcetateLinalyl Acetate
MentholMenthol
3-Methyl-5-(2,2,3-trimethyl-3-cyclopentenyl)pent-4-en-2-olTrimethylcyclopentenyl Methylisopentenol
o-HydroxybenzaldehydeSalicylaldehyde
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-naphthalenepropanolSclareol
2-(4-Methylcyclohex-3-en-1-yl)propan-2-ol p-menth-1-en-8-ol (α-terpineol); 1-methyl-4-(1-methylvinyl)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-oneTetramethyl Acetyloctahydronaphthalenes
3-(2,2-Dimethyl-3-hydroxypropyl)tolueneTrimethylbenzenepropanol
4-Hydroxy-3-methoxybenzaldehydeVanillin
Oil and extract of Cananga odorata flowers; oil and extract of ylang-ylang flowersCananga Odorata Flower Extract; Cananga Odorata Flower Oil
Cinnamomum Cassia Leaf OilCinnamomum Cassia Leaf Oil
Cinnamomum Zeylanicum Bark OilCinnamomum Zeylanicum Bark Oil
Oil of Citrus aurantium, amara, and dulcis flowersBitter Orange Flower Oil; Sweet Orange Flower Oil
Oil from the peels of Citrus aurantium, both amara and dulcisBitter Orange Peel Oil; Sweet Orange Peel Oil; Orange Peel Oil
Citrus aurantium bergamia oil (bergamot oil)Bergamot Citrus Aurantium Peel Oil
Citrus Limon OilCitrus Limon Peel Oil
Essential oils from Cymbopogon, citratus, schoenanthus or flexuosusCymbopogon Schoenanthus Oil; Cymbopogon Flexuosus Oil; Cymbopogon Citratus Leaf Oil
Globulus Eucalyptus OilEucalyptus Globulus Leaf Oil; Eucalyptus Globulus Leaf/Twig Oil
Eugenia Caryophyllus OilEugenia Caryophyllus Leaf Oil; Eugenia Caryophyllus Flower Oil; Eugenia Caryophyllus Stem Oil; Eugenia Caryophyllus Bud Oil;
Jasminum Oil and Extract, Grandiflorum or OfficinaleJasminum Grandiflorum Flower Extract; Jasminum Officinale Oil; Jasminum Officinale Flower Extract
Juniperus virginiana OilJuniperus Virginiana Oil; Juniperus Virginiana Wood Oil
Laurus nobilis OilLaurus 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 ExtractLavandula Angustifolia Oil; Lavandula Angustifolia Flower/Leaf/Stem Extract
Peppermint OilPeppermint Oil
Mentha spicata oil (spearmint oil)Spearmint Leaf Oil
Extract from Narcissus, poeticus, pseudonarcissus, jonquilla or tazettaExtract of Narcissus Poeticus
Extract from Narcissus, poeticus, pseudonarcissus, jonquilla or tazettaNarcissus Pseudonarcissus Flower Extract
Extract from Narcissus, poeticus, pseudonarcissus, jonquilla or tazettaNarcissus Jonquilla Extract; Narcissus Tazetta Extract
Pelargonium graveolens OilPelargonium Graveolens Flower Oil
Pogostemon Cablin OilPogostemon 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
Oil and extract of Rosa centifoliaRosa Centifolia Flower Oil; Rosa Centifolia Flower Extract
Rosa gallica flower oil;Rosa Gallica Flower Oil
Rosa moschata flower oilRosa Moschata Flower Oil
Rosa rugosa flower oilRosa Rugosa Flower Oil
Santalum album OilSandalwood Album Oil
2-Methoxy-4-(2-propenyl)-phenol AcetateEugenyl Acetate
Acetate of (2E)-3,7-dimethyl-2,6-octadien-1-olGeranyl Acetate
2-Methoxy-4-prop-1-enylphenyl AcetateIsoeugenyl 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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