Introduction
In 2012, in its opinion SCCS/1459/11, the SCCS concluded that consumers should be made aware of more fragrance allergens potentially present in cosmetic products, in order to protect sensitized people against the risk of skin rashes. The current list of 26 fragrance allergens, already subject to individual labelling as part of the list of ingredients, was called upon to grow.
European Commission review
It took several years to the European Commission and all relevant stakeholders to review this scientific opinion and transpose it into a pragmatic regulatory proposal.
As the number of allergens to label would increase from 26 to 87, 3 options have been investigated for their product labeling:
- Option 1: no change (no extension of the number of fragrance allergens to label)
- Option 2: on-pack labelling of all fragrance allergens
- Option 3: electronic labelling to limit the size of lists of ingredients, with 3 sub-options:
- By means of a website address
- By means of QR codes
- By means of extended barcodes
An impact assessment was performed by the European Commission and published end of 2020. On the basis of collected feedbacks, the Commission tends to favor the on-pack labeling option, postponing the possibility of e-labeling.
As for the current 26 fragrance allergens, the new fragrance allergens will have to be labeled if their concentration exceeds the labeling thresholds:
- > 0.001 % (10 ppm) in leave-on products
- > 0.01 % (100 ppm) in rinse-off products
Although the exact INCI names of the new allergens to label are yet to be confirmed, a provisional list of all the concerned materials is reported in annex.
The Commission prepared a regulatory proposal in June and this draft is now under review. Considering all the legal steps that still need to take place, this new piece of legislation is expected to be adopted in the first quarter of 2022 at the latest.
The transition periods should be as follows:
- 3 years after the entry into force, only products with compliant labels shall be placed on the EU market. The estimated deadline should be in the first quarter of 2025.
- 5 years after the entry into force, only products with compliant labels shall be made available on the EU market. The estimated deadline should be in the first quarter of 2027.
Within the context of cosmetics not manufactured in the EU, “placed on the EU market” means imported units of a product. Units of a product duly notified on CPNP that have entered the EU territory before the deadline of first quarter of 2025 (specific date to be confirmed) can be sold until first quarter of 2027 with a list of ingredients only including the 26 current fragrance allergens. However, units of a product that have not cleared the EU customs by first quarter 2025 cannot be marketed any longer.
Annex
| Chemical name / INN | Name of Common Ingredients Glossary | CAS | EC | Current or new |
|---|---|---|---|---|
| 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one | Alpha-Isomethyl ionone | 127-51-5 | 204-846-3 | Current |
| 2-Benzylideneheptanal | Amyl cinnamal | 122-40-7 | 204-541-5 | Current |
| 2-Pentyl-3-phenylprop-2-en-1-ol | Amylcinnamyl alcohol | 101-85-9 | 202-982-8 | Current |
| 4-Methoxybenzyl alcohol | Anise alcohol | 105-13-5 | 203-273-6 | Current |
| Benzyl alcohol | Benzyl alcohol | 100-51-6 | 202-859-9 | Current |
| Benzyl benzoate | Benzyl benzoate | 120-51-4 | 204-402-9 | Current |
| 2-Propenoic acid, 3-phenyl-, phenylmethyl ester | Benzyl cinnamate | 103-41-3 | 203-109-3 | Current |
| Benzyl salicylate | Benzyl salicylate | 118-58-1 | 204-262-9 | Current |
| 2-Propenal, 3-phenyl- | Cinnamal | 104-55-2 | 203-213-9 | Current |
| Cinnamyl alcohol | Cinnamyl alcohol | 104-54-1 | 203-212-3 | Current |
| 3,7-Dimethyl-2,6-octadienal | Citral | 5392-40-5 | 226-394-6 | Current |
| Citronellol/ (±) 3,7-Dimethyl-6-octen-1-ol | Citronellol | 106-22-9/ 26489-01-0/ 1117-61-9/ 7540-51-4 | 247-737-6/ 203-375-0/ 214-250-5/ 231-415-7 | Current |
| 2H-1-Benzopyran-2-one | Coumarin | 91-64-5 | 202-086-7 | Current |
| Phenol, 2-methoxy-4-(2-propenyl)- | Eugenol | 97-53-0 | 202-589-1 | Current |
| 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl- | Farnesol | 4602-84-0 | 225-004-1 | Current |
| 2,6-Octadien-1-ol, 3,7-dimethyl-,(2E)- | Geraniol | 106-24-1 | 203-377-1 | Current |
| 2-Benzylideneoctanal | Hexyl cinnamal | 101-86-0 | 202-983-3 | Current |
| 7-Hydroxycitronellal | Hydroxycitronellal | 107-75-5 | 203-518-7 | Current |
| Phenol, 2-methoxy-4- (1-propenyl) | Isoeugenol | 97-54-1 | 202-590-7 | Current |
| d,l-Limonene (racemic);d- limonene; l-limonene | Limonene | 138-86-3/ 5989-27-5/ 5989-54-8 | 231-732-0/ 227-813-5/ 227-815-6 | Current |
| 1,6-Octadien-3-ol, 3,7-dimethyl- | Linalool | 78-70-6 | 201-134-4 | Current |
| Methyl heptine carbonate | Methyl 2-octynoate | 111-12-6 | 203-836-6 | Current |
| Oak moss extract | Evernia Prunastri Extract | 90028-68-5 | 289-861-3 | Current |
| Treemoss extract | Evernia Furfuracea Extract | 90028-67-4 | 289-860-8 | Current |
| Pinus Mugo leaf and twig oil and extract | Pinus Mugo Leaf oil | 90082-72-7 | 290-163-6 | New |
| Pinus Pumila leaf and twig oil and extract | Pinus Pumila Needle Extract | 97676-05-6 | 307-681-6 | New |
| 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 | 92201-55-3/ 8023-85-6/ | 295-985-9/ -/ | New |
| Turpentine gum (Pinus spp.); Turpentine oil and rectified oil; Turpentine, steam distilled (Pinus spp.) | Turpentine | 9005-90-7/ 8006-64-2/ 8052-14-0 | 232-688-5/ 232-350-7/ – | New |
| 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 | 80-56-8/ 7785-70-8 127-91-3/ 18172-67-3 | 201-291-9/ 232-087-8 204-872-5/ 242-060-2 | New |
| p- Mentha-1,3-diene | alpha-Terpinene | 99-86-5 | 202-795-1 | New |
| p-Mentha-1,4(8)-diene; Terpinolene | Terpinolene | 586-62-9 | 209-578-0 | New |
| 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 | 8007-00-9 | 232-352-8 | New |
| 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) | 43052-87-5 23726-94-5 24720-09-0 23696-85-7 57378-68-4 71048-82-3 23726-92-3 23726-91-2 | – 245-845-8 246-430-4 245-833-2 260-709-8 275-156-8 245-843-7 245-842-1 | New |
| 3-Propylidene-phthalide | Propylidene phthalide | 17369-59-4 | 241-402-8 | New |
| Verbena absolute (Lippia citriodora Kunth.) | Lippia citriodora absolute | 8024-12-2/ 85116-63-8 | 285-515-0/ – | New |
| [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 | 32388-55-9 | 251-020-3 | New |
| Pentyl-2-hydroxy-benzoate | Amyl salicylate | 2050-08-0 | 218-080-2 | New |
| 1-Methoxy-4-(1E)-1-propen-1-yl-benzene (trans-Anethole) | Anethole | 104-46-1/ 4180-23-8 | 203-205-5/ 224-052-0 | New |
| Benzaldehyde | Benzaldehyde | 100-52-7 | 202-860-4 | New |
| Bornan-2-one; 1,7,7-Trimethylbi-cyclo[2.2.1]-2-heptanone | Camphor | 76-22-2/ 21368-68-3/ 464-49-3/ 464-48-2 | 200-945-0/ 244-350-4/ 207-355-2/ 207-354-7 | New |
| (1R,4E,9S)-4,11,11-Trimethyl-8-methylenebicyclo[ 7.2.0]undec-4-ene; | beta-Caryophyllene | 87-44-5 | 201-746-1 | New |
| 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 | 99-49-0 / 6485-40-1/ 2244-16-8 | 202-759-5/ 229-352-5/ 218-827-2 | New |
| 2-Methyl-1-phenyl-2-propyl acetate | Dimethylbenzyl Carbinyl Acetate | 151-05-3 | 205-781-3 | New |
| Oxacyclohepta-decan-2-one | Hexadecanolactone | 109-29-5 | 203-662-0 | New |
| 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta- γ-2-benzopyran | Hexamethylindanopyran | 1222-05-5 | 214-946-9 | New |
| 3,7-Dimethyl octa-1,6-diene-3-yl acetate | Linalyl acetate | 115-95-7 | 204-116-4 | New |
| Menthol; dl-menthol; l-menthol; d-menthol | Menthol | 89-78-1 / 1490-04-6 / 2216-51-5 / 15356-60-2 | 201-939-0/ 216-074-4/ 218-690-9/ 239-387-8 | New |
| Methyl 2- hydroxy benzoate; Methyl salicylate | Methyl salicylate | 119-36-8 | 204-317-7 | New |
| 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 | 67801-20-1 | 267-140-4 | New |
| o-Hydroxy-benzaldehyde | Salicylaldehyde | 90-02-8 | 201-961-0 | New |
| 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 | 11031-45-1/ 115-71-9/ 77-42-9 | 234-262-4/ 204-102-8/ 201-027-2 | New |
| [1R-(1alpha)]-alpha-Ethenyldecahydro-2-hydroxy-a,2,5,5,8a-pentamethyl-1-naphthalenepropanol | Sclareol | 515-03-7 | 208-194-0 | New |
| 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 | 8000-41-7 98-55-5 138-87-4 586-81-2 | 232-268-1 202-680-6 205-342-6 209-584-3 | New |
| 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 | 54464-57-2/ 54464-59-4/ 68155-66-8/ 68155-67-9/ – | 259-174-3/ 259-175-9/ 268-978-3/ 268-979-9/ 915-730-3 | New |
| 3-(2,2-Dimethyl-3-hydroxypropyl)toluene | Trimethyl-benzenepropanol | 103694-68-4 | 403-140-4 | New |
| 4-Hydroxy-3-methoxybenz-aldehyde | Vanillin | 121-33-5 | 204-465-2 | New |
| 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 | 83863-30-3/ 8006-81-3/ 68606-83-7/ 93686-30-7 | 281-092-1/ 297-681-1/ -/ | New |
| Cinnamomum Cassia Leaf Oil | Cinnamomum Cassia Leaf Oil | 8007-80-5/ 84961-46-6 | -/ 284-635-0 | New |
| Cinnamomum Zeylanicum Bark Oil | Cinnamomum Zeylanicum Bark Oil | 8015-91-6/ 84649-98-9 | 283-479-0/ – | New |
| Citrus Aurantium Flower oil | Citrus Aurantium Amara Flower Oil; Citrus Aurantium Dulcis Flower Oil; | 72968-50-4/ 8028-48-6/ 8016-38-4 | 277-143-2/ 232-433-8/ – | New |
| Citrus Aurantium Peel Oil | Citrus Aurantium Amara Peel Oil; Citrus Aurantium Dulcis Peel Oil; Citrus Sinensis Peel Oil | 68916-04-1/ 72968-50-4 97766-30-8/ 8028-48-6/ 8008-57-9 | -/ 277-143-2 307-891-8/ 232-433-8 | New |
| Bergamot oil | Citrus Aurantium Bergamia Peel Oil; Citrus Aurantium Bergamia Fruit Extract; Citrus Aurantium Bergamia Fruit Oil | 8007-75-8 89957-91-5 68648-33-9/ 8007-75-8/ 85049-52-1 | 616-915-9 289-612-9 -/ 616-915-9/ – | New |
| Citrus Limon oil | Citrus Limon Peel Oil | 84929-31-7/ 8008-56-8 | 284-515-8/ – | New |
| Cymbopogon Citratus / Schoenanthus/Flexuosus Oils |
Cymbopogon Schoenanthus Oil; Cymbopogon Flexuosus Oil; Cymbopogon Citratus Leaf Oil; Cymbopogon Citratus Extract | 8007-02-1/ 89998-16-3 91844-92-7 8007-02-1/ 91844-92-7 89998-14-1 | -/ 289-754-1 295-161-9 295-161-9/ 295-161-9 289-752-0 | New |
| Eucalyptus Globulus Oil | Eucalyptus Globulus Leaf Oil; Eucalyptus Globulus Leaf/Twig Oil | 97926-40-4/ 8000-48-4 | -/ 616-775-9 | New |
| Eugenia Caryophyllus Leaf Oil | Eugenia Caryophyllus Leaf Oil; Eugenia Caryophyllus Flower Oil; Eugenia Caryophyllus Stem Oil; Eugenia Caryophyllus Bud Oil; | 8000-34-8 / 8015-97-2/ 84961-50-2 | 616-772-2/ 284-638-7/ – | New |
| Jasminum Grandiflorum / Officinale oil and extract | Jasminum Grandiflorum Flower Extract; Jasminum Officinale Oil; Jasminum Officinale Flower Extract | 84776-64-7 90045-94-6/ 8022-96-6/ 8024-43-9 90045-94-6 | 283-993-5 289-960-1/ -/ – 289-960-1 | New |
| Juniperus Virginiana oil | Juniperus Virginiana Oil; Juniperus Virginiana Wood Oil | 8000-27-9 / 85085-41-2 | -/ 285-370-3 | New |
| Laurus Nobilis oil (with the exception of the substance in Annex II, reference number 359) | Laurus Nobilis Leaf Oil | 8002-41-3/ 8007-48-5/ 84603-73-6 | -/ -/ 283-272-5 | New |
| 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 | 91722-69-9/ 8022-15-9/ 93455-96-0/ 93455-97-1/ 92623-76-2/ 84776-65-8/ 8000-28-0/ 90063-37-9 | 294-470-6/ -/ -/ -/ 296-408-3/ 83-994-0/ -/ 289-995-2 | New |
| Mentha Piperita oil | Mentha Piperita Oil | 8006-90-4 / 84082-70-2 | -/ 282-015-4 | New |
| Spearmint oil/Spearmint ext. | Mentha Viridis Leaf Oil Mentha Spicata Oil | 8008-79-5 84696-51-5 | 616-927-4 283-656-2 | New |
| Narcissus extract | Narcissus Poeticus Extract Narcissus Pseudonarcissus Flower Extract Narcissus Jonquilla Extract Narcissus Tazetta Extract |
90064-26-9/68917-12-4 90064-27-0 90064-25-8 | 290-087-3/ – 290-086-8 |
New |
| Pelargonium Graveolens oil | Pelargonium Graveolens Flower Oil | 90082-51-2/ 8000-46-2 | 290-140-0/ – | New |
| Pogostemon Cablin oil | Pogostemon Cablin Oil | 8014-09-3/ 84238-39-1 | -/282-493-4 | New |
| 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 | 8007-01-0/ 93334-48-6/ 84696-47-9/ 84604-12-6/ 90106-38-0/ 84604-13-7/ 92347-25-6 | 297-1221/ 283-652-0/ 283-289-8/ 290-260-3/ 283-290-3/ 296-213-3/ – | New |
| Santalum Album oil | Santalum Album Oil; Santalum Album Wood Oil | 8006-87-9/ 84787-70-2 | -/ 284-111-1 | New |
| Phenol, 2-methoxy-4-(2-propenyl)-, acetate | Eugenyl acetate | 93-28-7 | 202-235-6 | New |
| 2,6-Octadien-1-ol, 3,7-dimethyl-,1-acetate, (2E)- | Geranyl acetate | 105-87-3 | 203-341-5 | New |
| 2-Methoxy-4-prop-1-enylphenyl acetate | Isoeugenyl acetate | 93-29-8 | 202-236-1 | New |
| 6-Methylcoumarin | 6-Methylcoumarin | 92-48-8 | 202-158-8 | New |