Labeling of additional fragrance allergens

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:
    1. By means of a website address
    2. By means of QR codes
    3. 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 / INNName of Common Ingredients GlossaryCASECCurrent or new
3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-oneAlpha-Isomethyl ionone127-51-5204-846-3Current
2-BenzylideneheptanalAmyl cinnamal122-40-7204-541-5Current
2-Pentyl-3-phenylprop-2-en-1-olAmylcinnamyl alcohol101-85-9202-982-8Current
4-Methoxybenzyl alcoholAnise alcohol105-13-5203-273-6Current
Benzyl alcoholBenzyl alcohol100-51-6202-859-9Current
Benzyl benzoateBenzyl benzoate120-51-4204-402-9Current
2-Propenoic acid, 3-phenyl-, phenylmethyl esterBenzyl cinnamate  103-41-3203-109-3Current
Benzyl salicylateBenzyl salicylate118-58-1204-262-9Current
2-Propenal, 3-phenyl-Cinnamal104-55-2203-213-9Current
Cinnamyl alcoholCinnamyl alcohol104-54-1203-212-3Current
3,7-Dimethyl-2,6-octadienalCitral5392-40-5226-394-6Current
Citronellol/ (±) 3,7-Dimethyl-6-octen-1-ol Citronellol106-22-9/ 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-oneCoumarin91-64-5202-086-7Current
Phenol, 2-methoxy-4-(2-propenyl)-Eugenol97-53-0202-589-1Current
2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl-Farnesol4602-84-0225-004-1Current
2,6-Octadien-1-ol, 3,7-dimethyl-,(2E)-Geraniol106-24-1  203-377-1Current
2-BenzylideneoctanalHexyl cinnamal101-86-0202-983-3Current
7-HydroxycitronellalHydroxycitronellal107-75-5203-518-7Current
Phenol, 2-methoxy-4- (1-propenyl)Isoeugenol97-54-1202-590-7  Current
d,l-Limonene (racemic);d- limonene; l-limoneneLimonene  138-86-3/ 5989-27-5/ 5989-54-8231-732-0/ 227-813-5/ 227-815-6Current
1,6-Octadien-3-ol, 3,7-dimethyl-Linalool78-70-6201-134-4Current
Methyl heptine carbonateMethyl 2-octynoate111-12-6203-836-6Current
Oak moss extractEvernia Prunastri Extract90028-68-5289-861-3Current
Treemoss extractEvernia Furfuracea Extract90028-67-4289-860-8Current
Pinus Mugo leaf and twig oil and extractPinus Mugo Leaf oil90082-72-7290-163-6New
Pinus Pumila leaf and twig oil and extractPinus Pumila Needle Extract97676-05-6307-681-6New
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 Oil92201-55-3/ 8023-85-6/295-985-9/ -/  New
Turpentine gum (Pinus spp.); Turpentine oil and rectified oil; Turpentine, steam distilled (Pinus spp.)Turpentine9005-90-7/ 8006-64-2/ 8052-14-0232-688-5/ 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/ 18172-67-3201-291-9/ 232-087-8 204-872-5/ 242-060-2 New
p- Mentha-1,3-dienealpha-Terpinene99-86-5202-795-1New
p-Mentha-1,4(8)-diene; TerpinoleneTerpinolene586-62-9209-578-0New
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 Extract8007-00-9232-352-8New
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-oneRose 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-phthalidePropylidene phthalide17369-59-4241-402-8New
Verbena absolute (Lippia citriodora Kunth.)Lippia citriodora absolute8024-12-2/ 85116-63-8285-515-0/ –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-oneAcetylcedrene32388-55-9251-020-3New
Pentyl-2-hydroxy-benzoateAmyl salicylate2050-08-0218-080-2New
1-Methoxy-4-(1E)-1-propen-1-yl-benzene (trans-Anethole)Anethole104-46-1/ 4180-23-8203-205-5/ 224-052-0 New
BenzaldehydeBenzaldehyde100-52-7202-860-4New
Bornan-2-one; 1,7,7-Trimethylbi-cyclo[2.2.1]-2-heptanoneCamphor76-22-2/ 21368-68-3/ 464-49-3/ 464-48-2200-945-0/ 244-350-4/ 207-355-2/ 207-354-7New
(1R,4E,9S)-4,11,11-Trimethyl-8-methylenebicyclo[ 7.2.0]undec-4-ene;beta-Caryophyllene87-44-5201-746-1New
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-cyclohexenoneCarvone99-49-0 / 6485-40-1/ 2244-16-8202-759-5/ 229-352-5/ 218-827-2New
2-Methyl-1-phenyl-2-propyl acetateDimethylbenzyl Carbinyl Acetate151-05-3205-781-3New
Oxacyclohepta-decan-2-oneHexadecanolactone109-29-5203-662-0New
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta- γ-2-benzopyranHexamethylindanopyran1222-05-5214-946-9New
3,7-Dimethyl octa-1,6-diene-3-yl acetateLinalyl acetate  115-95-7204-116-4New
Menthol; dl-menthol; l-menthol; d-mentholMenthol89-78-1 / 1490-04-6 / 2216-51-5 / 15356-60-2  201-939-0/  216-074-4/ 218-690-9/ 239-387-8New
Methyl 2- hydroxy benzoate;   Methyl salicylateMethyl salicylate119-36-8204-317-7New
3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl)pent-4-en-2-ol3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl)pent-4-en-2-ol67801-20-1267-140-4New
o-Hydroxy-benzaldehydeSalicylaldehyde90-02-8201-961-0New
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/ 201-027-2New
[1R-(1alpha)]-alpha-Ethenyldecahydro-2-hydroxy-a,2,5,5,8a-pentamethyl-1-naphthalenepropanolSclareol515-03-7208-194-0New
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   586-81-2232-268-1 202-680-6   205-342-6   209-584-3New
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)-ethanoneTetramethyl acetyloctahydro-naphthalenes54464-57-2/ 54464-59-4/ 68155-66-8/ 68155-67-9/ –259-174-3/ 259-175-9/ 268-978-3/ 268-979-9/ 915-730-3New
3-(2,2-Dimethyl-3-hydroxypropyl)tolueneTrimethyl-benzenepropanol103694-68-4403-140-4New
4-Hydroxy-3-methoxybenz-aldehydeVanillin121-33-5204-465-2New
Cananga Odorata flower oil; Cananga Odorata Flower Extract; Ylang Ylang Flower oil and ExtractCananga Odorata Flower Extract; Cananga Odorata Flower Oil; Cananga Odorata Flower Wax; Cananga Odorata Leaf Oil83863-30-3/ 8006-81-3/ 68606-83-7/ 93686-30-7 281-092-1/ 297-681-1/ -/  New
Cinnamomum Cassia Leaf OilCinnamomum Cassia Leaf Oil8007-80-5/ 84961-46-6-/ 284-635-0New
Cinnamomum Zeylanicum Bark OilCinnamomum Zeylanicum Bark Oil8015-91-6/ 84649-98-9283-479-0/ –New
Citrus Aurantium Flower oil  Citrus Aurantium Amara Flower Oil; Citrus Aurantium Dulcis Flower Oil;72968-50-4/ 8028-48-6/ 8016-38-4277-143-2/ 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/ 232-433-8New
Bergamot oil      Citrus Aurantium Bergamia Peel Oil; Citrus Aurantium Bergamia Fruit Extract; Citrus Aurantium Bergamia Fruit Oil8007-75-8 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 Oil84929-31-7/ 8008-56-8284-515-8/ –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/ 295-161-9 289-752-0New
Eucalyptus Globulus Oil  Eucalyptus Globulus Leaf Oil; Eucalyptus Globulus Leaf/Twig Oil97926-40-4/  8000-48-4-/ 616-775-9New
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/ 84961-50-2616-772-2/ 284-638-7/ –New
Jasminum Grandiflorum / Officinale oil and extract    Jasminum Grandiflorum Flower Extract;   Jasminum Officinale Oil; Jasminum Officinale Flower Extract84776-64-7   90045-94-6/ 8022-96-6/ 8024-43-9 90045-94-6283-993-5   289-960-1/ -/ – 289-960-1New
Juniperus Virginiana oil  Juniperus Virginiana Oil; Juniperus Virginiana Wood Oil8000-27-9 / 85085-41-2-/ 285-370-3New
Laurus Nobilis oil (with the exception of the substance in Annex II, reference number 359)Laurus Nobilis Leaf Oil8002-41-3/ 8007-48-5/ 84603-73-6-/ -/ 283-272-5New
Lavandula Hybrida oil;   Lavandula intermedia oil;   Lavandula Angustifolia OilLavandula 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 Extract91722-69-9/ 8022-15-9/ 93455-96-0/ 93455-97-1/   92623-76-2/               84776-65-8/ 8000-28-0/ 90063-37-9294-470-6/ -/ -/ -/   296-408-3/               83-994-0/ -/ 289-995-2New
Mentha Piperita oil  Mentha Piperita Oil  8006-90-4 / 84082-70-2-/ 282-015-4New
Spearmint oil/Spearmint ext.  Mentha Viridis Leaf Oil Mentha Spicata Oil8008-79-5 84696-51-5616-927-4 283-656-2New
Narcissus  extractNarcissus Poeticus Extract

Narcissus Pseudonarcissus Flower Extract Narcissus Jonquilla Extract Narcissus Tazetta Extract
90064-26-9/68917-12-4 90064-27-0 90064-25-8290-087-3/ –

290-086-8  
New
Pelargonium Graveolens oil  Pelargonium Graveolens Flower Oil90082-51-2/ 8000-46-2290-140-0/ –New
Pogostemon Cablin oilPogostemon Cablin Oil8014-09-3/ 84238-39-1-/282-493-4New
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 OilRosa 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 Oil8007-01-0/ 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 oilSantalum Album Oil; Santalum Album Wood Oil8006-87-9/ 84787-70-2-/ 284-111-1  New
Phenol, 2-methoxy-4-(2-propenyl)-, acetateEugenyl acetate93-28-7202-235-6 New
2,6-Octadien-1-ol, 3,7-dimethyl-,1-acetate, (2E)-Geranyl acetate105-87-3203-341-5New
2-Methoxy-4-prop-1-enylphenyl acetateIsoeugenyl acetate93-29-8202-236-1New
6-Methylcoumarin6-Methylcoumarin92-48-8202-158-8New

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