New allergen list
The number of potential allergens to be declared in future has been published in a new allergen list. A new Regulation (EU) 2023/1545 of 26 July 2023 amending the Annexes to the EC Cosmetics Regulation was published in the Official Journal of the EU of 27 July 2023 (L 188). The purpose of this regulation is to extend the labelling requirements for potentially allergenic fragrances in cosmetic products. The new regulation came into force on 15 August 2023. It brings extensive changes to the labelling of fragrance allergens.
The regulation on cosmetic products
The Cosmetic Products Regulation (EC 1223/2009) provides the legal framework for finished cosmetic products on the European Union market. It lays down the rules for cosmetic products to ensure safety and a high level of public health protection.
Fragrances are used in various cosmetic products to give them a pleasant, characteristic scent. However, they can lead to contact allergies and irritation.
The regulation stipulates the labelling criteria for cosmetics. Certain fragrances must be listed individually and are listed in Annex III of Regulation 1223/2009. The previous allergen declaration required individual labelling for 26 ingredients.
According to Article 19(1), point (g) of the Cosmetics Regulation, substances used as fragrance ingredients are listed in the labelling as “perfume” or “flavouring”. However, if such substances are to be regarded as fragrance allergens, they must be listed individually if they are contained in concentrations above 0.001% in leave-on products (cream, perfume, hair styling) and 0.01% in rinse-off products (shower gel, shampoo, soap).
New allergen list
The new Regulation (EU) 2023/1545 supplements and amends Annex III of the Cosmetics Regulation (EC) 1223/2009, requiring additional substances to be included as fragrance allergens and imposing further restrictions on fragrance allergens already listed, concerning certain product groups or maximum concentrations in ready-to-use preparations and purity requirements.
Scientific Committee on Consumer Safety (SCCS) identified 56 additional substances as allergens that had not previously been listed individually. As a result, the European Commission added the new allergen list with corresponding entries to Annex III of the Cosmetics Regulation.
This mainly concerns a large number of natural essential oils and their components, in particular citrus oils such as bergamot oil and orange oil, ylang ylang oil, lavender oils, jasmine oil and rose oil. Often found these potential allergens in natural cosmetic formulations.
The new allergen list also includes ingredients frequently used in cosmetic formulations, such as beta-caryophyllene, linalyl acetate, pinenes, rose ketones and vanillin.
Fragrance substances such as prehaptens and prohaptens, which can be converted into known contact allergens through oxidation or bioactivation, are treated in the same way as fragrance allergens, so that the same restrictions and changes apply to them.
In addition, various changes have been made to the names of existing entries and the addition of various common names of isomers.
In order to simplify labelling and make it more consumer-friendly, the labelling regulation for allergens specifies which term is to be used.
The identified fragrance allergens have been added to Annex III of Regulation 1223/2009 and must be indicated on the label in addition to the term “perfume” or “flavouring”.
The implementation
In order to allow a reasonable period of time to adapt to the updated labelling requirements, the European Commission is providing for a transitional period.
This period is five years, i.e. until 31 July 2028, to place new products that comply with the updated provisions on the EU market and three years, until 31 July 2026, to sell products already on the market or withdraw them from the market.
After that, monitoring authorities can oblige suppliers of products with old labelling to recall the goods.
The previous allergen declaration
According to the previous allergen declaration, the following allergens must be declared in the list of ingredients.
PREVIOUS ALLERGEN DECLARATION FOR THE 26 FRAGRANCES REQUIRING LABELLING
Amyl cinnamal
Benzyl Alcohol
Cinnamyl Alcohol
citral
eugenol
Hydroxy citronellal
isoeugenol
Amylcine-namyl alcohol
Benzyl salicylate
cinnamal
coumarin
geraniol
Hydroxy-methylpentylcyclohexenecarboxaldehyde
Anisyl Alcohol
Benzyl Cinnamate
farnesol
2-(4-tert-Butylbenzyl) propionaldehyde
linalool
Benzyl Benzoate
citronellol
Hexyl cinnamaldehyde
d-Limonene
Methyl Heptin Carbonate
3-Methyl-4-(2,6,6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one
Oak Moss Extract
Treemoss Extract
The extended new potential allergen list
The declaration obligation for use concentrations also applies to the new allergen list
≥ 0.001 % in leave-on products and ≥ 0.01 % in rinse-off products.
The new or amended entries in Annex III of the EC Cosmetics Regulation and the associated INCI designations to be used for labelling are listed below.
| CAS NUMBER | INCI Name | |
|---|---|---|
| 32388-55-9 | Acetyl Cedrene | |
| 122-40-7 | Amyl Cinnamal | |
| 2050-08-0 | Amyl Salicylate | |
| 101-85-9 | Amyl Cinnamyl Alcohol | |
| 105-13-5 | Anise Alcohol | |
| 4180-23-8;104-46-1 | Anethole | |
| 100-52-7 | Benzaldehyde | |
| 100-51-6 | Benzyl Acohol | |
| 120-51-4 | Benzyl Benzoate | |
| 103-41-3 | Benzyl Cinnamate | |
| 118-58-1 | Benzyl Salicylate | |
| 80-54-6 | Butyl Phenyl Methylpropional | |
| 76-22-2;464-49-3; 21368-68-3;464-48-2 | Camphor | |
| 83863-30-3;93686-30-7; 8006-81-3;68606-83-7 | Cananga Odorata Oil/Extract | |
| 99-49-0; 6485-40-1 2244-16-8 | Carvone | |
| 87-44-5 | Beta-Caryophyllene | |
| 92201-55-3;8023-85-6 | Cedrus Atlantica Oil/ Extract | |
| 104-55-2 | Cinnamal | |
| 84961-46-6; 8007-80-5 | Cinnamomum Cassia Leaf Oil | |
| 84649-98-9; 8015-91-6 | Cinnamomum Zeylanicum Bark Oil | |
| 104-54-1 | Cinnamyl Alcohol | |
| 5392-40-5; 141-27-5 106-26-3 | Citral | |
| 106-22-9 26489-01-0; 1117-61-9; 7540-51-4 | Citronellol | |
| 72968-50-4;8028-48-6 8016-38-4 | Citrus Aurantium Flower Oil | |
| 68916-04-1; 72968-50-4 97766-30-8; 8028-48-6; 8008-57-9 | Citrus Aurantium Peel Oil | |
| 8007-75-8; 89957-91-5 68648-33-9; 8007-75-8; 85049-52-1 | Citrus Aurantium Bergamia Peel Oil | |
| 84929-31-7; 8008-56-8 | Citrus Limon Peel Oil | |
| 91-64-5 | Coumarin | |
| 151-05-3 | Dimethyl Phenethyl Acetate | |
| 97926-40-4; 8000-48-4 | Eucalyptus Globulus Oil | |
| 8000-34-8; 8015-97-2 84961-50-2 | Eugenia Caryophyllus Oil | |
| 97-53-0 | Eugenol | |
| 93-28-7 | Eugenyl Acetate | |
| 90028-67-4 | Evernia Furfuracea Extract | |
| 90028-68-5 | Evernia Prunastri Extract | |
| 4602-84-0 | Farnesol | |
| 106-24-1 | Geraniol | |
| 105-87-3 | Geranyl Acetate | |
| 109-29-5 | Hexadecanolactone | |
| 1222-05-5 | Hexamethylindanopyran | |
| 101-86-0 | Hexyl Cinnamal | |
| 107-75-5 | Hydroxycitronellal | |
| 31906-04-4 | Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde | |
| 127-51-5 | alpha-Isomethyl Ionone | |
| 97-54-1 ; 5932-68-3; 5912-86-7 | Isoeugenol | |
| 93-29-8 | Isoeugenyl Acetate | |
| 84776-64-7;90045-94-6; 8022-96-6; 8024-43-9 90045-94-6 | Jasmine Oil/Extract | |
| 85085-41-2;8000-27-9 | Juniperus Virginiana Oil | |
| 84603-73-6;8002-41-3; 8007-48-5 | Laurus Nobilis Leaf Oil | |
| 91722-69-9; 8022-15-9 93455-96-0; 93455-97-1 92623-76-2; 84776-65-8; 8000-28-0; 90063-37-9 | Lavandula Oil/ Extract | |
| 89998-16-3;8007-02-1; 91844-92-7 | Lemongrass Oil | |
| 5989-27-5; 5989-54-8 138-86-3; 7705-14-8 | Limonene | |
| 78-70-6 | Linalool | |
| 115-95-7 | Linalyl Acetate | |
| 85116-63-8;8024-12-2 | Lippia Citriodora Absolute | |
| 84082-70-2;8006-90-4 | Mentha Piperita Oil | |
| 84696-51-5;8008-79-5 | Mentha Viridis Leaf Oil | |
| 89-78-1;2216-51-5; 1490-04-6;15356-60-2 | Menthol | |
| 111-12-6 | Methyl 2-Octynoate | |
| 92-48-8 | 6-Methyl coumarine | |
| 119-36-8 | Methyl Salicylate | |
| 8007-00-9 | Myroxylon Pereirae Oil/ Extract | |
| 90064-26-9; 68917-12-4 90064-27-0 90064-25-8 | Narcissus Extract | |
| 90082-51-2;8000-46-2 | Pelargonium Graveolens Flower Oil | |
| 80-56-8;7785-70-8; 127-91-3; 18172-67-3 | Pinene | |
| 90082-72-7 | Pinus Mugo | |
| 97676-05-6 | Pinus Pumila | |
| 84238-39-1 ;8014-09-3 | Pogostemon Cablin Oil | |
| 17369-59-4 | 3-Propylidenephthalide | |
| 8007-01-0; 93334-48-6; 84696-47-9; 84604-12-6; 90106-38-0; 84604-13-7; 92347-25-6 | Rose Flower Oil/Extract | |
| 23696-85-7; 43052-87-5; 23726-94-5, 24720-09-0; 23726-92-3; 57378-68-4;71048-82-3; 23726-91-2 | Rose Ketones | |
| 90-02-8 | Salicylaldehyde | |
| 11031-45-1;115-71-9;77-42-9 | Santalol | |
| 84787-70-2;8006-87-9 | Santalum Album Oil | |
| 515-03-7 | Sclareol | |
| 99-86-5 | alpha -Terpinene | |
| 98-55-5;138-87-4; 586-81-2;8000-41-7 | Terpineol | |
| 586-62-9 | Terpinolene | |
| 68155-66-8;54464-57-2; 54464-59-4;68155-67-9 | Tetramethyl Acetyloctahydronaphtalenes | |
| 103694-68-4 | Trimethylbenzenepropanol | |
| 67801-20-1 | Trimethylcyclopentenyl Methylisopentenol | |
| 8006-64-2;9005-90-7; 8052-14-0 | Turpentine | |
| 121-33-5 | Vanillin |
For more safety and better orientation
The extension of the previous allergen declaration by the new allergen list poses major challenges for manufacturers of cosmetic products, be it reformulation, the development of new formulations, compliance with updated lists for perfume oils or essential oils, the new labelling of existing products or the consideration of other potentially allergenic fragrance ingredients in new formulations, which are also increasingly affecting natural cosmetics. In order to exclude non-conformities, databases must be adapted, documentation elements, safety reports and product information files must be changed or adapted.
Cosmacon will be happy to advise and assist you in reformulating or reformulating your products in accordance with the new regulations. The existing allergen declaration and the extended new allergen list will ultimately help to provide customers with safe, well-tolerated products and good guidance. However, it will most likely also lead to more expensive products, as perfume suppliers will now have to carry out significantly more analyses and all distributors will have to provide significantly more documentation.
The significant increase in INCI lists should also be viewed critically, as these now require considerably more space on the packaging.
Literature:
German and English version of the legal text: