On July 27, 2023, the European Commission published Regulation 2023/1545 of July 26, 2023, amending Regulation (EC) No 1223/2009, to add new fragrance allergens in cosmetic products that must be mentioned in the list of ingredients. These changes aim to improve cosmetic products' safety for consumers prone to allergic reactions to fragrance substances.
Among the key changes introduced by Regulation 2023/1545, we can highlight the following:
The list of fragrance allergens that must be individually labeled on cosmetic products has been expanded by 56 new substances.
New fragrance allergens must be labeled if their concentration exceeds 0.001% in leave-on products and 0.01% in wash-off products.
Prehaptens and prohaptens, which can be converted into known contact allergens, have also been added to the list.
Some existing entries on fragrance allergens in Annex III to Regulation (EC) No 1223/2009 have also been updated for consistency and clarity. Isomers have been added and the corresponding CAS and EC numbers have been supplemented and changed to make it easier for manufacturers.
For new cosmetic products entering the EU market, within 3 years, until July 31, 2026.
For cosmetic products that are already on the EU market, within 5 years, until July 31, 2028.
First of all, the changes in EU legislation are important for companies supplying cosmetic products to the EU markets, as well as for those who are just planning to enter new markets of the European Union.
Since Ukrainian legislation will eventually be harmonized with EU legislation, cosmetic manufacturers should be aware of the new labeling requirements and plan for changes in advance.
Here is an example of how new substances can be marked on cosmetic product labels:
Pinus Mugo
Pinus Pumila
Cedrus Atlantica Oil/Extract
Turpentine
Alpha-Terpinene
Terpinolene
Myroxylon Pereirae Oil/Extract
Rose Ketones
3-Propylidenephthalide
Lippia citriodora absolute
Methyl Salicylate
Acetyl Cedrene
Amyl Salicylate
Anethole
Benzaldehyde
Camphor
Beta-Caryophyllene
Carvone
Dimethyl Phenethyl Acetate
Hexadecanolactone
Hexamethylindanopyran
Linalyl Acetate
Menthol
Trimethylcyclopentenyl Methylisopentenol
Salicylaldehyde
Santalol
Sclareol
Terpineol
Tetramethyl acetyloctahydronaphthalenes
Trimethylbenzenepropanol
Vanillin
Cananga Odorata Oil/Extract
Cinnamomum Cassia Leaf Oil
Cinnamomum Zeylanicum Bark Oil
Citrus Aurantium Flower Oil
Citrus Aurantium Peel Oil
Citrus Aurantium Bergamia Peel Oil
Citrus Limon Peel Oil
Lemongrass Oil
Eucalyptus Globulus Oil
Eugenia Caryophyllus Oil
Jasmine Oil/Extract
Juniperus Virginiana Oil
Laurus Nobilis Leaf Oil
Lavandula Oil/Extract
Mentha Piperita Oil
Mentha Viridis Leaf Oil
Narcissus Extract
Pelargonium Graveolens Flower Oil
Pogostemon Cablin Oil
Rose Flower Oil / Extract
Santalum Album Oil
Eugenyl Acetate
Geranyl Acetate
Isoeugenyl Acetate
Pinene
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