Cosmetic regulations concerning allergens are very strict in Europe, particularly under Regulation (EC) No 1223/2009 on cosmetic products.
Fragrance substances are organic compounds with characteristic, generally pleasant, odors. They are widely used in perfumes and other scented cosmetic products, as well as in many household products such as detergents, fabric softeners, etc.
Allergens can cause allergic skin reactions in some people and are regulated in Annex III of Regulation (EC) No 1223/2009.
Currently, 26 allergens are recognized under the cosmetics regulation (EC) No 1223/2009.
In Europe, the labeling of allergens in cosmetic products is strictly regulated by Regulation (EC) No 1223/2009. Substances recognized as allergens are listed in Annex III of this regulation. When present above certain thresholds, their declaration on the product label is mandatory to inform consumers and prevent allergic reactions.
These allergens are primarily derived from perfumes or essential oils and must be listed in the INCI list if their concentration exceeds:
0.001% (10 ppm) in leave-on products (creams, deodorants, perfumes, etc.)
0.01% (100 ppm) in rinse-off products (shampoos, shower gels, etc.)
Some of these allergens are now prohibited by the cosmetics regulation, such as lilial and lyral, while others are restricted substances, meaning they can only be used under certain conditions and within a maximum concentration limit.
New European Regulation (EU Regulation 2023/1545)
On July 26, 2023, the European Union published the new Regulation 2023/1545, which concerns the labeling of allergenic fragrance substances on cosmetic product labels. This regulation mandates the labeling of 80 substances identified as allergens and will come into effect in July 2026.
đź“… Implementation Timeline:
• Entry into force: August 16, 2023
• Transition Period:
o New products → mandatory compliance by July 2026
o Products already on the market → until July 2028 to sell off existing stock