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Nov 27, 2025 - Cosmetics
New limits for hexyl salicylate in cosmetics: EU and United Kingdom diverge regulatory
Hexyl Salicylate, an allergenic fragrance with a sweet, floral, and fruity aroma, has been classified as a CMR substance of category 2 (carcinogenic, mutagenic, toxic to reproduction) in both the European Union and the United Kingdom. As part of the omnibus procedure, the substance was included in Annex III of Regulation (EC) No 1223/2009 and is thus subject to specific concentration restrictions for different product categories, as explained in the SCCS Opinion (SCCS/1658/23) as well as the associated addendum (SCCS/1668/24).
For the EU the following applies: In products expressly intended for children under three years of age, Hexyl Salicylate is fundamentally prohibited – except for defined product groups. A maximum of 0.1 % is allowed in shower gel, hand soap, shampoo, hair conditioner, body lotion, face and hand cream, lip care, and perfumes; for toothpaste, a limit of 0.001 % applies.
In the United Kingdom, however, uniform concentration limits apply for all age groups: 2 % for hydroalcoholic-based fragrances, 0.5 % for rinse-off products, 0.3 % for leave-on products, and 0.001 % for oral care products. There is no special regulation for products specifically intended for children under three years in the UK.
The new requirements highlight the increasingly divergent development of cosmetic regulatory frameworks between the EU and the UK.
Sources:
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