On 14 November 2025, the UK Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) released a new scientific opinion on Hexyl Salicylate (CAS 6259-76-3).
Hexyl Salicylate, widely used as a fragrance ingredient for its sweet, floral, and fruity odour, has been classified as a Carcinogenic, Mutagenic or Reprotoxic (CMR) category 2 substance under both the EU and GB CLP regulations. In the European Union, the substance was recently added to Annex III of the Cosmetics Regulation through Omnibus Act VIII.
The specific concentration limits proposed by the UK SAG-CS differ from the limits adopted in the EU. This creates another point of divergence between the two regulatory frameworks.
SAG-CS proposed concentration limits
According to the table published in the SAG-CS opinion, Hexyl Salicylate is considered safe in the UK at the following maximum concentrations:
- Hydroalcoholic-based fragrances – 2%
- All rinse-off products – 0.5%
- All leave-on products – 0.3%
- Oral care (toothpaste and mouthwash) – 0.001%
New EU restrictions on Hexyl Salicylate
Compared to Great Britain’s approach, the EU restrictions incorporate additional conditions linked to product type and child exposure, following an addendum to the SCCS opinion first issued in 2023. This addendum specifically assessed the safety of Hexyl Salicylate in products intended for children under three years old, resulting in stricter, more specific, limits.
The EU Annex III entry regulates Hexyl Salicylate as follows:
- Hydroalcoholic-based fragrances – 2%
- All rinse-off products (excluding shower gel, hand wash, hair conditioner, and shampoo intended for children under 3) – 0.5% – an additional warning should be included to ban its use in products for children under 3 years
- All leave-on products (except hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm and fragrance products intended for children below 3 years of age)) – 0.3% – an additional warning should be included to ban its use in products for children under 3 years
- Toothpaste – 0.001% – (allowed for children under 3)
- Mouthwash – 0.001% – (not allowed for children under 3)
- Shower gel, hand wash, shampoo, hair conditioner, body/face/hand care products, lipstick/lip balm, and fragrances intended for children under 3 – 0.1%
Key differences between the SAG-CS and EU restrictions
Child-specific restrictions
The EU includes detailed limits for products intended for children under three years, depending on the product category.
Generally, in the EU the use of Hexyl Salicylate is banned in products intended for children under three years of age except for the following product categories:
- Shower gel, hand wash, shampoo, hair conditioner, body/face/hand care products, lipstick/lip balm, and fragrances intended for children under 3 – allowed at a concentration of 0.1%
- Toothpaste – allowed at a concentration of 0.001%
In contrast, the UK SAG-CS is not proposing child-specific provisions.
Oral care
Both the EU and SAG-CS permit the use of Hexyl Salicylate at 0.001% in toothpaste and mouthwash. However, the EU does not allow the use of mouthwash containing Hexyl Salicylate for children under three.
Do you have questions on compliance of cosmetics in the EU, UK, USA, and Canada? Contact us here or at coslaw@obelis.net.
References
SAG-CS. (2025). Final Opinion on Hexyl Salicylate in Cosmetic Products. Retrieved on 14 November 2025.
WTO. (2025). Draft Annex to the Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetics products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 21 May 2025.
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