UK updates regulations for hexyl salicylate; diverging from EU

EU regulations
The UK's new regulations for hexyl salicylate has diverged from the EU's view on this ingredient. (Getty Images)

As both UK and EU cosmetics regulations continue to change, the UK has recently updated its restrictions on the use of hexyl salicylate in cosmetic products and expanded the list of banned substances it considers to be carcinogenic, mutagenic, or toxic to reproduction.

Hexyl salicylate, an organic compound fragrance ingredient that has a sweet floral aroma, can be used to formulate a range of beauty and personal care products including colour cosmetics, fragrances, shampoos, soaps and other toiletries.

Based on the evidence that was available to the Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS), members agreed that hexyl salicylate is acceptable for use in cosmetic products intended for use by adults and children over the age of three at the following concentrations:

  • Hydroalcoholic-based fragrances (spray and non-spray): 2%
  • All rinse-off products: 0.5%
  • All leave-on products: 0.3%
  • All oral care products: 0.001%

However, as the data was limited for children (aged three and above), the SAG-CS said that a full risk assessment should be conducted when an adequate methodology and data become available.

Based on the evidence available to the SAG-CS, members agreed that hexyl salicylate is acceptable for use in cosmetic products intended for use by children aged 0-3 at the following concentrations:

  • 0.1% for use in shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm, fragrance products
  • 0.001% in toothpaste.

The SAG-CS said it based these conclusions on the exposures derived from the new baby study by Cosmetics Europe using P95 aggregate exposures.

Any products that contain hexyl salicylate that are placed on the market before 15 August 2026 may continue to be made available until 14 February 2027.

In addition to the hexyl salicylate restrictions, a host of other substances have also been banned or restricted in cosmetics formulations. Any products that contain the banned substances that are on the market before 23 March 2027 may continue to be made available until 22 September 2027.

Regulations divergence with the EU

The restrictions placed on hexyl salicylate restrictions are diverging with the EU regulations. In oral care products, the UK permits the use of hexyl salicylate in both toothpastes and mouthwashes for children under three whereas the EU restriction allows its use only in toothpastes for this age group.

In the EU, the following warning statement must be added to mouthwashes containing hexyl salicylate: “Not to be used for children under 3 years of age” – a requirement that is not included in the UK amendment.