UK SAG-CS Issued Opinion on Homosalate in Cosmetics

In May, 2025, Scientific Advisory Group of Chemical Safety of Non-food and Non-medicinal Consumer Products (SAG-CS) issued opinion on Homosalate in Cosmetics (Opinion 17).

SAG-CS concludes the following: 

Members agreed that the most appropriate dermal absorption value to use in the safety assessment was 5.3% based on the results of the study by Finlayson (2021).

Members agreed that the pivotal study by Dettwiler, (2013), contained deficiencies which had the potential to limit its usefulness in the safety assessment. However, members concluded that, whilst the reproductive rate was low, adverse effects were observed across the two highest dose groups and therefore they were happy to accept the results from this study. The NOAEL of 120mg/kg bw/day was therefore accepted as the point of departure for homosalate.

Members were content to accept the PBPK modelling presented by the applicant following an independent review provided by an invited expert and therefore the margin of safety could be reduced from 100 to 25 in this case due to removal of the interspecies safety factor of 4. Calculations based on the exposure metrics from the PBPK modelling (section 5), as well as those using the SED calculation from the SCCS notes of guidance (Annex 1)all give margins of safety in excess of 25.

Members concluded that homosalate is safe at a maximum concentration of 10% in sunscreen products. An adequate analytical method appears to be available for homosalate.

Regulatory Requirements Interpretation of Homosalate

The Global Cosmetic Ingredient Regulatory Database-Global CosIng, an upgraded version of China CosIng independently developed by CIRS Group indicates that Homosalate (CAS No.50-00-0) has been included in the following key lists globally.

【UK】Homosalate is currently included in the list of substances permitted for use as a UV filter in cosmetic products up to a concentration of 10% within Annex VI (Entry 3) of the Cosmetic Products Regulation UK No 1223/2009 (as amended).

【China】Homosalate has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) and List of UV filters allowed in cosmetic products. The maximum concentration in ready for use preparation is 10%.

About CIRS

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Our services

• Responsible Person (RP);
• Preliminary review of formula and label;
• Safety assessment;
• Create an accurate PIF;
• Labelling design; and
• SCPN submission.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

https://assets.publishing.service.gov.uk/media/682dde88a599d03a16bff3b3/sag-cs-opinion-17-homosalate-in-cosmetic-products.pdf