
On May 21, 2025, SAG-CS, the British Scientific Committee in charge of assessing the safety of cosmetic ingredients, published three Opinions, concerning formaldehyde releasers, Homosalate and 4-Methylbenzylidene Camphor. And one of them foreshadows new divergences with European regulations.
Formaldehyde Releasing Substances
SAG-CS members concluded that the current threshold of 0.05% for labelling formaldehyde releasing preservatives was insufficient to protect consumers.
Members agreed that a threshold for labelling formaldehyde releasing preservatives of 10 ppm (0.001%) would be adequate to protect consumers if used for leave-on products.
Members agreed that such a level would likely be sufficiently protective for use in rinse-off products also.
In Europe
Regulation (EU) 2022/1181 has lowered the previous labelling threshold for formaldehyde releasers on all finished products to 0.001% (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde.
The measure is applicable from July 30, 2024 for products placed on the market, and from July 31, 2026 for products made available on the market.
Homosalate
SAG-CS Members agreed that the most appropriate dermal absorption value to use in the safety assessment was 5.3%.
Calculations based on the exposure metrics from the PBPK modelling, as well as those using the SED calculation from the SCCS notes of guidance all give margins of safety in excess of 25. SAG-CS Mmmbers concluded that homosalate is safe at a maximum concentration of 10% in sunscreen products.
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