LIFE SCIENCES | Regulation (EU) 2025/877 on Toxic Substances in Cosmetics in force

On 1 September 2025, Regulation (EU) 2025/877 entered into force, introducing, among several new substances, a ban across all Member States on the use of two chemical substances widely used in aesthetic nail treatments, mainly in the professional sector: Trimethylbenzoyl Diphenylphosphine Oxide (TPO) and Dimethyltolylamine (DMPT). Both substances have been added to Annex II of Regulation (EU)1223/2009, specifically under category 1B, thereby classifying them as CMR substances, i.e. substances identified as carcinogenic, mutagenic, or toxic for human reproduction. The European Commission confirmed that the ban is fully applicable as of 1 September 2025, and its broad scope entails that products containing these substances cannot be used even if purchased before that date. This will consequently require the disposal of any existing stock and the replenishment of supplies by operators.

The enforcement of penalties is delegated to individual Member States. In Italy, sanctions may reach up to euro 15,000 in fines or imprisonment from six months to two years, depending on the seriousness of the violation.

Newsletter n. 111 – October 2025