As reported by the German Federal Environment Agency (UBA), urine samples from 259 children and adolescents between the ages of 6 and 17 were analysed between April and July 2025. The results show: 92 per cent of the samples contained mono-n-hexyl phthalate (MnHexP), a breakdown product of the reproductive toxicant di-n-hexyl phthalate (DnHexP).
It is especially concerning that up to 1% of the samples surpassed the HBM-I threshold of 60 µg/L, with peak values recorded at 83 and 107 µg/L. This pollution is mainly caused by the use of UV filters like DHHB in sunscreen products. Concentrations measured in 2024 ranged from 1.5 to 44 mg/kg, despite the EU SCCS stating that only 0.1 mg/kg would be permissible. Accordingly, effective 1 January 2027, a maximum threshold of 1 mg/kg DnHexP will be enforced for each sunblock product.
While this risk assessment shows that the HBM-I value does not indicate any immediate health risks in most cases and that the tolerable daily intake (63 µg/kg body weight/day) has not been surpassed, repeated exposure to substances harmful to reproduction remains a significant concern warranting careful attention. The UBA emphasises that the high proportion of contaminated samples and, in some cases, very high concentrations are surprising, and recommends continuous monitoring and the minimisation of exposure to plasticisers, particularly in products intended and made for children.
Product safety is not a disadvantage – it is an obligation
For producers of cosmetic products in Germany and Europe, this means that products must comply with the applicable regulations to protect consumers, particularly children and young people. Compliance with limit values for substances such as DnHexP is not only a legal requirement but also strengthens customer confidence in the brand. Unregulated third-party suppliers, on the other hand, pose a significant risk to users’ health as well as legal consequences for producers.
The ALISE study (“Aligned Study for Environmental Health”) clearly shows how product safety concerns us all. Alas, compliance with legal regulations is not optional. Producers who rely on compliant products protect their customers as well as their own business. This is particularly crucial for sensitive products such as children’s sun creams – unregulated products pose an avoidable risk.
trade-e-bility provides legal monitoring and risk analyses to help you meet product safety requirements and regulatory compliance.
Do you have questions about product safety, or have you received a Safety Gate alert regarding one of your products? Please feel free to contact our trade-e-bility advisory team on +49 40/750687-300 or send us an email.
