The Scientific Committee on Consumer Safety (SCCS) has issued a new scientific advice recommending stringent limits on a potentially harmful impurity found in the sunscreen agent Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB).
The opinion, published on June 30, 2025 (SCCS/1678/25), was initiated due to health concerns regarding the possible presence of the contaminant Di-n-hexyl phthalate (DnHexP) in DHHB. This follows a 2024 report from Germany that detected mono-n-hexyl phthalate (MnHexP), a degradation product of certain phthalate plasticizers, in children's urine. German authorities suggested that sunscreens could be a potential source, as DnHexP—which can metabolize into MnHexP—may be present as a pollutant in the manufacturing process of DHHB.
DHHB (CAS No. 302776-68-7) is a widely authorized UV filter in the European Union. It is listed in Annex VI, entry 28, of the EU Cosmetics Regulation (EC) No. 1223/2009, which permits its use at a maximum concentration of 10%. Conversely, DnHexP is explicitly prohibited in cosmetic products under Appendix II, entry 1559, of the same regulation.
In its newly released advice, the SCCS concluded that:
The maximum safe level for the DnHexP impurity in DHHB is 260ppm, or 0.026%. This value is derived based on the scenario where DHHB is used at its maximum allowed concentration of 10% and the presence of the impurity is deemed unavoidable.
However, the Committee strongly recommends that the maximum trace level for the DnHexP impurity should be set at just 1 ppm. This significantly lower limit is proposed because removing DnHexP from DHHB is considered technically feasible through modern manufacturing processes.
This scientific opinion from the SCCS will now inform the European Commission and EU member states as they consider potential regulatory measures to update the specifications for the DHHB ingredient, ensuring a high level of consumer protection, especially for vulnerable groups like children.
Our UNI_DHHB controls DnHexP ≤ 1 ppm, in compliance with European regulations, ensuring safe protection.
For more information on our UNI_DHHB, please contact us.
The link to the SCCS original text is as follows，