SCCS - Scientific Advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate - DHHB – S83

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson and Rapporteur), J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, Ch. Delmaar, A. Koutsodimou, H. Louro , W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1678/25
Adopted on: 14 February 2025

Conclusion of the opinion:

(1) Considering the recent concerns over the presence of DnHexP as a contaminant in the production of Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) used as a UV-filter in cosmetic products, as well as in view of technical and scientific progress and taking under consideration in particular the various health concerns, the SCCS is requested to identify the maximum safe level of DnHexP as a contaminant in DHHB preparations

Taking into account the health concerns associated with DnHexP, the SCCS calculated a maximum level of 0.026% (260 ppm) for this contaminant in the UV filter DHHB. This applies when DHHB is used up to 10% in cosmetic products and only if DnHexP is an unavoidable impurity.

2) Does the SCCS have any further scientific concerns regarding the presence of DnHexP in DHHB as a UV-filter in cosmetic products?

The SCCS has noted available information showing that DnHexP was below the level of detection in several DHHB containing sunscreen products and DHHB sources. The SCCS has also noted the available information showing that the levels of DnHexP in DHHB can be lowered down to 1ppm. Therefore, the SCCS is of the opinion that this trace level (1 ppm) should be the target for the maximal level of DnHexP as an unavoidable trace impurity in DHHB.

Keywords:

SCCS, scientific advice, Diethylamino Hydroxybenzoyl Hexyl Benzoate, DHHB, S83, Regulation 1223/2009, CAS/EC No. 302776-68-7/443-860-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), scientific advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate – DHHB -S83 (CAS/EC No. 302776-68-7/443-860-6) from cosmetic products, preliminary version of 14 February 2025, SCCS/1678/25.