Benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2)

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. Wijnhoven
SCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, M. Henriqueta D.L.G. 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/1660/23
Adopted on: 27 March 2024

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of benzophenone-4, does the SCCS consider benzophenone-4 safe when used as UV-Filter in cosmetic products up to a maximum concentration of 5%?

On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties, the SCCS is of the opinion that benzophenone-4 is safe when used as UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, all leave-on and rinse-off products (total dermal aggregate), lipstick, sunscreen propellant spray and pump spray, when used separately or in combination (based on deterministic aggregated exposure).

(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of benzophenone-4 in cosmetic products?

Any additional use of benzophenone-4, such as protectant for stabilising cosmetic formulations when exposed to light, should remain within the concentration mentioned above (i.e. 5%), including the use as UV-filter.

(3) Does the SCCS have any further scientific concerns with regard to the use of benzophenone-4 in cosmetic products?

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of benzophenone-4 for the environment.

Keywords:

SCCS, scientific opinion, benzophenone – 4, Regulation 1223/2009, (CAS No. 4065-45-6, EC No. 223-772-2)

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) used in cosmetics products. preliminary version of 14 December 2023, final version of 27 March 2024, SCCS/1660/23