SCCS Opinion on Benzophenone - 1 (CAS No. 131-56-6, EC No. 205-029-4)

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads (Chairperson), J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfentati (Rapporteur), N. Cabaton, E. Corsini, Ch. Delmaar, A. Koutsodimou, H. Louro , W. Uter, N. von Goetz
Contact: SANTE-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1672/24
Adopted on: 27 March 2025

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-1, does the SCCS consider Benzophenone-1 safe when used as a light stabilizer in cosmetic products up to a maximum concentration of 2%?

Having considered the data provided (including two new mutagenicity/genotoxicity studies submitted to ECHA as part of the REACH registration dossier), and the concerns relating to genotoxicity and potential endocrine disrupting properties, the SCCS considers Benzophenone-1 not safe when used as a light stabiliser in cosmetic products for the following reasons:

• The available data indicate genotoxicity potential of Benzophenone-1.
• The evidence assessed by the SCCS also shows that Benzophenone-1 is an endocrine-active substance due to clear demonstration of estrogenic activity and weak anti-androgenic activity both in vitro and in vivo, and potential activity against thyroid modality in vitro.

A new (2023) OECD TG 422 study relating to ED effects submitted to ECHA as part of the REACH registration dossier has not been assessed by the SCCS at this stage because of the remaining concerns over genotoxicity of Benzophenone-1. The SCCS will be ready to assess the evidence in support of the safe use of Benzophenone-1 in cosmetic products when received in a new mandate.

(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzophenone-1 in cosmetic products?

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(3) Does the SCCS have any further scientific concerns with regard to the use of Benzophenone-1 in cosmetic products?

The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of BP-1 for the environment.

Keywords:

SCCS, scientific opinion, benzophenone – 1, Regulation 1223/2009, CAS No. 131-56-6, EC No. 205-029-4

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Benzophenone-1 (CAS No. 131-56-6, EC No. 205-029-4), preliminary version of 25 October 2024, final version of 27 March 2025, SCCS/1672/24.