SCCS - Scientific Advice on Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5) as substances with potential endocrine disrupting properties in cosmetic products

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 (Rapporteur), M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfenati, 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/1679/25
Adopted on: 27 March 2025

Conclusion of the opinion:

In light of technical and scientific progress, available scientific literature, relevant in silico tools and the SCCS’ expert judgement and taking under consideration in particular the concerns related to potential endocrine disrupting properties, the SCCS is requested: 

1. to identify and justify whether there are specific concerns regarding the use of Benzophenone-2 and Benzophenone-5 in cosmetic products.

Benzophenone 2 (BP-2)

Having considered all the available data, and the concerns relating to potential endocrine disrupting properties, the SCCS cannot conclude on the safety of Benzophenone-2 because genotoxicity potential cannot be excluded. The data on repeated dose toxicity and reproductive toxicity of Benzophenone-2 are also either limited or not available. The available evidence shows that BP-2 is an endocrine-active substance, due to a clear demonstration of estrogenic activity both in vitro and in vivo.

Benzophenone 5 (BP-5)

Due to the scarcity of information for Benzophenone-5, the SCCS has considered that data from a close analogue BP-4 can be used for read-across for the safety assessment of BP-5. Thus, considering the toxicological data on Benzophenone-4, including the potential endocrine disrupting properties, the SCCS is of the opinion that BP-5 is safe when used as a UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination (based on deterministic aggregated exposure of BP-4).

2.to highlight if there is a potential risk for human health from the use of Benzophenone-2 and Benzophenone-5 in cosmetic products. 

The SCCS considers that the use of Benzophenone-2 in cosmetic products may pose a risk to the consumer because of the indications for genotoxicity and endocrine activity. The assessment of safety of BP-2 in cosmetic products also requires appropriate data on repeated dose toxicity and reproductive toxicity.

The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of BP-2 and BP-5 for the environment.

Keywords:

SCCS, scientific advice, benzophenone – 2, benzophenone-5, Regulation 1223/2009, CAS No. 131-55-5 and 6628-37-1, EC No. 205-028-9 and 613-918-7

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), scientific advice on the safety of Benzophenone-2 (BP-2) (CAS No. 131-55-5, EC No. 205-028-9) and Benzophenone-5 (BP-5) (CAS No. 6628-37-1, EC No. 613-918-7) as substances with potential endocrine disrupting properties in cosmetic products, preliminary version of 27 March 2025, SCCS/1679/25.