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Orientador(es)
Resumo(s)
The SCCS concludes the following: 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.
Descrição
SCCS External Experts: Benfenati, E; Cabaton, N; Corsini, E; Delmaar, Ch; Koutsodimou, A; Louro, Maria Henriqueta (INSA); Uter, W; von Goetz, N.
SCCS/1679/25 Final version. Scientific Advice on benzophenone – 2 and benzophenone - 5 (CAS No. 131-55-5 and 6628-37-1, EC No. 205-028-9 and 613-918-7) as substances with potential endocrine disrupting properties in cosmetic products. The SCCS adopted this document during the plenary meeting on 26 June 2025.
SCCS/1679/25 Final version. Scientific Advice on benzophenone – 2 and benzophenone - 5 (CAS No. 131-55-5 and 6628-37-1, EC No. 205-028-9 and 613-918-7) as substances with potential endocrine disrupting properties in cosmetic products. The SCCS adopted this document during the plenary meeting on 26 June 2025.
Palavras-chave
Environmental Genotoxicity SCCS Scientific Advice Benzophenon-2 Benzophenon-5 Regulation 1223/2009 CAS No. 131-55-5 and 6628-37-1 EC No. 205-028-9 and 613-918-7 Genotoxicidade Ambiental
Contexto Educativo
Citação
Editora
European Commission. Health and Food Safety