Logo do repositório
 
Publicação

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

2025-06-26Relatório Acesso restrito
Ver registo simples
dc.contributor.authorEuropean Comission. Scientific Committee on Consumer Safety
dc.date.accessioned2026-03-05T13:49:47Z
dc.date.available2026-03-05T13:49:47Z
dc.date.issued2025-06-26
dc.descriptionSCCS External Experts: Benfenati, E; Cabaton, N; Corsini, E; Delmaar, Ch; Koutsodimou, A; Louro, Maria Henriqueta (INSA); Uter, W; von Goetz, N.
dc.descriptionSCCS/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.
dc.description.abstractThe 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.eng
dc.identifier.urihttp://hdl.handle.net/10400.18/11167
dc.language.isoeng
dc.peerreviewedno
dc.publisherEuropean Commission. Health and Food Safety
dc.relation.hasversionhttps://health.ec.europa.eu/document/download/abb0eaac-a20b-43b1-8226-fb73d7167c6c_en?filename=sccs_o_301.pdf
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectEnvironmental Genotoxicity
dc.subjectSCCS
dc.subjectScientific Advice
dc.subjectBenzophenon-2
dc.subjectBenzophenon-5
dc.subjectRegulation 1223/2009
dc.subjectCAS No. 131-55-5 and 6628-37-1
dc.subjectEC No. 205-028-9 and 613-918-7
dc.subjectGenotoxicidade Ambiental
dc.titleScientific 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 productseng
dc.typereport
dspace.entity.typePublication
oaire.citation.endPage54
oaire.citation.startPage1
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

Ficheiros

Principais
A mostrar 1 - 1 de 1
Miniatura indisponível
Nome:
2025 sccs_o_301 - benzophenone2 and 5.pdf
Tamanho:
810.74 KB
Formato:
Adobe Portable Document Format
Ver/Abrir
Licença
A mostrar 1 - 1 de 1
Miniatura indisponível
Nome:
license.txt
Tamanho:
4.03 KB
Formato:
Item-specific license agreed upon to submission
Descrição:
Ver/Abrir

Coleções

DGH - Relatórios científicos e técnicos