On April 1, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion (SCCS/1672/24) on Benzophenone -1 (CAS No. 131-56-6). The preliminary opinion on Benzophenone -1 was issued on November 7, 2024.
Final opinion on Benzophenone -1
The SCCS concludes the following:
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.
Regulatory Requirements Interpretation of Benzophenone -1 in China
The Chinese Cosmetic Ingredient Regulatory Database (ChinaCosIng), independently developed by CIRS Group, indicates that Benzophenone -1, used as light stabilizer and UV absorber, has been included in the Inventory of Existing Cosmetic Ingredients in China" (IECIC) (2021 edition) with the maximum historical usage in leave-on products being 0.936%.
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Further Information
https://health.ec.europa.eu/document/download/1161e3b7-8e52-47d8-9153-54433fa0d7fe_en?filename=sccs_o_293.pdf