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On April 22, 2025, EU Scientific Committee on Consumer Safety (SCCS) published its preliminary opinion on the use of Benzophenone-2 (CAS No. 131-55-5) and Benzophenone-5 (CAS No. 6628-37-1) in cosmetics, with a focus on their potential endocrine disrupting properties. Input from industry stakeholders is invited by June 17, 2025. 1
Background to EU Rules on Endocrine Disruptors in Cosmetics
Endocrine disruptors (EDs) are chemical substances that interfere with the endocrine system, potentially leading to harmful health effects in both humans and animals. Although the Regulation (EC) No 1223/2009 on Cosmetic Products (Cosmetics Regulation) does not include specific provisions for EDs, these substances are currently subject to the general safety assessment conducted by SCCS, which addresses health risks posed by hazardous chemicals.
In early 2019, a priority list of 28 potential EDs was compiled following input from a stakeholder consultation. To support safety assessments for these substances, public calls for data were then organized by the European Commission in 2019 and 2021. Benzophenone-2 and Benzophenone-5 are included on this list, and have therefore undergone SCCS assessment.
Key Conclusions from the Assessment
1) Opinion on Benzophenone-2
After evaluating the available data and concerns over its potential endocrine disrupting properties, SCCS cannot conclude on the safety of Benzophenone-2 due to uncertainties regarding its genotoxicity. Data on repeated dose and reproductive toxicity are also limited or lacking. Additionally, existing evidence indicates that Benzophenone-2 is endocrine active, with clear estrogenic activity demonstrated in both in vitro and in vivo studies. Given these findings, SCCS considers that the use of Benzophenone-2 in cosmetics may pose a risk to consumers.
2) Opinion on Benzophenone-5
As data on Benzophenone-5 is insufficient, SCCS employed a read-across approach using data from its analogue Benzophenone-4. Considering the toxicological profile of Benzophenone-4, including potential endocrine disrupting properties, SCCS deems Benzophenone-5 safe for use as a UV filter at concentrations up to 5% in sunscreens, face and hand creams, lipsticks, and sunscreen sprays (both pump and propellant), whether used individually or in combination.
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