Key takeaway
What This Development Means
The EU’s SCCS has highlighted safety concerns over Benzophenone-2 due to endocrine and genotoxicity risks, while confirming Benzophenone-5’s safety at regulated levels. This signals potential reformulation needs and compliance planning across the cosmetics and chemical sectors ahead of the June 2025 consultation deadline.
Why is Benzophenone-2 considered a risk in cosmetics?
Benzophenone-2 has shown potential for endocrine disruption and genotoxicity, with insufficient safety data available. As a result, SCCS cannot confirm its safety, increasing the likelihood of future regulatory action impacting its use in EU cosmetics.
What is the status of Benzophenone-5 under EU regulation?
Benzophenone-5 is currently authorised as a UV filter in cosmetics up to 5%. Based on data from Benzophenone-4, the SCCS deems it safe at this concentration, and no new restrictions are proposed in the latest opinion.
The European Commission’s Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion examining the endocrine-disrupting potential of Benzophenone-2 and Benzophenone-5 in cosmetics. Released on 22 April 2025, this assessment underscores regulatory scrutiny under EU chemicals legislation and signals possible impacts on manufacturers, suppliers, and compliance professionals throughout the chemicals value chain.
Benzophenone-2 Raises Significant Regulatory Red Flags
Benzophenone-2 (CAS 131-55-5, EC 205-028-9), a UV filter and fragrance ingredient, has been flagged for its potential endocrine activity. The SCCS noted the compound shows clear oestrogenic activity in vitro and in vivo. Concerns also stem from incomplete toxicological data, particularly around genotoxicity, reproductive effects, and long-term exposure.
Due to these unresolved safety questions, the SCCS has not confirmed the compound’s safety for use in cosmetics. This development could initiate further regulatory restrictions under Regulation (EC) No. 1223/2009, prompting stakeholders to begin exploring alternatives or reformulation strategies to avoid future non-compliance.
Benzophenone-5 Deemed Safe Within Current Use Limits
Conversely, Benzophenone-5 (CAS 6628-37-1, EC 613-918-7), currently allowed as a UV filter up to 5% concentration, has been assessed as safe by the SCCS. Its evaluation was supported by a read-across approach using data from Benzophenone-4, a close structural analogue. Given its high water solubility and rapid systemic clearance, BP-5 poses less toxicological concern at authorised levels in cosmetics such as sunscreens and face creams.
The deadline for public comments is 17 June 2025, offering industry stakeholders a critical window to contribute data or feedback that could influence final regulatory decisions.
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