A preliminary opinion on Benzophenone-4 (CAS No. 4065-45-6) with the chemical name ‘2-Hydroxy-4-methoxybenzophenone-5-sulphonic acid’ was issued by the Scientific Committee on Consumer Safety (SCCS) and it is open for comments until February 16, 2024.
SCCS Preliminary Opinion on Benzophenone-4: The Background
On November 7, 2018, the Commission conducted a review of Regulation (EC) No 1223/2009 on cosmetic products, specifically focusing on substances with endocrine-disrupting (ED) properties. As part of the review, the Commission committed to establishing a priority list for potential EDs not covered by existing bans or restrictions in the Cosmetics Regulation, leading to the identification of 28 potential EDs in cosmetics.
The Commission carried out a public call for data in 2019 for 14 substances (Group A)3 and a second call in 2021 for 10 substances (Group B)5 in preparation of the safety assessment of these substances. Benzophenone 4 is one of the above-mentioned substances for which the call for data took place.
What is Benzophenone-4?
Benzophenone is an organic ketone-aromatic compound, including Benzophenone-3, Benzophenone-4, and Benzophenone-5, all approved in sunscreens under the EC regulation for cosmetic products.
Benzophenone-4 (benzophenone cosmetics) is a soluble UV-BB filter that provides protection against both UV-B and UV-A rays, with a maximum concentration of 5%. UV filters play a crucial role in sun protection products, preventing premature aging and the risk of skin cancer. While organic filters absorb UV radiation and convert it into heat, pigment-based filters reflect and disperse light on the skin’s surface. The distinctive features of organic UV filters, such as absorption range, photo stability, and solubility, classify them into UV-A, UV-B, and broad-spectrum categories based on the absorbed wavelengths.
Benzophenone in cosmetics: What is the reason behind the issuance of the SCCS Preliminary Opinion?
Benzophenone-4, a substance subject to the call for data, is currently regulated as a UV-filter in sunscreen products with a concentration limit of 5% (Annex VI/22). It has undergone a safety evaluation by SCCNFP in 1999, concluding that it can be safely used in cosmetic sunscreen formulations.
In response to stakeholders submitting scientific evidence during the data call, the Commission has requested the SCCS to conduct a safety assessment on Benzophenone 4, considering the provided information on its use as a UV-filter in cosmetic products.
Is Benzophenone-4 safe?
On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties of benzophenone-4, the SCCS concluded:
Benzophenone-4 is safe when used as 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).
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References:
- SCCS/1660/23 Preliminary Opinion. More info




