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Tuesday, January 2, 2024SCCS

Benzophenone-4: preliminary Opinion of the SCCS

Benzophenone-4 : Opinion préliminaire du CSSC

Following the mandate given by the European Commission to the SCCS, in the framework of the evaluation of ingredients listed as endocrine disruptors, the Scientific Committee has just published its preliminary Opinion on the safety of Benzophenone-4. It is open for comments until 16 February 2024.

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Background

Benzophenone-4 (CAS No.4065-45-6, EC No.223-772-2) is currently regulated as a UV-filter in sunscreen products in a concentration up to 5 % (Annex VI/22 to European Cosmetics Regulation 1223/2009).
During the call for data on substances suspected of having endocrine disrupting activity, stakeholders submitted scientific evidence demonstrating the safety of the substance.

For an exhaustive background information, see the article
Benzophenone-4, Benzophenone-1, Triphenyl Phosphate: requests for Opinions to the SCCS, CosmeticOBS, 24 April 2023

Opinion

1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Benzophenone-4, does the SCCS consider Benzophenone-4 safe when used as UV-Filter in cosmetic products up to a maximum concentration of 5%?

On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties of benzophenone-4, the SCCS is of the opinion that 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).

2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzophenone-4 …

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