On 22 April, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1679/25) on Benzophenone-2 (BP-2) (CAS No. 131-55-5) and Benzophenone-5 (BP-5) (CAS No. 6628-37-1). The deadline for comments is set for June 17, 2025.
Preliminary Opinion on Benzophenone-2 and Benzophenone-5
The SCCS concludes the following:
Regarding whether there are specific concerns regarding the use of Benzophenone-2 and Benzophenone-5 in cosmetic products.
- Benzophenone-2 (BP-2): Having considered all the available data, and the concerns relating to potential endocrine disrupting properties, the SCCS cannot conclude on the safety of Benzophenone-2 because genotoxicity potential cannot be excluded. The data on repeated dose toxicity and reproductive toxicity of Benzophenone-2 are also either limited or not available. The available evidence shows that BP-2 is an endocrine-active substance, due to a clear demonstration of estrogenic activity both in vitro and in vivo.
- Benzophenone-5 (BP-5): Due to the scarcity of information for Benzophenone-5, the SCCS has considered that data from a close analogue BP-4 can be used for read-across for the safety assessment of BP-5. Thus, considering the toxicological data on Benzophenone-4, including the potential endocrine disrupting properties, the SCCS is of the opinion that BP-5 is safe when used as a 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 of BP-4).
Regarding if there is a potential risk for human health from the use of Benzophenone-2 and Benzophenone-5 in cosmetic products.
The SCCS considers that the use of Benzophenone-2 in cosmetic products may pose a risk to the consumer because of the indications for genotoxicity and endocrine activity. The assessment of safety of BP-2 in cosmetic products also requires appropriate data on repeated dose toxicity and reproductive toxicity.
Regulatory Requirements Interpretation of Benzophenone-2 and Benzophenone-5 in China
Benzophenone-2: The Chinese Cosmetic Ingredient Regulatory Database (ChinaCosIng), independently developed by CIRS Group, indicates that Benzophenone-2, used as flavouring, fragrance, perfuming, masking, light stabilizer, 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 0.12%.
Benzophenone-5: Benzophenone-5 is used as light stabilizer, UV abosrber, UV filter in cosmetics which has been included in the "Inventory of Existing Cosmetic Ingredients in China" (IECIC) (2021 edition) and the “List of Allowed Sunscreen Agents” of “Safety and Technical Standards for Cosmetics”. The maximum allowable concentration when used in cosmetics is total 5% (as acid).
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