On 30 June, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific opinion(SCCS/1679/25) on Benzophenone-2 (BP-2)(CAS No. 131-55-5, EC No. 205-028-9) and Benzophenone-5 (BP-5) (CAS No. 6628-37-1, EC No. 613-918-7).
Final Scientific Advice on Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5)
1. 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).
2. Regarding if there is a potential risk for human health from the use of Benzophenone2 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.
The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of BP-2 and BP-5 for the environment.
Regulatory Requirements Interpretation of Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5)
The Global Cosmetic Ingredient Regulatory Database-Global CosIng, independently developed by CIRS Group indicates that BP-2 and BP-5 are both included in the following key lists globally.
【Benzophenone-2 (BP-2)】
In EU, BP-2 is suspected to be included in the List of substances prohibited in cosmetic products, more details could be found in the following figure.
In China, BP-2 has been included in Inventory of Existing Cosmetic Ingredients in China (IECIC) (I).
【Benzophenone-5 (BP-5)】
In EU, BP-5 is suspected to be included in the List of substances prohibited in cosmetic products and has been listed in the List of UV filters allowed in cosmetic products, the maximum concentration in ready for use preparation is 5% (as acid).
In China, BP-5 has been included in Inventory of Existing Cosmetic Ingredients in China (IECIC) (I) and the List of UV filters allowed in cosmetic products, the maximum concentration in ready for use preparation is total 5% (as acid).
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