EU SCCS Issues Scientific Opinion on Benzophenone-2 and Benzophenone-5

EU SCCS Issues Scientific Opinion on Benzophenone-2 and Benzophenone-5

On April 22, 2025, the European Commission's Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion (SCCS/1679/25) on Benzophenone-2 and Benzophenone-5 (CAS No. 131-55-5 and 6628-37-1; EC No. 205-028-9 and 613-918-7).  A public consultation period ran until June 17, 2025.

Background to the Assessment:

Substances with Endocrine-Disrupting Properties:

On November 7, 2018, the European Commission conducted a review of endocrine-disrupting substances within Regulation (EC) No 1223/2009 on cosmetic products.  The review concluded that the Cosmetics Regulation provides sufficient tools to regulate the use of cosmetic substances that pose a potential risk to human health, including those with endocrine-disrupting properties.

While the Cosmetics Regulation does not explicitly define endocrine-disrupting substances, it provides a regulatory framework designed to ensure a high level of protection of human health.  Potential environmental concerns arising from the use of substances in cosmetics are addressed through Regulation (EC) No 1907/2006.

The European Commission committed to establishing a priority list of potential endocrine-disrupting substances not yet prohibited or restricted under the Cosmetics Regulation for subsequent safety assessments.  In early 2019, a priority list of 28 potential endocrine-disrupting substances in cosmetics was compiled based on stakeholder input.

Available Data on the Substances:

Benzophenone-2: Benzophenone-2 (CAS No. 131-55-5, EC No. 205-028-9) is currently unregulated under Regulation (EC) No 1223/2009.  According to the CosIng database, its functions include sunscreen, UV stabilizer, and fragrance, protecting cosmetic products from light damage (including UV radiation) and enhancing or adding fragrance to the product. Benzophenone-2 is suspected to be an endocrine disruptor and is also suspected of contaminating surface waters and harming aquatic life.

Benzophenone-5: Benzophenone-5 (CAS No. 6628-37-1, EC No. 613-918-7) is currently regulated as a UV filter (entry 22 of Annex VI) with a maximum concentration of 5% (w/w, calculated as acid).  Benzophenone-5 is the sodium salt of Benzophenone-4, which is also regulated under the same entry.  Benzophenone-4 was definitively assessed by the SCCS on April 4, 2024, concluding that a maximum concentration of 5% as a UV filter is safe (see: SCCS Opinion on Benzophenone-4 and Aluminium in Cosmetics).  Due to its structural similarity to Benzophenone-4, Benzophenone-5 is also suspected to be an endocrine disruptor.

Given the potential health risks associated with these ingredients, the SCCS was requested to assess their safe use in cosmetics based on technical and scientific progress.  The Commission therefore requested the SCCS to provide scientific advice on the safety of Benzophenone-2 and Benzophenone-5 in cosmetics.

SCCS Latest Assessment:

Benzophenone-2: Considering all available data and concerns regarding potential endocrine-disrupting properties, the SCCS could not conclude on the safety of Benzophenone-2, as the possibility of genotoxicity could not be ruled out.  Data on repeated dose toxicity and reproductive toxicity were also limited or lacking. Existing evidence indicates that Benzophenone-2 is an endocrine-active substance, showing marked estrogenic activity both in vitro and in vivo.

Benzophenone-5: Due to the scarcity of information on Benzophenone-5, the SCCS considered that data on the closely related Benzophenone-4 could be used as a read-across for safety assessment. Therefore, considering the toxicological data on Benzophenone-4 (including its potential endocrine-disrupting properties), the SCCS considers that Benzophenone-5, used as a UV filter in sunscreens, creams, hand lotions, lipsticks, sun sprays, and pump sprays, at a maximum concentration not exceeding 5%, whether used alone or in combination (based on the defined cumulative exposure of Benzophenone-4), is safe.

The SCCS considers that the use of Benzophenone-2 in cosmetics may pose a risk to consumers due to its genotoxicity and endocrine activity.  Further suitable data on repeated dose toxicity and reproductive toxicity are needed for a safety assessment of Benzophenone-2 in cosmetics.  This assessment did not cover the environmental impact of Benzophenone-2 and Benzophenone-5.

Regulatory Status in China:

Benzophenone-2: Currently, China does not have specific regulatory requirements for Benzophenone-2.

Benzophenone-5:  Approved UV filter in cosmetics.