SCCS/1679/25: Benzophenone-2 and Benzophenone-5 in Cosmetics Reassessed

The SCCS (Scientific Committee on Consumer Safety, the EU's scientific committee for consumer safety) has published a scientific opinion on two benzophenone derivatives. The opinion SCCS/1679/25 assesses Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5) with regard to possible endocrine-disrupting properties. The outcome differs significantly between the two substances.

What the SCCS examined

The European Commission had asked the SCCS to clarify two questions: first, whether there are specific concerns regarding the use of BP-2 and BP-5 in cosmetic products, and second, whether these substances pose a potential risk to human health. The request was prompted by indications of possible endocrine (hormonally active) properties.

The opinion is numbered SCCS/1679/25. It was adopted in its final version on 26 June 2025. On 26 March 2026, a corrigendum followed, aligning the tables for Benzophenone-5 with Benzophenone-4 and additionally taking into account the safety assessment of all leave-on and rinse-off products (Total Dermal Aggregate) in accordance with the Notes of Guidance (NoG, 12th revision).

Important for context: the SCCS's mandate does not cover environmental aspects. The assessment concerns exclusively human safety, not the environmental safety of BP-2 and BP-5.

Benzophenone-2 (BP-2): safety cannot be established

For Benzophenone-2 (CAS No. 131-55-5, EC No. 205-028-9), the SCCS reaches a clear conclusion: it cannot confirm the safety of the substance. The decisive factor is that a genotoxic potential cannot be ruled out. Genotoxicity refers to a substance's ability to damage genetic material.

In addition, the data situation is incomplete: according to the SCCS, information on repeated dose toxicity and reproductive toxicity is either limited or entirely lacking. Furthermore, the available data show that BP-2 is endocrine active. The committee points to a clear estrogenic effect, demonstrated both in vitro (in a test tube) and in vivo (in a living organism).

The SCCS answers the second question accordingly: the use of BP-2 in cosmetic products may pose a risk to consumers, due to the indications of genotoxicity and endocrine activity. A robust safety assessment would also require suitable data on repeated dose toxicity and reproductive toxicity.

Benzophenone-5 (BP-5): assessed as a UV filter

For Benzophenone-5 (CAS No. 6628-37-1, EC No. 613-918-7), only limited data of its own were available. The SCCS therefore drew on data from the closely related analogue Benzophenone-4 (BP-4) by way of read-across. Read-across refers to a method in which toxicological data from a structurally similar substance are used for the assessment.

On this basis, including consideration of possible endocrine-disrupting properties, the SCCS considers BP-5 safe under certain conditions. The committee relies on the deterministically aggregated exposure of BP-4.

In addition, the SCCS considers all leave-on and rinse-off products (Total Dermal Aggregate) listed in the NoG to be safe, whether used alone or in combination. Leave-on products remain on the skin, rinse-off products are rinsed off.

Who is affected by the assessment

Those affected are primarily manufacturers and distributors of sunscreen products and decorative cosmetics who use benzophenone derivatives as UV filters or light protection in their formulations. Anyone using BP-2 or BP-5 should closely monitor the status of these substances.

Important for context: an SCCS opinion is a scientific assessment, not directly applicable legislation. Maximum concentrations and usage restrictions only become legally binding once the European Commission amends the annexes to Regulation (EU) 1223/2009 accordingly. Whether and when such an amendment will follow is not stated in the opinion at hand.

What manufacturers should check now

A review of existing formulations is a sensible first step. The following points can help with orientation:

• Review formulations: Do products contain BP-2 or BP-5? Comparing INCI lists with the CAS numbers 131-55-5 (BP-2) and 6628-37-1 (BP-5) provides clarity.
• Assess BP-2 critically: The SCCS could not confirm the safety of BP-2 and identifies a potential risk. Manufacturers should closely follow further developments.
• Keep BP-5 within its scope of use: The positive assessment applies to the product types mentioned, for the function as a UV filter, and for concentrations up to 5%.
• Update the safety assessment: New scientific findings may require a revision of the CPSR (Cosmetic Product Safety Report, safety report under Annex I of Regulation 1223/2009).

We support manufacturers in reviewing formulations in light of new SCCS opinions and keeping the safety assessment as well as the product information file up to date. The full text of opinion SCCS/1679/25 can be found in the publication by the European Commission. An overview of all opinions is available on the SCCS Opinions page.