EU SCCS Finalizes Opinions on Diethylamino Hydroxybenzoyl Hexyl Benzoate, Benzophenone-2, and Benzophenone-5

In February and April 2025, EU Scientific Committee on Consumer Safety (SCCS) released preliminary opinions on three UV filters, including diethylamino hydroxybenzoyl hexyl benzoate (CAS No. 302776-68-7), benzophenone-2 (CAS No. 131-55-5), and benzophenone-5 (CAS No. 6628-37-1). In light of the comments received, SCCS published its final opinions on these ingredients on June 30, 2025.^1-2

The key conclusions from the final opinions, summarized below, remain consistent with those drawn in the preliminary versions, with only minor updates indicated in red.

Opinion on Diethylamino Hydroxybenzoyl Hexyl Benzoate

Diethylamino hydroxybenzoyl hexyl benzoate (DHHB) is an authorized UV filter under Regulation (EC) No 1223/2009 (Cosmetics Regulation), with a maximum allowed concentration of 10%. In response to concerns regarding di-n-hexyl phthalate (DnHexP), a prohibited cosmetic ingredient that may be present as an impurity in DHHB, SCCS performed a safety assessment to evaluate the associated health risks.

Following its assessment, SCCS has calculated a maximum allowable limit of 0.026% (260 ppm) for DnHexP in DHHB, applicable when DHHB is used at concentrations up to 10% in cosmetics, and only if DnHexP is an unavoidable contaminant. Furthermore, SCCS noted that it is technically feasible to reduce DnHexP levels in DHHB to as low as 1 ppm through a specific manufacturing process. Accordingly, SCCS suggests that 1 ppm should be the target level for DnHexP as an unavoidable trace impurity in DHHB.

Opinion on Benzophenone-2

Although benzophenone-2 is not currently regulated under the Cosmetics Regulation, it is commonly used in cosmetics to prevent light-induced degradation and enhance fragrance. In view of its potential endocrine disrupting properties, SCCS reviewed its use in cosmetics and issued this opinion.

Based on the available data, the committee concluded that a definitive judgment on benzophenone-2's safety could not be reached due to uncertainties regarding its genotoxicity. Data on repeated dose and reproductive toxicity are also limited or lacking. Moreover, evidence shows that benzophenone-2 exhibits endocrine activity, with clear estrogenic effects observed in both in vitro and in vivo studies. Given these findings, SCCS considers the use of benzophenone-2 in cosmetics to pose a potential risk to consumer health.

Opinion on Benzophenone-5

In cosmetics, benzophenone-5 is permitted for use as a UV filter at a maximum concentration of 5% (as acid). It is the sodium salt of benzophenone-4, a substance previously assessed by SCCS due to its potential endocrine activity. Given the structural similarity between benzophenone-5 and benzophenone-4, benzophenone-5 is also suspected of having endocrine disrupting properties, which prompted SCCS to evaluate its safety.

As data on benzophenone-5 is insufficient, SCCS applied a read-across approach using data from benzophenone-4. Taking into account the toxicological profile of benzophenone-4, including potential endocrine disrupting properties, SCCS confirms that benzophenone-5 is safe for use as a UV filter at concentrations up to 5% in sunscreens, face and hand creams, lipsticks, and sunscreen sprays (both pump and propellant), whether used alone or in combination. 

Further Reading

• EU SCCS Drafts Opinion on the UV Filter DHHB

• EU SCCS Releases Preliminary Opinion on Benzophenone-2 and Benzophenone-5

• EU SCCS Consults on Opinions on Prostaglandin Analogues and Tea Tree Oil