Introduction
On June 30, 2025, the EU Scientific Committee on Consumer Safety (SCCS) published final opinions on Ethylhexyl Methoxycinnamate (EHMC), Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB), and Benzophenone-2 (BP-2)/Benzophenone-5 (BP-5). Earlier, on April 1, 2025, the SCCS released its final ruling on Benzophenone-1 (BP-1). These opinions address core concerns over endocrine activity, impurity risks, and genotoxicity, providing definitive compliance guidance for cosmetic manufacturers under EU Regulation (EC) No. 1223/2009.
Ethylhexyl Methoxycinnamate (EHMC)
Background
EHMC (CAS No. 5466-77-3/83834-59-7; EC No. 226-775-7/629-661-9), also known as Octylmethoxycinnamate (OMC) or Octinoxate, has the chemical name “2-ethylhexyl 4-methoxycinnamate.” It absorbs only UVB radiation (290–320 nm) and protects skin solely from UVB damage, not UVA.
Used for decades as a UV filter and formulation stabilizer in cosmetics, pharmaceuticals, intermediates, and fine chemicals, it was previously assessed by the SCC (1991, 1993) and SCCNFP (2001). In early 2019, it was included in the EU’s priority list of 28 potential endocrine-disrupting substances, leading to public data calls (2019 Group A, 2021 Group B) and a mandatory SCCS reassessment based on stakeholder-submitted scientific evidence.
Current Regulatory Limits
Authorized under EU Cosmetics Regulation Annex VI, Entry 12, with a maximum permitted concentration of 10% in cosmetic products.
Latest SCCS Conclusion (SCCS/1671/24)
The SCCS notes EHMC is an endocrine-active substance due to estrogenic activity and weak anti-androgenic activity both in vitro and in vivo. Nevertheless, it is safe when used as a UV filter up to 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray, and pump spray—whether used separately or in combination.
These products are also safe for children, as the high Margin of Safety precludes risks from higher internal exposure linked to their different surface area-to-body weight ratio compared to adults. The SCCS’s mandate does not address environmental aspects, so this assessment did not cover EHMC’s safety for the environment.
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Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB)
Background
DHHB (CAS No. 302776-68-7; EC No. 443-860-6) is the INCI name for “benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester,” with CosIng-listed functions as UV filter, UV absorber, and light stabilizer. Authorized under Annex VI, Entry 28 of the Cosmetics Regulation, it is valued for exceptional UVA absorption, excellent photostability, and compatibility with other ingredients, serving as a key component in sunscreens, moisturizers, foundations, and other skincare/makeup products.
Previously assessed by the SCCNFP (2003) and SCCP (2006, 2008), it was confirmed safe at 10% w/w. In 2024, German authorities detected “mono-n-hexyl phthalate (MnHexP)” (this substance can act as a metabolite of phthalates such as di-n-hexyl phthalate (DnHexP), and DnHexP has already been prohibited for use in cosmetics (Entry 1559 of Annex II to the Cosmetics Regulation)) in children’s urine, linking potential DnHexP contamination in DHHB to sunscreen exposure.
The BfR confirmed minimal risk from DHHB with up to 0.3% DnHexP but noted technical feasibility of removing DnHexP, prompting the SCCS to re-evaluate DHHB’s safety with a focus on DnHexP impurities.
Current Regulatory Limits
Authorized for use up to 10% w/w in cosmetics under EU Cosmetics Regulation Annex VI, Entry 28.
Latest SCCS Conclusion (SCCS/1678/25)
Considering health concerns associated with DnHexP, the SCCS calculated a maximum safe level of 0.026% (260 ppm) for this impurity in DHHB, applicable when DHHB is used up to 10% in cosmetics and DnHexP is unavoidable.
Available information shows DnHexP was below detection levels in several DHHB-containing products and sources when specific manufacturing processes are applied, and it is technically feasible to lower DnHexP to 1 ppm. Thus, the SCCS recommends 1 ppm as the target maximal level for DnHexP as an impurity in DHHB. Environmental safety was not covered in this assessment.
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Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5)
Background
BP-2 (CAS No. 131-55-5; EC No. 205-028-9), with the chemical name “2,2',4,4'-tetrahydroxybenzophenone,” is currently unregulated under EU Cosmetics Regulation. According to CosIng, it functions as UV filter, light stabilizer, and fragrance—protecting products from light-induced damage and enhancing scent. Suspected of being an endocrine disruptor, polluting surface waters, and endangering aquatic organisms, it was included in the EU’s 2019 priority list of 28 potential endocrine-disrupting substances. The EU organized a public call for data from May 16 to October 15, 2019, for 14 high-priority substances, including BP-2, leading to the SCCS’s mandatory safety evaluation.
BP-5 (CAS No. 6628-37-1; EC No. 613-918-7), with the chemical name “2-Hydroxy-4-methoxybenzophenone-5-sodium sulfonate,” is the sodium salt of Benzophenone-4 (BP-4) and regulated under the same entry (Annex VI, Entry 22) at a maximum concentration of 5% (as acid). BP-4 was recently re-evaluated by the SCCS for potential endocrine activity, with safety confirmed under certain conditions. Due to structural similarity to BP-4, BP-5 is suspected of being an endocrine disruptor. Included in the EU’s 2019 priority list of potential endocrine-disrupting substances, it was subject to a 2019 public data call, leading to the SCCS’s assessment using BP-4 data for read-across.
Current Regulatory Limits
BP-2: No official EU concentration limits; not listed in Annex VI (authorized) or Annex II (banned) of the Cosmetics Regulation.
BP-5: Authorized for use up to 5% (as acid) in cosmetics under EU Cosmetics Regulation Annex VI, Entry 22.
Latest SCCS Conclusion (SCCS/1679/25)
The SCCS cannot conclude on BP-2’s safety. Genotoxicity potential cannot be excluded, and data on repeated dose toxicity and reproductive toxicity are limited or unavailable. Available evidence shows BP-2 is an endocrine-active substance due to clear demonstration of estrogenic activity both in vitro and in vivo. The SCCS considers BP-2’s use in cosmetics may pose a risk to consumers due to indications of genotoxicity and endocrine activity. A comprehensive safety assessment requires appropriate data on repeated dose toxicity and reproductive toxicity. Environmental safety was not covered in this assessment.
Due to the scarcity of information for BP-5, the SCCS used data from its close analogue BP-4 for read-across. Considering BP-4’s toxicological profile (including potential endocrine-disrupting properties), the SCCS concludes BP-5 is safe when used as a UV filter up to 5% in sunscreen, face and hand cream, lipstick, sunscreen propellant spray, and pump spray—whether used separately or in combination (based on deterministic aggregated exposure of BP-4). Environmental safety was not covered in this assessment.
For more specific information, please refer to the original text:
Benzophenone-1 (BP-1)
Background
BP-1 (CAS No. 131-56-6; EC No. 205-029-4), with the chemical name “2,4-dihydroxybenzophenone,” is included in CosIng with functions as light stabilizer and UV absorber. Used in various rinse-off and leave-on cosmetics to protect formulations from UV damage, it is currently unregulated under EU Cosmetics Regulation.
Included in the EU’s 2019 priority list of 28 potential endocrine-disrupting substances, it was subject to public data calls (2019 Group A, 2021 Group B). Stakeholders submitted scientific evidence to demonstrate its safety as a light stabilizer, prompting the SCCS’s mandatory assessment.
Current Regulatory Limits
No official EU concentration limits; not listed in Annex VI (authorized) or Annex II (banned) of the Cosmetics Regulation.
Latest SCCS Conclusion (SCCS/1672/24)
The SCCS concludes BP-1 is not safe for use as a light stabilizer in cosmetic products. Available data indicate its genotoxicity potential, and evidence shows it is an endocrine-active substance due to clear demonstration of estrogenic activity and weak anti-androgenic activity both in vitro and in vivo, as well as potential activity against thyroid modality in vitro.
A new (2023) OECD TG 422 study on endocrine-disrupting effects, submitted to ECHA as part of the REACH registration dossier, was not assessed due to remaining genotoxicity concerns. The SCCS will be ready to assess evidence supporting BP-1’s safe use when received in a new mandate. Environmental safety was not covered in this assessment.
For more specific information, please refer to the original text:
SCCS Opinion on Benzophenone - 1 (CAS No. 131-56-6, EC No. 205-029-4) - Public Health
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