New SCCS Opinions published in June 2025

During the plenary meeting held on 26 June 2025, the Scientific Committee on Consumer Safety (SCCS) adopted several documents, namely three final opinions on the safety of the UV filters Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB – S83), Benzophenone-2 (BP-2), and Benzophenone-5 (BP-5), one final opinion on the safety of the nanomaterial and approved of a new mandate for a scientific opinion on Heliotropin.

The SCCS is a Scientific Committee providing providing opinions on health and safety risks of non-food consumer products – including cosmetics. These Opinions inform the policies and proposals implemented by the European Commission.

Below is a summary of the conclusions from each opinion.

SCCS Scientific Advice on the Safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB – S83, CAS 302776-68-7)

The SCCS concluded that, considering the health concerns associated with DnHexP, a maximum safe level of 0.026% (260 ppm) of DnHexP in DHHB is acceptable when DHHB is used at concentrations up to 10% in cosmetic products – provided that DnHexP is an unavoidable impurity.

Data showed that DnHexP levels were below the detection limit in several sunscreen products containing DHHB when a specific manufacturing process was used. Furthermore, evidence indicates that it is technically feasible to reduce DnHexP levels in DHHB down to 1 ppm. Given the existence of such manufacturing methods, the SCCS recommends that 1 ppm should be the target maximum level of DnHexP as an impurity in DHHB.

DHHB is currently listed in Annex VI of the EU Cosmetics Regulation as an approved UV filter at a maximum concentration of 10% in finished products.

SCCS Scientific Advice on Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5)

The SCCS assessed the safety of BP-2 and BP-5 due to concerns regarding their potential endocrine-disrupting properties.

Benzophenone-2 (BP-2)

After reviewing all available data, the SCCS concluded that it could not establish the safety of BP-2 due to the inability to exclude genotoxic potential and limited data on repeated-dose toxicity and reproductive toxicity. Additionally, evidence showed that BP-2 is an endocrine-active substance.

Consequently, the SCCS considers that the use of BP-2 in cosmetic products may pose a risk to consumers.

BP-2 is currently not among the UV filters permitted for use in cosmetics in the European Union.

Benzophenone-5 (BP-5)

Due to limited specific data on BP-5, the SCCS used a read-across approach based on its structural analogue, Benzophenone-4 (BP-4). Taking into account the toxicological data for BP-4, including potential endocrine effects, the SCCS concluded that BP-5 is considered 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. This assessment is based on deterministic aggregated exposure of BP-4.

BP-5 is currently permitted in the European Union as a UV filter in cosmetic products at a maximum concentration of 5% (as acid).

SCCS Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS 5466-77-3 / 83834-59-7)

The Committee found evidence of EHMC being an endocrine-active substance due to estrogenic activity and weak anti-androgenic activity, both in vitro and in vivo.

Despite these findings, the SCCS concluded that EHMC is safe for use as a UV filter at concentrations up to 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination.

Moreover, due to the high Margin of Safety, the Committed concluded that EHMC-containing products are also considered safe for use in children.

EHMC is currently included in the list of approved UV filters under the EU Cosmetics Regulation at a maximum concentration of 10% in finished products.

SCCS Scientific Opinion on Hydroxyapatite (nano)

Based on the available evidence indicating that hydroxyapatite (nano) does not pose mutagenic, cytotoxic, or inflammatory hazards – even when tested at high concentrations in buccal mucosa cell models – the SCCS has assessed hydroxyapatite (nano) as safe for use at concentrations up to 29.5% in toothpaste and up to 10% in mouthwash.

However, this safety evaluation applies only to hydroxyapatite (nano) that meet the following specific characteristics:

Composed of rod-shaped particles, with at least 87% (by particle number) having aspect ratios equal to or less than 3, and the remaining 13% not exceeding an aspect ratio of 9;
The particles are not coated or surface-modified;
The maximum length of the hydroxyapatite nanoparticles, as referenced in the Opinion, is 122 ± 43 nm.

Currently, hydroxyapatite (nano) is listed under entry 372 of Annex III of the EU Cosmetics Regulation, with concentration limits of 10% for toothpaste and 0.465% for mouthwash. However, the characteristics specified in the Regulation differ from those outlined in the latest SCCS opinion. Specifically, the Regulation refers to hydroxyapatite (nano) with the following characteristics:

Composed of rod-shaped particles, with at least 95.8% (by particle number) having an aspect ratio less than 3, and the remaining 4.2% with an aspect ratio not exceeding 4.9;
The particles must not be coated or surface-modified.

Request for a Scientific Opinion on Heliotropin (CAS No. 120-57-0)

During the plenary meeting, the SCCS accepted a mandate to assess the safety of Heliotropin, a substance commonly used as a fragrance in cosmetic products.

As part of this evaluation, the SCCS will examine whether Heliotropin can be considered safe when used in fine fragrances intended for adults, only at concentrations up to 1.8%. This request has been initiate due the potential classification of Heliotropin as a reproductive toxicant (Repr. 1B) under Regulation (EC) No 1272/2008 (CLP Regulation) and the conditions laid out in Article 15(2)(d) of Regulation (EC) No 1223/2009.

In addition, the Committee will determine what maximum concentration of Heliotropin can be regarded as safe for use in cosmetic products.

Heliotropin is currently not listed in any of the Annexes of the EU Cosmetics Regulation.

The agenda of the June Plenary meeting also included the mandate for a scientific opinion on the safety of Synthetic Amorphous Silica (nano). The document has not been officially published yet.

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