# Scientific Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) used in cosmetics products – SCCS/1660/23

Tamara van Haecke, Vera Rogiers, Ulrike Bernauer, Laurent Bodin, Qasim Chaudhry, Pieter Jan Coenraads, Janine Ezendam, Eric Gaffet, Corrado Lodovico Galli, Eirini Panteri, et al.

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Tamara van Haecke, Vera Rogiers, Ulrike Bernauer, Laurent Bodin, Qasim Chaudhry, et al. Scientific Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) used in cosmetics products – SCCS/1660/23. NAM Journal, 2025, 1, pp.100034. 10.1016/j.namjnl.2025.100034. hal-05139048

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Scientific Opinion on Benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) used in cosmetics products – SCCS/1660/23☆

Tamara Van Haecke<sup>a</sup>, Vera Rogiers<sup>a</sup>, Scientific Committee on Consumer Safety - SCCS<sup>*</sup>, SCCS members, Ulrike Bernauer<sup>h</sup>, Laurent Bodin<sup>c</sup>, Qasim Chaudhry<sup>d</sup>, Pieter Jan Coenraads<sup>e</sup>, Janine Ezendam<sup>f</sup>, Eric Gaffet<sup>g</sup>, Corrado L. Galli<sup>b</sup>, Eirini Panteri<sup>i</sup>, Vera Rogiers (rapporteur)<sup>j</sup>, Christophe Rousselle<sup>k</sup>, Maciej Stepnik<sup>l</sup>, Tamara Vanhaecke (rapporteur)<sup>j</sup>, Susan Wijnhoven<sup>m</sup>, Other SCCS experts, Emilio Benfenati<sup>n</sup>, Nicolas Cabaton<sup>o</sup>, Emanuela Corsini<sup>p q</sup>, Aglaia Koutsodimou<sup>q</sup>, Henriqueta Louro<sup>r s</sup>, Wolfgang Uter<sup>s</sup>, Natalie von Goetz<sup>t</sup>

ARTICLE INFO

Keywords:

SCCS
Scientific opinion
Benzophenone – 4
Regulation 1223/2009
(CAS No. 4065-45-6, EC No. 223-772-2)

<footnote><sup>a</sup> Vrije Universiteit Brussels, Brussels, Belgium</footnote>

<footnote><sup>b</sup> Faculty of Pharmaceutical Sciences University of Milan, Italy</footnote>

<footnote><sup>c</sup> Alternative Energies and Atomic Energy Commission (CEA), Saclay, France</footnote>

<footnote><sup>d</sup> Institute of Food Science & Innovation, University of Chester, United Kingdom</footnote>

<footnote><sup>e</sup> University Medical Center Groningen, Groningen, the Netherlands</footnote>

<footnote><sup>f</sup> National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands</footnote>

<footnote><sup>g</sup> Institute Jean Lamour (UMR 7198 CNRS – Université de Lorraine), Nancy, France</footnote>

<footnote><sup>h</sup> Federal Institute for Risk Assessment (BfR), Berlin, Germany</footnote>

<footnote><sup>i</sup> National and Kapodistrian University of Athens, School of Pharmacy, Division of Pharmaceutical Chemistry, Athens, Greece</footnote>

<footnote><sup>j</sup> Vrije Universiteit Brussel (VUB), Brussels, Belgium</footnote>

<footnote><sup>k</sup> French Agency for Food, Environmental and Occupational Health & Safety (ANSES), International and European Affairs Department, France</footnote>

<footnote><sup>l</sup> Qsar Lab Ltd., Gdańsk, Poland</footnote>

<footnote><sup>m</sup> RIVM, Centre for Safety of Substances and Products (VSP), Centre for Substances and Integrated Risk Assessment (SIR), Bilthoven, the Netherlands</footnote>

<footnote><sup>n</sup> Instituto di Ricerche Farmacologiche Mario Negri, Milano, Italy</footnote>

<footnote><sup>o</sup> French National Research Institute for Agriculture, Food and the Environment (INRAE TOXALIM), Toulouse, France</footnote>

<footnote><sup>p</sup> Università degli Studi di Milano, Italy</footnote>

<footnote><sup>q</sup> General Chemical State Laboratory, Greece</footnote>

<footnote><sup>r</sup> National Institute of Health Dr. Ricardo Jorge (INSA), Lisbon, Portugal</footnote>

<footnote><sup>s</sup> University of Erlangen/Nürnberg, Germany</footnote>

<footnote><sup>t</sup> Federal office of Public Health (FOPH), Switzerland</footnote>

<footnote>* Summary of the Opinion</footnote>

<footnote>See abstract</footnote>

<footnote>Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) used in cosmetics products. preliminary version of 14 December 2023, final version of 27 March 2024, SCCS/1660/23</footnote>

<footnote>SCCS Number: SCCS/1660/23
PDF ISSN 1831-4767 ISBN 978-92-68-28877-1
doi:10.2875/2085096 EW-01-25-089-EN-N</footnote>

<footnote>Adopted on: 27 March 2024</footnote>

<footnote>Link to the SCCS Opinion: Benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2) - European Commission</footnote>

<footnote>* Corresponding author at: Directorate General for Health and Food Safety, Unit B3 – Drosbach building, L-2920 Luxembourg.
E-mail address: SANTE-SCCS@ec.europa.eu (Scientific Committee on Consumer Safety - SCCS).</footnote>
## Background on substances with endocrine disrupting properties

On 7 November 2018, the Commission adopted the review1 of Regulation (EC) No 1223/2009 on cosmetic products ('Cosmetics Regulation') regarding substances with endocrine disrupting (ED) properties. The review concluded that the Cosmetics Regulation provides the adequate tools to regulate the use of cosmetic substances that present a potential risk for human health, including when displaying ED properties. The Cosmetics Regulation does not have explicit provisions on EDs. However, it provides a regulatory framework with a view to ensuring a high level of protection of human health. Environmental concerns that substances used in cosmetic products may raise are considered through the application of Regulation (EC) No 1907/2006 ('REACH Regulation'). In the review, the Commission commits to establishing a priority list of potential EDs not already covered by bans or restrictions in the Cosmetics Regulation for their subsequent safety assessment. A priority list of 28 potential EDs in cosmetics was consolidated in early 2019 based on input provided through a stakeholder consultation. The Commission carried out a public call for data in 20192 for 14 substances (Group A)3 and a second call in 20214 for 10 substances (Group B)5 in preparation of the safety assessment of these substances. Benzophenone-4 is one of the above-mentioned substances for which the call for data took place.

### Background on Benzophenone-4

Benzophenone-4 (CAS No. 4065-45-6, EC No. 223-772-2) with the chemical name '2-Hydroxy-4-methoxybenzophenone-5-sulphonic acid' is currently regulated as a UV-filter in sunscreen products in a concentration up to 5 % (Annex VI/22). Benzophenone-4 absorbs UV light across a broad range of UV wavelengths and, therefore, protects the skin from damage by UVB and UVA light. In addition, in the European database for information on cosmetic substances and ingredients (CosIng) Benzophenone-4 is also reported with the functions of 'UV-stabiliser' and UV-absorber' protecting cosmetic formulations against sunlight. Benzophenone-4 has been subject to a safety evaluation by SCCNFP in 19996, where the committee concluded that '...2-Hydroxy-4-methoxybenzophenone-5-sulphonic acid can be used safely in cosmetic sunscreen formulations at a maximum concentration of 5 %, expressed as acid' and proposed '...no further restrictions or conditions for its use in cosmetic products'. During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Benzophenone-4 as UV-filter in cosmetic products. The Commission requests the SCCS to carry out a safety assessment on Benzophenone-4 in view of the information provided.

### Opinion (The SCCS Opinion on benzophenone-4)

The SCCS concludes the following:

1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of benzophenone-4, does the SCCS consider benzophenone-4 safe when used as UV-Filter in cosmetic products up to a maximum concentration of 5 %?

On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties, the SCCS is of the opinion that benzophenone-4 is safe when used as UV filter up to a

maximum concentration of 5 % in sunscreen, face and hand cream, all leave-on and rinse-off products (total dermal aggregate), lipstick, sunscreen propellant spray and pump spray, when used separately or in combination (based on deterministic aggregated exposure).

2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of benzophenone-4 in cosmetic products?

Any additional use of benzophenone-4, such as protectant for stabilising cosmetic formulations when exposed to light, should remain within the concentration mentioned above (i.e. 5 %), including the use as UV-filter.

3. Does the SCCS have any further scientific concerns with regard to the use of benzophenone-4 in cosmetic products?

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of benzophenone-4 for the environment.

## CRediT authorship contribution statement

Tamara Van Haecke: Writing – review & editing. Vera Rogiers: Writing – review & editing. Ulrike Bernauer: Writing – review & editing. Laurent Bodin: Writing – review & editing. Qasim Chaudhry: Writing – review & editing. Pieter Jan Coenraads: Writing – review & editing. Janine Ezendam: Writing – review & editing. Eric Gaffet: Writing – review & editing. Corrado L. Galli: Writing – review & editing. Eirini Panteri: Writing – review & editing. Vera Rogiers (rapporteur): Writing – review & editing. Christophe Rousselle: Writing – review & editing. Maciej Stepnik: Writing – review & editing. Tamara Vanhaecke (rapporteur): Writing – review & editing. Susan Wijnhoven: Writing – review & editing. Emilio Benfenati: Writing – review & editing. Nicolas Cabaton: Writing – review & editing. Emanuela Corsini: Writing – review & editing. Aglaia Koutsodimou: Writing – review & editing. Henriqueta Louro: Writing – review & editing. Wolfgang Uter: Writing – review & editing. Natalie von Goetz: Writing – review & editing.

## Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

## Data availability

The data that has been used is confidential.

## Reference

The SCCS Opinion on benzophenone-4 (CAS No. 4065-45-6, EC No. 223-772-2) Used in Cosmetics Products - SCCS/1660/23, May Be Read in Full On the Website of the European Commission's Independent Scientific Committees: Benzophenone-4 (CAS No. 4065-45-6, EC No. 223-772-2) - European Commission. https://health.ec.europa.eu/publications/benzophenone-4-cas-no-4065-45-6-ec-no-223-772-2_en.