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SCCS Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6)– SCCS/1669/24

Bernauer, Ulrike
; 
Bodin, Laurent
; 
Chaudhry, Qasim
; 
Coenraads, Pieter Jan
; 
Ezendam, Janine
; 
Gaffet, Eric
; 
Galli, Corrado L.
; 
Panteri, Eirini
; 
Rogiers, Vera
; 
Rousselle, Christophe
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Federal Institute for Risk Assessment (BfR), Berlin; Alternative Energies and Atomic Energy Commission (CEA), France; University of Chester; University Medical Center Groningen; National Institute for Public Health and the Environment (RIVM), The Netherlands; Institute Jean Lamour, Université de Lorraine; University of Milan; National and Kapodistrian University of Athens; Centre for Substances and Integrated Risk Assessment (SIR), The Netherlands; Vrije Universiteit Brussel; French Agency for Food, Environmental and Occupational Health & Safety (ANSES); Qsar Lab Ltd; Medical University of Łódź; Instituto di Ricerche Farmacologiche Mario Negri; French National Research Institute for Agriculture, Food and the Environment; Università degli Studi di Milano; General Chemical State Laboratory, Greece; National Institute of Health, Lisbon; University of Erlangen/Nürnberg; Federal office of Public Health (FOPH), Switzerland
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2025-06-04
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Allied Health
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Abstract
‘Biphenyl-2-ol’ and ‘Sodium 2-biphenylolate’ (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) are known with the INCI names ‘o-Phenylphenol’ and Sodium ‘o-Phenylphenate’, respectively, as cosmetic ingredients. The use of o-Phenylphenol as a preservative is currently authorised in entry 7 of Annex V to the Cosmetics Regulation (EC) No.1223/2009, with a maximum concentration of 0.15 % (as phenol) in leave-on and 0.2 % (as phenol) in rinse-off cosmetic products. The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on o-Phenylphenol (OPP), Sodium o-Phenylphenate (SOPP), and Potassium o-Phenylphenate (POPP) (SCCS/1555/15) in June 2015, later revised on 15 December 2015, with the following conclusion: ‘Based on the information provided, no conclusions of safe use can be drawn for Sodium o-Phenylphenate and Potassium o-Phenylphenate’. In 2018, the SCCS released an addendum to the above scientific opinion, specifically addressing Sodium o-Phenylphenate, Potassium o-Phenylphenate, and MEA o-Phenylphenate. The SCCS concluded that ‘Due to the lack of relevant information, the SCCS is unable to answer the question regarding the safe use level of sodium-OPP, potassium-OPP, and MEA-OPP. In the SCCS's view, a direct comparison between the safety of o-Phenylphenate (OPP) and its three compounds cannot be made’. The conclusions of this opinion resulted in amending entry 7 of Annex V to the Cosmetics Regulation, removing from the list the previously authorised OPP salts. It should be noted that o-Phenylphenol, Sodium and Potassium o-Phenylphenate are active ingredients in broad-spectrum fungicides surface biocides. Under EU biocidal Regulation (EU) 528/2012, o-Phenylphenol has been evaluated for the different product types (PTs) such as PT 1, PT 2, PT4, PT 6 as a preservative ranging from 0.1 to 0.5 % w/w. The European Risk Assessment Committee (RAC) of ECHA issued in December 2022 an opinion recommending among others a classification for o-Phenylphenol as ‘Carcinogen of Category 2’. Following the RAC opinion, the European Commission may propose a classification for o-Phenylphenol as a ‘Carc.2’ (CLP Regulation Annex VI entry). According to Article 15(1) of the Cosmetics Regulation ‘the use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products’. In view of these provisions, regulatory measures must be adopted by the Commission services within 15 months of the classification as CMR 1A or 1B of the substance(s) concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008. In December 2023, the Commission services received a dossier to defend the safe use of o-Phenylphenol, as well as its sodium salt (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) as preservatives in cosmetic products according to Article 15(1) of the Cosmetics Regulation 1223/2009. The Commission, therefore, requests the SCCS to carry out a safety assessment on these ingredients in view of the information provided.
Citation
Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Ezendam, J., Gaffet, E., Galli, C.L., Panteri, E., Rogiers, V., Rousselle, C., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfenati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., & von Goetz, N. (2025). SCCS Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6)–SCCS/1669/24. NAM Journal, 1, article-number 100035. https://doi.org/10.1016/j.namjnl.2025.100035
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Elsevier
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NAM Journal
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http://hdl.handle.net/10034/629517
DOI
10.1016/j.namjnl.2025.100035
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Article
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Corrigendum to this article was published on 14th October 2025 and can be accessed here: https://www.sciencedirect.com/science/article/pii/S3050620425000545.
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3050-6204
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https://www.sciencedirect.com/science/article/pii/S3050620425000302