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 members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson),  J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz 
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1669/24
Adopted on: 25 October 2024

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the classification as ‘Carcinogen Cat. 2’, does the SCCS consider o-Phenylphenol safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off and 0.15 % in leave-on cosmetic products?

In light of the data provided, the SCCS considers o-Phenylphenol safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off and 0.15 % in leave-on cosmetic products. O-Phenylphenol and Sodium o-Phenylphenate, when used together:

• should not exceed the maximum concentration 0.15 % in leave-on cosmetic products.
• should not exceed the maximum concentration 0.2 % in rinse-off cosmetic products.

Since this safety dossier related to dermally applied products only, the SCCS did not consider oral and inhalation routes.

(2)Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of o-Phenylphenol in cosmetic products?

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(3) In light of the data provided and taking under consideration the classification as ‘Carcinogen Cat. 2’ of o-Phenylphenol, does the SCCS consider Sodium o-Phenylphenate safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off and 0.15 % in leave-on cosmetic products?

In light of the data provided, the SCCS consider Sodium o-Phenylphenate safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off and 0.15 % in leave-on cosmetic products. Sodium o-Phenylphenate and o-Phenylphenol, when used together:

• should not exceed the maximum concentration 0.15 % in leave-on cosmetic products.
• should not exceed the maximum concentration 0.2 % in rinse-off cosmetic products.

Since this safety dossier related to dermally applied products only, the SCCS did not consider oral and inhalation routes.

(4) Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of Sodium o-Phenylphenate in cosmetic products?

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(5) Does the SCCS have any further scientific concerns with regard to the use of O-Phenylphenol and Sodium o-Phenylphenate in cosmetic products?

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of O-Phenylphenol and Sodium o-Phenylphenate for the environment.

Keywords:

SCCS, scientific opinion, Biphenyl-2-ol, Sodium 2-biphenylolate, o-Phenylphenol and Sodium o-Phenylphenate, Regulation 1223/2009, CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of ‘Biphenyl-2-ol’ and ‘Sodium 2-biphenylolate’ (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products, preliminary version of 31 July 2024, final version of 25 October 2024, SCCS/1669/24.