Revision of the opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate

SCCS members: U. Bernauer, Q. Chaudhry, P. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, S. C. Rastogi, Ch. Rousselle, Ja. van Benthem
External experts: A. Bernard, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova,E. Panteri, T. Vanhaecke
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1555/15
Adopted on: 25 June 2015

Conclusion of the opinion:

1.Does SCCS consider o-Phenylphenol, Sodium o-phenylphenate, Potassium ophenylphenate safe for use as preservatives with a maximum concentration of 0.2 % (as o-phenylphenol), taking into account the information provided?

o-Phenylphenol as preservative with a maximum concentration of 0.2 % in leave-on cosmetic products is not safe. Also, in view of further exposures including noncosmetic uses (see Anses, 2014), the maximum concentration of o-Phenylphenol in leave-on cosmetic products should be lowered. However, the proposed maximum use concentration of up to 0.15% by the applicant can be considered safe.

The use of o-Phenylphenol as preservative with a maximum concentration of 0.2 % in rinse-off cosmetic products is considered safe.

Based on the information provided, no conclusions of safe use can be drawn for Sodium o-phenylphenate and Potassium o-phenylphenate.

2.Does the SCCS have any further scientific concerns with regard to the use of o- Phenylphenol, in particular on its potential endocrine disruptor properties as raised in the ANSM report?

In vitro data indicate an absent or very weak binding affinity of OPP to the oestrogen receptor, in line with limited stimulation of proliferation in oestrogen responsive cells. No information is available on androgenic and anti-androgenic effects of OPP in vitro. Agonistic or antagonistic effects on thyroid hormones were not observed with OPP. There might be a potential of injury to the vision system attributable to OPP.

Aggregate exposure to OPP should be considered.

Keywords:

SCCS, scientific opinion, o-Phenylphenol, Sodium o-phenylphenate, Potassium ophenylphenate, Regulation 1223/2009, CAS 90-43-7, 132-27-4, 13707-65-8, EC 201-993- 5, 205-055-6, 237-243-9

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on o- Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate, 25 June 2015, SCCS/1555/15.