Following the Opinion of SCCS on preservatives o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate, Member States raised specific concerns as regards the safety of Sodium o-phenylphenate, Potassium o-phenylphenate and MEA o-phenylphenate. The European Commission thus requested an addendum to the first Opinion to SCCS. The mandate was published on 26 February 2018.
Background
Biphenyl-2-ol and its salts, covering o-Phenylphenol (OPP), Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-phenylphenate (CAS No. 90-43-7, 132-27-4, 13707-65-8, 84145-04-0) as preservatives are regulated in Annex V, entry 7 of the Cosmetics Regulation (EC) No.1223/2009 at a maximum concentration of 0.2% (as phenol).
The substance MEA o-phenylphenate is also regulated through entry 61 of Annex III on Monoalkylamines, monoalkanolamines and their salts which are restricted for use in cosmetic products to a maximum secondary amine content of 0.5% in ready for use preparation.
The SCCS Committee adopted an Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate (
SCCS/1555/15
) in June 2015, later revised on
15 December 2015
, with the following conclusion:
'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 non-cosmetic uses, 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 …
