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Wednesday, January 13, 2016Regulation

o-Phenylphenol and its salts: the SCCS revises its Opinion

© CosmeticOBS-L'Observatoire des Cosmétiques

On June 25, 2015, the SCCS has adopted an Opinion on the cosmetic ingredients o-Phenylphenol, Sodium o-phenylphenate, and Potassium o-phenylphenate. This Opinion has just been revised, during the plenary meeting of December 15, 2015.

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Background

b-Phenyl-2-ol and its salts, covering o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate, (CAS: 90-43-7, 132-27-4, 13707-65-8) as preservatives are regulated in Annex V, entry 7 of the Cosmetics Regulation 1223/2009 at a maximum concentration of 0.2% (as phenol).
In February 2013, the Commission received a risk assessment submitted by the French Agency ANSM which rose concerns about the use of o-Phenylphenol in cosmetic products. In the ANSM report, o-Phenylphenol was identified as a potential endocrine disruptor.

For exhaustive background information, see the articles
SCCS: 7 requests for scientific Opinions (April 24, 2014).
o-Phenylphenol and its salts: Opinion of the SCCS (July 1, 2015)

Opinion

Note: the conclusion remained unchanged

 1. Does SCCS consider o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate 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 non-cosmetic 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 …

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