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Monday, April 17, 2017European Commission

o-Phenylphenol and its salts: Consultation by the European Commission

© CosmeticOBS-L'Observatoire des Cosmétiques

On 11 April 2017, the European Commission has launched a public consultation on its proposal to make regulations evolve as regard the cosmetic ingredients o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate and MEA o-phenylphenate, with new restrictions and bans. This consultation will remain open until July 7, 2017.

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This consultation concern 'any interested parties, including authorities of the EU countries, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers' associations. '

Background

Potassium o-phenylphenate, MEA o-phenylphenate are currently regulated as preservatives in Annex V, entry 7, of Regulation (EC) No. 1223/2009 on cosmetic products ("CosmeticsRegulation") at a maximum concentration of 0.2% (as phenol).
The Cosmetics Regulation also regulates Monoalkylamines, monoalkanolamines and their salts – which includes the ingredient MEA o-phenylphenate – in Annex III, entry 61, at a maximum concentration in ready for use preparation of 0.5% as maximum secondary amine content.

In February 2013, the Commission received a risk assessment submitted by the French Agency ANSM (Agence nationale de sécurité des médicaments et des produits de santé), raising concerns about the use of o-Phenylphenol as a preservative in cosmetic products.
In the context of the ANSM report, o-Phenylphenol was identified as likely to be an endocrine disruptor. The report concluded that the maximum authorised concentration of o-Phenylphenol for use as a preservative should be revised due to its low margin of safety.

In January 2014, in response to a call for data on o-Phenylphenol by the Commission , industry submitted a safety …

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