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Monday, November 21, 2016Regulation

European Commission calls for data on salts of o-Phenylphenol

© CosmeticOBS-L'Observatoire des Cosmétiques

On November 11th, 2016, the European Commission published a call for data on salts of o-Phenylphenol (Sodium o-phenylphenate, Potassium o-phenylphenate and MEA o-phenylphenate) in the framework of Regulation (EC) 1223/2009. In 2015, the SCCS was in the opinion that no conclusions of safe use could be drawn for Sodium o-phenylphenate and Potassium o-phenylphenate.

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This call for data targets any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumer associations.

Background

Salts of o-Phenylphenol, namely Sodium o-phenylphenate (CAS: 132-27-4), Potassium o‑phenylphenate (CAS: 13707-65-8) and MEA o-phenylphenate (CAS: 84145-04-0) are listed in Annex V, entry 7, of Regulation (EC) No 1223/2009 on cosmetic products as preservatives, together with o‑Phenylphenol, authorised up to a maximum concentration of 0.2% (as phenol) in the finished cosmetic product. MEA o-phenylphenate is also regulated under Annex III, entry 61, on 'Monoalkylamines, monoalkanolamines and their salts'.

In 2013, the Commission published a call for data on o‑Phenylphenol to collect available data for risk assessment by the Scientific Committee on Consumer Safety (SCCS) following concerns expressed by French authorities over the safety of the substance at the current maximum authorised concentration of 0.2% for its use as a preservative in cosmetic products.

This additional call for data is aimed at retrieving existing data for the safety assessment of the other three substances covered by entry 7 of Annex V used as preservatives. Due to the possible uses of salts of o-Phenylphenol in cosmetic products other than as preservative, this …

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