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.
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 …
