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Monday, July 30, 2012Authorities

2-Hydroxyethyl Picramic Acid: the French ANSM confirms it is safe for use

©CosmeticOBS-L'Observatoire des Cosmétiques

Used as a hair colourant, suspected to be an endocrine disruptor, 2- hydroxyethyl picramic acid has been evaluated by the French National Agency for the Safety of Medicines and cosmetics (ANSM). Its conclusion: when used at the maximum concentrations currently allowed by regulation, this substance has been declared safe for use.

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In the frame of its referral, in 2009, by the Ministry of Health about the risk due to toxic for the reproduction and/or endocrine disruptors cosmetics, the ANSM (then, Afssaps) continues to release on a regular basis its evaluations on the substances that it has identified as such.

This time, the evaluation is on the 2-Hydroxyethyl Picramic Acid, used as an oxidative colourant and as a non-oxidative colourant for hair dyeing.

Background

 2-Hydroxyethyl Picramic Acid (HEP) acid is listed in the 222 entry of the Annex III (substances allowed with restrictions) of the Cosmetics Directive 76/768/CEE. It may be used at 2% maximum, but if used as an oxidative colourant, the maximum concentration applied to the scalp shall not more than 1.5% in the blend.

Further, the regulation requires it does not come in contact with nitrosating agents, and states that using it makes it mandatory to display warnings about its potential allergenic effects.

In the CLP (CE) Regulation nbr 1272/2008 on dangerous substances, it is classified:
• in category 1, H228, as a flammable solid material,
• in category 4, H302, for its acute toxicity, harmful if ingested,
in category 2, H361f, may affect fertility.

The substance has …

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