Background
HC Yellow 16, with the chemical name ‘2-chloro-4-[(1E)-(1-8 methyl-1H-pyrazol-5-yl)diazenyl]-phenol’ (CAS No. 1184721-10-5, EC No. -), is used as an ingredient in oxidative and non-oxidative hair dye formulations.
In 2015, the European Commission received a dossier from industry to assess the safe use of ‘HC Yellow 16’ in cosmetic products. In its previous opinion (SCCS/1568/15), the SCCS concluded that the use of HC Yellow No. 16 (B123) as an ingredient was safe at 1% in oxidative hair dye formulations and at 1.5% in non-oxidative hair dye formulations.
Additionally, the SCCS stated that “The purity of HC Yellow No. 16 and impurities in it are not adequately quantified. Data on purity and impurities of HC Yellow No. 16 (B123) should be provided, together with purity specifications of the substance intended for use in cosmetic products”.
With the current submission, the goal was to assess the safety of ‘HC Yellow 16’ in view of the newly provided information on its purity, when used as an ingredient at the concentrations previously considered safe (1% in oxidative hair dye formulations and at 1.5% in non-oxidative hair dye formulations).
What’s new?
To ensure consistency of the data in respect to the old batches, the applicant provided additional high-performance liquid chromatography (HPLC) data to demonstrate the improvement in quality for the new commercial batches. The SCCS agrees that the purity of the new commercial batches has been improved.
In the light of the information provided, the SCCS considers that the use of HC Yellow No. 16 (B123)
as an ingredient at 1% in oxidative hair dye formulations and at 1.5% in non-oxidative hair dye formulations is safe, considering the specifications of the new commercial batches as described in the opinion.
The preliminary opinion is open for comments until September 27, 2024.
