Two hair dye ingredients are undergoing safety assessment by the SCCS, HC Yellow 16 (B123) and HC Red 18 (B124 or FPK 245). The European Commission has just published these two Opinion requests, and the Scientific Committee accepted these mandates on 24 March 2024.
B123
Background
The ingredient with the INCI name “HC Yellow 16” and chemical name “2-chloro-4-[(1E)-(1-methyl-1H-pyrazol-5-yl)diazenyl]-phenol” (CAS No.1184721-10-5, EC No.-) may be used as an ingredient in oxidative and non-oxidative hair dye formulations.
In 2015, the Commission services received a dossier from industry to support the safe use of “HC Yellow 16” in cosmetic products. In its corresponding opinion (SCCS/1568/15), the SCCS concluded 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.”
In addition, 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 (i.e., submission II), received in February 2024, the applicant requests to assess the safety of “HC Yellow 16” in view of the newly provided information on its purity, when used as an ingredient at 1% in oxidative hair dye formulations and at 1.5% in nonoxidative hair dye formulations.
Questions to SCCS
(1) In light of the data provided, does the …
