Following the mandate given by the European Commission to the SCCS in March 2022, the Scientific Committee has just published its preliminary Opinion on the safety of Sodium Bromothymol Blue (C186), a hair dye ingredient. It was adopted at the plenary meeting on 24-25 October 2022, and is open for comments until 23 December 2022.
Background
The ingredient with the INCI name “Sodium Bromothymol Blue” CAS No.34722-90-2, EC No.252-169-7) is a weak acid in solution and thus exists in ionized and non-ionized forms that result in the appearance of different colours. Sodium Bromothymol Blue is intended to be used as a hair dye in non-oxidative hair colouring products with a final on-head concentration up to 0.5%.
For an exhaustive background information, see the article
• Sodium Bromothymol Blue: request for Opinion to the SCCS, CosmeticOBS, 21 March 2022
Opinion
1. In light of the data provided, does the SCCS consider Sodium Bromothymol Blue, safe when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5 %?
Having considered the data provided, the SCCS is of the opinion that the safety of Sodium Bromothymol Blue cannot be assessed because:
• The Applicant used TTC approach to justify the safety of sodium bromothymol blue, whereas the SCCS estimated the SED to exceed the TTC threshold for Cramer class III substances (section 3.5)
• The use of TTC on its own to justify the safety of the substances that are regulated under the EU Cosmetic Regulation is not sufficient to waive the information …