SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) - SCCS/1645/22 - Final Version

International audience; SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) - SCCS/1645/22 - Final VersionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (47pages)Mise en ligne 23 Mars 2023 https://health.ec.europa.eu/publications/sccs-sodium-bromothymol-blue-c186-cas-no-34722-90-2-ec-no-252-169-7_enhttps://health.ec.europa.eu/system/files/2023-03/sccs_o_267.pdfDetailsPublication date23 March 2023AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1645/22Adopted on: 21-22 March 2023Conclusion of the opinion: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 of the following reasons:- The Applicant used TTC approach to justify the safety of sodium bromothymol blue, but the SCCS estimate of the SED indicates that it exceeds the TTC threshold for Cramer class III substances.- 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 requirements on essential toxicological endpoints.2. Does the SCCS have any further scientific concerns with regard to the use of Sodium Bromothymol Blue in cosmetic products?While the use of TTC is acceptable to justify the safety of impurities and cosmetic ingredients that are added to a final product at sufficiently low concentrations, it is not acceptable on its own for the substances that ar regulated under the EU Cosmetic Regulation. Additional supporting data from NAMs that are scientifically-accepted for the purpose, and/or other acceptable in vivo data on systemic toxicity, are also required in an overall weight of evidence to assess safety.Keywords:SCCS, scientific opinion, sodium bromothymol blue, C186, hair dye, Regulation 1223/2009, CAS No. 34722-90-2, EC No. 252-169-7Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on sodium bromothymol blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7), preliminary version of 24-25 October 2022, final version of 21-22 March 2023, SCCS/1645/22