SCCS Issued Final Opinion on the Safety of Sodium Bromothymol Blue (C186)

On March 23, 2023, the European Union Scientific Committee on Consumer Safety (SCCS) issued the final safety opinion on sodium bromothymol blue in cosmetics (SCCS/1645/22). The preliminary comments on sodium bromothymol blue were released on October 28, 2022.

The SCCS concludes the following:

1. In light of the data provided, does the SCCS consider Sodium Bromothymol Blue safe when used in non-oxidative hair coloring 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 the Threshold of Toxicological Concern (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 are regulated under the EU Cosmetic Regulation. Additional supporting data from new approach methodologies (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.

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Further Information

SCCS/1645/22：https://health.ec.europa.eu/system/files/2023-03/sccs_o_267.pdf