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Monday, February 20, 2023SCCS

HC Blue 18: new request for Opinion to the SCCS

HC Blue 18 : nouvelle demande d'Opinion au CSSC

Following the submission of new data by industry on the purity of the substance, the European Commission has requested the SCCS to re-evaluate the safety of the hair dye ingredient HC Blue 18 (B122). The Scientific Committee on Consumer Safety accepted this mandate by written procedure on 10 February 2023 and has three months to deliver its Scientific Opinion.

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Background

The ingredient with the INCI name “HC Blue 18” and chemical name “3-[(E)-(3-chloro-4-hydroxyphenyl)diazenyl]-2,1-benzisothiazole-5-sulfonamide (CAS No.1166834-57-6/852356-91-3, EC No.-/-) is used as an ingredient in oxidative and non-oxidative hair dye formulations.
In 2014, the Commission services received a dossier from industry to support the safe use of”HC Blue 18” in cosmetic products. In its corresponding Opinion (SCCS/1560/15), the SCCS concluded that “the use of HC Blue 18 (B122) as an ingredient in non-oxidative as well as in oxidative hair dye formulations at a maximum concentration of 0.35% on the head is safe.” In addition, the SCCS stated that “the purity of HC Blue 18 and impurities in it are not adequately quantified. Details on impurities will be submitted at a later date by the applicant”.
With the current submission (i.e., submission II), received in October 2022, the applicant requests to assess the safety of “HC Blue 18” in view of the newly provided information on its purity, when used as an ingredient in non-oxidative as well as in oxidative hair dye formulations at a maximum concentration of 0.35% on the head.

Questions to SCCS

1. In light of the data provided, does the SCCS consider HC Blue 18, safe when …

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