Monitoring report · published · reflects the rules at that date

SCCS publishes Scientific Advice on the hair dye ingredient HC Blue 18 – Submission II

Our monitoring reports record the changes to cosmetics rules in a given period, and we publish one each month. Each one is a dated publication: it reflects the rules on the date it was published and is not updated afterwards. For what applies today, read the latest briefings or ask us.

See what happens after launch

On May 8, 2023, the Scientific Committee on Consumer Safety (SCCS) published the updated scientific advice on the use of HC Blue 18 (B122) in cosmetics.

Background

The hair dye ‘HC Blue 18’ with the 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 European Commission received a dossier from the industry to support the safe use of ‘HC Blue 18’ in cosmetic products. In its 2015 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. The purity of HC Blue 18 and impurities in it are not adequately quantified’.

What’s new?

With submission II received by the SCCS in October 2022 and in view of the newly provided information on purity, the SCCS concluded that:

  • The use of HC Blue 18 as an ingredient in non-oxidative as well as in oxidative hair dye formulations up to a maximum on-head concentration of 0.35% is safe
  • HC Blue 18 is a moderate sensitiser
  • Only impurity 3B was detected at 575 nm in the test substance, and the assessment results indicated no genotoxic concern.

References:

Scientific Committee on Consumer Safety (SCCS) – Scientific Advice on HC Blue 18 (Colipa No. B122) Submission II, SCCS/1653/23

Need to know what this means for a product you have on the market now?

Ask the team for this area

One question works best. Leave out confidential product details; we can take those up by email.

Our team replies to every question. The reply goes to the email you gave.

We use your email to answer this question and for nothing else. Privacy and cookies

Follow an area

One email when an area publishes, in the language you choose. Nothing else.

Talk to us

Tell us the product, the market and the date you are working to. If the date is not realistic, we will say so.

Need a standing regulatory partner? See ongoing support →