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

Date of publication: 08/05/2023

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.

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

Linkedin Instagram Facebook

other REGULATORY UPDATES

UK Responsible Person Labelling Deadline Extension

RESPONSIBLE PERSON

Date of application: 31/12/2025

The UK Office for Product Safety and Standards (OPSS) have reviewed the requirement to label the product with the UK Responsible Person and have decided to extend this transitional provision for a total period of five years, until 31 December 2025.

Read More »
Any REGULATORY QUESTION?
E-mail

Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.

Read More »