EU Scientific Committee reveals safety of coloring agent HC Blue 18 use in hair dye

09 May 2023 --- EU’s Scientific Committee on Consumer Safety (SCCS) has deemed HC Blue 18 (Colipa No. B122) safe for hair dye use.

The committee advises using the chemical as an ingredient in non-oxidative hair dye formulations up to a maximum on-head concentration of 0.35%.

However, SCCS flags HC Blue 18 as a “moderate sensitizer.”

Purity and safety results
HC Blue 18 is an ingredient in oxidative and non-oxidative hair dye formulations. Oxidative colors need oxidation catalysts or developers that result in a dye after the reaction.

Based on new physicochemical data, SCCS finds that the new commercial batches’ purity has improved – with one impurity detected at 575 nm (impurity 3B).

This impurity was also present in old batches at 0.142%, shares SCCS. The highest concentration of impurity 3B found in new commercial batches was 0.019% – a noticeably lower concentration.

“The SCCS agrees that HC Blue 18 and the impurity 3B belong to Cramer Class III. Read-across and QSAR results indicate that the close analogs are negative for genotoxicity,” shares SCCS.SCCS flags HC Blue 18 as a moderate sensitizer.

“Hence, it can be considered that impurity 3B is not of genotoxicological concern.”

Furthermore, HC Blue 18 is stable in the presence of alkaline peroxide for up to 45 minutes.

Prior submission
Previously in 2014, European Commission services received a dossier from the industry for the safe use of HC Blue 18 in cosmetic products.

In response, SCCS concluded HC Blue 18 (B122) as an ingredient in non-oxidative and oxidative hair dye formulations at a maximum concentration of 0.35% on the head is safe.

However, the purity of HC Blue 18 and its impurities in it were not adequately quantified. The latest opinion considers the purity and impurity of the chemical in a new batch, finding it to show only one impurity at low levels.

Hair dye in news
In related news, SCCS will present its final opinion on the safe use of hair dye Hydroxypropyl p-phenylenediamine and its dihydrochloride salt next month.

Also, the transitional restriction of blue 15:3 and green 7 pigments used in tattoo inks and permanent makeup under the REACH chemicals regulation of the EU ended in February.

Last October, South Korea’s Ministry of Food and Drug Safety added five hair dye chemicals, including o-aminophenol, m-Phenylenediamine HCl, m-Phenylenediamine, Catechol and Pyrogallol, to the list of banned components for cosmetics.

In NPD, L’Oréal Paris introduced the Men Expert One-Twist Hair Color – its first permanent hair color technique was developed for men to cover up gray hair.

By Venya Patel

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