According to the opinion, published earlier this week, the ingredient HC Red No. 16 (chemical name: N-(2-nitro-4-aminophenyl)-allylamine (B114) can under current regulation be used in both non oxidative and oxidative hair dye formulations with a concentration limit of 1.5 per cent and 0.75 per cent respectively.
However, the committee has concluded after looking at the evidence submitted on a number of endpoints, including acute oral toxicity, skin irritation, skin sensitisation, dermal absorption and genotoxicity, that the ingredient at current use levels poses a risk to the consumer.
“Based on the low margin of safety for the use in both oxidative and non-oxidative hair dye formulations, the SCCS is of the opinion that the use of HC Red n° 16 as a hair dye ingredient up to a final on-head concentration of 0.75% under oxidative and 1.5% under non-oxidative conditions poses a risk to the health of the consumer,” the SCCS wrote in its report.
Ongoing review of hair dye ingredients
The opinion is part of an ongoing review of all hair dye ingredients with the ultimate aim of publishing a positive list of ingredients similar to that for UV filters and preservatives, Emma Meredith form the UK cosmetics trade association the CTPA explained.
While the rest of the ingredients published in this batch have received positive opinions, Meredith said she was disappointed that the HC Red No 16 had received this conclusion.
“Although we don’t know whether this is currently being used in hair dyes, there are obviously some companies who want to use the ingredient and believe it to be safe as the dossier is being supported. These companies will now have time to comment on this opinion,” she told CosmeticsDesign-Europe.com.
Other hair dye ingredients
In addition to the opinion on HC Red No. 16, SCCS published opinions on HC Yellow No.13, HC Red No. 3, HC Red No. 13, and picramic acid/sodium picramate, all used in hair colour preparations.
HC Yellow No.13 was deemed to be safe to use at a maximum concentration of 2.5 per cent, although the committee said it should not be used in the presence of a nitrosating agent.
HC Red No. 3 was deemed safe for use up to concentrations of 3 per cent, but the committee did acknowledge its sensitising potential. Likewise, HC Red No. 13 was also found to be a moderate skin sensitiser but safe for use under 1.25 per cent in oxidative hair dye formulations and 2.5 per cent in non oxidative.
Similarly, picramic acid was found to be safe for use with a maximum concentration of 0.6 per cent.
Comments on all these opinions (which can be found here) are requested before January 28.