Although it is dated November 25, 2013… it is applicable as from July 11, 2013! This new regulation is part of the outcome of the overall safety assessment strategy for hair dye substances, initiated by the European Union at the beginning of the 2000s. It amends Annex III to Cosmetics Regulation (EC) 1223/2009, which was dedicated to cosmetic ingredients subject to restrictions, and concerns 32 substances, all in all, from maximum concentrations to warnings to be printed on labels.
It all started in 2001 when, following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the then European expert committee (known today as SCCS), considered that "the potential risks of the use of hair dyes were of concern." This opinion led to an overall safety assessment strategy for hair dye substances at the European level, according to which the industry was required to submit files, containing updated scientific data on the safety of hair dye substances.
The first effect of this process was felt in 2006: 22 hair dye components were banned because the industry had failed to present the file providing evidence of their harmlessness in time.
And the SCCS has started to work on the evaluation of the other substances for which files had been submitted.
Regulation 1197/2013 ratifies all the opinions adopted since then by this expert committee, and amends Annex III to Cosmetic Regulation (EC) 1223/2009 to:
• introduce or bring modifications to maximum concentrations authorized in finished cosmetic products,
• impose warnings on labels,
• adapt regulations on substances to the definitions in the Cosmetic Regulation, since the definition of a hair and facial hair …
