Tuesday, August 12, 2014News

Quaternary ammonium, Citric acid (and) Silver citrate, Tris-biphenyl triazine: 3 annexes of the Cosmetics Regulation amended

© L'Observatoire des Cosmétiques

Regulation No.866/2014 of 8 August 2014 amends Annexes III (substances subject to restrictions), V (preservatives allowed) and VI (UV filters allowed). Here is the outcome, following various SCCS opinions: one more preservative, and one more UV filter (nano and non-nano) have been added to the positive lists, and new restrictions have been defined for quaternary ammonium compounds.

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This text was slightly modified by a Corrigendum published in the Official Journal of the European Union on 28 August 2014. In Annex III, entries numbers 265 and 266 have been replaced by numbers 286 and 287.

Quaternary ammonium compounds


The substances identified by the denominations alkyl (C12-22) trimethyl ammonium bromide and chloride are regulated as preservatives under entry 44 of Annex V to Regulation (EC) No 1223/2009 with a maximum concentration of 0,1%.

The Scientific Committee on Consumer Products (SCCP), subsequently replaced by the Scientific Committee on Consumer Safety (SCCS), evaluated the safety of alkyl (C16, C18, C22) trimethylammonium chloride (cetrimonium chloride, steartrimonium chloride and behentrimonium chloride) for other uses than as preservatives in 2005, 2007 and 2009.

The SCCS concluded in its opinion of 8 December 2009 that, apart from the fact that quaternary ammonium derivative formulations have the potential to be skin irritants, especially when combinations of the concerned compounds are used, the use of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride does not pose a risk to the health of the consumer in concentrations below certain limits, which are explicitly set out in the SCCS opinion.

In order to take into account the skin …

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