Tuesday, June 5, 2018SCCS

Climbazole: Request for an addendum to the SCCS' Opinion

Drapeau Commission européenne - Climbazole

The safety of Climbazole, a preservative also used as an anti-dandruff agent will be re-assessed by the SCCS. The request from the European Commission was published on May 25, 2018. The Scientific Committee has until June 2018 to give its Opinion.

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Background

The cosmetic ingredient Climbazole (CAS 38083-17-9), with the chemical name 1-(4-chlorophenoxy)-1-imidazol-1-yl-3,3-dimethyl-2-butanone, is currently regulated in the Cosmetics Regulation (EC) 1223/2009 as a preservative in Annex V, entry 32, up to a maximum authorized concentration of 0.5%.

Climbazole has been subject to different safety evaluations by the SCCP in 2005 (SCCP/0918/05) and 2009 (SCCP/1204/08) and by the SCCS in 2013 (SCCS/1506/13) and SCCS/1500/13).

In October 2017 the SCCS adopted an addendum (SCCS/1590/17) to the opinion of Climbazole (P64) ref. SCCS/1506/13 that concludes:
‘The maximum concentrations of Climbazole considered as safe for human health under an aggregate exposure scenario are as follows: 2% as anti-dandruff agent in rinse-off shampoos and 0.2% as cosmetic preservative in leave -on formulations (face cream, hair lotion, foot care) with the exception of cosmetics applied on a full body area (body lotion).’

Following the SCCS opinion, a discussion was held at the Working Group on Cosmetic Products on 28 February 2018 with a view to a COM proposal for a draft Regulation on Climbazole as preservative and as an anti-dandruff in rinse-off shampoos. During this discussion, Cosmetics Europe highlighted that Climbazole should also be safe for use as a preservative in rinse-off shampoos at …

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