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.
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 …
