The safety of the cosmetic ingredient Climbazole will be assessed again by the SCCS. The request from the European Commission, linked with new margin of safety data and a proposition to reduce the current maximum authorized concentrations, for a use as preservative or as anti-dandruff agent, was published on June 28, 2017.
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 particular, in the opinions of 2009 and later in 2013, the experts assessed the combined use of Climbazole in different cosmetic product categories as preservative at concentration up to 0.5% in leave-on cosmetics and as antidandruff in rinse-off hair products up to a maximum concentration of 2%. Margin of Safety (MoS) values were calculated for each product type and then combined to assess the safety of Climbazole for use in different product types (i.e. shampoo, hair lotion, face cream, foot care).
The SCCS concluded in 2013 that the separate use or combined use of 2 of the above products, all containing Climbazole at the maximum requested concentration, does not pose a risk to the health of consumers.
However, the two combinations of 3 products that include both hair lotion as well as foot care …
