Is Climbazole safe for use? Is the possible induction of antimicrobial cross-resistance to other antimicrobials, especially those used in medicinal products, consistent with the use of this preservative in cosmetic products? The question was asked to the SCCS. An opinion is waited for soon.
The text of the request
Climbazole, with the chemical name 1-(4-chlorophenoxy)-1-imidazol-1-yl-3,3-dimethyl-2-butanone (CAS: 38083-17-9), is currently regulated in the Cosmetics Directive as a preservative in Annex VI, entry 32, with a maximum authorized concentration of 0.5%.
In opinion SCCP/1204/08, adopted on 21 February 2009, the SCCP concluded that:
• The use of Climbazole as a preservative at a maximum concentration of 0.5% in all cosmetic products cannot be considered safe. However, when used as a preservative in hair cosmetics and face cosmetics at 0.5%, Climbazole does not pose a risk to the health of the consumer”;
• The (non-preservative) use of Climbazole in rinse-off hair cosmetics up to a maximum concentration of 2.0% does not pose a risk to the health of the consumer”;
• The non-preservative use of Climbazole in hair cosmetics and face cosmetics at 0.5% does not pose a risk to the health of the consumer. The use of Climbazole at 0.5% in leave-on products other than those mentioned above, however, is not considered safe.
In this opinion, the SCCP also remarked that no specific information regarding the potential development of (cross-) resistance had been provided.
A working document proposing to restrict the use of Climbazole as suggested …