Addendum to the opinion SCCS/1506/13 on climbazole : Cosmetics Europe: P64

Climbazole, with the chemical name 1-(4-chlorophenoxy)-1-imidazol-1-yl-3,3-dimethyl-2- butanone, is currently regulated in the Cosmetics Directive as a preservative in Annex VI, entry 32, with a maximum authorized concentration of 0.5%. In 2005, the SCCP adopted a scientific opinion (SCCP/0918/05) on climbazole in which the SCCP recommended a complete re-evaluation of the safety of this compound. In 2009, the SCCP adopted a scientific opinion (SCCP/1204/08) on climbazole with the following conclusion: Question 1: Does the SCCP consider with the scientific data provided that climbazole is safe for the consumers, when used as a preservative in cosmetic products up to a maximum concentration of 0.5%? The SCCP is of the opinion 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. Question 2: Does the SCCP consider with the scientific data provided that climbazole is safe for the consumers, when used for non-preservative purposes as an antidandruff active ingredient in hair care formulations up to a maximum concentration of 2.0% in rinse-off products? The SCCP is of the opinion that the 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. Question 3: Does the SCCP consider with the new scientific data provided that climbazole is safe for the consumers, when used for non-preservative purposes as an anti-aging ingredient in leave-on products up to a maximum concentration of 0.5%, even though this application might already be covered by Question 1? The SCCP is of the opinion that 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. The inhalation exposure to climbazole from spray products was not assessed in this opinion. Based on the above opinion, the Commission prepared a draft Cosmetic Directive to implement the restriction, which was submitted to a public consultation. The current mandate is the consequence of that consultation as a company applied to extend the group of face and hair products with the foot care products in which climbazole could be safely used as a preservative in a concentration up to 0.5%