Climbazole, also chemically known as (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 per cent for use in certain cosmetics.
Back in 2009, the Scientific Committee on Consumer Products put forward a working document to restrict the use of the preservative, while the EU member States declared their concerns about how safe it was, and asked the Commission to confer with the EMA on the issue.
The Commission subsequently consulted the EMA and the CHMP/EMA Innovation Task Force (ITF) concluded that, in its scientific opinion "the use of climbazole in cosmetics may increase the risk of cross-resistance to other azole antifungals, and that the greatest concern was the possible effect of microbiota on the human skin and the possibility for development of cross-resistance for other azole antifungals."
Therefore ruling that; “The use of Climbazole in hair and face cosmetics at 0.5 per cent did not pose a risk to the health of the consumer." But that "in leave-on products other than those mentioned above, is not considered safe.”
Now, three years on, the EC has called on the SCCS to determine whether the preservative is still considered safe to be used in cosmetic products, and if so, if any aspects need to be revised on the basis of the EMA dossier, whilst also establishing if there is any further scientific concern.
Kept busy
The Committee has, in recent months been called to work on numerous scientific opinions in areas like hair dye ingredients and fragrance allergens.
Last month, it identified potential allergenic ingredients and suggested concentration limits for some of them to protect consumers, while also identifying 26 ingredients already outlined by the SCCNFP, an additional 30 individual chemicals and 26 natural extracts.
While back in June, the advisory body looked into Tetrabromophenol Blue, used in hair dyes, as posing a risk to consumers and suggested that a maximum on-head concentration of 0.2 per cent in non-oxidative formulations did not pose a risk to the health of the consumer due to the low Margin of Safety.