On 4 December 2024, the European Chemicals Agency (ECHA) announced the publication of the conclusions of the evaluation of Climbazole (preservite and anti-dandruff agent) carried out by Belgium as part of the Community Rolling Action Plan (CoRAP). This could lead to the substance being classified as an endocrine disruptor.
1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (CAS No.38083-17-9, EC No.253-775-4, INCI: Climbazole) is listed in the CosIng with the functions: Anti-seborrheic, Antimicrobial, Preservative).
The substance is regulated by European Cosmetics Regulation 1223/2009 and is listed in Annex III/310 (for a use other than preservative, use limited to rinse-off anti-dandruff shampoos with a maximum concentration of 2.0%) and in Annex V/32 (as a preservative, limited to 0.2% in hair lotions, face creams and foot care products, and to 0.5% in rinse-off shampoos).
It is not currently listed in Annex VI of the European CLP Regulation 1272/2008.
It was included in CoRAP for several reasons for concern:
• Suspected CMR
• Consumer use
• Wide dispersive use
During the evaluation the following additional concern was identified:
• Endocrine disruption (environment)
Following an initial evaluation carried out by the United Kingdom, Belgium closed the file in November 2024, with the following conclusions.
• Suspected CMR
Concern removed (clarification of hazard/exposure). Based on the available data on Climbazole, it does not fulfil the classification criteria for reproductive toxicity.
No need for regulatory follow-up at EU level.
• Wide dispersive use
Concern confirmed.
Data demonstrate the wide dispersive use: use in cosmetics and personal care products.
No need for regulatory …
