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Monday, December 9, 2024ECHA

Climbazole: conclusions of the CoRAP evaluation

Climbazole : les conclusions de l'évaluation CoRAP

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.

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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 …

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