The Belgian Federal Public Service has finalised the evaluation of climbazole (EC 253-775-4, CAS 38083-17-9) under the EU’s REACH regulation as of 4 November 2024. The substance, commonly used in cosmetics, was assessed for potential risks, including endocrine disruption and aquatic toxicity.
Key Findings of the Evaluation
Belgium, following an earlier review by the UK, concluded that climbazole poses no immediate consumer or wide-dispersive use concerns at the EU level. However, evidence confirmed its classification as an endocrine disruptor for the environment. It will now undergo harmonised classification and labelling under the EU’s regulatory framework.
Regulatory Outcomes and Recommendations
The evaluation highlighted several regulatory actions:
- Endocrine Disruption: Climbazole meets the criteria for environmental endocrine disruption (ED ENV 1). Effects include disrupted steroidogenesis in aquatic species, impacting reproduction.
- Aquatic Toxicity: Classified as both acute (H400) and chronic (H410) aquatic hazard with a high concern for environmental persistence.
- Consumer and Worker Safety: No significant risks were identified under current cosmetic use concentrations (0.5% as a preservative), indicating sufficient consumer safety measures.
Background and Process
Initially listed in the Community Rolling Action Plan (CoRAP) in 2014, climbazole was selected due to suspected carcinogenic, mutagenic, or reproductive toxicity (CMR), as well as widespread consumer use. The evaluation involved extensive testing, including a Fish Sexual Development Test (OECD TG 234), which confirmed endocrine effects.
Implications for Industry
The regulatory process may lead to a harmonised classification in Annex VI of the CLP Regulation by early 2025. Manufacturers and formulators using climbazole in personal care products must adhere to updated labelling and risk management protocols.
Belgium’s comprehensive evaluation of climbazole underscores the EU’s commitment to safeguarding environmental health while balancing consumer safety. Stakeholders must prepare for forthcoming regulatory updates to ensure compliance.
