ECHA BPC Backs Ethanol Approval in Disinfectants under EU Biocidal Products Regulation

Ethanol Approval in Disinfectants: Scope and Scientific Assessment

The Biocidal Products Committee concluded that ethanol may be approved as an active substance for Product-type 1 human hygiene products such as hand disinfectants, Product-type 2 surface disinfectants and algaecides not intended for direct contact with humans or animals, and Product-type 4 products used in food and feed areas.

According to ECHA, safe use has been demonstrated for these applications. However, the Committee did not reach a conclusion on whether ethanol should be classified as carcinogenic or reprotoxic. No new hazard classification has been proposed at this stage.

The Committee cited data gaps as a key reason. Although the applicant's dossier was considered complete, it lacked sufficient dermal exposure data, a critical route for biocidal products. Available inhalation studies were not conducted in line with standard guidelines. In addition, much of the evidence on carcinogenicity and reproductive toxicity relates to voluntary oral consumption of alcoholic beverages, which the Committee deemed inappropriate for assessing biocidal uses.

New studies addressing more relevant exposure routes are underway. The Committee noted that waiting for these data could significantly delay the ethanol approval in disinfectants process.

Regulatory Process and Next Steps

Following adoption of the opinions, ECHA will forward them to the European Commission. The Commission will draft an Implementing Regulation proposing approval or non-approval. EU Member States will then vote in the Standing Committee on Biocidal Products. If supported, the decision becomes legally binding.

If ethanol approval in disinfectants is granted, companies may seek product authorisation at national level or via Union authorisation. If not approved, affected products must be withdrawn from the EU market within defined transition periods.

Implications for Industry Stakeholders

Ethanol is widely used in hand sanitisers, healthcare disinfectants, food processing hygiene and industrial cleaning. Approval would provide greater regulatory certainty for formulators, contract manufacturers, distributors and compliance teams. It may also influence supply chain planning, labelling strategies and safety data sheet updates.

However, the absence of a hazard conclusion means companies should closely monitor future classification discussions. Potential changes to carcinogenic or reproductive toxicity status could trigger downstream impacts under CLP, REACH and workplace safety legislation.

Businesses using ethanol in biocidal products should review their regulatory strategies and prepare for authorisation requirements to avoid disruption once the Commission decision is finalised.

Summary

ECHA's Biocidal Products Committee has backed ethanol approval in disinfectants, advancing the EU biocides process while hazard classification questions remain open. For industry, the decision improves near-term regulatory visibility but keeps a clear need for continued monitoring, authorisation planning and readiness for potential downstream classification changes.