Biocidal Products Committee supports proposal to approve ethanol

In February, an important step was taken for the future of hand sanitizers and general ethanol-based disinfectants in the EU.

The Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA) published its latest opinion, supporting the approval of ethanol as an active substance in the following product types:

Product Type 1: Human hygiene products, such as hand disinfectants
Product Type
2: Disinfectants and algaecides not intended for direct contact with humans or animals
Product Type
4: Products used in food and feed areas

With this assessment, the committee reaffirms the fundamental importance of ethanol for a wide range of hygiene‑related applications in healthcare, industry, and everyday life.

According to the BPC, these factors prevented an additional classification:

Although the applicant’s dossier was considered complete, data on dermal exposure – a key exposure route for biocidal products – were missing.
The available inhalation data were not fully performed in line with standard guidelines.
Most evidence regarding potential carcinogenic and reproductive toxic effects of ethanol was based on voluntary alcohol consumption, which is not an appropriate basis for evaluating biocidal uses.

Currently, new studies are being prepared on more relevant exposure routes for the assessment of ethanol. Nevertheless, the waiting period until the study results are presented could significantly slow down the approval process.

Next steps:

After adoption by the BPC, the opinion will be forwarded to the European Commission. The Commission will prepare a draft Implementing Regulation proposing the approval or non‑approval of the active substance. This draft will be submitted to the Standing Committee on Biocidal Products (SCBP) for a vote by the EU Member States. If supported, the Commission will formally adopt the draft decision, making it legally binding.
In parallel, attention is already turning to the next major topic: classification and labelling under the CLP Regulation. New “skin study data” will be included for this purpose.
The responsible Greek authority will submit the corresponding classification proposal by 31 December 2026. This will be decisive in determining whether ethanol will be newly classified in the future – with potential implications for numerous further applications.

Background:

Under the Biocidal Products Regulation, all active substances must be approved before a biocidal product containing them can be authorised. The BPC plays a central role in this process: it issues scientifically grounded opinions on these substances and assesses their safety and efficacy.

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