Ethanol’s potential classification under EU BPR

The European Chemical Agency (ECHA) Biocidal Products Committee (BPC) is due to announce an Opinion on the approval and hazard classification of ethanol at its 24-28 November 2025 meeting. We issued an advisory on this matter a few months ago. Here, we look at how things are progressing and consider potential implications for biocidal products that contain ethanol.

What is the proposed classification of ethanol?

A proposal from the EU’s Biocidal Products Regulation (BPR) Working Group on toxicology states that ethanol should be classified for carcinogenic, mutagenic, or toxic for reproduction (CMR) properties. A BPC Opinion on this proposal has been pending for several years, but there have been noteworthy developments in recent weeks.

On 28 September 2025, ECHA’s Human Health Toxicology Working Group recommended that ethanol should be classified as a Category 1A reproductive toxicant and carcinogen. A decision on mutagenicity is pending. Any of these classifications would result in ethanol being assigned CMR status, so the future for ethanol-based biocidal products is uncertain.

Could biocidal products containing ethanol be banned?

If ethanol is classified for CMR properties, there will be significant repercussions for biocidal products which contain it as an active substance or as a co-formulant.

Classification as a Category 1A reproductive toxicant and carcinogen could result in a de facto ban on the use of ethanol in consumer use biocidal products in the EU. Professional use of biocidal products containing ethanol would need to be authorised by derogation on a country-by-country basis, restricting availability. It is also likely that a change in classification would trigger a domino effect across other industries that use ethanol in non-biocidal applications, such as cosmetics.

Opponents to the proposed classification point out that reference data underpinning the BPR Working Group proposal relates to the hazards of oral consumption of ethanol. However, use cases of BPR Product Types (PT) 1 (human hygiene), 3 (veterinary hygiene), and 4 (feed and food areas) involve dermal or surface application.

Furthermore, many organisations and entities such as AISE, the European detergents and maintenance products industry association, say ethanol-based biocidal products are irreplaceable. ECHA’s public consultation on Candidates for Substitution generated 350 comments, many of which emphasise the essential role ethanol plays in hand sanitisers, surface disinfectants, and antiseptics.

Spotlight on ethanol-based hand sanitisers

Sagentia Regulatory has assessed ten potential alternatives to ethanol identified under BPR in terms of suitability for use in PT1 hand sanitisers. Our assessment encompassed a range of factors, including virucidal efficacy, skin compatibility, cost, availability, and regulatory status.

Several of the substances, such as peracetic acid and phenoxyethanol, are corrosive or irritant and therefore not suitable for use on skin. Others, such as propanols and citric acid, are more skin compatible and have regulatory approval. However, they are less virucidally efficacious and are more expensive. Two substances, lactic acid and hypochlorous acid, may hold promise but would require further development. What’s more, authorisation of products containing these actives would take at least four years, creating a substantial gap in availability if ethanol were not approved.

Our conclusion is that ethanol is irreplaceable as an active substance in PT1 hand sanitisers. No alternative matches it across efficacy, safety, cost-efficiency, availability, and regulatory acceptance, so substitution would compromise infection control and public health.

What can ethanol-based products owners do?

In the wake of the largest pandemic in a century – and given the BPC’s commitment to the protection of human health – it seems unlikely that fundamental biocidal products like personal hand sanitisers would be taken off market. Yet, if the BPC adopts the Opinion that ethanol should be classified for CMR properties, it is possible that this could happen.

To raise awareness and understanding of this matter, AISE has launched a dedicated campaign: Hands Up for Ethanol. A core aim is to encourage interested parties to engage with Members of European Parliament who will have the opportunity to comment on the draft Opinion ahead of the BPC vote in November. For companies wanting to support continued use of ethanol AISE is facilitating a joint statement that it will share with key decision makers.

It is also important to plan for a future where ethanol’s use as an active substance or co-formulant may be more tightly regulated. For some products, such as ethanol-based hand sanitisers, there could be profound implications.

Sagentia Regulatory’s biocides team is closely monitoring this evolving situation. Contact us for expert guidance on how to prepare for the BPC Opinion, whichever way it goes.