Biocides · Ethanol
Ethanol in disinfectants: preparing for authorisation
ECHA’s positive opinion on ethanol is an important step, but it should not be confused with approval of the active substance or authorisation of an individual disinfectant. Businesses can already review their documentation and plan the next steps.
Status reviewed on 5 November 2026.
What has been adopted?
In February 2026, ECHA’s Biocidal Products Committee (BPC) adopted opinions supporting the approval of ethanol for three product-types: PT 1 – human hygiene; PT 2 – disinfectants and algaecides not intended for direct application to humans or animals; and PT 4 – food and feed area. The Chemicals Office of the Republic of Slovenia also reported this development.
The BPC opinion provides the scientific basis for the European Commission’s decision. On its own, it does not set an approval date or mean that an individual product is authorised. In the ECHA record reviewed for ethanol/PT 4, the procedure is still listed as an initial application for approval under assessment, with no approval start date specified.
Ethanol approval and disinfectant authorisation are separate procedures
Under the BPR, an active substance is approved for a particular product-type, while the product itself requires the appropriate authorisation. Ethanol-based disinfectants covered by transitional provisions may be marketed and used under the applicable national rules. This is not a general exemption for every product containing ethanol: composition, uses, supply chain and product status need to be checked in each country.
If approval is granted, the date and conditions in the implementing act will be important for the transition to product authorisation. For existing products, it is generally necessary to check that the application is submitted by the approval date for the relevant product-type; where several active substances are present, the approval date of the last active substance may be decisive. It is therefore not appropriate to give a single calendar deadline for all ethanol products at this stage.
What can you prepare now?
BiSafe recommends reviewing your product portfolio before starting extensive dossier preparation. For each product, collect:
- the full composition, active substance identities and supplier information;
- intended uses, target organisms, users and countries of sale;
- current national notifications, labels and safety data sheets;
- efficacy reports and other available studies;
- information on access to protected data and any letters of access (LoA).
Using this information, we can assess data gaps, consider individual product or product family options and compare procedures for the target markets. The strategy, scope of work and costs are agreed on the basis of the documentation actually available.
Does the opinion introduce a new hazard classification for ethanol?
No, not on the basis of this opinion. The BPC did not reach a conclusion on ethanol’s carcinogenic or reproductive toxicity properties and did not propose a new classification. The BPR and CLP procedures are separate. A positive opinion should therefore not be presented as evidence of an absence of hazards or as a general approval of all ethanol uses.
Need a plan for your products?
Send us a list of your products, their uses and countries of sale. Through our biocidal product notification and authorisation support, we can identify the next steps. Contact info@bisafe.si.
