EU Notifies Draft Ethanol Biocide Approval With 2028 Start Date

Draft Ethanol Biocide Approval Reaches WTO Consultation

The European Union has notified a draft Commission Implementing Regulation that would approve ethanol as an active substance under Regulation (EU) No 528/2012, the Biocidal Products Regulation. World Trade Organization notification G/TBT/N/EU/1237 covers product-type 1 human-hygiene biocides, product-type 2 disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4 food and feed-area disinfectants.

This is not yet an approval. The notification gives 23 November 2026 as the comment deadline and February 2027 as the proposed adoption date. The draft regulation would enter into force 20 days after publication, but the active-substance approval period would run separately from 1 May 2028 to 30 April 2038.

The notified annex identifies ethanol as EC number 200-578-6 and Chemical Abstracts Service number 64-17-5. It sets the minimum evaluated purity at 92.6% by weight, equivalent to 95.1% by volume. That figure describes the active substance assessed for approval. Different purity is possible if technical equivalence is demonstrated. The figure is not a universal minimum concentration for every disinfectant product.

Ethanol Biocide Approval Would Carry Product-Specific Conditions

For all three product types, authorisation assessments would need to examine exposures, risks and efficacy for uses included in a product application but not addressed by the Union-level active-substance assessment. Product-types 2 and 4 would require particular attention to exposure of toddlers.

For product-types 2 and 4, competent authorities, or the Commission for Union authorisations, would specify relevant instructions and precautions for labels of treated articles containing ethanol. A person placing a treated article on the market would also need to ensure that its label provides the information required by Article 58(3), second subparagraph, of the Biocidal Products Regulation.

What remains unchanged is the need for a separate product authorisation. Active-substance approval would not automatically authorise every ethanol disinfectant, use pattern or claim. Product-authorisation applications and transitional arrangements remain subject to the applicable BPR provisions, including Article 89(3).

The Commission draft follows February opinions from the European Chemicals Agency's Biocidal Products Committee. Foresight reported that scientific step at the time. The Committee supported approval but could not conclude on carcinogenic or reproductive-toxicity properties because available evidence did not adequately address relevant dermal and inhalation exposure. The draft does not settle those classification questions.