EU Notifies Draft Ethanol Biocide Approval With 2028 Start Date

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. It should not be presented as a universal minimum concentration for every authorised 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.

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. Current transitional rules and existing national authorisations continue until the draft completes the legal process and the relevant approval and product-authorisation provisions take effect.

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.

Manufacturers and authorisation holders should compare their technical-grade ethanol, uses, exposure scenarios and treated-article instructions with the notified annex. Treated-article suppliers should map where ethanol is incorporated and review Article 58 information flows. Organisations with material evidence can submit comments through the WTO channel by 23 November.

Foresight analysis: the delayed 2028 approval date creates preparation time, but the unresolved hazard assessment and separate product-authorisation process prevent businesses from treating the proposal as ten years of unconditional market certainty.

Practical call to action: Review active-substance sourcing, product dossiers and treated-article labels against the annex, and submit evidence before 23 November 2026 where a condition is impracticable or incomplete.