▪︎ Biocidal Products Ordinance
Ethanol under the Biocidal Products Regulation:
EU Commission Signals Support for Approval
After years of discussion about potential health risks and the regulatory status of the substance, an important decision is now on the horizon at the European level:
The European Commission has announced its intention to approve ethanol for certain biocide applications.
Another Regulatory Milestone for Ethanol
Through an implementing regulation notified to the World Trade Organization (WTO) on September 24, 2026, the European Commission has clearly expressed its support for the approval of ethanol under the Biocidal Products Regulation (BPR). The proposed approval covers the use of ethanol in human hygiene disinfectants, surface disinfectants, and applications in the food and feed sector, corresponding to Product Types 1, 2, and 4.
According to the current draft, the approval period would run from May 1, 2028, to April 30, 2038. In doing so, the Commission is following the recommendation of the European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC), which had already issued a favorable opinion in February 2026.
The draft regulation provides for a standard active substance approval without additional restrictions. At the same time, it specifies that competent authorities must pay particular attention to potential exposure scenarios, risks, and efficacy aspects when evaluating individual biocidal products, where such considerations have not already been fully addressed during the active substance assessment.
Controversy Surrounding Hazard Assessment
The path to this decision has been marked by intensive scientific and political debate. At the center of the discussion was the question of whether ethanol could fall under the exclusion criteria of the Biocidal Products Regulation due to potential carcinogenic or reproductive toxicity properties.
In 2024, BPC working groups concluded that ethanol could potentially warrant classification as a Category 1A or 1B carcinogen and reproductive toxicant. Such a classification would have had significant regulatory implications, as it would generally preclude a standard approval under the BPR.
However, the Biocidal Products Committee ultimately reached a different conclusion. In its opinion, the Committee stated that it was not possible to draw definitive conclusions regarding carcinogenicity or reproductive toxicity in the context of biocidal uses. A key factor in this assessment was the view that the available evidence is derived predominantly from studies on the consumption of alcoholic beverages. These data were considered unsuitable as a basis for assessing biocidal applications, where exposure occurs primarily through dermal contact and inhalation. On this basis, the Committee recommended approval of the active substance.
The Next Decision Awaits
The final decision now rests with the representatives of the Member States in the Standing Committee on Biocidal Products (SCBP). Nevertheless, the Commission’s current position significantly increases the likelihood of a positive outcome.
Should the Committee endorse the proposal, the Commission plans to formally adopt the implementing regulation in February 2027. The regulation would then enter into force 20 days after its publication in the Official Journal of the European Union.
In addition, interested stakeholders may still submit comments on the proposal through the WTO notification procedure until November 23, 2026.
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