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EU Weighs Reclassifying Ethanol, Key Sanitiser Ingredient, as Hazardous Over Cancer and Reproductive Risk Concerns

The EU’s potential reclassification of ethanol highlights deep tensions between chemical safety and essential hygiene practices.

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The European Union is evaluating whether ethanol, a critical ingredient in many hand sanitisers and cleaning products, should be reclassified as a hazardous substance due to potential links with cancer and reproductive risks.

An internal recommendation by a European Chemicals Agency (ECHA) working group, dated 10 October 2025, flagged ethanol as potentially carcinogenic and toxic to reproduction, pushing for its replacement in cleaning and disinfecting products.

The ECHA Biocidal Products Committee will review this in late November, with the European Commission expected to make a final ruling by the end of 2026 or 2027. This move is stirring significant debate among health experts, industry bodies, and policymakers about balancing chemical safety with maintaining essential hygiene standards.

Ethanol: Essential Disinfectant Under Scrutiny

Ethanol has been the backbone of infection control measures worldwide, especially during the COVID-19 pandemic, widely used in hand sanitisers, hospital disinfectants, and food processing surfaces. The substance is praised for its effectiveness in neutralising bacteria, viruses, and fungi.

However, the ECHA’s October recommendation reflects concerns from toxicological studies mainly derived from alcohol consumption data, which linked ethanol exposure to increased cancer risk and reproductive harm.

Specifically, the working group proposed stricter hazard classifications for ethanol, including reproductive toxicity, organ damage upon prolonged exposure, and possible effects on lactation-classifications that go well beyond its current status as a flammable liquid under EU regulations.

An ECHA spokesperson emphasized that the final decision has yet to be taken, with a scientific review and public consultation process ongoing, including a scheduled Biocidal Products Committee meeting from 25 to 28 November 2025. There is also recognition that ethanol’s toxicological profile in oral intake (via alcoholic beverages) differs significantly from its use in topical applications like sanitizers, where exposure levels are substantially lower and regulated.

Nonetheless, if classified as carcinogenic and toxic to reproduction, ethanol’s approval for many consumer and industrial products could face tough restrictions or substitutions unless suitable alternatives are proven safe and effective.

Industry and Political Reactions: Challenging the Science

Industry groups, including the Association for the International Support of Ethanol (A.I.S.E.), have strongly criticised the ECHA’s approach, arguing that the proposed classification conflates health risks associated with drinking alcohol with the safe, controlled use of ethanol in biocidal products. A.I.S.E. points out that denaturation processes prevent ingestion of ethanol-containing products, mitigating abuse risks.

Moreover, the organisation warns that reclassification could disrupt supply chains and create severe economic impacts across sectors including healthcare, food safety, and consumer products.

The European Parliament has also expressed concern over the potential implications. In a resolution proposed in September 2025, Parliamentarians called for a clear distinction between ethanol’s oral consumption risks and its use in disinfectants. They urged comprehensive socio-economic impact assessments before any regulatory measures are implemented.

Member states like Hungary have raised alarms about how ethanol policy changes could threaten rural economies reliant on bioethanol production, a significant facet of agricultural exports and renewable energy initiatives.

Public health experts remain divided. Many acknowledge the need for caution regarding chemical exposures but stress that banning or severely restricting ethanol without sufficient alternatives could undermine hygiene practices in hospitals and public spaces.

The World Health Organization continues to list alcohol-based hand rubs as essential medicines, underscoring their vital role in infection prevention globally.

Regulatory Path Forward and Broader Implications

The regulatory review of ethanol is linked to the EU’s Biocidal Products Regulation and Classification, Labelling and Packaging (CLP) Regulation frameworks. Ethanol’s current classification under CLP lists it as a Category 2 flammable liquid, but the ECHA is proposing adding classifications for eye irritation, reproductive toxicity, specific target organ toxicity, and narcotic effects, based on new toxicological evidence.

The decision-making timeline has been extended, with the final classification expected by December 2026 or early 2027 due to requests for additional data on dermal absorption and exposure risks. If ethanol is designated as a carcinogen and reprotoxic agent, uses in sanitising products may be restricted unless derogations are granted.

This could pressure industries to find alternatives, though few are as effective, widely available, and economically viable as ethanol.

Beyond disinfectants, a reclassification would also impact ethanol’s use in other sectors, including cosmetics, medical devices, and biofuels. The EU’s FuelEU Maritime Regulation and bioethanol sustainability policies are being contested partly due to these regulatory shifts, highlighting the complex intersection of public health, environmental sustainability, and economic interests.

The Logical Indian’s Perspective

The EU’s initiative to reassess ethanol’s risks is grounded in a duty to protect public health, reflecting an appropriate precautionary principle. However, The Logical Indian emphasises that such regulatory decisions must be based on balanced, context-sensitive science-the mode of exposure, dose, and real-world use scenarios cannot be ignored.

Ethanol’s unparalleled utility in infection control and public health cannot be understated, especially in vulnerable environments such as hospitals and food industries.

This evolving case calls for increased transparency, ongoing dialogue among scientists, regulators, industry, and the public, and adaptive policies that support innovation in safer alternatives while not destabilising current hygiene standards.

Responsible regulation should aim not just to mitigate risks but also to sustain essential social goods like health security and economic livelihoods.

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