Ethanol is a key active substance in biocidal products, particularly disinfectants used on skin and surfaces. However, its regulatory status within the European Union (EU) has remained uncertain for several years. Despite the evaluation of this substance having begun some time ago, it is still incomplete, and upcoming decisions could significantly alter its conditions of use in the healthcare, hygiene, or chemical sectors. This article provides an update on regulatory developments regarding biocidal ethanol, identifying the risks, potential consequences, and the measures that should be taken today.
What is the current status of ethanol biocide’s regulatory evaluation?
Ethanol, identified by CAS number 64-17-5, is currently under evaluation for product types 1, 2, and 4 under the Biocidal Products Regulation (BPR – Regulation (EU) No 528/2012). The reporting Member State responsible for the dossier is Greece. In March 2024, the Greek authorities submitted a revised version of the evaluation report, which is currently under public consultation on the ECHA website. This consultation was open until April 28, 2025. As of now, the official approval date of the substance remains unknown. The Biocidal Products Committee (BPC) is continuing to develop its scientific opinion, which will be decisive in whether ethanol is approved as an active substance.
Towards CMR classification: What would this mean for biocidal ethanol?
One of the key issues in the evaluation is the classification of ethanol as a CMR substance – carcinogenic, mutagenic, or toxic to reproduction. As early as July 2020, Greece proposed classifying ethanol as a Category 2 reproductive toxicant. However, discussions are ongoing, and a stricter classification (Category 1A or 1B) is still under consideration. Such a development would have significant implications for its market authorization and use.
If classified as a CMR substance, ethanol use would be heavily restricted in non-professional applications. Use in hospital settings, especially for skin disinfectants, could also be jeopardized. EU regulations stipulate that CMR-classified active substances can only be approved under very strict conditions: their use must pose negligible risk under realistic conditions, or be proven essential to human or animal health, or environmental protection. Moreover, the societal impact of a refusal to approve the substance must be judged as disproportionate to the risks involved. These requirements are detailed in Articles 5.2 and 19.5 of the BPR.
What are the consequences for industries using biocidal ethanol?
Ethanol is used extensively across many industrial sectors. If classified as a CMR substance, the consequences would be considerable. In the detergent sector, for instance, manufacturers would have to demonstrate no risk or implement technical measures to drastically reduce user exposure. This would often require process adaptations, equipment requalification, or changes in usage instructions.
Beyond technical challenges, the logistical, economic, and regulatory consequences could also be severe. CMR classification would force many companies to thoroughly revise their supply chains, assess new suppliers, or reformulate their products. The hospital sector, where ethanol plays a key role in preventing healthcare-associated infections, would be directly impacted by any restrictions on its use.
Are there viable alternatives to biocidal ethanol?
In such an uncertain context, the question of alternatives naturally arises. Several active substances are already approved at the European level and can, in some cases, replace ethanol. Isopropanol and n-propanol, for example, are known to be effective against enveloped viruses. Other substances like lactic acid, chlorhexidine digluconate, or quaternary ammonium compounds are used for skin or surface disinfection.
However, ethanol cannot be replaced identically. Each alternative comes with its own properties, formulation constraints, regulatory requirements, and toxicological profiles. Before any substitution, it is essential to evaluate the substance’s compliance with BPR, its efficacy, cost, and compatibility with targeted materials and uses.
How can manufacturers anticipate regulatory changes affecting biocidal ethanol?
Given the uncertainty, it is essential to prepare a proactive regulatory strategy. The first step is to assess the current state of available and missing data on ethanol within the company’s products. Evaluating the potential impact of a CMR classification helps measure the risks in terms of compliance, safety, and commercial viability.
EcoMundo offers full support on this issue! Contact us today for a free, no-obligation discussion about your specific situation or consult our Biocides services.
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Ethanol is a key active substance in biocidal products, particularly disinfectants used on skin and surfaces. However, its regulatory status within the European Union (EU) has remained uncertain for several years. Despite the evaluation of this substance having begun some time ago, it is still incomplete, and upcoming decisions could significantly alter its conditions of use in the healthcare, hygiene, or chemical sectors. This article provides an update on regulatory developments regarding biocidal ethanol, identifying the risks, potential consequences, and the measures that should be taken today.
What is the current status of ethanol biocide’s regulatory evaluation?
Ethanol, identified by CAS number 64-17-5, is currently under evaluation for product types 1, 2, and 4 under the Biocidal Products Regulation (BPR – Regulation (EU) No 528/2012). The reporting Member State responsible for the dossier is Greece. In March 2024, the Greek authorities submitted a revised version of the evaluation report, which is currently under public consultation on the ECHA website. This consultation was open until April 28, 2025. As of now, the official approval date of the substance remains unknown. The Biocidal Products Committee (BPC) is continuing to develop its scientific opinion, which will be decisive in whether ethanol is approved as an active substance.
Towards CMR classification: What would this mean for biocidal ethanol?
One of the key issues in the evaluation is the classification of ethanol as a CMR substance – carcinogenic, mutagenic, or toxic to reproduction. As early as July 2020, Greece proposed classifying ethanol as a Category 2 reproductive toxicant. However, discussions are ongoing, and a stricter classification (Category 1A or 1B) is still under consideration. Such a development would have significant implications for its market authorization and use.
If classified as a CMR substance, ethanol use would be heavily restricted in non-professional applications. Use in hospital settings, especially for skin disinfectants, could also be jeopardized. EU regulations stipulate that CMR-classified active substances can only be approved under very strict conditions: their use must pose negligible risk under realistic conditions, or be proven essential to human or animal health, or environmental protection. Moreover, the societal impact of a refusal to approve the substance must be judged as disproportionate to the risks involved. These requirements are detailed in Articles 5.2 and 19.5 of the BPR.
What are the consequences for industries using biocidal ethanol?
Ethanol is used extensively across many industrial sectors. If classified as a CMR substance, the consequences would be considerable. In the detergent sector, for instance, manufacturers would have to demonstrate no risk or implement technical measures to drastically reduce user exposure. This would often require process adaptations, equipment requalification, or changes in usage instructions.
Beyond technical challenges, the logistical, economic, and regulatory consequences could also be severe. CMR classification would force many companies to thoroughly revise their supply chains, assess new suppliers, or reformulate their products. The hospital sector, where ethanol plays a key role in preventing healthcare-associated infections, would be directly impacted by any restrictions on its use.
Are there viable alternatives to biocidal ethanol?
In such an uncertain context, the question of alternatives naturally arises. Several active substances are already approved at the European level and can, in some cases, replace ethanol. Isopropanol and n-propanol, for example, are known to be effective against enveloped viruses. Other substances like lactic acid, chlorhexidine digluconate, or quaternary ammonium compounds are used for skin or surface disinfection.
However, ethanol cannot be replaced identically. Each alternative comes with its own properties, formulation constraints, regulatory requirements, and toxicological profiles. Before any substitution, it is essential to evaluate the substance’s compliance with BPR, its efficacy, cost, and compatibility with targeted materials and uses.
How can manufacturers anticipate regulatory changes affecting biocidal ethanol?
Given the uncertainty, it is essential to prepare a proactive regulatory strategy. The first step is to assess the current state of available and missing data on ethanol within the company’s products. Evaluating the potential impact of a CMR classification helps measure the risks in terms of compliance, safety, and commercial viability.
EcoMundo offers full support on this issue! Contact us today for a free, no-obligation discussion about your specific situation or consult our Biocides services.
