In light of increasing concerns over carcinogenic risks, the European Union is considering banning the use of ethanol as an active ingredient in hand sanitizers and other disinfectant products, triggering significant controversy. On October 10, a working group under the European Chemicals Agency (ECHA) issued an internal recommendation classifying ethanol as a hazardous substance that may increase the risk of cancer and suggested it should be replaced in cleaning and other disinfectant products.
The Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA) is scheduled to convene from November 25 to 28 to reach a decision. ECHA has deliberately left room for flexibility, stating that if the expert committee confirms ethanol’s carcinogenicity, it will recommend substitution. However, if specific use scenarios – such as disinfection – can demonstrate safe exposure levels, or if no viable alternatives are available, ethanol may still be approved for use as a biocidal active substance. The Agency has repeatedly emphasized that no final decision has been made at this stage, and further actions will only proceed after the conclusion of the upcoming meeting.
Earlier this year, ECHA launched a public consultation that received approximately 300 responses from stakeholders, the vast majority of whom opposed classifying ethanol as a hazardous substance. Notably, in May this year, the European Centre for Disease Prevention and Control (ECDC) specifically urged national health authorities to prioritize alcohol-based hand disinfection as the primary method for hand hygiene. The apparent contradiction between these positions has led to confusion and concern among industry professionals.
The critical role of ethanol in public health was demonstrated vividly during the COVID-19 pandemic. Ethanol-based hand sanitizers became an essential component of infection prevention strategies, as ethanol is effective in inactivating viruses, bacteria, and fungi. It is widely used in high-risk settings such as hospitals and food production facilities. Moreover, ethanol offers exceptional production flexibility – it can be synthesized from a wide variety of feedstocks. During the pandemic, many breweries were able to rapidly pivot to producing hand sanitizer, a level of adaptability that is not feasible with isopropanol. Converting a brewery into an isopropanol production facility is not practical, which raises concerns that a potential ban on ethanol could lead to supply shortages of disinfectants in emergency situations.
Regarding the carcinogenicity debate, it is important to clarify the classification issued by the World Health Organization (WHO). The International Agency for Research on Cancer (IARC), a specialized agency of the WHO, has classified alcoholic beverages as Group 1 carcinogens. However, this classification pertains specifically to the consumption of alcoholic beverages, which contain additional contaminants, and not to pure ethanol itself. To date, pure ethanol has not been independently classified by IARC. Furthermore, the WHO has explicitly stated that both ethanol and isopropanol are considered safe and effective for hand hygiene purposes.
It is essential to distinguish between the risks associated with ethanol as a disinfectant and those related to its use as an alcoholic beverage. A 75% ethanol solution is considered the gold standard for medical disinfection. It kills microorganisms by denaturing and coagulating their proteins through dehydration. When used correctly, it poses no harm to human health. However, improper use—such as exposure to open flames or excessive inhalation of vapors—can indeed present safety risks. These hazards stem from misuse rather than from the intrinsic properties of ethanol itself.
Should the EU ultimately classify ethanol as a toxic substance, companies may still apply for individual derogations to continue its use in the absence of viable alternatives. However, such exemptions are limited to a maximum of five years and are subject to case-by-case evaluation. This would significantly increase production costs and operational delays for manufacturers, with the burden likely to be passed on to healthcare systems and public health services.
At present, all eyes are on the upcoming ECHA committee meeting in late November. The debate over ethanol’s classification is not merely about the regulatory fate of a single disinfectant – it has far-reaching implications for the global healthcare sector’s infection control infrastructure. For the general public, this may appear to be just another piece of regulatory news. But for healthcare workers and patients who rely on ethanol-based disinfectants to safeguard their health every day, the outcome of this decision warrants close attention.
Regulatory Background
In the European Union, disinfectant products are classified as biocidal products and are primarily regulated under the EU Biocidal Products Regulation (Regulation (EU) No 528/2012, commonly referred to as the EU BPR). This regulation came into force on September 1, 2013. Under the EU BPR, all active substances used in biocidal products must be approved by the European Commission before they can be placed on the EU market. Additionally, any biocidal product containing an approved active substance must obtain product authorisation either at the national level or through EU-wide procedures before it can be marketed.
The BPR also includes a strict prohibition on the approval of substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) Category 1A or 1B for use as active ingredients in biocidal products. This provision aims to ensure a high level of protection for human health and the environment.
About CIRS
CIRS Group is one of the earliest professional technical consulting firms in China specializing in EU Biocidal Products Regulation (BPR) registration. With a wholly owned subsidiary in Europe, we are qualified to act as an EU Representative, providing comprehensive support for EU-level biocidal product registration and regulatory compliance. We have independently completed dozens of Article 95 active substance applications and biocidal product authorizations, all traceable on the ECHA official website. As one of the few Chinese technical service providers with a proven track record under the EU BPR, we welcome your inquiries or visits to learn more about our technical capabilities.
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- EU BPR Article 95 Active Substance Listing Application
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